EP3729448A1 - Procédé et dispositifs pour définir un régime de traitement destiné à modifier des paramètres de traitement lors de la dialyse d'un patient - Google Patents

Procédé et dispositifs pour définir un régime de traitement destiné à modifier des paramètres de traitement lors de la dialyse d'un patient

Info

Publication number
EP3729448A1
EP3729448A1 EP18829794.9A EP18829794A EP3729448A1 EP 3729448 A1 EP3729448 A1 EP 3729448A1 EP 18829794 A EP18829794 A EP 18829794A EP 3729448 A1 EP3729448 A1 EP 3729448A1
Authority
EP
European Patent Office
Prior art keywords
treatment
target
sodium
diffusive
blood
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP18829794.9A
Other languages
German (de)
English (en)
Inventor
Andreas Maierhofer
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Medical Care Deutschland GmbH
Original Assignee
Fresenius Medical Care Deutschland GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fresenius Medical Care Deutschland GmbH filed Critical Fresenius Medical Care Deutschland GmbH
Publication of EP3729448A1 publication Critical patent/EP3729448A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1601—Control or regulation
    • A61M1/1603—Regulation parameters
    • A61M1/1611—Weight of the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1601—Control or regulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1601—Control or regulation
    • A61M1/1603—Regulation parameters
    • A61M1/1605—Physical characteristics of the dialysate fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1601—Control or regulation
    • A61M1/1613—Profiling or modelling of patient or predicted treatment evolution or outcome
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654—Dialysates therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654—Dialysates therefor
    • A61M1/1656—Apparatus for preparing dialysates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/3403—Regulation parameters
    • A61M1/341—Regulation parameters by measuring the filtrate rate or volume
    • G—PHYSICS
    • G05—CONTROLLING; REGULATING
    • G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
    • G05B6/00—Internal feedback arrangements for obtaining particular characteristics, e.g. proportional, integral, differential
    • G05B6/02—Internal feedback arrangements for obtaining particular characteristics, e.g. proportional, integral, differential electric
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/40—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/40—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/30—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indices; for individual health risk assessment
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/50—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for simulation or modelling of medical disorders

Definitions

  • the present invention relates to methods according to
  • a blood treatment device according to claim 13. Further, the present invention relates to a digital
  • a storage medium according to claim 16 a computer program product according to claim 17 and a computer program according to claim 18.
  • the extracorporeal blood treatment by dialysis is known.
  • This blood is taken from the patient, the extracorporeal along a blood circulation and z. B. is guided by a blood filter.
  • the blood filter has a blood chamber through which blood is passed, and a blood vessel
  • Dialysis fluid is performed on. Both chambers are separated by a semi-permeable membrane. Blood and dialysis fluid are usually passed in countercurrent through the blood filter. The blood is purified in the blood filter, the dialysis fluid is considered to be used up as it exits the blood filter and is now discarded as dialysate. In addition to the dialysate, the fluid to be discarded also comprises filtrate, which comprises water which has been withdrawn from the blood in the blood filter. Filtrate and dialysate are hereinafter referred to individually or collectively simplified as effluent. Dialysis occurs - in addition to acute cases all - in patients with end-stage renal failure.
  • Hemodialysis treatment performed. In addition to the removal of substances such as urea and potassium, it is an essential task of dialysis, resulting from fluid intake resulting overhydration of the patient by
  • Fluid intake between dialyses is closely linked to the salt content of the diet as a change in the
  • Control mechanisms controls the thirst.
  • the body strives for a "sodium setpoint" dependent on the individual physiology (Keen, M.L., & Gotch, F.A., The association of the sodium "setpoint" to interdialytic weight gain and blood pressure in hemodialysis patients, The
  • Fluid intake then becomes the sodium concentration
  • Clinical studies have shown that the mortality of dialysis patients increases both with the degree of chronic overhydration and with the degree of relative interdialytic weight gain caused by fluid intake.
  • the water is distributed among various physiological compartments, which can be divided into the intracellular space, the extracellular space and the interstitium (Guyton & Hall, Textbook of Medical Physiology).
  • the distribution to these compartments is mainly determined by the osmotic balance, to which the sodium content in these compartments makes the main contribution.
  • Hemodialysis takes place in the dialyzer both a mass transfer with the blood and a liquid removal from the blood instead. After the return of the blood in the body is there by flow of liquid from others
  • the sodium concentration in the dialysis fluid is chosen so that it is above the blood sodium concentration. This leads as a result of an increase in osmolarity in the blood to an increased afterflow of body water.
