WO2024062221A1

WO2024062221A1 - A catheter

Info

Publication number: WO2024062221A1
Application number: PCT/GB2023/052405
Authority: WO
Inventors: Daniel Allen; Oliver PFLEGER
Original assignee: Convatec Limited
Priority date: 2022-09-20
Filing date: 2023-09-18
Publication date: 2024-03-28

Abstract

This disclosure provides a catheter comprising: an elongate main body having an insertion end for insertion into a urethra, an outlet end, and an external flushing portion extending between the insertion end and the outlet end. The external flushing portion comprises a plurality of cords extending longitudinally between the insertion end and the outlet end, and a plurality of cross-members connecting the plurality of cords together. The plurality of cords and the plurality of cross-members together define an open lattice through which fluid may flow from the insertion end and externally from the main body of the catheter.

Description

A Catheter

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 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 male catheter having a wire mesh support structure which allows urine to contact the urethra.

CN203507296U describes a catheter comprising a medicine-pouring pipe and a water injection pipe connected by contiguous blocks spaced at intervals. DE3202713A1 describes a catheter which, in one embodiment, comprises a solid, flexible core surrounded by an outer guide part in its peripheral area made of a liquid-permeable web or braid of metal, textile or plastic threads.

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 broad aspect, a catheter comprising an elongate main body having an insertion end for insertion into a urethra and an outlet end.

An external flushing portion may extend between the insertion end and the outlet end. The external flushing portion may comprise a plurality of cords extending longitudinally between the insertion end and the outlet end, and a plurality of crossmembers connecting the plurality of cords together.

The plurality of cords and the plurality of cross-members may together define an open lattice through which fluid may flow from the insertion end and externally from the main body of the catheter.

Providing an open lattice allows a flow of urine to contact the wall of the urethra in use, thereby flushing the urethra in use. Advantageously, a lattice structure may provide a relatively large amount of open 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.

The external flushing portion may comprise a lattice structure forming a plurality of openings through which fluid may flow from the lattice structure externally from the main body.

Accordingly, one embodiment of the invention provides a catheter comprising: an elongate main body having an insertion end for insertion into a urethra, an outlet end, and an external flushing portion extending between the insertion end and the outlet end, wherein the external flushing portion comprises a plurality of cords extending longitudinally between the insertion end and the outlet end, and a plurality of crossmembers connecting the plurality of cords together, wherein the plurality of cords and the plurality of cross-members together define an open lattice through which fluid may flow from the insertion end and externally from the main body of the catheter.

In a first aspect of the invention there is provided an intermittent urinary catheter comprising: an elongate main body having an insertion end for insertion into a urethra, an outlet end, and an external flushing portion extending between the insertion end and the outlet end, wherein the external flushing portion comprises a plurality of cords extending longitudinally between the insertion end and the outlet end, and a plurality of cross-members connecting the plurality of cords together, wherein the plurality of cords and the plurality of cross-members together define an open lattice through which fluid may flow from the insertion end and externally from the main body of the catheter.

The external flushing portion may comprise a three-dimensional structure formed from a plurality of longitudinal members extending longitudinally between the insertion end and the outlet end. The external flushing portion may further comprise a plurality of cross-members connecting the plurality of longitudinal members together. The longitudinal members and the cross-members may be arranged to form a plurality of openings through which fluid may flow externally from the main body. The three- dimensional structure may be configured to contact the urethra and support the urethra in an open state when the catheter is in use.

The cross-members may be evenly distributed along the external flushing portion. Each cord of the plurality of cords may be connected to another cord of the plurality of cords by at least one cross-member of the plurality of cross-members.

The catheter may comprise at least three cords. The catheter may comprise four cords. The plurality of cords may together define a spine of the external flushing portion.

The lattice may define a fluid passageway from the insertion end to the outlet end. The fluid passageway of the lattice may have a polygonal or circular cross-section.

The lattice may be shaped and configured to support the urethra in an open state when in use.

A majority of the lattice may be open to the outside of the main body of the catheter. More than 80% of the lattice may be open to the outside of the main body. More than 90% of the lattice may be open to the outside of the main body. One or more of the plurality of cords may extend longitudinally and parallel to the longitudinal axis of the main body.

Accordingly, in one embodiment there is provided an intermittent urinary catheter comprising an elongate main body having an insertion end for insertion into a urethra, an outlet end, and an external flushing portion extending between the insertion end and the outlet end, wherein the external flushing portion comprises a plurality of cords extending longitudinally between the insertion end and the outlet end, and a plurality of cross-members connecting the plurality of cords together, wherein the plurality of cords and the plurality of cross-members together define an open lattice through which fluid may flow from the insertion end and externally from the main body of the catheter, and wherein one or more of the plurality of cords may extend longitudinally and parallel to the longitudinal axis of the main body.

