DK177969B1 - An enema device and method of using the device - Google Patents

Abstract

A compact enema device (1) comprising a flexible delivery container (2) and an applicator nozzle (3) in fluid delivery container (2), communication with the delivary container (2), wherein thedevice (1) comprises at least two one-way valves (7,8) wherein the at least first one-way valve (7) is adapted for preventing leakage of fluid prior to use and for allowing said fluid to enter the delivery container (2), and the at least second one­ way valve (8) is adapted for allowing said fluid to be expelled from the enema device (l) via an exit opening (6) in the applicator nozzle (3) when a cracking pressure is applied to the delivery container. Thereby is provided a inexpensive and essentially maintenance free device can be used for administrating a cleaning liquid,e.g. an enema, which eannot only can be used several times but also ensures that uncontrolled flow of liquid into or out of the device is prevented.

Description

An enema device

The present invention relates to an enema device comprising a flexible delivery container and an applicator nozzle.

Administering an enema is a common medical procedure whereby fluid is injected into the rectum and lower intestine of a patient in order to induce bowel movement. The need for such a procedure typically arises in patients suffering from certain physical ailments in which voluntary bowel control is impaired or when the bowel needs to be cleaned before e.g. a coloscopy or a surgical operation.

Medical equipment currently exists in the art for administering an enema to patients in need of this procedure. At least one type of equipment consists of an enema squeeze bottle filled with the fluid intended to induce bowel movement, which is capped by a short applicator nozzle to be inserted into the patient's rectum. The applicator nozzle of this type of conventional enema application device often causes discomfort and irritation when being inserted. A compact enema device is e.g. disclosed in the international patent publication no. WO 2010/122537. Said device includes a flexible delivery container and an applicator nozzle, however the force required to squeeze the liquid from an enema dispenser affects the ease with which a user may administer the liquid. The self-administration of a conventional enema may be especially difficult for elderly patients, due to the squeeze force required to deliver a complete dose of the enema liquid.

Large complex enema devices are e.g. known from US 1,352,206, US 2,660,170 and CN 201168248Y. All of these known devices are connected to a large fluid reservoir. Furthermore, a relatively long thin tube connects a flexible pump and an applicator nozzle. Thus, the construction of these known devices ensures that a large squeeze force to the pump is required in order to deliver a dose of the enema liquid from the liquid reservoir to the applicator nozzle, which together with the large and complex structure of said devices makes them unsuitable for home-administrations of an enema, eg for patients unable to deliver the required squeeze force.

Although it would be advantageous to decrease the amount of squeeze force required to administer an enema, such a modification may adversely affect other desirable features of the device. In particular, it is desirable to prevent any reflux of liquid back into the dilevery container after the enema liquid has been delivered, and it is desirable to prevent leakage of the enema liquid from the dispenser prior to use. A simple reduction in the resistance to flow of the liquid through the device may compromise these features.

Moreover, enemas are often administered to a patient at home when the need for medical assistance does not necessitate a doctor or another health care assistant. However, it is often difficult for the patient to administer the enema to him or herself since the applicator nozzle must be inserted into such a small, sensitive area. Moreover, it is difficult for the patient to administer the fluid while steadily holding the enema in the required area. Often the patient is assisted by another individual; however, assistance may not always be available if, for instance, the patient lives alone. Thus, there is also a need for an enema device that can be effectively self-administered.

Therefore, it is a first aspect of the present invention to provide a handheld enema device that can safely and effectively administer a fluid, e.g. enema, to a patient without causing discomfort.

It is a second aspect of the present invention to provide an enema device where the fluid is easier to administer, and that prevents reflux of liquid into the container after use and / or prevents leakage of the fluid prior to use.

It is a third aspect of the present inveniton to provide an enema device that can be used to more easily administer a variety of different fluids.

It is a further aspect of the present inveniton to provide an enema device that can be used to more easily administer a range of doses of fluids.

In a fifth aspect according to the present invention, an enema device of the child is mentioned in the opening paragraph which is inexpensive to manufacture and is simple and reliable to use.

