DEVICE FOR MONITORING THE VASCULAR ACCESS IN AN EXTRACORPOREAL BLOOD TREATMENT

Abstract

The invention relates to a device and a method for monitoring access to a patient for a device by means of which a liquid is withdrawn from the patient and/or supplied to the patient via a flexible line, in particular for monitoring vessel access during extracorporeal blood treatment, in which blood of a patient is withdrawn from the patient via a flexible arterial line having an arterial puncture cannula and supplied to the patient via a flexible venous line having a venous puncture cannula. The monitoring device 20 has a line guide 21 for loosely guiding a line segment 7A of the flexible line 7. The invention is based on detecting a change in situation of the loosely guided line segment 7A due to tension applied if the puncture cannula slips out, it being concluded that incorrect vessel access is occurring if the situation of the line segment changes. Since only changes in situation are monitored, even slight applied tensions are already sufficient for reliably detecting incorrect vessel access.

Claims

1. Device for monitoring access to a patient for a device by means of which a liquid is withdrawn from the patient and/or supplied to the patient via a flexible line, in which blood of a patient is withdrawn from the patient via a flexible arterial line having an arterial puncture cannula and supplied to the patient via a flexible venous line having a venous puncture cannula, wherein the device for monitoring access to a patient has a line guide for guiding a line segment of the flexible line and an apparatus, for detecting the situation of the line segment guided by means of the line guide, which is configured in such a way that a change in situation of the line segment due to tension applied to the flexible line is detected, it being concluded that incorrect vessel access is occurring if the situation of the line segment changes.

2. The device according to claim 1, wherein the apparatus for situation detection comprises an optical image capture system, which is configured in such a way that a change in situation of the flexible line due to tension applied to the flexible line is detected.

3. The device according to claim 2, wherein the optical image capture system is configured to detect a plurality of spaced-apart markings, applied to the flexible line, individually in succession, and to count when the markings are moved relative to the optical image capture system, as a result of a change in situation of the flexible line, and pass through the detection region thereof, the optical image capture system having an evaluation unit, which is configured in such a way that the number of counted markings is compared with a predetermined threshold and it is concluded that there is a change in situation of the flexible line due to tension applied to the flexible line if the number of counted markings is greater than a predetermined threshold.

4. The device according to claim 2, wherein the optical image capture system is configured in such a way that a plurality of spaced-apart markings provided on the flexible line is determined within an observation window, the optical image capture system having an evaluation unit, which is configured in such a way that the number of markings in the observation window is compared with a predetermined threshold and it is concluded that there is a change in situation of the flexible line due to tension applied to the flexible line if the number of markings in the observation window is less than a predetermined threshold.

5. The device according to claim 1, wherein the apparatus for situation detection has a tactile sensor system, which is configured in such a way that a change in situation of the flexible line due to tension applied to the flexible line is detected.

6. The device according to claim 5, wherein the tactile sensor system has a tactile sensor which can be brought, under resilient bias, against the line segment guided by means of the line guide.

7. The device according to claim 6, wherein the tactile sensor system has an evaluation unit, which receives the measurement signal of a displacement meter, which is designed in such a way that the distance by which the tactile sensor is displaced when the situation of the line segment changes is measured, the evaluation unit being configured in such a way that the measured displacement is compared with a predetermined threshold and it is concluded that there is a change in situation of the flexible line due to tension applied to the flexible line if the measured displacement is greater than a predetermined threshold.

8. The device according to claim 6, wherein the tactile sensor is designed as an actuation member of an electrical switch.

9. The device according to claim 1, wherein the apparatus for situation detection has an elongate element, which actuates an electrical switch when deformed, the first end of the elongate element being in operative connection with a first portion of the line segment guided by means of the line guide, and the second end of the elongate element being in operative connection with a second portion of the line segment guided by means of the line guide, such that the elongate element is deformed in the event of a change in situation of the line segment due to tension applied to the flexible line.