At least one cross-member of the plurality of cross-members may extend diagonally between two cords of the plurality of cords. At least one of the plurality of cross-members may extend into the fluid passageway. One or each of the plurality of cross-members may be connected to another of the plurality of cross-members.

One or more cords of the plurality of cords may comprise a single continuous piece. One or more cords of the plurality of cords may comprise multiple components joined together to form a single piece.

At least one cord of the plurality of cords may extend the entire length of the external flushing portion. At least one of the cords may extend longitudinally with respect to the longitudinal axis of the main body. At least one of the cords may be straight.

One or more cross-members may be curved. One or more cross-members may be arranged to extend perpendicularly to the longitudinal axis of the main body.

Accordingly, in one embodiment there is provided an intermittent urinary catheter comprising an elongate main body having an insertion end for insertion into a urethra, an outlet end, and an external flushing portion extending between the insertion end and the outlet end, wherein the external flushing portion comprises a plurality of cords extending longitudinally between the insertion end and the outlet end, and a plurality of cross-members connecting the plurality of cords together, wherein the plurality of cords and the plurality of cross-members together define an open lattice through which fluid may flow from the insertion end and externally from the main body of the catheter, and wherein one or more cross members are arranged to extend perpendicularly to the longitudinal axis of the main body.

The external flushing portion may be configured, in use, to provide fluid communication between the catheter and the urethra via openings formed by the lattice of the external flushing portion.

The external flushing portion may be formed as one continuous piece. The external flushing portion may comprise multiple component pieces joined together to form the lattice structure.

The insertion end may comprise an insertion portion having a solid tubular wall 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 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 external flushing portion via an inlet lumen allows for urine to be efficiently drained from the bladder to the external flushing portion for wetting of the urethra.

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

The outermost surfaces of the insertion portion, cords, and outlet portion may be substantially aligned. The outermost surface of the cords may be convex with a curvature substantially equivalent to the curvature of the outer surfaces of the insertion portion and outlet portion, respectively. The insertion portion, outlet portion and external flushing portion may be formed as a singular piece. The insertion portion, outlet portion and external flushing portion may be formed as separate component pieces that are attached together.

The radially outermost surface of two diametrically opposed cords may define an outside diameter of the catheter. The outside diameter may be constant along the length of the catheter. Hence, the overall width of the catheter may be constant along the length thereof.

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

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, since the elongate channels, which may be referred to as inlet channels, function to receive a flow of urine in a range of insertion positions, the elongate open channels generally make the insertion position of the catheter less critical.

Providing an elongate open channel in an external surface at the insertion end of the catheter together with one or more eyelets formed in a wall of the insertion portion and in fluid communication with the external flushing portion via an inlet lumen allows for a more complete emptying of the bladder and flushing of the urethra via the external flushing portion. Additionally, providing more than one flow route for urine from the bladder provides a fail-safe in the event one of the flow routes becomes blocked.

The elongate open channel and external flushing portion may be arranged to allow wetting of the urethra along the full length of the urethra.

The elongate open channel may terminate at a junction between the insertion portion and the external flushing portion and be open to the external flushing portion at the junction.

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.

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 outlet end may comprise an outlet portion having a solid tubular wall defining an outlet lumen in fluid communication with the external flushing portion. Hence, the outlet portion may not comprise any apertures such that the flow of urine is contained within the outlet portion. The outlet lumen may terminate in an outlet 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 external flushing portion.

The insertion portion, external flushing portion, and outlet portion may be made from different material and/or have different rigidity. The insertion portion may comprise a softer material than the external flushing portion. The external flushing portion may comprise plastic. The external flushing portion may comprise high density polyethylene (HDPE). The insertion portion may comprise thermoplastic elastomer material (TPE).

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. Most of the length of the catheter may comprise the external flushing portion. The flushing portion may be longer than the outlet portion. The external flushing portion may comprise more than 60% of the length of the catheter. The external flushing portion may comprise more than 70% of the length of the catheter. The external flushing portion may comprise between 60% and 80% of the length of the catheter, preferably 70%. The catheter may be a male urinary catheter or a female urinary catheter. The catheter may be a permanent or intermittent catheter. In a preferred embodiment, the catheter is an intermittent catheter, preferably an intermittent female 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^A2 and 22mm^A2, preferably 15mm^A2.

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.

For a female catheter, the length of the catheter may be between 150mm and 180mm, preferably 160mm. For a male catheter, the length of the catheter may be between 360mm and 420mm, preferably 405mm.

