Patent Publication Number: US-2022226561-A1

Title: Connector adapted to attach an irrigation catheter to tubing of an anal or stomal irrigation system

Description:
BACKGROUND 
     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. Patients having undergone stomal surgery wherein a catheterizable stoma is constructed may suffer from similar difficulties. 
     It is known to accomplish bowel emptying by irrigation (i.e. flushing) of the rectum or stoma, by an irrigating liquid, 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 or stoma, where it remains in a fixed position by an expandable inflation element, such as a balloon. The balloon may be inflatable by air or by water. Once the rectum or stoma has been flushed with the irrigation liquid, the expandable retention element is allowed to collapse to its non-deflated state, allowing the catheter to be withdrawn from the rectum or stoma, and allowing irrigation liquid and faeces to evacuate. The catheter is connected to a reservoir of irrigation liquid through a tube, and a pump may be provided for displacing or pumping irrigation liquid from the reservoir to the catheter. 
     SUMMARY 
     There is a need for systems and//or methods increasing the safety for a user of an irrigation system and/or reduce the risk of damage or irritation of a user&#39;s bowel during and/or after irrigation. 
     Accordingly, an adapter for an irrigation system for anal and/or stomal irrigation is disclosed, the adapter comprising a first connector, and a second connector, wherein the first connector and the second connector are connected by a first fluid path for feeding irrigation liquid from the first connector to the second connector, the adapter comprising a pressure control device arranged in the first fluid path, wherein the pressure control device has an inlet side and an outlet side and is configured to keep a liquid pressure on the outlet side less than a first pressure threshold. 
     Further, an irrigation system for anal and/or stomal irrigation is provided, the irrigation system comprising a reservoir for an irrigation liquid; a tubing system with a first end connectable to the reservoir, and a second end connectable to a catheter and/or an adapter for provision of a first fluid path for the irrigation liquid between the reservoir and the catheter comprising a distal end for expelling irrigation liquid from the catheter; and a pump operable to pump the irrigation liquid from the reservoir to the second end of the tubing system. The irrigation system comprises a mechanical pressure control device, the pressure control device having an inlet side and an outlet side, wherein the inlet side is connected to a reservoir side of the first fluid path and the outlet side is connected to a catheter side of the first fluid path, wherein the pressure control device is configured to keep liquid pressure on the outlet side less than a first pressure threshold. 
     Also disclosed is a method for operating an irrigation system for anal and/or stomal irrigation, the irrigation system comprising a tubing system with a first end connectable to a reservoir, and a second end connectable to a catheter for provision of a first fluid path for the irrigation liquid between the reservoir and the catheter comprising a distal end for expelling irrigation liquid from the catheter; and an adapter, e.g. as described herein, comprising a first connector, and a second connector, wherein the first connector and the second connector are connected by a first fluid path for feeding irrigation liquid from the first connector to the second connector, the adapter comprising a pressure control device arranged in the first fluid path, wherein the pressure control device has an inlet side and an outlet side and is configured to keep a liquid pressure on the outlet side less than a first pressure threshold. The method comprises coupling the first connector of the adapter to the second end of the tubing system; coupling a catheter to the second connector of the adapter; and pumping irrigation liquid through the first fluid path. 
     The present disclosure enables more safe anal and/or stomal irrigation by improving the pressure control of the irrigation liquid flow in the irrigation system. The present disclosure enables more effective irrigation while at the same time providing a safe irrigation, by improving the accuracy of fluid pressure control in the irrigation system. Current systems, in order to comply with safety regulations, typically operate with a large safety margin, which in turn reduces the irrigation efficiency in certain use situations. The safety margins applied may result in irrigation liquid pressure at the catheter tip below a desired minimum pressure, e.g. in the range from 1.2 to 1.6 psi, for certain use situations. It is an advantage of the present disclosure that the liquid pressure control is improved, e.g. by increasing the minimum liquid pressure of the irrigation liquid at the catheter tip. 