  • Intradialytician addition of salt at the same time to an increase in the salt concentration in the body and thus to increased thirst, which is compensated in the period between the treatment sessions by an increased fluid intake.
  • the overhydration of the patient is intensified, so that in the following dialysis session a correspondingly larger volume of fluid must be withdrawn. Therefore, such an intradialytician salting should if possible
  • An object of the present invention is to provide methods for determining and / or implementing a treatment regime, in particular in or after which
  • control or regulating device a control or regulating device
  • Storage medium a suitable computer program product and a suitable computer program can be specified.
  • the object according to the invention is achieved by methods having the features of claims 1, 9, 10 and 11, a control or regulating device having the features of claim 12 and a blood treatment device having the features of claim 13.
  • the object of the invention is further achieved by a digital storage medium, a computer program product and a computer program according to claims 16, 17 and
  • the present invention relates to a treatment regime, or a method for establishing a treatment regime, in particular, a method for determining or changing (or changing) one or more
  • the method includes setting one herein as
  • diffuse total target sodium balance which is herein the target of the diffusive sodium balance to be achieved as desired after a variety of future treatment sessions in one of the future treatment sessions.
  • the diffusive total target sodium balance is thus the "procedural goal”.
  • the diffusive sodium balance may be due to the transfer of the substance between dialysate and blood, which proceeds without volume depletion for the blood. As a result of this diffusion of sodium, the sodium concentration in the blood changes, which
  • the diffusive sodium balance can be z. B. be understood as a result of mass transfer without concomitant volume deprivation.
  • This diffusive total target sodium balance should be achieved as a method goal, preferably at a first or later treatment session planned by the method according to the invention, or at least with or after completion of the method according to the invention or the transition treatment regime described below.
  • the diffusive sodium balance can be measured, for example, between the blood compartment and the dialysis fluid compartment of the dialyzer. Alternatively, the
  • Peritoneal dialysis in comparison to the sodium content of fresh dialysis fluid supplied to the patient, on the one hand, with the sodium content of the spent dialysate, which is discharged from the patient in the same treatment session, on the other hand, are measured. This measurement may reveal whether the overall diffusive target sodium balance (as
  • Target value has already been reached or not.
  • the method further includes setting a
  • Transitional treatment regime by which during the treatment session (or over the plurality of future treatment sessions, or following this), and z. B. towards the end, the diffusive total target sodium balance is achieved.
  • diffusive sodium balance which is tolerated by this.
  • a proposal is made as to how the diffusive total target sodium balance is progressively prepared over a number of treatment sessions, for example by reducing the diffusive sodium balance to a lower, desired one from a higher, or later tolerated by the patient in previous treatment sessions diffusive sodium balance, namely the diffusive total target sodium balance, can be lowered.
  • diffusive total target sodium balance may thus be the target of a gradual lowering of an original diffusive
  • the diffusive total target sodium balance may be adjusted or suggested at the first treatment session.
  • other parameters can be facilitated in the patient
  • Treatment planning be adapted or modified, as explained below.
  • the present invention further relates to a
  • a blood treatment device for dialyzing a patient wherein the ultrafiltration volume withdrawn or withdrawn from the patient by ultrafiltration is determined by the method for determining a treatment regimen.
  • the ultrafiltration function can be ultrafiltration his.
  • the ultrafiltration function can be achieved by means of
  • Blood treatment apparatus are carried out, the one for initiating or performing the
  • ultrafiltration function configured control or regulating device for. B. the control or regulating device according to the invention may have.
  • the present invention further relates to sodium (or
  • Procedure for defining a treatment regime is set. Alternatively or additionally, by means of
  • the present invention also relates to a method for mixing a dialysis fluid for treating a
  • the present invention also includes a control device. It is configured or programmed to perform and / or cause the performance of each method of the invention, particularly in each embodiment described herein, and in any combination of features disclosed herein, particularly method steps.
  • the control or regulating device is additionally or alternatively configured or
  • a blood treatment device based on the results of the method, or based on the predetermined, stored and / or determined hereby or herein
  • the control device may include facilities
  • the controller optionally includes means for establishing or is hereby connected to signal communication, referred to herein as a total target total sodium balance.
