Enema device and a method of refilling said device with an enema

Abstract

The present invention relates to an enema device (1;1′) comprising a delivery container (2) and an applicator nozzle (3), and wherein said delivery container (2) comprises two cavities (6,8;6′,8′), an outer cavity (6;6′) defined by an squeezable external body (7;7′), and an inner cavity (8;8′) defined by an inner flexible bladder (9;9′), and wherein one of said cavities (6;8′) is communicating with an outlet (10) for dispersing the enema though the applicator nozzle (3) and the other cavity (8;6′) is communicating with the surroundings via an air inlet (12). Thereby is provided a simple, inexpensive and essentially maintenance free enema device (1;1′) which can be used for self-administrating of an enema. The device (1;1′) will not only effectively prevent air from being mixed with the enema, but also ensure that the user easily can expel the enema, as the device (1;1′) will be perceived as full of enema at all times.

Claims

1. An enema device comprising a delivery container and an applicator nozzle, wherein said delivery container comprises two cavities, an outer cavity defined by a squeezable external body, and an inner cavity defined by an inner flexible bladder, wherein the outer cavity is communicating with an outlet for dispersing an enema accommodated in the outer cavity though the applicator nozzle and the inner cavity is communicating with the surroundings via an air inlet, and wherein the inner cavity is separated from the outer cavity by the inner flexible bladder, thereby preventing any exchange of fluid between the inner cavity and the outer cavity at any stage of an administration procedure.

2. An enema device according to claim 1, wherein the inner and outer cavity are not in flow communication.

3. An enema device according to claim 1, wherein a first non-return valve is placed in communication with the outlet, and/or a second non-return valve is placed in communication with the air inlet.

4. An enema device according to claim 1, wherein the air inlet is placed in the enema device at a position separate from the applicator nozzle, preferably opposite the applicator nozzle.

5. An enema device according to claim 1, wherein the enema device is arranged for deflating the inner cavity communicating with the air inlet.

6. An enema device according to claim 1, wherein the enema device is arranged for being opened and closed.

7. An enema device according to claim 1, wherein the enema device comprises a closure member arranged for being releasable attached to the delivery container, e.g. by means of a first coupling unit.

8. An enema device according to claim 7, wherein the outlet is placed in the closure member, and that the enema device is arranged such that when the closure member is opened/removed there is only access to the outer cavity communicating with the outlet.

9. An enema device according to claim 7, wherein the enema device is arranged for releasing the air in the inner cavity communicating with the air inlet, to the surroundings when the closure member is opened/removed from the delivery container.

10. An enema device according to claim 7, wherein the closure member is made of a rigid material, and releasable attached to the delivery container via an intermediate member.

11. An enema device according to claim 1, wherein air in the inner cavity communicating with the air inlet is released through a release valve, which is activated when the pressure drops in the outer cavity communicating with the outlet, or when the pressure in the inner cavity communicating with the air inlet exceeds a predetermined limit.

12. An enema device according to claim 11, wherein the air inlet and the release valve is combined in a dual function valve, preferably a diaphragm valve, a lip valve, a duck bill valve, an umbrella valve, a dome valve, and/or a combination valve, e.g. an umbrella/duckbill combination valve.

13. An enema device according to claim 1, wherein the delivery container has a shape arranged to fit into a user's hand, e.g. an elongated spherical shape, an oval shape or a bulb shape.

14. A method of refilling the enema device according to claim 1, with an enema, said method comprises the following consecutive steps: opening the delivery container, deflating the inner cavity communicating with the air inlet, refilling the outer cavity communicating with the outlet with an enema, and closing the delivery container.

15. The method according to claim 14, wherein air in the inner cavity with the air inlet automatically is expelled to the surroundings when the closure member is opened/removed from the delivery container.

16. An enema device according to claim 1, wherein the inner flexible bladder is made of a material arranged for expanding/unfolding and collapsing in response to the amount of air placed in the inner cavity.

