Organiser for peritoneal dialysis

The organizer addresses the lack of leukocyte monitoring in peritoneal dialysis by integrating a measurement device and processor for real-time alerts, facilitating prompt medical action and preventing infections.

WO2026032602A1PCT designated stage Publication Date: 2026-02-12BECKER FRANZ FERDINAND +1
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Patent Information

Application Number
PCT/EP2025/069716
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-08-07
Filing Date
2025-07-10
Publication Date
2026-02-12

AI Technical Summary

Technical Problem

Existing peritoneal dialysis organizers do not provide real-time monitoring of leukocyte levels in dialysate, leading to potential infections and complications like pleurisy due to delayed therapy initiation.

Method used

An organizer with a measuring device to detect leukocytes in the outgoing dialysate, integrated into the base body, and a processor to calculate leukocyte counts, coupled with visual or vibrational alerts for patients when thresholds are reached, along with a selector device for fluid management.

Benefits of technology

Enables immediate patient intervention upon detecting elevated leukocyte levels, reducing the risk of infections and complications by allowing timely medical consultation.

✦ Generated by Eureka AI based on patent content.

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    Figure EP2025069716_12022026_PF_FP_ABST
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Abstract

The invention relates to an organiser, in particular for home-based peritoneal dialysis, comprising a main body into which the end portions of two tubes are removably inserted, the tubes opening into a selector device which is likewise removably inserted into the main body and from which a tubular attachment protrudes from the organiser, wherein the selector device comprises a disc having a rotatable dial, by means of which selectively one of the two tubes can be brought into fluidic connection with the tubular attachment in order either to supply fresh dialysis fluid through the tubular attachment to the abdominal cavity of a patient or, after a dwell time in the abdominal cavity, the dialysis fluid is to be removed through the other tube, characterised in that a measuring device is integrated into the main body, through which measuring device the drain tube runs, and in that the measuring device is suitable for measuring leukocytes in the dialysis fluid.
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Description

[0001] Dr. Ulrich Paul Hinkel

[0002] Dr. Franz Ferdinand Becker

[0003] Organizer for peritoneal dialysis

[0004] The invention relates to an organizer that is preferably operated by a patient during home peritoneal dialysis. In peritoneal dialysis, a dialysis fluid is repeatedly filled into the patient's abdominal cavity, with the patient's peritoneum serving as a biological membrane through which the diffusion of waste products, such as urea, from the blood into the dialysis fluid takes place. After a certain residence time, the dialysis fluid, now called dialysate, is drained from the patient's abdominal cavity and discarded.

[0005] During dialysis treatment, the patient is connected via tubing to a bag containing fresh dialysis fluid and a collection bag for the used dialysate. This connection can be made using an organizer, which prevents the risk of contamination and thus infection of the patient, and simplifies handling. Such an organizer is known as the Staysafe® organizer, which allows the patient to control the supply of fresh dialysis fluid and the drainage of used fluid by turning a disc on the organizer.

[0006] The present invention is based on the objective of providing such an organizer with an additional function.

[0007] This problem is solved according to the invention by the features of claim 1.

[0008] Advantageous embodiments of the invention are characterized in the dependent claims.

[0009] The organizer according to the invention, which is preferably intended for home peritoneal dialysis, comprises a base body into which the end sections of two tubes are detachably inserted. These tubes open into a selector device that is also detachably inserted into the base body. The two tubes are available for handling by the patient in a coiled tube, in which the overlapping tube sections are glued together but can be torn apart. At least one of the tubes is made of a transparent material, which may also be the case for the other tube, but this is not mandatory. A tubular extension also protrudes from the selector device, to which the two tubes are preferably firmly connected via a push-fit connection during use.The selector device has a disc with a rotating pointer, which is used to connect either one of the two tubes to the tubular connector, or to connect the tubes to each other, in order to either introduce fresh dialysis fluid into the patient's abdominal cavity through the tubular connector or to drain the dialysate through the other tube after a certain period of residence in the abdominal cavity. To prevent air bubbles from the fresh dialysis fluid from entering the abdominal cavity, the two tubes can also be connected directly to each other.

