Apparatus and dialysis system for dialysis treatment

By using optical blood monitoring and pulse oximeter measurement, upper body blood flow is calculated to adjust dialysis parameters, solving the problem of inaccurate output estimation in existing technologies and improving the safety and effectiveness of the dialysis process.

CN116209485BActive Publication Date: 2026-06-23FRESENIUS MEDICAL CARE HOLDINGS INC

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
FRESENIUS MEDICAL CARE HOLDINGS INC
Filing Date
2021-07-21
Publication Date
2026-06-23

AI Technical Summary

Technical Problem

Existing methods for determining cardiac output during dialysis are typically invasive, time-consuming, and inaccurate, failing to effectively monitor and adjust the dialysis process to improve patient outcomes.

Method used

Hemoglobin concentration, venous and arterial oxygen saturation are measured using an optical blood monitor and pulse oximeter, upper body blood flow (UBBF) is calculated, and treatment recommendations are provided based on this to adjust dialysis process parameters such as dialysate temperature, ultrafiltration rate, and process duration.

Benefits of technology

It enables accurate estimation and real-time adjustment of cardiac output during dialysis, improving patients' health and reducing cardiovascular disease-related morbidity and mortality.

✦ Generated by Eureka AI based on patent content.

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Abstract

Techniques and apparatuses are described for determining an estimated cardiac output of a patient during a dialysis treatment. In one embodiment, for example, an apparatus can include a memory and logic coupled with the memory. The logic can be configured to determine an upper body oxygen consumption of the patient, determine, during the dialysis process, a hemoglobin concentration and a venous oxygen saturation, as measured via an optical blood monitor operably coupled to an extracorporeal circuit of a dialysis system performing the dialysis process, an arterial oxygen saturation as measured via a pulse oximeter operably coupled to the patient, an arterial-venous oxygen content difference based on the arterial oxygen saturation and the venous oxygen saturation, and an upper body blood flow (UBBF) as (the upper body oxygen consumption) / (the arterial-venous oxygen content difference), and determine a treatment recommendation based on the upper body blood flow. Other embodiments are also described.
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Description

[0001] Related applications

[0002] This application claims priority to U.S. Patent Application Serial No. 16 / 939,312, filed July 27, 2020, entitled "Technique for Noninvasive Determination of Estimated Cardiac Output During Dialysis Treatment". The contents of the above application are incorporated herein by reference in their entirety. Technical Field

[0003] The embodiments described herein generally relate to processes and apparatus configured to determine cardiac output estimates during dialysis, and more specifically to non-invasive techniques for determining cardiac output estimates for the upper body portion of a dialysis patient. Background Technology

[0004] Cardiac output is a measure of the efficiency with which the heart circulates blood through the circulatory system. Abnormal cardiac output is a typical indicator of cardiovascular disease. Compared to the general population, patients undergoing hemodialysis (HD) have an increased mortality rate, with cardiovascular disease (CVD) being a leading cause of death in this patient group. Furthermore, cardiac output (CO) may change during HD treatment, and a decrease in cardiac output is associated with poor patient outcomes.

[0005] Therefore, estimating cardiac output during hemorrhage (HD) treatment can provide an important indicator of patient mortality. However, traditional procedures for directly determining cardiac output can be invasive, time-consuming, and / or labor-intensive. For example, the standard indicator dye technique involves intravenous injection of an indicator dye and measuring a blood sample to determine the dye concentration in the blood. In another example, the thermodilution technique involves injecting a thermal indicator into the circulatory system (e.g., on the right side of the heart) and detecting temperature changes as the thermal indicator moves through the circulatory system (e.g., on the left side of the heart). Furthermore, attempts to estimate cardiac output, such as using correlated or proxies related to the patient's blood flow, have proven ineffective and inaccurate in some cases.

[0006] Therefore, accurately and effectively determining cardiac output during dialysis can promote safer and more aggressive dialysis treatment and improve patient health. It is with these factors in mind that the contents of this disclosure may be useful. Summary of the Invention

[0007] This overview is provided to present selected concepts in a simplified form, which will be further described in detail below. This overview is not intended to identify key or essential features of the claimed subject matter, nor is it intended to help determine the scope of the claimed subject matter.

[0008] According to various embodiments of this disclosure, an apparatus may include at least one memory and logic coupled to the at least one memory. The logic is operable to determine, during a dialysis procedure, a patient's upper body oxygen consumption, including: hemoglobin concentration and venous oxygen saturation, measurable via an optical blood monitor operatively coupled to the extracorporeal circuit of the dialysis system performing the dialysis procedure; arterial oxygen saturation, measurable via a pulse oximeter operatively coupled to the patient; arterial-venous oxygen content difference (UBBF) based on arterial and venous oxygen saturation; and upper body blood flow (UBBF or UBBF rate) as (upper body oxygen consumption) / (arterial-venous oxygen content difference); and to determine a treatment recommendation based on UBBF. In some embodiments, venous oxygen saturation may be or may include central venous oxygen saturation, for example, at the upper end of the vena cava or the right atrium (e.g., making oxygen saturation an indication of the patient's upper body oxygen saturation).

[0009] In some embodiments of the device, logic may operate to perform a dialysis procedure based on treatment recommendations. In various embodiments of the device, upper body oxygen consumption may include the sum of oxygen consumption of upper body tissues, which may include brain oxygen consumption, cardiac oxygen consumption, skeletal muscle oxygen consumption, or skin oxygen consumption, or any combination thereof. In some embodiments of the device, treatment recommendations may include variations in at least one of dialysate temperature, ultrafiltration rate, ultrafiltration target, or procedure duration. In various embodiments of the device, the arterial-venous oxygen content difference may be determined based on the difference between arterial and venous blood oxygen content. In exemplary embodiments of the device, the patient may have access to a central venous catheter (CVC). In some embodiments of the device, treatment recommendations may be configured to promote improvements in patient morbidity and / or mortality.

[0010] In some embodiments of the device, treatment recommendations may include adjustments to parameters of the dialysis process (e.g., adjustment parameters). In various embodiments of the device, adjustment parameters may include at least one of dialysate temperature, ultrafiltration rate, ultrafiltration target, or process duration. In exemplary embodiments of the device, logic may be operable to present adjustment information indicating the adjustment parameters to a user. In some embodiments of the device, logic may be operable to automatically adjust the dialysis process based on the adjustment parameters.