10. The device according to claim 1, wherein the apparatus for situation detection has an elongate element made of an electrically conductive material, the first end of the elongate element being in operative connection with a first portion of the line segment guided by means of the line guide, and the second end of the elongate element being in operative connection with a second portion of the line segment guided by means of the line guide, such that the elongate element is severed in the event of a change in situation of the line segment due to applied tension, and in that the apparatus for situation detection has an evaluation unit, which is configured in such a way that the electrical resistance of the elongate element is monitored.

11. The device according to claim 1, wherein the apparatus for situation detection has at least one roller, which can be brought into contact with the line segment guided in the line guide, and a rotation meter for measuring the rotations of the at least one roller, an evaluation unit which receives the measurement signal of the rotation meter being provided and being configured in such a way that the number of rotations of the roller is compared with a predetermined threshold.

12. The device according to claim 1, wherein the line guide is formed in such a way that the line segment is guided in the shape of a loop, which contracts if tension is applied.

13. The device according to claim 12, wherein the line guide has a housing body, comprising a first guide channel for receiving a first portion of the line segment and a second guide channel for receiving a second portion of the line segment of the flexible line.

14. The device according to claim 13, wherein the guide channels are formed in first and/or second housing halves of the housing body.

15. The device according to claim 13, wherein at least one roller is provided in at least one of the guide channels of the housing body.

16. The device according to claim 13, wherein the first and/or second housing halves of the housing body are releasably or openably interconnected.

17. The device according to claim 1, wherein the line guide is designed in such a way that the line segment is guided in the shape of an arc.

18. The device according to claim 17, wherein the line guide has a housing body, in which an arc-shaped contact face for the line segment is formed.

19. The device according to claim 1, wherein the line guide has an arc-shaped guide element for receiving the line segment, the arc-shaped guide element having a first arc-shaped portion for receiving a first sub-portion of the line segment and a second arc-shaped portion for receiving a second sub-portion of the line segment, the first and second arc-shaped portions of the guide element being movably interconnected in such a way that the distance between the opposite ends of the arc-shaped portions of the guide element increases when tension is applied to the flexible line.

20. The device according to claim 1, wherein the line guide has an arc-shaped guide element for receiving the line segment, the arc-shaped guide element consisting of a resilient material, such that the distance between the opposite ends of the arc-shaped portions of the guide element increases when tension is applied to the flexible line.

21. The device according to claim 1, wherein the apparatus for situation detection is configured in such a way that a control signal is generated when a change in situation of the line segment due to tension applied to the flexible line is detected.

22. A blood treatment device comprising an extracorporeal blood circuit which has (i) a central venous catheter or (ii) a flexible arterial line comprising an arterial puncture cannula and a flexible venous line comprising a venous puncture cannula, wherein the blood treatment device has the device for monitoring access to a patient according to claim 1.

23. The blood treatment device according to claim 22, wherein the blood treatment device has an alarm unit, which is configured in such a way that an alarm is provided if the apparatus for situation detection detects a change in the situation of the line segment due to tension applied to the flexible line.

24. The blood treatment device according to claim 22, wherein the blood treatment device has a blood pump for conveying blood in the extracorporeal blood circuit and a venous blocking member for blocking the flexible venous line, a control unit being provided, which is configured in such a way that the blood pump is stopped and/or the venous blocking member is closed if the apparatus for situation detection detects a change in situation of the line segment due to tension applied to the flexible line.

25. The blood treatment device according to claim 22, wherein the apparatus for monitoring has a transmitter and the blood treatment device has a receiver for wirelessly transmitting a control signal.

26. A method for monitoring access to a patient for a device by means of which a liquid is withdrawn from a patient and/or supplied to a patient, in which blood of a patient is withdrawn from the patient via a flexible arterial line having an arterial puncture cannula and supplied to the patient via a flexible venous line having a venous puncture cannula, wherein a line segment of the flexible line is guided by means of a line guide in such a way that the line segment forms a loop or arc, and in that the change in situation of the line segment forming a loop or arc due to tension applied to the flexible line is monitored by means of a monitoring system, it being concluded that incorrect vessel access is occurring if the situation of the line segment changes.

