GB2563933A - Improved nozzle and anal irrigation system - Google Patents

Improved nozzle and anal irrigation system Download PDF

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Publication number
GB2563933A
GB2563933A GB1710535.4A GB201710535A GB2563933A GB 2563933 A GB2563933 A GB 2563933A GB 201710535 A GB201710535 A GB 201710535A GB 2563933 A GB2563933 A GB 2563933A
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GB
United Kingdom
Prior art keywords
skirt
stem
nozzle
nozzle according
fluid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
GB1710535.4A
Other versions
GB201710535D0 (en
Inventor
John Robbins Paul
Ian Harvey Nicholas
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
AQUAFLUSH MEDICAL Ltd
AQUAFLUSH MEDICAL Ltd
Original Assignee
AQUAFLUSH MEDICAL Ltd
AQUAFLUSH MEDICAL Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by AQUAFLUSH MEDICAL Ltd, AQUAFLUSH MEDICAL Ltd filed Critical AQUAFLUSH MEDICAL Ltd
Priority to GB1710535.4A priority Critical patent/GB2563933A/en
Publication of GB201710535D0 publication Critical patent/GB201710535D0/en
Priority to GB1810836.5A priority patent/GB2565640B/en
Publication of GB2563933A publication Critical patent/GB2563933A/en
Withdrawn legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/02Enemata; Irrigators
    • A61M3/0279Cannula; Nozzles; Tips; their connection means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/02General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0216Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/10Trunk
    • A61M2210/1042Alimentary tract
    • A61M2210/1067Anus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00Medical syringes, e.g. enemata; Irrigators
    • A61M3/02Enemata; Irrigators
    • A61M3/0279Cannula; Nozzles; Tips; their connection means
    • A61M3/0295Cannula; Nozzles; Tips; their connection means with inflatable balloon

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

A nozzle 10 for irrigating the rectum and colon has an elongate stem 13 with a longitudinal channel 40 for fluid flow. The stem has a fluid inlet 35 and one or more fluid outlets 18 in a tip 11, and a first skirt (20, figure 1D) protruding radially which is sufficiently flexible to insert through the anus and rest against the internal wall of the rectum. The stem and first skirt may be integrally formed from a single piece of plastic and the first skirt may have radial slits or fold lines extending inwardly from its peripheral edge. Preferably a second skirt (26), which is thicker, wider and less flexible, is located near the fluid inlet. The base of the stem may form a connection portion 12 for attaching to a fluid supply tube and may have knurls 51 on its outer surface. Figure 3 shows a connection adapter. The sidewall of the stem may have a thinner portion to permit flexing.

