CN111542351B - IABP balloon catheter and IABP driving device - Google Patents
IABP balloon catheter and IABP driving device Download PDFInfo
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- CN111542351B CN111542351B CN201980007005.8A CN201980007005A CN111542351B CN 111542351 B CN111542351 B CN 111542351B CN 201980007005 A CN201980007005 A CN 201980007005A CN 111542351 B CN111542351 B CN 111542351B
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- iabp
- balloon
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- alarm
- catheter
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/40—Details relating to driving
- A61M60/497—Details relating to driving for balloon pumps for circulatory assistance
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
- A61M60/135—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
- A61M60/139—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting inside the aorta, e.g. intra-aortic balloon pumps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/295—Balloon pumps for circulatory assistance
Abstract
The present utility model provides an IABP balloon catheter which can be safely connected even when a drive history exists, and an IABP driving device for driving the same. An IABP balloon catheter driven by an IABP drive and having: a balloon portion that expands and contracts; a catheter that is connected to the rear end of the balloon portion and that has a pressure fluid passage that introduces a pressure fluid into the balloon portion and that leads out from the balloon portion; a handle portion that is connected to a rear end portion of the catheter and that has a connection passage formed therein, the connection passage having a pressure fluid introduction outlet that communicates with the fluid pressure passage; a storage unit that stores alarm history information related to an alarm generated by the IABP balloon catheter during driving by one IABP driving device; and an interface unit for inputting and outputting the IABP driving device to and from the storage unit.
Description
Technical Field
The present utility model relates to an IABP balloon catheter used in an IABP (intra-aortic balloon counterpulsation) method and an IABP driving device for driving the same.
Background
The IABP method is performed by indwelling an IABP balloon catheter in a patient and driving the IABP balloon catheter by an IABP driving device connected to the patient. The type of the balloon catheter used in the IABP driving device is not limited to the one, and various types of the IABP balloon catheters are used depending on the physical constitution of a patient to which the IABP method is applied. There has been proposed a technique in which an IC chip recording the size of a balloon or the like is mounted on such an IABP balloon catheter, and thereby an IABP driving device automatically recognizes the size of the IABP balloon catheter connected to the device from the IC chip (see patent document 1).
Prior art literature
Patent literature
Patent document 1: japanese patent laid-open publication No. 3177552.
Disclosure of Invention
Problems to be solved by the utility model
In the IABP method, an IABP balloon catheter to be placed in a patient is sometimes continuously driven for a long period of time depending on the state of the patient. Therefore, in the IABP method, when a fault or the like is suspected to occur during driving of the IABP driving device, there is a case where only the IABP driving device is attempted to be replaced to continue driving the IABP balloon catheter.
However, in the conventional IABP driving device, the IABP balloon catheter connected to and to be started to be driven cannot inherit history information about what driving state is in before. Therefore, when an attempt is made to replace the IABP drive device, there is a fear that the situation may be deteriorated. For example, when the drive of the balloon by the IABP drive device is stopped due to the pressure fluid leakage caused by the IABP balloon catheter, if the IABP drive device is attempted to be replaced by a failure of the IABP drive device, not only the 1 st IABP drive device but also the 2 nd IABP drive device may drive the IABP balloon catheter in which the pressure fluid leakage has occurred, and the disassembly and repair are required.
The present utility model has been made in view of such a practical situation, and provides an IABP balloon catheter capable of being safely connected even when a drive history exists, and an IABP drive device for driving the same.
Solution for solving the problem
In order to achieve the above object, an IABP balloon catheter according to the present utility model is driven by an IABP driving device, comprising:
a balloon portion that expands and contracts;
a catheter that is connected to the rear end of the balloon portion and that has a pressure fluid passage that introduces a pressure fluid into the balloon portion and that leads out from the balloon portion;
a handle portion that is connected to a rear end portion of the catheter and that has a connection passage formed therein, the connection passage having a pressure fluid introduction outlet that communicates with the pressure fluid passage;
a storage unit that stores alarm history information related to an alarm generated by the IABP balloon catheter during driving by one IABP driving device;
an interface unit for inputting/outputting the one IABP driver to/from the storage unit;
the other IABP driver may read the alarm history information written in the storage unit by the one IABP driver from the storage unit.
