CN111542351A

CN111542351A - IABP sacculus pipe and IABP drive arrangement

Info

Publication number: CN111542351A
Application number: CN201980007005.8A
Authority: CN
Inventors: 高桥克明
Original assignee: Zeon Corp
Current assignee: Zeon Corp
Priority date: 2018-01-25
Filing date: 2019-01-24
Publication date: 2020-08-14
Anticipated expiration: 2039-01-24
Also published as: CN111542351B; JPWO2019146688A1; WO2019146688A1; JP7331702B2

Abstract

The invention provides an IABP balloon catheter which can be safely connected even if a drive history exists and an IABP driving device for driving the IABP balloon catheter. An IABP balloon catheter driven by an IABP drive device and having: a balloon portion that expands and contracts; a catheter which is connected to a rear end of the balloon portion and has a pressure fluid passage formed therein for introducing and discharging a pressure fluid into and from the balloon portion; a handle portion coupled to a rear end portion of the catheter and having a connection passage formed therein, the connection passage having a pressure fluid introduction outlet communicated with the inside of the fluid pressure passage; a storage unit that stores alarm history information relating to an alarm generated by the IABP balloon catheter during driving by an IABP drive device; an interface unit for inputting and outputting the IABP driving device to and from the storage unit.

Description

IABP sacculus pipe and IABP drive arrangement

Technical Field

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

Background

The IABP method is performed by indwelling an IABP balloon catheter in a patient's body and driving the IABP balloon catheter by an IABP driving device connected to the outside of the body. The IABP driving device uses not only one type of balloon catheter, but also a plurality of types of IABP balloon catheters according to the physique and the like of a patient to which the IABP method is applied. A technique has been proposed in which an IC chip in which the size of the balloon is recorded is mounted on such an IABP balloon catheter, and the IABP driving device automatically recognizes the size of the IABP balloon catheter connected to the device from the IC chip (see patent document 1).

Documents of the prior art

Patent document

Patent document 1: japanese utility model No. 3177552.

Disclosure of Invention

Problems to be solved by the invention

In the IABP method, an IABP balloon catheter indwelling in a patient body is continuously driven for a long period of time in some cases depending on the condition of the patient. Therefore, in the IABP method, when a failure or the like is suspected to occur during the driving of the IABP driving device, there is a case where the IABP balloon catheter is continuously driven by replacing only the IABP driving device.

However, in the conventional IABP driving device, the IABP balloon catheter connected to start driving cannot inherit the historical information about the driving state before the IABP balloon catheter is driven. Therefore, when the IABP drive device is replaced, the situation may be deteriorated. For example, when the driving of the balloon by the IABP driving device is stopped due to the leakage of the pressure fluid caused by the IABP balloon catheter, if the IABP driving device is tried to be replaced due to the failure of the suspected IABP driving device, there is a risk that not only the 1 st IABP driving device but also the 2 nd IABP driving device drives the IABP balloon catheter in which the leakage of the pressure fluid occurs, and the IABP balloon catheter is brought into a state requiring disassembly and repair.

The present invention has been made in view of such circumstances, and provides an IABP balloon catheter that can be safely connected even in the presence of a drive history, and an IABP drive device that drives the catheter.

Means for solving the problems

In order to achieve the above object, an IABP balloon catheter according to the present invention is driven by an IABP driving device, and includes:

a balloon portion that expands and contracts;

a catheter which is connected to a rear end of the balloon portion and has a pressure fluid passage formed therein for introducing and discharging a pressure fluid into and from the balloon portion;

a handle portion coupled to a rear end portion of the catheter and having a connection passage formed therein, the connection passage having a pressure fluid introduction outlet communicated with the inside of the pressure fluid conduction passage;

a storage unit that stores alarm history information relating to an alarm generated by the IABP balloon catheter while being driven by one IABP drive device;

an interface unit for inputting and outputting the input and output of the one IABP drive apparatus to the storage unit;

the other IABP driving device can read the alarm history information written in the storage unit by the one IABP driving device from the storage unit.