Description

The technical field relates to a nozzle for irrigating the rectal and/or bowel cavities and to anal irrigation systems incorporating such nozzles.
The closest prior art know to the applicant is a nozzle employed in an anal irrigation system sold under the trade name Peristeen which is a registered trade mark. This system requires a rectal catheter which is of solid hard plastics and incorporates a solid elongate body with a fluid inlet at its tower most extremity and a fluid outlet at its upper most extremity, The elongate body has a single wide portion in order to facilitate its handling by an operator. As part of the stem of the catheter an inflatable portion is provided which once the catheter is in position can be inflated into an annular balloon for engaging the wall of the rectal cavity. The recomm? ided distance of insertion is indicated solely by a line on the outside of the catheter. The mf.atable portion and the hard plastics material used tend to cause damage. In addition, over insertion is a risk which can lead to other complications, in overall terms, the control system with wh ch it operates is necessarily complex with a counterintuitive selection between a pumping mode and an inflation mode for the balloon.
In a first broad independent aspect, the invention provides a nozzle 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; said stem incorporating a fluid inlet and one or more fluid outlets; and a first skirt protruding radially from the stem and which is inherently flexible; 'whereby the skirt Is sufficiently flexible for insertion through the anus and to thereafter rest against the internal wad of the rectum.
This configuration is particularly advantageous because it improves the insertion and removal of a nozzle for anal Irrigation whilst significantly simplifying the structure of the nozzle and the system with which it operates. in a subsidiary aspect,, the stem and the first skirt are integrally formed as a single piece of inherently flexible plastics material. This lends itself particularly for damage free insertion and removal whilst allowing the nozzle to be a disposable one use product. If necessary.
In a further subsidiary aspect, the nozzle further incorporates a second skirt protruding radially from the stem; the second skirt being provided in a location which is closer to the fluid inlet than the location of the first skirt. This is particularly advantageous in minimising the risk of over Insertion whilst Improving the comfort for a user.
In a further subsidiary aspect, the second skirt is less flexible than the first skirt which allows the first skirt to readily be inserted whilst allowing the second skirt to resist such insertion. in a further subsidiary aspect, the second skirt is thicker than the first skirt. This allows in particular a contrast between the insertion of the first skirt into the rectal cavity and a resistance to insertion when it concerns the second skirt.
In a further subsidiary aspect, the second skirt has a diameter which is greater than the diameter of the first skirt. This further facilitates the technical effects associated with the respective skirts.
In a further subsidiary aspect, the stem Increases In diameter in a lower portion towards the second skirt. This provides an improved structural strength and thus minimises the risk of fracture in this location.
In a further subsidiary aspect, the first skirt further incorporates radial slits extending inwardly from its peripheral edge. This configuration may be particularly advantageous for the smooth insertion and removal of the nozzle. It also minimises the risks of damage to the body during the insertion and removal process.
In a further subsidiary aspect, the first skirt further comprises fold lines for facilitating the folding of the first skirt on itself. This configuration may also be particularly advantageous for the smooth insertion and removal of the nozzle, it also minimises the risks of damage to the body during the insertion and removal process. in a further subsidiary aspect, the elongate stem incorporates a lip and at least one of the fluid outlets is formed as a first aperture in the tip. This configuration is particularly advantageous since It allows In certain embodiments for the apertures to be spaced from the first skirt in order to locate the fluid outlet in a position for improved anal irrigation.
In a further subsidiary aspect, the stem comprises a side wall, wherein the side wall further incorporates at least a fluid outlet. This provides lateral irrigation which will improve the efficiency of the fluid delivery,
In a further subsidiary aspect, the side wall Incorporates a further fluid outlet. This allows the pressure to be minimise In the outlets which improves the safety and efficiency of the irrigation process.
In a further subsidiary aspect, the further fluid outlet is located diametrically opposite a fluid outlet. in a further subsidiary aspect, the stem incorporates a recessed portion shaped and configured to be attached, in use, to a fluid supply connector, the recessed portion having a wall with an inner most portion which is surrounded by the second skirt and which is thicker than the wall of the stem between the first and second skirts. This provides a further improvement to the structural strength of the nozzle to improve its insertion capability.
In a further subsidiary aspect, the recessed portion incorporates a lowermost wall with one or more protruding knurls on the outside surface of said lowermost wall This is particularly advantageous in improving the handling of the nozzle.
In a further broad aspect, the invention provides an anal irrigation system comprising a nozzle in accordance with any of the preceding aspects.
