Urinary catheter with a funnel

Abstract

A urinary catheter assembly (100) is disclosed. The assembly comprises a catheter tube (101) and a catheter funnel (10). The catheter funnel (10) has a catheter receiving portion (22) defining an inner circumference (38) within which the catheter tube (101) is located; and the inner circumference (101) comprises a formation (40) that is separated from an entrance (12) and an exit (14) of the catheter funnel (10). The catheter tube is secured inside the funnel by adhesive (102), which acts on the catheter tube (101) and the formation (40).

Description

[0001] URINARY CATHETER WITH A FUNNEL

[0002] Technical Field of the Invention

[0003] The present invention relates to a catheter assembly and a catheter funnel for use in the catheter assembly.

[0004] Background to the Invention

[0005] A urinary catheter assembly may be used to empty a bladder of a user when the user has difficulty passing urine. In the case of an intermittent urinary catheter assembly, a catheter tube of the assembly is inserted into the bladder via the urethra by the user. Such intermittent urinary catheter assemblies usually comprise a catheter funnel provided at a distal end of the catheter tube to assist the user in directing urine exiting the assembly into a toilet or other collection receptacle.

[0006] There are various approaches to attaching the catheter tube to the catheter funnel. Typically, however, the simplest approaches have found favour in the industry, and thus, the usual approach is to simply use adhesive to attach the catheter tube to the catheter funnel. The bonding strength of the adhesive is dependent upon the materials from which the catheter funnel and the catheter tube are formed, and therefore only a limited number of materials can be selected for the catheter funnel and catheter tube. The most popular material used for the catheter funnel and catheter tube is Polyvinyl Chloride (PVC) plastic and adhesives that form a bond of sufficient strength between the catheter funnel and the catheter tube of PVC are readily available. However, PVC is not easily recyclable, meaning that catheter assemblies with PVC catheter funnels / tubes are often sent to landfill. Thus it is considered desirable to use alternative materials, which may be less easily assembled.

[0007] To overcome this, for example, there are processes which involve corona treating the material of the catheter tube and the catheter funnel to improve adhesion. These processes involving corona treatment are useful in that they allow the catheter tube and catheter funnel to be formed from a wide range of materials, but they have the downside of adding complexity (with an additional process) and are expensive to implement.

[0008] It is a object of the present invention to mitigate or obvate at least one problem with prior catheter funnels and their associated catheter assemblies.

[0009] Summary of the Invention The present invention provides a catheter assembly and a catheter funnel for use in the catheter assembly.

[0010] According to a broad aspect of the present invention there is provided a catheter assembly. The catheter assembly may comprise a catheter tube. The catheter assembly may comprise a catheter funnel. The catheter funnel may have: a catheter receiving portion. The catheter receiving portion may define an inner circumference within which the catheter tube is located. The inner circumference may comprise a formation. The formation may be separated from an entrance and an exit of the catheter funnel. The catheter tube may be secured inside the funnel by adhesive. The adhesive may act on the catheter tube and the formation.

[0011] According to another broad aspect of the present invention, there is provided a catheter funnel for use in a catheter assembly. The catheter funnel may have a catheter receiving portion. The catheter receiving portion may have an inner circumference within which a catheter tube is located in use. The inner circumference of the catheter receiving portion may comprise a formation. The formation may be separated from an entrance and an exit of the catheter funnel.

[0012] Accordingly, in a first aspect of the present invention, there is provided a catheter assembly comprising: a catheter tube; and a catheter funnel, the catheter funnel having: a catheter receiving portion defining an inner circumference within which the catheter tube is located; and the inner circumference comprising a formation that is separated from an entrance and an exit of the catheter funnel, wherein the catheter tube is secured inside the funnel by adhesive, which acts on the catheter tube and the formation.

[0013] In the present invention, the formation provides longitudinal resistance to the catheter being withdrawn from the catheter funnel in that hardened adhesive caught in or behind the formation must overcome the formation for the catheter tube to be withdrawn from the catheter funnel. The present invention therefore mechanically improves the strength of the connection between the funnel and catheter tube provided by the adhesive, meaning that the catheter funnel may be formed from a wider range of materials without the use of an additional process such as corona treatment. This means that the catheter funnel and catheter tube may each be formed from a non-PVC material relatively easily. As a non-PVC material may be used, catheter assemblies of th present invention may be more easily recycled.

[0014] The formation also provides an increase in bonding area available for the adhesive, thereby further improving the strength of the connection between the catheter funnel and catheter tube. The separation of the formation from the entrance means that the formation does not inhibit the passage of the adhesive into the funnel during assembly, meaning the adhesive is well distributed within the funnel once assembled to provide improved strength.

[0015] Advantageously, the assembly of the present invention can b assembled with little changes to existing and relatively simple production processes.

[0016] The catheter assembly may be a urinary catheter assembly. The catheter assembly may be an intermittent urinary catheter assembly. The catheter assembly may be a female intermittent urinary catheter assembly. The catheter assembly may be a male intermittent urinary catheter assembly.The catheter funnel may further comprise a throughbore extending between the entrance and exit. The formation may be closer to the entrance than the exit. The throughbore may taper (or narrow) from the entrance towards the formation.

[0017] This in practice means that there is a large gap between the catheter tube and the catheter funnel close to the entrance, meaning there is a large mass of adhesive close to the entrance of the funnel. This mass of adhesive provides radial strength and therefore resistance to bending of the catheter tube within the catheter funnel. This further improves the strength of the connection between the catheter tube and the catheter funnel. The taper of the throughbore also maximises the bonding area available to the adhesive on the catheter funnel, yet further improving the strength of the connection between the catheter tube and the catheter funnel. The taper also means that during assembly when the catheter tube is inserted into the funnel horizontally, the funnel does not fall off the catheter tube while the adhesive is uncured because the narrower end of the throughbore squeezes radially the end of the catheter tube.

[0018] The throughbore may have a longitudinal axis. The catheter funnel may be centred on the longitudinal axis. The catheter funnel may further comprise an abutment. The abutment may be for the catheter tube. The formation may be located between the abutment and the entrance. The formation may be spaced from the abutment.

[0019] The abutment may comprise a substantially annular surface. The inner diameter of the annular surface may be smaller than the outer diameter of the catheter tube. The throughbore may extend through the substantially annular surface. The throughbore may widen from the abutment to the exit. The throughbore may widen continuously away from the abutment to the exit. The annular surface may be orthogonal to the longitudinal axis of the throughbore.

[0020] The throughbore may taper (or narrow) from the formation towards the abutment.

[0021] The funnel may have an internal profile defining the throughbore. The formation may comprise one or more discontinuities in the internal profile. The formation may be provided in or on a first surface of the internal profile. The first surface may have a substantially circular cross-section.

[0022] The formation may comprise one or more elements. The one or more elements may comprise a plurality of elements or a single element. The plurality of elements may be spaced apart. The plurality of elements may be circumferentially spaced apart.

[0023] Spacing the elements apart reduces the friction encountered by the catheter tube when the catheter tube is inserted into the funnel during the production of the catheter assembly, making the production of the assembly more straight forward. The spacing of the elements means there are gaps between the elements, thereby making it easier for the adhesive provided on the catheter tube to get behind the formation when the catheter tube is inserted into the catheter funnel during production of the assembly.

[0024] The plurality of elements may be equidistantly spaced from the longitudinal axis of the throughbore.