[0011] According to various embodiments of this disclosure, a method for performing dialysis on a patient via a dialysis system is provided. The method may include determining the patient's upper body oxygen consumption during the dialysis process; determining: hemoglobin concentration and venous oxygen saturation, measurable via an optical blood monitor connected to an external circuit of the dialysis system performing the dialysis process; arterial oxygen saturation, measurable via a pulse oximeter operatively connected to the patient; arterial-venous oxygen content difference (UBBF) based on arterial and venous oxygen saturation; and upper body blood flow (UBBF or UBBF rate) as (upper body oxygen consumption) / (arterial-venous oxygen content difference); and determining a treatment recommendation based on the UBBF.

[0012] In some embodiments of the method, the method may include performing a dialysis procedure based on a treatment recommendation. In various embodiments of the method, upper body oxygen consumption may include the sum of oxygen consumption of upper body tissues, which may include brain oxygen consumption, cardiac oxygen consumption, skeletal muscle oxygen consumption, or skin oxygen consumption, or any combination thereof. In some embodiments of the method, the treatment recommendation may include at least one change in ultrafiltration rate, ultrafiltration target, or procedure duration. In various embodiments of the method, the arterial-venous oxygen content difference may be determined based on the difference between arterial and venous blood oxygen content. In exemplary embodiments of the method, the treatment recommendation may be configured to promote improvements in patient morbidity and / or mortality.

[0013] In some embodiments of the method, treatment recommendations may include adjustments to one or more parameters of the dialysis process. In various embodiments of the method, the adjustment parameters may include at least one of ultrafiltration rate, ultrafiltration target, or process duration. In exemplary embodiments of the method, the method may include presenting adjustment information to a user indicating the adjustment parameters. In some embodiments of the method, the method may include automatically adjusting the dialysis process based on the adjustment parameters.

[0014] According to various embodiments of this disclosure, a dialysis system is configured to perform a dialysis procedure on a patient. The dialysis system may include an extracorporeal circuit operatively coupled to the patient, an optical blood monitor operatively coupled to the extracorporeal circuit, a pulse oximeter operatively coupled to the patient, at least one processor, and a memory coupled to the at least one processor. The memory may include instructions, when executed by the at least one processor, to cause the at least one processor to determine, during the dialysis procedure, the following: hemoglobin concentration and venous oxygen saturation, measurable via the optical blood monitor operatively coupled to the extracorporeal circuit of the dialysis system performing the dialysis procedure; arterial oxygen saturation, measurable via the pulse oximeter operatively coupled to the patient; arterial-venous oxygen content difference based on arterial and venous oxygen saturation; and upper body blood flow (UBBF or UBBF rate) as (upper body oxygen consumption) / (arterial-venous oxygen content difference); and to determine a treatment recommendation based on UBBF.

[0015] In some embodiments of the dialysis system, when executed by at least one processor, instructions may cause the processor to perform a dialysis procedure based on a treatment recommendation. In various embodiments of the dialysis system, upper body oxygen consumption may include the sum of oxygen consumption of upper body tissues, which may include brain oxygen consumption, cardiac oxygen consumption, skeletal muscle oxygen consumption, or skin oxygen consumption, or any combination thereof. In some embodiments of the dialysis system, the treatment recommendation may include at least one change to the ultrafiltration rate, ultrafiltration target, or procedure duration. In various embodiments of the dialysis system, the arterial-venous oxygen content difference may be determined based on the difference between arterial blood oxygen content and venous blood oxygen content. In exemplary embodiments of the dialysis system, the patient may have a central venous catheter (CVC) access. In some embodiments of the dialysis system, the treatment recommendation may be configured to promote improvements in patient morbidity and / or mortality. Attached Figure Description

[0016] Figure 1 An embodiment of the first operating environment is described.

[0017] Figure 2 A table of physiological values ​​for upper body tissues according to some embodiments is provided.

[0018] Figure 3 An oxygen consumption information table for upper body tissues is provided according to some embodiments.

[0019] Figure 4 An example of a logical flow is described.

[0020] Figure 5 An exemplary hemodialysis system is described.

[0021] Figure 6This illustrates one embodiment of a computing architecture. Detailed Implementation

[0022] Various embodiments are generally directed to systems, methods, and / or apparatuses for determining cardiac output (CO) in patients undergoing dialysis. In some embodiments, the cardiac output analysis process may produce an estimated CO (eCO). In various embodiments, eCO may be a value of upper body blood flow (UBBF or UBBF rate). For example, in hemodialysis (HD) for patients with a central venous catheter (CVC), it may be based on the oxygen consumption of upper body organs (i.e., the sum of oxygen consumption of upper body tissues) and the central venous oxygen saturation (S) detected during dialysis. cv O2) and peripheral arterial oxygen saturation (S a The UBBF value is determined by measuring oxygen saturation (O2). Although the examples in this disclosure may describe a procedure for patients with CVC, such as determining oxygen saturation levels (e.g., S...),... cv O2, S v O2, etc.), but the embodiments are not so limited, because the embodiments can be operated using non-invasive procedures that do not require the patient to have a CVC. For example, in one example, S cv O2 can be measured by near-infrared spectroscopy in the internal jugular vein using S. v O2 is used as an approximation. For example, the method described by Ruan et al. in “Monitoring tissue oxygen saturation in the internal jugular vein region using near-infrared spectroscopy”, Genet Mol Res 31;14(1):2920-8 (March 2015) is the same or similar, and is incorporated herein by reference as if fully described herein. Other non-invasive methods may also be used. In different embodiments, the UBBF value may be determined continuously, periodically (e.g., at time intervals), or based on events (e.g., based on the patient’s life or other physiological parameters) during dialysis. In some embodiments, S cv O2 can be used to determine venous oxygen content (C). v ), S a O2 can be used to determine arterial oxygen saturation (C). a In an exemplary embodiment, UBBF can be determined as (the sum of oxygen consumption of upper body tissues) / (arterial-venous oxygen content difference). In some embodiments, the term "upper body" can refer to all tissues and organs into which venous blood drains into the superior vena cava.

