WO2023189099A1 - Poumon artificiel - Google Patents

Poumon artificiel Download PDF

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Publication number
WO2023189099A1
WO2023189099A1 PCT/JP2023/007195 JP2023007195W WO2023189099A1 WO 2023189099 A1 WO2023189099 A1 WO 2023189099A1 JP 2023007195 W JP2023007195 W JP 2023007195W WO 2023189099 A1 WO2023189099 A1 WO 2023189099A1
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Prior art keywords
blood
hollow fiber
density layer
fiber membrane
layer
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PCT/JP2023/007195
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English (en)
Japanese (ja)
Inventor
佐藤仁是
森武寿
田中浩貴
原伊吹
井上淳司
齋藤喬
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テルモ株式会社
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Publication of WO2023189099A1 publication Critical patent/WO2023189099A1/fr

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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D63/00—Apparatus in general for separation processes using semi-permeable membranes
    • B01D63/02—Hollow fibre modules

Definitions

  • the present invention relates to an artificial lung for removing carbon dioxide from blood and adding oxygen to blood via a hollow fiber membrane.
  • German Patent Application No. 10341221 discloses that blood is circulated in the axial direction inside a hollow fiber membrane layer in which hollow fiber membranes are wound in the radial direction, thereby achieving gas exchange and heat exchange of the blood.
  • a parallel flow oxygenator is disclosed.
  • the artificial lung of German Patent Application No. 10341221 includes: a gas exchange section having a hollow fiber membrane that performs gas exchange with blood; first and second housings for accommodating the gas exchange section; and a rotary pump that circulates blood through the hollow fiber membrane.
  • the first housing includes a gas inlet for introducing gas into the first housing, and a gas outlet for leading out the gas that has passed through the gas exchange section.
  • the second housing is disposed on the outer periphery of the first housing and includes a blood inlet through which blood is introduced and a blood outlet through which gas-exchanged blood is taken out.
  • thrombus is likely to form on the outer periphery of the hollow fiber membrane due to the stagnation of the flow in the outer periphery of the gas exchange section facing the first and second housings.
  • the present invention aims to solve the above-mentioned problems.
  • An aspect of the present invention includes a hollow fiber membrane layer formed by winding a hollow fiber membrane; a housing having a blood inflow port, a blood outflow port, and a housing chamber for accommodating the hollow fiber membrane layer, and formed in a cylindrical shape along the axial direction; an artificial lung in which blood flows through the accommodation chamber of the housing along the axial direction,
  • the hollow fiber membrane layer has a general density layer and a high density layer provided on the outer periphery of the general density layer and in which the hollow fiber membrane is wound at a higher density than the general density layer
  • the housing has a wall surrounding the high-density layer and extending in the axial direction, A blood outflow space is provided between the wall portion of the housing and the high-density layer, extending along the axial direction and allowing the blood to flow along the axial direction.
  • the hollow fiber membrane layer of the oxygenator has a high-density layer provided on the outer periphery of the general density layer and wound at a higher density than the general density layer, and the hollow fiber membrane layer of the oxygenator has a high-density layer wound at a higher density than the general density layer, and
  • FIG. 1 is an overall sectional view of an artificial lung according to an embodiment of the present invention.
  • FIG. 2 is an enlarged sectional view of the vicinity of a gas exchange section and a heat exchange section in the oxygenator of FIG. 1.
  • FIG. 3 is a table showing experimental results obtained by changing the resistance coefficient ratio between the first high-density layer and the first general-density layer.
  • FIG. 4 is a table showing experimental results obtained by changing the width dimension of the first blood outflow space.
  • the artificial lung 10 is a medical device that temporarily takes over the function of the lungs during a human heart surgery or other operation or when the heart or lungs experience some kind of malfunction. That is, the artificial lung 10 is a device for adjusting blood temperature, adding oxygen to the blood, and removing carbon dioxide during extracorporeal circulation.
  • the oxygenator 10 includes a housing 12, a heat exchange section 14, and a gas exchange section 16.
  • the housing 12 is formed from a hard resin material.
  • the housing 12 includes a housing body 18 that accommodates the heat exchange section 14 and the gas exchange section 16, and a first cover member 20 that is disposed at one axial end of the housing body 18 (the end in the direction of arrow A in FIG. 1). and a second cover member 22 disposed at the other axial end of the housing body 18 (the end in the direction of arrow B in FIG. 1).
