Enema device and delivery container for the enema device

Abstract

Enema device and delivery container for the enema device. The invention relates to an enema device comprising a delivery container arranged to contain an enema agent and an applicator nozzle for distributing the enema agent, and wherein the delivery container is arranged as a hand-held pump, and wherein the cross-section of the delivery container has an elliptical shape. Thereby a simple, cheap and essentially maintenance-free enema device is provided which can be used for self-administration of an enema agent.

Description

[0001] This application is a divisional application of Chinese national phase patent application No. 201980064749.3, entitled "Enema device and delivery container for said enema device", filed on October 2, 2019. Technical Field

[0002] The present invention relates to an enema apparatus comprising a flexible delivery container and an applicator nozzle. Background Technology

[0003] Enema administration is a common medical procedure in which fluid is injected into a patient's rectum and lower intestine to induce bowel movement. The need for this procedure often arises in patients with certain physical ailments in which autonomous bowel control is impaired, or when bowel cleansing is required before procedures such as colonoscopy or surgery.

[0004] Currently, there are medical devices in this field for administering enemas to patients requiring such procedures. At least one type of device includes an enema squeeze bottle filled with a fluid intended to induce bowel movement, the bottle being covered by a short applicator nozzle that is inserted into the patient's rectum. The applicator nozzle of this type of conventional enema applicator often causes discomfort and irritation upon insertion.

[0005] Furthermore, the force required to squeeze the liquid from the enema dispenser affects the ease with which the user can administer the liquid. Self-administration of routine enemas can be particularly difficult for patients with limited dexterity, for example, due to the squeezing force required to deliver a full dose of enema liquid.

[0006] While reducing the amount of pressure required to apply the enema is advantageous, such a modification would negatively impact other desired characteristics of the device. In particular, it is desirable to prevent any backflow of the enema liquid into the delivery container after delivery, and to prevent leakage of the enema liquid from the dispenser before use. Simply reducing the resistance to the flow of liquid through the device would compromise these characteristics.

[0007] In addition, enemas are usually administered to patients at home, where no medical assistance is required and a doctor or other healthcare assistant is needed.

[0008] However, patients often find it difficult to administer enemas themselves because the applicator nozzle must not only be inserted into the sensitive area, but the application position is also inconvenient for the user, making it difficult to apply the liquid while maintaining a stable position of the enema in the desired area. Patients are usually assisted by another person; however, assistance may not always be available, for example, if the patient lives alone. Therefore, there is a need for an enema device that can be effectively self-administered.

[0009] Such enema devices are known, for example, from WO2010122537, which discloses an apparatus for administering an enema agent. The enema apparatus ensures that uncontrolled inflow or outflow of liquid is prevented by using two one-way valves, one for delivering liquid and the other for refilling the apparatus.

[0010] The enema is administered by squeezing the delivery container, and after the compression is released, the container can be re-inflated by drawing in ambient air via a first one-way valve, or the container can be reloaded by drawing the enema into the container via the one-way valve.

[0011] The latter ensures the device can be used for multiple administrations as needed; however, research and user feedback indicate that most users cannot easily grasp the delivery container or maintain constant pressure on it. Therefore, users often administer a small amount of enema first, then release the pressure on the container, and administer another small amount shortly after. However, when the pressure on the delivery container is released, air can be inadvertently inhaled and mixed with the enema. When the next dose of enema is administered, this air is delivered into the colon. This can cause uncomfortable colonic distension, leading to pain and cramps. Therefore, to avoid inhaling air, users must maintain constant pressure on the delivery container throughout the administration process, which can be difficult for users / patients with weak fingers (e.g., due to arthritis).

[0012] Furthermore, as air is drawn into the container, expelling the enema becomes increasingly difficult. Due to the density difference between air and the enema fluid, the device must be correctly oriented to prevent or reduce air application. However, ensuring this orientation is nearly impossible because enemas are typically administered on a toilet or in bed, where the user / patient's posture obstructs this orientation.

[0013] Because air delivery can cause discomfort, the enema container often needs to be refilled multiple times to deliver an effective dose while preventing air delivery. However, refilling the container requires easy access to the enema. For example, if the enema is made of tap water, a user sitting on the toilet could use the sink as a reservoir; however, toilets and sinks are often too far apart to do so. Therefore, the user must have access to the enema reservoir nearby to facilitate easy refilling, making refilling both difficult and cumbersome. Summary of the Invention

[0014] Therefore, there is a need for a new enema device that is simple and easy to use, and that overcomes the limitations and shortcomings of existing technologies.

[0015] Therefore, a first aspect of the present invention is to provide a handheld enema device that can safely and effectively administer an enema to a patient without causing discomfort.

[0016] A second aspect of the invention is to provide an enema apparatus in which liquid is more easily applied and in which air is effectively prevented from mixing with the enema agent.

[0017] A third aspect of the invention is to provide an enema apparatus in which an effective dose of enema agent can be administered without the need to reload the delivery container.

[0018] A fourth aspect of the invention is to provide an enema apparatus that prevents liquid from flowing back into the container after use and / or prevents liquid from leaking before use.

[0019] According to a fifth aspect of the invention, an enema device is provided that is low in manufacturing cost and simple and reliable to use.

