Patent Application
20240001024
A portable system and a method for irrigation of the bowels is provided. The system comprises a container for an irrigation liquid, and an anal probe for insertion into the rectum of a user. In particular, the system comprises a pump cartridge to be connected to a base unit and tubing for controlling the supply of irrigation liquid to the anal probe.
Control of voluntary bowel functions is frequently limited or absent in patients suffering from certain disabilities, such as spinal injuries, multiple sclerosis, or spina bifida. Such lack of control of voluntary bowel functions typically results in faecal incontinence or intractable constipation, as patients have significantly reduced ability to sense the presence of faeces in the colon terminal part and the rectum and to sense the evacuation stimulus.
It is known to accomplish bowel emptying by irrigation (i.e. flushing) of the bowels via the rectum, by an irrigating fluid, such as tap water or saline, which is provided through an intermittent catheter with a tip which is configured and sized for insertion into the rectum (the rectum being the terminal section of the alimentary canal; from the sigmoid flexure to the anus), where it remains in a fixed position and held by an inflatable element, which may be inflatable by air or by water with a pump. Once the rectum or stoma has been flushed with the irrigating liquid, the inflatable element is removed, and the liquid and faeces can evacuate. Known irrigation systems suffer from being bulky, complicated, and difficult to clean proper after use.
Users of irrigation systems and health care professionals alike would welcome improvements and simplifications in the construct and use of irrigation systems.
The present disclosure provides aspects of a portable irrigation system according to the appended claims. In another aspect, the disclosure relates to a method of irrigating the bowels of a user with a system as disclosed herein.
The accompanying drawings are included to provide a further understanding of embodiments and are incorporated in and constitute a part of this specification. The figures illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. Like reference numerals designate corresponding similar parts.
Various exemplary embodiments and details are described hereinafter, with reference to the figures when relevant. It should be noted that the figures may or may not be drawn to scale and that elements of similar structures or functions are represented by like reference numerals throughout the figures. It should also be noted that the figures are only intended to facilitate the description of the embodiments. They are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention. In addition, an illustrated embodiment needs not have all the aspects or advantages shown. An aspect or an advantage described in conjunction with a particular embodiment is not necessarily limited to that embodiment and may be practiced in any other embodiments even if not so illustrated, or if not so explicitly described.
In the following Detailed Description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terminology, such as “top,” “bottom,” “front,” “back,” “leading,” “trailing,” etc., is used with reference to the orientation of the Figure(s) being described. Because components of embodiments can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other embodiments may be utilized, and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.
It is to be understood that the features of the various exemplary embodiments described herein may be combined with each other, unless specifically noted otherwise.
Throughout this disclosure, the solid and liquid wastes from the bowels may be referred to as both “output,” “waste(s),” and “fluids” interchangeably. A subject using the irrigation system may be referred to as “patient” or “user”. However, in some cases “user” may also relate or refer to a health care professional (HCP), such as a doctor/physician, nurse, or others. In those cases, it will either be explicitly stated, or be implicit from the context that the “user” is not the “patient” him- or herself.
The use of the phrase “substantially” as a qualifier to certain features or effects in this disclosure is intended to simply mean that any deviations are within tolerances that would normally be expected by the skilled person in the relevant field.
In the present disclosure a “cartridge” is to be understood as a module designed to be inserted into a larger piece of equipment (in this case into the base unit of the irrigation system).
In the present disclosure, “portable” is to be understood as something that is easy to carry or move, so that it can be used in different places, i.e. is easily and conveniently transported. Particularly, this should be understood is relation to some types of available irrigation systems for the bowels of a user, which are large and bulky and intended for bedridden or hospitalized users only.
In one aspect, the present disclosure relates to a portable system for irrigating the bowels of a user, comprising
In one implementation, the base unit is configured to be self-supporting and adapted to provide an individual element of the irrigation system. In embodiments, the base unit is configured to be able to stand by itself on a generally level surface of the surroundings. In embodiments, the base unit includes a housing. The base unit housing is configured to hold one or more components of the irrigation system. The one or more components can be held inside the housing and/or entirely or partially on an outer surface of the housing. Some components can be held inside the housing and other components can be held entirely or partially on the outside of the housing. In embodiments, the one or more components of the irrigation system can extend from inside the housing to outside the housing through a wall of the housing. In embodiments, a surface of an outer wall of the base unit housing is configured to receive a liquid container of the irrigation system. In embodiments, the base unit housing includes connectable injection moulded top and bottom portions. In embodiments, a top, or upwardly facing, wall surface of the base unit is configured to receive a liquid container of the irrigation system. In embodiments, the top wall surface of the base unit is shaped or formed such as to receive and provide support for the liquid container. In embodiments, the liquid container includes means for or is shaped to fit with a shape or form of the base unit, such as a shape of a top wall surface of the base unit. In embodiments, a shape of a bottom portion of the liquid container is complementary to a shape of a top surface of the base unit. Thereby, the liquid container and the base unit can combine to carry and hold the liquid container containing an irrigation liquid, thus making the system simple and intuitive and less bulky than known systems. In embodiments, complimentary shapes of the top wall surface of the base unit and the liquid container are generally rounded and adapted for abutment against each other.