Since the IABP balloon catheter according to the present utility model has the storage unit for storing the alarm history information, even when a plurality of IABP driving apparatuses drive one IABP balloon catheter, the second and subsequent IABP driving apparatuses can recognize the information on the history of the driving of the IABP balloon catheter. Therefore, in such an IABP balloon catheter, the IABP drive device to be connected can determine whether there is a problem in the drive 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 drive history is not entirely new.
For example, the alarm history information includes information on the occurrence or non-occurrence of at least one alarm selected from the group consisting of catheter kinking, pressure fluid leakage, and liquid invasion of the IABP balloon catheter.
In such an IABP balloon catheter, since the IABP driving device as a connection target can confirm whether the IABP balloon catheter has caused catheter kinking, pressure fluid leakage, or liquid invasion, the IABP driving device as a connection target can prevent the damage problem by driving the IABP balloon catheter having a 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.
In addition, for example, the interface section may have an antenna for noncontact communication.
By using the non-contact communication antenna, such an IABP balloon catheter can save time for connection when the IABP balloon catheter is connected to an IABP drive device.
An IABP driver according to the present utility model is an IABP driver for driving the IABP balloon catheter according to any one of the above, and comprises:
a balloon driving unit that expands and contracts the balloon unit;
an alarm unit that generates an alarm; the method comprises the steps of,
a control unit that reads and writes the alarm history information from and to the storage unit,
the control unit reads the alarm history information from the storage unit before the balloon driving unit starts the inflation and deflation of the balloon unit.
Such an IABP driver device can determine whether or not there is a problem in the drive history of the IABP balloon catheter even when an IABP balloon catheter driven by another IABP driver device is connected by reading the alarm history information from the storage section of the IABP balloon catheter before the start of the drive. Thus, the IABP driver can safely connect with an IABP balloon catheter of the drive history.
For example, when the alarm history information read from the storage unit includes information indicating that an alarm has been generated in relation to at least one of catheter kinking, pressure fluid leakage, and fluid invasion of the IABP balloon catheter, the control unit does not start the inflation and deflation of the balloon unit by the balloon driving unit, and causes the alarm unit to generate an alarm.
Such an IABP driver can confirm whether the IABP balloon catheter has caused catheter kinking or pressure fluid leakage, so that the IABP driver can prevent the damage problem by driving the IABP balloon catheter having a problem. .
For example, the control unit may write information of an alarm generated in association with driving of the IABP balloon catheter to the storage unit while the balloon driving unit continues to expand and contract the balloon.
Such an IABP drive device can reliably leave alarm information generated during driving in the storage unit of the IABP balloon catheter and transmit alarm history information to other IABP drive devices connected to the currently driving IABP balloon catheter 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 utility model.
Fig. 2 is a conceptual diagram 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 the 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 to 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 utility model.
Fig. 7 is an enlarged view of an interface portion of the IABP balloon catheter shown in fig. 6.
Fig. 8 is a schematic cross-sectional view of the interface section shown in fig. 7.
Detailed Description
The present utility model 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 according to a first embodiment of the present utility model (hereinafter, there is a case where only the "balloon catheter 20" is used). 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 beating of the heart. The balloon portion 21 has a balloon film 22 of a thin film 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, for example, polyurethane or the like.
The outer diameter and length of the balloon portion 21 are determined based on the content of the balloon portion 21, which has a large influence on the auxiliary effect of the heart function, the artery inner diameter of the patient, and the like. The inner volume of the balloon portion 21 is not particularly limited, but 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.
The distal chip portion 25 having the blood communication hole 23 formed in the distal end portion of the balloon portion 21 is attached to the balloon membrane 22 by a method such as heat fusion or adhesion. On the inner peripheral side of the distal chip portion 25, a distal end portion of the inner tube 30 penetrating the inside of the balloon portion 21 is attached by a method such as heat fusion or adhesion.