[0020] According to a sixth aspect of the invention, an enema apparatus is provided that is relatively small and easy to operate, especially with one hand.

[0021] According to a seventh aspect of the invention, an enema apparatus is provided, which is arranged for delivering an enema solution to a patient sitting on a toilet without the need to reload the enema solution.

[0022] The novelty and uniqueness of these and other aspects lies in the fact that the enema device according to the invention includes a flexible delivery container arranged to contain an enema agent and an applicator nozzle for distributing the enema agent, wherein the delivery container is arranged as a handheld pump, wherein the cross-section of the delivery container has an elliptical shape, and wherein the delivery container includes one or more compression zones arranged to provide controlled compression of the delivery container.

[0023] Because the delivery container has a roughly elliptical cross-section when placed in the use position, it is easier for the user to apply pressure to the sides of the delivery container. Compared to delivery containers with a circular cross-section, the user will intuitively place / rest the delivery container according to the invention in a specific orientation in the user's palm, allowing the user to compress the container by applying pressure to the two longer, curved sides of the delivery container using the fingers and palm (e.g., the thenar muscles at the base of the thumb). This will not only ensure a pleasant and comfortable fit in the hand, but will also reduce the necessary force required to compress the container and reduce any awkward postures.

[0024] This provides a simple, inexpensive, and essentially maintenance-free enema device for administering an enema solution, wherein the delivery container itself acts as a pump, i.e., the enema solution is expelled by the user applying pressure to the side of the pump; that is, the delivery container is arranged as a handheld pump. Therefore, the enema device according to the invention can operate without any external pumping device, making the enema device small and compact, i.e., occupying as little space or volume as possible, ensuring not only that the device can be held and easily operated, e.g., with one hand, but also that the enema device can be easily placed in a bag or the like.

[0025] In a preferred embodiment, the delivery container includes a bottom segment with a first elliptical cross-section and a top segment with a second elliptical cross-section, wherein the minor and / or major axes of the first cross-section are greater than the minor and / or major axes of the second cross-section. To provide a user-friendly delivery container, it is preferable that the bottom segment tapers towards the top segment, i.e., providing a smooth transition between the two segments. Therefore, it is preferable that the delivery container is shaped as an elongated sphere, which helps ensure that the user can apply pressure to the sides of the container and also provides a comfortable feel in the hand. Thus, the enema device according to the invention provides easy expulsion of the enema solution without compromising the structural features of the device. In a preferred embodiment, the device may have a substantially flat base, allowing the delivery container to stand upright, for example, during and / or after filling the container with the enema solution, as this will effectively prevent the enema solution from spilling out.

[0026] Preferably, the delivery container will have an elliptical cross-section, regardless of where the cross-section is cut within the delivery container; that is, the elliptical shape continues along the entire height of the delivery container. The ellipse can be of any kind; however, it is preferred that the ellipse be clearly distinguishable from a circle, because the inventors have found that users encounter difficulties when applying pressure to a delivery container with a circular cross-section, for example, the user cannot expel an effective dose of enema solution with such a container. Therefore, the ratio of the minor axis to the major axis of the ellipse is 2 / 3 or less; that is, if the major axis is 3 cm, the minor axis is 2 cm or less; if the major axis is 4.5 cm, the minor axis is no more than 3 cm, and so on.

[0027] While it is preferred that the first and second cross-sections have the same elliptical shape (even if they have different sizes), the ellipses can also have different shapes. However, it is preferred that the size and dimensions of the elliptical shapes of the corresponding cross-sections be chosen such that the resulting elongated spherical delivery container is arranged to sit securely in the user's hand, and the user will intuitively hold the delivery container with a cupped hand, thereby allowing the user to apply pressure to the two longer sides of the container using their palm and fingers. Those skilled in the art will understand that the user can apply pressure to the delivery container in any desired manner; however, the elliptical spherical shape of the container ensures that the user holds the container in a cupped hand.

[0028] In a preferred embodiment, the enema device includes a check valve such that when the patient / user releases the compressive force on the delivery container, the first check valve effectively prevents fluids (e.g., air, liquid, and feces) from flowing back into the enema device from the colon and / or rectum. This eliminates any potential contamination of the delivery container and its remaining contents that may occur during and / or after administration of the enema to the patient.

[0029] The check valve can be placed, for example, in the applicator nozzle, such as at or near the outlet of the nozzle. This may be preferred, for example, if the applicator nozzle is to be reused; otherwise, placing the check valve in the enema apparatus according to the invention would be a less expensive solution.

[0030] Such check valves are well known in the art and can be any valve capable of providing the desired characteristics (e.g., preventing air / fluid from being drawn into the enema apparatus according to the invention), such as rotary valves, ball valves, diaphragm valves, butterfly valves, etc.

[0031] The check valve also has the advantage that if the user releases the pressure on the container during the administration procedure, air will be prevented from being drawn into the delivery container. Therefore, air cannot be administered into the patient's colon, effectively preventing unnecessary discomfort caused by colonic dilation due to air.

