Improved nozzle, anal lavage system, and method for assembling anal lavage device

Abstract

A spray head suitable for lavaging the rectum and / or intestinal cavity, the spray head comprising: an elongated shaft comprising a passage extending therethrough; whereby a fluid can flow through the passage in use; the shaft comprising a liquid inlet and one or more liquid outlets; and a first skirt projecting radially from the shaft when secured to the elongated shaft; the first skirt having inherent flexibility; whereby the skirt is sufficiently flexible for insertion through the anus and thereafter resting against the inner wall of the rectum; wherein the first skirt comprises an annular hub secured to the elongated shaft.

Description

Technical Field

[0001] The technical field relates to a nozzle for irrigating the rectum and / or intestinal cavity and an anal douche system including such a nozzle. Further embodiments relate to methods of assembling a nozzle and assembling an anal douche. Background Art

[0002] The closest prior art known to the applicant is the spray head described in GB2565640, invented by the same inventors. Embodiments of the present invention seek to overcome a number of the shortcomings of its earlier disclosure. In particular, the spray heads of the prior art are only suitable for patients of a certain size and therefore do not provide the flexibility required in most applications. In addition, the spray heads of the prior art require the use of an introducer which holds the integrally formed flaps of the prior art in a retracted position during the insertion phase. Embodiments of the present invention improve the configuration of the spray head to improve insertion and thereby get rid of any reliance on an inserter. Therefore, certain preferred embodiments seek to improve the range of use of the spray head to improve the ability to insert the spray head and the overall comfort of the patient who relies on its use.

[0003] WO2016 / 007536 is also known to the applicant. It discloses a nozzle for irrigation that utilizes an inflatable balloon 38 and, therefore, does not include a skirt as contemplated in the aforementioned prior art. Inflatable balloons have been found to damage the rectal cavity under certain usage patterns. Certain embodiments of the present invention overcome these drawbacks while offering greater flexibility than other prior art embodiments.

[0004] WO 2018 / 009871 A1, like WO 2016 / 007536, requires that an inflatable bladder be located between the cuff and the patient-proximal end that provides a fluid outlet. Summary of the Invention

[0005] In a first broad independent aspect, an embodiment provides a nozzle suitable for lavaging the rectum and / or intestinal cavity, the nozzle comprising: an elongated shaft comprising a channel extending through the elongated shaft; whereby fluid can flow through the channel in use; the shaft comprising a fluid inlet and one or more fluid outlets; and a first skirt which, when secured to the elongated shaft, radially extends from the shaft and is disposed below the fluid outlets as a first radially extending member; the first skirt having inherent flexibility; whereby the skirt is sufficiently flexible for insertion through the anus and thereafter resting against the inner wall of the rectum; wherein the first skirt comprises an annular hub; the elongated shaft and the first skirt are formed as two separate components; the annular hub is secured to the elongated shaft.

[0006] This configuration is particularly advantageous because it allows the selection of a first skirt having a wide range of outer diameters, which can make the nozzle suitable for a wide range of individuals depending on their body shape and medical conditions. In certain embodiments, it not only improves the flexibility of attachment, but also improves strength. In addition, there is no need for an inflatable balloon, thereby avoiding the risk of damage caused by the balloon while providing flexibility to accommodate a variety of patient body shapes. In a preferred embodiment, the first skirt is constructed with one or more predetermined cuts (e.g., radial cuts seen between the flaps or pre-formed fold lines) to allow the first skirt to self-collapse when inserted through the anus.

[0007] In a subsidiary aspect, the rod includes an annular groove corresponding to the annular hub; thereby, the first skirt is fixed to the elongated rod. This configuration is particularly advantageous because it provides a precise attachment position in certain embodiments and allows for a readily secure and durable attachment.

[0008] In another subsidiary aspect, the spray head further comprises a second skirt extending radially from the stem; the second skirt being positioned closer to the fluid inlet than the first skirt; and wherein the inner diameter of the elongated stem in the region of the stem's fixed annular hub is smaller than the inner diameter in the region immediately above the second skirt. This configuration is particularly advantageous because it provides additional flexibility in certain embodiments, thereby allowing the lower portion to flex in certain loading directions.

[0009] In another subsidiary aspect, the annular hub is glued to the outer portion of the rod.This configuration is particularly advantageous because it further increases the level of security of the attachment in certain embodiments.

