WO2010122537A1 - An enema device and method of using the device - Google Patents

An enema device and method of using the device Download PDF

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Publication number
WO2010122537A1
WO2010122537A1 PCT/IB2010/051818 IB2010051818W WO2010122537A1 WO 2010122537 A1 WO2010122537 A1 WO 2010122537A1 IB 2010051818 W IB2010051818 W IB 2010051818W WO 2010122537 A1 WO2010122537 A1 WO 2010122537A1
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WO
WIPO (PCT)
Prior art keywords
valves
delivery container
enema
applicator nozzle
way valve
Prior art date
Application number
PCT/IB2010/051818
Other languages
French (fr)
Inventor
Henrik Bork Bjerregaard
Original Assignee
Mbh-International A/S
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mbh-International A/S filed Critical Mbh-International A/S
Publication of WO2010122537A1 publication Critical patent/WO2010122537A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/02Enemata; Irrigators
    • A61M3/0233Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs
    • A61M3/0254Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped
    • A61M3/0262Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped manually, e.g. by squeezing a bulb
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/10Trunk
    • A61M2210/1042Alimentary tract
    • A61M2210/1067Anus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/02Enemata; Irrigators
    • A61M3/0204Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity
    • A61M3/0208Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity before use
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/02Enemata; Irrigators
    • A61M3/0204Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity
    • A61M3/022Volume; Flow rate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/02Enemata; Irrigators
    • A61M3/0279Cannula; Nozzles; Tips; their connection means

