WO2023126622A1

WO2023126622A1 - Anal irrigation system, pump unit, methods of assembly and of anal irrigation

Info

Publication number: WO2023126622A1
Application number: PCT/GB2022/053343
Authority: WO
Inventors: Paul John Robbins; Nicholas Ian Harvey
Original assignee: Renew Medical UK Limited
Priority date: 2021-12-31
Filing date: 2022-12-21
Publication date: 2023-07-06
Also published as: GB2614535A; GB202119138D0

Abstract

An anal irrigation system comprises a fluid container; a pump unit; and a nozzle suitable for irrigating the rectal and/or bowel cavities, the nozzle comprising an elongate stem incorporating a channel extending there through; whereby fluid may flow, in use, through the channel; the stem incorporating a fluid inlet and one or more fluid outlets; wherein said pump unit further comprises a housing for said pump; at least a fluid conduit being provided between said fluid container and said pump unit; and at least a further fluid conduit being provided between said pump unit and said nozzle; wherein said pump unit comprises an electrically driven pump; said conduits and said pump unit being provided in succession to solely pump a liquid from said fluid container to one or more of said nozzle outlets.

Description

ANAL IRRIGATION SYSTEM, PUMP UNIT, METHODS OF ASSEMBLY AND OF ANAL IRRIGATION

Technical Field

The technical field relates to anal irrigation systems and pump unit for anal irrigation systems. Further embodiments concern methods of assembly of nozzles and of anal irrigation.

Background to the Invention

The closest prior art known to the applicant is the nozzle described in GB2565640 which was invented by the same inventors. Embodiments of the invention seek to overcome a range of drawbacks identified in their earlier disclosure.

Whilst users of the prior art system particularly appreciate the simplicity of the operation, the prior art system relies on users being able to grasp the flexible pumping chamber and exert sufficient pressure to cause liquid to flow up into the nozzle and through its outlets. Certain users may require therefore assistance from third parties. One of the objects of certain embodiments of the invention is to overcome these drawbacks to even further simplify the user interface and provide a readily deployable system. Summary of the Invention

In a first broad independent aspect, the invention provides an anal irrigation system comprising a fluid container; a pump unit; and a nozzle suitable for irrigating the rectal and/or bowel cavities, the nozzle comprising an elongate stem incorporating a channel extending therethrough; whereby fluid may flow, in use, through the channel; the stem incorporating a fluid inlet and one or more fluid outlets; wherein the pump unit further comprises a housing for the pump; and wherein the system further comprises at least a fluid conduit being provided between the fluid container and the pump unit; and at least a further fluid conduit being provided between the pump unit and the nozzle; wherein the pump unit comprises an electrically driven pump; the conduit and the pump unit being provided in succession to solely pump a liquid from the fluid container to one or more of the nozzle outlets.

This configuration is particularly advantageous because it allows the nozzle to receive only liquid without any of the drawbacks of pumping air into the nozzle. In other words, in a preferred embodiment, the pump pumps water directly. This is also particularly advantageous as, in certain embodiments, the pump may be removable from the system and temporarily replaced by a manual hand pump when, for example, the batteries are flat.

In a subsidiary aspect, the pump unit is in-line between the container and the nozzle. This is particularly advantageous in terms of providing a simple path from the container to the nozzle which would be more straightforward for patients to interact with and assemble as necessary.

In a further subsidiary aspect, the pump unit incorporates a fluid inlet and a fluid outlet; the fluid inlet and the fluid outlet being at opposite extremities of the unit. This further improves the ability of users to assemble the pump unit into the anal irrigation system.

In a further subsidiary aspect, the fluid conduits and the pump housing are integrally formed. In certain embodiments when assembly is to be further minimized, this allows the unit to be operational in the anal irrigation system with little or no prior assembly required. In a further subsidiary aspect, a releasable connector is provided between the pump unit and a further conduit; whereby the further conduit and the pump unit are separable modules. This configuration is particularly advantageous as it allows individual components to be replaced for various use scenarios.

In a further subsidiary aspect, a further releasable connector is provided between the pump unit and the first conduit; wherein the first conduit and the pump unit are separable modules. This configuration is also particularly advantageous in order to further allow the replacement of individual modules of the anal irrigation system.

In a further subsidiary aspect, a further releasable connector is provided between the first conduit and the container; whereby the first conduit and the container are separable modules. This further increases the modularity of the anal irrigation system to further allow the replacement of various components and parts as required during use cycles.

