Intermittent catheter

Abstract

A catheter assembly (1) comprising a catheter assembly body (10), the catheter assembly body (10) comprising a seat (70); a movable insert, the movable insert (14) comprising a tubular body with a deformable first end (16); and a catheter tube (121). In a first position the movable insert (14) is arranged radially within the catheter assembly body (10) and the catheter tube (121) is arranged radially within the movable insert (14), and the seat (70) bears against the first end of the movable insert (16), deforming the first end of the movable insert (16) such that the first end of the movable insert (16) grips the catheter tube (121). In a second position the movable insert (14) is disengaged from the seat (70) such that the first end of the movable insert (16) releases the catheter tube (121).

Description

[0001] Intermittent Catheter

[0002] Technical Field of the Invention

[0003] The present invention relates to an intermittent catheter (e.g. a urinary catheter).

[0004] Background to the Invention

[0005] A catheter is a medical device comprising a hollow catheter tube designed for insertion into canals, vessels, passageways or body cavities to permit injection, drainage or withdrawal of fluids or substances therefrom, or to ensure said canals, vessels, passageways etc. remain open. Urinary catheters are designed for use for insertion into a user’s bladder via the urethra to drain the bladder.

[0006] To maximise comfort and minimise the risk of trauma and / or infection, an outer surface of the catheter tube is typically wetted using a wetting agent prior to insertion by the user. In further developments, the catheter tube itself comprises, is integrated with or is coated with a hydrophilic component (e.g. a hydrophilic polymer) which serves to reduce friction further upon application of the wetting agent.

[0007] Some catheters may be supplied pre-wetted in a packaging, for instance, where the catheter is at least partially submerged within wetting agent within the packaging. Whilst this may ensure the catheter tube is adequately wetted prior to use, such arrangements suffer in that components of the catheter other than the catheter tube such as a gripper element or funnel can also become wetted. This has a detrimental effect of the experience of the user where it may become difficult to hold and direct the catheter tube as required. This is particularly problematic where the user is performing self-catheterisation. Further, having the catheter submerged may effectively reduce the shelf-life of the catheter due to long-term exposure of components of the catheter to moisture.

[0008] It is therefore seen advantageous to provide a catheter which may be wetted at or immediately prior to the point of use. In an attempt to address this, some catheters are provided in packaging which includes a rupturable container or sachet within the packaging which a user may burst to release the wetting agent. Typicaly, this involves the user squeezing the packaging to cause the container / sachet to break. However, such arrangements experience similar problems to those discussed above where the wetting agent is allowed to come into contact with other components of the catheter. Such arrangements also result in the possibility of the catheter tube not being fully wetted, or indeed wetted at all, prior to use. This can be harmful for the user. Furthermore such systems may require a degree of dexterity and offer no feedback to ensure wetting has occurred.

[0009] It is therefore advantageous to provide a cathater which includes a means of supplying a wetting agent solely to the catheter tube to improve user experience.

[0010] In further prior art solutions, the catheter may be packaged within a packaging which includes a wetting device. In use, the catheter tube may be moved through the wetting device as the catheter is removed from the packaging and in doing so wetting the catheter tube. Examples of such catheters are shown in PCT application No. PCT / IB2018 / 001539 in the name of ConvaTec Limited.

[0011] However, due to packaging constraints the amount of wetting agent able to be contained in such wetting devices is low, and there therefore remains a possibility of the catheter tube not being fully wetted in such solutions, especially where the catheter is near the end of its shelf life and some of the solution may have evaporated.

[0012] For mechanisms which wet the catheter tube from the distal end, an insufficient volume of wetting agent may result in the tip end not being wetted at all which is undesirable since the tip end will be introduced into the urethra first and is hence most likely to cause injury if inadequately wetted before use.

[0013] It is an aim of an embodiment or embodiments of the invention to overcome or at least partially mitigate one or more problems with the prior art and / or to provide an improved intermittent catheter. Summary of the Invention

[0014] The present invention provides a catheter assembly according to the appended claims.

[0015] According to a broad aspect of the disclosure there is provided a catheter assembly. The catheter assembly may comprise a catheter assembly body. The catheter assembly body may comprise a seat. The catheter assembly may comprise a movable insert. The movable insert may comprise a tubular body. The tubular body may have a deformable first end. The catheter assembly may comprise a catheter tube. In a first position the movable insert may be arranged radially within the catheter assembly body. In a first position the catheter tube may be arranged radially within the movable insert. In the first position the seat may bear against a first end of the movable insert. In the first position the seat bearing against the first end of the movable insert may deform the first end of the movable insert. The deformed first end of the movable insert may grip the catheter tube. In a second position the movable insert may be disengaged from the seat. In a second position the first end of the movable insert may release the catheter tube.

[0016] According to a first aspect of the disclosure there is provided a catheter assembly comprising: a catheter assembly body, the catheter assembly body comprising a seat; a movable insert, the movable insert comprising a tubular body with a deformable first end; and a catheter tube; wherein in a first position the movable insert is arranged radially within the catheter assembly body and the catheter tube is arranged radially within the movable insert, and wherein the seat bears against the first end of the movable insert, deforming the first end of the movable insert such that the first end of the movable insert grips the catheter tube; and wherein in a second position the movable insert is disengaged from the seat such that the first end of the movable insert releases the catheter tube.

[0017] Advantageously, by gripping the catheter whilst the assembly is in a first position, the position of the catheter relative to the wetting agent storage chamber can be ensured and this can improve consistency in the wetting process. Furthermore, it hinders or restricts the deployment of the catheter until the wetting agent storage chamber has been opened (and thus the catheter is wetted). The first end of the movable insert may comprise a hole. The first end of the movable insert may comprise a slot. The hole may taper in width. The slot may taper in width.

