WO2015046224A1 - Poumon artificiel à filtre intégré et son procédé de production - Google Patents

Poumon artificiel à filtre intégré et son procédé de production Download PDF

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Publication number
WO2015046224A1
WO2015046224A1 PCT/JP2014/075242 JP2014075242W WO2015046224A1 WO 2015046224 A1 WO2015046224 A1 WO 2015046224A1 JP 2014075242 W JP2014075242 W JP 2014075242W WO 2015046224 A1 WO2015046224 A1 WO 2015046224A1
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WIPO (PCT)
Prior art keywords
filter
space
blood
flow path
blood flow
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Application number
PCT/JP2014/075242
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English (en)
Japanese (ja)
Inventor
吉田伸一
和泉亮平
泉田秀樹
Original Assignee
株式会社ジェイ・エム・エス
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Application filed by 株式会社ジェイ・エム・エス filed Critical 株式会社ジェイ・エム・エス
Priority to CN201480052017.XA priority Critical patent/CN105555333B/zh
Priority to JP2015539247A priority patent/JP6135769B2/ja
Publication of WO2015046224A1 publication Critical patent/WO2015046224A1/fr

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    • 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
    • A61M1/3627—Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
    • A61M1/3633—Blood component filters, e.g. leukocyte filters
    • A61M1/3635—Constructional details
    • 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
    • A61M1/3627—Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • A61M2205/7545—General characteristics of the apparatus with filters for solid matter, e.g. microaggregates

Definitions

  • the present invention relates to an oxygenator for exchanging gas with respect to blood in extracorporeal circulation, and more particularly to a filter-incorporated oxygenator having a built-in filter device for capturing and discharging foreign substances and bubbles mixed and generated in blood.
  • an extracorporeal cardiopulmonary circuit for extracorporeal blood circulation is used to stop the patient's heart and perform the breathing and blood circulation functions during that time.
  • the artificial lung constituting the main part of the artificial heart-lung circuit provides a gas exchange function for blood (a function of supplying oxygen to blood and discharging carbon dioxide) in place of a patient's lung.
  • a hollow fiber membrane oxygenator is widely used as a structure of the oxygenator.
  • the hollow fiber membrane oxygenator is configured such that a gas containing oxygen and blood flow through a porous hollow fiber membrane, and gas exchange is performed between the blood and the gas. That is, a hollow fiber membrane laminate in which a large number of hollow fiber membranes are laminated is housed in a housing, and a blood flow path that passes across the hollow fiber membrane laminate is formed. When oxygen-containing gas is allowed to flow through the hollow fiber membrane and the blood flowing through the blood flow passage passes through the gaps between the hollow fiber membranes, gas exchange, that is, oxygenation and decarboxylation gas is performed through the hollow fiber membranes.
  • priming with a priming solution such as physiological saline is performed in advance to remove bubbles and foreign substances from the blood circuit, and to make the hollow fiber membrane of the gas exchange unit compatible with the liquid. After that, it is used for blood circulation.
  • a blood filter device is used to remove bubbles generated during priming and mixed foreign substances.
  • foreign substances and blood clots may be mixed into the circulating blood, so that a blood filter device is often incorporated in the cardiopulmonary circuit.
  • a blood filter device incorporates a filter formed by folding or winding a sheet-shaped filter medium in a housing, and using the blood flow path in the housing as a blood flow path, when blood passes through the filter medium, It is configured to capture and discharge foreign objects such as bubbles and bubbles.
  • a configuration is also known in which an artificial heart-lung circuit is simplified by being built in and integrated with an oxygenator without providing a blood filter device independently, and a blood filling amount is reduced by shortening a connection tube or the like.
  • FIG. 13 is a cross-sectional view showing the oxygenator according to the first embodiment of Patent Document 1.
  • the artificial lung includes a gas exchange unit 100A configured in the housing 101 and a heat exchange unit 100B configured in the heat exchanger housing 102.
  • the blood that flows in first flows into the heat exchanger 100B, and then flows out through the gas exchange unit 100A.
  • a cold / hot water port 103 (the other cold / hot water port is hidden) is formed at the lower end of the housing 102 of the heat exchange unit 100B. Further, a blood introduction port 104 is formed in the lower part on the left side of the housing 102. Inside the housing 102, a cylindrical heat exchange body 105 and a cylindrical heat medium chamber forming member (cylindrical wall) 106 disposed along the inner periphery of the heat exchange body 105 are installed. The heat medium flowing in from the cold / hot water port 103 enters a large number of concave portions of the bellows of the heat exchanger 105 and heat exchange is performed with blood flowing on the outer peripheral side of the heat exchanger 105.