[0023] In one embodiment, for example, in a HD patient with a CVC (or in a patient without a CVC via a noninvasive method), S can be measured by an optical blood monitor operatively coupled to the extracorporeal circuit of the HD dialysis system during HD treatment. cv O2 and blood cell concentration.cv O2 can be used to calculate C. v Hematocrit can be used to determine hemoglobin (Hgb) concentration. Meanwhile, S... a O2 can be measured by a pulse oximeter, which can be used to calculate C. a Therefore, S can be measured during HD. cv O2, S a The changes in O2 and Hgb can be used to calculate UBBF during HD, for example, continuously and / or periodically.

[0024] In some embodiments, hemoglobin concentration can be determined from a measured hematocrit value. For example, hemoglobin concentration (e.g., in g / dL) can be equal to hematocrit (%filled cell volume (PCV)) × about 0.3 (e.g., 0.34). In another example, hemoglobin concentration (e.g., in g / dL) can be equal to hematocrit (decimal fraction) × about 30 (e.g., 34). Other methods for determining hemoglobin concentration from hematocrit can also be used. The embodiments are not limited in this respect.

[0025] In some embodiments, the optical blood monitor may be or may include a hematocrit measurement device, such as a Crit-Line® monitor (CLM), available from Fresenius Medical Care in Waltham, Massachusetts, USA. Generally, the CLM may be an online monitor (e.g., operatively coupled to an external circuit for performing HD) that operates to measure hematocrit, oxygen saturation, and / or changes in blood volume during dialysis treatment. While a CLM may be used in some examples, the embodiments are not limited thereto, as this document contemplates any technology, device, process, etc., capable of measuring and / or predicting hematocrit according to some embodiments. In some embodiments, a pulse oximeter may be operatively coupled to the optical blood monitor (e.g., the CLM) to enable the measurement of hematocrit during HD. cv O2, S a The changes in O2 and Hgb, and thus the measurement of UBBF, are individual blood characteristics measured by the device. Although a pulse oximeter can be used to determine oxygen saturation in some examples, the embodiments are not limited to this, as other devices, methods, etc. can be used to measure oxygen saturation (e.g., invasive measurements on patients with arterial intubation in a hospital / intensive care unit (ICU) setting).

[0026] As mentioned above, changes in CO during HD treatment have been demonstrated in various patient studies. Generally, a decrease in CO is associated with poor patient prognosis. CO can be determined by certain direct measurements (e.g., thermodilution and indicative dye techniques) and / or by applying Fick's principle according to the following equation (1):

[0027] CO = Oxygen consumption (VO2) / (Arterial oxygen content - Venous oxygen content).

[0028] Systemic VO2 can be estimated using various methods, such as the formula 3 ml O2 / kg, the Dehmer formula, the LaFarge formula, and / or the Bergstra formula. In some embodiments, arterial (C) a ) and veins (C v Oxygen content can be based on S a O2 and S cv O2 is calculated and measured according to some embodiments. For example, arterial blood oxygen content can be determined based on the following equation (2):

[0029] C a O2 = (1.34 × Hgb × S) a O2) + (P a O2 × 0.0031),

[0030] Where P a O2 can be measured using arterial blood gas analysis or estimated as 100 Torr (or other similar estimates). In another example, venous oxygen content can be determined based on the following equation (3):

[0031] C v O2= (1.34 × Hgb × ScvO2) + (P v O2 × 0.0031),

[0032] Where P v O2 can be measured using venous blood gas analysis, or estimated at 35 Torr.

[0033] Upper body oxygen consumption (or upper body oxygen consumption rate) can be calculated by multiplying the weight of each tissue by the tissue-specific oxygen consumption per unit tissue mass, for example, according to the following equation (4):

[0034] Tissue mass (g) × (O2 consumption / 100 g mass / min) / 100

[0035] For example, the brain's oxygen consumption can be calculated as 1400 [g brain mass] * 3.5 [mL oxygen consumption / 100g brain mass / min] / 100. Similarly, the resting oxygen consumption of arm muscles can be calculated as 2000 [g arm muscle mass] * 0.2 [mL oxygen consumption / 100g muscle mass / min] / 100.

[0036] The sum of the oxygen consumption (or oxygen consumption rate) of the tissues in the upper body is the total oxygen consumption of the upper body. This value is considered stable at rest. Blood oxygen content, expressed in mL of oxygen per dL of blood, can be calculated using the following equation (5):

[0037] Hemoglobin (Hgb) concentration [g / dL] * Oxygen saturation [%] * 1.34 / 100

[0038] The constant 1.34 reflects that each gram of hemoglobin can carry a maximum of 1.34 milliliters of oxygen.

[0039] In some embodiments, one or more physiological measurement devices, such as a CLM, can measure oxygen saturation and hematocrit (for conversion to Hgb concentration), which can be used to determine blood oxygen content. In HD patients using a CLM (or other measurement device) with CVC as the vascular access, the CO estimation process according to some embodiments can estimate the proportion of CO perfused in the upper body, most notably the brain, arm muscles, and skin, by applying a modification of the Fick equation, where CO is replaced by upper body blood flow (UBBF). In some embodiments, UBBF can be determined according to the following equation (6):

[0040] UBBF = Sum of oxygen consumption of upper body tissues / Difference in oxygen content between arteries and veins.

[0041] The UBBF determined according to some embodiments can serve as a highly efficient, effective, and accurate estimate of CO in patients undergoing HD. Treatment modifications made to prevent a decrease in CO can be applied to high-risk patients identified by the process according to some embodiments. The CO estimation process according to some embodiments can be used to provide patients with improvements in cardiovascular-related morbidity and mortality.

[0042] Therefore, the CO analysis process according to some embodiments can provide more technical advantages and features than conventional systems, including improvements to computational techniques. One non-limiting example of a technical advantage may include determining an accurate CO estimate in the form of a UBBF (Underlying Biological Factor) continuously and / or periodically during dialysis treatment. Thus, the CO of HD patients can be monitored during HD treatment, providing real-time or near-real-time information on the patient's cardiac function during dialysis. Another non-limiting example of a technical advantage may include the ability of healthcare personnel and / or dialysis equipment to continuously receive treatment recommendations based on an accurate CO estimate in the form of a UBBF during dialysis treatment. In this way, the patient's HD treatment can be adjusted in real-time or near-real-time in response to changes in the patient's CO. Therefore, some embodiments can practically determine the estimated CO in the form of a UBBF for determining treatment recommendations for future HD treatment and / or modifying the ongoing HD treatment process (e.g., by changing the filtration rate, filtration time, drug dosage, etc.). Conventional HD computational techniques have at least one potential drawback: they cannot manage patients based on real-time, continuous, or periodically measured CO information. Therefore, some embodiments can improve computational techniques by facilitating real-time changes in HD treatment based on CO information in the form of a UBBF. Furthermore, some embodiments can provide practical applications of CO determination, including CO estimation, UBBF, etc. Non-limiting practical applications may include using CO determination according to some embodiments to implement dialysis and improve morbidity and / or mortality in dialysis patients. Other technical advantages, improvements, and / or practical applications are provided by the embodiments described in this disclosure. In this context, the embodiments are not limited.