[0018] Accordingly, one embodiment of the disclosure provides a catheter assembly comprising: a catheter assembly body, the catheter assembly body comprising a seat; a movable insert, the movable insert comprising a tubular body with a deformable first end; and a catheter tube; wherein in a first position the movable insert is arranged radially within the catheter assembly body and the catheter tube is arranged radially within the movable insert, and wherein the seat bears against the first end of the movable insert, deforming the first end of the movable insert such that the first end of the movable insert grips the catheter tube; and wherein in a second position the movable insert is disengaged from the seat such that the first end of the movable insert releases the catheter tube; wherein the first end of the movable insert comprises a hole or slot, the hole or slot tapering in width.

[0019] The hole may be wider proximate to an end of the first end. The slot may be wider proximate to an end of the first end. The first end of the movable insert may comprise at least two holes. The two holes may be on opposing sides of the tubular body. The first end of the movable insert may comprise at least two slots. The two slots may be on opposing sides of the tubular body. The first end of the movable insert may comprise two arms separated by two slots tapering in width. The two slots may define two gaps between the two arms. In the first position the two arms may bear against the seat the reduce the separation between the two arms. The arms may comprise a bearing projection to bear against the seat. The two arms may be provided with apertures. The apertures may extend between a radially inner face which engages with the catheter and a radially outer face which engages with the seat. The one, or more, or each slot may extend from a terminal edge of the first end of the movable insert. The one, or more, or each slot may comprise a first untapered portion and a second tapered portion. The first untapered portion may be proximate to a terminal edge of the first end of the movable insert.

[0020] Advantageously, by tapering the hole or slot, ease of assembly of the catheter assembly is improved as it reduces or eliminates the occurrence of the catheter tip becoming caught in the hole or slot as it is inserted. This is particularly beneficial where the catheter has a relatively small diameter, or has a shaped tip, for example a Coude-type tip.

[0021] The first end of the movable insert may comprise a first section. The first section may have a first cross-sectional area. The first end of the movable insert may comprise a second section. The second section may have a second cross-sectional area. The first cross-sectional area and the second cross-sectional area may be different. The first cross-sectional area may be greater than the second cross-sectional area. The first and / or second cross-sectional area may be measured perpendicular to a longitudinal axis of the catheter assembly. The one, or more, or each hole may extend through the first and second sections. The one, or more, or each slot may extend through the first and second sections.

[0022] Where the first end of the movable insert comprises a first section having a first cross-sectional area, and a second section having a second cross-sectional area it is advantageous for the slot or hole to extend through both sections as this allows the wetting agent to flow on to the catheter without having to flow over the step between the first and second sections where wetting agent may become trapped.

[0023] The one, or more, or each hole may be elongate. The one, or more, or each hole may have a length (measured axially along the movable insert), greater than its width (measured circumferentially around the movable insert).

[0024] A radially outer wall of the first end of the movable insert may comprise at least one bearing projection. The one, or more, or each bearing projection may comprise a circumferentially extending element. The one, or more, or each bearing projection may comprise an axially extending element. There may be at least two bearing projections. There may be at least three, four, five or six bearing projections.

[0025] Accordingly, one embodiment of the disclosure provides a catheter assembly comprising: a catheter assembly body, the catheter assembly body comprising a seat; a movable insert, the movable insert comprising a tubular body with a deformable first end; and a catheter tube; wherein in a first position the movable insert is arranged radially within the catheter assembly body and the catheter tube is arranged radially within the movable insert, and wherein the seat bears against the first end of the movable insert, deforming the first end of the movable insert such that the first end of the movable insert grips the catheter tube; and wherein in a second position the movable insert is disengaged from the seat such that the first end of the movable insert releases the catheter tube; wherein a radially outer wall of the first end of the movable insert comprises at least one bearing projection, the at least one bearing projection comprising a circumferentially extending element and an axially extending element

[0026] The provision of bearing projections improves the deformation of the deformable first end of the movable insert. The bearing projection increases the diameter of the movable insert where it is provided, thereby increased the deflection of the deformable movable insert when it is in the first position. The increased deflection is particularly beneficial for smaller diameter catheters, although an increased deflection increases the force with which any catheter is retained thereby reducing the risk of premature release of the catheter. Advantageously, the circumferentially extending element reduces the need to align the bearing projection with the seat. Advantageously, the axially extending element reinforces the movable insert increasing the area over which the deflection is applied, this reduces the risk of failure of the deformable portion and increases the amount of force which can be applied. The axially extending element may also ease assembly of the catheter assembly, it may help to guide the movable insert in a particular orientation within the catheter assembly housing. For example, where seat projections are provided, the axially extending element may guide the circumferentially extending element isn’t alignment with these.

[0027] The circumferentially extending element may intersect the axially extending element at a mid-point of the circumferentially extending element. The circumferentially extending element may intersect the axially extending element at an end of the axially extending element. That is to say, the one, or more, or each bearing projection may have a “T” shape. The circumferentially extending element may intersect the axially extending element at a point between the ends on the axially extending element. That is to say, the one, or more, or each bearing projection may have an overall “+” or “cross” shape.

[0028] The first end of the movable insert may comprise two opposing holes. The first end of the movable insert may comprise two opposing slots. Two opposing bearing projections may be arranged between the two holes. Two opposing bearing projections may be arranged between the two slots. The circumferentially extending element may extend between the two holes. The circumferentially extending element may extend between the two slots.

[0029] By providing the bearing projections between two slots the bearing projections can deform the movable insert into the hole or gap created by the slot.

[0030] The circumferentially extending element may extend between 10% and 90% of the distance between the two holes or slots, preferably between 20% and 60% of the distance between the two holes or slots, more preferably between 25% and 50% of the distance between the two holes or slots, for example between 30% and 40% of the distance between the two holes or slots, such as between 35% and 40% of the distance between the two holes or slots, i.e. 38% of the distance between the two holes or slots.

