WO2024242176A1 - 血液透析治療支援システム - Google Patents

血液透析治療支援システム Download PDF

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Publication number
WO2024242176A1
WO2024242176A1 PCT/JP2024/019067 JP2024019067W WO2024242176A1 WO 2024242176 A1 WO2024242176 A1 WO 2024242176A1 JP 2024019067 W JP2024019067 W JP 2024019067W WO 2024242176 A1 WO2024242176 A1 WO 2024242176A1
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WIPO (PCT)
Prior art keywords
treatment
hemodialysis
patient
hemodialysis treatment
during
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PCT/JP2024/019067
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English (en)
French (fr)
Japanese (ja)
Inventor
一嘉 宮脇
謙一 小久保
弘之 青木
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Physiologas Technologies Inc
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Physiologas Technologies Inc
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Priority to EP24811181.7A priority Critical patent/EP4678200A1/en
Priority to JP2025522454A priority patent/JPWO2024242176A1/ja
Publication of WO2024242176A1 publication Critical patent/WO2024242176A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • 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
    • 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
    • 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
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient

Definitions

  • the present invention relates to technology to assist medical professionals in blood purification treatment.
  • HDP high-power plasma
  • sf-Kt/V body weight and the removal efficiency (clearance) of the dialyzer.
  • HDP does not take into account weight or removal performance during dialysis, so the values can vary significantly depending on the treatment method and patient.
  • sf-Kt/V takes these factors into account, neither HDP nor sf-Kt/V can be applied when treatment times differ for each treatment or when dialysis days differ from week to week.
  • the present invention aims to provide a system that can improve the accuracy of evaluating the results of hemodialysis treatment.
  • the hemodialysis treatment support system of the present invention comprises: Based on treatment information including the clearance of a dialyzer used in the patient's hemodialysis treatment during a specified period, the duration of each hemodialysis treatment, the number of hemodialysis treatments during the specified period, and the patient's body fluid volume, the peak value of the concentration of a specified substance is calculated according to a kinetic model, and the outcome of the hemodialysis treatment for the patient during the specified period is evaluated based on the HDP or sf-Kt/V corresponding to the peak value.
  • the hemodialysis treatment support system having the above configuration, It is preferable to evaluate the results of hemodialysis treatment for the patient during at least one of the first designated period and the second designated period based on at least one of first treatment information as the treatment information representing the treatment history of the patient during the first designated period, which is the past designated period, and second treatment information as the treatment information representing the treatment plan for the patient during the second designated period, which is the future designated period.
  • the HDP or sf-Kt/V becomes smaller as the variation in at least one of the duration of each hemodialysis treatment, the time interval during which hemodialysis treatment is not performed, and the number of hemodialysis treatments during the specified period increases (resulting in uneven treatment).
  • an output interface output an evaluation result of the hemodialysis treatment outcome for the patient during the specified period.
  • FIG. 1 is a configuration explanatory diagram of a hemodialysis treatment support system according to an embodiment of the present invention
  • FIG. 1 is a functional explanatory diagram of a hemodialysis treatment support system according to an embodiment of the present invention.
  • the hemodialysis treatment support system includes a database 10, an input interface 11, an output interface 12, and a treatment support processing element 20.
  • the database 10 is configured to store and hold measurement results and models that represent the patient's condition, which will be described later.
  • the database 10 may be configured as a database server that is separate from the hemodialysis treatment support system.
  • the input interface 11 is composed of a keyboard, a touch panel, an imaging device, and/or a microphone (voice input device), and is configured to accept input of information about a patient in response to keyboard operations, touches, taps, swipes, pinches, and other operations, gestures, and/or speech by users such as medical staff.
  • the output interface 12 is composed of a monitor (image display device, touch panel display) and/or a speaker, and is configured to output information to assist users, such as medical professionals, in treating patients.
  • the treatment support processing element 20 is composed of an arithmetic processing device (such as a CPU, processor and/or processor core), a storage device (memory such as ROM and RAM, HDD, SSD, etc.), and an interface circuit.
  • the treatment support processing element 20 is configured to execute various arithmetic processing operations described below by the arithmetic processing device reading out the necessary data and programs (software) from the storage device (which may constitute the database 10) and executing arithmetic processing on the data in accordance with the programs.
  • First treatment information representing the treatment history of the patient during a first designated period (e.g., a plurality of days, such as the current day or the week up to the previous day) is acquired through the input interface 11 (FIG. 2/STEP 11).
  • the first treatment information includes the clearance of a dialyzer used in the patient's hemodialysis treatment, the duration and number of each hemodialysis treatment, and the patient's body fluid volume.