[0032] Furthermore, when the enema is expelled during the administration procedure, the delivery container collapses, and because a check valve prevents any intake of air into the container, the delivery container remains collapsed even after the user releases pressure. This ensures that the user can easily expel the remaining contents from the delivery container by alternately applying and releasing pressure until the desired dose or the entire enema contents have been expelled from the enema device. Because the delivery container collapses when the enema is expelled, the user can also easily sense when the enema has been expelled, thus providing a simple indication of when the desired dose (e.g., the full dose) of the enema has been administered, i.e., when the delivery container is fully or substantially fully compressed.

[0033] To obtain the aforementioned advantages, it is preferred that the enema apparatus according to the invention does not include any means for drawing air and / or fluid into the delivery container during the administration procedure.

[0034] The delivery container is arranged as a handheld pump and can therefore be made of a shape-memory, elastically deformable material, such as silicone, thermoplastic polymers, polyurethane, polyvinyl chloride, or similar soft polymers. This means that the user can apply pressure to the delivery container, causing it to collapse and force the enema solution out through the applicator nozzle attached to the enema device.

[0035] To provide controlled compression of the delivery container, the container includes one or more compression zones. The compression zones may also be arranged to ensure that when compressive force is applied to the delivery container, the container will collapse / compress, thereby expelling substantially all the contents of the enema device.

[0036] In the context of this invention, the term "compression zone" refers to a region / segment of a delivery container that has a design / construction / configuration different from the rest of the container.

[0037] The compression zone can be provided in a variety of different ways. In this regard, it is preferred that the compression zone constitutes a small portion of the delivery container, preferably less than 50% of the surface area of ​​the delivery container, and more preferably less than 30% of the surface area, thereby providing controlled compression of the container.

[0038] In one embodiment, the compression zone can be provided by adjusting the wall thickness of the delivery container in one or more compression zones such that the wall thickness of the container is greater in areas where high compressive force is desired (e.g., at the bottom of the delivery container) than in areas where lower compressive force is desired, such as the sides of the container. In a preferred embodiment, the bottom section of the delivery container will have greater compressive force and therefore greater wall thickness compared to the two smaller sides of the delivery container. Furthermore, the two longer sides of the container will have less compressive force and therefore less wall thickness than the two smaller sides. In this way, it is ensured that when a user applies pressure to the delivery container, the container will tend to collapse more at the longer sides, etc., thus providing controlled collapse. The compression zone can be one or more surfaces of the delivery container, but in a preferred embodiment it can be one or more finite regions of the container, such as two opposing circular regions on the two longer sides of the delivery container and / or two opposing circular regions on the two smaller sides of the delivery container, and / or a single circular region on the bottom of the delivery container. In different embodiments, one or more of the compression zones may be further arranged to prevent compression / collapse / bending even when a large compressive force is applied to the zone, thereby allowing for further adjustment / control of the compression of the delivery container.

[0039] Instead of altering the wall thickness of the delivery container in certain compression zones, the compression zones can also be provided by reducing the wall thickness of the delivery container through one or more bends arranged at relevant locations within the delivery container. In one embodiment, the bends may have the same depth, i.e., the wall thickness is the same for all bends, and / or have the same cutting angle, such as a V-shape. However, those skilled in the art will understand that the wall thickness and / or cutting angle of the bends can vary to adjust the desired bending force in the compression zones. Furthermore, the extension and / or shape of the bends can vary, and in one embodiment may extend from the bottom to the top of the delivery container, i.e., across the entire height of the delivery container, while in another embodiment they may extend only within a portion of the delivery container, and can be circular, triangular, etc.

[0040] Alternatively, the compression zone can be provided by providing reinforcing ribs on the inside and / or outside of the delivery container. The reinforcing ribs can have any desired shape and location, and therefore can be linear, circular, a segment of a circle, polygonal, etc.

[0041] The one or more compression zones of the delivery container can also be obtained by providing delivery containers made of different kinds of materials, wherein the corresponding materials have different hardness, making the delivery container more prone to deformation in some areas than in others.

[0042] Therefore, the compression zone can be provided in different ways, such as by using one or more of the possibilities discussed above, the compression zone can be arranged symmetrically or asymmetrically on the delivery container, etc. However, those skilled in the art will understand that the compression zone can also be obtained in other ways, the only requirement being to provide controlled compression of the delivery container.

[0043] To ensure that the enema device according to the invention can be used by patients / users with weak fingers, in an advantageous embodiment, the delivery container can be arranged such that it can be fully compressed by a force of less than about 150 Newtons, preferably less than 130 Newtons, and even more preferably less than 110 Newtons. However, to prevent premature collapse of the delivery container, i.e., collapse during manipulation of the enema device before the application procedure begins, it is preferable that a compressive force of at least 30 N must be applied before the delivery container begins to collapse / compress. Further preferably, however, the delivery container is arranged to be compressed when a compressive force of no more than 50 N is applied to the delivery container (e.g., the two long sides) by the palm and fingers. The desired force for compressing the delivery container can be obtained, for example, by using special materials, adjusting the wall thickness of the delivery container, using the compression zone, etc.

[0044] In a preferred embodiment, the delivery container is arranged such that at least 80% by volume, preferably at least 90% by volume, or even more preferably substantially all of the contents of the enema contained in the delivery container are discharged when the delivery container is fully compressed or when the user is unable to further compress the delivery container during the application procedure.

