JP2019063209A - Operating method of artificial lung and extracorporeal circulation system - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an operation method of an artificial lung capable of suppressing the generation of blood clots in the artificial lung and an extracorporeal circulation system. Suppress or eliminate. [Selection diagram] Fig. 3

Description

  The present invention relates to a method of operating an artificial lung and an extracorporeal circulation system.

  In the past, extracorporeal circulation systems have been widely used to support the patient's blood circulation and respiration to temporarily maintain life against open heart surgery for heart disease and against rapidly progressing circulatory failure and cardiopulmonary arrest. It is done.

  The extracorporeal circulation system is incorporated in an extracorporeal circulation circuit comprising a blood removal line and a blood supply line and the like, and an artificial lung performing gas exchange with blood, and is incorporated in the extracorporeal circulation circuit and sends blood to the artificial lung And a pump (see, for example, Patent Document 1 below). The extracorporeal circulation system performs gas exchange (oxygenation of the blood and removal of carbon dioxide) by the artificial lung to blood removal from the blood, and sends it to the blood supply channel.

Japanese Patent Application Publication No. 2014-504906

  When the extracorporeal circulation system is used for a long period of time, it is necessary to replace the artificial lung at an appropriate timing in order to prevent the thrombus from being generated in the slow blood flow region or stagnant region in the artificial lung. For this reason, there has been a problem that the workload on doctors and nurses increases and the cost of using the extracorporeal circulation system increases.

  The present invention has been made in view of the above problems, and an object of the present invention is to provide an operation method of an artificial lung and an extracorporeal circulation system capable of suppressing the generation of a thrombus in an artificial lung.

  A method of operating an artificial lung according to the present invention is a method of operating an artificial lung that is incorporated into an extracorporeal circulation circuit of blood and performs gas exchange with the blood, wherein the artificial lung is treated during extracorporeal circulation of the blood. And to suppress or eliminate the retention of the blood in the artificial lung.

  The extracorporeal circulation system according to the present invention is incorporated in an extracorporeal circulation circuit of blood and is incorporated in an artificial lung performing gas exchange with the blood, and incorporated in the extracorporeal circulation circuit, and the blood is delivered to the artificial lung. And a control unit capable of controlling the operation of the pump and the vibrating unit. The control unit may perform the vibration during extracorporeal circulation of the blood. The operation of the unit is controlled to vibrate the artificial lung to suppress or eliminate the stagnation of the blood in the artificial lung.

  According to the method of operating the artificial lung and the extracorporeal circulation system according to the present invention, the stagnation of blood in the artificial lung is suppressed or eliminated by vibrating the artificial lung. For this reason, it is possible to suppress the occurrence of thrombus in the artificial lung.

It is a schematic diagram which shows the whole structure of the extracorporeal circulation system which concerns on embodiment of this invention, Comprising: It is a figure which shows a mode that blood is circulated extracorporeally. It is a figure which shows the mode of the bubble removal of the extracorporeal circulation system which concerns on embodiment. It is a schematic perspective view which shows structures, such as an artificial lung of the extracorporeal circulation system concerning an embodiment, a centrifugal pump, and a holder. It is a disassembled perspective view which shows structures, such as an artificial lung of the extracorporeal circulation system which concerns on embodiment, a centrifugal pump, and a holder. It is a fragmentary sectional view of the longitudinal direction of an artificial lung concerning an embodiment. It is a fragmentary sectional view of a diameter direction of an artificial lung concerning an embodiment. It is a schematic diagram which shows the flow of the blood which flows in into an artificial lung from the blood inflow port at the time of seeing the artificial lung which concerns on embodiment from the arrow 7 A direction of FIG. It is a schematic diagram which shows the flow of the blood which flows in into the blood outflow port at the time of seeing the artificial lung which concerns on embodiment from the arrow 7 B direction of FIG. It is a block diagram showing the control system of the extracorporeal circulation system concerning an embodiment. It is a schematic diagram which shows the whole structure of the extracorporeal circulation system which concerns on a modification.

  Hereinafter, with reference to the attached drawings, a method of operating an artificial lung and an extracorporeal circulation system according to embodiments and modifications of the present invention will be described. The following description does not limit the technical scope or the meaning of terms described in the claims. Also, the dimensional proportions of the drawings are exaggerated for the convenience of the description, and may differ from the actual proportions.

  The extracorporeal circulation system 1 according to the present embodiment will be described with reference to FIGS. 1 to 8. 1 and 2 are diagrams provided to explain the overall configuration of the extracorporeal circulation system 1 according to the embodiment. FIGS. 3-8 is a figure where it uses for description of the structure of each part of the extracorporeal circulation system 1 which concerns on embodiment. 7A and 7B, the gas inflow port 132a, the gas outflow port 133b, the inflow port 132b of the heat medium, and the outflow port 132c of the heat medium are omitted.

  The extracorporeal circulation system 1 according to the present embodiment is a system for circulating and breathing blood of the patient M in order to temporarily maintain life against open heart surgery for heart disease and against rapidly progressing circulatory failure and cardiopulmonary arrest. It is configured as a system to assist the The extracorporeal circulation system 1 is used in a state of being incorporated into the extracorporeal circulation circuit C as shown in FIG.

<Extracorporeal circulation circuit>
The extracorporeal circuit C includes a blood removal catheter C1 for removing blood from the vein of the patient M, a blood feeding catheter C2 for transferring blood toward the artery of the patient M, and a priming step (air bubbles in the extracorporeal circuit C). And a switching unit C3 for switching the circuit when shifting from the step of removing the blood to the extracorporeal circulation step of blood. Hereinafter, the extracorporeal circulation circuit C will be described in detail.

  As shown in FIG. 1, one end of the blood removal catheter C1 communicates with the vein of the patient M, and the other end communicates with the blood inflow port 22 (see FIG. 3) of the pump 20 described later.

  As shown in FIG. 1, one end of the blood feeding catheter C2 communicates with the artery of the patient M, and the other end communicates with the blood outflow port 131a (see FIG. 3) of the artificial lung 10 described later. The blood feeding catheter C2 sends the blood subjected to gas exchange with the artificial lung 10 to the artery of the patient M.