  • control device further optionally includes means for establishing a
  • the present invention further relates to a
  • Blood treatment device This optionally has a
  • Control device according to the invention or is hereby connected in signal communication, in particular to be controlled or regulated by this. Additionally or alternatively, the blood treatment device has a control or
  • a control device configured or programmed to control the blood treatment device based on the results of the invention
  • volatile, storage medium in particular in the form of a machine-readable carrier, in particular in the form of a
  • Floppy disk, memory card, CD, DVD, Blu-ray Disc or (E) EPROM, with electrically readable control signals, can such with a programmable computer system Z Zammenrise that, in particular mechanical, steps of
  • inventive method be initiated.
  • a computer program product according to the invention has a volatile, volatile or machine-readable program code for initiating the, in particular mechanical, steps of the inventive method, when the computer program product runs on a computer.
  • a computer program product according to the invention for example, stored on a carrier
  • Computer program an embedded system as a comprehensive system with a computer program (eg electronic device with a computer program), a network of
  • Client / server system, cloud computing system, etc. or a computer on which a computer program is loaded, run, stored, executed or developed.
  • machine readable carrier as used herein
  • the carrier may be a data carrier such as a floppy disk, a CD, DVD, a USB stick, a flashcard, an SD card or the like.
  • a computer program according to the invention has one
  • a computer program according to the invention for example, a physical, distributable software product can be understood, which has a program.
  • a tolerated value such as a tolerated diffusive
  • the patient may indicate that the information obtained by the current or one or more of the past treatment sessions, e.g. B. was tolerated by him after the end of treatment achieved diffusive sodium balance.
  • the physician can use his experience to determine if the patient has the
  • diffused sodium balance (s) has tolerated.
  • the patient and the doctor may come to the conclusion that the treatment (s) and especially the diffusive sodium balance (s) have been tolerated.
  • These possibilities count as, or include, subjective criteria.
  • objective criteria can be created, the z. B. based on one or more measurable statements. For this vital signs, postdialytic or
  • intradialytic symptoms which are levels of dizziness, malaise, etc. that can be measured or classified by grading or otherwise.
  • sodium balance is intended to include or replace other salts and / or osmotically active substances with the term “sodium balance.” Instead of “sodium balance” and all terms relating thereto, it is also possible according to the invention to use B. "salt balance” can be used. When used herein by sodium, approximately in connection with the
  • sodium is representative of sodium as a pure substance, but also for any sodium salt or salt which has sodium, for example sodium chloride.
  • the present invention may further include
  • Treatment methods concern.
  • the method of treatment proceeds on the basis of the treatment regime previously determined by means of the method according to the invention.
  • the method according to the invention can be understood as a planning method.
  • the present invention relates
  • Treatment regimen can be fully run and completed before the start of treatment. B. before the first treatment session. It may alternatively during z. B. the first and last treatment session to be adjusted. However, an interaction with the patient is not required. The patient does not need to be connected to a treatment device when adjusting. The patient does not have to be present during the fitting. The settings the blood treatment device for performing the
  • Sign is used, if it is negative for the patient) and more preferably 0 mmol is to be set (for example by the physician) or
  • Providing eg by means of a table, patient record, etc.) a value of a target dry weight or other target value of the weight of the patient (for example, by dialysis with completion of the respective
  • the aim of the treatment session is, and / or the as
  • Treatment basis such as setting the ultrafiltration volume) for the first treatment session; a (em) determination (eg by calculation,
  • Treatment session is required or would be; and (e) specifying an ultrafiltration volume by which the value of the ultrafiltration volume to be withdrawn to achieve the target dry weight or the other target value of the weight of the ultrafiltration volume to be withdrawn at the first treatment session is calculated
  • setting and / or assigning is determining, inputting, storing and / or calculating.
  • the determining is calculating or looking up in a storage medium (table, list, etc.).
  • Treatment session immediately or indirectly (that is, without interruption or interruption) following
  • Ultrafiltration volume (can be used to achieve the
  • Ultrafiltration means that patients will lose more weight when they have increased their food and drink interdialytically (ie since the end of the last treatment session).
  • the volume F UFextra is in each case smaller than that
  • a total volume which is the ultrafiltration volume by which the value of the ultrafiltration volume to be withdrawn or withdrawn to reach the target dry weight or other target value has been computationally reduced, assumed, or exceeded for the upcoming treatment session.
  • Target sodium balance for a treatment session scheduled for a given day as where: equals a value during the
  • M diff, minus (d) corresponds to a fixed or
  • the diffusive total target sodium balance takes or becomes smaller than the latter.