  • the housing body 18 is formed into a cylindrical shape along the axial direction (direction of arrows A and B).
  • the housing body 18 includes a core portion 24 constituting the center portion of the oxygenator 10, an outer cylinder portion 26 disposed on the outer peripheral side of the core portion 24, and a space between the core portion 24 and the outer cylinder portion 26. and an intermediate wall (wall portion) 28 arranged therein.
  • the housing main body 18 has an annular and cylindrical storage chamber 30 extending in the axial direction (direction of arrows A and B).
  • the storage chamber 30 functions as a blood flow path through which blood flows.
  • the core portion 24 includes a first core 32 constituting one axial end of the core, and a second core 34 disposed at the other axial end of the first core 32.
  • the first core 32 and the second core 34 are arranged apart from each other in the axial direction (direction of arrows A and B).
  • the first core 32 has a tubular blood inflow portion 36 and an annular extending wall 38 extending radially outward from the blood inflow portion 36.
  • the blood inflow section 36 has a blood inflow port 40 that protrudes in one direction in the axial direction and into which blood led from the patient flows through a blood flow path (not shown).
  • the second core 34 is formed into a cylindrical shape with a bottom, and includes a cylindrical portion 42 and a closing portion 44 provided at one end of the cylindrical portion 42 in the axial direction.
  • the closing portion 44 faces the extending wall 38 and is arranged with a gap between the extending wall 38 and the extending wall 38 .
  • a blood introduction path 46 is formed between the closing portion 44 and the extending wall 38.
  • the blood introduction path 46 communicates with the blood inflow port 40 at the center, and blood is guided radially outward from the blood inflow port 40 through the blood introduction path 46.
  • the blood introduction path 46 is connected near one axial end of the cylindrical portion 42 and communicates with the storage chamber 30 .
  • the outer cylindrical portion 26 is formed in a cylindrical shape along the axial direction (directions of arrows A and B), and is spaced apart from the core portion 24 in the radial direction.
  • An annular blood outflow portion 50 is provided on the outer peripheral wall (wall portion) 48 of the outer cylinder portion 26 .
  • the blood outflow portion 50 bulges radially outward from the outer peripheral wall 48 .
  • the blood outflow section 50 communicates with a first storage section 54 of the storage chamber 30, which will be described later.
  • a blood outflow port 52 that extends outward, for example, obliquely, is connected to the blood outflow portion 50 .
  • the blood outflow port 52 is connected to a blood flow path to a living body (not shown).
  • the intermediate wall 28 has a cylindrical shape extending along the axial direction (directions of arrows A and B), and is spaced apart from the cylindrical portion 42 of the core portion 24 outward in the radial direction.
  • the intermediate wall 28 is disposed between the core portion 24 and the outer cylinder portion 26.
  • the intermediate wall 28 surrounds a second hollow fiber membrane layer 102 of the heat exchange section 14, which will be described later.
  • the intermediate wall 28 is parallel to the cylindrical portion 42 of the core portion 24 and the outer peripheral wall 48 of the outer cylindrical portion 26 .
  • An annular first accommodating portion 54 constituting the accommodating chamber 30 is provided between the intermediate wall 28 and the outer circumferential wall 48 of the outer cylinder portion 26 . That is, the first accommodating portion 54 is arranged on the outer peripheral side of the intermediate wall 28.
  • the cylindrical gas exchange section 16 is housed in the first housing section 54 .
  • One axial end of the first accommodating portion 54 is sealed with an annular first sealing body 56a.
  • the other axial end of the first housing portion 54 is sealed with an annular first sealing body 56b.
  • the first sealing bodies 56a and 56b are made of urethane or resin material.
  • An annular second accommodating portion 58 that constitutes the accommodating chamber 30 is provided between the intermediate wall 28 and the core portion 24 .
  • the cylindrical heat exchange section 14 is housed in the second housing section 58 . That is, the second accommodating portion 58 is arranged on the inner peripheral side of the intermediate wall 28.
  • the intermediate wall 28 and the outer circumferential wall 48 are parallel, and the first accommodating part 54 and the second accommodating part 58 are arranged in parallel.
  • One axial end of the second accommodating portion 58 is sealed with an annular second sealing body 60a.
  • the other axial end of the second accommodating portion 58 is sealed with an annular second sealing body 60b.