[0010] The invention further provides that a measuring device is integrated into the base body, through which the draining, preferably transparent, tube runs, and that the measuring device is suitable for measuring leukocytes in the outgoing dialysis fluid, the dialysate.

[0011] The measurement result is advantageously displayed on a screen that is clearly visible to the patient on the top of the organizer.

[0012] If the displayed leukocyte count reaches or exceeds a certain threshold, the patient is notified visually, or by vibration. The patient then contacts their doctor to discuss the next steps. This allows for immediate initiation of therapy, which is highly beneficial for the patient and can prevent severe pleurisy.

[0013] In one embodiment of the organizer according to the invention, it has a flat base and an associated circumferential edge, which has approximately the plan shape of a semicircle extending from a straight edge to an opposite, preferably approximately right-angled, bulge. The components of the measuring device are attached within this interior space of the organizer, preferably screwed to the base. The base can be equipped with suction cups for attachment to the underside. It is also possible to attach the organizer to a rod or stand. In another embodiment of the invention, a circular wall is attached to the base within the interior of the semicircle, preferably integrally formed, into which the selector device, into which the two hoses or associated hose connectors open, is precisely fitted.This circular wall preferably has three upward-opening protrusions, which may have a semicircular shape, on which the two hoses and the tubular extension of the selector device rest.

[0014] In further details, it is preferably provided that an upwardly open bulge is formed in the wall of the circumferential edge, which together with a bulge of the circular wall aligned at an angle to it forms a receptacle for the draining hose.

[0015] In one embodiment, it is preferably provided that an LED is arranged on one side of the tube held in the indentations, which is preferably made of transparent material. The light beam of this LED is directed through the tube onto an image sensor, which is attached to the base on the other side of the tube or inserted into a recess molded into the base. The light sources can also be arranged differently.

[0016] A further significant advantage is the provision that a laser diode is mounted on the bottom of the dialysate tube, directing its beam upwards through the tube. The image sensor, preferably a camera, receives the scattered light generated by the laser beam striking leukocytes passing through the tube. A processor integrated into the organizer and connected to the image sensor calculates the number of leukocytes in the dialysate from the LED light beam directed at the image sensor and the scattered light generated by the laser. In one embodiment, an open-topped groove extends from an opposing protrusion in the circumferential wall to a corresponding protrusion in the circular wall. The incoming dialysis fluid tube is placed onto this groove and connected to a hose port on the selector device.The hoses from both the outgoing and incoming bags are firmly connected to the selector device.

[0017] In one embodiment of the invention, the two hoses in the organizer are each fixed in their installation position by two opposing clamps which are acted upon by springs.

[0018] In a preferred embodiment, the organizer is manufactured as an injection-molded plastic part and is covered by a removable, preferably multi-part, lid.

[0019] The light sources and the image sensor are either attached to the base, preferably screwed on, or inserted into molded housings so that they are fixed in position.

[0020] Further details of the invention will become apparent from the following description of a preferred embodiment and from the drawings. These show:

[0021] Figure 1 shows an embodiment of the organizer according to the invention;

[0022] Figures 2A to 2D show different views of the lower housing of the organizer;

[0023] Figure 3 shows a perspective view of the lower housing with inserted

[0024] Hoses and a selection device; Figure 4 shows details of Figure 3 in schematic simplification.

[0025] Figure 1 shows an embodiment in a top view. In plan view, the organizer 1 has approximately the shape of a semicircle 2 with a straight edge 3 and a somewhat rectangular bulge 4 opposite this edge, on which an electronic display device 5 for a measurement result is arranged. In top view, the organizer has a circular dial 6, the pointer 7 of which can be set by a user of the organizer to either a channel 8 or a channel 9, in which hoses (not shown in the illustration) are arranged, which open into the selector device 10 (Figure 3) located below the dial 7.

[0026] A tubular extension 11 leads out of the organizer 1 from the selector device 10. The tubular extension 11 is connected by means of a tube to a catheter that leads through the abdominal wall of a patient into the abdominal cavity.

[0027] Figure 1 shows that the basic body, which is shown in more detail in Figures 2 and 3, is detachably closed by three upper cover parts 12, which are fastened with screws 13.

[0028] Figure 1 also shows an on / off switch 14 for the measuring device and an associated display device 15.

