Extracorporeal circulation system

Abstract

An extracorporeal circulation system (10) comprises: a holder unit (12) having a holder part (18) to which an artificial lung (100) for performing gas exchange is attached; and a holder (150) that can be attached to and detached from the holder unit (12) and can hold the holder unit (12). The holder (150) has an orientation-changing mechanism (164) capable of changing the orientation of the holder unit (12) with respect to the vertical direction in a connected state in which the holder (150) is connected to the holder unit (12).

Description

Extracorporeal circulation system

[0001] The present invention relates to an extracorporeal circulation system.

[0002] For example, when blood supply to a patient is required during surgery, extracorporeal circulation is performed to circulate the patient's blood outside the body using an extracorporeal circulation system having a cardiopulmonary bypass device or the like. The extracorporeal circulation system is disclosed, for example, in Japanese Patent Application Laid-Open No. 2007-14504.

[0003] Japanese Patent Application Laid-Open No. 2007-14504

[0004] Before use (before the start of extracorporeal circulation), the extracorporeal circulation system needs to perform priming to replace the air present in the circuit including the blood pump and the artificial lung with a liquid such as physiological saline. However, depending on the layout of the components of the circuit including the artificial lung, priming may be difficult to perform. In addition, the extracorporeal circulation system is a medical device with a high degree of urgency by its nature, and it is required that its installation can be carried out in a short time, including the priming operation before using the system. On the other hand, when trying to provide a mechanism that facilitates priming for the components of the circuit including the artificial lung, the configuration of the extracorporeal circulation system may become complicated or the weight of a part of the configuration may increase. In addition, when performing circulation management using the extracorporeal circulation system, in-hospital and out-of-hospital transfers may occur frequently. Therefore, while ease of transfer is required, if the weight of a specific component of the extracorporeal circulation system increases, the transferability may decrease.

[0005] An object of the present invention is to solve the above-described problems.

[0006] (1) A first aspect of the present disclosure includes a holder unit having a holder portion to which an artificial lung that performs gas exchange is attached, and a holder that is detachable from the holder unit and can hold the holder unit. The holder has a posture changing mechanism that can change the posture of the holder unit with respect to the vertical direction in a connection state where the holder is connected to the holder unit, and is an extracorporeal circulation system.

[0007] With this configuration, by changing the orientation of the holder unit during priming, air can be effectively removed from inside the artificial lung, thus enabling efficient priming. Furthermore, since the orientation-changing mechanism is provided in the retainer rather than the holder unit, an increase in the weight of the holder unit can be avoided. Therefore, there is no decrease in the transportability of the holder unit.

[0008] (2) In the extracorporeal circulation system described in item (1) above, the posture changing mechanism is capable of switching the posture of the holder unit between a first posture and a second posture, wherein the first posture is the posture used during extracorporeal circulation, and the second posture is the posture used during priming.

[0009] With this configuration, a second position can be adopted only during priming to efficiently remove air from the artificial lung. Outside of priming, the first position can be adopted, which is suitable for handling tubing (blood withdrawal catheter, blood delivery catheter, etc.).

[0010] (3) In the extracorporeal circulation system described in item (2) above, the position of the holder unit may be changed by 80° to 100° when changing from the first position to the second position, and the blood outflow port provided in the artificial lung may be moved to the upper part of the artificial lung.

[0011] This configuration allows the artificial lung to be positioned in a way that is suitable for air removal.

[0012] (4) In the extracorporeal circulation system described in item (2) or (3) above, the posture changing mechanism may be capable of rotating the holder unit about a rotation axis passing through the connection point with the holder unit in the connected state of the holder unit.

[0013] With this configuration, the orientation of the holder unit can be easily changed.

[0014] (5) In the extracorporeal circulation system described in item (4) above, the holder unit has a first connection portion, the posture changing mechanism has a second connection portion that can be connected to the first connection portion, one of the first connection portion and the second connection portion has a connection recess, and the other of the first connection portion and the second connection portion has a connection protrusion that can be inserted into the connection recess.

[0015] With this configuration, the holder unit and the attitude change mechanism can be attached and detached with a simple setup.

[0016] (6) In the extracorporeal circulation system described in item (5) above, the holder unit and the attitude changing mechanism may engage with the connecting projection by relative movement of the holder unit and the attitude changing mechanism in a direction perpendicular to the rotation axis while the holder unit and the attitude changing mechanism are facing each other.

[0017] With this configuration, the holder unit can be easily attached to the retainer.

[0018] (7) In the extracorporeal circulation system described in any one of the above items (2) to (6), the posture changing mechanism may have a locking mechanism capable of maintaining the holder unit in each of the first posture and the second posture.

[0019] This configuration prevents the holder unit's orientation from being changed unintentionally.

[0020] (8) In the extracorporeal circulation system described in any one of the above items (1) to (7), the holder unit may integrally include the holder portion and a pump drive unit for rotating a blood pump for circulating blood within the extracorporeal circulation circuit.

[0021] (9) An extracorporeal circulation system according to any one of the above items (2) to (7) may further include a base unit which integrally has a display unit for displaying information and an input unit for inputting information, and which is detachable from the holder unit.

[0022] (10) In the extracorporeal circulation system described in item (9) above, the posture changing mechanism may also be able to switch the holder unit from the first posture to the second posture when the base unit is separated from the holder unit.

[0023] (11) In the extracorporeal circulation system described in any one of the above items (1) to (10), the holder may have a tip portion on which the posture changing mechanism is provided, a base portion on the opposite side of the tip portion, and a joint portion provided between the tip portion and the base portion.

[0024] With this configuration, the position of the holder unit can be easily changed depending on the situation.

[0025] (12) In the extracorporeal circulation system described in any one of the above items (2) to (7), the holder unit has a holder unit body that supports the holder portion and support legs that support the holder unit body, and when the holder unit is in the second position, the support legs may be able to support at least a portion of the tubes that constitute the extracorporeal circulation circuit.

[0026] This configuration helps to suppress kinking of the tube during priming.

[0027] (13) In the extracorporeal circulation system described in any one of the above items (1) to (12), the retaining device may be provided on a medical cart.

[0028] (14) In the extracorporeal circulation system described in any one of the above items (1) to (12), the retaining device may be detachable from the medical cart.