Description

[0034] Hereinafter, various embodiments of the invention are described in greater detail with reference to the drawings, in which:

[0035] FIG. 1 is a highly simplified schematic drawing of the essential components of a blood treatment device together with the device according to the invention for monitoring patient access,

[0036] FIG. 2 shows a first embodiment of the device according to the invention for monitoring patient access, in which the change in situation of the flexible line is detected optically,

[0037] FIG. 3 is a partial view of an alternative embodiment of the first embodiment of the device according to the invention,

[0038] FIG. 4 shows a further embodiment of the device according to the invention for monitoring patient access, in which the change in situation of the flexible line is detected optically,

[0039] FIG. 5 is a front view of the embodiment from FIG. 4, with the line guide open,

[0040] FIG. 6 shows a further embodiment of the device according to the invention for monitoring patient access, in which the change in situation of the flexible line is detected optically,

[0041] FIG. 7 shows a further embodiment of the device according to the invention for monitoring patient access, in which the change in situation of the flexible line is detected by measuring the rotations of at least one roller,

[0042] FIG. 8 shows a further embodiment of the device according to the invention for monitoring patient access, in which the change in situation of the flexible line is detected in a tactile manner,

[0043] FIG. 9 shows an alternative embodiment of the device according to the invention from FIG. 8,

[0044] FIG. 10 shows a further embodiment of the device according to the invention for monitoring patient access,

[0045] FIG. 11 shows an alternative embodiment of the device according to the invention from FIG. 10, and

[0046] FIG. 12 shows a further embodiment of the device according to the invention for monitoring patient access.

[0047] FIG. 1 shows the essential components of a blood treatment device, by way of example a haemodialysis device, which has a device for monitoring venous vessel access. The blood treatment device has a dialyser 1, which is subdivided by a semipermeable membrane 2 into a blood chamber 3 and a dialysate chamber 4. A flexible arterial line 6 is connected to the fistula or shunt of the patient by means of an arterial puncture cannula 5, and leads to the inlet of the blood chamber 3 of the dialyser 1. A flexible venous line 7 leads away from the outlet of the blood chamber 3 of the dialyser 1, and is connected to the fistula or shunt of the patient by means of a venous puncture cannula 8. The flexible arterial line 6 is laid in an occlusive blood pump 9, which conveys the blood in the extracorporeal blood circuit I.

[0048] The dialysate circuit II of the blood treatment device comprises a dialysate source 10, to which a dialysate supply line 11 is connected, which leads to the inlet of the dialysate chamber 4 of the dialyser. A dialysate withdrawal line 12 leads away from the outlet of the dialysate chamber 4 of the dialyser 1 and leads to an outlet 13. A dialysate pump 14 is connected into the dialysate withdrawal line 12.

[0049] The blood treatment device is controlled by a central control unit 15, which actuates the blood and dialysate pump 9, 14 via control lines 16, 17. The central control unit 15 is connected via a data line 18 to an alarm unit 19, which provides an optical and/or acoustic and/or tactile alarm in the event of an abnormal occurrence.

[0050] The blood treatment device has a device 20 for monitoring venous vessel access. The monitoring device 20 comprises a line guide 21 (merely shown schematically in FIG. 1) which loosely fixes a line segment 7A of the flexible venous line 7 in a particular shape, for example in the shape of a loop. The monitoring device 20 further has an apparatus 22 (merely shown schematically in FIG. 1), for detecting the situation of the line segment 7A guided by means of the line guide 21, and an evaluation unit 23. The evaluation unit 23 generates a control signal if a change in situation of the line segment 7A is detected. The monitoring device 20 further has a transmitter 24 which emits the control signal. The blood treatment device has a receiver 25 which receives the control signal. The receiver 25 is connected to the central control unit 15 of the blood treatment device via a data line 26.