  The switching unit C3 forms a circulation circuit (see FIG. 2) which does not pass through the body of the patient M during the priming step, and forms a circulation circuit passing through the body of the patient M during the extracorporeal circulation process of blood (FIG. 1) reference). Specifically, as shown in FIG. 2, the user operates the switching portion C3 in the priming step to occlude the flow path between the vein and the blood removal catheter C1, and the artery and blood feeding catheter The flow path between C2 is closed, and blood removal catheter C1 and blood feeding catheter C2 are communicated. Furthermore, the user connects the priming solution supply part P which supplies a priming solution to the communication part of the blood removal catheter C1 and the blood feeding catheter C2. When the priming step is completed and the system shifts to an extracorporeal blood circulation step, the user operates the switching part C3 to release the communication between the blood removal catheter C1 and the blood feeding catheter C2 as shown in FIG. The blood removal catheter C1 is communicated with the vein, and the blood delivery catheter C2 is communicated with the artery.

<Extracorporeal circulation system>
The extracorporeal circulation system 1 is incorporated in the extracorporeal circulation circuit C, and is incorporated in the artificial lung 10 performing gas exchange with blood, and incorporated in the extracorporeal circulation circuit C, and blood and priming fluid can be delivered to the artificial lung 10 A pump 20, a holder 30 for holding the artificial lung 10 and the pump 20, a vibrating portion 40 for vibrating the holder 30, and a retention detecting portion 50 capable of detecting retention of blood in the prosthetic lung 10. There is. The extracorporeal circulation system 1 further blocks the blood flow path of the extracorporeal circulation circuit C, the gas supply unit 60 for supplying gas to the artificial lung 10, the air bubble detection unit 70 capable of detecting air bubbles in the extracorporeal circulation circuit C, and And a possible clamp 80. The extracorporeal circulation system 1 further includes a display 90 for displaying predetermined information, and a controller 100 for controlling the operation of each part. Hereinafter, the configuration of each part of the extracorporeal circulation system 1 will be described.

(Artificial lung)
The artificial lung 10 according to the present embodiment is configured of a membrane-type artificial lung that performs gas exchange with blood by a hollow fiber. As shown in FIG. 5, the artificial lung 10 is housed in a housing 13, a gas exchange unit 11 housed in the housing 13 and performing gas exchange with blood, and housed in the housing 13 while adjusting the temperature of the blood. And a heat exchange unit 12 to be performed. Hereinafter, the configuration of each part of the artificial lung 10 will be described in detail.

  The housing 13 will be described.

  The housing 13 includes a cylindrical housing body 131 extending in the longitudinal direction, and a first header 132 and a second header 133 airtightly connected to both ends of the housing body 131.

  The housing body 131 is provided with a blood outflow port 131a. The first header 132 is provided with a gas inlet port 132a, a heat medium inlet port 132b, and a heat medium outlet port 132c. The second header 133 is provided with a blood inflow port 133a and a gas outflow port 133b. The blood inflow port 133 a extends in the longitudinal direction of the housing body 131. The blood outlet port 131 a extends in a direction intersecting the longitudinal direction of the housing body 131.

  The housing 13 is preferably transparent to the extent that the blood flow therein is visible. In the present specification, “transparent” includes colorless and transparent, colored transparent, and semitransparent. Thereby, the stagnation of blood in the artificial lung 10 can be suitably detected by the stagnation detection unit 50 described later.

  The material constituting the housing 13 is not particularly limited, but for example, polyolefins such as polyethylene and polypropylene, ester resins such as polyethylene terephthalate, polystyrene, MS resin, styrene resins such as MBS resin, polycarbonate, etc. may be used. Can.

  The gas exchange unit 11 will be described.

  The gas exchange section 11 includes a cylindrical tubular core 111 extending in the longitudinal direction, a hollow fiber membrane bundle 112 provided on the outer periphery of the cylindrical core 111 and performing gas exchange with blood, and a hollow fiber membrane bundle 112 And a fixing member 114, 115 for fixing the hollow fiber membrane bundle 112 to the housing 13.

  Inside the cylindrical core 111, a heat exchange section 12 is provided. A gap is provided between the inner peripheral surface of the cylindrical core 111 and the outer peripheral surface of the heat exchange unit 12. The blood from the blood inflow port 133a flows into this gap (in FIG. 5, the flow of the blood is indicated by an arrow a1). Hereinafter, the gap between the inner peripheral surface of the cylindrical core 111 and the outer peripheral surface of the heat exchange unit 12 will be referred to as “first blood chamber Br1”.

  The cylindrical core 111 is provided with a large number of grooves 111 a on the outer peripheral surface. Each groove portion 111a is a fixed region (hereinafter referred to as "groove non-forming region 111c") on the side (lower side in FIGS. 5 and 6) where the blood outflow port 131a is provided in the circumferential direction of the cylindrical core 111 , And extends in an arc along the circumferential direction. Ribs 111d are formed between adjacent groove portions 111a. Each rib 111 d and the groove non-forming region 111 c abut on the inner circumferential surface of the hollow fiber membrane bundle 112. For this reason, the shape stability of the hollow fiber membrane bundle 112 can be improved. Each groove portion 111a may extend annularly over the entire circumferential direction of the cylindrical core 111 (that is, the groove non-forming region 111c may not be provided).

  As shown in FIGS. 5 and 6, the cylindrical core 111 is provided with a through hole 111b which penetrates the cylindrical core 111 in the thickness direction and communicates with the grooves 111a. FIG. 6 is a partial cross-sectional view in the radial direction passing through one groove portion 111a and the through hole 111b. Each through hole 111 b is provided in the cylindrical core 111 on the opposite side (upper side in FIGS. 5 and 6) to the side on which the blood outflow port 131 a is provided. The blood having flowed into the first blood chamber Br1 passes through the plurality of through holes 111b, travels toward the hollow fiber membrane bundle 112, and flows so as to expand in the circumferential direction by the plurality of grooves 111a (blood in arrow a3 in FIG. Show the flow of

  The material constituting the cylindrical core 111 is not particularly limited, and examples thereof include polyolefins such as polyethylene and polypropylene, ester resins such as polyethylene terephthalate, polystyrene, MS resin, styrene resins such as MBS resin, polycarbonate, etc. It can be used.

