WO2019146687A1 - Iabp balloon catheter and iabp drive device - Google Patents

Abstract

[Problem] To provide an IABP balloon catheter and IABP drive device that enable suitable management of cumulative IABP balloon catheter drive time. [Solution] An IABP balloon catheter driven by an IABP drive device, the IABP balloon catheter comprising: an balloon that expands and contracts; a catheter tube that is linked to a rear end of the balloon, and in which is formed a pressurized fluid guide path for guiding a pressurized fluid into and out of the interior of the balloon; a handle that is linked to a rear end of the catheter tube and in which is formed a connecting path comprising a pressurized fluid inlet/outlet communicating with the interior of the pressurized fluid guide path; a storage unit that, when the IABP balloon catheter has been driven by a plurality of IABP drive devices in succession, stores information pertaining to the cumulative drive time over which the IABP balloon catheter has been driven by the plurality of IABP drive devices; and an interface unit for the IABP drive device to make inputs to and outputs from the storage unit.

Description

IABP balloon catheter and IABP driving device

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

The IABP method is performed by placing an IABP balloon catheter in the patient's body and driving the IABP balloon catheter by an IABP driving device connected outside the body. The balloon catheter used in the IABP driving device is not limited to one type, and a plurality of types of IABP balloon catheters are used properly depending on the physical constitution of the patient to which the IABP method is applied. By mounting an IC chip in which the size and the like of the balloon are recorded on such an IABP balloon catheter, the IABP drive device automatically recognizes the size and the like of the IABP balloon catheter connected to the device from the IC chip. It is proposed (refer patent document 1).

Utility model registration 3177552 gazette

In the IABP method, depending on the condition of the patient, driving of an IABP balloon catheter placed in the patient's body may be continued for a relatively long time continuously. In addition, in the IABP method, for example, when the IABP method is applied through critical care and general medical care, or when a patient is transferred to a hospital, one IABP balloon catheter indwelled in the body is a plurality of IABP drive devices. It may take over and drive.

For example, when one IABP balloon catheter is taken over by two IABP driving devices and driven, the second IABP driving device controls the IABP balloon catheter that is targeted for how long the first IABP driving device operates. It can not be recognized by the conventional IABP drive device whether it was driving. Therefore, in the conventional IABP balloon catheter and IABP driving device, the operator can operate even when the IABP balloon catheter is driven beyond the specified cumulative driving time or when the predetermined cumulative driving time is approaching. Could not alert you to

The present invention has been made in view of such circumstances, and appropriately manages the accumulated drive time of the IABP balloon catheter even in the case where one IABP balloon catheter is taken over and driven by a plurality of IABP drivers. An IABP balloon catheter and an IABP driving device are provided.

In order to achieve the above object, the IABP balloon catheter according to the present invention is
An IABP balloon catheter driven by an IABP driver,
A balloon portion that expands and contracts;
A catheter tube connected to a rear end of the balloon portion and having a pressure fluid channel formed therein for introducing and discharging pressure fluid in the balloon portion;
A handle portion connected to a rear end of the catheter tube and having a connection passage having a pressure fluid inlet / outlet communicating with the inside of the pressure fluid channel;
A storage unit configured to store information on accumulated drive time driven by the plurality of IABP driving devices when the IABP balloon catheter is driven by the plurality of IABP driving devices;
An interface unit for the input / output to / from the storage unit;
Have.

Since the IABP balloon catheter according to the present invention has a storage unit for storing information on accumulated drive time taken over and driven by a plurality of IABP drives, even if a plurality of IABP drives are one IABP balloon catheter Even in the case of taking over and driving, the accumulated driving time of the IABP balloon catheter can be recognized. In addition, by performing the IABP method using the IABP balloon catheter according to the present invention, the IABP driving device generates an alarm when the IABP balloon catheter is driven beyond a prescribed cumulative driving time, or a prescribed accumulation. The operator can be alerted by notifying the operator that the driving time is approaching.

