Classifications

• • 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
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
  • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
  • A61M1/1698—Blood oxygenators with or without heat-exchangers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
  • A61M1/3621—Extra-corporeal blood circuits
  • A61M1/3623—Means for actively controlling temperature of blood
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2207/00—Methods of manufacture, assembly or production
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2207/00—Methods of manufacture, assembly or production
  • A61M2207/10—Device therefor
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01D—SEPARATION
  • B01D2313/00—Details relating to membrane modules or apparatus
  • B01D2313/10—Specific supply elements
  • B01D2313/105—Supply manifolds
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01D—SEPARATION
  • B01D2315/00—Details relating to the membrane module operation
  • B01D2315/22—Membrane contactor
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01D—SEPARATION
  • B01D2321/00—Details relating to membrane cleaning, regeneration, sterilization or to the prevention of fouling
  • B01D2321/20—By influencing the flow
  • B01D2321/2008—By influencing the flow statically
  • B01D2321/2025—Tangential inlet

Definitions

• the present invention relates to an artificial lung.
• Extracorporeal circulation systems have been widely used to assist a patient's blood circulation and breathing during open-heart surgery for cardiac disease, or to temporarily maintain life when rapidly progressing circulatory failure or cardiac arrest occurs.
• the extracorporeal circulation system includes an artificial lung that is incorporated into an extracorporeal circulation circuit consisting of a blood removal line and a blood delivery line and exchanges gas with the blood, and a pump that is incorporated into the extracorporeal circulation circuit and sends blood to the artificial lung (see, for example, Patent Document 1 below).
• the extracorporeal circulation system uses the artificial lung to exchange gas with the removed blood (adding oxygen to the blood and removing carbon dioxide), and sends the blood to the blood delivery line.
• the present invention was made in consideration of the above problems, and aims to provide an artificial lung that can prevent blood from accumulating near the top of the housing.
• a cylindrical housing A cylindrical core housed within the housing; a hollow fiber membrane layer formed by a bundle of hollow fiber membranes wound around the core; a first blood chamber formed between an outer peripheral surface of the core and an inner peripheral surface of the hollow fiber membrane layer; a second blood chamber formed between an outer circumferential surface of the hollow fiber membrane layer and an inner circumferential surface of the housing; a blood inlet port provided on the core so as to extend in a longitudinal direction of the core and communicating with the first blood chamber; a blood outlet port that is provided with respect to the housing and extends in a direction intersecting the longitudinal direction of the housing and in a tangential direction of the housing, the blood outlet port communicating with the second blood chamber; An oxygenator, in which, when viewed from the side, a straight line extending from the base end point of the blood outflow port through the center point of the housing and an imaginary center line of the housing intersect.
• the housing further includes a prime port through which air bubbles can flow during priming.
• the inner circumferential surface of the prime port has a recessed portion recessed radially outward and a continuous portion formed smoothly continuous to the recessed portion,
• the artificial lung described in (1) wherein a straight line passing from the base end point of the blood outflow port through the center point of the housing is inclined circumferentially with respect to the imaginary center line of the housing, at least to a point beyond the recessed portion.
• a cylindrical housing A cylindrical core housed within the housing; a hollow fiber membrane layer formed by a bundle of hollow fiber membranes wound around the core; a first blood chamber formed between an outer peripheral surface of the core and an inner peripheral surface of the hollow fiber membrane layer; a second blood chamber formed between an outer circumferential surface of the hollow fiber membrane layer and an inner circumferential surface of the housing; a blood inlet port provided on the core so as to extend in a longitudinal direction of the core and communicating with the first blood chamber; a blood outlet port that is provided with respect to the housing and extends in a direction intersecting the longitudinal direction of the housing and in a tangential direction of the housing, the blood outlet port communicating with the second blood chamber; An oxygenator, wherein in a side view, the base end point of the blood outflow port is offset from an imaginary center line of the housing toward the tangent direction of the housing.
• a cylindrical housing A cylindrical core housed within the housing; a hollow fiber membrane layer formed by a bundle of hollow fiber membranes wound around the core; a first blood chamber formed between an outer peripheral surface of the core and an inner peripheral surface of the hollow fiber membrane layer; a second blood chamber formed between an outer circumferential surface of the hollow fiber membrane layer and an inner circumferential surface of the housing; a blood inlet port provided on the core so as to extend in a longitudinal direction of the core and communicating with the first blood chamber; a blood outlet port that is provided with respect to the housing and extends in a direction intersecting the longitudinal direction of the housing and in a tangential direction of the housing, the blood outlet port communicating with the second blood chamber;
• An artificial lung in which, when viewed from the side, a protrusion protruding radially inward from the inner surface of the housing is provided in a region where a straight line from the base end point of the blood outflow port through the center point of the housing and the inner surface of the housing intersect, on the opposite side of the base end point
• the blood branching point where blood flows clockwise and counterclockwise in a side view and is prone to stagnation, can be moved away from the top of the housing. This makes it possible to improve the flow rate of blood flowing through the top of the housing and suppress blood stagnation at the top of the housing.
• the artificial lung of (5) above has a protrusion that protrudes radially inward from the inner circumferential surface of the housing. This shortens the distance to the point of collision of the blood compared to a configuration in which no protrusion is provided, and so the blood collides with the protrusion at a relatively high speed as it flows radially. Furthermore, by locating the protrusion on the top side of the circumference of the housing, a low shear rate region is less likely to occur at the top of the housing, and blood stagnation at the top of the housing can be suppressed.