In embodiments, the base unit includes means for removably attaching the liquid container to the base unit. The means keep the liquid container in secure connection with the base unit during irrigation. In embodiments, the means is/are located on an outer surface of the housing of the base unit. In embodiments, the means include(s) one or more protrusions extending out from an outer surface of the housing, such as out from a top wall surface of the housing of the base unit. In other embodiments, protrusions can be provided on an outer surface of the liquid container and adapted to engage with suitable receiving means (e.g. a notch or other indentation) on the base unit. Other suitable complementary means for removable attachment of the liquid container in secure connection with the base unit are acceptable. It is noted that the connecting means can also be provided on other surfaces of the base unit and the liquid container than the ones mentioned above.
The base unit includes a power supply configured to actuate the pump mechanism. The power supply is provided in the housing of the base unit and is a permanent component of the irrigation system. In embodiments, the power supply is battery driven. In embodiments, the power supply is driven by power from an external source, such as the mains. In embodiments, the mains provide power for a rechargeable battery pack of the system provided in the base unit which can be charged through a charging socket in the base unit.
The base unit includes a passage for allowing irrigation liquid from the liquid container to enter the pump mechanism of the pump cartridge through the irrigation liquid inlet of the pump cartridge. Thus, the irrigation liquid is supplied in a downstream direction from the liquid container, through the passage in the base unit, into and through the irrigation liquid inlet of the pump cartridge to the pump mechanism, the latter serving to eject (by pumping out) the irrigation liquid from the pump cartridge towards the anal probe via the first tubing. In embodiments, the passage in the base unit for the passage of irrigation liquid is configured to receive an irrigation liquid outlet guide of the liquid container and allow it to extend through the passage and into the irrigation liquid inlet of the pump cartridge.
The pump cartridge is configured to be removably attachable in the base unit. In embodiments, the pump cartridge is configured to be attachable and/or removed or replaced without the use of tools. To these ends, in embodiments, the pump cartridge can include one or more integrated attachment means for easy attachment of the pump cartridge to the base unit. The means can include, but are not limited to, clasp or buckle mechanisms, e.g. a spring actuated clasp. Alternatively, a snap locking mechanism and/or bayonet locking means can be used. According to the invention, these and other features of the pump cartridge provides for the pump cartridge to be replaceable. According to the invention, the removably attachable pump cartridge including the pump mechanism, but provided separately from the power supply in the base unit, provides a bowel irrigation system wherein there is no contact between the irrigation liquid and the drive mechanism of the pumping means. This advantageously prevents contamination of the drive mechanism of the pumping means and further offers a solution wherein the moving parts of the pump in contact with the irrigation liquid, provided in the pump cartridge, can be replaced separately without requiring substitution of the entire pump drive.
In embodiments, the base unit includes a socket or slot configured to receive the pump cartridge of the irrigation system. In embodiments, the socket is located closer to a bottom wall of the base unit than to a top wall of the base unit. In embodiments, the socket of the base unit includes one or more guides adapted to steer and securely receive and hold the pump cartridge of the irrigation system within the socket. In one implementation, the one or more guides in the socket of the base unit include(s) one or more rails or bars. The one or more rails or bars can extend from one or more of a bottom-, top-, end- or sidewall into an internal space of the base unit to form the socket of the base unit. In embodiments, the base unit includes an internal structure, e.g. made from polymer material and/or by injection moulding, which is configured to form the socket of the base unit and receive the pump cartridge. The internal structure of the base unit is also configured to provide support for other components of the irrigation system, including the power supply and/or battery box. In embodiments, an entrance to the socket or slot includes an opening in a sidewall of the housing of the base unit. In embodiments, the pump cartridge includes a flange portion. In embodiments, the flange portion includes an outwardly facing surface of the pump cartridge which is configured to be substantially flush or level with a sidewall of the base unit, in the situation wherein the pump cartridge is inserted in the socket of the base unit.
In embodiments, the pump cartridge includes a casing. In embodiments, the casing is formed from suitable polymer materials and/or lightweight metal materials and/or combinations thereof. In embodiments, the casing includes five walls. In embodiments, the casing includes six walls. In embodiments, the flange portion is configured to form one wall of the casing of the pump cartridge, such as an outwardly facing surface or portion of the casing.
