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 (14, 114, 214, 314, 414, 514, 614, 714), the movable insert comprising a tubular body with a deformable first end (16, 116, 216, 316, 416, 516, 616, 716); and a catheter tube (1021). In a first position the movable insert is arranged radially within the catheter assembly body (10) and the catheter tube (1021) is arranged radially within the movable insert, and the seat (70) 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 (1021). In a second position the movable is disengaged from the seat (70) such that the first end of the movable insert releases the catheter tube (1021) wherein at the first end of the movable insert (16, 116, 216, 316, 416, 516, 616, 716) the tubular body comprises a tapered portion (24, 124, 224, 324, 424, 524, 624, 724).

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 selfcatheterisation. 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.

[0009] 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.

[0010] 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.

[0011] 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.

[0012] 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.

[0013] 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.

[0014] 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.

[0015] Summary of the Invention

[0016] The present invention provides a catheter assembly according to the appended claims.

[0017] 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. At the first end of the movable insert the tubular body comprises a tapered section.

[0018] 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, wherein at the first end of the movable insert the tubular body comprises a tapered section.

[0019] Advantageously, by providing the tubular body with a tapered section, assembly of the catheter assembly can be improved, because the catheter may be guided into the first end of the movable insert. Alternatively, or additionally, the tapered portion may provide a portion of the movable insert with an increased diameter which may bear against the seat to provide a seal between the first end of the movable insert and the seat when the movable insert is in the second position. This can limit or prevent wetting agent flowing between the movable insert and the seat and instead direct it towards the catheter where lubrication is needed. The tapered portion may be arranged at an end edge of the first end. The tapered portion may have its greatest diameter at an end edge of the first end. The maximum diameter of the tapered portion may be equal to the diameter of the seat. The tapered portion may define a guide for guiding the catheter into the interior of the movable insert. The tapered portion may vary in width linearly. The tapered portion may have a curved profile. In that case, the diameter of the tapered portion may vary at a greater rate proximate to the end edge.

[0020] The first end of the movable insert may be deformed at a structurally weakened point. The structurally weakened point may comprise a hole. The structurally weakened point may comprise a slot. The hole may taper in width. The slot may taper in width.

[0021] 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.

[0022] 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. 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.

[0023] 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.

[0024] 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). The one, or more, or each hole may have an irregular shape. The one, or more, or each hole have a waisted section. The waisted section may be in the same axial position on the movable insert as a bearing projection. The waisted section may have a width less than the remainder of the hole. The one or more or each hole may be hourglass shaped. The one, or more, or each hole may comprise a lower section the width of which decreases towards the waisted section. The lower section of the one, or more, or each hole may be a rounded triangle. The lower section of the one, or more, or each hole may be teardrop shaped. The one, or more, or each hole may comprise an upper section the width of which decreases towards the waisted section. The upper section of the one, or more, or each hole may be a rounded triangle. The upper section of the one, or more, or each hole may be teardrop shaped.

[0025] A radially outer wall of the first end of the movable insert may comprise at least one bearing projection (which may project radially outward from the moveable insert). 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.

[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 increases 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 a pair of seat projections are provided, the axially extending element may engage between the pair of seat projections to guide the circumferentially extending element into 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 the two holes or slots. 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. That is to say, a profile of the circumferentially extending element to the right of the intersection with the axially extending element may have the same, but mirrored, profile as the part of the circumferentially extending element to the left of the intersection with 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. The circumferentially extending element may taper towards the tubular body. An upper edge of the circumferentially extending element may taper towards the tubular body. A lower edge of the circumferentially extending element may have a profile corresponding to a divergent portion of the catheter assembly body.

[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 because the seat is sized such that it is smaller than the bearing projections (and thus allows the bearing projections to deform the moveable insert, the bevelled ends allow the movable insert to move onto the seat and begin 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] The first end of the movable insert may comprise one or more drainage eyelets. The one or more drainage eyelets may be apertures through the tubular body of the movable insert. An upper drainage eyelet may be provided above one, or more, or each bearing projection. A lower drainage eyelet may be provided below one, or more, or each bearing projection. The upper and lower drainage eyelets may be the same size. The lower drainage eyelets may be larger than the upper drainage eyelets. The lower drainage eyelets may comprise an axial element. The lower drainage eyelets may comprise a circumferential element. The lower drainage eyelets may extend from the bearing projection to the end edge of the first end of the movable insert.

[0037] 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.

[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 (that is, the two pairs of seat projections may have the same angular separation between the two seat projections in the same pair) the two pairs of seat projections may be symmetric about a plane arranged on a longitudinal axis of the catheter assembly body.

[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 corresponding 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.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] 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.

[0051] 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 tapered section. The tapered section may be arranged between the first and second sections.

[0052] The provision of a tapered section is advantageous as it helps to guide the catheter into the catheter assembly during manufacture. The tapered section may have a sloped radially inner wall. The tapered section may have a tapered 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 bearing projection 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. When the wetting agent storage chamber is open a wetting agent may flow from the wetting agent storage chamber to the catheter.

[0059] The wetting agent storage chamber may comprise a lower seat section. The wetting agent storage chamber may comprise an intermediate section. The wetting agent storage chamber may comprise an upper section. The lower seat section may be narrower than the intermediate section. The intermediate section may be narrower than the upper section. A radially inner wall of the intermediate section may comprise a lower sealing surface. A radially inner wall of the upper section may comprise an upper sealing surface. The lower seat section and the intermediate section may be separated by a lower divergent portion. The lower divergent portion may comprise a step, a chamfer, or a slope. The intermediate section and the upper section may be separated by an upper divergent portion. The upper divergent portion may comprise a step, a chamfer, or a slope.

[0060] The movable insert may comprise a lower wetting agent storage chamber seal. The lower wetting agent storage chamber seal may comprise one or more annular ribs arranged around the movable insert. The lower wetting agent storage chamber seal may have a diameter equal to the diameter of the lower sealing surface. The lower wetting agent storage chamber seal may be configured to form a seal against the lower sealing surface.