     The present disclosure provides a simple, efficient, and easy-to-use irrigation system with a high degree of safety for a user. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings are included to provide a further understanding of embodiments and are incorporated into and a part of this specification. The drawings 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. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts. 
         FIG. 1  illustrates an exemplary irrigation system, 
         FIG. 2  illustrates an exemplary irrigation system, 
         FIG. 3  illustrates an exemplary pressure control device, 
         FIG. 4  illustrates an exemplary adapter, 
         FIG. 5  illustrates an irrigation system with an adapter coupled to the second end of tubing system, 
         FIG. 6  is an exploded view of parts of an irrigation system, 
         FIG. 7  is a cross section of an exemplary second connector of a tubing system, 
         FIG. 8  is a cross section of an exemplary second connector of a tubing system, and 
         FIG. 9  is a cross section of an exemplary second connector of a tubing system, 
     
    
    
     DETAILED DESCRIPTION 
     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 can be practiced in any other embodiments even if not so illustrated, or if not so explicitly described. 
     An irrigation system for anal and/or stomal irrigation, and an adapter for an irrigation system for anal and/or stomal irrigation is disclosed. The irrigation system may be a point-of-care (POC) irrigation system. A POC irrigation system must be safe to operate with low or no risk of errors, in particular with no risk of self-damaging of a user. The irrigation system may be an irrigation system with no return flow of fluid and faecal material in the tubing system of the irrigation system. 
     The irrigation system comprises a reservoir for an irrigation liquid. The reservoir may be configured to hold irrigation liquid having a volume of in the range from 100 mL to 3.0 L. In one or more exemplary irrigation systems, the reservoir has a reservoir volume less than 3 L. 
     The irrigation system comprises a tubing system with a first end and a second end. The first end is optionally connectable or connected to the reservoir and the second end is optionally connectable or connected to a catheter or an adapter for provision of a first fluid path for the irrigation liquid between the reservoir and the catheter comprising a distal end for expelling irrigation liquid from the catheter. The irrigation system may comprise a first fluid path and/or a second fluid path from the first end of the tubing system to the second end of the tubing system. The tubing system may comprise one or more tubing parts, such as a first tubing part and/or a second tubing part, for forming fluid path(s) between different housings of the irrigation system. The tubing system and parts thereof may comprise one or more first channels for forming parts of the first fluid path. The tubing system and parts thereof may comprise one or more second channels for forming parts of a second fluid path. The first fluid path of the irrigation system is for feeding irrigation liquid from the reservoir to the second end of the tubing system, e.g. for irrigating the bowel of the user. The second fluid path of the irrigation system may be for feeding irrigation liquid from the reservoir to the second end of the tubing system. The second fluid path may be for inflating or filling a balloon of the catheter, e.g. with irrigation liquid from the reservoir and/or air. 
     The tubing system may comprise a first connector at the first end of the tubing system. The tubing system may comprise a second connector at the second end of the tubing system. A tubing system with one or more connectors facilitate the use of different sized tubing system, e.g. to adapt to different users, and/or easy handling of the irrigation system, e.g. disassembly for storing. The second connector may be configured for coupling, e.g. detachable coupling, to a catheter and/or an adapter. 
     The irrigation system comprises a pump, such as an electrical pump, operable to pump the irrigation liquid from the reservoir to the second end of the tubing system. The pump may be arranged with the reservoir in a reservoir housing. 
     The irrigation system may comprise a user control interface housing with a user control interface. The user control interface enables a user to control the irrigation system. The user control interface housing may be attached to the tubing system. In one or more exemplary irrigation systems, the pump may be arranged in the user control interface housing. 
