WO1995011709B1 - Blood oxygenation system and reservoir and method of manufacture - Google Patents

Blood oxygenation system and reservoir and method of manufacture

Info

Publication number
WO1995011709B1
WO1995011709B1 PCT/US1994/011664 US9411664W WO9511709B1 WO 1995011709 B1 WO1995011709 B1 WO 1995011709B1 US 9411664 W US9411664 W US 9411664W WO 9511709 B1 WO9511709 B1 WO 9511709B1
Authority
WO
WIPO (PCT)
Prior art keywords
blood
heat exchanging
separation medium
housing
barrier
Prior art date
Application number
PCT/US1994/011664
Other languages
French (fr)
Other versions
WO1995011709A2 (en
WO1995011709A3 (en
Filing date
Publication date
Priority claimed from US08/142,809 external-priority patent/US5514335A/en
Application filed filed Critical
Priority to EP94931845A priority Critical patent/EP0725657B1/en
Priority to DE69422997T priority patent/DE69422997T2/en
Priority to JP51267295A priority patent/JP3532568B2/en
Publication of WO1995011709A2 publication Critical patent/WO1995011709A2/en
Publication of WO1995011709A3 publication Critical patent/WO1995011709A3/en
Publication of WO1995011709B1 publication Critical patent/WO1995011709B1/en

Links

Abstract

A novel integral cardiotomy/venous blood reservoir (100; 200), blood oxygenator and heat exchanging device (24; 26; 40; 52; 300; 400; 502), method of making a blood oxygenating and heat exchanging device and an extracorporeal circulatory support circuit. The reservoir (100; 200) includes a novel blood defoaming and filtering chamber (106) closely receiving filtering and defoaming media (122; 124). The blood oxygenating and heat exchanging device (24; 26; 40; 52; 300; 400; 502) includes thermal formed housing portions (306; 308; 406; 408), and a heat exchanging barrier (312; 412), blood oxygenating medium (310; 410) and/or filtering medium (413), which are sealed by potting compound (326; 426) at one time. The oxygenating medium (310; 410) comprises a hollow fiber type medium (310; 410), with its ends left open to be sealingly mounted in a gas path by a novel mounting bracket (36; 48; 76).