  • the housing 101 has a blood outlet port 107 formed in the lower portion of the side surface on the blood outflow side, a gas port 108 formed in the upper portion, and a gas port 109 and an exhaust port 110 formed in the lower portion.
  • a hollow fiber membrane layer 111 and bubble removing means (consisting of a filter member 112 and an exhaust hollow fiber membrane layer 113) are accommodated inside the housing 101.
  • the upper and lower ends of the hollow fiber membrane 111 of the hollow fiber membrane layer 111 are fixed by partition walls 114 and 115 made of a potting material, respectively.
  • a blood flow path is formed between the partition wall 114 and the partition wall 115 that passes through the hollow fiber membrane layer 111, the exhaust hollow fiber membrane layer 113, and the filter member 112.
  • the space above the partition wall 114 and below the partition wall 115 is divided by partition portions 116 and 117.
  • the exhaust hollow fiber membrane layer 113 is configured by integrating a number of hollow fiber membranes, and has a function of permeating and discharging the gas constituting the bubbles trapped by the filter member 112.
  • the filter member 112 is formed of a substantially rectangular sheet-like member, is provided in contact with the downstream surface of the exhaust hollow fiber membrane layer 113, and covers substantially the entire surface. The filter member 112 captures bubbles in the blood flowing through the blood channel and prevents them from flowing out from the blood outlet port 107. Air bubbles captured by the filter member 112 are discharged from the blood flow path through the exhaust hollow fiber membrane layer 113 and the exhaust port 110.
  • Patent Document 1 it is said that two or more sheets of the artificial lung filter member 112 may be used in an overlapping manner.
  • two sheets of blood are sequentially arranged with respect to the blood flow path. It is comprised so that each sheet
  • the upper limit is the cross-sectional area. For this reason, it is difficult to take a sufficiently large filter membrane area.
  • membrane area of the filter member in order to fully exhibit the ability to capture bubbles. That is, having a sufficient membrane area corresponds to a large cross-sectional area of the flow path, substantially lowering the blood flow rate with respect to the membrane surface, and facilitates gas-liquid separation. In addition, if there is a sufficient membrane area, even if some clogging occurs, the influence on the blood flow as a whole can be reduced. However, it is necessary not to increase the cross-sectional area of the blood flow path in order to suppress the blood filling amount to the artificial lung low.
  • the present invention provides a filter-embedded artificial lung that allows a substantially sufficiently large filter membrane area to function while suppressing the blood filling amount to be low, and that can effectively discharge trapped bubbles to the outside, and a method for manufacturing the same.
  • the purpose is to provide.
  • a filter built-in type artificial lung includes a housing forming a gas exchange part and a filter space adjacent to each other, a bundle of a plurality of hollow fiber membranes loaded in the gas exchange part, and a filter space.
  • a filter, a bundle of hollow fiber membranes, a blood flow path provided so as to pass through the filter sequentially, and a gas containing oxygen through the lumen of the hollow fiber membrane are provided in the housing.
  • a gas introduction port, a blood introduction port and a blood outlet port provided on the outer wall of the housing at both ends of the blood flow path, and an exhaust port for communicating the filter space with the external space.
  • the filter-embedded artificial lung of the present invention is configured such that the filter is formed of a sheet-like filter medium provided with a plurality of parallel pleats, and the direction of the pleats is the vertical direction of the blood channel.
  • the filter space is separated by the sheet-like filter medium into a primary space on the blood introduction port side and a secondary space on the blood outlet port side, and the exhaust port is connected to the blood flow path. It has an exhaust passage which is arranged at an upper end part and which exhausts exhaust from the primary side space and the secondary side space separately from each other.
  • a method for producing an oxygenator with a built-in filter according to the present invention is a method for producing an oxygenator having the above-described configuration, wherein the outer peripheral edge of the filter is sealed with a sealing material to form a part of the blood channel.
  • the method includes the steps of producing a filter module, loading the filter module into the filter space, and sealing the outer peripheral edge of the filter module together with the bundle of hollow fiber membranes to form the blood channel.
  • the step of producing the filter module includes preparing a primary side and secondary side masking block that sandwiches the filter and forms a molding die for molding a sealing portion by the sealing material on an outer peripheral edge thereof.