In a sixth aspect according to the present invention, an enema device of the child is mentioned in the opening paragraph which are relatively small and easy to operate, especially by one hand.

The novel and unique by which this is achieved is the fact that the device is compact and comprises at least two one-way valves while the at least first one-way valve is adapted to allow a fluid to enter the delivery container, and the at least second one-way valve is adapted to prevent leakage of the fluid prior to use and to allow said fluid to be expelled from the device via an exit opening in the applicator nozzle when acracking pressure / force is applied to the delivery container. In this way the delivery container prefers both functions as a fluid reservoir and as a pump.

It can be expected that the user of the device suffers from some form of impairment related to aging, diagnosis or trauma that will involve reduced hand strength and / or dexterity. For this reason, any additional force needed to deliver the fluid may have the consequence that the user is no longer able to use the device.

For this reason, preventing leakage of the fluid and at the same time allowing it to flow out requires the second one-way valve to be balanced within curtain limits if it is to enhance and improve the use of the device. The force provided by the preload or resistance of the system has to carefully match the hydrostatic pressure of the liquid present in the delivery pump. Thus, the resistance to hold back the fluid in the delivery pump has to be overcome by the user, adding to the force needed to compress the delivery container and deliver the fluid through the second one-way valve.

This specific balance is obtained when the cracking pressure of the at least one second one-way valve is between 0.005 and 0.02 bar, preferably between 0.008 and 0.015 bar, more preferably around 0.01 bar.

In this way, the second one-way valve ensures that the device, after being charged with fluid, can be pointing downwards without the fluid leaking from the device, but also that only a very small force has to be applied to the delivery container when the fluid has to be expelled, thereby allowing the device to be used by users having limited strength, eg in the hands and fingers.

As a rule, the provided cracking pressure should be somewhere between 50% and 150% of the highest hydrostatic pressure of the pump and ideally within +/- 10% taking into account any additional gravitational forces of the valve system that has to be overcome too. In the device according to the invention, the highest hydrostatic pressure is related to the inside height of the pump which is measured somewhere between 80 and 125 mm. The gravitational force of the valve system is 0.002N which has been added to the preload force.

There is also provided a simple, inexpensive and essentially maintenance free device which can be used for administering a liquid, e.g. an enema, which can only be used several times but also ensures that uncontrolled flow of liquid into or out of the device is prevented. If the device according to the invention is compact the device can e.g. be held in a single hand making the device very suitable for e.g. home administration of a liquid enema.

In the present application the term "compact" means that the device according to the invention has a structure where its parts or units are tightly packed or joined without additional tubes, hoses or pipings, in order to ensure that the device takes up as little spatial space or volume as possible. This will ensure that the device can be handheld and easily operated e.g. with a single hand.

The delivery container is loaded with the desired liquid, e.g. an enema, by depressing the flexible container and inserting a free end of the first one-way valve in the desired liquid. The flexible container is then released creating a vacuum that draws the liquid into the container. Since both the first oneway valve and the second one-way valve prevent inadvertent discharge of the liquid, a clean, efficient and fast process is provided while at the same time preventing any spillage or dripping of the liquid prior to administration.

The second one-way valve will further effectively prevent backflow of liquid and faeces from the colon and / or rectum into the device and said second one-way valve will therefore preclude any contamination of the delivery container and it's remaining content, which may occur after administration of the liquid to a patient.

Furthermore, since backflow is effectively prevented, the delivery container can easily be used for several applications, e.g. by refilling the container with a second dose of the same - or a different - liquid.

After the liquid is administered the user can release the compression of the delivery container. This will result in the container being re-inflated by drawing surrounding air into the container via the first one-way valve. Alternatively, the container can be re-loaded with liquid by drawing said liquid into the container. The laughter will ensure that the device according to the inventive can be used for several administrations as needed by the patient or user. This also ensures that the user, if desired, can administer different liquids. A very simple and effective embodiment according to the present invention is provided when the applicator nozzle is removably connectable to the delivery container by means of a coupling. In addition, the applicator nozzle e.g. a disposable nozzle or the nozzle can be individually cleaned and / or sterilized, whereas the delivery container can be reused several times. The device according to the present invention is therefore especially suited for a quick and simple administration of an enema to a patient.