In a further subsidiary aspect, a further releasable connector is provided between the further conduit and a nozzle or a nozzle assembly; whereby the further conduit and either the nozzle or the nozzle assembly are separable modules. This configuration is particularly advantageous in terms of being able to readily replace and upgrade modules of the anal irrigation system.

In a further subsidiary aspect, the pump is self-priming; whereby only liquid is pumped out of the pump unit into the further conduit. This configuration is particularly advantageous as it improves the accuracy of the operation and ensures that the user only receives the required amount of liquid.

In a further subsidiary aspect, the housing incorporates a button which switches ON the pump when pressed and switches OFF the pump when released. This configuration is particularly advantageous because it provides a simple yet responsive alternative to the prior art manual pump. It also particularly lends itself for use with those with limited ability to grasp a manually operated pump. In preferred embodiments, the pressure of a single finger or thumb is enough to activate and deactivate the pump. In a further subsidiary aspect, the button is biased so that it automatically returns to the OFF position when the user stops pressing it. This may take the form of a lever arm, a button on a spring or a flexible membrane which deforms under pressure and return to its original shape when the pressure is released.

In a further subsidiary aspect, the button is provided on a lever arm. This is particularly advantageous as it allows the button to readily return to its starting position. Such systems also lend themselves for operation not only by a user's hand but with their foot or other body part. Thus, the pump unit may be employed as a pedal. In a further subsidiary aspect, the pump housing incorporates a flat side opposite to the side which incorporates the button. This configuration allows the system to be placed on a flat surface such as a table or the floor for stable operation as the user would then simply require a relatively gentle pressure to be applied onto the button.

In a further subsidiary aspect, the housing incorporates one or more light emitted diodes or multiple spot light sources for indicating a mode of use or condition of a component of the pump. This configuration is particularly advantageous as it avoids the use of relatively power-hungry screens whilst also providing clear communication to the user.

In a further subsidiary aspect, the nozzle incorporates a first skirt projecting, when secured to the elongate stem, radially from the stem and being provided as the first radially projecting member below said nozzle's fluid outlets; and first skirt being inherently flexible; whereby the skirt is sufficiently flexible for insertion through the anus and thereafter rest against the internal wall of the rectum. This configuration is further advantageous as it allows a wholly liquid-based anal irrigation system to be not only simplified but improved in terms of its safety of operation.

In a further subsidiary aspect, the nozzle further incorporates a second skirt projecting radially from the stem; the second skirt being provided in a location which is closer to the fluid inlet and the location of the first skirt; wherein the second skirt is less flexible than the first skirt. This configuration further improves the safety when in combination with a liquid-only electrically driven pump. In a further broad aspect, the invention provides a pump unit for an anal irrigation system comprising a fluid inlet and a fluid outlet; an electrically driven pump; a power source compartment for receiving a battery for driving said pump; a housing for said pump; and a button for switching the pump ON and OFF; said pump unit comprising at least one of the following:

• The fluid inlet and the fluid outlet being provided on opposite ends of the housing;

• The fluid inlet and the fluid outlet being provided with connector portions for attaching to releasable connectors;

• The pump is self-priming; whereby only liquid is pumped out of the fluid outlet;

• The housing incorporates a button which switches ON the pump when pressed and switches OFF the pump when released.

In a further subsidiary aspect, the button is biased so that it automatically returns to the OFF position when the user stops pressing it

In a further subsidiary aspect, the pump housing incorporates a button which is provided on a lever arm.

In a further subsidiary aspect, the pump unit incorporates a flat side opposite to the side which incorporates the button.

In a further subsidiary aspect, the pump unit incorporates one or more light emitting diodes or multiple spot light sources for indicating a mode of use or condition of a component of the pump.

In a further broad independent aspect, embodiments of the invention provide a method of assembling an irrigation system or a method of anal irrigation for irrigating the rectal and/or bowel cavities comprising the steps of:

• Providing a fluid container; a pump unit containing an electrically driven pump; a nozzle with a fluid inlet and one or more fluid outlets suitable for irrigating the rectal and/or bowel cavities; at least a fluid conduit; at least a further fluid conduit; and a plurality of releasable connectors; • Assembling the components to form, when assembled, a succession of fluid containers, a releasable connector, a fluid conduit, a releasable connector, pump unit, a releasable connector, a further fluid conduit, a releasable connector, and a nozzle; and

• Solely pumping a liquid from said fluid container to one or more of the nozzle outlets.

In a further subsidiary aspect, the method comprises the step of providing an electrically driven pump unit.

In a further subsidiary aspect, the method comprises the step of removing a pump unit and replacing it with an alternative pump unit. This would allow a manual pump unit to be replaced by an electrically driven pump unit and vice versa.