[0029] The extracorporeal circulation system of this disclosure allows for efficient priming. Furthermore, since an increase in the weight of the holder unit can be avoided, there is no decrease in the transportability of the holder unit.

[0030] Figure 1 is a perspective view of the combined extracorporeal circulation system according to the present disclosure. Figure 2 is another perspective view of the combined extracorporeal circulation system. Figure 3 is a perspective view of the separated extracorporeal circulation system. Figure 4 is a schematic diagram of the extracorporeal circulation system. Figure 5 is a block diagram of the extracorporeal circulation system. Figure 6A is a side view of the separated extracorporeal circulation system. Figure 6B is a side view of the combined extracorporeal circulation system. Figure 7 is a perspective view of the base unit attached to a medical cart. Figure 8 is a perspective view of the base unit attached to a bed. Figure 9 is a perspective view of the holder unit held by a retainer in a first position. Figure 10 is a perspective view of the holder unit separated from the retainer. Figure 11 is a side view of the holder unit in a second position. Figure 12A is a perspective view of the holder unit restrained in the first position by a locking mechanism. Figure 12B is a perspective view of the holder unit restrained in the second position by a locking mechanism.

[0031] The extracorporeal circulation system 10 shown in Figure 1 is used to circulate a patient's blood outside the body. The extracorporeal circulation system 10 comprises a holder unit 12 and a base unit 14. In the following description, the height direction of the holder unit 12 and the base unit 14 is referred to as the Z direction. The width direction of the holder unit 12 and the base unit 14, which is perpendicular to the Z direction, is referred to as the X direction. The front-to-back direction (depth direction) of the holder unit 12 and the base unit 14, which is perpendicular to the X and Z directions, is referred to as the Y direction. Of the Y directions, the Y1 direction is considered the front, and the Y2 direction is considered the rear.

[0032] As shown in Figure 2, the holder unit 12 integrally comprises a holder unit body 16, a holder section 18, and a pump drive unit 20. The holder unit body 16 includes a housing 22 and a first control device 24. The first control device 24 is housed within the housing 22. Details of the first control device 24 will be described later.

[0033] The holder portion 18 is supported (fixed) to the holder unit body 16. The artificial lung 100 is attached to the holder portion 18. The holder portion 18 holds the artificial lung 100.

[0034] The artificial lung 100 is detachable from the holder portion 18. The artificial lung 100 performs gas exchange operations on the blood (adding oxygen to the blood and removing carbon dioxide). The artificial lung 100 is, for example, a membrane oxygenator, but is particularly preferably a hollow fiber membrane oxygenator. Oxygen gas is supplied to the artificial lung 100 through an oxygen supply tube (not shown). Blood that flows into the artificial lung 100 from the blood inflow port 102 undergoes gas exchange in the gas exchange section within the artificial lung 100. As shown in Figure 4, the blood that has undergone gas exchange flows out from the blood outflow port 104 of the artificial lung 100 and is returned to the human body HM via the blood delivery catheter 122.

[0035] In Figure 2, the pump drive unit 20 is a drive unit for rotating the blood pump 110. The pump drive unit 20 is supported (fixed) to the holder unit body 16. The pump drive unit 20 has a motor 26, a housing 28, and a pump mounting part 30. The motor 26 generates a rotational driving force for rotating the blood pump 110. A magnetic coupling part (not shown) is attached to the motor 26. The magnetic coupling part can magnetically couple with the impeller provided on the blood pump 110. The housing 28 houses the motor 26.

[0036] The blood pump 110 is detachable from the pump mounting section 30. The blood pump 110 is a pump for circulating blood within the extracorporeal circulation circuit. The blood pump 110 is a centrifugal pump. A blood withdrawal catheter 120 is connected to the blood inlet port 112 of the blood pump 110. One end of a relay tube 116 is connected to the blood outlet port 114 of the blood pump 110. The other end of the relay tube 116 is connected to the blood inlet port 102 of the artificial lung 100. The blood flowing out from the blood outlet port 114 of the blood pump 110 is introduced into the artificial lung 100 via the relay tube 116, and the gas exchange described above takes place.

[0037] The holder unit 12 further includes a holder unit-side display unit 65. The holder unit-side display unit 65 is provided on the upper surface of the housing 22. Alternatively, the holder unit-side display unit 65 may be provided on one side of the housing 22 in the width direction (X direction). The holder unit-side display unit 65 displays information regarding the physical properties of the extracorporeal circulation circuit (physical property information described later). The holder unit-side display unit 65 is, for example, a flat panel display such as a liquid crystal display.

[0038] As shown in Figure 4, the extracorporeal circulation circuit is equipped with a sensor group 34 consisting of multiple sensors for measuring various physical parameters within the circuit. Specifically, the sensor group 34 includes multiple pressure sensors (first pressure sensor 36a, second pressure sensor 36b, third pressure sensor 36c), an oxygen saturation sensor 38 (SO2 sensor), a temperature sensor 40, and a flow rate sensor 42. The first pressure sensor 36a, second pressure sensor 36b, third pressure sensor 36c, oxygen saturation sensor 38, temperature sensor 40, and flow rate sensor 42 are each connected to the holder unit 12 (first control device 24) via multiple signal lines 44a to 44f.

[0039] The first pressure sensor 36a is located in the blood delivery catheter 122. The first pressure sensor 36a is a pressure sensor for measuring the pressure of the blood flowing through the blood delivery catheter 122. The blood delivery catheter 122 is a catheter for returning blood after gas exchange to the human body's hemoglobin (HM). The second pressure sensor 36b is located in the intermediate tube 116. The second pressure sensor 36b is a pressure sensor for measuring the pressure of the blood flowing through the intermediate tube 116. The third pressure sensor 36c is located in the blood withdrawal catheter 120. The third pressure sensor 36c is a pressure sensor for measuring the pressure of the blood flowing through the blood withdrawal catheter 120. The blood withdrawal catheter 120 is a catheter for taking blood from the human body's HM.

