WO2009152568A1

WO2009152568A1 - Bowel irrigation method and apparatus

Info

Publication number: WO2009152568A1
Application number: PCT/AU2009/000770
Authority: WO
Inventors: Brian Bernard Mckeon; Robert Henry Frater; Linda Elizabeth Laidlaw; Anthony Clyde Neason Stephens
Original assignee: Colocare Holdings Pty Limited
Priority date: 2008-06-17
Filing date: 2009-06-17
Publication date: 2009-12-23
Also published as: AU2009260112A1; EP2303358A1

Abstract

The present invention relates to an apparatus for facilitating irrigation of the bowel, particularly useful for conditions where a patient has had a colostomy. The apparatus comprises a vessel in the form of a flexible bag which is mounted in a solid walled container. Variable pressure is applied, by an air pump, between the walls of the container and the vessel in order to cause irrigant to be introduced to an intestine via an irrigation member within the flexible bag. The variable pressure is reversed to facilitate an evacuation operation, once the irrigant has been introduced, the flexible bag being arranged to receive the matter expelled from the bowel. There is further disclosed the use of pressure applied to the abdomen to assist in peristalsis within the intestines and the use of a vibrational arrangement in a bowel irrigation apparatus. A control system is also disclosed, comprising a computational device for controlling the bowel irrigation.

Description

BOWEL IRRIGATION METHOD AND APPARATUS

The disclosure of Australian provisional patent applications numbers 2008903077, 2008905691 and 2009900598, filed on 17 June 2008, 4 November 2008 and 13 February 2009 respectively, are herein incorporated in their entirity by reference.

The disclosure of International patent applications numbers PCT/AU1997/00145, PCT/AU2000/00725, PCT/AU2006/000057 filed 11 March 1997, 26 March 2000 and 19 January 2006 respectively, are herein incorporated in their entirity by reference.

Field of the Invention

The present invention relates to a method and apparatus for irrigation of the bowel and, particularly, but not exclusively, to a method and apparatus for facilitating irrigation of the colon via a stoma in a patient's abdominal wall or via the anal canal.

Background of the Invention

Fecal incontinence (FI) is the involuntary loss of feces from the anus or a stoma (a surgical opening in the abdomen that allows feces to exit from the large bowel) . FI is common in people with medical disorders of the large intestine, in people with anal sphincter or pudendal nerve damage, or in the elderly population with reduced cognitive function. Colostomy patients who have had their recturns removed, have no sphincter around the stoma so passage of feces occurs spontaneously and often without warning .

Constipation or impacted feces may occur due to dietary deficiencies, physical bowel obstruction, restricted movement (bed or chair bovmd people) or disturbance of the neural processes controlling the peristaltic process required for evacuation of feces. These situations and other medical disorders of the large intestine can prevent the patient from adequately evacuating fecal material from the large intestine or prevent the person having effective control of fecal evacuations, leading to unwanted and unplanned incontinence episodes. Fecally incontinent and intractably constipated patients have difficulty managing their bowel movements .

It is known to achieve bowel management in a number of ways; for example, incontinence pads may be used to contain fecal loss, end dwelling catheters to allow passage of the feces into a plastic bag or a colostomy bag to collect waste.

Colonic irrigation is a known process for cleaning the lower bowel and reducing risk of unplanned and unwanted defecation, and also to facilitate loosening of impacted stools to alleviate constipation. Colonic irrigation may typically be accomplished by regular flushing (usually daily) of the large intestine by enema, wherein fluids are introduced into the large intestine to flush materials retained in the intestine. Fluids may be introduced from the rectum or through a surgically created opening, such as a stoma, and subsequently fluids are allowed to drain out through the rectum and/or stoma. The cycle of irrigation and drainage is generally termed an "irrigation session" .

An irrigation session will generally be implemented by the patient (self-administered) . The present irrigation systems are unsophisticated. They require manual control by the patient and require the patient to come into relatively frequent contact with fecal material. Typical systems are gravity fed. Irrigant is fed into the patient from a suspended container. The irrigation tube feeding the irrigant into the patient is then removed (disconnected from the patient) . Evacuation is triggered by the presence of the irrigant in the bowel and the patient senses the need to defecate and evacuation is achieved. In the case of a colostomy patient the irrigant is in the bowel and no sensation of the need to defecate is received (since this sensation is derived from the rectum which has been removed) . In these patients evacuation occurs spontaneously with no warning.

Irrigation systems tend to be bulky, difficult to carry around, and difficult to use. They are therefore quite inconvenient. They are also generally manually controlled by the patient.

Sophisticated colostomy pump systems have been proposed (see the present applicant's earlier International Patent Application No. PCT/AU2006/000057, the disclosure of which is incorporated herein by reference) .

Summary of the Invention

In accordance with a first aspect, the present invention provides an apparatus for facilitating bowel irrigation, comprising a vessel arranged to have a pressure applied to it to implement a bowel irrigation operation comprising introducing irrigant into the bowel, and the vessel acting to receive matter expelled from the bowel .

In an embodiment, the pressure is a variable pressure.

In an embodiment, the irrigation operation forms part - A - of or the whole of an irrigation session to irrigate a patient' s bowel .

In an embodiment, the bowel is a patient's colon, although in other embodiments it may be any other part of the patient's intestine.

Bowel irrigation may be via the anal canal and patient's rectum (where the rectum and anal canal exist), or it may be via a stoma in the patient's abdomen (for example, where the patient has had a colostomy) .

In an embodiment, the vessel has a deformable wall, via which the variable pressure may be applied.

In an embodiment, the vessel is a bag. Variable pressure applied to the outside of the bag facilities the bowel irrigation operation and/or the receipt of matter expelled from the bowel. In an embodiment, the bag is disposable after use. The bag may therefore be used to ' contain and introduce irrigant into the bowel, to receive matter expelled from the bowel, and optionally, may be used to provide a convenient means of directing the fecal matter into a toilet, or be disposed with the feces contained in it.

In an embodiment, the vessel is used to contain irrigant for introduction to the bowel and also to receive waste from the bowel. This has the advantage that only the vessel is required for irrigation and for receiving waste matter. This is advantageously more convenient for the patient.

In an embodiment, in use the vessel is contained within a container. In an embodiment the container has rigid walls. The variable pressure is introduced into the container, acting between the walls of the container and walls of the vessel. A seal is created between an opening of the container and the walls of the vessel. The container has an opening which is arranged to communicate with a stoma or anal canal, an irrigation operation may be carried out and then the vessel may be removed from the container (the vessel holding the expelled matter from the bowel) and disposed of. Advantageously, the container having rigid walls allows control of the variable pressure within the container, between the container walls and the walls of the vessel. The walls should be rigid enough so as to enable the use of pressure to be effective for the irrigation operation. In some cases this may mean the walls could be somewhat flexible or "semi-rigid" i.e. still sufficiently rigid to enable the variable pressure to be effective for the irrigation operation, but not totally rigid. In embodiments, parts of the container walls may be rigid and other parts may be non-rigid or somewhat flexible.

In an embodiment, a pump provides the variable pressure. The pump is connected to the container to introduce the variable pressure. In an embodiment, the pump is an air pump. In an embodiment, the pump is arranged to cause an increase of pressure within the container in order to facilitate introduction of irrigant to the bowel. In an embodiment, the pump is arranged to cause a decrease of pressure within the container in order to facilitate removal of matter from the bowel .

In an embodiment, an irrigation member, comprising walls defining a lumen, is mounted within the vessel. In an embodiment, the irrigation member is attached to a wall of the vessel to enable manipulation of the irrigation member via the wall of the vessel. The irrigation member may be arranged to be manipulated through a stoma or within the anal canal in order to facilitate introduction of irrigant via the lumen. In an embodiment, an attachment member is mounted to the outside wall of the vessel, enabling manipulation of the irrigation member via the attachment member. A manipulator, in one embodiment being in the form or a handle, may be connected to the attachment member to enable a user to manipulate the irrigation member. In the embodiment where a container holds the vessel, the manipulator may extend through a wall of the container.

In an embodiment, the vessel comprises a first compartment arranged to operate as a reservoir for irrigant and a second compartment arranged to receive matter from the bowel . This has the advantage that irrigant and waste matter from the bowel are not mixed. In an embodiment where the vessel is a bag the first and second compartments may be separated by a membrane within the bag. Alternatively, the vessel may comprise two bags, one bag placed within the other bag, or the bags positioned side by side.