Since the IABP balloon catheter according to the present invention has the storage unit for storing the alarm history information, even when a plurality of IABP driving devices inherit and drive one IABP balloon catheter, the second and subsequent IABP driving devices can recognize the information related to the history of driving of the IABP balloon catheter. Therefore, in such an IABP balloon catheter, the IABP driving device to be connected can determine whether or not there is a problem in the driving history of the IABP balloon catheter. Thus, the IABP balloon catheter can be safely connected to the IABP drive device even in a state where the IABP balloon catheter is not completely new but has a drive history.

In addition, for example, information related to the occurrence or non-occurrence of at least one of an alarm of a catheter kink, a pressure fluid leak, and a liquid invasion of the IABP balloon catheter is included in the alarm history information.

In such an IABP balloon catheter, since the IABP driving device to be connected can confirm whether or not the IABP balloon catheter has a catheter kink, a pressure fluid leak, or a liquid intrusion, the IABP driving device to be connected can prevent the IABP balloon catheter having a problem from being damaged by driving the IABP balloon catheter having the problem.

In addition, for example, the interface portion may have a contact terminal.

By using contact terminals, such an IABP balloon catheter is capable of stable signal interaction with an IABP drive device.

In addition, for example, the interface unit may have an antenna for contactless communication.

By using the antenna for non-contact communication, the IABP balloon catheter can save the connecting time when the IABP balloon catheter is connected to the IABP driving device.

An IABP driving device according to the present invention is an IABP driving device that drives any one of the IABP balloon catheters described above, and includes:

a balloon driving section configured to expand and contract the balloon section;

an alarm unit that generates an alarm; and the number of the first and second groups,

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 driving unit starts the expansion and contraction of the balloon portion.

Such an IABP driving device can determine whether or not there is a problem in the driving history of the IABP balloon catheter even when an IABP balloon catheter driven by another IABP driving device is connected by reading the alarm history information from the storage unit of the IABP balloon catheter before starting driving. Therefore, the IABP driving device can be safely connected with an IABP balloon catheter with a driving history.

For example, when the alarm history information read from the storage unit includes information indicating that an alarm related to at least one of a catheter kink, a pressure fluid leak, and a liquid intrusion of the IABP balloon catheter has occurred, the control unit causes the alarm unit to generate an alarm without starting the expansion and contraction of the balloon portion by the balloon driving unit.

Such an IABP driving device can confirm whether or not the IABP balloon catheter is kinked or pressure fluid leaks, and therefore the IABP driving device can prevent the problem of damage by driving the IABP balloon catheter having the problem. .

Further, for example, while the balloon driving unit continues to expand and contract the balloon portion, the control unit writes information of an alarm generated in association with driving of the IABP balloon catheter into the storage unit.

Such an IABP driving apparatus can reliably leave the alarm information generated during driving in the memory portion of the IABP balloon catheter, and transmit the alarm history information to another IABP driving apparatus connected to the IABP balloon catheter in the present drive in the future.

Drawings

Fig. 1 is a schematic cross-sectional view showing an IABP balloon catheter according to a first embodiment of the present invention.

Fig. 2 is a conceptual diagram illustrating an implementation state of the IABP method using the IABP balloon catheter shown in fig. 1 and an IABP driving device for driving the IABP balloon catheter.

Fig. 3 is a functional block diagram of the IABP balloon catheter and IABP drive device shown in fig. 2.

Fig. 4 is a flowchart showing a process of reading alarm history information based on the IABP driving device and the IABP balloon catheter shown in fig. 3.

Fig. 5 is a flowchart showing a process of writing alarm history information into the storage unit based on the IABP driving device and the IABP balloon catheter shown in fig. 3.

Fig. 6 is a schematic cross-sectional view showing an IABP balloon catheter according to a second embodiment of the present invention.

Fig. 7 is an enlarged view of an interface portion of the IABP balloon catheter shown in fig. 6.

FIG. 8 is a schematic sectional view of the interface section shown in FIG. 7.

Detailed Description

The present invention will be described below based on embodiments shown in the drawings.

