A Device Including A Device For Determining A Characteristic of the Device

Abstract

The present disclosure relates to a medical device with respectively at least one hard part with fluid paths for guiding a medical fluid, for example blood through the hard part. The medical device 200 also includes a converter and a device for determining a characteristic of the device 200. The converter is arranged to measure the characteristic of the fluid, while the fluid is present in one of the fluid paths. The characteristic may be geometric characteristic, for example, a fluid path.

Claims

1-15. (canceled)

16. A medical device comprising: a hard part defining fluid paths for conducting a fluid through the hard part; at least one converter, wherein the at least one converter is arranged to measure a characteristic of the fluid while it is present in one of the fluid paths; and a device configured to determine a characteristic of the medical device.

17. The medical device according to claim 16, wherein the device configured to determine the characteristic of the medical device comprises a device for acting on the fluid to make the fluid swing while the fluid is present in one of the fluid paths.

18. The medical device according to claim 16, wherein the device configured to determine the characteristic of the medical device comprises at least one piezo element.

19. The medical device according to claim 18, wherein the piezo element comprises a plastic piezo element.

20. The medical device according to claim 16, wherein at least one section of the converter and at least one section of the device configured to determine the characteristic of the medical device is applied by at least an additive application method.

21. The medical device according to claim 20, wherein the additive application method includes at least one of: a template free application and a conductive ink application.

22. The medical device according to claim 16, wherein at least one section of the converter or at least one section of the device configured to determine the characteristic of the medical device is applied by at least an additive application method.

23. The medical device according to claim 22, wherein the application method includes at least one of: a template free application and a conductive ink application.

24. The medical device according to claim 16, wherein the at least one converter is a MID flow sensor.

25. The medical device according to claim 16, wherein the at least one converter is configured or designed to measure or determine the conductivity, flow, pressure, tension or current.

26. The medical device according to claim 16, wherein the medical device is a blood cassette, a blood tube, or a blood filter.

27. The medical device according to claim 16, wherein the medical device is a disposable.

28. The medical device according to claim 16, wherein the characteristic is a geometric characteristic of the medical device.

29. The medical device according to claim 28, wherein the geometric characteristic is a fluid path of the medical device.

30. A method comprising: outputting a signal value in relation to a characteristic of a fluid present in a fluid path of a medical device using a converter of the medical device; providing a result of a reference measurement of the characteristic as a first value; and receiving a signal, related to the characteristic, from a device for determining a characteristic of the medical device as a second value; wherein the method further comprises at least one of: (i) outputting a value of the characteristic of the fluid using a relation between the first value and the second value, and (ii) correcting the signal value using the relation between the first value and the second value.

31. The method according to claim 30, wherein outputting a value of the characteristic is achieved when a difference between the first value and the second value has reached at least a predetermined difference.

32. The method according to claim 30, wherein correcting the signal value is achieved when a difference between the first value and the second value has reached at least a predetermined difference.

33. A treatment apparatus comprising: at least one device configured to receive or couple to a medical device at the treatment apparatus, a converter; a device configured to provide results of a reference measurement of a characteristic as a first value; a device configured to receive a signal, related to a characteristic, from a device configured to determine a characteristic of the medical device as a second value; and a device configured to execute an action using a relation between the first value and the second value.

34. The treatment apparatus according to claim 33, wherein the action is outputting a value of the characteristic of a fluid using the relation between the first value and the second value.

35. The treatment apparatus according to claim 33, wherein the action is correcting a signal value using the relation between the first value and the second value.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0117] In the following, the present invention is described with reference to the accompanying drawings. In the drawings, identical reference numerals denote similar or identical elements. The following applies:

[0118] FIG. 1 shows a medical system for blood treatment with a medical device as a partially functionalized disposable;

[0119] FIG. 2 shows a medical device according to a second exemplary embodiment;

[0120] FIG. 3 shows a section of the fluid-conducting channel or the tube of the hard part of the device with a device to determine a characteristic of a medical device, in particular of a fluid path in a first embodiment;

[0121] FIG. 4 shows a section of the fluid-conducting channel or the tube of the hard part of the device with a device to determine a characteristic of a medical device, in particular of a fluid path in a second embodiment;

[0122] FIG. 5 shows an exemplary embodiment of an evaluation unit.

DETAILED DESCRIPTION OF THE FIGURES

[0123] FIG. 1 shows a very schematic and only exemplary blood treatment apparatus 100 as an example of a treatment apparatus, with a medical device 200 (in short: device 200 cf) as an example of a disposable medical device.

[0124] The device 200 is exemplarily designed as a disposable. The device 200 is partially functionalized, purely optionally, by means of an additive, template-free printing method.

[0125] The blood treatment apparatus 100 and the device 200 are connected to each other via an interface 300 in signal communication.

[0126] The device 200 comprises a hard part 201. Parts of a sensor arrangement, here a conductive path 203 and a converter 205, are provided on the hard part 201.