Also, for example, the interface unit may have a contact terminal.

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

Also, for example, the interface unit may have a noncontact communication antenna.

By using a noncontact communication antenna, such an IABP balloon catheter can reduce connection time when connecting the IABP balloon catheter to the IABP driving device.

An IABP drive device according to the present invention is an IABP drive device for driving any of the above IABP balloon catheters,
A balloon drive unit that expands and contracts the balloon unit, and a control unit that reads and writes the information to the storage unit;
The control unit may read out the information from the storage unit before and after the balloon drive unit starts expansion and contraction of the IABP balloon catheter.

Such an IABP drive reads the information on the cumulative drive time from the storage of the IABP balloon catheter before and after the start of the drive, so that the IABP balloon catheter has already been driven by another IABP drive, even with respect to the IABP drive. Even in the case where is connected, it is possible to recognize the cumulative driving time of the IABP balloon catheter to be driven. In addition, by reading out information before and after the start of driving, it is possible to prevent the IABP balloon catheter from being driven beyond the defined cumulative driving time.

Also, for example, the control unit may calculate the accumulated driving time of the IABP balloon catheter at a predetermined cycle while the balloon drive unit continues the expansion and contraction of the balloon unit.

Such an IABP driving apparatus continuously monitors the IABP balloon catheter so that it is not driven beyond a prescribed time by calculating the accumulated driving time of the IABP balloon catheter in a predetermined cycle during driving. be able to.

Also, for example, the control unit may cause the alarm unit to perform an alarm operation when the accumulated driving time of the IABP balloon catheter exceeds a predetermined threshold.

Such an IABP drive generates an alarm when the IABP balloon catheter is driven beyond a prescribed cumulative drive time, and warns the operator to exchange the IABP balloon catheter. be able to.

Also, for example, the control unit may be configured to store the information related to the accumulated driving time of the IABP balloon catheter at a predetermined cycle while the balloon drive unit continues expansion and contraction of the balloon unit. You may write to

Such an IABP drive device has information on the accumulative drive time accurate for the IABP balloon catheter by writing information on the accumulative drive time of the IABP balloon catheter to the storage unit at a predetermined cycle while driving. You can

FIG. 1 is a schematic cross-sectional view of an IABP balloon catheter according to a first embodiment of the present invention. FIG. 2 is a conceptual view showing an implementation state of an IABP method using an IABP balloon catheter shown in FIG. 1 and an IABP driving device for driving the same. FIG. 3 is a functional block diagram of the IABP balloon catheter and IABP driving device shown in FIG. FIG. 4 is a flowchart showing calculation of accumulated driving time by the IABP driving device and the IABP balloon catheter shown in FIG. 3 and a writing process to the IC chip. FIG. 5 is a schematic cross-sectional view of an IABP balloon catheter according to a second embodiment of the present invention. 6 is an enlarged view of an interface portion of the IABP balloon catheter shown in FIG. FIG. 7 is a schematic cross-sectional view of the interface unit shown in FIG.

Hereinafter, the present invention will be described based on embodiments shown in the drawings.

First Embodiment FIG. 1 is a schematic view of an IABP balloon catheter 20 (hereinafter sometimes referred to simply as “balloon catheter 20”) according to a first embodiment of the present invention. The balloon catheter 20 is driven by an IABP driver shown in FIG. The balloon catheter 20 has a balloon portion 21 that expands and contracts in accordance with the pulsation of the heart. The balloon portion 21 has a balloon film 22 which is a thin film having a film thickness of about 50 to 100 μm. The material of the balloon film 22 is not particularly limited, but is preferably a material excellent in bending fatigue resistance, and is made of, for example, polyurethane or the like.