• FIG. 1 is a longitudinal sectional view of an oxygenator according to a first embodiment of the present invention.
• FIG. 2 is a schematic cross-sectional side view of the oxygenator according to the first embodiment.
• FIG. 2 is a schematic cross-sectional side view of the oxygenator according to the first embodiment.
• FIG. 3 is an enlarged view showing part A in FIG. 2 .
• FIG. 1 is a schematic cross-sectional side view of an oxygenator according to a comparative example.
• FIG. 1 is a diagram for explaining a blood branching point.
• FIG. 2 is a diagram showing a manufacturing apparatus for manufacturing an artificial lung according to the first embodiment.
• FIG. 6 is a longitudinal sectional view of an oxygenator according to a second embodiment of the present invention.
• FIG. 11 is a schematic cross-sectional side view of an artificial lung according to a second embodiment.
• FIG. 11 is a schematic cross-sectional side view of an artificial lung according to a second embodiment.
• FIG. 11 is a schematic cross-sectional view of a side of an artificial lung according to a second embodiment, illustrating the flow of blood.
• FIG. 1 is a schematic cross-sectional side view of an oxygenator according to a comparative example.
• FIG. 13 is a diagram showing a manufacturing apparatus for manufacturing an artificial lung according to a second embodiment.
• FIG. 13 is a schematic cross-sectional view of a side of an artificial lung according to a first modified example of the second embodiment.
• FIG. 1 is a longitudinal sectional view of the oxygenator 1 according to the first embodiment of the present invention.
• Figures 2 and 3 are schematic sectional views of the side of the oxygenator 1 according to the first embodiment.
• Figure 4 is an enlarged view showing part A in Figure 2. The dimensional ratios in each drawing are exaggerated for the convenience of explanation and may differ from the actual ratios.
• the artificial lung 1 is incorporated into the extracorporeal circulation circuit and exchanges gas with the blood.
• the artificial lung 1 is a membrane-type artificial lung that exchanges gas with the blood via a hollow fiber membrane 34.
• the artificial lung 1 has a cylindrical housing 10, a core 20 stored in the housing 10, a hollow fiber membrane layer 30 formed by a bundle of hollow fiber membranes 34 wound around the core 20, a first blood chamber 40 formed between the outer peripheral surface of the core 20 and the inner peripheral surface of the hollow fiber membrane layer 30, and a second blood chamber 50 formed between the outer peripheral surface of the hollow fiber membrane layer 30 and the inner peripheral surface of the housing 10.
• the outer peripheral surface of the core 20 and the inner peripheral surface of the hollow fiber membrane layer 30 are in partial contact with each other.
• the first blood chamber 40 is formed by a gap in the part where the outer peripheral surface of the core 20 and the inner peripheral surface of the hollow fiber membrane layer 30 do not contact each other.
• an arterial filter for example, may be interposed between the outer peripheral surface of the hollow fiber membrane layer 30 and the inner peripheral surface of the housing 10.
• the housing 10 constitutes the outer periphery of the artificial lung 1. As shown in FIG. 1, the housing 10 has a cylindrical housing body 11 that extends in the longitudinal direction (the left-right direction in FIG. 1), and a first header 12 and a second header 13 that are airtightly connected to both ends of the housing body 11.
• the housing body 11 has a blood outlet port 14 that extends in a direction (vertical in Figure 1) that intersects with the longitudinal direction of the housing body 11 (perpendicular in Figure 1) and in a tangential direction of the housing 10 (horizontal in Figure 2), and a prime port 15 through which air bubbles can flow out when priming is performed.
• the position of the blood outlet port 14 will be described later.
• a gas inlet port 12A and a heat medium inlet port 12B are provided on the upper side of the first header 12. Also, in FIG. 1, a gas outlet port 13A and a heat medium outlet port 13B are provided on the lower side of the second header 13. The gas outlet port 13A and the heat medium outlet port 13B are located on approximately the opposite side in the circumferential direction to the gas inlet port 12A and the heat medium inlet port 12B.
• the gas inlet port 12A, the heat medium inlet port 12B, the gas outlet port 13A, and the heat medium outlet port 13B extend in the longitudinal direction of the housing body 11.
• the prime port 15 is located at the top of the housing 10 as shown in Figures 2 and 3.
• the prime port 15 is formed in the top 19 of the housing 10.
• the prime port 15 is a hole for allowing air bubbles present in the oxygenator 1 to flow out when priming the inside of the oxygenator 1 with saline before starting the procedure.
• the inner circumferential surface 16 of the prime port 15 is formed with a recessed portion 16A that is recessed radially outward, and a continuous portion 16B that is smoothly continuous with the recessed portion 16A.
• air bubbles present near the continuous portion 16B can also be discharged from the prime port 15 during priming, allowing priming to be performed over a wider area.
• the housing 10 is preferably transparent enough to allow the blood flow inside to be visually observed.
• transparent includes colorless transparent, colored transparent, and translucent.
• the material constituting the housing 10 is not particularly limited, but examples that can be used include polyolefins such as polyethylene and polypropylene, ester-based resins such as polyethylene terephthalate, polystyrene, styrene-based resins such as MS resin and MBS resin, polycarbonate, etc.