     The irrigation system may comprise a mechanical pressure control device for controlling the fluid pressure of the irrigation liquid. The mechanical pressure control device increases the safety for a user while enabling a sufficiently high fluid pressure at the catheter tip to perform effective irrigation. The pressure control device has an inlet side and an outlet side. The inlet side of the pressure control device is optionally connected to a reservoir side of the first fluid path and the outlet side of the pressure control device is optionally connected to a catheter side of the first fluid path. 
     The pressure control device may be arranged at a distance less than 50 cm from the second end of the tubing system. The pressure control device may be arranged at a distance less than 30 cm from the second end of the tubing system, such as within 15 cm from the second end of the tubing system. The pressure control device may be arranged in the second connector of the tubing system. The pressure control device may be arranged in a pressure control housing, e.g. at a distance less than 30 cm from the second end of the tubing system. 
     In one or more exemplary irrigation systems, where the irrigation system comprises a user control interface housing attached to the tubing system, the pressure control device may be arranged in the user control interface housing or between the user control interface housing and the second end of the tubing system. 
     The adapter comprises a first connector and a second connector. The first connector and the second connector are connected by a first fluid path for feeding irrigation liquid from the first connector to the second connector. 
     The first connector of the adapter is optionally configured to be attached to an end of a tubing system, such as a second end, e.g. a second connector, of a tubing system of the irrigation system. The second connector of the adapter is optionally configured to be attached to a catheter. The adapter comprises a pressure control device arranged in the first fluid path, wherein the pressure control device has an inlet side and an outlet side and is configured to keep a liquid pressure on the outlet side less than a first pressure threshold. 
     The first pressure threshold may be in the range from 1.0 Psi to 3.0 Psi. In one or more exemplary irrigation systems and/or adapters, the first pressure threshold may be in the range from 1.6 Psi to 2.2 Psi. 
     The pressure control device may comprise a pressure regulator comprising a loading element including a first spring. The pressure control device/pressure regulator may comprise a restricting element arranged to vary the fluid flow through the pressure control device. The loading element may comprise a second spring. The pressure regulator may comprise a diaphragm, e.g. as part of the loading element. The loading element is optionally connected to the restricting element for loading and moving the restriction element when liquid flows in through the pressure control device. 
     The pressure control device may comprise a pressure relief valve comprising a secondary outlet, wherein the pressure relief valve is configured to open the secondary outlet when the liquid pressure in the pressure relief valve or on the outlet side reaches the first threshold pressure. The tubing system and/or the adapter may comprise a tube with a first end, wherein the first end of the tube is connected to the secondary outlet. The pressure relief valve may comprise a restricting element arranged to vary the fluid flow through the secondary outlet. The pressure relief valve may be configured to close the secondary outlet when the liquid pressure in the pressure relief valve is below the first threshold pressure. 
     A restriction element of the pressure control device may be made of a flexible material, such as rubber or silicone. 
     The adapter may comprise a second channel forming a part of a second fluid path and connecting the first connector and the second connector for feeding second fluid from the first connector to the second connector. Thus, feeding of a second fluid such as gas/air or liquid from the tubing system to the catheter is provided for, e.g. in order to inflate or fill soft inflatable balloon of the catheter in order to keep the catheter in place during irrigation. 
     The adapter may comprise a housing made of a plastic material, such as polypropylene or polyethylene. The adapter housing may be an elongate housing, e.g. with the first connector arranged at a first end of the adapter housing and/or with the second connector arranged at a second end of the adapter housing. The adapter housing may have a length or maximum extension along a longitudinal axis in the range from 1 cm to 15 cm. The adapter housing may have a width or maximum extension perpendicular to the longitudinal axis in the range from 1 cm to 5 cm. 