[0051] A blocking member 27, for example an electromagnetically actuable venous line clamp, is located downstream from the blood chamber 3 of the dialyser on the flexible venous line 7, and is closed by the central control unit 15 via a further control line 28 if the receiver 25 receives the control signal from the monitoring device 20 signalling an inadmissible change in situation of the line segment 7A. In this case, the control unit 15 stops the blood pump 9 and/or closes the blocking member 27, in particular the venous line clamp.

[0052] Hereinafter, various embodiments of the monitoring device 20 are disclosed in detail.

[0053] FIG. 2 is a perspective drawing of a first embodiment of the monitoring device 20, which has an optical image capture system. The line guide 21 has a housing body 30, which is manufactured by injection moulding and which has two guide channels 31, 32, which extend mutually parallel and the internal diameter of which is greater than the external diameter of the flexible line 7. The two end portions of a line segment 7A, which forms a loop 33, of the flexible line 7 are guided loosely in the two guide channels 31, 32. If a tensile force is exerted on the ends of the flexible line, as indicated by arrows in FIG. 1, the loop 33 contracts. The housing body 30 of the line guide 21 may be shaped differently, for example in the shape of a cuboid or in an arc shape.

[0054] FIG. 3 is a front view of the line guide 21 of an alternative embodiment, which differs from the embodiment from FIG. 2 in that only a portion of the line segment 7A is guided loosely in a guide channel 31, in such a way that the loop 33 only contracts if the loosely guided line portion is pulled on.

[0055] If the loop 33 contracts when tension is applied, the situation of the line segment 7A guided in the line guide 21 changes, the diameter D of the line segment decreasing. The apparatus 22 for detecting the situation of the line segment has an optical image capture system 34, which has an evaluation unit 23 (FIG. 1) which evaluates the image data. The optical image capture system 34 located in the housing body 30 has an optical sensor 35, for example a CCD sensor, which captures an image region in which the loop 33 is positioned. To detect a change in situation of the line segment 7A, the image processing methods known to a person skilled in the art may be used.

[0056] To simplify the situation detection using the optical image capture system, the flexible line may be provided with markings 36, for example in the form of stripes. The stripes, which are of a predetermined width and arranged at a predetermined distance from one another, can easily be detected by the image capture system 34. When the loop 33 contracts, in other words when there is a change in situation in the line segment 7A, the distance between the individual markings decreases. Furthermore, the number of markings 36 decreases for a predetermined observation window B, which is determined by the image region of a sub-region of the image region captured by the optical sensor 35.

[0057] The evaluation unit 23 is configured in such a way that the distance between any two markings of a plurality of markings 36 is determined and compared with a predetermined threshold, and it is concluded that there is a change in situation of the flexible line if the distance between the markings 36 is less than a predetermined threshold or decreases by a particular amount. Alternatively or in addition, the evaluation unit 23 may be configured in such a way that the number of markings 36 in the observation window B is determined and compared with a predetermined threshold, and it is concluded that there is a change in situation of the flexible line if the number of markings 36 is less than a predetermined threshold or decreases by a particular number.

[0058] Instead of an optical image capture system 34, a distance sensor, for example an optical distance sensor or an ultrasound distance sensor, which measures the distance from the opposite portion of the loop segment 7A, may be integrated into the housing body of the line guide. The evaluation unit 23 is configured in such a way that the measured distance value is compared with a predetermined threshold. If the distance value is less than the threshold or decreases by a particular amount, the control signal is generated.

[0059] FIGS. 4 and 5 show an embodiment of the monitoring device 20 which differs from the embodiment from FIG. 2 in that the housing body 30 of the line guide 21 has a first housing half 30A and a second housing half 30B, which are interconnected at a longitudinal face by a hinge 37 in such a way that the housing body 30 can be folded open. The mutually corresponding parts are provided with like reference numerals. FIG. 4 is a perspective view of the folded-up housing body 30, whilst FIG. 5 is a front view of the folded-open housing body 30. This embodiment has the advantage that the line segment 7A can be laid in the line guide 21 easily. To close the housing body 30, a bracket 38 is provided on a longitudinal face of the upper housing half 30A, and engages in a groove 39 on the lower housing half 30B by means of clamping.

