GB2607028A - Urinary catheter - Google Patents

Abstract

A drainage catheter 10, preferably a urinary catheter, comprising an elongate portion 12 defining a lumen (20, Fig 2), the elongate portion having a fluid inlet 30 and a fluid outlet 34, fluidly connected by the lumen. The catheter may include retention means 14, such as a balloon, for retaining in the bladder. An obstruction-dislodging element 16 is provided for moving fluid within the lumen to dislodge an obstruction. In one arrangement, the obstruction-dislodging element 16 includes a manually compressible pump body 52 disposed along the elongate portion, upstream of the urine outlet. A grip-enhancing portion 64 may be provided on an outer surface of the manual pump body, and may include at least one projection, such as a rib 68, and/or at least one recess (70, Fig 4), such as a dimple. An electrically energisable pump-activation device (280, Fig 7) may be provided. The pump-activation device may comprise a controllable compression element (288, Fig 7) receivable around the manual pump body, for selective compression of the pump body. In another arrangement, an electrically energisable pump may be provided, for receiving around or in the elongate portion of the catheter.

Description

Urinary Catheter The present invention relates to a urinary catheter in which an obstruction in the internal lumen can be easily dislodged by any user to enable free flow of urine in the catheter. The present invention also pertains to a urine drainage system in which a blocked urinary catheter can be easily unblocked by any user, including users with restricted movement or limited physical ability. The present invention also relates to an electrically energisable pump-activation device which can be retrofitted to a catheter. A catheter for body fluids and a urine drainage system are also provided, in which obstructions to the fluid flow are easily dislodged by a user of any physical condition.

A urinary catheter enables urine to be removed from the bladder into a collecting bag or receptacle. Urinary catheters are used by millions of people who have health issues such as bladder incontinence, who are bed-bound, or who have limited movement. Urinary catheters are also used by pre-or post-surgery patients. In the UK, a significant number of people living in the community and in care homes use an indwelling catheter to relieve the symptoms of bladder dysfunction, manage urinary incontinence and maintain skin integrity.

The most common type of urinary catheter is a Foley catheter. The Foley catheter is inserted into the bladder either through the urethra or by the isuprapubic' method, whereby the abdomen is punctured a few inches below the navel to provide access to the bladder. Fitting the catheter is typically done under a local anaesthetic or under light general anaesthetic. The Foley catheter further includes an inflatable balloon which is inflated once the catheter has been fitted to the user. The inflatable balloon in-use prevents or inhibits accidental removal of catheter.

A common issue of a catheter is the deposition of mineral salts in or on the catheter. 25 Over time, the flow of urine becomes restricted. Flow may be prevented altogether, resulting in the catheter becoming blocked. Up to half of the people who use indwelling catheters long-term experience blockages on a regular basis.

The catheter may become obstructed at any time and without warning. A sudden catheter blockage can be embarrassing, distressing and frightening. Regular blockages 30 can lead to the development of anxiety and worrying about when the next blockage may occur.

If not attended to rapidly, a blockage can result in serious health complications. As a result of the build-up of pressure from urine, the bladder may become steadily distended, causing the user to experience pain. Urine may flow back to the kidneys, which can lead to bacterial infection, kidney failure, septicaemia and death. Urine retained within the bladder can either leak around or bypass the catheter, causing incontinence. A blocked catheter may cause the blood pressure in a person with a spinal cord injury above T5-6 to become excessively high, a potentially life-threatening condition known as autonomic dysreflexia.

Usual solutions to restore the free flow of urine within the catheter involve an emergency appointment with a nurse or doctor to have the catheter changed, which is inconvenient for the user, and places a burden on healthcare systems, time-wise and financially. Other users may attempt a bladder washout, or use a pipe cleaner or syringe to dislodge the blockage themselves. This may result in urine spillage and risks causing an infection due contamination by a pathogen.

The present invention seeks to provide a solution to these problems.

According to a first aspect of the present invention, there is provided a urinary catheter for draining urine, the catheter comprising: an elongate portion defining a lumen, the elongate portion having a urine inlet and a urine outlet fluidly connected to the urine inlet by the lumen; retention means for at least temporarily retaining part of the elongate portion in the bladder; an obstruction-dislodging element along the elongate portion upstream of the urine outlet for dislodging an obstruction preventing or inhibiting urine flow in the lumen, the obstruction-dislodging element having a manual pump body for moving fluid within the lumen to dislodge an obstruction by temporarily compressing the pump body, and a grip-enhancing portion provided on an outer surface of the manual pump body and including at least one projection and/or at least one recess for improving the ease of gripping of the obstruction-dislodging element by a user, and thereby the ease of compression.

The obstruction-dislodging element enables a user to dislodge a flow-restricting or flow-preventing blockage whenever the blockage may occur and without aid from any medical professional. In particular, the user can activate or operate the obstruction-dislodging element, in the preferred embodiment, by squeezing or compressing the manual pump body, causing the fluid pressure to be altered within the lumen so as to dislodge the blockage. The term "fluid" used herein and throughout is intended to refer to liquid and/or gas. An example of a liquid may include urine. An example of a gas may include air, by way of example only. Air may be present in the lumen of the catheter, for example, when the blockage may be fluidly upstream of the pump, some or all the urine downstream of the blockage may exit the lumen due to operation of the pump and may be replaced by air. In other words, this enhanced catheter contains a pump device system that clears blockages in the catheter's main channel within seconds. When a blockage occurs within the catheter's main channel, one only needs to squeeze the pump device system on this improved catheter a few times to dislodge the blockage. The pump device can be operated by the catheter user or their carer very easily. There is no need to call a qualified medical practitioner such as a nurse or doctor. The pump device system can be operated discreetly and without embarrassment for the catheter user, even in public. The obstruction-dislodging element means that the unimpeded flow of urine from the bladder to the collecting bag or receptacle can be restored very quickly when blockages occur.

The grip-enhancing portion enables a user to more easily recognise the pump body. This may be beneficial for visually impaired-users and/or users in a low-light or dark environment. If the obstruction-dislodging element has an interesting shape and/or is colourful, this may increase the aesthetics of the catheter. In turn, a more aesthetic catheter may improve the experience of a catheter for the user, such as a child. The grip-enhancing portion also increases the ease of holding and/or operating the pump body.

For instance, the grip-enhancing portion may reduce the likelihood of a user's hand slipping when holding the pump body. The grip-enhancing portion may transmit a force applied by the user to the pump body. This may be advantageous for users who have limited physical ability, for example, users who may be unable to fully close their hand.

Beneficially, the or a said projection may be a rib. Furthermore, the or a said rib may have a longitudinal extent which may be linear. Alternatively, the or a said rib may have a longitudinal extent which may be curved. Optionally, the or a said rib may have a longitudinal extent which may be sinusoidal and/or saw-toothed. One or more ribs are distinctive features which are easily recognisable, particularly to visually-impaired users.

Alternatively or additionally, the or a said projection may be a spike. The spike may have a pyramidal, conical, frustopyramidal or frustoconical profile, by way of example. One or more spikes are distinctive features which improve the ease of recognition. Furthermore, a user may be able to position their fingers around a spike and/or between spikes depending on the spacing between a plurality of spikes.

Beneficially, the or a said projection may be elongate and may have a cantilevered end. Advantageously, the or a said projection may be at least partly rigid for transmitting a force applied by a user to compress the pump body when the user only partially closes their hand. The obstruction-dislodging element can be activated by a user of restricted physical ability.

Alternatively or additionally, the grip-enhancing portion may comprise an anti-slip coating. The surface roughness may be increased, to reduce slipping. This may be particularly advantageous if the pump body is wet. Furthermore, increased surface roughness increases friction. Increased friction reduces the likelihood of the obstruction-dislodging element falling off or sliding off any support the obstruction-dislodging element is on, such as a bed or table. In turn, the obstruction-dislodging element may remain within easy reach of the user for a greater proportion of the time.

Furthermore, the grip-enhancing portion may comprise an illuminable portion. Additionally, the illuminable portion may include a photoluminescent element for facilitating a user finding the obstruction-dislodging element in a dark or low-light environment. The illuminable portion enables a user to locate the obstruction-dislodging element in a dark or low-light setting.

Optionally, the obstruction-dislodging element may further comprise a force-transmitting element having an end portion engageable with the or a said recess, the force-transmitting element being engageable by the user for transmitting a force via the force-transmitting element to the pump body. Furthermore, the force-transmitting element may include a pin element. The force-transmitting element may be separate or separable from the pump body. The force-transmitting element may provide the user with more leverage.

Beneficially, the retention means may comprise an inflatable balloon at or adjacent the 25 urine inlet. An inflatable balloon prevents or inhibits accidental removal of the catheter when inflated.

According to a second aspect of the present invention, there is provided a urine drainage system for draining urine, the system comprising: a urinary catheter for draining urine, the catheter comprising: an elongate portion defining a lumen, the elongate portion having a urine inlet and a urine outlet fluidly connected to the urine inlet by the lumen; retention means for at least temporarily retaining part of the elongate portion in the bladder; an obstruction-dislodging element along the elongate portion upstream of the urine outlet for dislodging an obstruction preventing or inhibiting urine flow in the lumen, the obstruction-dislodging element having a manual pump body for moving fluid within the lumen to dislodge an obstruction by temporarily compressing the pump; and an electrically energisable pump-activation device receivable around the manual pump body.

