JP6908443B2 - Catheter information management device, catheter device, control program of catheter information management device and catheter information management method - Google Patents

Description

The present invention relates to, for example, a catheter information management device, a catheter device, a control program of a catheter information management device, and a catheter information management method for a catheter that is inserted and expanded into a blood vessel of a patient.

Conventionally, for example, a balloon catheter that expands to dilate a stenotic portion formed in a blood vessel or the like in a patient's body is widely known.
Such a balloon catheter is inserted into a blood vessel or the like, and the balloon can be expanded at the stenosis to expand the stenosis.
Further, when such a balloon catheter is expanded, a predetermined amount of contrast medium is injected into the balloon.
On the other hand, a proposal for accurately controlling the balloon of a balloon catheter has also been made (for example, Patent Document 1).

Japanese Unexamined Patent Publication No. 2007-185370

However, with a conventional balloon catheter, it was possible to detect whether or not the expansion of the balloon reached a specified pressure, but it is possible to consider the relationship between the balloon and the lesion of the blood vessel during the expansion process of the balloon. There was a problem that it could not be done. In addition, there is also a problem that the state of lesions of blood vessels cannot be grasped.

Therefore, in the present invention, while grasping the amount of change in the balloon expansion process, it is also possible to grasp the information of the balloon insertion target according to the balloon expansion process, and at the same time, notify the operator and the like of such information. An object of the present invention is to provide a catheter information management device, a catheter device, a control program of the catheter information management device, and a catheter information management method.

In the present invention, the above object is an injection information acquisition unit that acquires injection information regarding the amount of fluid to be injected to expand the balloon portion of a catheter placed in a living body, and an expanded state of the balloon portion. A balloon expansion information acquisition unit that acquires balloon expansion information indicating the above, a biological state determination unit that determines a biological change accompanying expansion of the balloon unit based on the injection information and the balloon expansion information, and the injection information and the above. It has a calculation unit that calculates balloon expansion change information based on balloon expansion information, the biological state determination unit determines a biological change based on the balloon expansion change information, and the biological state determination unit determines the biological state. It has a crack occurrence determination unit that determines whether or not a crack has occurred, and the crack occurrence determination unit determines the presence or absence of a crack based on the balloon expansion degree information generated from the balloon expansion change information. Achieved by the characteristic catheter information management device.

According to the above configuration, injection information regarding the amount of fluid injected to expand the balloon portion of the catheter placed in the living body is acquired, and expansion information of the balloon portion (for example, is acquired, and these information is acquired. Based on the above, the biological state determination unit determines the biological change of the blood vessel or the like (blood vessel wall contact state, etc.), and outputs the changed state of the biological body to the output unit.
Therefore, while grasping the amount of change in the expansion process of the balloon portion, it is possible to grasp the information of the living body such as the blood vessel to which the balloon is inserted according to the expansion process of the balloon.
Therefore, not only the changed state of blood vessels due to the expansion of the balloon part but also the fact can be promptly notified to the operator etc. even in the case of a dangerous state, and it becomes an extremely safe catheter information management device. ing.
Further, according to the above configuration, the balloon expansion information is the pressure information of the balloon portion and / or the volume information of the balloon portion.
In this way, since the state of the living body such as a blood vessel is determined based on the pressure information and the volume information, the state of the living body can be easily and accurately determined.

Preferably, the balloon expansion information is the pressure information or the volume information of the balloon portion.

According to the above configuration, the balloon expansion information is the pressure information of the balloon portion and / or the volume information of the balloon portion.
In this way, since the state of the living body such as a blood vessel is determined based on the pressure information and the volume information, the state of the living body can be easily and accurately determined.

Preferably, the balloon expansion degree information includes deviation information between the balloon expansion change information and the reference information of the balloon portion, change information between the inclinations of the balloon expansion change information at a plurality of points, and the inclination of the plurality of points. It is characterized by including any of the minute change amount information between.

According to the above configuration, when the balloon expansion degree information includes change information between the inclinations of a plurality of points in the balloon expansion change information, minute change amount information between the inclinations of a plurality of points, and the like, the crack generation is more accurate. You can make a good judgment.

Preferably, the biological state determination unit has a crack generation determination unit that determines whether or not a crack has occurred in the biological body, and the crack generation determination unit uses the balloon expansion change information to determine the current pressure at the current injection amount. It is characterized in that the increase rate or the current volume increase rate is acquired, and when the current pressure increase rate is 0 or less or the volume increase rate is 0 or more, it is determined that a crack has occurred.

According to the above configuration, the occurrence of cracks in blood vessels and the like can be automatically determined and shown to the user.

Preferably, the biological state determination unit has a crack generation determination unit that determines whether or not a crack has occurred in the biological body, and the crack generation determination unit has the latest pressure at the latest injection amount from the balloon expansion change information. It is characterized in that the increase rate is acquired, and when the latest pressure increase rate is larger than 0 and the current pressure increase rate is 0 or less, it is determined that a crack has occurred.

Preferably, the biological state determination unit has a crack generation determination unit that determines whether or not a crack has occurred in the biological body, and the crack generation determination unit has the latest volume at the latest injection amount from the balloon expansion change information. It is characterized in that the increase rate is acquired, and when the latest volume increase rate is smaller than 0 and the current volume increase rate is 0 or more, it is determined that a crack has occurred.

Preferably, the biological state determination unit has a biological contact determination unit that determines whether or not the balloon unit is in contact with the living body, and the crack generation determination unit is in contact with the living body at the latest injection amount. It is characterized in that it is determined that a crack has occurred only when the determination unit determines that it is in contact.

According to the above configuration, the crack occurrence determination unit determines that the crack has occurred only when the biological contact determination unit determines that the contact is caused at the latest injection amount, so that the accuracy of the determination can be improved. can.

Preferably, the biological contact determination unit makes a determination by comparing the current pressure information with the reference pressure information which is the reference information in the current injection amount of the balloon portion.

According to the above configuration, by comparing the reference pressure information with the current pressure information, it is possible to accurately determine whether or not the balloon portion has come into contact with the inner wall of the blood vessel or the like.

Preferably, the biological contact determination unit makes a determination by comparing the current volume information with the reference volume information which is the reference information in the current injection amount of the balloon portion.

According to the above configuration, by comparing the reference volume information with the current volume information, it is possible to accurately determine whether or not the balloon portion abuts on the inner wall of the blood vessel or the like.

Preferably, the biological contact determination unit makes a determination by comparing the current pressure increase rate with the increase rate of the reference pressure information which is the reference information in the corresponding injection amount of the balloon unit.

According to the above configuration, by comparing the reference pressure increase rate information with the current pressure increase rate information, it is possible to accurately determine whether or not the balloon portion has come into contact with the inner wall of the blood vessel or the like.

Preferably, the biological contact determination unit makes a determination by comparing the current volume increase rate with the increase rate of the reference volume information which is the reference information in the corresponding injection amount of the balloon unit.

According to the above configuration, by comparing the increase rate information of the reference volume information with the current volume increase rate information, it is possible to accurately determine whether or not the balloon portion abuts on the inner wall of the blood vessel or the like.

Preferably, the biological wall dissociation determination unit has a biological wall dissociation determination unit that determines the probability of biological wall dissociation based on the crack occurrence frequency information generated by the crack occurrence determination unit, and the biological wall dissociation determination unit has the crack occurrence frequency information. When the value is equal to or more than a predetermined value, the operator is notified of the probability of dissociation of the biological wall.

According to the above configuration, the operator is notified of a "blood vessel wall dissociation occurrence alarm" or the like, as there is a possibility that a "blood vessel wall dissociation" exceeding the crack may occur.
Therefore, it is possible to give an alarm to a doctor or the like who operates a balloon catheter or the like, and to prevent the occurrence of a serious situation.

The object of the present invention is to manage information about a catheter having an expandable balloon portion arranged in a living body, a fluid injection portion for injecting a fluid for expanding the balloon portion, and the catheter portion. The management unit has an injection information acquisition unit that acquires injection information regarding the amount of fluid injected to expand the balloon unit, and balloon expansion information indicating an expanded state of the balloon unit. The balloon expansion information acquisition unit to be acquired, the biological state determination unit that determines the biological change accompanying the expansion of the balloon unit based on the injection information and the balloon expansion information, and the balloon expansion by the injection information and the balloon expansion information. It has a calculation unit for calculating change information, the biological condition determination unit determines a biological change based on the balloon expansion change information, and the biological condition determination unit determines whether or not a crack has occurred in the biological body. The catheter device has a crack occurrence determination unit for determining whether or not a crack has occurred, and the crack occurrence determination unit determines the presence or absence of crack occurrence based on the balloon expansion degree information generated from the balloon expansion change information. Achieved.

The above object is, in the present invention, to obtain injection information regarding the amount of fluid injected to expand the balloon portion of the catheter arranged in the living body by the catheter information management device that manages the information about the catheter. Injection information acquisition unit, balloon expansion information acquisition unit that acquires balloon expansion information indicating the expansion state of the balloon unit, a living body that determines biological changes associated with expansion of the balloon unit based on the injection information and the balloon expansion information. It functions as a state determination unit , a calculation unit that calculates balloon expansion change information based on the injection information and the balloon expansion information, and a crack generation determination unit that determines whether or not a crack has occurred in the living body.
The biological state determination unit determines the biological change based on the balloon expansion change information, and determines the biological change.
The crack occurrence determination unit is achieved by a control program of a catheter information management device that determines the presence or absence of crack occurrence based on the balloon expansion degree information generated from the balloon expansion change information.

