WO2016139368A1

WO2016139368A1 - Multiport for medical device

Info

Publication number: WO2016139368A1
Application number: PCT/EP2016/054803
Authority: WO
Inventors: Stefan Puller; Sven-David Plate; Frank Lübeck
Original assignee: Plümat Plate & Lübeck GmbH & Co.
Priority date: 2015-03-05
Filing date: 2016-03-07
Publication date: 2016-09-09
Also published as: GB2536042A; KR102627091B1; GB201503749D0; KR20170128387A; MY190930A; GB2536042B

Abstract

A multiport valve (10) is disclosed which comprises at least three ports (60, 70, 80) disposed circumferentially about a bottom section. A top section (20) fits on a bottom section (30) and has an initial position and a depressed position. An inner ring (40) arranged to move within the bottom section (30) such that in a first position a first one of the at least three ports (60, 70, 80) is connected with a second one of the at least three ports (60, 70, 80) and in a second position the first one of the at least three ports (60, 70, 80) is connected with a third one of the at least three ports (60, 70, 80).

Description

Title: Multiport for Medical Device

Field of the invention

[0001] The invention relates to a multiport valve comprising a plurality of ports. In particular, the multiport valve can be used for medical devices, for example in a device for peritoneal dialysis Background of the invention

[0002] Peritoneal dialysis is a treatment for patients with severe chronic kidney disease. The treatment uses the patient's peritoneum in the abdomen as a membrane, across which fluids and dissolved substances are exchanged with the blood. The dissolved substances include electrolytes, urea, glucose, albumin and other small molecules. The fluid is introduced through a permanent catheter in the abdomen and flushed out either every night, whilst the patient is asleep, or via regular exchanges throughout the day. The regular flushing throughout the day is termed "continuous ambulatory peritoneal dialysis", abbreviated to CAPD. Peritoneal dialysis can be used as an alternative to hemodialysis, but it is far less commonly used in many countries. It has comparable risks to hemodialysis, but is significant less costly. The primary advantage of CAPD is the ability to undertake treatment without the need for a patient to visit a medical facility, such as a hospital or a doctor's surgery. The primary complication of peritoneal dialysis is an infection due to the permanent presence of the catheter in the abdomen.

Prior art

[0003] One product used for continuous ambulatory peritoneal dialysis is the StaySafe ® medical device, which is commercially available from Fresenius Medical Care.

[0004] A device for continuous ambulatory peritoneal dialysis is disclosed in international patent application No. WO 2011/113615 Al (assigned to Fresenius Medical Care Deutschland GmbH). The patent application discloses a device with a connector, which is connected to a catheter, a container which contains an osmotically active solution and is connected to the catheter, a distributor and a hose system. The device includes a semi-permeable membrane, which is made of a cellulose membrane, for the exchange of fluids.

[0005] A further device for continuous ambulatory peritoneal dialysis is disclosed in international patent application WO 2002/032479 A2 (Levin), which includes an abdominal sac including a dialysis solution. The abdominal sac has a semi-permeable membrane wall and the abdominal sac is adapted to be retained in the abdominal region of a patient's body for receiving unconcentrated urine through the semipermeable membrane wall without permitting the dialysis solution to exit through the wall of the abdominal sac. The device further includes a conduit passing the unconcentrated urine from the abdominal sac through a section of the patient' s bowel to an exit port. [0006] A further peritoneal dialysis system is taught in European patent application No. EP 2 623 139 Al, which includes a circuit to measure the conductivity of the fluid introduced into the peritoneal cavity.

[0007] All of the prior art applications have in common that they need a valve with a number of ports in order to switch the connection of the catheter entering the abdomen between a connector tube to a sac containing an electrolytic solution and a further bag for collecting waste products. This multiport valve is a potential source of infection, as it is located outside of the body connected to the catheter entering the patient's abdomen. It therefore needs to be made and operated in manner that substantially prevents infection entering the body.

Summary of the invention

[0008] This disclosure teaches a multiport valve with at least three ports. In the case of a device for CAPD one of the ports is connected to the catheter entering the abdomen, another one of the ports is connected to a fluid bag containing electrolytic fluids and a further one of the ports is connected to a waste bag containing waste products. The three ports are arranged circumferentially about a bottom section of the multiport valve. A top section is adapted to fit on the bottom section and has two positions. An initial position is used during rest or transportation of the multiport valve before the multiport valve is used in the CAPD device. The top section can be pushed down into a depressed position for use.