[0127] The converter may be, for example a pressure transducer. The converter can be printed on the hard part 201. On the disposable side, the converter can only convert the parameter of pressure to be measured into an analogue electrical signal.

[0128] The electrical signal is conducted via the—also optionally additively printed—conductive path 203 to the defined interface 300, which is connected to a machine-side evaluation unit 400. The evaluation unit 400, which is described further in FIG. 5, is represented in FIG. 1 by a monitor 101 for displaying the evaluation resultsiiobtained from it.

[0129] On the machine side the signal can be digitalized, by means of an AD (Analogue-to-digital) converter (short form ADC) 103. Post-processing steps (filtering, smoothing, Fourier transformation, zero filling etc.) may take place prior to a final evaluation and interpretation. All these optional steps may be carried out, for example, in the evaluation unit 400.

[0130] FIG. 2 shows a medical device 200 according to a second exemplary embodiment.

[0131] The medical device 200 is a partially functionalized disposable with three different converters 207, 209, 211.

[0132] Thereby FIG. 2,along with the following figures, shows each example of applied converters 207, 209, and 211 and conductive path 212, whereby converter and conductive path were applied by means of different application methods or by the same application method. Alternatively, at least one of the converters 207, 209, and 211 one of the conductive paths 212, have been each applied by means of more than one application method—but at least by a first and a second application method.

[0133] A converter 207 for measuring the conductivity is arranged in the upper left of FIG. 2. The converter consists of two conductive paths, which are applied in the interior of a fluid-conducting channel 202 of the device 200 by the additive, template-free printing method.

[0134] The two other converters 209, 211 show exemplary embodiments of pressure transducers. These can be arranged as strain gauges on the inner contour (see the converter 209) or on the outer contour (see the converter 211) on the fluid-conducting channel or tube 202 of the device 200.

[0135] Besides the converters 209, 211, FIG. 2 shows the electromagnetic signal guidance with conductive and contact 217 paths 212 towards the machine interface 300, here exemplarily a multipole connection device 214. The conductive paths 212 towards the signal line may be applied onto the planar surface of the hard part 201 with the same additive and template-free method, in particular, in the same process step.

[0136] However, non-planar (three-dimensional) line guidance, in the sense described supra, or crossings of (correspondingly insulated) lines are also possible.

[0137] The conductive paths 212 as well as the contacts 217 may also be applied by a second, additive and template-free printing method, e.g. in a second production step which follows the application of the converters 207, 209, 211. The entirety of the conductive paths 212 used to guide signals from the location of the respective converters 207, 209, 211, which converts the variable to be measured e.g. into an electro-magnetic signal that is guided by means of the conductive path 212 towards machine interface 300, may also contain individual parts, which are applied by a two-component injection molding of conductive polymers.

[0138] FIG. 3 shows a section of the fluid conducting channel or tube 202 of the hard part 201 of the device 200 with a device to determine a characteristic of a device, here a geometric characteristic of the medical device 200, in particular of the fluid path 202, in a first embodiment.

[0139] The converter 207 may be a part of the magnetic flow meter, which measures the flow through channel 202.

[0140] The channel 202 may comprise a circular, rectangular, or another cross-sectional form or basic shape on the area of converter 207. This particularly applies for the area in which the converter 207 is present, for example, the measuring cell.

[0141] The device 200 comprises, in this exemplary embodiment, at least two piezo elements or electromagnets 225, 227. These may be understood as an example of a device to determine the characteristic of a medical device 200 or of a part thereof. The piezo elements or electromagnets 225, 227 are optionally here arranged as coils. The coils optionally lie on or at opposite sides of the measuring cell.

[0142] The device to measure a characteristic of the medical device 200 may in each embodiment be the converter 207, part of the converter, or provided independent of these.

[0143] FIG. 4 shows a view into a section of the fluid conducting channel or tube 202 of the hard part 201 of the device 200 (here a disposable) in a second embodiment. The device 200 comprises a device to determine a (geometrical) characteristic of a medical device 200, in particular of the fluid path 202.

[0144] The channel 202 has a rectangular cross-sectional form or basic form, in the area of the measuring cell.

[0145] The device 200 comprises at least two piezo elements or electromagnets 225, 227. These are again optionally designed as coils. The coils optionally lie on or at the opposite sides of the measuring cell.

[0146] These coils 225, 227 are arranged on the machine side, however, the measuring cell of the medical device 200 is inserted in such a way between the coils 225, 227 that it will be penetrated by a largely homogeneous magnetic field. The measuring electrodes of the converter 207 are arranged perpendicular to the connecting axis of both coils 225, 227 (magnet field direction). These are positioned invasively, for example in direct contact with the fluid to be measured. Hereto they reach through the channel wall into the fluid path 202 or are printed on the channel wall of the fluid path 202.