[0010] In another subsidiary aspect, the elongated rod includes a tip tapered at its distal end, and the inner diameter of the annular hub is smaller than the outer diameter of the lower portion of the tip; the annular hub is sufficiently flexible to flex radially, thereby allowing the tip to be pushed through the annular hub and then flexed back into the annular groove and thereby retained. This configuration is particularly advantageous because it allows, in certain embodiments, the first skirt to be secured prior to any other bonding, other than chemical bonding.

[0011] In another subsidiary aspect, the flexibility of the second skirt is less than that of the first skirt. This allows the first skirt to be advantageously passed through the anus, while the second skirt will rest against the anus and remain outside.

[0012] In another subsidiary aspect, the second skirt is thicker than the first skirt, which also facilitates the abutment of the second skirt.

[0013] In another subsidiary aspect, the outer diameter of the rod increases in the region above the second skirt towards the second skirt. This results in a gradual increase in the rigidity of the second skirt.

[0014] In another subsidiary aspect, the first skirt further comprises radial slits extending inwardly from its peripheral edge, thereby forming a plurality of flaps. This allows each flap to move independently, thereby increasing the ease with which the spray head can be inserted and removed while providing support when in place.

[0015] In another subsidiary aspect, the first skirt comprises five or fewer flaps.This configuration is particularly advantageous because it facilitates passage while reducing the need for slits.

[0016] In another subsidiary aspect, the outer diameter of the first skirt is greater than the outer diameter of the second skirt. This is particularly advantageous when adjusting the spray head for patients requiring a larger diameter.

[0017] In another subsidiary aspect, the first skirt does not include a fold line. In certain embodiments, this configuration is an advantageous simplification over prior art spray heads, as no fold line is required, while the performance of the spray head is improved.

[0018] In another subsidiary aspect, the elongate rod comprises a tip, at least one of the fluid outlets being formed as a first opening in the tip.

[0019] In another subsidiary aspect, the tip comprises a side wall, wherein the side wall further comprises at least one fluid outlet. This provides an improvement in pressure balance between the various openings.

[0020] In another subsidiary aspect, the side wall comprises a further fluid outlet. This further improves the fluid dynamics in certain embodiments.

[0021] In another subsidiary aspect, the further fluid outlet is located diametrically opposite the fluid outlet. This configuration is particularly advantageous in certain embodiments in terms of minimizing clogging, etc.

[0022] In another subsidiary aspect, the fluid outlet has a distal lip that is rounded. This configuration is particularly advantageous because it minimizes the presence of any sharp edges in certain embodiments, thereby minimizing the risk of inadvertent injury to the patient.

[0023] In another subsidiary aspect, the annular hub includes a first outer diameter above the first skirt and a second outer diameter below the first skirt; the first outer diameter above the first skirt is smaller than the second outer diameter. This configuration provides improved support for the first skirt.

[0024] In another broad independent aspect, an embodiment relates to an anal irrigation system comprising a spray head according to any of the preceding aspects.

[0025] In another subsidiary aspect, the system further comprises a plurality of first skirts having two or more different outer diameters, wherein each of the skirts comprises an annular hub shaped and configured to be secured to the rod. This allows the system to have greater flexibility and readily adapt to use on a wider range of patients.

[0026] In another broad independent aspect, an embodiment provides a method of assembling a spray head suitable for irrigating a rectum and / or intestinal cavity, the method comprising the steps of:

[0027] providing an elongate rod comprising a passage extending therethrough; whereby, in use, a fluid may flow through the passage; the rod comprising a fluid inlet and one or more fluid outlets;

[0028] Selecting a first skirt having an annular hub; and

[0029] • Secure the annular hub to the rod.

[0030] In another subsidiary aspect, a method of assembling a spray head includes the steps of providing a stem having an annular groove and placing the annular hub in the annular groove.

[0031] In another subsidiary aspect, a method of assembling a spray head includes the step of bonding the annular hub to the stem.

[0032] In another subsidiary aspect, a method of assembling an anal irrigation system comprises the steps of: assembling a spray head according to any of the preceding aspects; further providing a plurality of tubular sections, a plurality of connectors suitable for connecting the plurality of tubular sections, and a pump for pressurizing the liquid of the irrigation system; and connecting the spray head, the tubular sections, and the pump.

[0033] In another broad independent aspect, a method of anal irrigation comprises the step of at least partially inserting a spray head according to any of the preceding aspects into a patient in need of anal irrigation.

[0034] In a subsidiary aspect, a method of anal douching includes the step of selecting a spray head having a first skirt from a group of spray heads having first skirts of different outer diameters.

