JPWO2021188602A5 - - Google Patents

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JPWO2021188602A5
JPWO2021188602A5 JP2022556003A JP2022556003A JPWO2021188602A5 JP WO2021188602 A5 JPWO2021188602 A5 JP WO2021188602A5 JP 2022556003 A JP2022556003 A JP 2022556003A JP 2022556003 A JP2022556003 A JP 2022556003A JP WO2021188602 A5 JPWO2021188602 A5 JP WO2021188602A5
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flow control
blood flow
control system
controllers
pump
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JP2023519191A (en
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Priority claimed from PCT/US2021/022644 external-priority patent/WO2021188602A2/en
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細長い本体と、前記細長い本体の一端部に結合されるバルーンと、前記バルーンの基端側で前記細長い本体に結合される第１のセンサーと、前記バルーンの末端側で前記細長い本体に結合される第２のセンサーとを備え、前記バルーンは患者の血管内に配置されるように構成された血流制御デバイスと、a blood flow control device comprising an elongate body, a balloon coupled to one end of the elongate body, a first sensor coupled to the elongate body proximal to the balloon, and a second sensor coupled to the elongate body distal to the balloon, the balloon configured to be placed within a blood vessel of a patient;
ハウジングを有し、前記第１のセンサーと前記第２のセンサーに通信可能に結合された一つ又は複数のコントローラと、one or more controllers having a housing and communicatively coupled to the first sensor and the second sensor;
前記バルーンと流体連通し、前記一つ又は複数のコントローラの前記ハウジングに着脱可能に結合されるポンプとを備え、a pump in fluid communication with the balloon and removably coupled to the housing of the one or more controllers;
前記ポンプは、The pump comprises:
前記一つ又は複数のコントローラの前記ハウジングから分離されて、前記バルーンの容積を調整するために手動操作され、the one or more controllers are separate from the housing and manually operable to adjust the volume of the balloon;
前記一つ又は複数のコントローラの前記ハウジングに結合されて、前記バルーンの容積を調整するために前記一つ又は複数のコントローラによって作動されるように構成された、血流制御システム。A blood flow control system coupled to the housing of the one or more controllers and configured to be actuated by the one or more controllers to adjust the volume of the balloon. 前記一つ又は複数のコントローラは、（ａ）前記第１のセンサー又は前記第２のセンサー若しくはそれらの両方の測定値、および（ｂ）前記一つ又は複数のコントローラに含まれる目標血圧又は目標血圧範囲、に基づいて前記バルーンの容積を自動的に調整するように構成されている、請求項１に記載の血流制御システム。2. The blood flow control system of claim 1, wherein the one or more controllers are configured to automatically adjust the volume of the balloon based on (a) measurements of the first sensor or the second sensor or both, and (b) a target blood pressure or a target blood pressure range included in the one or more controllers. 前記血流制御システムはさらに、前記ポンプを作動するように構成されたモータを有する、請求項１に記載の血流制御システム。The blood flow control system of claim 1 , further comprising a motor configured to operate the pump. 前記一つ又は複数のコントローラは、前記モータの移動に基づいて前記バルーンの容積の変化を判定するように構成されている、請求項３に記載の血流制御システム。The blood flow control system of claim 3 , wherein the one or more controllers are configured to determine a change in volume of the balloon based on movement of the motor. 前記モータはステッパモータである、請求項３に記載の血流制御システム。The blood flow control system of claim 3 , wherein the motor is a stepper motor. 前記ポンプは、少なくとも初期手動操作のために手動で作動されように構成されたシリンジポンプで、the pump being a syringe pump configured to be manually actuated for at least an initial manual operation;
前記初期手動操作後に前記ポンプのバレルが前記ハウジングに結合されたときの前記ポンプの位置に基づいて、手技に対する前記バルーンの最大膨張レベルを決定するように構成されている、請求項１に記載の血流制御システム。10. The blood flow control system of claim 1, configured to determine a maximum inflation level of the balloon for a procedure based on a position of the pump when the pump barrel is coupled to the housing after the initial manual operation. 前記ハウジングは開いたキャビティで、The housing is an open cavity;
前記ポンプが前記ハウジングに結合された状態で、前記ポンプの少なくとも一部が前記開いたキャビティ内に包含される、請求項１に記載の血流制御システム。The blood flow control system of claim 1 , wherein at least a portion of the pump is contained within the open cavity when the pump is coupled to the housing. 位置センサー又はモーションセンサー若しくはそれらの両方を有する、請求項１に記載の血流制御システム。The blood flow control system of claim 1 , further comprising a position sensor or a motion sensor or both. 位置センサーを有し、A position sensor is provided.