  • the second sealing bodies 60a and 60b are formed from urethane or a resin material. Note that the positions of the gas exchange section 16 and the heat exchange section 14 are not particularly limited, and their positional relationship within the oxygenator 10 may be reversed.
  • annular communication passage 62 that penetrates in the radial direction is formed.
  • the communication path 62 communicates the first accommodating portion 54 and the second accommodating portion 58 .
  • the first cover member 20 is attached to one axial end of the housing body 18 and fixed by adhesive or solvent bonding. One axial end of the heat exchange section 14 and the gas exchange section 16 is covered by the first cover member 20 .
  • the first cover member 20 has a first cover main body 64, a gas inflow part 66, and a heat medium outflow part 68.
  • the first cover body 64 is formed in an annular shape that covers one end of the housing body 18 in the axial direction.
  • the first cover body 64 has an annular first partition wall 70 that partitions the other axial space of the first cover member 20 .
  • the first partition wall 70 extends from the inner surface of the first cover main body 64 toward the other axial direction, and separates the first accommodating portion 54 and the second accommodating portion 58 .
  • the blood inflow portion 36 of the core portion 24 is arranged in the center of the first cover body 64.
  • the gas inflow portion 66 is formed into a tubular shape and is disposed in the first cover main body 64 at a position facing one end of the first accommodating portion 54 in the axial direction.
  • the gas inflow portion 66 protrudes from the first cover main body 64 in one axial direction (arrow A direction).
  • the gas inflow section 66 has a gas inflow port 72 that allows gas to flow into the first housing section 54 .
  • the gas inflow port 72 penetrates the first cover main body 64 and communicates with the inner cavity of each first hollow fiber membrane 88 of the first hollow fiber membrane layer 90 .
  • the gas inflow port 72 is connected to a gas supply path (not shown), and supplies gas into the first accommodating portion 54 through the gas supply path.
  • FIG. 1 shows a mode in which the gas inflow portion 66 protrudes toward one axial direction (direction of arrow A), for example, The portion 66 may protrude toward the other axial direction (arrow B direction).
  • the heat medium outflow portion 68 is formed into a tubular shape and is disposed in the first cover main body 64 at a position facing one axial end portion of the first accommodating portion 54 .
  • the heat medium outflow portion 68 extends radially outward of the first cover main body 64 .
  • the heat medium outflow section 68 has a heat medium outflow port 74 through which the heat medium (for example, water) that has circulated through the heat exchange section 14 flows out of the housing 12 .
  • the heat medium outflow port 74 penetrates the first cover main body 64 and communicates with the inner cavity of each second hollow fiber membrane 100 of the second hollow fiber membrane layer 102 .
  • the arrangement of the heat medium outflow portion 68 is not particularly limited, and for example, the heat medium outflow portion 68 may be provided on the second cover main body 76.
  • the second cover member 22 is attached to the other axial end of the housing body 18 and fixed by adhesive or solvent bonding.
  • the second cover member 22 covers the other end of the heat exchange section 14 and the gas exchange section 16 in the axial direction.
  • the second cover member 22 has a second cover main body 76, a gas outflow section 78, and a heat medium inflow section 80.
  • the second cover body 76 is formed in an annular shape that covers the other end of the housing body 18 in the axial direction.
  • the second cover main body 76 has an annular second partition wall 82 that partitions a space on one side of the second cover member 22 in the axial direction.
  • the gas outlet portion 78 is formed into a tubular shape and is arranged in the second cover main body 76 at a position facing the other end of the first accommodating portion 54 in the axial direction.
  • the gas outlet portion 78 protrudes from the second cover main body 76 in the other axial direction.
  • the gas outlet section 78 has a gas outlet port 84 that allows the gas that has circulated through the gas exchange section 16 to flow out of the housing 12 .
  • the gas outflow port 84 penetrates the second cover main body 76 and communicates with the lumen of each first hollow fiber membrane 88 of the first hollow fiber membrane layer 90 .
  • the direction of the gas outflow port 84 is not particularly limited, and although FIG. 1 shows a mode in which the gas outflow port 84 protrudes toward the other axial direction (arrow B direction), the direction is not limited to this.
  • the gas outflow port 84 may protrude in one axial direction (arrow A direction).
  • the heat medium inflow portion 80 is formed into a tubular shape and is disposed in the second cover main body 76 at a position facing the other axial end portion of the second accommodating portion 58 .