In a further broad aspect, the invention provides a nozzle or an anal Irrigation system substantially as herein described and/or illustrated in any appropriate combination of the accompanying text and figures,
BlMfealptM^Ih&.DiawIngs
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 is a first embodiment of an anal irrigation nozzle in multiple views. Figure 1a, is a first side view, Figure 1b is a second side view, Figure 1c is a cross-sectional view, Figure Id is a perspective view, and Figure 1e is a top view.
Figure 2 is a second embodiment of an anal Irrigation nozzle in multiple views. Figure 2a, is a side view. Figure 2b is a second side view, Figure 2c is a cross-sectional view, Figure 2d is a perspective view and Figure 2e is a top view.
Figure .3 is a second embodiment of an anal, irrigation nozzle and connecting adaptor in multiple views. Figure 3a is a side view. Figure 3b Is a second side view, Figure 3c is a second side view in cross-section and Figure 3d is a perspective view.
Detailed Descrlptlon of.tbe.Imbodlments
In an embodiment, the Invention provides a nozzle attachment designed and configured to be used in conjunction with a tune configuration, for use as part of an anal Irrigation apparatus. The primary function of the nozzle is to allow the introduction of fluid into a patient's bowel to initiate an irrigation session, The nozzle is designed to create an improved insert and location of the nozzle in the rectum of the patient to prevent premature and unwanted leakage of fluid and faecal matter from the anus during an irrigation session. The nozzle comprises a superior tip incorporating one or more holes and a first rad ally extending flexible skirt, a connector Incorporating a second radially extending skirt and an aperture suitable for attachment to a tube and a flexible stem connecting therebetween. In use, the tip is dessgr eo to be inserted in the anus, the first skirt capable of deforming such that it Is suitable tor insertion passed the anus of a patient. The second skirt on the connector is less flexible and is shaped to resist entry into the anus, preventing the nozzle from being fully inserted within the anus and optimally locating the nozzle such that the first skirt sits potentially across the anus and the flexible stem sits within the rectum. The flexible first skirt is resilient, and after deformation for insertion into the anus, returns to its original shape. At the conclusion of the irrigation session, the first skirt can deform in the opposite direction as for insertion, allowing the nozzle to be removed from the patient's rectum and the fluid and faecal matter to drain away.
Although the current embodiment, describes the use of the nozzle as a separate attachment for use with a tube, further embodiments provide a nozzle which is integral with a tube or pump apparatus.
Furthermore, embodiments are envisaged where the nozzle is integral with an anal irrigation system. It should be understood that the invention is particularly advantageous when optionally associated with mechanical, self-controlled systems or automated pump systems. The nozzle itself may be optionally a one-use disposable nozzle, in further embodiments, a lubricant may be employed either with the nozzle or the outer surface of the nozzle may have a particularly low level of friction or even an integral lubricated surface to allow the nozzle to be ready for use.
To provide clarity, the elements of the invention which are common to each figure have retained identical numerical references throughout.
Figures 1a-e show a first embodiment of an anal irrigation nozzle 10. The nozzle 10 comprises an elongate stem 13 extending along an axis 1, with a superior tip portion 11, an inferior connector portion 12 and a channel 40 extending therethrough.
Shown best in Figure 1c, the connector or connection portion 12 of the stem has a substantially hollow cylindrical shape, incorporating a cylindrical outer surface 16 and a cylindrical inner surface 14 defining a cavity 15, At the inferior end of the connector 12, as oriented in Figure 1, distal from the tip 11, a rim 25 defines the aperture of the cavity 15. The cavity 15 is substantially cylindrical in shape, centred around axis 1 with a diameter 42, At the superior end of the cavity 15 the ledge 41 defines the aperture 35 leading to a second substantially cylindrical cavity 46 defined by inner surface 32, At the superior end of the cavity 46, distal from the cavity 15. a second ledge 33 defines an aperture 47. These various cavities form together channel 40. The aperture 35 has a diameter less than the diameter 42 of the cavity 15 and in turn, the aperture 47 has a diameter less than the diameter of the cavity 46. In this embodiment, the cavity 46 and the narrowest part of the channel 40 are co~cenlrsc about axis 1.