[0045] In a preferred embodiment, the delivery container is arranged to contain at least an effective dose of the enema, preferably slightly more. In the context of this invention, the term "effective dose of enema" refers to the amount of enema required and / or sufficient to stimulate the patient's defecation. Although the effective dose is individual and particularly dependent on the patient's age (e.g., children versus adults), the administration of enemas is well known in the art, and those skilled in the art have no problem determining the effective dose of an enema.

[0046] In one embodiment, the delivery container is arranged to hold at least about 90 ml of enema solution, and preferably at least about 130 ml, which is slightly more than the dose of a typical adult enema. Since the amount required for an enema is individual, in some preferred embodiments the enema device may hold about 150 ml or even up to 250 ml; however, within the scope of this invention, the size of the enema device may be adjusted to hold higher or lower volumes of enema solution.

[0047] Using an enema device configured to contain an effective dose of enema solution ensures that the user can administer the full and effective dose of enema solution without having to reload the device or worry about air mixing with the enema solution. Therefore, the patient / user can release the pressure on the delivery container multiple times as needed, and the enema solution can be administered according to the patient's needs or requests without impairing the function of the enema device according to the invention, thereby providing high patient compliance.

[0048] This provides an enema device that is very suitable for self-administration because it significantly reduces the effort required to expel the enema fluid compared to known enema devices.

[0049] To ensure relatively high patient compliance with enema administration, the enema device according to the invention is arranged to connect to an applicator nozzle, which is preferably configured to alleviate potential discomfort and pain for the patient during insertion of the applicator nozzle. The applicator nozzle is in fluid communication with a delivery container, allowing the enema to be discharged via an outlet in the applicator nozzle. Since the applicator nozzle is inserted into the patient's rectum, it is preferable that the applicator nozzle is releasably connected to the enema device to allow it to be cleaned or removed.

[0050] To facilitate refilling and reuse of the enema device according to the invention, it is preferred that the enema device be able to return to its initial position, i.e., the position where the enema device is ready for a new enema administration procedure. In this regard, it is preferred that the delivery container be arranged to open and close to allow easy refilling of the container with the enema agent. In this regard, it is preferred that the enema device includes a closure member comprising a first closure component and a second closure component, the first closure component being arranged to attach to the delivery container, and the second closure component being arranged to detach from or connect to the first closure component, thereby opening and / or closing the delivery container accordingly.

[0051] Such closure members are known in the art and include threaded closure members, snap-fit ​​closure members, closable caps, etc. However, it is preferred that the closure member is a hinged closable cap, as this provides a simple embodiment in which the components of the closure member are ensured not to misalign. When the closure member is in the closed position, a fluid-impermeable seal is preferably provided between the first and second closure members to prevent leakage of the enema agent.

[0052] In a simplified embodiment, the check valve is incorporated into the closing member, thereby allowing the valve to be reused even if the applicator nozzle is removed.

[0053] Further preferably, a first opening is provided in the delivery container when the second closure is removed / separated from the first closure, and the size of the first opening allows for easy manual refilling of the enema solution into the delivery container. Therefore, preferably, the first opening constitutes at least 50%, preferably at least 60%, and even more preferably at least 80% of the cross-section taken at the top section of the delivery container. Providing a relatively large opening into the delivery container will also allow for effective cleaning and drying of the inside of the delivery container between different enema applications, thereby providing an enema device that is more hygienic than those known to date.

[0054] In a preferred embodiment, the second closure component may include a coupling unit arranged for releasably connecting the applicator nozzle to the enema apparatus and for providing fluid communication between the applicator nozzle and the delivery container. Therefore, the second closure component may include a second opening in fluid communication with the delivery container via the first opening, allowing the enema agent in the delivery container to be discharged via the applicator nozzle.

[0055] In one embodiment, the closing member may be made of a rigid material such as polypropylene or polyvinyl chloride, thereby ensuring not only that the closing member can be opened / closed, but also that the applicator nozzle can be easily and releasably attached to the closing member. The applicator nozzle can be attached to the closing member in any conventional and convenient manner, such as using a snap-fit, however, in a preferred embodiment, the applicator nozzle includes a tube defining an inlet at one end, and wherein the tube can be sealed into a second opening.

[0056] To ensure a fluid-tight seal between the closure member and the delivery container, the closure member is preferably attached to the delivery container via an intermediate member, which preferably matches the elliptical shape of the top section of the delivery container. The intermediate member is also preferably made of a rigid material and can be integrated with the second closure member, and can be attached to the top section of the delivery container via an adhesive or the like.

[0057] The term "enema" includes any liquid that can promote intestinal motility when introduced into the rectum and colon, such as enema liquid. Examples of enema liquids include water; hypertonic saline solutions; solutions or suspensions of laxatives such as bisacodyl or phenolphthalein; and mineral oil. Other liquids that can promote intestinal motility are well known in the art and are also within the scope of this invention. However, preferably, the enema has a low viscosity to ensure that the enema is easily and uniformly distributed in the colon, for example, a viscosity corresponding to or close to that of water. Therefore, gels or liquids with high viscosity (i.e., those that do not flow easily) are not preferred.

