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WO2024180910A1 - Indeflation device - Google Patents

Indeflation device Download PDF

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Publication number
WO2024180910A1
WO2024180910A1 PCT/JP2024/000184 JP2024000184W WO2024180910A1 WO 2024180910 A1 WO2024180910 A1 WO 2024180910A1 JP 2024000184 W JP2024000184 W JP 2024000184W WO 2024180910 A1 WO2024180910 A1 WO 2024180910A1
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WO
WIPO (PCT)
Prior art keywords
balloon
catheter
control unit
pressure
inflation device
Prior art date
Application number
PCT/JP2024/000184
Other languages
French (fr)
Japanese (ja)
Inventor
拓海 福田
一樹 仲宗根
康平 金谷
陽一郎 桑野
Original Assignee
テルモ株式会社
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Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2024180910A1 publication Critical patent/WO2024180910A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • This disclosure relates to an indeflation device.
  • Patent Document 1 discloses a device that can control the force with which a balloon at the distal end of a catheter inserted into the digestive tract or the like is pressed against the lumen.
  • Medical catheters with a balloon at the distal end are usually manufactured with the balloon in a folded state.
  • the balloon When the balloon is delivered to the treatment site, it passes through a lumen such as a blood vessel, and the balloon is usually folded in an orderly manner to improve its ability to pass through narrowed areas.
  • the balloon's outer diameter will increase and friction between parts of the balloon and the surface of the lumen will increase, reducing the balloon's ability to pass through the lumen.
  • the objective of this disclosure is to provide an inflation device that can improve the passability of a balloon through a lumen.
  • the present disclosure relates to [1] An inflation device that can be connected to a medical catheter having a balloon at a distal portion, A pump capable of pressurizing or depressurizing the balloon; A control unit for controlling the pump; a pressure sensor for measuring a pressure inside the balloon; The control unit is an inflation device capable of executing control to maintain the pressure inside the balloon at a negative pressure.
  • the control unit may execute control to maintain the pressure inside the balloon at a negative pressure based on the pressure inside the balloon measured by the pressure sensor.
  • the control unit may be capable of adjusting the magnitude of the negative pressure in response to an input operation from a user.
  • An output unit capable of issuing an alert is further provided,
  • the control unit may cause the output unit to issue an alert when the pressure inside the balloon exceeds a predetermined range.
  • the control unit may set the value of the negative pressure depending on the type of the catheter.
  • the present disclosure makes it possible to improve the passability of the balloon through the lumen.
  • FIG. 1 is a functional block diagram showing a schematic configuration of an indeflation device according to an embodiment of the present disclosure.
  • FIG. 1 is a schematic external perspective view of an indeflation device according to an embodiment of the present disclosure.
  • 13 is a flowchart illustrating an example of the operation of an indeflation device according to an embodiment of the present disclosure.
  • FIG. 1 is a functional block diagram showing the general configuration of an inflation device 10 according to an embodiment of the present disclosure.
  • FIG. 2 is a schematic external oblique view of an inflation device 10 according to an embodiment of the present disclosure. Note that in the external oblique view of the inflation device 10 shown in FIG. 2, some of the functional blocks of the inflation device 10 shown in FIG. 1 are omitted from the illustration.
  • the inflation device 10 can be connected to a catheter 200.
  • the catheter 200 is a medical catheter. As shown in FIG. 2, the catheter 200 includes a tube 201 and a balloon 202. The balloon 202 is provided at the distal portion of the tube 201.
  • Figure 2 shows the balloon 202 in an expanded state due to pressure being applied inside.
  • the balloon 202 does not expand until it reaches the treatment site.
  • the balloon 202 is in a regularly folded state.
  • the catheter 200 is inserted into the body and the balloon 202 is being delivered to the treatment site, the balloon 202 is in a folded state. This is because the outer diameter of the catheter 200 is smaller in the folded state, which works to the advantage of passing through the narrowed area.
  • the inflation device 10 can pressurize the balloon 202 and expand the balloon 202 by increasing the amount of expansion medium injected into the catheter 200.
  • the inflation device 10 can depressurize the balloon 202 and deflate the balloon 202 by decreasing the amount of expansion medium injected into the catheter 200.
  • the expansion medium injected into the catheter 200 may be, for example, a contrast agent, saline solution, helium gas, etc.
  • the inflation device 10 includes a pump 11, a pressure sensor 12, a control unit 13, an input unit 14, an output unit 15, a memory unit 16, and a power source 17.
  • the pump 11 includes a syringe 110, an actuator 120, and a driver 130.
  • the inflation device 10 includes a main body 1 and a syringe 110, as shown in the external perspective view in FIG. 2.
  • the syringe 110 is attached to the main body 1 during use, but can be detached from the main body 1.
  • the syringe 110 is detached from the main body 1.
  • FIG. 2 shows the syringe 110 being detached from the main body 1.
  • the medical professional connects the catheter 200 to the syringe 110 with the syringe 110 either detached from the main body 1 or attached to the main body 1. Note that in this embodiment, an example will be described in which the user of the inflation device 10 is a medical professional.
  • the medical staff attaches the syringe 110 to the main body 1.
  • the inflation device 10 can pressurize or depressurize the balloon 202 of the catheter 200 connected to the syringe 110.
  • the main body 1 of the inflation device 10 is mounted on a support 2.
  • the main body 1 may be movable in the vertical direction (z-axis direction) along the support 2.
  • the main body 1 includes the actuator 120, the driver 130, the control unit 13, the input unit 14, the output unit 15, the memory unit 16, and the power supply 17, which are the functional blocks of the inflation device 10 shown in Figure 1.
  • the memory unit 16 and the power supply 17 are not shown in Figure 2.
  • the pump 11 is capable of pressurizing or depressurizing the balloon 202 of the catheter 200.
  • the pump 11 can pressurize the balloon 202 and expand the balloon 202 by increasing the amount of expansion medium injected into the catheter 200.
  • the pump 11 can depressurize the balloon 202 and contract the balloon 202 by decreasing the amount of expansion medium injected into the catheter 200.
  • the pump 11 includes a syringe 110, an actuator 120, and a driver 130.
  • the syringe 110 includes a syringe body 111 and a syringe plunger 112.
  • the syringe body 111 can be connected to the tube 201 of the catheter 200.
  • an expansion medium is injected into the syringe body 111.
  • the balloon 202 is pressurized and expands.
  • the syringe plunger 112 is pulled out in the negative direction of the x-axis and the expansion medium is pulled out of the catheter 200, the balloon 202 is depressurized and contracts.
  • the actuator 120 can move the syringe plunger 112 of the syringe 110.
  • the actuator 120 can move the syringe plunger 112 along the x-axis direction.
  • the driver 130 receives a control signal from the control unit 13 and drives the actuator 120 in response to the control signal.
  • the pressure sensor 12 can measure the pressure inside the balloon 202.
  • the pressure sensor 12 may be provided, for example, inside the syringe body 111.
  • the pressure sensor 12 may be a sensor of any type capable of detecting pressure, such as a resistive film type, a capacitance type, a piezoelectric element type, or the like.
  • the pressure sensor 12 may also be of a type that estimates pressure using a force sensor such as a strain gauge.
  • the control unit 13 includes at least one processor, at least one programmable circuit, at least one dedicated circuit, or any combination of these.
  • the processor is a general-purpose processor such as a CPU or GPU, or a dedicated processor specialized for a specific process.
  • CPU is an abbreviation for Central Processing Unit.
  • GPU is an abbreviation for Graphics Processing Unit.
  • the programmable circuit is, for example, an FPGA.
  • FPGA is an abbreviation for Field-Programmable Gate Array.
  • the dedicated circuit is, for example, an ASIC.
  • ASIC is an abbreviation for Application Specific Integrated Circuit.
  • the control unit 13 executes processes related to the operation of the inflation device 10 while controlling each part of the inflation device 10.
  • the control unit 13 can control the pump 11. By controlling the pump 11, the control unit 13 can maintain the pressure inside the balloon 202 at a negative pressure. The function of the control unit 13 will be described in detail later.
