WO2003030968A1

WO2003030968A1 - Bowel irrigation system and probe therefore

Info

Publication number: WO2003030968A1
Application number: PCT/DK2002/000689
Authority: WO
Inventors: Malcolm Ian Falconer; Peter MØLLER-JENSEN; Kristoffer Zeuthen; Jimmy Grøtner; Christian GRÜNEWALDT
Original assignee: Coloplast A/S
Priority date: 2001-10-12
Filing date: 2002-10-14
Publication date: 2003-04-17

Abstract

A bowel irrigation system comprising a reservoir for irrigating liquid with a probe connected thereto and means for transferring the irrigating liquid from the reservoir to the probe wherein the reservoir is a sealed container and the pumping means is operable by the user to create a pressure in the container to displace the liquid therefrom and feed it to the probe. The reservoir may be collapsible in order to reduce volume when not is use, and facilitate easy handling of the system.

Description

Title

Bowel Irrigation System and Probe Therefore

Field of Invention This invention relates to a bowel irrigation system and more particularly but not exclusively to a portable system designed for use by disabled persons with limited limb movement for instance due to a spinal cord injury or being spina bifida or MS sufferers. The invention also relates to an irrigation probe for use with such a system.

Background of Invention

Due to the disabilities suffered by the aforementioned groups of persons, it is quite common that they cannot perform their normal bowel function without some form of outside help. This is usually in the form of drugs, digital stimulation, massage or colonic irrigation. Currently available colonic irrigation kits can be awkward to use and almost exclusively have to be used with the help of a third party.

Various bowel irrigation systems are known. One such system is the grav- ity fed arrangement which is disclosed in our published International application No. WO98/23312 in which the irrigation medium is fed by gravity from a bag hung from a frame arranged close to the patient. Flow of liquid from the bag to the user is controlled by a flow regulation device operated by the user. The problem with this system is that it relies on gravity feed so the bag needs to be located above the user in some way and it is therefore usually suspended from a frame. This means that the system cannot be readily portable unless the frame can be collapsed for storage, or the bag is in the form of a soft bag, which can be folded to take up minimum of space. However, such soft bag may be difficult to handle when filled, espe- cially by a person with reduced dexterity.

For a person in a wheel chair the filling of the bag, transporting the bag, and to hang the bag in the required height may be very difficult if not impossible. Portability of equipment is extremely important to disabled persons who are not hospitalised or bed-ridden if they are to lead as normal a life as possible and deal with their daily bodily functions. This is particularly important if they travel away from their home, for instance, to someone else's home or if they stay in a hotel. In this situation, they need to be able to deal with their bowel function easily and equipment currently available does not allow them to do this. Systems have been tried where the bag containing the irrigation liquid can be mounted on the wall of a bathroom using suction or adhesive pads but such systems have been found not to work particularly well because quite often the pads become detached from the wall and the bag falls to the floor spilling the contents all over it.

Bowel care systems are known which are movable on wheels such as those disclosed in US patent Nos. 5019056 or 4874363. These systems comprise a reservoir for the liquid irrigation fluid, a tank for discharged material, a probe for insertion into the patient and ancillary equipment including a pump to pump the irrigation liquid from the reservoir through the pump to the probe. The system is mounted on a carriage with wheels so that it can be moved from one location to another. However, although such systems are mobile, they are heavy and cumbersome and they are therefore not readily transportable by the user. They therefore tend to be restricted to use in hospitals or nursing homes where they can be wheeled from one patient to another. Because of their size and weight, these systems cannot be carried by their users from one place to another and thereby allow them to lead as normal a life as possible.

US Patent No. 5,330,447 discloses an irrigator for colostomy patients. The device comprises a sealed container in the form of a bag, said bag being separated into a liquid chamber and a gas chamber by a membrane. The gas chamber is equipped with a tube to pumping means, e.g. in the form of a rubber bulb, and when air is pumped into the gas chamber, the liquid in the liquid chamber will be displaced through a tube into the stoma for irrigation. The tube is provided with a valve for adjusting the pressure.

US Patent No. 6,264,636 discloses a device for flushing a body cavity. The device comprises a fluid reservoir and means for pumping the fluid to the body cavity by pumping air into the reservoir and thus displacing the fluid. After flushing the body cavity, the fluid is led back to the reservoir. The device is useful for flushing tissue pieces away after surgery, e.g. prostatic surgery. The device is made for flushing with quite high pressure, and does not contain a pressure relief valve; und will thus be unsuitable for use for anal irrigation, as too high pressure may damage the intestines.

Brief Description of Invention

It is therefore a first object of the invention to provide a bowel irrigation sys- tem which can be readily carried or transported by the user from one place to another during their daily lives so that they can lead as normal a life as possible.

It is another object of the invention to provide a bowel irrigation system, which is easy to operate and avoids the need for third party assistance to carry out the bowel management function and thereby provide the user with a greater degree of freedom to attend to their own bowel motion at any time.

It is a still further object of the invention to provide a probe which is easier to use than prior art probes.

According to a first aspect of the invention, there is provided a bowel irrigation system comprising a reservoir for irrigating liquid with a probe con- nected thereto and means for transferring the irrigating liquid from the reservoir to the probe, the reservoir comprises a sealed container, wherein said reservoir is rigid or semi-rigid and collapsible. The container may be integrated in a collapsible reservoir. The reservoir can be folded up so storage volume is minimized.

The system may further comprise pumping means.

Preferably the pumping means is a compressible member such as a resilient bulb or bellows connected to the reservoir so that, in use, compression of the bulb pressurises the liquid in the reservoir and displaces it and feeds it to the probe. The bulb or bellows can either be manually operated by the user or, in certain circumstances, it may be more convenient for the user to place the bulb or bellows elsewhere e.g. under the chin or under their armpit and compress it by moving their chin or arm towards and away from their body. The pumping means could however be provided by compressed gas, by gravity or by a pump powered by electricity (mains or low voltage), by gas or by hydraulic fluid.

In order to render the irrigation system as portable as possible, the container preferably has a capacity of less than 5 litres, more preferred less than 3 litres and most preferred less than 2 litres. If however the system is to be used for repeated irrigation, a larger capacity container may be necessary.

Further, in order to minimise the size of the system during transportation, the reservoir can be used for storing probes and tubes etc. thereby making transportation easier for the user.

In the preferred embodiment, the compressible member and probe are connected to the reservoir by a flexible tube.

Conveniently the probe has a connector at one end thereof to releasably connect it to the flexible tube connecting it to the reservoir. Detailed Description of the Invention

Many disabled persons with a spinal cord injury, spina bifida or multiple sclerosis need different devices such as urine bags, catheters, diapers etc. on a daily basis. These devices take up much room. Especially during travelling for holidays the volume of devices for a week consumption can amount to a full suitcase alone. It is therefore of great importance if the volume of each device can be reduced to a minimum. To address this problem the reservoir can be collapsed with the container folded inside the front and the bottom parts and thus minimizing the volume of the device.

The present invention relates to a bowel irrigation system comprising a reservoir for irrigating liquid with a probe connected thereto and means for transferring the irrigating liquid from the reservoir to the probe, the reservoir comprises a sealed container, wherein said reservoir is rigid or semi- rigid and collapsible.

The means for transferring the irrigating liquid from the reservoir to the probe may comprises pumping means being operable by the user to create a pressure in the container to displace the liquid therefrom and feed it to the probe. The pumping means may be a compressible member e.g. a resilient bulb or bellows, which is connected to the reservoir so that, in use, applying a compressive force to the bulb pressurises the liquid in the reservoir and feeds said liquid to the probe.

The compressible member may be connected to the reservoir by a flexible tube and the probe may be connected to the reservoir by a flexible tube which incorporates a one-way valve which allows liquid to flow only from the reservoir to the probe.

In one embodiment of the invention a tap or clamp may be provided between the reservoir and the probe. In a preferred embodiment of the invention the container is integrated in a collapsible reservoir. The reservoir can be folded up so storage volume is minimized.