  • the primary side masking block has a structure in which a group of linear protrusions having a shape corresponding to a valley portion of the pleat facing the primary side space is provided on a substrate, and an outer peripheral edge of the group of linear protrusions
  • the shape of the portion corresponds to the portion belonging to the primary space in the inner wall portion of the blood flow path formed by the sealing material, and the secondary masking block is formed of the pleat facing the secondary space.
  • a group of linear protrusions having a shape corresponding to the valley is provided on the substrate, and the shape of the outer peripheral edge of the group of linear protrusions is the inner wall of the blood flow path formed by the sealing material Among these, in the step of attaching the masking block corresponding to the portion belonging to the secondary side space, each of the linear protrusions is fitted into the valley portion of the pleat.
  • the filter membrane area can be set sufficiently large without being restricted by the cross-sectional area of the blood flow path, and by having the pleats There is a slight increase in blood filling. Further, since the plurality of pleats of the filter are oriented in the vertical direction, the bubbles rise along the pleats in the vicinity of the filter, are easily guided to the exhaust port, and are effectively discharged to the outside. Further, in the exhaust port, the bubbles from the primary side and secondary side spaces are separated and discharged, so that high exhaust ability can be obtained.
  • the process which seals the outer periphery part of the filter which has a pleat by using a primary side and a secondary side masking block, and produces a filter module easily is stabilized. It can be carried out.
  • FIG. 1 is a perspective view of a hollow fiber membrane oxygenator according to an embodiment of the present invention.
  • FIG. 2 is a cross-sectional view of the oxygenator as viewed from the side.
  • FIG. 3 is a cross-sectional view of the oxygenator as viewed from above.
  • FIG. 4 is a perspective view of a filter included in the oxygenator.
  • FIG. 5 is a perspective view of a filter module formed by sealing the outer peripheral edge of the filter with a sealing material.
  • FIG. 6 is an enlarged cross-sectional view of the upper part of the oxygenator.
  • FIG. 7 is a perspective view showing a section of the filter space 14 of the oxygenator in cross section.
  • FIG. 8 is an enlarged perspective view of a part of FIG. FIG.
  • FIG. 9A is a front view showing a specific structure of a filter module included in the artificial lung.
  • FIG. 9B is a bottom view of the filter module.
  • FIG. 9C is a cross-sectional view taken along line AA in FIG. 9A.
  • FIG. 9D (a) is a right side view of the filter module of FIG. 9A, and
  • FIG. 9D (b) is a cross-sectional view taken along line BB of FIG. 9A.
  • FIG. 10 is a front view showing a primary masking block for producing the filter module by insert molding.
  • FIG. 10B is a bottom view of the primary side masking block of FIG. 10A.
  • FIG. 10C is a right side view of FIG. 10A.
  • FIG. 11A is a front view showing a secondary masking block for producing the filter module by insert molding.
  • FIG. 11B is a bottom view of the secondary masking block of FIG. 11A.
  • FIG. 11C is a right side view of FIG. 11A.
  • FIG. 12A is a front view showing a state in which the primary side and secondary side masking blocks are mounted on both surfaces of the filter. 12B is a bottom view of FIG. 12A.
  • 12C (a) is a right side view of FIG. 12A
  • FIG. 12C (b) is a cross-sectional view taken along the line CC of FIG. 12A.
  • FIG. 13 is a cross-sectional view showing a conventional hollow fiber membrane oxygenator.
  • the filter-embedded artificial lung of the present invention can take the following modes based on the above configuration.
  • the exhaust port is a hollow flow path member, and may include first and second exhaust paths formed by dividing the cross section of the hollow flow path member and separating them from each other.
  • the first exhaust path may be in communication with the primary side space
  • the second exhaust path may be in communication with the secondary side space.
  • a stepped portion can be provided on the inner peripheral wall surface of the blood flow channel in the vicinity of the filter in such a direction that the flow channel cross section on the side close to the filter is smaller than the separated side.
  • a gap for collecting bubbles is formed by the stepped portion, and the bubbles are easily collected in the upper part over the entire circumference of the blood flow path.
  • the blood flow path in the filter space may be formed by a sealing material that seals the outer peripheral edge of the filter.
  • An inclined surface corresponding to each of the valley portions of the pleat may be formed on the inner peripheral wall surface of the sealing material at the upper end portion of the pleat. The direction of inclination of the inclined surface can be set so as to go from the shallow part to the deep part of the valley as it goes downward. As a result, the bubbles rising from below along the valley of the pleats are easily introduced into the exhaust port away from the filter while rising along the inclined surface.