Definitions

  • the present invention relates to an enema device comprising a flexible delivery container and an applicator nozzle.
  • Administrating 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.
  • 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.
  • 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 constructions 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, e.g. for patients unable to deliver the required squeeze force.
  • 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.
  • the patient is assisted by another individual; however, assistance may not always be available, if, for instance, the patient lives alone.
  • an enema device that can be effectively self-administered.
  • a handheld enema device that safely and effectively can administer a fluid, e.g. an enema, to a patient without causing discomfort .
  • an enema device of the kind mentioned in the opening paragraph that is inexpensive to manufacture and is simple and reliable to use.
  • an enema device of the kind mentioned in the opening paragraph that are relatively small and easy to operate, especially by one hand.
  • the device is compact and comprises at least two one-way valves wherein the at least first one-way valve is adapted for allowing a fluid to enter the delivery container, and the at least second one-way valve is adapted for allowing said fluid to be expelled from the device via an exit opening in the applicator nozzle when force is applied to the delivery container .
  • a simple, inexpensive and essentially maintenance free device which can be used for administrating a liquid, e.g. an enema, which cannot only can be used several times but also ensures that uncontrolled flow of liquid into or out of the device is prevented.
  • 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.
  • the term "compact” means that the device according to the invention has a structure where its parts or units are closely packed or joined in order to ensure that the device take 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 prevents 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.
  • 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.
  • valve minimizes or prevents fluid flow from the container through the exit opening until a critical compression force is applied to the delivery container. Once the critical compression force is applied, the fluid can flow through the second one-way valve and out of the device.
  • the critical compression force is greater than the forces typically encountered during normal handling of the fluid prior to administration.
  • the user can release the compression of the delivery container. This will result in that the container will be 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 latter 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 removable connectable to the delivery container by means of a coupling.
  • the applicator nozzle e.g. be a disposable nozzle or the nozzle can be individually cleaned and/or sterilised, 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 a patient.
  • the applicator nozzle is directly coupled to the delivery container e.g. by means of conventional coupling means.
  • the coupling means be adapted for removable connecting the applicator nozzle to the delivery container.
  • Said coupling means can e.g. comprise a first coupling part attach to the applicator nozzle and a second coupling part attached to the delivery container for providing a fluid communication between the two parts.
  • the first coupling part is a first tube and the second coupling part is a second tube.
  • Said second tube is preferably adapted for providing a liquid tight fit together with the first tube in order to provide the coupling, e.g.
  • first and second tube are made of a flexible material, such that e.g. the first tube can be placed in the second tube or vica versa.
  • said 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, preferrably between 10 and 25 mm and most preferrably around 20 mm.
  • 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 pleasant and comforting fit in the hand but will also reduce the necessary force needed to compress the container as the frictional forces in the device is 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 connects 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.
  • the delivery container functions as the only fluid reservoir.
  • the first one-way valve can be attached to a larger container holding several doses of the enema liquid e.g. via a tube.
  • 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 both are integrated in 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 application (in some situations for several users), whereas the applicator nozzle can be e.g. disposable.
  • 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 adminstration of the enema.
  • 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 remove the hand completely from the delivery container, as the closing of the first one-way valve will prevent surrounding air from re- inflating the delivery container.
  • the second one-way valve efficiently prevents backflow of fluid into the container, the administration of the liquid can take as long as the patient need or require without compromising the function of the device according to the invention.
  • the first one-vay waive can preferably be closed immediately after the cleaning liquid has been drawn into the delivery container .
  • the means for temporarily closing the first one-way valve is preferable a simple and inexpensive plug that will provide a sealingly fit with the valve's inlet.
  • other ways of temporarily closing the first one-way valve are well known for the person skilled in the art.
  • the one-way valves is preferably chosen 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 provide the desired properties to the device according to the invention, i.e. ensuring that flow of fluid uni-directional .
  • fluid means a substance as a liquid or a gas, which tend to flow or conform to the outline of its container.
  • the term fluid comprises the air that is 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.
  • 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 on any shape so long as the nozzle is able to perform the function of administrating the liquid to the patient's rectum and/or colon.
  • the nozzle could be relatively cylindrical, conical, prismatic, prolate spheroidal or pyramidal or consist of a simple tube.
  • the nozzle in whatever form it takes, could have smooth sides, ridges or undulations .
  • 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 automatically will 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.
  • the nozzle can furthermore be 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 in the rectum by reducing frictional force.
  • the applicator nozzle can preferably be disposable 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.
  • the applicator nozzle need not be discarded after every use, as the nozzle can be covered with a disposable sleeve or cover for protecting the applicator nozzle from contamination during physical contact with the patient. Said cover is placed over the applicator nozzle before use of the device and is disposed after each use. In this situation the nozzle can conviniently 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 removable 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.