A distal end portion of the catheter 24 is connected to a rear end portion of the balloon portion 21 on an outer peripheral side of the metal connection tube 27. The balloon portion 21 is inflated and deflated by a pressure fluid passage 29 formed in the catheter 24 so as to introduce and discharge a pressure fluid into and from the balloon portion. The connection between the balloon portion 21 and the catheter 24 is performed by hot melt or adhesion by an adhesive such as an ultraviolet curable resin.
The inner tube 30 extends in the axial direction 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. A blood passage 31 that does not communicate with the pressure fluid passage 29 formed in the balloon portion 21 and the catheter 24 is formed in the inner tube 30. The inner tube 30 located in the balloon portion 21 also serves as a guidewire through lumen through which a guidewire passes. When the balloon catheter 20 is inserted into an artery, the balloon portion 21 is contracted, and the balloon film 22 is wound around the inner tube 30. In addition, when the balloon catheter 20 is inserted into an artery, the guide wire passes through the inner tube 30, and the guide wire guides the tip of the balloon catheter 20, so that the balloon portion 21 can be quickly inserted into an appropriate position in the body.
The duct 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 0.4mm. The inner tube 30 is not particularly limited, but is composed of a hard tube, a metal spring reinforcing 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 0.3mm.
A handle 42 provided outside the patient is connected to the rear end of the catheter 24. The handle portion 42 is formed separately from the catheter 24 and is fixed to the catheter 24 by means of heat fusion, adhesion, or the like. The handle 42 is formed with: a first passage 47 as a connection passage having a pressure fluid introduction outlet 46 communicating with the pressure fluid introduction passage 29 in the conduit 24; a second passage 45 formed with a blood pressure measurement port 44 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 passage 29 of the catheter 24 through the pressure fluid introduction outlet 46, and is led out from the pressure fluid passage 29 of the catheter 24 to the first passage 47 of the handle portion 42.
Fig. 2 is a conceptual diagram showing the implementation states of the IABP method by the IABP driving device 10 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 the balloon portion 21 by the driving of 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 accordance with 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 fluctuation of the blood pressure in the artery introduced from the blood communication hole 23 at the distal end of the balloon portion 21. Based on the fluctuation of the blood pressure measured by the blood pressure measuring device, the IABP driving device 10 shown in fig. 2 controls the balloon driving unit 11 (see fig. 3) in accordance with the beating of the heart 1, and causes the balloon unit 21 to expand and contract in synchronization with a predetermined timing in the beating cycle of the heart 1. The blood pressure measurement device may be included in the IABP drive device 10, but may be a device independent of the IABP drive device 10, and may transmit data of blood pressure fluctuation to the IABP drive device 10.
As shown in fig. 1, in the handle portion 42, a first passage 47 forming the pressure fluid introduction outlet 46 is arranged in a straight line along the axial direction of the catheter 24, and a second passage 45 forming the blood pressure measurement port 44 is arranged with a predetermined slope 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 tube end holder 48 and a second inner tube end holder 50 for holding the ends of the inner tube 30. The first inner tube end holder 48 and the second inner tube end holder 50 are disposed with a predetermined gradient with respect to the axial center of the first passage 47 along the extending direction of the second passage 45. The inner tube 30 is fixed by the first inner tube end holder 48 and the second inner tube end holder 50, and is disposed eccentrically inside the handle portion 42 so as to contact the inner wall of the catheter 24.
In the balloon 20, since the first passage 47 communicating the pressure fluid introduction outlet 46 formed in the grip portion 42 is arranged linearly in the axial direction of the catheter 24, the flow resistance of the pressure fluid can be reduced and the responsiveness of the expansion and contraction of the balloon portion 21 can be improved as compared with the case where the blood pressure measurement port is arranged linearly in the axial direction of the catheter.