First embodiment

Fig. 1 is a schematic view showing 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 drive shown in fig. 2. 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 thin balloon membrane 22 having a thickness of about 50 to 100 μm. The material of the balloon membrane 22 is not particularly limited, but is preferably a material having excellent bending fatigue resistance, and is made of, for example, polyurethane.

The outer diameter and length of the balloon portion 21 are determined by the inner content of the balloon portion 21, which greatly affects the effect of assisting the cardiac function, the inner diameter of the artery of the patient, and the like. The inner volume of the balloon portion 21 is preferably 25 to 50cc, the outer diameter of the balloon portion 21 is preferably 12 to 18mm, and the length is preferably 160 to 250mm, although not particularly limited.

The distal end chip portion 25 having the blood communication hole 23 formed therein is attached to the balloon membrane 22 at the distal end portion of the balloon portion 21 by heat fusion, adhesion, or the like. A distal end portion of an inner tube 30 penetrating the inside of the balloon portion 21 is attached to the inner peripheral side of the distal end chip portion 25 by heat fusion, adhesion, or the like.

A distal end portion of the catheter 24 is connected to the rear end portion of the balloon portion 21 on the outer peripheral side of the metal connection pipe 27. The balloon portion 21 is expanded and contracted so that a pressure fluid is introduced into and discharged from the balloon portion through a pressure fluid conduction path 29 formed inside the catheter 24. The balloon portion 21 and the catheter 24 are connected by thermal fusion or adhesion with an adhesive such as an ultraviolet curable resin.

The inner tube 30 extends axially inside the balloon portion 21 and the catheter 24, and communicates with a blood pressure measurement port 44 of a handle portion 42 described later. Inside the inner tube 30, a blood conduction path 31 is formed which does not communicate with the pressure fluid conduction path 29 formed inside the balloon portion 21 and the catheter 24. The inner tube 30 located in the balloon portion 21 is also used as a guide wire penetrating lumen for passing a guide wire therethrough. 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. When the balloon catheter 20 is inserted into an artery, a guide wire is passed through the inner tube 30, and the guide wire is guided to the distal end of the balloon catheter 20, whereby the balloon portion 21 can be quickly inserted into an appropriate position in the body.

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

A handle portion 42 provided outside the patient's body is coupled to the rear end portion of the catheter 24. The handle portion 42 is formed separately from the duct 24 and fixed to the duct 24 by heat fusion or adhesion. The handle portion 42 includes: a first passage 47 serving as a connection passage having a pressure fluid introduction outlet 46 communicating with the pressure fluid conduction passage 29 in the conduit 24; and a second passage 45 having a blood pressure measurement port 44 formed therein and communicating with the inside of the inner tube 30. The pressure fluid that expands and contracts the balloon portion 21 is introduced into the pressure fluid conduction path 29 of the catheter 24 through the pressure fluid introduction outlet 46, and is led out from the pressure fluid conduction path 29 of the catheter 24 to the first path 47 of the grip portion 42.

Fig. 2 is a conceptual diagram illustrating an implementation state of the IABP method by the IABP driving device 10 for driving the balloon catheter 20 shown in fig. 1. The pressure fluid inlet outlet 46 of the handle portion 42 is connected to the pressure fluid connector tube 12 of the IABP drive device 10 shown in fig. 2. In the balloon catheter 20, the pressure fluid is introduced and discharged into and out of the balloon portion 21 by driving 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 low viscosity may be used to rapidly expand and contract the balloon portion 21 in response to the driving 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. 2, and the blood pressure measurement device can measure the variation of the blood pressure of the blood in the artery introduced from the blood communication hole 23 at the distal end of the balloon portion 21. The IABP drive device 10 shown in fig. 2 controls the balloon drive unit 11 (see fig. 3) in accordance with the pulsation of the heart 1 based on the fluctuation of the blood pressure measured by the blood pressure measurement device, and expands and contracts the balloon portion 21 in synchronization with a predetermined timing in the pulsation cycle of the heart 1. The blood pressure measuring device may be included in the IABP driving device 10, but may be a device independent from the IABP driving device 10 and configured to transmit data of blood pressure fluctuation to the IABP driving device 10.

