JP7331702B2 - IABP balloon catheter and IABP driving device - Google Patents

Description

TECHNICAL FIELD The present invention relates to an IABP balloon catheter used for IABP (intra-aortic balloon pumping) method and an IABP driving device used to drive the same.

The IABP method is performed by indwelling an IABP balloon catheter inside the patient's body and driving the IABP balloon catheter with an IABP driving device connected outside the body. Not only one kind of balloon catheter is used in the IABP driving device, but also plural kinds of IABP balloon catheters are selectively used according to the physique of the patient to whom the IABP method is applied. By mounting an IC chip that records the size of the balloon on such an IABP balloon catheter, the IABP driving device automatically recognizes the size of the IABP balloon catheter connected to the device from the IC chip. proposed (see Patent Document 1).

Utility Model Registration No. 3177552

In the IABP method, the IABP balloon catheter indwelled in the patient's body may be continuously driven for a relatively long period of time depending on the patient's condition. For this reason, in the IABP method, if failure or the like during driving of the IABP driving device is suspected, there is a case where only the IABP driving device is replaced and an attempt is made to continue driving the IABP balloon catheter.

However, with the conventional IABP driving device, it is not possible to take over history information regarding the driving state of the IABP balloon catheter that is about to be connected and started driving. Therefore, when attempting to replace the IABP drive, there was a risk of exacerbating the situation. For example, when the drive of the balloon by the IABP driver is stopped due to the IABP balloon catheter causing a pressure fluid leak, if the failure of the IABP driver is suspected and an attempt is made to replace the IABP driver, Not only the first IABP driving device, but also the second IABP driving device may have to be disassembled and repaired by driving an IABP balloon catheter that is leaking pressure fluid. be.

The present invention has been made in view of such circumstances, and provides an IABP balloon catheter that can be safely connected even if there is a driving history, and an IABP driving device for driving the same.

In order to achieve the above object, the IABP balloon catheter according to the present invention comprises:
An IABP balloon catheter driven by an IABP driver, comprising:
a balloon portion that expands and contracts;
a catheter tube connected to the rear end of the balloon portion and formed with a pressurized fluid conduit for introducing and discharging the pressurized fluid into the balloon portion;
a handle portion connected to the rear end portion of the catheter tube and formed with a connection passage having a pressure fluid introduction outlet communicating with the inside of the pressure fluid conduit;
a storage unit for storing alarm history information regarding alarms that occur while the IABP balloon catheter is driven by one IABP driving device;
The one IABP driving device has an interface unit for inputting and outputting to the storage unit,
The alarm history information written in the storage section by the one IABP drive device can be read out from the storage section by another IABP drive device.

Since the IABP balloon catheter according to the present invention has a storage unit that stores alarm history information, even if a plurality of IABP driving devices take over one IABP balloon catheter and drive it, the second and subsequent devices of the IABP driver can recognize information about the drive history of the IABP balloon catheter. Therefore, with such an IABP balloon catheter, it is possible to determine whether or not there is a problem in the driving history of the IABP balloon catheter in the IABP driving device to be connected. This allows the IABP balloon catheter to be safely connected to the IABP drive device even if it is not new and has a drive history.

Further, for example, the alarm history information may include information regarding whether or not at least one alarm of catheter tube kink, pressure fluid leak, and fluid intrusion of the IABP balloon catheter has occurred.

With such an IABP balloon catheter, the IABP driving device to be connected can check whether or not the IABP balloon catheter has a kink in the catheter tube, pressure fluid leak, or liquid intrusion. By driving the problematic IABP balloon catheter, the problem of damage can be avoided.

Further, for example, the interface section may have a contact terminal.

By using contact terminals, such an IABP balloon catheter can provide stable signal exchange with the IABP driver.

Further, for example, the interface section may have an antenna for non-contact communication.

By using an antenna for contactless communication, such an IABP balloon catheter can reduce the trouble of connecting the IABP balloon catheter to the IABP driving device.

An IABP driving device according to the present invention is an IABP driving device for driving any one of the IABP balloon catheters,
a balloon drive unit for expanding and contracting the balloon unit, an alarm unit for generating an alarm,
and a control unit that reads and writes the alarm history information to and from the storage unit,
The control unit reads the alarm history information from the storage unit before the balloon drive unit starts expanding and contracting the balloon unit.

