Method for calculating or approximating a value representing the relative blood volume and devices
11676712 · 2023-06-13
Assignee
Inventors
- Ulrich Moissl (Bad Vilbel, DE)
- Paul Chamney (Tring, GB)
- Volker Nier (Reichelsheim, DE)
- Peter Wabel (Darmstadt, DE)
- Sebastian Wieskotten (Riedstadt, DE)
Cpc classification
G16H20/40
PHYSICS
A61B5/0295
HUMAN NECESSITIES
A61M1/14
HUMAN NECESSITIES
A61B5/7225
HUMAN NECESSITIES
A61B5/4848
HUMAN NECESSITIES
A61M1/1613
HUMAN NECESSITIES
A61M1/30
HUMAN NECESSITIES
A61B5/4836
HUMAN NECESSITIES
A61B5/0205
HUMAN NECESSITIES
A61B5/7278
HUMAN NECESSITIES
International classification
A61B5/00
HUMAN NECESSITIES
A61B5/0205
HUMAN NECESSITIES
A61B5/0295
HUMAN NECESSITIES
A61M1/14
HUMAN NECESSITIES
A61M1/30
HUMAN NECESSITIES
Abstract
The present invention relates to a method for calculating or approximating a value representing the relative blood volume (RBV) at a certain point of time, or a value representing the refilling volume of a patient that may be observed or found during or due to a blood treatment of the patient, the method involving considering one or more calculated or measured value(s) reflecting an overhydration level of the patient or an approximation thereof. It relates further to an apparatus and a device for carrying out the present invention, a blood treatment device, digital storage means, a computer program product, and a computer program.
Claims
1. A blood treatment device for treating a patient by dialysis, the blood treatment device comprising a controller configured to control the blood treatment device based on: (i) a computer-implemented method for calculating a value representing a refilling volume (V.sub._refill) of the patient that may be observed or found during or due to a blood treatment session of the patient and (ii) relative blood volume (RBV) measurements of the patient that are measured and communicated to the controller during the blood treatment session of the patient, wherein a target range of a relative blood volume (RBV.sub._end) of the patient to be achieved by the blood treatment session is set by the controller based on the refilling volume (V.sub._refill) of the patient, wherein the refilling volume (V.sub._refill) of the patient is determined by the controller using an equation:
V.sub._refill=a*UFV+b*(UFR/Hb.sub.start)+c*OH+d
or
V.sub._refill=a*UFV/Hb+b*OH+c wherein: a, b, c, and d are parameters; Hb.sub._start is a haemoglobin concentration of the patient at a beginning of the blood treatment session; Hb is a haemoglobin concentration of the patient; UFV is an ultrafiltration volume; UFR is an ultrafiltration rate; and OH is the patient's overhydration when beginning the blood treatment session, wherein the controller is configured to adjust the ultrafiltration rate (UFR) during the blood treatment session such that, once the relative blood volume (RBV) measurements of the patient meet the target range of the relative blood volume (RBV.sub._end) that was set by the controller based on the refilling volume (V.sub._refill) of the patient determined by the controller, the relative blood volume (RBV) measurements of the patient do not drop below the target range of the relative blood volume (RBV.sub._end).
2. The blood treatment device according to claim 1, wherein the controller is configured to determine a relative blood volume (RBV) or the refilling volume (V.sub._refill) using an absolute start blood volume (BV.sub._start) upon or before beginning of the blood treatment session.
3. The blood treatment device according to claim 2, wherein the controller is configured to determine the absolute start blood volume (BV.sub._start) using at least one value reflecting a lean mass (LTM) of the patient's body and at least one value reflecting a fat mass (ATM) of the patient's body, or approximations thereof.
4. The blood treatment device according to claim 2, wherein the controller is configured to predict an end value of the relative blood volume (RBV) to be arrived at by an end of the blood treatment session without having caused intradialytic morbid events.
5. The blood treatment device according to claim 2, wherein a time a certain future blood treatment session lasts is calculated or optimized by taking the relative blood volume (RBV) or an end value of the relative blood volume (RBV) into account.
6. The blood treatment device according to claim 2, wherein the controller is configured to adjust the determined relative blood volume (RBV) based on the patient's overhydration (OH) level to be a normalized or normohydrated relative blood volume (RBV.sub._normohyd, or BV(t)/BV.sub._0).
7. The blood treatment device according to claim 1, wherein the controller is configured to determine a normalized or normohydrated relative blood volume (RBV.sub._normohyd) using an equation:
8. The blood treatment device according to claim 1, further comprising an output device for outputting results of the computer-implemented method.