As shown in fig. 1, in the grip portion 42, a first passage 47 forming a pressure fluid introduction outlet 46 is arranged linearly along the axial direction of the catheter 24, and a second passage 45 forming a blood pressure measurement port 44 is arranged with a predetermined inclination with respect to the axial center of the first passage 47.

In addition, 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 that hold the ends of the inner pipe 30. The first inner pipe end retainer 48 and the second inner pipe end retainer 50 are arranged along the extending direction of the second passage 45 with a predetermined inclination with respect to the axial center of the first passage 47. The inner tube 30 is fixed by a first inner tube end holder 48 and a second inner tube end holder 50, and is eccentrically disposed inside the grip portion 42 so as to contact the inner wall of the catheter 24.

In the balloon 20, since the first passage 47 communicating with the pressure fluid introduction outlet 46 formed in the grip portion 42 is linearly arranged along the axial direction of the catheter 24, the responsiveness of expansion and contraction of the balloon portion 21 can be improved while the flow resistance of the pressure fluid is reduced as compared with the case where the blood pressure measurement port is linearly arranged along the axial direction of the catheter.

As shown in fig. 1, the balloon portion 20 includes: an IC chip 60 serving as a storage unit (storage medium) for storing information; an interface unit 70 for inputting/outputting the IABP drive device 10 to/from the IC chip 60. The IC chip 60 is embedded in a part of the grip portion 42. The interface section 70 has a contact terminal 70a, and the contact terminal 70a and the IC chip 60 are connected via a cable 62. The cable 62 is not particularly limited, but is constituted by, for example, an RS232C cable or the like. Information stored in the IC chip 60 will be described later.

As shown in fig. 2, the contact terminal 70a of the interface unit 70 is detachably connected to the contact terminal 18 provided in the drive device 10. When the IC chip 60 is connected to the control unit 15 (see fig. 3) of the IABP drive apparatus 10 via the interface unit 70, the control unit 15 of the IABP drive apparatus 10 can read and write information from and into the IC chip 60.

The IABP driving device 10 is equipped with a display unit 16 such as a CRT or a flat panel display. As shown in fig. 3, the display unit 16 can display data necessary for the operation of the driving device, for example, an electrocardiogram waveform, a blood pressure waveform, a time-series waveform of the balloon-driving air pressure, a time point, an alarm, an event history, and the like.

Fig. 3 is a functional block diagram of the IABP balloon catheter 20 and the IABP drive device 10 shown in fig. 2. As shown in fig. 3, the IABP drive device 10 includes: a balloon driving unit 11 that expands and contracts the balloon unit 21; and a control unit 15 for reading and writing information from and to the IC chip 60. The balloon driving section 11 includes: a pressure tank for forming a pressure to be transmitted to the balloon portion 21, and an isolator for transmitting a pressure generated by the pressure tank to a pressure fluid in the pressure fluid passage 29 of the balloon catheter 20.

The IABP driving device 10 includes an operation signal input unit 13 for inputting an operation signal, an alarm unit 19 for generating an alarm, and the like, in addition to the control unit 15, the balloon driving 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 an operation signal input through the operation signal input unit 13 is transmitted to the control unit 15. The operator inputs an operation signal through the operation signal input unit 13 to change and adjust the driving conditions of the balloon catheter 20 by the IABP driving device 10, and starts and stops the driving of the balloon catheter 20 by the IABP driving device 10.

The alarm unit 19 of the IABP driving device 10 includes an indicator lamp and an alarm sound generation unit that generates an alarm sound, and can notify an operator of a problem or abnormality detected during driving of the IABP driving device 10. The alarm unit 19 operates in response to a control signal from the control unit 15. For example, when detecting the intrusion of a liquid such as blood into the balloon portion 21, the control unit 15 controls the alarm unit 19 to perform an alarm operation to stop the driving of the balloon portion 21 by the IABP driving device 10 and to display a warning content on the display unit 16 to urge the operator to take out the balloon catheter 20 from the body of the patient.