[0009] An inner ring is arranged within the bottom section of the multiport valve. This inner ring is designed to move into at least two positions. In a first position a first one of the ports is connected with a second one of the ports and in a second position the same first one of the ports is connected with a third one of the ports. The inner ring can be rotated by using a protrusion element on the outer side of the top section.

[0010] The inner ring has a seal on its outer side and the depression of the top section of the multiport valve from the initial position to the rest position enables a better sealing of the multiport valve. The seal in the initial position is not as compressed as the seal in the depressed position.

[0011] These two positions allow an easy transportation of the multiport valve in that the inner ring is sealed during the transportation. On use of the multiport valve in the device the connection is made between two of the ports, which allows a fluid to flow between two of the ports. A rotation of the top section can therefore allow the device to be either in a position in which an electrolyte solution is passed into the abdomen of the patient or waste products are removed from the abdomen of the patient.

[0012] The top section is provided with a rim, which fits within the bottom section. The top section has two extension elements of differing lengths, which match to a corresponding notch on the bottom section. In the initial position, a first one of the extension elements latches into a first corresponding position on the inner side of the bottom part and holds the top section in the initial position. A second one of the extension elements latches into a second position on the inner side of the bottom part and holds the top section in the depressed position within the multiport valve. [0013] In one aspect, the multiport valve further comprises a guidance rail for depressing the top section into the bottom section as the top section is turned in a clockwise manner. The multiport valve may also comprise at least one raster element which cooperates with a protrusion to prevent rotation of the top part in a second (anti-clockwise) direction, but allowing rotation of the top part in a first (clockwise) direction.

[0014] The multiport valve is provided with seals in order to prevent the entry of bacteria or virus into the multiport valve, which could course infections within the patient. [0015] The multiport valve can be used in a drainage system, for example for continuous ambulatory peritoneal dialysis.

Description of the figures [0016] Fig. 1 shows a perspective view of a first embodiment of the multiport valve of this disclosure;

[0017] Fig. 2A shows a first top view of the multiport valve with the fluid tube connected between the input port and the catheter port;

[0018] Fig. 2B shows a top view of a second position of the inner tube connected between the output port and the catheter port;

[0019] Fig. 3 shows a cross- sectional view of the first embodiment of the multiport valve in a first initial or resting position;

[0020] Fig. 4 shows a cross-sectional view of the first embodiment of multiport valve with the top section in a depressed or working position; [0021] Fig. 5 shows an example of the inner ring of the multiport valve with the inner tube visible; [0022] Fig. 6 shows an example of a continuous ambulatory peritoneal dialysis system in which the multiport valve can be used.

[0023] Fig.7 shows a perspective view of a second embodiment of the multiport valve.

[0024] Fig. 8 shows a top view of the second embodiment of the multiport valve. Detailed description of the invention [0025] Fig. 1 shows a perspective view of a multiport valve 10 in a first aspect of this disclosure. The multiport valve 10 is substantially cylindrical in nature and has a top section 20 mounted on a bottom section 30. A plurality of ports 60, 70 and 80 is connected around the circumference of the wall 34 of the bottom section 30. In the example depicted in Fig. 1 three ports 60, 70 and 80 are shown. An input port 60 is connected through a connector 65 to a bag containing, for example, electrolytic fluids for dialysis (shown in Fig. 6). An output port 70 is connected through a connector 75 to a bag (not shown) for collecting waste products. A catheter port 80 can be connected to a catheter 150, which enters the patient's body. The catheter 150 is not shown in Fig. 1, but can be seen in the system depicted in Fig. 6.