The reservoir may be produced from a rigid or semi-rigid material, on order to ease handling of the system.

The reservoir may comprise a front part and a bottom part being hinged together in a reopenable manner. The two parts may be connected with a hinge or a pivot joint. A flexible irrigation liquid container is secured to the front part. When the reservoir is closed, the two parts are adjacent to each others, preferably fixed to each other by a simple lock, e.g. a snap lock. When the reservoir is in an open position, the front part may be positioned in a vertical position, while the bottom part may be in a substantially horizontal position. The container, being secured to the upper section of the front part, will in filled condition be supported by the bottom part.

Preferably, the container is detachably secured to the reservoir, render it possible to detach the container, e.g. for exchange.

The container may be in the form of a flexible bag. The flexible container renders it possible to collapse the reservoir, when the container is empty, with the container folded in between the front and the bottom parts. Thus, the volume of the collapsed reservoir may be significantly smaller than the volume of the reservoir when filled.

The container may be provided with a lid for entering liquid into or out of the container. The lid may be located in the front or bottom part of the reservoir, and may preferably extend somewhat from the reservoir. In this way the lateral side of the hand may be used to push open the lid. The lid may be closable in any manner known per se, but preferably snap lock is used, as it is easy to close by simply applying some pressure on the lid. It is often desired that the closing system of the lid is adapted for persons with reduced dexterity. The reservoir may be provided with a handle, preferably of a size rendering it possible to insert an arm under the handle making the product easy to transport for people with poor hand dexterity. The handle may also render it possible to hang the reservoir, e.g. on the bed or the wheel chair, if desired.

Further to facilitate transport of a filled reservoir the front of the reservoir may, in open condition, be curved in such a way, that the top of the handle is placed centrally above the reservoir corresponding to the centre of gravity.

It is often a problem for the user of such devices to fill the container at the available sink, as there often only is a narrow space for such containers. The reservoir of the present invention may be designed rather compact so it fits most standard sinks and with the lid pulled forwards from the front part it can be easily filled with water. The design and the position of the spout make it easy to open the lid, fill the reservoir with water and close the lid. Alternatively, the container may be detached from the reservoir, filled with liquid, and mounted again in the reservoir.

In order to carry out a safe irrigation procedure the pressure in the bowel should not exceed 2-2.5 meter of water column. A higher pressure may be dangerous as it may lead to perforation of the bowel. To ensure that the pressure in the reservoir does not exceed the desired maximum a pressure relief valve may be contained in the reservoir. In a preferred embodiment this relief valve is placed in the lid above the waterline. When gas is pumped into the container and pressure exceeds the desired maximum, the relief valve opens and blow out some of the gas

In one embodiment of the invention the relief valve is activated at 2,5 meters of water column, more preferred at 2 meters of water column.

The reservoir may further be provided with space for the tubes, pumping means and probe, in such a manner that the whole irrigation system may be contained in the reservoir for transportation. A suitable material for the reservoir may be any suitable synthetic or natural polymeric material, metal, hard rubbery substances or other material having the desired rigidity.

Another problem associated with prior art anal irrigation systems concerns the difficulty the user has in inserting the probe and correctly positioning it in the anal opening. US patent No. 3.459.175 discloses an example of a prior art probe which has a shaft through which water can be supplied to the colon. The probe has an abutment around it which contacts the user's posterior on insertion of the probe in the anal opening and thereby limits the extent to which the probe can penetrate it. Spaced from this abutment is a balloon which is connected by a flexible tube to a syringe. Activation of the syringe forces air into the balloon to inflate it and thereby axially locate the probe in the anal opening and prevent its removal therefrom until the balloon is deflated. Having to inflate the balloon using a separate syringe complicates bowel management considerably for the user so such systems are extremely difficult to operate without outside assistance.

It is therefore a further object of the invention to provide a probe which is easy for the user to insert and remove without the need for outside assistance or easy to use if the probe has to be administered by a carer or helper if the user is unable to handle it alone.

According to a further aspect of the invention therefore, there is provided a probe for use in a bowel irrigation system comprising a shaft having a proximal end and a distal end and a duct therethrough for supplying irrigation liquid from the proximal end to an outlet at the distal end, an inflatable cuff mounted on the shaft adjacent said outlet to retain, in use, the probe in position in the user's anal opening, the invention being characterised by manually operable cuff inflation means operable to inflate the cuff, said cuff inflation means having associated therewith a one-way valve to admit ambient air to the interior thereof only during inflation of the cuff and means operable to release pressurised air from within the inflated cuff to deflate the said cuff.

The inflatable cuff is in a preferred embodiment mounted on the shaft of the probe adjacent its proximal end. Compared to prior art probes it simplifies handling and makes use of the probe easier to the user.

Preferably the manually operable cuff inflation means is a resilient compressible bulb mounted on the shaft of the probe. As an alternative, how- ever, the cuff inflation means and the pumping means can be provided by one and the same unit, further including means for directing the pressure either to the cuff or to the reservoir.

In the preferred embodiment, the shaft has an outlet opening into the inte- rior of the cuff, a separate duct connecting the interior of the bulb with said outlet.

Conveniently the pressure release means comprises a movable member operable to open the one-way valve to vent the contents of the inflated cuff to atmosphere.

In the preferred embodiment, the movable member is spring biased to a normal closed position, movement of said member opening the valve to release the pressure within the bulb and deflate the cuff.

Conveniently the movable member is a depressible button which forms part of the one-way valve. In the preferred embodiment, the one-way valve is located on the bulb and the button has a finger protruding therefrom which cooperates with the one-way valve to open it when the button is depressed.

According to a third aspect of the invention there is provided a probe for use in a bowel irrigation system in which irrigation liquid is supplied to an outlet adjacent the end of the probe, the probe comprising a shaft having a proximal end and a distal end and a duct therethrough for the supply of said irrigation liquid to the outlet, and an inflatable cuff mounted on the shaft, characterised in that the probe end is detachable and includes separate fluid supply means on the shaft to supply fluid to the interior of the cuff, the proximal end of the shaft being formed to make a releasable connection with the fluid supply used to inflate the cuff and the supply of irrigation liquid. The advantage of making the probe end readily releasable from the cuff inflation fluid source and the irrigation liquid source is that it can be made as a replaceable item which can be used once and then thrown away. This is particularly important as it means that a sterilised probe can be supplied to the user in a sealed sachet and disposed of after use thus rendering it very hygienic to use.

The invention further relates to an irrigation system wherein the pumping means are provided for pumping gas into the reservoir to transfer the irrigating liquid from the reservoir to the probe, that the fixation member includes an inflatable cuff, and that the system includes a control unit which may be set in at least a cuff inflating position and a liquid transferring position.

The combination of the pumping means and the incorporation of a control unit that may be set in a number of predetermined operating positions into the irrigation system entails that the user is able to perform the entire irrigation by himself or herself without the need for outside help. Due to the fact that gas is pumped into the reservoir and the irrigating liquid is forced out from the reservoir, it is possible to use a closed system. This entails, i.a., that the closed reservoir may easily be carried and may be placed in any position with respect to the user and not necessarily at a level substantially higher than the user as is the case in the above-mentioned WO 98/23312. Inflation of the cuff and the flow of irrigating liquid are controlled by the control unit, which may be e.g. held by the user or posi- tioned at a place near him or her. The probe is easily inserted with the cuff in its deflated condition, and the inflation of the cuff and the flow of irrigating liquid are controlled by the user in a simple manner by setting the control unit into the appropriate sequential positions. Furthermore, the control unit provides the user with a logical indication of the operational steps to be carried out in order to perform the irrigation.

In an advantageous embodiment, the control unit comprises at least two ele- ments that may be moved with respect to each other into at least said cuff inflating and liquid transferring positions. This provides for a simple and functional design of the control unit.

In an embodiment, which provides for a particularly compact design of the irriga- tion system, the conduit means includes a first part connecting the control unit with the probe and a second part connecting the reservoir with the control unit, and in which each of said first and second parts comprises a gas conducting tube and an irrigating liquid conducting tube.