By reading the alarm history information from the storage unit of the IABP balloon catheter before starting driving, such an IABP driving device even when an IABP balloon catheter driven by another IABP driving device is connected, the IABP It can be determined whether or not there is a problem with the driving history of the balloon catheter. Therefore, the IABP driver can safely connect an IABP balloon catheter that has a driving history.

Further, for example, the control unit includes information to the effect that an alarm related to at least one of catheter tube kink, leak, and liquid intrusion of the IABP balloon catheter has occurred in the alarm history information read from the storage unit. In this case, the alarm unit may generate an alarm without starting the expansion and contraction of the balloon unit by the balloon driving unit.

Such an IABP driving device can confirm whether or not the IABP balloon catheter has a catheter tube kink or a pressure fluid leak. Prevent damage problems.

Further, for example, the control unit may write information of an alarm generated while the IABP balloon catheter is being driven while the balloon driving unit continues to expand and contract the balloon unit to the storage unit. good.

Such an IABP driving device reliably retains information about alarms that occurred during driving in the memory of the IABP balloon catheter, so that other IABP driving devices connected in the future to the currently driven IABP balloon catheter can Alarm history information can be conveyed.

FIG. 1 is a schematic cross-sectional view of an IABP balloon catheter according to a first embodiment of the invention. FIG. 2 is a conceptual diagram showing the state of implementation of the IABP method by the IABP balloon catheter shown in FIG. 1 and the IABP driving device that drives it. 3 is a functional block diagram of the IABP balloon catheter and IABP driving device shown in FIG. 2. FIG. FIG. 4 is a flow chart showing reading processing of alarm history information by the IABP driving device and the IABP balloon catheter shown in FIG. FIG. 5 is a flow chart showing a process of writing alarm history information to the storage section by the IABP driving device and the IABP balloon catheter shown in FIG. FIG. 6 is a schematic cross-sectional view of an IABP balloon catheter according to a second embodiment of the invention. 7 is an enlarged view of the interface portion of the IABP balloon catheter shown in FIG. 6. FIG. 8 is a schematic cross-sectional view of the interface shown in FIG. 7. FIG.

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, the present invention will be described based on embodiments shown in the drawings.

First Embodiment FIG. 1 is a schematic diagram of an IABP balloon catheter 20 (hereinafter sometimes simply referred to as "balloon catheter 20") according to a first embodiment of the present invention. The balloon catheter 20 is driven by the IABP driving device shown in FIG. The balloon catheter 20 has a balloon portion 21 that expands and contracts according to heartbeats. The balloon portion 21 has a balloon membrane 22 which is a thin film having a thickness of about 50 to 100 μm. Although the material of the balloon membrane 22 is not particularly limited, it is preferably made of a material having excellent resistance to bending fatigue, such as polyurethane.

The outer diameter and length of the balloon portion 21 are determined according to the internal volume of the balloon portion 21 and the inner diameter of the patient's artery, which greatly affect the effect of assisting the heart function. Although the internal volume of the balloon portion 21 is not particularly limited, it is preferably 25 to 50 cc, the outer diameter of the balloon portion 21 is preferably 12 to 18 mm, and the length is preferably 160 to 250 mm.

A distal tip portion 25 having a blood communication hole 23 formed at the distal end portion of the balloon portion 21 is attached to the balloon membrane 22 by means such as heat fusion or adhesion. A distal end portion of an inner tube 30, which is inserted through the inside of the balloon portion 21, is attached to the inner peripheral side of the distal tip portion 25 by means of heat fusion or adhesion.

The distal end portion of the catheter tube 24 is connected to the rear end portion of the balloon portion 21 on the outer peripheral side of the connecting tube 27 made of metal. A pressure fluid is introduced into and discharged from the balloon portion 21 through a pressure fluid conducting path 29 formed inside the catheter tube 24, so that the balloon portion 21 expands and contracts. The connection between the balloon portion 21 and the catheter tube 24 is performed by heat sealing or bonding with an adhesive such as an ultraviolet curable resin.