[0025] The or each element or one or more of the plurality of elements may have a longitudinal length dimension (LLD) measured in a direction parallel to the longitudinal axis of the throughbore. The LLD may be smaller than a diameter of the entrance of the catheter funnel. The LLD may be smaller than the diameter of the exit of the catheter funnel. The LLD may be less than or equal to 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 15%, 13%, 10%, 8%, 6%, 5%, 4%, 3%, 2%, or 1% of the diameter of the entrance. Most preferably the LLD is less than or equal to 30% of the diameter of the entrance.

[0026] The or each element or one or more of the plurality of elements may have a surface area. The surface area may be less than an entrance area (the area of the entrance) of the entrance. The surface area may be less than or equal to 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 15%, 13%, 10%, 8%, 6%, 5%, 4%, 3%, 2%, or 1% of the entrance area. Most preferably the surface area is less than or equal to 20% of the entrance area.

[0027] The or each element or one or more of the plurality of elements may comprise a curved surface.

[0028] The or each element or one or more of the plurality of elements may comprise a converging surface that converges in a radial direction. The radial direction may be orthogonal to the longitudinal axis of the throughbore. The converging surface may converge inwardly in the radial direction (towards the longitudinal axis of the throughbore). The converging surface may converge outwardly in the radial direction (away from the longitudinal axis of the throughbore).

[0029] The or each element or one or more of the plurality of elements may extend (and / or converge) to a radial extremity thereof. The or each element or one or more of the plurality of elements may extend (and / or converge) in the radial direction to the radial extremity. The radial extremity may be rounded, flat or sharp.

[0030] The or each element or one or more of the plurality of elements may slope from the radial extremity in a first direction parallel to (or co-directionally with) the longitudinal axis of the throughbore. The or each element or one or more of the plurality of elements may slope from the radial extremity in a second direction opposite the first direction. The second direction may be parallel to (or co-directional with) the longitudinal axis of the throughbore.

[0031] When there is a plurality of elements at least some of the radial extremities of elements of the plurality of elements may have the same longitudinal position relative to the longitudinal axis of the throughbore. When there is a plurality of elements all the radial extremities of the elements of the plurality of elements may have the same longitudinal position relative to the longitudinal axis of the throughbore. When there is a plurality of elements, some of the radial extremities of elements of the plurality of elements may have the same longitudinal position relative to the longitudinal axis of the throughbore and at least another of the radial extremities of the elements may have a different position relative to the longitudinal axis of the throughbore.

[0032] When there is a plurality of elements, the elements may be arranged in one or more circumferential rows. The elements in each row may have the same longitudinal position relative to the longitudinal axis of the bore. The one or more circumferential rows may comprise a plurality of circumferential rows. The plurality of circumferential rows may comprise first and second circumferential rows. The first and second circumferential rows may have different longitudinal positions relative to the longitudinal axis of the throughbore. The elements of the first circumferential row may be circumferentially offset from the elements of the second circumferential row. Alternatively, the elements of the first circumferential row may be circumferentially aligned with the elements of the second circumferential row. The plurality of circumferential rows may further comprise a third circumferential row. The first, second and third circumferential rows may have different longitudinal positions relative to the longitudinal axis of the throughbore. The third circumferential row may be aligned with the elements of the first circumferential row. The second circumferential row may be located between the first and third circumferential rows. The first circumferential row may be located closest to the entrance. The elements of the first circumferential row may be bigger than the elements of the second and / or third circumferential rows. The elements of the second circumferential row may be bigger than the elements of the third circumferential row.

[0033] The or each element or one or more of the plurality of elements may be a recess. The or each element or one or more of the plurality of elements may be a protrusion. Accordingly, in an embodiment, there is provided a urinary catheter assembly comprising: a catheter tube; and a catheter funnel, the catheter funnel having: a catheter receiving portion defining an inner circumference within which the catheter tube is located; and the inner circumference comprising a formation that is separated from an entrance and an exit of the catheter funnel, wherein the catheter tube is secured inside the funnel by adhesive, which acts on the catheter tube and the formation, wherein the formation comprises one or more elements, wherein the one or more elements comprises a single element or a plurality of elements, wherein the or each element or one or more of the plurality of elements is a recess or protrusion.

[0034] In an embodiment, there is provided a urinary catheter assembly comprising: a catheter tube; and a catheter funnel, the catheter funnel having: a catheter receiving portion defining an inner circumference within which the catheter tube is located; and the inner circumference comprising a formation that is separated from an entrance and an exit of the catheter funnel, wherein the catheter tube is secured inside the funnel by adhesive, which acts on the catheter tube and the formation, wherein the formation comprises one or more elements, wherein the one or more elements comprises a single element or a plurality of elements, wherein the or each element or one or more of the plurality of elements is a recess or protrusion, wherein the catheter funnel further comprises an abutment, wherein the abutment is for the catheter tube, wherein the formation is located between the abutment and the entrance, wherein the formation is spaced from the abutment.

[0035] In an embodiment, there is provided a urinary catheter assembly comprising: a catheter tube; and a catheter funnel, the catheter funnel having: a catheter receiving portion defining an inner circumference within which the catheter tube is located; and the inner circumference comprising a formation that is separated from an entrance and an exit of the catheter funnel, wherein the catheter tube is secured inside the funnel by adhesive, which acts on the catheter tube and the formation, wherein the formation comprises one or more elements, wherein the one or more elements comprises a single element or a plurality of elements, wherein the or each element or one or more of the plurality of elements is a recess or protrusion, wherein the assembly further comprises a throughbore extending between the entrance and exit, wherein the formation is closer to the entrance than the exit, wherein the throughbore tapers from the entrance towards the formation.

[0036] In an embodiment, there is provided a urinary catheter assembly comprising: a catheter tube; and a catheter funnel, the catheter funnel having: a catheter receiving portion defining an inner circumference within which the catheter tube is located; and the inner circumference comprising a formation that is separated from an entrance and an exit of the catheter funnel, wherein the catheter tube is secured inside the funnel by adhesive, which acts on the catheter tube and the formation, wherein the formation comprises one or more elements, wherein the one or more elements comprises a single element or a plurality of elements, wherein the or each element or one or more of the plurality of elements is a recess or protrusion, wherein the assembly further comprises a throughbore extending between the entrance and exit, wherein the formation is closer to the entrance than the exit, wherein the throughbore tapers from the entrance towards the formation, wherein the funnel has an internal profile defining the throughbore, wherein the formation comprises one or more discontinuities in the internal profile.

[0037] In an embodiment, there is provided a urinary catheter assembly comprising: a catheter tube; and a catheter funnel, the catheter funnel having: a catheter receiving portion defining an inner circumference within which the catheter tube is located; and the inner circumference comprising a formation that is separated from an entrance and an exit of the catheter funnel, wherein the catheter tube is secured inside the funnel by adhesive, which acts on the catheter tube and the formation, wherein the formation comprises one or more elements, wherein the one or more elements comprises a single element or a plurality of elements, wherein the or each element or one or more of the plurality of elements is a recess or protrusion, wherein the catheter funnel further comprises an abutment, wherein the abutment is for the catheter tube, wherein the formation is located between the abutment and the entrance, wherein the formation is spaced from the abutment, wherein the assembly further comprises a throughbore extending between the entrance and exit, wherein the formation is closer to the entrance than the exit, wherein the throughbore tapers from the entrance towards the formation.