The control unit 15 includes a microprocessor or the like, and can perform various calculations necessary for controlling the balloon driving unit 11, the control display unit 16, and the IABP balloon catheter 20 in addition to the processes of reading and writing information from and to the IC chip 60.

As shown in fig. 3, examples of the information stored in the IC chip 60 include first information 81 that is alarm history information relating to an alarm generated while the IABP balloon catheter 20 is driven by the IABP driving device 10, and second information 82 such as an expanded outer diameter (for example, 7.0Fr), a volume (for example, 40ml), a product number (S/N), and a balloon type (for example, a short balloon) of the balloon portion 21. The second information 82 is information specific to the balloon catheter 20, which is stored in advance in the IC chip 60 and cannot be rewritten by the IABP driving device 10.

In contrast, the first information 81 as the alarm history information is information that is written and updated by the IABP driver in an accumulated manner. The first information 81 at the factory shipment stage of the balloon catheter 20 that is completely new (not driven) specifies only the area for storing the alarm history information, and the content of the first information 81 as the alarm history information is content indicating that the history of the alarm generated during driving is not essential.

The first information 81 stored as alarm history information includes information such as the type, time, frequency, and the like of an alarm to be generated. The first information 81 may be information related to all alarms generated during the driving of the IABP balloon catheter 20 by the IABP driving device 10, or may be information related to the occurrence of a specific kind of alarm, or may be information related to an alarm occurring at a specified time in the near future.

The first information 81 as the alarm history information preferably includes information related to the occurrence or non-occurrence of an alarm of at least one of a catheter kink (poor flow of the pressure fluid due to kinking of the catheter 24) of the balloon catheter 20, a pressure fluid leak (a decrease in the pressure fluid due to pressure fluid leakage caused by breakage of the balloon portion 21 and the catheter 24), and a liquid intrusion (an intrusion of a liquid such as blood into the pressure fluid line caused by breakage of the balloon portion 21 and the catheter 24), and more preferably includes information related to the occurrence or non-occurrence of an alarm of a catheter kink, a pressure fluid leak, and a liquid intrusion. These alarms are due to the high likelihood of problems with the balloon catheter 20 remaining in the patient. Therefore, the history information about the occurrence of these alarms is useful information for safe driving of the IABP driving device 10 to which the balloon catheter 20 having a driving history is connected.

Fig. 4 is a flowchart showing an example of processing the first information 81 and the like of the IC chip 60 by the control unit 15 of the IABP driving device 10 before the start of driving of the balloon catheter 20. In step S001 shown in fig. 4, the start control unit 15 starts signal input/output to/from the IC chip 60. For example, when the contact terminal 18 of the IABP drive device 10 is connected to the interface unit 70 of the balloon catheter 20 shown in fig. 2, the control unit 15 can start input and output of signals to and from the IC chip 60 before the balloon drive unit 11 starts expansion and contraction of the balloon portion 21.

In step S002, the control unit 15 shown in fig. 3 reads the first information 81 from the IC chip 60 of the balloon catheter 20. Further, in step S003, it is determined whether or not the first information 81 read in step S002 includes information indicating that a specific type of alarm has occurred. More specifically, in step S003, it is determined whether or not the first information 81 read out in step S002 includes information indicating that an alarm concerning at least one of a catheter kink of the balloon catheter 20, a pressure fluid leak, and a liquid intrusion has occurred.

In step S003, if the first information 81 does not include information indicating that the specific type of alarm has occurred, the control unit 15 proceeds to the process of step S004. In step S004, the controller 15 controls the balloon driver 11 to start the expansion and contraction of the balloon portion 21 in synchronization with the heartbeat of the patient.