  • a flushable material be used.
  • nozzle or cover 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 in the rectum by reducing frictional force. In embodiments were the same nozzle is used repeatedly said lubricant can be applied before use.
  • the applicator nozzle consist 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.
  • 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.
  • a first tube placed in the outer body is adapted for transporting the fluid from the medication delivery container to said exit opening.
  • it is simply the outer body which has the mainly frustoconical shape and the distal end of said body which is somewhat pliable.
  • the device according to the invention Since patient's 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.
  • the delivery container can preferably have a mainly elongated spherical shape and be made of a resilient deformable material, preferably with a memory. This will not only ensure a pleasant and comforting fit in the hand but will also reduce the necessary force needed to compress the container as well as reducing any awkward postures.
  • the delivery container can have any shape so long as the container is able to contain the desired fluid and aid in administrating the liquid to the patient's rectum and/or colon.
  • the delivery container 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 administrates the fluid, this will also provide the possibility of visually observing the volume administered and/or verifying if the entire content have been administered into the rectum and/or colon.
  • the invention also relates to a method of administrating an enema using the device according to the present invention.
  • the method comprising the following steps: a) squeezing the delivery container, thereby expelling the air contained in the container via 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.
  • step 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 total 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 unassistedly used in privacy.
  • 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 where the applicator nozzle and the delivery container are separated,
  • Fig. 3 is an exploded perspective view of the enema device in fig 1
  • 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 administrating 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.
  • the enema device 1 consist basically 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.
  • two one-way valves 7, 8 are integrated with the delivery container 2.
  • the first one-way valve 7 is adapted for allowing a fluid to enter the delivery container 2 and is located opposite the applicator nozzle 3.
  • the second one-way valve 8 is adapted for allowing 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 so that the distal end 5 of the applicator nozzle 3 may be placed into the rectum of the patient but that the portions of the outer body 9 nearer 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 patients skin and/or the users hand
  • 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.
  • 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 by a pressurized stream of fluid.
  • the delivery container 2 is a mainly elongated spherical shape and is preferably made of a resilient deformable material, preferably with a memory. This provides both a pleasant and comforting fit in the hand and will simultaneously reduce the necessary force needed to compress the container.
  • the delivery container 2 is preferably dimensioned such that it fit the size of a normal hand.
  • 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.
  • the first one-way valve 7 are connected to an inlet tube 12 placed in the first one-way valves 7's first opening 13'.
  • the inlet tube 12 could be completely removed or modified to a different shape.
  • the first one-way valve be attached e.g. via a tube, to a larger container holding several doses of the enema liquid.
  • the container is simply filled with additional enema liquid.
  • This embodiment is especially desirable if several doses of enema liquid are required.
  • the applicator nozzle 3 is removable 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 be either cleaned, sterilised or simply discarded.
  • the device comprises two coupling parts 16, and 17 as is best seen in the exploded view in fig. 3.
  • 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.
  • the tube 11 constitute 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 is sufficient to ensure a liquid tight fit and maintaining 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, preferrably between 10 and 25 mm and most preferrably around 20 mm.
  • the male coupling part 17 has a tapered end 18 for facilitating an simple engagement with the female part 16 when the male coupling part 17 is inserted into 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 are 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 partly extend 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 engage 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 connection the relevant parts are known for the person skilled in the art.
  • Fig. 4 shows an simple addition to the embodiment shown in fig. 1-3, as a plug 23 for closing the first one-way valve 7 are 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 (i.e. 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.
  • 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 in 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 prevents 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 .
  • the applicator nozzle is placed in the patients 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.
  • the patient can remove the hand e.g. if the patient experience discomfort during the administration without worrying that the delivery container is contaminated or re-inflated.
  • the patient is ready to continue the administration he/she simply starts to squeeze the delivery container again. Since no surrounding air has entered the delivery container 2 during the intermission, air will not be administered into the patients rectum and/or colon effectively preventing unnecessary distending of the colon.
  • the administration of the liquid can take as long as the patient needs or requires without compromising the function of the device according to the invention.
  • the device After the liquid is administrated into the rectum and/or colon the device is removed from the anal opening. If one or more doses of enema need to be administrated to the patient the above procedure is simply repeated as many time as desired.
  • the applicator nozzle 3 can be detached from the delivery container 2 and either be discarded or cleaned for later use.
  • the device according to the invenion are a relatively small and intended for use with a single hand, it can used equally well for both home-administrations of enema or for the use in medical or hospital facilities where larger irrigations/ enema devices are too troublesome and complicated to use.