  • the heat medium inflow portion 80 extends radially outward of the second cover main body 76 .
  • the heat medium inflow section 80 has a heat medium inflow port 86 for allowing the heat medium to flow into the heat exchange section 14 of the second housing section 58 .
  • the heat medium inflow port 86 penetrates the second cover main body 76 and communicates with the inner cavity of each second hollow fiber membrane 100 of the second hollow fiber membrane layer 102 .
  • the gas exchange section 16 is for supplying oxygen gas to the blood flowing through the blood flow path and removing carbon dioxide gas from the blood.
  • the gas exchange section 16 has a cylindrical first hollow fiber membrane layer 90 around which a plurality of first hollow fiber membranes 88 are wound.
  • the first hollow fiber membrane 88 has a tubular shape with an inner cavity.
  • a polymeric material such as polypropylene, polyethylene, or polyolefin (polymethylpentene, etc.) is used.
  • Each first hollow fiber membrane 88 is wound around the outer surface of the intermediate wall 28 so as to extend entirely along the axial direction (direction of arrows A and B) of the gas exchange section 16.
  • One axial end of each first hollow fiber membrane 88 penetrates the inside of the first sealing body 56a.
  • An opening at one axial end of the first hollow fiber membrane 88 opens at one axial end of the first sealing body 56 a and communicates with the gas inflow port 72 .
  • the other axial end of each first hollow fiber membrane 88 penetrates the inside of the first sealing body 56b.
  • the opening at the other axial end of the first hollow fiber membrane 88 opens at the other axial end of the first sealing body 56b and communicates with the gas outflow port 84.
  • a first blood passage 92 (see FIG. 2), which is a gap through which blood can flow, is formed outside the first hollow fiber membrane 88 inside the first storage portion 54.
  • the first blood passage 92 is a gap formed between the first hollow fiber membranes 88 adjacent to each other.
  • the first hollow fiber membrane layer 90 includes a first general density layer 94 around which a plurality of first hollow fiber membranes 88 are wound, and a first high density layer 96 disposed on the outer periphery of the first general density layer 94. Equipped with.
  • the first general density layer 94 and the first high density layer 96 together constitute the gas exchange section 16 .
  • the first high-density layer 96 is a layer that constitutes the outer peripheral portion of the first hollow fiber membrane layer 90 and is a layer that includes the first hollow fiber membrane 88 that is disposed most radially outward in the gas exchange section 16. .
  • the first high-density layer 96 is a layer in which the first hollow fiber membranes 88 are wound more densely than the first general-density layer 94 .
  • the resistance coefficient of the first high-density layer 96 to the blood is set as the first resistance coefficient K1
  • the resistance coefficient to the blood is set as the first resistance coefficient K1.
  • the resistance coefficient of the first general density layer 94 is a second resistance coefficient K2
  • the ratio (resistance coefficient ratio) of the first resistance coefficient K1 to the second resistance coefficient K2 is 2.0 or more. confirmed. More specifically, it has been confirmed that it is more preferable to set the ratio of the first resistance coefficient K1 to the second resistance coefficient K2 (resistance coefficient ratio: K1/K2) in the range of 2.0 to 4.0.
  • the resistance coefficient ratio (K1/K2) obtained by dividing the first resistance coefficient K1 by the second resistance coefficient K2 is 1.0
  • the first high-density layer 96 While no thrombus formation was confirmed in the test, it was confirmed that the gas exchange efficiency when exchanging carbon dioxide gas and oxygen gas in the blood was below the standard and was not achieved. It was confirmed that no thrombus was formed in the first general density layer 94 when the resistance coefficient ratio was 2.0 or more. Therefore, by setting the resistance coefficient ratio to 2.0 or more, it is possible to suppress the formation of thrombi in the first general density layer 94.
  • the first high-density layer 96 is arranged in a predetermined range radially inward from the outer circumference in the gas exchange section 16. Further, the width dimension of the first high-density layer 96 is constant along the axial direction of the gas exchange section 16 (direction of arrows A and B). When the gas exchange section 16 is housed in the first housing section 54 , the first high-density layer 96 is arranged facing the outer peripheral wall 48 of the outer cylinder section 26 . A first blood outflow space 98 is provided between the first high-density layer 96 and the outer peripheral wall 48 . Note that at this time, the first general density layer 94 is formed on the radially inner side of the first high density layer 96. The width dimension of the first general density layer 94 is also constant along the axial direction of the gas exchange section 16 (direction of arrows A and B).
