Blood oxygenation system and reservoir and method of manufacture

• US 5,514,335 A
• Filed: 10/25/1993
• Issued: 05/07/1996
• Est. Priority Date: 10/25/1993
• Status: Expired due to Fees

• Current Assignee: Terumo Cardiovascular Systems Corporation (Terumo Corporation)
• Original Assignee: 3M Company
• Inventors: Maurer, David B., Viitala, Daniel W., Lindsay, Erin J., Leonard, Ronald J.
• Primary Examiner(s): McMahon, Timothy M.
• Assistant Examiner(s): BHAT, NINA NMN
• Application Number:
  US08/142,809
• Time in Patent Office: 925 Days
• Field of Search: 422/46, 422/48, 210/321.6, 210/321.8, 210/646, 210/321.86, 165/96, 604/4, 604/5, 604/406
• US Class Current: 422/46
• CPC Class Codes: A61M 1/1625 Dialyser of the outside perfusion type, i.e. blood flow outside hollow membrane fibres or tubes
• CPC Class Codes: A61M 1/1629 with integral heat exchanger
• CPC Class Codes: 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
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3623 Means for actively controlling temperature of blood
• CPC Class Codes: A61M 1/3627 Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• CPC Class Codes: A61M 1/3632 Combined venous-cardiotomy reservoirs
• CPC Class Codes: A61M 2209/082 Mounting brackets, arm supports for equipment
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/232 Centrifugal pumps
• CPC Class Codes: A61M 60/279 Peristaltic pumps, e.g. roller pumps
• CPC Class Codes: A61M 60/38 Blood oxygenation
• CPC Class Codes: A61M 60/851 Valves
• CPC Class Codes: B01D 2313/221 Heat exchangers
• CPC Class Codes: B01D 2313/50 Specific extra tanks
• CPC Class Codes: B01D 63/02 Hollow fibre modules
• CPC Class Codes: Y10S 128/13 Infusion monitoring

Abstract

A novel integral cardiotomy/venous blood reservoir, blood oxygenator and heat exchanging device, method of making a blood oxygenating and heat exchanging device and an extracorporeal circulatory support circuit. The reservoir includes a novel blood defoaming and filtering chamber closely receiving filtering and defoaming media. The blood oxygenating and heat exchanging device includes thermal formed housing portions, and a heat exchanging barrier, blood oxygenating medium and/or filtering medium, which are sealed by potting compound at one time. The oxygenating medium comprises a hollow fiber type medium, with its ends left open to be sealingly mounted in a gas path by a novel mounting bracket.

Claims

1. 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 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.

2. Apparatus according to claim 1 wherein the housing includes opposite walls along opposite sides of the separation medium, the blood flow path being defined between the opposite walls of the housing along the outside of the hollow fibers of the separation medium, the opposite walls being resiliently-flexible within a range of flexure to allow the opposite walls to be compressed toward one another to adjust oxygenation of blood flowing through the blood flow path.

3. An apparatus according to claim 1 wherein the housing is formed of thermoplastic material that is vacuum formed to closely receive the separation medium and heat exchanging barrier.

4. 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.

5. A combination according to claim 4 wherein:

the housing of the apparatus includes opposite walls along opposite sides of the separation medium, the blood flow path being defined between the opposite walls of the housing along one surface of the separation medium, the opposite walls being resiliently-flexible within a range of flexure to allow the opposite walls to be compressed toward one another to adjust oxygenation of blood flowing through the blood flow path; and

the device further includes means in the mounting bracket for compressing the opposite walls of the housing toward one another to adjust oxygenation of blood flowing through the blood flow path.

6. A combination according to claim 4 wherein the mounting bracket supports the housing of the apparatus against internal pressure in the housing.

7. 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.

8. A circuit according to claim 7 further comprising a blood conduit bringing the outlet of the reservoir into fluid communication with the blood inlet of the apparatus, the blood conduit being adapted for pumping the blood through the blood conduit from the reservoir into the housing of the apparatus.