In an embodiment, the apparatus further comprises a vibration arrangement for providing vibration to the bowel via the patient's abdomen. The vibration arrangement may include vibration members contacting the patient's abdomen. For example, the vibration members may be mounted by an externally worn belt, or other means. In an embodiment, the vibration arrangement may be implemented by varying the pressure on the vessel, e.g. perturbation of the bowel by "pulsing" the vessel with a pressure wave. The vibration may advantageously be used to initiate, control or modulate a peristaltic reflex of the bowel to generate a more controlled expulsion of matter.

In an embodiment, the apparatus further comprises a pressure arrangement, arranged to apply pressure externally to assist peristalsis or other bowel motion. Pressure may be applied in order to assist massage of the -1 - bowel, during the evacuation phase.

In an embodiment, the apparatus further comprises a control arrangement for controlling the irrigation operation. In an embodiment, the control arrangement is arranged to control the variable pressure. In an embodiment, one or more sensors may be provided to sense one or more parameters in relation to the bowel irrigation operation. Data from the sensors may be used to facilitate control of the irrigation operation.

In an embodiment, the apparatus further comprises a memory which is arranged to store data relating to bowel irrigation operations. The memory may store data relating to pressure variations and/or other parameters relating to a bowel irrigation operation. This data may be utilized by a medical professional, for example, to monitor the performance of the apparatus. The data may also be used by the patient to monitor performance of the apparatus. The data may be used as feedback to adjust parameters of the apparatus .

In accordance with a second aspect, the present invention provides a method of facilitating irrigation of the bowel, comprising the steps of applying a variable pressure to a vessel in order to implement a bowel irrigation operation comprising introducing irrigant into the bowel, and receiving matter expelled from the bowel within the vessel.

In an embodiment, the pressure is a variable pressure.

In accordance with a third aspect, the present invention provides an apparatus for facilitating irrigation of the colon, comprising a bag arranged to receive waste matter expelled from the colon; and an irrigation member having walls defining a lumen, the irrigation member arranged to be extended within an orifice in the body to communicate with the bowel in order to implement a colon irrigation operation.

In an embodiment, the irrigation member is provided within the bag. In an embodiment, the irrigation member is attached to a wall of the bag, to enable manipulation of the irrigation member via the bag wall.

In an embodiment, the apparatus further comprises an attachment member attached to an outer wall of the bag, the attachment member enabling manipulation of the irrigation member via the attachment member.

In an embodiment, the bag and irrigation member are disposable.

In accordance with a fourth aspect, the present invention provides an apparatus for facilitating irrigation of the bowel, comprising a container arranged to receive within it a vessel, the container and vessel being arranged to have a pressure applied between the wall of the container and a wall of the vessel in order to implement a bowel irrigation operation.

In an embodiment, the pressure is a variable pressure.

In an embodiment, the bowel irrigation operation comprises introducing irrigant into the bowel. In an embodiment, the vessel is arranged to receive irrigant and then the variable pressure is applied to cause an increase of pressure within the container in order to facilitate introduction of irrigant to the bowel.

In an embodiment, the bowel irrigation operation comprises receiving matter expelled from the bowel and the variable pressure is applied to decrease the pressure within the container in order to facilitate removal of matter from the bowel .

In an embodiment, the vessel is arranged both to introduce irrigant and receive waste matter from the bowel. In an alternative embodiment, one vessel is used to introduce the irrigant, and then the vessel is replaced with another vessel which is arranged to receive the matter expelled from the bowel.

In an embodiment, the apparatus further comprises a manipulator extending through the wall of the container, the manipulator being arranged to enable the user to manipulate the wall of the vessel.

In an embodiment, the container comprises a transparent portion so that a user may view the vessel when inside the container.

In accordance with a fifth aspect, the present invention provides an apparatus for facilitating bowel irrigation, comprising a vibration arrangement, arranged to apply vibrations to the bowel in order to facilitate a bowel irrigation operation.

In an embodiment, the vibration arrangement is arranged to apply vibrations to the bowel via vibrating the abdomen of the patient.

In accordance with a sixth aspect, the present invention provides a method of facilitating bowel irrigation, comprising the steps of applying vibration to the abdomen to facilitate a bowel irrigation operation.

In accordance with a seventh aspect, the present invention provides a controller for a colonic irrigation device, comprising a control arrangement, arranged to control the amount of fluid delivered by the device to the bowel of a patient during an irrigation session, wherein the control arrangement is arranged to vary the rate of fluid infusion delivered to the patient over a defined period of time.

In an embodiment, variation of the rate of fluid infusion may comprise stopping fluid infusion. This may occur because of a fault condition during the irrigation session, such as detecting a blockage of the colon, for example .

In an embodiment, the rate may be varied by increasing the rate of fluid infusion from start of fluid infusion, gradually to a predetermined level.

The controller of this aspect of the invention may be used to control colonic irrigation by an apparatus in accordance with any one of the previous aspects of the invention. In an embodiment, the controller may vary the pressure on the vessel in order to vary the rate of fluid infusion.

In an embodiment, the controller includes a pressure sensor arranged to monitor variations of pressure on the vessel. The variations and pressure detected may be used to control the pressure to vary the rate of fluid infusion and/or to vary the rate of evacuation.

In other embodiments, the controller may be utilised with colonic irrigation apparatus other than that of the previously described aspects of the invention. In an embodiment, for example, the controller may be applied to control a colonic irrigation device which comprises a fluid pump which directly controls the flow of fluid infusion. The rate of fluid infusion may then be controlled directly by controlling the fluid pump. The controller may be used with other types of colonic irrigation device.

In accordance with an eighth aspect, the present invention provides an apparatus for facilitating bowel irrigation, comprising a vessel arranged to have a pressure applied to it to implement a bowel irrigation operation comprising introducing irrigant into the bowel, and the vessel being usable to dispose of contents expelled from the bowel .

In an embodiment, the vessel is a flexible bag, which can receive the expelled contents of the bowel and be handled by the patient to hygenically dispose of the waste.

A vessel may be the vessel of previous embodiments of the present invention.

Brief Description of the Drawings

Features and advantages of the present invention will become apparent from the following description of embodiments thereof, by way of example only, with reference to the accompanying drawings, in which;

Figures 1 to 6 are schematic sectional representations of an apparatus in accordance with an embodiment of the present invention, illustrating operation of the apparatus;

Figures 7a, b and c are diagrams showing sections of a manipulator arrangement of the apparatus of figures 1 to 6, for manipulating an irrigation member; Figures 8a, b, c and d are diagrams of a connector arrangement for connecting the apparatus of figures 1 to 6 to a stoma base plate of a patient;

Figures 9a, b, c and d are diagrams showing details of an apparatus in accordance with a further embodiment of the present invention, illustrating operation thereof;

Figure 10 is a block diagram of a control arrangement in accordance with an embodiment of the present invention;

Figures HA to HL are representations of a user interface of a control arrangement in accordance with an embodiment of the present invention,

Figure 12 is a schematic sectional representation of an apparatus in accordance with a further embodiment of the present invention,

Figure 13 is a perspective view of an apparatus in accordance with a further embodiment of the present invention,

Figure 14 is a schematic diagram of a further colonic irrigation apparatus which may be controlled by the control arrangement of Figures 10 and 11,

Figure 15 is a side on section of an irrigation member for a colonic irrigation apparatus in accordance with an embodiment of the present invention, and

Figure 16 is a diagram of part of a colonic irrigation apparatus in accordance with a further embodiment of the present invention. Detailed Description of Embodiments

Referring to Figures 1 to 6, an embodiment of the present invention comprises an apparatus, generally designated by reference numeral 1, for facilitating bowel irrigation. In this example, the apparatus is arranged for irrigation of the colon via a stoma in the abdominal wall of a patient.

The apparatus 1 comprises a vessel 2 arranged to have a variable pressure applied to it. In this example, the vessel 2 is a bag which may be of plastics or other materials (for example, it may be of biodegradable material) . The bag 2 has flexible walls via which the applied variable pressure may act on the internal contents of the bag 2.

In operation, irrigant is first placed in the bag 2. The pressure on the bag is then increased causing irrigant to enter the bowel via a stoma in the abdominal wall (in this example embodiment, via an irrigation member which, in this example, is in the form of an elongate tube having walls defining a lumen- see later) . A reduction of pressure about the bag results in a tendency to draw contents into the bag 2. In operation, the pressure about the bag 2 is reduced to facilitate expulsion of the bowel contents and receipt within the bag 2. An opening 3 is provided in the bag for communication with the bowel via the stoma.