The urine drainage system enables a user to unblock a blocked or partially blocked catheter without needing the user to physically press the pump body. This may be advantageous if the user is unable to reach the obstruction-dislodging element and/or does not have the strength to activate the pump body manually. The electrically energisable pump-activation device is able to activate or operate the pump body instead. A further advantage of an electrically energisable pump-activation device is that the pump body can be activated without necessitating a user input. For example, the pump-activation device may detect a blockage when the user is in a non-receptive condition, such as asleep or in a coma, and automatically activate the pump body to dislodge the blockage.

Preferably, the pump-activation device may comprise a processor, a user-input means for providing a user input communicable with the processor via a communication channel for controlling the pump-activation device via the user-input means. The or a further user is able provide an input to control the pump-activation device.

Additionally, the pump-activation device may further comprise a wearable element in or on which the user-input means is provided. Beneficially, the wearable element may include at least one of: a lanyard, a pendant, a watch, a strap, jewellery, a clip, and a bracelet. The user-input means being associated with a wearable element is easy to locate and/or the risk of loss of the user-input means is reduced. As the user-input means remains close to the user, the risk of the catheter being accidentally pulled away from the user may also be reduced, particularly if the user-input means communicable with the process via a wire. Furthermore, a wearable element may be discreet, which may be advantageous if the user is on the move.

Advantageously, the pump-activation device may further comprise a receiver and the user-input means may comprise a transmitter wirelessly communicable with the receiver. Wireless communication reduces the number of wires required. Fewer wires reduce the risk of accidentally pulling on the catheter which may be painful for the user and/or may result in the catheter being prematurely removed.

Alternatively, the pump-activation device may comprise a wire for connecting the processor and the user-input means for providing a wired communication channel. Wired communication may be more reliable than wireless communication and/or may be simpler to manufacture.

Preferably, the pump-activation device may include a compression device. Furthermore, the compression device may include a jaw clamp. The pump-activation device acts by compressing the pump body. The pump-activation device can be retrofitted to a catheter having a manual pump body, which provides flexibility.

According to a third aspect of the invention, there is provided an electrically energisable pump-activation device comprising a controllable compression element receivable around a manual pump body of a catheter for selectably compressing the manual pump body. A pump-activation device may be retrofittable to a manual pump body of a catheter, thereby providing greater modularity and flexibility. This may eliminate or reduce the need to source and fit a catheter comprising an electrical pump.

According to a fourth aspect of the invention, there is provided a catheter for draining a body fluid, the catheter comprising: an elongate portion defining a lumen, the elongate portion having a fluid inlet and a fluid outlet fluidly connected to the fluid inlet by the lumen; an obstruction-dislodging element along the elongate portion upstream of the body fluid outlet for dislodging an obstruction preventing or inhibiting fluid flow in the lumen, the obstruction-dislodging element having: a manual pump body for moving fluid within the lumen to dislodge an obstruction by temporarily compressing the pump body, and a grip-enhancing portion provided on an outer surface of the manual pump body and comprising at least one projection and/or at least one recess for improving the ease of gripping of the obstruction-dislodging element by a user, and thereby the ease of compression. The catheter may be used for any body fluid, not just urine. An obstruction in the catheter may easily be removed by virtue of comprising a pump. A grip-enhancing portion improves the ease of use.

According to a fifth aspect of the invention, there is provided a urine drainage system comprising: an elongate portion defining a lumen, the elongate portion having a urine inlet and a urine outlet fluidly connected to the urine inlet by the lumen; and an electrically energisable pump receivable around or in the elongate portion for moving fluid within the lumen to dislodge an obstruction therein. An electric pump, such as a peristaltic pump, can be retrofitted to an existing urinary catheter to enable dislodging of any obstructions.

The pump may be able to move fluid in both directions along the lumen or along only one direction.

The invention will now be more particularly described, by way of example only, with reference to the accompanying drawings, in which: Figure 1 shows a side representation of a first embodiment of a urinary catheter in accordance with the first aspect of the invention, with an inflatable balloon shown in an inflated condition, and part of an elongate portion within the inflatable balloon illustrated in dashed lines; Figure 2 illustrates a part cut-away side representation of the urinary catheter of 10 Figure 1 in-use and in-situ in a bladder, and part of a urine collection device; Figure 3 shows a perspective close-up representation of rectangle A of Figure 1, with an obstruction-dislodging element having a second embodiment of a grip-enhancing portion; Figure 4 illustrates a perspective close-up representation of rectangle A of Figure 15 1, with the obstruction-dislodging element having a third embodiment of a grip-enhancing portion; Figure 5 shows a perspective close-up representation of rectangle A of Figure 1, with the obstruction-dislodging element having a fourth embodiment of a grip-enhancing portion, in-use; Figure 6 shows a perspective view of a second embodiment of a urinary catheter in accordance with the first aspect of the invention, in-use.

Figure 7 is a perspective representation of a urine drainage system in accordance with the second aspect of the invention, the urine drainage system including a catheter and a pump-activation device in-use; Figure 8 shows a perspective view of the pump-activation device of Figure 7; Figure 9 illustrates a perspective view of a watch comprising a user-input means of the pump-activation device of Figure 7; Figure 10 illustrates a perspective view of a pendant comprising a user-input means of the pump-activation device of Figure 7; and Figure 11 is a perspective view of a clippable element comprising a user-input means of the pump-activation device of Figure 7 Referring now to Figure 1, there is shown a catheter, indicated generally at 10. The catheter or catheter element 10 in-use enables drainage of a bodily or body fluid, such as blood, pus, or urine by way of example. In the preferred embodiment, the catheter 10 is used, configured or adapted for drainage of urine from the bladder. Thus, the catheter 10 is preferably a urinary catheter, although any non-urinary catheter may be envisioned, such as an intravenous or IV catheter. The catheter 10 is preferably intended for human use but may alternatively be used for a non-human, such as an animal.

The catheter 10 preferably comprises an elongate portion 12, retention means 14 and an obstruction-dislodging element 16, although any of the above may be omitted and/or a plurality may be provided. The catheter 10 or any part thereof may comprise metal, plastics, a polymeric or elastomeric material, glass, carbon-fibre, glass-fibre, wood, any other suitable material, or any combination thereof. Examples of a polymer or elastomeric material include rubber and latex.

The elongate portion 12 comprises a main body 18a. As shown, the elongate portion 12 further comprises an axillary branch or body 18b, although this feature may be omitted, 20 or a plurality provided.

The main body 18a has an inner conduit or chamber, also referred to as a first lumen 20, body fluid lumen or urine lumen 20. The main body 18a includes an outer wall 22. The outer wall 22 defines at least in part the first lumen 20. The elongate portion 12 may therefore be considered to be a tube or tubular. The outer wall 22 or at least part thereof is preferably pliable, flexible, or foldable, but this is optional. The outer wall 22 may or may not be collapsible. The elongate portion 12 has a first end portion 24a and a second end portion 24b. A plurality of first end portions 24a and/or a plurality of second end portions 24b may be provided.

The first end portion 24a is insertable in-use into the body cavity 26, which is the bladder 30 in the preferred embodiment. Part of the bladder is illustrated in Figure 2. The first end portion 24a may be referred to as the upstream end or the proximal end of the catheter 10. The first end portion 24a comprises a first tip portion 28 and a fluid inlet 30, although a plurality of either feature may be provided.

The fluid inlet 30 is an opening or aperture which enables fluid egress from and/or, preferably, ingress into the first lumen 20. The fluid inlet 30 may be referred to as an eye. 5 In other words, the catheter eye is the or an opening through which urine may be drained from the bladder into a collecting device. The collecting device may also be referred to as a collection device, or receptacle, or a drainage element. The fluid inlet 30 may be provided at or adjacent the first tip portion 28 or spaced-apart therefrom. In the latter case, the first tip portion 28 may optionally be sealed or sealable. The first tip portion 28 10 may be any of: a straight tip, a Robinson tip, a Tiemanns tip, a whistle tip, an opposing eyes tip, a Coucill tip, a Coude tip, a Hematuria tip, or any other suitable type of catheter tip.

The second end portion 24b may be referred to as a downstream end or a distal end of the catheter 10. The second end portion 24b is opposite the first end portion 24a along 15 the catheter 10. The second end portion 24b comprises a second tip portion 32 and a fluid outlet 34, although a plurality of either feature may be provided.

The fluid outlet 34 enables ingress into and/or, preferably, egress from the first lumen 20. The fluid outlet 34 may be provided at or adjacent the second tip portion 32 or spaced-apart therefrom. In the latter case, the second tip portion 32 may optionally be sealed or sealable. The fluid outlet 34 is fluidly connected to the fluid inlet 30 by the first lumen 20.

In the preferred embodiment, as the catheter 10 is a urinary catheter, the fluid is or comprises urine. The fluid inlet 30 may be referred to as a urine inlet. Similarly, the fluid outlet 34 may be referred to as a urine outlet or a urine drainage port.

The retention means, element, part, or mechanism 14 in-use prevents or inhibits the first end portion 24a from accidentally slipping out, being removed or dislodged from the body cavity 26 in which the first end portion 24a is received. In other words, the retention means 14 at least temporarily retains part of the elongate portion 12 in the body cavity 26. The retention means 14 interacts with the wall or walls of the body cavity 26.

In the preferred embodiment, the retention means 14 includes an inflatable sac or balloon 36a, and inflation means 36b for inflating the inflatable balloon 36a, but either feature may be omitted and/or a plurality of either may be provided. The catheter balloon 36a is shown inflated in the figures, as it would be when in-use in the bladder, to prevent or inhibit the catheter 10 from being removed from the body cavity 26. Such a retention means 14 is typically found in a Foley catheter.