Description

DETAILED DESCRIPTION OF THE INVENTION

(1) The invention is described below with the assumption that the device according to the present invention is substantially bulb shaped in order to provide a convenient grip for the user. This assumption is not to be construed as limiting, and other shapes e.g. elongated, circular, oval or the like, is also contemplated within the scope of the invention, it is however preferred that the device has a size which facilitates administration by a single hand.

(2) FIG. 1. is a schematic view of a first embodiment of the enema device 1 according to the invention. Said device consist basically of a enema delivery container 2, having a substantially bulb shape, an applicator nozzle 3 and a closure member 4. The applicator nozzle 3 has an exit opening 5 through which the enema can be expelled when pressure is applied to the delivery container 2.

(3) A sectional view of said first embodiment 1 is shown in FIG. 2 wherein the delivery container 2 comprises two cavities, an outer cavity 6 being defined by an squeezable external body 7, and an inner cavity 8 being defined by an inner flexible bladder 9. The outer cavity 6 is in flow communicating with the exit opening 5 via an outlet 10, Thus enema placed in said outer cavity 6 can easily be expelled through the exit opening when pressure/compression force is placed on the delivery container 2 via the squeezable external body 7.

(4) The outlet 10 is a first non-return valve 11 placed in the closure member 4, and said non-return valve 11 will effectively prevent backflow of liquid and faeces from the colon and/or rectum into the enema device 1 when pressure is released on the squeezable external body 7. Accordingly, any contamination of the delivery container 2 and it's remaining content, which may occur during and/or after administration of the enema to a patient, is prevented.

(5) In a similar manner the inner cavity 8 is communicating with the surroundings via an air inlet 12, in the form of a second non-return valve 13, which in the embodiment shown may be a combination valve, such as a umbrella/duckbill combination valve. Said second non-return valve will allow air to be drawn into the inner cavity 8 when pressure is released on the squeezable external body 7, and prevent air from escaping unintentionally during the administration process, i.e. when pressure is applied to the delivery container.

(6) The flexible inner bladder 9 is securely attached to the delivery container 2 in such a manner that the inner cavity 8 defined by said bladder 9 can communicate with the air inlet, but that flow communication between the two cavities 6,8 is effectively prevented. Thus the flexible inner bladder may be attached to a part of inner surface of the squeezable external body 7 by glue, a welding or a connector member, preferably only in the lower part of the delivery container.

(7) Drawing air into the inner cavity 8 has the advantage that the size of the flexible bladder 9 increases, causing a change in the respective sizes of the cavities, i.e. when the size of the flexible bladder increases as air is drawn into said cavity, the size of the outer cavity 6 containing enema is reduced. In this way the enema device will always be perceived as “full of enema” by the user until the desired dosage or the entire enema content has been expelled from the device.

(8) The closure member 4 is releasable attached to the delivery container 2 via an intermediate member 14, and by means of a first coupling unit 15. In the embodiment shown in the figures the coupling unit is in the form of a snap fit, comprising a first coupling part 16, placed on the closure member, and a second coupling part 17, placed on the intermediate member 14. A person skilled in the art will understand that the shown coupling unit 15 is one of many possibilities of removing and remounting the closure member 4, and that others, e.g. threaded coupling units and hinged lids with snap-fittings, also are contemplated within the scope of the present invention.

(9) Said first and second coupling parts 16,17 are arranged for engaging each other in order to lock the closure member 4 and the intermediate member 14 in a closed position, and for being released when e.g. a twisting action is applied on the outer surface 18 of the closure member 4 in relation to the delivery container 2. When such an action is provided, the first and second coupling parts 16,17 will disengage each other, facilitating removal of the closing member 4 from the delivery container 2. The closing member 4 can then easily be remounted by simply clicking the closing member 4 back in placed, upon which the first and second coupling parts 16,17 will engage and close the delivery container 2.

(10) In order to prevent enema contained in the outer cavity 6 from escaping the cavity 6 unintentionally, it is preferred that a liquid tight seal between the first and second coupling parts 16,17 is provided. Sealing rings (not shown) or the like, may be used, if necessary, in order to ensure that said seal is obtained.