9. The blood treatment device according to claim 7, wherein the controller is configured to control the blood treatment device in relation to a value or target range representing the relative blood volume (RBV) of the patient or the normalized or the normohydrated blood volume (RBV.sub._normohyd) of the patient.
10. The blood treatment device according to claim 1, the controller being configured to control the blood treatment device in relation to a value or target range representing a target relative blood volume (RBV), wherein the target range is defined by a target overhydration status.
11. The blood treatment device according to claim 1, the controller being configured to control the blood treatment device such that the blood treatment session is terminated or interrupted once an end value of the relative blood volume (RBV) is measured or calculated that has been predicted as an end value or target range of the relative blood volume (RBV) at which the patient has not suffered intradialytic morbid events.
12. The blood treatment device according to claim 1, the controller being configured to control the blood treatment device such that the blood treatment session is terminated or interrupted once a threshold or a predetermined value of the patient's absolute blood volume has been detected or calculated.
13. The blood treatment device according to claim 1, the controller being configured to control the blood treatment device such that the blood treatment session is terminated or interrupted once a threshold or a predetermined value of the absolute blood volume of the patient has been detected or calculated, wherein the absolute blood volume of the patient is determined during the blood treatment session by taking the relative blood volume (RBV) of the patient determined during the blood treatment session into account.
14. The blood treatment device according to claim 1, wherein the blood treatment device is configured for treating the patient by haemofiltration, ultrafiltration, and/or haemodialysis.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) Other aspects, features, and advantages will be apparent from the description, figures, and claims.
(2)
(3)
(4)
(5)
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DETAILED DESCRIPTION
(13)
(14) As can be seen from
(15)
(16) As can be seen both from
(17) As can be also seen from
(18) The representations of
(19) Also,
(20) In the following, by way of example an approach reflecting said relevance of the overhydration before dialysis and its derivation are explained (with ABV being the drop, or change in general, of the absolute blood volume during dialysis):
(21)
(22) BV_start equals the normohydrated BV_0 plus the part of the excess fluid present in the blood compartment:
(23)
(24) Assuming that BV_0 equals 0.1*LTM+0.01*ATM, with LTM being the muscle mass and ATM the fat mass of the patient in question, the refilling volume may be expressed as follows:
(25)
(26) Solving (5) for RBV_end:
(27)
(28) In any equation presented within the present description, UFV stands for ultrafiltration volume, OH stands for the overhydration before starting the dialysis.
(29) V_refill may be estimated, by way of example, as follows:
(30)
(31) As stated above, in certain embodiments according to the present invention, parameter a equals 0.6015, b equals 0.0097, c equals 0.0223 and d equals 0.0442. This is, however, not to be understood as limiting. Any other estimation is also contemplated.
(32) The above stated values for parameters a, b, c and d have been empirically found. They have been step wisely analyzed for significance and cross validated.
(33) Other approaches for estimating the refilling volume based on the UFV, UFR and OH are of course also contemplated. In those alternative approaches, hb_start may be comprised.
(34) This is, however, not mandatory.
(35) Also, the duration of the dialysis session T_dialysis may be calculated by dividing UFV by UFR.
(36) Further, the overhydration OH may be expressed by a function f(UFV, UFR, LTM, ATM, hb_start, K_Guyton, RBV_end). The duration of the dialysis session T_dialysis may be expressed by a function f(UFV, OH, hb_start, LTM, ATM, K_Guyton, RBV_end). The ultrafiltration rate UFR may be expressed by a function f(UFV, OH, hb_start, LTM, ATM, K_Guyton, RBV_end, T_dialysis).
(37)
(38) In the embodiment that corresponds to
(39) As can be seen from
(40) Similarly, what has been demonstrated above with reference to
(41) The standard deviation (SD) of the values shown is +/−2.2%. Each point shown in
(42) It is noted that the data shown in the figures discussed here were achieved during or by treatments that were carried out with a constant ultrafiltration rate applied. It is, however, contemplated that the idea of the present invention may also be embodied with ultrafiltration rates that are not kept constant during treatment.
(43)
(44) Reference sign RBV_meas depicts the actual, measured course of the relative blood volume over time t. Reference sign RBV_pred shows the predicted relative blood volume. As can be seen, there is hardly any deviation (the deviation is represented by the arrow of
(45)
(46) In each of
(47) According to some embodiments of the present invention, a relative blood volume RBV_normohyd, (here also called a normohydrated relative blood volume) that is “corrected” for the overhydration found in the patient at issue before the dialysis session is used for controlling the dialysis machine.