The inflatable balloon 36a may be provided in or on the first end portion 24a, although spaced-apart therefrom is an option. The inflatable balloon 36a defines a balloon internal volume 38. The inflatable balloon 36a is either in a deflated condition or in an inflated condition. In the deflated condition, the inflatable balloon 36a has a maximal diameter or dimension which is less than a dimension of an access to the body cavity 26. In the inflated condition, the inflatable balloon 36a has a maximal diameter or dimension which is greater than a dimension of the access to the body cavity 26.

The inflation means 36b enables the condition of the balloon 36a to be changed, for example from a deflated condition to an inflated condition or vice-versa, or between two inflated conditions, or between two deflated conditions.

Although the term "inflation means" is used, it is understood that the inflation means also enables deflation. Thus, the inflation means 36b may also be referred to as deflation means, or inflation and deflation means. The inflation means 36b comprises a fluid conduit 40a and a stop element 40b, although either feature may be omitted and/or a plurality of either feature may be provided The fluid conduit 40a, also referred to as a second lumen, provides a duct for fluid to enter and/or exit the balloon internal volume 38. The fluid may be a gas or, preferably, a liquid. More preferably, the liquid may be water or saline. The fluid conduit or second lumen 40a is preferably at least partly provided within or contained within the elongate portion 12, although fully within or fully outside the elongate portion may be options. The first lumen 20 and the second lumen 40a may be defined at least in part by providing an inner wall 42 in the elongate portion 12. As shown, part of the fluid conduit 40a extends within the axillary body 18b. The axillary branch or body 18b may be alternatively referred to as the balloon inflation lumen external casing.

The second lumen 40a is preferably not fluidly connected with the first lumen 20, 30 although this altemative may be envisioned, for instance via a flap or switch. This may be advantageous to provide a secondary drainage means, should the first lumen 20 become blocked downstream of the fluid connection between the first and second lumens, by way of example only. Preferably, the fluid conduit 40a comprises a first aperture 44a and a second aperture 44b fluidly connected to the first aperture 44a via the second lumen 40a.

The first aperture or balloon-volume aperture 44a is provided in, at or adjacent the 5 balloon 36a. The first aperture 44a enables fluid to enter and/or exit the balloon internal volume 38 from the second lumen 40a. The second aperture 44b enables fluid to exit and/or enter the second lumen 40a from outside of the fluid conduit 40a. The second aperture 44b may be referred to as a balloon inflation port. In other words, in the preferred embodiment, the second lumen 40a is for the fluid for the balloon inflation process, and 10 extends longitudinally through the catheter 10 from the balloon inflation port all the way to the catheter balloon 36a.

The stop element or mechanism 40b in-use prevents or inhibits fluid flow in one or both directions at or adjacent the second aperture 44b and/or along the second lumen 40a. The stop element 40b may permit or enable fluid flow in one direction. The stop element 40b may selectably permit or enable fluid flow in the other direction. In the preferred embodiment, the stop element 40b includes a seal or sealing element 46. The seal 46 includes a valve 48 in the shown embodiment, but any non-valve may be used, such as a stopper, bung, clamp, cork, or flap, by way of example. More preferably, the valve 48 is a one-way valve or single check valve although a non-one-way valve or a non-single check valve may be used. In other words, there may be a check / non-return valve unit which may be used to stop the fluid inflating the balloon from leaking out of the balloon inflation port. Preferably, the valve 48 is biased into one of an open condition or a closed condition, preferably the latter, but there may be no biasing. In the shown embodiment, the valve 48 is biased by being spring-loaded, but any alternative biasing means or mechanism may be envisioned.

Alternative valves may include a double check valve, a ball valve, a butterfly valve, a gate valve, a knife gate valve, a globe valve, a needle valve, a pinch valve, or any other suitable valve.

The obstruction-dislodging element 16 in-use enables dislodging of an obstruction preventing or inhibiting free flow of fluid in the first lumen 20 and/or second lumen 40a. The obstruction-dislodging element 16 may be integrally formed with, connected, connectable or separably engageable with the elongate portion 12. The obstruction-dislodging element 16 may be associated with the elongate portion 12 downstream or, preferably, upstream of the fluid outlet 34. In other words, the pump device system may be upstream or proximal relative to the urine drainage port.

The obstruction-dislodging element 16 may be associated with the elongate portion 12 upstream or, preferably, downstream of the fluid inlet 30. The obstruction-dislodging element 16 preferably comprises a pump, pump element or pump device 50, although any non-pump may be envisioned. The pump 50 is preferably integrally formed with the elongate portion 12, but non-integrally formed therewith may be an option.

Preferably, the pump 50 is a manual pump, also known as a bulb pump or squeeze-bulb, but non-manual or part manual are options. In other words, the pump 50 may be manually activated, operated or actuated by a user. The pump 50 has a pump body or bulb 52. The pump body 52 has at least one pump wall 54. The or each pump wall 54 has a pump inner surface 56a and a pump outer surface 56b. The pump inner surface 56a defines at least in part a pump volume 58. If the pump body 52 has a plurality of pump walls 54, all or at least one of the pump inner surfaces 56a defines the pump volume 58. The first lumen 20 goes through the pump volume 58 in the shown embodiment but this is optional. In Figure 2, the dashed lines in the pump volume 58 indicated the first lumen 20 surrounded by the pump volume 58. In other words, the pump volume 58 and the first lumen 20 may be contiguous. In yet again other words, the pump volume 58 may be provided around or may surround the first lumen 20. Preferably, no barrier, permeable or impermeable, is provided between the pump volume 58 and the first lumen 20, although this alternative may be an option. This enables fluid from the first lumen 20 to freely flow into the pump volume 58, and vice-versa. In the preferred embodiment, the elongate portion 12 flares outwardly and/or transitions smoothly into the wall or walls of the pump body 52, but this is optional. This first transition or meeting area may be referred to as a first junction, first contact zone, or a first pole 60a. The wall or walls of the pump body 52 may narrow inwardly and/or transition smoothly back into the elongate portion 12 but once again, this is optional. This second transition or meeting area may be referred to as a second junction, second contact zone, or second pole 60b. The wall or walls of the pump body 52 are preferably deformable, collapsible or compressible. The pump body 52 may be in a compressed condition or in an uncompressed condition. The compressed condition may be referred to as an active or pressured condition. The uncompressed condition may be referred to as an inactive or unpressured condition. The pump volume 58 is reduced when in the compressed condition, relative to when it is in the uncompressed condition.

Preferably, the elongate portion 12 downstream of the fluid outlet 34 is at least as long as a collection bag connector 62, but this may be optional. The increased length enables the collection bag connector 62 to engage with the elongate portion 12 without interfering with the operation of the pump 50. In the shown embodiment, engagement is achieved via the collection bag connector 62 being received in, on or around the elongate portion 12.

In other words, in the illustrated embodiment, at least part of the collection bag, such as a leg / night bag connector is shown in the extended urine drainage port. This illustrates the need for an extended urine drainage port or elongate portion 12 downstream of the pump body 52 as otherwise the leg! night bag connector proximal end may be positioned inside the pump body 52 and may interfere with the operation of the pump 50 when in use.

In the shown embodiment, the pump 50 or the pump body 52 thereof is or is substantially spherical or part spherical. In other words, the pump body 52 is or is substantially circular in longitudinal and transverse cross-sections. It may easily be envisioned in an alternative embodiment that the pump body may be non-spherical. For example, the shape of the the pump or the pump body thereof in any of: a lateral cross-section, a longitudinal cross-section, and a transverse cross-section may be any of: curved; part curved; non-curved; circular; ellipsoid; parabolic; oval; linear; part linear; a regular polygonal shape, such as triangular, square, rectangular, trapezoidal or a trapezium, pentagonal, hexagonal, octagonal or any other polygonal shape; an irregular polygonal shape; a chamfered or rounded polygon; pear-shaped; or an abstract shape.

For clarity, a transverse cross-section is a cross-section along a plane intersecting the first lumen 20 perpendicularly. A longitudinal cross-section is a cross-section along a plane which includes or is parallel with the localised general direction of the first lumen 20. A longitudinal cross-section may or may not include one or both of the first pole 60a and the second pole 60b.

Optionally, the catheter 10 may further comprise a grip-enhancing portion 64, but this feature may be omitted and/or a plurality may be provided.

The grip-enhancing portion 64 is preferably part of the obstruction-dislodging element 16, but this need not be the case. The grip-enhancing portion 64 may also be referred to as a tactile element, an identifier, an identification part, or a visual identification element.

The grip-enhancing portion 64 may have any or any combination of the following functions A first function of the grip-enhancing portion 64 is to enhance or facilitate the ease with which a user grips and/or operates the obstruction-dislodging element 16 or the pump 5 50 thereof. In other words, the risk of a user's hand slipping when grasping and/or operating the pump 50 is reduced or eliminated.

In yet again other words, the ball feature of the pump may have a tactile surface. The surface may have raised knobbly parts or spikey parts. This will enable the pump to be squeezed more easily by people who do not have good dexterity or control of their fingers or who lack sensation in their hands. Having the tactile surface creates a non-slip surface that enables a person to squeeze the ball easier without their fingers sliding off the ball.