An advantageous embodiment is obtained when the applicator nozzle is directly coupled to the delivery container e.g. by means of conventional coupling means. Alternatively, the coupling means can be adapted for removable connecting the applicator nozzle to the delivery container. Said coupling means can e.g. Comprise a first coupling part attaching to the applicator nozzle and a second coupling part attached to the delivery container to provide fluid communication between the two parts. In an especially simple embodiment, the first coupling part is a first tube and the second coupling part is a second tube. Said second tube is preferably adapted to provide a liquid tight fit together with the first tube in order to provide the coupling, e.g. by providing that at least one of the first and second tubes is made of a flexible material such as e.g. the first tube can be placed in the second tube or vice versa. In order to ensure that the device is compact, first and second tubes preferably have dimensions, which are sufficient to provide the liquid tight fit, without adding any additional length to the device. This can e.g. be achieved when the tubes in the coupled state have a length of between 5 mm and 30 mm, preferably between 10 and 25 mm and most preferably around 20 mm.

Thus, in the present application "directly coupled" means that the applicator nozzle is coupled to the delivery container without the use of relatively long and thin fluid hoses and / or tubes. Such an embodiment will not only ensure a comfortable and comfortable fit in the hand but will also reduce the necessary force needed to compress the container as the frictional forces in the device are reduced. This is due to the much shorter distance the enema liquid has to travel in the device according to the invention compared to the distance in the prior art devices were long thin tubes connecting the delivery container and the application nozzle. Due to the reduced squeeze force required to deliver a complete dose of enema liquid the device according to the invention can easily be used by patients having e.g. rheumatism.

In order to keep the device compact and thereby handheld according to the invention it is preferable that the delivery container functions as the only fluid reservoir. However, alternatively the first one-way valve may be attached to a larger container holding several doses of the enema liquid e.g. via a tube. Thus, when the force is relaxed on the delivery container, the container is simply filled with additional enema liquid. This embodiment is especially desirable if several doses of enema liquid are required.

An especially advantageous embodiment is provided when the at least two one-way valves are both integrated into the delivery container. Said embodiment will have a very simple design and be easy to operate with one hand. This embodiment is furthermore inexpensive to manufacture as the delivery container can be reused for several applications (in some situations for several users), whereas the applicator nozzle can be e.g. disposable.

In order to provide additional security of preventing backflow into the delivery container, a third one-way valve can be placed in the applicator nozzle, preferably at the tip of the applicator nozzle.

The length of time it takes to administer an enema depends on the amount of liquid to be infused. The amount of liquid administered will vary depending on the age and size of the person receiving the enema, however in any case an increasing force needs to be applied to the delivery container in order to force the cleaning liquid out of the device, and force must be applied to the devices at all times during the administration of the enema.

Thus, in a preferred embodiment the device comprises a means for temporarily closing the first one-way valve. This will allow the user to release the pressure on the delivery container by either relaxing the hand or removing the hand completely from the delivery container, as closing the first one-way valve will prevent surrounding air from reinflating the delivery container. As the second one-way valve effectively prevents backflow of fluid into the container, administration of the liquid can take as long as the patient needs or require without compromising the operation of the device according to the invention.

The first one-vay valve can preferably be closed immediately after the liquid has been drawn into the delivery container.

The means for temporarily closing the first one-way valve is preferably a simple and inexpensive plug that will provide a sealing fit with the valve's inlet. However, other ways of temporarily closing the first one-way valve are well known to the person skilled in the art.

The one-way valves are preferably selected from the group consisting of slit valves, check valves including swing valves, lift valves, ball valves, tilting disk valves, dual plate (leaflet) valves, diaphragm valves, flap valves and general valves including ball valves , butterfly valves, check valves, diaphragm valves, gate valves, globe valves, plug valves, duck bill valves and pinch valves. The one-way valves can be with or without preload, and be either identical or different from each other. The only demand is that the valves are capable of providing the desired properties to the device according to the invention.

However, in a preferred embodiment the second one-way valve is an umbrella valve or a spring-loaded valve.

