EP-4736904-A2 - BLOOD OXYGENATOR

EP4736904A2EP 4736904 A2EP4736904 A2EP 4736904A2EP-4736904-A2

Abstract

An oxygenator including a housing defining an interior having improved gas exchange fluid pathways and/or heat exchange fluid pathways is disclosed. In some instances, the oxygenator includes a gas exchange fluid pathway for passing a gas sequentially from a gas exchange fluid inlet, through one or more layers of gas exchange fibers extending in a first direction, through one or more layers of gas exchange fibers extending in a second direction, and out a gas exchange fluid outlet. In some instances, the oxygenator includes a partition dividing the interior between a gas exchange chamber and a gas-and-heat exchange chamber. In some instances, the housing includes an insulating fluid barrier chamber configured to be filled with a flowing heat exchange fluid from the heat exchange fluid inlet to provide an insulating barrier between outflow ends of the gas exchange fibers and the gas exchange fluid outlet.

Inventors

PANDOLFINI, Clara
Madonia, Francesco
Galavotti, Andrea

Assignees

Sorin Group Italia S.r.l.

Dates

Publication Date: 20260506
Application Date: 20251001

Claims (20)

An oxygenator, comprising: a housing defining an internal chamber; a plurality gas exchange fibers within in the internal chamber; the plurality of gas exchange fibers including one or more layers of gas exchange fibers extending in a first direction and one or more layers of gas exchange fibers extending in a second direction, the second direction being generally orthogonal to the first direction; a gas exchange fluid inlet; a gas exchange fluid outlet; and a gas exchange fluid pathway for passing a gas through the plurality of gas exchange fibers to oxygenate blood within the internal chamber, the gas exchange fluid pathway passing sequentially from the gas exchange fluid inlet, through the one or more layers of gas exchange fibers extending in the first direction, through the one or more layers of gas exchange fibers extending in the second direction, and out the gas exchange fluid outlet.
The oxygenator of claim 1, wherein the housing includes a first side, a second side opposite the first side, a third side extending between the first side and the second side, and a fourth side extending between the first side and the second side, and opposite the third side; and wherein the gas exchange fluid pathway passes through the one or more layers of gas exchange fibers extending in the first direction from the fourth side to the third side, and then the gas exchange fluid pathway passes through the one or more layers of gas exchange fibers extending in the second direction from the first side to the second side.
The oxygenator of claim 2, wherein a first velocity of a gas exchange fluid flowing through the one or more layers of gas exchange fibers extending in the first direction from the fourth side to the third side is greater than a second velocity of the gas exchange fluid flowing through the one or more layers of gas exchange fibers extending in the second direction from the first side to the second side.
The oxygenator of claim 3, wherein the first velocity is 1.25 times or more the velocity of the second velocity.
The oxygenator of claim 1, further comprising a gas exchange fluid passage defined in the housing between gas outflow ends of the one or more layers of gas exchange fibers extending in the first direction and gas inflow ends of the one or more layers of gas exchange fibers extending in the second direction.
The oxygenator of claim 1, wherein the internal chamber is a gas exchange chamber, and the housing includes a second internal chamber which is a gas-and-heat exchange chamber, wherein the gas-and-heat exchange chamber includes a plurality of gas exchange fibers within the gas-and-heat exchange chamber and a plurality of heat exchange fibers within the gas-and-heat exchange chamber.
The oxygenator of claim 6, further comprising a partition between the gas exchange chamber and the gas-and-heat exchange chamber.
The oxygenator of claim 6, wherein the housing includes a blood inlet in fluid communication with the gas-and-heat exchange chamber and a blood outlet in fluid communication with the gas exchange chamber.
The oxygenator of claim 8, wherein a blood flow path passes sequentially from the blood inlet, through the gas-and-heat exchange chamber, through the gas exchange chamber, and out the blood outlet.
The oxygenator of claim 6, wherein the plurality of heat exchange fibers in the gas-and-heat exchange chamber are arranged in the first direction, and the plurality of gas exchange fibers in the gas-and-heat exchange chamber are arranged in the second direction.
The oxygenator of claim 1, wherein the housing includes a first side, a second side opposite the first side, a third side extending between the first side and the second side, and a fourth side extending between the first side and the second side, and opposite the third side; wherein the gas exchange fluid pathway passes through the one or more layers of gas exchange fibers extending in the first direction from the fourth side to the third side, and then the gas exchange fluid pathway passes through the one or more layers of gas exchange fibers extending in the second direction from the first side to the second side; and wherein the second side includes an insulating fluid barrier chamber configured to be filled with a flowing heat exchange fluid.
The oxygenator of claim 11, wherein the housing includes a heat exchange fluid port in fluid communication with the insulating fluid barrier chamber.
The oxygenator of claim 12, wherein the heat exchange fluid port and the gas exchange fluid outlet are both located on the second side of the housing.
The oxygenator of claim 11, wherein the insulating fluid barrier chamber is positioned between an outflow of the one or more layers of gas exchange fibers extending in the second direction at the second side and an exterior of the second side of the housing.
An oxygenator, comprising: a housing defining an interior, the interior including a gas exchange chamber and a gas-and-heat exchange chamber, a partition between the gas exchange chamber and the gas-and-heat exchange chamber; a plurality of gas exchange fibers within the gas exchange chamber; a plurality of gas exchange fibers within the gas-and-heat exchange chamber; and a plurality of heat exchange fibers arranged in the gas-and-heat exchange chamber.
The oxygenator of claim 15, wherein the plurality of gas exchange fibers within the gas exchange chamber include: one or more layers of gas exchange fibers extending in a first direction; and one or more layers of gas exchange fibers extending in a second direction, wherein the second direction is generally orthogonal to the first direction.
The oxygenator of claim 16, wherein a gas exchange fluid pathway for passing a gas through the plurality of gas exchange fibers in the gas exchange chamber to oxygenate blood within the in the gas exchange chamber sequentially passes through the one or more layers of gas exchange fibers extending in the first direction and thereafter through the one or more layers of gas exchange fibers extending in the second direction.
The oxygenator of claim 17, wherein a first velocity of a gas exchange fluid flowing through the one or more layers of gas exchange fibers extending in the first direction is greater than a second velocity of the gas exchange fluid flowing through the one or more layers of gas exchange fibers extending in the second direction.
The oxygenator of claim 17, further comprising a gas exchange fluid passage defined in the housing between gas outflow ends of the one or more layers of gas exchange fibers extending in the first direction and gas inflow ends of the one or more layers of gas exchange fibers extending in the second direction.
The oxygenator of claim 16, wherein: the plurality of heat exchange fibers arranged in the gas-and-heat exchange chamber include one or more layers of heat exchange fibers extending in the first direction; and the plurality of gas exchange fibers arranged in the gas-and-heat exchange chamber include one or more layers of gas exchange fibers extending in the second direction.

