Suction device and suction system

Abstract

A suction device according to the present disclosure can be connected to a suction catheter, can generate negative pressure in the suction catheter, and comprises a control unit that selects, on the basis of blood vessel lesion length information and flow path diameter information, one of either a first suction mode that maintains a constant suction pressure inside the suction catheter, and a second suction mode in which the strength of the suction pressure in the suction catheter is repeatedly changed.

Description

[Technical field]

[0001] The present disclosure relates to aspiration devices and aspiration systems. [Background technology]

[0002] As one of the treatment methods for removing foreign bodies such as blood clots from blood vessels, a method is known in which a suction catheter with a suction passage is inserted into the blood vessel, the foreign bodies are sucked from a suction port into the suction passage, and the foreign bodies are removed from the living body through the suction passage. Patent Document 1 discloses this type of suction catheter. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Special Publication No. 2019-511943 Summary of the Invention [Problem to be solved by the invention]

[0004] Depending on the condition of the lesion, foreign bodies such as thrombi in a lesioned area of ​​a blood vessel may or may not be easily aspirated by a suction catheter.

[0005] An object of the present disclosure is to provide a suction device and a suction system that are capable of controlling the suction of foreign matter according to the state of a lesion in a blood vessel. [Means for solving the problem]

[0006] A suction device according to a first aspect of the present disclosure is a suction device that can be connected to a suction catheter and generate negative pressure within the suction catheter, and includes a control unit that selects, based on length information of a diseased portion of a blood vessel and flow path diameter information, either a first suction mode in which a constant suction pressure is maintained within the suction catheter or a second suction mode in which the strength of the suction pressure within the suction catheter is repeatedly varied.

[0007] As one embodiment of the present disclosure, the control unit selects the first suction mode when the length of the lesion as the length information is less than or equal to a predetermined value and the flow path blockage rate at the lesion as the flow path diameter information is less than or equal to a predetermined value.

[0008] As one embodiment of the present disclosure, the control unit selects the second suction mode when the length of the lesion is longer than the predetermined value and the flow path blockage rate in the lesion is equal to or less than the predetermined value, when the length of the lesion is equal to or less than the predetermined value and the flow path blockage rate in the lesion is greater than the predetermined value, or when the length of the lesion is longer than the predetermined value and the flow path blockage rate in the lesion is greater than the predetermined value.

[0009] As one embodiment of the present disclosure, the control unit controls a variation in suction pressure in the second suction mode based on the length information and the flow path diameter information.

[0010] As one embodiment of the present disclosure, the second suction mode includes a low-flow mode and a high-flow mode having different suction flow rates per minute, and the control unit selects the high-flow mode of the second suction mode when the length of the lesion is longer than the predetermined value and the flow path blockage rate in the lesion is equal to or less than the predetermined value.

[0011] As one embodiment of the present disclosure, the control unit selects the low flow rate mode of the second suction mode when the length of the lesion is equal to or less than the predetermined value and the flow path blockage rate in the lesion is greater than the predetermined value.

[0012] As one embodiment of the present disclosure, the second suction mode includes a low flow mode and a high flow mode having different suction flow rates per minute, and the control unit selects the low flow mode of the second suction mode when the length of the lesion is equal to or less than the predetermined value and the flow path blockage rate in the lesion is greater than the predetermined value.

[0013] As one embodiment of the present disclosure, the control unit selects the high flow rate mode of the second suction mode when the length of the lesion is longer than the predetermined value and the flow path blockage rate in the lesion is greater than the predetermined value.

[0014] As one embodiment of the present disclosure, the second suction mode includes another mode in which the suction flow rate per minute is greater than the high-flow mode, and the control unit selects the other mode from the second suction mode when the length of the lesion is longer than the predetermined value and the flow path blockage rate in the lesion is greater than the predetermined value.