  The hollow fiber membrane bundle 112 is configured by stacking a large number of hollow fiber membranes (not shown). The hollow fiber membrane is configured by forming a large number of hollow fibers (not shown) having a gas exchange function in a tubular shape.

  The constituent material of the hollow fiber membrane is not particularly limited as long as gas exchange with blood is possible, but it is, for example, hydrophobic such as polypropylene, polyethylene, polysulfone, polyacrylonitrile, polytetrafluoroethylene, polymethylpentene, etc. Polymeric materials can be used.

  The filter 113 is provided in contact with the outer peripheral surface of the hollow fiber membrane bundle 112. In the present embodiment, the filter 113 has a substantially cylindrical shape, and covers the entire area of the outer peripheral surface of the hollow fiber membrane bundle 112 not covered by the fixing members 114 and 115, as shown in FIG. For this reason, compared with the case where the filter 113 partially covers the portion of the outer peripheral surface of the hollow fiber membrane bundle 112 which is not covered by the fixing members 114 and 115, air bubbles can be captured more suitably. The filter 113 may partially cover a portion not covered by the fixing members 114 and 115. In addition, the artificial lung 10 may not include the filter 113.

  A gap is provided between the outer peripheral surface of the filter 113 and the inner peripheral surface of the housing 13.

  The configuration of the filter 113 is not particularly limited as long as it can capture air bubbles. For example, the filter 113 may be configured by a screen filter having a mesh structure. Also, for example, the filter 113 may be made of a material having hydrophilicity, or the surface may be subjected to a hydrophilization treatment (for example, a plasma treatment or the like).

  The fixing member 114 is provided at an end (end on the right side in FIG. 5) closer to the gas inflow port 132 a among both ends in the longitudinal direction of the hollow fiber membrane bundle 112. The fixing member 115 is provided at an end (end on the left side in FIG. 5) closer to the gas outlet port 133 b among both ends in the longitudinal direction of the hollow fiber membrane bundle 112.

  Each fixing member 114, 115 has a substantially cylindrical shape, and is fixed to the inner surface of the housing 13 in a fluid tight manner. Therefore, a blood flow path (hereinafter, referred to as "second blood chamber Br2") is formed between fixing members 114 and 115, the outer peripheral surface of filter 113, and the inner peripheral surface of housing 13. . In addition, a first gas chamber Gr <b> 1 serving as a flow path of gas is formed between the fixing member 114 and the first header 132 of the housing 13. Further, between the fixing member 115 and the second header 133 of the housing 13, a second gas chamber Gr2 which is a flow path of gas is formed.

  The flow of blood in the artificial lung 10 will be described.

  The blood flows into the first blood chamber Br1 from the blood inflow port 133a (in FIG. 5, the flow of the blood is indicated by an arrow a1). Next, the blood moves in the first blood chamber Br1 in the circumferential direction and travels to the plurality of through holes 111b (in FIG. 6, the flow of blood is indicated by an arrow a2 in FIG. 7A). As shown in FIG. 7A, the blood flowing into the first blood chamber Br1 branches in the circumferential direction of the first blood chamber Br1 with the central axis of the blood inflow port 133a (indicated by a dashed dotted line in the drawing) as a boundary. As it flows. For this reason, the blood in the region S1 on the opposite side to the blood inflow port 133a of the first blood chamber Br1 is sandwiched between the flows in different directions in the circumferential direction and tends to stay.

  Next, the blood flows so as to spread in the circumferential direction of the cylindrical core 111 through the plurality of grooves 111a (the flow of the blood is indicated by an arrow a3 in FIG. 6). In addition, the blood passes through the hollow fiber membrane bundle 112 and the filter 113 in the radial direction and flows into the second blood chamber Br2 (the flow of the blood is shown by the arrow a4 in FIGS. 5 and 6). Next, the blood flows toward the blood outflow port 131a (indicated by an arrow a5 in FIGS. 5, 6 and 7B).

  In this way, after flowing in from the blood inflow port 133a, the blood spreads in the hollow fiber membrane bundle 112 and reaches the second blood chamber Br2. Therefore, the velocity of blood in the second blood chamber Br2 is generally slower than the velocity of blood in the blood inflow port 133a of the housing 13. Further, among the blood having reached the second blood chamber Br2, the blood in the vicinity of the inner surface of the housing 13 is particularly likely to be slow due to the friction with the wall, the viscosity of the blood, etc. Cheap. In particular, as shown in FIG. 7B, the blood in the second blood chamber Br2 flows toward the blood outflow port 131a. For this reason, the blood in the region S2 in the vicinity of both ends of the housing 13 sandwiching the blood outflow port 131a in the second blood chamber Br2 is sandwiched between the flows toward the blood outflow port 131a from different positions in the circumferential direction. It's easy to do. Thus, velocity distribution occurs in the blood in the second blood chamber Br2. When blood is retained for a long time, it causes a thrombus. The extracorporeal circulation system 1 according to the present embodiment, which will be described in detail later, suppresses or eliminates the stagnation of blood by the vibration unit 40, and suppresses the generation of a thrombus.

  The flow of gas in the artificial lung 10 will be described.

  A gas with a high oxygen concentration is supplied from the gas supply unit 60 to the artificial lung 10 via the gas inflow port 132a, as shown in FIG. Next, the gas flows into the first gas chamber Gr1. Next, the gas is supplied to the hollow fiber membrane bundle 112, supplies oxygen to the blood via the hollow fiber membrane bundle 112, and receives carbon dioxide from the blood (gas exchange). As a result, the oxygen concentration of the gas in the hollow fiber membrane bundle 112 is reduced. Next, the gas flows into the second gas chamber Gr2. Next, gas is exhausted from the oxygenating lung 10 via the gas outflow port 133b.

  The heat exchange unit 12 will be described.

  In the present embodiment, the heat exchange unit 12 includes a bellows-type heat exchange body 121. The heat medium from the heat medium inflow port 132 b of the housing 13 described later flows into the internal space (not shown) of the heat exchange body 121. The heat medium having undergone heat exchange with the blood via the heat exchanger 121 is discharged out of the artificial lung 10 from a heat medium outlet port 132c of the housing 13 described later. In addition, the structure of the heat exchange part 12 is not specifically limited as long as the temperature of the blood can be adjusted.