In embodiments, the pump cartridge includes means for engaging with the one or more guides in the socket of the base unit. In embodiments, the means include(s) one or more tracks configured to engage with the one or more rails or bars of the socket. In embodiments, the one or more tracks can be provided integral with one or more walls of the casing of the pump cartridge, such as integral with at least an external surface of the one or more walls of the casing. Alternatively, the one or more tracks can be attached to an outer surface of the casing of the pump cartridge. In embodiments, the socket of the base unit and the pump cartridge can include other suitable complementary means for engaging with each other. In embodiments, the casing of the pump cartridge (and/or the engagement means to engage with the socket) includes a shaft or axle opening configured to receive an axle or similar of an actuator provided in the base unit.
The pump cartridge includes an irrigation liquid inlet. The irrigation liquid inlet is provided in a wall of the casing of the pump cartridge. In embodiments, the irrigation liquid inlet is provided in a top wall of the casing of the pump cartridge. In this, and in other embodiments, the irrigation liquid inlet is configured to substantially align axially with the irrigation liquid passage in the base unit when it is inserted in the socket of the base unit. In embodiments, the liquid passage in the base unit is provided in a position immediately above and adjacent the irrigation liquid inlet in the top wall of the casing of the pump cartridge. In embodiments, gravity facilitates the supply of irrigation liquid from the liquid container to the pump mechanism. In other embodiments, a forced or actuated supply of irrigation liquid from the liquid container can alternatively or additionally be incorporated in the system. In embodiments, the irrigation liquid inlet in the pump cartridge comprises a check (or one-way) valve.
In embodiments, the liquid container includes an irrigation liquid outlet guide. In embodiments, the irrigation liquid outlet guide of the liquid container is provided in a bottom wall (downwardly facing wall when the liquid container is in an upright position) of the liquid container. In embodiments, a pump cartridge check valve includes a valve pushrod (or similar) configured to engage with the irrigation liquid outlet guide of the liquid container, such that the check valve in the pump cartridge can be brought to an open position when the liquid outlet guide of the liquid container engages with (contacts and/or pushes on) the check valve pushrod.
In embodiments, the opening and closing of the check valve are controllable via control means provided with the base unit. In embodiments, the system includes a check valve and a further separate valve allowing to close off the irrigation flow. In embodiments, the base unit includes a control device configured to control the irrigation system. The control device can be configured to include control of the opening and closing of the check valve of the pump cartridge. In embodiments, the control device is an electronic control device.
Further alternatively, or additionally, the irrigation liquid outlet guide in the liquid container can include a check valve. This alternative or additional check valve can similarly be controlled by the control device of the base unit.
Further alternatively, or additionally, in embodiments the irrigation liquid passage in the base unit includes a check valve. This further alternative or additional check valve can similarly be controlled by the control device of the base unit.
In embodiments, the electronic control device includes a processing unit (CPU), which is programmed (or programmable) to control the irrigation system, such as, but not necessarily, controlling an entire irrigation cycle of the system. More than one CPU can be incorporated in the irrigation system. In embodiments, the system includes a remote-control unit configured to communicate wirelessly with the base unit to allow controlling of the irrigation system. In embodiments, the irrigation system can be controlled by the CPU provided in the control device of the base unit or by the CPU in the remote-control unit. Alternatively, the CPUs combine in a joint controlling of the irrigation system.
The pump mechanism of the pump cartridge can be provided by different types of pumping options. The pumping means can be provided by a reciprocating or rotary pumping mechanism. In embodiments, the pump mechanism includes a gear pump. In other embodiments, the pump mechanism includes a peristaltic pump. Other types of pumping mechanisms can be acceptable provided they are suitable for the portable irrigation system according to the invention. In embodiments, gravity is sufficient to provide a priming pressure when the liquid container is located on top of the base unit. In embodiments, a pump vacuum requirement of the pump mechanism is between 5-20 mbar lift, preferably approximately 10 mbar lift. Requiring such a pump vacuum can help provide a certain “pull” pressure to overcome potential surface (or other) tension and thereby avoid any “dry” pump starts.