[0015] As one embodiment of the present disclosure, the control unit determines a maximum suction pressure in the second suction mode based on at least one of hardness information of a normal portion of the blood vessel and hardness information of a thrombus in the diseased portion of the blood vessel.

[0016] As one embodiment of the present disclosure, the control unit determines a maximum suction pressure in the second suction mode based on information on a change in the suction pressure in the suction catheter.

[0017] As one embodiment of the present disclosure, the control unit extracts the length information and the flow path diameter information based on imaging data of the blood vessel acquired from an imaging device.

[0018] An aspiration system according to a second aspect of the present disclosure includes a suction catheter to be inserted into a blood vessel, and a suction device connectable to the suction catheter and capable of generating negative pressure within the suction catheter. The suction device includes a control unit that selects, based on length information and flow path diameter information of the diseased portion of the blood vessel, either a first suction mode in which a constant suction pressure is maintained within the suction catheter, or a second suction mode in which the strength of the suction pressure within the suction catheter is repeatedly varied.

[0019] As one embodiment of the present disclosure, an imaging device capable of imaging the blood vessel is provided, and the control unit extracts the length information and the flow path diameter information from imaging data of the blood vessel acquired from the imaging device, and selects either the first suction mode or the second suction mode based on the extracted length information and the flow path diameter information.

[0020] As one embodiment of the present disclosure, the imaging device includes at least one of an X-ray imaging device that images the contrast-enhanced blood vessels from outside the living body, and an ultrasound imaging device that images the blood vessels from inside the blood vessels using ultrasound. Effect of the Invention

[0021] According to the present disclosure, it is possible to provide a suction device and a suction system capable of controlling the suction of foreign matter according to the state of a lesion in a blood vessel. [Brief description of the drawings]

[0022] [Figure 1] FIG. 1 illustrates an aspiration system according to one embodiment of the present disclosure. [Diagram 2] Fig. 2(a) is a diagram showing an example of an X-ray image acquired by an imaging unit of an X-ray image processing device, and Fig. 2(b) is a diagram showing an example of an ultrasonic image generated by a control unit of an ultrasonic image processing device. [Diagram 3] FIG. 4 is a control flow diagram of a control unit of the suction device according to one embodiment of the present disclosure. [Figure 4] 1A to 1C are diagrams showing four states of a lesion that can be identified by a control unit of a suction device according to an embodiment of the present disclosure. [Diagram 5] 13 is a diagram showing an example of suction control by a control unit of the suction device according to the state of a specified lesion area. FIG. [Figure 6A] 5 is a diagram showing an example of suction control that is executed when the state of the lesion belongs to the third quadrant of FIG. 4. [Figure 6B] 5 is a diagram showing an example of suction control that is executed when the state of the lesion belongs to the fourth quadrant of FIG. 4. [Figure 6C]5 is a diagram showing an example of suction control that is executed when the state of the lesion belongs to the second quadrant of FIG. 4. [Figure 6D] 5 is a diagram showing an example of suction control that is executed when the state of the lesion belongs to the first quadrant of FIG. 4. [Figure 7A] FIG. 7 is a diagram showing a modified example of suction control in a second suction mode by the control unit of the suction device shown in FIGS. 6B to 6D. [Figure 7B] FIG. 7 is a diagram showing a modified example of suction control in a second suction mode by the control unit of the suction device shown in FIGS. 6B to 6D. [Figure 7C] FIG. 7 is a diagram showing a modified example of suction control in a second suction mode by the control unit of the suction device shown in FIGS. 6B to 6D. [Figure 7D] FIG. 7 is a diagram showing a modified example of suction control in a second suction mode by the control unit of the suction device shown in FIGS. 6B to 6D. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] Hereinafter, embodiments of a suction device and a suction system according to the present disclosure will be described with reference to the drawings. In each drawing, the same reference numerals are used to designate the same components.