[0038] In an embodiment, there is provided a urinary catheter assembly comprising: a catheter tube; and a catheter funnel, the catheter funnel having: a catheter receiving portion defining an inner circumference within which the catheter tube is located; and the inner circumference comprising a formation that is separated from an entrance and an exit of the catheter funnel, wherein the catheter tube is secured inside the funnel by adhesive, which acts on the catheter tube and the formation, wherein the formation comprises one or more elements, wherein the one or more elements comprises a single element or a plurality of elements, wherein the or each element or one or more of the plurality of elements is a recess or protrusion, wherein the catheter funnel further comprises an abutment, wherein the abutment is for the catheter tube, wherein the formation is located between the abutment and the entrance, wherein the abutment comprises a substantially annular surface.

[0039] In an embodiment, there is provided a urinary catheter assembly comprising: a catheter tube; and a catheter funnel, the catheter funnel having: a catheter receiving portion defining an inner circumference within which the catheter tube is located; and the inner circumference comprising a formation that is separated from an entrance and an exit of the catheter funnel, wherein the catheter tube is secured inside the funnel by adhesive, which acts on the catheter tube and the formation, wherein the formation comprises one or more elements, wherein the one or more elements comprises a single element or a plurality of elements, wherein the or each element or one or more of the plurality of elements is a recess or protrusion, wherein the catheter funnel further comprises an abutment, wherein the abutment is for the catheter tube, wherein the formation is located between the abutment and the entrance, wherein the abutment comprises a substantially annular surface, wherein the assembly further comprises a throughbore extending between the entrance and exit, wherein the annular surface is orthogonal to the longitudinal axis of the throughbore.

[0040] When there is a plurality of elements, the plurality of elements may comprise one or more recesses and one or more protrusions.

[0041] The plurality of elements may comprise a plurality of protrusions. The protrusions may be equidistantly spaced around the longitudinal axis of the throughbore.

[0042] This is advantageous as using a plurality of protrusions means that during assembly it is easier to hold the catheter tube in a straight position on the central axis of the funnel during assembly as part of the tube not in contact with the throughbore about its circumference can be supported by the protrusions.

[0043] When there is a plurality of protrusions, there may be no more than 20, 15, 12, 10, 8, 7, 6, 5 or 4 protrusions, for example there may be four protrusions. The protrusions may be equidistantly spaced around the longitudinal axis of the throughbore.

[0044] The or each protrusion may be at least partially or fully hemispherical. The or each protrusion may be part-spherical. The or each protrusion may make up at least 25%, 30%, 35%, 40%, 45%, or 50% of a sphere. The or each protrusion may be a wedge. The wedge may have two sides that meet at a free edge of the protrusion. The free edge may comprise the radial extremity. One of the sides may have a greater area than the other. The one of the sides may be located closer to the entrance than the other of the sides (and may thereby form a ramp). The free edge may be rounded. The sides may be connected at connected edges to a remainder of the funnel. The connected edges may be substantially semi-circular.

[0045] In an embodiment, there is provided a urinary catheter assembly comprising: a catheter tube; and a catheter funnel, the catheter funnel having: a catheter receiving portion defining an inner circumference within which the catheter tube is located; and the inner circumference comprising a formation that is separated from an entrance and an exit of the catheter funnel, wherein the catheter tube is secured inside the funnel by adhesive, which acts on the catheter tube and the formation, wherein the assembly further comprises a throughbore extending between the entrance and exit, wherein the formation comprises one or more elements, wherein the one or more elements comprises a single element or a plurality of elements, wherein the or each element or one or more of the plurality of elements is a recess or protrusion, wherein the or each element or one or more of the plurality of elements extends to a radial extremity thereof, wherein the or each element or one or more of the plurality of elements slopes from the radial extremity in a first direction co-directional with a longitudinal axis of the throughbore, wherein the or each element or one or more of the plurality of elements slopes from the radial extremity in a second direction opposite the first direction.

[0046] In an embodiment, there is provided a urinary catheter assembly comprising: a catheter tube; and a catheter funnel, the catheter funnel having: a catheter receiving portion defining an inner circumference within which the catheter tube is located; and the inner circumference comprising a formation that is separated from an entrance and an exit of the catheter funnel, wherein the catheter tube is secured inside the funnel by adhesive, which acts on the catheter tube and the formation, wherein the assembly further comprises a throughbore extending between the entrance and exit, wherein the formation is closer to the entrance than the exit, wherein the throughbore tapers from the entrance towards the formation, wherein the formation comprises one or more elements, wherein the one or more elements comprises a single element or a plurality of elements, wherein the or each element or one or more of the plurality of elements is a recess or protrusion, wherein the or each element or one or more of the plurality of elements extends to a radial extremity thereof, wherein the or each element or one or more of the plurality of elements slopes from the radial extremity in a first direction co-directional with a longitudinal axis of the throughbore, wherein the or each element or one or more of the plurality of elements slopes from the radial extremity in a second direction opposite the first direction, wherein the catheter funnel further comprises an abutment, wherein the abutment is for the catheter tube, wherein the formation is located between the abutment and the entrance, wherein the formation is spaced from the abutment. The funnel may comprise a frustoconical portion. The frustoconical portion may extend from the catheter receiving portion. The frustoconical portion may be narrowest where the frustoconical portion meets the catheter receiving portion (e.g from the abutment). The frustoconical portion may widen from where the frustoconical portion meets the catheter receiving portion. The frustoconical portion and catheter receiving portion may together define the throughbore. The catheter receiving portion may comprise the abutment.

[0047] The catheter receiving portion may comprise the entrance of the catheter funnel. The frustoconical portion may comprise the exit of the catheter funnel. The receiving portion may comprise an entrance end opposite where the receiving portion meets the frustoconical portion. The entrance end may comprise the entrance of the catheter funnel. The frustoconical portion may comprise an exit end opposite where the frustoconical portion meets the receiving portion. The exit end may comprise the exit of the catheter funnel (through which, in use, urine exits the funnel).

[0048] The exit end may comprise an annular flange. The annular flange may project radially and outwardly from the rest of the frustoconical portion.

[0049] An exterior of the receiving portion may be ribbed. The exterior of the receiving portion may comprise a plurality of circumferential ribs. Preferably, the plurality of circumferential ribs are spaced apart. The circumferential ribs may be connected by one or more longitudinally extending ribs. Preferably, there are a plurality of longitudinally extending ribs. The catheter funnel may comprise a centre axis. The centre axis may be the longitudinal axis of the throughbore. Most preferably, there are a plurality of longitudinally extending ribs that are equidistantly spaced from the centre axis of the funnel.

[0050] The length of the frustoconical portion may be the same as or greater than the receiving portion. The length may be measured with respect to the centre axis of the catheter funnel. The length of the frustoconical portion may be at least two times greater than the receiving portion.

[0051] The funnel may comprise a locator. The locator may be configured to identify the orientation of the catheter. The locator may comprise a locator rib. The locator rib may extend longitudinally. The locator may comprise a locator marking. The locator may be provided on an outer surface of the frustoconical portion.

[0052] The catheter funnel may be formed from a funnel material (the material from which the funnel is made). The funnel material may comprise a synthetic material. The funnel material may comprise plastic. The plastic may be an ethylene vinyl acetate (EVA) copolymer. The funnel material may be Pharmalene FL 35 PH as sold by ENI and set out in the FL 35 PH Technical Datasheet dated November 2020.