• the core 20 constitutes the central part of the artificial lung 1.
• the core 20 extends in the longitudinal direction of the housing body 11.
• the core 20 has a blood inlet port 21 that communicates with the first blood chamber 40, and two support parts 22, 23 that support the hollow fiber membrane layer 30.
• the blood inlet port 21 extends in the longitudinal direction of the housing body 11. Blood flowing in from the blood inlet port 21 flows through a flow part 24 formed in the core 20 and into the first blood chamber 40.
• the material constituting the core 20 is not particularly limited, but examples that can be used include polyolefins such as polyethylene and polypropylene, ester-based resins such as polyethylene terephthalate, polystyrene, styrene-based resins such as MS resin and MBS resin, polycarbonate, etc.
• the housing 10 and the core 20 are attached to each other by a first header 12 and a second header 13.
• the hollow fiber membrane layer 30 is provided between the housing 10 and the core 20 as shown in FIG. 1.
• the hollow fiber membrane layer 30 is supported by support portions 22 and 23 provided on the core 20.
• the hollow fiber membrane layer 30 has a heat exchange section 31 arranged on the inner periphery side and a gas exchange section 32 arranged on the outer periphery side.
• a spacer 33 may be provided between the heat exchange section 31 and the gas exchange section 32.
• the heat exchange section 31 is formed by a bundle of hollow fiber membranes 34.
• the heat medium flowing through the heat medium flow path 31A of the heat exchange section 31 exchanges heat with the blood as it passes through the heat exchange section 31.
• the heat exchange section 31 is formed by a bundle of hollow fiber membranes 34.
• the heat medium that flows in through the heat medium inlet port 12B of the first header 12 undergoes heat exchange with the blood in the heat exchange section 31, and is then discharged to the outside of the oxygenator 1 through the heat medium outlet port 13B of the second header 13.
• the gas exchange section 32 is formed by a bundle of hollow fiber membranes 34.
• oxygen flowing through the gas flow path 32A of the gas exchange section 32 is diffused into the blood side as it passes through the hollow fiber membranes 34.
• carbon dioxide in the blood flowing through the gas exchange section 32 is discharged into the lumen of the hollow fiber membranes 34.
• gas exchange of oxygen and carbon dioxide takes place between the blood and the gas exchange section 32 via the hollow fiber membranes 34.
• Oxygen flowing in from the gas inlet port 12A of the first header 12 undergoes gas exchange with carbon dioxide in the blood in the gas exchange section 32, and the carbon dioxide that has undergone gas exchange is discharged to the outside of the artificial lung 1 through the gas outlet port 13A of the second header 13.
• the hollow fiber membrane layer 30 is formed by stacking a large number of hollow fiber membranes 34.
• the hollow fiber membranes 34 are formed by forming a large number of hollow fibers with gas exchange function into a cylindrical shape.
• the material that makes up the hollow fiber membrane 34 is not particularly limited as long as it allows gas exchange with the blood, but examples of materials that can be used include hydrophobic polymer materials such as polypropylene, polyethylene, polysulfone, polyacrylonitrile, polytetrafluoroethylene, and polymethylpentene.
• a straight line L1 that passes from the base end point 14P of the blood outflow port 14 through the center point 10P of the housing 10 intersects with the imaginary center line L2 of the housing 10.
• the "imaginary center line L2 of the housing 10” refers to a straight line drawn in the vertical direction from the center point 10P of the housing 10.
• the "base end point 14P of the blood outflow port 14" refers to the center points of both ends of the ideal inner surface of the housing 10 that passes through both ends of the opening 10S of the housing 10 that communicates with the blood outflow port 14.
• the angle ⁇ (corresponding to the intersection angle) of the straight line L1, which passes from the base end point 14P of the blood outflow port 14 through the center point 10P of the housing 10, and the virtual center line L2 of the housing 10 is not particularly limited, but is preferably greater than 0 degrees and less than or equal to 16 degrees.
• the lower limit of the angle ⁇ of the straight line L1, which passes from the base end point 14P of the blood outflow port 14 through the center point 10P of the housing 10, and the virtual center line L2 of the housing 10 is preferably set to exceed at least the recessed portion 16A in the circumferential direction.
• the blood branching point BP described below will coincide with the recessed portion 16A where blood accumulates, making it easier for blood to accumulate.
• the blood branching point BP can be set at a point beyond the recessed portion 16A, and the flow rate of blood in the recessed portion 16A can be improved. Therefore, blood accumulation in the recessed portion 16A can be suppressed.
• a configuration in which the angle ⁇ is shifted to an extent that does not exceed the recessed portion 16A is also included in the present invention.
• the base end point 14P of the blood outflow port 14 will move (offset) to the right in Figures 2 and 3 to a large extent, and blood may not flow out properly from the base end point 14P of the blood outflow port 14.
• Note that configurations in which the angle ⁇ exceeds 16 degrees are also included in the present invention.
• the base end point 14P of the blood outflow port 14 is offset from the imaginary center line L2 of the housing 10 toward the tangent direction of the housing (to the right in FIG. 3) (see the arrow in FIG. 3).
• the blood branching point BP will be described.