[0024] Fig. 1 is a diagram showing an aspiration system 100 as one embodiment of the aspiration system according to the present disclosure. As shown in Fig. 1, the aspiration system 100 of this embodiment includes a suction catheter 1, a suction device 2, and an imaging device 3. The aspiration system 100 of this embodiment includes, as the imaging device 3, an X-ray image processing device 3a and an ultrasonic image processing device 3b.

[0025] 1, the suction catheter 1 can be inserted into a blood vessel BV. The suction catheter 1 of this embodiment includes a tubular catheter body 11, a hub 12, a covering tube 13, and a balloon .

[0026] The catheter main body 11 is a portion that can be inserted into a living body (hereinafter simply referred to as the "inserted portion"). In contrast, the hub 12 and the covering tube 13 are portions that are not inserted into a living body (hereinafter simply referred to as the "non-inserted portion"). The hub 12 and the covering tube 13 are located outside the living body when the catheter main body 11 is inserted into the living body, and are operated by an operator. For ease of explanation, in the longitudinal direction A of the catheter main body 11, which is the longitudinal direction of the suction catheter 1, the direction from the non-inserted portion to the inserted portion is referred to as the "distal side" or "distal direction A1". In addition, in the longitudinal direction A of the catheter main body 11, the direction from the inserted portion to the non-inserted portion is referred to as the "proximal side" or "proximal direction A2".

[0027] As shown in Fig. 1, the tubular catheter main body 11 defines an aspiration flow passage 11a and a guidewire insertion hole 11b therein. In this embodiment, the diameter of the guidewire insertion hole 11b is smaller than the diameter of the aspiration flow passage 11a. The guidewire insertion hole 11b extends in the longitudinal direction A along the aspiration flow passage 11a. In other words, the aspiration flow passage 11a and the guidewire insertion hole 11b are not in communication with each other, but are adjacent to each other and parallel to each other.

[0028] As shown in FIG. 1, the suction flow path 11a extends from a suction port 11a1 located at the distal end of the catheter body 11 to a communication port located at the proximal end of the catheter body 11 (hereinafter referred to as the “proximal end”) that communicates with an internal hub flow path of the hub 12.

[0029] 1, the guidewire insertion hole 11b extends from a distal opening 11b1 on the distal side to a proximal opening 11b2 on the proximal side. The guidewire insertion hole 11b is a so-called rapid exchange type, and is formed along only a portion of the distal side of the suction channel 11a. In other words, the proximal opening 11b2 of the guidewire insertion hole 11b is located distal to the communication port of the suction channel 11a.

[0030] The suction port 11a1 in this embodiment is formed on the distal end surface of the catheter main body 11. The suction port 11a1 in this embodiment is formed on the distal end surface that is inclined with respect to the longitudinal direction A of the catheter main body 11, but is not limited to this configuration. The suction port 11a1 may also be formed on the distal end surface that is perpendicular to the longitudinal direction A.

[0031] In this embodiment, the peripheral wall defining the guidewire insertion hole 11b includes a coil tube made of an X-ray opaque metal. The coil tube is made of a material such as gold or platinum that is opaque to X-rays (radiation). This allows the position of the distal end of the catheter main body 11 in the living body to be visually confirmed by X-ray imaging.

[0032] Examples of materials that can be used to form the catheter body 11 include polymeric materials such as polyolefins (e.g., polyethylene, polypropylene, polybutene, ethylene-propylene copolymers, ethylene-vinyl acetate copolymers, ionomers, or mixtures of two or more of these), polyolefin elastomers, crosslinked polyolefins, polyvinyl chloride, polyamides, polyamide elastomers, polyesters, polyester elastomers, polyurethanes, polyurethane elastomers, fluororesins, polycarbonates, polystyrenes, polyacetals, polyimides, polyetherimides, polyetheretherketones, and mixtures of these.

[0033] In this embodiment, a hub 12 and a covering tube 13 are attached to the proximal side of the catheter body 11.

