Anal irrigation systems

Abstract

An anal irrigation system comprises a nozzle suitable for insertion into at least part of the anal cavity of a user; the nozzle comprising a tubular portion with a plurality of elongate strands; the nozzle comprising at its distal extremity an outlet through which, in use, an anal irrigation fluid exits the nozzle into the anal cavity; a conduit extending from the nozzle and through which liquid flows to the nozzle; a control unit which, in a first mode of use, causes the plurality of elongate strands to bow radially outwards and in a second mode of use, causes the plurality of elongate strands to return to their rest position; wherein the control unit responds to a user input; the control unit being spaced apart from the nozzle.

Description

[0001]

[0002] Anal irrigation systems

[0003] Field of the Invention

[0004] The invention relates to anal irrigation systems. More specifically, the invention relates to anal irrigation systems for bowel management and cleansing. The systems described herein are particularly useful for individuals requiring assistance with bowel function, such as patients with neurogenic bowel dysfunction (e.g., resulting from spinal cord injury, spina bifida, or multiple sclerosis), chronic constipation, or fecal incontinence. The system may also be used for routine bowel cleansing, for example in relation to colostomy care, or for bowel preparation prior to medical or surgical procedures such as a colonoscopy.

[0005] Background to the Invention

[0006] US11541163B2 contains a large number of prior art proposals. One of these shows an anal irrigation system with a nozzle which can be actuated remotely by causing a balloon to inflate. Alternatively, a nozzle is shown which can change its configuration by the user directly applying pressure on the nozzle in a similar fashion to a syringe. Both of theseapproaches have serious drawbacks as the balloon inflation option can cause injury due to over inflation whereas the syringe type actuation is both wholly impractical requiring an operator other than the user whilst at the same time requiring pressure to be applied directly on the nozzle preventing appropriate control. Furthermore, these proposals are not customisable and therefore do not suit a wide range of sizes.

[0007] Summary of the invention

[0008] In a first broad independent aspect, the invention provides an anal irrigation system comprising a nozzle suitable for insertion into at least part of the anal cavity of a user; the nozzle comprising a tubular portion with a plurality of elongate strands; the nozzle comprising at its distal extremity an outlet through which an anal irrigation fluid exits the nozzle into the anal cavity; a conduit extending from the nozzle and through which liquid flows to the nozzle; a control unit which, in a first mode of use, causes the plurality of elongate strands to bow radially outwards and in a second mode of use, causes the plurality of elongate strands to return to their rest position; wherein the control unit responds to a user input; the control unit being spaced apart from the nozzle. This configuration is particularly advantageous as, in preferred embodiments, there is no risk of bursting, as no water or air is used to expand the retaining nozzle. It is particularly advantageous as it allows the user to control the size of the nozzle in an efficient and comfortable manner. Thus, the operation of the nozzle is adaptable whilst being safer to operate than the prior art proposals.

[0009] In a subsidiary aspect in accordance with the first broad independent aspect, the tubular portion houses the fluid conduit. In this configuration, the tubular portion extends to the control unit and the fluid conduit is designed to be movable relative to the tubular portion, such that when it is pulled away from the nozzle, the elongate strands expand outward. In other words, in a preferred embodiment, the control unit pulls on the fluid conduit which draws the head towards the base of the nozzle causing the bowing of the strands. This configuration reverses the prior art teaching and avoids having to apply pressure in the upwards direction as in the prior art proposal.In a subsidiary aspect, the control unit comprises a manually rotatable dial that adjusts the displacement of the fluid conduit relative to the tubular portion based on the degree of rotation. This configuration enables precise and remote user-controlled displacement of the fluid conduit relative to the tubular portion, enabling fine-tuned, reliable and repeatable control over the nozzle expansion.

[0010] In a subsidiary aspect, the dial has distinct pre-determined positions corresponding to predetermined volumes of nozzles. In preferred embodiments, the pre-determined positions ensure repeatable and reliable nozzle expansion each time.