  • the inclination angle of the inclined surface with respect to the horizontal direction can be set within a range of 5 ° to 80 °. If it is this range, it will be easy to remove
  • the cross-sectional shape of the blood channel may have a vertex that is the highest point of the outer peripheral edge of the cross-section.
  • the direction of the tangent to the outer peripheral edge of the cross section may be inclined downward as viewed from the apex.
  • the exhaust port provided at the uppermost part (top) of the inner wall surface of the blood channel is located at the apex of the filter space, so that the raised bubbles are likely to collect and the effect of air discharge is great.
  • the cross-sectional shape of the blood channel may be a circle or a rhombus arranged with one corner as a vertex.
  • FIG. 1 shows a perspective view of a filter built-in oxygenator according to an embodiment of the present invention.
  • FIG. 2 shows a cross-sectional view of the oxygenator as seen from the side
  • FIG. 3 shows a cross-sectional view as seen from the top.
  • FIG. 4 is a perspective view showing the shape of a filter included in the oxygenator.
  • a space region of the heat exchange part 2 and the gas exchange part 3 is formed in the housing 1, and elements for heat exchange and gas exchange are accommodated, respectively.
  • a blood channel 4 (shown only in FIGS. 2 and 3) having a circular cross section is formed by penetrating the lumen formed by the heat exchange unit 2 and the gas exchange unit 3 in the horizontal direction.
  • a blood introduction port 5 (see FIGS. 2 and 3) and a blood outlet port 6 (see FIGS. 1 to 3) are provided on the outer shell wall of the housing 1 corresponding to both ends of the blood flow path 4, respectively.
  • the blood introduction port 5 and the blood outlet port 6 are disposed so as to open at the center of the circular cross section of the blood flow path 4.
  • Cold water / hot water ports 7 and 8 are provided in the outer shell walls of the housing 1 at the left and right ends of the heat exchange unit 2 to allow cold water or hot water (cold / hot water) to flow in and out, respectively.
  • Gas ports 9 and 10 are provided in the outer shell wall of the housing 1 at the upper and lower ends of the gas exchange unit 3 for inflow and outflow of oxygen-containing gas.
  • a bundle of stainless pipes 11 is arranged in a horizontal direction as a heat transfer thin tube through which a heat medium (cold / warm water) for heat exchange flows. It is loaded. Cold / hot water flows through the stainless steel pipe 11 through the cold / hot water ports 7, 8.
  • a bundle of hollow fiber membranes formed by laminating a plurality of hollow fiber membranes 12 is loaded in the internal space of the gas exchange unit 3 with the tube axis of the hollow fiber membranes 12 oriented in the vertical direction.
  • a gas containing oxygen flows through the lumen of the hollow fiber membrane 12 through the gas ports 9 and 10.
  • the outer peripheral area of the heat exchanging portion 2 and the gas exchanging portion 3 in the housing 1 is sealed by a sealing member 13 formed using a sealing material made of polyurethane resin or epoxy resin. Stopped. The internal space of the seal member 13 forms the blood channel 4.
  • the blood flow path 4 extends across the bundle of the stainless pipe 11 and the hollow fiber membrane 12 in the horizontal direction. Thereby, blood can be circulated so as to contact the outer surfaces of the stainless steel pipe 11 and the hollow fiber membrane 12.
  • a filter space 14 is formed downstream of the gas exchange unit 3, that is, between the side of the bundle of hollow fiber membranes 12 facing the blood outlet port 6 and the inner wall surface of the housing 1.
  • a filter 15 is inserted into the filter space 14 so as to cover the entire cross section of the blood channel 4.
  • the seal member 13 is also provided over the outer peripheral region of the filter space 14, and a part of the peripheral portion of the filter 15 is embedded in the seal member 13.
  • An exhaust port 16 is provided at the upper part of the housing 1 so as to be positioned at the upper end of the blood flow path.
  • the exhaust port 16 is configured by a tubular member extending laterally from the outer surface of the housing 1, and opens to the uppermost portion of the inner peripheral wall surface of the blood flow path 4 located in the filter space 14. ing.
  • the exhaust port 16 has a function of an exhaust path for discharging the bubbles captured by the filter 15 by communicating the filter space 14 with the external space.
  • the filter 15 and the exhaust port 16 arranged as described above provide a bubble removing function for capturing bubbles in the blood and discharging them to the outside of the housing 1.
  • the exhaust port 16 is not limited to a tubular member, and any member may be used as long as it forms a hollow flow path.