[0061] The one, or more, or each bearing projection may be arranged between the lower wetting agent storage chamber seal and the end edge of the movable insert.

[0062] The movable insert may comprise a lower dam. The lower dam may comprise an annular projection arranged between the bearing projection and the end edge of the movable insert. The dam may be configured to seal against the lower seat section to prevent wetting agent from flowing between the movable insert and lower seat section below the dam.

[0063] The movable insert may comprise an upper wetting agent storage chamber seal. The upper wetting agent storage chamber seal may comprise one or more annular ribs arranged around the movable insert. The upper wetting agent storage chamber seal may have a diameter equal to the diameter of the upper sealing surface. The upper wetting agent storage chamber seal may be configured to form a seal against the upper sealing surface.

[0064] The catheter tube may be gripped with an insertion end proximal to an opening in the wetting agent storage chamber. The movable insert may be movable along an axis relative to the catheter assembly body between the first position and the second position.

[0065] 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.

[0066] 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. The catheter may be a urinary catheter.

[0067] 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.

[0068] 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.

[0069] 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.

[0070] 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.

[0071] 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.

[0072] 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.

[0073] Where the catheter assembly comprises a sheath, the method may further comprise attaching the sheath to the catheter assembly body.

[0074] 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.

[0075] 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.

[0076] 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. 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.

[0077] 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.

[0078] Detailed Description of the Invention

[0079] 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:

[0080] Figure 1 shows a perspective view of a catheter assembly according to an embodiment of the disclosure;

[0081] Figure 2 shows a longitudinal sectional view of the catheter assembly of Figure 1 in a closed or sealed configuration;

[0082] Figure 3 shows a cross-sectional view of an external housing of the catheter assembly of Figure 1;

[0083] Figure 4 shows a projection view of a distal end of the catheter assembly of Figure 1;

[0084] Figure 5 shows a longitudinal sectional view of the catheter of Figure 1 in an open or deployed configuration;

[0085] Figure 6 shows a perspective view of a movable insert of the catheter assembly according to an embodiment of the disclosure;

[0086] Figure 7 shows an enlarged perspective view of the bearing projections of the movable insert of Figure 6;

[0087] Figure 8 shows a projection view of the first end of the movable insert of Figure

[0088] 6; Figure 9 shows an enlarged longitudinal sectional view of the movable insert of Figure 6 detailing a first end thereof;

[0089] Figure 10 shows a perspective view of a further embodiment of the movable insert of the catheter assembly according to the disclosure;

[0090] Figure 11 shows a perspective view of a further embodiment of the movable insert of the catheter assembly according to the disclosure;

[0091] Figure 12 shows a perspective view of a further embodiment of the movable insert of the catheter assembly according to the disclosure;

[0092] Figure 13 shows a perspective view of a further embodiment of the movable insert of the catheter assembly according to the disclosure;

[0093] Figure 14 shows a perspective view of a further embodiment of the movable insert of the catheter assembly according to the disclosure;

[0094] Figure 15 shows a perspective view of a further embodiment of the movable insert of the catheter assembly according to the disclosure;

[0095] Figure 16 shows a perspective view of a further embodiment of the movable insert of the catheter assembly according to the disclosure; and

[0096] Figure 17 shows a cross-sectional view of a catheter assembly comprising the movable insert of figure 16 in an open configuration.

[0097] With reference to figures 1-16, a number of catheter assemblies 1 according to the present invention is described. In each instance, as will be elaborated upon below, the assemblies vary only in the construction of the first end of the inserter, in particular the catheter gripper. As such a common structure of the assemblies will be described in detail first, followed by the various embodiments of the first end of the inserter. The common structure of the assembly is however only one such example of a catheter assembly suitable for use with the inserter and is provided to give context to the inserter.

[0098] Referring to figures 1 and 2, the catheter assembly 1 comprises an external housing 10, a cap 1040, a sheath 1080 and a catheter 1020 (dashed in figure 2). The catheter assembly 1 may be configured such that the catheter 1020 may be wetted prior to being withdrawn from the external housing 10. A wetting mechanism may be provided within the external housing 10.

[0099] Referring to figures 2 and 3, 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. The textured portion 13 is 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. The textured portion 13 may be integrally formed with the outer surface 8, alternatively the textured portion 13 may be formed of a different material, for example one which provides increased grip when wet.

[0100] 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 with respect to the various embodiments.

[0101] 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 is arranged within the catheter end 12 of the external housing 10.

[0102] The cap 1040 is formed in two parts, a connecting part 1041 and a removable part 1050. The connecting part 1041 has an annular shape with an aperture 1042 through the centre, it is connected to the cap end 11 of the external housing 10. The removable part 1050 has a tubular shape with an open end 1051 and a closed end 1052, the interior of the removable part 1050 defines a cavity 1053 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 1050 is shaped to engage with the aperture 1042 in the connecting part 1041. On the exterior of the removable part 1050 at the closed end 1052 there is provided a grab loop 1054 by which a user can grip the cap 1040.

[0103] The catheter 1020 is of a type known to the art, comprising a catheter tube 1021 with an insertion end 1022 and an opposing drainage end (not shown). The catheter tube 1021 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 1022 there may be provided one or more drainage apertures 1033, 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 1033 may differ.

[0104] The exterior surface of the catheter tube 1021 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 1021 is reduced. The outer surface of the catheter tube 1021 may be comprised of, or coated in, a functionalising material; for example the outer surface of the catheter tube 1021 may have hydrophilic properties. The hydrophilic properties serve to reduce the coefficient of friction of the outer surface when the wetting agent is introduced.

[0105] The catheter 1020 and inserter 14 are concentrically arranged such that the insertion end 1022 of the catheter 1020 engages with the catheter gripper 16 with the distal end of the catheter 1020 extending away from the inserter 14 as will be described in further detail below.