[0058] The applicator nozzle can have any shape, as long as it is capable of performing the function of applying an enema to the patient's rectum and / or colon. In a preferred embodiment, the applicator nozzle has a generally truncated conical shape, with its outer diameter gradually decreasing from its proximal end to its distal end, because this shape will automatically ensure a tight fit with the anal opening.

[0059] The applicator nozzle can also be modified in size, shape, and possibly other physical properties (such as flexibility, rigidity, and suppleness) to become a plug suitable for forming a sealing fit with the anal opening. For example, if the nozzle is at least slightly flexible, it will conform to the shape of the patient's rectum and help reduce the physical discomfort and pain that the patient may experience during nozzle insertion.

[0060] The nozzle may also be provided with, for example, a blunt tip to further alleviate the discomfort, and may also be provided with a lubricant or an activated hydrophilic coating to help the nozzle be inserted into the rectum by reducing friction.

[0061] The applicator nozzle can preferably be disposable to reduce environmental contamination, for example, by providing a nozzle that can be flushed down the toilet after use. This will also make the device more convenient and hygienic to use; however, if desired, the nozzle can also be arranged for reuse after cleaning and / or disinfection. In any case, it is preferred that the applicator nozzle is made of a hypoallergenic material that does not react with the patient's tissue.

[0062] The enema device according to the invention has a simple and user-friendly design, making it extremely easy to operate with one hand, thus ensuring that the device can be used privately without assistance. When a new application is to be initiated, the user can easily refill the delivery container with the enema solution, close the closure member, and connect the applicator nozzle to the delivery container, thereby preparing the enema device according to the invention for the next enema application.

[0063] The user can then place the enema device in the cup-shaped hand and apply pressure to the side of the delivery container. Since air, feces, or liquid cannot be drawn into the delivery container, the user can reduce the pressure, for example, by simply keeping the enema device in place and applying pressure again when convenient for the user, until the delivery container is sufficiently (e.g., fully) compressed and the desired dose of enema solution has been delivered to the colon.

[0064] After the application procedure is completed, the user can, for example, remove the applicator nozzle and open the closing mechanism, allowing air to enter the delivery container and restore it to its initial shape. The relatively large first opening in the delivery container further ensures that the container can be cleaned and dried between application procedures.

[0065] In a preferred embodiment, the delivery container has a height of approximately 7 cm, the bottom section has a cross-section with a minor axis of 2.50 cm and a major axis of 3.75 cm, the top section has a cross-section with a minor axis of 2.00 cm and a major axis of 3.00 cm, and the first opening is a circle with a radius of 1.75 cm. Attached Figure Description

[0066] The invention will now be explained in more detail, with reference to the accompanying drawings describing only exemplary embodiments of the enema apparatus, wherein...

[0067] Figure 1 A perspective view of an enema apparatus according to the invention is shown, having a first embodiment of a delivery container.

[0068] Figures 2a-2b The views from the bottom and top are shown respectively. Figure 1 An exploded perspective view of the enema apparatus shown.

[0069] Figures 3a-3b They show the following along Figure 1 The cross-sections of the delivery container taken by lines IIIa-IIIa and IIIb-IIIb in the diagram.

[0070] Figures 4a-4b Exploded perspective views of the closed component, as seen from the top and bottom, are shown respectively.

[0071] Figure 5 A cross-sectional view of a second embodiment of the enema device is shown.

[0072] Figure 6 A second embodiment of the delivery container according to the invention is shown.

[0073] Figure 7 A cross-section of a third embodiment of the delivery container according to the present invention is shown.

[0074] Figure 8a It shows along Figure 7 The cross-section of the delivery container cut by line VIII-VIII in the middle, and

[0075] Figure 8b It shows Figure 8a The enlarged cross section C. Specific Implementation

[0076] Figure 1Figure 1 is a schematic diagram of a first embodiment of the enema device 1 according to the present invention, and Figure 2 is an exploded view thereof. The device basically consists of an enema delivery container 2, an applicator nozzle 3, and a closing member 4. The enema delivery container 2 is arranged as a handheld pump with a generally elliptical cross-section. The applicator nozzle 3 has an outlet opening 5 through which the enema agent can be discharged when pressure is applied to the delivery container 2.

[0077] exist Figure 1 In the embodiment shown in FIG2, the delivery container 2 includes an opening 6, a bottom segment 7 having a first cross-section 8 having a first ellipse 9 shape, and a top segment 10 having a second cross-section 11 having a second ellipse 12 shape. Figure 3a It shows along Figure 1 The first ellipse 9 is intercepted by line IIIa-IIIa in the middle. Figure 3b It shows along Figure 1 The second ellipse 12 is intercepted by line IIIb-IIIb in the middle.

[0078] The major axis Xa and minor axis Ya of the first ellipse 9 are larger than the major axis Xb and minor axis Yb of the second ellipse 12, and the bottom segment 7 gradually tapers towards the top segment 10, thereby providing a smooth transition 13 between the two segments 7 and 10, thereby allowing the delivery container 2 to obtain, for example... Figure 1 The elongated spherical object 14 shown has a base 15 that allows the enema device 1 to rest on a surface (not shown), two long curved sides 16a, 16b and two short curved sides 17a, 17b.