The above object is, in the present invention, the amount of fluid injected to expand the balloon portion of the catheter placed in vivo in order to expand into the balloon portion of the catheter placed in vivo and expandable. The injection information acquisition unit acquires the injection information regarding the balloon, the balloon expansion information acquisition unit acquires the balloon expansion information indicating the expansion state of the balloon unit, and the biological state determination unit obtains the injection information and the balloon expansion information. The biological change accompanying the expansion of the balloon portion is determined , the calculation unit calculates the balloon expansion change information from the injection information and the balloon expansion information, and the biological state determination unit determines the biological change based on the balloon expansion change information. The crack occurrence determination unit, which determines whether or not a crack has occurred in the living body, is characterized in that it determines the presence or absence of a crack based on the balloon expansion degree information generated from the balloon expansion change information. Achieved by the catheter information management method.

As described above, according to the present invention, while grasping the amount of change in the balloon expansion process, the information of the balloon insertion target according to the balloon expansion process is also grasped, and such information is obtained by the operator. There is an advantage that a catheter information management device, a catheter device, a control program of the catheter information management device, and a catheter information management method can be provided.

FIG. 5 is a schematic view showing a main configuration of, for example, a balloon catheter device, which is a catheter device according to the first embodiment of the present invention. It is a schematic block diagram which shows the main structure of the PC of FIG. It is a schematic block diagram which shows the main structure of the 1st various information storage part. It is a schematic block diagram which shows the main structure of the 2nd various information storage part. It is a schematic block diagram which shows the main structure of the 3rd various information storage part. It is a schematic flowchart which shows the main operation example of the balloon catheter apparatus of FIG. It is another schematic flowchart which shows the main operation example of the balloon catheter apparatus of FIG. It is another schematic flowchart which shows the main operation example of the balloon catheter apparatus of FIG. It is a schematic flowchart which shows the main process of the modification of the 1st Embodiment. It is a schematic diagram which shows the relationship between the injection amount and a pressure value (balloon internal pressure). It is the schematic which shows the relationship between the injection amount (feed amount) of the contrast medium and the pressure value of a balloon which shows the 1st modification about "determination of the possibility of crack occurrence". It is the schematic which shows the relationship between the injection amount (feed amount) of the contrast medium and the pressure value of a balloon which shows the 2nd modification about "determination of the possibility of crack occurrence". It is a schematic diagram which shows the balloon catheter device which is the 1st modification of the balloon catheter device of the 1st Embodiment described above. It is the schematic which shows the relationship between the strain gauge of a balloon and a blood vessel. It is a schematic diagram which shows the balloon catheter device which is the 2nd modification of the balloon catheter device of the 1st Embodiment described above. It is a schematic block diagram which shows the main structure of the balloon catheter apparatus which concerns on 2nd Embodiment of this invention. It is a schematic block diagram which shows the main structure of the eleventh various information storage units. It is a schematic block diagram which shows the main structure of the twelfth various information storage part. It is a schematic block diagram which shows the main structure of the thirteenth various information storage part. It is a schematic flowchart which shows the main operation example of the balloon catheter apparatus 300 of FIG. It is a schematic flowchart which shows the main operation example of the balloon catheter apparatus of FIG. It is another schematic flowchart which shows the main operation example of the balloon catheter apparatus of FIG. It is the schematic which shows the relationship between the injection amount and the volume value. It is a schematic diagram which shows the relationship between the injection amount (feeding amount) of the contrast medium which shows the 1st modification concerning "determination of the possibility of crack occurrence", and the volume value of a balloon. It is the schematic which shows the relationship between the injection amount (feed amount) of the contrast medium and the volume value of a balloon which shows the 2nd modification about "determination of the possibility of crack occurrence".

Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings and the like.
Since the embodiments described below are suitable specific examples of the present invention, various technically preferable limitations are attached, but the scope of the present invention particularly limits the present invention in the following description. Unless otherwise stated, the present invention is not limited to these aspects.

(First Embodiment)
FIG. 1 is a schematic view showing a main configuration of, for example, a balloon catheter device 1, which is a catheter device according to the first embodiment of the present invention.
As shown in FIG. 1, the balloon catheter device 1 shown in FIG. 1 has, for example, a balloon catheter 2 which is a living body of a patient, for example, a catheter for inserting and arranging in a blood vessel.
The balloon catheter 2 has a structure in which a balloon 21 which is a balloon portion expands at the tip thereof by injecting a liquid, for example, a contrast medium.
Specifically, by expanding the balloon 21 at the stenosis (lesion) in the blood vessel of the patient, the stenosis can be expanded and treated.

The balloon catheter 2 of the present embodiment is, for example, a balloon catheter for PTCA (Percutaneous Transluminal Coronary Angioplasty) dilation used for widening a narrowed portion of a coronary artery.
In addition, the balloon catheter 2 of the present embodiment treats a stenosis formed in a biological organ such as another blood vessel, bile duct, trachea, esophagus, other gastrointestinal tract, urethra, ear nose lumen, and other organs. And can be configured to be used for the purpose of improvement.

As shown in FIG. 1, the balloon catheter 2 has a long shaft 22 having flexibility that can be inserted into a living lumen, and the above-mentioned expandable and contractible balloon is provided at the tip of the shaft 22. 21 is arranged.
Further, a hub 24 for connecting the balloon catheter 2 to another device is arranged on the proximal end side of the shaft 22.
Further, the shaft 22 is also formed with an opening 25 from which the guide wire 23 is led out.

Further, as shown in FIG. 1, a bifurcated connector 3 is attached to the hub 24 on the proximal end side of the balloon catheter 2.
For example, a pressure sensor 8 which is a balloon expansion change information acquisition unit is connected to one side of the bifurcated connector 3.
Therefore, since the pressure sensor 8 communicates with the inside of the balloon catheter 2 via the connector 8, the pressure sensor 8 has a configuration capable of measuring the internal pressure of the balloon 21.
The pressure sensor 8 is an example of a balloon expansion information acquisition unit.

Further, as shown in FIG. 1, a liquid injection portion, for example, a syringe 4, is connected to the other side of the bifurcated connector 3.
The above-mentioned contrast medium is housed inside the syringe 4, and a predetermined contrast medium is injected into the balloon 21 of the balloon catheter 3 by the operation of the syringe feeding mechanism 5, and the balloon 21 is expanded. There is.

Further, the syringe feeding mechanism 5 is controlled by a stepping motor 6 controlled by a motor driver 7.
Further, as shown in FIG. 1, the pressure sensor 8 and the motor driver 7 are connected to an analog / digital (A / D) converter 9, and the analog / digital converter 9 is, for example, a catheter information management device. It is connected to a personal computer (PC) 10.
Therefore, the injection amount of the contrast medium in the syringe 4 is controlled by the PC 10, and the information of the pressure sensor 8 is input to the PC 10.

Further, as shown in FIG. 1, the PC 10 has, for example, a display 11 which is an output unit for outputting various information, and also includes various information input devices 12 (keyboard) for inputting various information.

As described above, the balloon catheter device 1 has a balloon catheter 2, a connector 3, a syringe 4, a syringe feeding mechanism 5, a stepping motor 6, a motor driver 7, a pressure sensor 8, an A / D converter 9, and a PC 10. There is.

By the way, the PC 10 shown in FIG. 1 has a CPU (Central Processing Unit), a RAM (Random Access Memory), a ROM (Read Only Memory), and the like (not shown), and these are connected via a bus.

FIG. 2 is a schematic block diagram showing a main configuration of the PC 10 of FIG.
As shown in FIG. 2, the PC 10 has a “PC control unit 13”, and the PC control unit 13 has a “communication device 14”, a “timekeeping device 15”, and a diagram for communicating with the A / D converter 9. It is configured to control the display 11 and various information input units 12 shown in 1.

Further, the PC control unit 13 controls the "first various information storage units 30", the "second various information storage units 40", and the "third various information storage units 50" shown in FIG.
3 to 5 are schematic block diagrams showing the main configurations of the "first various information storage units 30", the "second various information storage units 40", and the "third various information storage units 50", respectively. be. These contents will be described later.

6 to 9 are schematic flowcharts showing a main operation example of the balloon catheter device 1 of FIG. Hereinafter, the configurations of FIGS. 1 to 5 and the like will be described with reference to these flowcharts.
First, the balloon catheter 2 of FIG. 1 is inserted into the blood vessel of the patient, and the balloon 21 is placed in the stenosis (lesion).
Next, in step 1 of FIG. 6 (hereinafter referred to as “ST”) 1, an operator such as a doctor operates the PC 10 of FIG. 1 and inputs “contrast medium injection start information” to the PC 10.

Then, the operation of the balloon catheter device 1 of FIG. 1 is started, and the process proceeds to ST2. In ST2, the “contrast medium injection processing unit (program) 31” of FIG. 3 operates, and the injection information storage unit of FIG. 3, for example, the “contrast medium injection amount information storage unit 32” is referred to.