  • the filter 15 has a function of capturing foreign substances in the blood flowing through the blood flow path 4 and a function of capturing and discharging bubbles.
  • the filter 15 is composed of a mesh-like sheet-like filter medium 17 made of, for example, polyethylene terephthalate, and is folded back so as to form a plurality of pleats 18.
  • the pleat 18 has a ridge shape curved in a mountain shape as illustrated.
  • the shape is not limited to such a curved ridge line shape, and may be a creased shape, and the pleats in the present embodiment are used in the meaning including any case.
  • the plurality of pleats 18 are arranged in a plane orthogonal to the blood flow path 4, and the direction of the pleats 18 is oriented in the vertical direction (vertical direction).
  • the plurality of pleats 18 are not necessarily arranged in a plane orthogonal to the blood flow path 4, and may be arranged in a plane that “crosses” the blood flow path 4.
  • the filter space 14 is separated into a primary space 14 a on the blood introduction port 5 side and a secondary space 14 b on the blood outlet port 6 side by the sheet-like filter medium 17.
  • the area of the membrane surface of the sheet-like filter medium 17 in contact with the primary space 14a is remarkably wider than that of the flat sheet-like filter medium by repeating the peaks and valleys formed by the plurality of pleats 18.
  • the restriction due to the cross-sectional area of the blood channel 4 can be eliminated, and the filter membrane area can be set sufficiently large. Therefore, an effect similar to the fact that the cross-sectional area of the flow path is substantially large is obtained, and the flow rate of the priming liquid / blood with respect to the membrane surface is reduced to facilitate gas-liquid separation and to fully demonstrate the ability to trap bubbles. can do.
  • the increase in the thickness of the filter 15 in the direction of the blood flow path 4 due to the provision of the pleats 18 is slight, and the blood filling amount can be sufficiently suppressed.
  • the outer peripheral edge of the filter 15 is sealed with a sealing material 19 to form a filter module 20.
  • 5 is a view seen from the side facing the primary space 14a in FIGS.
  • the inner peripheral wall surface of the sealing material 19 is a cylindrical surface and forms the blood flow path 4 in the region of the filter 15.
  • an end portion of the exhaust port 16 is disposed at a position adjacent to the upper end region of the blood flow path 4 of the sealing material 19, and opens at the upper end of the blood flow path 4.
  • FIG. 6 is a cross-sectional view conceptually showing the upper part of the oxygenator according to the present embodiment.
  • FIG. 7 is a perspective view showing a region of the filter space 14 of the oxygenator in a cross section
  • FIG. 8 is a perspective view showing a part of FIG.
  • the artificial lung is placed in the opposite direction to FIGS. 1 and 2, that is, with the blood introduction port 5 on the left side and the blood outlet port 6 on the right side. It is drawn.
  • the exhaust port 16 includes first and second exhaust passages 21a and 21b separated from each other.
  • the first and second exhaust passages 21a and 21b are formed by dividing the inside of one tubular exhaust port 16.
  • the first exhaust path 21a has an inner end opened to the primary space 14a
  • the second exhaust path 21b has an inner end opened to the secondary space 14b.
  • the outer end portions of the first and second exhaust passages 21a and 21b are opened to the outside of the oxygenator. Therefore, the exhaust from the primary side space 14a and the secondary side space 14b can be separated and led out by the first and second exhaust passages 21a and 21b.
  • first and second exhaust passages 21a and 21b it is possible to simultaneously open and close the primary and secondary spaces 14a and 14b by opening and closing a single opening / closing plug provided in one exhaust port 16. You may comprise so that it may exhaust.
  • the operation of the opening / closing plug is performed as necessary to block communication between the filter space 14 and the outside of the housing 1 when priming is completed and extracorporeal blood circulation is started. Thereby, it is possible to prevent blood from leaking from the exhaust port 16 during extracorporeal blood circulation.
  • the direction of the plurality of pleats 18 of the filter 15 is oriented in the vertical direction (vertical direction). Therefore, when the priming liquid or bubbles in the blood are trapped by the filter 15 in the primary space 14a, the bubbles rise along the pleats 18. Then, the air enters the first exhaust path 21a and is discharged to the outside. Similarly, in the secondary side space 14b, the bubbles rise along the pleats 18, enter the second exhaust path 21b, and are discharged to the outside.