(11) The intermediate member is permanently and securely connected to the squeezable external body 7, e.g. using a glue, welding or similar means, thereby providing a reliable and durable construction, in which the closing member 4 in a simple manner can be removed from and remounted on the delivery container 2.

(12) In the embodiment shown in the figures, the applicator nozzle 3 is removable connected to the delivery container 2 by means of a second coupling unit 19. This ensures that the applicator nozzle 3 can be removed after use and then be either cleaned, sterilised or simply discarded.

(13) The second coupling unit 19 consist of a female coupling part 20 located in the closure member 4 and arranged for engaging a male coupling part 21 placed on the applicator nozzle 4. In the embodiment shown the male coupling part 21 is a short flexible tube 22, extending via an inner tube 23 in the applicator nozzle 4, to the exit opening 5. The female coupling part 20 is made of a rigid material, such that a liquid tight seal is provided between the two parts 20 and 21 when they are engaging. The male coupling part 21 has a tapered end for facilitating an simple engagement with the female part 20 when the male coupling part 21 is inserted into and retracted from the female coupling part 20.

(14) The applicator nozzle further comprises an annular, substantially fructoconical extension 24, which not only provides a comfortable design for the user and a tight fit with the anal opening during the administration proceedings, but also a stop for limiting the extension of the male coupling part 21 into the female coupling part 20 when the two parts are connected. Thereby is an especially simple and inexpensive design of the enema device according to the invention obtained.

(15) In order to provide a comfortable design without any sharp edges, the outer edge 25 of the fructoconical structure 24, flushes into the outer surface 18 of the closure member 4, which again flushes into the outer surface of the delivery container 2, as shown in the drawings.

(16) FIG. 3 schematically illustrates the administration procedure using the first embodiment 1 of the enema device according to the invention.

(17) In a first embodiment 1 according to the present invention the enema is placed in the outer cavity 6 which is communicating with the outlet 10, and air can be drawn into the inner cavity 8 though the air inlet 12.

(18) In order to initiate the administration procedure, the applicator nozzle 3 is placed in the patients anal opening and it is ensured that the nozzle 3 provides a tight fit with the opening.

(19) Compression force is then applied to the delivery container 2 by squeezing the hand holding the delivery container 2. The enema is allowed to flow through the outlet, into the tube 23 and out of the exit opening 5 in the applicator nozzle 3, resulting in the enema being injected into the rectum and colon.

(20) When the user during the administration procedure releases the compression force on the squeezable external body 7, said body will resumes its original shape, and air will be drawn into the inner flexible bladder 9 via the air inlet 12. FIG. 3a shows the enema device 1 after a small amount of enema has been expelled and a corresponding amount of air has been introduced into the flexible inner bladder 9.

(21) After each squeezing and subsequent release action more and more air will be drawn into the inner cavity 8, gradually increasing the size of the flexible bladder 9 and simultaneously reducing the size of the outer enema container cavity 6, as shown in FIGS. 3a, 3b and 3c. Thus, the air in the inner cavity 8 will function as a displacement fluid, forcing the enema in the outer cavity 6 towards the outlet 10, and the enema device 1 will always be perceived as “full” by the user, until the desired dosage of enema has been administered, or the entire enema content, as shown in FIG. 3d has been expelled from the device 1.

(22) As the outer cavity with the enema gradually is reduced, the user can easier expel the enema from the device according to the present invention, compared to the known enema devices.

(23) Furthermore, since the inner 8 and outer cavity 6 cannot communicate with each other, air in the inner cavity 8 is effectively prevented from being mixed with the enema in the outer cavity 6. Accordingly, air cannot be administered into the patients colon and unnecessary discomfort caused by distending of the colon by air, is effectively prevented.

(24) After the liquid is administrated into the rectum and/or colon the enema device 1 is removed from the anal opening, and the applicator nozzle 3 can be detached from the delivery container 2 and either be discarded or cleaned for later use.

