# US 11,433,173 B2 · System for extracorporeal blood treatment, treatment apparatus, kit and method for operating a system for extracorporeal blood treatment

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- Number: US 11,433,173 B2
- Document ID: US11433173B2
- Status: Granted
- Kind: B2
- Application number: 16/468,299
- Filed: 2017-12-14
- Published: 2020-03-05
- Granted: 2022-09-06
- Earliest claimed: 2016-12-15
- Assignees: Fresenius Medical Care Deutschland GmbH
- Applicants: Fresenius Medical Care Deutschland GmbH
- Inventors: Jorg Rammo; Jurgen Klewinghaus
- Web page: https://patentgrep.com/patent/US11433173B2

## CPC

- A61M 1/3413: {Diafiltration}
- A61M 1/16: with 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 1/267: {used for pumping}
- A61M 1/34: Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
- A61M 1/342: {Adding solutions to the blood, e.g. substitution solutions (for preventing coagulation A61M1/3672)}
- A61M 1/3434: {with pre-dilution and post-dilution}
- A61M 1/3441: {Substitution rate control as a function of the ultrafiltration rate}
- A61M 1/3496: {Plasmapheresis; Leucopheresis; Lymphopheresis (A61M1/3472 takes precedence)}
- A61M 1/3603: {in the same direction}
- A61M 1/3621: {Extra-corporeal blood circuits (single-needle circuits A61M1/30)}
- A61M 1/36225: {with blood pumping means or components thereof}
- A61M 1/3626: {Gas bubble detectors}
- A61M 1/3639: {Blood pressure control, pressure transducers specially adapted therefor}
- A61M 1/3653: {Interfaces between patient blood circulation and extra-corporal blood circuit}
- A61M 1/3666: {Cardiac or cardiopulmonary bypass, e.g. heart-lung machines}
- A61M 1/3679: {by absorption (A61M1/3675 takes precedence)}
- A61M 2202/203: Bacteria
- A61M 2202/206: Viruses
- A61M 2205/0238: the material being a coating or protective layer
- A61M 2205/12: with interchangeable cassettes forming partially or totally the fluid circuit
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3337: Controlling, regulating pressure or flow by means of a valve by-passing a pump
- A61M 2205/7509: for virus
- A61M 2205/7518: bacterial
- A61M 2250/00: Specially adapted for animals
- 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)}

## Abstract

The present invention relates to a system (100) for extracorporeal blood treatment comprising a first inlet (1) for introducing a bloodstream to be treated into the system (100), three blood treatment apparatus (A, D, G), as well as an outlet (2) for discharging a treated bloodstream from the system (100), wherein the system comprises an adsorber apparatus (A) and/or a plasma separator apparatus, a dialysis apparatus (D) and a gas exchange apparatus (G), and wherein the three blood treatment apparatus (A, D, G) are sequentially connected in series in a functional state of system (100) application between the inlet (1) and the outlet (2) of the system relative to a direction of blood flow of a bloodstream to be treated and can be consecutively perfused extracorporeally by a bloodstream to be treated. The present invention further relates to a treatment apparatus comprising such a system, a kit comprising the components of such a system, a method for operating such a system (100) as well as a method for extracorporeal blood treatment with such a system (100).

## Claims

### Claim 1

A system for extracorporeal blood treatment, wherein the system comprises:
a first inlet configured to introduce a bloodstream to be treated, into the system,
a first blood treatment apparatus configured to receive the bloodstream to be treated and form a first-treated bloodstream,
a second blood treatment apparatus configured to receive the first-treated bloodstream and form a second-treated bloodstream,
a third blood treatment apparatus configured to receive the second-treated bloodstream and form a third-treated bloodstream, and
a first outlet configured to discharge the third-treated bloodstream from the system,
wherein the first blood treatment apparatus is or comprises (a) an adsorber configured to remove at least one exogenous and/or at least one endogenous pathogen, (b) a plasma separator apparatus for separating blood plasma from the other blood components, or (a) and (b),
wherein the second blood treatment apparatus is designed as a dialysis apparatus, and
wherein the third blood treatment apparatus is designed as (c) a gas exchange apparatus, (d) a gas supply apparatus for supplying a gas or gas mixture into a stream of blood flowing through the third blood treatment apparatus, or both (c) and (d), and
wherein the first, second, and third blood treatment apparatuses are sequentially connected, in series, in a functional state of system application between the first inlet and the first outlet of the system relative to a direction of blood flow of a bloodstream to be treated, and are configured to be consecutively perfused extracorporeally by the bloodstream to be treated, the first-treated bloodstream, and the second-treated bloodstream, respectively.