In use. the cavity 15 is suitable for the insertion of a tube (not shown), such that the outer surface of the tube, is in frictional engagement with the inner surface 14 of the connector portion 12, substantially forming a seal. A downstream portion of the tube inserted into the cavity 15 of the connector 12, comes into contact with the ledge 41 preventing further insertion into the nozzle 10, In an embodiment, the aperture 35 allows the movement of fluid from the downstream end of the tube to pass along the narrowest portion of channel 40. In a preferred embodiment, the diameter of the aperture 35 is equal to the diameter of the inner surface of the tube, such that the flow of fluid is undisturbed. in an alternative embodiment, the connector portion 12 can be attached to a tube by any suitable means such that the tube and the cavity 15 are in fluid attachment. For example, in an alternative embodiment, the outer surface 16 of the connector portion 12 can be of a diameter substantially equal to that of the aperture within the tube such that in use the connector portion 12 is inserted into a tube, such that the outer surface 16 in is frictional attachment with the inner surface of s tube, substantially forming a seal in a further alternative embodiment, adaptors can be used to create fluid attachments between the connector portion 12 of the nozzle 10 and tubes of varied diameter. in a preferred embodiment, \hcwn in Figure la, the outer surface 16 of the connector portion 12 further incorporates gripping protrusions 51 which may be knurls. The gripping protrusions 51 increase the coefficient of friction Improving the users grip on the connector portion 12 during use, in this embodiment, the gripping protrusions 51 are elongate ridges extending from a superior end of the connector 12 to the inferior end. In an alternative embodiment, the gripping protrusions, could be a plurality of domed protrusions or cut away grooves, or any other suitable means of improving the grip the user has when interacting with the connector 12.
Referring to Figures 1c and 1 d, at. the superior end of the connector portion 12 is a second skirt 26, The skirt 26 extends radially around axis 1 in a substantially perpendicular direction. The skirt 26 has an upper surface 27, a lower surface 28 and a peripheral edge 29 at the exterior confluence of the two. In the current embodiment, the skirt 26 Is integrally formed with the nozzle 10, such that the upper surface 27 of the skirt 26 is continuous with the outer surface 19 of the stem 13 and the lower surface 28 of the skirt 26 is continuous with the outer surface 16 of the connector portion 12. Alternatively, in further embodiments, the skirt 26 can be separately formed and attached to the nozzle 10 by any suitable means known in the art, such as adhesive, clipping, bolting or melding.
The upper surface 27 of the skirt 26 has an upwardly inflecting curve tending towards its centre at the confluence with the outer surface IS of the stem 13. The lower surface 28 of the skirt 26, also has an upwardly inflecting curve tending towards its centre, forming an acute angle of intersection at the confluence with the outer surface 16 of the connector 12.
The distance between the upper surface 27 and the lower surface 28 of the skirt 26 is uniform around the periphery giving it a vertical thickness 31, The radius of curvature of the upper surface 27 is substantially equal to the radius of curvature of the lower surface 28 and therefore the thickness 31 of the skirt 26 is substantially equal al ail points. The diameter of the connector portion 12 is greater than the diameter of the uopoer portion of stem 13 and therefore the radius of the upper surface 27 is correspondingly greater than the radius of the lower surface 28,
At the superior end of the skirt 26 is an elongate portion of stem 13 with a centre around axis 1, The stem 13 has a substantially cylindrical wall 48 with an outer surface 19 which is continuous with the upper surface 27 of the skirt 26. The diameter of the stem 13 increases as it tends towards the skirt 26, The wall 48 of the stem 13 has a substantially cylindrical inner surface 34 defining a channel 40. The channel 40 extends through the stem 13 connecting the aperture 18 in the tip 11 with the aperture 47 proximal to the cavity 46, In the current embodiment, the cavity 46 is located within the stem 13. At the inferior end of the stem 13, as oriented in Figure 1c( proximal to the cavity 46, the wail 48 decreases in thickness. This decreased thickness of the 'wall 48 increases the flexibility of the stem 13 enabling the nozzle 10 to be angled slightly during an irrigation session, reducing the requirement for the tube and nozzle to be perfectly oriented. The result is a more comfortable experience for the patient,
The tip 11 of the nozzle 10 has a substantially cylindrical wall 49 with a substantially cylindrical outer surface 17. At the superior end, distal from the stem 13, the tip 11 incorporates an aperture 18 with rim 44. In the current embodiment, the rim 44 is substantially circular, in an alternative embodiment, the rim 44 can be selected from the following: elliptical, teardrop shaped, square, rectangular, or hexagonal. The outer surface 17 of the tip 11 tapers at the superior end as it converges with the rim 44 such that the rim 44 is rounded at its confluence with the outer surface 17. This is so that the nozzle does not damage the delicate tissue within the rectal canal during insertion,
Referring now to Figure la and 1 b, the wall 49 of the tip 11 further Incorporates two laterally facing apertures S3 and 54 respectively. The apertures S3 and 54 extend into channel 40 such that fluid entering channel 40 at its inferior end proximal to cavity 15, can exit from apertures 53 and 54. In the current embodiment, the apertures S3 and 54 are substantially oval with two longer edges 55a and 55b, and two shorter edges 56a and 56b respectively. In an alternative embodiment, the apertures 53 and 54 are selected from the following: elliptical, teardrop shaped, square, rectangular, or hexagonal.
The confluence between the apertures S3 and 54 and the outer surface 17 of the tip 11 Is rounded to remove any sharp edges and prevent damage to the soft anal tissue of the patient during use. In the current embodiment, the apertures 53 and 54 are located on substantially opposite sides of the tip 11. In use, the side apertures 53 and 54 spray fluid fluids up the side wails of the anal canal in addition to the upwardly facing aperture 18. The orientation of the apertures 53 and 54 assists in dislodging faecal matter at all regions of the bowel creating the greatest coverage of fluid spray.