[0040] The oxygen saturation sensor 38 is located on the blood withdrawal catheter 120. The oxygen saturation sensor 38 is a sensor for measuring the oxygen saturation of the blood flowing through the blood withdrawal catheter 120. The temperature sensor 40 is located on the blood withdrawal catheter 120. The temperature sensor 40 is a sensor for measuring the temperature of the blood flowing through the extracorporeal circulation circuit. The temperature sensor 40 may also be located on the relay tube 116 or the blood delivery catheter 122. The flow rate sensor 42 is a sensor for measuring the flow rate of the blood flowing through the extracorporeal circulation circuit. The flow rate sensor 42 is located on the blood delivery catheter 122. The flow rate sensor 42 may also be located on the relay tube 116 or the blood withdrawal catheter 120.

[0041] As shown in Figure 5, the first control device 24 includes a first arithmetic unit 46, a first storage unit 47, and a first communication unit 48. Although not shown, the first control device 24 is also equipped with a power supply circuit that converts external power into the required power and outputs it. The first arithmetic unit 46 is composed of a processor, such as a CPU (Central Processing Unit) or a GPU (Graphics Processing Unit), i.e., a processing circuit.

[0042] The first arithmetic unit 46 includes a first acquisition unit 50 and a pump control unit 52. The first acquisition unit 50 and the pump control unit 52 can be realized by the first arithmetic unit 46 executing a program stored in the first storage unit 47. At least a portion of the first acquisition unit 50 and the pump control unit 52 may be realized by integrated circuits such as ASICs (Application Specific Integrated Circuits) and FPGAs (Field-Programmable Gate Arrays). Alternatively, at least a portion of the first acquisition unit 50 and the pump control unit 52 may be composed of electronic circuits including discrete devices.

[0043] The first acquisition unit 50 acquires information (hereinafter referred to as "physical property information") from the first pressure sensor 36a, the second pressure sensor 36b, the third pressure sensor 36c, the oxygen saturation sensor 38, the temperature sensor 40, and the flow rate sensor 42 via the first communication unit 48. The first acquisition unit 50 acquires information (hereinafter referred to as "input information") from the base unit 14 (input unit 67 described later) via the first communication unit 48.

[0044] The pump control unit 52 includes a sensor signal input unit (not shown) to which signals from the various sensors described above are input to the pump control unit 52. The pump control unit 52 controls the pump drive unit 20 based on the physical property information and the input information obtained via the sensor signal input unit. The pump control unit 52 is a motor driver. Specifically, the pump control unit 52 performs various information processes such as signal processing and determination based on the physical property information and the input information, and controls the rotation speed of the blood pump 110. In the rotation speed control, the pump control unit 52 controls the rotation speed of the blood pump 110 by controlling the rotation speed of the motor 26. In the case where the pump control unit 52 (motor driver) has a function of sending a signal for rotating the motor 26 based on the input information, the physical property information of the sensor may be directly used. In this case, the pump control unit 52 does not perform the rotation speed control.

[0045] The first storage unit 47 is composed of a volatile memory (not shown) and a non-volatile memory (not shown). Examples of the volatile memory include a RAM (Random Access Memory) and the like. The volatile memory is used as the working memory of the processor and temporarily stores data and the like necessary for processing or calculation. Examples of the non-volatile memory include a ROM (Read Only Memory), a flash memory, and the like. The non-volatile memory is used as a storage memory and stores programs, tables, maps, and the like. At least a part of the first storage unit 47 may be provided in the processor, integrated circuit, or the like as described above.

[0046] The first communication unit 48 communicates with the sensor group 34 and the pump drive unit 20, and transmits and receives various kinds of information and various signals. Further, the first communication unit 48 communicates with the base unit 14 (the second communication unit 74 described later), and transmits and receives various kinds of information and various signals with the base unit 14.

[0047] As shown in FIG. 2, the holder unit 12 further includes a support leg portion 54 and a grip portion 56. The support leg portion 54 is a support member for holding the holder unit 12 in a predetermined posture on the ground surface, and is connected (fixed) to the lower portion of the holder unit main body 16 (the housing 22). The support leg portion 54 protrudes rearward (in the Y2 direction) from the housing 22. The support leg portion 54 is connected to both end portions in the width direction of the housing 22. The support leg portion 54 is formed in a U shape. The support leg portion 54 has a width direction portion 54a extending in the width direction of the holder unit 12 and a pair of side portions 54b extending from both end portions of the width direction portion 54a toward the housing 22.

[0048] The grip portion 56 is a portion to be gripped by a user such as a medical staff. The grip portion 56 is connected to the lower portion of the holder unit main body 16. The grip portion 56 is connected to both end portions in the width direction of the housing 22. The grip portion 56 is formed in a U shape. The grip portion 56 has a grip bar 56a extending in the width direction of the holder unit 12 and a pair of side arm portions 56b extending downward from both end portions of the grip bar 56a.

[0049] The grip portion 56 is rotatably supported with respect to the holder unit main body 16 via a hinge portion 57. The rotation axis of the grip portion 56 (the hinge portion 57) is parallel to the width direction (X direction) of the holder unit 12. The grip portion 56 can be switched between a first position P1 (FIG. 6A) and a second position P2 (FIG. 6B) inclined by a predetermined angle with respect to the first position P1. As shown in FIG. 6A, the grip portion 56 is inclined by a predetermined angle toward the rear (Y2 direction) side with respect to the Z direction at the first position P1. As shown in FIG. 6B, the grip portion 56 is inclined by a predetermined angle toward the front (Y1 direction) side with respect to the first position P1 at the second position P2 and is substantially parallel to the Z direction.

[0050] Although not shown in detail, the connection between the gripping portion 56 and the holder unit body 16 is provided with a locking mechanism that allows the gripping portion 56 to be fixed in the first position P1 and the second position P2. The distinction between the first position P1 and the second position P2 will be described later. In other embodiments, the gripping portion 56 may be fixed to the holder unit body 16 in a manner that prevents rotation.

[0051] The base unit 14 is a separate device from the holder unit 12. The base unit 14 is detachable from the holder unit 12. When the base unit 14 is connected to the holder unit 12, the holder unit 12 may supply power to an internal power supply located within the base unit 14, or power may be supplied to the holder unit 12 via a communication cable or the like.