### Claim 2 (depends on 1)

The system according to claim 1, wherein the first blood treatment apparatus is or comprises an adsorber apparatus designed for endotoxin adsorption, cytokine adsorption and/or immunoadsorption, wherein the adsorber apparatus is designed to remove at least one pharmaceutical and/or medical drug and/or at least one phytotoxin and/or at least one organic toxin and/or at least one other toxic substance and/or to remove bacteria, viruses, fungi and/or other organisms and/or at least one immune complex and/or at least one immunoglobulin and/or at least one inflammatory response substance of the body and/or antibodies and/or at least one pathogen-associated molecular pattern and/or at least one alarmin.

### Claim 3 (depends on 1)

The system according to claim 1, wherein the system comprises at least one first pump, for pumping at least a portion of a bloodstream to be treated, wherein the at least one first pump is arranged between the first inlet in the blood flow direction and the first blood treatment apparatus in the blood flow direction, and is designed to pump the bloodstream to be treated, the first-treated bloodstream, the second-treated bloodstream, and the third-treated bloodstream.

### Claim 4 (depends on 3)

The system according to claim 3, wherein the system comprises a further inlet for the addition of a first compound into the bloodstream, wherein the further inlet is arranged in the direction of blood flow such that the compound can be fed into the bloodstream upstream of the at least one first pump and/or upstream of the first blood treatment apparatus.

### Claim 5 (depends on 1)

The system according to claim 1, wherein the system comprises a further inlet for the addition of a second compound into the bloodstream wherein the further inlet is arranged in the direction of blood flow such that the compound is capable of being fed into the bloodstream downstream of the dialysis apparatus.

### Claim 6 (depends on 1)

The system according to claim 1, wherein the adsorber apparatus and/or the plasma separator apparatus is/are arranged upstream of the gas exchange apparatus in the blood flow direction.

### Claim 7 (depends on 1)

The system according to claim 1, wherein the adsorber apparatus and/or the plasma separator apparatus is an adsorber apparatus.

### Claim 8 (depends on 1)

The system according to claim 1, wherein the adsorber apparatus and/or the plasma separator apparatus is/are arranged upstream of the dialysis apparatus in the blood flow direction, wherein the dialysis apparatus is designed for hemodialysis.

### Claim 9 (depends on 1)

The system according to claim 1, wherein the adsorber apparatus and/or the plasma separator apparatus is a plasma separator apparatus.

### Claim 10 (depends on 1)

The system according to claim 1, wherein the dialysis apparatus is arranged upstream of the gas exchange apparatus in the blood flow direction.

### Claim 11 (depends on 1)

The system according to claim 1, wherein the dialysis apparatus is designed for hemofiltration and comprises a hemofilter.

### Claim 12 (depends on 1)

The system according to claim 1, wherein the system comprises at least one pressure sensor device for determining a bloodstream flow pressure at a defined point in the system, wherein at least one pressure sensor device is arranged directly ahead of and/or directly after at least one treatment segment of a blood treatment apparatus in the blood flow direction.

### Claim 13 (depends on 1)

The system according to claim 1, wherein the system comprises at least one gas bubble detection device for detecting a gas bubble in the bloodstream.

### Claim 14 (depends on 1)

The system according to claim 1, wherein a treatment segment for at least one blood treatment apparatus is at least partially formed by an exchangeable treatment module.

### Claim 15 (depends on 1)

The system according to claim 1, wherein the system comprises at least one switchable bypass device for bypassing at least one blood treatment apparatus.