In step S003, when the first information 81 includes information indicating that the specific type of alarm has occurred, the control unit 15 proceeds to the process of step S005 without starting the expansion and contraction of the balloon portion 21 by the balloon driving unit 11. In step S005, the control unit 15 causes the alarm unit 19 to generate an alarm. For example, since the controller 15 controls the alarm unit 19 to turn on an indicator lamp indicating attention or warning, and there is a high possibility that a problem occurs in the balloon catheter 20 left in the patient, it is possible to display information prompting the operator to pull out and replace the balloon catheter 20 on the display unit 16 before resuming the IABP method.

After step S004 or step S005, the control unit 15 proceeds to step S006 to end the processing for the IC chip 60 at the start of the expansion and contraction of the balloon portion 21 by the balloon driving unit 11.

When the IABP balloon catheter to which the IABP drive device 10 is connected is a brand-new IABP balloon catheter having NO drive history, it is determined as "NO" in step S003, and the drive of the balloon portion 21 is started in the next step (S004). Further, the control unit 15 can read the second information 82 from the IC chip 60 before the start of the driving of the balloon portion 21 in step S004. The control unit 15 can calculate, for example, the amount of the pressure fluid flowing into the pressure fluid conduction path 29 using the second information 82 read from the IC chip 60.

Fig. 5 is a flowchart showing an example of the writing process of the first information 81 read in step S003 in fig. 4. In step S101 shown in fig. 5, the control unit 15 starts the process of writing the first information 81 as the alarm history. While the balloon driving unit 11 continues to expand and contract the balloon portion 21, the control unit 15 performs the processing shown in step S101 to step S103 at the time when the alarm is generated in association with the driving of the IABP balloon catheter 20. 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.

In step S102, the control unit 15 writes information of the alarm that has been triggered in step S101 into the first information 81 as alarm history information, and updates the first information 81. The content of the first information 81 written in the IC chip 60 includes the type of alarm, the time when the alarm is generated, the S/N of the IABP driver 10 when the alarm occurs, and the like.

In step S103, the control unit 15 starts the writing process of the first information 81. The control unit 15 performs the processing shown in step S101 to step S103 each time an alarm is generated in association with the driving of the balloon catheter 20 or each time an alarm to be written in the first information 81 is generated. Thus, the IABP driving device 10 reliably retains the information of the alarm generated during driving in the IC chip 60 of the IABP balloon catheter 20, and transmits the alarm history information to the other IABP driving device 10 to which the IABP balloon catheter 20 in the front driving will be connected in the future.

As shown in fig. 4 and 5, in the balloon catheter 20 having the IC chip 60 storing the first information 81 as the alarm history information, the other IABP driving device 10 that continues the driving of the balloon catheter 20 can read the alarm history information written in the IC chip 60 by one IABP driving device 10 from the IC chip 60. Therefore, in the IABP balloon catheter, the IABP driving device 10 to be connected can determine whether or not there is a problem in the driving history of the IABP balloon catheter 20. Thus, the balloon catheter 20 can be safely connected to the IABP drive device 10 even in a state where there is a drive history.

The IABP driving device 10 shown in fig. 2 and 3 can read the first information 81 as the alarm history information before starting the expansion and contraction of the balloon portion 21, and can generate the alarm without starting the driving of the balloon portion 21 when the first information 81 includes information indicating that the specific alarm has occurred. Therefore, the IABP driving device 10 can prevent the occurrence of a problem of starting driving of the damaged balloon catheter 20, and for example, even when a suspected IABP driving device has failed and replacement of the IABP driving device 10 is attempted, it is possible to avoid the failure of a plurality of IABP driving devices 10.

Although the present invention has been described above by way of the illustrated 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 naturally include various other embodiments and modifications. For example, the memory unit (IC chip) 60 is not limited to a part embedded in the grip portion 42, and may be attached to another part of the balloon catheter 20.

Second embodiment

Fig. 6 is a schematic view showing an IABP balloon catheter 120 according to a second embodiment of the present invention (hereinafter, may be simply referred to as "balloon catheter 120"). The balloon catheter 120 of the second embodiment is different from the balloon catheter 20 described above in that the pressure sensor 40 is housed in the distal end chip portion 125, and the like, but the balloon portion 21 and the like are the same as the balloon catheter 20. Only the points different from the balloon catheter 20 will be described for the balloon catheter 120 of the second embodiment, and the description of the points identical to those of the balloon catheter 20 will be omitted.