[0026] The multiport valve 10 is manufactured from a plastic, such as a polyolefin, e.g. polypropylene, or polycarbonate. The top section 20 is rotatable about the bottom section 30 and fits snugly over the bottom section 30 such that rim 26 of the top section 20 fits over the top of the wall 34 of the bottom section 30 (best seen in Figs. 3 and 4). On the top surface 21 an element 28 protrudes from the top surface 21, which is used by the patient or a medical practitioner to rotate the top section 20 about the bottom section 30. It will be noted that the element 28 in this first aspect has two arrows, which can be used by the patient or the medical practitioner to line up the top section with the ports 60, 70 or 80. The top section 20 can be depressed into the bottom section 30 to operate the multiport valve 10, as will be explained later. The top surface 21 has also a plurality of markings showing the various positions that the multiport valve can take and the associated function. [0027] Figs. 2A and 2B show a top view of the multiport valve 10 in which the top section 20 has been removed to reveal an inner ring 40, which fits tightly into the bottom section 30 and can rotate within the bottom section 20. The inner ring 40 comprises a ring element 48 into which a tubular passage 46 is formed. This can be seen more clearly in Fig. 5. The passage 46 is designed to allow passage of a fluid from the cathode port 80 to the input port 60, as shown in Fig. 2A, or to allow passage of a fluid from the output port 70 to the cathode port 80, as is shown in Fig. 2B. The passage 46 can be rotated between either of the two positions by moving the element 28 on the top surface 21 of the multiport valve 10.

[0028] The inner ring 40 is shown in more detail in Fig. 5. It will be seen that the inner ring 40 has a seal 44 mounted on the outer circumference of the inner ring 40. The seal 44 is made, for example, from an elastomeric material and allows sealing of inner workings of the multiport valve 10 from the environment. In particular, the seal 44 ensures that no infections reach the passage 46, from where the infectious material could enter into the body through catheter port 80, as the seal 44 is between the inner ring 44 and the inner side of the walls of the bottom section 30. The inner ring 40 has two notches 45 on the inner side 41 to engage with latches on the bottom side of the top surface 20, as will be explained below. The two notches 45 are located diametrically opposite each other on the upper rim. The two notches 45 interlock with a projection on the lower surface of the top section 20 when the top section 20 is depressed into the working position (explained below) and enable the inner ring 40 to be rotated - in a clockwise direction - by a user using the element 28 on the top surface 21 of the top section. Thus the inner ring 40 can only be turned when the top section 20 is in the depressed or working position. This ensures that the fluid passageways are not accidentally exposed during transport of the multiport valve 10.

[0029] Figs. 3 and 4 show a cross-sectional view of the multiport valve 10 in two different positions. Fig. 3 shows the multiport valve 10 of the first aspect in a rest position or travelling position. This rest position is engaged after manufacture of the multiport valve 10 and before the multiport valve 10 is used. Fig. 4 shows the depressed or working position of the multiport valve 10. In this working position, the top part 20 of the multiport valve 10 has been depressed or pushed down.

[0030] It will be seen from both Figs. 3 and 4 that the top port 20 has on its bottom surface two extension elements 22 and 23 which extend into the cavity formed by the bottom part 30 and act as latches with a latch lip 221 and 231 which engage with the corresponding positions 42 and 43 on the bottom section 30. In the rest or initial position shown in Fig. 3, the latch 221 on the extension element 22 latches into the first one of the positions 42 and is held in place. On depression of the top section 20, the latch 231 on the extension element 23 moves down the inner side 41 and is then latched into place in the second one of the positions 43. The depression of the top section 20 also pushes the inner ring 40 down into the inside of the bottom section 30

[0031] The top part 20 also has a protruding element 27 located near to the rim 26 on the bottom side of the top part. The protruding element 27 and the rim 26 form a cavity into which the wall 34 of the bottom section 30 fits. On depression of the top part 20, the top of the wall 34 moves into the cavity. The protruding element 27 projects onto the top of the inner ring 40 and, on being depressed, pushes the inner ring 40 down into the bottom section 30. It can be seen, by comparison of the bottom of the inner ring 40 depicted in Figs. 3 and 4, that in the rest position in Fig. 3, there is a slight gap between the bottom of the inner ring 40 and the bottom section 30, whereas in Fig. 4, there is substantially no gap.

[0032] It will be noted that the wall of the inner ring 40 and the wall 34 of the bottom section 30 are inclined at a slight angle. This results in the seal 44 on the outer circumference of the inner ring 40 (shown in Fig. 5) being compressed more on depression of the top section 20. As a result, the seal 44 better seals the inside of the multiport valve 10. In other words, the seal 44 in the rest position has only a slight compressive force exerted on the seal 44, but in the working position has a much greater force exerted on the seal 44.