A second function of the grip-enhancing portion 64 is to enable users to activate, actuate or operate the pump 50 despite having with limited physical ability to close their hand.

A third function of the grip-enhancing portion 64 is to help a user identify the pump 50.

In other words, the grip-enhancing portion 64 helps the user locate the correct portion to activate to unblock the catheter. This may be particularly helpful in a low-light or dark environment, such as at night by way of example. The grip-enhancing portion 64 may be particularly important for visually-impaired users. In other words, the tactile surface features may be helpful to blind and partially-sighted people. It may enable them to make sure they are pressing the correct part of the pump when trying to remove a blockage.

The grip-enhancing portion 64 may additionally be aesthetically pleasing. For example, the grip-enhancing portion 64 may enable easy identification of the pump 50 for a child user whilst bright colour or colours and/or an interesting shape may improve the child's experience of using the catheter 10. The grip-enhancing portion may be shaped like a plant, such as a sunflower for example. The grip-enhancing portion may be shaped like an animal, such as a hedgehog for example.

Any of the above functions may be omitted. Although ordered first, second and third, any of the above functions may be greater in importance relative to any other of the functions. All or at least two functions may be equally important.

Preferably, the grip-enhancing portion 64 is provided in or on the pump outer surface 56b. The grip-enhancing portion 64 or at least part thereof may be connectable, connected or, preferably, integrally formed therewith. The grip-enhancing portion 64 or part thereof may be selectable from a range of grip-enhancing portions. If not integrally formed therewith, the grip-enhancing portion 64 or part thereof may be repositionable in or on the pump outer surface 56b. The grip-enhancing portion 64 comprises a projection 66 and/or a recess, although either or both features may be omitted and/or a plurality of either or both features may be provided.

The grip-enhancing portion 64 or part thereof may be deformable, part deformable, or non-deformable. For example, the grip-enhancing portion 64 or part thereof may be compressible, extendable or stretchable. The grip-enhancing portion 64 or part thereof, such as a projection 66, may be at least partly rigid. This may be advantageous for transmitting a force applied by a user to compress the pump body when the user only partially closes their hand.

If the grip-enhancing portion 64 comprises a plurality of projections 66, all or a subset of projections 66 may be identical to each other. Alternatively, all projections 66 may be 15 different from each other. In a third alternative, one or more projections 66 may differ from one or more further projections 66.

Similarly, if the grip-enhancing portion 64 comprises a plurality of recesses, all or a subset of recesses may be identical to each other. Alternatively, all recesses may be different from each other. In a third alternative, one or more recesses may differ from 20 one or more further recesses Each projection 66 and/or each recess may have any size. Optionally, each, all or at least one projection 66 and/or each, all or at least one recess may comprise, form or be part of a pattern, such as a three-dimensional pattern. The pattern may or may not be regular, for example periodic. The pattern may be sinusoidal, crenulated, saw-toothed, any other pattern, or any other combination of patterns, by way of example only.

Each projection 66 and/or each recess may have a longitudinal extent or length, a lateral extent or width, and a depth. The depth of a projection 66 and/or of a recess may be variable or non-variable, such as constant or uniform. The depth of at least two projections 66 may differ or be the same as each other. The depth of at least two recesses may differ or be the same as each other.

The or a said projection 66 may be any of: a rib, a spike, a dome, a conical projection, a cylindrical projection, an abstract shape, or any other form, such as but not limited to, an animal or part thereof, a plant or part thereof, or an object. The or a said recess may be any of: a groove, slit, slot, or a negative of a projection.

However, each projection and/or each recess may have any shape in any of: lateral cross-section, longitudinal cross-section, and transverse cross-section. For instance, the shape in any of: plan view, side view, lateral cross-section, longitudinal cross-section, and transverse cross-section of a projection and/or a recess may be any of: curved; part curved; non-curved; circular; ellipsoid; parabolic; oval; linear; part linear; a regular polygonal shape, such as triangular, square, rectangular, trapezoidal or a trapezium, pentagonal, hexagonal, octagonal or any other polygonal shape; an irregular polygonal shape; a chamfered or rounded polygon; pear-shaped; or an abstract shape.

Each projection 66 and/or recess may extend in a plane or surface. The plane may be a transverse plane, a longitudinal plane, or any plane forming an angle with a transverse plane and/or a longitudinal plane. Each plane may only contain one projection 66 and/or recess, although a plurality of projections and/or recesses extending in the same plane may easily be envisioned. A plurality of planes containing at least one projection 66 and/or at least one recess may be regularly spaced apart from each other, although irregular spacing is an option.

The or a said projection 66 may be elongate or elongated. In other words, the depth of the projection 66 may be greater than a width and/or length, or diameter of the projection. The projection 66 may also have a free or cantilevered end. The cantilevered end may be rounded, part rounded, or non-rounded.

A first embodiment of the grip-enhancing portion 64a, illustrated in Figures 1 and 2, includes a plurality of ribs 68. Each rib 68 extends or substantially extends outwardly from the pump body 52 radially and/or in a transverse plane. Thus, each rib 68 is or is substantially linear in side view. All or at least a subset of the transverse planes are preferably parallel with each other, but non-parallel may be an option. The transverse planes are or are substantially equidistant from each other but this is optional. Each rib 68 may be or be substantially a ring or torus. In other words, the depth of each rib 68 may be or be substantially constant along all or at least a major portion of the longitudinal extent of the rib 68, although the depth being constant along a minor portion of the longitudinal extent may be an option. The depth may be variable in a further modified embodiment.

A second embodiment of a grip-enhancing portion 64b is shown in Figure 3. The second embodiment of the grip-enhancing portion 64b also has a plurality of ribs 68b. Preferably, each rib 68 extends at least in part along a longitudinal plane. Each longitudinal plane may include one, two or at least three ribs. The longitudinal planes may be intersecting and/or non-intersecting with each other. A plurality of ribs may or may not extend co-linearly or sequentially with each other within a plane. In other words, each rib 68 preferably extends at least in part from the first junction 60a to the second junction 60b.

A third embodiment of a grip-enhancing portion 64c is shown in Figure 4. The third embodiment of the grip-enhancing portion 64c comprises a plurality of recesses or dimples. In the shown embodiment, the recesses 70 are or are substantially circular in side view but any non-circular shape may be envisioned. Each or at least one recess may be inwardly curved. Additionally or alternatively, each or at least one recess may have a recessed planar or part-planar surface. At least one dimple may be sized to receive a finger therein.

A fourth embodiment of a grip-enhancing portion 64d is shown in Figure 5. The fourth embodiment of the grip-enhancing portion 64d comprises a plurality of protrusions or projections 66d. The protrusions are preferably curved, or part curved. Thus, the 20 protrusions may be referred to as domes, knobs, or bobbles.

The recesses 70 of the third embodiment and/or the domes of the fourth embodiment are preferably spaced-apart from each other. The spacing may be regular and/or irregular. The recesses 70 of the third embodiment and/or the domes of the fourth embodiment may or may not be aligned with each other. As shown in Figures 4 and 5, the recesses 70 of the third embodiment and/or the domes of the fourth embodiment have different sizes but all or a subset of recesses and/or domes may have the same size.

Any additional or alternative feature which may fulfil any of the above functions of the grip-enhancing portion may be envisioned, such as a different texture and/or a coating.

For example, the grip-enhancing portion may comprise an anti-slip coating or texture. The grip-enhancing portion may optionally comprise an illuminable portion. An illuminable portion may help a user identify the obstruction-dislodging element, for example, in a dark or low-light environment. The illuminable portion may include a lighting element, such as an LED for example. The illuminable portion may include a photoluminescent element, portion or paint.

In use, the catheter 10 may be assembled if not already in an assembled condition. If 5 not assembled, the catheter 10 may be provided as a kit of parts.

If the stop element 40b is required and not already provided, the user connects the stop element 40b with the catheter 10. More preferably, the stop element 40b is connected with, placed in, on or adjacent to the second lumen 40a if a second lumen is provided. The retention means 14 may be connected or mounted in or onto the catheter 10 if not already associated therewith.

If not integrally formed therewith, the pump 50 is connected with, mounted in, on or around the elongate portion 12.

The second end portion 24b may empty into a sink or drainage element. In the latter case, the second end portion 24b may need to be connected to the drainage element. A 15 drainage element may include a body fluid collection bag, such as a urine collection bag. The collection bag connector 62 is shown in Figure 2.

Once ready for use, the catheter 10 is fitted to a user, usually by a medical professional. This involves inserting the first end portion 24a into the relevant body cavity. In the case of a urinary catheter 10, this is the bladder. The first end portion 24a may be inserted via 20 the urethra, via a suprapubic opening, or any other suitable method of insertion.

If provided with retention means 14, the retention means 14 is preferably activated, operated or actuated from a removal and/or insertion condition into a retaining condition. In the retaining condition, the retention means 14 prevents or inhibits accidental removal of the catheter 10 from the body cavity. In the removal and/or insertion condition, the retention means 14 has a state, shape or configuration which reduces or eliminates resistance to enable removal from and/or insertion of the catheter 10 into the body cavity.

In the preferred embodiment, actuating, activating or operating the retention means 14 into the retaining containing involves injecting a fluid, such as a gas or, preferably, liquid into the second lumen 40a. This may be done via an injection device, such as a syringe.

In the preferred embodiment, the stop element 40b includes a valve 48 in a closed condition and/or biased towards the closed condition when displaced therefrom. The injection device may bear against the valve 48 so as to displace the valve 48 away from the closed condition and into an open condition. Alternatively, the pressure of the injected fluid may be sufficient to displace the valve 48 away from the closed condition and into an open condition without contact between the injection device and the stop element 40b.