The components of the irrigation system, including the pump cartridge (with the pump mechanism), should be suitable for handling tap water with a temperature of between 5 and 60 degrees centigrade. The components of the irrigation system should allow a flow within the levels of approximately 1000 mL/min at 0 mbar and 250 mL/min at 100 mbar. Some or all the components of the irrigation system are preferably configured for a bi-directional flow with low pulsation. The components of the irrigation system are adapted for a duty cycle of at least 5 minutes continuous running time per 24 hours. The irrigation system should preferably have a dry run capability sufficient to de-air and dry run at the end of an irrigation cycle of at least 1 minute. In embodiments, the pump cartridge is configured to fulfil a service life of at least 20 hours or 300 L running time. In embodiments, the pump cartridge is configured to fulfil a service life of up to 120 hours or 1500 L running time. Alternatively, or additionally, the pump cartridge is configured to fulfil a service life of at least 2 years shelf time and 1-year usage time.
In embodiments, the pump cartridge defines a first portion of the irrigation liquid flow path extending from the pump cartridge towards the anal probe. In embodiments, the first portion of the irrigation liquid flow path is provided by a first tubing. In embodiments, the first tubing extends through an opening in a wall of the casing of the pump cartridge. In embodiments, the first tubing extends through an opening in the flange portion of the pump cartridge. In embodiments, a minor portion of the first tubing extends from an exit of the pump mechanism inside the pump cartridge and a major portion of the first tubing extends externally of the pump cartridge. In embodiments, one or more of the second tubing and possibly further tubing can extend from inside the pump cartridge to outside the pump cartridge in a similar manner as the first tubing. In embodiments, pump cartridges (in some cases designated pump heads) currently available on markets and suitable and adaptable for use together with the components of the irrigation system include the CAPIOX® SP Disposable Centrifugal Pump, or the Sarns™ Centrifugal Disposable Pump, both available from the company Terumo Cardiovascular of Ann Arbor, Michigan, United States. Other suitable, marketed pump cartridges (pump heads) can be acceptable.
In embodiments, the system includes a pressure regulator in the irrigation liquid flow path between the pump cartridge and the anal probe. The pressure regulator allows for regulation of the pressure in the system. The pressure regulator allows for regulation of the pressure with which the irrigation liquid enters the bowels of the user when it exits from the anal probe. In embodiments, the pressure regulator is an automatic pressure regulator. In embodiments, the pressure regulator is a manually controllable pressure regulator. In embodiments, the pressure regulator includes at least one automatic security valve. In embodiments, a pressure sensor measuring the pressure in the irrigation liquid flow path is configured to signal to the security valve in the event of liquid pressure in the irrigation liquid flow rising above a set threshold value. In embodiments, a pressure sensor is configured to measure the pressure in both the irrigation liquid flow path and in the second flow path (for an inflatable balloon). In embodiments, the security valve is provided together with the pressure regulator in a housing of the pressure regulator. In embodiments, the pressure regulator housing includes a spring-actuated lock mechanism and a button for releasably connecting the pressure regulator to tubing or to a tubing adapter. In other embodiments, the pressure sensor and the security valve can be provided in another portion of the irrigation liquid flow path. In some embodiments, the security valve can be a manual security valve. In embodiments, the security valve is a weeping valve.
In embodiments, the first tubing extends from the pump cartridge to the pressure regulator provided in the irrigation liquid flow path between the pump cartridge and the anal probe. In embodiments, the first tubing extends from a liquid exit of the pump mechanism (located inside the casing of the pump cartridge) to the pressure regulator provided in the irrigation liquid flow path between the pump cartridge and the anal probe. In another embodiment, the first tubing extends from a position at an opening in a wall of the casing of the pump cartridge (but not from a position inside the casing) to the pressure regulator provided in the irrigation liquid flow path between the pump cartridge and the anal probe. In the context of the present invention, it is to be understood that the irrigation system can include further tubing, such as, but not limited to, a second, third, and fourth tubing or even further tubing. Moreover, in this disclosure, the term “towards the anal probe” is to be understood as meaning in a downstream flow direction wherein the irrigation liquid exits from the pump mechanism and flows in the direction of the anal probe through the first tubing, and, in embodiments, additionally through a second and potentially further tubing.
In embodiments, the irrigation system includes an expandable retention element provided on or with the anal probe. The expandable retention element is adapted to be expanded after the anal probe has been inserted into the rectum of a user to retain the anal probe in the rectum during the irrigation cycle of the system. [claim 20] In embodiments, the irrigation system includes a second flow path for supplying and withdrawing liquid to and from an inflatable balloon provided on the anal probe. The inflatable balloon on the anal probe then provides the expandable retention element and is expanded by pumping liquid into it for retaining the anal probe in the rectum of the user for the duration of the irrigation cycle. When the irrigation cycle is completed, the inflatable balloon can be collapsed to a deflated state such that the anal probe can be withdrawn from the rectum. The inflatable balloon is adapted to receive liquid for inflation thereof from the liquid in the liquid container through the second flow path. The inflatable balloon is deflated by reversing the flow of liquid in the second flow path. In embodiments, the second flow path includes a separate tube, i.e. a separate, dedicated “balloon tube” extending from the pump cartridge to the anal probe. It is therefore to be understood that in embodiments, the irrigation liquid is configured to fulfil the dual purposes of supplying irrigation liquid to irrigate the bowels, and to provide liquid to inflate the inflatable balloon on the anal probe to retain it in the rectum during the irrigation cycle.