9. A circuit according to claim 8 further comprising a centrifugal blood pump mounted along the blood conduit to pump blood from the reservoir through the apparatus;

the housing of the apparatus being formed of at least one sheet of thermoplastic material thermal 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, the sheet of thermoplastic material forming the housing also including a portion holding the centrifugal blood pump.

10. A circuit according to claim 9 wherein the centrifugal blood pump is releasably held on the sheet of thermoplastic material.

11. A circuit according to claim 8 wherein the blood conduit is formed of resiliently flexible tubing which is adapted to be placed in a positive displacement roller pump to pump blood from the reservoir through the housing of the apparatus.

12. A circuit according to claim 7 wherein the housing of the apparatus includes opposite walls along opposite sides of the separation medium, the blood flow path being defined between the opposite walls of the housing along one surface of the separation medium, the opposite walls being resiliently-flexible within a range of flexure to allow the opposite walls to be compressed toward one another to adjust oxygenation of blood flowing through the blood flow path.

13. A circuit according to claim 7 further comprising a device that brings a source of oxygen rich gas and heat-exchanging fluid into fluid communication with the apparatus, the device comprising:

a mounting bracket for releasably receiving and supporting the apparatus, the mounting bracket being configured to closely receive the housing of the apparatus to support the weight of the apparatus and support the housing of the apparatus against internal pressure in the housing;

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.

14. A circuit according to claim 13 wherein:

the housing of the apparatus includes opposite walls along opposite sides of the separation medium, the blood flow path being defined between the opposite walls of the housing along one surface of the separation medium, the opposite walls being resiliently-flexible within a range of flexure to allow the opposite walls to be compressed toward one another to adjust oxygenation of blood flowing through the blood flow path; and

the device further includes means in the mounting bracket for compressing the opposite walls of the housing of the apparatus toward one another to adjust oxygenation of blood flowing through the blood flow path.

15. A circuit according to claim 7 wherein the housing of the apparatus is formed of thermoplastic material that is vacuum formed to closely receive the separation medium and heat exchanging barrier.

16. A circuit according to claim 7 wherein the reservoir is mounted on the apparatus above the apparatus.

17. A circuit according to claim 16 further comprising an elongate clip mounting the reservoir on the apparatus.

18. A circuit according to claim 7 wherein the reservoir further comprises:

a housing having walls defining two interior chambers including the blood storage chamber and the defoaming and filtering chamber, each chamber having a top and a bottom, the blood storage chamber and defoaming and filtering chamber being separated from one another by a generally vertical dividing wall formed of substantially liquid impervious material, the dividing wall having a vent generally adjacent the top of the defoaming and filtering chamber communicating with the blood storage chamber, and a port generally adjacent the bottom of the defoaming and filtering chamber communicating with the blood storage chamber;

the blood defoaming and filtering mediums of the reservoir comprising;

a blood filtering medium in the defoaming and filtering chamber for filtering blood to remove clots and other undesired matter from the blood, the blood filtering medium being positioned in the defoaming and filtering chamber such that blood entering the defoaming and filtering chamber from the cardiotomy blood inlet must pass through the blood filtering medium; and

a blood defoaming medium taking up substantially the entire space of the defoaming and filtering chamber not occupied by the filtering medium such that blood entering the defoaming and filtering chamber through the cardiotomy blood inlet and venous blood inlet must pass through the blood defoaming medium before exiting the defoaming and filtering chamber through the port.

19. A circuit according to claim 18 wherein the reservoir is mounted on the apparatus above the apparatus.

20. A circuit according to claim 18 wherein the blood filtering medium of the reservoir is positioned such that blood entering the defoaming and filtering chamber through the venous inlet does not pass through the blood filtering medium.

21. A circuit according to claim 20 wherein the reservoir includes a generally vertically extending exterior wall forming, together with the dividing wall, the defoaming and filtering chamber, the cardiotomy blood inlet or inlets being positioned on the exterior wall generally adjacent the top of the defoaming and filtering chamber, and the venous blood inlet or inlets being positioned on the exterior wall generally adjacent the bottom of the defoaming and filtering chamber.

22. A circuit according to claim 21 wherein the walls of the reservoir are formed by thermal forming of thermoplastic material and sealing the walls together along peripheral portions thereof to form the chambers.