[0031] The radial extent to which the circumferentially extending element projects may vary across the length thereof. The greatest radial extent of the circumferentially extending element may be at the mid-point of the circumferentially extending element. The radial extent of the circumferentially extending element may taper towards the ends thereof. The radial extent of the circumferentially extending element may have a curved profile. The curved profile of the circumferentially extending element may, in combination with a profile of the first end of the movable insert may define an elliptical shape. The circumferentially extending element may be symmetric about a line defined by the axially extending element.

[0032] By providing the circumferentially extending element of the bearing projection with a curved profile, and in particular, where in combination with the profile of the first end of the movable insert define an elliptical shape, the force applied to grip the catheter can be applied in a direction perpendicular to the radial maxima of the circumferentially extending element, preferentially deforming the movable insert in a “pincer” fashion.

[0033] The axially extending element may comprise a first bevelled end. The axially extending element may comprise a second bevelled end. Where the first end of the movable insert has a first section having a first cross-sectional area and a second section having a second, different, cross-sectional area, the axially extending element may extend over both sections. Where the first end of the movable insert has a first section having a first cross-sectional area and a second section having a second, different, cross-sectional area, the axially extending element may extend over at least one of the first and second sections and a sloping portion between the two sections.

[0034] The provision of bevelled ends to the axially extending element allows for smooth transitions as the movable insert moves between the first and second positions. It may also allow for ease of assembly, allowing for the movable insert to be inserted into the catheter assembly body and being the deformation.

[0035] Edges of the one, or more, or each bearing projection may be rounded. An interface between the projections and the radially outer wall of the first end of the movable insert may be rounded. The provision of rounded edges on the projections is beneficial as due to surface tension wetting agent can become trapped on abrupt edges and thus cannot wet the catheter. The provision of rounded edges increases the efficiency of the wetting, reducing the amount of wetting agent required to fully wet the catheter.

[0036] A radially inner wall of the seat may comprise at least one seat projection. The one, or more, or each seat projection may project radially inwards. The one, or more, or each seat projection may extend axially. The one, or more, or each seat projection may comprise one or more, pips, fins, ridges, columns or pedestals. The one, or more, or each seat projection may be a rib.

[0037] Accordingly, one embodiment of the disclosure provides a catheter assembly comprising: a catheter assembly body, the catheter assembly body comprising a seat; a movable insert, the movable insert comprising a tubular body with a deformable first end; and a catheter tube; wherein in a first position the movable insert is arranged radially within the catheter assembly body and the catheter tube is arranged radially within the movable insert, and wherein the seat bears against the first end of the movable insert, deforming the first end of the movable insert such that the first end of the movable insert grips the catheter tube; and wherein in a second position the movable insert is disengaged from the seat such that the first end of the movable insert releases the catheter tube, wherein a radially inner wall of the sear and / or a radially inner wall of the first end of the movable insert comprise at least one projection.

[0038] Advantageously, the provision of seat projections can increase the amount of deformation in the first end of the movable insert, thereby increasing the retaining force.

[0039] Where the seat projection is an axially extending rib a first end of the rib may be bevelled. The catheter assembly body may comprise a first open end though which the catheter tube enters the catheter assembly body. The catheter assembly body may comprise a second open end through which the catheter tube exits the catheter assembly body. The bevelled first end of the seat projection may be proximate to the second open end of the catheter assembly body. As the separation of the seat projections is less that the diameter of the deformable portion, the bevelled first end of the seat allows the movable insert to be mounted within the seat projections.

[0040] The catheter assembly body may comprise at least two seat projections. The catheter assembly body may comprise at least four seat projections. The four seat projections may be provided in two pairs. Each pair of seat projections may have an angular separation of between 10 and 90 degrees, preferably between 20 and 80 degrees, more preferably between 30 and 70 degrees, for example between 40 and 60 degrees, such as between 45 and 55 degrees, i.e. 50 degrees. The two pairs of seat projections may be symmetric.

[0041] Where the catheter assembly comprises one or more bearing projections, the, or each, seat projection may be aligned with a corresponding bearing projection. The seat projections may be aligned with the circumferentially extending elements of the bearing projections. When the movable insert is in the first position, the one or more bearing projections may bear against the one or more seat projections. When the movable insert is in the second position. The one or more bearing projections may be axially misaligned with the one or more seat projections.

[0042] By aligning one or more bearing projections with correspond seat projections the force applied to the catheter can be tailored by adjusting the sizes of these components without the need to modify the overall structure of movable insert or the catheter assembly body.

[0043] A radially inner wall of the first movable end of the movable insert may comprise at least one grip projection. The one, or more, or each grip projection may project radially inwards. The one, or more, or each grip projection may extend axially. The one, or more, or each grip projection may comprise one or more, pips, fins, ridges, columns or pedestals. The one, or more, or each grip projection may be a rib.

[0044] The provision of grip projections is advantageous as it reduces the separation between the movable insert and the catheter, increasing the retention of the catheter. Furthermore, it allows the assembly to be more easily modified to suit different diameter catheters without the need to modify the catheter assembly body for example. Additionally, it reduces the contact area between the catheter and the movable insert thereby reducing the risk of damage to the catheter.

[0045] There may be at least two grip projections. There may be at least four grip projections. There may be at least six grip projections. The grip projections may at the same axial location on the first end of the movable insert as the holes or slots.

[0046] Where the first end of the movable insert has a first section having a first cross-sectional area and a second section having a second, different, cross-sectional area, the first section may have a first diameter, and the second section may have a second, larger, diameter. The grip projections may project radially inwards from the second section. The grip projections may project radially inwards from the second section such that radially inner faces of the projections are flush with a radially inner surface of the first section. The grip projections may be made of a softer material than the catheter tube. The grip projections may be over moulded. The grip projections may be thermoplastic elastomer, EVA, PU or silicone.

[0047] By making the grip projections of a material softer than the catheter tube, damage to the catheter tube from storage can be avoided, it also allows the grip projections to be more readily deformed this may allow the same catheter assembly to be used for a variety of catheter diameters, simplifying manufacture.