The contrast agent injection amount information storage unit 32 contains injection information such as "contrast agent injection amount information", that is, information on the injection amount of the contrast agent per hour, for example, time information and 0.011 mL, time information and 0. Information such as 047 mL, time information and 0.1 mL is stored. That is, information on how much contrast medium should be injected is stored over time.
This "contrast medium injection amount information" is acquired by an "injection information acquisition unit (program)" (not shown), and this "injection information acquisition unit (program)" is an example of the "injection information acquisition unit".

Next, the contrast medium injection processing unit (program) 31 transmits drive information to the motor driver 7 based on the contrast medium injection amount of the “contrast medium injection amount information”.

Then, the process proceeds to ST3. In ST3, the motor driver 7 drives the stepping motor 6, the stepping motor 6 operates the syringe feeding mechanism 5, and the syringe 4 performs a predetermined amount of contrast medium at a predetermined time based on the contrast medium injection amount information obtained in ST2. The agent is injected into the balloon catheter 2.

Then, the process proceeds to ST4. In ST4, the PC 10 acquires the "pressure information" of the pressure sensor 8 together with the time information and stores it in the "pressure information storage unit 33" of FIG.
The pressure information at this time is the internal pressure information of the inside of the balloon catheter 2, that is, the balloon 21, and the internal pressure information is stored together with the time information.
The "pressure information" of the pressure sensor 8 is an example of "balloon expansion information" and "pressure information of the balloon portion".

Then, the process proceeds to ST5. In ST5, the “injection amount-related pressure information generation unit (program) 34” of FIG. 3 operates, and the “pressure information with time information” of the “pressure information storage unit 33” and the “contrast agent injection amount information storage unit 32” "Injection amount information with time information" is acquired, injection amount information and pressure information of the same time information are linked to generate injection amount-related pressure information, and the "injection amount-related pressure information storage unit 35" in FIG. 3 is used. Remember.

That is, information on the injection amount and the pressure value of the balloon 21 at that time is stored.
Therefore, the injection volume related pressure information is an example of balloon expansion change information.
Further, the “injection amount-related pressure information generation unit (program) 34” is an example of a calculation unit that calculates balloon expansion change information.

Then, the process proceeds to ST6. In ST6, the “pressure change graph information display processing unit (program) 36” of FIG. 3 operates, and the change graph of the injection amount and the pressure value is based on the injection amount-related pressure information of the “injection amount-related pressure information storage unit 35”. Is generated and displayed on the display 11.

Further, the pressure change graph information display processing unit (program) 36 generates a change graph of the injection amount and the pressure value based on the reference injection amount pressure information of the “reference injection amount pressure information storage unit 37” of FIG. It is displayed overlaid on the change graph of quantity and pressure value.
Here, the "reference injection amount pressure information" is the pressure information corresponding to the reference injection amount, that is, the relationship between the injection amount and the pressure when it is assumed that the expansion of the balloon 21 is expanded without being restricted by the blood vessel. Information.
The "reference injection amount pressure information" is an example of "reference information" and "reference pressure information".

FIG. 10 is a schematic view showing the relationship between the injection amount and the pressure value (balloon internal pressure).
The arrow G in FIG. 10 indicates the injection amount-related pressure information which is the relationship between the actual injection amount (volume) and the corresponding internal pressure (kPa) of the balloon 21 actually measured by the pressure sensor 8. The arrow S indicates the reference injection amount pressure information which is the relationship between the reference injection amount and the pressure described above.

Further, in ST6, the graph G and the graph S shown in FIG. 10 are displayed on the display 11 of the PC 10 of FIG.
Therefore, an operator such as a doctor who is injecting a contrast medium into the balloon catheter 2 of FIG. 1 visually recognizes the graph of arrow G in FIG. 10 to change the internal pressure of the balloon 21 in relation to the injection amount. Can be clearly grasped.
Also, in comparison with the reference of arrow S. By visually recognizing the arrow G, it is possible to predict not only whether or not the balloon 21 has come into contact with the inner wall of the blood vessel, but also whether or not a crack has occurred in the inner wall of the blood vessel.

Specifically, when the graph of arrow G in FIG. 10 is separated from the arrow S and the pressure is increased (graph of arrow G in the section shown by L1 in FIG. 10), the expansion of the balloon 21 hits the inner wall of the blood vessel. It can be expected that the balloon 21 is in contact with the inner wall of the blood vessel and is in contact with the balloon 21.

On the other hand, when the internal pressure drops sharply after contacting the inner wall of the blood vessel in this way (graph of arrow G in the section shown by L2 in FIG. 10), the factor that hinders the expansion of the balloon 21 disappears. It can be expected that the pressure has decreased, that is, cracks and the like have occurred on the inner wall of the blood vessel.

By displaying the graph of FIG. 10 on the display 11 in this way, a doctor or the like operating the balloon catheter 2 can predict the state of the balloon 21 and the inner wall of the blood vessel.
Further, in the present embodiment, the PC 10 has a configuration in which the relationship between the inner wall of the blood vessel and the balloon 21 is automatically determined with high accuracy, and the determination result is displayed on the display 11. Hereinafter, a detailed description will be given.

First, in ST7, the “current pressure increase rate information generation processing unit (program) 41” of FIG. 4 operates, and the “injection amount-related pressure information storage unit 35” of FIG. 3 is referred to.
Then, the pressure value at the latest injection amount is compared with the pressure value at the current injection amount to generate "current pressure increase rate Δn" information, which is stored in the "current pressure increase rate information storage unit 42" of FIG. ..

For example, V [mL] (current volume (injection volume)) -0.001 [mL] (current volume minus 0.001 [mL] pressure value, "latest volume pressure value", and V The "current pressure increase rate Δn" is obtained from the "current volume pressure value" which is the pressure value in [mL] (current volume), and the value of this "current pressure increase rate Δn" is set to the "current pressure". It is stored in the increase rate information storage unit 42 ”.

Then, the process proceeds to ST8. In ST8, the biological state determination unit of FIG. 4, and the biological contact determination unit, for example, the “first blood vessel wall contact state determination processing unit (program) 45” operates, and the “current pressure increase” of FIG. 4 is performed. Rate storage unit 42 ”.
Then, whether or not the value of the "current pressure increase rate Δn" is "large" as compared with the corresponding increase rate of the "reference injection amount pressure information" of the "reference injection amount pressure information storage unit 37" in FIG. to decide.

Then, in ST9, when the value of the "current pressure increase rate Δn" is larger than the corresponding increase rate of the "reference injection amount pressure information", the balloon portion 21 is in contact with the inner wall of the blood vessel, that is, the "blood vessel". The "wall contact state" is determined, and the "blood vessel wall contact" is displayed on the display 11.
This "blood vessel wall contact state" information is an example of biological change information and blood vessel contact information.

As described above, in the present embodiment, the change in the pressure (internal pressure of the balloon 21) in the graph of the arrow G in FIG. 10 and the change in the pressure in the corresponding injection amount in the graph of the arrow S in FIG. To compare.
For example, in the section of “L1” where the injection amount of FIG. 10 is 0.011 mL to 0.047 mL, the rate of increase in the graph of arrow G is “larger” than the rate of increase in arrow S.

This indicates that the pressure is higher than usual, that is, the balloon 21 is in contact with the inner wall of the blood vessel.
Therefore, in the present embodiment, in such a case, it is determined that the balloon portion 21 is in contact with the inner wall of the blood vessel in the "blood vessel wall contact state", and the "blood vessel wall contact" is displayed on the display 11. .. (ST10)

Further, by displaying the balloon 21 on the display 11 in this way, it is possible to accurately notify the doctor or the like operating the balloon catheter 2 that the balloon 21 has come into contact with the inner wall of the blood vessel.

On the other hand, in the present embodiment, when the value of "current pressure increase rate Δn" is "large" as compared with the corresponding increase rate of "reference injection amount pressure information", the balloon portion 21 comes into contact with the inner wall of the blood vessel. Although it is determined that the blood vessel wall is in contact with the blood vessel wall, the present invention is not limited to this, and the following cases are also included.
That is, the current pressure information of the “injection amount-related pressure information storage unit 35” of FIG. 3 is acquired, and FIG. 3
It is compared with the pressure information corresponding to the "current injection amount" in the "reference injection amount pressure information" of the "reference injection amount pressure information storage unit 37".

Then, if the pressure value of the current injection amount is "10%" or more higher than the pressure value of the corresponding "reference injection amount pressure information", it is determined that the blood vessel wall is in contact with the blood vessel wall.
By making such a judgment, it is possible to make a more accurate judgment.

By the way, after ST10, the process proceeds to ST11. In ST11, the “first blood vessel wall dissociation alarm generation processing unit (program) 51” of FIG. 5 operates, and the crack number information of the “crack number information storage unit 46” of FIG. 4 is acquired.
The information on the number of cracks will be described later, but it is the number of times that it was determined in the past that there was a risk of cracks occurring on the inner wall of the blood vessel due to a change in pressure.
Then, in this step, it is determined whether or not the number of cracks has reached a predetermined number of times (for example, twice).
The "first blood vessel wall dissociation alarm generation processing unit (program) 51" is an example of the "biological wall dissociation determination unit".

Then, when it is determined in ST12 that the number of cracks has reached a predetermined number of times (for example, twice), the process proceeds to ST13.
In ST13, the “blood vessel wall dissociation occurrence alarm” is displayed on the display 11 of the PC 10.