The outer diameter and length of the balloon portion 21 are determined according to the inner volume of the balloon portion 21 which largely affects the auxiliary function of cardiac function, the inner diameter of the patient's artery, and the like. The internal volume of the balloon portion 21 is not particularly limited, but is 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 end tip 25 having a blood communication hole 23 formed at the distal end of the balloon 21 is attached to the balloon membrane 22 by means such as heat fusion or adhesion. On the inner peripheral side of the distal end tip portion 25, the distal end portion of the inner tube 30 passing through the inside of the balloon portion 21 is attached by means such as 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 metal connection tube 27. The pressure fluid is introduced into and drawn out of the balloon portion 21 through the pressure fluid conducting path 29 formed inside the catheter tube 24, and the balloon portion 21 is expanded and contracted. The balloon portion 21 and the catheter tube 24 are connected by heat fusion or adhesion with an adhesive such as an ultraviolet curing resin.

The inner tube 30 axially extends inside the balloon portion 21 and the catheter tube 24 so as to communicate with the blood pressure measurement port 44 of the handle portion 42 described later. Inside the inner tube 30 is formed a blood channel 31 which does not communicate with the inside of the balloon portion 21 and the pressure fluid channel 29 formed in the catheter tube 24. The inner tube 30 located in the balloon portion 21 is also used as a guide wire insertion lumen for passing a guide wire. When the balloon catheter 20 is inserted into the artery, the balloon portion 21 is contracted and the balloon membrane 22 is wound around the inner tube 30. In addition, when the balloon catheter 20 is inserted into the artery, the balloon portion 21 can be rapidly inserted to an appropriate position in the body by passing a guide wire through the inner tube 30 and guiding the tip end of the balloon catheter 20 to the guide wire. 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. Further, the inner pipe 30 is not particularly limited, but is constituted by a hard tube, a metal spring reinforced tube, a stainless steel capillary or the like. The inner diameter and the wall thickness of the inner pipe 30 are not particularly limited, but the inner diameter is preferably 0.1 to 1.0 mm, and the wall thickness is preferably 0.05 to 0.3 mm.

The rear end of the catheter tube 24 is connected to a handle portion 42 installed outside the patient's body. The handle portion 42 is formed separately from the catheter tube 24 and is fixed to the catheter tube 24 by means such as heat fusion or adhesion. The handle portion 42 is formed with a first passage 47 as a connecting passage having a pressure fluid inlet / outlet 46 communicating with the pressure fluid conducting passage 29 in the catheter tube 24 and a blood pressure measurement port 44 communicating with the inner tube 30. And a second passage 45 is formed. The pressure fluid that causes the balloon portion 21 to expand and contract is introduced into the pressure fluid channel 29 of the catheter tube 24 through the pressure fluid inlet 46, and from the pressure fluid channel 29 of the catheter tube 24 to the handle portion 42. To the first passage 47 of the

FIG. 2 is a conceptual diagram showing an implementation state of the IABP method by the balloon catheter 20 shown in FIG. 1 and the IABP driving device 10 for driving the same. The pressure fluid inlet / outlet 46 of the handle portion 42 is connected to the pressure fluid connector tube 12 of the IABP drive 10 shown in FIG. In the balloon catheter 20, pressure fluid is introduced into and drawn out of the balloon portion 21 by the drive by the IABP driving device 10. The fluid introduced into the balloon portion 21 is not particularly limited, but helium gas or the like having a small viscosity is used so that the balloon portion 21 expands and contracts rapidly 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 drive device 10 shown in FIG. 2 and measures the blood pressure fluctuation of the blood in the artery taken from the blood communication hole 23 at the tip of the balloon portion 21 It can be measured by the device. The IABP drive device 10 shown in FIG. 2 controls the balloon drive unit 11 (see FIG. 3) according to the pulsation of the heart 1 based on the fluctuation of the blood pressure measured by the blood pressure measurement device. The balloon portion 21 is expanded and contracted in synchronization with a predetermined timing. The blood pressure measurement device may be included in the IABP drive device 10, but is a device separate from the IABP drive device 10, and may transmit blood pressure fluctuation data to the IABP drive device 10. Good.