       FIG. 1  shows an exemplary irrigation system for anal and/or stomal irrigation. The irrigation system  2  comprises a reservoir  4  for an irrigation liquid; a tubing system  6  with a first end  8  (not shown in  FIG. 1 ) connectable to the reservoir  4 , and a second end  10  with a second connector  12  connectable to a catheter  14  for provision of a first fluid path for the irrigation liquid between the reservoir  4  and the catheter  14  comprising a distal end  16  for expelling irrigation liquid from the catheter  16 . The irrigation system  2  comprises a pump operable to pump the irrigation liquid from the reservoir  4  to the second end  10  of the tubing system  6 . The pump is optionally arranged in reservoir housing  20  with reservoir  4 , such as in bottom part  20  of the reservoir housing  18 . 
     The irrigation system  2  comprises a mechanical pressure control device  22  arranged in the second connector  12 . The pressure control device has an inlet side  26  and an outlet side  28 , wherein the inlet side  26  is connected to a reservoir side of the first fluid path and the outlet side is connected to a catheter side of the first fluid path, wherein the pressure control device  22  is configured to keep liquid pressure on the outlet side  26  less than a first pressure threshold of in the range from 1.6 Psi to 2.2 Psi. The tubing system  6  comprises a first tubing part  32  and a second tubing part  34  each forming a part of the first fluid path of the irrigation system. The first tubing part  32  extends between the reservoir housing  18  and a user control interface housing  30  attached to the tubing system  6 . The second tubing part  34  extends between the user control interface housing  30  and the pressure control device  22 /second connector  12 . 
       FIG. 2  shows an exemplary irrigation system for anal and/or stomal irrigation. The irrigation system  2 A comprises a reservoir  4  for an irrigation liquid; a tubing system  6  with a first end  8  (not shown in  FIG. 1 ) connectable to the reservoir  4 , and a second end  10  with a second connector  12  connectable to a catheter  14  for provision of a first fluid path for the irrigation liquid between the reservoir  4  and the catheter  14  comprising a distal end  16  for expelling irrigation liquid from the catheter  16 . The irrigation system  2 A comprises a pump operable to pump the irrigation liquid from the reservoir  4  to the second end  10  of the tubing system  6 . The pump is optionally arranged in reservoir housing  20  with reservoir  4 , such as in bottom part  20  of the reservoir housing  18 . The irrigation system  2 A comprises a mechanical pressure control device  22  arranged in a pressure control housing  24  at a distance of 20 cm, i.e. less than 50 cm, from the second end  10  of the tubing system  6 . The distance is measured along the first fluid path. The pressure control device has an inlet side  26  and an outlet side  28 , wherein the inlet side  26  is connected to a reservoir side of the first fluid path and the outlet side is connected to a catheter side of the first fluid path, wherein the pressure control device  22  is configured to keep liquid pressure on the outlet side  26  less than a first pressure threshold of in the range from 1.6 Psi to 2.2 Psi. The irrigation system  2 A comprises a user control interface housing  30  attached to the tubing system  6 , wherein the pressure control device  22  is arranged between the user control interface housing  30  and the second end  10  of the tubing system. The tubing system  6  comprises first tubing part  32 , second tubing part  34 , and a third tubing part  36  each forming a part of the first fluid path of the irrigation system. The first tubing part  32  extends between the reservoir housing  18  and the user control interface housing  30 . The second tubing part  34  extends between the user control interface housing  30  and the pressure control device  22 , and the third tubing part  36  extends between the pressure control device  22  and the second end  10  of the tubing system. The length of the third tubing part is less than 50 cm, such as less than 30, e.g. about 20 cm. 
       FIG. 3  illustrates a cross-section of an exemplary pressure control device. The pressure control device  22  has an inlet side  26  and an outlet side  28 , wherein the inlet side  26  is connected or connectable to a reservoir side of the first fluid path  29  and the outlet side is connected or connectable to a catheter side of the first fluid path, wherein the pressure control device is configured to keep liquid pressure on the outlet side less than a first pressure threshold. The pressure control device  22  comprises a pressure regulator  38  comprising a loading element including a first spring  40 , a second spring  42 , and a diaphragm  44 . The pressure regulator  38  comprises a valve or restriction element  46 . A poppet valve forms the restriction element  46 . Other suitable valves may be used as a restriction element. The second spring  42  on the inlet side and the first spring  40  and the diaphragm  44  on the outlet side adjusts the valve opening size such that liquid pressure on the outlet side  28  is less than a first pressure threshold, such as in the range from 1.6 Psi to 2.2 Psi, e.g. 2.0 Psi. 