[0079] The base 15 also ensures that the enema device 1 can stand upright when the container 2 is filled with enema agent and during the operation of the device 1 (e.g., when the closing member 4 is closed and the applicator nozzle 3 is connected).

[0080] The delivery container 2 has an elliptical cross-section 9, 12, regardless of where the cross-section is cut within the delivery container 2; that is, the elliptical shape continues along the entire height H of the delivery container 2. The elliptical cross-sections 8, 11 and the elongated spherical shape 14 of the delivery container 2 ensure that the user can more easily apply pressure, for example, to the sides 16a, 16b of the delivery container 2. The user will intuitively place / rest the bottom of the delivery container 2 in the palm of their hand, thereby easily compressing the container 2 by applying pressure to the two long, curved sides 16a, 16b of the delivery container 2 using the fingers and palm (e.g., the thenar muscles at the base of the thumb). Therefore, the use of the elliptical cross-sections 8, 11 provides a pleasant fit in the user's hand and reduces the compressive force required to compress the container 2. Those skilled in the art will understand that, if desired, the user can apply pressure to the delivery container 2 in different ways, such as by placing the palm on one of the two short, curved sides 17a, 17b of the delivery container 2.

[0081] Figure 4a and 4b Exploded perspective views of the closure member 4, viewed from the top and bottom, are shown respectively. The closure member 4 includes a first closure component 18 and a second closure component 21. The first closure component 18 is arranged for attachment to the top 19 of the delivery container 2 via an intermediate member 20. The second closure component 21 is arranged for separation from or attachment to the first closure component 18 via a hinge member 22 and a snap-fit ​​connector 23. In this way, the closure member 4 functions as a hinged, closable cap, with the advantage that the second closure component 21 will not misalign during use. Furthermore, the snap-fit ​​connector 23 ensures that the user knows when the closure member 4 is closed, i.e., when a fluid-tight seal is provided between the first closure component 18 and the second closure component 21 to prevent enema leakage. Those skilled in the art will understand that the illustrated closure member 4 is one of many possible solutions for providing an opening 6 in the delivery container 2, and other components, such as threaded closure components, are also within the scope of the invention. If desired, sealing rings (not shown) or the like can be used to ensure a liquid-tight seal.

[0082] The intermediate component 20 is permanently and securely attached to the inside of the top 19 of the delivery container 2, for example by means of glue, welding, etc., thereby providing a reliable and durable construction in which the closing member 4 can be opened and closed in a simple manner. However, the intermediate component can also be attached to the delivery container using an overmolding process, a 2K injection molding process, and / or a similar process, the only requirement being that the closing member 4 is securely attached to the delivery container 2.

[0083] To ensure that the enema agent can be discharged from the delivery container 2, the first closure member 18 includes a first opening 24 and the second closure member 21 includes a second opening 25, which together provide fluid communication between the delivery container 2 and the output opening 5 of the applicator nozzle 3 when the nozzle is attached to the closure member 4.

[0084] In the embodiment shown in the accompanying drawings, the applicator nozzle 3 is removably connected to the closing member 4 via a coupling unit 26. This is best seen in Figure 2. The coupling unit ensures that the applicator nozzle 3 can be removed after use and then cleaned, disinfected, or simply discarded.

[0085] The connecting unit 26 comprises a concave connecting member 27 arranged in the second connecting member 21 and extending into the second opening 25, and is arranged to engage a convex connecting member 28 disposed on the applicator nozzle 3. In the illustrated embodiment, the convex connecting member 28 is a short flexible tube 29 extending through an inner tube 30 in the applicator nozzle 3 to the output opening 5. The concave connecting member 27 is made of a rigid material to provide a liquid-proof seal between the two components 27, 28 when they are engaged. The convex connecting member 28 has a tapered end 31 for easy engagement with the concave connecting member 27 when the convex connecting member 28 is inserted into and withdrawn from the concave connecting member 27.

[0086] The applicator nozzle 3 also includes an annular, basically truncated conical extension 32, which not only provides a comfortable design for the user and a close fit with the anus during application, but also provides a stop to limit the extension from the convex connector 28 to the concave connector 27 when the two parts are connected. This results in a particularly simple and inexpensive design for the enema device 1 according to the invention.

[0087] In the illustrated embodiment, the applicator nozzle 3 has a single output opening 5 at its distal end 33. In a variation, several output openings may be formed at the distal end 33 of the applicator nozzle 3, including one or more orifices (not shown) located at an offset position along the surface of the distal end of the applicator nozzle. This offset configuration of the output opening position would be particularly desirable in cases where the user has inflammation of the rectum or colon or is sensitive to contact with the pressurized fluid jet for other reasons.

[0088] like Figure 4bAs best shown, a cylindrical valve seat 34 for a check valve (not shown) is sealingly fitted into the second closing member 21 via a corresponding cylindrical flange 35 disposed on the inner side 36 of the second member 21, such that if / when the patient / user releases the compressive force on the delivery container, backflow of fluid (e.g., air, liquid, and feces) from the colon and / or rectum into the enema device is effectively prevented at the second opening. The valve seat 34 includes three openings 37, which can be closed, for example, as a check valve using an umbrella valve.