In the handle portion 42, as shown in FIG. 1, the first passage 47 in which the pressure fluid inlet / outlet 46 is formed is disposed straight along the axial center direction of the catheter tube 24, and the blood pressure measurement port 44 is formed. The second passage 45 is disposed at a predetermined inclination with respect to the axial center of the first passage 47.

Further, as shown in FIG. 1, the handle portion 42 is provided with a first inner pipe end holder 48 and a second inner pipe end holder 50 for holding the end of the inner pipe 30. The first inner pipe end holder 48 and the second inner pipe end holder 50 are disposed along the extension direction of the second passage 45 with a predetermined inclination with respect to the axis of the first passage 47. It is The inner tube 30 is fixed by the first inner tube end holder 48 and the second inner tube end holder 50 so that the inner tube 30 is decentered so as to contact the inner wall of the catheter tube 24 inside the handle portion 42. It is arranged.

In the balloon catheter 20, since the first passage 47 communicating with the pressure fluid inlet / outlet 46 formed in the handle portion 42 is disposed straight along the axial direction of the catheter tube 24, the blood pressure measurement port is As compared with the case of arranging in a straight shape along the axial direction of the above, it is possible to reduce the flow path resistance of the pressure fluid, and the responsiveness of expansion and contraction in 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 unit 70 has a contact terminal 70 a, and the contact terminal 70 a and the IC chip 60 are connected via a cable 62. Although the cable 62 is not particularly limited, it is configured of, for example, an RS232C cable. The information stored in the IC chip 60 will be described later.

As shown in FIG. 2, the contact terminal 70 a of the interface unit 70 is detachably connected to the contact terminal 18 provided in the drive device 10. The IC chip 60 is connected to the control unit 15 (see FIG. 3) of the IABP drive device 10 through the interface unit 70, whereby the control unit 15 of the IABP drive device 10 reads and writes information of the IC chip 60. Is possible.

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

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

The IABP driving device 10 includes an operation signal input unit 13 and an alarm unit 19 in addition to the control unit 15, the balloon drive unit 11, and the display unit 16. The operation signal input unit 13 includes signal input means such as input buttons, switches, and a touch panel, and the operation signal input from the operation signal input unit 13 is transmitted to the control unit 15. The operator changes or adjusts the drive condition of the balloon catheter 20 by the IABP drive unit 10 by inputting the operation signal via the operation signal input unit 13 or starts the drive of the balloon catheter 20 by the IABP drive unit 10 And can be stopped.

The alarm unit 19 of the IABP drive device 10 has a pilot lamp and an alarm sound generation unit that generates an alarm sound, and informs the operator of a problem or abnormality detected while the IABP drive device 10 is driven. Can. The alarm unit 19 operates in response to a control signal from the control unit 15. For example, when detecting that the liquid such as blood enters the balloon unit 21, the control unit 15 controls the alarm unit 19 to perform an alarm operation, and drives the balloon unit 21 by the IABP driving device 10. At the same time as stopping, warning content is displayed on the display unit 16 to urge the operator to take appropriate measures such as removing the balloon catheter 20 from the patient's body.

The control unit 15 has a microprocessor or the like, and controls the balloon drive unit 11 and controls the display unit 16 in addition to performing reading and writing processing of information to the IC chip 60, and the IABP balloon catheter 20 It can perform various operations necessary for control.

As shown in FIG. 3, the information stored in the IC chip 60 includes first information 81 related to the cumulative driving time when the balloon catheter 20 is driven by the IABP driving device 10 and the expanded outer diameter of the balloon portion 21 (for example, 7 And second information 82 such as a volume (for example, 40 ml), a product number (S / N), and a type of balloon (for example, a short balloon). The second information 82 is information specific to the balloon catheter 20, which is stored in advance in the IC chip 60 and can not be rewritten by the IABP driving device 10.