[0034] The proximal end of the catheter main body 11 is connected to the distal end of the hub 12. The proximal end of the hub 12 is connected to the suction device 2 directly or via a medical tube 80. The flow path within the hub defined by the hub 12 is liquid-tightly connected to the suction flow path 11a defined by the catheter main body 11. The flow path within the hub defined by the hub 12 is also liquid-tightly connected to the suction device 2 directly or via a medical tube 80, for example, via a luer lock connector.

[0035] Examples of materials for forming the hub 12 include polyolefins such as polyethylene, polypropylene, and ethylene-propylene copolymers; ethylene-vinyl acetate copolymers (EVA); polyvinyl chloride; polyvinylidene chloride; polystyrene; polyamide; polyimide; polyamideimide; polycarbonate; poly-(4-methylpentene-1); ionomers; acrylic resins; polymethyl methacrylate; acrylonitrile-butadiene-styrene copolymers (ABS resins); acrylonitrile-styrene copolymers (AS resins); butadiene-styrene copolymers; and polyethylene terephthalate. Examples of the resin materials include polyesters such as polystyrene (PET), polybutylene terephthalate (PBT), and polycyclohexane terephthalate (PCT); polyether; polyether ketone (PEK); polyether ether ketone (PEEK); polyetherimide; polyacetal (POM); polyphenylene oxide; modified polyphenylene oxide; polysulfone; polyether sulfone; polyphenylene sulfide; polyarylate; aromatic polyester (liquid crystal polymer); polytetrafluoroethylene, polyvinylidene fluoride, and other fluorine-based resins. Blends and polymer alloys containing one or more of these may also be used. In addition, various glass materials, ceramic materials, and metal materials may also be used.

[0036] As shown in Fig. 1, the covering tube 13 covers the proximal end of the catheter main body 11. More specifically, the covering tube 13 of this embodiment covers the proximal end of the catheter main body 11 so as to span both the portion of the proximal end of the catheter main body 11 that is inserted into the hub 12 and the portion distal to this portion that is not inserted into the hub 12. By providing such a covering tube 13, it is possible to suppress the occurrence of kinking at the connection portion of the catheter main body 11 with the hub 12. Examples of materials for forming the covering tube 13 include the same materials as those exemplified above as the materials for forming the catheter main body 11.

[0037] The balloon 14 is attached to the outer surface of the catheter main body 11, and is expandable radially outwardly of the catheter main body 11 when supplied with a fluid such as liquid. The balloon 14 expands and comes into contact with the inner wall of the blood vessel BV, thereby enabling the catheter main body 11 to be positioned within the blood vessel BV.

[0038] As shown in Fig. 1, the suction device 2 can be connected to the suction catheter 1. In this embodiment, the suction device 2 is connected to the hub 12 of the suction catheter 1 via a medical tube 80, but the configuration is not limited to this. The suction device 2 may be directly connected to the suction catheter 1. When the suction device 2 is connected to the suction catheter 1, it can generate negative pressure inside the suction catheter 1.

[0039] As shown in FIG. 1, the suction device 2 of this embodiment includes a control unit 21, a storage unit 22, an input / output unit 23, and a suction pump 24.

[0040] The control unit 21 is one or more processors. The control unit 21 is realized by a dedicated processor specialized for processing such as controlling the operation of the suction pump 24, communicating with the X-ray image processing device 3a and the ultrasonic image processing device 3b via the input / output unit 23, and extracting length information and flow path diameter information of the lesion part Z of the blood vessel BV based on image data acquired from the X-ray image processing device 3a and the ultrasonic image processing device 3b, but may be realized by a general-purpose processor such as a CPU (Central Processing Unit). The control unit 21 may include one or more dedicated circuits, or one or more processors in the control unit 21 may be replaced with one or more dedicated circuits. The dedicated circuit is, for example, an FPGA (Field-Programmable Gate Array) or an ASIC (Application Specific Integrated Circuit). The control unit 21 controls each part of the suction device 2 to execute information processing related to the operation of the suction device 2.