[0089] The closing member 4 is preferably made of a rigid material such as polypropylene or polyvinyl chloride, thereby ensuring not only that the closing member 4 can be opened / closed, but also that the applicator nozzle 3 can be easily attached to the second closing member in a releasable manner. (See from...) Figure 4b As best seen, the first opening 24 is relatively large, allowing both easy manual refilling of the enema agent into the delivery container 2 and allowing the inside of the delivery container 2 to be cleaned and dried between different enema applications. In the illustrated embodiment, the first opening 24 constitutes approximately 60% of the area A of the cross-section 11 taken at the top segment 10 of the delivery container 2; however, those skilled in the art will understand that this size can be varied if desired.

[0090] Figure 5 A cross-sectional view of a second embodiment of the enema device 1' is shown. This embodiment corresponds to... Figure 1 The embodiment shown in -3 differs in that the closing member 4' is modified. Therefore, the same reference numerals are used for similar components. In the second embodiment 1', the closing member 4' does not include the valve seat 34, but rather the second opening 25 of the second closing member 21 includes a base 38 having an opening 37, onto which the check umbrella valve 39 is fitted.

[0091] Figure 6A second embodiment of a delivery container 2' for an enema device 1 according to the invention is shown. This embodiment 2' corresponds to a first embodiment of the delivery container 2, the modification being the provision of multiple compression zones 40 within the delivery container 2'. Therefore, the same reference numerals are used for similar components. In the illustrated embodiment, the compression zone 40 is defined by two opposing circular regions 41a, 41b on the two long curved sides 16a, 16b of the delivery container 2', two opposing circular regions 42a, 42b on the two small sides 17a, 17b of the delivery container 2', and a single circular region 43 on the base 15 of the delivery container 2'. The top section 10 of the delivery container is reinforced by the middle section 20 from the closing member 4 and therefore cannot be significantly compressed. However, the different circular compression zones 40 can have different controllability (e.g., thickness) and are thus arranged to bend / yield when different forces are applied to the zone 40. For example, the force required to compress the delivery container at the circular region 43 of the base 15 may be greater than the force required to compress the delivery container at the two opposing circular regions 42a, 42b on the two small sides 17a, 17b of the delivery container 2', and the force required to compress the delivery container at the two opposing circular regions 41a, 41b on the two long curved sides 16a, 16b may be the lowest. In this way, it is ensured that when the user applies pressure to the delivery container 2', the container will collapse / compress, thereby allowing substantially all the contents of the enema device to be expelled.

[0092] The compression zones can be provided by adjusting the wall thickness of the delivery container in the compression zones 40, for example, minimizing the wall thickness in the compression zones 41a and 41b on the long sides and maximizing the wall thickness in the compression zone 43 at the base. Alternatively, the different compression zones 40 can be made of different materials with different hardness, have different curvatures (e.g., hypercurvature), etc.

[0093] Those skilled in the art will understand that more or fewer compression zones 40 can be provided, each with a different hardness / wall thickness. The compression zones need not be circular, but can have other desired shapes, such as triangles. Furthermore, one or more of the compression zones can be arranged so that they do not collapse at all, even when large compressive forces are applied to the zones.

[0094] Figure 7 A third embodiment of the delivery container 2” according to the invention is shown, wherein the compression zone 40 is provided by reducing the wall thickness X of the delivery container in two curved lines 44 arranged on a long curved surface 16a. Figure 8a The cross-section 45 along line VIII-VIII is shown. See also... Figure 8bThe enlarged view of the bends in the diagram shows that the bends are shaped into a V-shape with the same cutting angle α and the same depth d, i.e., the characteristics of the bends are identical for both bends 44. However, those skilled in the art will understand that the shape and / or depth (wall thickness) and / or cutting angle of the bends can be varied to adjust the required bending force in the compression zone. Furthermore, the number and / or arrangement of the bends can be adjusted.

[0095] Alternatively, the compression zone can be provided by providing reinforcing ribs (not shown) on the inner and / or outer sides of the delivery container. The reinforcing ribs can have any desired shape and location, and therefore can be linear, circular, a segment of a circle, polygonal, etc.

[0096] When the enema is to be administered, the enema agent (e.g., saline or tap water) is filled into the delivery containers 2, 2', 2" through the first opening 24, then the closing member 4 is closed, and the applicator nozzle 3 is arranged on the closing member 4 via the connecting unit 26. To prevent air from entering the colon, it is preferable that the delivery containers 2, 2', 2" are completely or at least substantially filled with the enema agent.

[0097] To begin the application procedure, the applicator nozzle 3 is then placed in the patient's anus, ensuring that the nozzle 3 provides a tight fit with the opening.

[0098] Then, by squeezing the delivery containers, a compressive force is applied to the delivery containers 2, 2', 2" . The enema agent is allowed to flow through the first opening 24 and the second opening 25, into the tube 30 of the applicator nozzle 3, and out of the output opening 5, thereby injecting the enema agent into the rectum and colon.

[0099] When the user releases the compressive force on delivery containers 2, 2', 2" during the application procedure, the containers will remain compressed because check valve 39 will prevent fluid from entering the delivery containers. Furthermore, since check valve 39 effectively prevents air from mixing with the enema solution, air cannot be applied to the patient's colon, effectively preventing unnecessary discomfort caused by colonic distension due to air.