In more detail, the apparatus 1 also comprises a solid walled container 4, which is arranged to contain the bag 2 in operation. In the embodiment shown in Figures 1 to 6 , the container 4 completely surrounds the bag 2 in operation (apart from at the opening 5 of the container) . At the opening 5 of the container 4, the neck 6 of the bag opening 3 is sealed to the neck 7 of the opening 5 of the container 4. Variable pressure may be introduced into the space 8 between the walls of the container and vessel in order to implement the irrigation operation. In the illustrated embodiment, an air pump (shown schematically and indicated by reference numeral number 9) is connected to the container 4 by line 10, for the introduction of the variable pressure into the space 8. The air pump 9 may, for example, be driven by a motor (not shown) .

In the illustrated embodiment, the bag 2 is provided with an irrigation member 11. The irrigation member 11 is in the form of a tube including walls defining a lumen 13. The tube has a proximal end 12 which is arranged in use to extend towards the bottom of the bag 2 in order that irrigant can enter the lumen from towards the bottom of the bag 2. In operation, a distal end 14 of the tube 11 is arranged to extend through the stoma to communicate with the bowel. The tube 11 bends substantially at right angles so that the proximal end 12 is directed downwards in use whilst the distal end 14 may project into the stoma.

A portion 15 of the tube 11 (in this case a shoulder portion) is connected to the wall of the bag 2, so that the tube 11 can be manipulated via the wall of the bag 2.

On the opposite side of the bag wall to the tube 11 is provided an attachment member 16. The attachment member 16 is arranged to attach a handle 17 for enabling a user, in use, to manipulate the irrigation member 11. A shank 18 of the handle 17 extends through an opening 19 in the container wall. The opening 19 is provided with a sealing member 20, which may, for example, be in the form of corrugated plastics or rubber, to maintain the variable pressure within the space 8. In operation, the handle 17 is utilized by the user to manipulate the irrigation member 11 into and out of the stoma. The walls of the container may be of a rigid plastics or a semi-rigid plastics material. The rigidity of the wall should be sufficient to enable the variable pressure to effectively implement the irrigation operation. They may be resilient or flexible whilst still enabling the irrigation operation, but in this embodiment they are quite rigid. Parts of the container walls may not be totally rigid. For example the part of the wall that mounts the handle 17.

An irrigation operation of the apparatus will now be described with reference to Figures 1 to 6. In this embodiment, figures 1 to 6 illustrate an irrigation session of a patient who has had a colostomy.

Referring to Figure 1, the apparatus 1 is shown orientated so that the bag 2 may be filled with irrigant fluid via the opening 3. In this example, the bag is being filled with water 21 from a faucet. It will be appreciated that other irrigants may be used (e.g. distilled water) . This illustrates the portability and convenience of the apparatus 1. If the patient is traveling, for example, they could take the apparatus 1 with them to a bathroom to obtain irrigant and undertake the irrigation session.

Figure 2 illustrates the next stage, showing the apparatus 1 orientated for the irrigation session. As shown, the opening 3 and neck 5 of the container 4 are connected to a stoma base plate 25 affixed to the abdominal wall 26 of a patient about the stoma 27. The neck 6 of the bag 2 is sealed between the neck 5 of the flask 4 and the face plate 4, to facilitate retention of the variable pressure within the space 8. A locking ring is arranged to seal the container neck 5 against the stoma base plate 25 (see later) . The patient utilises the handle 17 to manipulate the irrigation tube 11 so that the distal end 14 extends into the stoma 27. Note that, although not shown here, the distal end 14 of the irrigation tube 11 may include an irrigation cone. During the infusion process, the irrigation member 11 is used to introduce irrigation fluid. It may then be removed from the stoma during the evacuation process.

In order to facilitate manipulation of the irrigation tube 11 by the patient, a portion of the container 4 may be transparent so that the bag 2 and irrigation tube 11 are visible. In this embodiment, the bag 2 is a transparent bag. In this embodiment the portion of the container which is visible is the upper part of the container in use (as indicated by the arrow 30 in Figure 2) . In another embodiment, the container 4 may be opaque and other means may be used to monitor the irrigation process. For example, the mass of the irrigant may be monitored by a sensor, or the time of the irrigation process may be monitored, or a combination of these. Pressure may be monitored (i.e. pressure on the outside of the bag 2) . The control system may use one or all of these parameters to control the irrigation and an evacuation process and communicate progress to the user (see later) .

Once the distal end 13 of the irrigation member is within the stoma, the patient is ready to start the infusion process. Figure 3 shows the apparatus part-way through the infusion cycle. In a first phase, the pump 9 pumps air into the space 8 resulting in an increase in pressure on the bag 2.

The increase in pressure causes fluid 21 to flow into the lumen 13 of the irrigation member 11, and into the bowel via the stoma 27.

Figure 4 illustrates the apparatus at the end of the infusion cycle. The pump 9 has been stopped and the handle 17 has been used by the patient to withdraw the distal end 14 of the irrigation member 11 from the stoma 27.

Peristaltic cycles will then begin in the patient's bowel, resulting in the expulsion of feces and irrigant. Note that the peristaltic cycles may be regulated and/or instigated by vibration of air pressure within the bowel by the pump or by vibration of the bowel via vibrating members transmitting vibrations via the abdomen (see later description) .

Figure 5 shows the apparatus during this stage. Feces and irrigant 35 are bring expelled from the stoma 27. The pump 9 is reversed from the irrigation cycle to cause a decrease in pressure in the space 8 between the container 4 and bag 2. This provides a suction effect on the stoma and assists the expulsion of feces and fluid 35 which is collected in the bag 2. The negative pressure produced by the pump 9 during this phase also aids maintaining contact between the apparatus 1 and the patient's body, reducing risks of leaks from the stoma 27 and bag 2 or in the worst case dislodgement of the apparatus from the stoma site.

After evacuation is complete, the patient disengages the container 4 and bag 2 from the stoma base plate 25 to enable the collected feces and other waste matter 35 to be disposed of.

Figure 6 shows the disposal phase. Waste matter 35 is being emptied (e.g. into a toilet) and pump 9 is applying positive pressure in order to facilitate emptying of the contents from the bag via the opening 3. Once the bag has been substantially emptied, the patient, utilizing the handle 17 may push the irrigation member 11 so that the distal end 14 may be grasped (e.g. with toilet paper, for example, and used to withdraw the bag 2 from the container 4) . The bag 2 can then be washed. Alternatively, if the bag is disposable (it can be discarded and replaced by another bag. The bag may even be constructed of biodegradable materials.

One embodiment of a manipulation arrangement for manipulating the irrigation member is illustrated in Figure 7. In this embodiment, the manipulation arrangement 40 is in the form of a handle 41, a shaft 42 of which, in operation, extends through the opening 19 of the container 4 wall, and a connector arrangement 43 which is arranged to connect with the attachment member 16 mounted to the wall of the bag 2.

The shaft 42 comprises a sleeve 44 defining an axially extending passageway 45. A manipulation member 46, having a shaft portion 47, a head portion 48 at the proximal end and a tip portion 49 at the distal end, is slidably seated within the passageway 45, for axial motion in the passageway 45. The handle 41 has walls 59 which define a space 50 arranged to receive the head portion 48 of the manipulator member 46. A spring 51 is seated within the space 50 operating against the underside of the head 48 and against a base 52 of the space 50.

In operation, when the flexible bag 2 is placed inside the container 4, the patient is required to engage the manipulator arrangement 40 with the attachment member 16, so that the patient is able to manipulate the irrigation member 11.

The patient first depresses the head 48 of the manipulation member against the spring 51. This results in the broad tip 49 of the connector arrangement 43 extending out from the sleeve 44 (Figure 7b) . A plurality of slots 55 are provided in the sleeve 44 to define expandable leaves 56 of the sleeve 44. With the broad tip 49 protruding, the leaves 56 are in a retracted state (Figure 7b) .

With the tip 49 protruding from the sleeve 44, the tip is able to be seated within a complimentary shaped slot 57 formed by extending members 58 of the attachment member 16 (Figure 7c) . The tip 49 is then retracted (by the patient releasing the head end 48 of the manipulator member 46) . The leaves 56 expand and engage the members 58 to retain the manipulator arrangement 40 in contact with the attachment member 16. A raised portion 60 of the attachment member extends within the space 57 to maintain contact with the tip 49 when it is retracted, to facilitate maintaining the tip 49 within the attachment member 16.

This is one arrangement only of a manipulator arrangement. It will be appreciated that many other variations on this are available. For example, one alternative engagement mechanism may be based on the insertion of a tip into an attachment member and rotating the handle to engage the tip within the attachment member. Another arrangement may include a magnetically connectable attachment member and a manipulator arrangement .

The transparent portion 30 of the container 4 facilitates the patient being able to view and therefore attach the manipulator arrangement to the attachment member 16.