That is, when the balloon 21 abuts on the inner wall of the blood vessel and the balloon 12 further expands to apply pressure to the blood vessel in a state where the crack has occurred twice in the past, "vascular wall dissociation" exceeding the crack occurs. As there is a possibility, a "blood vessel wall dissociation occurrence alarm" is displayed on the display 11.
Therefore, it is possible to give an alarm to a doctor or the like who operates the balloon catheter 2 in advance, and it is possible to prevent the occurrence of a serious situation.

In the present embodiment, when the probability that the blood vessel wall dissociation occurs is high, the “blood vessel wall dissociation occurrence alarm” is displayed on the display 11, but in the present invention, an alarm by sound may be issued. Further, the injection of the contrast medium into the balloon catheter 2 may be forcibly stopped.
In this case, the balloon catheter device 1 is safer.

Then, the process proceeds to ST14. It is determined in ST14 whether or not the "contrast medium injection stop information" has been input, and if there is an input, the process ends.
On the other hand, if there is no input of "contrast medium injection stop information" in ST14, the process proceeds to ST15.
In ST15, the crack occurrence determination unit of FIG. 5, for example, the “first crack occurrence determination processing unit (program) 52” operates and is stored in the “current pressure increase rate information storage unit 42” of FIG. The latest data is acquired as the "most recent pressure increase rate Δn-1", and this value is compared with the corresponding increase rate of the "reference injection amount pressure information" of the "reference injection amount pressure information storage unit 37" in FIG. Judge whether it is "large" or not.

If it is determined in ST15 that the value of the "most recent pressure increase rate Δn-1" is "larger" than the corresponding increase rate of the "reference injection amount pressure information", the process proceeds to ST16.
In ST16, it is determined whether or not the “current pressure increase rate Δn” of the “current pressure increase rate information storage unit 42” of FIG. 4 is “smaller” than “0”, and if it is “smaller”, the process proceeds to ST17.

In ST17, it is determined that there is a risk of “cracking” on the inner wall of the blood vessel, and the “risk of cracking” is displayed on the display 11.

That is, in ST15, for example, the change in pressure (internal pressure of the balloon 21) due to the change in the injection amount in the graph of arrow G in FIG. 10 is compared with the change in pressure in the corresponding injection amount in the graph in arrow S in FIG. For example, in the section of "L1" where the injection amount of FIG. 10 is 0.011 mL to 0.047 mL, the rate of increase in the graph of arrow G is "larger" than the rate of increase in arrow S.
This indicates that the pressure is higher than usual, that is, the balloon 21 is in contact with the inner wall of the blood vessel.

After that, in the section of L2 after 0.047 mL of the injection amount in FIG. 10, the rate of increase in the graph of arrow G is “smaller” than “0”.
It is presumed that this is because the pressure on the balloon 21 decreased because the inner wall of the blood vessel cracked and the blood vessel expanded.
In this way, when it is determined that the pressure has decreased after the balloon 21 hits the inner wall of the blood vessel and the pressure has increased, it can be determined that this decrease in pressure is due to a crack.

Next, the first crack occurrence presence / absence determination processing unit (program) 52 updates and stores the information in ST17 by adding “+1” to the crack number information of the “crack number information storage unit 46” of FIG.

In the present embodiment, as in ST15 and ST16, when the pressure increases from the reference value and then the increase rate becomes smaller than "0", it is determined that "there is a risk of cracking".
However, the present invention is not limited to this, and may be simply configured to determine that “there is a risk of cracking” when the current pressure increase rate is smaller than “0”.

As described above, according to the present embodiment, while grasping the amount of change in the expansion process of the balloon 21, the information of the living body such as the blood vessel to which the balloon 21 is inserted is grasped according to the expansion process of the balloon 21. can do.
Further, by displaying such information on the display 11, it is possible to appropriately notify the operator and the like.
As described above, the balloon catheter device 1 of the present embodiment can promptly notify the operator and the like not only of the changed state of the blood vessel or the like due to the expansion of the balloon 21 but also in the case of a dangerous state. It is a balloon catheter device 1 that is extremely safe.

In this embodiment, after the number of cracks has reached a predetermined number of times (for example, twice), an example of issuing a "blood vessel dissection occurrence alarm" when it is determined that the balloon 21 has come into contact with the inner wall of the blood vessel again. As shown, the timing of the "vascular dissection occurrence alarm" is not limited to this example.

FIG. 9 is a schematic flowchart showing the main steps of the modified example of the present embodiment.
As shown in FIG. 9, for example, immediately after determining that "crack" may occur in ST17, it is determined whether or not the number of cracks has reached a predetermined number (for example, 2 times), and "crack" is determined at an early stage. A "vascular dissection occurrence alarm" may be issued. In this case, it may be a "warning for the occurrence of vascular dissection".

In the case of this modification, the steps shown in FIGS. 7 and 8 of the first embodiment are modified. Specifically, ST14 is deleted from ST11 in FIG. 7, and ST18 to ST21 are added after ST17 in FIG.
That is, in ST17, the crack count information is "+1" and stored, and then the process proceeds to ST18.

In ST18, the crack number information of the “crack number information storage unit 46” of FIG. 4 is acquired, and it is determined whether or not the crack number has reached a predetermined number (for example, 2 times).
Then, when it is determined in ST19 that the number of cracks has reached a predetermined number of times (for example, twice), the process proceeds to ST20, and the "blood vessel wall dissociation occurrence alarm" is displayed on the display 11 of the PC 10.

Further, as another modification, different alarms may be issued at two timings.
Specifically, immediately after determining that "crack" may occur in ST17, when it is determined that the number of cracks has reached a predetermined number (for example, 2 times), a "blood vessel dissection occurrence warning" is issued. After that, when it is determined that the blood vessel has come into contact with the inner wall, a "blood vessel dissection occurrence alarm" is issued.

In the case of this modification, after proceeding from ST8 to ST14 shown in FIG. 7, the process proceeds from ST15 to ST16 shown in FIG. 8, and further proceeds from ST17 to ST21 shown in FIG.
In this case, the "warning for the occurrence of blood vessel dissection" is issued in ST20, and the "warning for the occurrence of blood vessel dissection" is issued in ST13.
In these cases, it is possible to call attention to a doctor or the like who operates the balloon catheter 2 from an early stage, and it is possible to prevent the occurrence of a serious situation.

Further, instead of issuing an alarm, the injection of the contrast medium into the balloon catheter 2 may be forcibly stopped.
In this case, the balloon catheter device 1 is safer.

(First modification of the first crack generation determination of the present embodiment)
FIG. 11 is a schematic view showing the relationship between the injection amount (feed amount) of the contrast medium and the pressure value of the balloon, which shows the first modification regarding the “determination of the possibility of cracking”.
In this modification, unlike the first embodiment described above, the method of determining "risk of crack occurrence" is different, and therefore, the differences will be mainly described below.

First, the step of determining the “risk of cracking” in the first embodiment described above will be described.
In the first embodiment described above, as shown in ST15 and ST16 of FIG. 8, first, the rate of increase in pressure at the latest injection amount immediately before is determined.
That is, the "most recent pressure increase rate Δn-1" information is generated by comparing the pressure value at the latest injection amount with the pressure value of the most recent injection amount.

Then, in the "reference injection amount pressure information" indicated by the arrow S in FIG. 10, the pressure value at the most recent injection amount and the pressure value of the latest injection amount corresponding to the pressure value of the latest injection amount are further closest to the "reference injection amount pressure information". The pressure value and the latest pressure value are extracted and compared to generate "most recent increase rate" information.
Then, the "most recent pressure increase rate Δn-1" and the "most recent increase rate of the reference injection amount pressure information" are compared.
Specifically, if the value of the “most recent pressure increase rate Δn-1” in the graph G is “larger” than the “most recent increase rate of the reference injection amount pressure information” in the graph S, the balloon 21 is the “vessel wall”. Judged as "contact state".

Next, the "current pressure increase rate Δn" information is generated by comparing the pressure value at the actual latest injection amount with the pressure value at the current injection amount.
Then, it is determined whether or not this "current pressure increase rate Δn" is smaller than "0", and if it is smaller, it is determined that "cracks may occur".

On the other hand, in the first modification, the "risk of crack occurrence" is determined by a different method.
First, for example, the "measured pressure value" which is the pressure of the injection amount for each injection amount of FIG. 11 (for example, 0.0011 mL.0.0012 mL, etc.) and the "reference injection amount pressure information" of FIG. 11 at the corresponding injection amount. , And store it as the "pressure standard deviation value".
That is, the "pressure reference deviation value" for each feed amount (injection amount) of the contrast medium (for example, 0.011 mL, 0.012 mL, etc.) is obtained and stored.
For example, as shown by arrows E1 to En in FIG. 11, the "pressure reference deviation value" for each feed amount is stored.

Then, the "increase rate" of the "most recent reference deviation value", which is the latest "pressure reference deviation value" immediately before the present, that is, the "most recent increase rate of the pressure reference deviation value" is obtained.
Specifically, the "most recent increase rate of the pressure reference deviation value" is obtained from the latest "pressure reference deviation value" and the latest "pressure reference deviation value".
For example, when "E11" in FIG. 11 is the current "pressure reference deviation value", the latest is "E9", and the latest is "E10", the "pressure reference deviation value" of E9 and E10 is changed to E10. Find the latest "rate of recent increase in pressure reference deviation value".

