# US 11,077,023 B2 · Method for producing a medical preparation using a peristaltic pump

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- Number: US 11,077,023 B2
- Document ID: US11077023B2
- Status: Granted
- Kind: B2
- Application number: 16/083,984
- Filed: 2017-03-15
- Published: 2020-09-17
- Granted: 2021-08-03
- Earliest claimed: 2016-03-15
- Assignees: Fresenius Kabi Deutschland GmbH
- Applicants: Fresenius Kabi Deutschland GmbH
- Inventors: Martin Biehl; Michael Hock; Henrik Schaake; Martin Bohm; Ulla Schöbel
- Web page: https://patentgrep.com/patent/US11077023B2

## CPC

- A61J 3/002: {Compounding apparatus specially for enteral or parenteral nutritive solutions (bottling liquids B67C)}
- A61M 1/1645: {with mechanically linked peristaltic dialysis fluid pumps one upstream, the other one downstream of the dialyser}
- A61M 1/1668: {Details of containers}
- A61M 1/262: {rotating}
- A61M 1/267: {used for pumping}
- A61M 1/3626: {Gas bubble detectors}
- A61J 2200/74: for weight
- F04B 43/12: having peristaltic action
- F04B 53/10: Valves; Arrangement of valves
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- 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)}
- F04B: POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS (machines for liquids, or pumps, of rotary-piston or oscillating-piston type F04C; non-positive-displacement pumps F04D; pumping of fluid by direct contact of another fluid or by using inertia of fluid to be pumped F04F)

## Abstract

The invention relates to a method and a system for synthesizing a medical preparation, a peristaltic pump being used for pumping liquid from a plurality of source containers. According to the invention, micro-amounts are extracted only in the linear region of the peristaltic pump.

## Claims

### Claim 1

A method for producing a medical preparation, in particular for parenteral nutrition, the method comprising:
transferring liquids by a peristaltic pump from a plurality of source containers into a target container, wherein the peristaltic pump has at least one region with a linear characteristic curve and one region with a non-linear characteristic curve of the pump output, and metering from at least one source container by bringing the peristaltic pump to a position such that the metering from the at least one source container takes place entirely in the region with the linear characteristic curve of the pump output.

### Claim 2 (depends on 1)

The method for producing a medical preparation as claimed in claim 1, wherein the peristaltic pump is brought to a position in which the suction-side characteristic curve of the peristaltic pump is linear.

### Claim 3 (depends on 1)

The method for producing a medical preparation as claimed in claim 1, wherein, in order to bring the peristaltic pump to the desired position with a linear characteristic curve, liquid is removed from another source container than the one from which metering is intended to take place, the other source container being from a source container with universal liquid or water.

### Claim 4 (depends on 1)

The method for producing a medical preparation as claimed in claim 1, wherein a very small quantity with a volume of under 10 ml is delivered in the region of the linear characteristic curve.

### Claim 5 (depends on 4)

The method for producing a medical preparation as claimed in claim 4, wherein the volume is under 5 ml.

### Claim 6 (depends on 1)

The method for producing a medical preparation as claimed in claim 1, wherein precisely one single peristaltic pump is used for transferring the liquids from all of the source containers into the target container.

### Claim 7 (depends on 1)

The method for producing a medical preparation as claimed in claim 1, wherein, in at least one further metering step, a quantity with a volume of over 15 ml is delivered, wherein the peristaltic pump is operated both in the region with the linear characteristic curve and also in the region with a non-linear characteristic curve.

### Claim 8 (depends on 1)

The method for producing a medical preparation as claimed in claim 1, further comprising using an impeller to take a quantity of liquid that is to be removed from the respective source container, wherein a rotation of an impeller required to remove the quantity of liquid is calculated on the basis of the suction-side characteristic curve of the peristaltic pump.

### Claim 9 (depends on 1)

The method for producing a medical preparation as claimed in claim 1, wherein at each metering step, the target container is weighed and the quantity of the respectively transferred liquid is thus checked.

### Claim 10 (depends on 1)

The method for producing a medical preparation as claimed in claim 1, wherein a quantity of the liquid delivered by the peristaltic pump is calculated and the target container is weighed in order to check the quantity of the liquid delivered, wherein the sequence of different liquids in an inflow of the target container is taken into consideration in order to allow for the specific mass of the liquid in the check during weighing.

### Claim 11 (depends on 1)

The method for producing a medical preparation as claimed in claim 1, wherein the target container is weighed at each individual metering step, and a quantity of the liquid transferred into the target container is thus checked at the each individual metering step.

### Claim 12 (depends on 1)

The method for producing a medical preparation as claimed in claim 1, wherein a quantity of the liquid transferred into the target container in one metering step is calculated taking into account the pressure-side characteristic curve of the peristaltic pump.

### Claim 13 (depends on 1)

The method for producing a medical preparation as claimed in claim 1, wherein a delivery rate of the peristaltic pump is checked with a flow sensor.

### Claim 14 (depends on 1)

The method for producing a medical preparation as claimed in claim 1, wherein a metering factor of the peristaltic pump is determined in a preceding calibration step by means of weighing a target container.

### Claim 15 (depends on 1)

The method for producing a medical preparation as claimed in claim 1, wherein in order to transfer the liquids from the source containers into the target container, a transfer set is used which comprises a valve unit, a hose, which is insertable into the peristaltic pump, and a plurality of hoses for attachment of the source containers.

### Claim 16 (depends on 1)

An installation for producing a medical preparation, in particular an installation for producing parenteral nutrition, comprising a peristaltic pump and a system for carrying out a method as claimed in claim 1.

### Claim 17 (depends on 1)

The method for producing a medical preparation as claimed in claim 1, wherein a bubble sensor is used to check that there are no bubbles in an inflow to the target container.

### Claim 18 (depends on 1)

The method for producing a medical preparation as claimed in claim 1, wherein the metering factor of the pump is calibrated in a metering step from a source container in which an impeller of the peristaltic pump rotates through at least one full revolution.