Figure 8 illustrates an embodiment of a retention arrangement for retaining the apparatus 1 in contact with a stoma base plate 25 of the patient.

In this embodiment, the retention arrangement comprises a retention clip 70 having engagement surfaces 71 arranged to engage with co-operating surface 72 on the stoma base plate 25 and surface 73 on the neck 7 of the container 4.

Figure 8a shows the bag 2 seated within the opening 5 of the container 4. The neck 6 of the bag has a lip 80 which, in use, extends over a corresponding projection 81 of the container 4 neck 7. The bag lip 80 can optionally include an elastic or pre- formed rim to provide a degree of positive retention of the bag lip 80 about the extending portion 81 of the container neck 5.

With the bag 2 inserted in the container 4, the substantially circular mating clip 70 is held by the patient in a open state and placed over the neck 7 of the container 4. The mating clip 70 has tabs 52 which can be engaged by the patient to open the clip so that it can be put over the container 4 neck 7. When the patient releases the tabs 82, the clip 70 closes on the neck 7 of the container 4 and the engagement surface 71 engages with the surface 73 of the neck 7 (see Figure 8d) .

The patient then opens the clip 70 again, (by pressing the tabs 82) and engages the other retention surface 71 with the retention surface 72 of the stoma base plate 25 (Figure 8d) . The patient releases the tabs 82. The engagement surfaces 71, 72 and 73 are inclined such that, as the surfaces mate, closure of the clip 70 forces the container 4 neck 7 towards the stoma base plate 25, resulting in the bag 2 sealing against the stoma base plate 25, in order to minimize leakage of irrigant or feces. Bag 2 is also sealed against the neck 7 of the container 4, minimizing the leakage of air in or out of the flask during irrigation or evacuation.

Alternative arrangements than that illustrated in Figure 8 can be used to secure the container to a stoma base plate. Screw arrangements, for example, where the container and base plate may have complimentary screw threads in complimentary openings could be one alternative, and there others.

In the above embodiment, a single vessel in the form of a bag 2 is used both for the injection of irrigation fluid and the receipt of waste matter. In an alternative embodiment, one bag may be used for the injection of irrigation fluid, then the apparatus 1 may be removed and another bag may be placed in the container and used to receive the waste matter. The bag 4 receiving the waste matter may be a conventional colostomy bag, or another type of bag adapted for use with the container or a colostomy bag adapted for use with the container. Similarly, a conventional colostomy bag may be used as the vessel for injection.

Figure 9 illustrates another embodiment of a vessel that may be used in the present invention. In this embodiment, the vessel 100 is a flexible bag but comprises a partition 101 within the bag which partitions the bag 100 into a first chamber 102 and a second chamber 103. In operation, the first chamber 102 is used to contain irrigant for the irrigant injection operation, and the chamber 103 is used to receive feces and used irrigant.

The partition membrane 101 has a tab portion 104 extending from it. This is used by the patient to ensure that each respective chamber 102, 103 is used for its respective function. In operation, during irrigant filling, the tab 104 is positioned by the patient such that the bag opening 105 reveals the entry to the first chamberlO2 for receiving irrigant.

Once irrigant has been placed in the chamber 102, the tab 104 is manipulated by the patient so that the opening to the effluent receiving chamber 103 is revealed. There is a hole 107 in the partition 101 which enables the distal end 14 of the irrigation member 11 to project through it so that it can be manipulated into the patient's stoma. Any expelled matter or feces however, will go through the revealed opening into the chamber 103 for receipt of the waste matter.

When the container 4 is attached to the patient's stoma base plate 25 as described above, the tab 104 is sealed between the base plate and the neck 7 of the container, in the position illustrated in Figure 9c. This will ensure that the effluent will be diverted to the effluent chamber 103.

The bag 100 may be a specially designed bag with a central partition, or may be two bags, one within the other, one of the bag's walls acting as the partition 107. The patient could form a hole 107 for the irrigation member, within the partition 101 themselves, or it could be formed during manufacture.

The configuration of Figure 9 may have advantages where a patient is required to perform some irrigation and then needs to manage expelled feces and then perform further irrigation.

A modified embodiment of a dual chamber vessel will now be described with reference to Figure 12. In Figure 12, the same reference numerals have been used to indicate the same components as the embodiment of Figures 1 to 6, and no further description will be given of these components . In this embodiment, the vessel 200 is in the form of a dual chamber bag 200. A membrane 201 divides the bag 200 into an irrigant chamber 210 and a chamber 211 for receiving matter expelled from the bowel.

The distal end 14 of the irrigation member 11 is provided with a conical irrigation cone 215 that, in operation, provides a seal with the stoma 27. The cone may be made of soft material or other means of conforming intimately to the stoma to assist in the sealing process. For example, heating the cone may facilitate this conforming process. The irrigation cone 14 merges at its base with the membrane 201. The connection 220 between the base of the cone 215 and the membrane 201 is elastic. A stiffening ring 221 is provided so that insertion of the cone 215 into the stoma 27 draws the stiffening ring 221 forward so that the front of the bag 200 is pushed against the inner surface of the container 4.

In operation, the cone 215 is inserted in the stoma and pressure is applied to cause irrigant to flow into the bowel. When irrigation is complete, the distal end 14 of the irrigation member 11 is withdrawn, providing a path for expelled material into the chamber 211.

Figure 13 shows a further embodiment of an apparatus in accordance with the present invention, where the vessel, pump and control system are supported on a belt 300 which, in use, is fixed around the waist of the patient so that the stoma base plate and opening of the container and vessel are adjacent to each other and the vessel and container opening can be fixed to the base plate.

In this embodiment, the container 301 is in the form of a three part arrangement which is mounted on the belt 300. The arrangement comprises a substantially oblong tank 308 mounted at the side of the belt, an interface part 304 for interfacing with the patient stoma base plate and a connector portion 303, which is a corrugated tube connecting the tank 308 and interface portion 304. The interface portion 304 at the stoma operates to hold and connect the vessel (not shown) inside the container 301 to the stoma base plate in a similar manner to as shown in previous embodiments. The interface portion 304 has an opening 305 (not shown) through the belt to the stoma base plate in use. This has a similar configuration to previous embodiments and the internal vessel (not shown) mates with the walls of the opening 305 in a similar way to previous embodiments. A handle 302 is connected to the interface portion 304 and vessel in a similar manner to the handle 17 and manipulator arrangement of previous embodiments. A pump, battery and user interface module 307 is mounted on the front part of the belt 300. The module 307 may contain electrical components for control of the system. A hose 310 connects the pump to the internal volume of the tank 308 so the internal pressure of the container 301 can be varied to achieve irrigation, as with the previously described embodiments. Additionally, tank 308 can be provided in different sizes to more conveniently accommodate different vessel sizes and so enable operation by the pressure changes created by the pump. Additionally, the tank 308 may be in different shapes depending on the patient's preferred posture when using the apparatus (for example walking around or sitting, or wearing on one side of the body or placed with the weight of the apparatus more towards the midline) .

Note that the interface portion 304 of the container 301 may be transparent, as in previous embodiments as one means of providing feedback to the user.

The apparatus of this embodiment may come in modular foπn. That is, different sizes of tanks may be provided to suit the physical requirements of a particular patient, different sizes of interface and/or different belts.

Although not essential, in some embodiments of the invention it may be advantageous to provide the irrigation member 11 with a cone at its distal end 14, or other device for providing a reasonable seal between the stoma and the irrigation member 11. This facilitates the application of pressure to ensure the irrigant enters the stoma through the lumen 13. The embodiment of Figure 12 is provided with irrigation cone 215 which is integral with the membrane 201 of the dual chamber bag 200.

Figure 15 illustrates in cross section an embodiment of an irrigation member, designated by reference numeral HA, that can be used with apparatus in accordance with embodiments of the present invention, in place of the irrigation member 11. Irrigation member HA is provided at its distal end 14A with a cone 350 which, in this embodiment, is formed integrally with the irrigation member HA. Alternatively, the cone 350 may be a separate member attached at the end 14A to the irrigation member HA.

The cone 350 operates to facilitate a reasonable seal between the distal end 14A of the irrigation member HA, and the patient's stoma.

A further embodiment of a colonic irrigation apparatus in accordance with the present invention will now be described with reference to Figure 16.

In this embodiment, a vessel 2A, in the form of a flexible bag 2A is shown. No container 4 is shown in Figure 16, but it would be appreciated that in operation the container may be present, as in previous embodiments. The walls of the bag 2A form at the opening of the bag a bag lip 360 which may be re-inforced and in operation extends over the rim of the container 4 (see previous embodiments) .