In a further subsidiary aspect, the method comprises the step of providing a button which is biased so that it automatically returns to the OFF position when the user stops pressing it.

In a further subsidiary aspect, the method comprises the step of providing a pump housing incorporating a button which is provided on a lever arm.

In a further subsidiary aspect, the method comprises the step of providing a pump unit incorporating a flat side opposite to the side which incorporates the button.

In a further subsidiary aspect, the method comprises the step of providing a pedal and pressing the button with a foot to activate and deactivate the pump.

In certain embodiments, these methods significantly simplify the assembly and the operation of anal irrigation systems whilst at the same time improving the safety of the irrigation process. Brief Description of the Drawings

The invention will now be described with reference to the accompanying drawings which show by way of example only, embodiments of an apparatus for facilitating irrigation of the rectum and/or the bowel and/or the colon cavities via the anus. In the drawings:

Figure 1 shows an embodiment of an anal irrigation system in side elevation where an electrically driven pump unit is provided in-line with the tubulars.

Figure 2 shows a perspective view of a pump unit.

Figure 3 shows a bottom view or rear elevation of the pump unit.

Figure 4 shows a side elevation of the pump unit.

Figure 5 shows the liquid only nozzle of the anal irrigation system in accordance with an embodiment of the invention. The view shown is a perspective view.

Detailed Description of the Figures

Figure 1 shows an anal irrigation system generally referenced 1 with a fluid container 2, a pump unit 3, a tubular 4 located between the fluid container 2 and the pump unit 3 and a further tubular 5 located between the pump unit and a nozzle assembly 6. For simplicity the nozzle is not shown in this view, instead, a tubular 7 with a bend is provided where a nozzle of the kind shown in Figure 5 would be secured.

The fluid container may be of flexible material and optionally formed by sealing two walls together around a perimeter region 8. The fluid container 2 has a cap 9 fitting into a neck 9' through which liquid may be poured to fill the container. In addition, the cap may incorporate a loop 10 whereby the container may be secured to a hook or simply held in an appropriate position to facilitate anal irrigation. A first connector 11 may be provided between tubular 4 and the container. A valve 12 may be provided in line with the tubular 4 in order to manually open/close the flow of liquid if desired. This valve may be optional as the pump unit 3 may provide this stop valve function in itself. A further releasable connector or connector 13 may be provided between tubular 4 and the pump unit 3. Furthermore, a third connector or connector 14 may be provided between tubular 5 and the pump unit. In an alternative embodiment, the pump unit incorporates tubulars 4 and 5 so that these are integral to the pump housing.

A fourth connector or connector 15 may be provided between tubular 5 and the tubular bend 7. The tubular bend whilst being preferred is entirely optional dependent upon the anal irrigation system configuration.

As can be observed in Figure 1, the central longitudinal axis of tubular 4 and the central longitudinal axis of tubular 5 are both in-line with the pump unit. The pump unit has a first extremity 16 and a second extremity 17 whereby respectively the inlet and outlet to the pump unit are provided. The liquid inlet is configured to releasably connect to connector 13 whilst the liquid outlet is configured to releasably connect to connector 14. The connectors have ears such as ears 18 and 19 which allow a user to readily rotate the connector relative to its mating connection portion. The connectors may preferably incorporate a thread in order to be threaded onto and off a mating connector portion. Alternatively, these may simply be push-fit connections.

The fluid container may incorporate a number of volume measurement lines in order to serve as a visual indicator to the user or the operator of the pump unit to understand how much of the container liquid has been pumped out during use. In this embodiment, the pump unit requires no screen or complex display systems to meter the amounts of liquid that flow through the pump. In other words, the operator or user will simply observe as the fluid container is held upright where the fluid line is relative to the appropriate markings on the transparent fluid container.

In Figure 2 the details of the pump unit 3 may be further appreciated. The pump unit 3 is generally of an oblong shape with a rounded perimeter region 20. At extremity 16, a fluid inlet 21 is provided whilst at extremity 17 a fluid outlet 22 is provided. Both the fluid inlet and the fluid outlet have connector portions 23 and 24 with thread portions 25 and 26 respectively to facilitate the mating connection with the connectors 13 and 14. A button 27 is provided in the central portion of a first face of the pump unit. The button is formed with a slightly domed shaped portion so as to be easily recognisable by touch and readily located by a user or operator. The domed shaped or circular portion 28 is provided at the end of a lever arm 29 which is built-in or secured at one extremity to the pump unit and displaceable at its free end. The pump unit has a housing formed of two halves 30 and 31.