• blood flowing to point m of the second blood chamber 50 tends to flow in the A direction after reaching the vicinity of the inner wall of the housing 10. This is because the path to the base end point 14P of the blood outlet port 14 in the A direction is shorter than the path to the base end point 14P of the blood outlet port 14 in the B direction.
• the lower diagram of FIG. 6 shows that as shown in the lower diagram of FIG.
• blood flowing to point n of the second blood chamber 50 flows in the A direction and the B direction because the path to the base end point 14P of the blood outlet port 14 in the A direction and the path to the base end point 14P of the blood outlet port 14 in the B direction are the same length, and this point n becomes the blood branching point BP.
• the flow velocity of the part sandwiched between the flow in the A direction and the flow in the B direction is almost zero, so that blood tends to stagnate.
• the straight line L3 passing from the base end point 914P of the blood outflow port 914 through the center point 910P of the housing 910 and the imaginary center line L4 of the housing 910 are the same straight line, in other words, if the base end point 914P of the blood outflow port 914 is not offset from the imaginary center line L4 of the housing 910 in the tangent direction of the housing 910, the blood branching point BP will be at the same location as the prime port 15. Therefore, by matching the top 19 of the housing 10, where blood is likely to accumulate, with the blood branching point BP, the configuration is such that blood is more likely to accumulate at the top 19 of the housing 10.
• a straight line L1 passing from the base end point 14P of the blood outflow port 14 through the center point 10P of the housing 10 intersects with the imaginary center line L2 of the housing 10.
• the base end point 14P of the blood outflow port 14 is offset from the imaginary center line L2 of the housing 10 toward the tangent direction of the housing (the right side in FIG. 3), so that the blood branching point BP is shifted in the counterclockwise direction from the top 19 of the housing 10 as shown in FIGS. 2 and 3. Therefore, compared to the artificial lung according to the comparative example, the flow rate of blood flowing through the top 19 of the housing 10 can be improved, and blood stagnation at the top 19 of the housing 10 can be suppressed.
• Blood flowing in from the blood inlet port 21 flows through the circulation section 24 of the core 20 and is guided to the first blood chamber 40.
• the blood guided to the first blood chamber 40 moves radially outward through the hollow fiber membrane layer 30, passing through the heat exchange section 31 and then the gas exchange section 32, and through the gaps in the hollow fiber membrane 34, it undergoes heat exchange with the heat medium in the heat exchange section 31, and gas exchange with oxygen in the gas exchange section 32.
• the heat medium that flows in through the heat medium inlet port 12B of the first header 12 undergoes heat exchange with the blood in the heat exchange section 31, and is then discharged to the outside of the oxygenator 1 through the heat medium outlet port 13B of the second header 13.
• the oxygen flowing in from the gas inlet port 12A of the first header 12 undergoes gas exchange with the carbon dioxide in the blood in the gas exchange section 32, and the carbon dioxide that has undergone gas exchange is discharged to the outside of the artificial lung 1 through the gas outlet port 13A of the second header 13.
• the blood that has undergone gas exchange After the blood that has undergone gas exchange reaches the second blood chamber 50, it flows out of the artificial lung 1 through the blood outlet port 14 that is connected to the second blood chamber 50 and returns to the human body.
• Fig. 7 is a diagram showing a manufacturing apparatus 100 for manufacturing the oxygenator 1 according to the first embodiment.
• the manufacturing apparatus 100 has a rotating device 110 that rotates the core 20 and a winding device 120 that winds the hollow fiber membrane 34 around the core 20.
• the rotating device 110 has a motor 111, a motor shaft 112 that transmits the rotation of the motor 111, and a connecting member 113 that is connected to the motor shaft 112 and to which the core 20 is attached.
• the core 20 is rotated around its axis by the motor 111 while attached to the connecting member 113.
• the winding device 120 has a main body 121 with a hollow fiber membrane 34 inside, and a discharge part 122 that discharges the hollow fiber membrane 34.
• the discharge part 122 is configured to be movable in the axial direction, as shown by the arrow A in FIG. 7.
• the main body 121 is fixed to a linear table 124 that moves on a linear rail 123, and a ball nut 125.
• the ball nut 125 is movable parallel to the axial direction of the main body 121 by the motor 126 driving the ball screw shaft 127 to rotate.
• the drive of the motor 126 is adjusted by a controller C.
• the controller C is, for example, a computer.
• the manufacturing apparatus 100 further includes a fixing device that fixes the hollow fiber membrane 34 wound around the core 20 with a fixing thread, as disclosed in International Publication WO 2018/062271. A detailed description of the fixing device is omitted.
• the core 20 is set on the connecting member 113 of the manufacturing device 100.
• the hollow fiber membrane 34 is discharged from the discharge portion 122 of the winding device 120, and the hollow fiber membrane 34 is wound in a spiral shape around the outer circumference of the core 20.
• both ends of the hollow fiber membrane layer 30 are fixed with urethane and then cut off. This process exposes the ends of the hollow fiber membrane layer 30, allowing the heat transfer medium and oxygen to enter.
• the housing 10 is attached to the outer periphery of the core 20 on which the hollow fiber membrane layer 30 is formed, thereby obtaining the artificial lung 1.