In this embodiment, the irrigation member HB is formed as part of the wall of the bag. Irrigation member HB comprises walls 12B, one of which is integral with the wall of the bag 2A, defining a lumen 13B. The irrigation member HB may be manufactured integrally with the vessel 2A. In an alternative embodiment, it may be provided as a separate irrigation tube and glued or affixed in another way to the wall of the vessel 2A. A distal end 14B of the irrigation member HB is positioned so that, together with a portion 361 of the wall of the vessel 2A, it can form a cone 362 for at least part insertion to the patient's stoma and also to make a seal with the patient's stoma.

A shank 18B of a manipulation member is arranged to be attached to a handle (not shown, but will be similar to the handle 17 of the Figures 1 to 6 embodiment) so that the shank 18B can be manipulated within the container 4. A distal end of the shank 18B comprises a cone former 363. The cone former 363 is conical in shape and in use is arranged to abut the portion 361 of the walls of the vessel 2A and the distal portion 14B of the irrigation member HB, and form and support the cone 362 for insertion into the stoma. The irrigation operation can subsequently be undertaken, the cone 361 removed from the stoma and the evacuation operation can then occur into the bag 2A.

In the above embodiments, evacuation material (e.g. including feces) are evacuated into the vessel. In embodiments, as discussed above, the vessel may be a flexible bag, which may be of plasties. The bag may be removed from the container by the patient after the container has been removed from the stoma base plate. Because the evacuant is in a bag, the bag may be used to assist disposal of feces. That is, it may be removed from the bag (without the patient needing to touch the evacuant) and disposed of.

An apparatus in accordance with an embodiment of the present invention may be used with or without a controller for controlling operation of the irrigation apparatus, including controlling the application of variable pressure. An appropriate controller will now be described with reference to Figures 10 through HL.

Referring to Figure 10, a controller, in the form of a control system generally designated by reference numeral 150, may be used to control aspects of the irrigation process. In the embodiments of Figures 1 to 9 and 12 and 13, for example, the variable pressure required for irrigation and evacuation may be controlled by way of the control system 150.

A pump 9 of an apparatus in accordance with an embodiment of the present invention is referenced in Figure 10 and is connected to a computational device 151 of the control system 150. The computational device 151 can therefore control the operation of the pump 9.

An apparatus in accordance with an embodiment of the present invention for carrying out a colonic irrigation process is schematically illustrated and indicated by reference numeral 152. The apparatus 152 may be the same as the embodiment described with reference to Figures 1 to 9, 12 and 13, or may be a different type of colonic irrigation apparatus. In this embodiment, the apparatus 152 is the same as one of the embodiments of Figures 1 to 9 , 12 and 13 .

The computational device 151 may include any suitable sub components necessary to effect computational/logic operations and control the apparatus 152. That is, the computational device 151 may include a central processing unit, volatile and/or non volatile memory, and such appropriate apparatus as required to carry out the functionality described in more detail below. A user interface 153 is also provided. The user interface 153 comprises a key pad 154 for user input and a display 155.

The computational device 151 includes software 156. The control system 150 also includes appropriate sensors 157, 158, 159 and 160 placed in appropriate locations. They may include temperature and pressure sensors and other sensors . Some may be placed on or within the patient's abdomen or bowel and others may be placed on or within the apparatus 152, depending upon their function. One sensor that may be included is an accelerometer to provide input to the computational device 151 that the patient is moving around. The computational device 151 may then interpret other sensor readings, such as pressure readings, in a different way as to when the patient is stationery.

In this embodiment, vibrating members 161, 162 are also provided. In use, these are attached to the patient's abdomen and are used to vibrate the patient's abdomen and the bowel via the abdomen in order to provide some control on the peristaltic process. These will be described in more detail later.

The sensors 159, 160, 157, 158 are used to, for example, measure the temperature of the irrigant and the pressure of the variable pressure, compression, irrigational flow, and other measures. Data received from the sensors can then be used to control the irrigation process by, for example, controlling the pump 9 by- controlling its direction, monitoring its power input (for example to vary the pressure) . Temperature sensors can warn the patient via the display 155 that the temperature of the irrigant that they have put in the vessel is too hot, in which case they will need to replace with cooler irrigant, for example. Not shown in Figures 1 to 6 or 12 embodiment, but a heater may be included in an appropriate embodiment to heat the irrigant. The heater may be included in the container 4.

Sensors may also be included to measure evacuation flow, evacuation suction and patient movement/activity.

The sensors may also include a flow sensor 2, for example, measuring the flow of irrigant into the stoma. The pump may be varied to vary the flow rate. The device may infer air flow through the air pump from the power consumption of the air pump.

The control system 150 monitors irrigation pressure to detect a number of conditions that may occur during irrigation. If pressure exceeds a programmed threshold the control system 150 will indicate to the user via the user interface 153 that the irrigation process appears to be blocked. With the embodiments of Figures 1 to 9, 12 and 13, when the irrigation process is blocked, irrigant flow will drop dramatically. The pump 9 will still be able to pump air, however, but the air pressure in the flask 4 will start to rise. The rate of rise will depend on the air volume in the flask which will depend on the amount of irrigant which has already been injected into the colon. Nevertheless, from the rate of rise of pressure, an indication can be obtained that there is a blockage to the irrigation process. If the rate of rise exceeds a threshold, for example, the computational device 151 determines that an irrigation blockage has occurred.

In an embodiment, the control system 150 may be programmed to wait a short period during the occurrence of a pressure rise event, to determine whether the problem is irrigation blockage. It may control the pump 9 to first of all reduce air pressure, in case the problem is a transient peristaltic contraction that is opposing the irrigation flow, or another proglem. The control system 150 may then restart airflow and if the pressure rise rate indicates that opposition is still present, then alert the user to the blockage via the display 155. It may also at this stage stop the pump 9.

If the irrigation member becomes dislodged from the stoma, this may also result in a rate of pressure rise which indicates a problem similar to blockage or peristalsis. A similar message may therefore be provided to the user to both conditions, such as "check irrigation member position for blockage or dislodgement" . The pump 9 would be stopped.

There is the possibility of the irrigation member being partially dislodged, and, in this case, air pressure around the stoma/irrigation member interface may lead to some air being introduced into the bowel. These pressures would be similar to irrigant pressures so there is no increased pressure on the colon wall but the introduced air could increase flatulance. There is the possibility that the control system 150 may interpret this condition to infer that more irrigant volume has been introduced than was actually introduced, as it measures air flow into the container, not the actual fluid flow out (unless a flow sensor is included) . This could lead to the control system 150 indicating that irrigation was complete when there was really more irrigant to go. The control system 150 includes a user over-ride to allow the user to complete the irrigation.

In an embodiment, a mass sensor may be included in the wall of the container 4 (of embodiments Figures 1 to 9 and 12 above) to provide a direct measure of irrigant volume yet to be infused, giving a positive measure of irrigant volume as an alternative to volume being inferred from air flow and pressure.

In an embodiment, a purge valve (not shown) is included in the container 4, the purge valve being opened once the container 4 and irrigation member are in position. Pump 9 is then started so that air in the flexible bag is purged to atmosphere before irrigation starts. Irrigation can then continue knowing that any leakage around a partially dislodged irrigation member would result in fluid, not air, being introduced into the colon. If the container 4 dislodges from the stoma, this may be detected by the control system 150 as a drop in pressure. The pump 9 will attempt to draw the flexible bag towards the walls of the flask, with atmospheric pressure inside the flexible bag 2. Suction to the stoma would be lost or decreased and the evacuation would be driven mainly by peristalsis into a well open flexible bag. The outcome would be some loss in efficiency of evacuation and possibly a longer evacuation cycle. There may also be a leak issue of effluent possibly onto the patient.

On detection of low pressure during the evacuation cycle, the interface 155 may indicate this to the patient so that they could take action to correct any dislodgment.

User interface indications can optionally be accompanied by audible signals. The control system 150 allows selection of further thresholds based on rate of change of pressure combined with pressure level. Flatus is determined by one pressure increase rate whereas peristaltic action associated with passing of stool while attempting to infuse is associated with a different pressure increase rate and threshold. Other aspects of pressure profile can be used in other implementations to add further discrimination of patient biological events to allow the controller to better tailor irrigant flow and evacuation to patient biological activity.

The computational device 151 also records the temperature, infusion and evacuation pressures and infusion and evacuation pump power consumption levels during an irrigation session, and may also be arranged to record associated data, such as the date and time of the session. These parameters may be recorded in a suitable storage device 165 (e.g. solid state memory), for later retrieval via an appropriate interface 166, such as a USB port or via a wireless connection, such as Bluetooth™, or wireless internet protocol, such as the IEEE 802.11 standard. The storage device may optionally be removable. The controller may interface to multiple storage devices, some of which may be removable.