(48) The normohydrated relative blood volume RBV_normohyd can be calculated, e.g., as follows:
(49)
wherein BV_absolute_startDialysis stands for the absolute blood volume at the beginning of the treatment session, and wherein BV_0 stands for the absolute blood volume corrected for the fluid contribution to the vessel system due to the overhydration. The Guyton factor K_Guyton indicates what portion of the overhydration is comprised within the vessel system.
(50) That way, an overhydrated patient would start his or her dialysis treatment with a normohydrated relative blood volume RBV_normohyd that is higher than 100% as can be seen from
(51) As is readily understood from
(52)
(53) Additionally, as is indicated in
(54) For example, the target range TR may be set 3%, 5% or more below and/or above the 100% envisaged.
(55) Further, the target range TR does not necessarily cover an end value of the normohydrated relative blood volume RBV_normohyd that is always 100%. The range may also be used to cover an area around any desired end value for the treatment in question. Hence, under certain circumstances, a target range may relate to an end value of, e. g., 90% or 95%, depending on the patient.
(56)
(57) It is noted that instead of OH as described above, a time averaged value of OH (TAFO, a mean between pre and post overhydration values) can be used for embodying the idea of the present invention, including the idea described with regard to
(58) In
(59) At end point C2 the patient has a normohydrated blood volume BV; however, the patient is still overhydrated. In consequence, a rebound of water from the interstices into the blood vessels has to be expected as the end point C2 will still rise in the illustration of
(60) On the other hand, at end point C1 there is no rebound because the patient is not overhydrated, and also because the distribution of water between blood volume BV and interstices has found an equilibrium.
(61) In certain embodiments, a control according to the present invention is contemplated as follows:
(62) After 10 to 30 minutes after the begin of the treatment the direction of the curve (e. g. in a representation like that of
(63) In contrast, in case the curve of
(64) In certain embodiments of the control method or the devices for carrying out the methods, the manipulated variables comprise in first place the ultrafiltration rate and/or the duration of the dialysis treatment. Besides, additional means such as salt boli and their administration for enhancing the refilling are contemplated.
(65)
(66) As can be seen from
(67) The bioimpedance measurement means 69 can be capable of automatically compensating for influences on the impedance data like contact resistances.
(68) An example for such a bioimpedance measurement means 69 is a device from Xitron Technologies, distributed under the trademark Hydra™ that is further described in WO 92/19153, the disclosure of which is hereby explicitly incorporated in the present application by reference.
(69) The bioimpedance measurement means 69 may comprise various electrodes. In
(70) Each electrode implied can comprise two or more (“sub”-)electrodes in turn. Electrodes can comprise a current injection (“sub”-)electrode and a voltage measurement (“sub”-)electrode. That is, the electrodes 69a and 69b shown in
(71) Generally spoken, the apparatus according to the present invention can be provided with means such as weighing means, a keyboard, a touch screen etc. for inputting the required data, sensors, interconnections or communication links with a lab, any other input means, etc.
(72) Similarly, the apparatus 61 may have further means 71 for measuring or calculating means for obtaining a value reflecting the overhydration and/or for obtaining values reflecting the mass, the volume or the concentration of Hb that can be provided in addition to the external database 65 or in place of the external database 65 (that is, as an substitute).
(73) The means 71 can be provided as a weighing means, a keyboard, touch screen etc. for inputting the required data, sensors, interconnections or communication links with a lab, an Hb concentration probe, any other input means, etc.
(74) Below, an exemplary way is described of how an apparatus according to the present invention works that is configured to control a device for treating a patient's blood such that the treatment session is terminated or interrupted once a threshold or a predetermined value of the patient's absolute blood volume has been detected or calculated: The patient's absolute blood volume at the beginning of the treatment session is known as BV_start=BV_0+OH/K_Guyton. In the following example, BV_start is 5.0 L. Now, the relative blood volume determined by, e.g., a blood volume monitor several times during the treatment is multiplied with BV_start. Once the relative blood volume (in %) has fallen to 95%, the absolute blood volume may be calculated as 5.0 L*0.95=4.75 L.
(75) It may be desired that the blood treatment has to be terminated once the absolute blood volume has fallen under a threshold of, e.g., 4.0 L. That way, the relative blood volume is taken into account during the blood treatment session. Of course, the threshold may be set for each patient and/or treatment session individually.
(76) Of course, what has been explained above with regard to the approximation or prediction of a tolerated relative blood volume during blood treatment may in certain embodiments also be true for the absolute blood volume. In other words, by means of the present invention it may be possible to approximate or predict also an absolute blood volume that is still tolerated. Such a tolerated absolute end blood volume BV_end may be obtained by multiplying BV_start with RBV_predicted.
(77) Therefore, what has been said above with regard to the present invention in the light of a relative blood volume is in many embodiments also true for an absolute blood volume.