[0052] As shown in Figure 1, the base unit 14 comprises a base unit body 60 and a connection part 62. The base unit body 60 comprises a housing 63, a grip 64, a display unit 66, an input unit 67, and a second control device 68 (see Figure 5). Therefore, the base unit 14 integrally includes the display unit 66 and the input unit 67.

[0053] The housing 22 is formed in a flattened shape overall. The grip 64 is provided on the upper part of the housing 22. The grip 64 extends in the width direction of the base unit body 60. Both ends of the grip 64 are connected to the upper part of the housing 22. An opening 64a is formed between the grip 64 and the housing 22.

[0054] The base unit body 60 has a first surface 60a, which is the front, and a second surface 60b, which is the back. The first surface 60a is provided with a display unit 66 and an input unit 67. The second surface 60b is the surface opposite to the first surface 60a. The display unit 66 displays various information. For example, the display unit 66 can display physical property information (pressure, temperature, flow rate, oxygen saturation) within the circuit acquired from the holder unit 12. For example, the display unit 66 can display a setting screen for various parameters (pump rotation speed, etc.). The display unit 66 is, for example, a flat panel display such as a liquid crystal display.

[0055] The input unit 67 is a user interface that accepts input operations from the user. The user can set various parameters (such as pump rotation speed) by operating the input unit 67. The input unit 67 may have multiple operation units. These operation units may include, for example, a rotary knob 67a, a button 67b, etc. The base unit body 60 may also be equipped with a touch panel that combines the functions of the display unit 66 and the input unit 67.

[0056] As shown in Figure 5, the second control device 68 includes a second arithmetic unit 70, a second storage unit 72, and a second communication unit 74. The second arithmetic unit 70 is composed of a processor, such as a CPU (Central Processing Unit) or a GPU (Graphics Processing Unit), i.e., a processing circuit.

[0057] The second arithmetic unit 70 includes a second acquisition unit 76 and a display control unit 78. The second acquisition unit 76 and the display control unit 78 can be realized by the execution of a program stored in the second storage unit 72 by the second arithmetic unit 70. At least a portion of the second acquisition unit 76 and the display control unit 78 may be realized by integrated circuits such as ASICs (Application Specific Integrated Circuits) and FPGAs (Field-Programmable Gate Arrays). Alternatively, at least a portion of the second acquisition unit 76 and the display control unit 78 may be composed of electronic circuits including discrete devices.

[0058] The second acquisition unit 76 acquires input information from the input unit 67. The second calculation unit 70 transmits the input information acquired by the second acquisition unit 76 to the first control device 24 of the holder unit 12. The second acquisition unit 76 also acquires physical property information from the first control device 24 of the holder unit 12 via the second communication unit 74. The acquired physical property information is processed by the display control unit 78 and displayed on the display unit 66. The display control unit 78 controls the display content of the display unit 66.

[0059] The second communication unit 74 communicates with the holder unit 12 (first communication unit 48) and transmits and receives various information and signals between it and the holder unit 12.

[0060] The holder unit 12 and the base unit 14 are connected to each other via a single communication cable 80. The communication cable 80 may include signal lines for supplying power from the base unit 14 to the holder unit 12. The holder unit 12 or the base unit 14 may be provided with a housing (pocket) capable of accommodating the communication cable 80. The holder unit 12 and the base unit 14 may also be configured to communicate wirelessly with each other.

[0061] The base unit 14 may be composed of a tablet terminal instead of a dedicated device as described above. In this case, the tablet terminal functions as a base unit 14 by installing application software to realize various functions such as display processing, input processing, and communication processing. By using a general-purpose tablet terminal as the base unit 14, a base unit 14 equipped with predetermined functions can be easily obtained.

[0062] As shown in Figures 2 and 3, the connecting portion 62 is provided on the second surface 60b of the base unit body 60. The connecting portion 62 allows the base unit 14 to be attached to and detached from the holder unit 12. As shown in Figure 2, when the base unit 14 is connected to the holder unit 12 by the connecting portion 62, the second surface 60b of the base unit 14 faces the front surface (Y1 direction side) of the holder unit body 16 (housing 22). The connecting portion 62 is rotatably supported on the upper part of the base unit body 60 via a hinge portion 61. The axis of rotation of the connecting portion 62 is parallel to the width direction (X direction) of the base unit 14. Therefore, the connecting portion 62 can tilt in the front-rear direction on the second surface 60b of the base unit body 60.

[0063] In this embodiment, the connecting portion 62 is a clip that can be opened and closed relative to the base unit body 60 by rotation. The connecting portion 62 has a lever portion 82, an intermediate portion 84, and an engaging portion 86. The connecting portion 62 has an S-shaped bend formed by the lever portion 82, the intermediate portion 84, and the engaging portion 86. The lever portion 82 constitutes the upper part of the connecting portion 62. The lever portion 82 has an opening 82a into which the user's finger can be inserted. The lever portion 82 is positioned to face the grip 64 of the base unit body 60. This makes it easy for the user to operate the lever portion 82 because they can grasp the grip 64 and the lever portion 82 at the same time.

[0064] The intermediate portion 84 forms the space between the lever portion 82 and the engaging portion 86 at the connecting portion 62. The intermediate portion 84 connects the lower part of the lever portion 82 and the upper part of the engaging portion 86. The engaging portion 86 protrudes downward from the intermediate portion 84. The upper part of the holder unit body 16 can be inserted between the base unit body 60 and the engaging portion 86. Therefore, the engaging portion 86 can engage with the upper part of the holder unit body 16. The connecting portion 62 is elastically biased by a biasing member 88 in the direction that closes the engaging portion 86. The biasing member 88 is composed of, for example, a torsion spring.

[0065] The connecting portion 62 does not necessarily have to be rotatable relative to the base unit body 60. Therefore, the connecting portion 62 may be a hook fixed to the base unit body 60 in a non-movable manner. The connecting portion 62 may also have a structure that includes a hook-and-loop fastener, a magnet, etc.

[0066] As described above, the gripping portion 56 provided on the holder unit 12 can be switched between a first position P1 (Figure 6A) and a second position P2 (Figure 6B). The first position P1 and the second position P2 are set as follows.