In an embodiment, the apertures 53 and 54 are equally distributed along the vertical axis of the tip 11, as oriented in Figure 1b, In an alternative embodiment, the apertures 53 and 54 are located on the same side of the tip 11. In a further alternative embodiment, the aperture 53 and 54 are dlsparateiy located along the vertical axis of the tip 11.
Referring again to Figures 1c and Id, at the inferior end of the tip 11, proximal to the stem 13, is a first, skirt. 20. The skirt 20 forms a planar disc extending radially from the outer surface 19 of the stem 13 centred around axis 1. The skirt 20 has an upper surface 21, lower surface 22 and an edge 23 at the peripheral confluence of the two. The upper surface 21 and lower surface 22 of the skirt 20 are substantially parallel giving the skirt 20 a substantially uniform thickness 30. in the current embodiment, the skirt 20 is integrally formed with the nozzle 10, such that the upper surface 21 of the skirt 20 is continuous with the outer surface 17 of the tip 11 and the lower surface 22 of the skirt 20 is continuous with the outer surface 19 of the stem 13. Alternatively, the skirt 20 can be separately formed and attached to the nozzle 10 at a junction 52 by adhesive. In this embodiment, the upper surface 21 and the lower surface 22 are upwardly projecting as oriented in Figure 1c, such that, the edge 23 is superior to the junction 52, The confluence of the upper surface 21 of the skirt 20 and the outer surface 17 of the tip 11 is acute. This angled confluence between the skirt 20 and the stem 13 allows easier removal of the nozzle 10 from the anus after completion of the irrigation session.
In an alternative embodiment, the skirt 20 could extend substantially perpendicular from the stem 13. in a further alternative embodiment, the edge 23 of the skirt 20 could be inferior from the junction with the stem 13 such that the upper surface 21 and lower surface 22 are downwardly projecting as oriented in Figure 1 and the skirt 20 is substantially frustoconlcal in shape.
Optionally, the confluence of the lower surface 22 of the skirt 20 and the outer surface 13 of the stem 13 can incorporate a curvature. This curvature can prevent sharp edges that can catch during removal of the nozzle 10 after an irrigation session.
In an embodiment, as shown in Figure 1e, the skirt 20 extends radially from axis 1 such that the edge 23 is equidistant from axis 1 at all points around the circumference, in an embodiment, the edge 23 of the skirt 20 is substantially circular, when viewed along the axis 1, In an alternative embodiment, the skirt 20 can be offset around the axis 1, such that the edge 23 is closer to the axis 1 at certain points around the circumference and further away at other points, in a further alternative embodiment, the edge 23 can be oval, square, or rectangular. In use, the diameter and circumference of the skirt 20 should be substantially equal to the diameter and circumference of the patient's inner wall of the anal canal in an alternative embodiment, the skirt 20 can be pre-designed to be shaped to fit the rectal canal of the user, tailored for a given patient to create the best fit during use. In a further alternative embodiment, the skirt 20 could be shaped to have a diameter greater than the diameter of a patient’s rectal canal and then trimmed to fit the dimensions of the patient's canal
The thickness 30 of the skirt 20 Is uniform, with the distance between the upper surface 21 and the Lower surface 22 equal at all locations. In a preferred embodiment, the thickness 31 of the skirt 26 is greater than the thickness 30 of the skirt 20. As a result, the skirt 26 is less flexible than the skirt 20 and unable to deform to the same degree as the skirt 20,
In use, the nozzle 10 is attached to a suitable tube and pumping apparatus. The user, either the patient themselves or the practitioner, takes hold of the outer surface 16 of the connector 12 controlling the movement of the nozzle 10, The gripping portions 51 provide increased grip, allowing the user to better control the movement of the nozzle 10. This is particularly beneficial if small amounts of fluid leak onto the nozzle making it wet and decreasing the frictional grip. The tip 11 of the nozzle 10 is brought into contact with the anal sphincter of the patient and gentle pressure is applied. The rounded rim 44 of the tip 11 slides into the anus, followed by the tip 11. As the first skirt 20 comes into contact with the anus, it deforms. The thickness 30 of the skirt 20 is suitable to allow the skirt 20 to conform to different positions with minimal external pressure. As the user pushes the nozzle 10 into the anal sphincter, the peripheries of the skirt are forced into a position distal from the tip 11, The edge 23 of the skirt 20 moves from a location superior to the junction 52, as oriented in figure 1, to a location inferior to the junction 52. The upper surface 21 and lower surface 22 of the skirt 20 move proximal to the stem 13, The diameter of the skirt 20 is generally decreased allowing the first skirt 20 to be inserted through the patient’s anus. The nozzle 10 sits partially within the rectal cavity and partially external to the anus.
As the nozzle 10 is inserted into the rectal cavity, the upper surface 27' of the second skirt 26 may come into contact with the anal sphincter of the patient in order to prevent the nozzle for further insertion. The second skirt 26 is relatively Inflexible and resists insertion into the anus, preventing the user from inserting the nozzle 10 any further into the anal canal. The increased diameter of the stem 13 as it tends towards the second skirt 26 creates an improved fit with the anus of the patient.