Umbrella valves comprise elastomeric valve components that have a diaphragm shaped sealing disk. When mounted in a seat, the convex diaphragm flattens out against the valve seat and absorbs a certain amount of seat irregularities and creates a certain sealing force. The umbrella valve will allow forward flow once the cracking pressures of e.g. 0.01 bar is applied, lifting the convex diaphragm from the seat allowing flow in one way and preventing back flow immediately in the opposite way.

The main advantage of an umbrella valve is that it uses its elastic material properties to create the sealing force against the seat and that it uses the central stem to hold the component in place so as to avoid the need for additional components.

In the spring loaded valve the closing force or spring force is applied by a compressed helical spring. The spring force is transferred via the spindle onto a ball, which seals against the nozzle as long as the spring force is greater than the cracking pressure, i.e. the pressure created at the inlet of the valve. This simplifies the design of the valve and makes the valve adaptable to minimal space, reduces the number of pieces in a valve, simplifies assembly and last but not least is very cost effective.

In the present application the term "fluid" means a substance such as a liquid or a gas, which tends to flow or conform to the outline of its container.

In respect of the present invention, the term fluid comprises the air contained in the delivery container before it is squeezed the first time in order to prepare for loading of the enema and the air, which enters the delivery container when it is re-inflated after use.

The term fluid also covers any liquid which is capable of promoting bowel movement when introduced into the rectum and colon, such as an enema liquid. Examples of enema liquids include water; hypertonic aqueous salt solutions; solutions or suspensions of cathartic agents, such as bisacodyl or phenolphthalein; and mineral oil. Other liquids capable of promoting bowel movements are well known in the art.

The nozzle can take any form as long as the nozzle is capable of performing the function of administering the liquid to the patient's rectum and / or colon. Thus, the nozzle could be relatively cylindrical, conical, prismatic, prolate spheroidal or pyramidal or consist of a simple tube. Further, the nozzle in whatever form it takes, could have smooth sides, ridges or undulations.

In a preferred embodiment the applicator nozzle has a mainly fructoconical shape whose outside diameter progressively decreases from it's proximal end to it's distal as said shape will automatically ensure a tight fit with the anal opening.

The applicator nozzle can furthermore be modified in size, shape and possibly other physical properties such as flexibility, rigidity and pliancy to become a plug that accommodates forming a sealing fit with the anal opening. For example, if at least the nozzle is somewhat pliable, it will conform to the shape of the patient's rectum and aid in alleviating the physical discomfort and pain that the patient may experience during insertion of the nozzle. The nozzle can be furthermore provided with e.g. a pointed blunt tip in order to further reduce said discomfort or a lubricant in order to aid the insertion of the nozzle into the rectum by reducing frictional force.

The applicator nozzle can preferably be disposed in order to reduce contamination of the surroundings e.g. by providing a nozzle, which can be flushed down the toilet after use. This will also make the device more convenient and hygienic in use. The nozzle is preferably made of a hypoallergenic material that is non-reactive with the patient's tissue.

In a different embodiment, the applicator nozzle need not be discarded after each use, as the nozzle can be covered with a disposable sleeve or cover to protect the applicator nozzle from contamination during physical contact with the patient. Said cover is placed over the applicator nozzle before using the device and is disposed after each use. In this situation the nozzle can be used repeatedly simply by using a new cover for each subsequent administration of the enema.

The cover or sleeve of the present invention is adapted to be removably secured to the applicator nozzle such that the nozzle is completely covered, thereby physically isolating the nozzle from contamination by the patient and effectively reducing the risk of cross contamination.

The cover or sleeve may e.g. be made of a transparent disposable plastic material such as polyethylene (PE) or ethylene vinyl acetate (EVA), both of which can be incinerated in an inexpensive manner together with usual hospital waste. As an alternative, a flushable material can be used.

In situations where the nozzle or cover is disposable at least part of the nozzle or cover could preferably be coated with a lubricant in order to aid the insertion of the nozzle into the rectum by reducing frictional force. In embodiments were the same nozzle is used repeatedly said lubricant can be applied before use.