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

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 end for insertion into a urethra and an outlet end, and an external flushing portion extending between the insertion end and the outlet end, the external flushing portion comprising an open lattice through which fluid may flow from the insertion end and externally from the main body of the catheter, the outlet end comprising an outlet portion defining an outlet lumen for the outflow of fluid from the catheter, wherein the external flushing portion is in fluid communication with the outlet lumen, 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 via the open lattice of the external flushing portion. The outlet portion may be partially inserted into the urethra such that the opening to the outlet lumen is fully located inside the urethra.

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 cross sectional view of the insertion portion and part of the external flushing portion of the catheter shown in Figure 1;

Figure 3 shows a perspective view of the insertion end of the catheter shown in Figure 1;

Figure 4 shows a perspective view of the outlet end of the catheter shown in Figure 1;

Figure 5 shows a first side view of the urinary catheter shown in Figure 1;

Figure 6 shows a second side view of the urinary catheter shown in Figure 1 ;

Figure 7 shows a third side view in cross section of the urinary catheter shown in Figure 1 ;

Figure 8 shows a side view of a schematic representation of the catheter of Figure 1 with a funnel provided at the outlet end; and,

Figure 9 shows a cross section view of the catheter shown in Figure 8.

Detailed Description of the Invention

In the following detailed description, numerous specific details are set forth 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. However, it will be appreciated that the inventive concepts and features described herein may be applied to indwelling urinary catheters and may be applied to male or female catheters whether intermittent or indwelling.

Figures 1 to 7 show various features, some optional, of an exemplary urinary catheter 1. The catheter 1 comprises an elongate main body 2 comprising an insertion portion 3 at an insertion end 4, an outlet portion 5 at an outlet end 6, and an external flushing portion 7 extending between the insertion potion 3 and the outlet portion 5.

The external flushing portion 7 comprises a plurality of substantially straight, solid cords 8 extending longitudinally between the insertion portion 3 and the outlet portion 5, and a plurality of solid cross-members 9 substantially evenly distributed along the length of the external flushing portion 7 and connecting the cords 8 together. The cords 8 and cross-members 9 together define a 3 -dimensional framework or lattice structure which is shaped and configured to contact the walls of the urethra in use and support the urethra in an open state for the passage of urine therethrough.

The cords 8 are substantially equally circumferentially spaced apart around the main body 2 and arranged to form the outer boundaries of the external flushing portion 7. The cords 8 form a spine of the external flushing portion 7 and together with the cross-members 9 define an internal passageway 10 through which urine may flow from the insertion portion 3 to the outlet portion 5. The cross-members 9 extend between the cords 8 through the internal passageway 10 to hold the cords 8 together in the substantially equally spaced apart arrangement. It will be appreciated that one or more cords may additionally extend longitudinally within the outer boundaries of the external flushing portion 7 for added rigidity. For example, an additional cord (not shown) may extend longitudinally along the central axis of the main body 2 from the insertion portion 3 to the outlet portion 5 and be connected to one or more outer cords 8 via the cross-members 9.

A space or opening 11 is formed between each pair of adjacent cords 8 along the full length of the external flushing portion 7. In the present embodiment, the external flushing portion 7 comprises four cords 8 such that four straight, longitudinal openings 11 are formed between adjacent cords 8 along the full length of the external flushing portion 7. The openings 11 enable fluid communication between the external flushing portion 7 and exterior of the main body 2 and urethral wall in use. Advantageously, four continuous openings 11 extending along the full length of the external flushing portion 7 create a relatively large open area, thereby allowing a large proportion of the urethra wall to come into fluid communication with the internal passageway 10. Accordingly, a majority of the external flushing portion 7 may be open to the urethra, preferably greater than 80%, and more preferably greater than 90%. The continuous, unobstructed openings 11 also enable an improved flow rate along the urethra from the insertion end 4 to the outlet end 6.

Each cord 8 has a substantially rectangular cross-section having a radial depth which extends from the outer surface to the inner surface. The width of the cords 8 may be determined based on a required strength and/or to provide the required surface area for the openings 11 and/or retention of the catheter 1 in the urethra when in use. It will be appreciated that the cords 8 may have any suitable cross-section to provide the required strength and/or surface area. For example, the cords 8 may have a circular cross-section and, thus, the distance between the outer surface and the inner surface of a cord 8 would be determined by the cord diameter, which will be driven by the outer diameter required for each catheter size. Although the cords 8 are described as extending straight in the longitudinal direction, this is not a limitation, and one or more cords 8 may be spiral in some embodiments.