As shown in fig. 1, the balloon portion 20 includes: an IC chip 60 as a storage section (storage medium) for storing information; an interface unit 70 for inputting and outputting the IABP driving device 10 to and from the IC chip 60. The IC chip 60 is embedded in a part of the handle portion 42. The interface 70 has a contact terminal 70a, and the contact terminal 70a is connected to the IC chip 60 via the cable 62. The cable 62 is not particularly limited, but is constituted by an RS232C cable or the like, for example. Information stored in the IC chip 60 will be described later.
As shown in fig. 2, the contact terminal 70a of the interface 70 is detachably connected to the contact terminal 18 provided in the driving device 10. The IC chip 60 is connected to the control unit 15 (see fig. 3) of the IABP driving device 10 via the interface unit 70, whereby the control unit 15 of the IABP driving device 10 can read and write information of the IC chip 60.
The IABP driving device 10 is provided 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 required for the operation of the driving device, such as an electrocardiographic waveform, a blood pressure waveform, a time-series waveform of 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 10 shown in fig. 2. As shown in fig. 3, the IABP driving 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 transmitted to the balloon portion 21, and a separator 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, in addition to the control unit 15, the balloon driving unit 11, and the display unit 16, an operation signal input unit 13 for inputting an operation signal, an alarm unit 19 for generating an alarm, and the like. The operation signal input unit 13 has signal input means such as an input button, a switch, 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, thereby changing and adjusting the driving conditions of the balloon catheter 20 by the IABP driving device 10, and starting and stopping 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 generating 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 according 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 portion 15 controls the alarm portion 19 to perform an alarm operation, stops driving of the balloon portion 21 by the IABP driving device 10, and displays a warning content on the display portion 16 to prompt the operator to perform an appropriate response such as pulling out the balloon catheter 20 from the patient.
The control unit 15 includes a microprocessor or the like, and can perform various operations necessary for controlling the balloon driving unit 11, the control display unit 16, and the IABP balloon catheter 20 in addition to the reading and writing processes of information to the IC chip 60.
As shown in fig. 3, as information stored in the IC chip 60, there are illustrated first information 81, which is alarm history information concerning an alarm generated during the period in which the IABP balloon catheter 20 is driven by the IABP driving device 10, and second information 82, which is the expanded outer diameter (for example, 7.0 Fr), capacity (for example, 40 ml), product number (S/N), balloon type (for example, short balloon) and the like of the balloon portion 21. The second information 82 is information unique to the balloon catheter 20 that is stored in the IC chip 60 in advance and cannot be rewritten by the IABP driving device 10.
In contrast, the first information 81, which is the alarm history information, is information that is accumulated and written by the IABP driving device and updated. The first information 81 at the factory stage of the balloon catheter 20 which is completely new (not driven) designates only an area for storing alarm history information, and the content of the first information 81 as alarm history information is a content indicating the history of the alarm which is not generated during driving.
The first information 81 stored as alarm history information includes, for example, information such as the type of alarm to be generated, the time of occurrence, and the frequency. The first information 81 may be information related to all alarms generated during the period in which the IABP balloon catheter 20 is driven by the IABP driving device 10, but may be information related to the occurrence of a specific type of alarm, or may be information related to an alarm occurring in a predetermined time period in the recent past.
The first information 81 as alarm history information preferably includes information on the occurrence or non-occurrence of an alarm of at least one of catheter kink of the balloon catheter 20 (poor circulation of pressure fluid due to kink of the catheter 24), pressure fluid leak (decrease in pressure fluid due to pressure fluid leak caused by breakage of the balloon portion 21 and the catheter 24), and liquid invasion (invasion of liquid such as blood into a pressure fluid line caused by breakage of the balloon portion 21 and the catheter 24), and more preferably includes information on the occurrence or non-occurrence of an alarm of catheter kink, pressure fluid leak, and liquid invasion. Regarding these alarms, the probability of problems with the balloon catheter 20 remaining in the patient is high. Thus, the history information about the occurrence of these alarms is useful information for driving the IABP driving device 10 to which the balloon catheter 20 having the driving history is connected in order to secure the safe driving.