前記位置センサーは、前記ポンプが前記ハウジングに結合された状態で、前記ポンプの一部の位置を監視するように構成されている、請求項１に記載の血流制御システム。The blood flow control system of claim 1 , wherein the position sensor is configured to monitor a position of a portion of the pump while the pump is coupled to the housing. 前記ポンプは、プランジャを有するシリンジポンプで、The pump is a syringe pump having a plunger,
前記位置センサーは、前記プランジャの位置を測定するように構成されている、請求項９に記載の血流制御システム。The blood flow control system of claim 9 , wherein the position sensor is configured to measure a position of the plunger. モーションセンサーを有し、It has a motion sensor,
前記モーションセンサーは、前記ポンプが前記モータを用いて作動されるとき、前記モータの動きを監視するように構成されている、請求項１に記載の血流制御システム。The blood flow control system of claim 1 , wherein the motion sensor is configured to monitor movement of the motor when the pump is operated using the motor. 前記一つ又は複数のコントローラは、システムコントローラを有し、the one or more controllers comprising a system controller;
前記血流制御システムは、前記血流制御デバイスの前記細長い本体に結合された血流制御デバイスコントローラを有する、請求項１に記載の血流制御システム。The blood flow control system of claim 1 , further comprising a blood flow control device controller coupled to the elongate body of the blood flow control device. 前記細長い本体は膨張管腔を有し、the elongate body having an inflation lumen;
前記ポンプはチューブを介して前記膨張管腔に結合されている、請求項１に記載の血流制御システム。The blood flow control system of claim 1 , wherein the pump is coupled to the inflation lumen via a tube. 大気圧を測定するように構成された気圧計を有する、請求項１に記載の血流制御システム。The blood flow control system of claim 1 , further comprising a barometer configured to measure atmospheric pressure. 前記目標血圧又は前記目標血圧範囲は、近位平均圧又は近位平均血圧範囲である、請求項２に記載の血流制御システム。The blood flow control system of claim 2 , wherein the target blood pressure or the target blood pressure range is a proximal mean pressure or a proximal mean blood pressure range. 前記一つ又は複数のコントローラは、前記一つ又は複数のコントローラで受信するユーザ入力に基づいて、前記バルーンの容積を調整するように構成されている、請求項２に記載の血流制御システム。The blood flow control system of claim 2 , wherein the one or more controllers are configured to adjust the volume of the balloon based on user input received at the one or more controllers. 入力デバイスを有するユーザインターフェースを有し、a user interface having an input device;
前記ユーザ入力が前記ユーザ入力デバイスを介して受信される、請求項１６に記載の血流制御システム。The blood flow control system of claim 16 , wherein the user input is received via the user input device. ユーザインターフェースを有し、A user interface is provided.
前記一つ又は複数のコントローラはさらに、前記ユーザインターフェースを介してユーザから前記目標血圧又は前記目標血圧範囲を受信するように構成されている、請求項１に記載の血流制御システム。The blood flow control system of claim 1 , wherein the one or more controllers are further configured to receive the target blood pressure or the target blood pressure range from a user via the user interface. 細長い本体と、前記細長い本体の一端部に結合されて患者の血管内に配置されるように構成されたバルーンと、基端側の血圧センサーと、末端側の血圧センサーとを有する血流制御デバイスと、a blood flow control device having an elongate body, a balloon coupled to one end of the elongate body and configured to be placed in a blood vessel of a patient, a proximal blood pressure sensor, and a distal blood pressure sensor;
前記基端側の血圧センサー及び前記末端側の血圧センサーと通信可能に結合された一つ又は複数のコントローラと、one or more controllers communicatively coupled to the proximal blood pressure sensor and the distal blood pressure sensor;
前記バルーンと流体連通されたシリンジポンプと、を備えた血流制御システムであって、a syringe pump in fluid communication with the balloon,
前記血流制御システムは、The blood flow control system comprises:
前記シリンジポンプのプランジャが、前記バルーンの大きさを制御するために、ユーザによって手動調整可能である、第１のモードと、a first mode in which the plunger of the syringe pump is manually adjustable by a user to control the size of the balloon;
前記基端側の血圧センサー又は前記末端側の血圧センサー若しくはそれらの両方の測定値に基づいて、前記バルーンの大きさを自動的に制御するように構成された第２のモードとを有する、血流制御システム。and a second mode configured to automatically control the size of the balloon based on measurements from the proximal blood pressure sensor, the distal blood pressure sensor, or both. 前記血流制御システムが前記第２のモードのとき、前記一つ又は複数のコントローラは、（ａ）前記基端側のセンサー又は前記末端側のセンサー若しくはそれらの両方の測定値、および（ｂ）前記一つ又は複数のコントローラに含まれる目標血圧又は目標血圧範囲、に基づいて前記バルーンの容積を自動的に制御するように構成されている、請求項１９に記載の血流制御システム。The blood flow control system of claim 19, wherein when the blood flow control system is in the second mode, the one or more controllers are configured to automatically control the volume of the balloon based on (a) measurements from the proximal sensor or the distal sensor or both, and (b) a target blood pressure or target blood pressure range included in the one or more controllers. 前記ポンプを作動するように構成されたモータを有する、請求項１９に記載の血流制御システム。20. The blood flow control system of claim 19, further comprising a motor configured to operate the pump. 前記モータの動きに基づいて、前記バルーンの容積の変化を決定するように構成されている、請求項２１に記載の血流制御システム。The blood flow control system of claim 21 , configured to determine a change in volume of the balloon based on movement of the motor. 前記シリンジポンプは、少なくとも初期手動操作のために手動で作動されように構成され、the syringe pump is configured to be manually actuated for at least an initial manual operation;