[0053] The funnel material may have a Shore Hardness A value (HA) in the range of 89 to 95. The HA of the funnel material may be in the range of 90 to 98, 91 to 97, 92 to 96, or 93 to 95. Most preferably, the HA of the funnel material is 94. The HA may be measured using an ISO 868:2003 (reviewed and confirmed in 2018 and current as of 4 October 2023). The funnel material may have a Shore Hardness D value (HD) in the range of 37 to 47. Accordingly, in an embodiment, there is provided a urinary catheter assembly comprising: a catheter tube; and a catheter funnel, the catheter funnel having: a catheter receiving portion defining an inner circumference within which the catheter tube is located; and the inner circumference comprising a formation that is separated from an entrance and an exit of the catheter funnel, wherein the catheter tube is secured inside the funnel by adhesive, which acts on the catheter tube and the formation, wherein the catheter funnel is formed from a funnel material, wherein the funnel material has a Shore Hardness D value (HD) in the range of 37 to 47.

[0054] The HD of the funnel material may be in the range of 38 to 46, 39 to 45, 40 to 44, or 41 to 43. Most preferably, the HD of the funnel material is 42. The HD may be measured using an ISO 868:2003 (reviewed and confirmed in 2018 and current as of 4 October 2023).

[0055] The adhesive may be UV cured adhesive. Alternatively, the adhesive may be pressure sensitive adhesive. The UV cured adhesive may be a light-cure adhesive. The UV cured adhesive may be acrylic based. The UV cured adhesive may be Loctite AA 3921 as sold by Henkel North American Consumer Goods and set out in the Loctite AA 3921 Technical Datasheet dated September 2020.

[0056] The catheter tube may have a catheter tube outer circumference (the outer circumference of the catheter tube). The adhesive may surround a portion of the catheter tube outer circumference. The adhesive may comprise a substantially annular region within which the portion of the catheter tube outer circumference is located. An annular region outer circumference (the outer circumference of the annular region) of the annular region may be substantially circular. The annular region may have a maximum thickness. The maximum thickness may be measured in a radial direction orthogonal to the centre axis of the funnel. The maximum thickness of the annular region may be more than or equal to 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 110%, 120%, 130%, 140%, 150% of a wall thickness of the catheter tube. Preferably, the maximum thickness is in the range of 40% to 120% of the wall thickness of the catheter tube and most preferably 55% to 105% of the wall thickness of the catheter tube. The maximum thickness of the annular region may be located between the formation and the entrance.

[0057] There may be a longitudinal midpoint between the abutment and the entrance. A greater amount of the adhesive may be located between the longitudinal midpoint and the entrance than between the longitudinal midpoint and the abutment. At least part of the formation may be located between the longitudinal midpoint and the entrance. At least a majority of the formation may be located between the longitudinal midpoint and the entrance. The formation may not be located between the longitudinal midpoint and the abutment.

[0058] In an embodiment, there is provided a urinary catheter assembly comprising: a catheter tube; and a catheter funnel, the catheter funnel having: a catheter receiving portion defining an inner circumference within which the catheter tube is located; and the inner circumference comprising a formation that is separated from an entrance and an exit of the catheter funnel, wherein the catheter tube is secured inside the funnel by adhesive, which acts on the catheter tube and the formation, wherein the assembly further comprises a throughbore extending between the entrance and exit, wherein the formation is closer to the entrance than the exit, wherein the throughbore tapers from the entrance towards the formation, wherein the formation comprises one or more elements, wherein the one or more elements comprises a single element or a plurality of elements, wherein the or each element or one or more of the plurality of elements is a recess or protrusion, wherein the or each element or one or more of the plurality of elements extends to a radial extremity thereof, wherein the or each element or one or more of the plurality of elements slopes from the radial extremity in a first direction co-directional with a longitudinal axis of the throughbore, wherein the or each element or one or more of the plurality of elements slopes from the radial extremity in a second direction opposite the first direction, wherein the catheter funnel further comprises an abutment, wherein the abutment is for the catheter tube, wherein the formation is located between the abutment and the entrance, wherein the formation is spaced from the abutment, wherein there is a longitudinal midpoint between the abutment and the entrance, wherein at least a majority of the formation is located between the longitudinal midpoint and the entrance.

[0059] In an embodiment, there is provided a urinary catheter assembly comprising: a catheter tube; and a catheter funnel, the catheter funnel having: a catheter receiving portion defining an inner circumference within which the catheter tube is located; and the inner circumference comprising a formation that is separated from an entrance and an exit of the catheter funnel, wherein the catheter tube is secured inside the funnel by adhesive, which acts on the catheter tube and the formation, wherein the formation comprises one or more elements, wherein the one or more elements comprises a single element or a plurality of elements, wherein the or each element or one or more of the plurality of elements is a recess or protrusion, wherein the catheter funnel further comprises an abutment, wherein the abutment is for the catheter tube, wherein the formation is located between the abutment and the entrance, wherein the formation is spaced from the abutment, wherein there is a longitudinal midpoint between the abutment and the entrance, wherein at least a majority of the formation is located between the longitudinal midpoint and the entrance, wherein the assembly further comprises a throughbore extending between the entrance and exit, wherein the formation is closer to the entrance than the exit, wherein the throughbore tapers from the entrance towards the formation, wherein the catheter funnel is formed from a funnel material, wherein the funnel material has a Shore Hardness D value (HD) in the range of 37 to 47.

[0060] In an embodiment, there is provided a urinary catheter assembly comprising: a catheter tube; and a catheter funnel, the catheter funnel having: a catheter receiving portion defining an inner circumference within which the catheter tube is located; and the inner circumference comprising a formation that is separated from an entrance and an exit of the catheter funnel, wherein the catheter tube is secured inside the funnel by adhesive, which acts on the catheter tube and the formation, wherein the formation comprises one or more elements, wherein the one or more elements comprises a single element or a plurality of elements, wherein the or each element or one or more of the plurality of elements is a recess or protrusion, wherein the catheter funnel further comprises an abutment, wherein the abutment is for the catheter tube, wherein the formation is located between the abutment and the entrance, wherein the formation is spaced from the abutment, wherein there is a longitudinal midpoint between the abutment and the entrance, wherein at least a majority of the formation is located between the longitudinal midpoint and the entrance, wherein the assembly further comprises a throughbore extending between the entrance and exit, wherein the formation is closer to the entrance than the exit, wherein the throughbore tapers from the entrance towards the formation, wherein the funnel has an internal profile defining the throughbore, wherein the formation comprises one or more discontinuities in the internal profile.

[0061] In an embodiment, there is provided a urinary catheter assembly comprising: a catheter tube; and a catheter funnel, the catheter funnel having: a catheter receiving portion defining an inner circumference within which the catheter tube is located; and the inner circumference comprising a formation that is separated from an entrance and an exit of the catheter funnel, wherein the catheter tube is secured inside the funnel by adhesive, which acts on the catheter tube and the formation, wherein the formation comprises one or more elements, wherein the one or more elements comprises a single element or a plurality of elements, wherein the or each element or one or more of the plurality of elements is a recess or protrusion, wherein the catheter funnel further comprises an abutment, wherein the abutment is for the catheter tube, wherein the formation is located between the abutment and the entrance, wherein the formation is spaced from the abutment, wherein there is a longitudinal midpoint between the abutment and the entrance, wherein at least a majority of the formation is located between the longitudinal midpoint and the entrance, wherein the assembly further comprises a throughbore extending between the entrance and exit, wherein the formation is closer to the entrance than the exit, wherein the throughbore tapers from the entrance towards the formation.