The inner tube 30 extends axially inside the balloon portion 21 and the catheter tube 24 and communicates with a blood pressure measurement port 44 of the handle portion 42, which will be described later. Inside the inner tube 30 , a blood conduit 31 is formed that does not communicate with the pressure fluid conduit 29 formed inside the balloon portion 21 and the catheter tube 24 . An inner tube 30 located within the balloon portion 21 is also used as a guidewire insertion lumen for passing a guidewire. When the balloon catheter 20 is inserted into the artery, the balloon portion 21 is deflated and the balloon membrane 22 is wrapped around the inner tube 30 . Further, when inserting the balloon catheter 20 into the artery, a guide wire is passed through the inner tube 30 and the tip of the balloon catheter 20 is guided by the guide wire, thereby rapidly inserting the balloon portion 21 to an appropriate position in the body. can do.

The catheter tube 24 is made of, but not limited to, polyurethane, polyvinyl chloride, polyethylene terephthalate, polyamide, or the like. The inner diameter and wall thickness of the catheter tube 24 are not particularly limited, but the inner diameter is preferably 1.5 to 4.0 mm and the wall thickness is preferably 0.05 to 0.4 mm. In addition, the inner tube 30 is composed of, but not limited to, a hard tube, a metal spring-reinforced tube, a stainless thin tube, or the like. Although the inner diameter and wall thickness of the inner tube 30 are not particularly limited, the inner diameter is preferably 0.1 to 1.0 mm, and the wall thickness is preferably 0.05 to 0.3 mm.

A handle portion 42 is connected to the rear end portion of the catheter tube 24 to be placed outside the patient's body. The handle portion 42 is molded separately from the catheter tube 24 and is fixed to the catheter tube 24 by means of heat sealing or adhesion. The handle portion 42 is formed with a first passage 47 as a connection passage having a pressure fluid introduction outlet 46 that communicates with the pressure fluid conduit 29 in the catheter tube 24 and a blood pressure measurement port 44 that communicates with the inner tube 30 . A second passageway 45 is formed. The pressure fluid for expanding and contracting the balloon portion 21 is introduced into the pressure fluid conducting passage 29 of the catheter tube 24 via the pressure fluid introduction outlet 46, and is also introduced from the pressure fluid conducting passage 29 of the catheter tube 24 into the handle portion 42. is led out to the first passage 47 of.

FIG. 2 is a conceptual diagram showing the state of implementation of the IABP method by the balloon catheter 20 shown in FIG. 1 and the IABP driving device 10 that drives it. A pressure fluid introduction outlet 46 of the handle portion 42 is connected to the pressure fluid connector tube 12 of the IABP driving device 10 shown in FIG. The balloon catheter 20 is driven by the IABP driving device 10 so that pressure fluid is introduced into and discharged from the balloon portion 21 . The fluid introduced into the balloon portion 21 is not particularly limited, but helium gas or the like with low viscosity is used so that the balloon portion 21 expands and contracts quickly according to the drive of the IABP driving device 10 .

The blood pressure measurement port 44 shown in FIG. 1 is connected to the blood connector tube 14 of the IABP driving device 10 shown in FIG. It can be measured by the device. 2 controls the balloon driving unit 11 (see FIG. 3) according to the pulsation of the heart 1 based on the fluctuation of the blood pressure measured by this blood pressure measuring device, The balloon portion 21 is expanded and contracted in synchronization with predetermined timing. The blood pressure measurement device may be included in the IABP drive device 10, or may be a device separate from the IABP drive device 10 and transmit blood pressure fluctuation data to the IABP drive device 10. good.

In the handle portion 42, as shown in FIG. 1, a first passage 47 having a pressure fluid introduction port 46 is arranged straight along the axial direction of the catheter tube 24, and a blood pressure measurement port 44 is formed. The second passage 45 is arranged with a predetermined inclination with respect to the axis of the first passage 47 .