The interface 153 of the control system 150 also provides a display 155 (which may include any suitable number of warning lights, or a more sophisticated display, such as a touch screen, or a monitor such as an LCD display) to provide signals or warnings to the patient to allow them to respond to events such as a blockage to irrigation input .

Correspondingly, the interface may also provide appropriate switches (or a touch screen) to allow the patient to provide input to the control system 150 to advise of cramping or other events, thereby causing the control system 150 to reduce or modify suction or irrigation as needed. Such events can optionally be recorded by the computational device 151.

An example interface is shown with reference to Figures 11a to 111. The interface is described in more detail below.

If the control system 150 interprets pressure, flow and temperature to indicate an event such as peristalsis or flatus such events can optionally be recorded by the computational device 151.

That is, the control system 150 includes a user interface 153 whereby a patient has some control over the pump 9 behaviour to allow choice of a number of programs pre-selected by the medical professional, to allow management of exception situations such as desire to terminate a session or respond to cramping and spasm.

For example, referring now to Figures 11a through to 111, there are shown a number of "screens" which may be displayed on a suitable touch sensitive LCD or plasma screen 155 provided by the interface 153 of the control system 150.

At figure 11a, there is shown an initial start up screen 300, which includes a startup message 302 and a "start button" which may be touched or pushed by the user to initiate the irrigation cycle. Similarly, Figure lib shows a running screen 306, which comprises a message or information section 308 and 3 buttons 310, 312 and 314, which provide the user with three options during the irrigation cycle. - M -

Similarly, Figure lie is an example of a screen which may be displayed if the controller determines that a blockage has occurred. Screen 316 includes an information section 318 and 3 options 320, 322 and 324. The same screen layout is also repeated at Figures Hd, which shows a screen which may appear when a low pressure event is detected. Figure He, Hf, Hg, Hh, Hi, Hj, Hk and Hl also display other functions of the controller and provide an information display plus a touch sensitive area where a user may vary the controller values, as required.

In other words, the controller interface 153 may include both input and output capabilities, which may be provided separately (i.e. separate switches and warning lights) or in an integrated fashion (i.e. a touch screen which functions as both an input device and a display) . Such variations are within the purview of a person skilled in the art .

As described above, the control system 150 includes an output interface 166, to allow the storage device to be accessed to transfer recorded data to a separate analysis system. The analysis system may be a dedicated system (i.e. a proprietary system) or it may be a generic computing device utilizing analysis software as described herein below.

The analysis system (and/or software) is arranged to receive data from the storage device in the computational device 151 and present the data in a summary form to a physician. Moreover, the software allows the physician or other medical professional to manipulate the settings of the computational device 151, if the medical professional believes any settings are incorrect. The settings may be manipulated in one of two ways. Firstly, the medical professional may have complete control over all functions, and thereby adjust each parameter individually. Secondly, the control system 150 includes a number of "preset" controller programs that can be selected by the medical professional. Typically, such presets would be used for new patients, until the medical professional has enough information to begin fine tuning the parameters.

The control system 150 also includes a mode whereby different programs can be selected for different time periods. For example, the medical professional may choose to cycle between two programs, one on odd and the other on even weeks . After one or more cycles through each program the patient can report which time period resulted in a preferable irrigation outcome and the program associated with that time period can be selected by the medical professional for continuous use, thereby reducing the number of clinical visits.

The software also includes diagnostic tools, which check for errors in the sensors, motor, or other parts of the control system 150.

In other words, the software program provides three functions. The first function allows the medical professional to build a database of information with regard to a patient's use of the device, which may then be used as the basis for other treatment regimes or as the basis for modifying the operation of the controller. The second function allows the medical professional to modify the working of the controller. The third function provides a diagnostic tool, to ensure that the controller and the irrigation pump are working correctly.

The system described above is better illustrated with reference to an example, which is given below.

The physician estimates a patient's colon capacity at 500ml based on size of the patient and sets the control system program such that the initial flow rate would be 100ml/min with the flow rate increasing by 60ml/min over each minute of irrigation.

This results in an infused volume of 125OmIs after 5 minutes of irrigation. In other words, the controller is arranged to vary flow rate over time, in contrast to fixed flow-rate devices which start with an initial flow rate of 250ml/min to achieve the same volume over the same time. However, fixed flow rate devices begin with a significantly higher initial flow rate, which is not acceptable or comfortable for many patients.

The controller measures irrigation pressure and reduces flow rate if pressure increases beyond 50cm H₂O. This can arise due to the activity of the patient's bowel. The flow is increased when the pressure event passes. The patient can also interrupt irrigation flow at any point via the user interface on the device.

While the irrigation session is occurring, the controller periodically measures the temperature of the water and prevents any flow if the temperature is above 38⁰C. The patient is alerted that the water must be changed. If the temperature of the water supply is lower than 32⁰C the in-flow water heater will be activated. Optionally the controller may limit the flow rate to match the water heater capacity and incoming water temperature.

The recording function of the controller logs pressure and flow events and the patient's annotation of events such as peristalsis and cramping. At a medical professional's visit the record can be summarized to display pressure, flow and temperature profiles associated with cramping, and profiles not associated with cramping, and allow the controller program to be adjusted to minimize cramping. In a similar way the presence or otherwise of peristalsis can be used to refine the controller program to minimize the degree of peristalsis during the infusion phase.

As such, the patient is provided with an irrigation session which is comfortable, suited to their particular medical problems, and fully adjustable depending on changing circumstances.

The embodiment described herein also provides a number of advantages.

The embodiment allows for an infusion flow time profile to be programmed, senses the behaviour of the bowel in response to infused liquid and adapts to the bowel behaviour to produce an improved irrigation experience for the patient .

The embodiment, by recording the irrigation pump output and the measured response by the bowel during irrigation procedures allows data from the recordings to be accessed at a later time and processed and presented in a format to enable a physician or stoma therapist to adjust the flow profile and the parameters of the automated response of the irrigation pump to better suit the patient.

The wall of the bowel is known to include stretch receptors that play a role in triggering and propagation of peristaltic contractions that expel bowel contents and thus are assumed central to the conduct of a successful irrigation session. As such, constant flow infusion techniques can result in relative bowel wall stretch that becomes less effective with increasing volume. The present embodiment, in contrast, provides the ability to control the amount of irrigant over time, and thereby optimize the amount of irrigant. This feature, combined with a degree of suction during evacuation, serves to optimize the entire evacuation process, leading to a shortening of total irrigation time and less inconvenience and discomfort to the patient.

As discussed above, vibration members 161 and 162 are also provided (Figure 10) . These may be vibrating plates which are arranged to be affixed to the abdomen at appropriate points. The control apparatus 150 may cause these plates to vibrate. It may use the power from the pump motor 9 to cause the plates to vibrate selectively. The vibration may be low frequency and arranged to control and modulate the peristaltic reflex of the colon to generate a more controlled expulsion of colon contents. Where the air pump is based on a motor, the same motor may generate the required low frequency vibrations .

Additionally and /or alternatively, the air pump may be used to pulse the pressure into the bowel to assist in the evacuation process (e.g. by helping to loosen feces) .

Additionally and/or alternatively, a pressure arrangement may be used to apply pressure to the outside of the abdomen to assist in the peristaltic and/or evacuation process . Pressure may be applied by a massage pressure arrangement, for example, using plates and a belt or by mounting an inflatable means on the belt (for example, embodiment utilizing a three part arrangement as shown in Figure 13) . This can be used in addition or as an alternative to vibration and/or air pressure pulsing.

In the embodiments of Figures 1 to 9, 12 and 13, 15 and 16 the simplest way to implement the control system of Figure 10 is to use pressure sensing to monitor variations of pressure within the flask 4. In this simple approach, no other sensors than pressure sensors need be used. For example, pressure sensing may be used to monitor pressure in the air line from the pump 9 to the interior of the flask 4 (e.g. air line 310) in Figure 13. Note also that in the Figure 13 embodiment, the control system 150 may be mounted in module 307, with the display and touch screen mounted on the module 307.

In the above described embodiment, fluid flow of irrigant and evacuant is measured indirectly by measuring the variation of pressure within the flask 4. It may be possible to, in other embodiments, sense irrigant and evacuation flow directly. Sensors using Doppler flow measurement and velocity of irrigant flow may be used, for example. Measurement of fluid level within the container 4 using ultrasonics to measure the surface level are another possibility or using the capacitive strips (e.g. on the side of the container 4) . Measurement of weight of the fluid bag using pressure sensors on the bottom surface of the flask 4 may also be implemented. These sensed parameters may be compared with air flow and air pressure by the control system 150 to give a better estimate of irrigant flow and volume of irrigant that has been delivered, and also of flow of evacuant. The use of further sensors adds more complexity to the overall system, but may be appropriate to some embodiments .