[0067] As shown in Figure 6A, when the holder unit 12 is separated from the base unit 14 and the gripping portion 56 is set to the first position P1, the holder unit 12 is lifted by gripping the gripping portion 56, and the bottom of the holder unit 12 (support legs 54) becomes approximately horizontal. Hereinafter, the state in which the holder unit 12 is separated from the base unit 14 will be referred to as the "separated state". In the separated state, the center of gravity of the holder unit 12 is the first center of gravity position GP1. When the holder unit 12 is placed on a horizontal mounting surface, the upper end of the gripping portion 56 (gripping bar 56a) set to the first position P1 is located approximately directly above the first center of gravity position GP1.

[0068] As shown in Figure 6B, when the holder unit 12 and the base unit 14 are integrated via the connecting portion 62 and the gripping portion 56 is set to the second position P2, the holder unit 12 and the base unit 14 are lifted by gripping the gripping portion 56, and the bottom of the holder unit 12 (support leg portion 54) becomes approximately horizontal. Hereinafter, the state in which the holder unit 12 and the base unit 14 are connected to each other and integrated will be referred to as the "combined state". The holder unit 12 and the base unit 14 in the combined state will be collectively referred to as the "combined unit 15".

[0069] In the combined state, the center of gravity of the combined unit 15 is the second center of gravity position GP2. The second center of gravity position GP2 is located in front of the center of gravity position (first center of gravity position GP1) of the holder unit 12 in the separated state. When the combined unit 15 is placed on a horizontal mounting surface, the upper end of the gripping portion 56 (gripping bar 56a), which is set to the second position P2, is located approximately directly above the second center of gravity position GP2.

[0070] The connection portion 62 of the base unit 14 can be attached to medical equipment other than the holder unit 12. For example, as shown in Figure 7, the connection portion 62 can be attached to a cylindrical bar 132 provided on a medical cart 130. Also, as shown in Figure 8, the connection portion 62 can be attached to an edge portion 142 (headboard or footboard) or pole provided on a bed 140.

[0071] As shown in Figure 9, the extracorporeal circulation system 10 further comprises a holder 150. The holder 150 is detachable from the holder unit 12 and can hold the holder unit 12. The holder 150 is provided on the medical cart 130. In this case, the holder 150 is part of the medical cart 130. Alternatively, the holder 150 may be detachable from the medical cart 130. In this case, the holder 150 is detachable from, for example, a pole 131 provided at the bottom of the medical cart 130.

[0072] The holder 150 comprises an arm portion 152 and a bracket 154. One end of the arm portion 152 is attached to the medical cart 130. The other end of the arm portion 152 constitutes the base end portion 150B of the holder 150. The bracket 154 is supported at the other end of the arm portion 152. The arm portion 152 has multiple arms. In this embodiment, the multiple arms include a first arm 152a and a second arm 152b. The first arm 152a is rotatably supported on the pole 131. Therefore, the first arm 152a is rotatable relative to the medical cart 130 about a vertical first axis a1. That is, the first arm 152a is pivotable in the horizontal plane.

[0073] One end of the second arm 152b is rotatably connected to the other end of the first arm 152a via a first joint 156. The first joint 156 has a hinge portion 156a. Therefore, the second arm 152b is rotatable relative to the first arm 152a about a vertical second axis a2. In other words, the second arm 152b is pivotable in the horizontal plane.

[0074] Bracket 154 constitutes the tip portion 150A of the holder 150. Bracket 154 is rotatably connected to the other end of the second arm 152b via a second joint portion 158. The second joint portion 158 has a hinge portion 158a. Therefore, bracket 154 is rotatable relative to the second arm 152b about a vertical third axis a3. That is, bracket 154 is pivotable in the horizontal plane. In this way, the holder 150 is rotatably connected to the medical cart 130 and has a first joint portion 156 and a second joint portion 158, so it is foldable and deployable (extendable). Note that the holder 150 may have only one joint portion. Alternatively, the holder 150 may not have any joint portions.

[0075] The bracket 154 has a shaft portion 160 and a bracket body 162. The shaft portion 160 is rotatably supported at the other end of the second arm 152b. The bracket body 162 is connected to the upper end of the shaft portion 160. The bracket body 162 is formed in a U shape. The bracket body 162 is provided with a posture changing mechanism 164. The posture changing mechanism 164 can change the posture of the holder unit 12 with respect to the vertical while the holder 150 is connected to the holder unit 12 (hereinafter referred to as the "connected state").

[0076] The posture changing mechanism 164 can switch the posture of the holder unit 12 between a first posture (Figure 9) and a second posture (Figure 11). The first posture of the holder unit 12 is the posture used during extracorporeal circulation. The second posture of the holder unit 12 is the posture used during priming.

[0077] In Figure 9, the attitude changing mechanism 164 can rotate the holder unit 12 around the rotation axis Ax, which passes through the connection point with the holder unit 12 in the connected state. As shown in Figure 10, the holder unit 12 has a first connection part 166. The attitude changing mechanism 164 has a second connection part 168 that can be connected to the first connection part 166. A pair of the combination of the first connection part 166 and the second connection part 168 is provided on both sides in the width direction. The first connection part 166 is provided at the lower end of the gripping part 56 (the lower end of the side arm part 56b). The first connection part 166 has a connection recess 167. The second connection part 168 is provided at the tip of the bracket 154. The second connection part 168 has a connection projection 169 that can be inserted into the connection recess 167. Alternatively, the first connection part 166 may be provided with a connection projection 169 and the second connection part 168 may be provided with a connection recess 167.

[0078] The connecting recess 167 is a groove recessed inward in the width direction from the side surface of the first connecting portion 166 that is outward in the width direction. The connecting recess 167 has a connecting groove 170 and a guide groove 172. The connecting groove 170 has an arc-shaped inner surface. The guide groove 172 is connected to the connecting groove 170. The guide groove 172 communicates the lower part of the connecting groove 170 with the lower outer surface of the first connecting portion 166. The guide groove 172 is a groove for receiving the connecting projection 169 and guiding the connecting projection 169 to the connecting groove 170. The width of the guide groove 172 narrows as it approaches the connecting groove 170. The first connecting portion 166 further has a stopper projection 174. The stopper projection 174 is provided at a different position from the connecting recess 167 (above the connecting recess 167).