[0062] Some of the adhesive may be present at a longitudinal point between the formation and the abutment.

[0063] The catheter tube may be transparent. The catheter tube may be formed from a tube material (the material from which the catheter tube is made). The tube material may comprise a synthetic material. The tube material may comprise a flexible thermoplastic elastomer (TPE) compound. The tube material may be PVC (Polyvinyl chloride) free. The flexible thermoplastic elastomer compound may be the “Flexible Polyolefine based Compound” as sold by Melitek and with reference to product data sheet M6906-02 (Version 2020 / 07).

[0064] The tube material may have a Shore Hardness Scale A (HA) value in the range of

[0065] 76 to 86, preferably in the range of 77 to 87, 78 to 86, 79 to 85, 80 to 84, or 81 to 83. Most preferably, the tube material has a HA of 82. In an embodiment, there is provided a urinary catheter assembly comprising: a catheter tube; and a catheter funnel, the catheter funnel having: a catheter receiving portion defining an inner circumference within which the catheter tube is located; and the inner circumference comprising a formation that is separated from an entrance and an exit of the catheter funnel, wherein the catheter tube is secured inside the funnel by adhesive, which acts on the catheter tube and the formation, wherein the catheter funnel is formed from a funnel material, wherein the funnel material has a Shore Hardness D value (HD) in the range of 37 to 47, wherein the catheter tube is formed from a tube material, wherein the tube material has a Shore Hardness Scale A (HA) value in the range of 76 to 86.

[0066] In another embodiment, there is provided a urinary catheter assembly comprising: a catheter tube; and a catheter funnel, the catheter funnel having: a catheter receiving portion defining an inner circumference within which the catheter tube is located; and the inner circumference comprising a formation that is separated from an entrance and an exit of the catheter funnel, wherein the catheter tube is secured inside the funnel by adhesive, which acts on the catheter tube and the formation, wherein the formation comprises one or more elements, wherein the one or more elements comprises a single element or a plurality of elements, wherein the or each element or one or more of the plurality of elements is a recess or protrusion, wherein the catheter funnel is formed from a funnel material, wherein the funnel material has a Shore Hardness D value (HD) in the range of 37 to 47, wherein the catheter tube is formed from a tube material, wherein the tube material has a Shore Hardness Scale A (HA) value in the range of 76 to 86.

[0067] In an embodiment, there is provided a urinary catheter assembly comprising: a catheter tube; and a catheter funnel, the catheter funnel having: a catheter receiving portion defining an inner circumference within which the catheter tube is located; and the inner circumference comprising a formation that is separated from an entrance and an exit of the catheter funnel, wherein the catheter tube is secured inside the funnel by adhesive, which acts on the catheter tube and the formation, wherein the formation comprises one or more elements, wherein the one or more elements comprises a single element or a plurality of elements, wherein the or each element or one or more of the plurality of elements is a recess or protrusion, wherein the catheter funnel further comprises an abutment, wherein the abutment is for the catheter tube, wherein the formation is located between the abutment and the entrance, wherein the formation is spaced from the abutment, wherein there is a longitudinal midpoint between the abutment and the entrance, wherein at least a majority of the formation is located between the longitudinal midpoint and the entrance, wherein the assembly further comprises a throughbore extending between the entrance and exit, wherein the formation is closer to the entrance than the exit, wherein the throughbore tapers from the entrance towards the formation, wherein the catheter funnel is formed from a funnel material, wherein the funnel material has a Shore Hardness D value (HD) in the range of 37 to 47, wherein the catheter tube is formed from a tube material, wherein the tube material has a Shore Hardness Scale A (HA) value in the range of 76 to 86.

[0068] The HA may be obtained via the ISO 868:2003 (reviewed and confirmed in 2018 and current as of 4 October 2023).

[0069] The shore harnesses of the catheter funnel and tube mean that the materials that make up the funnel and tube are relatively soft and flexible. Using relatively soft materials may be beneficial in terms of patient comfort. According to a second aspect of the present invention, there is provided a catheter funnel for use in the catheter assembly of the first aspect, the catheter funnel having: a catheter receiving portion having an inner circumference within which a catheter tube is located in use, the inner circumference of the catheter receiving portion comprising a formation that is separated from an entrance and an exit of the catheter funnel.

[0070] The catheter funnel of the second aspect may comprise any of the optional features outlined above in relation to the first aspect of the invention.

[0071] According to a third aspect of the present invention, there is provided a method of manufacturing a catheter assembly. The catheter assembly may be the catheter assembly of the first aspect.

[0072] The method may comprise: providing a catheter funnel. The catheter funnel may be the catheter funnel of the second aspect.

[0073] The method may further comprise: securing a catheter tube within the catheter funnel with adhesive that acts on the tube and the funnel so as to form the catheter assembly.

[0074] The method may further comprise providing the catheter tube. Providing the catheter tube may comprise forming the catheter tube. Forming the catheter tube may comprise extruding a synthetic material. The synthetic material may be synthetic plastic.

[0075] Providing the catheter funnel may comprise forming the catheter funnel. Forming the catheter funnel may involve moulding the catheter funnel. Moulding the catheter funnel may involve using injection moulding to mould the catheter funnel.

[0076] The adhesive may be UV cured adhesive. Alternatively, the adhesive may be pressure sensitive adhesive or hot melt adhesive.

[0077] Securing the catheter tube within the catheter funnel with adhesive may comprise: coating a first portion of the catheter tube with a curable adhesive; inserting the first portion of the catheter tube into the catheter funnel such that the adhesive is in contact with both the catheter tube and catheter funnel.

[0078] The method of inserting the first portion of the catheter tube into the catheter funnel may ensure that the adhesive is within or behind the formation (such that when solidified the adhesive holds the catheter tube in the funnel both chemically, by adherence, and mechanically, by interaction with the formation). The method may comprise supporting the catheter tube co-axially with the funnel as the adhesive solidifies. Where the formation comprises one or more protrusions, the protrusions may support the catheter tube co-axially as the adhesive solidifies.

[0079] When the adhesive is UV cured adhesive, securing the catheter tube within the catheter funnel with adhesive may further comprise: irradiating the UV curable adhesive with ultra-violet light so as to cure the UV curable adhesive and secure the catheter tube within the funnel.

[0080] The catheter tube and / or the funnel may be transparent to UV. Irradiating the UV curable adhesive may comprise shining the ultra-violent light along the catheter tube and / or through the funnel.

[0081] According to a fourth aspect of the present invention, there is provided a method of draining a bladder of a user. The method may comprise providing the catheter assembly of the first aspect. The method may further comprise inserting the catheter tube of the catheter assembly into a urethra of the user such that the catheter tube is in communication with the bladder. The method may further comprise discharging urine from the bladder via the catheter tube. The method may comprise using the catheter funnel to direct fluid exiting the catheter assembly into a collection receptacle.

[0082] The methods of the third and fourth aspects may comprise any of the optional features outlined above in relation to the first and the second aspects of the invention.