The conduit means may include a first part connecting the control unit with the probe and a second part connecting the reservoir with the control unit, and each of said first and second parts may comprise a gas conducting tube and an irrigating liquid conducting tube.

In an embodiment, the conduit means includes an irrigating liquid conducting tube connecting the reservoir with the probe, and at least one gas conducting tube connecting the control unit with the reservoir.

In a preferred embodiment, the control unit may be set in a first position corre- sponding to an inactive position, a second position corresponding to said liquid transferring position and in which gas is pumped into the reservoir and irrigating liquid is transferred from the reservoir to the probe, and a third position corresponding to said cuff inflating position and in which gas is pumped into the inflatable cuff. By this design, all of the operational steps necessary in order to carry out irrigation, i.e. inflation of the cuff, flow of irrigating liquid and deflation of the cuff are controlled by an appropriate sequential adjustment of the control unit.

Preferably the pumping means is a manually operated pump, such as a bulb or a bellow pump.

The pumping means may also be a powered pump, such as an electrically or pneumatically operated pump, and when used in the above-mentioned preferred embodiment the pump may be deactivated when the control unit is set in the first position and is activated automatically when said control unit is set in the second position.

In a particularly compact design of the irrigation system, such a pump, whether manually operated or a powered pump, is integrated with the control unit rendering the operation of the device easier for the user.

Other features and advantages will readily be appreciated from the following description of examples of embodiments.

The invention should not be regarded as being limited to the embodiments described in the above but various modifications of and combinations between the various embodiments may be carried out without departing from the scope of the following claims.

For instance, the control unit may comprise activating and deactivating means for electronic control of pumping means in the form of e.g. a number of pumps distributed in the irrigation system.

Furthermore, the irrigation system may be used for dispensing any fluid, such as e.g. fluids introduced into the body with a view to radiological examination.

Brief Description of the Drawings

The invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

Figure 1 shows the system of the invention where the reservoir is in a collapsed position, Figure 2 shows the reservoir in an open position,

Figure 3 is a perspective view of a portable bowel irrigation system of the invention;

Figure 4 is a schematic view showing the system of Figure 2 in use; Figure 5 is a side view of one form of probe for use with the system shown in Figures 3 and 4;

Figure 6 is an enlarged cross section of the probe shown in Figure 5; Figure 6A is a view of the probe shown in Figures 5 and 6 but with the replaceable probe end separated from the remainder of the probe; Figure 7 is a view showing the probe of Figures 5 and 6 in position in a user; and

Figure 8 is an enlarged cross section of the valve shown in Figures 5-7. Figs. 9a to 9e show an irrigation system according to the invention in different operating positions, Fig. 10a shows a perspective view of a detail of a control unit in a first embodiment of the irrigation system,

Fig. 10b shows an exploded perspective view of the detail shown in Fig. 10a, Figs. 11 a to 11e show sectional views of the detail of the control unit of Fig. 10,along the line Ill-Ill, in different operating positions, Fig. 12 shows a perspective view of a detail of a control unit in a second embodiment of the irrigation system,

Fig. 13 shows a sectional view of the detail of the control unit of Fig. 12, along the line V-V, Figs. 14 to 16 show sectional views of the detail of the control unit of Fig. 12, along the lines VI-VI, VII-VII, VIII-VIII in Fig. 13,

Figs. 17a to 17c show schematic plan views of the detail of the control unit of Fig. 12 in different operating positions,

Fig. 18 shows a perspective view of a detail of a control unit in a third embodiment of the irrigation system, Fig. 19 shows a sectional view of the detail of the control unit of Fig. 18, along the line XI-XI,

Figs. 20 and 21 show sectional views of the detail of the control unit of Fig. 18, along the lines XII-XII and XIII-XIII in Fig. 19, and Figs. 22a to 22c show schematic plan views of the detail of the control unit of Fig. 18 in different operating positions.

Detailed Description of Preferred Embodiments Referring now to the drawings, Figure 1 shows an embodiment of the reservoir of the invention in collapsed position and Figure 2 shows the reservoir in an open position. The reservoir comprises a front panel (1) which may be extended into a handle (2), said handle preferably being large enough to render it possible to put an arm through. The handle (2) may have any suitable conformation other than the shown here, e.g. a flexible strap, or it may not have a handle at all. The handle may also serve as a hanger, e.g. to the wheel chair or the bed.

The front panel (1) is connected to the bottom panel (3) by a hinge or a pivot joint (4). When the reservoir is in a closed position as shown in Figure 1 , the bottom panel (3) is in a position adjacent to the front panel (1).

When the reservoir is in an open position the bottom panel (3) is opened into a position substantially perpendicular to the front panel (1) thus creating a free volume (5) behind the front panel (1). In use, this volume (5) may be occupied by the container (not shown) for irrigation liquid.

The front panel (1) further comprises a lid (6) for entering liquid into or out of the container. The lid (6) may further comprise a relief valve (7) which may be adjusted to let out excess air if the pressure in the container exceeds a predefined level. The lid (6) is closable with a suitable lock, preferably a snap-lock being easy to operate by a person with reduced dexterity.

The reservoir may further be equipped with one or more perforations for entering tubes, both tubes for entering air into the container or tubes for displacing liquid out of the container and to the probe. In the shown embodiment of the invention, the gas and the liquid tube is combined into a double tubing (8) extending from the front panel, next to the lid (6). The container (not shown) is gas-tightly secured to the to a spout (9) and located on the back side of the front panel (1). The spout (9) may comprise the lid (6) and the entry for the tubes (8), and the spout (9) may optionally be detachable from the reservoir, which may ease the filling of the container. The container may 5 be in the form of a flexible bag, which when empty, is folded together in between the front and the back panel when the reservoir is collapsed. When the reservoir is in an open, expanded position, the container may be filed with water or any other irrigation liquid. The filled container will then, dependent on the degree of filling, occupy the space (5) between the front and the bottom panel. The reser- 10 voir is also stable in open and filled condition and may easily be moved around if desired.

Referring now to Figure 3 a bowel irrigation system which comprises a free standing reservoir 10 for the irrigation liquid with a top 1 having an inlet 15 therein closed by a screw cap 12. The top 1 1 makes an airtight seal with the reservoir 10 to provide a sealed container for the irrigation liquid. A pressure relief valve 12A is mounted on the lid 1 1 for reasons to be explained hereafter. The side wall of the reservoir 10 can have an optional . sight glass 18 in it to indicate the level of liquid 17 inside the reservoir 10.

20

A flexible tube 13 is connected to the side wall of the reservoir 10 and the outlet therefrom opens into the interior of the reservoir 10 above the upper level 17 of the liquid therein. A compressible member in the form of a rubber bulb 14 is attached to the end of the tube 13.

25

A second tube 15 is also connected at one end to the reservoir 10 via a one-way valve 15A which opens into the bottom thereof below the liquid level 17. A probe 16 with manually operable cuff inflation means in the form of compressible bulb 24 is attached to the free end of the flexible tube 30 15. The probe 16, preferably provided with a relatively small diameter to ease insertion of the probe into the body opening, will be described hereafter in more detail with reference to Figures 5 and 6. The probe 16 comprises a detachable end shaft 16A having a distal end 21 with a liquid outlet 22 therein. In connection with this invention, the distal end of the probe is understood to be the insertable end of the probe. The end shaft 16A also has a second opening 32 therein which communicates with the interior of an inflatable cuff 23 whose edges 23A are secured in an airtight manner to the shaft 16A in known manner e.g. using an adhesive, a heat weld or a thread. A secondary duct 31 is provided within the body of the probe and communicates with the interior of the cuff 23 via outlet 32.

A moulded plastic connector 27A is fitted in the proximal end of the probe 16 and releasably connects the detachable end 16A of the probe to the compressible bulb 24 as can be seen in Figure 6A. This allows the probe to be separated from the bulb 24 after each irrigation and replaced with a new one.