  • the input unit 14 includes at least one input interface.
  • the input interface is, for example, a physical key, a capacitive key, a pointing device, a touch screen integrated with a display, or a microphone.
  • the input unit 14 accepts an operation to input data used in the operation of the indeflation device 10.
  • the input unit 14 may be connected to the indeflation device 10 as an external input device instead of being provided in the indeflation device 10.
  • a connection interface for example, an interface compatible with standards such as USB, HDMI (registered trademark), or Bluetooth (registered trademark) can be used.
  • USB is an abbreviation for Universal Serial Bus.
  • HDMI registered trademark
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  • the output unit 15 includes at least one output interface.
  • the output interface is, for example, a display such as an LCD or an organic EL display.
  • LCD is an abbreviation for Liquid Crystal Display.
  • EL is an abbreviation for Electro Luminescence.
  • the output unit 15 may further include a speaker as an output interface.
  • the output unit 15 outputs data obtained by the operation of the inflation device 10.
  • the output unit 15 may be connected to the inflation device 10 as an external output device instead of being provided in the inflation device 10.
  • a connection interface for example, an interface compatible with standards such as USB, HDMI (registered trademark), or Bluetooth (registered trademark) can be used.
  • the output unit 15 is capable of issuing an alert.
  • the output unit 15 may issue an alert by displaying the alert, or may issue an alert by sound.
  • the memory unit 16 includes at least one semiconductor memory, at least one magnetic memory, at least one optical memory, or any combination thereof.
  • the semiconductor memory is, for example, a RAM or a ROM.
  • RAM is an abbreviation for Random Access Memory.
  • ROM is an abbreviation for Read Only Memory.
  • the RAM is, for example, an SRAM or a DRAM.
  • SRAM is an abbreviation for Static Random Access Memory.
  • DRAM is an abbreviation for Dynamic Random Access Memory.
  • the ROM is, for example, an EEPROM.
  • EEPROM is an abbreviation for Electrically Erasable Programmable Read Only Memory.
  • the memory unit 16 functions, for example, as a main memory device, an auxiliary memory device, or a cache memory.
  • the memory unit 16 stores data used in the operation of the inflation device 10 and data obtained by the operation of the inflation device 10.
  • the power supply 17 supplies power to each functional block of the indeflation device 10.
  • the power supply 17 may be a battery or an adapter capable of receiving power from a commercial power source.
  • the memory unit 16 prestores a negative pressure value suitable for the catheter 200 in association with the type of catheter 200.
  • the type is determined based on the name of the catheter 200 and the size of the balloon 202.
  • This negative pressure value is an appropriate negative pressure value to set as the pressure inside the balloon 202 when the catheter 200 is inserted into the patient's body and passed through a lumen such as a blood vessel to deliver the balloon 202 to the treatment site.
  • negative pressure means a pressure lower than atmospheric pressure.
  • the balloon 202 of the catheter 200 is maintained at a negative pressure associated with the type of catheter 200, preventing it from becoming dislodged as it moves through a lumen within the patient's body.
  • the memory unit 16 may store a negative pressure value suitable for the catheter 200, in association with not only the type of catheter 200 but also the type and temperature of the catheter 200. In this way, by associating the negative pressure value with the temperature, the inflation device 10 can set a negative pressure that takes into account the effects of temperature.
  • the memory unit 16 may also store a negative pressure value suitable for the catheter 200 in association with other surrounding environments, such as humidity, in addition to temperature.
  • the memory unit 16 may also store data relating to the relationship between the amount of expansion medium injected into the catheter 200 and the pressure inside the balloon 202, in association with the type of catheter 200.
  • the data relating to the relationship between the amount of expansion medium injected into the catheter 200 and the pressure inside the balloon 202 may be data previously obtained through experiments.
  • the inflation device 10 can inject an appropriate amount of expansion medium into the catheter 200 when adjusting the pressure inside the balloon 202.
  • the input unit 14 acquires information on the type of catheter 200 through an input operation by a medical professional. Note that input operations and input correction operations may be performed after connecting the catheter 200 to the inflation device 10.
  • the control unit 13 recognizes the type of catheter 200 to be connected to the inflation device 10 based on the information acquired by the input unit 14.
  • the medical staff connects the catheter 200 to the inflation device 10. Once the catheter 200 is connected to the inflation device 10, the medical staff drives the pump 11 to remove any air from inside the catheter 200. Removing air means removing the gas from inside the catheter 200. This operation may be performed by the medical staff via the input unit 14, or may be performed automatically upon detection of the connection of the catheter 200 to the inflation device 10.
  • the medical staff After performing the air removal, the medical staff then injects the expansion medium into the catheter 200. At this time, the medical staff operates the catheter 200 so that the internal pressure of the catheter 200 does not exceed atmospheric pressure, causing the outer diameter of the balloon 202 to not become larger than the outer diameter before it was connected to the inflation device 10.
  • the control unit 13 executes control to maintain the pressure inside the balloon 202 at a negative pressure.
  • the control unit 13 refers to the memory unit 16 and controls the pressure inside the balloon 202 so as to maintain a negative pressure value according to the type of catheter 200 connected. Note that the medical professional can change the negative pressure value referenced from the memory unit 16 via the input unit 14 at any time.
  • the medical staff inserts the catheter 200 into the patient's body while the pressure inside the balloon 202 is maintained at negative pressure, and delivers the balloon 202 to the treatment site.
  • the control unit 13 executes control to maintain the pressure inside the balloon 202 at negative pressure. In this way, by maintaining the pressure inside the balloon 202 at negative pressure, the balloon 202 is less likely to unfold even if there is abrasion between the balloon 202 and the lumen during delivery to the treatment site. This makes it possible to improve the passability of the balloon 202 through the lumen.
  • the control unit 13 may execute control to maintain the pressure inside the balloon 202 at a negative pressure based on the pressure inside the balloon 202 measured by the pressure sensor 12. For example, when the pressure inside the balloon 202 measured by the pressure sensor 12 is higher than the desired negative pressure value, the control unit 13 reduces the pressure inside the balloon 202 by pulling out the syringe plunger 112 to reduce the amount of expansion medium injected into the catheter 200. Also, when the pressure inside the balloon 202 measured by the pressure sensor 12 is lower than the desired negative pressure value, the control unit 13 increases the pressure inside the balloon 202 by pushing in the syringe plunger 112 to increase the amount of expansion medium injected into the catheter 200.
  • control unit 13 When the control unit 13 executes control to maintain the pressure inside the balloon 202 at a negative pressure, the control unit 13 may adjust the amount of expansion medium injected into the catheter 200 based on data stored in the memory unit 16 on the relationship between the amount of expansion medium injected into the catheter 200 and the pressure inside the balloon 202. Note that the amount of expansion medium injected into the catheter 200 is proportional to the amount of movement of the syringe plunger 112 when the inner diameter of the syringe body 111 is within a certain range.
  • the control unit 13 can adjust the magnitude of the negative pressure in response to an input operation by the medical staff on the input unit 14.
  • the control unit 13 controls the pump 11 to maintain a negative pressure higher than the current negative pressure as a set value.
  • the control unit 13 controls the pump 11 to maintain a negative pressure lower than the current negative pressure as a set value.
  • the control unit 13 determines whether the pressure inside the balloon 202 is within a predetermined range while maintaining the pressure inside the balloon 202 at a negative pressure. When the pressure inside the balloon 202 exceeds the predetermined range, the control unit 13 causes the output unit 15 to issue an alert. This allows the inflation device 10 to warn medical personnel that there may be an abnormality in the balloon 202, for example, if the balloon 202 is damaged.
  • control unit 13 ends the control to maintain the pressure inside the balloon 202 at negative pressure in response to an input operation by the medical professional on the input unit 14, and returns the pressure inside the balloon 202 to atmospheric pressure.
  • control unit 13 starts pressurizing the balloon 202 in response to input operations made by the medical professional to the input unit 14, expanding the balloon 202 and performing the treatment.
  • Step S101 The control unit 13 of the inflation device 10 recognizes the type of catheter 200 to be connected to the inflation device 10 based on information acquired by the input unit 14 from a medical professional.