[0083] Detailed Description of the Invention

[0084] 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:

[0085] Figure 1 shows a perspective view of a catheter assembly with a catheter funnel according to a first embodiment of the present invention;

[0086] Figure 2A shows a sectional view of the catheter assembly shown in Figure 1 ;

[0087] Figure 2B shows a formation shown in Figure 2A in greater detail;

[0088] Figure 3 shows an end view of the catheter assembly shown in Figure 1 ;

[0089] Figure 4 shows a perspective view of the catheter funnel of Figure 1 ;

[0090] Figure 5 shows a sectional view of the catheter funnel of Figure 1 ; Figure 6 shows a perspective view of a catheter funnel according to a second embodiment of the present invention;

[0091] Figure 7 shows a sectional view of the catheter funnel of Figure 6;

[0092] Figure 8 shows a perspective view of a catheter funnel according to a third embodiment of the present invention;

[0093] Figure 9 shows a sectional view of the catheter funnel of Figure 8; and

[0094] Figure 10 shows a sectional view of a catheter funnel according to a fourth embodiment of the present invention.

[0095] With reference to Figures 1 to 3, there is shown a catheter assembly 100 with a catheter funnel 10 according to a first embodiment of the present invention. The depicted catheter assembly 100 is an intermittent urinary catheter assembly. More specifically, the depicted embodiment is a female intermittent urinary catheter assembly but those skilled in the art will understand that the invention may equally apply to male intermittent urinary catheter assemblies. The assembly 100 includes the catheter funnel 10 and a catheter tube

[0096] 101 secured within the funnel 10 by adhesive 102 that acts on both the funnel 10 and the catheter tube 101. In this embodiment, the catheter tube 101 is transparent and the adhesive

[0097] 102 is cured ultraviolet light (UV) curable adhesive. During assembly of this embodiment, the catheter tube 101 is secured within the funnel 10 by fitting the catheter tube which is coated with uncured UV curable adhesive into the funnel and then shining UV light down the catheter tube to cure the UV curable adhesive. In this embodiment, the UV curable adhesive is a light-cure and acrylic based adhesive. In this embodiment, the UV curable adhesive is Loctite AA 3921 as sold by Henkel North American Consumer Goods and set out in the Loctite AA 3921 Technical Datasheet dated September 2020.

[0098] The catheter tube 101 is formed from a tube material that comprises plastic. In this embodiment, the plastic is a flexible thermoplastic elastomer compound. The flexible thermoplastic elastomer compound is the “Flexible Polyolefine based Compound” as sold by Melitek and with reference to product data sheet M6906-02 (Version 2020 / 07). The tube material has a Shore Hardness Scale A (HA) value in the range of 76 to 86, and specifically the tube material has a HA of 82. The HA is obtained via the ISO 868:2003 (reviewed and confirmed in 2018 and current as of 4 October 2023). The funnel 10 is formed from a funnel material. In this embodiment, the funnel material comprises plastic. The plastic is an ethylene vinyl acetate (EVA) copolymer and specifically Pharmalene FL 35 PH as sold by ENI and set out in the FL 35 PH Technical Datasheet dated November 2020.

[0099] The funnel material has a Shore Hardness A value (HA) in the range of 89 to 95, and specifically the HA of the funnel material is 94. The HA is measured using an ISO 868:2003 (reviewed and confirmed in 2018 and current as of 4 October 2023). The funnel material has a Shore Hardness D value (HD) in the range of 37 to 47 and specifically the HD of the funnel material is 42. The HD is measured using an ISO 868:2003 (reviewed and confirmed in 2018 and current as of 4 October 2023).

[0100] The funnel 10 is provided to assist the user in directing urine exiting the assembly into a toilet or other collection receptacle in use. As best shown in Figure 2A, the funnel 10 comprises an entrance 12 and exit 14 which are connected by a throughbore 16 that extends longitudinally through the funnel 10. The entrance 12 is an opening in the funnel 10 into which during assembly the catheter tube 101 is fitted and the exit is an opening in the funnel 10 through which in use urine exits the funnel 10. The entrance 12 is provided at an entrance end 18 of the funnel, whereas the exit 14 is provided at an exit end 20 of the funnel 10 opposite the entrance end. As shown the diameter of the exit 14 is greater than the diameter of the entrance 12.

[0101] The funnel 10 includes a catheter receiving portion 22 and a frustoconical portion 24 which extends from the catheter receiving portion 22, as best shown in Figure 2A and 2B and also in Figures 4 and 5 (which show the funnel 10 in isolation). The catheter receiving portion 22 receives the catheter tube 101 (or in other words the catheter tube 101 is fitted into the catheter receiving portion 22) and in use urine flows from the catheter tube 101 through the frustoconical portion and out of the funnel 10. The catheter receiving portion 22 and the frustoconical portion 24 together define the throughbore 16.

[0102] As shown the length of the frustoconical portion 24 is greater than the receiving portion 22, and in this embodiment in particular is approximately three times greater than the receiving portion 22. An annular flange 30 is provided at the exit end 20 of the frustoconical portion 24. The annular flange 30 projects radially and outwardly from the rest of the frustoconical portion 24. A locator rib 32 that is configured to identify the orientation of the catheter extends longitudinally along an outer surface of the frustoconical portion 24.

[0103] As best shown in Figure 4, an exterior of the receiving portion 22 of this embodiment is ribbed. In particular, the exterior of the receiving portion comprises a plurality of circumferential ribs 34, which are essentially spaced apart annular rings. The circumferential ribs 34 are connected by a plurality of longitudinally extending ribs 36. The longitudinally extending ribs 36 are equidistantly spaced from a centre axis of the funnel 10.

[0104] The catheter receiving portion 22 defines an inner circumference 38 within which the catheter tube 101 is located.

[0105] As best shown in Figures 2 A, 2B and 5, the inner circumference 38 has a formation 40 that is separated from an entrance 12 and an exit 14 of the catheter funnel 10. In this embodiment, the formation 40 is a plurality of spaced apart protrusions 41. However, other formations with different constructions may be present as will be explained below. The depicted formation 40 comprises a plurality of discontinuities in the internal profile of the catheter funnel that are provided on a first surface of the internal profile which has a substantially circular cross-section.

[0106] The throughbore 16 has a longitudinal axis, which is also the centre axis of the catheter funnel 10. As shown, the protrusions 41 are equidistantly spaced from the longitudinal axis of the throughbore 16. The protrusions 41 that are depicted are relatively small, and each protrusion 41 has a longitudinal length dimension (LLD) measured in a direction parallel to the longitudinal axis of the throughbore 16. As shown, the LLD of each of the protrusions 41 is smaller than the diameter of the entrance 12 of the funnel 10. In particular, the LLD of each of the protrusions 41 is less than or equal to 30% of the diameter of the entrance 12. Each of the protrusions 41 has a surface area that is less than an entrance area of the entrance, and in particular the surface area is less than or equal to 20% of the entrance area.

[0107] Each of the protrusions 41 extend inwardly in a radial direction orthogonal to the longitudinal axis of the throughbore 16 to a radial extremity 42 thereof. In this embodiment, each of the protrusions 41 comprise curved surfaces 44 that converge to the radial extremity and the radial extremity 42 is a rounded crown of each protrusion. The curved surfaces 44 of the protrusions 41 define opposing slopes 43 which slope in opposing directions parallel to the longitudinal axis of the throughbore 16. Also in this embodiment all of the radial extremities 42 of the protrusions 41 have the same longitudinal position relative to the longitudinal axis of the throughbore 16.

[0108] Each protrusion 41 of this embodiment is part-spherical and makes up around 30% of a sphere).