[0041] The storage unit 22 includes any storage module including, for example, a RAM (Random Access Memory) and a ROM (Read-Only Memory). The storage unit 22 may function as, for example, a main storage device or a cache memory that stores image data acquired from the X-ray image processing device 3a and the ultrasonic image processing device 3b. The storage unit 22 stores any information used in the operation of the suction device 2, such as, for example, a suction operation program for each suction mode of the suction pump 24. In addition, the storage unit 22 may further store a system program, an application program, various information received by the input / output unit 23, and the like.

[0042] The input / output unit 23 inputs and outputs signals between the X-ray image processing device 3a and the ultrasonic image processing device 3b. The suction device 2 of this embodiment acquires X-ray image data from the X-ray image processing device 3a via the input / output unit 23. The suction device 2 of this embodiment acquires ultrasonic image data from the ultrasonic image processing device 3b via the input / output unit 23. The input / output unit 23 may include at least one of a wireless communication interface such as a USB interface, a wireless LAN (Local Area Network) interface, and a Bluetooth interface, and a wired communication interface. Furthermore, the input / output unit 23 may include at least one of a touch panel, a button, an LED (Light Emitting Diode), and a buzzer as an interface with a user.

[0043] The suction pump 24 is capable of creating a negative pressure inside the suction catheter 1, and its operation is controlled by the control unit 21. That is, the control unit 21 controls the suction by the suction pump 24. The control unit 21 is capable of controlling, for example, the suction pressure, suction time, suction cycle, and the like of the suction pump 24. Although details will be described later, the control unit 21 of this embodiment controls the suction pressure, suction time, and suction cycle inside the suction catheter 1 by controlling the suction pump 24 based on length information and flow path diameter information of the lesion Z of the blood vessel BV.

[0044] The X-ray image processing device 3a serving as the imaging device 3 can image the contrast-enhanced blood vessel BV from outside the living body. The X-ray image processing device 3a of this embodiment includes a control unit 31a, a storage unit 32a, an input / output unit 33a, and an imaging unit 34a.

[0045] The control unit 31a is one or more processors. The control unit 31a is realized by a dedicated processor specialized for processing of controlling the operation of the imaging unit 34a and communicating with the suction device 2 via the input / output unit 33a, but may be realized by a general-purpose processor such as a CPU (Central Processing Unit). The control unit 31a may include one or more dedicated circuits, or one or more processors in the control unit 31a may be replaced with one or more dedicated circuits. The dedicated circuits are, for example, FPGAs (Field-Programmable Gate Arrays) or ASICs (Application Specific Integrated Circuits). The control unit 31a controls each unit of the X-ray image processing device 3a to execute information processing related to the operation of the X-ray image processing device 3a.

[0046] The storage unit 32a includes any storage module including, for example, a RAM (Random Access Memory) and a ROM (Read-Only Memory). The storage unit 32a may function, for example, as a main storage device or cache memory that stores X-ray images captured by the imaging unit 34a. The storage unit 32a stores any information used in the operation of the X-ray image processing device 3a. In addition, the storage unit 32a may further store system programs, application programs, various information received by the input / output unit 33a, and the like.

[0047] The input / output unit 33a inputs and outputs signals to and from the suction device 2. The X-ray image processing device 3a of this embodiment can transmit X-ray image data to the suction device 2 via the input / output unit 33a. Furthermore, the X-ray image processing device 3a may output an X-ray image captured by the imaging unit 34a to a display or the like via the input / output unit 33a in response to an instruction from the control unit 31a. The input / output unit 33a may include at least one of a wireless communication interface such as a USB interface, a wireless LAN (Local Area Network) interface, and a Bluetooth interface, and a wired communication interface. Furthermore, the input / output unit 33a may include at least one of a touch panel, a button, an LED (Light Emitting Diode), and a buzzer as an interface with a user.