Next, the "current increase rate of the pressure reference deviation value" is obtained from the latest "pressure reference deviation value" and the current "pressure reference deviation value".
Specifically, the "current increase rate of the pressure reference deviation value" of E11 is obtained from the "pressure reference deviation value" of E10 in FIG. 11 and the "pressure reference deviation value" of E11.
Then, when the "current increase rate of the pressure reference deviation value" is "smaller" than "0", it is determined that "there is a risk of cracking".

In this way, by using the "current increase rate of the pressure reference deviation value" as a reference, it is possible to determine the "blood vessel wall contact state" and the "risk of crack occurrence" as in the first embodiment described above. Can be done.
The above-mentioned "pressure reference deviation value" is an example of "deviation information between balloon expansion change information and reference information".

(Second modification of the first crack generation determination of the present embodiment)
FIG. 12 is a schematic view showing the relationship between the injection amount (feed amount) of the contrast medium and the pressure value of the balloon showing the second modification regarding “determination of the possibility of crack occurrence”.
In this modification, unlike the first embodiment described above, the method of determining "risk of crack occurrence" is different, and therefore, the differences will be mainly described below.

In this modification, as shown in FIG. 12, the “most recent increase rate of pressure Δn-1 (T1)”, which is the slope of the tangent line of the pressure values at the two points at the latest injection amount, and the pressure value at the current injection amount. The "current rate of increase in pressure Δn (T2)", which is the slope of, is obtained.
For example, in FIG. 12, the slope indicated by T1 “the most recent increase rate of pressure Δn-1 (T1)” is “500 kPa / 0.03 mL≈17 MPa / mL”, and the slope indicated by T2 is “pressure”. Currently, the rate of increase Δn (T2) ”is“ −400 kPa / 0.002 mL ≈ −200 MPa / mL ”.

Then, in this modification, the “most recent increase rate of pressure Δn-1 (T1)” in FIG. 12 and the “current increase rate of pressure Δn (T2)” are compared, and the degree of decrease during that period is calculated. When the degree of decrease is equal to or higher than a predetermined threshold value, it is determined that "cracks may occur".

When this threshold value is, for example, "100 MPa / mL", the "most recent increase rate of pressure Δn-1 (T1)" in FIG. 12 is "500 kPa / 0.03 mL≈17 MPa / mL", which is indicated by T2 and ". Since the current rate of increase in pressure Δn (T2) ”is“ −400 kPa / 0.002 mL ≈ −200 MPa / mL ”, the degree of decrease thereof is“ 183 MPa / mL ”.
Then, since the degree of decrease is equal to or greater than the threshold value, in this example, it is determined that "cracks may occur" due to the balloon 21.

Further, when T3 in FIG. 12 is set to "the most recent increase rate of pressure Δn-1 (T3)" and T4 is set to "the current rate of increase of pressure Δn (T4)", the rate of increase (slope) of T3 is "150 MPa". When the rate of increase (slope) of "/ mL" and T4 is "0 MPa / mL", the degree of decrease is "150 MPa / mL".
Therefore, since the degree of decrease is equal to or greater than the threshold value, it is determined that "cracks may occur" due to the balloon 21 in this example as well.

As described above, in this modification, the change in the internal pressure of the balloon 21 due to the injection amount (feed amount) is determined by the change (decrease degree) between the plurality of inclinations.
Therefore, even when the "current pressure increase rate Δn" in the actual injection amount is not smaller than "0", it is possible to accurately determine whether or not there is a possibility of crack occurrence.

Note that the “degree of decrease between the latest pressure increase rate Δn-1 (T1) and the current pressure increase rate Δn (T2)” in FIG. 12 is an example of “change information between inclinations of a plurality of points”. ing.

(Modification example of the second modification of the first crack generation determination of the present embodiment)
In the second modification described above, the “most recent increase rate of pressure Δn-1” (T1 etc.) and the “current increase rate Δn of pressure” (T2 etc.) in FIG. 12 are compared, and the degree of decrease is calculated. When the degree of decrease is equal to or greater than a predetermined threshold value, it is determined that "cracks may occur".
In the case of the second modification described above, the degree of decrease at the two rates of increase (slope) can be grasped, but these two "most recent rate of increase of pressure Δn-1" (T1 etc.) and "pressure" It is not possible to grasp the degree of change (whether the change is rapid or gradual, etc.) during the current rate of increase Δn (T2, etc.).
Therefore, in the present embodiment, the amount of minute change between the two increase rates (slopes) can be grasped, and whether the change is sudden or gentle between the two increase rates (slopes) can be grasped. It has become.

For example, the slope of T1 (the most recent rate of increase in pressure Δn-1) in FIG. 12 is “17 MPa / mL”, the slope of T2 (the current rate of increase in pressure Δn) is “−200 MPa / mL”, and the injection amount during that period. When the width of (feed amount) is, for example, 0.002 mL, the degree of decrease in the amount of minute change between the slopes of T1 and T2 is obtained.
That is, it becomes "(-200-17) -0.002", which becomes "-109 GPa / mL ^ 2", and this is the degree of decrease in the amount of minute change.

Then, in this modification, the threshold value of the degree of decrease of the minute change amount is set. That is, it is a criterion for determining whether or not there has been a more abrupt change, and if a more abrupt change has occurred, it is determined that the above-mentioned "crack may occur".
For example, in this modification, "50 GPa / mL ^ 2" is defined as "the degree of decrease in the amount of minute change".
Then, since the degree of decrease in the amount of minute change between the increase rates (slopes) of T1 and T2 in FIG. 12 is "-109 GPa / mL ^ 2", the threshold value "50 GPa / mL ^ 2" is exceeded and a rapid change occurs. Etc. are determined to have occurred, and it is determined that there is a risk of cracks occurring.

In this way, in this modified example, the amount of minute change between inclinations is grasped, the degree of change in the amount of minute change is grasped, and the "risk of cracking" is determined based on this, so that the accuracy is extremely high. Judgment becomes possible.

The above-mentioned "-109 GPa / mL ^ 2" is an example of "information on the amount of minute change between the inclinations of a plurality of points".

(First modification of the first embodiment)
FIG. 13 is a schematic view showing a balloon catheter device 100 which is a first modification of the balloon catheter device 1 of the first embodiment described above.
Since many configurations of the balloon catheter device 100 of this modification are common to the balloon catheter device 1 of the first embodiment described above, the overlapping configurations are assumed to have the same reference numerals and the like, and the description thereof will be omitted. Will be mainly explained.

As shown in FIG. 13, the balloon catheter device 100 of the present modification does not have the “pressure sensor 8” unlike the balloon catheter device 1 of the first embodiment, and instead has a “pressure sensor 8” on the surface of the balloon 121. A plurality of "strain gauges 126a and 126b" for detecting the surface pressure information of the balloon 121 are arranged.

FIG. 14 is a schematic view showing the relationship between the strain gauges 126a and 126b of the balloon 121 and the blood vessel.
As shown in FIG. 14, when the contrast medium is injected into the balloon 121, the balloon 12 expands, and comes into contact with the inner wall of the blood vessel, the strain gauges 126a and 126b detect the surface pressure, and the A / D conversion of FIG. It is configured to be input to the PC 10 via a vessel 9 or the like.

Therefore, in this modification, the pressure information is acquired not by the "internal pressure" acquired by the pressure sensor 8 of the first embodiment but by the surface pressure information detected by the strain gauges 126a and 126b of the balloon 121. It has become.
Further, unlike the pressure sensor 8 of the first embodiment, this pressure information is direct information of the surface pressure of the balloon 121, so that the pressure information can be acquired more accurately.

(Second variant of the first embodiment)
FIG. 15 is a schematic view showing a balloon catheter device 200 which is a second modification of the balloon catheter device 1 of the first embodiment described above.
Since many configurations of the balloon catheter device 200 of this modification are common to the balloon catheter device 1 of the first embodiment described above, the overlapping configurations are assumed to have the same reference numerals and the like, and the description thereof will be omitted. Will be mainly explained.

As shown in FIG. 15, unlike the balloon catheter device 1 of the first embodiment, the balloon catheter device 200 of the present modification has a syringe 4, a syringe feeding mechanism 5, a stepping motor 6, and a motor driver 7. Instead, it has an indeflator 201.
Further, the deflator 201 is connected to the balloon catheter 2 via the connector 203.

That is, by operating the indeflator 201 by the operator, the contrast medium contained therein is injected into the balloon catheter 2 at a predetermined flow rate.
Therefore, in this modification, unlike the balloon catheter 1 of the first embodiment, the operator operates the indeflator 201 without using the syringe 4, the syringe feeding mechanism 5, the stepping motor 6, and the motor driver 7. Since the contrast medium can be injected into the balloon catheter 2, the balloon catheter device 200 is extremely easy to use.
In this case, a sensor for measuring the flow rate of the contrast medium injected into the balloon catheter 2 is provided, and the measured value is stored in the “contrast medium injection amount information storage unit 32” of FIG.

(Second Embodiment)
FIG. 16 is a schematic block diagram showing a main configuration of the balloon catheter device 300 according to the second embodiment of the present invention.
Since many configurations of the balloon catheter device 300 according to the second embodiment shown in FIG. 16 are common to the balloon catheter 1 according to the first embodiment described above, the common configurations are hereinafter referred to as the same reference numerals and the like. The explanation will be omitted, and the differences will be mainly explained.