On the other hand, the first information 81 related to the cumulative driving time by the balloon catheter 20 is the information rewritten and updated by the IABP driving device 10, and the same balloon catheter 20 is taken over by the plurality of IABP driving devices 10. In the case where the drive is performed, the information is rewritten and updated by each of the plurality of IABP driving devices 10. Then, at the stage where a new (undriven) balloon catheter 20 is shipped from the factory, the IC chip 60 stores first information 81 indicating that the cumulative driving time is 0 minutes.

FIG. 4 is a flowchart showing an example of processing performed by the control unit 15 of the IABP driving device 10 on the first information 81 of the IC chip 60 and the like. In step S001 shown in FIG. 4, the control unit 15 starts input / output of a signal to / from the IC chip 60. For example, when the interface unit 70 of the balloon catheter 20 shown in FIG. 2 is connected to the contact terminal 18 of the IABP driving device 10, the control unit 15 can start input / output of a signal to / from the IC chip 60. .

In step S002, the control unit 15 shown in FIG. 3 reads out the first information 81 from the IC chip 60 of the balloon catheter 20 and recognizes the cumulative driving time of the balloon catheter 20. After the power supply of the IABP drive device 10 is activated, the control unit 15 reads out the first information 81 in step S002 before the balloon drive unit 11 starts the expansion and contraction of the balloon unit 21 synchronized with the heartbeat of the patient. It can be performed.

In step S002, when the IABP balloon catheter 20 immediately after being placed in the patient's body connected to the IABP drive device 10 is connected to the IABP drive device 10, the control unit 15 sets the cumulative drive time to 0 (not driven Is read out from the IC chip 60. On the other hand, when the balloon catheter 20 driven by using different IABP driving devices 10 is replaced and connected, or when the IABP driving device 10 is restarted, the control unit 15 has a cumulative driving time of 0 (not driven). The first information 81 indicating that it is not the predetermined value is read out from the IC chip 60.

Thereby, the control unit 15 can recognize the cumulative driving time of the balloon catheter 20 at an early stage. The control unit 15 may display the cumulative driving time of the balloon catheter 20 read in step S002 on the display unit 16 so that the operator can recognize the cumulative driving time. In addition, the control unit 15 may read not only the first information 81 but also the second information 82 from the IC chip 60 in step S002. In this case, using the second information 82 read from the IC chip 60, the control unit 15 can calculate, for example, the amount of pressure fluid to be introduced into the pressure fluid passage 29.

After step S002 is completed, the control unit 15 shown in FIG. 3 controls the balloon drive unit 11, and expansion and contraction of the balloon catheter 20 by the balloon drive unit 11 are started (step S003).

When expansion and contraction of the balloon unit 21 by the balloon drive unit 11 are started, the control unit 15 always performs the processing shown in steps S 004 to S 009 of FIG. 4 while the balloon catheter 20 is being driven. It continues and updates the 1st information 81 of IC chip 60 which balloon catheter 20 has.

In step S 004, the control unit 15 resets a timer t that measures the calculation period of the accumulated driving time of the IABP balloon catheter 20 and the writing (updating) period of the first information 81. The timer t is a variable that increases with the passage of time.

In step S005, it is determined whether the value of the timer t has exceeded a predetermined value T that defines the calculation period of the cumulative driving time of the balloon catheter 20 and the writing period of the first information 81. Step S005 is repeated until the value of timer t exceeds the predetermined value T defining the cycle, and when the value of timer t exceeds the predetermined value T defining the cycle, control unit 15 proceeds to the process of step S006. . The calculation cycle of the cumulative drive time of the balloon catheter 20 and the writing cycle of the first information 81 can be, for example, about 300 seconds.

In step S006, the control unit 15 calculates the cumulative driving time Ta of the balloon catheter 20. For example, the control unit 15 sets the calculation period of the cumulative driving time to 1 in the cumulative driving time Ta calculated in the most recent step S002 (the cumulative driving time read in step S002 only in the case of the first step S006 after power on). The cumulative driving time Ta can be calculated by adding the periods.