       FIG. 4  illustrates a cross-section of an exemplary adapter for an irrigation system for anal and/or stomal irrigation. The adapter  50  has an adapter housing  51  made of a plastic material and comprises a first connector  52 , and a second connector  54 , wherein the first connector  52  and the second connector  54  are connected by a first channel  56  of first fluid path  29  for feeding irrigation liquid from the first connector to the second connector. The first connector  52  is configured for connection to a second connector  12  at a second end of a tubing system of the irrigation system, see also  FIG. 5 . The second connector  54  is configured for connection to a catheter. The first connector  52  and the second connector  54  are optionally connected by a second channel  58  for forming part of a second fluid path and feeding second fluid from the first connector to the second connector, e.g. in order to inflate or fill soft inflatable balloon of the catheter in order to keep the catheter in place during irrigation. 
     The adapter  50  comprises a pressure control device  22  (within dotted oval) arranged in the first fluid path  56 . The pressure control device  22  has an inlet side  26  and an outlet side  28  and is configured to keep a liquid pressure on the outlet side less than a first pressure threshold. An exemplary pressure control device is described in further detail above and shown in  FIG. 3 . 
     The adapter housing  51  is an elongate housing with the first connector arranged at a first end of the adapter housing and with the second connector arranged at a second end of the adapter housing. The adapter housing  51  has a length or maximum extension along longitudinal axis X of about 2-3 cm. 
       FIG. 5  shows an exemplary irrigation system for anal and/or stomal irrigation with an adapter inserted between the tubing system and the catheter. The irrigation system  2 B comprises a reservoir  4  for an irrigation liquid; a tubing system  6  with a first end  8  (not shown in  FIG. 5 ) connectable to the reservoir  4 , and a second end  10  with a second connector  12  connected to first connector of adapter  50 . Further, second connector of adapter  50  is connected to catheter  14  for provision of a first fluid path for the irrigation liquid between the reservoir  4  and the catheter  14  comprising a distal end  16  for expelling irrigation liquid from the catheter  16 . The irrigation system  2 B comprises a pump operable to pump the irrigation liquid from the reservoir  4  to the second end  10  of the tubing system  6 . The pump is optionally arranged in reservoir housing  20  with reservoir  4 , such as in bottom part  20  of the reservoir housing  18 . The first tubing part  32  extends between the reservoir housing  18  and the user control interface housing  30 . The second tubing part  34  extends between the user control interface housing  30  and the second connector  12 . 
       FIG. 6  shows an exploded view of a second connector of an exemplary tubing system of an irrigation system, and a catheter connectable to the second connector. The second connector  12  comprises a pressure control device in the form of a pressure relief valve. The pressure relief valve comprises a secondary outlet  60  arranged in first connector part  62  of the second connector. The second connector comprises a second connector part  64  and a third connector part  66 . The first connector part  62  is, in an assembled second connector, snap-locked to the second connector part  64 . The second connector part  64  is, in an assembled second connector, snap-locked to the third connector part  66 . The pressure relief valve comprises a restriction element  68  inserted in the first connector part  62 . The pressure relief valve is configured to open the secondary outlet when the liquid pressure in the pressure relief valve (first fluid path) reaches the first threshold pressure. The second connector  12  has a first outlet  70  of first fluid path  29  and a second outlet  72  of a second fluid path  74  (if present) of the tubing system  6 . 