[0011] In certain embodiments, the control unit comprises a lever which causes the fluid conduit to displace relative to the tubular portion dependent upon the extent by which the lever is displaced. This configuration is also particularly advantageous as it further minimises the risk of applying pressure directly on the nozzle as the pressure is applied on the lever and thereafter as in the other embodiments safely transmitted to cause the controlled radial expansion of the nozzle once it is in place.

[0012] In a subsidiary aspect, the lever has distinct pre-determined positions corresponding to predetermined volumes of nozzles. The pre-determined positions ensure repeatable and reliable nozzle expansion each time.

[0013] In certain embodiments, the control unit comprises a linear push-pull button or linear slider which causes the fluid conduit to displace relative to the tubular portion dependent upon the extent by which the push-pull button is displaced and / or dependent upon the extent by which the linear slider is displaced. This form of transmission is particularly advantageous as it separates the user input from the nozzle whilst being particularly intuitive to use.

[0014] In a subsidiary aspect, the linear push-pull button or linear slider have distinct predetermined positions corresponding to pre-determined volumes of nozzles. The predetermined positions ensure repeatable and reliable nozzle expansion each time. This form of input in combination with the improved transmission configuration of preceding aspects, is particularly safe and intuitive to use.

[0015] In a subsidiary aspect in accordance with the first broad independent aspect, the elongate strands are integrally formed in the tubular portion and are separated from one another byone or more longitudinal slits. This configuration allows even, predictable expansion of the nozzle for effective retention. This also allows the nozzle to be formed with very few separate parts which further enhances the safety of the operation. For example, the nozzle, including the tubular portion and the integrally formed elongate strands, may be manufactured as a single piece using methods such as injection molding or 3D printing. The materials used are preferably biocompatible polymers such as polypropylene (PP), Poly ether ether ketone (PEEK), or a medical-grade silicone, selected for their flexibility and durability.

[0016] In a subsidiary aspect, the system comprises a sheath which is shaped and configured to cover at least part of the nozzle and which has an aperture at its distal extremity which corresponds, in use, with the outlet in the nozzle. This configuration helps create a seal to the inside of the rectum to prevent the water coming out. The sheath is also particularly advantageous as it prevents contamination of the catheter which may thus be reused. The sheath by contrast is optionally disposable after each irrigation session. The sheath may be made from a variety of flexible, waterproof, and biocompatible materials, including but not limited to latex, silicone, or a thin polyurethane film.

[0017] In certain embodiments, the control unit may wirelessly send a signal to the nozzle; whereby the signal causes an actuator, in a first mode of use, to displace the plurality of elongate strands so that they bow radially outwards. This configuration is ideal for users with limited mobility, allowing remote activation of nozzle expansion.

[0018] In a further broad aspect, embodiments of the invention provide a method of performing anal irrigation on a user, the method comprising: a. providing an anal irrigation system comprising a nozzle with a plurality of elongate strands, a fluid conduit passing through the nozzle, and a control unit spaced apart from the nozzle; b. inserting the nozzle in a rest position into at least part of the anal cavity of the user; c. actuating the control unit to cause a relative displacement between the fluid conduit and a tubular portion of the nozzle, thereby causing the plurality of elongate strands to bow radially outwards to an expanded position to retain the nozzle within the anal cavity; d. delivering an irrigation fluid through the fluid conduit and out of an outlet at a distal extremity of the nozzle; and e. actuating the control unit to cause the plurality of elongate strands to return to their rest position before removing the nozzle from the anal cavity.In a further subsidiary aspect, the method comprises the step of actuating the control unit to cause the strands to bow outwards comprises rotating a dial.

[0019] In a further subsidiary aspect, the method comprises the step of actuating the control unit comprises displacing a lever or a linear slider.

[0020] In a further subsidiary aspect, the method further comprises the step of actuating the control unit comprises wirelessly sending a signal from the control unit to an actuator within the nozzle.