  • Step S102 The medical professional connects the catheter 200 to the inflation device 10.
  • Step S103 The medical staff removes the air from inside the catheter 200.
  • Step S104 The medical staff injects the expansion medium into the catheter 200.
  • Step S105 When the input unit 14 receives an instruction from the medical professional to start control to maintain the pressure inside the balloon 202 at a negative pressure, the control unit 13 executes control to maintain the pressure inside the balloon 202 at a negative pressure.
  • Step S106 While maintaining the pressure inside the balloon 202 at negative pressure, the medical staff inserts the catheter 200 into the patient's body and delivers the balloon 202 to the treatment site.
  • Step S107 When the balloon 202 reaches the treatment site, the control unit 13 ends the control to maintain the pressure inside the balloon 202 at negative pressure in response to an input operation by the medical professional to the input unit 14, and returns the pressure inside the balloon 202 to atmospheric pressure.
  • Step S108 Once the balloon 202 has been delivered to the treatment site, the control unit 13 starts pressurizing the balloon 202 in response to an input operation by the medical professional to the input unit 14.
  • the control unit 13 can execute control to maintain the pressure inside the balloon 202 at a negative pressure. This makes it difficult for the balloon 202 to unfold even if abrasion occurs between the balloon 202 and the lumen during delivery to the treatment site. Therefore, the inflation device 10 of this embodiment can improve the passability of the balloon 202 within the lumen.
  • the inflation device 10 is equipped with a pressure sensor 12 and a control unit 13, but the pressure sensor 12 and the control unit 13 may be external to the inflation device 10.
  • the pressure sensor 12 is provided inside the syringe body 111 of the syringe 110, but the pressure sensor 12 may also be provided inside the catheter 200.
  • the pressure sensor 12 may also be connected to the tube 201.
  • the pressure sensor 12 may also be provided in the actuator 120, and may be of a type capable of measuring pressure from the force applied to the syringe plunger 112.
  • the main body 1 of the inflation device 10 is installed on the support 2, but the main body 1 of the inflation device 10 does not have to be installed on the support 2.

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Abstract

This indeflation device is an indeflation device that can be connected to a medical catheter having a balloon at the distal end thereof, the indeflation device including a pump that can compress or decompress the balloon, a control unit that controls the pump, and a pressure sensor that measures the pressure inside the balloon, wherein the control unit can control to maintain the pressure inside the balloon at negative pressure.

Description

インデフレーション装置Indeflation device
　本開示は、インデフレーション装置に関する。 This disclosure relates to an indeflation device.
　従来、遠位部にバルーンを有する医療用のカテーテルのバルーンを、ポンプによって拡張及び収縮させることが可能な装置が知られている。 　Conventionally, there is known a device that can use a pump to expand and contract the balloon of a medical catheter that has a balloon at its distal end.
　例えば特許文献１は、消化管などに挿入されたカテーテルの遠位部のバルーンを管腔へ押し付ける力を制御可能な装置を開示している。 For example, Patent Document 1 discloses a device that can control the force with which a balloon at the distal end of a catheter inserted into the digestive tract or the like is pressed against the lumen.
特開２０１４－１８８０８１号公報JP 2014-188081 A
　遠位部にバルーンを有する医療用のカテーテルは、通常、製造段階ではバルーンが折りたたまれた状態で製造されている。バルーンを治療部位まで送達する際、バルーンは血管などの管腔を通過するが、狭窄部を通過する際の通過性を高めるために、バルーンは、通常、規則正しく折りたたまれている。 Medical catheters with a balloon at the distal end are usually manufactured with the balloon in a folded state. When the balloon is delivered to the treatment site, it passes through a lumen such as a blood vessel, and the balloon is usually folded in an orderly manner to improve its ability to pass through narrowed areas.
　治療部位までの送達時において、バルーン内の圧力変化、バルーンと血管との擦過などによってバルーンの折りたたみが乱れると、バルーンの外径が大きくなったり、バルーンの一部と管腔表面との摩擦が上昇したりすることで、バルーンが管腔を通過する際の通過性が低下する。 If the balloon becomes unfolded during delivery to the treatment site due to pressure changes within the balloon or friction between the balloon and the blood vessel, the balloon's outer diameter will increase and friction between parts of the balloon and the surface of the lumen will increase, reducing the balloon's ability to pass through the lumen.
　本開示の目的は、管腔内におけるバルーンの通過性を向上させることができるインデフレーション装置を提供することにある。 The objective of this disclosure is to provide an inflation device that can improve the passability of a balloon through a lumen.
　本開示は、
［１］遠位部にバルーンを有する医療用のカテーテルと接続可能なインデフレーション装置であって、
　前記バルーンを加圧又は減圧することが可能なポンプと、
　前記ポンプを制御する制御部と、
　前記バルーンの内部の圧力を測定する圧力センサと、を備え、
　前記制御部は、前記バルーンの内部の圧力を陰圧に維持する制御を実行することが可能である、インデフレーション装置である。 The present disclosure relates to
[1] An inflation device that can be connected to a medical catheter having a balloon at a distal portion,
A pump capable of pressurizing or depressurizing the balloon;
A control unit for controlling the pump;
a pressure sensor for measuring a pressure inside the balloon;
The control unit is an inflation device capable of executing control to maintain the pressure inside the balloon at a negative pressure.
［２］前記［１］に記載のインデフレーション装置において、
　前記制御部は、前記圧力センサが測定した前記バルーンの内部の圧力に基づいて、前記バルーンの内部の圧力を陰圧に維持する制御を実行してよい。 [2] In the inflation device described in [1],
The control unit may execute control to maintain the pressure inside the balloon at a negative pressure based on the pressure inside the balloon measured by the pressure sensor.
［３］前記［１］又は［２］に記載のインデフレーション装置において、
　前記制御部は、ユーザからの入力操作に応じて、前記陰圧の大きさを調整可能であってよい。 [3] In the inflation device according to [1] or [2],
The control unit may be capable of adjusting the magnitude of the negative pressure in response to an input operation from a user.
［４］前記［１］から［３］のいずれかに記載のインデフレーション装置において、
　アラートを発報することが可能な出力部をさらに備え、
　前記制御部は、前記バルーンの内部の圧力が所定の範囲を超えると、前記出力部にアラートを発報させてよい。 [4] In the inflation device according to any one of [1] to [3],
An output unit capable of issuing an alert is further provided,
The control unit may cause the output unit to issue an alert when the pressure inside the balloon exceeds a predetermined range.
［５］前記［１］から［４］のいずれかに記載のインデフレーション装置において、
　前記制御部は、前記カテーテルの種類に応じて前記陰圧の値を設定してよい。 [5] In the inflation device according to any one of [1] to [4],
The control unit may set the value of the negative pressure depending on the type of the catheter.
　本開示によれば、管腔内におけるバルーンの通過性を向上させることができる。 The present disclosure makes it possible to improve the passability of the balloon through the lumen.
本開示の実施形態に係るインデフレーション装置の概略構成を示す機能ブロック図である。FIG. 1 is a functional block diagram showing a schematic configuration of an indeflation device according to an embodiment of the present disclosure. 本開示の実施形態に係るインデフレーション装置の概略的な外観斜視図である。FIG. 1 is a schematic external perspective view of an indeflation device according to an embodiment of the present disclosure. 本開示の実施形態に係るインデフレーション装置の動作の一例を示すフローチャートである。13 is a flowchart illustrating an example of the operation of an indeflation device according to an embodiment of the present disclosure.
　以下、本開示の実施形態について、図面を参照して説明する。 Embodiments of the present disclosure are described below with reference to the drawings.
　各図中、同一又は相当する部分には、同一符号を付している。本実施形態の説明において、同一又は相当する部分については、説明を適宜省略又は簡略化する。 In each figure, identical or corresponding parts are given the same reference numerals. In the description of this embodiment, the description of identical or corresponding parts will be omitted or simplified as appropriate.