[0033] It is known that the seal 44 can lose at least part of its resilience when it is compressed for a long period. The time between manufacture of the multiport valve and use of the multiport valve 10 is unknown and there is therefore a risk that the seal 44 might lose at least some of its sealant properties if the time prior to use is too long. The multiport valve 10 of this disclosure reduces the risk of inadequate sealing of the inside of the multiport valve 10. [0034] Fig. 6 shows an overview of a continuous ambulatory peritoneal dialysis system 100 comprising a waste bag 110 connected to the output port 70 of the multiport valve 10 by a connector 120. A dialysis solution bag 130 is connected to the input port 60 of the multiport valve 10 through the connector 140. A catheter 150 is connected into a bag in the abdomen 170 of a patient 160. The catheter 150 is connected to the catheter port 80 of the multiport valve 10.

[0035] The use of the multiport valve in the continuous ambulatory peritoneal dialysis system of Fig. 6 enables a simple multiport valve 10 to be developed, which is sterile and can be used by patients outside of hospitals.

[0036] A second aspect of the multiport valve 10 is shown in Fig. 7. The reference numerals used in Fig. 7 are the same as those used in the other figures for the same elements. The second aspect of the multiport valve 10 differs from the first aspect in that the depression of the top section 20 to the depressed position (or working position) is not carried out by depressing the top section 20 onto the bottom section 30. The smultiport valve 10 in this second aspect is provided with a guidance rail 710 on the inside of the bottom section 30 which cooperates with a protrusion 700 on the top section 20. The guidance rail 710 has a first position 710a which is arranged at a greater distance 720a from the bottom of the bottom part 30 than the second position 710c which is arranged at a smaller distance 720c from the bottom of the bottom part 30. There is an intermediate section 720b between the first position 710a and the second position 710c which slopes down and adjusts the distance from the first position 710a to the second position 710c.

[0037] In the rest position the protrusion 700 and the guidance rail 710 in the first position 720a cooperate to enable the top part 20 to be spaced at a distance from the bottom part 30. In the depressed or working position the protrusion 700 and the guidance rail 720 cooperate to depress the top part 20 onto the bottom part 30. The changeover from the first position 710a to the second position 720c is carried out by rotating the top part 20 in a clockwise manner with respect to the bottom part 30. During this rotation - of approximately 20°, but this is not limiting of the invention - the protrusion 700 is forced down by the guidance rail 710 in the intermediate section 710b to depress the top part 30. The depression of the top part 30 only happens in this intermediate section 710b. Thereafter a further rotation of the top part 30 does not lead to any further depression as the second distance 720 over the rest of the period of the rotation is constant.

[0038] Fig. 7 also shows raster elements 740 located on the bottom of the bottom part 30 and an associated protrusion 750 located on the underside of the inner ring 40. There are three raster elements 740 located approximately spaced at an equal radius within the multiport valve 10 and these raster elements 740 are used to stop the top part 20 being rotated in an anticlockwise manner about the bottom part 30, for reasons that will be explained below.

[0039] The raster elements 740 and the associated protrusions 750 have one wedge shaped edge to slide over each other when the top part 20 is turned clockwise. The raster element 740 and the associated protrusion 750 have parallel orientated faces that abut each other to prevent further rotation should the top element 20 be rotated in an anti-clockwise direction.

[0040] Fig. 8 shows a top view of the top surface 21 of the top part of the second aspect of the multiport valve 10. It will be seen that there are five markings 810, 820, 830, 840 and 850 on the top surface 21 together with a pointer 865 and an arrow 860. The arrow 860 indicates that the top part 20 should be turned clockwise. The multiport valve 10 is transported in an initial position 800 at which the pointer 865 points to the initial position 800, as shown in Fig. 8.

[0041] The pointer 865 is turned clockwise to the first marking 810. The first marking 810 corresponds to the position at which the guidance rail 710 starts the second section 710c and the intermediate section 710b ends. In other words, turning the top part 20 in the direction of the arrow 860 results from the initial position 800 to the first marking 810 results in the depression of the top part 20 from the initial position to the depressed or working position at the first marking 810. At this point, the catheter 150 can be connected to the patient.