[0106] Arranged at the catheter end 12 of the external housing 10 is the sheath 1080. The sheath 1080 extends away from the external housing 10 so as to surround at least a part of the catheter tube 120. The sheath 1080 is formed of a flexible material. The sheath 1080 is attached to the external housing in such a way as to provide a leak resistant seal. 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 1080 and pouch may be integrally formed. The sheath may allow for fluid communication from the external housing 10 to the pouch. Referring to figure 2, the arrangement of the external housing 10, inserter 14 and cap 1040 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.

[0107] As shown in figures 3 and 4, the radially inner wall of the third portion 9c of the external housing 10 may be provided with four seat projections 70. 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] The inserter 14 is radially nested with the external housing 10. To ensure the alignment of the inserter 14 in the external housing the inserter 14 is provided with two pairs of ribs 21,22. Alternatively, the external housing may be provided with projections such as ribs.

[0109] 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.

[0110] 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. 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.

[0111] As noted above, the cap 1040 is formed in two parts with the inner surface of the connector part 1041 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 1042 is provided. The connector part 1041 and external housing 10 are joined with a cantilever snap-fit connection, with corresponding projections and recesses on the connector part 1041 and external housing 10. Alternatively, other methods of attachment may be used for example, adhesive, welding or interference fit.

[0112] Proximate to the open end 1051 of the cap, there are provided a pair of rectangular apertures 1059 the long axis of which extends circumferentially around the cap. The apertures 1059 are sized and shaped to receive the cap tabs 23 of the inserter 14. About the apertures 1059 the thickness of the wall of the connector part 1041 increases with a chamfered step provided on the radially outer surface.

[0113] 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.

[0114] 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.

[0115] 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. The removable part 1050 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 1059.

[0116] The removable part 1050 of the cap 1040 is also arranged through the aperture 142 in the connecting part 1041 to seal the catheter assembly 10 and prevent wetting agent leaking.

[0117] During storage and transport the catheter 1020 is retained within the external housing 10 by the catheter gripper 16. This is achieved by the third section 9c of the inner wall deforming the catheter gripper 16, decreasing the space within such that it grips the catheter 1020. Securing the catheter 1020 during storage is advantageous as it ensures the catheter 1020 is in an optimal position prior to wetting and also that the catheter cannot be deployed without having been wetted.

[0118] 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 1020. Gripping the textured portion 13 and the grab loop 1054 a user pulls the removable part 1050 of the cap 1040 axially away from the external housing 10 as indicated by an arrow 1045 on the cap 1040. .

[0119] 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 catheter gripper 16 moves over the second step 34b and becomes axially misaligned with the third inner wall portion 9c. As the catheter gripper 16 is no longer deformed by the third inner wall portion 9c it returns to its original shape and disengages with the catheter 1020. The catheter 1020 is free to be moved and the entire functionalised surface of the catheter tube 1021 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.

[0120] As the removable part 1050 of the cap 1040 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 5, a flow path is thereby opened between the storage chamber 80 and a cavity defined between the catheter 1020 and sheath 1080, in this regard the interior of the sheath can be considered a wetting chamber 1071. The wetting agent flows from the wetting agent storage chamber 80 to the catheter 1020 around the second rib pair 22.

[0121] As the storage chamber 80 is being opened the cap tabs 23 are drawn through the aperture 1042. Although the cap tabs 23 are wider than the aperture 1042 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 1042. 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.

[0122] As the removable part 1050 of the cap is no longer radially nested within the aperture 1042 or external housing 10 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 1050 of the cap 140 can be removed.

[0123] With the removable part 1050 of the cap 1040 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 10 when introduced into the urethra because the cap tabs 23 cannot return through the aperture 1042.

[0124] Once the inserter tip 15 is in place the user can grip the catheter 120 through the sheath 1080 and introduce it into the urethra and drain the bladder in the usual manner.

[0125] The common features and operation of an example catheter assembly having been described, the numbered embodiments of the movable insert (14, 114, 214, 314, 414, 514, 614, 714), in particular the catheter gripper (16, 116, 216, 316, 416, 516, 616, 716) will be described in detail. Like components will be assigned the same reference numeral, advanced by a multiple of 100.

[0126] First Embodiment of the Movable Insert

[0127] With reference to figures 6 to 9 a first embodiment of the movable insert 14 is described. As seen in figure 6, in this embodiment at approximately 1 / 3 of the distance between the second pair of ribs 22 and the end of the catheter gripper 16 the tubular body of the inserter 14 comprises a tapered portion 24 beyond which the tubular body comprises a wider section 25 having greater diameter than the remainder of the inserter 14. In this embodiment, the outer diameter of the wider section 25 is equal to the inner diameter of the third section 9c of the external housing 10.

[0128] As seen in figures 6 and 9, at the catheter gripper 16 end of the inserter 14 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 1020 is inserted. The gripper arms 31 are configured to engage with the catheter tube 1021 when the assembly 1 is in a storage configuration as will be expanded upon below.

[0129] In this embodiment, each slot 30 extends axially along the inserter 14 across the inserter step 24 and beyond the wider 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. The second part 30b narrows away from the step 30c and terminating 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 3 lb which improves the degree by which the gripper arms 31 can be deformed without colliding with one another.

[0130] 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 1020 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.

[0131] The radially inner wall of the wider section 25 of the inserter is provided with a plurality of catheter grips 50 in the form of axially and radially extending grip projections 51. As can be seen in figure 8, in this embodiment there are six catheter grips 50 spaced equally about the circumference of the wider section 25. Each grip projection 51 along the entire axial extent of the wider 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 grip projections 51 proximate to the free ends 31b of the grippers comprise a tapered edge 52 to prevent the catheter 1020 becoming trapped on the grip projections 51 during assembly.

[0132] Arranged at the base 3 la of each arm 31 on the radially outer side is a bearing projection 60 projecting radially outward. As best shown in figure 7, 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 wider 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.