[0079] The connecting projection 169 is a projection that protrudes inward in the width direction from the side surface of the second connecting portion 168 in the width direction. In this embodiment, the connecting projection 169 is formed in a circular shape. The second connecting portion 168 has a notched groove 176. The notched groove 176 extends in an arc shape. The notched groove 176 is provided within a predetermined angle range (90° in this embodiment).

[0080] With the holder unit 12 and the attitude changing mechanism 164 facing each other, the holder unit 12 and the attitude changing mechanism 164 move relative to each other in a direction perpendicular to the rotation axis Ax, causing the connecting projection 169 to connect (engage) with the connecting recess 167.

[0081] When the first connecting portion 166 and the second connecting portion 168 are connected to each other, the stopper projection 174 is inserted into the notch groove 176. When the second connecting portion 168 rotates relative to the first connecting portion 166, the stopper projection 174 moves within the notch groove 176. Since the range of motion of the stopper projection 174 is limited to the range of the notch groove 176, the second connecting portion 168 can rotate by a predetermined angle relative to the first connecting portion 166. Therefore, changing the posture from the first posture to the second posture changes the posture of the holder unit 12 by a predetermined angle. Changing the posture from the first posture to the second posture causes the blood outflow port 104 provided on the artificial lung 100 to move to the top of the artificial lung 100 (see Figure 11).

[0082] The angle of the posture change (angle range of the notch groove 176) is set so that when the holder unit 12 is in the second posture, the blood outflow port 104 of the artificial lung 100 is located at the top (highest point) of the artificial lung 100. For this reason, the angle of the posture change is set in the range of 80° to 100°, depending on the position of the blood outflow port 104 in the first posture. The notch groove 176 described above is formed according to the angle of the posture change.

[0083] As shown in Figure 9, the posture change mechanism 164 can switch the holder unit 12 from a first posture to a second posture when the base unit 14 is separated from the holder unit 12. If the holder unit 12 is to be rotated while the base unit 14 is attached to the holder unit 12, the base unit 14 will interfere with the holder 150 (bracket 154). For this reason, when the base unit 14 is attached to the holder unit 12, the switching of the holder unit 12 from the first posture to the second posture is prevented.

[0084] As shown in Figure 12A, the attitude change mechanism 164 further includes a locking mechanism 178. The locking mechanism 178 is configured to maintain the holder unit 12 in both the first and second attitudes. The locking mechanism 178 is provided on one of the second connection portions 168. The locking mechanism 178 has a locking member 180. The locking member 180 is supported on the second connection portion 168 so as to be displaceable in the width direction (X direction). The locking member 180 is a rod-shaped locking pin 182.

[0085] The lock pin 182 is inserted into a support hole 168b that penetrates the second connecting portion 168 in the width direction. The lock pin 182 is elastically biased inward in the width direction (in the direction from the second connecting portion 168 toward the first connecting portion 166 when the first connecting portion 166 and the second connecting portion 168 are connected) by a biasing member (not shown). The biasing member is, for example, a compression coil spring. The user can displace the lock pin 182 outward in the width direction (away from the first connecting portion 166) by grasping the lock pin 182 and pulling it outward in the width direction.

[0086] As shown in Figure 10, the first connecting portion 166 has a first locking hole 184 and a second locking hole 186. The first locking hole 184 and the second locking hole 186 are formed at positions separated from each other by an angle corresponding to the attitude change angle (90° in this embodiment). The stopper projection 174 described above is formed between the first locking hole 184 and the second locking hole 186.

[0087] In Figure 12A, the holder unit 12 is in a first position, and the tip of the lock pin 182 (hereinafter referred to as "pin tip 183") is inserted into the first locking hole 184 of the first connecting portion 166. With the pin tip 183 inserted into the first locking hole 184, relative rotation between the first connecting portion 166 and the second connecting portion 168 is prevented. Therefore, the holder unit 12 is constrained in the first position. When the lock pin 182 is pulled outward in the width direction from this state, and the pin tip 183 is removed from the first locking hole 184, the posture constraint is released.

[0088] In Figure 12B, the holder unit 12 is in the second position, and the pin tip 183 is inserted into the second locking hole 186 of the first connecting portion 166. With the pin tip 183 inserted into the second locking hole 186, relative rotation between the first connecting portion 166 and the second connecting portion 168 is prevented. Therefore, the holder unit 12 is constrained in the second position. When the lock pin 182 is pulled outward in the width direction from this state, and the pin tip 183 is removed from the second locking hole 186, the posture constraint is released.

[0089] The holder 150 configured as described above is used as follows.

[0090] In Figure 10, it is assumed that priming has not yet been performed. Prior to priming, in order to attach the holder unit 12 to the holder 150, the orientation changing mechanism 164 of the holder 150 and the holder unit 12 are aligned in the vertical direction. Then, by moving the holder unit 12 (first connection part 166) and the orientation changing mechanism 164 (second connection part 168) relative to each other in a direction that brings them closer together, the first connection part 166 and the second connection part 168 are connected to each other. In this case, the connection projection 169 of the second connection part 168 is guided by the guide groove 172 of the connection recess 167 of the first connection part 166 and inserted into the connection groove 170. With the first connection part 166 and the second connection part 168 connected to each other, the holder unit 12 is held in the holder 150 in the first orientation, as shown in Figure 9.

[0091] Next, the holder unit 12 is rotated to switch its orientation to the second orientation, as shown in Figure 11. When switching the orientation of the holder unit 12 to the second orientation, the locking mechanism 178 is operated to release the constraint on the relative rotation between the first connection part 166 and the second connection part 168. As the orientation of the holder unit 12 is switched to the second orientation, the blood outflow port 104 provided on the artificial lung 100 moves to the upper part (topmost) of the artificial lung 100.

[0092] Once the holder unit 12 is switched to the second position, the locking pin 182 of the locking mechanism 178 is operated to insert the pin tip 183 into the second locking hole 186 (see Figure 12B). This restrains the holder unit 12 in the second position. As shown in Figure 11, when the holder unit 12 is in the second position, the support legs 54 can support at least a portion of the tubing that constitutes the extracorporeal circulation circuit (in Figure 11, the blood delivery catheter 122).