In the present embodiment, the external flushing portion 7 comprises six crossmembers 9 evenly distributed along the length of the external flushing portion 7. Each cross-member 9 comprises a central body 12 and four arms 13 each extending from the central body 12 to a corresponding cord 8 to brace the cords 8 together in the desired spaced-apart arrangement. It will be appreciated that the cross-members 9 may take any form and be provided in any number necessary to adequately perform the function of connecting the cords 8 and holding them together in a rigid manner. For example, a cross-member 9 could be a singular piece extending between two cords 8 and may be curved or straight. A cross-member 9 may extend diagonally between two cords 8 or substantially perpendicularly to the longitudinal axis 100 of the main body 2. A crossmember 8 may comprise a ring extending around the circumference of the catheter 1 and connecting the cords 8 together. The cross-members 9 need not be of the same form and could be provided in a combination of different shapes, positions, sizes, and orientations. The cross-members 9 may extend between two adjacent cords 8 or traverse the internal passageway 10 between non-adjacent cords 8.

It will be appreciated that the described configuration of cords 8 and crossmembers 9 is not a limitation and there may be fewer or more cords 8 and/or crossmembers 9. The cords 8 and cross-members 9 may be arranged as a lattice with any suitable configuration necessary to provide the structural strength to ensure that the catheter 1 remains sufficiently rigid and able to support and maintain the urethra in an open state when in use. The external flushing portion 7 may be formed as one continuous piece or may comprise multiple component pieces joined together to form the lattice structure. The external flushing portion 7 may be defined by the cords 8 and cross-members 9 and the presence of the plurality of openings 11.

The insertion portion 3 extends from the proximal end of the external flushing portion 7 to the terminal end 14 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 Figures 1 to 8, the insertion portion 3 is provided with a rounded terminal end 14 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.

In the present embodiment, the insertion portion 3 comprises a solid tubular wall 15 defining an inlet lumen 16 which is closed at the terminal end 14 of the catheter 1 and open to the external flushing portion 7 via an outlet 17 formed at a junction 18 between the insertion portion 3 and the external flushing portion 7. A pair of stadium shaped eyelets 19 are formed through the wall 15 of the insertion portion 3 on opposite sides respectively and extend into the inlet lumen 16. The eyelets 19 are longitudinally offset such that one eyelet 19a is closer to the terminal end 14 of the catheter 1 and the other eyelet 19b is closer to the external flushing portion 7. Accordingly, a fluid flow path is formed from the insertion end 4 to the external flushing portion 7 via the eyelets 19, inlet lumen 16 and outlet 17 so that urine may drain from the bladder through the insertion portion 3 and into the external flushing portion 7.

It will be appreciated that the number, shape, and position of the eyelets 19 need not be limited as described above and that more, or less, eyelets 19 may be formed through the insertion wall 15 in different positions along the insertion portion 3. For example, the eyelets 19 could be rectangular, oval, square or circular and/or may be diametrically opposed at substantially the same longitudinal position. There could be just one eyelet 19 or more than two eyelets 19 arranged at various locations about and/or along the wall 15 of the insertion portion 3.

The insertion portion 3 may comprise one or more elongate open channels (not shown) in an external surface of the wall 15. The, or each, elongate open channel may extend longitudinally parallel to the longitudinal axis of the catheter 1 and provide fluid communication between the exterior of the catheter 1 at the insertion end 4 and the external flushing portion 7. Although the elongate open channels are described as extending purely in the longitudinal direction, this is not a limitation, and the channels may additionally extend circumferentially in some embodiments.

Referring to Figures 4 and 7, the outlet portion 5 comprises a solid tubular wall 20 extending from the distal end of the external flushing portion 7. The tubular outlet wall 20 defines an outlet lumen 21 extending from a junction 22 between the external flushing portion 7 and the outlet portion 5 through to an outlet 23 provided in the end face 24 of the outlet portion 5 to provide a nozzle for an exiting flow of urine from the catheter 1. In some embodiments the outlet portion 5 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.

To facilitate insertion of the catheter 1 and to ensure user comfort, the outer surfaces of the insertion wall 15, cords 8, and outlet wall 20 are substantially aligned so that there are no steps or bumps at the junctions 18, 22 between the cords 8 and insertion portion 3 and outlet portion 5, respectively (as can most clearly be seen from Figures 5 to 7). The outer surface of the cords 8 may be convex with a curvature substantially equivalent to the curvature of the outer surfaces of the insertion portion 3 and outlet portion 5, respectively. The insertion portion 3, outlet portion 5 and external flushing portion 7 may be formed as a singular piece or may be formed as separate component pieces that are attached together. The insertion portion 3, outlet portion 5, and external flushing portion 7 may be formed from different materials and/or have different rigidity. The insertion portion 3 may be softer than the external flushing portion 7.