[0060] FIG. 6 shows a further embodiment of the monitoring device 20, which differs from the embodiment from FIG. 2 in terms of the image capture system 34. The image capture system 34 of the embodiment from FIG. 6 does not have an optical sensor (FIG. 2) located outside the housing body 30, but rather one or more optical sensors 40 which are provided inside the housing body 30 on one or both guide channels 31, 32 of the line guide 21. The optical sensors 40 capture the markings 36 on the line segment 7A, for example in the form of stripes, which have a predetermined width and are arranged at a predetermined distance from one another. A single optical sensor 40 is sufficient for capturing the markings. The optical sensor may for example be a phototransistor which for example detects the markings using brightness/darkness detection. When the loop 33 contracts, the relevant portion of the line segment is displaced in the guide channel 32 in the longitudinal direction. The evaluation unit 23 of the image capture system 34 may be configured in such a way that the change in situation of the markings 36 is detected and if tension is applied the control signal is generated. The evaluation unit 23 may also be configured in such a way that the number of markings 36 is counted if the markings 36 are moved relative to the optical sensor 40 of the image capture system as a result of a change in situation of the flexible line (7) and pass through the capture region thereof, and the number of markings 36 is compared with a predetermined threshold. If the number of markings 36 is greater than the threshold, the control signal is generated. Since the width and spacing of the stripe-like markings 36 are known, the evaluation unit 23 can calculate the distance by which the loop 33 contracts. The markings may also consist of materials which cannot be captured optically, for example markings which cause a change in the magnetic field, inductance or capacitance. In this case, instead of optical sensors, the apparatus for situation detection has sensors for detecting these physical variables.

[0061] FIG. 7 shows an alternative embodiment, in which rollers 41 are provided in the housing body 30 of the line guide 21, which may be designed in accordance with FIG. 2 or FIG. 4, along at least one of the guide channels 31, 32, and can roll along on the relevant portion of the line segment 7A when it changes in situation, in such a way that the loop 33 can contract particularly easily. In this embodiment, the apparatus 22 for situation detection has a rotation meter 42 (merely shown schematically in FIG. 7), which is associated with one of the rollers 41, such that the number of rotations of the roller can be detected. Furthermore, an evaluation unit 23 which receives the measurement signal of the rotation meter 42 is provided, and is configured in such a way that the number of rotations of the roller 41 is compared with a predetermined threshold. The control signal is generated if the number of rotations is greater than the threshold.

[0062] Hereinafter, referring to FIGS. 8 to 12, further embodiments are disclosed, in which the change in situation is not detected by optical means. In the embodiments of FIGS. 8 to 12, the line segment 7A is fixed in the shape of an arc 43. However, it is also possible to apply the principle for detecting a change in situation to the other embodiments, in which the line segment 7A forms a loop 33.

[0063] The line guide 21 from FIG. 8 has a housing body 30 comprising a first and a second housing half, which are interconnected by a hinge 37 in such a way that the housing halves 30A, 30B can be folded together. Latch tabs 55 may be provided on one housing half 30A, which engage in recesses 56 on the other housing half 30B. One housing half 30B has an arc-shaped contact face 44 comprising a semi-circular portion 44A and two parallel straight-line portions 44B, against which the line segment 7A can be laid in such a way that the line segment is loosely fixed in the shape of an arc 43. For further guidance of the line segment 7A, further guide elements 45 may be provided, which may in particular be arranged in the regions at which the flexible line portions extend out of the housing body 30.