In one embodiment, the applicator nozzle consistency of shell defining an outer body having a distal end and a proximal end. The shell will use less material than a solid nozzle and therefore be less expensive to manufacture. Furthermore, a disposable nozzle consisting of a shell will be degraded or decomposed more rapidly than a solid nozzle.

The exit opening is preferably located at the distal end of the nozzle and a first tube placed in the outer body is adapted for transporting the fluid from the medication delivery container to said exit opening. In this situation it is simply the outer body which has the mainly frustoconical shape and the distal end of said body which is somewhat pliable.

Since patients are different it may be desirable to produce the device according to the invention with several sizes of the nozzle or outer body in order to have an optimal sealing fit with the patient's anal opening.

In order to facilitate an ergonomic handling of the device according to the invention the delivery container may preferably have a mainly elongated spherical shape and be made of resilient deformable material, preferably with a memory. This will not only ensure a comfortable and comfortable fit in the hand but will also reduce the necessary force needed to compress the container as well as reduce any awkward postures.

The delivery container can have any shape as long as the container is able to contain the desired fluid and aid in administering the liquid to the patient's rectum and / or colon.

It may furthermore be desirable for the delivery container to be transparent or translucent, e.g. with a volumetric scale printed on the outside, permitting the contents to be viewed and the administered volume to be evaluated. Furthermore, if a different person than the patient administers the fluid, this will also provide the possibility of visually observing the volume administered and / or verifying if the entire contents have been administered into the rectum and / or colon.

The device according to the present invention can be used to administer an enema by: a) squeezing the delivery container, thereby expelling the air contained in the container through the exit opening in the applicator nozzle through the second one-way valve, b) filling the container with an enema liquid through the first one-way valve, c) placing the applicator nozzle into a patient's rectum, d) squeezing the container thereby expelling the enema liquid contained in the container via the exit opening in the applicator nozzle, and e. ) removing the device from the patient's rectum.

When pressure is relieved from the delivery container, container resumes its original shape and is ready for a further cycle of squeezing and re-inflation, thus steps a) - e) can be repeated one or several times according to the individual need and desire .

The device according to the invention is not only relatively small, having in a preferred embodiment an overall length in assembled state of less than 25 cm, but also has a simple and user-friendly design, making it extremely easy to operate with a single hand ensuring that the device can be used unassistedly in privacy.

The invention will be explained in greater detail below, describing only exemplary embodiments of the enema device with reference to the drawing, in which

FIG. 1 shows a front perspective view of an embodiment of an assembled enema device according to the present invention,

FIG. 2 shows a perspective view of the enema device in fig 1, in which the applicator nozzle and the delivery container are separated,

FIG. 3 is an exploded perspective view of the enema device in FIG. 1, and

FIG. 4 shows the embodiment in fig. 1-3, with a plug closing the first one-way valve.

The invention is described below with the assumption that the device according to the present invention is used for administering an enema liquid. This assumption is not to be construed as limiting, and other liquids e.g. Medications or more thorough irrigation procedures can also be administered or performed using the device.

In FIG. 1 the enema device 1 basically consists of a medication delivery container 2 and an applicator nozzle 3. The applicator nozzle 3 has a proximal end 4 and distal end 5 with an exit opening 6.

In the embodiment, two one-way valves 7, 8 are integrated with the delivery container 2. The first one-way valve 7 is adapted to allow a fluid to enter the delivery container 2 and is located opposite the applicator nozzle 3. The second one-way valve 8 is adapted to allow said fluid to be expelled from the delivery container 2 via the exit opening 6 in the applicator nozzle 3 when force is applied to the delivery container 2. The second one-way valve 8 is therefore placed in fluid communication with the applicator nozzle 3.

The applicator nozzle 3 consist of a shell defining an outer body 9. The function of outer body 9 is to contact and provide a seal with the patient's anal opening. Consequently, the outer body 9 is relatively frustoconical in shape, and dimensioned such that the distal end 5 of the applicator nozzle 3 may be inserted into the rectum of the patient but that the portions of the outer body 9 near the proximal end 4 of the nozzle 3 will provide the desired sealing effect.

