# US 11,433,168 B2 · Dual chamber gas exchanger and method of use for respiratory support

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- Number: US 11,433,168 B2
- Document ID: US11433168B2
- Status: Granted
- Kind: B2
- Application number: 16/791,117
- Filed: 2020-02-14
- Published: 2020-07-02
- Granted: 2022-09-06
- Earliest claimed: 2017-08-15
- Assignees: University of Maryland, Baltimore; Breethe, Inc.
- Applicants: University of Maryland, Baltimore; Breethe, Inc
- Inventors: Zhongjun Wu; Bartley P. Griffith; Jiafeng Zhang; Steven J. Orwig
- Web page: https://patentgrep.com/patent/US11433168B2

## CPC

- 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 1/1629: {with integral heat exchanger}
- A61M 1/3607: {Regulation parameters}
- A61M 1/3623: {Means for actively controlling temperature of blood}
- A61M 60/113: in other functional devices, e.g. dialysers or heart-lung machines
- A61M 2202/0225: Carbon oxides, e.g. Carbon dioxide
- A61M 2206/20: having means for promoting or enhancing the flow, actively or passively
- 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 device of the present invention includes a dual chamber gas exchanger that is configured for increased flexibility and scalability for many clinical applications. The dual chamber oxygenator can be configured and used in various applications, such as in a heart-lung machine for cardiopulmonary support during cardiothoracic surgery, in an extracorporeal membrane oxygenation (ECMO) circuitry, as a respiratory assist device for patients with lung failure, and the like. The dual chamber gas exchanger features two sweep gas flow paths and two gas exchange membrane bundles enclosed in a housing structure with various blood flow distribution and gas distribution mechanisms. The gas exchanger includes an outer housing, an intermediate housing, two gas exchange fiber bundles, a blood inlet, a blood outlet, two gas inlets, two gas outlets, two gas distribution chambers and an optional heat exchanger.

## Claims

### Claim 1

A blood oxygenator comprising:
a housing comprising a blood inlet, a blood outlet, a stripping gas inlet, an oxygenation gas inlet, and at least one gas outlet; and
an oxygenator fiber bundle disposed within the housing and configured so that blood flows through a blood flow region in the oxygenator fiber bundle in a predetermined path from the blood inlet to the blood outlet;
wherein the stripping gas inlet is configured to direct a flow of stripping gas through a stripping region of the oxygenator fiber bundle to the at least one gas outlet and the oxygenation gas inlet is configured to direct a flow of oxygenation gas through an oxygenation region of the oxygenator fiber bundle to the at least one gas outlet; and
wherein the stripping gas region of the oxygenator fiber bundle is upstream of the oxygenation region of the oxygenator fiber bundle.

### Claim 2 (depends on 1)

The blood oxygenator of claim 1, wherein the fiber bundle is cylindrical and at least a portion of the blood flow path is radially inward or radially outward.

### Claim 3 (depends on 1)

The blood oxygenator of claim 1, wherein the fiber bundle is cylindrical and at least a portion of the blood flow path follows an annular path.

### Claim 4 (depends on 1)

The blood oxygenator of claim 1, wherein at least a portion of the blood flow path is unidirectional across the oxygenator fiber bundle.

### Claim 5 (depends on 1)

The blood oxygenator of claim 1, wherein the fiber bundle is cylindrical and an outer portion of the blood flow path follows an annular path and an inner portion follows a radially inward path.

### Claim 6 (depends on 5)

The blood oxygenator of claim 5, wherein the blood inlet feeds the outer portion and the inner portion feeds the blood outlet.

### Claim 7 (depends on 6)

The blood oxygenator of claim 6, wherein the stripping region is disposed at least in part in the outer portion of the blood flow path and the oxygenation region is disposed at least in part in the inner portion of the blood flow path.

### Claim 8 (depends on 5)

The blood oxygenator of claim 5, wherein the blood inlet feeds the inner portion and the outer portion feeds the blood outlet.

### Claim 9 (depends on 8)

The blood oxygenator of claim 8, wherein the stripping region is disposed at least in part in the inner portion of the blood flow path and the oxygenation region is disposed at least in part in the outer portion of the blood flow path.