[0043] In this specification, numerous specific details, such as components and system configurations, may be listed to provide a more thorough understanding of the described embodiments. However, those skilled in the art will understand that the described embodiments can be implemented without these specific details. Furthermore, some well-known structures, elements, and other features are not shown in detail to avoid unnecessarily obscuring the described embodiments.

[0044] In this detailed description, references to "an embodiment," "an embodiment," "an exemplary embodiment," "various embodiments," etc., indicate that embodiments of the technology thus described may include specific features, structures, or characteristics. However, more than one embodiment may include such features, and not every embodiment necessarily includes specific features, structures, or characteristics. Furthermore, some embodiments may have some, all, or none of the features described with respect to other embodiments.

[0045] As used in this description and claims, unless otherwise specified, the use of ordinal adjectives such as “first,” “second,” “third,” etc., to describe an element indicates only a particular instance of an element or a different instance of a similar element mentioned, and is not intended to imply that the elements so described must be in a particular order, whether temporally, spatially, sequentially, or in any other way.

[0046] Figure 1 Examples of operating environments 100, which may represent some embodiments, are illustrated. Operating environment 100 may include an analysis system 105 operable to perform a CO estimation process according to some embodiments. Figure 1 As shown, the analysis system 105 may include one or more physiological measurement devices 150a-n and / or dialysis devices 160 (e.g., see...). Figure 5 The computing device 110 is either communicatively linked to or otherwise configured to receive and store data therefrom. Physiological measurement devices 150a-n and / or dialysis system 160 may be operable to provide data and / or other signals to locations on network 180 (e.g., a cloud computing environment), such as nodes 182a-n, healthcare information database 184, etc., accessible to the computing device 110. In some embodiments, the computing device 110 may be operable to control, monitor, manage, or otherwise process various operational aspects of the physiological measurement devices 150a-n and / or dialysis system 160. In some embodiments, the computing device 110 may be or may include a standalone computing device, such as a personal computer (PC), server, tablet computing device, cloud computing device, smartphone, tablet computing device, etc. In some embodiments, the computing device 110 may be an embedded computing device of one or more of the physiological measurement devices 150a-n and / or medical devices 160a-n.

[0047] like Figure 1 As shown, the computing device 110 may include processing circuitry 120, memory unit 130, transceiver 170, and / or display 172. The processing circuitry 120 may be communicatively connected to the memory unit 130, transceiver 170, and / or display 172.

[0048] Processing circuitry 120 may include and / or have access to various logics for performing processes according to some embodiments. For example, processing circuitry 120 may include and / or have access to UBBF determination logic 122 and / or dialysis processing logic 124. Processing circuitry 120, UBBF determination logic 122 and / or dialysis processing logic 124, or portions thereof, may be implemented in hardware, software, or a combination thereof. As used herein, the terms “logic,” “component,” “layer,” “system,” “circuit,” “decoder,” “encoder,” and / or “module” refer to computer-related entities that may be hardware, a combination of hardware and software, software, or software in execution, examples of which are provided by exemplary computing architecture 1400. For example, logic, circuitry, or layers can be and / or may include, but are not limited to, processes running on a processor, processors, hard disk drives, multiple storage drives (of optical and / or magnetic storage media), objects, executable files, execution threads, programs, computers, hardware circuits, integrated circuits, application-specific integrated circuits (ASICs), programmable logic devices (PLDs), digital signal processors (DSPs), field-programmable gate arrays (FPGAs), system-on-a-chip (SoCs), memory cells, logic gates, registers, semiconductor devices, chips, microchips, chipsets, software components, programs, application programs, firmware, software modules, computer code, and any combination thereof.

[0049] although Figure 1 The description shows that UBBF determination logic 122 and dialysis processing logic 124 are located within processing circuitry 120, but the embodiments are not so limited. For example, UBBF determination logic 122 and / or dialysis processing logic 124 may be located within an accelerator, processor core, interface, or single processor chip, implemented entirely as software applications (e.g., UBBF determination application 140 and / or dialysis application 142). Furthermore, the analysis system 105 may include multiple computing devices 110, although... Figure 1 The figure describes a single computing device 110 for the purpose of simplification. For example, a computing device 110 may be configured to perform a CO estimation process (and include UBBF determination logic 122 and / or UBBF determination application 140) according to some embodiments, while a second computing device 110 may be configured to perform a dialysis process (e.g., as a dialysis controller device (e.g., see...)). Figure 5 (and includes dialysis processing logic 124 and / or dialysis application 142).

[0050] In some embodiments, the physiological measurement device 150a-n may include various devices operable to measure a patient's physiological characteristics. Non-limiting examples of the physiological device 150a-n may include oxygen concentration measuring devices, hematocrit measuring devices (e.g., CLM), hemoglobin measuring devices, optical blood measurement devices, pulse oximeters, etc. Although a hematocrit measuring device (e.g., CLM) may be used as an illustrative physiological measurement device 150a-n, the embodiments are not limited thereto, as the physiological measurement device 150a-n may include any type of device capable of measuring a patient's physiological information.

[0051] In some embodiments, physiological measurement devices 150a-n can be operatively coupled online to an extracorporeal circuit connected to patient 102 for use by dialysis system 160 to perform dialysis procedures (e.g., HD procedures). In some embodiments, the physiological measurement devices may include the ability to measure S continuously, semi-continuously, periodically, or event-based during HD treatment. cv O2, S a A single measuring device for O2 and / or Hgb (measurement of hematocrit).

