Blood oxygenation system and reservoir and method of manufacture

A combination of an integral blood oxygenating and heat exchanging apparatus for oxygenating blood and heating or cooling blood with a mounting device that brings a source of oxygen rich gas and heat-exchanging fluid into fluid communication with the apparatus;

• the apparatus comprising:
• a separation medium comprising hollow fibers for separating blood and gas while permitting transfer of oxygen and carbon dioxide across the medium to oxygenate the blood, the separation medium being arranged in an array having opposite ends, the hollow fibers having internal lumens with open ends open at the opposite ends of the separation medium such that gas may flow through the lumens of the hollow fibers;
• a heat exchanging barrier for separating blood and a heat-exchanging fluid while permitting heat transfer across the barrier to heat or cool the blood, the barrier having opposite ends positioned generally adjacent and generally aligned with the opposite ends of the separation medium, the heat exchanging barrier having at least one internal lumen with open ends open at the opposite ends of the heat exchanging barrier;
• a housing holding the separation medium and the heat exchanging barrier, the housing being formed into a configuration corresponding to the separation medium and the heat exchanging barrier without enclosing the open ends of the lumens of the hollow fibers of the separation medium and the open ends of the lumen of the heat exchanging barrier;
• and
• potting compound sealing the housing adjacent the ends of the separation medium and heat exchanging barrier without closing the open ends of the lumens of the hollow fibers of the separation medium and the open ends of the lumen of the heat exchanging barrier;
• a blood inlet and outlet into the housing defining a blood flow path inside the housing across the separation medium outside of the hollow fibers and along the outside of the heat exchanging barrier;
• and
• the open ends of the lumens of the hollow fibers and the open ends of the lumen of the heat exchanging barrier opening directly into the environment outside the housing to allow them to be brought into direct fluid communication with the device;
• the mounting device comprising:
• a mounting bracket for releasably receiving and supporting the apparatus, the mounting bracket being configured to closely receive the apparatus to support the weight of the apparatus;
• means in the mounting bracket for engaging the apparatus to form a seal with the apparatus adjacent the open ends of the lumens of the hollow fibers of the separation medium and to bring the lumens of the hollow fibers into fluid communication with a source of oxygen rich gas;
• and
• means in the mounting bracket for engaging the apparatus to form a seal with the apparatus adjacent the open ends of the lumen of the heat exchanging barrier and to bring the lumen of the heat exchanging barrier into fluid communication with a source of heat exchanging fluid.

An extracorporeal circulatory support circuit for supporting a patient during cardiopulmonary bypass, the circuit comprising:

• blood reservoir having a defoaming and filtering chamber and a blood storage chamber in fluid communication with the defoaming and filtering chamber, the reservoir having at least one cardiotomy blood inlet and at least one venous blood inlet into the defoaming and filtering chamber and an outlet for draining the blood storage chamber, the defoaming and filtering chamber including defoaming and filtering mediums;
• and
• an integral blood oxygenating and heat exchanging apparatus for oxygenating blood and heating or cooling blood, the apparatus being adapted to be operatively connected with a device that brings a source of oxygen rich gas and heat-exchanging fluid into fluid communication with the apparatus, the apparatus comprising:
• a separation medium comprising hollow fibers for separating blood and gas while permitting transfer of oxygen and carbon dioxide across the medium to oxygenate the blood, the separation medium being arranged in an array having opposite ends, the hollow fibers having internal lumens with open ends open at the opposite ends of the separation medium such that gas may flow through the lumens of the hollow fibers;
• a heat exchanging barrier for separating blood and a heat-exchanging fluid while permitting heat transfer across the barrier to heat or cool the blood, the barrier having opposite ends positioned generally adjacent and generally aligned with the opposite ends of the separation medium, the heat exchanging barrier having at least one internal lumen with open ends open at the opposite ends of the heat exchanging barrier;
• a housing holding the separation medium and the heat exchanging barrier, the housing being formed into a configuration corresponding to the separation medium and heat exchanging barrier without enclosing the open ends of the lumens of the hollow fibers of the separation medium and the open ends of the lumen of the heat exchanging barrier;
• potting compound sealing the housing adjacent the ends of the separation medium and heat exchanging barrier without closing the open ends of the lumens of the hollow fibers of the separation medium and the open ends of the lumen of the heat exchanging barrier;
• and
• a blood inlet and outlet into the portion of the housing holding the separation medium and heat exchanging barrier, the blood inlet and outlet defining a blood flow path inside the housing across the separation medium outside of the hollow fibers and along the outside of the heat exchanging barrier;
• and
• the open ends of the lumens of the hollow fibers and the open ends of the lumen of the heat exchanging barrier being open to allow them to be brought into direct fluid communication with the device;
• the blood inlet of the apparatus being in fluid communication with the blood outlet of the reservoir.