1, a first inner tube end holder 48 and a second inner tube end holder 50 for holding the ends of the inner tube 30 are attached to the handle portion 42. As shown in FIG. The first inner pipe end holder 48 and the second inner pipe end holder 50 are arranged along the extending direction of the second passage 45 with a predetermined inclination with respect to the axis of the first passage 47 . There is. The inner tube 30 is fixed by the first inner tube end retainer 48 and the second inner tube end retainer 50 so that the inner tube 30 is eccentrically in contact with the inner wall of the catheter tube 24 inside the handle portion 42 . are placed.

In the balloon catheter 20, the first passage 47 communicating with the pressure fluid introduction port 46 formed in the handle portion 42 is arranged straight along the axial direction of the catheter tube 24. As compared with the case of arranging in a straight shape along the axial direction of , it becomes possible to reduce the flow path resistance of the pressure fluid, and the responsiveness of the expansion and contraction of the balloon portion 21 is improved.

As shown in FIG. 1, the balloon catheter 20 has an IC chip 60 as a storage unit (storage medium) for storing information, and an interface unit 70 for the IABP driving device 10 to input/output to/from the IC chip 60 . The IC chip 60 is embedded in part of the handle portion 42 . The interface section 70 has a contact terminal 70 a , and the contact terminal 70 a and the IC chip 60 are connected via a cable 62 . The cable 62 is not particularly limited, but is composed of, for example, an RS232C cable. Information stored in the IC chip 60 will be described later.

The contact terminal 70a of the interface section 70 is detachably connected to the contact terminal 18 provided in the driving device 10, as shown in FIG. By connecting the IC chip 60 to the control unit 15 (see FIG. 3) of the IABP driving device 10 via the interface unit 70, the control unit 15 of the IABP driving device 10 reads and writes information from the IC chip 60. is possible.

The IABP driving device 10 is equipped with a display unit 16 such as a CRT or flat display. As shown in FIG. 3, the display unit 16 can display data necessary for driving the driving device, such as electrocardiogram waveforms, blood pressure waveforms, time-series waveforms of balloon drive gas pressure, timing, alarms, and event history. ing.

FIG. 3 is a functional block diagram of the IABP balloon catheter 20 and IABP driving device 10 shown in FIG. As shown in FIG. 3 , the IABP drive device 10 has a balloon drive section 11 that expands and contracts the balloon section 21 and a control section 15 that reads and writes information to and from the IC chip 60 . The balloon driving section 11 has a pressure tank that forms pressure to be transmitted to the balloon section 21, an isolator that transmits the pressure generated in the pressure tank to the pressure fluid in the pressure fluid conduit 29 in the balloon catheter 20, and the like.

The IABP driving device 10 has, in addition to the control section 15, the balloon driving section 11 and the display section 16, an operation signal input section 13 for inputting an operation signal, an alarm section 19 for generating an alarm, and the like. The operation signal input section 13 has signal input means such as an input button, a switch, and a touch panel. By inputting an operation signal through the operation signal input unit 13, the operator changes/adjusts the driving conditions of the balloon catheter 20 by the IABP driving device 10, or starts driving the balloon catheter 20 by the IABP driving device 10. and can be stopped.

The alarm unit 19 of the IABP driving device 10 has a pilot lamp and an alarm sound generating unit that generates an alarm sound, and notifies the operator of problems and abnormalities detected during driving of the IABP driving device 10. can be done. The alarm section 19 operates according to a control signal from the control section 15 . For example, when the control unit 15 detects that a liquid such as blood enters the balloon unit 21, the control unit 15 controls the alarm unit 19 to perform an alarm operation, and causes the IABP driving device 10 to drive the balloon unit 21. Along with stopping, a warning is displayed on the display unit 16 to prompt the operator to take appropriate measures such as withdrawing the balloon catheter 20 from the patient's body.

The control unit 15 has a microprocessor or the like, and in addition to reading and writing information to the IC chip 60, controls the balloon driving unit 11 and the display unit 16, and controls the IABP balloon catheter 20. Various calculations necessary for control can be performed.

As shown in FIG. 3, the information stored in the IC chip 60 includes first information 81, which is alarm history information regarding alarms that occurred while the IABP balloon catheter 20 was being driven by the IABP driving device 10, Second information 82 such as 21 expanded outer diameter (eg 7.0 Fr), volume (eg 40 ml), product number (S/N), balloon type (eg short balloon). The second information 82 is stored in advance in the IC chip 60 and is information unique to the balloon catheter 20 that cannot be rewritten by the IABP driving device 10 .