(pump)
In the present embodiment, the pump 20 is configured by a centrifugal pump. The pump 20 is provided on the head 21 and the head 21 as shown in FIGS. 3 and 4, and is provided on the blood inflow port 22 to which the blood removal catheter C1 can be connected, and the head 21 via a tube C4. The blood outlet port 23 communicating with the blood inlet port 133a of the artificial lung 10 and the motor drive 24 connected to the head 21 are provided. The pump 20 is not limited to a centrifugal pump as long as it can deliver blood to the artificial lung 10. The pump 20 may be configured by, for example, a roller pump.

(holder)
As shown in FIGS. 3 and 4, the holder 30 includes a substrate 31 and a connecting member 32 which is detachably mounted on the substrate 31.

  As shown in FIG. 4, the substrate 31 includes a flat portion 311, and vertical walls 312 and 313 which are continuous with both ends of the flat portion 311 and rise in a direction intersecting the flat portion 311.

  An engaging portion 311 a that engages with the connecting member 32 is provided on a surface of the flat portion 311 on which the vertical walls 312 and 313 are rising (hereinafter, referred to as “front”). In the present embodiment, the engaging portion 311a is configured by a hook-like protrusion. The vertical walls 312 and 313 are connected with rotation shafts 411 and 412 of a vibration unit 40 described later.

  The connecting member 32 is formed of a crank-like plate member. The connecting member 32 includes an artificial lung holding unit 321 for holding the artificial lung 10, a pump holding unit 322 for holding the pump 20, an engaged portion 323 engaged with the engaging portion 311a of the substrate 31, and a connecting member. A handle 324 is provided which is held by the user when attaching and detaching 32 to and from the substrate 31.

  The artificial lung holding unit 321 is configured of a plurality of claws 321 a provided on one side (right side in FIG. 4) of the front of the connecting member 32. The oxygenator holding unit 321 fixes the oxygenator 10 to the connecting member 32 by hooking the plurality of claws 321a in a recess (not shown) provided on the outer peripheral surface of the oxygenator 10. However, the configuration of the artificial lung holding unit 321 is not particularly limited as long as the artificial lung 10 can be held.

  The pump holding portion 322 is constituted by an annular frame portion 322 a provided on one side (left side in FIG. 4) of the connecting member 32. The pump holding portion 322 fixes the pump 20 to the connecting member 32 by fitting the pump 20 to the annular frame portion 322 a. However, the configuration of the pump holding portion 322 is not particularly limited as long as the pump 20 can be held.

  The engaged portion 323 is constituted by a through hole which penetrates the connecting member 32 in the thickness direction. The connecting member 32 can be connected to the substrate 31 by inserting and hooking the engaging portion 311 a of the substrate 31 into the engaged portion 323. However, the configuration of the engaging portion 311 a and the engaged portion 323 is not particularly limited as long as the connecting member 32 and the substrate 31 can be connected.

  The handle 324 is provided near the engaged portion 323. The user can grip the handle 324 and easily attach and detach the connecting member 32 for holding the artificial lung 10 and the pump 20 on the substrate 31.

  The constituent material of the holder 30 is not particularly limited. For example, polyolefins such as polyethylene and polypropylene, ester resins (for example, polyesters such as polyethylene terephthalate and polybutylene terephthalate), styrene resins (for example, polystyrene, MS resin, MBS) Resin materials, resin materials such as polycarbonate, various ceramic materials, metal materials and the like can be used.

(Vibration part)
The vibrating portion 40 includes a first vibrating portion 41 capable of vibrating the holder 30 in the circumferential direction R of the artificial lung 10, a support portion 42 supporting the first vibrating portion 41, and a supporting portion 42 in the longitudinal direction of the artificial lung 10. And a second vibrating portion 43 capable of vibrating in the intersecting direction Z.

  The first vibration unit 41 includes rotary shafts 411 and 412 connected to the vertical walls 312 and 313 of the holder 30, and rotary support units 413 and 414 rotatably supporting the rotary shafts 411 and 412 with respect to the support unit 42. And a motor 415 connected to the rotating shaft 411 and rotating the rotating shaft 411. The longitudinal direction of the rotation axes 411 and 412 of the holder 30 coincides with the longitudinal direction of the artificial lung 10 (indicated by a dashed-dotted line in FIG. 3).

  When the control unit 110 of the controller 100 described later drives the motor 415, the holder 30 vibrates in the circumferential direction R of the artificial lung 10 together with the rotary shafts 411 and 412. Therefore, the artificial lung 10 vibrates in the circumferential direction R. As shown in FIG. 6, the housing 13 is cylindrical. For this reason, there is nothing to prevent the blood in the first blood chamber Br1 from moving in the circumferential direction R due to vibration, and the first vibrating portion 41 is the blood staying in the first blood chamber Br1 (in particular, the region of FIG. 7A). The blood of S1) can be suitably agitated (forced flow can be created). In addition, since the blood in the second blood chamber Br2 also has nothing to prevent movement in the circumferential direction R due to vibration, the first vibrating portion 41 is a blood staying in the second blood chamber Br2 (especially in FIG. 7B). The blood in the region S2 can be suitably agitated. Therefore, retention of blood can be suitably suppressed or eliminated. Also, the pump 20 rotates with the artificial lung 10. Therefore, the relative position of the pump 20 with respect to the oxygenating lung 10 can be fixed at the time of vibration, and the tube C4 (see FIG. 3) connecting the oxygenating lung 10 and the pump 20 is twisted. It is possible to prevent the connection between the pump 10 and the pump 20 from being disconnected. In addition, the first vibration unit 41 can suppress or eliminate the stagnation of blood in the pump 20. In addition, although the angle range (amplitude) when the 1st vibration part 41 vibrates the holder 30 to circumferential direction R is not specifically limited, For example, it can vibrate 90 degree | times.

  The support part 42 is comprised by the flat plate, as shown to FIG. 3, FIG. The rotary support portions 413 and 414 are fixed to the support portion 42.