The connector 27A comprises a first tube 27B and a second shorter tube 27C with an annular shoulder 27D intermediate its ends which seats against the proximal end of the detachable probe end 16A. An annular rib 27E is formed around one end of tube 27B which locates in an annular groove 27F around the interior of the tube 30. It will be appreciated therefore that when the probe 16 is pushed into the bulb 24, the tubes 27B and 27C slide into the bulb 24 until the annular shoulder 27D seats against the bulb 27, and the rib 27E on the connector tube 27B locates in the groove 27F in the tube 30 to retain it therein. As the connector 27A makes a snap connection with the tube 30, it can be readily separated therefrom by applying an axial force thereto.

A liquid supply tube 30 extends through the compressible bulb 24 and has a connector 25 at its proximal end to which liquid supply tube 15 can be at- tached. The compressible bulb 24 is attached to the main feed tube 30 in an airtight manner by securing annular flanges 28 and 29 thereto in known manner, e.g. using an adhesive, a heat weld or thread. A tap or clamping tube 24A can be provided in the tube 15 between the reservoir 10 and the probe 16 (see Figure 3). This can either be a separate tap or incorporated into connector 25 of probe 16 (see Figures 5 and 6).

Referring now to Figures 5, 6 and 8, a valve assembly 26 having a depress- ible button 26A is mounted in the wall of the bulb 24. The valve assembly 26 has a flap or flutter valve 35 therein (see Figure 8) which is axially movable in recess 36A and normally seals against seat 36 in its rest position. However, when the bulb 24 is compressed, air is sucked into the interior of the bulb 24 through the valve 26 which lifts the flap valve 35 off its seat 36. On release of the compressive force on the bulb 24, air pressure in the bulb 24 forces the flutter valve 35 to reseat on the seat 36 and form a seal therewith. Thus, the valve 26 operates as a one-way valve which only allows ambient air to enter the bulb 24 when it is compressed. The pressurised air in the bulb 24 then travels via secondary inner duct 31 to the inte- rior of the cuff 23 via outlet 32. As a result, the cuff 23 is inflated from its deflated condition shown in Figure 5 to its inflated condition shown in Figure 6.

To deflate the cuff 23, the user presses on the button 26A which com- presses resilient legs 26C and allows the pin 26B to come into contact with the flutter valve 35 and push it away from sealing engagement with the seat 36. As a result, the pressurised air within the inflated cuff 23 and the bulb 24 can vent to atmosphere so the cuff 23 deflates and returns to its configuration shown in Figure 5. Release of the pressure on the button 26A al- lows the flutter valve 35 to reseat on the seat 36 and form a seal therewith.

Figure 7 shows the probe 16 of Figures 5 and 6 in position in anal opening 34 of a user. It can be seen that the enlarged portion 27 of the probe 16 limits the axial extent to which the probe can be inserted into the anal open- ing 34. When the cuff 23 is inflated, it seats on the entry of the anal opening into the colon 33 and axially locates the probe 16 therein. One way in which the bowel irrigation system of the invention is used by a user, carer or helper will now be described with reference to Figure 4.

As can be seen from the drawing, user 20 sits on toilet 19. If the user is in a wheelchair, it will be appreciated that this should not be too difficult as it is possible to slide from the wheelchair onto the toilet. The liquid reservoir 10 is placed on the floor opposite the user and the user 20 can then insert the tube 15 with probe 16 at its distal end into position as shown in Figure 7. The system is primed by pumping water to the probe prior to insertion of the probe into position in order to avoid introducing air into the bowel system of the user. The probe 16 of the present invention makes this procedure much easier because the user can grip the bulb 24 quite readily and push the probe 16 into the anal opening 34 until the bulb 14 abuts the outer surface 38 of the user's posterior 39. Once this occurs, the user knows that the probe 16 is fully inserted. The user can then start squeezing the bulb 24 to inflate the cuff 23 to axially locate the probe 16 in the anal opening 34 as shown in Figure 7. This is an operation which the user can easily perform as the user is already holding the bulb 24. It is therefore very easy for the user to simply squeeze the bulb and inflate the cuff 23.

Once the cuff 23 has been inflated and the probe 16 is properly located in the anal opening 34, the user can then repeatedly squeeze the other bulb 14 to pressurise the container 10 and thereby displace the liquid therein through the duct 15 to the probe 16 where it exits via outlet 22 into the co- Ion 33. So long as the user continues to squeeze the bulb 14, the liquid will continue to flow. It stops when the user stops squeezing the bulb 14. Pressure relief valve 12A prevents over-pressurisation of the container and thus the pressure of the water entering the bowel. The valve 12A is preferably set to vent at approximately 2.5 m of water to avoid the risk of ex- posing the bowel system to a harmful pressure.

The valve 12A can be a simple pressure relief valve of known type which releases at the pre-set pressure or it could be a simple stopper which pops out of the lid at the required predetermined pressure. As a consequence thereof the valve 12A can easily be manually operated to release the pressure built up in the container when the user for one reason or another wishes to stop administration of the irrigation liquid.

Once sufficient irrigating liquid has been pumped into the colon, the user presses the button 26A to vent the air in the inflated cuff 23 to atmosphere. The cuff therefore collapses back to its original configuration shown in Figure 5 which allows the user to withdraw the probe from the anal opening 34. Once this has been done, water and faeces in the colon can leave the anal opening for collection in the toilet 19.

The one-way valve 15A prevents the possibility of back flow of contaminated liquid into the reservoir and the tap or clamp 24A prevents the flow of water to the probe 16 should the probe outlet 22 be positioned below the water level in the reservoir 10 at any time.

It will be seen from the foregoing description that the bowel irrigation system of the present invention provides a very simple and compact apparatus which is easy to use so a user's bowel management is dramatically simplified. It also is readily transportable from place to place thereby giving the patient greater freedom to travel away from home without the need to have a third party assist them with their bowel management.

Although the invention has been described in relation to its use in a retrograde irrigation procedure, i.e. one in which the probe is inserted into the user's anal opening, it could be used in any irrigation procedure be it e.g. a stomal, ileostomal or an antegrade irrigation procedure whereby the probe is inserted into the exposed end of a stoma protruding through the user's stomach wall and connected to the user's bowel. The irrigation medium to be used with the system of the invention can be any suitable medium e.g. tap water, isotonic salt water, sterile water or oily substances.

Preferred materials for the bulb 14 and the cuff inflation bulb 15 can be any suitable material e.g. such as PVC, TPE or PU.

Preferred materials for the inflatable cuff 23 are PU, latex or PVC although other materials providing similar properties can likewise be used.

In Figs. 9a, an irrigation system is shown in a starting position, in which a reservoir 40 is filled with irrigating liquid 41 to a predetermined level. The irrigating liquid may be any suitable medium such as tap water, isotonic salt water, sterile water or oily substances. The reservoir 40 is formed as a substantially sealed container and is connected with a probe generally designated 42 for arrangement in a user by means of a conduit means in a manner that will be described in further detail in the following.

The probe 42 comprises a shaft portion 43 and a fixation member in the form of an inflatable cuff 44. The inflatable cuff 44 is connected with a tube 45 for conducting an inflating medium to the cuff. This medium may be any suitable fluid, such as gas, e.g. ambient air or any other gas or mixture of gases provided by a pneumatic container, or any liquid, e.g. the same liquid as the irrigating liquid to be described in the following. In this respect, it is noted that the terms "inflate" and "inflatable" etc. should be interpreted as meaning "distend" or "distendable" by means of any suitable medium. In the following the term "gas conducting tube" will be used. However, as explained in the above this does not exclude that fluids other than gas may be used. The probe 42 is furthermore connected with an irrigating liquid conducting tube 46. In the embodiment shown, the gas con- ducting tube 45 and the irrigating liquid conducting tube 46 form a first part of the conduit means.