  • the pleats 18 are oriented in the vertical direction, there is an effect that bubbles are easily guided to the exhaust port 16 in the vicinity of the filter 15. Therefore, air bubbles in the filter space 14 can be collected in the exhaust port 16 without requiring an operation of tilting the artificial lung. Further, the air bubbles in the primary and secondary spaces 14a and 14b are separated and discharged through the first and second exhaust passages 21a and 21b, so that high exhaust performance can be obtained. By separating the exhaust from each other, it is possible to avoid the possibility that the blood in the primary side space 14a is mixed into the blood in the secondary side space 14b after filtration.
  • a step portion 22 is provided on the inner peripheral wall surface of the blood channel 4 in the vicinity of the filter 15 over the entire circumference of the circular cross section.
  • the stepped portion 22 facing the primary side space 14a is shown, but the stepped portion 22 is similarly provided on the side facing the secondary side space 14b.
  • the stepped portion 22 is formed in a direction in which the flow path cross section on the side close to the filter 15 is smaller than the separated side.
  • the sealing material 19 forms inclined surfaces 23 a and 23 b in the region where the blood flow path 4 is formed, that is, in the upper end portion of the pleat 18.
  • the inclined surfaces 23a and 23b correspond to the valley portions of the pleat 18, the inclined surface 23a is formed in the valley portion 18a facing the primary space 14a (front side in FIG. 8), and the inclined surface 23b is secondary. It is formed in the trough part 18b facing the side space 14b.
  • the direction of inclination of the inclined surfaces 23a and 23b is set so as to go from the shallow part to the deep part of the valley as it goes downward.
  • the bubbles rising from below along the valleys 18a of the pleats 18 are introduced along the inclined surfaces 23a away from the filter 15 and introduced into the first exhaust path 21a.
  • the operation of the inclined surface 23b is the same.
  • the bubbles rising along the peripheral pleats 18 are guided to the central portion by the step portion 22 and reach the open ends of the first and second exhaust passages 21a and 21b.
  • the inclination angle of the inclined surfaces 23a and 23b with respect to the horizontal direction has a range in which bubbles can easily escape, and according to experimental results, it functions effectively when set within a range of 5 ° to 80 °.
  • the inclination angle is smaller than 5 °, the bubbles are difficult to rise, and when it is larger than 80 °, it is difficult to secure a sufficient effective area as the filter membrane area. Further, if it is set within the range of 20 ° to 60 °, it is more preferable as a realistic design range.
  • a priming solution or blood is introduced from the blood introduction port 5, passed through the blood flow path 4 extending from the heat exchange unit 2 to the gas exchange unit 3, and further to the filter space 14. And is derived from the blood outlet port 6.
  • Cold water or hot water which is a heat exchange liquid flowing in from the cold / hot water inlet port 8, exchanges heat with blood in the heat exchange section 2 while passing through each stainless steel pipe 11.
  • the oxygen-containing gas flowing in from the gas inlet port 9 exchanges gas with the blood in the gas exchange unit 3 while passing through each hollow fiber membrane 12.
  • the blood after the gas exchange reaches the filter space 14 and is mixed into the priming solution / blood.
  • the generated foreign matter and blood clots are trapped by the filter 15, and the priming solution / blood from which bubbles and foreign matter have been removed becomes the blood derivation. It is led out of the housing 1 from the port 6.
  • the bubbles are trapped by the filter 15, rise along the sheet-like filter medium 17, and reach the upper region of the blood flow path 4 in the filter space 14. Since the exhaust port 16 is open in this region, the bubbles are exhausted to the outside through the exhaust port 16.
  • the effect of discharging air from the exhaust port 16 is great because the cross section of the blood flow path 4 is circular. This is because the exhaust port 16 provided at the uppermost part (top) of the inner wall surface of the blood flow path 4 facing the filter space 14 is located at the apex of the filter space 14, so that the raised bubbles gather. .
  • the cross section of the blood flow path 4 is not limited to a circular shape, and any cross-sectional outer peripheral shape aggregated at the apex may be used.
  • the filter built-in artificial lung having the above-described configuration is manufactured by manufacturing the filter module 20 as shown in FIG. It includes a step of forming the blood flow path 4 by sealing the peripheral edge. Other steps are performed using known techniques.
  • FIGS. 9A to 9D An example of a specific structure of the filter module 20 manufactured by this manufacturing method is shown in FIGS. 9A to 9D.
  • 9A is a front view seen from the side facing the primary space 14a of the filter module 20, and
  • FIG. 9B is a bottom view.
  • FIG. 9C is a cross-sectional view taken along line AA in FIG. 9A.