前記初期手動操作後に前記ポンプのバレルが前記ハウジングに結合されたときの前記ポンプの位置に基づいて、手技に対する前記バルーンの最大膨張レベルを決定するように構成されている、請求項１９に記載の血流制御システム。20. The blood flow control system of claim 19, configured to determine a maximum inflation level of the balloon for a procedure based on a position of the pump when the pump barrel is coupled to the housing after the initial manual operation. 前記一つ又は複数のコントローラはハウジングを有し、the one or more controllers having a housing;
前記シリンジのバレルが前記ハウジングに取り外し可能に結合される、請求項１９に記載の血流制御システム。The blood flow control system of claim 19 , wherein the barrel of the syringe is removably coupled to the housing. 前記一つ又は複数のコントローラの前記ハウジングは、開いたキャビティを有し、the housing of the one or more controllers has an open cavity;
前記シリンジポンプの前記バレルは、前記ハウジングに結合された状態で、前記開いたキャビティ内に包含される、請求項２４に記載の血流制御システム。25. The blood flow control system of claim 24, wherein the barrel of the syringe pump is contained within the open cavity while coupled to the housing. 前記一つ又は複数のコントローラは、前記血流制御デバイスの前記細長い本体に結合された血流制御デバイスコントローラと、システムコントローラとを有する、請求項１９に記載の血流制御システム。20. The blood flow control system of claim 19, wherein the one or more controllers include a blood flow control device controller coupled to the elongate body of the blood flow control device and a system controller. 前記モータが、前記シリンジポンプを作動するために、前記第２のモードにおいて前記プランジャに操作可能に連結されたステッパモータである、請求項１９に記載の血流制御システム。20. The blood flow control system of claim 19, wherein the motor is a stepper motor operably coupled to the plunger in the second mode to actuate the syringe pump. モーションセンサーを有し、It has a motion sensor,
前記モーションセンサーは、前記シリンジポンプが前記第２のモードで前記モータを用いて作動される場合、前記モータの動きを監視するように構成される、請求項２７に記載の血流制御システム。28. The blood flow control system of claim 27, wherein the motion sensor is configured to monitor movement of the motor when the syringe pump is operated with the motor in the second mode. 前記血流制御システムは第３のモードを有し、the blood flow control system has a third mode;
前記第３のモードでは、前記一つ又は複数のコントローラで受信されたユーザ入力に基づいて前記モータを用いて前記バルーンの大きさを制御するように、前記一つ又は複数のコントローラが構成されている、請求項２１に記載の血流制御システム。22. The blood flow control system of claim 21, wherein in the third mode, the one or more controllers are configured to control the size of the balloon using the motor based on user input received by the one or more controllers. 前記目標血圧又は前記目標血圧範囲は、近位平均圧又は近位平均血圧範囲である、請求項１９に記載の血流制御システム。The blood flow control system of claim 19 , wherein the target blood pressure or the target blood pressure range is a proximal mean pressure or a proximal mean blood pressure range. 前記細長い本体は膨張管腔を有し、the elongate body having an inflation lumen;
前記シリンジポンプはチューブを介して前記膨張管腔に結合されている、請求項１９に記載の血流制御システム。20. The blood flow control system of claim 19, wherein the syringe pump is coupled to the inflation lumen via a tube. 前記一つ又は複数のコントローラは、大気圧を測定するように構成された気圧計を有する、請求項１９に記載の血流制御システム。20. The blood flow control system of claim 19, wherein the one or more controllers include a barometer configured to measure atmospheric pressure.
JP2022556003A 2020-03-16 2021-03-16 BLOOD CONTROL DEVICES, SYSTEMS AND METHODS AND THEIR ERROR DETECTION Pending JP2023519191A (en)

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US202062990302P 2020-03-16 2020-03-16
US62/990,302 2020-03-16
PCT/US2021/022644 WO2021188602A2 (en) 2020-03-16 2021-03-16 Blood flow control devices, systems, and methods and error detection thereof

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JPWO2021188602A5 true JPWO2021188602A5 (en) 2024-06-21

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EP (1) EP4121159A2 (en)
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