In step S 007, the control unit 15 determines whether or not the cumulative driving time Ta calculated in the immediately preceding step S 006 exceeds a predetermined threshold value Tar regarding the appropriate limit value of the cumulative driving time of the balloon catheter 20. If the cumulative driving time Ta exceeds the predetermined threshold Tar, the control unit 15 proceeds from step S006 to step S008. The predetermined threshold Tar regarding the appropriate limit value of the cumulative driving time of the balloon catheter 20 can be, for example, about 336 hours.

In step S008, the control unit 15 controls the alarm unit 19 to perform an alarm operation. For example, the control unit 15 controls the alarm unit 19 to turn on a pilot lamp indicating a warning or a warning, and displays information for notifying the operator that the cumulative driving time of the balloon catheter 20 is limited. Can be displayed.

After step S008, and when the cumulative driving time Ta does not exceed the predetermined threshold Tar, after step S006, the control unit 15 uses the cumulative driving time Ta calculated in the most recent step S007 to set the IC chip 60 to the IC chip 60. The first information 81 is written, and the first information 81 stored in the IC chip 60 is updated. After completing step S009, the control unit 15 returns to step S004, and thereafter repeats the processing shown in steps S004 to S009 (step S008 is performed only under a predetermined condition).

Thus, while the balloon drive unit 11 shown in FIG. 3 continues the expansion and contraction of the balloon unit 21 synchronized with the heart beat of the patient, the control unit 15 keeps the cumulative driving time of the balloon catheter 20 at a predetermined cycle. Calculate In addition, while the balloon drive unit 11 continues the expansion and contraction of the balloon unit 21 synchronized with the heartbeat of the patient, the control unit 15 performs the first information 81 on the cumulative driving time of the balloon catheter 20 at a predetermined cycle. , Write to the IC chip 60, and update the information of the IC chip 60.

By driving the balloon catheter 20 having the IC chip 60 storing the first information 81 as shown in FIG. 3 by the IABP driving device 10 having the control unit 15, even if a plurality of IABP driving devices 10 are one, Even when the balloon catheter 20 is taken over and driven, the cumulative driving time of the balloon catheter 20 can be correctly calculated. Also, the IABP driving device 10 notifies the operator of a state in which the prescribed cumulative driving time is approaching and warns the operator, or an alarm when the balloon catheter 20 is driven beyond the prescribed cumulative driving time. Can be generated.

Second Embodiment FIG. 5 is a schematic view of an IABP balloon catheter 120 (hereinafter sometimes referred to simply as “balloon catheter 120”) according to a second embodiment of the present invention. The balloon catheter 120 according to the second embodiment is different from the balloon catheter 20 described above in that the pressure sensor 40 is accommodated in the distal end tip portion 125, but the balloon portion 21 and the like are the same as the balloon catheter 20. is there. About the balloon catheter 120 which concerns on 2nd Embodiment, only differences with the balloon catheter 20 are demonstrated, and description is abbreviate | omitted about the common points with the balloon catheter 20. FIG.

The balloon catheter 120 has a pressure sensor 40 that measures the blood pressure of the patient. The pressure sensor 40 is housed inside the pipe member 37 embedded in the distal end tip portion 125. The pressure (blood pressure) in the blood vessel on which the balloon catheter 120 is placed is transmitted to the inside of the pipe member 37 through an insertion hole (not shown) and a pressure transmitting filling material. The pressure sensor 40 detects the pressure (blood pressure) of the space in the pipe member 37 using a path difference of light transmitted through the optical fiber 33 connected to the proximal end of the pressure sensor 40 or the like. As the pressure sensor 40, those described in JP-A-2008-524606, JP-A-2000-35369 and the like can be used.