[0048] The first end of the movable insert may define a catheter channel. The catheter channel may be a tubular portion through which the catheter passes. The catheter channel may comprise a first section having a first cross-sectional area. The catheter channel may comprise a second section having a second cross-sectional area. The first cross-sectional area may be different to the second cross-sectional area. The second cross-sectional area may be greater than the first cross-sectional area.

[0049] As the movable insert is moved to the second position and the movable insert becomes misaligned with the seat a volume may open up between the movable insert and an inner wall of the catheter assembly body where wetting agent could become trapped. By providing a second section of the first movable insert with a larger cross- sectional area, this volume can be reduced, limiting or eliminating the amount of wetting agent that becomes trapped.

[0050] Accordingly, one embodiment of the disclosure provides a catheter assembly comprising: a catheter assembly body, the catheter assembly body comprising a seat; a movable insert, the movable insert comprising a tubular body with a deformable first end; and a catheter tube; wherein in a first position the movable insert is arranged radially within the catheter assembly body and the catheter tube is arranged radially within the movable insert, and wherein the seat bears against the first end of the movable insert, deforming the first end of the movable insert such that the first end of the movable insert grips the catheter tube; and wherein in a second position the movable insert is disengaged from the seat such that the first end of the movable insert releases the catheter tube, wherein the first end of the movable insert defines a catheter channel, the catheter channel comprising a first section having a first cross- sectional area and a second section having a second, different, cross-sectional area. The second section may be arranged between the first section and an open end of the movable insert. The first end of the movable insert may comprise a sloped section. The sloped section may be arranged between the first and second sections.

[0051] The provision of a sloped section is advantageous as it helps to guide the catheter into the catheter assembly during manufacture.

[0052] The sloped section may have a sloped radially inner wall. The sloped section may have a sloped radially outer wall. A radially outer wall of the second section may have the same diameter as a radially inner wall of the seat.

[0053] By providing a radially outer wall of the second section that has the same diameter as a radially inner wall of the seat, the second section can when the movable insert is in the second position, provide a seal against the inner wall of the seat, ensuring the wetting agent is directed towards the tip of the catheter.

[0054] The catheter assembly body may be the external housing. The catheter assembly body may be a wetting chamber. The movable insert may be an inserter or inserter tip.

[0055] The deformable first end may be resiliently deformable.

[0056] The seat may comprise a divergent portion over which the deformable first end passes when transitioning between the first position and second position such that the distance between the movable insert and seat at the axial location of the rib is increased when in the second position when compared to the first position. The distance may be a radial distance with respect to the longitudinal axis. The divergent portion may comprise a widening of a cavity adjacent to the seat. The cavity may be that of a wetting agent storage chamber and / or an adjacent chamber. The adjacent chamber may be provided within the catheter assembly body. The adjacent chamber may house the catheter tube. The adjacent chamber may be a priming chamber or a wetting chamber.

[0057] The divergent portion may comprise a step, a chamfer, or a slope.

[0058] The catheter assembly may further comprise a wetting agent storage chamber. The wetting agent storage chamber may be defined by the catheter assembly body and the movable insert. In the first position the wetting agent storage chamber may be sealed. In the second position the wetting agent storage chamber may be open.

[0059] The catheter tube may be gripped with an insertion end proximal to an opening in the wetting agent storage chamber.

[0060] The movable insert may be movable along an axis relative to the catheter assembly body between the first position and the second position.

[0061] The catheter assembly may further comprise an aperture through which the movable insert extends from an interior of the catheter body assembly to an exterior of the catheter body assembly. The aperture may be the seat.

[0062] The catheter tube may be functionalised. For example it may comprise, be integrated with or be coated with a hydrophilic component (e.g. a hydrophilic polymer). The hydrophilic component serves to reduce friction further upon application of the wetting agent. At least an external surface of the catheter tube may be functionalised, e.g. the hydrophilic component may be provided on at least an external surface of the catheter tube (which is in contact with the urethra in use). The catheter may comprise a main flow path for the passage of urine. The main flow path may extend along and define a longitudinal axis of the catheter. The main flow path may be provided by a wall of catheter tube. The main flow path may have a proximal inlet at an insertion end of the catheter, and a distal outlet.

[0063] The catheter may comprise an outlet body. The outlet body may incorporate the terminal end of the catheter tube. The outlet body may comprise the external handling surface of the catheter. The outlet body may comprise one or more flow enhancing features for aiding the flow from catheter tube. The one or more flow enhancing features may comprise a funnel, for example.

[0064] The outlet body may comprise or be referred to as a connector which connects the outlet end, e.g. a funnel and / or the external handling features, and the catheter tube.

[0065] The catheter assembly may further comprise a sheath. The sheath may surround the catheter. The sheath may define a cavity in which a portion of the catheter is contained. The sheath may be a retractable sheath. The retractable sheath may be configured to be retracted during insertion of the catheter such that it provides a temporary enclosure around the catheter tube prior to insertion.

[0066] According to a second aspect of the disclosure there is provided a method of manufacturing a catheter assembly comprising: a catheter assembly body, the catheter assembly body comprising a seat; a movable insert, the movable insert comprising a tubular body with a deformable first end; and a catheter tube, the method comprising: inserting the movable insert into the catheter assembly body; inserting the catheter tube into the movable insert; moving the movable insert into a first position wherein the seat bears against the first end of the movable insert, deforming the first end of the movable insert such that the first end of the movable insert grips the catheter tube. The catheter assembly of the second aspect of the disclosure may be the catheter assembly of first aspect of the disclosure, optionally including any optional features thereof.

[0067] Where the catheter assembly comprises a wetting agent storage chamber, the method may further comprise filling the wetting agent storage chamber with a wetting agent.

[0068] Where the catheter assembly comprises a sheath, the method may further comprise attaching the sheath to the catheter assembly body.

[0069] The sheath may be attached to prior to filling the wetting agent storage chamber. The sheath may be attached after the filling of the wetting agent storage chamber.