  • the first blood outflow space 98 is a gap in which the first high-density layer 96 and the outer peripheral wall 48 are spaced apart in the radial direction, and is an annular space along the circumferential direction of the housing 12.
  • the first blood outflow space 98 is formed to extend along the axial direction (directions of arrows A and B) so that blood can flow along the axial direction.
  • the first blood outflow space 98 is formed over the entire length of the first high-density layer 96 along the axial direction (direction of arrows A and B).
  • the widthwise distance L of the first blood outflow space 98 along the radial direction is approximately constant along the axial direction of the housing body 18 and the gas exchange section 16.
  • the width direction distance L is the separation distance between the first high-density layer 96 and the outer peripheral wall 48 in the first hollow fiber membrane layer 90 along the radial direction.
  • the widthwise distance L of the first blood outflow space 98 is preferably in the range of 0.1 mm to 1.0 mm.
  • the flow rate (outflow amount) of blood flowing out into the first blood outflow space 98 through the first high density layer 96 becomes smaller than the flow rate of blood flowing through the first general density layer 94. increase relatively.
  • the amount of blood flowing through the first blood outflow space 98 increases, and the blood flows linearly along the axial direction in the first blood outflow space 98. Therefore, compared to when blood flows through the first general density layer 94, gas exchange of blood flowing through the first blood outflow space 98 is not performed sufficiently, resulting in a decrease in gas exchange efficiency.
  • the heat exchange section 14 is for exchanging heat between blood flowing through the blood flow path and a heat medium.
  • the heat exchange section 14 is arranged on the inner peripheral side of the gas exchange section 16.
  • the gas exchange section 16 and the heat exchange section 14 are arranged so as to overlap each other in the radial direction.
  • the axial length of the heat exchange section 14 and the axial length of the gas exchange section 16 are the same.
  • the heat exchange section 14 has a cylindrical second hollow fiber membrane layer 102 around which a plurality of second hollow fiber membranes 100 are wound.
  • the second hollow fiber membrane 100 has a tubular shape with an inner cavity. Each second hollow fiber membrane 100 is wound around the outer surface of the second core 34 so as to extend entirely along the axial direction (direction of arrows A and B) of the heat exchange section 14 .
  • a second blood passage 104 (see FIG. 2) through which blood can flow is formed outside the second hollow fiber membrane 100 inside the second storage portion 58.
  • the second blood passage 104 is a gap formed between the second hollow fiber membranes 100 adjacent to each other.
  • each second hollow fiber membrane 100 penetrates the inside of the second sealing body 60a.
  • An opening at one end in the axial direction of the second hollow fiber membrane 100 opens at one end in the axial direction of the second sealing body 60a and communicates with the heat medium outflow port 74.
  • the other axial end of each second hollow fiber membrane 100 penetrates the inside of the second sealing body 60b.
  • the opening at the other axial end of the second hollow fiber membrane 100 opens at the other axial end of the second sealing body 60b and communicates with the heat medium inflow port 86. That is, the heat medium flows through the inner cavities of the plurality of second hollow fiber membranes 100.
  • the second hollow fiber membrane 100 is configured to be impermeable to the heat medium and blood.
  • the material of the second hollow fiber membrane 100 is the same as that of the first hollow fiber membrane 88.
  • the second hollow fiber membrane layer 102 includes a second general density layer 106 around which a plurality of second hollow fiber membranes 100 are wound, and a second high density layer 108 disposed on the outer periphery of the second general density layer 106. Equipped with.
  • the second general density layer 106 and the second high density layer 108 together constitute the heat exchange section 14.
  • the second high-density layer 108 is the layer of the second hollow fiber membrane 100 that is disposed most radially outward in the heat exchange section 14 .
  • the second high-density layer 108 is a layer in which the second hollow fiber membrane 100 is wound more densely than the second general-density layer 106 .
  • the density of the second hollow fiber membrane 100 in the second high density layer 108 is greater than the density of the second hollow fiber membrane 100 in the second general density layer 106.
  • the high-density layer in which the hollow fiber membranes are wound at high density is provided in the gas exchange section 16 having the first hollow fiber membrane layer 90 and the heat exchange section 14 having the second hollow fiber membrane layer 102, respectively.