The other end of the first part of the conduit means is connected with a control unit generally designated 47 and comprising an adjustable knob 47a. In the embodiment shown, the control unit is set in different positions by turning the knob and thus at least a part of the control unit with respect to another part or other parts thereof. However, other operating manners are conceivable, such as those involving any displacement of mutually movable parts, e.g. in a series of sliding movements in a combination of sliding and rotational movements. In connection with the control unit 47, a pumping means 48 is provided. The control unit 47 is furthermore connected with one end of a second part of the conduit means comprising a gas conducting tube 49 connected with the control unit 47 and the res- ervoir 40 and an irrigating liquid conducting tube 50. The first and the second part of the conduit means may be provided in the form of separate tubes, but each part may also be incorporated into a single tube having two lumens. Alternatively, only the inflating medium conducting tubes, i.e. in the embodiment shown the gas conducting tubes 45 and 49, are connected with the control unit whereas the irrigating liquid conducting tubes 46 and 50 constitute a single tube connecting the reservoir 40 with the probe 42. This arrangement may e.g. be carried out by means of a two-lumen tube, known per se, of which one lumen is split at the control unit into the two gas conducting tubes leading to and from, respectively, the control unit, whereas the other lumen by-passes the control unit.

Generally, irrigation is carried out by inflating the cuff in order to secure the probe in position in the user, and subsequently feeding irrigating liquid from the reservoir to the probe. In the irrigation system according to the invention, the following operational steps are carried out:

In the position shown in Fig. 9a, the control unit 47 is in a first or inactive position, indicated by '0' on the knob 47a. By turning the knob 47a to '1', the control unit 47 is brought to a second position, shown in Fig. 9b, in which gas, e.g. air, is pumped through the gas conducting tube 49 into the reservoir 40. As the reser- voir is formed as a substantially sealed container, a pressure is built up in the reservoir 40 and irrigating liquid 41 is forced into the conducting tube 50. This step is carried out in order to secure that the liquid conducting tube 48 is emptied of air which would otherwise enter into the bowels of the user and thus cause discomfort to him or her.

The knob 47a is turned to '2' and the control unit 47 is brought to a third position shown in Fig. 9c. Subsequently, the probe 42 is inserted into the anal opening of the user. When the insertion has been carried out, the cuff 44 is inflated to the desired extent, and the probe 42 is thus secured in the user. In this respect it is noted that the extent to which the cuff is inflated may vary between the individual users. Usually, initial tests are carried out in order to determine the desired extent and during subsequent irrigation procedures, the same amount of inflating medium is lead to the cuff, e.g. by counting the number of compressions in the case of pumping means in the form of a manually compressible bulb.

The control unit 47 is now brought back to its second position, in which gas is pumped to the reservoir 40 and irrigating liquid 41 is pumped to the probe 42. In the embodiment shown in Fig. 9, this operational step is marked as a separate indication on the knob 47a, viz. '3', e.g. in a manner that will be described in connection with Figs. 10 and 11 , below. It is of course conceivable to have only three indications on the knob 47a for the first, second and third operating positions.

When irrigation has been completed, e.g. because the reservoir 40 has been emptied of its contents or because the user considers it appropriate, the knob 47a is turned to position '0' and the control unit 47 is thus brought back to its first position. Gas present in the system is allowed to escape to the ambience. It is noted that means may be provided in the reservoir in order to secure that gas is prevented from entering the liquid conducting tube leading from the reservoir and possibly further into the user. Such means may e.g. comprise a stop valve containing a floater that follows the surface of the irrigating liquid. Usually, however, a visual inspection of the level of remaining irrigating liquid will be sufficient, possibly in combination with the noise generated by the last of the liquid being forced into the irrigating liquid conducting tube.

In addition to the visual indications on the knob 47a in the form of marks '0', the different positions may be indicated by temporary arresting means such as a mechanism comprising a ball and recesses to be engaged by the ball in the different positions.

It is furthermore possible to include one or more back-flow valves into the system 5 in order to ensure that irrigating liquid or contents of the bowels do not flow backwards in the irrigating liquid conducting tube or tubes.

In a first embodiment of the irrigation system, the operational steps described in the above are carried out by means of a control unit 108 shown in Figs. 10 and

10 11.

In this embodiment, the control unit 108 comprises a first disc 120, a second disc 121 and an intermediate disc 122 positioned between the first and second discs 120, 121. The intermediate disc 122 is rotatable about an axis of rotation 123 with respect to the first and second discs 120, 121 in any suitable manner, e.g.

15 by means of a shaft extending through all of the discs 120, 121 , 122 and engaging drivingly with the intermediate disc 122 only, or with an element extending along at least a part of the periphery of the intermediate disc 122 and engaging drivingly with this disc. The shaft or the element may be connected with a knob as described in the above with respect to Figs. 9a to 9e. The first disc 120 is pro-

20 vided with a connecting pipe 124 for connection with the gas conducting tube leading to the inflatable cuff at the probe of the irrigation system, and a connecting pipe 125 for connection with the irrigating liquid conducting tube leading to the probe. As suggested in the above description of Fig. 9, these tubes, which constitute the first part of the conduit means, may be incorporated into a single 5 tube having two lumens.

Correspondingly, the second disc 121 is provided with similar connecting pipes (not shown) for connection with the second part of the conduit means, i.e. the gas conducting tube and the irrigating liquid conducting tube leading to the res- 0 ervoir of the irrigation system. The second disc is furthermore provided with a connecting pipe (not shown) forming the inlet for gas supplied by the pumping means of the irrigation system. As shown in Fig. 11 , the first disc 120 is provided with a first through-going cavity 126 at a first distance from the axis of rotation 123 and a second through-going cavity 127 at a second distance from the axis of rotation 123, the second distance being larger than the first distance. The first cavity 126 opens into the con- necting pipe 125 and is thus in connection with the irrigating liquid conducting tube of the first part of the conduit means connecting the control unit with the probe. The second cavity 127 opens into the connecting pipe 124 and is thus in connection with the gas conducting tube of the first part of the conduit means.

The second disc 121 is provided with a first through-going cavity 128 at the first distance from the axis of rotation 123, a second through-going cavity 129 at the second distance from the axis of rotation 123 and a third through-going cavity 130 at a third distance from the axis of rotation 123, the third distance being larger than the second distance. The first cavity 128 opens into the connecting pipe at the outside of the second disc 121 that is connected with the irrigating liquid conducting tube of the second part of the conduit means leading to the reservoir and the third cavity 130 opens into the connecting pipe that is connected with the gas conducting pipe. The second cavity 129 opens into the connecting pipe connected with the pumping means of the irrigation system.

In the embodiment shown in Figs. 10a, 10b and 11a to 11e, the intermediate disc 122 is provided with a number of through-going cavities and recesses that are distributed as follows:

Along a first line A1 extending from the axis of rotation 123 towards the periphery of the intermediate disc 122, the intermediate disc 122 has a through-going cavity 131 at the second distance from the axis of rotation 123 and an oblong recess 132 extending from the cavity 131 to the periphery of the intermediate disc 122. Along a second line A2 extending at an angle with respect to the first line A1 from the axis of rotation towards the periphery of the intermediate disc, the intermediate disc 122 has a through-going cavity 133 at the first distance from the axis of rotation 123 and an oblong recess 134 opening towards second disc 121 and extending substantially over a distance corresponding to the second and third through-going cavities 129, 130 in the second disc 121. Along a third line A3 extending at angle with respect to the second line from the axis of rotation towards the periphery of the intermediate disc 122, the intermediate disc 122 has a through-going cavity 135 at the second distance from the axis of rotation 123. Along a fourth line A4 extending at an angle with respect to the third line A3 from said axis of rotation 123 towards the periphery of the intermediate disc 122, the intermediate disc 122 has a through-going cavity 136 at the first distance from the axis of rotation and an oblong recess 137 opening towards the second disc and extending substantially over a distance corresponding to the second and third through-going cavities 129,130 in the second disc 121.

It is noted that the cavity and the recess along the above-mentioned fourth line A4 are only necessary in the case, in which the control unit 108 may be set in four discrete positions, as is the case in the embodiment shown in Figs. 9a to 9e.