The outer body 9 terminates in a circumferential flange 10 for proving a comfortable rest against the patient's skin and / or the users hand.

As best seen in fig. 2 the applicator nozzle 3 has a central tube 11 which extends from the delivery container 2 to the distal end 5 of the applicator nozzle 3 where the tube 11 terminates in the exit opening 6. In a variant, several exit openings may be formed at the distal end 5 of the applicator nozzle, including one or more orifices (not shown) located at offset locations along the surface of the distal end of the outer body 9. This offset configuration for the location of the exit openings may be particularly desirable where the user's rectum or colon is inflamed or otherwise sensitive to contact with a pressurized stream of fluid.

The delivery container 2 is a mainly elongated spherical shape and is preferably made of resilient deformable material, preferably with a memory. This provides both a pleasant and comfortable fit in the hand and will simultaneously reduce the necessary force needed to compress the container. The delivery container 2 is preferably sized such that it fits the size of a normal hand.

In the embodiment shown, the two one-way valves 7.8 are both check valves, i.e. they have a first opening 13 ', 13' 'for fluid to enter and a second opening 14', 14 '' for fluid to leave. Check valves are especially desirable as they are available in a wide range of sizes and costs and since they work automatically reducing maintenance.

In order to prevent the first one-way valve 7 from being inserted directly into the enema liquid, the first one-way valve 7 is connected to an inlet tube 12 placed in the first one-way valves 7's first opening 13 '. However, in a different embodiment the inlet tube 12 could be completely removed or modified to a different shape.

Alternatively, the first one-way valve may be attached e.g. via a tube, to a larger container holding several doses of the enema liquid. Thus, when force is relaxed on the delivery container 2, the container is simply filled with additional enema liquid. This embodiment is especially desirable if several doses of enema liquid are required.

In the embodiment shown in the figures, the applicator nozzle 3 is removably connected to the delivery container 2 by means of a coupling 15. This ensures that the applicator nozzle 3 can be removed after use and then either cleaned, sterilized or simply discarded.

In order to facilitate said coupling the device comprises two coupling parts 16, and 17 as is best seen in the exploded view in fig. Third

The coupling 15 consist of a female coupling part 16 placed in connection with the applicator nozzle 3 and arranged for engaging a male coupling part 17 placed in connection with the exit opening 14 '' of the second one-way valve 8. In the case shown the tube 11 constitutes the female coupling part 16 whereby an especially simple and inexpensive design of the device according to the invention is obtained.

The dimensions of said coupling 15 are sufficient to ensure a liquid tight fit and maintain the feature that the device is compact, i.e. the coupling does not add any substantial additional length to the device. This can e.g. be achieved when the tubes in the coupled state have a length of between 5 mm and 30 mm, preferably between 10 and 25 mm and most preferably around 20 mm.

The male coupling part 17 has a tapered end 18 for facilitating a simple engagement with the female part 16 when the male coupling part 17 is inserted and retracted from the female coupling part 16. The male coupling part 17 further comprises an annular rim 19, which not only provides a sealing means when the coupling 15 is in an assembled state, but also a stop for limiting the extension of the male coupling part 17 into the female coupling part 16 when the male part 17 is inserted into the female part 16.

The male coupling part 17 is attached to the second one-way valve 8 by means of an annular attachment part 20 which partially extends into the exit opening 14 '' of the second one-way valve 8 and is arranged for sealingly engaging with a tapered second end 21 of the male coupling part 17.

The female coupling part 16 and / or the male coupling part 17 is preferably made of a flexible material such that when male coupling part 17 engages with the female coupling part 16 a liquid tight seal is obtained.

The two one-way valves 7, 8 and their respective parts are connected to the delivery container 2 and / or each other by conventional means, such as welding, heat sealing, or gluing. But other ways of connecting the relevant parts are known to the person skilled in the art.