Fig. 4 is a flowchart showing an example of processing of 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 inputs and outputs signals to and 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 starts inputting and outputting signals to and from the IC chip 60 before the balloon driving unit 11 starts the expansion and contraction of the balloon unit 21.
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. Further, in step S003, it is determined whether or not 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, it is determined whether or not the first information 81 read out in step S002 includes information indicating that an alarm has occurred regarding at least one of catheter kinking, pressure fluid leakage, and liquid invasion of the balloon catheter 20.
In step S003, when the first information 81 does not include information indicating that a specific type of alarm has occurred, the control unit 15 proceeds to the process of step S004. In step S004, the control unit 15 controls the balloon driving unit 11 to start the expansion and contraction of the balloon unit 21 in synchronization with the heartbeat of the patient.
In step S003, when the first information 81 includes information indicating that a specific type of alarm has occurred, the control unit 15 does not start the expansion and contraction of the balloon portion 21 by the balloon driving unit 11, but proceeds to the process of step S005. In step S005, the control unit 15 causes the alarm unit 19 to generate an alarm. For example, since the control unit 15 controls the alarm unit 19 to turn on an indicator lamp indicating attention or warning and the balloon catheter 20 to be placed in the patient has a high possibility of a problem, it is possible to display information prompting the operator to pull out and replace the balloon catheter 20 on the display unit 16 before restarting the IABP method.
After step S004 or step S005, the control unit 15 proceeds to step S006, and ends 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.
If the IABP balloon catheter to which the IABP driving device 10 is connected is an entirely new one, and the drive history is not yet set, the determination is made as "NO" in step S003, and the driving of the balloon portion 21 is started in the next step (S004). The control unit 15 can read the second information 82 from the IC chip 60 before starting the driving of the balloon unit 21 in step S004. The control unit 15 can calculate, for example, the amount of the pressure fluid flowing into the pressure fluid passage 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 writing process of the first information 81 as the alarm history. The control unit 15 performs the processing shown in steps S101 to S103 at the time when the alarm is generated in association with the driving of the IABP balloon catheter 20 while the balloon driving unit 11 continuously expands and contracts the balloon 21. The processing in steps S101 to S103 may be performed simultaneously with the alarm operation by the alarm unit 19 or after the alarm operation by the alarm unit 19.
In step S102, the control unit 15 writes information of the alarm that is triggered in step S101 in 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 driving device 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 steps S101 to 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 to the first information 81 is generated. Thus, the IABP driver 10 reliably retains information of the alarm generated during driving in the IC chip 60 of the IABP balloon catheter 20, and transmits alarm history information to other IABP driver 10 to be connected to the currently driving IABP balloon catheter 20 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 one of the IABP driving devices 10 that continues driving the balloon catheter 20 can read out the alarm history information written in the IC chip 60 by one of the IABP driving devices 10 from the IC chip 60. Therefore, in the IABP balloon catheter, the IABP driving device 10 as a connection target can determine whether there is a problem in the driving history of the IABP balloon catheter 20. Thereby, 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 reads the first information 81 as alarm history information before starting the inflation and deflation of the balloon portion 21, and can generate an alarm without starting the driving of the balloon portion 21 when the first information 81 includes information indicating that a specific alarm has occurred. Therefore, the IABP driver 10 can prevent the occurrence of a problem of starting to drive the damaged balloon catheter 20, and for example, even when the IABP driver is suspected to be faulty and replacement of the IABP drivers 10 is attempted, it is possible to avoid a situation in which a plurality of the IABP drivers 10 are faulty.
The present utility model has been described above by way of example with reference to the embodiments, but the balloon catheter 20 and the IABP drive device 10 of the present utility model are not limited to the above embodiments, and naturally include various other embodiments and modifications. For example, the memory unit (IC chip) 60 is not limited to being embedded in a part of the handle portion 42, and may be attached to another part of the balloon catheter 20.