The distance between the first skirt 20 and the second skirt 26 is designed to allow the nozzle to traverse the anus, 'with the tip 11 and the first skirt 20 housed within the anal cavity and the connector 12 and second skirt 26 exterior to the anus, and the stem 13 within the anus Itself. The length of the stem 13 also optimally locates the nozzle 10 in the anal cavity to pump fluids and loosen the stool.
Once inside the anal canal, the deformed and resilient first skirt 20, returns to its original shape. The lower surface 22 of the skirt 20 comes into a resting contact with the inner surface of the patient’s rectum. Optionally, the skirt 20 is sized so that the edge 23 of the skirt 20 is in dose proximity with the 'wall of the anal canal, inhibiting the movement of fluid fluids past the first skirt 20 and towards the anal sphincter. The diameter of the stem 13 is shaped to sit comfortably with the anus of the patient during the irrigation session.
When the irrigation session has been completed and the patient is in a suitable position and location, the nozzle 10 can be removed, As the user begins to pull on the connector portion 12 of the nozzle 10, the first skirt 20 can deform to a second position suitable for removal from the patient’s anal cavity. The edge 2.3 of the skirt 20 moves in an upward direction as oriented In figure 1, proximal to the tip 11. The upper surface 21 of the skirt 20 moves proximal and substantially parallel to the outer surface 17 of the tip 11 and the radial width of the skirt 20 is generally decreased and can slide from the patient's anus. The tip 11 is also removed, allowing the fluid and faecal matter to run out of the patient's anus in the controlled environment.
Figures 2a-e shows a second embodiment of an anal irrigation nozzle 10, The displayed embodiment, has the features of the embodiment of Figure 1 with a partitioned first skirt 20 and a relocated cavity 46. The skirt 20 incorporates radial slits 61 extending from the edge 23 towards the axis 1, and as a result the skirt 20 is separated into petal shaped protrusions 60a-f. Each protrusion 60a-f has a peripheral width greater than the medial width. In the current embodiment, the protrusions 60a-f have rounded exterior corners proximal to the radial slits 61, This prevents the potentially sharp comers from catching on the delicate tissue in the anal canal. In the current embodiment, the radial slits 61 create a gap between adjacent protrusions. tn use, the separated protrusions 60a-f created by the radial slits 61, facilitates the deformation of the skirt 20 during Insertion and removal of the nozzle from the anus. In the current embodiment, the skirt 20 has been divided into six protrusions 60a-f, in an alternative embodiment, the skirt 20 could be separated into 3, 4, 5 or any other number of protrusions, in the current embodiment, the protrusions 6Ga-f are equally sized and distanced around the circumference and the radial slits 61 are also equally sized and distributed. In an alternative embodiment, the protrusions could be of varied sizes. In a further alternative embodiment, the protrusions can be separated by unequal spaces, with some protrusions closer together than others.
In use, as the nozzle 10 is inserted into the patient’s anus, the skirt deforms into a first position with the edge 23 moving proximal to the stem 13. In the embodiment of Figure 1, the length of the edge 23 itself cannot change, therefore so that the skirt 20 can occupy a decreased radial diameter, the edge 23 displaces from proximal to the stem 13 to distal to the stem, in the current embodiment, during insertion, the slits 61 separating the protrusions 60a-f decrease as the diameter of the skirt 20 decreases. Furthermore, the individual protrusions 80a-f can move independently of each other, allowing the protrusions 60a-f to overlay one another and further decrease the diameter of the skirt 20 and as a result, increasing the ease of insertion end removal of the nozzle 10. in this embodiment, the slits 61 In the skirt 20 do not extend to the stem 13. In an alternative embodiment, the slits may be replaced by fold line which may be thinner portions for greater flexibility of Insertion and removal
Figures 3a-d shows the second embodiment of an anal irrigation nozzle 10 attached to an adaptor 80 for use in attaching to a tube and pump assembly suitable for an anal irrigation session.
The adaptor 80 incorporates a substantially cylindrical tube 81 suitable for the delivery of fluids for use during an anal irrigation session, The tube 81 has a diameter substantially equal to the cavity 46 such that, in use, the tube 81 can be inserted into the cavity 46 substantially forming a seal with the inner surface 32 of the cavity 48. The adaptor 80 further incorporates a ridge 82 extending radially from the outer surface of the tube 81, The ridge 82 has a radial diameter substantially equal to the cavity 15, such that, in use, the ridge 82 sits against the ridge 41 whist the tube 81 enters the cavity 46 via the aperture 35. The downstream tip of the tube 81 comes into contact with the ledge 33 at the superior end of the cavity 46 preventing insertion into the channel 40.
The nozzle 10 is formed from a flexible resilient material. Preferably the nozzle is formed of a plastics material. Further preferably the nozzle is formed of a single moulded piece to reduce connection points which can create ledges which can snag the delicate anal tissue during insertion or removal of the nozzle from the anus.