  • the step of establishing the transient treatment regimen includes or consists of determining the overall diffusive target sodium balance
  • target_totai should be between -300 mmol and +300 mmol, preferably 0 mmol ("neutral diffusive sodium balance") should be. In some embodiments, the total target total sodium balance Mdiff, target_totai is between -300 mmol and
  • the blood treatment device comprises sensors which are inserted upstream and / or downstream of a dialyzer of the blood treatment device to the electrolyte and / or the
  • Dialysis fluid side and / or on the blood side are dialyzed blood side and / or on the blood side.
  • Blood treatment device on a control or regulating device.
  • the control device may be programmed and / or configured to carry out the method according to the invention in cooperation with further devices, in particular a blood treatment device.
  • the controller is configured to provide treatment parameters based on input from the physician or user, in particular
  • Treatment device for a treatment by means of or to control or regulate based on these treatment parameters.
  • the control or regulation may optionally influence the dialysis fluid mixed by a device, such as the treatment device, in particular its
  • composition and / or its sodium content
  • the controller may be configured to
  • Issue machine signals which are addressed as control signals to the treatment device based on inputs by the physician, or - alternatively or additionally thereto - based on stored algorithms such
  • the controller may adjust or set the treatment parameters for individual or specific treatment sessions and
  • control or regulation can be inventively set or changed on the fly, d. H. during the course of a treatment session or parallel to it. Alternatively, it may be set and stored prior to the beginning of a treatment session and stored as later, e.g. During future treatment sessions.
  • the controller may be configured to receive input from the physician, algorithms for calculating
  • Storage devices may be provided according to the invention. Corresponding and optionally provided for this purpose
  • Input fields, switches, regulators, etc. for the physician may be included by the control device, a display device, and / or a portion of the blood treatment device.
  • the control device can be configured to provide the physician or user with treatment parameters, in particular the
  • control device or the treatment device includes means configured to perform steps of the methods of the invention. This is true for any step disclosed herein.
  • the method may include the steps, individually or in any combination, of the following
  • the dry weight m ⁇ usually increases by liquid removal
  • the following parameters are parameters of the treatment session, which can be optionally taken into account:
  • Predialytic plasma sodium concentration as the sodium concentration measurable in the blood before starting a treatment session: is decisive for the gradient of the sodium concentration between blood and
  • Dialysis session The gradient between blood and
  • Treatment session constant. However, it can vary during the dialysis session due to adjustments of the user, change in the sodium profile or automated control of the dialysis fluid sodium.
  • Dialysis dose KtIV rBW Decisive for the amount of
  • Kt / V is a parameter for determining the dialysis efficiency.
  • K is the clearance, it is determined by the urea content of the blood before and after dialysis, t is the effective dialysis time in minutes.
  • V can be set at 60% of the body mass (weight) at which the blood can circulate (body water content).
  • the present invention comprises and may be a concrete
  • Delay time which requires a volume element on the way from the measuring point for C di to the measuring point for C do .
  • c di and c do z.
  • Dialysis fluid comprising the through the
  • HF Hemofiltration
  • HDF hemodiafiltration
  • the temperature-compensated total conductivity s can be measured and from this, taking into account the composition of the dialysis fluid, the sodium concentration at the respective measuring point can be concluded:
  • composition of the spent dialysate is downstream of the
  • Dialysis fluid in the dialyzer a priori unknown.
  • the concentration of sodium and / or the addition of sodium to the conductivity contributing ions means
  • Concentration course of the relevant ions in blood and dialysate can be determined downstream of the dialyzer.
  • symptom-free treatments are derived at a given value of the diffusive sodium balance M m .
  • the goal is, regardless of the course of action for one
  • Treatment regimen which will be treated with the diffusive total target sodium balance (here: regime 2, ie a treatment regime with reduced or regulated
  • Dialysis fluid sodium is that value of the diffusive sodium balance
  • Ultrafiltration volume (UF volume short) was withdrawn, to avoid symptoms by the user a higher medium dialysate sodium was prescribed. Likewise, periodic fluctuations of c ⁇ in the range of weeks due to the biorhythm of the patient are possible.
  • Dialyzing fluid sodium affect the diffusion gradient, leading to this in the sequence to periodic
  • a target value for the diffusive sodium balance difftarget (Regime2) to be achieved is defined for the desired treatment regime of the patient, here referred to as the diffusive total target sodium balance M diff target total .