Fluid travels through or past the stop element 40b. The injected fluid can then travel along the second lumen 40a. The fluid exits the second lumen 40a and enters inflatable balloon 36a. In other words, the catheter balloon 36a is inflated by inserting a syringe into the balloon inflation port and injecting sterile water into the balloon inflation lumen external casing. The inflated catheter balloon 36a prevents or inhibits removal of the catheter 10 from the body cavity 26.

Upon removal of the injection device and/or upon pressured fluid ceasing to be injected 15 into the second lumen 40a, the valve 48 is biased back towards the closed condition. The valve 48 prevents or inhibits injected fluid from exiting the second lumen 40a and therefore from exiting the inflated balloon 36a.

To deflate the balloon 36a, the valve 48 is operated or actuated into the open condition. In the preferred embodiment, this may involve applying a biasing force of sufficient magnitude against the valve 48 to actuate or operate the valve 48 into the open condition. This biasing force may optionally be provided by the same injection device or a further device. In the open condition, the fluid can be drained from the second lumen 40a and inflatable balloon 36a. The fluid may be drained into a sink and/or drawn into a syringe. As the balloon 36a is drained, the retention means 14 returns to the removal and/or insertion condition.

Although the preferred embodiment comprises a biased valve 48, a non-biased valve may be simply actuated or operated between the closed and open conditions, for example using a toggle or switch. In yet a further embodiment, there may be no valve. Any altemative known retention means may be provided and operated as standard.

The user's cavity 26, preferably a bladder in the preferred embodiment, fills up with the body fluid to be drained, here urine. Upon normal use, the urine enters the fluid inlet 30 of the catheter 10, travels along the first lumen 20 and exits via the fluid outlet 34. If a drainage element is provided, the urine is collected in the drainage element.

Over time, mineral deposits accumulate on the internal surface of the wall or walls defining the first lumen 20. The mineral deposits may occur anywhere along the elongate 5 portion 12. Due to the mineral deposits, the diameter of the first lumen 20 may narrow which reduces the drainage flow velocity or rate. If the first lumen 20 becomes completely obstructed, flow is prevented along the elongate portion 12. There may even be mineral deposits at or adjacent either or both the fluid inlet 30 and the fluid outlet 34, within or outside of the first lumen 20. If there is a blockage or if the drainage flow rate is less than 10 the rate of urine production, urine may accumulate in the first lumen 20 and/or in the bladder without being drained. Pressure on the bladder may increase, causing pain and health issues.

To clear a partially or fully blocked first lumen 20, the user locates the pump 50. If the obstruction-dislodging element 16 thereof comprises a grip-enhancing portion 64, the 15 grip-enhancing portion 64 may help the user locate the pump 50 in the dark or low light conditions, or if the user is visually-impaired.

The user wraps their hand around and/or inserts their fingers in and/or between the grip-enhancing portion 64, depending on the configuration and/or shape of the the grip-enhancing portion 64. This may improve the ease of gripping of the obstruction-20 dislodging element 16 by a user, and thereby the ease of operating the pump 50.

The user operates or activates the pump 50 to dislodge the obstruction. In the case of a manual pump 50, the user places their hand adjacent to or around the manual pump 50. The method of operating the pump 50 is illustrated by the arrows B in Figure 5. The user squeezes, or applies a compressive or constrictive force to the pump body 52. This causes the pump volume 58 to decrease. The pump volume 58 is preferably full of fluid. Upon reduction of the pump volume 58, fluid may flow into the first lumen 20 upstream and/or downstream. The composition of the fluid may optionally depend on the location of the pump 50 along the fluid path relative to the blockage. The fluid may be a body fluid, such as urine. The fluid may comprise gas and/or liquid. The gas may comprise air.

The fluid being gas may occur for example if the blockage is fluidly upstream of the pump 50 and/or if the liquid has exited the first lumen 20. Gas may even enter through the fluid outlet and/or another aperture into the first lumen.

It may easily be envisioned that fluid, such as water, may be injected into the first lumen to aid in dislodging the blockage. For example, fluid may be injected via the fluid outlet and/or another aperture. As liquids are or are largely incompressible, or at least less compressible relative to gas, injecting a liquid may be more effective at applying pressure to dislodge a blockage compared to a gas.

Reducing the pump volume 58 may cause the fluid, referred to as pumped fluid for clarity, to flow away from the pump 50. The pumped fluid may flow in an upstream direction and/or in a downstream direction along the first lumen 20. The pumped fluid may apply an increased pressure against the mineral deposits.

Instead of or in addition to the dislodging action being due to an increased pressure, the blockage may be dislodged due to the mechanical action and/or impact of fluid being moved back and forth against and/or past the obstruction.

The pump may alternatively dislodge a blockage by applying a reduced pressure instead of an increased pressure. For instance, the pump volume may create a vacuum or suction which may be sufficient to dislodge a blockage. A one-way flap, for example within the lumen, may be provided, so as to create or help create a vacuum by permitting fluid to be evacuated downstream, but not upstream.

In all cases, the pump body 52 enables moving of fluid within the first lumen 20 to dislodge an obstruction by temporarily compressing the pump body.

Release of the pump body 52 may result in the pumped fluid flowing back towards the pump 50 and/or downstream along the first lumen 20. This may be due to the natural direction of flow and/or may be the result of a suction or vacuum force caused by the pump body 52. If one compression of the pump body 52 is insufficient to dislodge the blockage, the user may compress and release the pump body 52 a plurality of times.

In other words, the pump 50 can be operated by squeezing one outer side of the pump 50 towards the other side or both sides towards each other. In other words, the sides of the pump body 52 are pushed in an inward direction as shown by the direction of the two arrows B in Figure 5. In yet again other words, the diametrically opposed outer sides are pushed towards each other. The user may repeat the step of squeezing together the outer sides of the pump 50, in an inward direction, such that the diametrically opposed outer sides are pushed toward each other, for as many times as necessary. This method of operating the pump 50 will restart fluid flow through the catheter 10, when the urine drainage or first lumen 20 of the catheter 10 is blocked. Any blockage of flow of fluid within the first lumen 20 that extends longitudinally through the catheter 10 from the catheter eye 30 to the urine drainage port 34 may be flushed or removed.

The pump device may work similarly to a plunger when trying to unblock a sink or drain. VVhen the pump device is pressed, it may pump pressure back up the catheter's channel to force the blockage to move. When the pump device is released, it may suck the blockages back down the catheter's channel. Pressing the pump device a few times may rock the blockage back and forth. This may cause it to breakdown enough to be able to flow out of the catheter's channel.

Once dislodged, the obstruction is generally removed, preferably by being washed out, evacuated or flushed, preferably by the body fluid, along the first lumen 20. The dislodged obstruction usually exits the first lumen 20 via the fluid outlet 34. The free flow is thereby restored along the first lumen 20. Urine is free to drain out of the bladder, into the fluid inlet 30, along the first lumen 20, through the urine drainage port and, if provided, into a collection device or bag. In other words, urine flows into the leg / night bag connector.

The catheter 10 prevents or reduces the likelihood of the distress, severe pain and discomfort suffered by the user. The catheter 10 prevents or reduces the likelihood of danger to life of the catheter user ordinarily caused by catheter blockages. A medical professional, such as a district nurse or doctor, or being admitted to an emergency ward in a hospital to have the catheter changed, are no longer required. The risk of the bladder being distended, and urine being pushed back up from the bladder into the kidneys, and being exposed to the risk of kidney failure, septicaemia and death is reduced. Leakage around or bypass the catheter causing incontinence, are less likely. The risks of damage to the skin or incontinence-associated dermatitis (IAD), caused by prolonged exposure of the skin to urine are reduced. Long-term catheter users need no longer worry or be anxious all the time about when the catheter might next block, because they will know they can unblock the catheter simply, discreetly and without embarrassment -any time, and anywhere. Frequent and/or unplanned catheter changes are no longer required, and allow people who use a catheter on a long-term basis, to have scheduled catheter changes every 6 to 10 weeks or so. The catheter 10 reduces the challenges for nurses practising in community settings. The cost to healthcare services in terms of time and resources is reduced.

Referring now to Figure 6 there is shown part of a second embodiment of a catheter 110.

Features of the second embodiment of the catheter 110 which are similar or the same 5 as features of the first embodiment of the catheter 10 have similar or the same reference numerals with the prefix "1" added.

The catheter 110 of the second embodiment is similar to the catheter 10 of the first embodiment, having similar elongate portion 112, retention means 114 and an obstruction-dislodging element 116, although any of the above may be omitted and/or a 10 plurality provided. Detailed description of the common features is omitted for brevity.

In Figure 6, part of the elongate portion 112 and part of the retention means 114 are omitted for clarity.

The second embodiment of the catheter 110 differs from the first embodiment of the catheter 10 as follows. The obstruction-dislodging element 116 preferably does not comprise a projection, but this alternative may be envisioned. Additionally or alternatively, the obstruction-dislodging element 116 preferably comprises at least one recess 170 but this may be omitted. In other words, the grip-enhancing portion 164 may or may not be provided.