　図１は、本開示の実施形態に係るインデフレーション装置１０の概略構成を示す機能ブロック図である。図２は、本開示の実施形態に係るインデフレーション装置１０の概略的な外観斜視図である。なお、図２に示すインデフレーション装置１０の外観斜視図においては、図１に示すインデフレーション装置１０の機能ブロックのうち図示を省略している機能ブロックがある。 FIG. 1 is a functional block diagram showing the general configuration of an inflation device 10 according to an embodiment of the present disclosure. FIG. 2 is a schematic external oblique view of an inflation device 10 according to an embodiment of the present disclosure. Note that in the external oblique view of the inflation device 10 shown in FIG. 2, some of the functional blocks of the inflation device 10 shown in FIG. 1 are omitted from the illustration.
　図１及び図２を参照して、本開示の実施形態に係るインデフレーション装置１０の構成及び機能について説明する。 The configuration and functions of the inflation device 10 according to an embodiment of the present disclosure will be described with reference to Figures 1 and 2.
　インデフレーション装置１０は、カテーテル２００と接続可能である。カテーテル２００は、医療用のカテーテルである。図２に示すように、カテーテル２００は、チューブ２０１と、バルーン２０２とを備える。バルーン２０２は、チューブ２０１の遠位部に設けられている。 The inflation device 10 can be connected to a catheter 200. The catheter 200 is a medical catheter. As shown in FIG. 2, the catheter 200 includes a tube 201 and a balloon 202. The balloon 202 is provided at the distal portion of the tube 201.
　図２は、バルーン２０２の内部が加圧されて拡張した状態を示している。実際には、バルーン２０２が拡張した状態となるのは、バルーン２０２が治療部位に到達してからである。製造段階においては、バルーン２０２は、規則正しく折りたたまれた状態である。また、カテーテル２００を体内に挿入して、バルーン２０２を治療部位に送達している間は、バルーン２０２は、折りたたまれた状態である。これは、折りたたまれた状態の方がカテーテル２００の外径が小さく、狭窄部の通過に有利に働くためである。 Figure 2 shows the balloon 202 in an expanded state due to pressure being applied inside. In reality, the balloon 202 does not expand until it reaches the treatment site. During the manufacturing stage, the balloon 202 is in a regularly folded state. Also, while the catheter 200 is inserted into the body and the balloon 202 is being delivered to the treatment site, the balloon 202 is in a folded state. This is because the outer diameter of the catheter 200 is smaller in the folded state, which works to the advantage of passing through the narrowed area.
　インデフレーション装置１０は、カテーテル２００に注入する拡張媒体の量を増やすことによって、バルーン２０２を加圧し、バルーン２０２を拡張させることができる。インデフレーション装置１０は、カテーテル２００に注入された拡張媒体の量を減らすことによって、バルーン２０２を減圧し、バルーン２０２を収縮させることができる。 The inflation device 10 can pressurize the balloon 202 and expand the balloon 202 by increasing the amount of expansion medium injected into the catheter 200. The inflation device 10 can depressurize the balloon 202 and deflate the balloon 202 by decreasing the amount of expansion medium injected into the catheter 200.
　カテーテル２００に注入される拡張媒体は、例えば、造影剤、生理食塩水、ヘリウムガスなどであってよい。 The expansion medium injected into the catheter 200 may be, for example, a contrast agent, saline solution, helium gas, etc.
　図１に示すように、インデフレーション装置１０は、ポンプ１１と、圧力センサ１２と、制御部１３と、入力部１４と、出力部１５と、記憶部１６と、電源１７とを備える。 As shown in FIG. 1, the inflation device 10 includes a pump 11, a pressure sensor 12, a control unit 13, an input unit 14, an output unit 15, a memory unit 16, and a power source 17.
　ポンプ１１は、シリンジ１１０と、アクチュエータ１２０と、ドライバ１３０とを備える。 The pump 11 includes a syringe 110, an actuator 120, and a driver 130.
　インデフレーション装置１０は、図２に示す外観斜視図のように、本体１と、シリンジ１１０とを備える。シリンジ１１０は、使用時は本体１に装着されているが、本体１から脱着することが可能である。カテーテル２００をシリンジ１１０に接続する際などは、シリンジ１１０は、本体１から脱着される。 The inflation device 10 includes a main body 1 and a syringe 110, as shown in the external perspective view in FIG. 2. The syringe 110 is attached to the main body 1 during use, but can be detached from the main body 1. When connecting the catheter 200 to the syringe 110, for example, the syringe 110 is detached from the main body 1.
　図２は、シリンジ１１０が、本体１から脱着されている様子を示している。シリンジ１１０にカテーテル２００を接続する際は、医療従事者は、シリンジ１１０を本体１から取り外した状態又は本体１に装着した状態で、カテーテル２００をシリンジ１１０に接続する。なお、本実施形態においては、インデフレーション装置１０のユーザが医療従事者である場合を例として説明する。 FIG. 2 shows the syringe 110 being detached from the main body 1. When connecting the catheter 200 to the syringe 110, the medical professional connects the catheter 200 to the syringe 110 with the syringe 110 either detached from the main body 1 or attached to the main body 1. Note that in this embodiment, an example will be described in which the user of the inflation device 10 is a medical professional.
　シリンジ１１０を本体１から外した状態でカテーテル２００をシリンジ１１０に接続した場合、医療従事者は、シリンジ１１０を本体１に装着する。この状態において、インデフレーション装置１０は、シリンジ１１０に接続されたカテーテル２００のバルーン２０２を、加圧又は減圧することが可能である。 When the catheter 200 is connected to the syringe 110 with the syringe 110 removed from the main body 1, the medical staff attaches the syringe 110 to the main body 1. In this state, the inflation device 10 can pressurize or depressurize the balloon 202 of the catheter 200 connected to the syringe 110.
　図２に示すように、インデフレーション装置１０の本体１は、支柱２に設置されている。本体１は、支柱２に沿って上下方向（ｚ軸方向）に移動可能であってよい。 As shown in FIG. 2, the main body 1 of the inflation device 10 is mounted on a support 2. The main body 1 may be movable in the vertical direction (z-axis direction) along the support 2.
　本体１は、図１に示したインデフレーション装置１０の機能ブロックのうち、アクチュエータ１２０と、ドライバ１３０と、制御部１３と、入力部１４と、出力部１５と、記憶部１６と、電源１７とを備える。図２においては、記憶部１６及び電源１７の図示を省略している。 The main body 1 includes the actuator 120, the driver 130, the control unit 13, the input unit 14, the output unit 15, the memory unit 16, and the power supply 17, which are the functional blocks of the inflation device 10 shown in Figure 1. The memory unit 16 and the power supply 17 are not shown in Figure 2.
　図１を参照して、インデフレーション装置１０の各機能ブロックについて説明する。 Referring to Figure 1, we will explain each functional block of the indeflation device 10.
　ポンプ１１は、カテーテル２００のバルーン２０２を加圧又は減圧することが可能である。ポンプ１１は、カテーテル２００に注入する拡張媒体の量を増やすことによって、バルーン２０２を加圧し、バルーン２０２を拡張させることができる。ポンプ１１は、カテーテル２００に注入された拡張媒体の量を減らすことによって、バルーン２０２を減圧し、バルーン２０２を収縮させることができる。 The pump 11 is capable of pressurizing or depressurizing the balloon 202 of the catheter 200. The pump 11 can pressurize the balloon 202 and expand the balloon 202 by increasing the amount of expansion medium injected into the catheter 200. The pump 11 can depressurize the balloon 202 and contract the balloon 202 by decreasing the amount of expansion medium injected into the catheter 200.
　上述のように、ポンプ１１は、シリンジ１１０と、アクチュエータ１２０と、ドライバ１３０とを備える。 As described above, the pump 11 includes a syringe 110, an actuator 120, and a driver 130.
　シリンジ１１０は、図２に示すように、シリンジ本体１１１と、シリンジ押子１１２とを備える。 As shown in FIG. 2, the syringe 110 includes a syringe body 111 and a syringe plunger 112.