[0052] Memory cell 130 may include various types of computer-readable storage media and / or systems in the form of one or more higher-speed memory cells, such as read-only memory (ROM), random access memory (RAM), dynamic RAM (DRAM), dual data rate DRAM (DDRAM), synchronous DRAM (SDRAM), static RAM (SRAM), programmable ROM (PROM), erasable programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM), flash memory, polymer memory such as ferroelectric polymer memory, ovonic memory, phase-change or ferroelectric memory, silicon-oxygen-nitride-oxygen (SONOS) memory, magnetic cards or optical cards, arrays of devices such as redundant array of independent disk drives (RAID), solid-state storage devices (e.g., USB storage, solid-state drives (SSDs), and any other type of storage media suitable for storing information. Additionally, memory cell 130 may include various types of computer-readable storage media in the form of one or more lower-speed memory cells, including internal (or external) hard disk drives (HDDs), floppy disk drives (FDDs), and optical disk drives for reading from or writing to removable optical discs (e.g., CD-ROMs or DVDs), solid-state drives (SSDs), etc.

[0053] The memory unit 130 may store patient information 132, patient group information 134, UBBF information 136, dialysis treatment information 138, UBBF determination application 140, and / or dialysis application 142. In some embodiments, patient information 132 may generally include information related to one or more patients, such as patient 102, receiving dialysis treatment via dialysis system 160. Patient information 132 may include medical records and / or the patient's physical information, such as height, weight, gender, dialysis treatment prescription information, etc.

[0054] Patient population information 134 may include physiological information of various groups of patients undergoing dialysis treatment. Non-limiting examples of population information 134 may include S cv O2, S a O2, Hgb, tissue characteristics (e.g., mass, blood flow, oxygen consumption, arterial-venous (AV) difference; see, for example) Figure 2 UBBF estimation, CO information, its historical information, and dynamic information during one or more dialysis treatments, etc. Figure 2 A table of physiological values ​​for body organs and tissues according to some embodiments is provided. In some embodiments, population information 134 can be used to determine certain values ​​of UBBF information 136, such as the UBBF value of patient 102 undergoing HD, as described in more detail below. Figure 2 As shown, values ​​for quality, blood flow, maximum blood flow, oxygen consumption, AV difference, and resistance can be determined based on the patient population.

[0055] In some embodiments, the UBBF determination application 140, for example via UBBF determination logic 122, may use patient information 132 and / or patient group information 134 to determine UBBF information 136. In various embodiments, UBBF information 136 may be the UBBF value of patient 102 undergoing HD. In some embodiments, UBBF information 136 may be or may include the patient's historical UBBF information, such as information on dynamic changes in UBBF during treatment, UBBF trajectories, or other historical measurements during treatment.

[0056] In some embodiments, the UBBF determination application 140 may determine the UBBF based on equation (6), specifically:

[0057] UBBF = Sum of oxygen consumption of upper body tissues / AV difference of oxygen content.

[0058] The sum of oxygen consumption of upper body tissues (upper body oxygen consumption) can be based on one or more upper body tissues, such as the brain, heart, skeletal muscle, skin, etc. (see, for example, see upper body oxygen consumption). Figure 2 The oxygen content difference (AV oxygen content difference) can be determined based on C. According to some embodiments, the AV difference of oxygen content can be determined based on C.a -C v Determined, where C a Based on S a O2 is determined, and C v Based on S cv O2 is confirmed.

[0059] Figure 3 This document describes a table of oxygen consumption information for upper body tissues based on some embodiments. One aspect compares the oxygen consumption data obtained in HD patients. cv O2 and S a The population average of O2 and upper body oxygen consumption calculated from literature data on CO (e.g., as patient population information 134), on the other hand, comparisons of organ-specific oxygen uptake rates showed very consistent results (e.g. Figure 3 As shown in Table 305 (65 and 64 mL / min), the effectiveness and accuracy of the CO estimation process according to some embodiments are demonstrated.

[0060] In some embodiments, the UBBF determination application 140, for example via UBBF determination logic 122, can generate dialysis treatment information 138, for example, in the form of a diagnosis, treatment recommendation, treatment adjustment, etc. For example, treatment recommendations, adjustments, or modifications may be determined by the UBBF determination application 140 based on UBBF information 136 (e.g., UBBF values ​​used as estimates / substitutes for CO) and / or historical UBBF information 136, for example, indicating trends or other dynamic changes during one or more dialysis treatment recommendations. Non-limiting examples of treatment recommendations may include discontinuing dialysis treatment, changing dialysis treatment (adjustment) parameters (e.g., ultrafiltration rate (UFR), ultrafiltration target (UFG)), changing drug dosages (e.g., diuretics, calcium channel blockers, etc.), etc. In some embodiments, treatment recommendations or adjustments may be communicated to patient 102 and / or patient 102's healthcare provider, for example, by presentation on display 172 and / or via communication messages (e.g., email, SMS messages, etc.). In various embodiments, treatment recommendations or adjustments may be implemented automatically, for example, via a dialysis application. In other embodiments, treatment recommendations or adjustments may be displayed so that healthcare professionals can make final decisions and / or implement them.

[0061] In some embodiments, dialysis application 142, for example via dialysis treatment logic 124, may operate to manage or otherwise control at least a portion of the dialysis process of dialysis system 160. For example, dialysis application 142 may include software for controlling the HD process of patient 102, for example, based on a prescription with specific (adjustment) parameters, such as UFR, UFG, drug dosage, etc. In various embodiments, dialysis application 142, for example via dialysis treatment logic 124, may modify dialysis treatment based on treatment recommendations generated according to UBBF information. For example, dialysis application 142 may discontinue dialysis, change UFR, change UFG, change drug dosage, etc., based on patient CO determined based on UBBF.

[0062] In some embodiments, UBBF determination application 140 and / or dialysis application 142 may include application programming interfaces (APIs) and / or graphical user interfaces (GUIs) to read, write, and / or otherwise access UBBF information 136 and / or dialysis treatment information 138, such as via displays 172 and / or physiological measurement devices 150a-n, dialysis systems, nodes 182a-n, healthcare information 184, network interfaces, mobile applications (“mobile app” or “app”), and other corresponding displays. In this way, in some embodiments, an operator can search, visualize, read, add, or otherwise access patient records, UBBF information 136, and / or dialysis treatment information 138.