When a user presses the button, an electrically driven pump which is located within the housing is activated. Due to the lever arm providing a bias, when a user ceases to press on the button, the lever arm return to its original position which causes the pump to stop pumping. Thus, the pump is deactivated when the pressure is released allowing the user to precisely control the amount of liquid being pumped.

A control unit for the pump is also provided within the housing. The electrically driven pump is preferably self-priming whereby only liquid is pumped out of the pump unit into the further conduit. The pump unit is able to detect whether or not water is in the fluid line and should no water be present, no pumping will take place. This is particularly advantageous as it prevents air from being inadvertently pumped into the fluid outlet and to the nozzle.

In addition, the housing incorporates ports 32 and 33, as best seen in figure 4, for connecting an external power source for either charging rechargeable batteries should they be located within the unit or to directly power the operation of the electrically driven pump. In addition, the unit has a number of light emitting diodes (LEDs) or other spot light sources or similar kind such as LED 34.

On the opposite side of the pump unit, a flat surface 35 is provided which is formed as a closure leaf 36 (see figure 3) which may be opened to reveal a battery compartment which may be sized to receive standard batteries. This would therefore allow both rechargeable batteries or non-rechargeable batteries to be inserted into the pump unit as desired.

The domed shaped portion 28 of the button can be readily seen in Figure 4 together with the relatively flat side of the pump unit. For completeness, Figure 5 shows a nozzle which may be employed together with the anal irrigation system described previously. This kind of nozzle incorporates a first skirt 37 projecting, when secured to the elongate stem 38, radially from the stem and being provided as the first radially projecting member in the nozzle's fluid outlets such as fluid outlets 39 and 40. This first skirt may incorporate a number of petals such as petal 41. The skirt is sufficiently flexible for insertion through the anus and to thereafter rest against the internal wall of the rectum. A second skirt 42 projects radially from the stem. The second skirt is provided in a location which is closer to the fluid inlet than the location of the first skirt. In preferred embodiments, the thickness of the second skirt is greater than the thickness of the first skirt so that it is much less flexible than the first skirt.

Embodiments of the invention provide a method of assembling an irrigation system or a method of anal irrigation for irrigating the rectal and/or bowel cavities comprising the steps of:

• Providing a fluid container 2; a pump unit 3 containing an electrically driven pump; a nozzle with a fluid inlet and one or more fluid outlets 39, 40 suitable for irrigating the rectal and/or bowel cavities; at least a fluid conduit such as conduit 4 or 5; at least a further fluid conduit such as conduit 4 or 5; and a plurality of releasable connectors such as connectors 11, 13, 14 and 15;

• Assembling the components to form, when assembled, a succession of fluid containers 2, a releasable connector 11, a fluid conduit 4, a releasable connector 13, pump unit 3, a releasable connector 14, a further fluid conduit 5, a releasable connector 15, and a nozzle (see figure 5); and

In a further subsidiary aspect, the method comprises the step of providing an electrically driven pump unit 3.

In a further subsidiary aspect, the method comprises the step of removing a pump unit 3 and replacing it with an alternative pump unit. In a further subsidiary aspect, the method comprises the step of providing a button 27 which is biased so that it automatically returns to the OFF position when the user stops pressing it. In a further subsidiary aspect, the method comprises the step of providing a pump housing incorporating a button 27 which is provided on a lever arm 29.

In a further subsidiary aspect, the method comprises the step of providing a pump unit incorporating a flat side 35 opposite to the side which incorporates the button.

Claims

1. An anal irrigation system comprising a fluid container; a pump unit; and a nozzle suitable for irrigating the rectal and/or bowel cavities, the nozzle comprising an elongate stem incorporating a channel extending there through; whereby fluid may flow, in use, through the channel; the stem incorporating a fluid inlet and one or more fluid outlets; wherein said pump unit further comprises a housing for said pump; and wherein said system comprises at least a fluid conduit being provided between said fluid container and said pump unit; and at least a further fluid conduit being provided between said pump unit and said nozzle; wherein said pump unit comprises an electrically driven pump; said conduits and said pump unit being provided in succession to solely pump a liquid from said fluid container to one or more of said nozzle outlets.

2. The anal irrigation system of claim 1, wherein said pump unit is in-line between said container and said nozzle.

3. The anal irrigation system of claim 2, wherein said pump unit incorporates a fluid inlet and a fluid outlet; said fluid inlet and said fluid outlet being at opposite extremities of said unit.

4. The anal irrigation system according to any of the preceding claims, wherein said fluid conduits and said housing are integrally formed.