### Claim 16 (depends on 1)

The system according to claim 1, wherein at least one component of the system has a biocompatible and functional coating on a surface coming into contact with the bloodstream to be treated, the first-treated bloodstream, or the second-treated bloodstream.

### Claim 17 (depends on 1)

A method for operating a system for extracorporeal blood treatment designed in accordance with claim 1, comprising:
providing a volume of blood to be treated,
introducing a bloodstream to be treated, comprising the volume of blood to be treated, into the system via the first inlet,
perfusing the first blood treatment apparatus with the bloodstream to be treated, to form a first-treated bloodstream,
then perfusing the second blood treatment apparatus with the first-treated bloodstream, to form a second-treated bloodstream,
then perfusing the third blood treatment apparatus with the second-treated bloodstream, to form a third-treated bloodstream, and
discharging the third-treated bloodstream out of the system via the first outlet.

### Claim 18 (depends on 17)

The method according to claim 17, wherein the volume of blood to be treated is provided in a first receptacle, and the third-treated bloodstream is discharged into a second receptacle.

### Claim 19 (depends on 1)

A method for extracorporeal blood treatment with a system for extracorporeal blood treatment designed in accordance with claim 1, comprising:
incorporating the system for extracorporeal blood treatment into an intracorporeal blood circulation system of a human or animal to be treated, and establishing an extracorporeal blood circuit by connecting the first inlet of the system for extracorporeal blood treatment to a first blood vessel of the human or animal to be treated and connecting the first outlet of the system for extracorporeal blood treatment to a first blood vessel and/or to a second blood vessel of the human or animal,
withdrawing a bloodstream to be treated from the intracorporeal blood circulation system of the human or animal and introducing a bloodstream to be treated into the system for extracorporeal blood treatment via the first inlet of the system for extracorporeal blood treatment,
perfusing the first blood treatment apparatus with the bloodstream to be treated, to form a first-treated bloodstream,
then perfusing the second blood treatment apparatus with the first-treated bloodstream, to form a second-treated bloodstream,
then perfusing the third blood treatment apparatus with the second-treated bloodstream, to form a third-treated bloodstream,
discharging the third-treated bloodstream via the first outlet of the system, and
returning the third-treated bloodstream into the intracorporeal blood circulation system of the human or animal.

### Claim 20 (depends on 1)

A treatment apparatus for extracorporeal blood treatment, wherein the treatment apparatus comprises a system designed in accordance with claim 1, wherein the first, the second and the third blood treatment apparatuses of the system are arranged in a common housing and/or accommodated by a common base.

### Claim 21

A kit for making a system for extracorporeal blood treatment, wherein, as components, the kit comprises at least:
a first blood treatment apparatus configured to receive a bloodstream to be treated and form a first-treated bloodstream,
a second blood treatment apparatus configured to receive the first-treated bloodstream and form a second-treated bloodstream,
a third blood treatment apparatus configured to receive the second-treated bloodstream and form a third-treated bloodstream,
a tubing set having a first inlet for introducing a bloodstream to be treated and a first outlet for discharging a third-treated bloodstream via one or more tubes,
connections enabling the first blood treatment apparatus, the second blood treatment apparatus, and the third blood treatment apparatus to be sequentially connected, in series, between the first inlet and the first outlet of the system relative to a direction of blood flow of a bloodstream to be treated, and
an installation and/or operating guide,
wherein the first blood treatment apparatus is or comprises (a) an adsorber apparatus for removing at least one exogenous and/or at least one endogenous pathogen, (b) a plasma separator apparatus for separating blood plasma from the remaining blood components, or (a) and (b),
wherein the second blood treatment apparatus is designed as a dialysis apparatus, and
wherein the third blood treatment apparatus is designed as (c) a gas exchange apparatus, (d) a gas supply apparatus for supplying a gas or gas mixture into a bloodstream flowing through the third blood treatment apparatus, or (c) and (d), and
wherein the components of the kit are configured to be combined into a system for extracorporeal blood treatment.