FIG. 4 shows a simple addition to the embodiment shown in fig. 1-3, as a plug 23 for closing the first one-way valve 7 is placed in the inlet tube 12 whereby a fluid tight seal is provided. Said closing of the first one-way valve 7 ensures that the user (ie either the assistant or the patient) can release the pressure on the delivery container 2 by removing or relaxing the hand, and at the same time prevent surrounding air from re- inflating the delivery container 2.

In use the delivery container 2 is loaded with the desired liquid by depressing the flexible delivery container 2 by squeezing the hand and inserting the free end 22 of the inlet tube 12 into the desired liquid. The flexible container is then released creating a vacuum that draws the liquid into the container 2.

Both the first one-way valve 7 and the second one-way valve 8 prevent inadvertent discharge of the liquid, ensuring that the liquid is placed in the device according to the invention in a clean, efficient and fast manner and at the same time preventing any spillage or dripping of the liquid prior to administration.

After the delivery container is loaded with the desired liquid the applicator nozzle is placed in the patient's anal opening and it is ensured that the nozzle provides a tight fit with the opening.

Compression force is then applied to the delivery container 2 by squeezing the hand holding the delivery container. The liquid is allowed to flow through the second one-way valve 8, into tube 11 and out of the exit opening 6 in the applicator nozzle 3, resulting in the liquid being injected into the rectum and colon.

If the plug 23 has been inserted into the inlet tube 12 the patient can remove the hand e.g. if the patient experiences discomfort during administration without worrying that the delivery container is contaminated or re-inflated. When the patient is ready to continue the administration he / she simply starts squeezing the delivery container again. Since no surrounding air has entered the delivery container 2 during the intermission, air will not be administered into the patient's rectum and / or colon effectively preventing unnecessary distension of the colon.

As the second one-way valve effectively prevents backflow of fluid and faeces into the container, administration of the liquid can take as long as the patient requires or requires without compromising the operation of the device according to the invention.

After the liquid is administered into the rectum and / or colon the device is removed from the anal opening. If one or more doses of enema need to be administered to the patient the above procedure is simply repeated as many times as desired.

After using the applicator nozzle 3 can be detached from the delivery container 2 and either discarded or cleaned for later use.

Since the device according to the invenion is relatively small and intended for single hand use, it can be used equally well for both home administrations of enema or for use in medical or hospital facilities where larger irrigations / enema devices are also troublesome and complicated to use.

Modifications and combinations of the above principles and designs are foreseen within the scope of the present invention.

Claims (9)

An enema device (1) comprising a flexible delivery container (2) and an applicator nozzle (3) in fluid communication with the delivery container (2), said device being compact and comprising at least two one-way valves (7, 8), wherein the at least first one-way valve (7) is arranged to allow a fluid to enter the delivery vessel (2) and the at least second one-way valve (8) is arranged to prevent leakage of the fluid prior to use and to allow said fluid to be expelled from the enema device (1) via a outlet opening (6) in the applicator nozzle (3) when the delivery vessel (2) is applied to an opening pressure, characterized in that the opening pressure of the at least one other one-way valve is between 0.005 and 0.02 bar. Device (1) according to claim 1, characterized in that the opening pressure of the at least one other one-way valve is between 0.008 and 0.015 bar, more preferably about 0.01 bar. Device (1) according to claim 1 or 2, characterized in that the at least one other one-way valve is selected from an umbrella valve or a spring-loaded valve. Device (1) according to any one of the preceding claims, characterized in that the delivery container (2) acts as the only fluid reservoir. Device (1) according to any one of the preceding claims, characterized in that a third one-way valve is located in the applicator nozzle (3). Device (1) according to any one of the preceding claims, characterized in that the device (1) further comprises a means (23) for closing the first one-way valve (7). Device (1) according to any one of the preceding claims, characterized in that the fluid is a cleaning liquid e.g. an enema. Device (1) according to any one of the preceding claims, characterized in that the applicator nozzle (3) comprises: an outer body (9) having a distal end (5) and a proximal end (4) and in which the outlet opening (6) is located at said distal end (5), and a first tube (11) arranged to transport the fluid from the delivery vessel (2) to the outlet port (6). Device (1) according to any one of the preceding claims, characterized in that the delivery container (2) is made of an elastic, deformable material, preferably with a memory.