The obstruction-dislodging element 116 preferably further comprises a force-transmitting 20 element 172 The force-transmitting element 172 is preferably understood to be part of the catheter 110 even though the force-transmitting element 172 may be separate or separable from the pump 150. It may easily be envisioned however that the force-transmitting element may be distinct and not part of the catheter. In this case, the force-transmitting element and the catheter may be considered to form a catheter arrangement or system. The force-transmitting element may be provided in isolation.

The force-transmitting element 172 enables or facilitates transmission of a force via the force-transmitting element 172 to the pump body 152. The force-transmitting element 172 also increases the ease of finding pump 150 for a user. The force-transmitting 30 element 172 may be connected to, connectable or engageable with the pump 150. The force-transmitting element 172 has a force-transmitting body 174a and a force-transmitting end portion 174b, although either feature may be omitted and/or a plurality of either may be provided.

The force-transmitting body 174a is a graspable element or graspable portion by the user 5 or an element which is engageable with the user's hand. The force-transmitting body 174a may enable the user's hand to be connected, permanently or temporarily, to the force-transmitting element 172. In the shown embodiment, the force-transmitting body 174a includes a strap or strap element, but any other non-strap may be envisioned. For instance, the force-transmitting body may include a glove or glove element, a knob, a 10 lever, or a handle element by way of example only.

The force-transmitting end portion 174b is engaged or engageable with the pump body 152. The force-transmitting end portion 174b extends from the force-transmitting body 174a. The force-transmitting end portion 174b may comprise a pin element 176a and a tip portion 176b, although either feature may be omitted and/or a plurality may be provided. The pin element 176a may be referred to as a projection, pin, or poker. The pin element 176a is preferably an elongate part. Optionally, the pin element 176a is linear but non-linear may be an option. The pin element 176a may comprise metal, plastics, wood, any other suitable material, or any combination thereof. The pin element 176a extends from the force-transmitting body 174a and preferably has a free end. In other words, the pin element 176a is preferably cantilevered. The free end of the pin element 176a preferably does not terminate in a point as this may present a risk of puncturing the pump body when used, but this alternative may be envisioned. In other words, the free end is preferably rounded or chamfered. If provided, the tip portion or cap 176b may improve the engagement of the force-transmitting end portion 174b with the pump 150.

For instance, the tip portion 176b may comprise an anti-slip material or coating. The tip portion 176b may be associated, received in, on or around the free end of the pin element 176a.

The force-transmitting end portion 174b is preferably engageable with the grip-enhancing portion 164. If the obstruction-dislodging element 116 comprises a recess 170, the force-transmitting end portion 174b may be received at least in part within the recess 170. If the obstruction-dislodging element 116 comprises at least one projection, the grip-enhancing portion may be receivable one, around or against the projection, or between a plurality of projections. The tip portion 176b and/or poker 176a may be complementarily shaped and/or sized so as to engage with the recess 170 and/or projection.

The uses of the second embodiment of the catheter 110 are similar to the uses of the first embodiment. Detailed description of the common steps is omitted for brevity.

To activate or operate the pump, instead of the user wrapping their hand around the pump 150 and compressing the manual pump 150, the user uses the force-transmitting element 172. The user engages their hand with the force-transmitting element 172. As shown in Figure 6, the user's hand is received within the strap.

If separate from the pump 150, the force-transmitting end portion 174b is engaged with the pump 150. In the shown embodiment, the obstruction-dislodging element 116 comprises a grip-enhancing portion 164. The force-transmitting end portion 174b is engaged with the grip-enhancing portion 164. The user is then able to push or move their arm and/or hand towards the pump 150. The force-transmitting element 172 conveys the force exerted to activate or operate the pump 150. In the shown embodiment, the force-transmitting element 172 compresses the pump 150.

In other words, the ball feature of the pump 150 may optionally have a tactile surface. The surface may have indents or ridges. This may enable the pump 150 to be squeezed more easily by people with limited physical ability. In particular, such people may not have good dexterity, or may have poor motor control of their fingers. These people may have little or no sensation in their hand. Having the tactile surface with indents and/or ridges may create a non-slip surface that may enable a person to squeeze the ball more easily with an external strap in the preferred embodiment that may engage with or hold a poker 176a. The indents and/or ridges may create a resting area for the end of the poker 176a to nestle in and when the poker 176a is pressed inward and/or downward onto the ball feature of the pump 150, the poker 176a will not slide or may be less likely to disengage from the pump 150. A person can operate the pump 150 by this method.

In an alternative embodiment, the pin and/or tip portion may be connected or connectable with the pump via a connector. A connector may include a hinge or hinged engagement portion or portions, screw threaded portions, bayonet engagement portions, an interference fit engagement, or any alternative connector. The grip-enhancing portion may optionally be omitted in this alternative embodiment.

Referring now to Figure 7, there is shown a body fluid drainage system 278 for draining a body or bodily fluid. The body fluid drainage system 278 may be a urine drainage system. The body fluid drainage system 278 comprises a catheter 210 and a pump-activation device or system 280, but either feature may be omitted and/or a plurality provided.

The catheter 210 may be referred to as a third embodiment of a catheter 210, for clarity. The third embodiment of a catheter 210 is similar or the same as the first embodiment of the catheter 10, having similar elongate portion 212, retention means 214, and obstruction-dislodging element 216, although any of the above features may be omitted and/or a plurality provided. The obstruction-dislodging element 216 preferably comprises a pump 250 and a grip-enhancing portion 264. Preferably, the pump 250 is a manual pump, but a non-manual pump may be envisioned. Detailed description of the common feature is omitted for brevity.

Features of the third embodiment of the catheter 210 which are similar or the same as 15 features of the first embodiment of the catheter 10 have similar or the same reference numerals with the prefix "2" added.

The third embodiment of the catheter 210 may differ as follows.

Although the obstruction-dislodging element 216 comprises a grip-enhancing portion 264 as shown, the grip-enhancing portion may be omitted. For instance, the pump may have 20 a smooth or substantially smooth outer surface.

The pump-activation device 280 in-use activates, operates, or actuates the pump 250, at least temporarily and/or selectively. In the preferred embodiment, the pump-activation device 280 is received or receivable in, on or at least in part around the pump 250 and/or the pump body 252. The pump-activation device 280 is preferably electrically energisable but non-electrically energisable is an option. If the grip-enhancing portion 264 is provided, a further function of the grip-enhancing portion 264 may be to enable or improve the engagement between the pump 250 and the pump-activation device 280.

The pump-activation device, mechanism, or system 280 comprises: an actuator 282, a processor, a user-input means 284, a receiver, a communication channel, a power 30 source, a button support 286, a memory unit, although any of these features may be omitted and/or a plurality of any feature may be provided.

The pump-activation device 280 is shown in Figure 7, and more clearly in Figure 8.

The actuator 282 in-use may cause the pump body 252 to change from the uncompressed condition to the compressed condition, and/or vice-versa. The actuator 282 includes a compression device 288 and a motor or motor element, although either 5 feature may be omitted and/or a plurality may be provided.

The compression device, element or mechanism 288 in-use enables at least temporary compression or constriction of part of any or any combination of: the catheter 210, the elongate portion 212, the obstruction-dislodging element 216, the pump 250, and the pump volume.

The compression device 288 may include at least one clamp, although any non-clamp may be envisioned. Preferably, the clamp may be a jaw clamp, but any non-jaw clamp may be envisioned. The jaw clamp may comprise at least one jaw 290 and more preferably three jaws 290 as shown. A plurality of jaws 290 may increase the stability and/or efficiency of the compression device 288 when received around the pump body 252. The jaws 290 may be independently operable or at least one jaw 290 may be non-independently operable from at least one other said jaw.

The motor element may move or change the condition of the compression device 288. More preferably, the motor element may move at least one said jaw 290.

The processor in-use processes inputs, such as from the user. The processor may also 20 control the actuator 282. The processor may comprise a PCB or chip.

The user-input means 284 enables a user to receive and/or at least provide an input for controlling the pump-activation device 280 via the user-input means 284. The user-input means 284 is communicable with the processor via the communication channel. The user-input means 284 may be referred to as a user-input mechanism or device or a user-interface. Preferably, the user-input means 284 includes a control button, as shown, but any alternative to a control button may be envisioned, such as a screen. The user-input means 284 preferably includes a physical and/or analogue control button. However, a non-physical and/or non-analogue control button, such as a digital button or slider may be envisioned, as required.

In the preferred embodiment, the user-input means 284 further comprises a transmitter, although this feature may be omitted and/or a plurality may be provided. The transmitter, also known as an emitter, emits or provides a, preferably wireless, output. The output may be provided in response to a user input, for instance. The user-input means 284 may be in, on or associated with the button support 286.

The receiver in-use receives the output from the transmitter. Thus, the communication channel is preferably wireless. The transmitter is therefore preferably wirelessly communicable with the receiver. The receiver is associated or at least communicable with the processor. Upon receipt of an output from the transmitter, the receiver may provide an output to the processor.

The power source enables the pump-activation device 280 to be electrically energisable.

Thus, the pump-activation device 280 may be powered. The power source may include one or more batteries. Additionally or alternatively, the pump-activation device may be connected or connectable to an external power source. An external power source may include electrical mains, by way of example.

The button support or user-input support 286 may provide a support for the user-input means 284. The user-input means 284 may be associated with the button support 286. More preferably, the user-input means 284 may be received in or on the button support 286. The button support 286 may include any or any combination of: a housing or casing, a pager, a wearable element 292, or any other suitable support.