  • the duration and number of each hemodialysis treatment, etc., included in the first treatment information may or may not be uniform.
  • Second treatment information representing the treatment schedule for the patient in a second specified period (e.g., multiple days, such as the current day or one week from the following day), which is a specified period in the future, is acquired through the input interface 11 (FIG. 2/STEP 12).
  • the second treatment information includes the clearance of the dialyzer used in the patient's hemodialysis treatment, the duration and number of each hemodialysis treatment, and the patient's body fluid volume.
  • the duration and number of each hemodialysis treatment, etc., included in the second treatment information may or may not be uniform.
  • the peak concentration value of the designated substance e.g., uremic substance and/or uremic toxin substance (at least one of K, Ca, Na, phosphate, free small molecule substance (urea, creatinine, uric acid, etc.)
  • the kinetic model for example, a single-pool model, a two-pool model, or a local blood flow model is adopted.
  • the peak value can be calculated using a kinetic model (see “Kinetic Model for Urea” and “Kinetic Model for ⁇ 2-microglobulin” in Non-Patent Document 1) according to the method described in "Methods" in Non-Patent Document 1.
  • the peak values of the concentration of the specified substance in each of the first and second specified periods are converted to HDP (Hemodialysis Product) or sf-Kt/V (Square Frequency Kt/V) under the condition that the treatment conditions are uniform ( Figure 2/STEP 16).
  • the peak values can be converted to HDP or sf-Kt/V according to the method described in Non-Patent Document 1 (see, for example, "Fig. 4" in Non-Patent Document 1).
  • HDP is calculated according to the relationship (1) using the number of dialysis sessions per week n and the time per session t (hr).
  • Sf-Kt/V is calculated according to the formula (2) using the number of dialysis sessions per week n, the time per session t (hr), clearance K (catalog data), and body weight W (kg).
  • any other estimation formula can be used for the volume of body fluids V (mL) other than 0.6 times the body weight.
  • the distribution volume of the relevant substance can also be used.
  • the clearance CL which indicates the performance of the dialyzer under dialysis conditions, can be calculated, for example, according to the following relational expression (3) using the blood flow rate Q B , the dialysate flow rate Q D , and the performance coefficient K 0 A calculated from catalog data.
  • Table 1 shows the HDP according to the number of dialysis sessions per week n and the dialysis time per session t (hr), as well as the judgment result of whether the patient's dialysis treatment is sufficient (an “*" indicates that the dialysis treatment is sufficient, and no “*” indicates that the dialysis treatment is insufficient).
  • a similar table is calculated for the body fluid volume V calculated from the patient's weight and the clearance CL for each treatment condition.
  • the patient's body fluid volume V is evaluated as 60% of the patient's weight, and may also be evaluated according to Watson's formulas (41) and (42) using the patient's age, height H (cm), and dry weight DW (kg).
  • WatsonV 2.447-0.09516 ⁇ Age+0.1074 ⁇ H+0.3362 ⁇ DW (41).
  • WatsonV -0.2097+0.1069 ⁇ H+0.2466 ⁇ DW (42).
  • the above equations (1) to (3) are based on the assumption that the duration of each dialysis session and the duration of dialysis per week are always the same, and therefore do not hold under non-uniform treatment conditions. These values are not the average value of the solute concentration (time average or integral average, etc.) but depend on the peak concentration, so even if average values are used, they do not hold under non-uniform treatment conditions.
  • the results of the patient's hemodialysis treatment during each of the first and second designated periods are evaluated (FIG. 2/STEP 18). Specifically, a process is performed to determine whether the patient's HDP is equal to or greater than a predetermined value (e.g., 72) or whether the patient's sf-Kt/V is equal to or greater than a predetermined value (e.g., 23).
  • a predetermined value e.g. 72
  • a predetermined value e.g., 23
  • the outcome evaluation results of the hemodialysis treatment for each of the first and second designated periods are output via the output interface 12 ( Figure 2/STEP 20).
  • both the first treatment information and the second treatment information are input to the kinetic model, but in other embodiments, only one of the first treatment information and the second treatment information may be input to the kinetic model.
  • ⁇ 1 e.g., variance and/or standard deviation
  • HDP ⁇ 1 n ⁇ t (11).
  • ⁇ 2 e.g., variance and/or standard deviation
  • ⁇ 1 and ⁇ 2 may be generated using a relationship previously determined by a kinetic model.
  • HDP and/or sf-Kt/V may be calculated from the converted peak concentration using a kinetic model, i.e., the peak concentration ⁇ 1 when dialysis is performed with equal dialysis time and equal dialysis intervals and the HDP or sf-Kt/V at that time are determined by the standard formula (13) or (14).
  • HDP f 3 ( ⁇ 1 ) (13).
  • the peak concentration under actual dialysis conditions of uneven dialysis times and dialysis intervals can be calculated using a kinetic model (for example, the method described in Non-Patent Document 2).
  • the peak concentration ⁇ 2 under actual uneven dialysis times and dialysis intervals calculated using the kinetic model is substituted into the standard formula expressed by formula (13) or (14) to obtain the converted value of HDP or sf-Kt/V.
  • a power function of ⁇ 1 may be used approximately as shown in the following equation (130).
  • HDP a ⁇ 1 n (130).
  • a power function of ⁇ 1 may be used approximately as shown in the following equation (140).