[0035] In another broad independent aspect, embodiments provide a spray head suitable for lavaging the rectum and / or intestinal cavity, the spray head comprising: an elongated shaft comprising a passage extending therethrough; whereby, in use, fluid may flow through the passage; the shaft comprising a fluid inlet and one or more fluid outlets; and a first skirt extending radially from the elongated shaft when secured thereto; the first skirt having inherent flexibility; whereby, the skirt is sufficiently flexible for insertion through the anus and thereafter resting against the inner wall of the rectum;

[0036] wherein the spray head further comprises a second skirt extending radially from the rod; the second skirt being arranged in a position closer to the fluid inlet than the first skirt; and wherein the inner diameter of the elongated rod in the region of the rod where the first skirt is fixed is smaller than the inner diameter in the region immediately above the second skirt.

[0037] In another broad independent aspect, an embodiment provides a spray head suitable for lavaging the rectum and / or intestinal cavity, the spray head comprising: an elongated shaft comprising a channel extending therethrough; whereby fluid may flow through the channel in use; the shaft comprising a fluid inlet and one or more fluid outlets; and a first skirt extending radially from the shaft when secured to the elongated shaft; the first skirt having inherent flexibility; whereby the skirt is sufficiently flexible for insertion through the anus and thereafter resting against the inner wall of the rectum; wherein the first skirt comprises five or fewer petals.

[0038] In another broad independent aspect, an embodiment provides a nozzle suitable for lavaging the rectum and / or intestinal cavity, the nozzle comprising: an elongated shaft comprising a channel extending through the elongated shaft; whereby fluid can flow through the channel in use; the shaft comprising a fluid inlet and one or more fluid outlets; and a first skirt extending radially from the shaft when secured to the elongated shaft; the first skirt having inherent flexibility; whereby the skirt is sufficiently flexible for insertion through the anus and thereafter resting against the inner wall of the rectum; wherein the nozzle further comprises a second skirt extending radially from the shaft; the second skirt being disposed in a position closer to the fluid inlet than the position of the first skirt; wherein the outer diameter of the first skirt is greater than the outer diameter of the second skirt. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] The invention will now be described with reference to the accompanying drawings which show, by way of example only, embodiments of a device for facilitating per anal irrigation of the rectum and / or intestinal and / or colonic lumen. In the drawings:

[0040] Figure 1 It is a multi-view stereoscopic image of an anal irrigation nozzle.

[0041] Figure 2 A in FIG. 1 shows the rod of the anal lavage nozzle in a side elevation view;

[0042] Figure 2 B in FIG. 1 shows a perspective view of a first skirt member adapted to be attached to an anal lavage nozzle;

[0043] Figure 3 shows a side elevation view of an anal lavage nozzle according to an embodiment of the present invention;

[0044] Figure 4 A cross-sectional view of the showerhead is shown;

[0045] Figure 5 Components of an anal irrigation system are shown. DETAILED DESCRIPTION

[0046] In an embodiment, the present invention provides a spray head attachment designed and configured for use in conjunction with a tube configuration for use as part of an anal irrigation system or an anal irrigation device, the anal irrigation system being Figure 5 The anal irrigation system of the type shown in FIG. The main function of the nozzle is to allow fluid to be introduced into the patient's intestine to initiate the irrigation process. The nozzle is designed to improve the insertion and positioning of the nozzle in the patient's rectum to prevent premature and unnecessary leakage of fluid and feces from the anus during the irrigation process. The nozzle 1 includes an upper tip 2, a connector 7 (see FIG. Figure 4 ) and a flexible rod connected between the upper end tip 2 and the connector 7, the upper end tip 2 includes 3 (see Figure 2 ), one or more holes designated by 4 and 5 and a first radially extending flexible skirt 6, the connector 7 includes a second radially extending skirt 8 and an opening 9 suitable for attachment to a tube. In use, the tip 2 is designed to be inserted into the anus, and the first skirt 6 is deformable so that the first skirt 6 is suitable for insertion through the patient's anus. The second skirt 8 on the connector is less flexible and is shaped to block access to the anus, thereby preventing the nozzle from being fully inserted into the anus and optimally positioning the nozzle so that the first skirt may be placed across the anus and the flexible rod 10 placed in the rectum. The flexible first skirt 6 is elastic and returns to its original shape after being deformed and inserted into the anus. At the end of the irrigation process, the first skirt 6 can be deformed in the opposite direction to that of insertion, thereby allowing the nozzle to be removed from the patient's rectum and allowing fluid and feces to drain away.

