# US 10,478,105 B2 · Extracorporeal circulation management device and extracorporeal circulation device having it

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 10,478,105 B2
- Document ID: US10478105B2
- Status: Granted
- Kind: B2
- Application number: 15/629,898
- Filed: 2017-06-22
- Published: 2017-10-05
- Granted: 2019-11-19
- Earliest claimed: 2014-12-25
- Assignees: Terumo Kabushiki Kaisha
- Applicants: Terumo Kabushiki Kaisha
- Inventors: Tomoki Utsugida; Tomoaki Hashimoto; Tsuyoshi Hasegawa
- Web page: https://patentgrep.com/patent/US10478105B2

## CPC

- A61M 1/3666: {Cardiac or cardiopulmonary bypass, e.g. heart-lung machines}
- A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20)
- A61B 5/14542: {for measuring blood gases (A61B5/14551 takes precedence)}
- A61M 1/32: Oxygenators without membranes
- A61M 1/1698: {Blood oxygenators with or without heat-exchangers (intracorporal A61M1/1678; manufacturing of membranes therefor B01D67/00; semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi-permeable membranes characterised by their material B01D71/00)}
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2230/205: partial oxygen pressure (P-O2)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

An extracorporeal blood circulation management device having an oxygenator accurately determines oxygen consumption by the target person and oxygen delivery by the oxygenator. Oxygenation-related parameter values in the blood are determined at regular intervals. An in-body passing time (a cycle time for a particular volume of blood to pass from input sensors to output sensors) is determined. Parameter values separated by the in-body passing time are selected as comparison targets to evaluate oxygenation consumption of the target person. An oxygenator unit passing time is determined. Parameter values separated by the oxygenator unit passing time are selected as comparison targets to evaluate oxygenation delivery of the oxygenation unit.

## Claims

### Claim 1

An extracorporeal circulation management device comprising:
first controller means programmed for determining a plurality of first oxygenation-related parameter values of blood supplied from an output of an oxygenator unit that carries out gas exchange of blood to a target person with time-course information and for determining a plurality of second oxygenation-related parameter values of blood introduced from the target person into an input of the oxygenator unit with time-course information;
calculation means programmed for determining in-body passing time information defining a time period for blood supplied from the output of the oxygenator unit to the target person to be discharged from the target person according to a bloodstream volume of the target person and a flow rate of the supplied blood; and
second controller means programmed for selecting first oxygenation-related parameter values separated by the stored in-body passing time information and for selecting second oxygenation-related parameter values separated by the calculated in-body passing time information as comparison targets to evaluate oxygenation consumption of the target person;
wherein the calculation means is further programmed to correct the in-body passing time information according to locations on the target person where the blood is introduced from the oxygenator unit into the target person and where the blood is discharged from the target person.

### Claim 2 (depends on 1)

The extracorporeal circulation management device according to claim 1
wherein the calculation means is further programmed for generating the in-body passing time information based on detected change of the first oxygenation-related parameter values and the second oxygenation-related parameter values.

### Claim 3 (depends on 1)

The extracorporeal circulation management device of claim 1 further comprising:
third controller means programmed for determining oxygenator unit passing time information defining a time period for blood supplied from the target person to the input of the oxygenator unit to be discharged from the output of the oxygenator unit; and
fourth controller means programmed for selecting first oxygenation-related parameter values separated by the oxygenator unit passing time information and for selecting second oxygenation-related parameter values separated by the oxygenator unit passing time information as comparison targets to evaluate oxygenation delivery of the oxygenation unit.

### Claim 4 (depends on 3)

The extracorporeal circulation management device according to claim 3 further comprising:
fifth controller means programmed for detecting an abnormality of either the oxygenation consumption of the target person or the oxygenation delivery of the oxygenation unit; and
sixth controller means programmed for identifying which of the oxygenation delivery or the oxygenation consumption is abnormal in response to a measured temperature and expected oxygenation consumption at the measured temperature.

### Claim 5 (depends on 1)

The extracorporeal circulation management device according to claim 1 wherein the first and second oxygenation-related parameters are comprised of saturation of oxygen and partial pressure of oxygen.