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Abstract

An enema device and method of using the device A compact enema device (1) comprising a flexible delivery container (2) and an applicator nozzle (3) in fluid communication with the delivery container (2), wherein the device (1) comprises at least two one-way valves (7,8) wherein the at least first one-way valve (7) is adapted for allowing a 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 (1) via an exit opening (6) in the applicator nozzle (3) when force is applied to the delivery container (2). Thereby is provided a simple, inexpensive and essentially maintenance free device (1) which can be used for administrating a cleaning liquid, e.g. an enema, which cannot 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 and method of using the device
The present invention relates to an enema device comprising a flexible delivery container and an applicator nozzle.
Administrating 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.
Furthermore, 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 constructions 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, e.g. 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 safely and effectively can administer a fluid, e.g. an enema, to a patient without causing discomfort .
It is a second aspect of the present inveniton 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 forth 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 is provided an enema device of the kind mentioned in the opening paragraph that is inexpensive to manufacture and is simple and reliable to use.
In a sixth aspect according to the present invention is provided an enema device of the kind mentioned in the opening paragraph that are relatively small and easy to operate, especially by one hand.
The novel and unique whereby this is achieved is the fact that the device is compact and comprises at least two one-way valves wherein the at least first one-way valve is adapted for allowing a fluid to enter the delivery container, and the at least second one-way valve is adapted for allowing said fluid to be expelled from the device via an exit opening in the applicator nozzle when force is applied to the delivery container .
Thereby is provided a simple, inexpensive and essentially maintenance free device which can be used for administrating a liquid, e.g. an enema, which cannot only can be used several times but also ensures that uncontrolled flow of liquid into or out of the device is prevented. As 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 closely packed or joined in order to ensure that the device take 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 prevents 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 efficiently is 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.
It is preferred that the valve minimizes or prevents fluid flow from the container through the exit opening until a critical compression force is applied to the delivery container. Once the critical compression force is applied, the fluid can flow through the second one-way valve and out of the device.
Preferably the critical compression force is greater than the forces typically encountered during normal handling of the fluid prior to administration.
After the liquid is administered the user can release the compression of the delivery container. This will result in that the container will be 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 latter 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 removable connectable to the delivery container by means of a coupling. Thereby can the applicator nozzle e.g. be a disposable nozzle or the nozzle can be individually cleaned and/or sterilised, 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 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 can the coupling means be adapted for removable connecting the applicator nozzle to the delivery container. Said coupling means can e.g. comprise a first coupling part attach to the applicator nozzle and a second coupling part attached to the delivery container for providing a 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 for providing 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 tube is made of a flexible material, such that e.g. the first tube can be placed in the second tube or vica versa. In order to ensure that the device is compact said 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, preferrably between 10 and 25 mm and most preferrably 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 pleasant and comforting fit in the hand but will also reduce the necessary force needed to compress the container as the frictional forces in the device is 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 connects 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 according to the invention compact and thereby handheld it is preferably that the delivery container functions as the only fluid reservoir. However, aalternatively the first one-way valve can 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 both are integrated in 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 application (in some situations for several users), whereas the applicator nozzle can be e.g. disposable.
In order to provide an 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 adminstration 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 remove the hand completely from the delivery container, as the closing of the first one-way valve will prevent surrounding air from re- inflating the delivery container. As the second one-way valve efficiently prevents backflow of fluid into the container, the administration of the liquid can take as long as the patient need or require without compromising the function of the device according to the invention.
The first one-vay waive can preferably be closed immediately after the cleaning liquid has been drawn into the delivery container .
The means for temporarily closing the first one-way valve is preferable a simple and inexpensive plug that will provide a sealingly fit with the valve's inlet. However, other ways of temporarily closing the first one-way valve are well known for the person skilled in the art.
The one-way valves is preferably chosen 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 provide the desired properties to the device according to the invention, i.e. ensuring that flow of fluid uni-directional .
In the present application the term "fluid" means a substance as a liquid or a gas, which tend to flow or conform to the outline of its container.
In respect of the present invention the term fluid comprises the air that is 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 on any shape so long as the nozzle is able to perform the function of administrating 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 automatically will 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 expire during insertion of the nozzle. The nozzle can furthermore be 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 in the rectum by reducing frictional force.
The applicator nozzle can preferably be disposable 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 every use, as the nozzle can be covered with a disposable sleeve or cover for protecting the applicator nozzle from contamination during physical contact with the patient. Said cover is placed over the applicator nozzle before use of the device and is disposed after each use. In this situation the nozzle can conviniently 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 removable 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 can a flushable material 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 in 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 consist 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 patient's 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 can preferably have a mainly elongated spherical shape and be made of a resilient deformable material, preferably with a memory. This will not only ensure a pleasant and comforting fit in the hand but will also reduce the necessary force needed to compress the container as well as reducing any awkward postures.
The delivery container can have any shape so long as the container is able to contain the desired fluid and aid in administrating 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 administrates the fluid, this will also provide the possibility of visually observing the volume administered and/or verifying if the entire content have been administered into the rectum and/or colon.
The invention also relates to a method of administrating an enema using the device according to the present invention. The method comprising the following steps: a) squeezing the delivery container, thereby expelling the air contained in the container via 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 relived from the delivery container, said container resumes its original shape and is ready for a further cycle of squeezing and re-inflation, thus step 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 total 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 unassistedly used 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 where 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 administrating 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 consist basically 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 shown two one-way valves 7, 8 are integrated with the delivery container 2. The first one-way valve 7 is adapted for allowing a fluid to enter the delivery container 2 and is located opposite the applicator nozzle 3. The second one-way valve 8 is adapted for allowing 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 so that the distal end 5 of the applicator nozzle 3 may be placed into the rectum of the patient but that the portions of the outer body 9 nearer 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 patients 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 by a pressurized stream of fluid.
The delivery container 2 is a mainly elongated spherical shape and is preferably made of a resilient deformable material, preferably with a memory. This provides both a pleasant and comforting fit in the hand and will simultaneously reduce the necessary force needed to compress the container. The delivery container 2 is preferably dimensioned such that it fit 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 to be inserted directly into the enema liquid, the first one-way valve 7 are 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 can the first one-way valve 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 removable 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 be either cleaned, sterilised 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. 3.
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 constitute 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 is sufficient to ensure a liquid tight fit and maintaining 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, preferrably between 10 and 25 mm and most preferrably around 20 mm.
The male coupling part 17 has a tapered end 18 for facilitating an simple engagement with the female part 16 when the male coupling part 17 is inserted into 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 are 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 partly extend 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 engage 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 connection the relevant parts are known for the person skilled in the art.
Fig. 4 shows an simple addition to the embodiment shown in fig. 1-3, as a plug 23 for closing the first one-way valve 7 are 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 (i.e. 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 in 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 prevents 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 patients 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 experience discomfort during the 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 to squeeze the delivery container again. Since no surrounding air has entered the delivery container 2 during the intermission, air will not be administered into the patients rectum and/or colon effectively preventing unnecessary distending of the colon.
As the second one-way valve efficiently prevents backflow of fluid and faeces into the container, the administration of the liquid can take as long as the patient needs or requires without compromising the function of the device according to the invention.
After the liquid is administrated into the rectum and/or colon the device is removed from the anal opening. If one or more doses of enema need to be administrated to the patient the above procedure is simply repeated as many time as desired.
After the use the applicator nozzle 3 can be detached from the delivery container 2 and either be discarded or cleaned for later use.
Since the device according to the invenion are a relatively small and intended for use with a single hand, it can used equally well for both home-administrations of enema or for the use in medical or hospital facilities where larger irrigations/ enema devices are too troublesome and complicated to use.
Modifications and combinations of the above principles and designs are foreseen within the scope of the present invention.