The lines A1-A4 may be distributed uniformly over a revolution, i.e., with a difference of 90° between the lines A1-A4 in the above embodiment, or with any arbitrary angle between the lines.

The operational steps carried out in order to complete irrigation will now be described with reference to Figs. 11a to 11e.

Fig. 11a indicates an inactive starting position, in which the intermediate disc 122 is set such that the through-going cavity 131 and the oblong recess 132 along the first line A1 are positioned opposite the through-going cavities 126,127 and 128,129,130 of the first and second discs 120,121 , such that a through-going passageway for gas is provided at the second distance from the axis of rotation 123, as the cavity 127 of the first disc 120, the cavity 131 of the intermediate disc 122 and the cavity 129 of the second disc 121 are in flush with each other.

In the position shown in Fig. 11b, the intermediate disc 122 has been rotated such that the cavity 133 and the recess 134 along the second line A2 are positioned opposite the cavities of the first and second discs. Thus, gas supplied by the pumping means (not shown) into the cavity 129 of the second disc 121 is directed to the reservoir via the recess 134 in the intermediate disc 122, the cavity

130 in the second disc 121 and further on through the gas conducting tube leading from the control unit to the reservoir. As described in the above, the pressure created by the gas supplied to the reservoir causes the irrigating liquid to flow from the reservoir through the irrigating liquid conducting tube leading from the reservoir to the control unit, through the passageway formed by cavities 128, 133 and 126 in the control unit and further through the irrigating liquid conducting tube leading from the control unit to the probe of the irrigation system.

In the position shown in Fig. 11c, the intermediate disc 122 has been turned once again such that the through-going cavity 135 along the third line A3 is positioned opposite the cavities in the first and second discs. In this position, gas supplied from the pumping means is allowed to flow through the passageway formed by cavities 129, 135 and 127 in the control unit and further through the gas conducting tube leading from the control unit to the inflatable cuff, thus inflating the cuff.

When the cuff has been inflated, the intermediate disc 122 is brought to the posi- tion in which the cavity 136 and the recess 137 along the fourth line A4 are positioned opposite the cavities in the first and second discs. As explained in the above, this corresponds to the situation shown in Fig. 11 b. Thus, gas is allowed to flow from the pumping means to the reservoir, and irrigating liquid is forced from the reservoir through the control unit and further on to the probe, thus per- forming the irrigation for as long it is possible or desirable.

The irrigation step may be terminated by turning the intermediate disc 122 further or back to its inactive first position, shown in Figs. 11a and 11e. Gas present in the system, primarily in the inflatable cuff, is allowed to flow off to the ambience through the recess 132. In this respect it is noted that the recess 132 may be replaced by any opening in the intermediate disc, as long as it connects the cavity

131 with the outside of the intermediate disc 122. The pumping means may be any manually operated pump, such as a resilient bulb, or any pump powered by external means, such as electricity or a pressurized medium.

In case the pump is a powered pump, it may be automatically activated when setting the control unit in its second position, and automatically deactivated in the first position.

As suggested in the embodiment shown in Figs 9a to 9e, the pump may be inte- gral with the control unit.

As described in connection with the embodiment of Figs 9a-9e it is possible to use a single tube for irrigating liquid leading from the reservoir to the probe. It is also conceivable to inflate the cuff by other media than gas supplied by the pumping means. For instance, the inflating medium may be provided in a separate container, e.g. with a predetermined fluid content. Such a container may be provided with a valve which may be activated in order to deflate the cuff when the irrigation has been completed.

It is furthermore conceivable to design the discs such that the control unit may be set only in a cuff inflating and a liquid transferring position. In this case, ventilation of gas present in the system following irrigation must be carried out in any alternative manner, e.g. in the above suggested solution by a separate vent in the container containing the inflating medium. Alternatively, deflation may be carried out by disconnecting the conducting tube from the control unit and/or the probe. The cross-section of the through-going cavities may be chosen arbitrarily but is advantageously circular.

In order to provide a substantially sealed transition between the first disc and the intermediate disc and between the intermediate disc and the second disc, at least the intermediate disc is advantageously formed from a resilient material. Alternatively, the first and discs are formed from a resilient material, or all of the discs may be formed from the same, possibly resilient material. The material should possess such a degree of resilience that a satisfying sealing effect is achieved without impeding the movement of the intermediate disc with respect to the first and second discs.

Figs. 12 to 17 shows a control unit 208 of a second embodiment of the irrigation system.

In this embodiment, the control unit 208 comprises an accommodating element 220 and a cylindrical element 222 accommodated in a cylindrical aperture 220a with dimensions corresponding substantially to the outer dimensions of the cylindrical element 222. The cylindrical element 222 is rotatable about an axis of rotation 223 with respect to the accommodating element 220, and the cylindrical element 222 may be set in a number of predetermined operating positions. The first and second part of the conduit means are connected with the accommodating element 220 in a manner that will be described in further detail in the following.

In a first angular position A10, the accommodating element 220 has a first canal 226 in a first height position and a second canal 227 in a second height position. In a second angular position A20, the accommodating element 220 has a third canal 228 in the first height position and a fourth canal 230 in the second height position. In a third angular position A30 the accommodating element has a fifth canal 229 in a third height position, and in a fourth angular position A40 a sixth canal 238 in the third height position. Each canal 226,227,228,230,229,238 ex- tends from the periphery of the accommodating element 220 to the substantially cylindrical aperture 220a.

In the embodiment shown, the cylindrical element 222 comprises an internal gas distribution compartment 231 having in a first angular position A11 a first pas- sage 231a, in a second angular position A21 a second passage 231b, in a third angular position A31 a third passage 231c and in a fourth angular position A41 a fourth passage 232. The cylindrical element comprises in the third angular position A31 a first channel 233a extending from substantially the axis of rotation 223 to the periphery of the cylindrical element 222. A second channel 233b extends from substantially the axis of rotation 223 to the periphery of the cylindrical element in a fifth angular position A51 that forms an angle with the third angular position A31 corresponding to the angle between said first and second angular positions A10 and A20 of the accommodating element 220, said first and second channels 223a, 223b being connected with each other at the axis of rotation 223.

The first canal 226 is connected with the irrigating liquid conducting tube and the second canal 227 with the gas conducting tube of the first part of the conduit means, i.e. the part leading to the probe. The third canal 228 is connected with the irrigating liquid conducting tube and the fourth canal 230 with the gas conducting tube of the second part of the conduit means, i.e. the part leading to the reservoir. The fifth canal 229 is connected with the pumping means of the irrigation system, and the sixth canal 238 is connected with the ambience.

Alternatively, the fifth canal may be positioned such that the internal gas distribution compartment is supplied with gas from the pumping means independently of the movement of the cylindrical element with respect to the accommodating element. This may, e.g. be carried out by extending the compartment with a portion below the cylindrical element and leading the gas to this portion of the compartment. This eliminates the risk that the cylindrical element is inadvertently turned into a position, in which the cuff is deflated before irrigation has been completed.

Furthermore, sealing means known perse may be provided between at least the first and second heights such that the liquid conducting passageways are sealed with the gas conducting passageways, and between the liquid conducting passageways and the exterior of the control unit.

The operational steps carried out in order to complete irrigation will now be described with reference to Figs. 17a to 17c. In Fig. 17a, the cylindrical element 222 is in its first position, in which the first angular positions A11 and A10 of the cylindrical element 222 and the accommodating element 220, respectively, substantially coincide with each other. The second angular positions A21 and A20, the third angular positions A31 and A30, and the 5 fourth angular position A41 and A40 coincide as well. Gas present in the irrigation system is thus allowed to flow off to the ambience through the fourth passage 232 and the sixth canal 238, the internal gas distribution compartment 231 thus being in connection with the probe via the second canal 227, the reservoir via the fourth canal 230 and the pumping means via the fifth canal 229 in addi- 10 tion to the sixth canal 238 and thus with the ambience.