  • 9D is a right side view of the filter module 20 of FIG. 9A
  • FIG. 9D is a cross-sectional view taken along line BB of FIG. 9A.
  • the same reference numerals are given to the same elements as the respective parts of the filter module 20 shown in FIGS. 5 to 8, and the description thereof is omitted.
  • FIGS. 11A to 11C show the secondary side masking block 24b.
  • the primary side and secondary side masking blocks 24a and 24b are used for manufacturing the filter module 20 by insert molding. That is, a molding die for molding a sealing portion by the sealing material 19 is formed on the outer peripheral edge portion by combining the primary side and secondary side masking blocks 24a and 24b with the filter 15 interposed therebetween.
  • FIG. 10A is a front view of the primary side masking block 24a
  • FIG. 10B is a bottom view
  • FIG. 10C is a right side view.
  • the primary side masking block 24 a has a structure in which a group of linear protrusions 26 is provided on the substrate 25.
  • the linear protrusion 26 has a shape corresponding to the valley portion 18a of the pleat 18 facing the primary space 14a. Further, the shape of the outer peripheral edge portion of the group of linear protrusions 26 corresponds to a portion belonging to the primary space 14 a in the inner wall portion of the blood flow path 4 formed by the sealing material 19.
  • an inclined surface molding portion 27 for forming the inclined surface 23a of the valley portion 18a facing the primary space 14a shown in FIG.
  • a step forming portion 28 for forming the step portion 22 shown in FIG. 8 is provided outside the peripheral portion of the group of linear protrusions 26.
  • a protrusion 29 for forming a mounting hole for mounting the exhaust port 16 is provided on the upper portion of the group of linear protrusions 26.
  • the protrusion 29 is provided with an engagement hole 29a (see FIG. 10C).
  • FIG. 11A is a front view of the secondary side masking block 24b
  • FIG. 11B is a bottom view
  • FIG. 11C is a right side view.
  • the secondary side masking block 24b has a structure in which a group of linear protrusions 31 is provided on the substrate 30 in substantially the same manner as the primary side masking block 24a.
  • the linear protrusion 31 has a shape corresponding to the valley portion 18b of the pleat 18 facing the secondary space 14b. Further, the shape of the outer peripheral edge portion of the group of linear protrusions 31 corresponds to a portion belonging to the secondary space 14 b in the inner wall portion of the blood flow path 4 formed by the sealing material 19.
  • an inclined surface molding portion 32 for forming the inclined surface 23b of the valley portion 18b facing the secondary space 14b shown in FIG.
  • a step forming portion 33 for forming the step portion 22 shown in FIG. 8 is provided outside the peripheral portion of the group of linear protrusions 31.
  • a protrusion 34 for forming a mounting hole for mounting the exhaust port 16 is provided on the upper portion of the group of linear protrusions 31.
  • FIGS. 12A to 12C show a state where the primary and secondary masking blocks 24a and 24b are combined and the mold is assembled. However, when actually molding, both masking blocks 24a and 24b are assembled with the filter 15 interposed therebetween.
  • 12A is a bottom view of the assembled mold
  • FIG. 12C (a) is a right side view of FIG. 12A
  • FIG. 12C (b) is a cross-sectional view taken along the line CC of FIG. 12A.
  • Each of the linear protrusions 26 of the primary side masking block 24a is inserted between the adjacent linear protrusions 31 of the secondary side masking block 24b.
  • each of the linear protrusions 31 is between the adjacent linear protrusions 26.
  • the linear protrusions 26 and 31 are fitted into the valley portions 18a and 18b of the pleat 18, respectively.
  • the projection 34 of the secondary masking block 24b is fitted in the engagement hole 29a of the projection 29 of the primary masking block 24a.
  • the primary side and secondary side masking blocks 24a and 24b are assembled as described above with the filter 15 in between.
  • a space formed between the substrates 25 and 30 on the outer peripheral edge of the filter is filled with a sealing material made of a thermosetting resin such as polyurethane and cured. After the sealing material is cured, the masking blocks 24a and 24b are removed, and the filter module 20 formed by the sealing material is taken out.
  • a hard resin is used for one of the masking blocks 24a and 24b, and a soft resin is used for the other. It is desirable to use it.
  • the present invention is not limited to this.
  • any of the masking blocks 24a and 24b can be made using a soft resin.