  The second vibration unit 43 includes a linear motion mechanism 431 and a coupling portion 432 that couples the support portion 42 and the linear motion mechanism 431. The linear motion mechanism 431 is not particularly limited as long as the support portion 42 can vibrate in the direction Z intersecting the longitudinal direction of the artificial lung 10, for example, known linear bush mechanisms, cylinder stroke mechanisms, ball screw mechanisms, etc. It can be configured by a linear motion mechanism. In the present embodiment, as shown in FIG. 3, the oxygenating lung 10 is disposed on the holder 30 so that the longitudinal direction of the oxygenating lung 10 is horizontal, and the blood outflow port 131a is positioned on the lower side. The linear motion mechanism 431 vibrates the support portion 42 in the vertical direction (vertical direction in FIG. 3) in a state in which the artificial lung 10 is disposed at the position.

  When the control unit 110 of the controller 100 described later drives the linear motion mechanism 431, the support unit 42 vibrates in the direction Z intersecting the longitudinal direction of the artificial lung 10. For this reason, the second vibrating unit 43 can vibrate the artificial lung 10 in the direction Z intersecting the longitudinal direction. The second vibration unit 43 vibrates the oxygenating lung 10 in a direction intersecting the flows of blood in the first blood chamber Br1 and the second blood chamber Br2 (indicated by arrows a2 and a5 in FIG. 6). Can be transferred to an area where blood is flowing normally, and blood retention can be suppressed or eliminated.

  The vibrating portion 40 may vibrate the artificial lung 10 in both the circumferential direction R and the direction Z intersecting the longitudinal direction when vibrating the artificial lung 10, or the artificial lung 10 may be vibrated only in the circumferential direction R. The oxygen may be vibrated, or the artificial lung 10 may be vibrated only in the direction Z intersecting the longitudinal direction. However, in the case of vibrating the artificial lung 10 in the circumferential direction R, retention can be more easily eliminated as compared with the case of vibrating in the direction Z intersecting the longitudinal direction. For this reason, it is preferable that the vibration unit 40 vibrate the artificial lung 10 at least in the circumferential direction R.

(Dwelling detection unit)
As shown in FIG. 1, the staying detection unit 50 is disposed so as to face the artificial lung 10 and to face the artificial lung 10 with the imaging unit 51 capable of imaging the blood in the second blood chamber Br2. And a light source 52 for irradiating the artificial lung 10 with light.

  The imaging unit 51 is not particularly limited as long as it can image the blood in the second blood chamber Br2, but can be configured by, for example, a CCD camera. In addition, it is preferable to arrange the imaging unit 51 at a position at which the region S2 (see FIG. 7B) in which the retention of the second blood chamber Br2 is likely to occur can be imaged.

  The light source 52 just needs to be able to brighten the region to be photographed of the artificial lung 10 to such an extent that the flow of blood can be analyzed from the plurality of images photographed by the imaging unit 51, and can be configured by, for example, a halogen lamp. Since hemoglobin (present in red blood cells) in the blood absorbs infrared rays, for example, the imaging unit 51 may be configured by an infrared camera and the light source 52 may be configured by an infrared light source.

  During extracorporeal circulation of blood, the control unit 110 of the controller 100 described later drives the imaging unit 51 to image the blood in the second blood chamber Br2 at constant time intervals. Next, the control unit 110 binarizes each captured image, and creates a red blood cell extraction image in which red blood cells in each captured image are extracted. Then, the correlation vector is used to calculate the velocity vector of red blood cells from two continuous red blood cell extraction images. When the velocity of the red blood cells is equal to or less than a predetermined value, the control unit 110 determines that the blood is stagnant. Thus, as used herein, retention of blood refers not only to blood having a velocity of 0, but also includes blood having a velocity equal to or less than a predetermined value.

  The staying detection unit 50 may further include a microscope capable of magnifying and observing the artificial lung 10, and the imaging unit 51 may be configured to capture an image enlarged by the microscope. Further, the configuration of the retention detecting unit 50 is not particularly limited as long as the retention of blood in the artificial lung 10 can be detected. For example, the stagnation detection unit measures the pressure upstream of the blood inflow port of the artificial lung and the pressure downstream of the blood outflow port of the artificial lung, and the control unit 110 of the controller 100 tends to increase the pressure loss, or When the pressure loss exceeds a predetermined value, it may be determined that retention has occurred, and the artificial lung may be vibrated.

(Gas supply unit)
The gas supply unit 60 includes an oxygen cylinder, an air cylinder, and a gas blender airtightly connected to the oxygen cylinder and the air cylinder and supplying a mixed gas of oxygen and air to the artificial lung 10 (all not shown). Have. The gas blender is in communication with the gas inflow port 132a of the artificial lung 10 (see FIG. 5).

(Air bubble detection unit)
The air bubble detection unit 70 detects air bubbles flowing through the blood feeding catheter C2, as shown in FIG. The air bubble detection unit 70 is not particularly limited as long as air bubbles flowing through the blood feeding catheter C2 can be detected. For example, the air bubble detection unit 70 may be configured by an ultrasonic transmitter-receiver or an optical transmitter-receiver disposed across the blood supply catheter C2. it can.

(Clamp)
The clamp 80 is provided downstream of the air bubble detection unit 70, and can close the flow path of the blood feeding catheter C2. If air bubbles are detected by the air bubble detection unit 70 during extracorporeal circulation of blood, the control unit 110 controls the clamp 80 to immediately block the flow path of the blood feeding catheter C2. This can prevent air bubbles from flowing into the patient M's body.

(display)
The display 90 displays information to be provided for the operation of the extracorporeal circulation system 1. For example, the display 90 can display the velocity distribution of the blood in the artificial lung 10 acquired by the residence detection unit 50. Therefore, the user can appropriately grasp the velocity distribution of the blood in the artificial lung 10.

(controller)
The controller 100 includes a control unit 110 that controls the operation of each part of the extracorporeal circulation system 1 and an operation unit 120 that can receive an instruction from the user to the extracorporeal circulation system 1.