In embodiments, the single tubing includes a double-lumen tube, wherein one lumen forms at least a portion of the first irrigation liquid flow path for the liquid for irrigating the bowels of the user, and the second lumen forms at least a portion of the second flow path for the liquid for inflating the balloon on the anal probe. In embodiments, the first irrigation liquid flow path includes a check valve (one-way valve) to prevent back-flow of the irrigation liquid used for irrigating the bowels of the user. The second flow path does not include a check valve (a one-way valve) because it provides for bi-directional flow of the (irrigation) liquid used for expanding the inflatable balloon on the anal probe. The second flow path can, however, include a separate valve allowing to close off the liquid flow (to the balloon) in the second flow path. [claim 17] In embodiments, the first tubing includes a double-lumen tube.
In accordance with the invention, the irrigation system is adapted to offer the user increased flexibility during use of an irrigation system as well as to offer increased convenience to the user. One factor in that respect is to reduce complexity of the irritation system and to minimize the requirements for cleaning, drying and other maintenance of the irrigation system. Thus, in implementations, some components of the present irrigation system are configured for single-use, some are configured for multiple-uses (but not permanent use) and some are configured for permanent use. “Permanent” is to be understood as “throughout the lifetime” of the irrigation system. In embodiments, particularly the base unit including the power supply is configured as a permanent component of the irrigation system. In embodiments, particularly the anal probe is configured as a single-use component. In embodiments, particularly the liquid container, the tubing(s), and the pump cartridge are configured as multiple-use components. In embodiments, the tubing(s) and the pump cartridge are provided are provided as one integrated component configured for multiple uses (and replaceable as a whole). In embodiments, the tubing(s), the pump cartridge, and the pressure regulator are provided as one integrated component configured for multiple uses (and replaceable as a whole). In other embodiments, the tubing(s) is/are configured as single-use component(s). In embodiments, the tubing(s) and the anal probe are provided as one integrated single-use component. In embodiments, the pressure regulator is configured as a single-use component. In embodiments, the pump cartridge includes fastening means, such as, but not limited to, one or more screws provided for temporary fastening of the pump cartridge to the base unit. In such embodiments, the pump cartridge is a multiple-use component and can therefore suitably be temporarily fastened to the base unit when inserted in the socket of the base unit. In this respect, “temporary” and “temporarily” is to be understood as ranging from only one use of the system to repeated uses over a period of about 12 months. In embodiments, the pump cartridge is designed to have a lifetime of at least six months from first use.
One advantage of providing a replaceable pump cartridge according to the invention is that the moving parts of the pump mechanism can be substituted, in turn allowing for less costly materials to be used in the construction of the pump mechanism (e.g. plastic material gears). Moreover, a replaceable pump cartridge allows for a high standard of cleanliness in that the pump cartridge can be replaced in the event of bacteria and/or other contaminants forming on the surfaces of those portions of the cartridge being in contact with the irrigation liquid, or for other reasons. Similar effects can be achieved in embodiments wherein other components of the irrigation system, including the tubing(s) and/or the pressure regulator, are provided as one integrated component. Further advantageously, the irrigation system of the present invention provides a system solution without any electrical connections/engagement between the component holding the irrigation liquid, i.e. the liquid container, and the base unit. Moreover, in the present invention, the irrigation liquid does not engage with the power supply of the base unit, and there is no possibility of electrical current passing between the irrigation liquid and the pump actuating component of the system. This construction reduces complexity and is increases security, reliability, and easy drying and cleaning of the irrigation system.
In embodiments, the base unit includes one (and only one) control button. In embodiments, the base unit includes one control button configured to communicate with the control device of the irrigation system. The control button can be arranged substantially at level with an outer surface of the housing of the base unit. In embodiments, the control button is provided in a sidewall of the housing of the base unit. In embodiments, the control button is configured to communicate electronically with the control device. In embodiments, the control device is programmed to initiate different program cycles or different cycle segments in response to different numbers of engagement of the (one and only one) control button by a user (i.e. one push of the button triggers one type of action, two consecutive pushes trigger another type of action etc.). Alternatively, the control button can be configured to be in mechanical engagement with one or more components or mechanisms of the irrigation system such as, but not limited to, the control device, the check valve(s) described above, the power supply, and the pump mechanism of the pump cartridge.