  • a high-density layer (first high-density layer 96) may be provided only in the gas exchange section 16.
  • the second high-density layer 108 is arranged facing the inner peripheral surface of the intermediate wall 28.
  • a second blood outflow space 110 is formed between the second dense layer 108 and the intermediate wall 28 .
  • the second blood outflow space 110 is an annular space formed by separating the second high-density layer 108 and the intermediate wall 28 in the radial direction, and extending along the circumferential direction of the housing 12.
  • the second blood outflow space 110 is formed to extend along the axial direction (directions of arrows A and B) so that blood can flow along the axial direction.
  • the second blood outflow space 110 is formed over the entire length of the second high-density layer 108 along the axial direction.
  • a heat medium for example, water
  • the heat medium supplied to the heat medium inflow port 86 is introduced into the inner cavity of each second hollow fiber membrane 100 from the other axial end of the heat exchange section 14 in the second storage section 58 .
  • Oxygen gas is supplied to the gas inlet port 72 of the oxygenator 10.
  • the gas supplied to the gas inlet port 72 is introduced into the inner cavity of each first hollow fiber membrane 88 from one axial end of the gas exchange section 16 in the first housing section 54 .
  • the direction of gas inflow is not particularly limited, and may be reversed.
  • Blood led from the patient via the blood flow path is taken into the oxygenator 10 from the blood inflow port 40 by driving a pump (not shown).
  • Blood supplied to the blood inflow port 40 is led to the second storage section 58 via the blood introduction path 46.
  • blood flows along the axial direction (direction of arrow B) from one axial end of the heat exchange section 14 to the other axial end.
  • blood flows through the second blood passage 104 formed between the adjacent second hollow fiber membranes 100, and the heat medium flowing through the inner cavity of each second hollow fiber membrane 100 and the second hollow fiber Heat exchange takes place with the blood flowing outside the membrane 100.
  • blood flowing through the heat exchange section 14 is divided into a main flow M1 flowing axially along the second blood passage 104 (gap) in the second general density layer 106 and a main flow M1 flowing radially outward from the main flow M1.
  • the blood flows towards the blood flow and is divided into a branch flow S1 that flows between the second hollow fiber membranes 100 of the second high-density layer 108 and flows out into the second blood outflow space 110.
  • the branched flow S1 flows toward the other axial direction (arrow B direction) along the second blood outflow space 110.
  • the flow direction of the main flow M1 and the flow direction of the branch flow S1 are the same.
  • the blood that has undergone heat exchange in the heat exchange section 14 flows to the other end in the axial direction in the second storage section 58, and then flows radially outward through the annular communication path 62 to the first storage section. 54.
  • blood flows along the axial direction (direction of arrow A) from the other axial end of the gas exchange section 16 toward one axial end. Blood flows through the first blood passages 92 of each first hollow fiber membrane 88 constituting the gas exchange section 16 .
  • blood flowing through the gas exchange section 16 is divided into a main flow M2 flowing axially along the first blood passage 92 (gap) in the first general density layer 94, and a main flow M2 flowing radially outward from the main flow M2.
  • the blood flows toward the first high-density layer 96 and is divided into a branch flow S2 that flows out into the first blood outflow space 98 through the spaces between the first hollow fiber membranes 88 of the first high-density layer 96.
  • the branched flow S2 flows along the first blood outflow space 98 in one axial direction (arrow A direction).
  • the flow direction of the main flow M2 and the flow direction of the branch flow S2 are the same.
  • the gas flowing through the inner cavity of the first hollow fiber membrane 88 passes through the wall of the first hollow fiber membrane 88 and is supplied to the blood, and the carbon dioxide gas in the blood passes through the first hollow fiber membrane 88. It passes through the wall of the hollow fiber membrane 88 and is discharged inside the first hollow fiber membrane 88 . That is, oxygen gas dissolves in the blood.
  • the blood that has undergone gas exchange flows toward one end in the axial direction, is led out from the blood outflow port 52 to a blood flow path (not shown), and is returned to the patient.
  • the heat medium that has passed through the heat exchange section 14 and has been heat exchanged is led out from one axial end of the heat exchange section 14 to the heat medium outflow port 74 and flows out of the oxygenator 10 .
  • the gas flowing through the gas exchange section 16 is led out from the other axial end of the gas exchange section 16 to the gas outflow port 84 and discharged to the outside of the oxygenator 10 .