  The control unit 110 includes a CPU and a storage unit. The storage unit is a ROM that stores various programs and data in advance, a RAM that temporarily stores programs and data as a work area, stores various programs and data, or temporarily stores image data and the like obtained by image processing. It consists of a hard disk etc. used in order to save. The storage unit will be described later in detail, but (i) the presence / absence of the blood in the artificial lung 10 is monitored by the residence detecting unit 50 during extracorporeal circulation of blood, and (ii) the oxygenation 10 is detected. , And (iii) a series of programs for confirming whether or not the retention has been eliminated after the completion of the vibration operation of the oxygenating lung 10 is stored.

  The control unit 110 is electrically connected to the pump 20, the vibration unit 40, the staying detection unit 50, the gas supply unit 60, the air bubble detection unit 70, the clamp 80, the display 90, and the operation unit 120, as shown in FIG. doing. The control unit 110 controls the operation of the pump 20, the vibrating unit 40, the gas supply unit 60, the clamp 80, and the display 90. The control unit 110 also determines the presence or absence of blood stagnation based on the signal from the stagnation detection unit 50. The control unit 110 also determines the presence or absence of the air bubble in the blood feeding catheter C2 based on the signal from the air bubble detection unit 70.

(Method of operation)
As an example of the method of operating the artificial lung 10 and the method of controlling the extracorporeal circulation system 1, a flow of performing a cardiopulmonary support operation of the patient M by the artificial lung 10 will be described.

  Prior to performing extracorporeal circulation of blood of patient M using extracorporeal circulation system 1, extracorporeal circulation system 1 and extracorporeal circulation circuit C are filled with priming solution, and air bubbles in extracorporeal circulation system 1 and extracorporeal circulation circuit C are filled. Perform a priming step to remove.

  First, the user operates the switching portion C3 to block the path of the extracorporeal circuit C into the body of the patient M, and forms a circuit that passes only outside the patient M and communicates with the priming fluid supply portion P. (See Figure 2).

  Next, the user operates the operation unit 120 to instruct the control unit 110 to start priming.

  As a result, the control unit 110 drives the pump 20 to fill the extracorporeal circuit C with the priming solution. The priming solution is circulated a plurality of times in the extracorporeal circuit C, and air bubbles are discharged from a bubble discharge port (not shown) on the extracorporeal circuit C. When the priming solution is circulated, the presence or absence of air bubbles flowing in the extracorporeal circuit C may be detected by the air bubble detection unit 70.

  Next, the user confirms that the priming is completed based on visual observation or the signal of the air bubble detection unit 70, and then operates the operation unit 120 to instruct the control unit 110 to complete the priming. As a result, the control unit 110 stops the pump 20.

  Next, the user operates the switching unit C3 to switch the extracorporeal circuit C into a circuit passing through the body of the patient M (see FIG. 1).

  Next, the user operates the operation unit 120 to set the blood flow rate, the gas supply amount, the amplitude, the cycle, etc. when the vibration unit 40 vibrates the artificial lung 10, and Give instructions to start extracorporeal circulation.

  As a result, the control unit 110 drives the pump 20 based on the set blood flow rate, and drives the gas supply unit 60 based on the set gas supply amount. By driving the pump 20, blood extracted from the blood removal catheter C1 flows into the artificial lung 10 via the pump 20. Blood exchanges gas (oxygenation, carbon dioxide removal) with the oxygenator 10. The gas-exchanged blood is fed into the body of the patient M from the blood feeding catheter C2. If air bubbles are detected by the air bubble detection unit 70, the control unit 110 drives the clamp 80 to close the flow path of the blood feeding catheter C2 to stop blood feeding.

  The control unit 110 monitors the presence or absence of the stagnation of the blood in the artificial lung 10 based on the signal from the stagnation detection unit 50 during the extracorporeal circulation of the blood. When the control unit 110 detects the stagnation of blood in the artificial lung 10, the control unit 110 drives the vibration unit 40 to vibrate the holder 30 (vibration step). As a result, the artificial lung 10 vibrates, and retention of blood in the artificial lung 10 can be resolved. For this reason, it is possible to suppress the occurrence of thrombus in the artificial lung 10. The control unit 110 may vibrate both the first vibrating unit 41 and the second vibrating unit 43, or may vibrate either one of the first vibrating unit 41 or the second vibrating unit 43.

  In the present embodiment, the control unit 110 causes the vibrating unit 40 to stop after being driven for a predetermined time. Next, the control unit 110 causes the residence detection unit 50 to confirm the presence or absence of the residence of blood in the artificial lung 10. This makes it possible to confirm whether the stagnation of blood in the artificial lung 10 has been eliminated by the vibration. If the stagnation of blood in the artificial lung 10 is not resolved, the control unit 110 once again drives the vibration unit 40 to vibrate the artificial lung 10. The control unit 110 may continuously drive the vibrating unit 40 until the user instructs to stop the extracorporeal circulation of blood without stopping the vibrating unit 40 as in the present embodiment.

  Next, the user operates the operation unit 120 at a desired timing to instruct the control unit 110 to stop the extracorporeal circulation of blood.

  As a result, the control unit 110 stops the pump 20 and the gas supply unit 60. Moreover, the control part 110 stops the vibration part 40, when the vibration part 40 is driving.

  As described above, according to the operation method of the oxygenator 10 of the present embodiment, the oxygenator 10 is vibrated during extracorporeal circulation of blood, and the vibration step of suppressing or eliminating the stagnation of the blood in the oxygenator 10 is provided. For this reason, it is possible to suppress the generation of a thrombus in the artificial lung 10.

  In addition, in the vibration process, after detection of blood stagnation in the artificial lung 10, the artificial lung 10 is vibrated. For this reason, stagnation of the blood in the artificial lung 10 can be eliminated, and generation | occurrence | production of a thrombus can be prevented suitably. In addition, since the artificial lung 10 is vibrated at the timing when the stagnation is detected, it is possible to suppress the power required to vibrate the artificial lung 10.

  In addition, the oxygenator 10 includes a hollow housing 13 extending in the longitudinal direction, and blood flows into the housing 13 along the longitudinal direction and then flows so as to expand in the housing 13. It vibrates in the direction Z intersecting the longitudinal direction. For this reason, the blood which has flowed so as to spread in the housing 13 and has become slow can be vibrated in the direction Z crossing the blood flow. Therefore, retention of blood in the artificial lung 10 can be suitably suppressed or eliminated.