A distal end opening 125 a is formed in the distal end tip portion 125. The tip opening 125 a communicates with a wire passage 131 formed in the inner tube 30. The wire passage 131 in the inner tube 30 is used as a guide wire insertion hole or the like for passing a guide wire. The rear end of the wire passage 131 is in communication with the secondary port 144 of the handle portion 142. The handle portion 142 connected to the rear end of the catheter tube 24 has a first passage 147 as a connecting passage having a pressure fluid inlet / outlet 146 communicating with the pressure fluid passage 29 in the catheter tube 24; A second passage 145 is formed in which a secondary port 144 communicating with the wire passage 131 in 30 is formed. In the handle portion 142, the second passage 145 in which the secondary port 144 is formed is disposed straight along the axial direction of the catheter tube 24, and the first passage 147 in which the pressure fluid inlet / outlet 146 is formed is formed. The second passage 145 is disposed at a predetermined inclination with respect to the axial center of the second passage 145.

The optical fiber 33 connected to the pressure sensor 40 is drawn from the distal end tip portion 125 to the inside of 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 as shown in FIG. As shown in FIG. 5, it is pulled out to the tertiary port 49 of the handle portion 142, and is connected to the sensor connector 170a (see FIG. 6) of the interface portion 170. In FIG. 5, although a part of the optical fiber 33 is not shown for simplification, the optical fiber 33 is actually connected from the pressure sensor 40 to the sensor connector 170a. Similar to the interface unit 70 shown in FIG. 2, the interface unit 170 shown in FIG. 5 is detachably connected to the contact-type terminal 18 provided in the IABP drive device 10.

6 is an enlarged view of the interface section 170 connected to the proximal end of the optical fiber 33, and FIG. 7 is a cross-sectional view of the interface section 170 shown in FIG. The interface unit 170 has a sensor connector 170a as a contact terminal. As shown in FIG. 6, the sensor connector 170 a has a grip portion 171 on the distal end side and a connector body 172 on the proximal end side.

As shown in FIG. 6, the grip portion 171 is provided with a non-slip portion 171 a whose surface is formed with a concavo-convex shape, and is easy to pick with the finger of the operator. The connector body 172 has an outer diameter smaller than that of the grip portion 171, and as shown in FIG. 7, can be inserted into a socket portion 18a provided on the contact type terminal 18. As shown in FIGS. 6 and 7, a flexible tube forming a cable 162 is connected to the distal end of the grip portion 171, and the optical fiber 33 passes through the inside of the cable 162. The proximal end of the optical fiber 33 is coupled to the end ferrule 102 of the connector body 172, as shown in FIG.

As shown in FIG. 6, on the surface of the connector body 172, the pair of electrical connection terminals 110 and the proximal end 102 a of the end ferrule 102 are exposed. As shown in FIG. 7, when the connector main body 172 is inserted into the socket portion 18 a, optical connection between the end ferrule 102 and the receiving ferrule 202 becomes possible, and at the same time, the electrical connection terminal 110 and the receiving electrical connection terminal 210. Electrical connection is possible.

Inside the contact terminal 18, a receiving optical fiber 88 B is connected to the receiving ferrule 202. The signal of the pressure sensor 40 shown in FIG. 5 is sent to the control unit 15 (see FIG. 3) of the IABP driving device 10 via the receiving side ferrule 202 shown in FIG. 7 and the receiving side optical fiber 88B connected thereto.

As shown in FIG. 7, an IC chip 160 as a storage unit is mounted inside the sensor connector 170 a, and the IC chip 160 is electrically connected to the electrical connection terminal 110. When the connector body 172 is inserted into the socket portion 18a, the control unit 15 (see FIG. 3) of the IABP drive device 10 can read and write information of the IC chip 160 through the receiving electrical connection terminal 210. .

Similar to the IC chip 60 shown in FIG. 3, the IC chip 160 can store first information 81 related to the cumulative driving time and second information 82 such as the expanded outer diameter of the balloon section 21. Further, the IC chip 160 shown in FIG. 7 can store data for compensating for individual differences of the pressure sensor 40 that the balloon catheter 120 has. In this case, the controller 15 of the IABP driving device 10 performs calibration of the pressure sensor 40 or data of the pressure sensor 40 stored in the IC chip 160 to compensate for the individual differences of the pressure sensor 40 or detection of the pressure sensor 40. It can be used when calculating the blood pressure value from the signal, etc., and the measurement accuracy of the blood pressure by the pressure sensor 40 can be enhanced.