[0133] As is best shown in figures 7 and 8 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.

[0134] 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 corners of the projections, increasing the percentage of water delivered to the catheter 1020.

[0135] As shown in figure 4, in the first position the insertion end 1022 is nested between the gripper arms 31 with the catheter grippers 50 bearing against the catheter tube 1021. In this embodiment 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 1022 holding the catheter 1020 in place. In other embodiments the seat projections may be omitted and the bearing projections 60 may be sized to bear against third inner wall portion 9c directly.

[0136] During deployment to the second position as outlined above, the inserter 14 is axially displaced and the bearing projections 60 become axially misaligned with the seat projections 70 or third inner wall portion 9c. This allows the gripper arms 31 to relax to an undeformed configuration and release the catheter 1020.

[0137] With continued axial movement of the inserter 14, the wider 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 of the space between the inserter and the second inner wall section 9b, thereby reducing the amount of wetting agent that becomes trapped in this volume and unable to wet the catheter 1020. The wetting agent flows through the slots 30 in the gripper arms 31 ensuring that wetting agent contacts the insertion end of the catheter 1020 (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 1020 flows into the sheath 1080.

[0138] Second Embodiment of the Movable Insert

[0139] With reference to figure 10, a second embodiment of the movable insert 114 is described. In this embodiment a tapered section 124 is provided at the end of the catheter gripper 116, such that an open end 117 of the inserter 114 has a diameter equal to the diameter of the third inner wall section 9c. Moving away from the open end 117 the tapered section 124 decreases in diameter until it has the same diameter as the remainder of the tubular body of the inserter 114. The tapered section 124 improves the manufacturing of the catheter assembly 10, during assembly, the catheter 1020 is inserted into the inserter 114 from the open end 117. As the tapered section 124 bears against the third inner wall section 9c and tapers inwards, the catheter 1020 does not need to be accurately aligned on insertion, the tapered section 124 will guide it into the correct alignment.

[0140] Arranged at 1 / 3 of the distance between the open end 117 and the second pair of ribs 122 there is provided a dam 118. The dam 118 comprises an annular projection around the tubular body of the inserter 114. The radial extent of the dam (i.e. the “height”) is such that the radially outer diameter of the dam is equal to the diameter of the third inner wall section 9c, the dam 118 may thus bear against the third inner wall section 9c, which may be also be referred to as a lower seat 9c to form a seal, the purpose of which will be described below. Four reinforcements 119 are equally spaced about the outer surface of the inserter 114 and extend between the dam 118 and the open end

[0141] 117 to provide reinforcement to the tapered section 124.

[0142] Arranged at 2 / 3 of the distance between the open end 117 and the second pair of ribs 122 are two opposing elongate gripper holes 130 through the tubular body, the long axis of the gripper holes 130 extend axially along the inserter 114 from just above the dam 118. The two elongate gripper holes 130 provide an area of structural weakness in the inserter 114 which may be more readily deformed.

[0143] Extending circumferentially around the inserter 114 between the two gripper holes 130 are two bearing projections 160. The bearing projections 160 comprise circumferentially extending elements 162, the radial extent of which provides the bearing projections 160 with an outer diameter greater than the third inner wall section 9c.

[0144] Arranged above and below the bearing projections 160 are four drain eyelets 135. The four drain eyelets 135 are holes through the tubular body of the inserter 114 and are arranged perpendicular to the two gripper holes 130, that is to say that the drain eyelets 135 have an angular separation of 90° about the circumference of the inserter 114 from the gripper holes 130.

[0145] When the catheter assembly 1 is in the first, sealed, position, the open end 117, dam

[0146] 118 and bearing projections 160 all bear against the third inner wall section 9c. As the bearing projections 160 are oversized with respect to the third inner wall section 9c, the inserter 114 is deformed proximate to the bearing projections 160, with the width of the gripper holes 130 decreasing as the inserter 114 is deformed into the holes 130. This deformation forces the inserter 114 to grip onto the catheter 1020.

[0147] As the inserter 114 is moved axially to the second, deployed, position, the bearing projections 160 become axially misaligned with the third inner wall section 9c, this allows the inserter 114 to relax back to its undeformed shape thereby releasing the catheter 1020.

[0148] With continued axial movement of the inserter 114, the wetting agent storage chamber 80 is opened and wetting agent flows towards the catheter. The dam 118 and tapered section 124 bear against the radially inner wall of the third section 9c of external housing 10 preventing wetting agent flowing between the inserter 114 and the external housing 10 below the dam 118. This forces the wetting agent to flow through the gripper holes 130 and drain eyelets 135 ensuring that wetting agent contacts the insertion end of the catheter 1020 (which as the first part of the catheter to enter the body, most requires lubrication) before flowing down the remainder of the catheter 1020.

[0149] In this embodiment any excess wetting agent which does not contact the catheter 1020 flows into the sheath 1080.

[0150] Third Embodiment of the Movable Insert

[0151] With reference to figure 11, a third embodiment of the movable insert 214 is described. In this embodiment a tapered section 224 is provided at the end of the catheter gripper 216, such that an open end 217 of the inserter 214 has a diameter equal to the diameter of the third inner wall section 9c. Moving away from the open end 217 the tapered section 224 decreases in diameter until it has the same diameter as the remainder of the tubular body of the inserter 214.

[0152] The tapered section 224 improves the manufacturing of the catheter assembly 10, during assembly, the catheter 1020 is inserted into the inserter 214 from the open end 217. As the tapered section 224 bears against the third inner wall section 9c and tapers inwards, the catheter 1020 does not need to be accurately aligned on insertion, the tapered section 224 will guide it into the correct alignment. Extending from the point where the tapered section 224 meets the remainder of the tubular body of the inserter 214 to the second pair of ribs are two opposing elongate gripper holes 230 through the tubular body, the long axis of the gripper holes 230 extend axially along the inserter 214. The two elongate gripper holes 230 provide an area of structural weakness in the inserter 214 which may be more readily deformed.