  • V m (d) and the diffusive sodium balance should deviate from the desired diffusive sodium balance.
  • Formula 1 thus remains unchanged also for hemofiltration, in which dialysis fluid is mixed on-line, ie by the treatment machine, and in both pre- and post-dilution mode.
  • M diff (t) For peritoneal dialysis and for hemofiltration with dialysis fluid from bags and without fluid removal, M diff (t) would be practically the integration of Formula 1:
  • determining sodium concentration gradient can be varied.
  • the sodium concentration is the
  • Sodium transfer can therefore only be actively influenced by varying the dialysate flow or the duration of treatment. At the same time, however, these measures also concern the removal of uremic toxins.
  • z. B. may be provided in the treatment plan.
  • Model for mass transfer taking into account the Sodium concentration of the bag contents and the measurement of C do advantageous to the time or points of, for
  • the invention runs
  • Procedures on a computer or computer For input, an input option for the user may be provided. To present results of the procedure or
  • Treatment instructions can be output or
  • the method includes
  • the diffusive sodium balance is calculated from the volume of distribution V or M EBW of the patient
  • Intradialytic changes in sodium concentration are typically between +/- 3 mmol / l, changes greater than 6 mmol / l are rare, at most for sodium intake to hyponatremic patients.
  • Some or all embodiments according to the invention may have one, several or all of the advantages mentioned above and / or below.
  • One advantage of the present invention is its ease of implementation, which does not require the measurement of values such as the relative volume of blood or its course to avoid intradialytic complications.
  • Fluid volume is lower than planned and thus the dry weight is not reached.
  • Dialysis fluid sodium reacts. This leads to an (increased) salt supply to the patient, so that the original goal of reducing both the
  • Dialysis fluid can be chosen so that in
  • Dialysis fluid sodium of the dialysis center visited is reduced due to external requirements flat rate, z. For efforts to generally reduce patient intradialytic salt loading.
  • Dialysis fluid sodium but now lacks the osmotic support for the afterflow of body water in the
  • Fig. 1 shows a simplified representation of a
  • Blood treatment device with an extracorporeal blood circulation in a first embodiment
  • Fig. 2 shows the tracking of the deviation from the
  • FIG. 3 shows tracking of the deviation of the UF volumes in another simulation in another embodiment according to the invention.
  • Fig. 1 shows a greatly simplified representation of a
  • Blood treatment device 100 connected to an extracorporeal blood circulation 300 and a drainage hose system with only one indicated
  • the extracorporeal blood circuit 300 has a first one
  • Line 301 here in the form of an arterial
  • the first line 301 is in fluid communication with a blood treatment device, here exemplarily a blood filter or dialyzer 303.
  • the blood filter 303 has a
  • Dialysis fluid chamber 303a and a blood chamber 303b which are separated by a mostly semi-permeable membrane 303c.
  • the extracorporeal blood circuit 300 also has at least one second conduit 305, here in the form of a venous one
  • Both the first conduit 301 and the second conduit 305 may be for connection to the vascular system of the patient, not shown.
  • the first line 301 is optionally with a (first)
  • Hose clamp 302 connected to block or close the line 301.
  • the second conduit 305 is optionally connected to a (second) hose clamp 306 for blocking or closing the conduit 305.
  • the blood treatment device 100 shown in FIG. 1 only by some of its devices and schematically represents a blood pump 101.
  • the blood pump 101 during treatment of the patient, promotes blood through portions of the extracorporeal blood circuit 300 and toward the blood filter or dialyzer 303, such as the small arrowheads which generally indicate the direction of flow in the figure.
  • Dialysis fluid chamber 303a pumped.
  • Dialysis fluid chamber 303a as dialysate, if necessary enriched by filtrate, toward the spout 600 and is referred to herein as effluent.
  • the source 200 may be, for example, a bag or a bag
  • the source 200 may further be a fluid conduit from which online and / or continuously generated or mixed fluid is provided, e.g. B. a
  • Another source 201 with substituate may be optional
  • the substituate may optionally be heated, e.g. B. in the optional bag heater Hl.
  • the arrangement shown in FIG. 1 also has, as an option, a series of further, respectively optional pumps, namely the pump 111 for
  • the pump 121 is provided to dialysing out of the source 200, such as a bag, out and about an optional bag heater with a bag H2 by means of a Dialysier remplikeitszulauf admir 104
  • the dialysis fluid supplied in this way exits via a dialysate drain line 102, assisted by the pump 131, and can be discarded.