• the artificial lung 1 of the first embodiment has a cylindrical housing 10, a cylindrical core 20 stored within the housing 10, a hollow fiber membrane layer 30 formed by a bundle of hollow fiber membranes 34 wound around the core 20, a first blood chamber 40 formed between the outer surface of the core 20 and the inner surface of the hollow fiber membrane layer 30, a second blood chamber 50 formed between the outer surface of the hollow fiber membrane layer 30 and the inner surface of the housing 10, a blood inlet port 21 provided on the core 20 to extend in the longitudinal direction of the core 20 and communicate with the first blood chamber 40, and a blood outlet port 14 provided on the housing 10 to extend in a direction intersecting the longitudinal direction of the housing 10 and in a tangential direction of the housing 10 and communicates with the second blood chamber 50.
• the blood branching point BP where blood flows clockwise and counterclockwise and is prone to stagnation, can be moved away from the top 19 of the housing 10. This makes it possible to improve the flow rate of blood flowing through the top 19 of the housing 10 and suppress blood stagnation at the top 19 of the housing 10.
• the oxygenator 1 further includes a prime port 15 provided in the housing 10, through which air bubbles can flow out during priming.
• the inner surface 16 of the prime port 15 includes a recessed portion 16A recessed radially outward, and a continuous portion 16B that is gently continuous with the recessed portion 16A.
• a straight line L1 passing from the base end point 14P of the blood outlet port 14 through the center point 10P of the housing 10 is inclined in the circumferential direction with respect to the imaginary center line L2 of the housing 10 to a point beyond the recessed portion 16A.
• the artificial lung 1 has a cylindrical housing 10, a cylindrical core 20 stored in the housing 10, a hollow fiber membrane layer 30 formed by a bundle of hollow fiber membranes 34 wound around the core 20, a first blood chamber 40 formed between the outer peripheral surface of the core 20 and the inner peripheral surface of the hollow fiber membrane layer 30, a second blood chamber 50 formed between the outer peripheral surface of the hollow fiber membrane layer 30 and the inner peripheral surface of the housing 10, a blood inlet port 21 provided to extend in the longitudinal direction of the core 20 and communicates with the first blood chamber 40, and a blood outlet port 14 provided to extend in a direction intersecting the longitudinal direction of the housing 10 and in a tangential direction of the housing 10 and communicates with the second blood chamber 50.
• the base end point 14P of the blood outlet port 14 is offset from the imaginary center line L2 of the housing 10 toward the tangential direction of the housing 10.
• FIG. 8 is a longitudinal sectional view of the oxygenator 1 according to the second embodiment of the present invention.
• Figs. 9 to 11 are schematic sectional views of the side of the oxygenator 1 according to the second embodiment.
• the dimensional ratios in each drawing are exaggerated for the convenience of explanation and may differ from the actual ratios.
• the artificial lung 1 is incorporated into the extracorporeal circulation circuit and exchanges gas with the blood.
• the artificial lung 1 is a membrane-type artificial lung that exchanges gas with the blood via a hollow fiber membrane 34.
• the artificial lung 1 has a cylindrical housing 10, a core 20 stored in the housing 10, a hollow fiber membrane layer 30 formed by a bundle of hollow fiber membranes 34 wound around the core 20, a first blood chamber 40 formed between the outer peripheral surface of the core 20 and the inner peripheral surface of the hollow fiber membrane layer 30, and a second blood chamber 50 formed between the outer peripheral surface of the hollow fiber membrane layer 30 and the inner peripheral surface of the housing 10.
• the outer peripheral surface of the core 20 and the inner peripheral surface of the hollow fiber membrane layer 30 are in partial contact with each other.
• the first blood chamber 40 is formed by a gap in the part where the outer peripheral surface of the core 20 and the inner peripheral surface of the hollow fiber membrane layer 30 do not contact each other.
• an arterial filter for example, may be interposed between the outer peripheral surface of the hollow fiber membrane layer 30 and the inner peripheral surface of the housing 10.
• the housing 10 constitutes the outer periphery of the artificial lung 1. As shown in FIG. 8, the housing 10 has a cylindrical housing body 11 that extends in the longitudinal direction (the left-right direction in FIG. 8), and a first header 12 and a second header 13 that are airtightly connected to both ends of the housing body 11.
• the housing body 11 has a blood outflow port 14 that extends in a direction (vertical in Figure 8) that intersects with the longitudinal direction of the housing body 11 (perpendicular in Figure 8) and in a tangential direction of the housing 10 (horizontal in Figure 9), and a protrusion 15 that protrudes radially inward from the inner peripheral surface of the housing 10 in a side view.
• a gas inlet port 12A and a heat medium inlet port 12B are provided on the upper side of the first header 12. Also, in FIG. 8, a gas outlet port 13A and a heat medium outlet port 13B are provided on the lower side of the second header 13. The gas outlet port 13A and the heat medium outlet port 13B are located on approximately the opposite side in the circumferential direction to the gas inlet port 12A and the heat medium inlet port 12B.
• the gas inlet port 12A, the heat medium inlet port 12B, the gas outlet port 13A, and the heat medium outlet port 13B extend in the longitudinal direction of the housing body 11.
• the protrusion 15 is located on the opposite side of the center point 10P of the housing 10 from the base end point 14P of the blood outflow port 14.
• the base end point 14P of the blood outflow port 14 refers to the center points of both ends of the ideal inner surface of the housing 10 that passes through both ends of the opening 10S of the housing 10 that communicates with the blood outflow port 14.