[0093] Next, priming is performed. During priming, the blood pump 110 is activated, and medical fluid such as saline solution is circulated into the circuit including the blood pump 110 and the artificial lung 100, thereby replacing the air in the circuit with the medical fluid. At this time, since the blood outflow port 104 is located at the top (highest part) of the artificial lung 100, the air inside the artificial lung 100 moves to the upper part of the artificial lung 100 and is effectively discharged to the outside of the artificial lung 100 from the blood outflow port 104 along with the medical fluid. Priming is completed when sufficient air has been discharged from the circuit.

[0094] Next, the locking mechanism 178 is operated to release the constraint on the relative rotation between the first connection part 166 and the second connection part 168, and the holder unit 12 is rotated to switch the position of the holder unit 12 to the first position, as shown in Figure 9. Once the position of the holder unit 12 is switched to the first position, the locking pin 182 of the locking mechanism 178 is operated to insert the pin tip 183 into the first locking hole 184, as shown in Figure 12A. As a result, the position of the holder unit 12 is constrained to the first position. Subsequently, as shown in Figure 4, the extracorporeal circulation system 10 is connected to the patient, and extracorporeal circulation is performed on the patient.

[0095] This embodiment provides the following effects.

[0096] As shown in Figure 11, the holder 150 has a posture changing mechanism 164 that can change the orientation of the holder unit 12 relative to the vertical when the holder 150 is connected to the holder unit 12. With this configuration, by changing the orientation of the holder unit 12 during priming, air can be effectively removed from inside the artificial lung 100, thus enabling efficient priming. Furthermore, since the posture changing mechanism 164 is provided on the holder 150 rather than the holder unit 12, an increase in the weight of the holder unit 12 can be avoided. Therefore, there is no decrease in the transportability of the holder unit 12.

[0097] The posture changing mechanism 164 can switch the posture of the holder unit 12 between a first posture (Figure 10) and a second posture (Figure 11). The first posture is used during extracorporeal circulation. The second posture is used during priming. With this configuration, the holder unit 12 can be set to the second posture, which allows for efficient removal of air from the artificial lung 100, only during priming. Except during priming, the holder unit 12 can be set to the first posture, which is suitable for handling tubes (blood withdrawal catheter 120, blood delivery catheter 122, etc.).

[0098] As shown in Figure 11, changing from the first posture to the second posture changes the posture of the holder unit 12 by 80° to 100°, and the blood outflow port 104 provided on the artificial lung 100 moves to the top of the artificial lung 100. With this configuration, changing from the first posture to the second posture allows the artificial lung 100 to be positioned in a posture suitable for air removal. Then, by changing back from the second posture to the first posture, the blood outflow port 104 moves (returns) to a position shifted by a predetermined angle from the top of the artificial lung 100, thereby performing extracorporeal circulation to the patient in an appropriate posture. In other words, since the blood outflow port 104 is not located at the highest position, it is possible to prevent air, etc., from accidentally going towards the patient.

[0099] The attitude changing mechanism 164 can rotate the holder unit 12 around the rotation axis Ax, which passes through the connection point with the holder unit 12 in the connected state. With this configuration, the attitude of the holder unit 12 can be easily changed.

[0100] As shown in Figure 10, the holder unit 12 has a first connecting portion 166. The attitude changing mechanism 164 has a second connecting portion 168 that can be connected to the first connecting portion 166. One of the first connecting portion 166 and the second connecting portion 168 has a connecting recess 167, and the other of the first connecting portion 166 and the second connecting portion 168 has a connecting projection 169 that can be inserted into the connecting recess 167. With this configuration, the holder unit 12 and the attitude changing mechanism 164 can be attached and detached with a simple configuration.

[0101] With the holder unit 12 and the attitude changing mechanism 164 facing each other, the holder unit 12 and the attitude changing mechanism 164 move relative to each other in a direction perpendicular to the rotation axis Ax, causing the connecting projection 169 to engage with the connecting recess 167. With this configuration, the holder unit 12 can be easily attached to the holder 150.

[0102] As shown in Figures 12A and 12B, the attitude change mechanism 164 has a locking mechanism 178 that can maintain the holder unit 12 in the first and second attitudes, respectively. With this configuration, it is possible to prevent the attitude of the holder unit 12 from being changed unintentionally.

[0103] As shown in Figure 9, the holder 150 has joints (a first joint 156 and a second joint 158) provided between the tip 150A and the base 150B. With this configuration, the position of the holder unit 12 can be easily changed depending on the situation.

[0104] As shown in Figure 11, when the holder unit 12 is in the second position, the support legs 54 can support at least a portion of the tubes that constitute the extracorporeal circulation circuit. With this configuration, kinking of the tubes can be suppressed during priming.

[0105] In addition to the effects described above, this embodiment provides the following effects.

[0106] As shown in Figure 4, since the pump control unit 52 is located in the holder unit 12, the wiring (signal lines 44a to 44f) extending from various sensors is concentrated around the holder unit 12. This reduces the effort required for wiring and improves the flexibility of the extracorporeal circulation system 10's placement. Furthermore, because the pump control unit 52, which processes key control parameters that are significantly affected by electromagnetic waves, is integrated into the holder unit 12, noise countermeasures for the cable electrically connecting the pump control unit 52 and the pump drive unit 20 can be implemented within the holder unit 12. In other words, since the cable is not exposed to the outside of the holder unit 12, it is less susceptible to the influence of electromagnetic waves from the motor 26. Therefore, it is easy to implement noise immunity against electromagnetic waves.

[0107] As shown in Figure 1, the extracorporeal circulation system 10 includes a base unit 14 that integrally has a display unit 66 and an input unit 67. With this configuration, the display unit 66 and the input unit 67 can be handled integrally as part of the base unit 14, thus improving convenience.

[0108] As shown in Figure 5, the base unit 14 has a display control unit 78 that controls the display content of the display unit 66. With this configuration, the control functions necessary for the operation of the extracorporeal circulation system 10 can be appropriately shared between the holder unit 12 and the base unit 14.

