# US 12,178,946 B2 · Blood oxygenator

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- Number: US 12,178,946 B2
- Document ID: US12178946B2
- Status: Granted
- Kind: B2
- Application number: 17/380,319
- Filed: 2021-07-20
- Published: 2021-11-11
- Granted: 2024-12-31
- Earliest claimed: 2013-12-23
- Assignees: University of Maryland, Baltimore
- Applicants: University of Maryland, Baltimore
- Inventors: Zhongjun Wu; Bartley P. Griffith
- Web page: https://patentgrep.com/patent/US12178946B2

## 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 1/3623: {Means for actively controlling temperature of blood}
- A61M 60/113: in other functional devices, e.g. dialysers or heart-lung machines
- A61M 60/232: Centrifugal pumps
- A61M 60/38: Blood oxygenation
- A61M 2202/0208: Oxygen
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3368: Temperature
- A61M 2205/366: by liquid heat exchangers
- A61M 2206/10: Flow characteristics
- A61M 2206/16: Rotating swirling helical flow, e.g. by tangential inflows
- A61M 2209/088: on the body
- 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

A blood oxygenator is disclosed comprising a housing, a blood inlet, a blood outlet, a spiral volute, a gas inlet, an oxygenator fiber bundle, and a gas outlet. The housing encloses the fiber bundle and provides the structure for the blood flow path and connectors. The fiber bundle comprises gas-exchange membranes which transfer oxygen to the blood and remove carbon dioxide when the blood flows across the membranes. The spiral volute guides the blood to flow through the fiber bundle. A gas flow chamber receives sweep gas containing oxygen and distributes the sweep gas into the fiber membranes, which gas is then exchanged with the blood being oxygenated.

## Claims

### Claim 1

A blood oxygenation system comprising:
a housing having a top and a bottom;
a blood inlet located at a bottom of the housing and a blood outlet located at a top of the housing;
a spiral volute within the housing configured to guide blood from the blood inlet to flow circumferentially around an oxygenator fiber bundle, wherein the oxygenator fiber bundle comprises microporous hollow fibers arranged to form a cylindrical annulus; and
a gas flow chamber configured to distribute oxygen-containing sweep gas into the microporous hollow fibers, wherein the sweep gas facilitates the transfer of oxygen into the blood and the removal of carbon dioxide from the blood.

### Claim 2 (depends on 1)

The blood oxygenation system of claim 1, further comprising:
an integrated heat exchanger located adjacent to the oxygenator fiber bundle configured to control the temperature of blood flowing through the oxygenator fiber bundle.

### Claim 3 (depends on 1)

The blood oxygenation system of claim 1, wherein the fibers are coated with an anti-thrombogenic agent.

### Claim 4 (depends on 3)

The blood oxygenator of claim 3, wherein the anti-thrombogenic agent is heparin.

### Claim 5 (depends on 1)

The blood oxygenator of claim 1, wherein the spiral volute is configured to decrease in cross-sectional area from the blood inlet towards the blood outlet to maintain a consistent blood flow velocity.

### Claim 6 (depends on 1)

The blood oxygenator of claim 1, further comprising a control system configured to adjust the flow rate of the sweep gas based on the oxygen saturation levels detected in the blood exiting the blood outlet.

### Claim 7 (depends on 1)

The blood oxygenator of claim 1, wherein the fiber bundle is configured to have a porosity ranging from 0.4 to 0.7 to optimize the diffusion of gases.

### Claim 8

A compact blood oxygenator for ambulatory use, comprising:
a cylindrical housing with integrated inlet and outlet ports for blood and gas positioned to facilitate vertical blood flow through the device;
a blood inlet at the lower end of the housing and a blood outlet at the upper end of the housing;
a fiber bundle comprising gas-exchange membranes configured to transfer oxygen to the blood and remove carbon dioxide, wherein the fiber bundle is arranged in a cylindrical configuration within the housing; and
a spiral volute configured to direct blood entering through the blood inlet to flow in a helical pattern around the fiber bundle before passing radially inward through the fiber bundle.

### Claim 9 (depends on 8)

The compact blood oxygenator of claim 8, further comprising a heat exchange element integrated within the housing and positioned to regulate the temperature of blood before it enters the fiber bundle, wherein the heat exchange element comprises a series of capillaries that circulate a temperature-controlled fluid.

### Claim 10 (depends on 8)

The blood oxygenator of claim 8, wherein the fiber bundle is arranged to provide a radial flow path for the blood from the outer diameter towards the inner diameter of the cylindrical configuration.

### Claim 11 (depends on 8)

The blood oxygenator of claim 8, wherein the blood inlet includes a filter configured to remove particulate matter from the blood prior to entering the spiral volute.

### Claim 12 (depends on 8)

The blood oxygenator of claim 8, wherein the system is configured for use with a wearable power supply to facilitate ambulatory use.

### Claim 13

A method for oxygenating blood in an ambulatory setting, comprising:
providing a blood oxygenator comprising a cylindrical housing, a spiral volute, a fiber bundle with gas-exchange membranes, and an integrated heat exchanger;
introducing blood into the blood oxygenator through a blood inlet at a bottom of the housing;
directing the blood to flow helically around the fiber bundle via the spiral volute to ensure uniform distribution of blood across the fiber bundle;
transferring oxygen to the blood and removing carbon dioxide from the blood via the gas-exchange membranes as the blood flows radially through the fiber bundle;
regulating the temperature of the blood using the integrated heat exchanger before the blood contacts the fiber bundle; and
discharging the oxygenated and temperature-regulated blood from a blood outlet at a top of the housing.

### Claim 14 (depends on 13)

The method of claim 13, wherein the step of introducing blood into the blood oxygenator includes pre-filtering the blood to remove debris before it enters the blood inlet.

### Claim 15 (depends on 13)

The method of claim 13, wherein the step of transferring oxygen to the blood and removing carbon dioxide includes adjusting the flow rate of the sweep gas based on real-time blood gas analysis results.

### Claim 16 (depends on 13)

The method of claim 13, wherein the step of regulating the temperature of the blood uses a feedback system that adjusts the temperature based on continuous temperature measurements of the blood exiting the blood oxygenator.