Second embodiment
Fig. 6 is a schematic diagram showing an IABP balloon catheter 120 (hereinafter, there is a case where only "balloon catheter 120") according to a second embodiment of the present utility model. The balloon catheter 120 of the second embodiment is different from the balloon catheter 20 described above in that the tip chip portion 125 accommodates the pressure sensor 40 and the like, but the balloon portion 21 and the like are the same as the balloon catheter 20. Only points of distinction from the balloon catheter 20 will be described for the balloon catheter 120 of the second embodiment, and the description of the same points as 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 pipe member 37 fitted into the tip 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 and a pressure transmission filling material, not shown, inside the tube member 37. The pressure sensor 40 detects the pressure (blood pressure) in the space inside the tube member 37 by using an optical path difference or the like of light transmitted through the optical fiber 33 connected to the proximal end of the pressure sensor 40. As the pressure sensor 40, a pressure sensor described in japanese patent application laid-open No. 2008-524606, japanese patent application laid-open No. 2000-35369, or the like can be used.
A distal opening 125a is formed in the distal chip portion 125. The distal end 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 or the like through which a guide wire passes. The rear end of the wire passage 131 communicates with the secondary port 144 of the handle portion 142.
The handle 142 connected to the rear end of the catheter 24 is formed with: a first passage 147 as a connection passage having a pressure fluid introduction outlet 146 communicating with the pressure fluid introduction passage 29 in the conduit 24; a second passage 145 formed with a secondary port 144 communicating with the wire passage 131 within the inner tube 30. In the handle portion 142, a second passage 145 having a secondary port 144 formed therein is arranged in a straight line along the axial direction of the conduit 24, and a first passage 147 having a pressure fluid introduction outlet 146 formed therein 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 portion 125 to the inside of the balloon portion 21, extends along the outer wall of the inner tube 30 inside the balloon portion 21 and the catheter 24, is led out to the tertiary port 49 of the handle portion 142 as shown in fig. 6, and is then connected to the sensor connector 170a of the interface portion 170 (refer to fig. 7). In fig. 6, a part of the optical fiber 33 is simplified and is not shown, but in reality, the optical fiber 33 is connected from the pressure sensor 40 to the sensor connector 170a. The interface 170 shown in fig. 6 is detachably connected to the contact terminal 18 provided in the IABP driving device 10, similarly to the interface 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 cross-sectional view of the interface 170 shown in fig. 7. The interface 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 main body 172 on the proximal end side.
As shown in fig. 7, the grip portion 171 is provided with an anti-slip portion 171a having a concave-convex shape formed on the surface thereof, so that the grip portion is easily gripped by the fingers of the operator. The outer diameter of the connector body 172 is smaller than the outer diameter of the grip portion 171, and as shown in fig. 8, the connector 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 portion 171 is connected to a flexible tube constituting the cable 162, and the optical fiber 33 penetrates the inside of the cable 162. As shown in fig. 8, the proximal end of the optical fiber 33 is connected to the end sleeve 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 the surface of the connector body 172. As shown in fig. 8, when the connector body 172 is inserted into the socket portion 18a, optical connection between the end sleeve 102 and the receiving-side sleeve 202 is possible, and electrical connection between the electrical connection terminal 110 and the receiving-side electrical connection terminal 210 is possible.
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 driving 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 terminals 110. When the connector body 172 is inserted into the socket 18a, the control unit 15 (see fig. 3) of the IABP driving device 10 can read and write information from and to 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 inflation outer diameter of the balloon portion 21, like the IC chip 60 shown in fig. 3. In addition, the IC chip 160 shown in fig. 8 can store data for compensating individual differences of the pressure sensor 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 stored in the IC chip 160 for compensating the individual difference of the pressure sensor 40 when the pressure sensor 40 is calibrated or when the blood pressure value is calculated from the detection signal of the pressure sensor 40.