### Claim 10 (depends on 5)

The blood oxygenator of claim 5, further comprising a cylindrical wall separating the outer portion and the inner portion of the cylindrical fiber bundle, wherein blood flows from the blood inlet through an axial opening in the housing into the outer portion of the fiber bundle and flows annularly through the outer portion of the fiber bundle to and through an axial opening in the cylindrical wall into a distribution ring surrounding the inner bundle from where the blood flows radially inwardly through the inner portion of the fiber bundle to an axial collection region along a center axis of the inner portion of the fiber bundle.

### Claim 11 (depends on 1)

The blood oxygenator of claim 1, wherein the oxygenation fiber bundle has a cross-sectional area and the stripping region that receives the stripping gas from the stripping gas inlet has an inlet area that comprises from 20% to 80% of the cross-sectional area and the oxygenation region that receives the oxygenation gas from the oxygenation gas inlet has an inlet area that comprises from 80% to 20% of the cross-sectional area.

### Claim 12 (depends on 11)

The blood oxygenator of claim 11, further comprising a manifold divider which directs the stripping gas from the stripping gas inlet to the stripping region of the oxygenator fiber bundle and directs the oxygenation gas from the oxygenation gas inlet to the oxygenation region of the oxygenator fiber bundle.

### Claim 13 (depends on 12)

The blood oxygenator of claim 12, wherein the manifold divider is disposed in a manifold which receives the stripping gas from the stripping gas inlet and the oxygenation gas from the oxygenation gas inlet, wherein the manifold is open to an entire gas inlet side of the oxygenation fiber bundle and placement of the manifold divider controls an inlet area of the stripping region that receives the stripping gas from the stripping gas inlet and an inlet area of the oxygenation region that receives the oxygenation gas from the oxygenation gas inlet.

### Claim 14 (depends on 13)

The blood oxygenator of claim 13, wherein the manifold divider is moveable.

### Claim 15 (depends on 14)

The blood oxygenator of claim 14, wherein the manifold divider is fixed.

### Claim 16 (depends on 1)

The blood oxygenator of claim 1, wherein the oxygenation fiber bundle further comprises an upper potting and a lower potting, wherein the manifold is located within the housing adjacent to one of the pottings.

### Claim 17 (depends on 1)

The blood oxygenator of claim 1, further comprising a blood pump connected to said blood inlet, an oxygenation gas source connected to the oxygenation gas inlet and a stripping gas source connected to the stripping gas inlet.

### Claim 18

A method for oxygenating blood comprising:
providing a blood oxygenator having (1) a housing with a blood inlet, a blood outlet, a stripping gas inlet, an oxygenation gas inlet, and at least one gas outlet and (2) an oxygenator fiber bundle disposed within the housing;
flowing blood through the blood inlet, through the oxygenator fiber bundle, and out the blood outlet;
flowing a stripping gas through the stripping gas inlet and an oxygenation gas through the oxygenation gas inlet, wherein the stripping gas flows through a stripping region of the oxygenator fiber bundle to the at least one gas outlet and the oxygenation gas through an oxygenation region of the oxygenator fiber bundle to the at least one gas outlet;
wherein the stripping gas region of the oxygenator fiber bundle is upstream of the oxygenation region of the oxygenator fiber bundle.

### Claim 19 (depends on 18)

The method of claim 18, wherein the blood travels through the stripping region of the oxygenator fiber bundle in an annular flow path.

### Claim 20 (depends on 19)

The method of claim 19, wherein the blood travels through the oxygenation region of the oxygenator fiber bundle in a radially inward flow path.

### Claim 21 (depends on 19)

The method of claim 19, wherein the blood travels through the stripping region and the oxygenation region of the oxygenator fiber bundle in a straight direction.

### Claim 22 (depends on 18)

The method of claim 18, wherein the blood travels through the oxygenator fiber bundle in a substantially uniform blood flow distribution.

### Claim 23 (depends on 18)

The method of claim 18, wherein the fiber bundle has a cross-sectional area and the stripping region that receives the stripping gas from the stripping gas inlet has an inlet area that comprises from 20% to 80% of the cross-sectional area and the oxygenation region that receives the oxygenation gas from the oxygenation gas inlet has an inlet area that comprises from 80% to 20% of the cross-sectional area.

### Claim 24 (depends on 23)

The method of claim 23, further comprising moving a manifold divider which directs the stripping gas from the stripping gas inlet to the stripping region of the oxygenator fiber bundle and directs the oxygenation gas from the oxygenation gas inlet to the oxygenation region of the oxygenator fiber bundle to adjust relative areas of the stripping region and the oxygenation region of the oxygenation fiber bundle.
