# US 8,540,879 B2 · Steam-sterilizable blood separating device

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- Number: US 8,540,879 B2
- Document ID: US8540879B2
- Status: Granted
- Kind: B2
- Application number: 11/989,497
- Filed: 2006-07-26
- Published: 2009-10-22
- Granted: 2013-09-24
- Earliest claimed: 2005-07-26
- Assignees: Hemacon GmbH
- Applicants: Gerd H. Heim
- Inventors: Gerd H. Heim
- Web page: https://patentgrep.com/patent/US8540879B2

## CPC

- A61M 1/0209: {Multiple bag systems for separating or storing blood components}
- A61L 2/07: Steam
- A61M 1/0218: {with filters}
- A61M 1/0231: {with gas separating means, e.g. air outlet through microporous membrane or gas bag}
- A61M 1/34: Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
- A61M 1/36: Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation {; Extra-corporeal blood circuits}
- 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)}
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

A device for separating blood into individual components and/or groups of components, in the form of a sterilizable system includes a filter arrangement forming inlet and outlet chambers using filter elements arranged therein, and respective receptacles for cellular blood components and for blood plasma. The inlet chamber can be connected to the blood source via a line on the inlet side to conduct the blood and is connected, on the outlet side, to the cellular blood components receptacle. The outlet chamber is connected to the blood plasma receptacle via a line on the outlet side. Thermal sterilization is used to sterilize the device by opening a respective line into the inlet-side line of the inlet chamber, into the inlet chamber and the outlet-side line of the outlet chamber, or into the outlet chamber, the line being connected to the exterior via a hydrophobic or hydrophilic filter.

## Claims

### Claim 1

A device for fractionating blood comprising
a filter arrangement which, forms an inlet chamber and an outlet chamber, and
a receptacle for cellular blood components and a receptacle for blood plasma,
the inlet chamber of the filter arrangement having (i) an inlet chamber entry side connected by a first conduit to a blood source and (ii) an inlet chamber exit side connected via a second conduit to the receptacle for cellular components of the blood,
wherein blood enters the inlet chamber, passes through the filter element to separate the blood plasma from the blood, and exits into the second conduit, the blood plasma so separated being collected in the outlet chamber for separate removal, the outlet chamber having an outlet chamber exit side connected by a third conduit to the receptacle for blood plasma,
wherein said system is sterilizable with superheated moist steam,
said first and second conduits are connected to a first and second connected conduit, respectively,
said outlet chamber is connected to a third connected conduit,
said first, second, and third connected conduits comprise a first, second, and third terminating, porous, liquid-impermeable bacterial filter, respectively, allowing the superheated moist steam to be moved through the device via said bacterial filters, and
said first, second, and third conduits, and said connected conduits comprise flexible plastic tubing.

### Claim 2 (depends on 1)

The device as claimed in claim 1, wherein each terminating hydrophobic bacterial filter is associated with a conduit closure element.

### Claim 3 (depends on 2)

The device as claimed in claim 2, wherein the conduit closure element is disposed in the respective connected conduit closer to the filter arrangement than to the respective associated terminating hydrophobic bacterial filter.

### Claim 4 (depends on 1)

The device as claimed in claim 1, wherein the filter element is impregnated with a blood-compatible liquid.

### Claim 5 (depends on 1)

The device as claimed in claim 1, wherein a disposable rupture closure valve is disposed in the first conduit on the inlet chamber entry side.

### Claim 6 (depends on 1)

The device as claimed in claim 1, wherein the filter element is a hollow fiber filer made of material having micropores.

### Claim 7 (depends on 1)

The device as claimed in claim 1, wherein the device further comprises a leukocyte depletion filter.

### Claim 8 (depends on 7)

The device as claimed in claim 7,
wherein a first terminating hydrophobic bacterial filter of the terminating hydrophobic bacterial filters is associated with the first conduit, and
wherein the leukocyte depletion filter is disposed in the first conduit.

### Claim 9 (depends on 1)

The device as claimed in claim 1, wherein the blood source comprises a blood receptacle.

### Claim 10 (depends on 9)

The device as claimed in claim 9, wherein an exit conduit of the blood receptacle is connected by a fourth conduit to the first conduit on the inlet chamber entry side.

### Claim 11 (depends on 9)

The device as claimed in claim 9, wherein the blood receptacle is connected with a blood feed conduit and the first conduit, the blood feed conduit being provided at an end of the blood feed conduit with a connecting element which can be coupled to one or more blood vessels of a donor.

### Claim 12 (depends on 7)

The device as claimed in claim 7, wherein the receptacle for cellular blood components or the filter arrangement which comprise a vaporizable liquid at the time of steam sterilization include a disposable rupture closure valve, in their respective connecting conduit to the filter arrangement and/or to the leukocyte depletion filter.

### Claim 13 (depends on 1)

The device as claimed in claim 1, wherein the receptacles comprise receiving bags.

### Claim 14 (depends on 13)

The device as claimed in claim 13, wherein the receiving bags and the filter arrangement are disposed at a distance from one another such that the fractionation of blood takes place exclusively through gravity.

### Claim 15

A method for steam sterilization comprising:
assembling a device for fractionating blood into single components and/or groups of its components comprising a filter arrangement which, via a filter element disposed therein, forms an inlet chamber and an outlet chamber, and a receptacle for cellular blood components and a receptacle for blood plasma, by connecting an inlet chamber entry side of the inlet chamber of the filter arrangement by a first conduit to a blood source and an inlet chamber exit side of the inlet chamber via a second conduit to the receptacle for cellular components of the blood,
wherein blood enters the inlet chamber, passes through the filter element to separate the blood plasma from the blood, and exits into the second conduit, the blood plasma so separated being collected in the outlet chamber for separate removal, and
connecting an outlet chamber exit side of the outlet chamber by a third conduit to the receptacle for blood plasma,
wherein said first and second conduits are connected to a first and second connected conduit, respectively,
said outlet chamber is connected to a third connected conduit,
said first, second, and third connected conduits comprise a first, second, and third terminating, porous, liquid-impermeable bacterial filter, respectively, allowing the superheated moist steam to be moved through the device via said bacterial filters, and
said first, second, and third conduits, and said connected conduits comprise flexible plastic tubing, and
passing superheated moist sterilization steam through the bacterial filters into the device.

### Claim 16 (depends on 1)

The device for fractionating blood according to claim 1, wherein the filter element is U-shaped.