On the other hand, the first information 81, which is alarm history information, is information cumulatively written and updated by the IABP driving device 10. FIG. The first information 81 at the stage when a new (undriven) balloon catheter 20 is shipped from the factory only designates an area for storing alarm history information. indicates that there is no history of alarms that occurred during driving.

The first information 81 stored as alarm history information includes, for example, information such as the type of alarm that has occurred, the time of occurrence, and frequency. The first information 81 may be information relating to all alarms that occur while the IABP balloon catheter 20 is being driven by the IABP driver 10, but may also be information relating to the occurrence of specific types of alarms, Alternatively, the information may be information related to an alarm generated in the most recent predetermined time.

The first information 81, which is alarm history information, includes a catheter tube kink of the balloon catheter 20 (imperfect flow of pressure fluid caused by a kink of the catheter tube 24), a pressure fluid leak (pressure fluid (reduction of pressure fluid caused by leakage) and liquid intrusion (intrusion of liquid such as blood into the pressure fluid path caused by breakage of balloon part 21 or catheter tube 24). is preferred, and more preferably includes information regarding the presence or absence of alarms for catheter tube kinks, pressure fluid leaks and liquid intrusion. The occurrence of these alarms is most likely due to problems with the balloon catheter 20 indwelling in the patient's body. Therefore, the history information regarding the generation of these alarms is useful information for ensuring safe driving of the IABP driving device 10 to which the balloon catheter 20 having driving history is connected.

FIG. 4 is a flow chart showing an example of processing that the control unit 15 of the IABP drive device 10 performs on the first information 81 of the IC chip 60 before starting to drive the balloon catheter 20 . In step S001 shown in FIG. 4, input/output of signals to/from the IC chip 60 by the control unit 15 is started. For example, when the interface section 70 of the balloon catheter 20 shown in FIG. Before that, input/output of signals to/from the IC chip 60 can be started.

In step S<b>002 , the control unit 15 shown in FIG. 3 reads the first information 81 from the IC chip 60 of the balloon catheter 20 . Furthermore, in step S003, it is determined whether the first information 81 read out in step S002 includes information indicating that a specific type of alarm has occurred. More specifically, in step S003, the first information 81 read out in step S002 includes information indicating that an alarm regarding at least one of catheter tube kink, pressure fluid leak, and liquid intrusion of the balloon catheter 20 has occurred. Determine whether it is included.

In step S003, if the first information 81 does not include information indicating that a specific type of alarm has occurred, the control section 15 proceeds to the process of step S004. In step S004, the control section 15 controls the balloon driving section 11 to start expanding and contracting the balloon section 21 in synchronization with the patient's heartbeat.

In step S<b>003 , if the first information 81 includes information indicating that a specific type of alarm has occurred, the control unit 15 causes the balloon drive unit 11 not to start expanding and contracting the balloon unit 21 . , the process proceeds to step S005. At step S005, the control unit 15 causes the alarm unit 19 to generate an alarm. For example, the control unit 15 controls the alarm unit 19 to turn on a pilot lamp indicating caution or warning, and since there is a high possibility that there is a problem with the balloon catheter 20 placed in the patient, the IABP method is restarted. In advance, information prompting the operator to remove and replace the balloon catheter 20 can be displayed on the display unit 16 .

After step S004 or step S005, the control unit 15 proceeds to step S006 and ends the processing for the IC chip 60 when the balloon drive unit 11 starts expanding and contracting the balloon unit 21 .

If the IABP balloon catheter connected to the IABP drive device 10 is new and has no drive history, the determination in step S003 is "NO", and the balloon unit 21 is driven in the next step (S004). be started. Also, the control unit 15 can read the second information 82 from the IC chip 60 before starting to drive the balloon unit 21 in step S004. The control unit 15 can use the second information 82 read from the IC chip 60 to calculate, for example, the amount of pressure fluid to flow into the pressure fluid conduit 29 .