• the protrusion 15 is provided in the area where a straight line L1 passing from the base end point 14P of the blood outflow port 14 to the center point 10P of the housing 10 intersects with the inner circumferential surface of the housing 10.
• the protrusion 15 is configured in a mountain shape so that the amount of protrusion from the center outward in the circumferential direction (left and right direction in FIG. 9) decreases.
• the protrusion 15 in this mountain shape, when the radially flowing blood collides with the protrusion 15 and branches to the left and right, the blood flow forms an obtuse angle greater than 90° (indicated by ⁇ 1 in FIG. 11), making it difficult for vortexes to occur and suppressing blood stagnation at the top 19 of the housing 10.
• the three-dimensional shape of the protrusion 15 can be a mountain shape, or it can be a convex surface that curves along the length of the housing 10. This is the same in the modified examples described below.
• the protrusion amount A of the most protruding point of the protrusion 15 is greater than 0% and less than 5% of the inner diameter D of the housing 10.
• the protrusion amount A indicates the distance from the imaginary line L2 to the most protruding point when the inner circumference of the housing 10 where the protrusion 15 is not provided is extended to the point where the protrusion 15 is provided as an imaginary line L2 as shown in FIG. 10.
• the protrusion amount A is greater than 5% of the inner diameter D of the housing 10, it is not preferable because the protrusion 15 may come into contact with the hollow fiber membrane layer 30 arranged on the inner circumference of the housing 10. Note that a configuration in which the protrusion amount A is greater than 5% of the inner diameter D of the housing 10 is also included in the present invention.
• the protrusion 15 is provided in a range of -60° to 60° (angle ⁇ 2 in FIG. 10) with the center point 10P of the housing 10 as the center with respect to the straight line L1 that passes from the base end point 14P of the blood outflow port 14 to the center point 10P of the housing 10 in a side view.
• the area in which the protrusion 15 is provided is not limited to the above range.
• the protrusion 15 is integrally formed with the housing 10 on the inner peripheral surface of the housing 10.
• the protrusion 15 may be formed separately from the housing 10 and fixed to the inner peripheral surface of the housing 10 with an adhesive or the like.
• the housing 10 is preferably transparent enough to allow the blood flow inside to be visually observed.
• transparent includes colorless transparent, colored transparent, and translucent.
• the material constituting the housing 10 is not particularly limited, but examples that can be used include polyolefins such as polyethylene and polypropylene, ester-based resins such as polyethylene terephthalate, polystyrene, styrene-based resins such as MS resin and MBS resin, polycarbonate, etc.
• the core 20 constitutes the central part of the artificial lung 1.
• the core 20 extends in the longitudinal direction of the housing body 11.
• the core 20 has a blood inlet port 21 that communicates with the first blood chamber 40, and two support parts 22, 23 that support the hollow fiber membrane layer 30.
• the blood inlet port 21 extends in the longitudinal direction of the housing body 11. Blood flowing in from the blood inlet port 21 flows through a flow part 24 formed in the core 20 and into the first blood chamber 40.
• the material constituting the core 20 is not particularly limited, but examples that can be used include polyolefins such as polyethylene and polypropylene, ester-based resins such as polyethylene terephthalate, polystyrene, styrene-based resins such as MS resin and MBS resin, polycarbonate, etc.
• the housing 10 and the core 20 are attached to each other by a first header 12 and a second header 13.
• the hollow fiber membrane layer 30 is provided between the housing 10 and the core 20, as shown in FIG. 8.
• the hollow fiber membrane layer 30 is supported by support portions 22 and 23 provided on the core 20.
• the hollow fiber membrane layer 30 has a heat exchange section 31 arranged on the inner periphery side and a gas exchange section 32 arranged on the outer periphery side.
• a spacer 33 may be provided between the heat exchange section 31 and the gas exchange section 32.
• the heat exchange section 31 is formed by a bundle of hollow fiber membranes 34.
• the heat medium flowing through the heat medium flow path 31A of the heat exchange section 31 exchanges heat with the blood as it passes through the heat exchange section 31.
• the heat exchange section 31 is formed by a bundle of hollow fiber membranes 34.
• the heat medium that flows in through the heat medium inlet port 12B of the first header 12 exchanges heat with the blood in the heat exchange section 31, and then is discharged to the outside of the oxygenator 1 through the heat medium outlet port 13B of the second header 13.
• the gas exchange section 32 is formed by a bundle of hollow fiber membranes 34.
• oxygen flowing through the gas flow path 32A of the gas exchange section 32 is diffused into the blood side as it passes through the hollow fiber membranes 34.
• carbon dioxide in the blood flowing through the gas exchange section 32 is discharged into the lumen of the hollow fiber membranes 34.
• gas exchange of oxygen and carbon dioxide takes place between the blood and the gas exchange section 32 via the hollow fiber membranes 34.
• Oxygen flowing in from the gas inlet port 12A of the first header 12 undergoes gas exchange with carbon dioxide in the blood in the gas exchange section 32, and the carbon dioxide that has undergone gas exchange is discharged to the outside of the artificial lung 1 through the gas outlet port 13A of the second header 13.
• the hollow fiber membrane layer 30 is formed by stacking a large number of hollow fiber membranes 34.