[0070] According to a third aspect of the disclosure there is provided a method of deploying a catheter from a catheter assembly, the catheter assembly comprising: a catheter assembly body, the catheter assembly body comprising a seat; a movable insert, the movable insert comprising a tubular body with a deformable first end; and a catheter tube; wherein in a first position the movable insert is arranged radially within the catheter assembly body and the catheter tube is arranged radially within the movable insert, and wherein the seat bears against the first end of the movable insert, deforming the first end of the movable insert such that the first end of the movable insert grips the catheter tube; the method comprising: moving the movable insert to a second position where the movable insert is disengaged from the seat such that the first end of the movable insert releases the catheter tube.

[0071] The catheter assembly of the third aspect of the disclosure may be the catheter assembly of first aspect of the disclosure, optionally including any optional features thereof.

[0072] The method may further comprise releasing a wetting agent from a wetting agent storage chamber when the movable insert is moved to the second position. The wetting agent may be directed onto the catheter tube.

[0073] The movable insert may be an inserter. The inserter may comprise an inserter tip. The method may further comprise inserting the inserter tip into a urethra. The method may further comprise guiding the catheter through the inserter and into the urethra to the bladder. The method may further comprise draining the bladder via the catheter.

[0074] Detailed Description of the Invention

[0075] 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:

[0076] Figure 1 shows a perspective view of a catheter assembly according to an embodiment of the disclosure;

[0077] Figure 2 shows a longitudinal sectional view of the catheter assembly of Figure 1 in a closed or sealed configuration;

[0078] Figure 3 shows a perspective view of a movable insert of the catheter assembly of Figure 1;

[0079] Figure 4 shows an enlarged perspective view of the bearing projections of the movable insert of Figure 3;

[0080] Figure 5 shows an enlarged longitudinal sectional view of the movable insert of Figure 3 detailing a first end thereof; Figure 6 shows a projection view of the first end of the movable insert of Figure 5;

[0081] Figure 7 shows a cross-sectional view of an external housing of the catheter assembly of Figure 1;

[0082] Figure 8 shows a projection view of a distal end of the catheter assembly of Figure 1 ; and

[0083] Figure 9 shows a longitudinal sectional view of the catheter of Figure 1 in an open or deployed configuration.

[0084] With reference to figures 1-9, a catheter assembly 1 according to the present invention is described.

[0085] Referring to figures 1 and 2, the catheter assembly 1 comprises an external housing 10, a cap 140, a sheath 180 and a catheter 120 (dashed in figure 2). The catheter assembly 1 may be configured such that the catheter 120 may be wetted prior to being withdrawn from the external housing 10. A wetting mechanism may be provided within the external housing 10.

[0086] Referring to figures 2 and 7, the external housing or catheter assembly body 10 has a tubular shape with a radially outer surface 8, a radially inner surface 9, an open cap end 11 and an open catheter end 12. The outer surface 8 of the external housing comprises a textured portion 13 to improve grip, in this embodiment provided by a plurality of ribs extending circumferentially around and radially outward of the outer surface 8. The textured portion 13 extends from the cap end 11 to the catheter end 12. In some embodiments the textured portion 13 may be integrally formed with the outer surface 8, in other embodiments the textured portion 13 may be formed of a different material, for example one which provides increased grip when wet.

[0087] Referring to figures 2 and 3, within the external housing 10 and projecting from the open cap end 11 is a movable insert in the form of an inserter 14, the inserter 14 having an overall tubular shape and comprising an inserter tip 15 and a catheter gripper 16. The external housing 10 and inserter 14 are concentrically arranged such that the inserter 14 is located within the external housing 10 in a radially nested configuration. The inserter tip 15 is provided at a first end of the inserter 14 and closes the tubular body with a hemispherical end 15a, the hemispherical end 15a is provided with one or more apertures or openings such as slits (not shown) which allow the end 15a to be opened to allow passage of a catheter therethrough. The opposite end of the inserter 14 is provided with the catheter gripper 16, the structure and operation of which will be elaborated upon below.

[0088] In this embodiment the inserter 14 is arranged within the external housing 10 such that in the storage position (as will be elaborated upon below) the inserter tip 15 extends out of the cap end 11 and the catheter gripper 16 extends out of the catheter end 12 of the external housing 10.

[0089] In this embodiment the cap 140 is formed in two parts, a connecting part 141 and a removable part 150. The connecting part 141 has an annular shape with an aperture 142 through the centre, it is connected to the cap end 11 of the external housing 10. The removable part 150 has a tubular shape with an open end 151 and a closed end 152, the interior of the removable part 150 defines a cavity 153 shaped to receive the inserter tip 15. The cavity may be sized and shaped to closely conform to the inserter tip 15. The exterior of the removable part 150 is shaped to engage with the aperture 142 in the connecting part 141. On the exterior of the removable part 50 at the closed end 152 there is provided a grab loop 154 by which a user can grip the cap 40.

[0090] The catheter 120 is of a type known to the art, comprising a catheter tube 121 with an insertion end 122 and an opposing drainage end (not shown). The catheter tube 121 has a longitudinal axis A-A which can be taken to be the principal axis of the catheter assembly 10. Proximate to the insertion end 122 there may be provided one or more drainage apertures 133, in this embodiment the drainage apertures 133 are oval in shape with the major axis being parallel with the principal axis A-A. It will be appreciated that the size and shape of the drainage apertures 133 may differ.

[0091] The exterior surface of the catheter tube 121 may be, as is known in the art, functionalised such that when wetted by the wetting agent the co-efficient of friction of the catheter tube 121 is reduced. The outer surface of the catheter tube 121 may be comprised of, or coated in, a functionalising material; for example the outer surface of the catheter tube 121 may have hydrophilic properties. The hydrophilic properties serve to reduce the coefficient of friction of the outer surface when the wetting agent is introduced.

[0092] The catheter 120 and inserter 14 are concentrically arranged such that the insertion end 122 of the catheter 120 engages with the catheter gripper 16 with the distal end of the catheter 120 extending away from the inserter 14 as will be described in further detail below.