The wearable element 292 in-use enables the button support 286 and/or user-input means 284 to be worn by a user. This enables the wearable element 292 to be easily located when the user needs to provide an input via the user-input means 284 and/or prevents or inhibits loss of the user-input means 284. The wearable element 292 may also reduce the risk of the user accidentally providing an input to the user-input means 284. A wearable element 292 may also provide greater discretion than a casing. The wearable element 292 may include any or any combination of: a lanyard, a watch, a strap 294, a pendant 296, a belt, jewellery, a clip 298, and a bracelet, or any other item of clothing. Figure 9 shows the user-input means 284 associated with a strap. Figure 10 illustrates a button support 286 in the form of a pendant. In Figure 11, the user-input means 284 is provided on a housing having a clip 298.

In other words, in a preferred embodiment, an electronic jaw clamp may be receivable around the pump 250. The jaw clamp may controllable via a remote control. For people who are unable to move their fingers and with very limited movement or control of their hands, a remote user-input means may be used to operate the pump 250. A jaw clamp may sit around the ball feature of the pump. The jaw clamp may be communicable with or powered by a power source, such as a battery. The jaw clamp may be communicable with a radio wave receiver. A small motor may be provided to move or draw the jaws of the clamp together. A person may have a remote control to operate the pump via a button. The button may be provided on a pendant worn around the neck. The or a button may alternatively or additionally be provided on a watch strap style remote control. A clip-on remote control that could clip on a trouser belt or something similar, as a pager may be options.

The memory unit may enable data storage. The memory unit may store a user input and/or any data associated therewith. For example, the memory unit may store metadata, such a time stamp of the user input and/or the number of compressions required to clear a blockage. This data may be useful for example, for statistical and/or monitoring purposes. The memory unit may alternatively or additionally store at least one computer program or software. A computer program may comprise a series of commands to control the actuator 282. A computer program may be selectable by the user. An example of a computer program may be to automatically impart a series of compressions to the pump body 252. The duration and/or strength of each compression may be predetermined and/or selectable. The number of compressions may be predetermined or continuous. In the latter case, a further input from the user may be required to stop the compressions.

The uses of the catheter 210 of the third embodiment are similar to the uses of the first embodiment. Detailed description of the common steps is omitted for brevity.

During assembly of the body fluid drainage system 278, if a separate pump-activation 25 device 280 is provided, this may be mounted around the elongate portion 212 and/or around the pump 250. This step may be done at any time, including before, during or after the catheter 210 has been fitted to a user.

To activate or operate the pump 250, instead of the user wrapping their hand around the pump 250 and operating the manual pump 250 with their hand, the user activates or operates the pump 250 via the pump-activation device 280. The pump-activation device 280 in the preferred embodiment is associated, received or engaged with the pump 250. The pump-activation device 280 may be retrofitted to a catheter 210 comprising a manually operated pump if desired.

The user-input means 284 is provided within easy reach of the user. This may be achieved, for example, by the user wearing a wearable element 292 associated or comprising a user-input means 284, such as a watch or strap.

The user may provide an input via the user-input means 284, for example, to activate 5 the pump-activation device 280. The input is transmitted by the transmitter, via the communication channel to the processor. The processor controls the actuator 282. The actuator 282 causes the pump 250 to be activated or operated. As the pump 250 is preferably a compressible pump, the pump 250 is compressed or constricted due to the actuator 282. Here, the at least one jaw 290 presses inwards, against the wall or walls 10 of the pump body 252 against a support and/or against at least another said jaw 290. The user may be able to control any of: the degree or extent of compression, the timing of compressions, and the number of compressions, for example, via providing a plurality of inputs and/or selecting an input from a range of possible inputs.

In other words, the user may press the button on the remote control. This may send a 15 radio wave to the electronic jaw clamp resting around the ball feature of the pump. On receiving the radio wave, the jaws of the electronic jaw clamp may come together to squeeze the ball feature of the pump and clear the blockage in the catheter.

The pump-activation device 280 may be configured or configurable to reduce the pressure applied to the pump 250 automatically and/or upon receipt of a further input 20 from the user. For example, the pump-activation device 280 may automatically release the pressure after a time delay, by way of example.

Once the blockage has been dislodged, the fluid is free to flow along the first lumen.

It may be envisioned that a plurality of fluid inlets and/or a plurality of fluid outlets may be provided. This may be advantageous to enable fluid to enter and/or exit the lumen if 25 one or more of the fluid inlets and/or one or more of the fluid outlets becomes obstructed.

Whilst the pump body is or is substantially spherical or part spherical, or a bulb in the preferred embodiments, any non-spherical shape may be envisioned. For instance, the pump body may be pear shaped, diamond shaped, elliptical, cuboidal, or oblong. The shape of the pump body in longitudinal and/or transverse cross-section may be any of: curved; part curved; non-curved; circular; ellipsoid; parabolic; oval; linear; part linear; a regular polygonal shape, such as triangular, square, rectangular, trapezoidal or a trapezium, pentagonal, hexagonal, octagonal or any other polygonal shape; an irregular polygonal shape; a chamfered or rounded polygon; or an abstract shape.

Alternatives to a jaw clamp may include any or any combination of: a sash clamp, a spring clamp, a power clamp, a pneumatic clamp, a toggle clamp, a pinch dog, a bench clamp, a web clamp, a pipe clamp, a wire rope clamp, a marmon clamp, a quick action clamp, a mitre clamp, a G clamp, a handscrew clamp, a trigger clamp, a hose clamp, a screw clamp, or any other suitable clamp or clip.

In a modified embodiment, in addition to or instead of a clamp, an alternative actuator may comprise a drivable screw or screw element. Any feature which enables the pump 10 body to be selectively and/or temporarily activated may be envisioned.

Whilst the communication channel is wireless, it may easily be envisioned that the pump-activation device may comprises a wire for connecting the processor, and the user-input means. Thus, the communication channel may be a wired communication channel. The receiver and transmitter may optionally be omitted in this embodiment. In a further modification, both a wireless communication channel and a wired communication channel may be provided in a same pump-activation device, for redundancy.

Whilst in the preferred embodiments, the pump is provided as part of the catheter, it may easily be envisioned that the pump may be omitted from the catheter. Whether the catheter may include a pump or be pumpless, the catheter may be used with a separate, pump device. The separate pump device may be a non-manually operated pump device. In other words, the body fluid drainage system and/or urine drainage system may include a catheter and a pump device. For example, it may easily be envisioned that a peristaltic pump and/or a diaphragm pump may be used with the, optionally urinary, catheter or at least the elongate portion thereof.

In the preferred embodiments, the retention means include an inflatable balloon and inflation means. It may easily be envisioned that the inflatable balloon and/or inflation means may be omitted. One or more, preferably foldable or retractable, wing, arm or arm elements may be provided instead. This arm may interact, engage with or contact the body cavity in-use. The catheter may be self-retaining by having a Malecot wing tip, such as a Malecot 2 or 4 wing tip by way of example. The catheter may comprise a Pezzer tip or Mushroom tip. Friction may be sufficient to maintain the catheter in place without any retention means.

Whilst the preferred embodiments include an indwelling catheter such as a Foley catheter, a non-indwelling and/or non-Foley catheter may be envisioned. For example any external catheter or any intermittent catheter may be envisioned.

Although in the preferred embodiments, the catheter includes two lumens, one or at least three lumens may be envisioned. A third lumen may be useful for inserting a fluid into the body cavity. This may be useful for irrigation of the body cavity, by way of example only. The third lumen may have at least one aperture to allow fluid into and/or out of the body cavity.

As fluid may exit via the fluid inlet and/or fluid outlet upon compression of the pump body, the maximum pressure that may be applied to dislodge a blockage may be reduced. Backflow of urine into the bladder may also occur. To counter these issues, the fluid inlet and/or fluid outlet may be temporarily blocked. A plug element may be provided to this effect. Additionally or alternatively, the first lumen may be temporarily blocked to prevent or inhibit fluid from exiting via the fluid inlet and/or fluid outlet. For example, the user may pinch or squeeze the elongate portion to temporarily obstruct the first lumen. A clip or clamp may be used.

Although the pump is integrally formed with the elongate portion in the preferred embodiment, non-integrally formed therewith may be an option. For example, the pump may be engageable with the catheter and/or the elongate portion thereof. The pump may be selectable from a range of pumps. The range of pumps may have different shapes and/or sizes. This may enable customisability to the patient and/or to the blockage. The pump or part thereof may be received in, on, or at least partly around the elongate portion.

To enable engagement of the pump and the elongate portion, the elongate portion may comprise an attachment portion for enabling attachment of a pump thereto. The attachment portion may or may not extend radially outwardly from the elongate portion. The pump and the attachment portion may comprise an engagement means or mechanism, such as screw threaded portions, bayonet engagement portions, an interference fit engagement, or any alternative connector. When a pump body is connected to the attachment portion, the pump volume may be fluidly communicable with the first lumen. The attachment portion may be sealable to avoid fluid leakage via the attachment portion, such as via a seal, when no pump is connected to the attachment portion.

The pump or part thereof may be fluidly connected or connectable to an end of the elongate portion.

The elongate portion may optionally comprise a slot into which the pump body or part thereof is insertable. The elongate portion and the pump body may together form the 5 pump body when engaged with each other.

The elongate portion may comprise a plurality of separable sub-portions. The sub-portions may be connectable to the pump body.