Sensors may utilise wireless connection rather than wired connections, where possible.

In addition, temperature sensors and other sensors could be provided in the flask 4 and also be wireless connected.

The control system of this embodiment of the invention is not limited to use with the bowel irrigation apparatus of the embodiments of Figures 1 to 9, 12 and 13, 15 and 16. The control system may be used with other bowel irrigation apparatus. For example, bowel irrigation apparatus are known that pump fluid directly (i.e. not via an air pressure pump, but directly by a liquid flow pump) . These systems are more complex, but the control systems of the present invention could be arranged to have fluid flow sensors to detect fluid flow and therefore control the irrigation process this way.

A controller in accordance with this embodiment could be utilised with the colonic irrigation apparatus described in the applicant's above-referenced International applications, for example.

Figure 14 schematically illustrates a type of colonic irrigation apparatus which directly controls fluid flow, with which the controller of this embodiment of this invention could be utilised. The apparatus is generally designated by reference numeral 400. It includes an irrigation fluid reservoir 402, arranged to hold a suitable fluid, such as distilled water or a saline solution, or any other suitable solution to be used for irrigation of the intestine. The irrigation reservoir 402 is in fluid communication with an infusion pump 404, arranged to pump fluid in the fluid reservoir 402 through an irrigation tube 406. The irrigation tube 406 may optionally include an irrigation cone 408, arranged to be inserted into a patient's stoma or rectum to facilitate irrigation. Evacuation from the stoma or rectum is achieved via an evacuation chamber 410, which is a chamber arranged to surround the stoma. The evacuation chamber 410 is connected to an evacuation pump 412 which is arranged to provide a suitable level of suction in order to facilitate the evacuation. The evacuation pump 412 includes an outlet 414, which may be connected to a waste disposal point, such as a toilet or temporary holding tank.

The apparatus 400 may be controlled by the controller of the embodiment of Figures 10 and 11, replacing the pump 9 shown in Figure 10 with the infusion pump 414 and evacuation pump 112.

In above embodiments, an air pump is used to provide variable pressure within the container. Note that other ways of providing variable pressure may be utilized, e.g. utilizing a variable pressure fluid (perhaps other than an air) to apply variable pressure to the vessel within the container.

In above embodiments, the container has solid walls (they may be of plastics, metal or any other appropriate material) .

In above embodiments, the vessel is a bag. It need not be a bag. It could be an alternative vessel that had one, two or more solid sides and some flexible sides to allow the effect of the variable pressure, for example. It could be any vessel which allows the variable pressure to be applied to the outside of the vessel affecting fluids within the vessel.

The vessel may be disposable, as discussed above. For example, the vessel may comprise a bag with an irrigation member within the bag attached to the bag wall and the entire combination may be disposable. Alternatively, the vessel and irrigation member may be non disposable and it may be necessary to clean them before each irrigation operation. In an embodiment, colostomy bags may be used as the vessel . Or a colostomy bag may be used as the vessel and an irrigation member may be provided separately to be placed within the colostomy bag so that irrigant can be injected into the stoma.

In some embodiments, an irrigation member may not be necessary, and pressure alone may be used to force irrigant from the vessel into the bowel via the stoma.

In above embodiments, the example shown is that of a patient having had a colostomy and therefore having a stoma in their abdomen wall. The invention is not limited to this. The apparatus may be adapted for use for patients with ileostomies, illeal pouches or other surgical procedures that benefit from retrograde irrigation (or even for example, anterograde irrigation as used following a Malone procedure) . Patients who have not had colostomies may be benefit from use of apparatus in accordance with the present invention to provide an irrigation operation via the anal canal .

In the above embodiments, the solid-walled container is generally oval or pear shaped or rectangular. The invention is not limited to containers of this shape. They may be any convenient shape e.g. rectilinear shape, cylindrical or any other shape.

In the above embodiments, where variable pressure is used to inject irrigant there is no need to elevate the vessel during the irrigant injection process so that the irrigant injection is assisted by gravity. The invention does not prohibit elevation of a vessel with a connection to a stoma, however. Elevation may be used to assist irrigant injection. In the above embodiments, however, elevation is not used and the vessel remains in substantially the same position for both irrigation injection and receipt of evacuated material.

In the embodiments of Figures 1 to 9, 12, 13, 15 and 16, there may be a small amount of air in the irrigation member 11, HA, HB when the irrigation member is introduced to the patient's stoma. The amount of air is generally only a small amount (a few millilitres) and will not lead to undue flatulance if it is introduced into the bowel when pressure is applied. It can generally be ignored. Alternatively, however, the apparatus may be "primed" by initially increasing pressure on the bag before introduction of the irrigation member into the stoma, to enable excess air to exit the bag. Once the apparatus is primed, the irrigation member may be introduced into the stoma and further pressure may be exerted on the bag to cause irrigant to enter the bowel .

In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word "comprise" or variations such as "comprises" or "comprising" is used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the invention as shown in the specific embodiments without departing from the spirit or scope of the invention as broadly described. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.

Claims

1. An apparatus for facilitating bowel irrigation, comprising a vessel arranged to have a variable pressure applied to it to implement a bowel irrigation operation comprising introducing irrigant into the bowel, and the vessel acting to receive matter expelled from the bowel.

2. An apparatus in accordance with claim 1, wherein the pressure is a variable pressure.

3. An apparatus in accordance with claim 2, the vessel having a deformable wall via which the variable pressure may be applied.

4. An apparatus in accordance with claim 3, further comprising a container arranged to contain the vessel within it, the container being arranged such that the variable pressure may be applied between a container wall and the vessel .

5. An apparatus in accordance with claim 4, the container having rigid walls, and being arranged to have variable pressure applied between the rigid walls and the vessel .

6. An apparatus in accordance with claim 4 or claim 5, the container having a container opening, the vessel arranged to be sealed against the container opening to create a seal between the container and a vessel wall, the vessel having an opening arranged for communication with the bowel .

7. An apparatus in accordance with claim 4, 5, or 6 further comprising a pump arranged to be connected to the container to provide the variable pressure.

8. An apparatus in accordance with claim 7, wherein the pump is an air pump.

9. An apparatus in accordance with claim 7 or claim 8, wherein the pump is arranged to cause an increase of pressure within the container in order to facilitate introduction of irrigant to the bowel.

10. An apparatus in accordance with claim 7, 8 or 9, wherein the pump is arranged to cause a decrease of pressure within the container in order to facilitate removal of matter from the bowel.

11. An apparatus in accordance with any one of claims 4 to 10, wherein the container is mounted on the patient by a belt.

12. An apparatus in accordance with anyone of claims 3 to 11, wherein the vessel is a bag.

13. An apparatus in accordance with claim 12, wherein the bag is disposable after use.

14. An apparatus in accordance with any one of the preceding claims, the vessel mounting an irrigation member, comprising walls defining a lumen, the irrigation member being mounted within the vessel and arranged to enable introduction of irrigant into the bowel via the lumen.

15. An apparatus in accordance with claim 14, the irrigation member being attached to a wall of the vessel, to enable manipulation of the irrigation member via the wall of the vessel.

16. An apparatus in accordance with claim 15, further comprising an attachment member mounted to the outside of a wall of the vessel, and enabling manipulation of the irrigation member via the attachment member.

17. An apparatus in accordance with claim 16, wherein the attachment member is arranged for connection to a handle to enable a user to manipulate the irrigation member.

18. An apparatus in accordance with any one of the preceding claims, wherein the vessel comprises a first compartment arranged to operate as a reservoir of irrigant and a second compartment arranged to receive matter from the bowel .

19. An apparatus in accordance with any one of the preceding claims, further comprising a vibration arrangement arranged to apply stimulation to the bowel.

20. An apparatus in accordance with claim 19, the vibration arrangement being arranged to apply vibration to the abdomen in order to stimulate the bowel.

21. An apparatus in accordance with any one of the preceding claims, further comprising a controller arranged to control the variable pressure.

22. An apparatus in accordance with claim 21, the controller being arranged to control the variable pressure to control the irrigation operation by varying the pressure applied to facilitate introduction of irrigant into the bowel.

23. An apparatus in accordance with claim 21 or claim 22, the controller being arranged to control the pressure to control a suction operation for facilitating the expulsion of matter from the bowel.

24. An apparatus in accordance with claim 21, 22 or 23, further comprising one or more sensors arranged to sense one or more parameters relating to the bowel irrigation operation.