Unlike the balloon catheter device 1 according to the first embodiment described above, the balloon catheter device 300 according to the present embodiment does not have the "pressure sensor 8" and has the X-ray imaging device 301.
Then, the X-ray imaging device 301 is configured to measure the volume change of the balloon 21 by imaging the expanded state of the balloon 21 of the balloon catheter device 300.

17 to 19 show the main configurations of the "11th various information storage units 330", the "12th various information storage units 340", and the "16th various information storage units 350" of FIG. 16, respectively. It is a schematic block diagram. These contents will be described later.

20 to 22 are schematic flowcharts showing a main operation example of the balloon catheter device 300 of FIG. Hereinafter, the configurations of FIGS. 16 to 19 and the like will be described with reference to these flowcharts.
First, the balloon catheter 2 of FIG. 16 is inserted into the blood vessel of the patient, and the balloon 21 is placed in the stenosis (lesion).
Next, in step 51 of FIG. 20, an operator such as a doctor operates the PC 10 of FIG. 16 and inputs “contrast medium injection start information” to the PC 10.

Then, the operation of the balloon catheter device 300 of FIG. 16 is started, and the process proceeds to ST51. In ST51, the “contrast medium injection processing unit (program) 31” of FIG. 17 operates, and the “contrast medium injection amount information storage unit 32” of FIG. 17 is referred to.
The content of the "contrast medium injection amount information storage unit 32" is the same as that of the "contrast medium injection amount information storage unit 32" of FIG. 3 of the first embodiment described above.

Next, the contrast medium injection processing unit (program) 31 transmits drive information to the motor driver 7 based on the contrast medium injection amount of the “contrast medium injection amount information”.

Then, the process proceeds to ST53. In ST53, the motor driver 7 drives the stepping motor 6, the stepping motor 6 operates the syringe feeding mechanism 5, and the syringe 4 performs a predetermined amount of contrast medium at a predetermined time based on the contrast medium injection amount information obtained in ST52. The agent is injected into the balloon catheter 2.

Then, the process proceeds to ST54. In ST54, the PC 10 acquires the "balloon image information" of the X-ray imaging apparatus 301 together with the time information and stores it in the "balloon information storage unit 331" of FIG.
Then, the process proceeds to ST55. In ST55, the “volume information generation unit (program) 332” of FIG. 17 operates, refers to the “balloon image information storage unit 331” of FIG. 17, generates volume information from the balloon image information, and converts the volume information into time information. And related items are stored in the “volume information storage unit 333” of FIG.

Then, the process proceeds to ST56. In ST56, the “injection amount-related volume information generation processing unit (program) 334” of FIG. 17 operates, and the volume information with time information of the “volume information storage unit 333” of FIG. The injection amount information with time information of the "information storage unit 32" is acquired, the injection amount information and the volume information of the same time information are linked to generate "injection amount-related volume information", and the "injection amount-related volume information storage unit 335" is generated. Remember in.

That is, information on the injection amount and the volume value of the balloon 21 at that time is stored. Therefore, the injection volume-related volume information is an example of balloon expansion change information.

Then, the process proceeds to ST57. In ST57, the “volume change graph information display processing unit (program) 341” of FIG. 18 operates, and the injection amount and volume value are based on the injection amount-related volume information of the “injection amount-related volume information storage unit 335” of FIG. The change graph of is generated and displayed on the display 11.

Further, based on the reference injection amount volume information of the "reference injection amount volume information storage unit 336" of FIG. 17, a change graph of the injection amount and the volume value is generated, and the change graph of the injection amount and the volume value is superimposed and displayed. ..
Here, the "reference injection volume volume information" is the volume information corresponding to the reference injection volume, that is, the relationship between the injection volume and the volume when it is assumed that the expansion of the balloon 21 is expanded without being restricted by the blood vessel. Information.
This "reference injection volume volume information" is an example of "reference volume information".

FIG. 23 is a schematic view showing the relationship between the injection amount and the volume value.
The arrow G1 in FIG. 23 indicates the actual injection amount (volume) and the corresponding volume (mL) of the balloon 21, and the arrow S1 indicates the relationship between the above-mentioned reference injection amount and volume.

Further, in ST57, the graph G1 and the graph S1 shown in FIG. 23 are displayed on the display 11 of the PC 10 of FIG.
Therefore, an operator such as a doctor who is injecting a contrast medium into the balloon catheter 2 of FIG. 1 visually recognizes the graph of the arrow G1 of FIG. 23 to change the volume of the balloon 21 in relation to the injection amount. Can be clearly grasped.
Also, in comparison with the reference of arrow S1. By visually recognizing the arrow G1, it is possible to predict not only whether or not the balloon 21 has come into contact with the inner wall of the blood vessel, but also whether or not a crack has occurred in the inner wall of the blood vessel.

Specifically, when the graph of arrow G1 in FIG. 23 is separated from the arrow S1 and the volume does not increase (graph of arrow G1 in the section shown by L3 in FIG. 23), the expansion of the balloon 21 hits the inner wall of the blood vessel. It can be expected that the balloon 21 is in contact with the inner wall of the blood vessel, that is, the balloon 21 is in contact with the inner wall of the blood vessel.

On the other hand, when the volume suddenly increases after being in contact with the inner wall of the blood vessel and the volume does not increase (graph of arrow G1 in the section shown by L4 in FIG. 23), the factor that hinders the expansion of the balloon 21 disappears. It can be expected that the volume has increased, that is, cracks and the like have occurred on the inner wall of the blood vessel.

By displaying the graph of FIG. 23 on the display 11 in this way, a doctor or the like operating the balloon catheter 2 can predict the state of the balloon, 21 and the inner wall of the blood vessel.
Further, in the present embodiment, the PC 10 automatically determines the relationship between the inner wall of the blood vessel and the balloon 21 with high accuracy, and displays the determination result on the display 11. Hereinafter, a detailed description will be given.

First, in ST58, the "current volume increase rate information generation processing unit (program) 342" of FIG. 18 operates, and with reference to the "injection amount-related volume information storage unit 335" of FIG. 17, the volume value at the latest injection amount. And the volume value of the current injection amount are compared to generate "current volume increase rate Δn" information, which is stored in the "current volume increase rate information storage unit 343" of FIG.

For example, V [mL] (current volume (injection volume)) -0.001 [mL] (volume value obtained by subtracting 0.001 [mL] from the current volume, "most recent volume volume value", and V The "current volume increase rate Δn" is obtained from the "current volume system value" which is the volume value in [mL] (current volume).
Then, the value of this "current volume increase rate Δn" is stored in the "current volume increase rate information storage unit 343" of FIG.

Then, the process proceeds to ST59. In ST59, the “second blood vessel wall contact state determination processing unit (program) 351” of FIG. 19 operates, and the volume value of the current injection amount of the “injection amount-related volume information storage unit 335” of FIG. Compare with the volume value corresponding to the current injection amount of the "reference injection amount volume information storage unit 336" of FIG.

Then, when it is determined in ST60 that the volume value of the current injection amount is "10% or more" lower than the volume value of the reference injection amount volume information storage unit 336 (FIG. 15) corresponding to the current injection amount, ST61 Proceed to.
In ST61, it is determined that the "blood vessel wall contact state" is determined, and the "blood vessel wall contact" is displayed on the display 11.

As described above, in the present embodiment, the change in volume due to the change in the injection amount in the graph of arrow G1 in FIG. 23 and the change in volume in the corresponding injection amount in the graph in arrow S1 in FIG. 23 are compared.
For example, in the section of “L3” where the injection amount of FIG. 23 is 0.011 mL to 0.047 mL, the volume value of the graph of arrow G1 is “10% or more lower” than the volume value of arrow S1.
This indicates that the volume does not increase, that is, the balloon 21 is in contact with the inner wall of the blood vessel.
Therefore, in the present embodiment, in such a case, it is determined that the balloon portion 21 is in contact with the inner wall of the blood vessel in the "blood vessel wall contact state", and the "blood vessel wall contact" is displayed on the display 11. ..

Further, by displaying the balloon 21 on the display 11 in this way, it is possible to accurately notify the doctor or the like operating the balloon catheter 2 that the balloon 21 has come into contact with the inner wall of the blood vessel.

On the other hand, the present invention also includes the following forms. That is, the latest data stored in the "current volume increase rate storage unit 343" of FIG. 18 is acquired as the "most recent volume increase rate Δn-1", and this value is the "reference injection amount volume information storage unit" of FIG. It is a form in which it is judged whether or not it is "small" in comparison with the corresponding increase rate of "reference injection amount volume information" of "336", and when it is "small", it is judged as "vascular wall contact state". ..
in this case. Even a slight change can be notified to a doctor or the like, and a highly accurate judgment can be made.

By the way, after ST61, the process proceeds to ST62. In ST62, the “second blood vessel wall dissociation alarm generation processing unit (program) 352” of FIG. 19 operates, the crack number information of the “crack number information storage unit 46” of FIG. 19 is acquired, and the number of cracks is a predetermined number of times. Determine if it has reached (eg, twice).
The information on the number of cracks will be described later, but it is the number of times it has been determined in the past that cracks may occur on the inner wall of the blood vessel due to the change in volume.