• the hollow fiber membranes 34 are formed by forming a large number of hollow fibers with gas exchange function into a cylindrical shape.
• the material that makes up the hollow fiber membrane 34 is not particularly limited as long as it allows gas exchange with the blood, but examples of materials that can be used include hydrophobic polymer materials such as polypropylene, polyethylene, polysulfone, polyacrylonitrile, polytetrafluoroethylene, and polymethylpentene.
• Blood flowing in from the blood inlet port 21 flows through the circulation section 24 of the core 20 and is guided to the first blood chamber 40.
• the blood guided to the first blood chamber 40 moves radially outward through the hollow fiber membrane layer 30, passing through the heat exchange section 31 and then the gas exchange section 32, and through the gaps in the hollow fiber membrane 34, it undergoes heat exchange with the heat medium in the heat exchange section 31, and gas exchange with oxygen in the gas exchange section 32.
• the heat medium that flows in through the heat medium inlet port 12B of the first header 12 undergoes heat exchange with the blood in the heat exchange section 31, and is then discharged to the outside of the oxygenator 1 through the heat medium outlet port 13B of the second header 13.
• the oxygen flowing in from the gas inlet port 12A of the first header 12 undergoes gas exchange with the carbon dioxide in the blood in the gas exchange section 32, and the carbon dioxide that has undergone gas exchange is discharged to the outside of the artificial lung 1 through the gas outlet port 13A of the second header 13.
• the blood that has undergone gas exchange After the blood that has undergone gas exchange reaches the second blood chamber 50, it flows out of the artificial lung 1 through the blood outlet port 14 that is connected to the second blood chamber 50 and returns to the human body.
• Figure 11 is a diagram showing the blood flow in the artificial lung 1 according to the second embodiment
• Figure 12 is a schematic cross-sectional view of the side of the artificial lung according to the comparative example.
• the artificial lung 1 has a protrusion 15 that protrudes radially inward from the inner circumferential surface of the housing 10, as shown in Figures 9 and 10.
• the artificial lung 1 according to the second embodiment has a protrusion 15 that protrudes radially inward from the inner circumferential surface of the housing 10. This shortens the time it takes for the blood to collide with the inner circumferential surface of the housing 10 (in other words, the protrusion 15) compared to the artificial lung 900 according to the comparative example, suppresses a decrease in flow velocity, and suppresses a decrease in shear rate, thereby suppressing blood stagnation at the top 19 of the housing 10.
• the radially flowing blood collides with the inner surface of the housing 910 of the artificial lung 900, and when it branches to the left and right, the blood flow forms an acute angle less than 90° (indicated by ⁇ 3 in FIG. 12), generating a vortex and causing the blood to stagnate.
• the artificial lung 1 has a protrusion 15 that protrudes radially inward from the inner circumferential surface of the housing 10.
• the protrusion 15 has a mountain shape, so that when the radially flowing blood collides with the protrusion 15 and branches to the left and right, the blood flow forms an obtuse angle greater than 90° (indicated by ⁇ 1 in FIG. 11), making it difficult for vortexes to form and preventing blood from stagnating.
• Fig. 13 is a diagram showing a manufacturing apparatus 100 for manufacturing the oxygenator 1 according to the second embodiment.
• the manufacturing apparatus 100 has a rotating device 116 that rotates the core 20 and a winding device 120 that winds the hollow fiber membrane 34 around the core 20.
• the rotating device 116 has a motor 111, a motor shaft 112 that transmits the rotation of the motor 111, and a connecting member 113 that is connected to the motor shaft 112 and to which the core 20 is attached.
• the core 20 is rotated around its axis by the motor 111 while attached to the connecting member 113.
• the winding device 120 has a main body 121 with a hollow fiber membrane 34 inside, and a discharge part 122 that discharges the hollow fiber membrane 34.
• the discharge part 122 is configured to be movable in the axial direction, as shown by arrow A in FIG. 13.
• the main body 121 is fixed to a linear table 124 that moves on a linear rail 123, and a ball nut 125.
• the ball nut 125 is movable parallel to the axial direction of the main body 121 by the motor 126 driving the ball screw shaft 127 to rotate.
• the drive of the motor 126 is adjusted by a controller C.
• the controller C is, for example, a computer.
• the manufacturing apparatus 100 preferably further includes a fixing device that fixes the hollow fiber membrane 34 wound around the core 20 with a fixing thread, as disclosed in International Publication WO 2018/062271. A detailed description of the fixing device is omitted.
• the core 20 is set on the connecting member 113 of the manufacturing device 100.
• the hollow fiber membrane 34 is discharged from the discharge portion 122 of the winding device 120, and the hollow fiber membrane 34 is wound in a spiral shape around the outer circumference of the core 20.
• both ends of the hollow fiber membrane layer 30 are fixed with urethane and then cut off. This process exposes the ends of the hollow fiber membrane layer 30, allowing the heat transfer medium and oxygen to enter.
• the housing 10 is attached to the outer periphery of the core 20 on which the hollow fiber membrane layer 30 is formed, thereby obtaining the artificial lung 1.