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 tube member 37 fitted into the distal end chip portion 125. The pressure (blood pressure) in the blood vessel on which the balloon catheter 120 is placed is transmitted through a through hole (not shown) and the pressure transmission filler inside the tube member 37. The pressure sensor 40 detects the pressure (blood pressure) in the space inside the tube member 37 by using the optical path difference of light transmitted through the optical fiber 33 connected to the proximal end of the pressure sensor 40. The pressure sensor 40 may be a pressure sensor described in, for example, japanese patent application laid-open No. 2008-524606 and japanese patent application laid-open No. 2000-35369.

The distal end chip portion 125 has a distal end opening 125 a. The tip opening 125a 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 through-hole for passing a guide wire. The rear end of the wire passage 131 communicates with the secondary port 144 of the grip portion 142.

The handle portion 142 connected to the rear end portion of the duct 24 is formed with: a first passage 147 serving as a connection passage having a pressure fluid introduction outlet 146 communicating with the pressure fluid conduction passage 29 in the conduit 24; and a second passage 145 formed with a secondary port 144 communicating with the wire passage 131 in the inner tube 30. In the grip portion 142, the second passage 145 formed with the secondary port 144 is arranged linearly in the axial direction of the catheter 24, and the first passage 147 formed with the pressure fluid introduction outlet 146 is arranged with 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 led out from the tip chip section 125 to the inside of the balloon section 21, extends along the outer wall of the inner tube 30 inside the balloon section 21 and the catheter 24, is led out to the tertiary port 49 of the handle section 142 as shown in fig. 6, and is then connected to the sensor connector 170a of the interface section 170 (refer to fig. 7). In fig. 6, a part of the optical fiber 33 is simplified and is not illustrated, but actually, the optical fiber 33 is connected from the pressure sensor 40 to the sensor connector 170 a. The interface unit 170 shown in fig. 6 is detachably connected to the contact terminal 18 provided in the IABP drive device 10, similarly to the interface unit 70 shown in fig. 2.

Fig. 7 is an enlarged view of the interface 170 connected to the proximal end of the optical fiber 33, and fig. 8 is a sectional view of the interface 170 shown in fig. 7. The interface part 170 has a sensor connector 170a as a contact terminal. As shown in fig. 7, the sensor connector 170a has a grip 171 on the distal end side and a connector body 172 on the proximal end side.

As shown in fig. 7, the grip 171 is provided with a slip-preventing portion 171a having a concave-convex shape on the surface thereof, and is easily pinched by the fingers of the operator. The outer diameter of the connector main body 172 is smaller than the outer diameter of the grip portion 171, and as shown in fig. 8, the connector main body 172 can be inserted into the socket portion 18a provided in the contact terminal 18. As shown in fig. 7 and 8, the distal end of the grip 171 is connected to a flexible tube constituting the cable 162, and the optical fiber 33 passes through the cable 162. As shown in fig. 8, the proximal end of the optical fiber 33 is connected to the end ferrule 102 of the connector body portion 172.

As shown in fig. 7, a pair of electrical connection terminals 110 and a proximal end 102a of the end sleeve 102 are exposed on a surface of the connector body 172. As shown in fig. 8, when the connector body 172 is inserted into the socket portion 18a, the end sleeve 102 and the receiving-side sleeve 202 are optically connected, and the electrical connection terminal 110 and the receiving-side electrical connection terminal 210 are electrically connected.

Inside the contact terminal 18, the receiving-side optical fiber 88B is connected to the receiving-side ferrule 202. The signal of the pressure sensor 40 shown in fig. 6 is transmitted to the control unit 15 (see fig. 3) of the IABP drive device 10 via the receiving-side ferrule 202 shown in fig. 8 and the receiving-side 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 terminal 110. When the connector main body 172 is inserted into the socket portion 18a, the control unit 15 (see fig. 3) of the IABP driving device 10 can read and write information from and into the IC chip 160 via the receiving-side electrical connection terminal 210.