[0021] In a further subsidiary aspect, the method further comprises the step of placing a disposable sheath over at least part of the nozzle prior to the insertion step.

[0022] In a further subsidiary aspect, the anal irrigation is performed to treat or manage a condition selected from the group consisting of: chronic constipation, fecal incontinence, and neurogenic bowel dysfunction.

[0023] In a further subsidiary aspect, the anal irrigation system is for use in therapy.

[0024] In a further subsidiary aspect, the anal irrigation system is for use in a method of treating or managing a condition selected from the group consisting of: chronic constipation, fecal incontinence, and neurogenic bowel dysfunction.

[0025] In a further subsidiary aspect, the anal irrigation system is for use in a method of bowel preparation prior to a medical procedure.

[0026]

[0027] FIG. 1 shows a side view of an anal irrigation system in which the dial is in a predetermined position corresponding to a pre-determined volume of the nozzle.

[0028] FIG. 2 shows a side view of an anal irrigation system in which the dial is in a first position corresponding to a rest or collapsed mode of the nozzle.FIG. 3 shows a side view and a perspective view of the nozzle in one of its expanded or deployed mode.

[0029] FIG. 4 shows a side view and a perspective view of the nozzle in its rest or collapsed mode.

[0030] FIG. 5 shows a side view and a perspective view of the nozzle in one of its deployed or laterally expanded modes whilst being covered by a translucent flexible sheath.

[0031] FIG. 6 shows a side view and a perspective view of the nozzle in one of its collapsed or rest modes whilst being covered by a translucent sheath.

[0032] FIG. 7 shows a side view and a perspective view of the nozzle in one of its deployed or expanded modes whilst being covered by an opaque sheath.

[0033] FIG. 8 shows a side view and a perspective view of the nozzle in one of its collapsed or rest modes and covered by an opaque sheath.

[0034] FIG. 9 shows a side view and a perspective view of the opaque sheath in one of its deployed or expanded modes.

[0035] FIG. 10 shows a side view and a perspective view of the opaque sheath in one of its collapsed or rest modes.

[0036] FIG. 11 shows a perspective view of the dial in its closed configuration.

[0037] FIG. 12 shows a front view of the dial in its closed configuration.

[0038] FIG. 13 shows a block diagram of an anal irrigation system.

[0039] Detailed Description of the FiguresFigure 1 shows the system 1 comprising a nozzle 8 with a tubular portion 2 and with a plurality of elongate strands 3. The nozzle 8 features at its distal extremity an outlet 4, which in one embodiment, allows anal irrigation fluid to exit the nozzle 8 into the anal cavity. The system 1 further comprises a conduit 6, extending from the nozzle 8 along the longitudinal direction L, and allowing fluid to flow into the nozzle 8. The control unit 15, which located apart from the nozzle 8, comprises a manually rotatable dial 7. When rotated from its closed position 12a — where the elongate strands 3 remain in their rest or collapsed mode — to a pre-determined position 12b or 12c, the dial adjusts the position of the fluid conduit 6 relative to the tubular portion 2. This relative movement causes the elongate strands 3 to bow radially outward along the transverse direction T, thereby securing the nozzle within the anal cavity. Figure 1, shows the dial 7 rotated to pre-determined position 12c, corresponding to the maximum radial expansion of the elongate strands 3. In this configuration, since the expansion is controlled through mechanical displacement rather than pressurised inflation, the risk of rupture or leakage is minimised. Furthermore, since the control unit is positioned apart from the nozzle 8, it allows users to operate the system remotely. This design is particularly beneficial for individuals with limited mobility, as it reduces the need for precise manual adjustments near the insertion site. In other words, the remotely disposed control unit is separated from the nozzle by a transmission mechanism or means to facilitate the displacement of the strands from their rest position to their deployed position.