By turning the cylindrical element 222 in the clockwise direction to the position shown in Fig. 9b, gas supplied from the pumping means flows into the internal gas distribution compartment via the fifth canal 229 and the first passage 231a

15 and further on through the third passage 231c into the reservoir. Irrigating liquid is forced from the reservoir back into the control unit 208. As the channels 233a and 233b of the cylindrical element 222 are positioned opposite the third and first canals 228 and 226, respectively, in the accommodating element 220, a passageway for irrigating liquid is formed in the control unit 208, and irrigating liquid

20 is thus allowed to flow off from the first canal 226 to the irrigating liquid conducting tube and further on to the probe.

In the third position shown in Fig. 17c, gas is allowed to flow from the pumping means to the internal gas distribution compartment 231 through the fifth canal 25 229 and the second passage 231b, and from the compartment 231 via the third passage 231c and the second canal 227 further on to the inflatable cuff.

The cylindrical element is then turned back into the second position and irrigation is carried out for as long as desired. By turning the cylindrical element back into 30 the first position shown in Fig. 17a, the cuff may be deflated and the probe removed from the user.

As suggested in connection with the embodiment of Figs 9a-9c the control unit may comprise arresting means for arresting the cylindrical element temporarily in the different positions. In the embodiment shown, the accommodating element comprises a ball (not shown) displaceable in the radial direction and a number of recesses corresponding to the first, second and third positions, of which one re- cess 250 is shown in Fig. 13.

As described in the above in connection with the embodiment of Figs 10 and 11 , the first and second parts of the conduit means may be formed as single tubes with two lumens, or as separate tubes, whereby it is possible to position the ca- nals in the accommodating element differently from the positions shown in Figs. 12 to 17. Likewise it is possible to let the irrigating liquid conducting tube by-pass the control unit and to have a separate container for supplying the inflating medium.

It is furthermore conceivable to design the control unit 208 such that the cylindrical element may be set in the cuff inflating and liquid transferring positions only.

In Figs. 18 to 22, an alternative embodiment to the embodiment shown in Figs. 12 to 17 is illustrated. Elements having the same or.analogous function have the same reference numerals with '100' added to them.

In this embodiment the accommodating element 320 comprises an abutment face 320a for a bottom face 322a of the cylindrical element 322. As in the above embodiment, the cylindrical element 322 is rotatable with respect to the accom- modating element 320 about the axis of rotation 323.

In a first angular position A100 the accommodating element 320 has a first canal 326, and in a second angular position A200 a third canal 328. Each of the first and third canals 326, 328 extends from the periphery of the accommodating element 320 in a direction towards the axis of rotation 323 to a predetermined position and from said predetermined position to the abutment face 320a. Along a line substantially parallel with a line extending through said first angular position A100, the accommodating element 320 has a second canal 327, and along a line substantially parallel with a line extending through the second angular position A200 a fourth canal 330. Each of the second and fourth canals 327, 330 extends from the periphery of the accommodating element 320 to a predetermined position and from said predetermined position to the abutment face 320a. In a third angular position A300 the accommodating element 320 has a fifth canal 329 extending from the periphery of the accommodating element to the axis of rotation 323 and further on to the abutment face 320a, and in a fourth angular position A400 a sixth canal 338 extending from the periphery of the accommodating element towards the axis of rotation to a predetermined position and from that position to the abutment face 320a.

In the bottom face 322a the cylindrical element 322 has a first oblong recess 340 opening towards the abutment face 320a and having an extent corresponding substantially to the distance between the first and third canals 326 and 328 of the accommodating element 320, and a second oblong recess 341 opening towards the abutment face 320a and having such a configuration that it extends, in a first position, from the fourth canal 330 through the fifth canal 329 and the second canal 327 to the sixth canal 338.

In the embodiment shown, the first oblong recess 340 has a substantially curved shape.

The first canal 326 is connected with the irrigating liquid conducting tube and the second canal 327 with the gas conducting tube of the first part of the conduit means, the third canal 328 is connected with the irrigating liquid conducting tube and the fourth canal 330 with the gas conducting tube of the second part of the conduit means. The fifth canal 329 is connected with the pumping means, and the sixth canal 338 is connected with the ambience.

The operational steps carried out in order to complete irrigation will now be described with reference to Figs. 22a to 22c.

In the first position shown in Fig. 22a the second recess 341 provides connection between the second, fourth, fifth and sixth canals as described in the above, gas present in the irrigation system is allowed to flow off to the ambience through the sixth canal 338.

By turning the cylindrical element 322 in the clockwise direction to the position shown in Fig. 22b, the first recess 340 is moved into a position, in which it covers the first and third canals 326, 328, and the second recess 341 is moved into a position, in which it covers the fourth and fifth canals 330, 329 only. Gas supplied from the pumping means flows through the fifth canal 329 and out through the fourth canal 330 via the second recess 341 and further on through the gas conducting tube of the second part of the conduit means and into the reservoir. As described in connection with the above embodiments, irrigating liquid is forced from the reservoir into the control unit 308. As the first recess 340 provides a passageway, irrigating liquid is able to flow on to the probe through the irrigating liquid conducting means of the first part of the conduit means.

In the third position shown in Fig. 22c, the second recess 341 has been moved into a position in which it covers the second and fifth canals 327, 329 only. Consequently, gas may flow from the pumping means through the control unit and into the inflatable cuff via the gas conducting tube of the first part of the conduit means leading to the probe of the irrigation system.

The cylindrical element 322 is then turned back into the second position and irrigation is carried out for as long as desired. By turning the cylindrical element 322 back into the first position shown in Fig. 22a, the cuff may be deflated and the probe removed from the user.

In case the first and second parts of the conduit means are not formed as single tubes with two lumens, it is possible to position the canals in the accommodating element differently from the positions shown in Figs. 18 to 22.

It is furthermore conceivable to design the control unit 308 such that the cylindrical element may be set in the cuff inflating and liquid transferring positions only. The invention should not be regarded as being limited to the embodiments described in the above but various modifications of and combinations between the various embodiments may be carried out without departing from the scope of the following claims.

The invention relates further to an irrigation system comprising a reservoir for irrigating liquid, a probe for arrangement in a user, conduit means for conducting the irrigating fluid from the reservoir to the probe, and a fixation member for fixation of the probe in the user, wherein pumping means are provided for pumping gas into the reservoir to transfer the irrigating liquid from the reservoir to the probe, that the fixation member includes an inflatable cuff, and that the system includes a control unit which may be set in at least a cuff inflating position and a liquid transferring position.

The control unit may comprise at least two elements that may be moved with respect to each other into at least said cuff inflating and liquid transferring posi- tions.

The conduit means may include a first part connecting the control unit with the probe and a second part connecting the reservoir with the control unit, and in which each of said first and second parts comprises a gas conducting tube and an irrigating liquid conducting tube.

The conduit means may include an irrigating liquid conducting tube connecting the reservoir with the probe, and at least one gas conducting tube connecting the control unit with the reservoir. The irrigation system may furthermore comprise a separate container containing an inflating medium.

The control unit may be set in a first position corresponding to an inactive posi- tion, a second position corresponding to said liquid transferring position and in which gas is pumped into the reservoir and irrigating liquid is transferred from the reservoir to the probe, and a third position corresponding to said cuff inflating position and in which gas is pumped into the inflatable cuff.

The control unit may comprise a first disc connected with at least an irrigating liquid tube connecting the control unit with the probe, a second disc connected with at least an irrigating liquid tube connecting the reservoir with the control unit, and an intermediate disc positioned between and being rotatable about an axis of rotation with respect to the first and second discs, and in which said intermedi- ate disc may be set in at least said cuff inflating and liquid transferring positions.