  • an artificial lung having a configuration in which the heat exchange unit 2 and the gas exchange unit 3 are formed by the housing 1 is shown as an example, but the application of the present invention is not limited to this. That is, even in a hollow fiber membrane oxygenator having only the gas exchange part 3 without the heat exchange part 2, the same effect as described above can be obtained by applying the structure of the bubble removing part by the filter 15 described above. be able to.
  • the built-in filter type artificial lung of the present invention has a built-in filter device that allows a substantially sufficiently large filter membrane area to function while suppressing the amount of blood filling, and that can effectively discharge trapped bubbles to the outside. Therefore, it is useful as a heart-lung machine for extracorporeal blood circulation.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • Emergency Medicine (AREA)
  • Urology & Nephrology (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne un poumon artificiel qui est pourvu d'un faisceau de membranes à fibres creuses (12) chargées dans une partie d'échange de gaz (3) et un filtre (15) chargé dans un espace de filtre (14) adjacent à la partie d'échange de gaz, un canal sanguin (4) étant formé de manière qu'il passe transversalement dans le faisceau de membranes à fibres creuses et le filtre. Au niveau de la partie terminale supérieure du canal sanguin, un orifice d'échappement (16) pour permettre la communication de l'espace de filtre avec l'espace extérieur est placé. Le filtre est formé d'un matériau filtrant de type feuille (17) comprenant une pluralité de plis parallèles (18) orientés dans le sens vertical du canal sanguin. L'espace de filtre est divisé en un espace côté primaire (14a) et un espace côté secondaire (14b) par le matériau filtrant de type feuille. L'orifice d'échappement est placé au niveau de la partie terminale supérieure du canal sanguin et comprend des passages d'échappement (21a, 21b) par lesquels les gaz d'échappement déchargé par les espaces côté primaire et côté secondaire sortent séparément les uns des autres.
PCT/JP2014/075242 2013-09-24 2014-09-24 Poumon artificiel à filtre intégré et son procédé de production WO2015046224A1 (fr)

Priority Applications (2)

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CN201480052017.XA CN105555333B (zh) 2013-09-24 2014-09-24 过滤器内置型人工肺及其制造方法
JP2015539247A JP6135769B2 (ja) 2013-09-24 2014-09-24 フィルタ内蔵型人工肺及びその製造方法

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JP2013196551 2013-09-24

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WO2017135358A1 (fr) * 2016-02-03 2017-08-10 株式会社ジェイ・エム・エス Poumon artificiel doté d'un filtre intégré
KR101907539B1 (ko) 2017-04-18 2018-10-12 한양대학교 산학협력단 체내 산소화 장치
CN109793956A (zh) * 2017-10-16 2019-05-24 心血管系统公司 具有集成的空气去除系统的体外氧合器
WO2021075466A1 (fr) * 2019-10-15 2021-04-22 ニプロ株式会社 Poumon artificiel
US11707559B2 (en) 2017-10-16 2023-07-25 Terumo Cardiovascular Systems Corporation Extracorporeal oxygenator with integrated air removal system

Families Citing this family (1)

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CN113398354B9 (zh) 2021-07-14 2022-05-03 江苏赛腾医疗科技有限公司 集成式膜式氧合器

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JPH06312015A (ja) * 1993-04-30 1994-11-08 Terumo Corp 濾過装置
JPH0975451A (ja) * 1995-09-19 1997-03-25 Jms Co Ltd 気泡除去性の良い熱交換器
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WO2017135358A1 (fr) * 2016-02-03 2017-08-10 株式会社ジェイ・エム・エス Poumon artificiel doté d'un filtre intégré
JP2017136198A (ja) * 2016-02-03 2017-08-10 株式会社ジェイ・エム・エス フィルタ内蔵型人工肺
CN108495662A (zh) * 2016-02-03 2018-09-04 株式会社Jms 过滤器内置型人工肺
KR101907539B1 (ko) 2017-04-18 2018-10-12 한양대학교 산학협력단 체내 산소화 장치
CN109793956A (zh) * 2017-10-16 2019-05-24 心血管系统公司 具有集成的空气去除系统的体外氧合器
US11707559B2 (en) 2017-10-16 2023-07-25 Terumo Cardiovascular Systems Corporation Extracorporeal oxygenator with integrated air removal system
WO2021075466A1 (fr) * 2019-10-15 2021-04-22 ニプロ株式会社 Poumon artificiel

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JP6135769B2 (ja) 2017-05-31
JPWO2015046224A1 (ja) 2017-03-09
CN105555333B (zh) 2018-05-08
CN105555333A (zh) 2016-05-04

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