　シリンジ本体１１１は、カテーテル２００のチューブ２０１と接続可能である。カテーテル２００のバルーン２０２を加圧又は減圧する際、シリンジ本体１１１には、拡張媒体が注入されている。 The syringe body 111 can be connected to the tube 201 of the catheter 200. When the balloon 202 of the catheter 200 is pressurized or depressurized, an expansion medium is injected into the syringe body 111.
　シリンジ押子１１２がｘ軸の正方向に押し込まれて拡張媒体がカテーテル２００に注入されると、バルーン２０２は加圧されて拡張する。シリンジ押子１１２がｘ軸の負方向に引き出されて拡張媒体がカテーテル２００から引き出されると、バルーン２０２は減圧されて収縮する。 When the syringe plunger 112 is pushed in the positive direction of the x-axis and the expansion medium is injected into the catheter 200, the balloon 202 is pressurized and expands. When the syringe plunger 112 is pulled out in the negative direction of the x-axis and the expansion medium is pulled out of the catheter 200, the balloon 202 is depressurized and contracts.
　アクチュエータ１２０は、シリンジ１１０のシリンジ押子１１２を動かすことができる。図２に示す例においては、アクチュエータ１２０は、シリンジ押子１１２をｘ軸方向に沿って動かすことができる。 The actuator 120 can move the syringe plunger 112 of the syringe 110. In the example shown in FIG. 2, the actuator 120 can move the syringe plunger 112 along the x-axis direction.
　ドライバ１３０は、制御部１３から制御信号を受信し、当該制御信号に応じて、アクチュエータ１２０を駆動する。 The driver 130 receives a control signal from the control unit 13 and drives the actuator 120 in response to the control signal.
　圧力センサ１２は、バルーン２０２の内部の圧力を測定することができる。圧力センサ１２は、例えば、シリンジ本体１１１の内部に設けられていてよい。圧力センサ１２は、抵抗膜方式、静電容量方式、圧電素子方式などのような、圧力を検出することが可能な任意の方式のセンサであってよい。また、圧力センサ１２は、歪みゲージなどの力センサを用いて圧力を推定する形式であってもよい。 The pressure sensor 12 can measure the pressure inside the balloon 202. The pressure sensor 12 may be provided, for example, inside the syringe body 111. The pressure sensor 12 may be a sensor of any type capable of detecting pressure, such as a resistive film type, a capacitance type, a piezoelectric element type, or the like. The pressure sensor 12 may also be of a type that estimates pressure using a force sensor such as a strain gauge.
　制御部１３は、少なくとも１つのプロセッサ、少なくとも１つのプログラマブル回路、少なくとも１つの専用回路、又はこれらの任意の組合せを含む。プロセッサは、ＣＰＵ若しくはＧＰＵなどの汎用プロセッサ、又は特定の処理に特化した専用プロセッサである。「ＣＰＵ」は、Central Processing Unitの略語である。「ＧＰＵ」は、Graphics Processing Unitの略語である。プログラマブル回路は、例えば、ＦＰＧＡである。「ＦＰＧＡ」は、Field-Programmable Gate Arrayの略語である。専用回路は、例えば、ＡＳＩＣである。「ＡＳＩＣ」は、Application Specific Integrated Circuitの略語である。制御部１３は、インデフレーション装置１０の各部を制御しながら、インデフレーション装置１０の動作に関わる処理を実行する。 The control unit 13 includes at least one processor, at least one programmable circuit, at least one dedicated circuit, or any combination of these. The processor is a general-purpose processor such as a CPU or GPU, or a dedicated processor specialized for a specific process. "CPU" is an abbreviation for Central Processing Unit. "GPU" is an abbreviation for Graphics Processing Unit. The programmable circuit is, for example, an FPGA. "FPGA" is an abbreviation for Field-Programmable Gate Array. The dedicated circuit is, for example, an ASIC. "ASIC" is an abbreviation for Application Specific Integrated Circuit. The control unit 13 executes processes related to the operation of the inflation device 10 while controlling each part of the inflation device 10.
　制御部１３は、ポンプ１１を制御することができる。制御部１３は、ポンプ１１を制御することによって、バルーン２０２の内部の圧力を陰圧に維持することができる。制御部１３の機能の詳細については後述する。 The control unit 13 can control the pump 11. By controlling the pump 11, the control unit 13 can maintain the pressure inside the balloon 202 at a negative pressure. The function of the control unit 13 will be described in detail later.
　入力部１４は、少なくとも１つの入力用インタフェースを含む。入力用インタフェースは、例えば、物理キー、静電容量キー、ポインティングデバイス、ディスプレイと一体的に設けられたタッチスクリーン、又はマイクロフォンである。入力部１４は、インデフレーション装置１０の動作に用いられるデータを入力する操作を受け付ける。入力部１４は、インデフレーション装置１０に備えられる代わりに、外部の入力機器としてインデフレーション装置１０に接続されてもよい。接続用インタフェースとしては、例えば、ＵＳＢ、ＨＤＭＩ（登録商標）、又はBluetooth（登録商標）などの規格に対応したインタフェースを用いることができる。「ＵＳＢ」は、Universal Serial Busの略語である。「ＨＤＭＩ（登録商標）」は、High-Definition Multimedia Interfaceの略語である。 The input unit 14 includes at least one input interface. The input interface is, for example, a physical key, a capacitive key, a pointing device, a touch screen integrated with a display, or a microphone. The input unit 14 accepts an operation to input data used in the operation of the indeflation device 10. The input unit 14 may be connected to the indeflation device 10 as an external input device instead of being provided in the indeflation device 10. As a connection interface, for example, an interface compatible with standards such as USB, HDMI (registered trademark), or Bluetooth (registered trademark) can be used. "USB" is an abbreviation for Universal Serial Bus. "HDMI (registered trademark)" is an abbreviation for High-Definition Multimedia Interface.
　出力部１５は、少なくとも１つの出力用インタフェースを含む。出力用インタフェースは、例えば、ＬＣＤ又は有機ＥＬディスプレイなどのディスプレイである。「ＬＣＤ」は、Liquid Crystal Displayの略語である。「ＥＬ」は、Electro Luminescenceの略語である。出力部１５は、出力用インタフェースとして、さらに、スピーカを含んでいてもよい。出力部１５は、インデフレーション装置１０の動作によって得られるデータを出力する。出力部１５は、インデフレーション装置１０に備えられる代わりに、外部の出力機器としてインデフレーション装置１０に接続されてもよい。接続用インタフェースとしては、例えば、ＵＳＢ、ＨＤＭＩ（登録商標）、又はBluetooth（登録商標）などの規格に対応したインタフェースを用いることができる。 The output unit 15 includes at least one output interface. The output interface is, for example, a display such as an LCD or an organic EL display. "LCD" is an abbreviation for Liquid Crystal Display. "EL" is an abbreviation for Electro Luminescence. The output unit 15 may further include a speaker as an output interface. The output unit 15 outputs data obtained by the operation of the inflation device 10. The output unit 15 may be connected to the inflation device 10 as an external output device instead of being provided in the inflation device 10. As a connection interface, for example, an interface compatible with standards such as USB, HDMI (registered trademark), or Bluetooth (registered trademark) can be used.
　出力部１５は、アラートを発報することが可能である。出力部１５は、アラートを表示することによってアラートを発報してもよいし、音声によってアラートを発報してもよい。 The output unit 15 is capable of issuing an alert. The output unit 15 may issue an alert by displaying the alert, or may issue an alert by sound.