Claims

AMENDED CLAIMS [received by the International Bureau on 7 July 1995 (07.07.95); original claims 7, 11, 19 and 23 cancelled; original claim 6 amended; original claims 8-10, 14-18 and 19-22 amended and renumbered as claims 7-9, 12-16 and 17-19; original claims 12 and 13 unchanged but renumbered as claims 10 and 11; remaining claims unchanged (12 pages)]
1. An integral venous blood and cardiotomy reservoir (100; 200; 500) for use in an extracorporeal circulatory support circuit, the reservoir (100; 200; 500) comprising;
a housing (102) having walls defining two
interior chambers (104 and 106) including a blood storage chamber (104 and 106) and a defoaming and filtering
chamber (106), each chamber (104 and 106) having a top and a bottom, the blood storage chamber (104) and defoaming and filtering chamber (106) being separated from one another by a generally vertical dividing wall (108) formed of substantially liquid impervious material, the dividing wall (108) having a vent (110) generally adjacent the top of the defoaming and filtering chamber (106) communicating with the blood storage chamber (104), and a port (112) generally adjacent the bottom of the defoaming and
filtering chamber (106) communicating with the blood storage chamber (104);
at least one cardiotomy blood inlet (116; 210) communicating with the defoaming and filtering chamber (106) for supplying scavenged blood to the reservoir (100; 200; 500), and at least one venous blood inlet (118; 214) communicating with the defoaming and filtering chamber (106);
a blood filtering medium (122) in the defoaming and filtering chamber (106) for filtering the blood to remove clots and other undesired matter from the blood, the blood filtering medium (122) being positioned in the defoaming and filtering chamber (106) such that blood entering the defoaming and filtering chamber (106) from the cardiotomy blood inlet (116; 210) must pass through the blood filtering medium (122); and a blood defoaming medium (124) taking up substantially the entire space of the defoaming and filtering chamber (106) not occupied by the filtering medium (122) such that blood entering the defoaming and filtering chamber (106) through the cardiotomy blood inlet
(116; 210) and venous blood inlet (118; 214) must pass through the blood defoaming medium (124) before exiting the defoaming and filtering chamber (106) through the port
(112).
2. A reservoir (100; 200; 500) according to claim 1 further characterized in that the blood filtering medium (122) is positioned such that blood entering the defoaming and filtering chamber (106) through the venous inlet (118; 214) does not pass through the blood filtering medium (122).
3. A reservoir (100; 200; 500) according to claims 1 or 2 further characterized in that the reservoir (100; 200; 500) includes a generally vertically extending exterior wall (114) forming, together with the dividing wall (108), the defoaming and filtering chamber (106), the cardiotomy blood inlet or inlets (116; 210) being
positioned on the exterior wail (114) generally adjacent the top of the defoaming and filtering chamber (106), and the venous blood inlet or inlets (118; 214) being
positioned on the exterior wall (114) generally adjacent the bottom of the defoaming and filtering chamber (106).
4. A reservoir (100; 200; 500) according to any of claims 1-3- further characterized in that the walls of the reservoir (100; 200; 500) are formed by thermal forming of thermoplastic material and sealing the walls together along peripheral portions thereof to form the chambers (104 and 106).
5. A reservoir (100; 200; 500) according to any of claims 1-4 further characterized in that the reservoir (100; 200; 500) further comprises an outlet (120) adjacent the bottom of the blood storage chamber (104)
communicating with the interior of the blood storage chamber (104) for draining blood from the blood storage chamber (104).
6. 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 (24; 26; 40, 52; 300; 400; 502) that brings a source of oxygen rich gas and heat-exchanging fluid into fluid communication with the apparatus, the apparatus comprising:
a separation medium (310; 410) comprising hollow fibers for separating blood and gas while permitting transfer of oxygen and carbon dioxide across the medium (310; 410) to oxygenate the blood, the separation medium (310; 410) 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 (312; 412) for separating blood and a heat-exchanging fluid while permitting heat transfer across the barrier (312; 412) to heat or cool the blood, the barrier (312; 412) having opposite ends positioned generally adjacent and generally aligned with the opposite ends of the separation medium (310; 410), 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 (46; 306; 308; 406; 408) holding the separation medium (310; 410) and the heat exchanging barrier (312; 412), the housing (46; 306; 308; 406; 408) being formed into a configuration corresponding to the separation medium (310; 410) and the heat exchanging barrier (312; 412) 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 (326; 426) sealing the housing
(46; 306; 308; 406; 408) adjacent the ends of the
separation medium (310; 410) and heat exchanging barrier (312; 412) 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 (334; 434) and outlet (336; 437; 439) into the housing (46; 306; 308; 406; 408) defining a blood flow path inside the housing across the separation medium (310; 410) outside of the hollow fibers and along the outside of the heat exchanging barrier (312; 412); and the open ends of the lumens of the hollow fibers and the open ends of the lumen of the heat exchanging barrier opening into the environment outside the housing to allow them to be brought into direct fluid
communication with the device.
7. Apparatus according to claim 6 wherein the housing (46; 306; 308; 406; 408) includes opposite walls (306; 308; 406; 408) along opposite sides of the
separation medium (310; 410), the blood flow path being defined between the opposite walls (306; 308; 406; 408) of the housing (46; 306; 308; 406; 408) along the outside of the hollow fibers of the separation medium (310; 410), the opposite walls (306; 308, 406; 408) being resiliently-flexible within a range of flexure to allow the opposite wails (306; 308; 406; 408) to be compressed toward one another to adjust oxygenation of blood flowing through the blood flow path.
8. A combination of an integral blood oxygenating and heat exchanging apparatus according to claim 6 with a mounting device that brings a source of oxygen rich gas and heat-exchanging fluid into fluid communication with the apparatus,
the mounting device comprising:
a mounting bracket (36; 48; 76) for releasably receiving and supporting the apparatus (24; 26; 40; 52; 300; 400; 502), the mounting bracket (36; 48; 76) being configured to closely receive the apparatus (24; 26; 40; 52; 300; 400; 502) to support the weight of the apparatus (24; 26; 40; 52; 300; 400; 502);
means in the mounting bracket (36; 48; 76) for engaging the apparatus (24; 26; 40; 52; 300; 400; 502) to form a seal with the apparatus (24; 26; 40; 52; 300; 400; 502) adjacent the open ends of the lumens of the hollow fibers of the separation medium (310; 410) 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 (36; 48; 76) for engaging the apparatus (24; 26; 40; 52; 300; 400; 502) to form a seal with the apparatus adjacent the open ends of the lumen of the heat exchanging barrier (312; 412) and to bring the lumen of the heat exchanging barrier (312; 412) into fluid communication with a source of heat exchanging fluid.
9. A combination according to claim 8 wherein: the housing (46; 306; 308; 406; 408) of the apparatus (24; 26; 40; 52; 300; 400; 502) includes opposite walls (306; 308; 406; 408) along opposite sides of the separation medium (310; 410), the blood flow path being defined between the opposite walls (306; 308; 406; 408) of the housing (46; 306; 308; 406; 408) along one surface of the separation medium (310; 410), the opposite walls (306; 308; 406; 408) being resiliently-flexible within a range of flexure to allow the opposite walls (306; 308; 406; 408) 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 (36; 48; 76) for compressing the opposite walls (306; 308; 406; 408) of the housing (46; 306; 308; 406; 408) toward one another to adjust oxygenation of blood flowing through the blood flow path.
10. A method of forming an integral blood oxygenating and heat exchanging apparatus, the method comprising the following steps:
(a) providing a separation medium (310; 410) for separating blood and gas from one another while allowing oxygen and carbon dioxide transfer across the separation medium (310; 410), the separation medium (310; 410) having opposite ends;
(b) providing a heat exchanging barrier (312; 412) for separating blood and heat exchanging fluid from one another while allowing heat transfer therebetween across the heat exchanging barrier (312; 412), the heat exchanging barrier (312; 412) having opposite ends;
(c) thermal forming at least one sheet (306; 308; 406; 408) of thermoplastic material to form a housing for receiving the separation medium (310; 410) and heat exchanging barrier (312; 412) with the opposite ends of the separation medium (310; 410) and heat exchanging barrier (312; 412) generally adjacent and generally aligned with one another, the housing forming a channel (320; 420) for directing potting compound (326; 426) adjacent the opposite ends of the separation medium (310; 410) and heat exchanging barrier (312; 412);
(d) placing the separation medium (310; 410) and the heat exchanging barrier (312; 412) between the sheets
(306; 308; 406; 408) forming the housing;
(e) sealing the sheets (306; 308; 406; 408) together to form an assembly comprising the housing, separation medium (310; 410) and heat exchanging barrier (312; 412);
(f) placing the assembly in a centrifuge (188);
(g) spinning the assembly in the centrifuge (188) with the opposite ends of the separation medium (310, 410) and heat exchanging barrier (312; 412) along opposite sides of the axis of rotation;
(h) pouring uncured potting compound into the channel (320; 420) of the housing while the assembly is spinning in the centrifuge (188); and
(i) continue spinning the assembly in the centrifuge (188) until after the potting compound
solidifies.
11. A method according to claim 10 further comprising providing a kiln (188) surrounding the
centrifuge (188); and
during the steps (g), (h) and (i), heating the assembly in the kiln (188) while the centrifuge (188) spins the assembly until the potting compound (320; 420) is cured.
12. 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 inco 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 (310; 410) comprising hollow fibers for separating blood and gas while permitting transfer of oxygen and carbon dioxide across the medium (310; 410) to oxygenate the blood, the separation medium (310; 410) 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 (312; 412) for separating blood and a heat-exchanging fluid while permitting heat transfer across the barrier (312; 412) to heat or cool the blood, the barrier (312; 412) having opposite ends positioned generally adjacent and generally aligned with the opposite ends of the separation medium (310; 410), 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.
13. A circuit according to claim 12 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.
14. A circuit according to claim 13 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.
15. A circuit according to claim 14 wherein the centrifugal blood pump is releasably held on the sheet of thermoplastic material.
16. A circuit according to claim 13 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.
17. A circuit according to claim 12 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.
18. A circuit according to claim 12 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 (36; 48; 76) for releasably receiving and supporting the apparatus, the mounting bracket (36; 48; 76) 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.
19. A circuit according to claim 18 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 (36; 48; 76) 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.
PCT/US1994/011664 1993-10-25 1994-10-21 Blood oxygenation system and reservoir and method of manufacture WO1995011709A2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP94931845A EP0725657B1 (en) 1993-10-25 1994-10-21 Blood oxygenation system and method of manufacture
DE69422997T DE69422997T2 (en) 1993-10-25 1994-10-21 BLOOD OXYGEN SYSTEM AND MANUFACTURING PROCESS
JP51267295A JP3532568B2 (en) 1993-10-25 1994-10-21 Blood oxygenation system and container and method for producing the same

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/142,809 1993-10-25
US08/142,809 US5514335A (en) 1993-10-25 1993-10-25 Blood oxygenation system and reservoir and method of manufacture

Publications (3)

Publication Number Publication Date
WO1995011709A2 WO1995011709A2 (en) 1995-05-04
WO1995011709A3 WO1995011709A3 (en) 1995-06-08
WO1995011709B1 true WO1995011709B1 (en) 1995-08-03

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PCT/US1994/011664 WO1995011709A2 (en) 1993-10-25 1994-10-21 Blood oxygenation system and reservoir and method of manufacture

Country Status (7)

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US (3) US5514335A (en)
EP (1) EP0725657B1 (en)
JP (1) JP3532568B2 (en)
CN (1) CN1133566A (en)
CA (1) CA2173854A1 (en)
DE (1) DE69422997T2 (en)
WO (1) WO1995011709A2 (en)

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