FIG. 5 is a flow chart showing an example of writing processing of the first information 81 read in step S003 of FIG. In step S101 shown in FIG. 5, the control unit 15 starts writing processing of the first information 81, which is alarm history information. While the balloon drive unit 11 continues to inflate and deflate the balloon unit 21, the control unit 15 performs the processing shown in steps S101 to S103 at the timing when an alarm accompanying driving of the IABP balloon catheter 20 occurs. The processing of steps S101 to S103 may be performed simultaneously with the alarm operation by the alarm unit 19, or may be performed after the alarm operation by the alarm unit 19. FIG.

In step S<b>102 , the control unit 15 adds the information of the alarm that triggered step S<b>101 to the first information 81 that is the alarm history information, and updates the first information 81 . Contents written in the IC chip 60 as the first information 81 include the type of alarm, the time when the alarm occurred, the S/N of the IABP driving device 10 at the time of the alarm occurrence, and the like.

In step S<b>103 , the control unit 15 starts writing the first information 81 . The control unit 15 performs the processing shown in steps S101 to S103 each time an alarm occurs due to the driving of the balloon catheter 20 or each time an alarm to be written in the first information 81 occurs. As a result, the IABP driving device 10 reliably leaves alarm information generated during driving in the IC chip 60 of the balloon catheter 20, and other IABP driving devices 10 connected to the currently driven IABP balloon catheter 20 in the future. alarm history information can be transmitted to

As shown in FIGS. 4 and 5, in the balloon catheter 20 having the IC chip 60 that stores the first information 81 as alarm history information, the alarm history information written in the IC chip 60 by one IABP driving device 10 is can be read from the IC chip 60 by another IABP driving device 10 that takes over the driving of the balloon catheter 20 . Therefore, in the balloon catheter 20, it is possible to determine whether or not the IABP driving device 10 to be connected has a problem in the driving history of the balloon catheter 20 or not. This allows the balloon catheter 20 to be safely connected to the IABP driving device 10 even if it has a driving history.

Further, the IABP driving device 10 shown in FIGS. 2 and 3 reads the first information 81, which is alarm history information, before starting expansion and contraction of the balloon portion 21, and the first information 81 indicates that a specific alarm has occurred. If the information indicating that there was an accident is included, the alarm can be generated without starting the driving of the balloon unit 21 . Thus, the IABP driver 10 can prevent the problem of starting to drive a balloon catheter 20 that is damaged, e.g. Even in such a case, it is possible to avoid a situation in which a plurality of IABP driving devices 10 are broken down.

Although the present invention has been described by showing the embodiments, the balloon catheter 20 and the IABP driving device 10 according to the present invention are not limited to the above-described embodiments, and may include many other embodiments and modifications. Needless to say. For example, the storage unit (IC chip) 60 is not limited to being embedded in a portion of the handle portion 42, and may be attached to other portions of the balloon catheter 20. FIG.

Second Embodiment FIG. 6 is a schematic diagram of an IABP balloon catheter 120 (hereinafter sometimes simply referred to as "balloon catheter 120") according to a second embodiment of the present invention. The balloon catheter 120 according to the second embodiment differs from the balloon catheter 20 described above in that the pressure sensor 40 is accommodated in the distal tip portion 125, etc., but the balloon portion 21 and the like are the same as those of the balloon catheter 20. be. As for the balloon catheter 120 according to the second embodiment, only the points of difference from the balloon catheter 20 will be described, and the description of the points in common with the balloon catheter 20 will be omitted.

Balloon catheter 120 has a pressure sensor 40 that measures the patient's blood pressure. The pressure sensor 40 is housed inside the pipe member 37 embedded in the distal tip portion 125 . Intravascular pressure (blood pressure) in which the balloon catheter 120 is mounted is transmitted to the inside of the pipe member 37 via an insertion hole (not shown) and a pressure-transmitting filling material. The pressure sensor 40 detects the pressure (blood pressure) in the space inside the pipe member 37 by utilizing the path difference of light transmitted through the optical fiber 33 connected to the proximal end of the pressure sensor 40 . As the pressure sensor 40, those described in Japanese Unexamined Patent Publication No. 2008-524606, Japanese Unexamined Patent Publication No. 2000-35369, etc. can be used.