Then, the process proceeds to ST63, and when it is determined in ST63 that the number of cracks has reached a predetermined number of times (for example, twice), the process proceeds to ST64.
In ST64, the “blood vessel wall dissociation occurrence alarm” is displayed on the display 11 of the PC 10.
That is, when the balloon 21 abuts on the inner wall of the blood vessel and the balloon 12 further expands to apply pressure to the blood vessel in a state where the crack has occurred twice in the past, "vascular wall dissociation" exceeding the crack occurs. As there is a possibility, a "blood vessel wall dissociation occurrence alarm" is displayed on the display 11.
Therefore, it is possible to give an alarm to a doctor or the like who operates the balloon catheter 2 in advance, and it is possible to prevent the occurrence of serious itself.

In the present embodiment, when the probability that the blood vessel wall dissociation occurs is high, the “blood vessel wall dissociation occurrence alarm” is displayed on the display 11, but in the present invention, the injection of the contrast medium into the balloon catheter 2 is further forced. It may be configured to stop as a target.
In this case, the balloon catheter device 1 is safer.

Then, the process proceeds to ST65. It is determined in ST65 whether or not the "contrast medium injection stop information" has been input, and if there is an input, the process ends.
On the other hand, if there is no input of "contrast medium injection stop information" in ST65, the process proceeds to ST66.

In ST66, the “second crack occurrence determination processing unit (program) 353” of FIG. 19 operates, and the latest data stored in the “current volume increase rate storage unit 343” of FIG. Obtained as a rate Δn-1 ”, and whether or not this value is“ small ”as compared with the corresponding increase rate of the“ reference injection volume volume information ”of the“ reference injection volume volume information storage unit 336 ”in FIG. to decide.

In ST66, when the value of "most recent volume increase rate Δn-1" is "small" compared to the corresponding increase rate of "reference injection volume volume information", in ST67, the "current volume increase rate information storage" of FIG. 18 is stored. It is determined whether or not the "current volume increase rate Δn" of "Part 343" is larger than "0".
Then, if it is determined to be "larger" than "0", the process proceeds to ST68.

In ST68, it is determined that there is a possibility that "crack" has entered the inner wall of the blood vessel, "the possibility of crack occurrence" is displayed, and "+1" is added to the crack count information of the "crack count information storage unit 46" in FIG. Remember.

That is, in ST66, for example, the change in volume due to the change in the injection amount in the graph of arrow G1 in FIG. 23 is compared with the change in volume in the corresponding injection amount in the graph in arrow S1 in FIG. In the section of "L3" where the injection volume of is 0.011 mL to 0.047 mL, the rate of increase in the graph of arrow G1 is "smaller" than the rate of increase in arrow S.
This indicates that the pressure is higher than usual, that is, the balloon 21 is in contact with the inner wall of the blood vessel.

After that, in the section of L4 after 0.047 mL of the injection amount in FIG. 23, the rate of increase in the graph of arrow G1 is larger than “0”.
It is highly probable that the volume of the balloon 21 increased because the inner wall of the blood vessel cracked and the blood vessel expanded.
As described above, when the balloon 21 hits the inner wall of the blood vessel and the volume does not increase, and then it is determined that the volume has increased, it can be determined that this increase in volume is due to a crack.

In the present embodiment, as in ST66 and ST67, when the volume increases at a lower rate than the reference and then the increase rate becomes larger than "0", it is determined that "there is a risk of cracking".
However, the present invention is not limited to this, and "cracks" may simply occur when the current volume increase rate is larger than "0".

As described above, according to the present embodiment, while grasping the amount of change in the expansion process of the balloon 21, the information of the living body such as the blood vessel to which the balloon 21 is inserted is grasped according to the expansion process of the balloon 21. can do.
Further, by displaying such information on the display 11, it is possible to appropriately notify the operator and the like.

..
As described above, the balloon catheter device 1 of the present embodiment can promptly notify the operator and the like not only of the changed state of the blood vessel or the like due to the expansion of the balloon 21 but also in the case of a dangerous state. The balloon catheter device 300 is extremely safe.

In this embodiment, after the number of cracks has reached a predetermined number of times (for example, twice), an example of issuing a "blood vessel dissection occurrence alarm" when it is determined that the balloon 21 has come into contact with the inner wall of the blood vessel again. As shown, the timing of the "vascular dissection occurrence alarm" is not limited to this example.

For example, immediately after determining that "crack" may occur in ST68, it is determined whether or not the number of cracks has reached a predetermined number (for example, 2 times), and a "vascular dissection occurrence alarm" is issued at an early stage. You may. In this case, it may be a "warning for the occurrence of vascular dissection".

Further, as an example of another embodiment, different alarms may be issued at two timings. Specifically, immediately after determining that "crack" may occur in ST68, when it is determined that the number of cracks has reached a predetermined number (for example, 2 times), a "blood vessel dissection occurrence warning" is issued. After that, when it is determined that the blood vessel has come into contact with the inner wall, a "blood vessel dissection occurrence alarm" is issued.

In these cases, it is possible to call attention to a doctor or the like who operates the balloon catheter 2 from an early stage, and it is possible to prevent the occurrence of a serious situation.

Further, instead of issuing an alarm, the injection of the contrast medium into the balloon catheter 2 may be forcibly stopped.
In this case, the balloon catheter device 1 is safer.

(First modification of the second crack generation determination of the present embodiment)
FIG. 24 is a schematic view showing the relationship between the injection amount (feed amount) of the contrast medium and the volume value of the balloon showing the first modification regarding “determination of the possibility of crack occurrence”.
In this modification, unlike the second embodiment described above, the method of determining "risk of crack occurrence" is different, and therefore, the differences will be mainly described below.

First, the step of determining the “risk of cracking” in the second embodiment described above will be described.
In the second embodiment described above, as shown in ST66 and ST67 of FIG. 8, first, the rate of increase in volume at the latest injection amount immediately before is determined.
That is, the "most recent volume increase rate Δn-1" information is generated by comparing the volume value at the latest injection amount with the volume value of the most recent injection amount.

Then, in the "reference injection volume volume information" indicated by the arrow S in FIG. 23, the most recent "reference injection volume volume information" corresponding to the volume value at the most recent injection volume and the volume value of the latest injection volume described above. The volume value and the latest volume value are extracted and compared to generate "most recent increase rate" information.
Then, the "most recent volume increase rate Δn-1" and the "most recent increase rate of the reference injection volume volume information" are compared.
Specifically, if the value of the “most recent volume increase rate Δn-1” in the graph G1 is “smaller” than the “most recent increase rate of the reference injection amount pressure information” in the graph S1, the balloon 21 is the “vessel wall”. Judged as "contact state".

Next, the "current volume increase rate Δn" information is generated by comparing the volume value at the actual latest injection amount with the volume value of the current injection amount.
Then, it is determined whether or not this "current volume increase rate Δn" is larger than "0", and if it is large, it is determined that "crack generation may occur".

On the other hand, in the first modification, the "risk of crack occurrence" is determined by a different method.
First, for example, the "measured volume value" which is the pressure of the injection amount for each injection amount in FIG. 24 (for example, 0.0011 mL.0.0012 mL, etc.) and the "reference injection amount volume information" in FIG. 24 at the corresponding injection amount. , And store it as a "volume-based deviation value".
That is, the "volume-based deviation value" for each feed amount (injection amount) of the contrast medium (for example, 0.011 mL, 0.012 mL, etc.) is obtained and stored.
For example, as shown by arrows F1 to Fn in FIG. 24, the “volume-based deviation value” for each feed amount is stored.

Then, the "increase rate" of the "most recent reference deviation value", which is the latest "volume reference deviation value" immediately before the present, that is, the "most recent increase rate of the volume reference deviation value" is obtained.
Specifically, the "most recent increase rate of the volume-based deviation value" is obtained from the latest "volume-based deviation value" and the latest "volume-based deviation value".
For example, when "F11" in FIG. 24 is the current "pressure reference deviation value", the latest is "F9", and the latest is "F10", the "volume reference deviation value" of F9 and F10 is changed to F10. Find the latest "most recent increase rate of volume-based deviation value".

Next, the "current increase rate of the volume-based deviation value" is obtained from the latest "volume-based deviation value" and the current "volume-based deviation value".
Specifically, the "current increase rate of the volume-based deviation value" of F11 is obtained from the "volume-based deviation value" of F10 and the "volume-based deviation value" of F11 of FIG. 24.
Then, when the "current increase rate of the volume reference deviation value" is "larger" than "0", it is determined that "there is a risk of cracking".

In this way, by using the "current increase rate of the volume reference deviation value" as a reference, it is possible to determine the "blood vessel wall contact state" and the "risk of crack occurrence" as in the second embodiment described above. Can be done.

(Second modification of the second crack generation determination of the present embodiment)
FIG. 25 is a schematic view showing the relationship between the injection amount (feed amount) of the contrast medium and the volume value of the balloon showing the second modification regarding “determination of the possibility of crack occurrence”.
In this modification, unlike the second embodiment described above, the method of determining "risk of crack occurrence" is different, and therefore, the differences will be mainly described below.

In this modified example, as shown in FIG. 25, “the most recent increase rate of volume Δn-1 (T5)”, which is the slope of the tangent line of the volume values of the two points in the latest injection amount, and two points in the current injection amount. The "current increase rate of volume Δn-1 (T6)", which is the slope of the tangent line of the volume value of, is obtained.

Then, in this modification, the “most recent increase rate of volume Δn-1 (T5)” in FIG. 25 and the “current increase rate of volume Δn (T6)” are compared, and the degree of decrease between them is calculated. When the degree of decrease is equal to or greater than a predetermined threshold value, it is determined that "cracks may occur".