  • a dialysate drain line 102 Upstream of the blood pump 101, an optional arterial sensor PSI is provided. During a patient's treatment, he measures the pressure in the arterial line.
  • Blood filter 303 and, if provided, an addition point 25 for heparin, another, optional pressure sensor PS2 is provided. It measures the pressure upstream of the blood filter 303 ("pre-hemofilter").
  • Yet another pressure sensor may be provided as PS4 downstream of the blood filter 303, but preferably upstream of the pump 131 in the dialysate drain line 102 for measuring the filtrate pressure or membrane pressure of the blood filter 303.
  • Blood exiting the blood filter 303 flows through an optional venous blood chamber 29 which has a blood vessel 29
  • Venting device 31 may be in fluid communication with another pressure sensor PS3.
  • the exemplary arrangement shown in FIG. 1 includes a control device 150. It may be connected to any of the components mentioned herein, in any case, or in particular to the blood pump 101, in wired or wireless signal connection for controlling the
  • Blood treatment device 100 stand. It is optionally configured to the method described herein
  • the blood treatment device may include a device for online mixing of the dialysis fluid from a plurality of components, which may include an acidic concentrate, a bicarbonate component and reverse osmosis water.
  • Variation of the sodium content of the dialysis fluid controlled by the control device 150, within certain limits possible.
  • the blood treatment device 100 optionally includes a device for exact accounting of the in the
  • Dialyzer 303 incoming and outflowing dialysate.
  • the blood treatment device 100 further comprises means for accurately removing a predetermined by the user and / or by the control device 150 liquid volume V ⁇ from the balanced circuit as a
  • Sensors 106 and 108 serve to determine the conductivity, which is temperature-compensated in some embodiments, as well as the liquid flow upstream and downstream of the
  • Dialysators 303 may also be a suitable equivalent combination of actuators such as calibrated pumps, balancing chambers and pressure sensors. Instead of an optional determination of the temperature-compensated conductivity, means for ion-selective measurement are optionally also possible.
  • Control device 150 the electrolyte and / or
  • An internal or external computing and / or storage unit may also be provided. It may be able to provide the historical data necessary to calculate the current electrolyte and fluid balance
  • FIG. 1 Although the blood treatment device according to the invention is shown in FIG. 1 as a device for hemo (dia) filtration.
  • peritoneal dialysis devices are also within the scope of the present invention, although not specifically illustrated by way of FIG.
  • FIG. 2 and FIG. 3 show in simulations how a patient from a previous treatment regime
  • Dialysis fluid sodium is transferred, which begins in day 2 on day 19 in FIG. 2 and on day 27 in FIG.
  • model patient is a
  • Dialysis or treatment session reaches the "setpoint" of 130 mmol / 1.
  • Dialysis fluid sodium will be the patient's plasma sodium at the typical for his treatment
  • the associated diffusive salt transfer is determined by means of the sensors 106, 108 of the treatment apparatus 100.
  • the UF volume is set in each case so that the triggered by the salt intake fluid supply between the treatment sessions is completely balanced again. Therefore, UF volume and predialytic overhydration are in the regime 1 identical.
  • the patient attains his dry weight m dTy . This previous one
  • Fig. 2 shows the tracking of the deviation from the diffusive sodium balance in a simulation of the
  • Fig. 2 shows above the plasma sodium [mmol / 1] via
  • successive days which also include the treatment days d, wherein the predialytic sodium of the plasma is indicated by small diamonds, the postdialytic plasma by squares.
  • Fig. 2 shows in the middle the ultrafiltration volume UF [1] over the consecutive days.
  • Ultrafiltration volume UF [1] corresponds to the respective, interdialytic
  • Fig. 2 shows the diffusive sodium balance, each on successive days.
  • Fig. 2 is the gradual achievement of a diffusive intradialytic sodium zero balance as an example of target total target sodium concentration diff target total .
  • the dialyzing sodium is adjusted stepwise.