[0040] Figure 2 shows the system 1 with the dial 7 rotated to its closed position 12a, corresponding to no radial expansion of the elongate strands 3. In this configuration, the nozzle 8 can be easily inserted into or removed from the anal cavity. The ability to fully retract the elongate strands 3 (closed position 12a of the dial) facilitates easier insertion and extraction compared to conventional devices.

[0041] Figure 3 presents both a side view and a perspective view of the nozzle 8 in its open or deployed mode, i.e. with the dial 7 rotated to one of its pre-determined positions 12b or 12c, as shown in Figure 1, causing the elongate strands 3 to bow radially outwards accordingly. Each strand 3 has an elbow 16 which optionally has a pre-determined fold line to allow the strands to readily collapse when the conduit is pulled on by the control unit. The conduit(not visible in figure 3) is, in preferred embodiments, attached to the head 17 of the nozzle which also comprises the fluid outlet.

[0042] Figure 4 presents both a side view and a perspective view of the nozzle 8 in its closed mode, i.e. with the dial 7 rotated to its closed position 12a, as shown in Figure 2, causing the elongate strands 3 to return to their rest position. With the elongate strands 3 in their rest position, the nozzle 8 maintains a compact profile, reducing friction and making insertion and removal smoother and more comfortable. In the lower portion of the nozzle, a skirt 18 is provided to impede the full insertion of the nozzle as it would abut against the rectum of a user. The nozzle also comprises an end tubular 5 located within the skirt. The conduit (not shown in the figures) would be placed inside the end tubular and act as a transmission line when attached to the head of the nozzle.

[0043] Figure 5 presents both a side view and a perspective view of the nozzle 8 in its open mode, i.e. with the dial 7 rotated to one of its pre-determined positions 12b or 12c, as shown in Figure 1, causing the elongate strands 3 to bow radially outwards accordingly, and covered by a sheath 10 which may optionally be translucent and / or opaque. This configuration enhances the safety, usability and comfort of the system 1. The sheath 10 acts as a protective barrier, reducing direct contact with the nozzle 8. The translucent nature of the sheath 10 allows users or caregivers to visually inspect the expansion of the elongate strands 3, ensuring proper positioning.

[0044] Figure 6 presents both a side view and a perspective view of the nozzle 8 in its closed mode, i.e. with the dial 7 rotated to its closed position 12a, as shown in Figure 2, causing the elongate strands 3 to return to its rest mode, and covered by a translucent sheath 10. The translucent sheath may in other embodiments be opaque. The sheath may be of latex or other polymeric flexible material. This configuration keeps the nozzle clean and allows it to be a re-usable element, the sheath also provides a water seal to the rectum and is in this arrangement single-use. In alternative embodiments, it may be re-usable and washable. This configuration enhances the safety, usability and comfort of the system 1. The sheath 10 acts as a protective barrier, reducing direct contact with the nozzle 8 and minimising the risk of contamination.Figure 7 presents both a side view and a perspective view of the nozzle 8 in its open mode, i.e. with the dial 7 rotated to one of its pre-determined position 12b or 12c, as shown in Figure 1, causing the elongate strands 3 to bow radially outwards accordingly, and covered by an opaque sheath 11. This configuration enhances the safety, hygiene and comfort of the system 1. The sheath 11 acts as a barrier, reducing direct contact with the nozzle 8 whereby the sheath may be disposed after a single use whilst the nozzle may be re-used.

[0045] Figure 8 presents both a side view and a perspective view of the nozzle 8 in its closed mode, i.e. with the dial 7 rotated to one of its pre-determined position 12b or 12c, as shown in Figure 2, causing the elongate strands 3 to return to its rest mode, and covered by an opaque sheath 11. This configuration enhances the safety, hygiene and comfort of the system 1. The sheath 11 acts as a barrier, reducing direct contact with the nozzle 8, thus allowing the nozzle to be readily re-used whilst the sheath may be disposed of. In this configuration, with the elongate strands 3 in their rest position and enclosed within the sheath 11, the nozzle 8 remains compact and smooth, making insertion and removal easier and more comfortable.