Referring to Figs. 8 and 9, a funnel portion 127 is provided at the end of the outlet portion 5 and forms a conical cavity 128 which expands toward an outlet at the end face of the funnel portion 127 for the outflow of urine from the catheter 1.

The funnel portion 127 comprises a substantially tubular solid wall portion 129 with a diameter greater than that of the outlet portion 105 and external flushing portion 107. The tubular wall 129 defines a cylindrical cavity 130 which extends from the proximal end of the funnel portion 127 through to the conical cavity 128. The cylindrical cavity 130 is shaped and configured for the insertion of the outlet portion 105 therein with a tight fit. Accordingly, when the funnel portion 127 is attached to the outlet portion 105, a passageway from the external flushing portion 107 is defined by the outlet portion 105 and funnel portion 127 to provide a fluid flow path for an exiting stream of urine from the bladder and urethra, when in use.

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 the 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 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. The flushing portion may be longer than the outlet portion. Most of the length of the catheter may comprise the external flushing portion. The flushing portion may comprise more than 60% of the length of the catheter. The flushing portion may comprise more than 70% of the length of the catheter. The length of the insertion portion may be between 10mm and 50mm, preferably 20mm. 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. 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 the size requirements of the intended user.

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

Claims

1. An intermittent urinary catheter comprising: an elongate main body having an insertion end for insertion into a urethra, an outlet end, and an external flushing portion extending between the insertion end and the outlet end, wherein the external flushing portion comprises a plurality of cords extending longitudinally between the insertion end and the outlet end, and a plurality of cross-members connecting the plurality of cords together, wherein the plurality of cords and the plurality of cross-members together define an open lattice through which fluid may flow from the insertion end and externally from the main body of the catheter.

2. The intermittent urinary catheter of claim 1, wherein the cross-members are evenly distributed along the external flushing portion.

3. The intermittent urinary catheter of claim 1 or claim 2, wherein each cord of the plurality of cords is connected to another cord of the plurality of cords by at least one cross-member of the plurality of cross-members.

4. The intermittent urinary catheter of any preceding claim, comprising at least three cords.

5. The intermittent urinary catheter of any preceding claim, comprising four cords.

6. The intermittent urinary catheter of any preceding claim, wherein the plurality of cords together define a spine of the external flushing portion.

7. The intermittent urinary catheter of any preceding claim, wherein the lattice defines a fluid passageway from the insertion end to the outlet end.

8. The intermittent urinary catheter of claim 7, wherein the fluid passageway of the lattice has a polygonal or circular cross-section.

9. The intermittent urinary catheter of any preceding claim, wherein the lattice is shaped and configured to support the urethra in an open state when in use.

10. The intermittent urinary catheter of any preceding claim, wherein a majority of the lattice is open to the outside of the main body.

11. The intermittent urinary catheter of any preceding claim, wherein more than

The intermittent urinary catheter of any preceding claim, wherein more than 90% of the lattice is open to the outside of the main body. The intermittent urinary catheter of any preceding claim, wherein one or more of the plurality of cords extend longitudinally and parallel to the longitudinal axis of the main body. The intermittent urinary catheter of any preceding claim, wherein one or more of the plurality of cords are curved. The intermittent urinary catheter of any preceding claim, wherein at least one cross-member of the plurality of cross-members extends diagonally between two cords of the plurality of cords. The intermittent urinary catheter of any preceding claim, wherein at least one cord of the plurality of cords extends the entire length of the external flushing portion. The intermittent urinary catheter of any preceding claim, wherein one or more cross-members is curved. The intermittent urinary catheter of any preceding claim, wherein one or more cross-members are arranged to extend perpendicularly to the longitudinal axis of the main body. The intermittent urinary catheter of any preceding claim, wherein the external flushing portion is configured, in use, to provide fluid communication between the catheter and the urethra via openings formed by the lattice of the external flushing portion. The intermittent urinary catheter as claimed in any preceding claim, wherein the insertion end comprises an insertion portion having a solid tubular wall defining an inlet lumen, and wherein one or more eyelets are formed through the solid tubular wall such that the one or more eyelets are in fluid communication with the external flushing portion via the inlet lumen. The intermittent urinary catheter as claimed in any preceding claim, wherein the outlet end comprises an outlet portion having a solid tubular wall defining an outlet lumen in fluid communication with the external flushing portion. The intermittent urinary catheter as claimed in any preceding claim, wherein the insertion portion comprises an open elongate channel in an external surface thereof, the elongate channel being in fluid communication with the external flushing portion.