Although the grip-enhancing portions in Figures 3 and 4 extend in only one plane, it may be envisioned that a grip-enhancing portion in any embodiment may not extend in any plane. Alternatively, a grip-enhancing portion may extend in a plurality of planes. The grip-enhancing portion may form or substantially form a helix or coil around the pump body. It may easily be envisioned that different types of projections and/or recesses may be provided within a same embodiment.

Optionally, the catheter and/or drainage system may comprise at least one sensor. The sensor may be a pressure sensor. For example, the pressure sensor may be able to detect a pressure or change in pressure in the catheter and/or body cavity. A pressure change may be indicative of a blockage. The sensor may be a flow rate sensor. Such a sensor may detect a variation in the flow rate of body fluid. For example, the sensor may detect a reduction in the flow rate of urine or even the absence of flow. This change in flow rate may, once again, be indicative of a blocked catheter and/or possibly a health issue resulting in abnormal body fluid flow. The sensor may be a chemical sensor. The sensor may detect, for example, the concentration of the fluid. This may be useful for diagnostics purposes, such as dehydration.

In a further modified embodiment, any of the above sensors may be communicable with the processor if a processor is provided. Upon detecting a predetermined and/or selectable value of the monitored parameter, the sensor may be able to provide an input to the processor to activate the actuator. Thus, the sensor may indirectly operate the pump device when required, such as when a blockage is detected. This may be useful for instance, at night when a user is asleep, or in a patient who is in a coma.

In a further modification, the catheter and/or drainage system may comprise at least one speaker or speaker element. This may be useful to emit a sound, for instance to further facilitate the ease of locating the pump body, in dark conditions and/or for visually impaired users VVhilst compression or constriction is the preferred method of operating the pump, any alternative method of operating the pump may be envisioned, such as expanding the 5 walls of the pump body to increase the pump volume. This may create a vacuum. Any alternative to a manual pump may be envisioned, such as a vacuum pump.

It could easily be envisioned envisioned that one or both the transmitter and the receiver may be transceivers, for permitting two-way communication, rather than one-way communication, as required. The user-input means may further comprise a receiver in addition to a transmitter. Such a receiver may provide an output from the processor to the user, by way of example.

It is therefore possible to provide a urinary catheter which enables a user to dislodge a blockage by themselves discreetly and hygienically, without requiring medical assistance or removal of the catheter. This is enabled by virtue of the catheter comprising an 15 obstruction-dislodging element which includes a pump body actionable by the user.

If the obstruction-dislodging element also includes a grip-enhancing portion or tactile portion, these features enable the pump body to be easily recognised by a visually-impaired user and/or a user in the dark. Additionally or alternatively, the grip-enhancing portion may aid a user to compress the pump body, particularly a user who may have difficulty in closing their hand fully or grasping the pump body devoid of a grip-enhancing portion.

It is also possible to provide a urinary drainage system in which a user can remotely dislodge an obstruction. This is enabled by provided a catheter is having a pump body and an electronically energisable pump-activation device which can compress the pump body upon receiving a remote input from a user. A user who may not be physically able to squeeze the manual pump may still unblock the catheter via the pump-activation device.

It is also possible to provide a pump-activation device which can be retrofitted to an existing catheter. Retrofitting a pump-activation device when required provides flexibility 30 and may reduce the number of pump-activation devices that need to be stocked.

Additionally, it is also possible to provide a catheter for draining a body fluid in which obstructions in the lumen can be easily dislodged by a user. This is enabled by virtue of the catheter having an obstruction-dislodging element which includes a manual pump. Furthermore, a grip-enhancing portion is provided to help a user, particularly a user with limited physical ability, to grasp and/or compress the pump body. The catheter includes but is not limited to urinary catheters.

Furthermore, it is possible to provide a urine drainage system in which a blockage in a urinary catheter element may be dislodged by virtue of providing an electrically energisable pump. The pump may be retrofitted to a standard catheter.

The words 'comprises/comprising' and the words 'having/including' when used herein with reference to the present invention are used to specify the presence of stated features, integers, steps or components, but do not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination.

The embodiments described above are provided by way of examples only, and various 20 other modifications will be apparent to persons skilled in the field without departing from the scope of the invention as defined herein.

Claims (25)

1. Claims 1 Urinary catheter for draining urine, the catheter comprising: an elongate portion defining a lumen, the elongate portion having a urine inlet and a urine outlet fluidly connected to the urine inlet by the lumen; retention means for at least temporarily retaining part of the elongate portion in the bladder; an obstruction-dislodging element along the elongate portion upstream of the urine outlet for dislodging an obstruction preventing or inhibiting urine flow in the lumen, the obstruction-dislodging element having: a manual pump body for moving fluid within the lumen to dislodge an obstruction by temporarily compressing the pump body, and a grip-enhancing portion provided on an outer surface of the manual pump body and including at least one projection and/or at least one recess for improving the ease of gripping of the obstruction-dislodging element by a user, and thereby the ease of compression.
2. 2. Urinary catheter as claimed in claim 1, wherein the or a said projection is a rib.
3. 3. Urinary catheter as claimed in claim 2, wherein the or a said rib has a longitudinal extent which is linear.
4. 4. Urinary catheter as claimed in claim 2 or claim 3, wherein the or a said rib has a longitudinal extent which is curved.
5. 5. Urinary catheter as claimed in any one of claims 2 to 4, wherein the or a said rib has a longitudinal extent which is sinusoidal and/or saw-toothed.
6. 6. Urinary catheter as claimed in any one of the preceding claims, wherein the or a said projection is a spike.
7. 7. Urinary catheter as claimed in any one of the preceding claims, wherein the or a said projection is elongate and has a cantilevered end.
8. 8 Urinary catheter as claimed in any one of the preceding claims, wherein the or a said projection is at least partly rigid for transmitting a force applied by a user to compress the pump body when the user only partially closes their hand.
9. 9. Urinary catheter as claimed in any one of the preceding claims, wherein the grip-enhancing portion comprises an anti-slip coating.
10. 10. Urinary catheter as claimed in any one of the preceding claims, wherein the grip-enhancing portion comprises an illuminable portion.
11. 11. Urinary catheter as claimed in claim 10, wherein the illuminable portion includes a photoluminescent element for facilitating a user finding the obstruction-dislodging element in a dark or low-light environment.
12. 12. Urinary catheter as claimed in any one of the preceding claims, wherein the obstruction-dislodging element further comprises a force-transmitting element having an end portion engageable with the or a said recess, the force-transmitting element being engageable by the user for transmitting a force via the force-transmitting element to the pump body.
13. 13. Urinary catheter as claimed in claim 12, wherein the force-transmitting element includes a pin element.
14. 14. Urinary catheter as claimed in any one of the preceding claims, wherein the retention means comprises an inflatable balloon at or adjacent the urine inlet.
15. 15. Urine drainage system for draining urine, the system comprising: a urinary catheter for draining urine, the catheter comprising: an elongate portion defining a lumen, the elongate portion having a urine inlet and a urine outlet fluidly connected to the urine inlet by the lumen; retention means for at least temporarily retaining part of the elongate portion in the bladder; an obstruction-dislodging element along the elongate portion upstream of the urine outlet for dislodging an obstruction preventing or inhibiting urine flow in the lumen, the obstruction-dislodging element having a manual pump body for moving fluid within the lumen to dislodge an obstruction by temporarily compressing the pump; and an electrically energisable pump-activation device receivable around the manual pump body.
16. 16. Urine drainage system as claimed in claim 15, wherein the pump-activation device comprises a processor, a user-input means for providing a user input, communicable with the processor via a communication channel for controlling the pump-activation device via the user-input means.
17. 17. Urine drainage system as claimed in claim 16, further comprising a wearable element in or on which the user-input means is provided. 15
18. 18. Urine drainage system as claimed in claim 17, wherein the wearable element includes at least one of: a lanyard, a pendant, a watch, a strap, jewellery, a clip, and a bracelet.
19. 19. Urine drainage system as claimed in any one of claims 16 to 18, wherein the pump-activation device further comprises a receiver and the user-input means comprises a transmitter wirelessly communicable with the receiver.
20. 20. Urine drainage system as claimed in any one of claims 16 to 19, wherein the pump-activation device comprises a wire for connecting the processor and the user-input means for providing a wired communication channel.
21. 21. Urine drainage system as claimed in any one of claims 15 to 20, wherein the pump-activation device includes a compression device. 30
22. 22. Urine drainage system as claimed in claim 21, wherein the compression device includes a jaw clamp.
23. 23. Electrically energisable pump-activation device comprising a controllable compression element receivable around a manual pump body of a catheter for selectably compressing the manual pump body.
24. 24. Catheter for draining a body fluid, the catheter comprising: an elongate portion defining a lumen, the elongate portion having a fluid inlet and a fluid outlet fluidly connected to the fluid inlet by the lumen an obstruction-dislodging element along the elongate portion upstream of the body fluid outlet for dislodging an obstruction preventing or inhibiting fluid flow in the lumen, the obstruction-dislodging element having: a manual pump body for moving fluid within the lumen to dislodge an obstruction by temporarily compressing the pump body, and a grip-enhancing portion provided on an outer surface of the manual pump body and comprising at least one projection and/or at least one recess for improving the ease of gripping of the obstruction-dislodging element by a user, and thereby the ease of compression.
25. 25. Urine drainage system comprising: an elongate portion defining a lumen, the elongate portion having a urine inlet and a urine outlet fluidly connected to the urine inlet by the lumen; and an electrically energisable pump receivable around or in the elongate portion for moving fluid within the lumen to dislodge an obstruction therein.