As described above, in this modification, the change in the volume of the balloon 21 due to the injection amount (feed amount) is determined by the change (increase degree) between the plurality of inclinations.
Therefore, even when the "current volume increase rate Δn" in the actual injection amount is not larger than "0", it is possible to accurately determine whether or not there is a possibility of crack occurrence.

(Modification example of the second modification of the second crack generation determination of the present embodiment)
In the second modification described above, the “most recent increase rate of volume Δn-1” (T5) and the “current increase rate of volume Δn” (T6) in FIG. 25 are compared, and the degree of increase is calculated. When the degree of increase is equal to or higher than a predetermined threshold value, it is determined that "cracks may occur".
In the case of the second modification described above, the degree of increase at the two growth rates (slopes) can be grasped, but these two "most recent increase rate Δn-1 of volume" (T5) and "volume" At present, it is not possible to grasp the degree of change (whether the change is rapid or gradual, etc.) during the rate of increase Δn ”(T6).
Therefore, in the present embodiment, the amount of minute change between the two rates of increase (slope) is grasped, and the amount of minute change such as whether the change is rapid or gentle between the two rates of increase (slope). It is configured so that the degree of increase can be grasped.

Then, in this modification, the threshold value of the degree of increase of the minute change amount is set. That is, it is a criterion for determining whether or not there has been a more abrupt change, and if a more abrupt change has occurred, it is determined that the above-mentioned "crack may occur".

In this way, in this modified example, the amount of minute change between inclinations is grasped, the degree of change in the amount of minute change is grasped, and the "risk of cracking" is determined based on this, so that the accuracy is extremely high. Judgment becomes possible.

By the way, the present invention is not limited to the above-described embodiment.

1 ... Balloon catheter device, 2 ... Balloon catheter, 3 ... Connector, 4 ... Syringe, 5 ... Syringe feeder, 6 ... Stepping motor, 7 ... Motor drive , 8 ... Pressure sensor, 9 ... A / D converter, 10 ... PC, 11 ... Display, 12 ... Various information input devices, 13 ... PC control unit, 14 ... -Communication device, 15 ... Time measuring device, 21 ... Balloon, 22 ... Shaft, 23 ... Guide wire, 24 ... Hub, 25 ... Opening, 30 ... First Various information storage units, 31 ... contrast agent injection processing unit (program), 32 ... contrast agent injection amount information storage unit, 33 ... pressure information storage unit, 34 ... injection amount related pressure information generation unit (Program), 35 ... Injection amount related pressure information storage unit, 36 ... Pressure change graph information display processing unit (program), 37 ... Reference injection amount pressure information storage unit, 40 ... Second Various information storage units, 41 ... current pressure increase rate information generation processing unit (program), 42 ... current pressure increase rate information storage unit, 45 ... first blood vessel wall contact state determination processing unit (program) ), 46 ... Crack count information storage unit, 50 ... Third various information storage units, 51 ... First blood vessel wall dissociation alarm generation processing unit (program), 52 ... First crack Occurrence / absence judgment processing unit (program),

Claims (15)

Injection information acquisition unit that acquires injection information regarding the amount of fluid injected to expand the balloon portion of the catheter placed in the living body, and balloon expansion information that acquires balloon expansion information indicating the expanded state of the balloon portion. An acquisition unit, a biological state determination unit that determines a biological change accompanying expansion of the balloon unit based on the injection information and the balloon expansion information, and a biological state determination unit.
It has a calculation unit that calculates balloon expansion change information from the injection information and the balloon expansion information, and the biological state determination unit determines a biological change based on the balloon expansion change information.
The biological state determination unit has a crack generation determination unit that determines whether or not a crack has occurred in the living body, and the crack generation determination unit is based on balloon expansion degree information generated from the balloon expansion change information. , Catheter information management device characterized by determining the presence or absence of cracks The catheter information management device according to claim 1, wherein the balloon expansion information is pressure information or volume information of the balloon portion. The balloon expansion degree information is between the difference information between the balloon expansion change information and the reference information of the balloon portion, the change information between the inclinations of the plurality of points of the balloon expansion change information, and the inclinations of the plurality of points. The catheter information management device according to claim 1 or 2, wherein the catheter information management device includes any of the minute change amount information. The biological state determination unit has a crack generation determination unit that determines whether or not a crack has occurred in the living body, and the crack generation determination unit is based on the balloon expansion change information and the current pressure increase rate at the current injection amount or get the current volume increase rate, any one of claim 1 to claim 3 wherein the current rate of pressure increase is less than or equal to 0, or the volume increase rate, characterized in that it is determined that a crack occurs when it is 0 or more The catheter information management device according to. The biological state determination unit has a crack generation determination unit that determines whether or not a crack has occurred in the living body, and the crack generation determination unit determines the latest pressure increase rate in the latest injection amount from the balloon expansion change information. The catheter information management device according to claim 4, further comprising determining that a crack has occurred when the latest pressure increase rate is greater than 0 and the current pressure increase rate is 0 or less. The biological state determining section includes a crack occurrence determination unit that determines whether a crack is generated in the living body, the crack occurrence determination unit, the last volume increase rate in the most recent injection amount from the balloon expandable change information The catheter information management device according to claim 4 , wherein it is determined that a crack has occurred when the latest volume increase rate is smaller than 0 and the current volume increase rate is 0 or more. The biological state determination unit has a biological contact determination unit that determines whether or not the balloon unit is in contact with the living body, and the crack generation determination unit is such that the biological contact determination unit determines whether or not the balloon unit is in contact with the living body. The catheter information management device according to any one of claims 4 to 6, wherein it is determined that a crack has occurred only when it is determined that the catheter is abutting. The catheter information management according to claim 7 , wherein the biological contact determination unit makes a determination by comparing the current pressure information with the reference pressure information which is the reference information in the current injection amount of the balloon portion. Device. The catheter information management according to claim 7 , wherein the biological contact determination unit makes a determination by comparing the current volume information with the reference volume information which is the reference information in the current injection amount of the balloon portion. Device. The seventh aspect of claim 7, wherein the biological contact determination unit makes a determination by comparing the current pressure increase rate with the increase rate of the reference pressure information which is the reference information in the corresponding injection amount of the balloon unit. Catheter information management device. The seventh aspect of claim 7, wherein the biological contact determination unit makes a determination by comparing the current volume increase rate with the increase rate of the reference volume information which is the reference information in the corresponding injection amount of the balloon unit. Catheter information management device. The biological wall dissociation determination unit has a biological wall dissociation determination unit that determines the probability of biological wall dissociation based on the crack occurrence frequency information generated by the crack occurrence determination unit, and the biological wall dissociation determination unit has a predetermined value of the crack occurrence frequency information. The catheter information management device according to any one of claims 4 to 11, wherein the operator is notified of the probability of dissociation of the biological wall when the value is equal to or higher than the value. The management unit has a catheter having an expandable balloon portion arranged in a living body, a fluid injection portion for injecting a fluid for expanding the balloon portion, and a management unit for managing information about the catheter portion. , An injection information acquisition unit that acquires injection information regarding the amount of fluid injected to expand the balloon unit, a balloon expansion information acquisition unit that acquires balloon expansion information indicating an expansion state of the balloon unit, and the injection. Based on the information and the balloon expansion information, a biological state determination unit that determines a biological change accompanying expansion of the balloon unit, and a biological state determination unit.
It has a calculation unit that calculates balloon expansion change information from the injection information and the balloon expansion information, and the biological state determination unit determines a biological change based on the balloon expansion change information.
The biological state determination unit has a crack generation determination unit that determines whether or not a crack has occurred in the living body, and the crack generation determination unit is based on balloon expansion degree information generated from the balloon expansion change information. , features and to Luke Tete Le equipment to determine the presence or absence of cracks. A catheter information management device that manages information about a catheter, an injection information acquisition unit that acquires injection information regarding the amount of fluid to be injected to expand the balloon portion of a catheter placed in a living body, and an expanded state of the balloon portion. Balloon expansion information acquisition unit that acquires balloon expansion information indicating, a biological state determination unit that determines a biological change accompanying expansion of the balloon unit based on the injection information and the balloon expansion information, the injection information and the balloon expansion. It functions as a calculation unit that calculates balloon expansion change information based on the information, and a crack occurrence determination unit that determines whether or not a crack has occurred in the living body.
The biological state determination unit determines the biological change based on the balloon expansion change information, and determines the biological change.
The crack occurrence determination unit is a control program of a catheter information management device that determines the presence or absence of crack occurrence based on the balloon expansion degree information generated from the balloon expansion change information . The injection information acquisition unit acquires injection information regarding the amount of fluid injected to expand the balloon portion of the catheter placed in the living body in order to expand the balloon portion of the catheter placed in the living body and expandable. , The balloon expansion information acquisition unit acquires the balloon expansion information indicating the expansion state of the balloon unit, and the biological state determination unit determines the biological change accompanying the expansion of the balloon unit based on the injection information and the balloon expansion information. Then, the calculation unit calculates the balloon expansion change information from the injection information and the balloon expansion information, and the biological state determination unit determines the biological change based on the balloon expansion change information.
The catheter information management unit, which determines whether or not a crack has occurred in the living body, determines whether or not a crack has occurred based on the balloon expansion degree information generated from the balloon expansion change information. Method .

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