[0047] While the current embodiment describes the use of a spray head as a separate attachment to a tube, further embodiments provide a spray head that is integral to the tube or pump apparatus.

[0048] In addition, it is also envisaged that, for example, Figure 5 The present invention relates to an embodiment in which the nozzle is integrated with the anal irrigation system. It should be understood that the present invention is particularly advantageous when optionally associated with a mechanical, automated, or automatic pump system. The nozzle itself can optionally be a disposable nozzle. In further embodiments, a lubricant can be used with the nozzle, or the outer surface of the nozzle can have a particularly low friction level, or even an integrally lubricated surface, to allow the nozzle to be used at any time.

[0049] For clarity, elements common to the various figures of embodiments of the present invention retain the same reference numerals across the various figures.

[0050] The first skirt 6 comprises five flaps, such as flap 11, separated by a plurality of radially extending slits, such as slit 12. The slits are generally elliptical in shape, having a radius in the region closest to the rod. The adjacent outermost edges of the flaps are also rounded. The slits do not extend all the way to the rod and begin at a distance of at least 1 / 6 of its length, thereby providing a web between the slits and the rod.

[0051] An annular hub 13 is provided (see Figure 2 B), the annular hub 13 defines a hole through which the stem of the spray head can be inserted. The annular hub is generally cylindrical and can include an inner diameter that can remain constant along its length. However, the outer diameter of the annular hub has at least several diameters. The upper outer diameter 14 located above the first skirt has a smaller outer diameter than the lower outer diameter 15 located below the skirt (see Figure 4 ). In other words, the upper portion of the annular hub is not as thick as the lower portion of the annular hub. This provides greater support under the skirt.

[0052] In a preferred embodiment, as shown in region 16, the stem 10 tapers outward toward the lower diameter 15. This provides a wider support surface against which the annular hub can rest once it is fitted onto the stem. In a preferred embodiment, the shape and configuration of the annular hub 13 precisely correspond to the annular groove 17. The annular hub is preferably constructed of an inherently resilient material to allow it to expand as the stem tip 2 is forced into the aperture defined by the annular hub. To facilitate insertion of the tip into the annular hub, the tip may have a distal region 18 whose diameter decreases toward its distal end and is thus rounded or tapered. The presence of the distal aperture and side apertures 3 and 4 also facilitates temporarily reducing the diameter of the stem to allow the upper portion of the tip to pass through the annular hub. Once the stem is fully inserted into the annular hub, causing it to flex back into the correspondingly sized annular groove, the annular hub is effectively secured in place without requiring any additional bonding between the two separate components of the spray head. In a preferred embodiment, the annular hub may be further secured to the rod by application of a suitable adhesive or by other bonding mechanisms that may, for example, result in the components being chemically bonded. While the previous embodiments contemplate the use of a first skirt of a particular size, other embodiments contemplate a first skirt that may have a larger outer diameter to accommodate use with a particular patient based on their specific requirements.

[0053] like Figure 4 As shown, the inner diameter 19 of the stem in the region of the second skirt 8 is larger than the inner diameter of the stem on either side of the annular groove, as shown by the inner diameter 20. This, combined with the reduced outer diameter above the second skirt, results in an area 21 of reduced wall thickness of the stem, which, depending on the load applied to the spray head, results in an area where the stem may be more susceptible to bending. This area of ​​reduced wall thickness is also advantageous because it can also allow the operator to see or feel the end of the tubing when it is inserted into the section.

[0054] Figure 5 An assembled anal irrigation system is shown, comprising a nozzle 1 of the type described above, secured to a tubular portion 22 that is inserted into the nozzle's opening 9 and inner diameter 19 to achieve a substantially watertight fit. Tubular portion 22 has a bend forming a substantially right angle and, in turn, is connected to a flexible tubing 24 via a connector 23. Another connector 31 connects tubing 24 to a manually operable pump or chamber 25 having flexible walls. Pump 25, in turn, is attached via a connector 26 to tubing 27, which engages a receptacle for a valve 28. Thereafter, another tubing 29 extends between valve 28 and a connector 32 for securing to a reservoir 30. The reservoir includes a filling inlet 33 and an eyelet for facilitating attachment of the reservoir to any suitable securing device, such as a hook.