Claims

Claims
1. An enema device (1) comprising a flexible delivery container (2) and an applicator nozzle (3) in fluid communication with the delivery container (2) characterized in that the device is compact and comprises at least two one-way valves (7,8) wherein the at least first one-way valve (7) is adapted for allowing a fluid to enter the medication 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 (1) via an exit opening (6) in the applicator nozzle (3) when force is applied to the delivery container (2 ) .
2. A device (1) according to claim 1, characterized in that the enema device comprising a coupling means (15) for removable connecting the applicator nozzle (3) to the delivery container (2) .
3. A device (1) according to claim 1 or 2 characterized in that the applicator nozzle (3) is directly coupled to the delivery container (2) .
4. A device (1) according to any of the preceding claims characterized in that the applicator nozzle (3) is coupled to the delivery container (2) without using fluid hoses and/or tubes.
5. A device (1) according to of the preceding claims characterized in that the delivery container (2) functions as the only fluid reservoir.
6. A device (1) according to of the preceding claims, characterized in that a third one-way valve are located in the applicator nozzle (3).
7. A device (1) according to of the preceding claims, characterized in that the device (1) further comprises a means (23) for closing the first one-way valve (7) .
8. A device (1) according to any of the preceding claims, characterized in that the at least two one-way valves (7,8) is chosen 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.
9. A device (1) according to any of the preceding claims, characterized in that the fluid is a cleaning liquid e.g. an enema.
10. A device (1) according to any 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 wherein the exit opening (6) is located at said distal end (5), and a first tube (11) adapted for transporting the fluid from the delivery container (2) to the exit opening (6 ) .
11. A device (1) according to any of the preceding claims, characterized in that the delivery container (2) is made of a resilient deformable material, preferably with a memory.
12. A method of administrating an rectal injection using the device (1) according to any of the claims 1 - 11, the method comprising the steps of: a) squeezing the delivery container (2), thereby expelling the air contained in the delivery container (1) via the exit opening (6) in the applicator nozzle (3) through the second one-way valve ( 8 ) , b) filling the delivery container (1) with an enema liquid through the first one-way valve (7), c) placing the applicator nozzle (3) into a patient's rectum, d) squeezeing the delivery container (2) thereby expelling the enema liquid contained in the delivery container (2) via the exit opening (6) in the applicator nozzle (3) through the second one-way valve ( 8 ) , and e) removing the device (1) from the patient's rectum.
13. A Method according to claim 12, characterized in, that step b) - e) is repeated at least once, optionally including step a) .
PCT/IB2010/051818 2009-04-24 2010-04-26 An enema device and method of using the device WO2010122537A1 (en)

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ITPD20120069A1 (en) * 2012-03-08 2013-09-09 A U S Srl EQUIPMENT FOR THE INTRODUCTION OF LIQUIDS IN THE RIGHT
WO2015000488A1 (en) * 2013-07-02 2015-01-08 Mbh International A/S An enema device and method of using the device
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CN110769871B (en) * 2017-06-30 2021-07-23 医研比赫国际股份公司 Enema device and method of refilling said device with an enema
CN110769871A (en) * 2017-06-30 2020-02-07 医研比赫国际股份公司 Enema device and method of refilling said device with an enema
WO2019001674A1 (en) 2017-06-30 2019-01-03 Mbh-International A/S An enema device and a method of refilling said device with an enema
US20210128843A1 (en) * 2017-07-21 2021-05-06 Min Bo SHIM Tip for intra-tympanic injection
US11730894B2 (en) * 2017-07-21 2023-08-22 Min Bo SHIM Tip for intra-tympanic injection
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EP3860678B1 (en) 2018-10-03 2022-12-21 MBH-International A/S An enema device, and a delivery container for use in said enema device
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EP4321187A2 (en) 2018-10-03 2024-02-14 Qufora A/S An enema device, and a delivery container for use in said enema device
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