The interface unit 70 for inputting and outputting the memory unit 60 by the IABP driving device 10 is not limited to the interface unit having the contact terminal 70a connected to the memory unit 60 through the cable 62 as shown in fig. 1, and the contact terminal may be directly provided on the surface of the memory unit 60. Further, the interface unit is not limited to the contact type, and may be configured to perform non-contact communication with the IABP driving device 10 by having a non-contact type communication antenna. The storage unit 60 may be a storage medium using an electronic circuit, such as an IC chip, or may be a storage medium other than an electronic circuit, such as magnetic or optical.
In the example shown in fig. 5, the IABP driving device 10 writes the information in the storage unit 60 to update the first information 81 when the alarm is generated, but the time when the IABP driving device 10 writes the information in the storage unit 60 is not limited to this. For example, the IABP drive device 10 may write information to the storage unit 60 periodically at a predetermined cycle.
The specific alarm to be determined in step S003 in fig. 4 is not limited to the catheter kink, the pressure fluid leak, and the liquid intrusion, and other alarms recognized as the occurrence of a problem not by the IABP driving device 10 but by the balloon catheter 20 may be determined in step S003.
Description of the reference numerals
10: an IABP driving device;
11: a balloon driving part;
12: a pressure fluid connector tube;
13: an operation signal input unit;
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 tip chip portion;
27: a connecting pipe;
29: a pressure fluid conduit;
30: an inner tube;
31: a blood conduction path;
42. 142: a handle portion;
44: a blood pressure measurement port;
45. 145: a second passage;
46. 146: a pressure fluid inlet and outlet;
47. 147: a first passage (connection passage);
48: a first inner tube end retainer;
50: a second inner tube end retainer;
60. 160: an IC chip (memory section);
62: a cable;
70. 170: an interface part;
70a: contact terminals.
Claims (4)
1. An IABP driving device for driving an IABP balloon catheter, characterized in that,
the IABP balloon catheter has:
a balloon portion that expands and contracts;
a catheter that is connected to the rear end of the balloon portion and that has a pressure fluid passage that introduces a pressure fluid into the balloon portion and that leads out from the balloon portion;
a handle portion that is connected to a rear end portion of the catheter and that has a connection passage formed therein, the connection passage having a pressure fluid introduction outlet that communicates with the pressure fluid passage;
a storage unit that stores alarm history information related to an alarm generated during a period driven by the IABP driving device;
an interface unit for inputting/outputting the alarm history information to/from the storage unit by an IABP driving device,
the IABP driving device comprises:
a balloon driving unit that expands and contracts the balloon unit;
an alarm unit that generates an alarm; the method comprises the steps of,
a control unit that reads and writes the alarm history information from and to the storage unit via the interface unit,
the control unit reads the alarm history information from the storage unit before the balloon driving unit starts the inflation and deflation of the balloon unit, and when the alarm history information read from the storage unit includes information indicating that an alarm has occurred regarding at least one of catheter kinking, pressure fluid leakage, and liquid invasion of the IABP balloon catheter, the control unit does not start the inflation and deflation of the balloon unit by the balloon driving unit, and causes the alarm unit to generate an alarm.
2. The IABP driving apparatus according to claim 1, wherein,
the control unit writes information of an alarm generated in association with the driving of the IABP balloon catheter to the storage unit while the balloon driving unit continues the inflation and deflation of the balloon unit.
3. The IABP drive according to claim 1 or 2, wherein,
the interface portion has a contact terminal that,
the control unit performs contact communication with the IABP balloon catheter via the contact terminal, and reads and writes the alarm history information from and to the storage unit.