5. The anal irrigation system according to any one of claims 1 to 3, wherein a releasable connector is provided between said pump unit and said further conduit; whereby said further conduit and said pump unit are separable modules.

6. The anal irrigation system according to any one of claims 1 to 3 and 5, wherein a further releasable connector is provided between said pump unit and said first conduit; whereby said first conduit and said pump unit are separable modules.

7. The anal irrigation system according to any one of claims 1 to 3, 5 and 6, wherein a further releasable connector is provided between said first conduit and said container; whereby said first conduit and said container are separable modules.

8. The anal irrigation system according to any one of claims 1 to 3, 5, 6 and 7, wherein a further releasable connector is provided between said further conduit and a nozzle or a nozzle assembly; whereby said further conduit and either said nozzle or said nozzle assembly are separable modules.

9. The anal irrigation system according to any one of the preceding claims, wherein said pump is self-priming; whereby only liquid is pumped out of said pump unit into said further conduit.

10. The anal irrigation system according to any one of the preceding claims, wherein said housing incorporates a button which switches ON the pump when pressed and switches OFF the pump when released.

11. The anal irrigation system according to claim 10, wherein said button is biased to deactivate the pump when the button is released.

12. The anal irrigation system according to either claim 10 or claim 11, wherein said button is provided on a lever arm.

13. The anal irrigation system according to any one of claims 10 to 12, wherein said housing incorporates a flat side opposite to said side which incorporates said button.

14. The anal irrigation system according to any of the preceding claims, wherein said housing incorporates one or more light emitting diodes or multiple spot light sources for indicating a mode of use or condition of a component of said pump.

15. The anal irrigation system according to any of the preceding claims, wherein said nozzle incorporates a first skirt projecting, when secured to the elongate stem, radially from the stem and being provided as the first radially projecting member below said nozzle 's fluid outlets; the first skirt being inherently flexible; whereby the skirt is sufficiently flexible for insertion through the anus and to thereafter rest against the internal wall of the rectum. 14

16. The anal irrigation system according to any of the preceding claims, wherein said nozzle further incorporates a second skirt projecting radially from said stem; said second skirt being provided in a location which is closer to the fluid inlet than the location of the first skirt; wherein said second skirt is less flexible than said first skirt.

17. A pump unit for an anal irrigation system comprising a fluid inlet and a fluid outlet; an electrically driven pump; a power source compartment for receiving a battery for driving said pump; a housing for said pump; and a button for switching the pump ON/OFF; said pump unit comprising at least one of the following:

• said fluid inlet and said fluid outlet being provided on opposite ends of said housing;

• said fluid inlet and said fluid outlet being provided with connector portions for attaching to releasable connectors;

• said pump is self-priming; whereby only liquid is pumped out of said fluid outlet;

• said button is configured to switch ON the pump when pressed and switch OFF the pump when released.

18. The pump unit according to claim 17, wherein said pump housing incorporates a button which is provided on a lever arm.

19. The pump unit according to either claim 17 or claim 18, incorporating a flat side opposite to said side which incorporates said button.

20. The pump unit according to any one of claims 17 to 19, incorporating one or more light emitting diodes or multiple spot light sources for indicating a mode of use or condition of a component of said pump.

21. A method of assembling an anal irrigation system or method of anal irrigation for irrigating the rectal and/or bowel cavities comprising the steps of:

• providing a fluid container; a pump unit containing an electrically driven pump; a nozzle with a fluid inlet and one or more fluid outlets suitable for irrigating the rectal and/or bowel cavities; at least a fluid conduit; at least a further fluid conduit; and a plurality of releasable connectors; 15

• assembling said components to form, when assembled, a succession of fluid container, a releasable connector, a fluid conduit, a releasable connector, a pump unit, a releasable connector, a further fluid conduit, a releasable connector, and a nozzle; and

• solely pumping a liquid from said fluid container to one or more of said nozzle outlets.

22. The method of claim 21, further comprising the step of removing a pump unit and replacing it with an alternative pump unit.

23. The method of either claim 21 or claim 22, further comprising the step of providing a button which is biased so that it automatically returns to the OFF position when the user stops pressing it.

24. The method of any one of claims 21 to 23, further comprising the step of providing a pump housing incorporating a button which is provided on a lever arm.

25. The method of any one of claims 21 to 24, further comprising the step of providing a pump unit incorporating a flat side opposite to the side which incorporates the button.

26. The method of any one of claims 21 to 25, further comprising the step of providing a pedal and pressing the button with a foot to activate and deactivate the pump.