[0064] The apparatus 22 for situation detection has a tactile sensor system 46, which has an axially displaceably guided tactile sensor 47 which is biased against the semi-circular portion 44A of the line segment 7A by a spring 48 in such a way that the line segment is pressed against the semi-circular portion. The apparatus 22 for situation detection further comprises a displacement meter 49 (merely shown schematically in FIG. 8) and an evaluation unit 23 which receives the measurement signal of the displacement meter 49. The evaluation unit 23 is designed in such a way that the distance by which the tactile sensor 47 is displaced during a change in situation of the line segment due to tension applied to the flexible line is measured. The evaluation unit 23 compares the measured displacement with a predetermined threshold and generates the control signal if the measured distance is greater than a predetermined threshold.

[0065] FIG. 9 shows an alternative embodiment which differs from the embodiment of FIG. 8 in that the tactile sensor 47 is designed as an actuation member of an electrical switch 50. The switch 50 has a first, movable switch contact 50A, which is provided on the tactile sensor 47, and a second, stationary switch contact 50B, which is provided on the housing body 30. During displacement of the tactile sensor 47 due to applied tension, the switch 50 opens. In this embodiment, for example an alarm unit 19 (FIG. 1), which may also be provided on the monitoring device 21 itself, can be switched on by the switch 50 if there is an inadmissible change in situation of the line segment 7A, without further signal processing being required.

[0066] FIG. 10 shows an embodiment in which the line guide 21 has an arc-shaped guide element 51, it being possible for the line segment 7A to be laid so as to fit therein. In the present embodiment, the arc-shaped guide element 51 is a curved, substantially U-shaped rail comprising a semi-circular portion 51A and two parallel straight-line portions 51B. The arc-shaped guide element 51 consists of a resilient material, for example plastics material, such that the guide element can bend. When tension is applied to the flexible line 7, the distance between the opposite outer ends of the guide element 51 increases, as indicated by arrows in FIG. 10. The guide element 51 may be a plastics material profile which encloses the line segment in part.

[0067] The apparatus 22 for situation detection has an elongate, strip-shaped element 52, one end of which is connected to one straight-line portion 51B and the other end of which is connected to the other straight-line portion 51B of the guide element 51, the strip-shaped element 52 preferably being fastened in the region of the ends of the guide element. The strip-shaped element 52, which may be a metal strip, is resiliently biased into a curved shape. If tension is applied to the flexible line 7, at least one of the two straight-line portions 51B of the guide element 51 is bent outwards, such that the strip-shaped element 52 is deformed counter to the bias and is no longer curved. When the strip-shaped element 52 is deformed, a switch 53 (merely shown schematically) is actuated. Instead of a switch, however, a strain gauge (not shown in FIG. 10) may also be provided on the strip-shaped element.

[0068] FIG. 11 shows an alternative embodiment, which differs from the embodiment from FIG. 10 in that the apparatus 22 for situation detection has an elongate element 54 made of an electrically conductive material, which is fastened to the ends of the straight-line portions 51B of the guide element 51. In the present embodiment, the elongate element 54 is an electrical wire, which is severed if at least one of the two straight-line portions 51B of the guide element 51 curves outwards when there is a change in situation of the line segment 7A due to applied tension. In an alternative embodiment, the apparatus 22 for situation detection has an evaluation unit 23, which is configured in such a way that the electrical resistance of the wire is monitored. When the resistance is zero, the control signal is generated.

[0069] FIG. 12 shows an alternative embodiment, which differs from the embodiment from FIG. 10 in that the guide element 51 has a first arc-shaped portion 51C for receiving a first sub-portion of the line segment 7A and a second arc-shaped portion 51D for receiving a second sub-portion of the line segment 7A. The mutually corresponding parts are again provided with like reference numerals. The first and second portions 51C, 51D of the guide element 51 are movably interconnected at the ends by means of an articulation 57, in such a way that the distance between the opposite free ends of the guide element increases when tension is applied to the flexible line, as again indicated by arrows. In this embodiment, the sub-portions may consist of a non-resilient material. Instead of a resilient strip-shaped element 52 as in FIG. 10, in particular a metal strip, in the embodiment in FIG. 12, a strain gauge or an electrical wire 54 (FIG. 11) may be provided for actuating a switch 53.