  • the embodiment of the present invention includes the housing 12 and the first hollow fiber membrane layer 90 accommodated in the accommodation chamber 30 of the housing 12. a general density layer 94; and a first high density layer 96 provided on the outer periphery of the first general density layer 94 and having a first hollow fiber membrane layer 90 wound around the first general density layer 94 at a high density. Be prepared.
  • a first blood outflow space 98 is provided between the outer peripheral wall 48 of the housing 12 and the first high-density layer 96, through which blood can flow along the axial direction.
  • the first high density layer 96 when blood flows along the axial direction of the first hollow fiber membrane 88, blood (division S2) flows from the first general density layer 94 to the first blood outflow space 98. This prevents the amount from becoming too large. Therefore, the flow rate of blood in the first general density layer 94 can be suitably maintained, and the gas exchange efficiency between blood and gas in the first hollow fiber membrane layer 90 can be maintained.
  • the heat exchange section 14 has a second hollow fiber membrane 100, and the second hollow fiber membrane 100 includes a second general density layer 106 and a second general density layer provided on the outer periphery of the second general density layer 106.
  • a second high-density layer 108 is provided in which the second hollow fiber membrane 100 is wound with high density from the layer 106.
  • a second blood outflow space 110 is provided between the intermediate wall 28 of the housing 12 and the second high-density layer 108, through which blood can flow along the axial direction.
  • the second high-density layer 108 By providing the second high-density layer 108, when blood flows along the axial direction of the second hollow fiber membrane 100, blood (division S1) flows from the second general density layer 106 to the second blood outflow space 110. It is possible to prevent the amount from becoming too large. Therefore, the flow rate of blood in the second general density layer 106 can be suitably maintained, and the heat exchange efficiency between the blood and the heat medium in the second hollow fiber membrane layer 102 can be maintained.
  • the width direction distance L along the radial direction between the first high-density layer 96 of the first hollow fiber membrane 88 and the outer peripheral wall 48 of the housing 12 is set in the range of 0.1 mm to 1.0 mm.
  • the widthwise distance L between the first high-density layer 96 of the first hollow fiber membrane 88 and the outer peripheral wall 48 is set to 1.0 mm or less.
  • the width direction distance L between the first high-density layer 96 of the first hollow fiber membrane 88 and the outer peripheral wall 48 of the housing 12 is in the range of 0.2 mm to 0.8 mm, the first hollow fiber It becomes possible to prevent the formation of thrombi on the outer periphery of the membrane 88, and moreover, the gas exchange efficiency in the first hollow fiber membrane 88 can be suitably maintained.
  • the ratio of the first resistance coefficient K1 of the first high-density layer 96 to the second resistance coefficient K2 of the first general density layer 94 is 2.0 or more, the blood that becomes the main stream M2 is A decrease in the flow rate can be suppressed, and a sufficient flow rate of the main stream M2 can be ensured. Thereby, the efficiency of gas exchange between blood and gas by each first hollow fiber membrane 88 of the first general density layer 94 can be maintained.
  • the first hollow fiber membrane layer 90 by setting the ratio of the first resistance coefficient K1 of the first high density layer 96 to the second resistance coefficient K2 of the first general density layer 94 to be 2.0 or more, the first high density The layer 96 can control the amount of blood flowing from the first general density layer 94 to the first blood outflow space 98 to an appropriate amount. Therefore, a sufficient flow rate of blood is ensured in the first general density layer 94 of the first hollow fiber membrane layer 90, and formation of thrombi in the first general density layer 94 is suitably suppressed.
  • a gas exchange section 16 having a first hollow fiber membrane layer 90 and performing gas exchange with blood is provided, and the blood outflow port 52 is connected to the blood outflow port 52 provided on the outer periphery of the storage chamber 30.
  • the first hollow fiber membrane layer of the gas exchange section 16 can maintain the gas exchange efficiency in the gas exchange section 16 by the first high-density layer 96. Formation of a thrombus between 90 and the outer peripheral wall 48 of the housing 12 can be suppressed.
  • the first and second blood outflow spaces 98 and 110 are annular along the circumferential direction of the housing 12, and a part of the blood is allowed to flow through the annular first and second blood outflow spaces 98 and 110. Also, the formation of thrombi can be effectively suppressed in the entire circumferential area of the second hollow fiber membrane layers 90 and 102.