       FIG. 7  shows a cross-section of the second connector  12  shown in  FIG. 6  attached to a tubing part, such as a second tubing part  34  of tubing system  6 . A first channel  76  of the second tubing part  34  and first channel  80  of the first connector part  62  forms a part of the first fluid path  29 . A second channel  78  of the second tubing part  34  and second channel  82  of the first connector part  62  forms a part of the second fluid path  74 . The pressure control device/pressure relief valve has an inlet side  26  and an outlet side  28 , wherein the inlet side  26  is connected to a reservoir side of the first fluid path  29  and the outlet side  28  is connected to a catheter side of the first fluid path. The pressure control device  22  is configured to keep liquid pressure on the outlet side  26  less than a first pressure threshold of in the range from 1.6 Psi to 2.2 Psi by allowing irrigation liquid in the first fluid path to bleed out through the secondary outlet if the pressure in the pressure relief valve exceeds a first pressure threshold of in the range from 1.6 Psi to 2.2 Psi. Thus, the pressure relief valve formed by the first connector part  62  and the restriction element  68  is configured to open the secondary outlet  60  when the liquid pressure in the pressure relief valve reaches the first threshold pressure by the flexible restriction element being deformed. 
       FIG. 8  shows a cross-section perpendicular to longitudinal axis X of the second connector  12  shown in  FIG. 6 . When the liquid/fluid pressure in the first channel  80  is below the first pressure threshold, the restriction element  68  closes the secondary outlet  60 . When the liquid/fluid pressure in the first channel  80  reaches the first pressure threshold, the restriction element  68  is deformed allowing irrigation fluid to flow or bleed from the first fluid path through the secondary outlet  60  into the space  84  between first connector part  62  and second connector part  64 . When the fluid pressure drops below the first pressure threshold, the restriction element returns to closing the secondary outlet  60 . 
       FIG. 9  shows a cross-section of an exemplary second connector of the tubing system  6 . The second connector  12  comprises a pressure regulator  38  as shown in further detail in  FIG. 3  and described in further detail above. A second tubing part (not shown) is attached to the inlet side  86  of the second connector  12  for connecting first and second channels  80 , 82  of the second connector to respective first and second channels of second tubing part. 
     Also disclosed are adapters, irrigation systems, and methods according to any of the following items. 
     Item 1. An adapter for an irrigation system for anal and/or stomal irrigation, the adapter comprising a first connector, and a second connector, wherein the first connector and the second connector are connected by a first fluid path for feeding irrigation liquid from the first connector to the second connector, the adapter comprising a pressure control device arranged in the first fluid path, wherein the pressure control device has an inlet side and an outlet side and is configured to keep a liquid pressure on the outlet side less than a first pressure threshold. 
     Item 2. Adapter according to item 1, wherein the first pressure threshold is in the range from 1.0 Psi to 3.0 Psi. 
     Item 3. Adapter according to any of items 1-2, wherein the pressure control device comprises a pressure regulator comprising a loading element including a first spring. 
     Item 4. Adapter according to any of items 1-3, wherein the pressure control device comprises a pressure relief valve comprising a secondary outlet, wherein the pressure relief valve is configured to open the secondary outlet when the liquid pressure in the pressure relief valve reaches the first threshold pressure. 
     Item 5. Adapter according to item 4, wherein the adapter comprises a tube with a first end, wherein the first end of the tube is connected to the secondary outlet. 
     Item 6. Adapter according to any of items 1-5, wherein the adapter comprises a second channel connecting the first connector and the second connector for feeding second fluid from the first connector to the second connector. 
     Item 7. Adapter according to any of items 1-6, wherein the adapter comprises an adapter housing made of a plastic material. 