[0153] Extending circumferentially around the inserter 214 between the two gripper holes 230 are two bearing projections 260. The bearing projections 260 comprise circumferentially extending elements 262, the radial extent of which provides the bearing projections 260 with an outer diameter greater than the third inner wall section 9c. Adjacent to the gripper holes 230, the radial extent of the bearing projections tapers off, such that they do not extend through a plane defined by an outer edge of each gripper hole 230.

[0154] Arranged above and below the bearing projections 260 are four drain eyelets 235. The four drain eyelets 235 are holes through the tubular body of the inserter 214 and are arranged perpendicular to the two gripper holes 230, that is to say that the drain eyelets 235 have an angular separation of 90° about the circumference of the inserter 214 from the gripper holes 230.

[0155] When the catheter assembly 1 is in the first, sealed, position, the open end 217 and bearing projections 260 bear against the third inner wall section 9c. As the bearing projections 260 are oversized with respect to the third inner wall section 9c, the inserter 214 is deformed proximate to the bearing projections 260, with the width of the gripper holes 230 decreasing as the inserter 214 is deformed into the holes 230. This deformation forces the inserter 214 to grip onto the catheter 1020.

[0156] As the inserter 214 is moved axially to the second, deployed, position, the bearing projections 260 become axially misaligned with the third inner wall section 9c, this allows the inserter 214 to relax back to its undeformed shape thereby releasing the catheter 1020.

[0157] With continued axial movement of the inserter 214, the wetting agent storage chamber 80 is opened and wetting agent flows towards the catheter. The tapered section 224 continues to bear against the radially inner wall of the third section 9c of external housing 10 preventing wetting agent flowing between the inserter 214 and the external housing 10 below the tapered section. This forces the wetting agent to flow through the gripper holes 230 and drain eyelets 235 ensuring that wetting agent contacts the insertion end of the catheter 1020 (which as the first part of the catheter to enter the body, most requires lubrication) before flowing down the remainder of the catheter 1020.

[0158] In this embodiment any excess wetting agent which does not contact the catheter 1020 flows into the sheath 1080.

[0159] Fourth Embodiment of the Movable Insert

[0160] With reference to figure 12, a fourth embodiment of the movable insert 314 is described. In this embodiment a tapered section 324 is provided at the end of the catheter gripper 316, such that an open end 317 of the inserter 314 has a diameter equal to the diameter of the third inner wall section 9c. Moving away from the open end 317 the tapered section 324 decreases in diameter until it has the same diameter as the remainder of the tubular body of the inserter 314.

[0161] The tapered section 324 improves the manufacturing of the catheter assembly 10, during assembly, the catheter 1020 is inserted into the inserter 314 from the open end 317. As the tapered section 324 bears against the third inner wall section 9c and tapers inwards, the catheter 1020 does not need to be accurately aligned on insertion, the tapered section 324 will guide it into the correct alignment.

[0162] Extending from the point where the tapered section 324 meets the remainder of the tubular body of the inserter 314 to the second pair of ribs 322 are two opposing elongate gripper holes 330 through the tubular body, the long axis of the gripper holes 330 extend axially along the inserter 314. The two elongate gripper holes 330 provide an area of structural weakness in the inserter 314 which may be more readily deformed.

[0163] Extending circumferentially around the inserter 314 between the two gripper holes 330 are two bearing projections 360. The bearing projections 360 comprise circumferentially extending elements 362, the radial extent of which provides the bearing projections 360 with an outer diameter greater than the third inner wall section 9c.

[0164] Arranged above and below the bearing projections 360 are four drain eyelets 335. The four drain eyelets 335 are holes through the tubular body of the inserter 314 and are arranged perpendicular to the two gripper holes 330, that is to say that the drain eyelets 335 have an angular separation of 90° about the circumference of the inserter 314 from the gripper holes 330.

[0165] When the catheter assembly 1 is in the first, sealed, position, the open end 317 and bearing projections 360 bear against the third inner wall section 9c. As the bearing projections 360 are oversized with respect to the third inner wall section 9c, the inserter 314 is deformed proximate to the bearing projections 360, with the width of the gripper holes 330 decreasing as the inserter 314 is deformed into the holes 330. This deformation forces the inserter 314 to grip onto the catheter 1020.

[0166] As the inserter 314 is moved axially to the second, deployed, position, the bearing projections 360 become axially misaligned with the third inner wall section 9c, this allows the inserter 314 to relax back to its undeformed shape thereby releasing the catheter 1020.

[0167] With continued axial movement of the inserter 314, the wetting agent storage chamber 80 is opened and wetting agent flows towards the catheter. The tapered section 324 continues to bear against the radially inner wall of the third section 9c of external housing 10 preventing wetting agent flowing between the inserter 314 and the external housing 10 below the tapered section. This forces the wetting agent to flow through the gripper holes 330 and drain eyelets 335 ensuring that wetting agent contacts the insertion end of the catheter 1020 (which as the first part of the catheter to enter the body, most requires lubrication) before flowing down the remainder of the catheter 1020.

[0168] In this embodiment any excess wetting agent which does not contact the catheter 1020 flows into the sheath 1080.

[0169] Fifth Embodiment of the Movable Insert With reference to figure 13, a fifth embodiment of the movable insert 414 is described. In this embodiment a tapered section 424 is provided at the end of the catheter gripper 416, such that an open end 417 of the inserter 414 has a diameter equal to the diameter of the third inner wall section 9c. Moving away from the open end 417 the tapered section 424 decreases in diameter until it has the same diameter as the remainder of the tubular body of the inserter 414.

[0170] The tapered section 424 improves the manufacturing of the catheter assembly 10, during assembly, the catheter 1020 is inserted into the inserter 414 from the open end 417. As the tapered section 424 bears against the third inner wall section 9c and tapers inwards, the catheter 1020 does not need to be accurately aligned on insertion, the tapered section 424 will guide it into the correct alignment.