  • First and second blood outflow spaces 98, 110 are formed along the entire length of the first and second high-density layers 96, 108, and a portion of the blood flows through the first and second blood outflow spaces 98, 110. This makes it possible to effectively suppress the formation of thrombus in the entire axial region of the first and second hollow fiber membrane layers 90 and 102.
  • the above embodiment includes a hollow fiber membrane layer (90, 102) formed by winding a hollow fiber membrane (88, 100); a housing (12) formed in a cylindrical shape along the axial direction, having a blood inflow port (40), a blood outflow port (52), and a storage chamber (30) for accommodating the hollow fiber membrane layer;
  • An artificial lung (10) wherein blood flows through the accommodation chamber of the housing along the axial direction
  • the hollow fiber membrane layer includes a general density layer (94, 106) and a high density layer (96, 108) and the housing has a wall (28, 48) surrounding the dense layer and extending in the axial direction;
  • a blood outflow space (98, 110) is provided between the wall portion of the housing and the high-density layer, extending along the axial direction and allowing the blood to flow along the axial direction.
  • the distance (L) between the high-density layer and the wall is in the range of 0.1 mm to 1.0 mm.
  • the distance is in the range of 0.2 mm to 0.8 mm.
  • the resistance coefficient of the high-density layer to the blood is a first resistance coefficient (K1)
  • the resistance coefficient of the general density layer to the blood is a second resistance coefficient (K2)
  • the resistance coefficient of the high-density layer to the blood is a second resistance coefficient (K2).
  • 1 resistance coefficient ratio (K1/K2) is 2.0 or more.
  • the ratio of the first resistance coefficient to the second resistance coefficient is It ranges from 2.0 to 4.0.
  • the hollow fiber membrane layer is a gas exchange part (16) that performs gas exchange with the blood
  • the wall portion is an outer peripheral wall (48) provided on the outer periphery of the accommodation chamber, connected to the blood outflow port, and surrounding the high-density layer of the hollow fiber membrane layer.
  • the blood outflow space is annular along the circumferential direction of the housing.
  • the blood outflow space is arranged over the entire length of the high-density layer along the axial direction.

Landscapes

  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • External Artificial Organs (AREA)

Abstract

Un poumon artificiel (10) comprend une première couche de membrane à fibres creuses (90) qui est obtenue par enroulement d'une première membrane à fibres creuses (88). La première couche de membrane à fibres creuses (90) présente une première couche de densité typique (94) et une première couche à haute densité (96) qui est disposée sur une partie périphérique externe de la première couche de densité typique (94) et dans laquelle la première membrane à fibres creuses (88) est enroulée à une densité plus élevée que dans la première couche de densité typique (94). Un boîtier (12) qui loge la première couche de membrane à fibres creuses (90) présente une paroi périphérique externe (48) qui s'étend dans une direction axiale et entoure la première couche à haute densité (96). Entre la paroi périphérique externe (48) et la première couche à haute densité (96) est formé un premier espace d'écoulement de sang (98) qui permet la circulation sanguine le long de la direction axiale.
PCT/JP2023/007195 2022-03-28 2023-02-28 Poumon artificiel WO2023189099A1 (fr)

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JP2022051268 2022-03-28
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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0458959A (ja) * 1990-06-26 1992-02-25 Terumo Corp 中空糸型血液処理装置およびその製造方法
JP2002239348A (ja) * 2000-10-30 2002-08-27 Hospal Ind 血液・血漿処理装置用中空繊維束及びその製法
JP2014518686A (ja) * 2011-04-29 2014-08-07 メドトロニック，インコーポレイテッド 体外血液回路において血液を処理するための連続巻きの中空ファイバーのファイバーバンドルを有する複合型の酸素供給器および動脈フィルターデバイス

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0458959A (ja) * 1990-06-26 1992-02-25 Terumo Corp 中空糸型血液処理装置およびその製造方法
JP2002239348A (ja) * 2000-10-30 2002-08-27 Hospal Ind 血液・血漿処理装置用中空繊維束及びその製法
JP2014518686A (ja) * 2011-04-29 2014-08-07 メドトロニック，インコーポレイテッド 体外血液回路において血液を処理するための連続巻きの中空ファイバーのファイバーバンドルを有する複合型の酸素供給器および動脈フィルターデバイス

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