  • the physician determines how much M minus minus (d) at each treatment session will be tolerated by the previous treatment session BS_d-1
  • intradialytic sodium balance may look like this:
  • / lä difi; mimis ( ⁇ i) can be a constant value. This amount can be expressed as an absolute amount (in mmol or g) or as an expected change in the
  • a medical assumption may be that a deviation of the plasma sodium concentration at the end of the dialysis session (ie
  • Dialysis fluid sodium one on accounting for salt transfer between blood and dialysis fluid
  • Dialyzer 303 controls the dialysis fluid sodium so that at the end of the current
  • Treatment session BS_d the specified target value for the salt transfer of this treatment session is achieved. Since in the present example the intradialytician diffusive
  • the plasma sodium increases less from session to session during the treatment session on.
  • the patient must drink less as a physiological response between treatment sessions, so that the
  • Treatment regimen a new osmotic balance without intradialytician diffusive salt intake and achieved at lower UF volume.
  • FIG. 3 shows the tracking of the deviation of the UF volume in another simulation of the method according to the invention.
  • Fig. 3 shows above the plasma sodium [mmol / 1] via
  • successive days which also include the treatment days d, wherein the predialytic sodium of the plasma is indicated by small diamonds, the postdialytic plasma by squares.
  • Fig. 3 shows in the middle the ultrafiltration volume UF [1] (denoted by small diamonds) and the overhydrogenation (denoted by squares) over the successive days.
  • Fig. 3 shows the diffusive sodium balance, over each successive day.
  • the dialysate sodium is already from day 8
  • Fig. 3 shows another way to avoid the critical coincidence of a high UF volume with the discontinuation of intradialytic diffusive salt delivery. This procedure suggests, when discontinuing the salt intake on
  • Treatment session end would reach its dry weight lip ry (see Fig. 3). This reduction, however, causes the patient to end up with
  • Treatment session Bs_d just did not reach dry weight m dTy . Instead, this is missing
  • the reduction in UF volume to be undertaken at the beginning and / or during the transition or transitional regime can be determined by means of various physiological models.
  • Treatment sessions diffusively administered amount of salt a fluid volume calculated or otherwise determined (eg by means of table), the salt intake so compensates for the fact that the concentration of plasma sodium remains unchanged.
  • Osmolality the latter in each compartment (EC and IC) is equal to twice the respective sodium concentration in each compartment:
  • the described, greatly simplified osmotic model can be extended to include other osmotically active substances as well as volume and substance removal by ultrafiltration.
  • This may be a fixed value or a value in relation to a maximum tolerated ultrafiltration volume , z. B. determined from the
  • Treatment regimen the regime 1, is determined.
  • Observation of the relative blood volume RBV can be determined by additionally withdrawing as much volume in each treatment until either a critical value of RBV is reached
  • fj jpextra for example, a patient or
  • the maximum value can be reached when a maximum ultrafiltration rate determined from a given ultrafiltration volume and duration of treatment has been reached.
  • the maximum ultrafiltration rate can be
  • md is the weight that the patient puts on the scale on the day d before the start of the dialysis session.
  • the return to the dry weight may be other than linear (but, for example, exponential), or taking into account the presence of a long or short interval, e.g. B. by a return only after the short intervals, so that after the long interval anyway increased UF volume is not further increased.
  • the residence time remaining in the abdomen of a peritoneal dialysis fluid is changed over several treatment sessions.
  • Transitional treatment regime includes or consists here in a setting of different residence times of the introduced fluid.
  • the length of stay depends the diffusive sodium balance together.

Abstract

La présente invention concerne des procédés permettant de définir un régime de traitement destiné à modifier des paramètres de traitement lors de la dialyse d'un patient, sur une pluralité de séances de traitement (BS_d) devant se dérouler à des dates futures (d, d+1, d+2, d+3,...), un dispositif de commande ou de réglage configuré en conséquence et un dispositif de traitement du sang.
EP18829794.9A 2017-12-19 2018-12-17 Procédé et dispositifs pour définir un régime de traitement destiné à modifier des paramètres de traitement lors de la dialyse d'un patient Pending EP3729448A1 (fr)

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DE102017130548.3A DE102017130548A1 (de) 2017-12-19 2017-12-19 Verfahren und Vorrichtungen zum Festlegen eines Behandlungsregimes zum Verändern von Behandlungsparametern beim Dialysieren eines Patienten
PCT/EP2018/085222 WO2019121523A1 (fr) 2017-12-19 2018-12-17 Procédé et dispositifs pour définir un régime de traitement destiné à modifier des paramètres de traitement lors de la dialyse d'un patient

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US20200330668A1 (en) 2020-10-22
WO2019121523A1 (fr) 2019-06-27
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