The irrigation system includes a liquid container for an irrigation liquid. The irrigation liquid can be temperate tap water or in some cases a saline physiological solution. The irrigation liquid container is configured to be removably connected to the base unit. In embodiments, the liquid container includes one or more means configured to engage with the means for removably attaching the liquid container in secure connection provided on the base unit. In embodiments, the liquid container includes one or more oblong indentations configured to engage with the one or more protrusions extending from the outer surface of the housing of the base unit.
In embodiments, the irrigation liquid outlet guide of the liquid container, which is provided in a bottom wall of the liquid container, includes a piece of pipe formed sealingly around (encircling) an opening in the bottom wall of the liquid container and adapted to extend into the irrigation liquid passage in the base unit. In embodiments, the piece of pipe is adapted to extend through the liquid passage in the base unit and into the irrigation liquid inlet of the pump cartridge. In embodiments, the piece of pipe is relatively rigid and made from polymeric material (‘rigid’ being relative to a polymeric material of the walls of the liquid container). In embodiments, the relatively rigid piece of pipe is configured to engage with a spring-actuated check valve of the irrigation liquid inlet of the pump cartridge. The engagement causes the check valve to open and allow irrigation liquid to enter from the liquid container into the pump mechanism of the pump cartridge when the liquid container is engaged with the base unit. One advantage of providing a piece of pipe extending into engagement with the irrigation liquid inlet (and/or with the check valve opening) of the pump cartridge, is that contact between the irrigation liquid and the base unit can be entirely excluded, thus providing a “dry” connection between the liquid container and the base unit of the irrigation system, and thereby avoiding the need for drying and cleaning of the base unit. Further, this also avoids contact between the irrigation liquid and the components inside the base unit, particularly the power supply for actuating the pump mechanism.
The base unit includes a power supply configured to actuate the pump mechanism. In embodiments, the power supply comprises at least one electric motor. The electric motor can be powered by one or more batteries or by supply of electricity from an external source. The base unit can comprise a transformer for transforming the voltage of an external source into a low voltage for use in the system. In embodiments, the base unit includes two power supplies configured to actuate two or more individual parts of the pump mechanism. If suitable, the base unit can include more than two power supplies, such as more than two electric motors.
In embodiments, the power supply includes at least one shaft configured to engage with the pump mechanism through a casing of the pump cartridge and configured to actuate the pump mechanism. In embodiments, a portion of the shaft includes a gear wheel which is configured to engage with a gear wheel of the pump mechanism inside the casing such that the pump mechanism is actuated when the power supply makes the shaft rotate. Other suitable engagement solutions between the shaft and the pump mechanism are also acceptable.
In embodiments, the first tubing extends between the pump cartridge and the pressure regulator, and the system further comprises a second tubing that extends between the pressure regulator and the anal probe such that the first tubing, the pressure regulator, and the second tubing, combine to form the irrigation liquid flow path from the pump cartridge to the anal probe. In other words, the irrigation liquid flow path includes at least the first tubing and the second tubing and the pressure regulator. In embodiments, the irrigation liquid flow path includes additional tubing and/or additional components, such as, but not limited to, the anal probe and/or the pump cartridge.
In embodiments, the irrigation system comprises a second tubing extending from the pressure regulator to the anal probe, i.e. downstream of the pressure regulator in the direction of flow of the irrigation liquid. In embodiments, a check valve is provided in the second tubing. The check valve in the second tubing prevents reflux of irrigation liquid form the anal probe to the pressure regulator (i.e. upstream), thereby preventing any unintended and undesired contamination of the pressure regulator and/or other upstream components of the irrigation system (e.g. by incorrect operation). In other embodiments, the check valve is provided at a liquid outlet of the pressure regulator and can be provided integral with the pressure regulator.
In embodiments, the portable irrigation system includes a first pinch valve tube downstream of the pump mechanism. Alternative valve types including knife valves can be applied. A pinch valve tube is to be understood as being the pinch valve and a portion of a tube (or tubing) to which the pinch valve is connected and effects on. In embodiments, the first pinch valve tube is provided with the pump cartridge. In embodiments, the first pinch valve tube is provided within the casing of the pump cartridge. In embodiments, the first pinch valve tube is provided externally of the casing of the pump cartridge. Alternatively, the first pinch valve tube is provided in (or as part of) the first tubing. The first pinch valve tube can be provided in (or as part of) the first tubing between the pump cartridge and the pressure regulator. Particularly, the first pinch valve tube can be provided in a portion of the irrigation liquid flow path being in the first tubing and within the casing of the pump cartridge. In embodiments, the first tubing includes a single-lumen tubing. The first pinch valve is adapted to open to allow for the supply of irrigation liquid to the irrigation liquid flow path from the pump cartridge towards the anal probe. The first pinch valve tube is configured to communicate with the control device of the base unit, the control device configured to signal opening and closing instructions to the first pinch valve.