[0171] Extending from the point the tapered section 424 to the second pair of ribs 422 are two opposing gripper holes 430 through the tubular body. The gripper holes 430 each comprise two lobes, an upper lobe 431 and a lower lobe 432. The upper lobe 431 has an inverted triangular shape with rounded comers and tapers towards the middle of the hole 430. The upper lobe 431 is approximately 1 / 5 of the length (measured axially) of the gripper hole 430. The lower lobe 432 has an elongate triangular shape with rounded corners and tapers towards the middle of the hole 430. The lower lobe 432 is approximately 3 / 5 the length (measured axially) of the gripper hole. The upper 431 and lower 432 lobes have the same maximum width (measured circumferentially). Between the upper 431 and lower 432 lobes the gripper hole 430 comprises a waisted section 433 the edges of which are parallel to the longitudinal axis of the inserter 414. The two gripper holes 430 provide an area of structural weakness in the inserter 414 which may be more readily deformed.

[0172] Extending circumferentially around the inserter 414 between the two gripper holes 430 are two bearing projections 460. The two bearing projections 460 are aligned axially with the waisted portion 433 of the gripper holes 430. The bearing projections 460 comprise circumferentially extending elements 462, the radial extent of which provides the bearing projections 460 with an outer diameter greater than the third inner wall section 9c. The bearing projections 460 are each provided with three pairs of braces 465 spaced equally along the projection. One of each pair 465 extends above, and the other below the bearing projection the reinforce it to the inserter 414.

[0173] When the catheter assembly 1 is in the first, sealed, position, the open end 417 and bearing projections 460 bear against the third inner wall section 9c. As the bearing projections 460 are oversized with respect to the third inner wall section 9c, the inserter 414 is deformed proximate to the bearing projections 460, with the width of the waisted portion 434 of the gripper holes 430 decreasing as the inserter 414 is deformed. This deformation forces the inserter 414 to grip onto the catheter 1020.

[0174] As the inserter 414 is moved axially to the second, deployed, position, the bearing projections 460 become axially misaligned with the third inner wall section 9c, this allows the inserter 414 to relax back to its undeformed shape thereby releasing the catheter 1020.

[0175] With continued axial movement of the inserter 414, the wetting agent storage chamber 80 is opened and wetting agent flows towards the catheter. The tapered section 424 continues to bear against the radially inner wall of the third section 9c of external housing 10 preventing wetting agent flowing between the inserter 414 and the external housing 10 below the tapered section. This forces the wetting agent to flow through the gripper holes 430 ensuring that wetting agent contacts the insertion end of the catheter 1020 (which as the first part of the catheter to enter the body, most requires lubrication) before flowing down the remainder of the catheter 1020.

[0176] In this embodiment any excess wetting agent which does not contact the catheter 1020 flows into the sheath 1080.

[0177] Sixth Embodiment of the Movable Insert

[0178] With reference to figure 14, a sixth embodiment of the movable insert 514 is described. In this embodiment a tapered section 524 is provided at the end of the catheter gripper 516, such that an open end 517 of the inserter 514 has a diameter equal to the diameter of the third inner wall section 9c. Moving away from the open end 517 the tapered section 524 decreases in diameter until it has the same diameter as the remainder of the tubular body of the inserter 514. The tapered section 524 improves the manufacturing of the catheter assembly 10, during assembly, the catheter 1020 is inserted into the inserter 514 from the open end 517. As the tapered section 524 bears against the third inner wall section 9c and tapers inwards, the catheter 1020 does not need to be accurately aligned on insertion, the tapered section 524 will guide it into the correct alignment.

[0179] Extending from the open end 517 to the second pair of ribs 522 are two opposing elongate gripper slots 530 through the tubular body, the long axis of the gripper slots 530 extend axially along the inserter 514. The two elongate gripper slots 530 define a gap between two gripper arms 531 and provide an area of structural weakness in the inserter 514 which may be more readily deformed.

[0180] Extending circumferentially across each gripper arm 531 between the two gripper slots 530 are two bearing projections 560. The bearing projections 560 comprise circumferentially extending elements 562, the radial extent of which provides the bearing projections 560 with an outer diameter greater than the third inner wall section 9c. The two bearing projections 560 are arranged approximately 2 / 3 of the way between the open end 517 and the second pair of ribs 522.

[0181] Arranged above and below the bearing projections 560 are four drain eyelets 535. The four drain eyelets 535 are holes through the tubular body of the inserter 514 and are arranged perpendicular to the two gripper slots 530, that is to say that the drain eyelets 535 have an angular separation of 90° about the circumference of the inserter 314 from the gripper holes 530. The two drain eyelets 535a above the bearing projections 560 extend between the bearing projections and the second pair of ribs 522. The two drain eyelets 535b below the bearing projections 560 extend from the bearing projections into the tapered section 524.

[0182] When the catheter assembly 1 is in the first, sealed, position, the open end 517 and bearing projections 560 bear against the third inner wall section 9c. As the bearing projections 560 are oversized with respect to the third inner wall section 9c, the inserter 514 is deformed proximate to the bearing projections 560. The gripper arms 531 bend into the provided by the gripper slots 530 in a pincer manner. As the inserter 514 is moved axially to the second, deployed, position, the bearing projections 560 become axially misaligned with the third inner wall section 9c, this allows the gripper arms 531 to relax back to their undeformed shape thereby releasing the catheter 1020.

[0183] With continued axial movement of the inserter 514, the wetting agent storage chamber 80 is opened and wetting agent flows towards the catheter. The tapered section 524 continues to bear against the radially inner wall of the third section 9c of external housing 10 partially preventing wetting agent flowing between the inserter 514 and the external housing 10 below the tapered section (except where the gripper slots 530 extend through the tapered section). This encourages the wetting agent to flow through the gripper slots 530 and drain eyelets 535 ensuring that most of the wetting agent contacts the insertion end of the catheter 1020 (which as the first part of the catheter to enter the body, most requires lubrication) before flowing down the remainder of the catheter 1020.