Claims (14)

  1. Llaims
    1. A nozzle 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 said channel; said stem incorporating a fluid inlet and one or more fluid outlets; and a first skirt protruding radially from said stem and which is inherently flexible; whereby said skirt, is sufficiently flexible for Insertion through the anus and to thereafter rest against the internal wall of the rectum.
  2. 2. A nozzle according to claim 1.. wherein said stem and said first skirt are integrally formed as a single piece of inherently flexible plastics material.
  3. 3. A nozzle according to either claim 1 or claim 2, wherein said nozzle further incorporates a second skirt protruding 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.
  4. 4. A nozzle according to claim 3, wherein said second skirt is less flexible than said first skirt,
  5. 5. A nozzle according to either claim 3 or claim 4, wherein said second skirt is thicker than said first skirt.
  6. 6. A nozzle according to any one of claims 3 to 5, wherein said second skirt has a diameter which Is greater than the diameter of said first skirt.
  7. 7. A nozzle according to any one of claims 3 to 5., wherein said stem increases in diameter tn a lower portion towards said second skirt.
  8. 8. A nozzle according to any of the preceding claims, wherein said first, skirt further incorporates radial slits extending inwardly from its peripheral edge,
  9. 9. A nozzle according to any of the preceding claims, wherein said first skirt further comprises fold lines for facilitating the folding of said first skirt on itself, '10. A nozzle according to any of the preceding claims, wherein said elongate stem Incorporates a tip and at least one of said fluid outlets Is formed as a first aperture in said tip.
  10. 11. A nozzle according to any of the preceding claims, wherein said stem comprises a side wall, wherein said side wall further incorporates at. least a fluid outlet.
  11. 12. A nozzle according to claim 11, wherein said side wall Incorporates a further fluid outlet.
  12. 13. A nozzle according to claim 12, wherein said further fluid outlet Is located diametrically opposite a fluid outlet,
  13. 14. A nozzle according to any one of claim 3 to 13, wherein said stem incorporates a recessed portion shaped and configured to be attached, in use, to a fluid supply connector, said recessed portion having a wall with an inner most portion which is surrounded by said second skirt and which is thicker than the wall of the stem between the first and second skirts, 1.5, A nozzle according to claim! 14, wherein said recessed portion incorporates a lowermost wall with one or more protruding knurls on the outside surface of said lowermost wall.
  14. 16. An anal irrigation system comprising a nozzle in accordance with any of the preceding claims.
GB1710535.4A 2017-06-30 2017-06-30 Improved nozzle and anal irrigation system Withdrawn GB2563933A (en)

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GB2596602A (en) * 2020-07-03 2022-01-05 Renew Medical Uk Ltd Improved nozzle, anal irrigation system, methods of assembly and of anal irrigation

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DK181106B1 (en) * 2020-08-20 2022-12-21 Mbh International As A self-retaining enema nozzle and an enema system comprising said enema nozzle
US20220105257A1 (en) * 2020-10-05 2022-04-07 Guy Merz Rectal Irrigation Apparatus
GB2614535A (en) 2021-12-31 2023-07-12 Renew Medical Uk Ltd Anal irrigation system, pump unit, methods of assembly and of anal irrigation

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GB2596602A (en) * 2020-07-03 2022-01-05 Renew Medical Uk Ltd Improved nozzle, anal irrigation system, methods of assembly and of anal irrigation

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GB201810836D0 (en) 2018-08-15
GB201710535D0 (en) 2017-08-16
GB2565640A (en) 2019-02-20
GB2565640B (en) 2019-10-16

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