4. The IABP drive according to claim 1 or 2, wherein,
the interface part is provided with an antenna for non-contact communication,
the control unit performs non-contact communication with the IABP balloon catheter via the non-contact communication antenna, and reads and writes the alarm history information from and to the storage unit.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2018-010851 | 2018-01-25 | ||
| JP2018010851 | 2018-01-25 | ||
| PCT/JP2019/002243 WO2019146688A1 (en) | 2018-01-25 | 2019-01-24 | Iabp balloon catheter and iabp drive device |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN111542351A CN111542351A (en) | 2020-08-14 |
| CN111542351B true CN111542351B (en) | 2023-05-26 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201980007005.8A Active CN111542351B (en) | 2018-01-25 | 2019-01-24 | IABP balloon catheter and IABP driving device |
Country Status (3)
| Country | Link |
|---|---|
| JP (1) | JP7331702B2 (en) |
| CN (1) | CN111542351B (en) |
| WO (1) | WO2019146688A1 (en) |
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| JPH09173443A (en) * | 1995-12-22 | 1997-07-08 | Nippon Zeon Co Ltd | Medical exapnsion and contraction driving device |
| JP2016002347A (en) * | 2014-06-18 | 2016-01-12 | 日本ゼオン株式会社 | IABP drive unit |
| JP2016190011A (en) * | 2015-03-31 | 2016-11-10 | 日本ゼオン株式会社 | Optical connector for medical appliance |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| JPH03112563A (en) * | 1989-09-28 | 1991-05-14 | Toyobo Co Ltd | Auxiliary circulating device and its driving method |
| ES2077519B1 (en) * | 1993-11-22 | 1996-07-01 | Fernandez De Lomana Euge Anaya | INTRAAORTIC CATHETER FOR RENAL PERFUSION AND CONSERVATION. |
| JPH09225022A (en) * | 1996-02-23 | 1997-09-02 | Nippon Zeon Co Ltd | Driver for medical equipment |
| JPH11155945A (en) * | 1997-11-28 | 1999-06-15 | Aisin Seiki Co Ltd | Blood pump driving device |
| JP4778543B2 (en) * | 2008-07-28 | 2011-09-21 | 泉工医科工業株式会社 | Balloon pump drive device |
| JP5898190B2 (en) * | 2010-06-22 | 2016-04-06 | ソラテック コーポレーション | Fluid delivery system and method for monitoring a fluid delivery system |
| AU2011332014B2 (en) * | 2010-11-27 | 2016-12-22 | Securus Medical Group, Inc. | Ablation and temperature measurement devices |
| JP2012213468A (en) * | 2011-03-31 | 2012-11-08 | Nippon Zeon Co Ltd | Expansion and contraction drive unit for medical treatment |
| DE102012207056B4 (en) * | 2012-04-27 | 2021-11-11 | Abiomed Europe Gmbh | CATHETHER SYSTEM AND INTRAVASAL BLOOD PUMP WITH THIS CATHETER SYSTEM |
| JP3177552U (en) * | 2012-05-28 | 2012-08-09 | 日本ゼオン株式会社 | Balloon catheter and drive system |
| CN104511060A (en) * | 2013-10-03 | 2015-04-15 | 北京精密机电控制设备研究所 | Blood pump control system and blood pump system |
| US9931490B2 (en) * | 2013-12-17 | 2018-04-03 | Zoll Circulation, Incorporated | Control system for arterial catheter |
| JP6638224B2 (en) * | 2015-07-06 | 2020-01-29 | 日本ゼオン株式会社 | IABP driving device and battery control method in IABP driving device |
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2019
- 2019-01-24 CN CN201980007005.8A patent/CN111542351B/en active Active
- 2019-01-24 JP JP2019567144A patent/JP7331702B2/en active Active
- 2019-01-24 WO PCT/JP2019/002243 patent/WO2019146688A1/en active Application Filing
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH09173443A (en) * | 1995-12-22 | 1997-07-08 | Nippon Zeon Co Ltd | Medical exapnsion and contraction driving device |
| JP2016002347A (en) * | 2014-06-18 | 2016-01-12 | 日本ゼオン株式会社 | IABP drive unit |
| JP2016190011A (en) * | 2015-03-31 | 2016-11-10 | 日本ゼオン株式会社 | Optical connector for medical appliance |
Also Published As
| Publication number | Publication date |
|---|---|
| JPWO2019146688A1 (en) | 2021-01-07 |
| CN111542351A (en) | 2020-08-14 |
| JP7331702B2 (en) | 2023-08-23 |
| WO2019146688A1 (en) | 2019-08-01 |
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