The distal tip portion 125 is formed with a distal opening 125a. The tip opening 125 a communicates with a wire passage 131 formed inside the inner tube 30 . A wire passage 131 in the inner tube 30 is used as a guide wire insertion hole through which a guide wire is passed. The rear end of wire passage 131 communicates with secondary port 144 of handle portion 142 .

A handle portion 142 connected to the rear end portion of the catheter tube 24 has a first passage 147 as a connection passage having a pressure fluid introduction outlet 146 that communicates with the pressure fluid conducting passage 29 in the catheter tube 24, and an inner tube. A second passageway 145 is formed in which a secondary port 144 is formed which communicates with the wire passageway 131 in 30 . In the handle portion 142, a second passage 145 formed with a secondary port 144 is arranged straight along the axial direction of the catheter tube 24, and a first passage 147 formed with a pressure fluid introduction outlet 146 is formed. , are arranged with a predetermined inclination with respect to the axis of the second passage 145 .

The optical fiber 33 connected to the pressure sensor 40 is pulled out from the distal tip portion 125 into the balloon portion 21, and extends along the outer wall of the inner tube 30 inside the balloon portion 21 and the catheter tube 24. 6, it is pulled out to the tertiary port 49 of the handle portion 142 and connected to the sensor connector 170a of the interface portion 170 (see FIG. 7). Although part of the optical fiber 33 is not shown in FIG. 6 for simplification, the optical fiber 33 is actually connected from the pressure sensor 40 to the sensor connector 170a. The interface section 170 shown in FIG. 6 is detachably connected to the contact-type terminal 18 provided in the IABP driving device 10, similarly to the interface section 70 shown in FIG.

7 is an enlarged view of the interface portion 170 that connects to the proximal end of the optical fiber 33, and FIG. 8 is a cross-sectional view of the interface portion 170 shown in FIG. The interface section 170 has a sensor connector 170a as a contact terminal. As shown in FIG. 7, the sensor connector 170a has a grip portion 171 on the distal end side and a connector body 172 on the proximal end side.

As shown in FIG. 7, the grip portion 171 is provided with a non-slip portion 171a having an uneven surface to facilitate gripping with fingers of the operator. The connector main body 172 has an outer diameter smaller than that of the grip portion 171, and can be inserted into the socket portion 18a provided in the contact-type terminal 18, as shown in FIG. As shown in FIGS. 7 and 8, a flexible tube forming a cable 162 is connected to the distal end of the grip portion 171 , and the optical fiber 33 is passed through the cable 162 . The proximal end of optical fiber 33 is coupled to end ferrule 102 of connector body 172, as shown in FIG.

As shown in FIG. 7, a pair of electrical connection terminals 110 and the proximal end 102a of the end ferrule 102 are exposed on the surface of the connector body 172. As shown in FIG. As shown in FIG. 8, when the connector main body 172 is inserted into the socket portion 18a, the end ferrule 102 and the receiving ferrule 202 can be optically connected, and at the same time, the electrical connection terminals 110 and the receiving side electrical connection terminals 210 can be connected. Electrical connection becomes possible.

Inside the contact type terminal 18, a receiving ferrule 202 is connected to a receiving optical fiber 88B. A signal from the pressure sensor 40 shown in FIG. 6 is sent to the controller 15 (see FIG. 3) of the IABP driving device 10 via the receiving ferrule 202 shown in FIG. 8 and the receiving optical fiber 88B connected thereto.

As shown in FIG. 8, an IC chip 160 as a storage unit is mounted inside the sensor connector 170a, and the IC chip 160 is electrically connected to the electrical connection terminals 110. As shown in FIG. When the connector main body 172 is inserted into the socket portion 18a, the control portion 15 (see FIG. 3) of the IABP driving device 10 can read and write information on the IC chip 160 via the receiving side electrical connection terminal 210. .