  In addition, the artificial lung 10 includes a cylindrical housing 13 extending in the longitudinal direction, and vibrates the artificial lung 10 in the circumferential direction R of the housing 13 in the vibration process. Since the housing 13 has a cylindrical shape and there is no barrier in the circumferential direction R, the blood can be suitably agitated by vibrating the oxygenating lung 10 in the circumferential direction R. Therefore, retention of blood in the artificial lung 10 can be suitably suppressed or eliminated.

  Further, according to the extracorporeal circulation system 1 according to the present embodiment, the artificial lung 10 that is incorporated in the extracorporeal circulation circuit C of blood and performs gas exchange with blood, and the extracorporeal circulation circuit C are incorporated. And a vibration unit 40 for vibrating the oxygenator 10, and a control unit 110 capable of controlling the operation of the pump 20 and the vibration unit 40. The control unit 110 controls the operation of the vibrating unit 40 to vibrate the artificial lung 10 during extracorporeal circulation of blood, thereby suppressing or eliminating the stagnation of the blood in the artificial lung 10. For this reason, it is possible to suppress the generation of a thrombus in the artificial lung 10.

  In addition, the extracorporeal circulation system 1 further includes a retention detection unit 50 capable of detecting retention of blood in the artificial lung 10, and the control unit 110 detects the retention of blood in the artificial lung 10. In this case, the operation of the vibration unit 40 is controlled to vibrate the artificial lung 10. For this reason, stagnation of the blood in the artificial lung 10 can be eliminated, and generation | occurrence | production of a thrombus can be prevented suitably. In addition, since the artificial lung 10 is vibrated at the timing when the stagnation is detected, it is possible to suppress the power required to vibrate the artificial lung 10.

  The oxygenator 10 further includes a hollow housing 13 extending in the longitudinal direction. Blood flows into the housing 13 along the longitudinal direction and then flows so as to expand in the housing 13. Are vibrated in the direction Z intersecting the longitudinal direction. For this reason, it is possible to vibrate the blood which has flowed and spread so as to expand in the artificial lung 10 in the direction Z crossing the blood flow. Therefore, retention of blood in the artificial lung 10 can be suitably suppressed or eliminated.

  In addition, the oxygenator 10 includes a cylindrical housing 13 extending in the longitudinal direction, and the vibration unit 40 vibrates the oxygenator 10 in the circumferential direction R of the housing 13. Since the housing 13 has a cylindrical shape and there is no barrier in the circumferential direction, the blood can be suitably agitated by vibrating the oxygenating lung 10 in the circumferential direction. Therefore, retention of blood in the artificial lung 10 can be suitably suppressed or eliminated.

  In addition, the extracorporeal circulation system 1 further includes a holder 30 for holding the artificial lung 10 and the pump 20, and the vibration unit 40 vibrates the holder 30. Therefore, retention of blood in the pump 20 can also be suppressed or eliminated. Further, since the artificial lung 10 and the pump 20 can be interlocked and vibrated, it is possible to preferably prevent the connection between the artificial lung 10 and the pump 20 from being released.

<Modification>
Next, an extracorporeal circulation system 2 according to a modification will be described with reference to FIG. The extracorporeal circulation system 2 according to the modification is different from the extracorporeal circulation system 1 according to the above-described embodiment in that the residence detection unit 50 is not provided and the timing at which the artificial lung 10 is vibrated. Hereinafter, an operation method of the oxygenator 10 and a control method of the extracorporeal circulation system 2 according to the modification will be described. In addition, about the structure same as the extracorporeal circulation system 1 which concerns on the said embodiment, the same code | symbol is attached | subjected and description is abbreviate | omitted.

  The extracorporeal circulation system 2 also fills the extracorporeal circulation system 2 and the extracorporeal circulation circuit C with priming fluid prior to performing extracorporeal circulation of the blood of the patient M, similarly to the extracorporeal circulation system 1 according to the above embodiment. A priming step is performed to remove air bubbles in the system 2 and the extracorporeal circuit C. The priming step and the detailed procedure for switching from the priming step to the extracorporeal circulation step of blood have been omitted in the above description of the embodiment.

After completion of switching from the priming process to the extracorporeal circulation process of blood, the user can
The operation unit 120 is operated to set the blood flow rate, the gas supply amount, the amplitude, frequency and the like when the vibration unit 40 vibrates the artificial lung 10, and instructs the control unit 110 to start extracorporeal circulation of blood. .

  As a result, the control unit 110 drives the pump 20 based on the set blood flow rate, drives the gas supply unit 60 based on the set gas supply amount, and the vibration unit 40 based on the set amplitude / frequency etc. To drive. The extracorporeal blood circulation start time can be a time when the pump 20 is driven for extracorporeal blood circulation. That is, even if the priming fluid remains in the extracorporeal circuit C and the inside of the extracorporeal circuit C is not completely filled with blood, the time when the pump 20 is driven for extracorporeal circulation of blood is It can be the start point of extracorporeal circulation. As described above, since the vibration unit 40 is driven simultaneously with the driving of the pump 20 at the start of extracorporeal blood circulation, the occurrence of blood stagnation in the artificial lung 10 can be suppressed. The control unit 110 may vibrate both the first vibrating unit 41 and the second vibrating unit 43, or may vibrate either one of the first vibrating unit 41 or the second vibrating unit 43. The control unit 110 may continuously drive the vibrating unit 40 until an instruction to stop extracorporeal circulation described later is given, or every desired time interval (for example, 6 hours) until an instruction to stop extracorporeal circulation described later is issued. The vibrating unit 40 may be driven.

  Next, the user operates the operation unit 120 at a desired timing to instruct the control unit 110 to stop the extracorporeal circulation of blood.

  As a result, the control unit 110 stops the pump 20, the gas supply unit 60, and the vibrating unit 40.

  As mentioned above, according to the operation method of the oxygenator 10 which concerns on a modification, the vibration process which vibrates the oxygenator 10 simultaneously with the start of the extracorporeal circulation of the blood is provided. Further, the control unit 110 controls the operation of the vibrating unit 40 to vibrate the artificial lung 10 at the same time as driving the pump 20 for extracorporeal circulation of blood. Therefore, retention of blood in the artificial lung 10 can be suppressed. For this reason, the generation of a thrombus in the artificial lung 10 can be suitably suppressed.