• the artificial lung 1 of the second embodiment has a cylindrical housing 10, a cylindrical core 20 stored within the housing 10, a hollow fiber membrane layer 30 formed by a bundle of hollow fiber membranes 34 wound around the core 20, a first blood chamber 40 formed between the outer surface of the core 20 and the inner surface of the hollow fiber membrane layer 30, a second blood chamber 50 formed between the outer surface of the hollow fiber membrane layer 30 and the inner surface of the housing 10, a blood inlet port 21 arranged on the core 20 to extend in the longitudinal direction of the core 20 and communicates with the first blood chamber 40, and a blood outlet port 14 arranged on the housing 10 to extend in a direction intersecting the longitudinal direction of the housing 10 and in a tangential direction of the housing 10 and communicates with the second blood chamber 50.
• a protrusion 15 protruding radially inward from the inner peripheral surface of the housing 10 is provided in the region where the straight line L1 passing from the base end point 14P of the blood outflow port 14 through the center point 10P of the housing 10 and the inner peripheral surface of the housing 10 intersect, on the opposite side of the base end point 14P.
• the protrusion 15 protruding radially inward from the inner peripheral surface of the housing 10 is provided, the distance to the collision point of the blood is shortened, and the blood collides with the protrusion at a relatively high speed when flowing radially.
• a low shear rate region is unlikely to occur at the top 19 of the housing 10, and blood stagnation at the top 19 of the housing 10 can be suppressed.
• the protrusions 15 are configured in a mountain shape so that the amount they protrude outward from the center decreases.
• an artificial lung 1 configured in this way, when the radially flowing blood collides with the protrusions 15 and branches to the left and right, the blood flow forms an obtuse angle greater than 90° (indicated by ⁇ 1 in FIG. 11), making it difficult for vortexes to form and preventing blood from stagnation.
• Fig. 14 is a schematic cross-sectional view of a side surface of the oxygenator 2 according to the first modification of the second embodiment.
• the artificial lung 2 according to the first modified example is different from the artificial lung 1 according to the above-described embodiment in terms of the configuration of the housing 110, etc. Note that the same components as those of the artificial lung 1 according to the above-described embodiment are given the same reference numerals and the description thereof is omitted.
• the artificial lung 2 has a cylindrical housing 110, a core 20 stored in the housing 110, a hollow fiber membrane layer 30 formed by a bundle of hollow fiber membranes 34 wound around the core 20, a first blood chamber 40 formed between the outer peripheral surface of the core 20 and the inner peripheral surface of the hollow fiber membrane layer 30, and a second blood chamber 50 formed between the outer peripheral surface of the hollow fiber membrane layer 30 and the inner peripheral surface of the housing 110.
• the configurations of the core 20, hollow fiber membrane layer 30, first blood chamber 40, and second blood chamber 50 are the same as those of the artificial lung 1 according to the embodiment, and therefore will not be described.
• the housing 110 has a blood outflow port 114, a protrusion 115 that protrudes radially inward from the inner circumferential surface of the housing 110, and a prime port 16 through which air bubbles can flow out when priming is performed.
• a straight line L3 that passes from the base end point 114P of the blood outflow port 114 through the center point 110P of the housing 110 intersects with the imaginary center line L4 of the housing 110.
• the "imaginary center line L4 of the housing 110” refers to a straight line drawn in the vertical direction from the center point 110P of the housing 110.
• the protrusion 115 is provided on the left side of the imaginary center line L4 of the housing 110.
• the prime port 16 is located at the top of the housing 110 as shown in FIG. 14.
• the prime port 16 is formed in the top 19 of the housing 110.
• the prime port 16 is a hole for allowing air bubbles present in the oxygenator 1 to flow out when priming the inside of the oxygenator 1 with saline before starting the procedure.
• point n is the point where line L3, which runs from base end point 114P of blood outflow port 114 through center point 110P of housing 110, intersects with protrusion 115 in side view.
• Blood flowing to point n of second blood chamber 50 flows in directions A and B because the path to base end point 114P of blood outflow port 114 in direction A and the path to base end point 114P of blood outflow port 114 in direction B are the same length, and point n becomes the blood branching point.
• the flow velocity in the portion sandwiched between the flow in direction A and the flow in direction B is nearly zero, which results in blood tending to stagnate.
• the blood branching point is shifted in a counterclockwise direction from the top 19 of the housing 110, as shown in FIG. 14. This improves the flow rate of blood flowing through the top 19 of the housing 110, and suppresses blood stagnation at the top 19 of the housing 110.
• the protrusion 115 is provided, so that blood stagnation at the top 19 of the housing 110 can be suppressed, as in the above-described embodiment. Furthermore, in a side view, the straight line L3 passing from the base end point 114P of the blood outflow port 114 through the center point 110P of the housing 110 intersects with the imaginary center line L4 of the housing 110, so that the blood branching point BP is shifted counterclockwise from the top 19 of the housing 110 as shown in FIG. 14, and the flow rate of blood flowing through the top 19 of the housing 110 can be improved, and blood stagnation at the top 19 of the housing 110 can be suppressed.
• the artificial lung 1 according to the present invention has been described above through the embodiments, but the present invention is not limited to the configurations described in the embodiments, and can be modified as appropriate based on the claims.
• the protrusion 15 is configured to have a mountain shape, but the protrusion is not particularly limited as long as it is configured to protrude radially inward from the inner circumferential surface of the housing 10.

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• 2024
  • 2024-02-19 EP EP24763683.0A patent/EP4656214A1/en active Pending
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