[0093] Arranged at the catheter end 12 of the external housing 10 is the sheath 180. The sheath 180 extends away from the external housing 10 so as to surround at least a part of the catheter tube 120. The sheath 180 is formed of a flexible material. In some embodiments, the sheath 180 is attached to the external housing in such a way as to provide a leak resistant seal. In some embodiments the distal end of the sheath (not shown) may be joined to a pouch for collection of the fluid discharged from the catheter, alternatively the sheath 180 and pouch may be integrally formed. The sheath may allow for fluid communication from the external housing 10 to the pouch.

[0094] Referring to figure 2, the arrangement of the external housing 10, inserter 14 and cap 140 are described in greater detail. The radially inner wall 9 of the external housing 10 is provided with a first step 34a proximate to the catheter end 12 such that the diameter of the inner wall 9 is reduced proximate to the catheter end 12. The first, wider, portion 9a of the inner wall 9 provides a first sealing surface 18 and the second, narrower, portion 9b of the inner wall 9 provides a second sealing surface 19. The internal diameter of the inner wall 9 is further reduced at the catheter end 12 edge by a further step 34b to form a third, narrowest, portion 9c.

[0095] The inserter 14 is radially nestled with the external housing 10. In this embodiment to ensure the alignment of the inserter 14 in the external housing the inserter 14 is provided with two pairs of ribs 21,22. In other embodiments the external housing may be provided with projections such as ribs.

[0096] In this embodiment a first (upper) pair of ribs 21 project circumferentially around, and radially outward, from the inserter 14 at a point approximately one third of the distance from the inserter tip 15a to the catheter gripper 16. The first pair of ribs 21 are sized such that they extend radially to the first sealing surface 18 of the external housing 10, the first pair of ribs 21 are formed from a single broader projection, the outer circumference of which is provided with a groove 21a with a depth equal to have the radial extent of the projection, this separates the projection into two equally sized ribs 21.

[0097] In this embodiment a second (lower) pair of ribs 22 project circumferentially around, and radially outward, from the inserter 14 at a point proximate to the catheter gripper 16. The second pair of ribs are sized such that they extend radially to the second sealing surface 19 of the external housing 10. The two ribs 22 of the second pair project separately from the inserter 14.

[0098] In this embodiment proximate to the first pair of ribs 21 are provided two cap tabs 23, the cap tabs 23 are two projections on opposing sides of the inserter 14. The cap tabs 23 have a rectangular base with the major edge normal to the principal axis A- A of the catheter assembly 1.

[0099] Between the second pair of ribs 22 and catheter grip end 16 the outer (and inner) diameter of the inserter increases at an inserter step 24 to form a flared section 25. In this embodiment, the outer diameter of the flared section 25 is equal to the inner diameter of the third section 9c of the external housing 10.

[0100] As best seen in figures 3 to 5, in this embodiment at the catheter gripper 16 end of the inserter two slots 30 extend from the edge of the inserter 14 parallel to the principal axis A-A of the catheter assembly 1. The two slots 30 define a gap between two gripper arms 31, the gripper arms 31 comprise a base 31a where they attach to the remainder of the inserter 14 and a free end 31b where the catheter 120 is inserted. The gripper arms 31 are configured to engage with the catheter tube 121 when the assembly 1 is in a storage configuration as will be expanded upon below.

[0101] In this embodiment, each slot 30 extends axially along the inserter 14 across the inserter step 24 and beyond the flared section 25. Each of the slots 30 are formed in two parts, a first part 30a proximate to the edge of the inserter and has a constant width, a second part 30b tapers, the first 30a and second 30b parts are separated by a width reducing step 30c. The second part 30b narrows away from the step 30c and terminates at a rounded end 30d. The provision of the first part 30a and the step 30c increases the separation between the two gripper arms 31 at their ends 31b which improves the degree by which the gripper arms 31 can be deformed without colliding with one another.

[0102] By providing slots 30 in the inserter 14 the structural rigidity of the inserter 14 proximate to the gripper arms 31 is reduced and the gripper arms 31 are deformable to vary the separation between the two arms 31. Additionally, the tapering of the slots 30 helps to guide the catheter 120 into the inserter 14 and prevent it catching on the slots, this is particularly beneficial where the catheter has a Coude-type tip which bends away from the centre.

[0103] The radially inner wall of the flared section 25 of the inserter is provided with a plurality of catheter grips 50 in the form of axially and radially extending projections 51. As can be seen in figure 5, in this embodiment there are six catheter grips 50 spaced equally about the circumference of the flared section 25. Each projection 51 along the entire axial extent of the flared section 25 and extends radially so as to be flush with the inner diameter of the remainder of the inserter 14. The ends of the projections 51 proximate to the free ends 3 lb of the grippers comprise a tapered edge 52 to prevent the catheter 120 becoming trapped on the projections 51 during assembly.

[0104] Arranged at the base 31a of each arm 31 on the radially outer side is a bearing projection 60 projecting radially outward. Each bearing projection 60 comprises an axially extending element 61 and a circumferentially extending element 62. In this embodiment, the axially extending element 61 extends over the step such that a lower portion 61b is arranged on the radially outer wall of the flared section 25 and an upper portion 61a is arranged on the radially outer wall of the remainder of the inserter 14. The circumferentially extending element 62 is arranged on the inserter step 24. The circumferentially 62 and axially 61 extending elements are perpendicular to one another and intersect to form a “cross”-shape. The axially extending element 61 intersects the midpoint of the circumferentially extending element 62, with the lower portion 61b being approximately twice the length of the upper portion 61a.

[0105] As seen in figures 3 to 6 the extent to which the bearing projections 60 project radially varies. The maximum radial extent (“height”) of the circumferentially extending element 62 is found at the point it intersects the axially extending element 61, the height of the circumferentially extending element 62 decreases away from this intersection, such that when combined, the outer profile of the circumferentially extending element 62 and the inserter step 24 have an oval cross section, perpendicular to the longitudinal axis A-A.