[0100] After each squeeze and subsequent release action, the delivery containers 2, 2', 2" will be compressed more and more, thereby gradually reducing the size of the containers, allowing the user to sense when the desired dose of enema has been administered, or when all the contents of the enema have been expelled from the device.

[0101] After the enema is administered 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 containers 2, 2', 2" and discarded or cleaned for later use. The second closure member 21 can then be released from the first closure member 18 to allow cleaning and / or drying of the inside of the delivery containers 2, 2', 2" via the first opening 24. When a new administration procedure begins, as already described, the enema device 1 can be returned to its initial position by refilling the delivery containers 2, 2', 2" with the enema.

[0102] Since the enema device 1 according to the invention is relatively small and designed for one-handed use, it is equally suitable for home administration of enema agents or for medical or hospital facilities where large flushing / enema devices are too cumbersome and complicated to use.

[0103] Modifications and combinations of the above principles and designs can be foreseen within the scope of this invention.

Claims

1. An enema device comprising a flexible delivery container arranged to contain an enema agent and an applicator nozzle for distributing the enema agent, and wherein, The delivery container is arranged as a hand-held pump, and the delivery container is arranged for maintaining an at least partially compressed configuration when, in use, a user releases pressure on the delivery container, and wherein the enema device comprises a check valve arranged to prevent fluid from being drawn into the delivery container during operation.

2. The enema device of claim 1, wherein, The delivery container has an elliptical shape in cross-section.

3. The enema device according to claim 1 or 2, wherein the delivery container comprises a bottom section and a top section, the bottom section having a first cross-section in the shape of an ellipse, and the top section having a second cross-section in the shape of an ellipse, and wherein a minor axis of the first cross-section is larger than a minor axis of the second cross-section and / or a major axis of the first cross-section is larger than a major axis of the second cross-section.

4. The enema device according to claim 3, wherein the ratio of the minor axis to the major axis of the ellipse is 2 / 3 or less.

5. The enema device of claim 3, wherein, The bottom section tapers towards the top section, thereby providing a smooth transition between the two sections.

6. The enema device according to claim 1 or 2, wherein the fluid is air and liquid.

7. The enema device according to claim 1 or 2, wherein the delivery container is made of an elastically deformable material having a memory.

8. The enema device according to claim 7, wherein the elastically deformable material is a soft polymer.

9. The enema device according to claim 8, wherein the soft polymer is a silicone, a thermoplastic polymer, a polyurethane or a polyvinyl chloride.

10. The enema device of claim 1 or 2, wherein, The delivery container is arranged for expelling at least 80% of the volume of an enema agent contained in the delivery container.

11. The enema device according to claim 1 or 2, wherein the delivery container comprises one or more compression zones arranged for providing a controlled compression of the delivery container.

12. The enema device of claim 11, wherein, The one or more compression zones constitute less than 50% of the surface area of the delivery container.

13. The enema device of claim 12, wherein, The one or more compression zones constitute less than 30% of the surface area of the delivery container.

14. The enema device of claim 11, wherein, The one or more compression zones are provided by adjusting the wall thickness of the delivery container in one or more compression regions.

15. The enema device according to claim 11, wherein the one or more compression zones are provided by reducing the wall thickness of the delivery container in one or more curved lines.

16. The enema device according to claim 11, wherein the one or more compression zones are provided by providing reinforcing ribs on the inside and / or outside of the delivery container.

17. The enema device of claim 11, wherein, The delivery container is made of more than one material, and wherein the respective materials have different hardnesses so as to define the one or more compression zones.

18. The enema device of claim 1 or 2, wherein, The delivery container is arranged to be fully compressed by a force of less than 150 Newton.

19. The enema device of claim 18, wherein, The delivery container is arranged to be fully compressed by a force of less than 130 Newton.

20. The enema device of claim 18, wherein, The delivery container is arranged to be fully compressed by a force of less than 110 Newton.

21. The enema device of claim 1 or 2, wherein the delivery container is arranged such that the delivery container is not compressed prior to a force between about 30 N and about 50 N being applied to a side of the delivery container.

22. The enema device of claim 1 or 2, wherein the delivery container is arranged to hold at least 90 milliliters of enema.

23. The enema device of claim 3, wherein the enema device comprises a closure member comprising a first closure component arranged to attach to the delivery container and a second closure component arranged to separate from or connect to the first closure component.

24. The enema device of claim 23, wherein a first opening is provided in the delivery container when the second closure component is separated from the first closure component, and wherein the first opening constitutes at least 50% of a cross-section taken at the top section of the delivery container.

25. The enema device of claim 24, wherein, the first opening constitutes at least 60% of a cross-section taken at the top section of the delivery container.

26. The enema device of claim 24, wherein, the first opening constitutes at least 80% of a cross-section taken at the top section of the delivery container.

27. The enema device of claim 23, wherein, the second closure component comprises a female coupling arranged for releasable connection of a male coupling of the applicator nozzle to the enema device, and the female coupling is arranged for providing fluid communication between the applicator nozzle and the delivery container.

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