　記憶部１６は、少なくとも１つの半導体メモリ、少なくとも１つの磁気メモリ、少なくとも１つの光メモリ、又はこれらの任意の組合せを含む。半導体メモリは、例えば、ＲＡＭ又はＲＯＭである。「ＲＡＭ」は、Random Access Memoryの略語である。「ＲＯＭ」は、Read Only Memoryの略語である。ＲＡＭは、例えば、ＳＲＡＭ又はＤＲＡＭである。「ＳＲＡＭ」は、Static Random Access Memoryの略語である。「ＤＲＡＭ」は、Dynamic Random Access Memoryの略語である。ＲＯＭは、例えば、ＥＥＰＲＯＭである。「ＥＥＰＲＯＭ」は、Electrically Erasable Programmable Read Only Memoryの略語である。記憶部１６は、例えば、主記憶装置、補助記憶装置、又はキャッシュメモリとして機能する。記憶部１６には、インデフレーション装置１０の動作に用いられるデータと、インデフレーション装置１０の動作によって得られたデータとが記憶される。 The memory unit 16 includes at least one semiconductor memory, at least one magnetic memory, at least one optical memory, or any combination thereof. The semiconductor memory is, for example, a RAM or a ROM. "RAM" is an abbreviation for Random Access Memory. "ROM" is an abbreviation for Read Only Memory. The RAM is, for example, an SRAM or a DRAM. "SRAM" is an abbreviation for Static Random Access Memory. "DRAM" is an abbreviation for Dynamic Random Access Memory. The ROM is, for example, an EEPROM. "EEPROM" is an abbreviation for Electrically Erasable Programmable Read Only Memory. The memory unit 16 functions, for example, as a main memory device, an auxiliary memory device, or a cache memory. The memory unit 16 stores data used in the operation of the inflation device 10 and data obtained by the operation of the inflation device 10.
　電源１７は、インデフレーション装置１０の各機能ブロックに電源を供給する。電源１７は、バッテリであってもよいし、商用電源から電力供給を受けることが可能なアダプタであってもよい。 The power supply 17 supplies power to each functional block of the indeflation device 10. The power supply 17 may be a battery or an adapter capable of receiving power from a commercial power source.
（インデフレーション装置の動作）
　続いて、インデフレーション装置１０の動作について説明する。 (Operation of the indeflation device)
Next, the operation of the indeflation device 10 will be described.
　記憶部１６は、カテーテル２００の種類に関連付けて、当該カテーテル２００に適した陰圧の値を予め格納している。なお、種類とはカテーテル２００の品名及びバルーン２０２のサイズに基づき分けられるものである。この陰圧の値は、カテーテル２００を患者の体内に挿入して、血管などの管腔内を通過させてバルーン２０２を治療部位へ送達する際に、バルーン２０２の内部の圧力として設定することが適切な陰圧の値である。なお、陰圧は、大気圧より低い圧力を意味する。 The memory unit 16 prestores a negative pressure value suitable for the catheter 200 in association with the type of catheter 200. The type is determined based on the name of the catheter 200 and the size of the balloon 202. This negative pressure value is an appropriate negative pressure value to set as the pressure inside the balloon 202 when the catheter 200 is inserted into the patient's body and passed through a lumen such as a blood vessel to deliver the balloon 202 to the treatment site. Note that negative pressure means a pressure lower than atmospheric pressure.
　カテーテル２００のバルーン２０２は、当該カテーテル２００の種類に関連付けられた陰圧に維持されていることにより、患者の体内において管腔内を移動する際に、折りたたまれた状態が乱れることを防ぐことができる。 The balloon 202 of the catheter 200 is maintained at a negative pressure associated with the type of catheter 200, preventing it from becoming dislodged as it moves through a lumen within the patient's body.
　記憶部１６は、カテーテル２００の種類だけでなく、カテーテル２００の種類及び温度に関連付けて、当該カテーテル２００に適した陰圧の値を格納していてもよい。このように、陰圧の値を温度にも関連付けることにより、インデフレーション装置１０は、温度の影響も考慮した陰圧を設定することができる。 The memory unit 16 may store a negative pressure value suitable for the catheter 200, in association with not only the type of catheter 200 but also the type and temperature of the catheter 200. In this way, by associating the negative pressure value with the temperature, the inflation device 10 can set a negative pressure that takes into account the effects of temperature.
　また、記憶部１６は、温度だけでなく、例えば湿度のような、その他の周辺環境に関連付けて、カテーテル２００に適した陰圧の値を格納していてもよい。 The memory unit 16 may also store a negative pressure value suitable for the catheter 200 in association with other surrounding environments, such as humidity, in addition to temperature.
　また、記憶部１６は、カテーテル２００の種類に関連付けて、カテーテル２００に注入する拡張媒体の量と、バルーン２０２の内部の圧力との関係のデータを格納していてよい。カテーテル２００に注入する拡張媒体の量と、バルーン２０２の内部の圧力との関係のデータは、予め実験によって取得したデータであってよい。カテーテル２００に注入する拡張媒体の量と、バルーン２０２の内部の圧力との関係のデータを参照することにより、インデフレーション装置１０は、バルーン２０２の内部の圧力を調整する際に、適切な量の拡張媒体をカテーテル２００に注入することができる。 The memory unit 16 may also store data relating to the relationship between the amount of expansion medium injected into the catheter 200 and the pressure inside the balloon 202, in association with the type of catheter 200. The data relating to the relationship between the amount of expansion medium injected into the catheter 200 and the pressure inside the balloon 202 may be data previously obtained through experiments. By referring to the data relating to the relationship between the amount of expansion medium injected into the catheter 200 and the pressure inside the balloon 202, the inflation device 10 can inject an appropriate amount of expansion medium into the catheter 200 when adjusting the pressure inside the balloon 202.
　カテーテル２００をインデフレーション装置１０に接続する前に、入力部１４は、カテーテル２００の種類の情報を、医療従事者の入力操作によって取得する。なお、カテーテル２００をインデフレーション装置１０に接続した後に、入力操作及び入力の訂正操作などを行ってもよい。 Before connecting the catheter 200 to the inflation device 10, the input unit 14 acquires information on the type of catheter 200 through an input operation by a medical professional. Note that input operations and input correction operations may be performed after connecting the catheter 200 to the inflation device 10.
　制御部１３は、入力部１４が取得した情報に基づいて、インデフレーション装置１０に接続するカテーテル２００の種類を認識する。 The control unit 13 recognizes the type of catheter 200 to be connected to the inflation device 10 based on the information acquired by the input unit 14.
　医療従事者は、カテーテル２００をインデフレーション装置１０に接続する。医療従事者は、カテーテル２００がインデフレーション装置１０に接続されると、ポンプ１１を駆動させてカテーテル２００の内部のエア抜きを実行する。エア抜きとは、カテーテル２００の内部の気体を抜くことである。この操作は医療従事者による入力部１４を介した操作に従って行ってもよいし、カテーテル２００のインデフレーション装置１０への接続を検知して自動で行ってもよい。 The medical staff connects the catheter 200 to the inflation device 10. Once the catheter 200 is connected to the inflation device 10, the medical staff drives the pump 11 to remove any air from inside the catheter 200. Removing air means removing the gas from inside the catheter 200. This operation may be performed by the medical staff via the input unit 14, or may be performed automatically upon detection of the connection of the catheter 200 to the inflation device 10.
　医療従事者は、エア抜きを実行すると、続いて、カテーテル２００の内部に拡張媒体を注入する。この際、カテーテル２００の内部圧力が大気圧以上になって、バルーン２０２の外径がインデフレーション装置１０への接続前の外径よりも大きくなることがないように操作する。 After performing the air removal, the medical staff then injects the expansion medium into the catheter 200. At this time, the medical staff operates the catheter 200 so that the internal pressure of the catheter 200 does not exceed atmospheric pressure, causing the outer diameter of the balloon 202 to not become larger than the outer diameter before it was connected to the inflation device 10.
　バルーン２０２の内部の圧力を陰圧に維持する制御を開始するとの指示を入力部１４が医療従事者から受け付けると、制御部１３は、バルーン２０２の内部の圧力を陰圧に維持する制御を実行する。この際、制御部１３は、記憶部１６を参照して、接続されたカテーテル２００の種類に応じた陰圧の値を維持するように、バルーン２０２の内部の圧力を制御する。なお、医療従事者は、任意のタイミングで入力部１４を介して、記憶部１６から参照された陰圧の値を変更することができる。 When the input unit 14 receives an instruction from a medical professional to start control to maintain the pressure inside the balloon 202 at a negative pressure, the control unit 13 executes control to maintain the pressure inside the balloon 202 at a negative pressure. At this time, the control unit 13 refers to the memory unit 16 and controls the pressure inside the balloon 202 so as to maintain a negative pressure value according to the type of catheter 200 connected. Note that the medical professional can change the negative pressure value referenced from the memory unit 16 via the input unit 14 at any time.