[0106] Likewise, the axially extending element 61 tapers towards the ends of the upper 61a and lower 61b portions. This, along with the rounding of the edges of the bearing projections 60 reduces the trapping of wetting agent in comers of the projections, increasing the percentage of water delivered to the catheter 120.

[0107] As shown in figures 7 and 8, the radially inner wall of the third portion 9c of the external housing 10 is provided with four seat projections 70. In this embodiment the seat projections 70 comprise axially extending ribs 71, the ribs 71 are provided in two rib pairs 72. The two ribs 71 in each rib pair 72 are arranged at an angle of 50°from one another. The two pairs 72 are arranged with a 130° separation. The end of the ribs facing the cap end 11 are tapered 73.

[0108] As noted above, the cap 140 is formed in two parts with the inner surface of the connector part 141 attached to the outer surface of the cap end 11 of the external housing 10. The connector part forms the end wall 64 of the external housing through which the aperture 142 is provided. In this embodiment the connector part 141 and external housing 10 are joined with a cantilever snap-fit connection, with corresponding projections and recesses on the connector part 141 and external housing 10. In other embodiments other methods of attachment may be used for example, adhesive, welding or interference fit.

[0109] Proximate to the open end 151 of the cap, there are provided a pair of rectangular apertures 159 the long axis of which extends circumferentially around the cap. The apertures 159 are sized and shaped to receive the cap tabs 23 of the inserter 14. About the apertures 159 the thickness of the wall of the connector part 141 increases with a chamfered step provided on the radially outer surface.

[0110] As shown in figure 2, when provided in the sealed configuration, for example for storage and shipping the inserter 14 is provided in a retracted position within the external housing 10. The first and second pairs of ribs 21, 22 bear against the sealing surfaces 18,19 of the radially inner wall 9 to align the inserter 14 within the external housing 10 such that they are radially nested.

[0111] Together the inner wall 9 of the external housing 10, outer surface of the inserter 14, and ribs 21,22 define a wetting agent storage chamber 80, the inserter 14 and external housing 10 defining the radial extent and the upper and lower ribs 21,22 the axial extent. The wetting agent storage chamber 80 contains a wetting agent, which in this embodiment is water.

[0112] In the sealed configuration the inserter 14 is inserted to the maximum extent into the external housing 14, and the second pair of ribs 22 abut the further step 34b restricting any further insertion.

[0113] The removable part 150 of the cap 140 is arranged on the inserter 14 such that the inserter tip 15 is within the cavity 153. The cap tabs 23 project into the apertures 159.

[0114] The removable part 150 of the cap 140 is also arranged through the aperture 142 in the connecting part 141 to seal the catheter assembly 10 and prevent wetting agent leaking.

[0115] During storage and transport the catheter 120 is retained within the external housing 10 by the catheter gripper 16. As shown in figure 7, the insertion end 122 is nested between the gripper arms 31 with the catheter grippers 50 bearing against the catheter tube 121. The bearing projections 60 bear against the seat projections 70, with the circumferentially extending element 62 bearing against both ribs 71 in a pair with the axially extending element 61 aligned with midway between the pair. Because of the bearing projections 60, at the catheter gripper 16 the inserter 14 has a diameter greater than the radially inner edges of the seat projections 70, the gripper arms 31 are therefore deformed radially inwards and bear against the insertion end 122 holding the catheter 120 in place. Securing the catheter 120 during storage is advantageous as it ensures the catheter 120 is in an optimal position prior to wetting and also that the catheter cannot be deployed without having been wetted.

[0116] To deploy the catheter, the assembly 10 is held in a vertical orientation (or near to) so as to allow the wetting agent to flow down the catheter 120. Gripping the textured portion 13 and the grab loop 154 a user pulls the removable part 150 of the cap 140 axially away from the external housing 10 as indicated by an arrow 145 on the cap 140. As the removable part 150 is displaced axially away from the external housing 10 the catheter assembly 10 is no longer hermetically sealed.

[0117] With continued axial displacement, the cap tabs 23 abut the edge of their corresponding apertures 159, with this the inserter 14 begins to be axially displaced. As the inserter 14 is displaced the bearing projections 60 pass the second step 34b and becomes axially misaligned with the third inner wall portion 9c. As the bearing projections 60 are no longer pressed against the seat projections the gripper arms 31 are no longer retained in a deformed position and relax in a radially outward manner increasing the separation between the two arms 31. This increase in separation results in the gripper arms 31 disengaging with the catheter 120 such that the catheter is free to be moved and the entire functionalised surface of the catheter tube 121 is exposed. Movement of the inserter 14 within the external housing 10 is guided by the first and second rib pairs 21,22 bearing against and moving along the sealing surfaces 18,19.

[0118] In this embodiment as the removable part 150 of the cap 140 and inserter 14 continue to be displaced, the second pair of ribs 22 pass the first step 34a and become axially misaligned with the second sealing surface 19. As shown in figure 9, a flow path is thereby opened between the storage chamber 80 and a cavity defined between the catheter 120 and sheath 180, in this regard the interior of the sheath can be considered a wetting chamber 71. The wetting agent flows from the storage chamber 80 to the catheter 120 around the second rib pair 22. The flared section 25 bears against the radially inner wall of the third section 9c of external housing 10 preventing wetting agent flowing between the inserter 14 and the external housing, it also decreases free volume in the second section 9b, thereby reducing the amount of wetting agent that becomes trapped in this section and unable to wet the catheter 120. The wetting agent flows through the slots 30 in the gripper arms 31 ensuring that wetting agent contacts the insertion end of the catheter 120 (which as the first part of the catheter to enter the body, most requires lubrication) before flowing down the remainder of the catheter. In this embodiment any excess wetting agent which does not contact the catheter 120 flows into and is collected in the sheath 180.