[0184] In this embodiment any excess wetting agent which does not contact the catheter 1020 flows into the sheath 1080.

[0185] Seventh Embodiment of the Movable Insert

[0186] With reference to figure 15, a seventh embodiment of the movable insert 614 is described. In this embodiment a tapered section 624 is provided at the end of the catheter gripper 616, such that an open end 617 of the inserter 614 has a diameter equal to the diameter of the third inner wall section 9c. Moving away from the open end 617 the tapered section 624 decreases in diameter until it has the same diameter as the remainder of the tubular body of the inserter 614.

[0187] The tapered section 624 improves the manufacturing of the catheter assembly 10, during assembly, the catheter 1020 is inserted into the inserter 614 from the open end 617. As the tapered section 624 bears against the third inner wall section 9c and tapers inwards, the catheter 1020 does not need to be accurately aligned on insertion, the tapered section 624 will guide it into the correct alignment.

[0188] Extending from the open end 617 to the second pair of ribs 622 are two opposing elongate gripper slots 630 through the tubular body, the long axis of the gripper slots 630 extend axially along the inserter 614. The two elongate gripper slots 630 define a gap between two gripper arms 631 and provide an area of structural weakness in the inserter 614 which may be more readily deformed. Where the gripper slots 630 extend through the tapered section 624, the width (as measured circumferentially) of the slots 630 decreases, this helps to prevent the catheter 1020 entering the slots 630 during assembly.

[0189] Extending circumferentially across each gripper arm 631 between the two gripper slots 630 are two bearing projections 660. The bearing projections 660 comprise axially extending elements 661 and circumferentially extending elements 662. The circumferentially extending elements are arranged at approximately 2 / 3 the distance between the open end 617 and the second pair of ribs 622 the radial extent of which provides the bearing projections 660 with an outer diameter greater than the third inner wall section 9c.

[0190] The axially extending elements 661 are arranged above and below the circumferentially extending elements 662. Upper axially extending elements 661a extend between the circumferentially extending elements 662 and the second pair of ribs 622. Lower axially extending elements 661b extend between the circumferentially extending elements 662 and the tapered section 624.

[0191] The maximum radial extent (“height”) of the circumferentially extending elements 662 is found at the point it intersects the axially extending element 661, the height of the circumferentially extending element 662 decreases away from this intersection such that the two circumferentially extending elements, in combination, have an oval cross section, perpendicular to the longitudinal axis A-A.

[0192] Likewise, the axially extending element 61 tapers towards the bottoms of the upper 661a and lower 661b parts.

[0193] When the catheter assembly 1 is in the first, sealed, position, the open end 617 and bearing projections 660 bear against the third inner wall section 9c. As the bearing projections 660 are oversized with respect to the third inner wall section 9c, the inserter 614 is deformed proximate to the bearing projections 660. The gripper arms 631 bend into the provided by the gripper slots 630 in a pincer manner. The oval cross section of the circumferentially extending elements 662 helps to direct the deformation of the gripper arms 631 directly towards one another. The axially extending elements 661 provide structural reinforcement to the gripper arms, allowing them to apply a greater gripping force to the catheter 1020 without the gripping arms bending outward.

[0194] As the inserter 614 is moved axially to the second, deployed, position, the circumferentially extending elements 662 of the bearing projections 660 become axially misaligned with the third inner wall section 9c, this allows the gripper arms 631 to relax back to their undeformed shape thereby releasing the catheter 1020.

[0195] With continued axial movement of the inserter 614, the wetting agent storage chamber 80 is opened and wetting agent flows towards the catheter. The tapered section 624 continues to bear against the radially inner wall of the third section 9c of external housing 10 partially preventing wetting agent flowing between the inserter 614 and the external housing 10 below the tapered section (except where the gripper slots 630 extend through the tapered section). This encourages the wetting agent to flow through the gripper slots 630 ensuring that most of the wetting agent contacts the insertion end of the catheter 1020 (which as the first part of the catheter to enter the body, most requires lubrication) before flowing down the remainder of the catheter 1020. In this embodiment any excess wetting agent which does not contact the catheter 1020 flows into the sheath 1080.

[0196] Eighth Embodiment of the Movable Insert

[0197] With reference to figures 16 and 17, an eighth embodiment of the movable insert 714 is described. In this embodiment entire radially inner wall of the catheter gripper 716 is tapered 724 from an open end 717 of the inserter 714 decreasing in diameter until it has the same inner diameter as the remainder of the tubular body of the inserter 714 at just below the second pair of ribs 722.

[0198] The tapered section 724 improves the manufacturing of the catheter assembly 10, during assembly, the catheter 1020 is inserted into the inserter 714 from the open end 717. As the tapered section 724 tapers inwards, the catheter 1020 does not need to be accurately aligned on insertion, the tapered section 724 will help to guide it into the correct alignment. Extending from the open end 717 to the second pair of ribs 722 are two opposing elongate gripper slots 730 through the tubular body, the long axis of the gripper slots 730 extend axially along the inserter 714. The two elongate gripper slots 730 define a gap between two gripper arms 731 and provide an area of structural weakness in the inserter 714 which may be more readily deformed. Proximate to the open end 717 the width (as measured circumferentially) of the slots 730 decreases, this helps to prevent the catheter 1020 entering the slots 730 during assembly.

[0199] Extending circumferentially across each gripper arm 731 between the two gripper slots 730 are two bearing projections 760. The bearing projections 760 comprise circumferentially extending elements 762. The circumferentially extending elements are arranged at approximately 1 / 3 the distance between the open end 717 and the second pair of ribs 722 the radial extent of which provides the bearing projections 760 with an outer diameter equal to the diameter of the second inner wall section 9b, which is greater than the diameter of the third inner wall section 9c.