　医療従事者は、バルーン２０２の内部の圧力が陰圧に維持された状態で、カテーテル２００を患者の体内に挿入し、バルーン２０２を治療部位に送達する。この間、制御部１３は、バルーン２０２の内部の圧力を陰圧に維持する制御を実行している。このように、バルーン２０２の内部の圧力が陰圧に維持されていることにより、治療部位までの送達時において、バルーン２０２と管腔との間で擦過などがあっても、バルーン２０２の折りたたみが解除されにくくなる。したがって、管腔内におけるバルーン２０２の通過性を向上させることができる。 The medical staff inserts the catheter 200 into the patient's body while the pressure inside the balloon 202 is maintained at negative pressure, and delivers the balloon 202 to the treatment site. During this time, the control unit 13 executes control to maintain the pressure inside the balloon 202 at negative pressure. In this way, by maintaining the pressure inside the balloon 202 at negative pressure, the balloon 202 is less likely to unfold even if there is abrasion between the balloon 202 and the lumen during delivery to the treatment site. This makes it possible to improve the passability of the balloon 202 through the lumen.
　制御部１３は、圧力センサ１２が測定したバルーン２０２の内部の圧力に基づいて、バルーン２０２の内部の圧力を陰圧に維持する制御を実行してよい。例えば、制御部１３は、圧力センサ１２が測定したバルーン２０２の内部の圧力が所望の陰圧の値より高い場合、シリンジ押子１１２を引き出してカテーテル２００に注入されている拡張媒体の量を減らすことにより、バルーン２０２の内部の圧力を低減させる。また、制御部１３は、圧力センサ１２が測定したバルーン２０２の内部の圧力が所望の陰圧の値より低い場合、シリンジ押子１１２を押し込んでカテーテル２００に注入されている拡張媒体の量を増やすことにより、バルーン２０２の内部の圧力を増加させる。 The control unit 13 may execute control to maintain the pressure inside the balloon 202 at a negative pressure based on the pressure inside the balloon 202 measured by the pressure sensor 12. For example, when the pressure inside the balloon 202 measured by the pressure sensor 12 is higher than the desired negative pressure value, the control unit 13 reduces the pressure inside the balloon 202 by pulling out the syringe plunger 112 to reduce the amount of expansion medium injected into the catheter 200. Also, when the pressure inside the balloon 202 measured by the pressure sensor 12 is lower than the desired negative pressure value, the control unit 13 increases the pressure inside the balloon 202 by pushing in the syringe plunger 112 to increase the amount of expansion medium injected into the catheter 200.
　制御部１３は、バルーン２０２の内部の圧力を陰圧に維持する制御を実行する際、記憶部１６に格納されている、カテーテル２００に注入する拡張媒体の量とバルーン２０２の内部の圧力との関係のデータに基づいて、カテーテル２００に注入する拡張媒体の量を調整してよい。なお、カテーテル２００に注入する拡張媒体の量は、シリンジ本体１１１の内径が一定の範囲内である場合、シリンジ押子１１２の移動量に比例する。 When the control unit 13 executes control to maintain the pressure inside the balloon 202 at a negative pressure, the control unit 13 may adjust the amount of expansion medium injected into the catheter 200 based on data stored in the memory unit 16 on the relationship between the amount of expansion medium injected into the catheter 200 and the pressure inside the balloon 202. Note that the amount of expansion medium injected into the catheter 200 is proportional to the amount of movement of the syringe plunger 112 when the inner diameter of the syringe body 111 is within a certain range.
　制御部１３は、医療従事者による入力部１４への入力操作に応じて、陰圧の大きさを調整することができる。医療従事者が現在の陰圧よりも高い陰圧にすることを指示する入力操作をした場合、制御部１３は、現在の陰圧よりも高い陰圧を設定値として当該陰圧を維持するようにポンプ１１を制御する。医療従事者が現在の陰圧よりも低い陰圧にすることを指示する入力操作をした場合、制御部１３は、現在の陰圧よりも低い陰圧を設定値として当該陰圧を維持するようにポンプ１１を制御する。 The control unit 13 can adjust the magnitude of the negative pressure in response to an input operation by the medical staff on the input unit 14. When the medical staff performs an input operation to instruct a negative pressure higher than the current negative pressure, the control unit 13 controls the pump 11 to maintain a negative pressure higher than the current negative pressure as a set value. When the medical staff performs an input operation to instruct a negative pressure lower than the current negative pressure, the control unit 13 controls the pump 11 to maintain a negative pressure lower than the current negative pressure as a set value.
　制御部１３は、バルーン２０２の内部の圧力を陰圧に維持している間、バルーン２０２の内部の圧力が所定の範囲内にあるかどうかを判定している。制御部１３は、バルーン２０２の内部の圧力が所定の範囲を超えると、出力部１５にアラートを発報させる。これにより、インデフレーション装置１０は、バルーン２０２が破損している場合などに、バルーン２０２に異常がある可能性があることを医療従事者に警告することができる。 The control unit 13 determines whether the pressure inside the balloon 202 is within a predetermined range while maintaining the pressure inside the balloon 202 at a negative pressure. When the pressure inside the balloon 202 exceeds the predetermined range, the control unit 13 causes the output unit 15 to issue an alert. This allows the inflation device 10 to warn medical personnel that there may be an abnormality in the balloon 202, for example, if the balloon 202 is damaged.
　バルーン２０２が治療部位に到達すると、制御部１３は、医療従事者による入力部１４への入力操作に応じて、バルーン２０２の内部の圧力を陰圧に維持する制御を終了し、バルーン２０２の内部の圧力を大気圧に戻す。 When the balloon 202 reaches the treatment site, the control unit 13 ends the control to maintain the pressure inside the balloon 202 at negative pressure in response to an input operation by the medical professional on the input unit 14, and returns the pressure inside the balloon 202 to atmospheric pressure.
　バルーン２０２が治療部位に送達された状態において、制御部１３は、医療従事者による入力部１４への入力操作に応じて、バルーン２０２の加圧を開始し、バルーン２０２を拡張させて治療行為を実行する。 When the balloon 202 has been delivered to the treatment area, the control unit 13 starts pressurizing the balloon 202 in response to input operations made by the medical professional to the input unit 14, expanding the balloon 202 and performing the treatment.
　図３に示すフローチャートを参照して、インデフレーション装置１０の動作の一例について説明する。 An example of the operation of the indeflation device 10 will be described with reference to the flowchart shown in FIG. 3.
　ステップＳ１０１：インデフレーション装置１０の制御部１３は、医療従事者から入力部１４が取得した情報に基づいて、インデフレーション装置１０に接続するカテーテル２００の種類を認識する。 Step S101: The control unit 13 of the inflation device 10 recognizes the type of catheter 200 to be connected to the inflation device 10 based on information acquired by the input unit 14 from a medical professional.
　ステップＳ１０２：医療従事者は、カテーテル２００をインデフレーション装置１０に接続する。 Step S102: The medical professional connects the catheter 200 to the inflation device 10.
　ステップＳ１０３：医療従事者は、カテーテル２００の内部のエア抜きを実行する。 Step S103: The medical staff removes the air from inside the catheter 200.
　ステップＳ１０４：医療従事者は、カテーテル２００の内部に拡張媒体を注入する。 Step S104: The medical staff injects the expansion medium into the catheter 200.
　ステップＳ１０５：バルーン２０２の内部の圧力を陰圧に維持する制御を開始するとの指示を入力部１４が医療従事者から受け付けると、制御部１３は、バルーン２０２の内部の圧力を陰圧に維持する制御を実行する。 Step S105: When the input unit 14 receives an instruction from the medical professional to start control to maintain the pressure inside the balloon 202 at a negative pressure, the control unit 13 executes control to maintain the pressure inside the balloon 202 at a negative pressure.
　ステップＳ１０６：医療従事者は、バルーン２０２の内部の圧力が陰圧に維持された状態で、カテーテル２００を患者の体内に挿入し、バルーン２０２を治療部位に送達する。 Step S106: While maintaining the pressure inside the balloon 202 at negative pressure, the medical staff inserts the catheter 200 into the patient's body and delivers the balloon 202 to the treatment site.