[0109] In this embodiment, there are a plurality of protrusions 41. In particular, there are four protrusions 41 provided. The protrusions 41 are spaced apart, and therefore there are gaps between the protrusions for the adhesive to pass further into the throughbore beyond the formation when the catheter tube 101 is fitted into the throughbore 16 during assembly. The equidistant spacing of the protrusions 41 around the longitudinal axis of the throughbore is advantageous because it means that during assembly it is easier to hold the catheter tube 101 in a straight position on the central axis of the funnel during assembly as part of the catheter tube 101 not in contact with the throughbore 16 about its circumference can be supported by the protrusions 41.

[0110] The catheter receiving portion 22 comprises an abutment 50 for the catheter tube 101 (i.e. an element that the catheter tube 101 makes contact with when it is inserted into the catheter funnel 10 during assembly). The abutment 50 comprises a substantially annular surface through which the throughbore 16 extends. As shown, the inner diameter of the annular surface 50 is smaller than the outer diameter of the catheter tube 101 so that the catheter tube 101 is prevented from moving further into the throughbore when the catheter tube is inserted into the throughbore 16 via the entrance 12 during assembly. As shown, the formation 40 is located between the abutment 50 and the entrance 12, and is spaced from both the abutment 50 and entrance 12.

[0111] As best shown in Figure 2B, there is a longitudinal midpoint 51 between the entrance 12 and the abutment 50. The formation 40 is located between the longitudinal midpoint 51 and the entrance 12. A greater amount of the adhesive 102 is located between the longitudinal midpoint 51 and the entrance 12 than between the longitudinal midpoint 51 and the abutment 50. However, there is at least some adhesive between the abutment 50 and the longitudinal midpoint 51. In particular, there is a small gap 53 between the catheter tube 101 and the inner circumference 38 located directly behind each protrusion 41 in which some of the adhesive is located. As best shown in Figure 3, the adhesive 102 comprises an annular region 71 that surrounds a portion of the catheter tube outer circumference 72 of the catheter tube 101. In this embodiment, an annular region outer circumference 73 is substantially circular. A maximum thickness of the annular region 71 is located between the entrance 12 and the formation 40, and the maximum thickness may be in the range of 40% to 120% of the wall thickness of the catheter tube 101. In other words, the maximum thickness of the annular region 71 may be relatively similar to the wall thickness of the catheter tube 101.

[0112] As best shown in Fig. 2B, the throughbore 16 tapers (or narrows) from the entrance 12 towards the formation 40, and tapers from the formation 40 towards the abutment 50. As best shown in Fig. 2A, the throughbore 16 widens away from the abutment 50 towards the exit 14.

[0113] Referring now to Figures 6 and 7, there is shown a catheter funnel 10’ according to a second embodiment of the present invention. The construction of the catheter funnel 10’ is similar to the catheter funnel 10, and the same reference numerals have been used with the addition of an apostrophe. In this embodiment, the formation 40’ comprises first, second and third circumferential rows 82’ , 84’ , 86’ of part-spherical protrusions 41’ , and a tapering throughbore 16’. The first, second and third circumferential rows 82’, 84’, 86’ are longitudinally spaced from one another with the first circumferential row 82’ being located closest to the entrance 12’ of the funnel 10’. The third circumferential row 86’ is located closest to the abutment 50’, and the second circumferential row 84’ is located between the first and second circumferential rows 82’, 86’. The protrusions of the first, second and third circumferential rows 82’, 84’, 86’ increase in size away from the entrance 12’. In particular, the protrusions of the second circumferential row 84’ have a greater size than the protrusions of the first circumferential row 82’, and the protrusions of the third circumferential row 86’ have a greater size than the protrusions of the second circumferential row 84’. This with the taper in the throughbore 16 means that the distance between crowns of opposing protrusions of the rows 82, 84, 86 is substantially the same. The distance is substantially equal to the outer diameter of the catheter tube, meaning that the catheter tube is well supported by the protrusions of the catheter funnel 10’ when the catheter tube is inserted horizontally into the catheter funnel 10’ during assembly. Accordingly, the catheter tube can be maintained coaxial with the funnel as the adhesive solidifies. The protrusions of the first and third circumferential rows 82’ and 86’ are circumferentially aligned, and the protrusions of the second circumferential row 84’ are circumferentially offset from the protrusions of the first and third circumferential rows 82’, 86’.

[0114] Referring now to Figures 8 and 9, there is shown a catheter funnel 10” according to a third embodiment of the present invention. The construction of the catheter funnel 10’ ’ is similar to the catheter funnel 10, and the same reference numerals have been used with the addition of two apostrophes. In this embodiment, the formation 40” comprises four protrusions 41”, where each protrusion 41” comprises a wedge. Each wedge has two sides 46”, 47” that meet at a free edge of the protrusion, which comprises the radial extremity 42” of the protrusion 41”. The side 47” of the wedge located closest to the entrance 12” has a greater area than the other side 47”, and thereby forms a ramp. In this embodiment, the free edge is rounded, and the sides 46”, 47” are connected at connected edges 48” to a remainder of the funnel 10”. As shown the connected edges 48” are substantially semicircular.

[0115] Referring now to Figure 10, there is shown (in section) a catheter funnel 10’” according to a fourth embodiment of the present invention. The construction of the catheter funnel 10” ’ is similar to the catheter funnel 10, and the same reference numerals have been used with the addition of three apostrophes. In this embodiment, the formation 40’” comprises a single annular recess which extends around the inner circumference 38’” of the catheter funnel. The recess 40’” serves to capture adhesive acting on the funnel 10’” and catheter tube (not shown) therein. The captured adhesive within the recess 40” provides significant longitudinal resistance to the catheter tube being withdrawn from the funnel 10’” in that the captured adhesive must escape the recess for the catheter tube to be withdrawn from the funnel 10’”.

[0116] When using the catheter assembly 100, the user firstly inserts the end of the catheter tube opposite the funnel into their urethra and pushes the catheter tube 101 along the urethra until the catheter tube is in communication with the bladder. Urine is then discharged from the bladder via the catheter tube 101. The user is able to direct the urine leaving the catheter tube into a collection receptacle (such as a toilet) using the catheter funnel 10.

[0117] How the catheter assembly 100 of Figure 1 may be manufactured will now be described. Firstly, the catheter funnel 10 and catheter tube 101 are provided. In this embodiment, providing the catheter funnel 10 comprises actually forming the catheter funnel 10, and the catheter funnel is formed by moulding the catheter funnel (using injection moulding). Providing the catheter tube 101 comprises forming the catheter tube 101, and the catheter tube is formed by extruding plastic.

[0118] A first portion of the catheter tube 101 coated with UV curable adhesive is then inserted into the throughbore 16 of the catheter funnel 10 via the entrance 12 such that the UV curable adhesive is in contact with the catheter funnel 10 and the catheter tube 101, and at least some of the adhesive is forced into the space behind the protrusions 41. In this embodiment, the catheter tube 101 is inserted in a horizontal direction until the catheter tube abuts the abutment 50 and the protrusions 41 mean that the catheter tube 101 is held in a straight position on the central axis of the funnel 10 as the catheter tube 101 is supported by the protrusions 41.

[0119] In this embodiment, the catheter tube 101 is transparent and ultra-violent light is then shone down the catheter tube 101 to cure the UV curable adhesive such that the UV cured adhesive bonds the funnel 10 and catheter tube 101 together to form the catheter assembly 100. An identical method is used to manufacture the other embodiments.