### Claim 6

An extracorporeal circulation system, comprising:
an oxygenator unit;
a first tube part for providing blood from an output of the oxygenator unit to a target person;
a second tube part for providing blood from the target person to an input of the oxygenator unit;
first oxygenation sensors measuring first oxygenation-related parameters values in the first tube part;
second oxygenation sensors measuring second oxygenation-related parameters values in the second tube part; and
an extracorporeal circulation management device comprising first controller means programmed for determining in-body passing time information defining a time period for blood supplied from the output of the oxygenator unit to the target person to be discharged from the target person according to a bloodstream volume of the target person and a flow rate of the supplied blood, and second controller means programmed for selecting first oxygenation-related parameter values separated by the determined in-body passing time information and for selecting second oxygenation-related parameter values separated by the determined in-body passing time information as comparison targets to evaluate oxygenation consumption of the target person, wherein the in-body passing time information is corrected according to locations on the target person where the blood is introduced from the oxygenator unit into the target person and where the blood is discharged from the target person.

### Claim 7 (depends on 6)

The extracorporeal circulation management system according to claim 6, wherein the extracorporeal circulation management device further comprises:
third controller means programmed for generating the in-body passing time information based on detected change of the first oxygenation-related parameter values and the second oxygenation-related parameter values.

### Claim 8 (depends on 6)

The extracorporeal circulation management system of claim 6 wherein the extracorporeal circulation management device further comprises:
fourth controller means programmed for determining oxygenator unit passing time information defining a time period for blood supplied from the target person to the input of the oxygenator unit to be discharged from the output of the oxygenator unit; and
fifth controller means programmed for selecting first oxygenation-related parameter values separated by the oxygenator unit passing time information and for selecting second oxygenation-related parameter values separated by the oxygenator unit passing time information as comparison targets to evaluate oxygenation delivery of the oxygenation unit.

### Claim 9 (depends on 8)

The extracorporeal circulation management system according to claim 8, wherein the extracorporeal circulation management device further comprises:
sixth controller means programmed for detecting an abnormality of either the oxygenation consumption of the target person or the oxygenation delivery of the oxygenation unit; and
seventh controller means programmed for identifying which of the oxygenation delivery or the oxygenation consumption is abnormal in response to a measured temperature and expected oxygenation consumption at the measured temperature.

### Claim 10 (depends on 6)

The extracorporeal circulation management system according to claim 6 wherein the first and second oxygenation-related parameters are comprised of saturation of oxygen and partial pressure of oxygen.

### Claim 11

A method of managing extracorporeal circulation in a target patient using an oxygenation unit, the method comprising the steps of:
determining a plurality of first oxygenation-related parameter values of blood supplied from an output of the oxygenator unit that carries out gas exchange of blood to the target person with time-course information;
determining a plurality of second oxygenation-related parameter values of blood introduced from the target person into an input of the oxygenator unit with time-course information;
determining in-body passing time information defining a time period for blood supplied from the output of the oxygenator unit to the target person to be discharged from the target person according to a bloodstream volume of the target person and a flow rate of the supplied blood;
selecting first oxygenation-related parameter values separated by the determined in-body passing time information and for selecting second oxygenation-related parameter values separated by the determined in-body passing time information as comparison targets to evaluate oxygenation consumption of the target person; and
correcting the in-body passing time information according to locations on the target person where the blood is introduced from the oxygenator unit into the target person and where the blood is discharged from the target person.

### Claim 12 (depends on 11)

The method of claim 11, further comprising the step of:
generating the in-body passing time information based on detected change of the first oxygenation-related parameter values and the second oxygenation-related parameter values.

### Claim 13 (depends on 11)

The method of claim 11 further comprising the steps of:
determining oxygenator unit passing time information defining a time period for blood supplied from the target person to the input of the oxygenator unit to be discharged from the output of the oxygenator unit;
selecting first oxygenation-related parameter values separated by the oxygenator unit passing time information and selecting second oxygenation-related parameter values separated by the oxygenator unit passing time information as comparison targets to evaluate oxygenation delivery of the oxygenation unit.

### Claim 14 (depends on 13)

The method of claim 13 further comprising the steps of:
detecting an abnormality of either the oxygenation consumption of the target person or the oxygenation delivery of the oxygenation unit; and
identifying which of the oxygenation delivery or the oxygenation consumption is abnormal in response to a measured temperature and expected oxygenation consumption at the measured temperature.

### Claim 15 (depends on 11)

The method of claim 11 wherein the first and second oxygenation-related parameters are comprised of saturation of oxygen and partial pressure of oxygen.