Claims

1. A nozzle suitable for lavage of the intestinal cavity, comprising: an elongated rod comprising a passage extending therethrough; Thereby, fluid can flow through the passage in use; The shaft comprises a fluid inlet and one or more fluid outlets; and a first skirt that, when secured to the elongated shaft, radially extends from the shaft and is disposed below the fluid outlets as a first radially extending member; the first skirt being inherently flexible; whereby the skirt is sufficiently flexible for insertion through the anus and thereafter resting against the inner wall of the rectum; wherein the first skirt comprises an annular hub; The rod includes an annular groove corresponding to the annular hub; whereby the first skirt is fixed to the elongated rod; The elongated rod includes a tip tapered at its distal end, and the annular hub has an inner diameter that is smaller than an outer diameter of a lower portion of the tip; the annular hub is sufficiently flexible to flex radially to allow the tip to be pushed through the annular hub and subsequently returned to the annular groove and thereby retained; The elongated rod and the first skirt are formed as two separate components; the annular hub is fixed to the elongated rod.

2. The nozzle according to claim 1, wherein The spray head also includes a second skirt extending radially from the rod; the second skirt is arranged at a position closer to the fluid inlet than the first skirt; and wherein the inner diameter of the elongated rod in the area of ​​the rod where the annular hub is fixed is smaller than the inner diameter in the area immediately above the second skirt.

3. The nozzle according to claim 1 or 2, wherein: The annular hub is bonded to the outer portion of the rod.

4. The nozzle according to claim 2, wherein: The flexibility of the second skirt is less than that of the first skirt.

5. The nozzle according to claim 2, wherein: The second skirt is thicker than the first skirt. The nozzle according to claim 2 , wherein: The outer diameter of the rod increases in a region above the second skirt towards the second skirt.

7. The nozzle according to claim 1 or 2, wherein: The first skirt also includes radial slits extending inwardly from its peripheral edge, thereby forming a plurality of petals.

8. The nozzle according to claim 7, wherein: The first skirt includes five or fewer petals.

9. The nozzle according to claim 2, wherein: The outer diameter of the first skirt is greater than the outer diameter of the second skirt.

10. The nozzle according to claim 1 or 2, wherein: The first skirt does not include a fold line.

11. The nozzle according to claim 1 or 2, wherein: The elongated rod includes a tip, and at least one of the fluid outlets is formed as a first opening in the tip.

12. The nozzle according to claim 11, wherein The tip includes a sidewall, wherein the sidewall further comprises at least one fluid outlet.

13. The nozzle according to claim 12, wherein: The side wall includes another fluid outlet.

14. The nozzle according to claim 13, wherein: The further fluid outlet is located diametrically opposite the fluid outlet.

15. The nozzle according to claim 11, wherein The fluid outlet has a distal lip that is rounded.

16. The nozzle according to claim 1 or 2, wherein: The annular hub includes a first outer diameter above the skirt and a second outer diameter below the skirt; the first outer diameter above the skirt is smaller than the second outer diameter.

17. An anal irrigation system comprising a spray head according to any one of the preceding claims.

18. The anal irrigation system according to claim 17, further comprising a plurality of first skirt members having two or more different outer diameters; wherein Each of the skirts includes an annular hub shaped and configured to be secured to the rod.

19. A method of assembling a nozzle suitable for lavaging an intestinal cavity, the method comprising the following steps: providing an elongate rod comprising a passage extending therethrough; whereby, in use, fluid can flow through the passage; the rod comprising a fluid inlet and one or more fluid outlets; Selecting a first skirt having an annular hub; as well as securing the annular hub to the stem; wherein the first skirt projects radially and is the first radially projecting member of the spray head below the fluid outlet, The method further comprises the steps of providing a rod having an annular groove and placing the annular hub in the annular groove, wherein The annular groove corresponds to the annular hub; thereby, the first skirt is fixed to the elongated rod; The elongated rod includes a tip that is tapered at its distal end, and the inner diameter of the annular hub is smaller than the outer diameter of the lower portion of the tip; the annular hub is sufficiently flexible to flex radially to allow the tip to be pushed through the annular hub and then returned to the annular groove and thereby retained.

20. A method of assembling a spray head according to claim 19, including the step of bonding the annular hub to the stem.

21. A method of assembling an anal irrigation system, the method comprising the steps of: Assembling a nozzle according to any one of claims 1-16; further providing a plurality of tubular sections, a plurality of connectors suitable for connecting the plurality of tubular sections, and a pump for pressurizing the liquid of the irrigation system; and connecting the nozzle, the tubular sections and the pump.

Images