(25) FIG. 4 shows a second embodiment 1′ according to the present invention, this embodiment corresponds to the embodiments in FIGS. 1-3, and for like parts the same reference numbers are used.

(26) The second embodiment 1′ differ from the first embodiment in that the cavities for accommodating the enema and air is reversed.

(27) In the second embodiment the delivery container 2 also comprises two cavities, an outer cavity 6′ and an inner cavity 8′. Said outer cavity 6′ is being defined by an squeezable external body 7′ arranged in communication with the air inlet, and said inner cavity 8′ is defined by an inner flexible bladder 9′ being in flow communicating with the exit opening 5 via an outlet 10.

(28) Enema is accommodated in the inner flexible bladder 9′ and will, when pressure/compression force is placed on the delivery container 2 via the squeezable external body 7′ be expelled through the exit opening 5, in a manner similar to the first embodiment 1, as shown in FIGS. 5a-5d.

(29) In short, FIG. 5a shows the second embodiment 1′ of the enema device according to the invention in an initial position, i.e. where the device 1′ is fully loaded with the enema and ready to be used. Compression force is then applied to the delivery container 2 whereby enema flows through the outlet 10, and out of the exit opening 5 in the applicator nozzle 3.

(30) When the compression force on the squeezable external body 7′ is released, said body will resumes its original shape, and air will be drawn into the outer cavity 6′ via the air inlet 12.

(31) FIG. 5b shows the enema device 1′ after a small amount of enema has been expelled and a corresponding amount of air has been introduced into the outer cavity 6′. After each squeezing and subsequent release action more and more air will be drawn into the outer cavity 6′, gradually reducing the size of the flexible bladder 9′, as shown in FIG. 5b, 5c, 5d.

(32) Thus, just as for the first embodiment 1, the air will function as a displacement fluid, forcing the enema in the flexible bladder 9′ towards the outlet 10, thereby ensuring that the enema device 1′ will be considered full whereby the user easily can expel the enema.

(33) As for the first embodiment 1, the flexible inner bladder 9′ of the second embodiment 1′ is also securely attached to the delivery container 2 such that the inner cavity 8′ communicate with the outlet 10, but that flow communication between the two cavities 6′,8′ is effectively prevented, also when the closure member 4, is detached from the delivery container 2. As shown e.g. in FIG. 4, the flexible inner bladder 9′ is securely attached to an upper part of the inner surface of the squeezable external body 7.

(34) After use, the enema device can be restored to it's initial position by deflating the air cavity 8, 6′ and refilling the enema cavity 6, 8′ with enema.

(35) This is obtained in the embodiments shown 1, and 1′ by removing the closure member 4 providing an opening into the cavity in communication with the outlet i.e. the enema cavity whereby an easy manual refilling of enema into said cavity is possible. Simultaneously the pressure inside the enema cavity 6, 8′ will drop whereby the combination valve 13 will release air from the air cavity 8, 6′ deflating the air cavity.

(36) After the air cavity 8, 6′ has been emptied, the user can easily refill the enema cavity 6,8′ with enema, and remount the closure member on the delivery container, whereby the enema device according to the invention is ready for the next enema administration.

(37) In the embodiments shown 1, 1′, the closure member 4 is removed by applying a twisting action on the outer surface 18 of the closure member 4 whereby the first and second coupling parts 16,17 are disengaged and the closure member 4 can be removed. The closing member 4 can then easily be remounted by simply clicking the closing member 4 back in placed, upon which the first and second coupling parts 16,17 will engage and close the delivery container 2.

(38) It should be noted that the closure member may be releasable attached to the delivery container by other suitable means, and said opening/removal and remounting procedure may be adjusted accordingly.

(39) Since the device according to the invention are 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.

(40) A person skilled in the art will understand that the enema device accordingly to the invention can be combined with electronical means arranged to automatically expel the enema from said device, e.g. electronic pumping means.

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