Description

TECHNICAL FIELD The present disclosure pertains to extracorporeal blood conditioning devices, such as blood oxygenators. More particularly, the present disclosure pertains to blood oxygenators, the construction and use thereof, which provide improved fluid flow paths therethrough. BACKGROUND Blood perfusion typically entails pumping blood through the blood vessels of the body of a patient using one or more pumps in an extracorporeal circuit that is interconnected with the vascular system of the patient. The extracorporeal circuit typically includes an oxygenator, such as a hollow fiber blood oxygenator, used to exchange oxygen (O2) and carbon dioxide (CO2) in extracorporeal circulation of the blood from the patient. Cardiopulmonary bypass surgery typically requires a perfusion system that provides for the temporary cessation of the heart to create a still operating field by replacing the function of the heart and lungs. Such isolation allows for the surgical correction of vascular stenosis, valvular disorders, congenital heart defects, and other medical procedures. In perfusion systems used for cardiopulmonary bypass surgery, an extracorporeal blood circuit is established that includes at least one pump and an oxygenation device to replace the functions of the heart and lungs. More specifically, in cardiopulmonary bypass procedures oxygen-poor blood, i.e., venous blood, is gravity-drained or vacuum suctioned from a large vein entering the heart or other veins in the body (e.g., femoral) and is transferred through a venous line in the extracorporeal circuit. The venous blood is pumped to an oxygenator that provides for oxygen transfer to the blood. Oxygen may be introduced into the blood by transfer across a membrane or, less frequently, by bubbling oxygen through the blood. Concurrently, carbon dioxide is removed across the membrane. The oxygenated blood is filtered and then returned through an arterial line to the aorta, femoral artery, or other artery of the patient. There are many drawbacks to currently available oxygenators. For example, there is an ongoing need to improve the efficiency of oxygen exchange from the gas-exchange fibers into the blood passing through the oxygenator. Additionally, during the use of an oxygenator, vapor condensation may occur within the gas-exchange fibers of the oxygenator, leading to a progressive decrease in performance of gas exchange within the oxygenator. Accordingly, there is an ongoing need for alternative oxygenator configurations which may increase the efficiency of the oxygenator, reduce vapor condensation, or otherwise improve the performance of the oxygenator. BRIEF SUMMARY This disclosure provides design, material, manufacturing method, and use alternatives for blood oxygenators. A first example is an oxygenator including a housing defining an internal chamber. A plurality gas exchange fibers are disposed within in the internal chamber. The plurality of gas exchange fibers include one or more layers of gas exchange fibers extending in a first direction and one or more layers of gas exchange fibers extending in a second direction. The second direction is generally orthogonal to the first direction. The oxygenator also includes a gas exchange fluid inlet and a gas exchange fluid outlet. A gas exchange fluid pathway is provided for passing a gas through the plurality of gas exchange fibers to oxygenate blood within the internal chamber. The gas exchange fluid pathway passes sequentially from the gas exchange fluid inlet, through the one or more layers of gas exchange fibers extending in the first direction, through the one or more layers of gas exchange fibers extending in the second direction, and out the gas exchange fluid outlet. Alternatively or additionally to any of the examples herein, in another example, the housing includes a first side, a second side opposite the first side, a third side extending between the first side and the second side, and a fourth side extending between the first side and the second side, and opposite the third side. The gas exchange fluid pathway passes through the one or more layers of gas exchange fibers extending in the first direction from the fourth side to the third side, and then the gas exchange fluid pathway passes through the one or more layers of gas exchange fibers extending in the second direction from the first side to the second side. Alternatively or additionally to any of the examples herein, a first velocity of a gas exchange fluid flowing through the one or more layers of gas exchange fibers extending in the first direction from the fourth side to the third side is greater than a second velocity of the gas exchange fluid flowing through the one or more layers of gas exchange fibers extending in the second direction from the first side to the second side. Alternatively or additionally to any of the examples herein, the first velocity is 1.25 times or more the velocity of the second velocity. Alternatively or add