[0046] Figure 9 presents both a side view and a perspective view of the opaque sheath 11 in its open position.

[0047] Figure 10 presents both a side view and a perspective view of the opaque sheath 11 in its closed position.

[0048] Figure 11 and 12 respectively show a side and a perspective view of the dial 7, highlighting its three predetermined positions — 12a, 12b, and 12c. Each of these positions corresponds to a specific predetermined volume of the nozzle 8, allowing for precise control of its expansion.

[0049] Figure 13 shows a system 20 comprising a first unit 21 comprising the nozzle with a tubular portion and with a plurality of elongate strands. These may be configured as in one or more of the preceding aspects. The first unit 21 comprises a wireless receiver 22 and an actuator23 which when actuated causes the strands to change configuration between a rest configuration and a bowed configuration. In this configuration, a control unit 24 comprises a user interface 25 for receiving user input and a wireless transmitter 27 which may be configured to send signals of actuation to the receiver as illustrated by arrow 26. The control unit may be a user equipment such as a mobile phone with an appropriate software application to instruct the actuation from a spaced apart position. The mode of transmission may be selected from any known wireless or wired transmission protocol which are widely known. For example, the mode of transmission may be a low-energy wireless protocol such as Bluetooth® or Bluetooth Low Energy (BLE), allowing the control unit 24 to be a common user device like a smartphone or a dedicated remote. The nozzle unit 21 would in such a case include a power source, such as a rechargeable battery. A software application on the control unit may provide a graphical user interface (GUI) to allow the user to select pre-determined expansion levels, monitor the duration of the irrigation session, or activate safety lock-out features to prevent accidental actuation.

[0050] This configuration comprises the same structure as defined in the broadest independent aspect of an actuatable nozzle, a transmission causing the actuation of the nozzle and a user interface to facilitate the input into the device.

[0051] Method of Use and Operation

[0052] In a typical application, a method for performing anal irrigation using the system 1 is as follows. First, the user or a caregiver ensures the control unit 15 is set to its initial or rest position (e.g., dial position 12a), ensuring the elongate strands 3 of the nozzle 8 are in their collapsed state (as in Figure 4). Optionally, a new, disposable sheath (10, 11) is placed over the nozzle 8 for hygiene and to provide a seal.

[0053] Next, the nozzle 8 is gently inserted into the user's anal cavity. The skirt 18 at the base of the nozzle acts as a stop to prevent over-insertion. Once the nozzle is in position, the user actuates the control unit 15. For example, the user may rotate the dial 7 from position 12a to a pre-determined expanded position (12b or 12c). This actuation causes the fluid conduit 6 to be drawn proximally relative to the tubular portion 2, creating a compressive force that causes the elongate strands 3 to bow radially outwards (as in Figure 3). This expansion anchors the nozzle securely and comfortably within the rectum.With the nozzle anchored, an irrigation fluid is then delivered from a fluid source (not shown), through the conduit 6, and out of the fluid outlet 4 into the anal cavity. After the irrigation procedure is complete, the user actuates the control unit 15 back to its rest position 12a. This relieves the compressive force, allowing the elongate strands 3 to return to their collapsed, rest position. Finally, the nozzle 8 can be smoothly and comfortably withdrawn from the anal cavity. If a disposable sheath was used, it can be removed and discarded, allowing the nozzle to be cleaned for re-use.

Claims

CLAIMS1. An anal irrigation system comprising a nozzle suitable for insertion into at least part of the anal cavity of a user; the nozzle comprising a tubular portion with a plurality of elongate strands; the nozzle comprising at its distal extremity an outlet through which, in use, an anal irrigation fluid exits the nozzle into the anal cavity; a conduit extending from the nozzle and through which liquid flows to the nozzle; a control unit which, in a first mode of use, causes the plurality of elongate strands to bow radially outwards and in a second mode of use, causes the plurality of elongate strands to return to their rest position; wherein the control unit responds to a user input; the control unit being spaced apart from the nozzle.