In embodiments, the portable irrigation system comprises a first pinch valve tube downstream of the pump mechanism and a second pinch valve tube downstream of the pump mechanism. In embodiments, the first pinch valve tube and the second pinch valve tube are provided with the pump cartridge. In embodiments, the first pinch valve tube and the second pinch valve tube are provided within the casing of the pump cartridge. Alternatively, the first pinch valve and the second pinch valve are provided in (or as part of) the first tubing. In embodiments, the first pinch valve and the second pinch valve are provided in (or as part of) the first tubing between the pump cartridge and the pressure regulator. In embodiments, the first pinch valve and the second pinch valve are provided in a portion of the irrigation liquid flow path being in (or as part of) the first tubing and within the casing of the pump cartridge.
In embodiments, the first pinch valve tube is provided in (or as part of) a first lumen of a double-lumen first tubing and the second pinch valve is provided in (or as part of) a second lumen of the double-lumen first tubing. The first pinch valve is adapted to open and close to allow for the supply of irrigation liquid in the irrigation liquid flow path from the pump cartridge towards the anal probe. In embodiments, the second pinch valve is adapted to open and close to allow for supply of liquid to a liquid inflatable balloon provided on the anal probe to retain the anal probe in the rectum of a user during irrigation. Each of the first pinch valve and the second pinch valve is configured to communicate with the control device of the base unit, the control device signalling opening or closing instructions to the respective pinch valve.
In embodiments, the base unit includes at least one valve actuator unit configured to engage with and actuate a pinch valve. In embodiments, the valve actuator unit is an electrical actuator. In embodiments, wherein the first pinch valve tube is provided with or within the pump cartridge, and in embodiments wherein the first pinch valve tube and the second pinch valve tube are provided with or within the pump cartridge, the valve actuator unit can include a shaft or axle configured to engage with the pinch valve. In embodiments, wherein there are more than one pinch valve tube, each pinch valve can be actuated by separate valve actuator units. In embodiments, the irrigation system includes at least two valve actuator units to engage with a first and a second pinch valve tube. In embodiments, wherein the pump cartridge includes a casing, the valve actuator unit can be adapted to engage with the pinch valve tube through a wall of the casing, such as, but not limited to, via a shaft or axle extending from the valve actuator unit to the pinch valve tube through the casing wall. In embodiments, the valve actuator unit is configured to engage the pinch valve tube within the casing through an opening in a sidewall of the casing of the pump cartridge. In embodiments, a shaft or axle of the valve actuator unit is configured for mating engagement with a drive mechanism of the pinch valve tube through an opening in the casing of the pump cartridge. In embodiments, the shaft or axle engages with the pinch valve through an axial movement of the shaft or axle of the valve actuator unit. In embodiments, the shaft or axle engages with the pinch valve through rotational movement of the shaft or axle.
The irrigation system includes an anal probe configured to be inserted into the rectum of a user. In embodiments, the anal probe includes a catheter portion. The catheter portion is suitable for insertion into the rectum of the user and for expelling of the irrigation liquid from the catheter portion. In embodiments, the catheter portion includes a catheter tip for insertion into the rectum of the user and for expelling of the irrigation liquid from the catheter tip. In embodiments, the anal probe includes a catheter portion and a handle portion. In embodiments, the handle portion is a separate component which is configured to be connected to the catheter portion of the anal probe and to the tubing of the system (first or second and/or other tubing). In embodiments, the handle portion is configured to be connected to the catheter portion and the tubing delivering the liquid such that rotation of the handle portion is possible even when connected to one or both other portions. In embodiments, the handle portion is configured to offer full (360 degrees) rotation. In embodiments, this is facilitated by a rotatable hinge connection.
In embodiments, the irrigation system includes a manual separator unit located in the irrigation liquid flow path downstream of the pump cartridge. The manual separator unit can be located to allow for disconnection of at least the irrigation liquid flow path between the pump cartridge and the pressure regulator; or between the pressure regulator and the anal probe. In that manner, the pressure regulator and/or the anal probe and/or the tubing can be exchanged individually and/or cleaned and/or dried individually. In embodiments, the manual separator provides an “emergency stop” capable of immediate disconnection of liquid flow to both the anal probe and the inflatable balloon. In embodiments, multiple manual separator units can be included in the irrigation system. In embodiments, the manual separator unit is releasably connectable to the anal probe. In embodiments, the manual separator unit includes a spring-actuated lock mechanism and a button for its release for providing the releasable connection. In embodiments, the manual separator unit is provided integral with the handle portion of the anal probe, such that they present as integrated component.