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

Further, the interface unit 70 for the IABP driving device 10 to input / output to / from the storage unit 60 is not limited to one having the contact type terminal 70a connected to the storage unit 60 by the cable 62 as shown in FIG. The formula terminal may be provided on the surface of the direct storage unit 60. Furthermore, the interface unit is not limited to contact only, and may have a noncontact communication antenna, and may communicate with the IABP drive device 10 in a noncontact manner.

Further, in the example shown in FIG. 4, the IABP driving device 10 writes the first information 81 on the cumulative driving time of the balloon catheter 20 in the storage unit (IC chip) 60 at a predetermined cycle. The timing of writing information in 60 is not limited to this. For example, after the occurrence of a predetermined event, such as when the balloon drive unit 11 stops driving the balloon unit 21, the IABP drive device 10 stores the first information 81 on the cumulative drive time of the balloon catheter 20 in the storage unit 60. You may write it. The IABP drive device 10 is not limited to the timing before the start of driving of the balloon unit 21 and the timing of reading out the first information 81 related to the cumulative driving time of the balloon catheter 20 from the storage unit 60. The first information 81 may be read out at a predetermined timing.

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 portion 22 ... balloon membrane 23 ... blood introduction port 24 ... catheter tube 25, 125 ... tip end portion 27 ... connection tube 29 ... pressure fluid conduction path 30 ... inner pipe 31 ... blood conduction path 42, 142 ... handle portion 44 ... blood pressure measurement port 45, 145 ... second passage 46, 146 ... pressure fluid inlet / outlet 47, 147 ... first passage (connection passage)
48 ... 1st inner tube end holder 50 ... 2nd inner tube end holder 60, 160 ... IC chip (storage unit)
62 ... Cable 70, 170 ... Interface section 70a ... Contact terminal

Claims (7)

An IABP balloon catheter driven by an IABP driver,
A balloon portion that expands and contracts;
A catheter tube connected to a rear end of the balloon portion and having a pressure fluid channel formed therein for introducing and discharging pressure fluid in the balloon portion;
A handle portion connected to a rear end of the catheter tube and having a connection passage having a pressure fluid inlet / outlet communicating with the inside of the pressure fluid channel;
A storage unit configured to store information on accumulated drive time driven by the plurality of IABP driving devices when the IABP balloon catheter is driven by the plurality of IABP driving devices;
An interface unit for the input / output to / from the storage unit;
IABP balloon catheter. The IABP balloon catheter according to claim 1, wherein the interface unit comprises a contact terminal. The IABP balloon catheter according to claim 1, wherein the interface unit has a noncontact communication antenna. An IABP driving device for driving the IABP balloon catheter according to any one of claims 1 to 3, comprising:
A balloon drive unit that expands and contracts the balloon unit, and a control unit that reads and writes the information to the storage unit;
The IABP drive device, wherein the control unit reads the information from the storage unit before and after the balloon drive unit starts expansion and contraction of the balloon unit. 5. The controller according to claim 4, wherein the control unit calculates the cumulative driving time of the IABP balloon catheter at a predetermined cycle while the balloon drive unit continues expansion and contraction of the balloon unit. IABP drive as described. The IABP driving device according to claim 5, wherein the control unit causes the alarm unit to perform an alarm operation when the accumulated driving time of the IABP balloon catheter exceeds a predetermined threshold. The control unit writes the information on the accumulated driving time of the IABP balloon catheter in the storage unit at a predetermined cycle while the balloon drive unit continues the expansion and contraction of the balloon unit. The IABP driving apparatus according to any one of claims 4 to 6, characterized in that

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