As with the IC chip 60 shown in FIG. 3, the IC chip 160 can store first information 81 that is alarm history information and second information 82 such as the expanded outer diameter of the balloon portion 21 . Also, the IC chip 160 shown in FIG. 8 can store data for compensating individual differences in the pressure sensor 40 of the balloon catheter 120 . In this case, the control unit 15 of the IABP driving device 10 uses the data for compensating the individual difference of the pressure sensor 40 stored in the IC chip 160 when calibrating the pressure sensor 40 or detecting the pressure sensor 40 . It is used when calculating a blood pressure value from a signal, and the accuracy of blood pressure measurement by the pressure sensor 40 can be improved.

Further, the interface unit 70 for the IABP driving device 10 to input/output to/from the storage unit 60 is not limited to having the contact type terminal 70a connected to the storage unit 60 by the cable 62 as shown in FIG. A type terminal may be provided on the surface of the direct storage unit 60 . Furthermore, the interface unit is not limited to the contact type, and may have a non-contact communication antenna and communicate with the IABP driving device 10 in a non-contact manner. The storage unit 60 may employ not only a storage medium using an electronic circuit such as an IC chip, but also a storage medium other than an electronic circuit such as a magnetic or optical medium.

In the example shown in FIG. 5, when the IABP driving device 10 generates an alarm, it writes the information into the storage unit 60 and updates the first information 81. The write timing is not limited to this. For example, the IABP driving device 10 may periodically write information to the storage section 60 at a predetermined cycle.

In addition, specific alarms to be determined in step S003 of FIG. 4 are not limited to catheter tube kink, pressure fluid leak, and liquid intrusion, and are thought to be caused by a problem on the balloon catheter 20 side, not the IABP driving device 10. Other alarms to be issued can be the determination target of S003.

DESCRIPTION OF SYMBOLS 10... IABP drive device 11... Balloon drive part 12... Pressure fluid connector tube 13... Operation signal input part 14... Blood connector tube 15... Control part 16... Display part 18... Contact type terminal 19... Alarm part 20, 120... IABP balloon Catheter 21 balloon section 22 balloon membrane 23 blood introduction port 24 catheter tube 25, 125 distal tip section 27 connection tube 29 pressure fluid conducting path 30 inner tube 31 blood conducting path 42, 142 handle section 44... Blood pressure measurement port 45, 145... Second passage 46, 146... Pressure fluid introduction outlet 47, 147... First passage (connection passage)
48 First inner tube end holder 50 Second inner tube end holder 60, 160 IC chip (storage unit)
62... Cable 70, 170... Interface section 70a... Contact type terminal

Claims (4)

a balloon portion that expands and contracts;
a catheter tube connected to the rear end of the balloon portion and formed with a pressurized fluid conduit for introducing and discharging the pressurized fluid into the balloon portion;
a handle portion connected to the rear end portion of the catheter tube and formed with a connection passage having a pressure fluid introduction outlet communicating with the inside of the pressure fluid conduit;
a storage unit that stores alarm history information regarding alarms that occurred while being driven by the IABP drive;
An IABP driving device for driving an IABP balloon catheter having an interface unit for the IABP driving device to input and output the alarm history information to the storage unit ,
a balloon driving unit that expands and contracts the balloon unit, an alarm unit that generates an alarm, and a control unit that reads and writes the alarm history information to and from the storage unit via the interface unit ;
The control unit reads the alarm history information from the storage unit before the balloon drive unit starts expanding and deflating the balloon unit, and stores the IABP in the alarm history information read from the storage unit. without initiating inflation and deflation of the balloon portion by the balloon driver if the information includes information that an alarm has occurred regarding at least one of catheter tube kink, pressure fluid leak, and liquid intrusion of the balloon catheter; An IABP driving device , wherein the alarm unit generates an alarm . The control unit writes alarm information caused by driving the IABP balloon catheter into the storage unit while the balloon driving unit continues to expand and contract the balloon unit. Item 1. The IABP driving device according to item 1 . The interface section has a contact terminal,
3. The control unit communicates with the IABP balloon catheter via the contact terminal, and reads and writes the alarm history information from and to the storage unit. 3. The IABP driver according to 2. The interface unit has an antenna for contactless communication,
3. The control unit communicates with the IABP balloon catheter in a non-contact manner via the non-contact communication antenna, and reads and writes the alarm history information to and from the storage unit. 3. The IABP driver of claim 1 or claim 2.

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