[0109] As shown in Figure 1, the holder unit 12 has a gripping portion 56 that is rotatably supported relative to the holder unit body 16. The gripping portion 56 is switchable between a first position P1 (Figure 6A) and a second position P2 (Figure 6B). As shown in Figure 6A, when the holder unit 12 is separated from the base unit 14 and the gripping portion 56 is set to the first position P1, the bottom of the holder unit 12 becomes approximately horizontal when the holder unit 12 is lifted by gripping the gripping portion 56. On the other hand, as shown in Figure 6B, when the holder unit 12 and the base unit 14 are integrated via the connecting portion 62 and the gripping portion 56 is set to the second position P2, the bottom of the holder unit 12 becomes approximately horizontal when the holder unit 12 and the base unit 14 are lifted by gripping the gripping portion 56.

[0110] With this configuration, the appropriate position of the gripping portion 56 can be selected according to each state: when the holder unit 12 and the base unit 14 are separated (separated state) and when the holder unit 12 and the base unit 14 are combined to form a combined unit 15 (combined state). Although the center of gravity is different in the separated state and the combined state, by selecting the position of the gripping portion 56 according to the state, the base unit 14 or the combined unit 15 is easy to hold in both the separated and combined states.

[0111] As shown in Figure 2, the holder unit 12 has a holder unit-side display unit 65. With this configuration, information related to the circuit (such as physical property parameters) can also be checked on the holder unit 12.

[0112] The extracorporeal circulation system 10 is equipped with a detachable connector 62 that connects the holder unit 12 and the base unit 14. With this configuration, when moving the extracorporeal circulation system 10 from one location to another, the base unit 14 and the holder unit 12 can be integrated via the connector 62. This makes it easy to move the extracorporeal circulation system 10. In addition, because the base unit 14 and the holder unit 12 are integrated, the areas that need to be observed are concentrated in one place, making management easier. As shown in Figure 3, the base unit 14 is detachable from the holder unit 12 and has a high degree of freedom in placement, so the display unit 66 can be easily viewed by the user by placing the base unit 14 above the bed floor.

[0113] The connection section 62 is provided on the second surface 60b (back) of the base unit body 60. With this configuration, the connection section 62 is provided on the opposite side of the display unit 66, making it easier for the user to see the display content of the display unit 66.

[0114] As shown in Figures 7 and 8, the connecting portion 62 is provided on the base unit 14 and can be attached to medical equipment other than the holder unit 12 (medical cart 130, bed 140, etc.). With this configuration, the base unit 14 can be attached to equipment other than the holder unit 12, thus improving the flexibility of the base unit 14's placement. Furthermore, it does not occupy space on the bed, etc., and the occupied area can be reduced.

[0115] As shown in Figure 5, the holder unit 12 and the base unit 14 are connected to each other via a single communication cable 80. With this configuration, since there is only one wire between the holder unit 12 and the base unit 14, wiring is easy to manage.

[0116] On the other hand, if the holder unit 12 and the base unit 14 are configured to communicate wirelessly with each other, there is no wiring between the holder unit 12 and the base unit 14, which further improves the flexibility of the placement of the base unit 14.

[0117] While this disclosure has been described in detail, it is not limited to the individual embodiments described above. These embodiments can be added, replaced, modified, partially deleted, etc., in any way that does not depart from the gist of this disclosure or from the intent of this disclosure derived from the claims and their equivalents. These embodiments can also be implemented in combination. For example, the order of operations and processes in the embodiments described above are given as examples only and are not limited thereto. The same applies when numerical values ​​or mathematical formulas are used in the description of the embodiments described above.

Claims

1. An extracorporeal circulation system comprising: a holder unit having a holder portion to which an artificial lung for gas exchange is attached; and a holder that is detachable from the holder unit and capable of holding the holder unit, wherein the holder has a posture changing mechanism that can change the orientation of the holder unit relative to the vertical direction when the holder is connected to the holder unit.

2. An extracorporeal circulation system according to claim 1, wherein the posture changing mechanism is capable of switching the posture of the holder unit between a first posture and a second posture, the first posture being a posture used during extracorporeal circulation, and the second posture being a posture used during priming.

3. An extracorporeal circulation system according to claim 2, wherein the posture of the holder unit is changed by 80° to 100° when changing from the first posture to the second posture, and the blood outflow port provided in the artificial lung moves to the upper part of the artificial lung.

4. An extracorporeal circulation system according to claim 2, wherein the posture changing mechanism is capable of rotating the holder unit about a rotation axis passing through the connection point with the holder unit in the connected state of the holder unit.

5. An extracorporeal circulation system according to claim 4, wherein the holder unit has a first connecting portion, the posture changing mechanism has a second connecting portion connectable to the first connecting portion, one of the first connecting portion and the second connecting portion has a connecting recess, and the other of the first connecting portion and the second connecting portion has a connecting protrusion insertable into the connecting recess.

6. An extracorporeal circulation system according to claim 5, wherein the holder unit and the posture changing mechanism are facing each other, and the holder unit and the posture changing mechanism move relative to each other in a direction perpendicular to the rotation axis, thereby engaging the connecting projection with the connecting recess.

7. An extracorporeal circulation system according to claim 2, wherein the posture changing mechanism has a locking mechanism capable of maintaining the holder unit in each of the first posture and the second posture.

8. An extracorporeal circulation system according to claim 1, wherein the holder unit integrally comprises the holder portion and a pump drive unit for rotating a blood pump for circulating blood within the extracorporeal circulation circuit.

9. An extracorporeal circulation system according to claim 2, further comprising a base unit which integrally includes a display unit for displaying information and an input unit which is operated for inputting information, and which is detachable from the holder unit.

10. An extracorporeal circulation system according to claim 9, wherein the posture changing mechanism can switch the holder unit from a first posture to a second posture when the base unit is separated from the holder unit.

11. An extracorporeal circulation system according to claim 1, wherein the holder has a tip portion on which the posture changing mechanism is provided, a base portion on the opposite side of the tip portion, and a joint portion provided between the tip portion and the base portion.

12. An extracorporeal circulation system according to claim 2, wherein the holder unit comprises a holder unit body that supports the holder portion and support legs that support the holder unit body, and when the holder unit is in the second position, the support legs are capable of supporting at least a portion of the tubes constituting the extracorporeal circulation circuit.

13. An extracorporeal circulation system according to any one of claims 1 to 12, wherein the retainer is provided on a medical cart.

14. An extracorporeal circulation system according to any one of claims 1 to 12, wherein the retainer is detachable from a medical cart.

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