The IC chip 160 can store first information 81 as alarm history information and second information 82 such as the expanded outer diameter of the balloon portion 21, as in the IC chip 60 shown in fig. 3. In addition, the IC chip 160 shown in fig. 8 can store data for compensating for individual differences of the pressure sensors 40 included in the balloon catheter 120. In this case, the control unit 15 of the IABP driving device 10 can improve the accuracy of measuring the blood pressure of the pressure sensor 40 by using 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 when calculating the blood pressure value from the detection signal of the pressure sensor 40.

The interface unit 70 for inputting and outputting the input and output of the IABP drive apparatus 10 to and from the storage unit 60 is not limited to an interface unit having the contact terminals 70a connected to the storage unit 60 by the cable 62 as shown in fig. 1, and the contact terminals may be provided directly on the surface of the storage unit 60. Further, the interface unit is not limited to a contact type, and may be configured to have a noncontact communication antenna and perform noncontact communication with the IABP drive device 10. The storage unit 60 may be a storage medium other than an electronic circuit such as an IC chip, for example, magnetic or optical storage medium, as well as a storage medium using an electronic circuit such as an IC chip.

In the example shown in fig. 5, the IABP driving device 10 updates the first information 81 by writing the information into the storage unit 60 when the alarm is generated, but the timing when the IABP driving device 10 writes the information into the storage unit 60 is not limited to this. For example, the IABP drive device 10 may periodically write information into the storage unit 60 at a predetermined cycle.

The specific alarm to be evaluated in step S003 in fig. 4 is not limited to the catheter kink, the pressure fluid leak, and the liquid intrusion, and another alarm that is assumed to be a problem occurring on the balloon catheter 20 side rather than the IABP driver 10 can be evaluated in step S003.

Description of the reference numerals

10: an IABP drive device;

11: a balloon driving section;

12: a pressure fluid connector tube;

13: an operation signal input section;

14: a blood connector tube;

15: a control unit;

16: a display unit;

18: a contact terminal;

19: an alarm unit;

20. 120: an IABP balloon catheter;

21: a balloon portion;

22: a balloon membrane;

23: a blood inlet;

24: a conduit;

25. 125: a top chip section;

27: a connecting pipe;

29: a pressure fluid conduction path;

30: an inner tube;

31: a blood conduction path;

42. 142: a handle portion;

44: a blood pressure measuring port;

45. 145: a second path;

46. 146: a pressure fluid introduction outlet;

47. 147: a first path (connection path);

48: a first inner tube end retainer;

50: a second inner tube end retainer;

60. 160: an IC chip (memory unit);

62: a cable;

70. 170: an interface section;

70 a: a contact terminal.

Claims

1. An IABP balloon catheter driven by an IABP drive device, comprising:

a balloon portion that expands and contracts;

2. The IABP balloon catheter according to claim 1,

information relating to the presence or absence of an alarm of at least one of a catheter kink, a pressure fluid leak, and a liquid intrusion of the IABP balloon catheter is included in the alarm history information.

3. The IABP balloon catheter according to claim 1 or 2,

the interface portion has a contact terminal.

4. The IABP balloon catheter according to claim 1 or 2,

the interface part is provided with a non-contact communication antenna.

5. An IABP driving device for driving the IABP balloon catheter according to any one of claims 1 to 4, comprising:

6. The IABP drive according to claim 5,

when the alarm history information read from the storage unit includes information indicating that an alarm related to at least one of a catheter kink, a pressure fluid leak, and a liquid intrusion of the IABP balloon catheter has occurred, the control unit does not start the expansion and contraction of the balloon portion by the balloon driving unit and causes the alarm unit to generate an alarm.

7. The IABP drive according to claim 5 or 6,

while the balloon driving unit continues to expand and contract the balloon portion, the control unit writes information of an alarm generated in association with driving of the IABP balloon catheter in the storage unit.