[0063] This document includes one or more logical flows representing exemplary methods for performing novel aspects of the disclosed architecture. Although, for simplicity, the one or more methodologies shown herein are presented and described as a series of actions, those skilled in the art will understand and appreciate that this methodology is not limited by the order of actions. Accordingly, some actions may occur in a different order and / or concurrently with other actions shown and described herein. For example, those skilled in the art will understand and appreciate that a method may alternatively be represented as a series of interrelated states or events, such as those represented in a state diagram. Furthermore, not all actions described in the methodology are necessary for a new implementation. Blocks designated by dashed lines may be optional blocks of the logical flow.

[0064] The logical flow can be implemented in software, firmware, hardware, or any combination thereof. In software and firmware embodiments, the logical flow can be implemented by computer-executable instructions stored on a non-transitory computer-readable medium or a machine-readable medium. In this context, this embodiment is not limited.

[0065] Figure 4An embodiment of logic flow 400 is illustrated. Logic flow 400 may represent some or all of the operations performed by computing device 110, as described herein, in one or more embodiments. In some embodiments, logic flow 400 may represent some or all of the operations of a CO estimation process according to some embodiments.

[0066] In block 402, logic flow 400 can determine hemoglobin concentration. For example, physiological measurement devices 150a-n may include a CLM configured to measure a patient's hematocrit, which can be used to determine Hgb concentration. Logic flow 400 can determine oxygen saturation information in block 404. For example, one or more physiological measurement devices 150a-n can measure the S... a O2 and S cv O2. UBBF determines that application 140 can be based on S respectively. a O2 and S cv O2 determines C a and C v (For example, see equations (2) and (3) and / or) Figure 3 In block 406, logic flow 400 can determine upper body oxygen consumption. For example, UBBF determination application 140 can determine upper body oxygen consumption as the sum of tissue oxygen consumption of the upper body portion of patient 102 (e.g., see...). Figure 2 and / or Figure 3 ). Logic flow 400 can determine upper body blood flow information at block 408. For example, UBBF determination application 140 can determine the UBBF value of patient 102 at one or more measurement intervals during the HD procedure. The UBBF value can be determined according to equation (6).

[0067] At block 410, logic flow 400 may generate treatment recommendations based on UBBF. For example, UBBF determination application 140 may generate treatment recommendations based on the UBBF value determined in block 408 for the patient's current and / or future HD treatment. Generally, treatment recommendations may be generated to maintain or achieve the patient 102's healthy CO (as much as possible). For example, treatment recommendations may include modifications to UFR and / or UFG during active HD treatment. In some embodiments, treatment recommendations may be communicated to the patient and / or the healthcare professional administering HD treatment. In various embodiments, treatment recommendations may be communicated to dialysis system 160 to modify the current treatment. At block 412, logic flow 400 may execute treatment based on the treatment recommendations. For example, dialysis application 142 may determine or receive treatment recommendations and may control dialysis system 160 to implement the treatment recommendations. For example, dialysis application 142 may cause a change in the patient 102's UFR via the dialysis system. In some embodiments, the execution of the dialysis treatment process at block 412 may include continuing and / or modifying active dialysis treatment modified according to the treatment recommendations.

[0068] Although the logic flow 400 block is in Figure 4 The events are depicted as occurring in a certain order, but the embodiments are not limited to this. For example, blocks 402, 404, and / or 406 may occur simultaneously or semi-simultaneously, with information provided in block 408 for determining UBBF information.

[0069] Figure 5 Figures illustrating an exemplary embodiment of a dialysis system 500 according to this disclosure are provided. The dialysis system 500 can be configured to provide hemodialysis (HD) treatment to a patient 501. A reservoir 502 can deliver fresh dialysate to a dialyzer 504 via tubing 503, while a reservoir 506 can receive waste dialysate via tubing 505 after the dialysate has passed through the dialyzer 504. Hemodialysis operations can be performed by filtering particulate matter and / or contaminants from the patient's blood through an external filtration device, such as the dialyzer 504. As dialysate passes through the dialyzer 504, unfiltered patient blood also enters the dialyzer 504 via tubing 507, and filtered blood is returned to the patient 501 via tubing 509. Arterial pressure can be monitored via pressure sensor 510, inflow pressure via sensor 518, and venous pressure via pressure sensor 514. An air trap and detector 516 ensure that air is not introduced when the patient's blood is filtered and returned to the patient 501. The flow rates of blood 507 and dialysate can be controlled by their respective pumps, including blood pump 512 and dialysate pump 520. Heparin 522, a blood thinner, can be used in conjunction with saline 524 to ensure that blood clots do not form or obstruct blood flow through the system.

[0070] In some embodiments, the dialysis system 500 may include a controller 550, which may resemble the computing device 110 and / or components thereof (e.g., processor circuitry 50). The controller 550 may be configured to monitor fluid pressure readings to identify fluctuations in patient parameters, such as heart rate and / or respiratory rate. In some embodiments, the patient's heart rate and / or respiratory rate may be determined by fluid streamlines and fluid pressure in the fluid bag. In various embodiments, the controller may receive and / or calculate hemoglobin concentration, AR measurements, flow rate, etc. The controller 550 may also be operatively connected to and / or communicate with additional sensors or sensor systems, devices, etc., although the controller 550 may use any available data regarding the patient's biological function or other patient parameters. For example, the controller 550 may send patient data to the computing device 110, the healthcare exchange platform 205, and / or the integrated care system 305 and / or 405 to determine AR values ​​according to some embodiments. Machine 500 and / or its components, such as controller 550, may be operatively coupled to hematocrit measuring devices, CLM, hemoglobin concentration measuring devices, etc., to facilitate processes executed by computing device 110.

[0071] Figure 6 Embodiments of an exemplary computing architecture 600 suitable for implementing the various embodiments described above have been illustrated. In various embodiments, the computing architecture 600 may include or be implemented as part of an electronic device. In some embodiments, the computing architecture 600 may be, for example, a representative of computing device 110. In this context, this embodiment is not limited.

[0072] As used herein, the terms “system,” “component,” and “module” refer to computer-related entities that can be hardware, a combination of hardware and software, software, or software in execution, examples of which are provided by the exemplary computing architecture 600. For example, a component can be, but is not limited to, a process running on a processor, a processor, a hard disk drive, multiple storage drives (of optical and / or magnetic storage media), an object, an executable file, an execution thread, a program, and / or a computer. For example, an application running on a server and the server itself can both be a component. One or more components can reside in a process and / or an execution thread, and a component can be located on one computer and / or distributed across two or more computers. Furthermore, components can communicate with each other via various types of communication media to coordinate operations. This coordination may involve one-way or two-way exchange of information. For example, components can communicate information in the form of signals communicated via a communication medium. This information can be implemented as signals assigned to various signal lines. In such an assignment, each piece of information is a signal. However, further embodiments may alternatively employ data information. This data information can be sent via various connections. Exemplary connections include parallel interfaces, serial interfaces, and bus interfaces.