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  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Urology & Nephrology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Primary Health Care (AREA)
  • Biomedical Technology (AREA)
  • Epidemiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pathology (AREA)
  • Surgery (AREA)
  • Data Mining & Analysis (AREA)
  • Emergency Medicine (AREA)
  • Databases & Information Systems (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)
PCT/JP2024/019067 2023-05-25 2024-05-23 血液透析治療支援システム Ceased WO2024242176A1 (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP24811181.7A EP4678200A1 (en) 2023-05-25 2024-05-23 Hemodialysis treatment assistance system
JP2025522454A JPWO2024242176A1 (https=) 2023-05-25 2024-05-23

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JP2023086341 2023-05-25
JP2023-086341 2023-05-25

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6018567B2 (ja) 2010-04-16 2016-11-02 バクスター・インターナショナル・インコーポレイテッドＢａｘｔｅｒ Ｉｎｔｅｒｎａｔｉｏｎａｌ Ｉｎｃｏｒｐ０Ｒａｔｅｄ 腎不全血液治療、特に、家庭血液透析のための治療予測および最適化
JP2016535644A (ja) * 2013-08-16 2016-11-17 バクスター・インターナショナル・インコーポレイテッドＢａｘｔｅｒ Ｉｎｔｅｒｎａｔｉｏｎａｌ Ｉｎｃｏｒｐ０Ｒａｔｅｄ 腎不全血液療法、特に在宅血液透析のための血清カリウムの療法予測及び最適化

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6018567B2 (ja) 2010-04-16 2016-11-02 バクスター・インターナショナル・インコーポレイテッドＢａｘｔｅｒ Ｉｎｔｅｒｎａｔｉｏｎａｌ Ｉｎｃｏｒｐ０Ｒａｔｅｄ 腎不全血液治療、特に、家庭血液透析のための治療予測および最適化
JP2016535644A (ja) * 2013-08-16 2016-11-17 バクスター・インターナショナル・インコーポレイテッドＢａｘｔｅｒ Ｉｎｔｅｒｎａｔｉｏｎａｌ Ｉｎｃｏｒｐ０Ｒａｔｅｄ 腎不全血液療法、特に在宅血液透析のための血清カリウムの療法予測及び最適化

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
MURAKAMI ET AL.: "Squared frequency-Kt/V: a new index of hemodialysis adequacy-correlation with solute concentrations by computer simulation", RENAL REPLACEMENT THERAPY, vol. 5, 2019, pages 8, Retrieved from the Internet <URL:https://doi.org/10.1186/s41100-019-0198-7>
MURAKAMI KAYA, KOKUBO KENICHI, HIROSE MINORU, KOBAYASHI KOZUE, KOBAYASHI HIROSUKE: "Squared frequency-Kt/V: a new index of hemodialysis adequacy—correlation with solute concentrations by computer simulation", RENAL REPLACEMENT THERAPY, vol. 5, no. 1, 1 December 2019 (2019-12-01), XP093242612, ISSN: 2059-1381, DOI: 10.1186/s41100-019-0198-7 *
SCRIBNER BHOREOPOLUS DG: "The Hemodialysis product (HDP): A better index of dialysis adequacy than Kt/V.", DIAL TRANSPLANT, vol. 31, 2002, pages 13 - 15
See also references of EP4678200A1

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JPWO2024242176A1 (https=) 2024-11-28
EP4678200A1 (en) 2026-01-14

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