[0200] A lower edge 762a of the circumferentially extending element 762 is provided with a step which corresponds in profile to the further step 34b in the external housing 10. An upper edge 762b of the circumferentially extending element 762 is provided with a tapered profile 724 tapering towards the base of the second pair of ribs 722.

[0201] When the catheter assembly 1 is in the first, sealed, position, the bearing projections 760 bear against the third inner wall section 9c. As the bearing projections 760 are oversized with respect to the third inner wall section 9c, the inserter 714 is deformed proximate to the bearing projections 760. The gripper arms 731 bend into the provided by the gripper slots 730 in a pincer manner.

[0202] As the inserter 714 is moved axially to the second, deployed, position, the circumferentially extending elements 762 of the bearing projections 760 become axially misaligned with the third inner wall section 9c, and pass over the further step 34b this allows the gripper arms 731 to relax back to their undeformed shape thereby releasing the catheter 1020.

[0203] As shown in figure 17, with continued axial movement of the inserter 714, the wetting agent storage chamber 80 is opened and wetting agent flows towards the catheter. The lower edge 762a of the circumferential extending element 762 engages with the further step 34b forming a partial seal partially preventing wetting agent flowing between the inserter 714 and the external housing 10 below the tapered section (except where the gripper slots 730 extend through the tapered section). This encourages the wetting agent to flow through the gripper slots 730 ensuring that most of the wetting agent contacts the insertion end of the catheter 1020 (which as the first part of the catheter to enter the body, most requires lubrication) before flowing down the remainder of the catheter 1020.

[0204] The taper on the upper edge 762b of the circumferentially extending element 762 partially fills the space between the movable insert 714 and the second inner wall section 9b, this reducing in volume decreases the volume in which wetting agent can become trapped, thereby ensuring a greater percentage of the wetting agent in the wetting agent storage chamber 80 reaches the catheter 1020 improving wetting efficiency. In this embodiment any excess wetting agent which does not contact the catheter 1020 flows into the sheath 1080.

[0205] The one or more embodiments are described above by way of example only. In light of the above disclosure those skilled in the art will appreciate that features disclosed in one embodiment may be combined with features of other embodiments. 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 wherein at the first end of the movable insert the tubular body comprises a tapered portion.

2. A catheter assembly according to claim 1 wherein the tapered portion is arranged at an end edge of the first end.

3. A catheter assembly according to claim 1 or 2 wherein the maximum diameter of the tapered portion is equal to the diameter of the of the seat.

4. A catheter assembly according to any preceding claim wherein the movable insert comprises a sealing surface adjacent to the first end, and the tapered portion is provided adjacent to the sealing surface.

5. A catheter assembly according to claim 4 wherein the sealing surface is an annular element with a diameter greater than the first end of the movable insert.

6. A catheter assembly according to any preceding claim wherein the first end of the movable insert comprises two opposing holes or slots extending through tubular body.

7. A catheter assembly according to claim 6 wherein two bearing projections are provided between the two holes or slots.

8. A catheter assembly according to claim 7 wherein the bearing projections comprise circumferentially extending elements.

9. A catheter assembly according to claim 8 wherein the circumferentially extending elements extend from an edge of one hole or slot to an edge of the other hole or slot.

10. A catheter assembly according to any of claims 7 to 9 wherein drain eyelets are provided above the bearing projections.

11. A catheter assembly according to any of claims 7 to 10 where drain eyelets are provided below the bearing projections.

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

13. A catheter assembly according to any preceding claim wherein the first end of the movable insert comprises two opposing slots extending from and end edge of the first end, wherein the width of the slots decreases proximate to the end edge.

14. A catheter assembly according to claim 13 when wherein the two slots provide gaps into which the first end may be deformed.

15. A catheter assembly according to any preceding claim wherein the first end of the movable insert comprises two opposing holes, wherein the holes are wider at their respective ends and relatively narrower between the two ends.

16. A catheter assembly according to claim 7 or directly or indirectly dependent upon claim 7 wherein the bearing projections comprise an axially extending element.

17. A catheter assembly according to either of claims 8 or 9 when directly or indirectly dependent upon claim 6 wherein the circumferentially extending element extends between 20% and 60% of the distance between the two holes or slots.

18. 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.

19. A catheter assembly according to claim 18 wherein the radial extent of the circumferentially extending element has a curved profile, wherein the curved profile of the circumferentially extending element, in combination, with a profile of the first end of the movable insert, defines an elliptical shape.

20. A catheter assembly according to claim 8 or 9 wherein an upper edge of the circumferentially extending element tapers towards the tubular body.

21. A catheter assembly according to any preceding claim wherein the movable insert comprises a dam.

22. A catheter assembly according to claim 21 when directly, or indirectly dependent upon claim 7, the dam comprising an annular projection arranged between the bearing projections and the end edge of the movable insert.

23. A catheter assembly according to claim 21 or 22 wherein the dam is configured to seal against the seat to prevent a wetting agent from flowing between the movable insert and the seat below the dam.

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

25. A catheter assembly according to any preceding claim further comprising a wetting agent storage chamber.

26. A catheter assembly according to claim 25 wherein the wetting agent storage chamber is defined by the movable insert and the catheter assembly body.

27. A catheter assembly according to claim 25 or 26 wherein in the first position, the wetting agent storage chamber is sealed.

28. A catheter assembly according to any of claims 25 to 27 wherein in the second position the wetting agent storage chamber is open, wherein a wetting agent can flow from the wetting agent storage chamber to the catheter.

29. A catheter assembly according to any of claims 25 to 27 wherein in a third position the wetting agent storage chamber is in an open configuration wherein a wetting agent can flow from the wetting agent storage chamber to the catheter.

30. A catheter assembly according to any preceding claim wherein the catheter is a urinary catheter.

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