The first disc may include a first through-going cavity at a first distance from said axis of rotation and a second through-going cavity at a second distance from said axis of rotation, in which the second disc includes a first through-going cav- ity at said first distance from said axis of rotation, a second through-going cavity at said second distance from said axis of rotation and a third through-going cavity at a third distance from said axis of rotation, and in which the intermediate disc along a first line (A1) extending from said axis of rotation towards the periphery of the intermediate disc has a through-going cavity at said second dis- tance from the axis of rotation and an oblong recess extending from said through-going cavity to the periphery of the intermediate disc, and along a second line (A2) extending at an angle with respect to said first line (A1) from said axis of rotation towards the periphery of the intermediate disc has a through- going cavity at said first distance from the axis of rotation and an oblong recess opening towards said second disc and extending substantially over a distance corresponding to the second and third through-going cavities in the second disc, and along a third line (A3) extending at an angle with respect to said second line (A2) from said axis of rotation towards the periphery of the intermediate disc has a through-going cavity at said second distance from the axis of rotation.

The conduit means may include a first part connecting the control unit with the probe and a second part connecting the reservoir with the control unit, each of said first and second parts comprising a gas conducting tube and an irrigating liquid conducting tube, in which the gas conducting tube of the first part of the conduit means is connected with the second through-going cavity of the first disc and the irrigating liquid conducting tube of the first part is connected with the first through-going cavity of the first disc, in which the gas conducting tube of the sec- ond part of the conduit means is connected with the third through-going cavity of the second disc and the irrigating liquid conducting tube of the second part is connected with the first through-going cavity of the second disc, and in which the pumping means is connected with the second through-going cavity of the second disc.

The intermediate disc along a fourth line (A4) may extend at an angle with respect to said third line (A3) from said axis of rotation towards the periphery of the intermediate disc has a through-going cavity at said first distance from the axis of rotation and an oblong recess opening towards said second disc and extending substantially over a distance corresponding to the second and third through- going cavities in the second disc.

Each of said angles may be substantially 90°. At least said intermediate disc may be formed from a resilient material.

The control unit may comprise a cylindrical element and an accommodating element having a cylindrical aperture with dimensions corresponding substantially to the dimensions of the cylindrical element, in which said cylindrical element is ro- tatable about an axis of rotation with respect to the accommodating element, and in which said cylindrical element may be set in at least said cuff inflating and liquid transferring positions, at least irrigating liquid conducting tubes connecting the control unit with the probe and the reservoir with the control unit, respectively being connected with the accommodating element. The accommodating element in a first angular position (A10) may have a first canal in a first height position and a second canal in a second height position, in which the accommodating element in a second angular position (A20) has a third canal in said first height position and a fourth canal in said second height position, in which the accommodating element in a third angular position (A30) has a fifth canal in a third height position, and in which the accommodating element in a fourth angular position has (A40) a sixth canal in said third height position, each canal extending from the periphery of the accommodating means to the substantially cylindrical aperture.

The cylindrical element may comprise an internal gas distribution compartment having in a first angular position (A11) a first passage, in a second angular position (A21) a second passage, in a third angular position (A31) a third passage and in a fourth angular position (A41) a fourth passage.

The cylindrical element may comprise in said third angular position a first channel extending from substantially the axis of rotation to the periphery of the cylindrical element, and a second channel extending from substantially the axis of ro- tation to the periphery of the cylindrical element in a fifth angular position (A51) that forms an angle with the third angular position (A31) corresponding to the angle between said first and second angular positions (A10,A20) of the accommodating element, said first and second channels being connected with each other at the axis of rotation.

The conduit means may include a first part connecting the control unit with the probe and a second part connecting the reservoir with the control unit, each of said first and second parts comprising a gas conducting tube and an irrigating liquid conducting tube, in which the first canal is connected with the irrigating liq- uid conducting tube and the second canal with the gas conducting tube of the first part of the conduit means, in which the third canal is connected with the irrigating liquid conducting tube and the fourth canal with the gas conducting tube of the second part of the conduit means, in which the fifth canal is connected with the pumping means, and in which the sixth canal is connected with the ambience.

The accommodating element may comprise an abutment face for a bottom face of the cylindrical element, in which the accommodating element in a first angular position (A100) has a first canal, and in a second angular position a third canal, each of said first and third canals extending from the periphery of the accommodating element in a direction substantially towards the axis of rotation to a predetermined position and from said predetermined position to the abutment face, in which the accommodating element along a line substantially parallel with a line extending through said first angular position (A100) has a second canal, and along a line substantially parallel with a line extending through said second angular position (A200) has a fourth canal, each of said second and fourth canals extending from the periphery of the accommodating element to a predetermined position and from said predetermined position to the abutment face, in which the accommodating element in a third angular position (A300) has a fifth canal extending from the periphery of the accommodating element to the axis of rotation and further on to the abutment face, in which the accommodating element in a fourth angular position (A400) has a sixth canal extending from the periphery of the accommodating element towards the axis of rotation to a predetermined position and from that position to the abutment face, and in which the cylindrical element in the bottom face has a first oblong recess opening towards the abutment face and having an extent corresponding substantially to the distance between the first and third canals of the accommodating element, and a second oblong recess opening towards the abutment face and having such a configuration that, in a first position, it extends from the fourth canal through the fifth and second canals to the sixth canal. The first oblong recess may have a substantially curved shape.

The pumping means may be a manually operated pump, such as a bulb or a bellow pump. The pumping means may be a powered pump, such as an electrically or pneumatically operated pump. The pump may be deactivated when the control unit is set in the first position and is activated automatically when said control unit is set in the second position. The pump may be integrated with the control unit.

Claims

1. A bowel irrigation system comprising a reservoir for irrigating liquid with a probe connected thereto and means for transferring the irrigating liquid from the reservoir to the probe, the reservoir comprises a sealed container, wherein said reservoir is rigid or semi-rigid and collapsible.

2. A system according to claim 1 , wherein the volume of the reservoir in closed position is smaller than the volume of the container in filled position.

3. A system according to any of claims 1 or 2 wherein the means for transferring the irrigating liquid from the reservoir to the probe comprises pumping means.

4. A system according to claims 3 wherein the pumping means is operable by the user to create a pressure in the container to displace the liquid therefrom and feed it to the probe.

5. A probe for use in a bowel irrigation system comprising a shaft having a proximal end and a distal end and a duct therethrough for supplying irriga- tion liquid from the proximal end to an outlet at the distal end, an inflatable cuff mounted on the shaft adjacent said outlet to retain, in use, the probe in position in the user's anal opening, manually operable cuff inflation means, operable by the user to inflate the cuff , said cuff inflation means having associated therewith a one-way valve to admit ambient air to the interior thereof only during inflation of the cuff and retain said air therein and means operable to release the pressure within the inflated cuff to deflate said cuff.

6. A probe as claimed in claim 5 characterised in that the manually oper- able cuff inflation means is a resilient compressible bulb mounted on the shaft.

7. A probe as claimed in claim 6 characterised in that the shaft has an outlet opening into the interior of the cuff, a separate duct connecting the interior of the bulb with said outlet.

8. A probe as claimed in claim 6 or claim 7 characterised in that the pressure release means comprises a movable member normally biased to a closed position, movement of said member opening the valve to vent the contents of the cuff to atmosphere and deflate the cuff.

9. A probe as claimed in any of claims 6-8 characterised in that the movable member is a depressible button which forms part of the one-way valve.

10. A probe as claimed in any of claims 5-9 characterised in that the cuff inflation means includes a connector operable to releasably connect the probe shaft thereto.

11. A probe for use in a bowel irrigation system in which irrigation liquid is supplied to an outlet adjacent the end of the probe, the probe comprising a shaft having a proximal end and a distal end and a duct therethrough for the supply of said irrigation liquid to the outlet, and an inflatable cuff mounted on the shaft wherein the probe end is detachable and includes separate fluid supply means on the shaft to supply a fluid to the interior of the cuff , the proximal end of the shaft being formed to make a releasable connection with the fluid supply used to inflate the cuff and the supply of ir- rigation liquid.

12. A probe as claimed in claim 11 characterised in that the secondary fluid supply means is a secondary duct inside the probe shaft.