[0073] The computing architecture 600 includes various common computing elements, such as one or more processors, multi-core processors, coprocessors, memory units, chipsets, controllers, peripherals, interfaces, oscillators, timing devices, video cards, audio cards, multimedia input / output (I / O) components, power supplies, and so on. However, this embodiment is not limited to implementations of the computing architecture 600.

[0074] like Figure 6As shown, the computing architecture 600 includes a processing unit 604, a system memory 606, and a system bus 606. The processing unit 604 can be any of a variety of commercial processors, including but not limited to AMD® Athlon®, Duron®, and Opteron® processors; ARM® application, embedded, and security processors; IBM® and Motorola® DragonBall® and PowerPC® processors; IBM and Sony® Cell processors; Intel® Celeron®, Core (2) Duo®, Itanium®, Pentium®, Xeon®, and XScale® processors; and similar processors. Dual-microprocessor, multi-core processor, and other multi-processor architectures can also be used as the processing unit 604.

[0075] System bus 606 provides interfaces for system components, including but not limited to system memory 606 to processing unit 604. System bus 606 can be any of several types of bus architectures, which can further interconnect with memory buses (with or without memory controllers), peripheral buses, and local buses using any of a variety of commercially available bus architectures. Interface adapters can be connected to system bus 606 via slot structures. Example slot architectures can include, but are not limited to, Accelerated Graphics Port (AGP), Card Bus, (Extended) Industry Standard Architecture ((E)ISA), Micro Channel Architecture (MCA), NuBus, Peripheral Component Interconnect (Extended) (PCI(X)), PCI Express, PCMCIA, etc.

[0076] System memory 606 may include various types of computer-readable storage media in the form of one or more higher-speed memory cells, such as read-only memory (ROM), random access memory (RAM), dynamic RAM (DRAM), dual data rate DRAM (DDRAM), synchronous DRAM (SDRAM), static RAM (SRAM), programmable ROM (PROM), erasable programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM), flash memory, polymer memories such as ferroelectric polymer memories, ovonic memories, phase-change or ferroelectric memories, silicon-oxygen-nitrogen-oxygen-silicon (SONOS) memories, magnetic cards or optical cards, arrays of devices such as redundant arrays of independent disk drives (RAID), solid-state storage devices (e.g., USB storage, solid-state drives (SSDs), and any other type of storage media suitable for storing information. Figure 6In the illustrated embodiment, system memory 606 may include non-volatile memory 610 and / or volatile memory 612. The basic input / output system (BIOS) may be stored in non-volatile memory 610.

[0077] Computer 602 may include various types of computer-readable storage media in the form of one or more low-speed memory units, including internal (or external) hard disk drive (HDD) 614, magnetic floppy disk drive (FDD) 616 for reading from or writing to removable disk 616, and optical disc drive 620 for reading from or writing to removable optical disc 622 (e.g., CD-ROM or DVD). HDD 614, FDD 616, and optical disc drive 620 may be connected to system bus 606 via HDD interface 624, FDD interface 626, and optical disc drive interface 626, respectively. HDD interface 624 for external drive implementation may include at least one or both of Universal Serial Bus (USB) and IEEE 6144 interface technologies.

[0078] Drives and associated computer-readable media provide volatile and / or non-volatile storage for data, data structures, computer-executable instructions, etc. For example, some program modules may be stored in drive and memory units 610, 612, including operating system 630, one or more application programs 632, other program modules 634, and program data 636. In one embodiment, one or more application programs 632, other program modules 634, and program data 636 may include, for example, various applications and / or components of computing device 110.

[0079] Users can input commands and information into computer 602 through one or more wired / wireless input devices, such as keyboard 636 and directional devices such as mouse 640. Other input devices may include microphones, infrared (IR) remote controls, radio frequency (RF) remote controls, gamepads, styluses, card readers, dongles, fingerprint readers, gloves, graphics tablets, joysticks, keyboards, retinal readers, touchscreens (e.g., capacitive, resistive, etc.), trackballs, trackpads, sensors, styluses, etc. These and other input devices are typically connected to processing unit 604 via input device interface 642, which is coupled to system bus 606, but can be connected via other interfaces such as parallel ports, IEEE 694 serial ports, game ports, USB ports, infrared interfaces, etc.

[0080] Monitor 644 or other types of display devices are also connected to system bus 606 via an interface, such as video adapter 646. Monitor 644 can be internal or external to computer 802. In addition to monitor 644, computers typically include other peripheral output devices, such as speakers, printers, etc.

[0081] Computer 602 can operate in a networked environment using logical connections via wired and / or wireless communications with one or more remote computers, such as remote computer 648. Remote computer 648 can be a workstation, server computer, router, personal computer, laptop computer, microprocessor-based entertainment device, peer-to-peer device, or other common network node, and typically includes many or all of the elements described relative to computer 602, although for simplicity only memory / storage device 650 is shown. The described logical connections include wired / wireless connections to a local area network (LAN) 652 and / or a larger network, such as a wide area network (WAN) 654. Such LAN and WAN network environments are common in offices and companies and facilitate enterprise-wide computer networks, such as intranets, all of which can connect to global communication networks, such as the Internet.

[0082] When used in a LAN network environment, computer 602 is connected to LAN 652 via a wired and / or wireless communication network interface or adapter 656. Adapter 656 facilitates wired and / or wireless communication with LAN 652, which may also include a wireless access point configured thereon for communicating with the wireless functionality of adapter 656.

[0083] When used in a WAN network environment, computer 602 may include modem 658, or a communication server connected to WAN 654, or have other means for establishing communication via WAN 654, such as via the Internet. Modem 658 may be internal or external, and may be a wired and / or wireless device connected to system bus 606 via input device interface 642. In a network environment, program modules, or portions thereof, described for computer 602 may be stored in remote memory / storage device 650. It is understood that the network connections shown are exemplary, and other means of establishing communication connections between computers may be used.