[0029] Figures 2A to 2D and 3 show that the base body has a flat bottom wall 16. A continuous circumferential wall 17 at the lower straight edge touches a circular wall 18 into which the selector 10 is fitted (Figure 3). Two tubes 19 and 20 open into this selector 10. Tube 19 rests on a groove 9 that opens into the circular wall 18. Tube 20, which is to be examined for leukocytes, is made of a transparent material and rests on indentations 21 and 22, with the space between them allowing an LED 23 attached to the bottom 16 to direct its light onto an image sensor 24a positioned opposite it. The image sensor measures the light intensity as a measure of the presence of leukocytes.

[0030] On the front side are two recesses for temporarily attaching an old and a new cap, which serve to close the tube from the patient's abdomen.

[0031] As shown schematically in Figure 4, the tube 20 is fixed between clamps 24, which are pressed into the closed position by springs 25, thus immobilizing the tube 20. A laser 26 is located beneath the tube 20, directing the laser beam vertically upwards through the tube 20. The image sensor 24a, positioned laterally to the side, receives scattered light generated by the laser 26, which is reflected by leukocytes flowing through the tube.

[0032] The lower housing also contains a battery TI, which supplies power to the light sources 23 and 26, the image sensor 24a and the display device 5 together with the electronic evaluation unit.

Claims

Patent claims 1. Organizer, particularly for home peritoneal dialysis, comprising a base body (2) into which the end sections of two tubes (19, 20) are detachably inserted, which open into a selector device (10) also detachably inserted into the base body, from which a tubular extension (11) projects out of the organizer (1), wherein the selector device (10) has a disc (6) with a rotatable pointer (7) by which one of the two tubes (19, 20) can be selectively connected to the tubular extension (11) in order to either supply fresh dialysis fluid through the tubular extension (11) to the abdominal cavity of a patient or to drain the dialysis fluid through the other tube (19) after a residence time in the abdominal cavity, characterized in that a measuring device is integrated into the base body (2) through which the draining tube (20) runs, and that the measuring device is suitableTo measure leukocytes in the dialysis fluid.

2. Organizer according to claim 1, characterized in that the organizer has a flat base (16) and a circumferential edge (17) which is approximately in the form of a semicircle extending from a straight edge (3) to an opposite, preferably right-angled, bulge (4).

3. Organizer according to claim 2, characterized in this respect. that inside the semicircle a circular wall (18) is attached to the floor (16), into which the selection device (10) is fitted.

4. Organizer according to claim 3, characterized in that three upwardly open indentations are formed in the circular wall (18), on which the hoses (19, 20) or hose connections and the tubular extension (11) rest.

5. Organizer according to one of claims 2 to 4, characterized in that an upper indentation (21) is formed in the wall of the circumferential edge (17), which together with an indentation (22) of the circular wall (10) aligned therewith forms a receptacle for the draining hose (20).

6. Organizer according to one of claims 1 to 5, characterized in that an LED (13) is arranged on one side of the draining tube (20) which is made of a transparent material, the light beam of which is directed through the tube (20) onto an image sensor (24a) which is attached to the other side of the tube (20).

7. Organizer according to one of claims 1 to 6, characterized in that a laser diode (26) is attached to the bottom (16) below the draining tube (20), which directs its light beam upwards through the tube (20).

8. Organizer according to one of claims 2 to 7, characterized in that a straight, open-topped groove extends from an opposite indentation in the circumferential wall (17) to an adjacent indentation in the circular wall (10), onto which the incoming hose (19) is placed.

9. Organizer according to one of claims 1 to 8, characterized in that the two hoses (19, 20) are fixed in their installation position by clamps (24) which are acted upon by springs (25).

10. Organizer according to one of claims 1 to 9, characterized in that the organizer (1 ) is covered by a multi-part removable lid (12).

11. Organizer according to one of claims 1 to 10, characterized in that the organizer (1) is manufactured as an injection-molded part made of plastic.

12. Organizer according to one of claims 1 to 11, characterized in that the light sources (23, 26) and the image sensor (24a) are screwed onto the base (16) or are inserted into molded receiving housings.

Citation Information

Patent Citations

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