In embodiments, the irrigation system includes one or more pressure sensors. The system can include one single pressure sensor to sense the pressure in the irrigation liquid flow path. Alternatively, the system can include a plurality of pressure sensors for detecting the pressure at a plurality of positions in the irrigation system. In embodiments, the system includes at least one pressure sensor per tubing or lumen extending downstream from the pump cartridge. In embodiments, the pressure sensor includes a tubing portion including a short-; sectioned bypass channel inside which a pressure in the irrigation liquid flow path or in the second flow path (for the inflatable balloon) can be detected (possibly further provided with a liquid membrane to secure complete “dry” pressure detection). In embodiments, the pressure sensor is a relative pressure sensor (configured to sense a relative pressure) and includes a separate atmospheric pressure sensor in the base unit. Further, in embodiments, the base unit (or the separate atmospheric pressure sensor in the base unit) includes a fluid blocked air inlet port (or canal) in contact with the surroundings for allowing the detection of the surrounding atmospheric pressure.
In embodiments, the pump cartridge includes at least one pressure sensor. In embodiments, the pump cartridge includes one pressure sensor per downstream tubing or lumen extending from the pump cartridge. In embodiments, a pressure sensor is provided in the first tubing. In embodiments, a pressure sensor is provided in the second tubing. In embodiments, a pressure sensor is provided with the pressure regulator.
In another aspect, the disclosure relates to a method of irrigation of the bowels of a user with the portable bowel irrigation system, comprising the steps of:
In embodiments, the method according to this aspect further includes a step (b2) before step (c) of engaging an upstream connection of the first tubing with the pump cartridge. This caters for implementations of the system, wherein the tubing is separately attachable to the pump cartridge. Thereby, a further option for providing a separately cleanable and replaceable pump cartridge is provided.
The system 20 also includes a pump cartridge 28, which in the illustrated view is shown inserted in the base unit 22. The pump cartridge 28 is removably attached to the base unit 22. In
The system 20 also includes an anal probe 32 to be inserted into the rectum of a user for irrigation of the bowels. In the illustrated embodiment, a first tubing 34 provides at least a portion of an irrigation liquid flow path from the pump cartridge 28 towards the anal probe 32. In
The base unit 22 includes a housing 36 configured to hold one or more components of the irrigation system 20. The housing 36 includes an outer wall 38. In the illustrated embodiment, a surface of the outer wall 38 of the base unit housing 36 is ready to receive the liquid container 24. Particularly, a top, or upwardly facing, surface 40 of the outer wall of the base unit 22 is ready to receive the liquid container 24. In the illustrated embodiment, the top wall surface 40 of the base unit 22 is shaped to receive and provide support for the liquid container 24 in that a generally rounded shape of a bottom portion 42 (wall) of the liquid container 24 is complementary to the shape of the top wall surface 40 of the base unit 22. In embodiments, complimentary shapes of the top wall surface of the base unit and the liquid container are generally rounded and adapted for abutment against each other.
In the illustrated embodiment, the base unit 22 a first protrusion 44 extending out from a portion of the top wall surface 40 of the housing 38 of the base unit 22. It is to be understood that the top wall surface 40 in the illustrated embodiment is not planar. In this embodiment it has a bowl shape. A second protrusion (not shown) extends out from another portion of the top wall surface 40 across from the first protrusion 44. The protrusions 44 are adapted to engage with indentations 46 on the liquid container 24. In the embodiment of
Turning for a moment now to the view of
The irrigation liquid inlet 50 in
In
In the embodiment of
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In the embodiment of
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It is to be understood that in
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The irrigation system 20 of
The power supply 95 is configured to actuate the pump mechanism of the pump cartridge 28. The power supply 95 is provided in the housing 38 of the base unit 22 and is a permanent component of the irrigation system 20. In the embodiment of
In the embodiment of
In the embodiment of
In the embodiments of
In the embodiments of
In the embodiments of
The embodied system 20 of
In the system overview provided by
Further, in the system overview provided by
Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present invention. This application is intended to cover any adaptations or variations of body side members for ostomy appliances as discussed herein. Therefore, it is intended that this invention be limited only by the claims and the equivalents thereof.
| Number | Date | Country | Kind |
|---|---|---|---|
| PA 2020 70784 | Nov 2020 | DK | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/DK2021/050347 | 11/24/2021 | WO |