     Item 8. An irrigation system for anal and/or stomal irrigation, the irrigation system comprising:
         a reservoir for an irrigation liquid;   a tubing system with a first end connectable to the reservoir, and a second end connectable to a catheter or an adapter for provision of a first fluid path for the irrigation liquid between the reservoir and the catheter comprising a distal end for expelling irrigation liquid from the catheter; and   a pump operable to pump the irrigation liquid from the reservoir to the second end of the tubing system,
 
wherein the irrigation system comprises a mechanical pressure control device, the pressure control device having an inlet side and an outlet side, wherein the inlet side is connected to a reservoir side of the first fluid path and the outlet side is connected to a catheter side of the first fluid path, wherein the pressure control device is configured to keep liquid pressure on the outlet side less than a first pressure threshold.
       

     Item 9. Irrigation system according to item 8, wherein the pressure control device is arranged at a distance less than 50 cm from the second end of the tubing system. 
     Item 10. Irrigation system according to any of items 8-9, wherein the irrigation system comprises a user control interface housing attached to the tubing system, wherein the pressure control device is arranged in the user control interface housing or between the user control interface housing and the second end of the tubing system. 
     Item 11. Irrigation system according to any of items 8-10, wherein the first pressure threshold is in the range from 1.0 Psi to 3.0 Psi. 
     Item 12. Irrigation system according to any of items 8-11, wherein the pressure control device comprises a pressure regulator comprising a loading element including a first spring. 
     Item 13. Irrigation system according to any of items 8-12, wherein the pressure control device comprises a pressure relief valve comprising a secondary outlet, wherein the pressure relief valve is configured to open the secondary outlet when the liquid pressure on the outlet side reaches the first threshold pressure. 
     Item 14. Method for operating an irrigation system for anal and/or stomal irrigation, the irrigation system comprising a tubing system with a first end connectable to a reservoir, and a second end connectable to a catheter for provision of a first fluid path for the irrigation liquid between the reservoir and the catheter comprising a distal end for expelling irrigation liquid from the catheter; and an adapter comprising a first connector, and a second connector, wherein the first connector and the second connector are connected by a first fluid path for feeding irrigation liquid from the first connector to the second connector, the adapter comprising a pressure control device arranged in the first fluid path, wherein the pressure control device has an inlet side and an outlet side and is configured to keep a liquid pressure on the outlet side less than a first pressure threshold, the method comprising
         coupling the first connector of the adapter to the second end of the tubing system;   coupling a catheter to the second connector of the adapter; and   pumping irrigation liquid through the first fluid path.       

     Item 15. Method according to item 14, wherein the first pressure threshold is in the range from 1.0 Psi to 3.0 Psi. 
     Although particular features have been shown and described, it will be understood that they are not intended to limit the claimed invention, and it will be made obvious to those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the claimed invention. The specification and drawings are, accordingly to be regarded in an illustrative rather than restrictive sense. The claimed invention is intended to cover all alternatives, modifications and equivalents. 
     LIST OF REFERENCES 
     
         
           2  irrigation system 
           4  reservoir 
           6  tubing system 
           8  first end of tubing system 
           10  second end of tubing system 
           12  second connector 
           14  catheter 
           16  distal end of catheter 
           18  reservoir housing 
           20  bottom part 
           22  pressure control device 
           24  pressure control housing 
           26  inlet side of pressure control device 
           28  outlet side of pressure control device 
           29  first fluid path 
           30  user control interface housing 
           32  first tubing part 
           34  second tubing part 
           36  third tubing part 
           38  pressure regulator 
           40  first spring 
           42  second spring 
           44  diaphragm 
           46  restriction element 
           50  adapter 
           51  adapter housing 
           52  first connector 
           54  second connector 
           56  first channel 
           58  second channel 
           60  secondary outlet 
           62  first connector part 
           64  second connector part 
           66  third connector part 
           68  restriction element 
           70  first outlet of second connector 
           72  second outlet of second connector 
           74  second fluid path 
           76  first channel of second tubing part 
           78  second channel of second tubing part 
           80  first channel of first connector part 
           82  second channel of first connector part 
           84  space between first connector part and second connector part 
           86  inlet side of second connector 
         X longitudinal axis