  As mentioned above, although the operating method and the extracorporeal circulation of the artificial lung concerning the present invention were explained through an embodiment and a modification, the present invention is not limited only to each composition explained, and based on a statement of a claim. It is possible to change suitably.

  For example, although the control unit drives the vibrating unit to vibrate the artificial lung in the above embodiment, the user may manually vibrate the artificial lung during extracorporeal circulation of blood.

  Further, for example, the timing of vibrating the artificial lung is not particularly limited as long as it is after the start of extracorporeal circulation of blood (after the time of driving the pump for extracorporeal circulation of blood). For example, the extracorporeal circulation system does not include the stagnation detection unit, and includes a blood flow detection unit that detects the flow of blood in the extracorporeal circulation circuit, and the control unit is based on the signal from the blood flow detection unit. If it is determined that blood is flowing, the artificial lung may be vibrated. The blood flow detection unit is not particularly limited as long as the blood flow in the extracorporeal circulation circuit can be detected. For example, the blood flow detection unit can be configured by a CCD camera provided to face the extracorporeal circulation circuit. The control unit determines that blood is flowing when the inside of the extracorporeal circulation circuit is red in the captured image.

  The vibration direction of the artificial lung is not particularly limited as long as the entire artificial lung is vibrated, and may not be the direction (circumferential direction and vertical direction) of the above embodiment. Further, the “direction intersecting with the longitudinal direction” includes not only the vertical direction described in the above embodiment but also a direction which is inclined from the vertical direction and intersects the longitudinal direction. In addition, the vibrating portion may include only one of the first vibrating portion and the second vibrating portion.

  The extracorporeal circulation system according to the present invention is not particularly limited as long as it has an artificial lung, a pump, a vibration unit, and a control unit, and for example, in addition to these, it is provided in an extracorporeal circulation circuit and blood. Blood filter for filtering and removing air bubbles, a flow rate detection unit provided in the extracorporeal circulation circuit capable of measuring the flow rate of blood, an oxygen concentration detection unit provided in the extracorporeal circulation circuit and capable of measuring the oxygen concentration of blood, You may further have a blood reservoir (reservoir) etc. which are integrated in an extracorporeal-circulation circuit.

  Further, the external shape of the artificial lung, the internal configuration, the blood flow path and the like are not particularly limited. For example, the artificial lung may have a hollow rectangular parallelepiped shape, and a rectangular heat exchange unit and a gas exchange unit may be accommodated therein. In addition, the artificial lung may not include the heat exchange unit.

  Further, the positions at which the blood inflow port and the blood outflow port, the gas inflow port and the gas outflow port, the heat medium inflow port and the heat medium outflow port are provided in the artificial lung are not particularly limited.

  Further, in the above embodiment, the embodiment has been described in which both the artificial lung and the pump are vibrated by vibrating the artificial lung and the holder holding the pump. However, the pump need not be vibrated as long as at least the artificial lung can be vibrated.

1, 2 Extracorporeal circulation system,
10 artificial lungs,
13 housing,
20 pumps,
30 holders,
40 vibrators,
50 stagnation detection unit,
110 control unit,
C extracorporeal circuit,
R circumferential direction,
Z Direction to cross the longitudinal direction.

Claims (11)

A method of operating an artificial lung, which is incorporated in an extracorporeal circulation circuit of blood and performs gas exchange with said blood,
A method of operating an artificial lung, comprising a vibration step of vibrating the artificial lung during extracorporeal circulation of the blood to suppress or eliminate retention of the blood in the artificial lung.   The method of operating the artificial lung according to claim 1, wherein, in the vibration step, when the stagnation of the blood is detected in the artificial lung, the artificial lung is vibrated.   The method of operating the artificial lung according to claim 1, wherein in the vibration step, the artificial lung is vibrated simultaneously with the start of extracorporeal circulation of the blood. The oxygenator comprises a longitudinally extending hollow housing.
The blood flows into the housing along the longitudinal direction and then flows so as to expand in the housing,
The method of operating the artificial lung according to any one of claims 1 to 3, wherein in the vibration step, the artificial lung is vibrated in a direction intersecting the longitudinal direction. The oxygenator comprises a longitudinally extending cylindrical housing,
The method of operating the artificial lung according to any one of claims 1 to 4, wherein in the vibration step, the artificial lung is vibrated in the circumferential direction of the housing. An artificial lung which is incorporated into the extracorporeal circulation circuit of the blood and performs gas exchange with the blood;
A pump incorporated into the extracorporeal circuit and capable of delivering the blood to the artificial lung;
A vibration unit that vibrates the artificial lung;
A control unit capable of controlling the operation of the pump and the vibration unit;
The extracorporeal circulation system, wherein the control unit controls the operation of the vibrating unit to vibrate the artificial lung during extracorporeal circulation of the blood, thereby suppressing or eliminating the stagnation of the blood in the artificial lung. It further has a retention detection unit capable of detecting retention of the blood in the artificial lung,
The extracorporeal circulation system according to claim 6, wherein the control unit controls the operation of the vibrating unit to vibrate the artificial lung when the stagnation detecting unit detects the stagnation of the blood in the artificial lung. .   The extracorporeal circulation system according to claim 6, wherein the control unit controls the operation of the vibrating unit to vibrate the artificial lung simultaneously with driving the pump for extracorporeal circulation of the blood. The oxygenator comprises a longitudinally extending hollow housing.
The blood flows into the housing along the longitudinal direction and then flows so as to expand in the housing,
The extracorporeal circulation system according to any one of claims 6 to 8, wherein the vibration unit vibrates the artificial lung in a direction intersecting the longitudinal direction. The oxygenator comprises a cylindrical housing,
The extracorporeal circulation system according to any one of claims 6 to 9, wherein the vibration unit vibrates the artificial lung in the circumferential direction of the housing. And a holder for holding the oxygenator and the pump.
The extracorporeal circulation system according to any one of claims 6 to 10, wherein the vibration unit vibrates the holder.