2. The system of claim 1, wherein the control unit is separated from the nozzle by a transmission mechanism.

3. The system of claim 1, wherein the tubular portion is provided around a portion of the fluid conduit; wherein the fluid conduit extends to the control unit and the fluid conduit is moveable relative to the tubular portion; whereby when the fluid conduit is drawn away from the nozzle the plurality of elongate strands bow radially outwards.

4. The system of claim 3, wherein the control unit comprises a dial which is manually rotatable; and which causes the fluid conduit to displace relative to the tubular portion dependent upon the extent by which the dial is rotated.

5. The system of claim 4, wherein the dial has distinct pre-determined positions corresponding to pre-determined volumes of nozzles.

6. The system of claim 3, wherein said control unit comprises a lever which causes the fluid conduit to displace relative to the tubular portion dependent upon the extent by which the lever is displaced.

7. The system of claim 6, wherein the lever has distinct pre-determined positions corresponding to pre-determined volumes of nozzles.

8. The system of claim 3, wherein said control unit comprises a linear push-pull button or linear slider which causes the fluid conduit to displace relative to the tubular portion dependent upon the extent by which the push-pull button is displaced and / or dependent upon the extent by which the linear slider is displaced.

9. The system of claim 8, wherein the linear push-pull button or linear slider have distinct pre-determined positions corresponding to pre-determined volumes of nozzles.

10. The system of any one of the preceding claims, wherein the elongate strands are integrally formed in the tubular portion and are separated from one another by one or more longitudinal slits.

11. The system of any one of the preceding claims, comprising a sheath which is shaped and configured to cover at least part of the nozzle and which has an aperture at its distal extremity which corresponds, in use, with the outlet in the nozzle.

12. The system of claim 11, wherein the sheath is configured to provide a seal to the inside of the rectum.

13. The system of claim 1, wherein the control unit wirelessly sends a signal to the nozzle;whereby the signal causes an actuator, in a first mode of use, to displace the plurality of elongate strands so that they bow radially outwards.

14. A method of performing anal irrigation on a user, the method comprising: a. providing an anal irrigation system comprising a nozzle with a plurality of elongate strands, a fluid conduit passing through the nozzle, and a control unit spaced apart from the nozzle; b. inserting the nozzle in a rest position into at least part of the anal cavity of the user; c. actuating the control unit to cause a relative displacement between the fluid conduit and a tubular portion of the nozzle, thereby causing the plurality of elongate strands to bow radially outwards to an expanded position to retain the nozzle within the anal cavity; d. delivering an irrigation fluid through the fluid conduit and out of an outlet at a distal extremity of the nozzle; and e. actuating the control unit to cause the plurality of elongate strands to return to their rest position before removing the nozzle from the anal cavity.

15. The method of claim 14, wherein the step of actuating the control unit to cause the strands to bow outwards comprises rotating a dial.

16. The method of claim 14, wherein the step of actuating the control unit comprises displacing a lever or a linear slider.

17. The method of claim 14, wherein the step of actuating the control unit comprises wirelessly sending a signal from the control unit to an actuator within the nozzle.

18. The method of any one of claims 14 to 17, further comprising the step of placing a disposable sheath over at least part of the nozzle prior to the insertion step.

19. The method of any one of claims 14 to 18, wherein the anal irrigation is performed to treat or manage a condition selected from the group consisting of: chronic constipation, fecal incontinence, and neurogenic bowel dysfunction.

20. The anal irrigation system of any one of claims 1 to 13, for use in therapy.

21. The anal irrigation system of any one of claims 1 to 13, for use in a method of treating or managing a condition selected from the group consisting of: chronic constipation, fecal incontinence, and neurogenic bowel dysfunction.

22. The anal irrigation system of any one of claims 1 to 13, for use in a method of bowel preparation prior to a medical procedure.

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