[0119] In this embodiment as the storage chamber 80 is being opened the cap tabs 23 are drawn through the aperture 142. Although the cap tabs 23 are wider than the aperture 142, as they pass through the aperture they are resiliently deformed, flexing away from the inserter tip 15a, this allows the cap tabs 23 to pass through the aperture 142. The inserter 14 continues to move axially until the first pair of ribs 21 abut the end wall 64. Throughout the entire movement of the inserter 14 the first pair of ribs 21 remain in contact with the first sealing surface 18 ensuring no wetting agent leaks from the cap end 11 of the external housing 10.

[0120] As the removable part 150 of the cap is no longer radially nested within the aperture 142 or external housing 14 it can be deformed (either plastically or resiliently, depending upon the material) such that the cap tabs 23 are no longer within the apertures 159 and the removable part 150 of the cap 140 can be removed.

[0121] With the removable part 150 of the cap 140 removed, the inserter tip 15 is exposed, gripping the textured portion 13 the user can introduce the inserter tip 15 into the urethra. Though the inserter 14 is movable it does not retract back into the external housing when introduced into the urethra because the cap tabs 23 cannot return through the aperture 142.

[0122] Once the inserter tip 15 is in place the user can grip the catheter 120 through the sheath 180 and introduce it into the urethra and drain the bladder in the usual manner.

[0123] 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

Claims:

1. A catheter assembly comprising: a catheter assembly body, the catheter assembly body comprising a seat; a movable insert, the movable insert comprising a tubular body with a deformable first end; and a catheter tube; wherein in a first position the movable insert is arranged radially within the catheter assembly body and the catheter tube is arranged radially within the movable insert, and wherein the seat bears against the first end of the movable insert, deforming the first end of the movable insert such that the first end of the movable insert grips the catheter tube; and wherein in a second position the movable insert is disengaged from the seat such that the first end of the movable insert releases the catheter tube.

2. A catheter assembly according to claim 1 wherein the first end of the movable insert comprises a hole or slot, the hole or slot tapering in width.

3. A catheter assembly according to claim 2 wherein the hole or slot is wider proximate to an end of the first end.

4. A catheter assembly according to any preceding claim wherein the first end of the movable insert comprises two arms separated by two slots tapering in width.

5. A catheter assembly according to any preceding claim wherein the first end of the movable insert comprises a first section having a first cross-sectional area and a second section having a second, different, cross-sectional area, the slot, or hole extending through the first and second sections.

6. A catheter assembly according to any preceding claim wherein the deformable first end of the movable insert is resiliently deformable.

7. A catheter assembly according to claim 6 when directly or indirectly dependent upon claim 4, wherein the two slots provide gaps into which the first end may be deformed.

8. A catheter assembly according to any preceding claim wherein a radially outer wall of the first end of the movable insert comprises at least one bearing projection, the at least one bearing projection comprising a circumferentially extending element and an axially extending element.

9. A catheter assembly according to claim 8 wherein there are at least two bearing projections.

10. A catheter assembly according to claim 9 wherein the first end of the movable insert comprises two opposing holes or slots extending through a wall of the tubular body and two bearing projections arranged between the two holes or slots.

11. A catheter assembly according to any of claims 8 to 10 wherein the circumferentially extending element and the axially extending element intersect at a mid-point of the circumferentially extending element and a point between the ends on the axially extending element.

12. A catheter assembly according to claim 10 wherein the circumferentially extending element extends between 20% and 60% of the distance between the two holes or slots.

13. A catheter assembly according to any of claims 8 to 12 wherein the radial extent to which the circumferentially extending element projects varies across the length thereof.

14. A catheter assembly according to claim 13 wherein the greatest radial extend of the circumferentially extending element is at the mid-point of the circumferentially extending element and the radial extend tapers towards the ends of the circumferentially extending element.

15. A catheter assembly according to any of claims 8 to 14 wherein the radial extent of the circumferentially extending element has a curved profile, wherein the curved profile of the circumferentially extending element has, in combination, with a profile of the first end of the movable insert, define an elliptical shape.

16. A catheter assembly according to any of claims 8 to 15 wherein the edges of the bearing projections are rounded.

17. A catheter assembly according to any preceding claim wherein a radially inner wall of the seat and / or a radially inner wall of the first end of the movable insert comprise at least one projection.

18. A catheter assembly according to claim 17 wherein the or each projection projects radially inward and axially.

19. A catheter assembly according to claim 17 or 18 wherein the movable insert comprises an insertion end opposite to the first deformable end wherein the projection is a gripping rib arranged on the radially inner wall of the first movable insert and the end of the rib proximal to the insertion end is bevelled.

20. A catheter assembly according to claim 19 wherein the gripping rib is formed of an overmolded material.

21. A catheter assembly according to any of claims 17 to 20 wherein the projection is a seat projection arranged on a radially inner wall of the seat, and wherein the movable insert comprises at least one bearing projection arranged on a radially outer wall, wherein the seat projection and bearing projection are circumferentially aligned.

22. A catheter assembly according to claim 21 wherein the seat projection comprises two pairs of axially extending seat ribs.

23. A catheter assembly according to claim 22 further comprising two bearing projections according to claim 8, wherein each pair of axially extending seat ribs bear against the circumferentially extending element of a corresponding bearing projection.

24. A catheter assembly according to any preceding claim wherein the first end of the movable insert defines a catheter channel, the catheter channel comprising a first section having a first cross-sectional area and a second section having a second, different, cross-sectional area.

25. A catheter assembly according to any preceding claim wherein the second section is arranged between the first section and an open end of the movable insert and the second cross-sectional area is greater than the first cross-sectional area.

26. A catheter assembly according to claim 24 or 25 wherein between the first and second sections there is provided an inclined section.

27. A catheter assembly according to any of claims 24 to 26 wherein a radially outer wall of the second section has the same diameter as the seat.

28. A catheter assembly according to any preceding claim wherein the movable insert is an inserter tip.

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