[0048] The imaging unit 34a irradiates X-rays from outside the patient's body toward the body and acquires an X-ray image of a lesion Z of a blood vessel BV. FIG. 2(a) is a diagram showing an example of an X-ray image acquired by the imaging unit 34a. The imaging unit 34a can acquire an X-ray image of the blood vessel BV as shown in FIG. 2(a) by injecting a contrast agent into the blood vessel BV. FIG. 2(a) shows, as an example, a state in which a lesion Z that has been thinned by a foreign body such as a thrombus Y (see FIG. 1) is present in a part of the imaged blood vessel BV. Although details will be described later, the control unit 21 of the suction device 2 of this embodiment can extract length information and flow path diameter information of the lesion Z of the blood vessel BV based on the X-ray image acquired by the imaging unit 34a as shown in FIG. 2(a).

[0049] The ultrasonic image processing device 3b as the imaging device 3 is capable of imaging a blood vessel BV from within the blood vessel BV using ultrasonic waves. The ultrasonic image processing device 3b of this embodiment includes a control unit 31b, a storage unit 32b, an input / output unit 33b, an ultrasonic catheter 4, and a motor drive unit 5.

[0050] The control unit 31b is one or more processors. The control unit 31b is realized by a dedicated processor specialized for processing such as controlling the operation of the motor drive unit 5 supporting the ultrasonic catheter 4, generating an ultrasonic image based on ultrasonic data acquired from the ultrasonic catheter 4, and communicating with the suction device 2 via the input / output unit 33b, but may be realized by a general-purpose processor such as a CPU (Central Processing Unit). The control unit 31b may include one or more dedicated circuits, or one or more processors in the control unit 31b may be replaced with one or more dedicated circuits. The dedicated circuits are, for example, FPGAs (Field-Programmable Gate Arrays) or ASICs (Application Specific Integrated Circuits). The control unit 31b controls each unit of the ultrasonic image processing device 3b to execute information processing related to the operation of the ultrasonic image processing device 3b.

[0051] The storage unit 32b includes any storage module including, for example, a RAM (Random Access Memory) and a ROM (Read-Only Memory). The storage unit 32b may function as, for example, a main storage device or cache memory that stores ultrasound data acquired from the ultrasound catheter 4, ultrasound image data generated by the control unit 31b based on the ultrasound data, and the like. The storage unit 32b stores any information used in the operation of the ultrasound image processing device 3b. In addition, the storage unit 32b may further store system programs, application programs, various information received by the input / output unit 33b, and the like.

[0052] The input / output unit 33b inputs and outputs signals to and from the suction device 2. The ultrasonic image processing device 3b of this embodiment can transmit ultrasonic image data to the suction device 2 via the input / output unit 33b. Furthermore, the ultrasonic image processing device 3b may output an ultrasonic image generated by the control unit 31b to a display or the like via the input / output unit 33b. The input / output unit 33b may include at least one of a wireless communication interface such as a USB interface, a wireless LAN (Local Area Network) interface, and a Bluetooth interface, and a wired communication interface. Furthermore, the input / output unit 33b may include at least one of a touch panel, a button, an LED (Light Emitting Diode), and a buzzer as an interface with a user.