　ステップＳ１０７：バルーン２０２が治療部位に到達すると、制御部１３は、医療従事者による入力部１４への入力操作に応じて、バルーン２０２の内部の圧力を陰圧に維持する制御を終了し、バルーン２０２の内部の圧力を大気圧に戻す。 Step S107: When the balloon 202 reaches the treatment site, the control unit 13 ends the control to maintain the pressure inside the balloon 202 at negative pressure in response to an input operation by the medical professional to the input unit 14, and returns the pressure inside the balloon 202 to atmospheric pressure.
　ステップＳ１０８：バルーン２０２が治療部位に送達された状態において、制御部１３は、医療従事者による入力部１４への入力操作に応じて、バルーン２０２の加圧を開始する。 Step S108: Once the balloon 202 has been delivered to the treatment site, the control unit 13 starts pressurizing the balloon 202 in response to an input operation by the medical professional to the input unit 14.
　このように、本実施形態に係るインデフレーション装置１０によれば、制御部１３は、バルーン２０２の内部の圧力を陰圧に維持する制御を実行することが可能である。これにより、治療部位までの送達時において、バルーン２０２と管腔との間で擦過などがあっても、バルーン２０２の折りたたみが解除されにくくなる。したがって、本実施形態に係るインデフレーション装置１０は、管腔内におけるバルーン２０２の通過性を向上させることができる。 In this way, with the inflation device 10 of this embodiment, the control unit 13 can execute control to maintain the pressure inside the balloon 202 at a negative pressure. This makes it difficult for the balloon 202 to unfold even if abrasion occurs between the balloon 202 and the lumen during delivery to the treatment site. Therefore, the inflation device 10 of this embodiment can improve the passability of the balloon 202 within the lumen.
　本開示は上述の実施形態に限定されるものではない。例えば、ブロック図に記載の複数のブロックを統合してもよいし、又は１つのブロックを分割してもよい。フローチャートに記載の複数のステップを記述に従って時系列に実行する代わりに、各ステップを実行する装置の処理能力に応じて、又は必要に応じて、並列的に又は異なる順序で実行してもよい。その他、本開示の趣旨を逸脱しない範囲での変更が可能である。 The present disclosure is not limited to the above-described embodiments. For example, multiple blocks shown in the block diagram may be integrated, or one block may be divided. Instead of executing multiple steps shown in the flowchart in chronological order as described, each step may be executed in parallel or in a different order depending on the processing capabilities of the device executing each step, or as needed. Other modifications are possible without departing from the spirit of the present disclosure.
　例えば、上述した実施形態において、インデフレーション装置１０は、圧力センサ１２及び制御部１３を備えているが、圧力センサ１２及び制御部１３は、インデフレーション装置１０の外部にあってもよい。 For example, in the above-described embodiment, the inflation device 10 is equipped with a pressure sensor 12 and a control unit 13, but the pressure sensor 12 and the control unit 13 may be external to the inflation device 10.
　例えば、上述した実施形態において、圧力センサ１２は、シリンジ１１０のシリンジ本体１１１の内部に設けられているが、圧力センサ１２は、カテーテル２００の内部に設けられていてもよい。また、圧力センサ１２は、チューブ２０１に連結していてもよい。また、圧力センサ１２は、アクチュエータ１２０に設けられていて、シリンジ押子１１２にかかる力から圧力を測定できる形式でもよい。 For example, in the above-described embodiment, the pressure sensor 12 is provided inside the syringe body 111 of the syringe 110, but the pressure sensor 12 may also be provided inside the catheter 200. The pressure sensor 12 may also be connected to the tube 201. The pressure sensor 12 may also be provided in the actuator 120, and may be of a type capable of measuring pressure from the force applied to the syringe plunger 112.
　例えば、上述した実施形態において、インデフレーション装置１０の本体１が支柱２に設置されている場合を示したが、インデフレーション装置１０の本体１は、支柱２に設置されていなくてもよい。 For example, in the above embodiment, the main body 1 of the inflation device 10 is installed on the support 2, but the main body 1 of the inflation device 10 does not have to be installed on the support 2.
　１　本体
　２　支柱
　１０　インデフレーション装置
　１１　ポンプ
　１２　圧力センサ
　１３　制御部
　１４　入力部
　１５　出力部
　１６　記憶部
　１７　電源
　１１０　シリンジ
　１１１　シリンジ本体
　１１２　シリンジ押子
　１２０　アクチュエータ
　１３０　ドライバ
　２００　カテーテル
　２０１　チューブ
　２０２　バルーン REFERENCE SIGNS LIST 1 Main body 2 Support 10 Inflation device 11 Pump 12 Pressure sensor 13 Control unit 14 Input unit 15 Output unit 16 Memory unit 17 Power supply 110 Syringe 111 Syringe body 112 Syringe plunger 120 Actuator 130 Driver 200 Catheter 201 Tube 202 Balloon

Claims (5)

  1. 　遠位部にバルーンを有する医療用のカテーテルと接続可能なインデフレーション装置であって、
    　前記バルーンを加圧又は減圧することが可能なポンプと、
    　前記ポンプを制御する制御部と、
    　前記バルーンの内部の圧力を測定する圧力センサと、を備え、
    　前記制御部は、前記バルーンの内部の圧力を陰圧に維持する制御を実行することが可能である、インデフレーション装置。     An inflation device connectable to a medical catheter having a balloon at a distal portion,
    A pump capable of pressurizing or depressurizing the balloon;
    A control unit for controlling the pump;
    a pressure sensor for measuring a pressure inside the balloon;
    An inflation device, wherein the control unit is capable of executing control to maintain the pressure inside the balloon at a negative pressure.
  2. 　請求項１に記載のインデフレーション装置において、
    　前記制御部は、前記圧力センサが測定した前記バルーンの内部の圧力に基づいて、前記バルーンの内部の圧力を陰圧に維持する制御を実行する、インデフレーション装置。     2. The indeflation device according to claim 1,
    The control unit of the inflation device performs control to maintain the pressure inside the balloon at a negative pressure based on the pressure inside the balloon measured by the pressure sensor.
  3. 　請求項１に記載のインデフレーション装置において、
    　前記制御部は、ユーザからの入力操作に応じて、前記陰圧の大きさを調整可能である、インデフレーション装置。     2. The indeflation device according to claim 1,
    The control unit is capable of adjusting the magnitude of the negative pressure in response to an input operation from a user.
  4. 　請求項１に記載のインデフレーション装置において、
    　アラートを発報することが可能な出力部をさらに備え、
    　前記制御部は、前記バルーンの内部の圧力が所定の範囲を超えると、前記出力部にアラートを発報させる、インデフレーション装置。     2. The indeflation device according to claim 1,
    An output unit capable of issuing an alert is further provided,
    An inflation device, wherein the control unit causes the output unit to issue an alert when the pressure inside the balloon exceeds a predetermined range.
  5. 　請求項１に記載のインデフレーション装置において、
    　前記制御部は、前記カテーテルの種類に応じて前記陰圧の値を設定する、インデフレーション装置。     2. The indeflation device according to claim 1,
    The control unit sets the negative pressure value according to the type of the catheter.
PCT/JP2024/000184 2023-02-28 2024-01-09 Indeflation device WO2024180910A1 (en)

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JPH09168596A (en) * 1995-12-18 1997-06-30 Nippon Zeon Co Ltd Medical expansion / contraction drive device
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JP2017537735A (en) * 2014-12-22 2017-12-21 スマート・メディカル・システムズ・リミテッド Balloon endoscope reprocessing system and balloon endoscope reprocessing method
JP2018523506A (en) * 2016-06-02 2018-08-23 プリタイム・メディカル・デバイシーズ・インコーポレイテッドＰｒｙｔｉｍｅ Ｍｅｄｉｃａｌ Ｄｅｖｉｃｅｓ，Ｉｎｃ． System and method for low profile occlusion balloon catheter

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