[0120] In the present invention, the formation provides longitudinal resistance to the catheter being withdrawn from the catheter funnel in that hardened adhesive caught in or behind the formation must overcome the formation for the catheter tube to be withdrawn from the catheter funnel. Th present invention therefore mechanically improves the strength of the connection between the funnel and catheter tube provided by the adhesive, meaning that the catheter funnel may be formed from a wider range of materials without the use of an additional process such as corona treatment. This means that the catheter funnel and catheter tube may each be formed from a non-PVC material relatively easily. As a non-PVC material may be used, catheter assemblies of the present invention may be more easily recycled.

[0121] The formation also provides an increase in bonding area available for the adhesive, thereby further improving the strength of the connection between the catheter funnel and catheter tube. The separation of the formation from the entrance means that the formation does not inhibit the passage of the adhesive into the funnel during assembly, meaning the adhesive is well distributed within the funnel once assembled to provide improved strength.

[0122] Very advantageously, the assembly of the present invention can be assembled with little changes to existing and relatively simple production processes. This reduces the cost associated with using different materials for the catheter tube and catheter funnel and makes it much easier to use such different materials because for the most part existing manufacturing equipment can be used.

[0123] It is preferred to use a UV adhesive in the present invention as this is used in the applicant’s existing processes to attach a catheter funnel to a catheter tube. However, the invention mechanically improves the strength of the connection between the catheter funnel and catheter tube, and is therefore applicable to other methods of manufacture which use different adhesives such as pressure sensitive or heat-cured adhesive.

[0124] It is preferred to use a formation comprising one or more protrusions. However, a formation comprising one or more recesses also provides improved strength in the longitudinal direction by capturing adhesive therein as described above.

[0125] 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. A urinary catheter assembly comprising: a catheter tube; and a catheter funnel, the catheter funnel having: a catheter receiving portion defining an inner circumference within which the catheter tube is located; and the inner circumference comprising a formation that is separated from an entrance and an exit of the catheter funnel, wherein the catheter tube is secured inside the funnel by adhesive, which acts on the catheter tube and the formation.

2. The urinary catheter assembly of claim 1, further comprising a throughbore extending between the entrance and exit.

3. The urinary catheter assembly of claim 2, wherein the formation is closer to the entrance than the exit, wherein the throughbore tapers from the entrance towards the formation.

4. The urinary catheter assembly of claim 2 or 3, wherein the funnel has an internal profile defining the throughbore, wherein the formation comprises one or more discontinuities in the internal profile.

5. The urinary catheter assembly of any preceding claim, wherein the formation comprises one or more elements, wherein the one or more elements comprises a single element or a plurality of elements, wherein the or each element or one or more of the plurality of elements is a recess or protrusion.

6. The urinary catheter assembly of claim 5, wherein the or each element or one or more of the plurality of elements has a longitudinal length dimension (LLD) measured in a direction parallel to a longitudinal axis of the throughbore, wherein the LLD is smaller than a diameter of the entrance of the catheter funnel7. The urinary catheter assembly of claim 5 or 6, wherein the or each element or one or more of the plurality of elements has a surface area, wherein the surface area is less than an entrance area of the entrance.

8. The urinary catheter assembly of any of claims 5 to 7, wherein the or each element or one or more of the plurality of elements comprises a converging surface that converges in a radial direction.

9. The urinary catheter assembly of any of claims 5 to 8, wherein the or each element or one or more of the plurality of elements extends to a radial extremity thereof.

10. The urinary catheter assembly of claim 9 when dependent on claim 8, wherein the converging surface converges in the radial direction to the radial extremity. 11.The urinary catheter assembly of any of claims 5 to 10, wherein there are a plurality of elements.

12. The urinary catheter assembly of claim 11, wherein the plurality of elements are spaced apart.

13. The urinary catheter assembly of any preceding claim, wherein the catheter funnel further comprises an abutment, wherein the abutment is for the catheter tube, wherein the formation is located between the abutment and the entrance.

14. The urinary catheter assembly of claim 13, wherein the formation is spaced from the abutment.

15. The urinary catheter assembly of claim 13 or claim 14, wherein there is a longitudinal midpoint between the abutment and the entrance, wherein a greater amount of the adhesive is located between the longitudinal midpoint and the entrance than between the longitudinal midpoint and the abutment.

16. The urinary catheter assembly of claim 15, wherein at least a majority of the formation is located between the longitudinal midpoint and the entrance.

17. The urinary catheter assembly of any preceding claim, wherein the catheter tube has a catheter tube outer circumference, wherein the adhesive surrounds a portion of the catheter tube outer circumference, wherein the adhesive comprises a substantially annular region within which the portion of the catheter tube outer circumference is located, wherein the annular region has a maximum thickness, wherein the maximum thickness of the annular region is more than or equal to 30%, 40%, 50%, 60%, 70%,80%, 90%, 100%, 110%, 120%, 130%, 140%, 150% of a wall thickness of the catheter tube.

18. The urinary catheter assembly of any preceding claim, wherein the catheter funnel is formed from a funnel material, wherein the funnel material has a Shore Hardness D value (HD) in the range of 37 to 47.

19. The urinary catheter assembly of any preceding claim, wherein the catheter tube is formed from a tube material, wherein the tube material has a Shore Hardness Scale A (HA) value in the range of 76 to 86.

20. A catheter funnel for use in the urinary catheter assembly of any preceding claim, the catheter funnel having: a catheter receiving portion having an inner circumference within which a catheter tube is located in use, the inner circumference of the catheter receiving portion comprising a formation that is separated from an entrance and an exit of the catheter funnel.

21. The catheter funnel of claim 20, further comprising a throughbore extending between the entrance and exit, wherein the formation is closer to the entrance than the exit, wherein the throughbore tapers from the entrance towards the formation.

22. The catheter funnel of claim 20 or 21, wherein the formation comprises one or more elements, wherein the one or more elements comprises a single element or a plurality of elements, wherein the or each element or one or more of the plurality of elements is a recess or protrusion.

23. The catheter funnel of claim 22 when claim 22 is dependent on claim 21, wherein the or each element or one or more of the plurality of elements extends to a radial extremity thereof wherein the or each element or one or more of the plurality of elements slopes from the radial extremity in a first direction co-directional with a longitudinal axis of the throughbore, wherein the or each element or one or more of the plurality of elements slopes from the radial extremity in a second direction opposite the first direction.

24. The catheter funnel of claim 22 or 23, wherein there are a plurality of elements, wherein the plurality of elements are spaced apart.

25. The catheter funnel of any of claims 22 to 24, wherein the or each element or one or more of the plurality of elements comprises a converging surface that converges in a radial direction.

26. The catheter funnel of any of claims 20 to 25, wherein the funnel further comprises an abutment, wherein the abutment is for the catheter tube, wherein the formation is located between the abutment and the entrance.

27. The catheter funnel of claim 26, wherein the formation is spaced from the abutment.

28. The catheter funnel of claim 26 or 27, wherein there is a longitudinal midpoint between the abutment and the entrance, wherein at least a majority of the formation is located between the longitudinal midpoint and the entrance.

29. The urinary catheter assembly of any of claims 20 to 28, wherein the catheter funnel is formed from a funnel material, wherein the funnel material has a Shore Hardness D value (HD) in the range of 37 to 47.

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