[0084] Computer 602 is operable to communicate with wired and wireless devices or entities using the IEEE 802 series of standards, such as wireless devices operable in wireless communication (e.g., IEEE 802.16 air modulation technology). This includes at least Wi-Fi (or Wireless Fidelity), WiMax, and Bluetooth™ wireless technologies, etc. Therefore, communication can be a predefined structure like a traditional network, or it can be a simple, temporary communication between at least two devices. Wi-Fi networks use radio technology known as IEEE 802.11x (a, b, g, n, etc.) to provide secure, reliable, and fast wireless connectivity. Wi-Fi networks can be used to interconnect computers, connect to the Internet, and connect to wired networks (which use the media and functions associated with IEEE 802.3).

[0085] This document has set forth numerous specific details to provide a thorough understanding of the embodiments. However, those skilled in the art will understand that these embodiments can be practiced without these specific details. In other instances, well-known operations, components, and circuits have not been described in detail to avoid obscuring the embodiments. It is understood that the specific structural and functional details disclosed herein may be representative and do not necessarily limit the scope of the embodiments.

[0086] Some embodiments may be described using the terms "connection" and "linkage," as well as their derivatives. These terms are not intended to be synonyms. For example, some embodiments may use the terms "connection" and / or "linkage" to indicate that two or more elements are in direct physical or electrical contact with each other. However, the term "linkage" may also indicate that two or more elements are not in direct contact with each other, but still cooperate or interact with each other.

[0087] Unless otherwise specified, it is understood that terms such as “processing,” “computing,” and “determining” refer to the actions and / or processes of a computer or computing system or similar electronic computing device that operate and / or convert data represented as physical quantities (e.g., electrons) in the registers and / or memory of the computing system into other data represented as physical quantities in the memory, registers, or other such information storage, transmission, or display devices of the computing system. This embodiment is not limited in this respect.

[0088] It should be noted that the methods described herein do not necessarily have to be performed in the order described or in any particular order. Furthermore, the various activities described with respect to the methods defined herein can be performed serially or in parallel.

[0089] While specific embodiments have been illustrated and described herein, it should be understood that any arrangement calculated to achieve the same purpose may substitute for the specific embodiments shown. This statement is intended to cover any and all adaptations or variations of the various embodiments. It should be understood that the above description is illustrative and not restrictive. Combinations of the above embodiments, as well as other embodiments not specifically described herein, will be apparent to those skilled in the art upon review of the above description. Therefore, the scope of the various embodiments includes any other application using the above compositions, structures, and methods.

[0090] Although the subject matter has been described in language specific to structural features and / or methodological actions, it should be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or actions described above. Rather, the specific features and actions described above are disclosed as examples of implementing the claims.

Claims

1. A device for dialysis treatment, comprising: At least one memory; and The logic associated with the at least one memory, the logic being: Determine the patient's upper body oxygen consumption. Determined during dialysis: Hemoglobin concentration and venous oxygen saturation, which are measured via an optical blood monitor operatively connected to the extracorporeal circuit of the dialysis system performing the dialysis process; Arterial oxygen saturation, which is measured via a pulse oximeter operatively connected to the patient; Based on the arterial oxygen saturation and the venous oxygen saturation, the arterial-venous oxygen content difference; as well as Upper body blood flow UBBF is the ratio of the upper body oxygen consumption to the arterial-venous oxygen difference. Treatment recommendations will be determined based on the UBBF.

2. The apparatus of claim 1, wherein the logic performs the dialysis procedure based on the treatment recommendation.

3. The apparatus of claim 1, wherein the treatment recommendations include adjustments to the parameters governing the dialysis process.

4. The apparatus of claim 3, wherein the adjustment parameters include at least one of ultrafiltration rate, ultrafiltration target, and process duration.

5. The apparatus of claim 3, wherein the logic presents to the user adjustment information indicating the adjustment parameters.

6. The apparatus of claim 3, wherein the logic automatically adjusts the dialysis process based on the adjustment parameters.

7. The apparatus of claim 1, wherein the upper body oxygen consumption comprises the sum of the oxygen consumption of the upper body tissues, the upper body tissues comprising the brain, heart, skeletal muscle, skin, or any combination thereof.

8. The apparatus of claim 1, wherein the method for determining the arterial-venous oxygen content difference is replaced by the difference between arterial blood oxygen content and venous blood oxygen content.

9. The apparatus of claim 1, wherein the treatment recommendation is determined to promote improvement in the patient's morbidity.

10. A dialysis system configured to perform a dialysis procedure on a patient, the dialysis system comprising: It can be operatively connected to the patient's external circuitry; An optical blood monitor that can be operatively connected to the external circuit; A pulse oximeter that can be operatively connected to the patient; At least one processor; and A memory coupled to the at least one processor, the memory including instructions that, when executed by the at least one processor, cause the at least one processor to: Determine the oxygen consumption of the patient's upper body; During the dialysis process, the following was determined: Hemoglobin concentration and venous oxygen saturation can be measured using an optical blood monitor. Arterial oxygen saturation, which is measured via the pulse oximeter; Based on the arterial oxygen saturation and the venous oxygen saturation, the arterial-venous oxygen content difference; as well as Upper body blood flow UBBF, which is the ratio of upper body oxygen consumption to the arterial-venous oxygen difference; and Treatment recommendations will be determined based on the UBBF.

11. The dialysis system of claim 10, wherein when executed by the at least one processor, the instructions cause the at least one processor to perform the dialysis procedure based on the treatment recommendations.

12. The dialysis system of claim 10, wherein the upper body oxygen consumption comprises the sum of the oxygen consumption of the upper body tissues, the upper body tissues comprising the brain, heart, skeletal muscle, skin, or any combination thereof.

13. The dialysis system of claim 10, wherein the treatment recommendation includes adjustments to parameters of the dialysis process, the parameters including at least one of ultrafiltration rate, ultrafiltration target, and process duration.

14. The dialysis system of claim 13, wherein when executed by the at least one processor, the instructions cause the dialysis system to present adjustment information to the user indicating the adjustment parameters.

15. The dialysis system of claim 14, wherein when executed by the at least one processor, the instructions cause the dialysis system to automatically adjust the dialysis process based on the adjustment parameters.

16. The dialysis system of claim 10, wherein when executed by the at least one processor, the instructions cause the dialysis system to determine the arterial-venous oxygen content difference based on the difference between arterial blood oxygen content and venous blood oxygen content.