[0147] The evaluation unit 400 (see FIG. 5) is provided on the machine side, or on the device 200 The device 200 shown in FIG. 4 functions to determine a characteristic of the medical fluid depending on a signal value, which is determined by the converter 207. The function may be a generic type-specified calibration. This may apply to the corresponding converter-device/disposable-combination. In the present example, calibration represents a function, which indicates the present flow for the respective measurement value, for example, the measured voltage at the measuring electrodes of the converter 207. The evaluation unit 400 may use the signal value or characteristic of the medical fluid in later evaluations

[0148] Q_abs=f (U_meas)

[0149] The above-mentioned, exemplary calibration function f is, amongst others, linearly dependent on the cross section of the measuring cell. While the deviations from a set-point, which are caused by manufacturing or handling, do not strongly influence the accuracy of the calibration in the axis of the measuring electrodes i.e. of the diameter dx perpendicular to the magnetic field indicated in FIG. 4, deviations from a set-point dy_0 of the diameter dy, that is the axis parallel to the magnetic field can lead to a significant malfunction in the absolute-calibration if they are not corrected.

[0150] The device 200 can therefore provide for the example shown herein in FIG. 4 that the distance of the walls of the measurement cell is verified in y-direction by the device 403 of the evaluation unit 400 shown in FIG. 5 to determine a characteristic of the medical device 200, at least in the axis of the magnet field in situ taking into consideration its deviation from the target distance dy_0. The interval may be stored or readable as the result of a reference measurement.

[0151] If a correction is found to be necessary e.g. due to the difference between the interval/desired distance dy_0, so may a correction of the calibration be made regarding absolute flow values. In this way, the necessary accuracy of the measurement can be ensured even with measurements at disposables by injection molding which are by nature subject to manufacturing tolerances.

[0152] For example, for these corrections, the above calibration formula f with the ratio of actually measured diameter dy meas as a second value and the target/desired diameter dy_0 of the fluid channel as the first value may be multiplied or otherwise taken into account as follows:

[0153] Q_abs_korr=f(U_meas)*(dy_meas/dy_0)

[0154] Alternatively the signal U_meas could be suitably corrected.

[0155] In FIG. 4, a Piezo element 225, 227 can be induced to oscillate to determine the actual diameter dy meas as a second value.

[0156] FIG. 5 shows an shows an exemplary embodiment of an evaluation unit 400, which is programmed and/or configured to carry out the method.

[0157] The evaluation unit 400 may be part of the blood handling apparatus 100. Alternatively, it may be provided independent of this. As discussed in the following in the example of FIG. 5, devices to carry out the methods are part of the evaluation unit 400. They could alternatively be part of the blood handling apparatus 100 or another unit, which is not evaluation unit 400.

[0158] FIG. 5 shows a device 401 for providing the result of a reference measurement or—determination of a geometric characteristic dx, dy as a “first value”. The result of the reference measurement may herein be an example of the extension in x-direction and/or in y-direction. The result in FIG. 5 is therefore not restrictively referred to as dx_0 respectively dy_0. The first value may be stored in the device 401, it may alternatively be stored in a further device inside or outside of the evaluation unit 400. Alternatively, it may be read out by the medical device 200, e.g. as it is held as a bar code or by a label on the medical device 200.

[0159] FIG. 5 further shows a device 403 to receive a signal from the device to determine the geometric characteristic dx, dy of the medical device 200, e.g. from one or both of the piezo elements 225, 227 whereby the signal relates to the geometric characteristic dx, dy. In the following considerations, the signal is referred to as “second value”.

[0160] FIG. 5 further shows a device 405 which has to output a value Q_abs_korr of the characteristic Q of the medical fluids or a corrected signal valueU_meas as output. Both value Q_abs_korr or a corrected signal valueU_meas are determined or corrected by using a relation between the first value dx_0, dy_0 and the second value dx meas, dy meas.

[0161] The device 405 may be connected with the monitor 101 or with another display device via signal connection to display the value Q_abs_korr of the characteristic Q of the medical fluids or the corrected signal valueU_meas.

LIST OF REFERENCE NUMERALS

[0162] 100 blood treatment apparatus [0163] 101 monitor [0164] 103 AD-converter [0165] 200 blood cassette as an example of a medical device [0166] 201 cassette body or cassette main body, hard part; hard body [0167] 202 fluid path, channel, flow channel [0168] 203 conductive path, conductor or signal conductor [0169] 205 converter [0170] 207 converter [0171] 209 converter [0172] 210 converter [0173] 211 DMS element as a converter [0174] 212 conductive path, conductor or signal conductor [0175] 217 contacts [0176] 225, 227 piezo element or electromagnets [0177] 300 interface, machine interface [0178] 400 evaluation unit [0179] 401 device for providing the results of a reference measurement or reference determination for the characteristic [0180] 403 device for receiving a signal from the device for determining a characteristic (dx, dy) of the medical device [0181] 405 device for outputting a value (Q_abs_korr) of the characteristic