[0042] The second marking 820 is the position in which the inner ring 40 is arranged such that the catheter 80 is connected to the output 70 and enables fluids from a bag in the abdomen of the patient to be expelled into the waste bag 110 connected to the output 70 (and shown in Fig. 6). The third marking 830 is the position at which the inner ring 40 is arranged such that the bag in the abdomen of the patient can be rinsed. Finally, the fourth marking 840 is the position at which the input port 60 is connected to the catheter to enable the dialysis solution from the solution bag 130 to be transferred to the bag in the abdomen of the patient. Each of the second marking 820, the third marking 830 and the fourth marking 840 is so arranged that one of the raster elements 740 shown in Fig. 4 engages with the protrusion 750 to ensure that the top part 20 cannot be rotated anti-clockwise, against the direction indicated by the arrow 850.

[0043] Finally, the pointer 865 is turned to the fourth marking 850 at which point there is no fluid connection between the catheter 150 and any one of the input port 60 or the output port 70. The multiport valve 80 can be detached from the patient. [0044] It will be appreciated that the multiport valve 10 of this disclosure can find applications in other medical fields.

Reference Numerals

10 Multiport valve

20 Top section

21 Top surface

22 Extension element

221 Latch lip

23 Extension element

231 Latch lip

26 Rim

27 Protrading element

28 Element

30 Bottom section

34 Wall

40 Inner ring

41 Inner side

42 Position

43 Position

44 Seal

45 Notches

46 Tubular passage

48 Ring element

60 Input port

65 Connector

70 Output port

75 Connector

80 Catheter port

100 Continuous ambulatory peritoneal dialysis system

110 Waste bag

120 Connector

130 Solution bag

140 Connector 150 Catheter

160 Patient

170 Abdomen

700 Protrusion

710 Guidance rail

710a First position

710b Intermediate section

710c Second section

720a Greater distance

720c Smaller distance section

740 Raster elements

750 Protrusion

800 Initial position

810 First marking

820 Second marking

830 Third marking

840 Fourth marking

850 Fifth marking

860 Arrow

865 Pointer

Claims

1. A multiport valve (10) comprising:

at least three ports (60, 70, 80) disposed circumferentially about a bottom section; a top section (20) adapted to fit on a bottom section (30) and having an initial position and a depressed position; and

an inner ring (40) arranged to move within the bottom section (30) such that in a first position a first one of the at least three ports (60, 70, 80) is connected with a second one of the at least three ports (60, 70, 80) and in a second position the first one of the at least three ports (60, 70, 80) is connected with a third one of the at least three ports (60, 70, 80).

2. The multiport valve (10) of claim 1, wherein the top section (20) and the bottom section (30) are substantially cylindrical.

3. The multiport valve (10) of any of the above claims, wherein one of the at least three ports (60, 70, 80) is connectable to a catheter (150) entering a patient (160).

4. The multiport valve (10) of any of the above claims, wherein one of the at least three ports (60, 70, 80) is connectable to a connector (120) to a waste bag (110).

5. The multiport valve (10) of any of the above claims, wherein one of the at least three ports (60, 70, 80) is connectable to a connector (140) to a solution bag (130).

6. The multiport valve (10) of any of the above claims, wherein the top section (20) is provided with a rim (22) fitting to the bottom section (30).

7. The multiport valve (10) of any of the above claims, wherein the top section (20) is provided with at least one extension element (22, 23) matching to a position (42, 43) of the bottom section (30).

8. The multiport valve (10) of any of the above claims, wherein the top part (20) is provided with two extension elements (22, 23) of differing lengths and wherein in the initial position a first one of the two extension elements (22) latches into a first position(42) on the inner side (41) and in the depressed position a second one of the two extension elements (23) latches into a second position (43) on the inner side

(41).

9. The multiport valve (10) of any of the above claims, wherein the inner ring (40) is provided with a seal (44) on its outer side.

10. The multiport valve (10) of any of the above claims, further comprising a guidance rail (710) for depressing the top section (20) into the bottom section (20).

11. The multiport valve (10) of any of the above claims further comprising at least one raster element (740) cooperating with a protrusion (750) to prevent rotation of the top part (20) in a second direction, but allowing rotation of the top part (20) in a first direction.

12. A drainage system (100) comprising the multiport valve (10) of any one of the above claims and a first bag (110, 130) connected to a first one of the at least three ports (60, 70, 80) and a catheter (85, 150) connected to a second one of the at least three ports (60, 70, 80).