25. An apparatus in accordance with claim 24, the controller being arranged to utilize information from the sensors in control of the variable pressure.

26. An apparatus in accordance with any one of the preceding claims, further comprising a memory arranged to store data relating to bowel irrigation operations that have been carried out .

27. A method of facilitating irrigation of the bowel, comprising the steps of applying a variable pressure to a vessel in order to implement a bowel irrigation operation, comprising introducing irrigant into the bowel, and receiving matter expelled from the bowel within the vessel.

28. A method in accordance with claim 27, wherein the step of applying pressure comprises the step of applying a variable pressure.

29. A method in accordance with claim 28, wherein the step of applying the variable pressure comprises the step of applying the variable pressure between a wall of a container containing the vessel, and the wall of the vessel .

30. A method in accordance with claim 28 or claim 29, wherein the step of applying a variable pressure comprises the step of increasing the pressure to cause irrigant to be introduced to the bowel .

31. A method in accordance with claim 28, 29 or 30, wherein the step of applying a variable pressure comprises the step of decreasing the pressure to facilitate expulsion of matter from the bowel.

32. A method in accordance with any one of claims 27 to

31, comprising the further step of manipulating an irrigation member within the bag, the irrigation member comprising walls defining a lumen, such that the irrigation member extends through a bodily orifice to communicate with the bowel .

33. A method in accordance with any one of claims 27 to

32, comprising the further step of applying vibration to the abdomen in order to stimulate the bowel .

34. An apparatus for facilitating irrigation of the colon, comprising a bag arranged to receive waste matter expelled from the colon, and also containing an irrigation member having walls defining a lumen, the irrigation member arranged to be extended within an orifice in the body to communicate with the bowel in order to implement a colon irrigation operation.

35. An apparatus in accordance with claim 34, wherein the irrigation member is attached to a wall of the bag, to enable manipulation of the irrigation member via the wall of the bag.

36. An apparatus in accordance with claim 35, further comprising an attachment member attached to an outer wall of the bag, the attachment member being manipulatable to enable manipulation of the irrigation member.

37. An apparatus for facilitating irrigation of the bowel, comprising a container arranged to receive within it a vessel, the container and vessel being arranged to have a pressure applied between the wall of the container and a wall of the vessel in order to implement a bowel irrigation operation.

38. An apparatus in accordance with claim 35 [37?] , wherein the bowel irrigation operation comprises introducing irrigant into the bowel and wherein the vessel is arranged to receive irrigant and have variable pressure applied to cause an increase of pressure within the container in order to facilitate introduction of irrigant to the bowel.

39. An apparatus in accordance with claim 37 or claim 38, wherein the bowel irrigation operation comprises receiving matter expelled from the bowel, and the apparatus is arranged such that a variable pressure is applied to decrease the pressure within the container in order to facilitate removal of matter from the bowel.

40. An apparatus in accordance with claim 37, 38 or 39 further comprising a manipulator extending through the wall of the container, the manipulator being arranged to enable the user to manipulate the wall of the vessel .

41. An apparatus in accordance with any one of claims 37 to 40, the container comprising a transparent portion so that a user may view the vessel when inside the container.

42. An apparatus for facilitating bowel irrigation, comprising a vibration arrangement, arranged to apply vibrations to the bowel in order to facilitate a bowel irrigation operation.

43. An apparatus in accordance with claim 42, wherein the vibration arrangement is arranged to apply vibrations to the bowel via vibrating the abdomen of a patient.

44. A method of facilitating bowel irrigation, comprising the steps of applying vibration to the abdomen to facilitate a bowel irrigation operation.

45. A method in accordance with claim 44, wherein the vibration is applied during the bowel irrigation operation comprising introducing irrigant into the bowel and receiving matter expelled from the bowel.

46. An apparatus for facilitating bowel irrigation, comprising a pressure arrangement arranged to apply pressure externally to the abdomen to assist peristalsis or other bowel motion.

47. A method of facilitating bowel irrigation, comprising the step of applying pressure externally to the abdomen to assist peristalsis or other bowel motion.

48. A controller for a colonic irrigation device, comprising a control arrangement, arranged to control the amount of fluid delivered by the device to the bowel of a patient during an irrigation session, wherein the control arrangement is arranged to vary the rate of fluid infusion delivered to the patient over a defined period of time.

49. A controller in accordance with claim 48, further including at least one sensor arranged to monitor at least one parameter of the fluid delivery to the patient over the period of time.

50. A controller in accordance with claim 48, wherein the at least one sensor comprises a pressure sensor for measuring a variable pressure applied to facilitate fluid delivery to the patient.

51. A controller in accordance with claim 50, further comprising a processor arranged to monitor the variable pressure and determine progress of the irrigation session.

52. A controller in accordance with claim 51, the processor being arranged to make a determination as to whether the fluid infusion process has been interrupted.

53. A controller in accordance with claim 52, being arranged to cease the fluid infusion process when the processor determines the fluid infusion process has been interrupted.

54. A controller in accordance with any one of claims 51 to 53, the processor being arranged to determine whether an evacuation process has been interrupted.

55. A controller in accordance with claim 54, wherein, if the processor determines that the evacuation process has been interrupted, it controls the device to cease evacuation .

56. A controller in accordance with any one of claims 49 to 55, wherein the at least one sensor is a flow sensor.

57. A controller in accordance with claim 56, wherein the flow sensor is arranged to measure the volume of fluid entering the patient's bowel over a defined period of time.

58. A controller in accordance with claim 57, wherein the flow sensor is arranged to measure the volume of fluid exiting the patient's bowel over a defined period of time.

59. A controller in accordance with any one of claims 50 to 58, wherein the at least one sensor is a temperature sensor.

60. A controller in accordance with claim 59, wherein the temperature sensor is arranged to measure the temperature of the fluid prior to the fluid entering the patient's bowel .

61. A controller in accordance with any one of claims 49 to 60, wherein the at least one sensor is arranged to measure the speed of a pump as a measure of flow.

62. A controller in accordance with claim 61, wherein the at least one sensor measures the pressure of infusion and utilizes the pressure measurement to control flow.

63. A controller in accordance with any one of claims 48 to 62, the control arrangement being arranged to control a suction pump arranged to assist in evacuation of the patient's bowel during the irrigation session.

64. A controller in accordance with claim 63, wherein the at least one sensor measures the pressure of the evacuation and utilize the pressure measurement to control the suction pump.

65. A controller in accordance with any one of claims 48 to 64, further including memory arranged to store information related to the irrigation session.

66. A controller in accordance with claim 65, wherein the information includes data received from the at least one sensor.

67. A controller in accordance with claim 65 or 66, wherein the information includes the date and time at which an irrigation session commenced or ended.

68. A controller in accordance with any one of claims 65 to 67, further including a communications interface arranged to allow information to be retrieved from the memory.

69. A controller in accordance with any one of claims 48 to 67, further comprising an input interface arranged to receive input to vary at least one function of the irrigation device.

70. A controller in accordance with any one of claims 48 to 69, further comprising an output interface arranged to display output regarding at least one parameter associated with a function of the irrigation device.

71. A controller in accordance with any one of claims 48 to 70, further including a cleaning function arranged to cause the irrigation device to be flushed to remove fecal or other matter.

72. A controller in accordance with any one of claims 48 to 71, further comprising a programmable module arranged to allow modification of at least one parameter associated with a function of the irrigation device.

73. A controller in accordance with claim 72, wherein the at least one parameter is one of the flow rate of the irrigation fluid, the temperature of the irrigation fluid and the flow rate of the irrigation fluid over a defined period of time.

74. A controller in accordance with claim 72 or claim 73 when dependent on claim 63, wherein the at least one parameter is one of the flow rate of the suction pump and the flow rate of the suction pump over a period of time.

75. A controller in accordance with claim 72, 73 or 74, wherein the programmable module includes at least one preset program, wherein the preset program includes predetermined values for at least one of the parameters associated with a function of the irrigation device.

76. A controller in accordance with claim 72, 73, 74 or 75, wherein the preset program may be altered via instructions received via one of the output interface or the communications interface.

77. A control system arranged to interface with a controller in accordance with any one of claims 48 to 76, comprising an apparatus arranged to modify at least one of parameter associated with a function of the irrigation device .

78. A control system in accordance with claim 77, further comprising a communications apparatus arranged to receive data from the memory of the control arrangement, wherein the data may be analysed to provide information regarding the performance of the irrigation device.

79. A control system in accordance with claim 77 or 78, further comprising a diagnostic module arranged to send a test signal to the at least one sensor to determine whether the sensor is functioning within desired tolerances .