[0053] As described above, in the ultrasonic image processing device 3b of this embodiment, the control unit 31b controls the operation of the motor drive unit 5 and acquires ultrasonic data from the ultrasonic catheter 4. The ultrasonic catheter 4 includes an imaging unit capable of transmitting and receiving ultrasonic waves. The proximal end of the ultrasonic catheter 4 is connected to the motor drive unit 5. The motor drive unit 5 can move the imaging unit of the ultrasonic catheter 4 along the longitudinal direction according to an instruction from the control unit 31b of the ultrasonic image processing device 3b. The motor drive unit 5 can also rotate the imaging unit of the ultrasonic catheter 4 according to an instruction from the control unit 31b of the ultrasonic image processing device 3b. That is, the imaging unit of the ultrasonic catheter 4 moves along the longitudinal direction of the blood vessel BV while rotating within the blood vessel BV, and acquires ultrasonic data within the blood vessel BV. The control unit 31b of the ultrasonic image processing device 3b generates ultrasonic image data within the blood vessel BV based on this ultrasonic data. FIG. 2(b) is a diagram showing an example of an ultrasonic image generated by the control unit 31b. 2(b) shows, as an example, a state in which a part of the imaged blood vessel BV has a lesion Z whose diameter has been narrowed by a foreign body such as a thrombus Y (see FIG. 1). As will be described in detail later, the control unit 21 of the suction device 2 of this embodiment is capable of extracting length information and flow path diameter information of the lesion Z of the blood vessel BV based on an ultrasound image of the inside of the blood vessel BV generated based on ultrasound data acquired from an ultrasound catheter 4 as shown in FIG. 2(b).

[0054] Next, with reference to Figs. 1 to 6, the details of the suction control of the suction catheter 1 by the suction device 2 will be described. Fig. 3 is a control flow diagram of the control unit 21 of the suction device 2. Fig. 4 is a diagram showing four states of the lesion Z that can be specified by the control unit 21. Fig. 5 is a diagram showing an example of the suction control by the control unit 21 according to the specified state of the lesion Z. Fig. 6A is a diagram showing an example of the suction control executed when the state of the lesion Z belongs to the third quadrant of Fig. 4. Fig. 6B is a diagram showing an example of the suction control executed when the state of the lesion Z belongs to the fourth quadrant of Fig. 4. Fig. 6C is a diagram showing an example of the suction control executed when the state of the lesion Z belongs to the second quadrant of Fig. 4. Fig. 6D is a diagram showing an example of the suction control executed when the state of the lesion Z belongs to the first quadrant of Fig. 4. The horizontal axis of Figs. 6A to 6D indicates time t, and the vertical axis indicates the suction pressure p.

[0055] 3, the control unit 21 of the suction device 2 acquires imaging data (see S1 in FIG. 3). In this embodiment, the control unit 21 acquires X-ray image data from the X-ray image processing device 3a. The control unit 21 also acquires ultrasound image data from the ultrasound image processing device 3b.

[0056] In this embodiment, before the suction catheter 1 is inserted into the blood vessel BV, an X-ray image of the lesion Z (see FIG. 2(a)) is captured by the X-ray image processing device 3a, and an ultrasound image of the lesion Z (see FIG. 2(b)) is captured by the ultrasound image processing device 3b. The X-ray image of the lesion Z (see FIG. 2(a)) by the X-ray image processing device 3a may be continuously captured while the suction catheter 1 is inserted into the blood vessel BV as shown in FIG. 1. The X-ray image data and ultrasound image data of the lesion Z are transmitted to the suction device 2.

[0057] The control unit 21 of the suction device 2 extracts length information and flow path diameter information of the lesion Z of the blood vessel BV based on the X-ray image data and the ultrasound image data acquired from the X-ray image processing device 3a and the ultrasound image processing device 3b (see S2 in FIG. 3). The control unit 21, for example, analyzes the X-ray image shown in FIG. 2(a) to identify the lesion Z in the blood vessel BV that has been narrowed by a foreign body such as a thrombus Y (see FIG. 1). The control unit 21 then extracts length information and flow path diameter information of the identified lesion Z. The length information may be any information that can identify the entire length of the lesion Z in the extension direction of the blood vessel BV, and may be, for example, the length L (see FIG. 1) of the lesion Z in the extension direction of the blood vessel BV. The flow path diameter information may be any information that can identify the narrowing state of the flow path of the lesion Z, and may be, for example, the degree of blockage of the flow path of the blood vessel BV in the lesion Z (hereinafter, simply referred to as "flow path blockage rate"). The flow path blockage rate may be, for example, the degree of narrowing of the flow path diameter D0 (see FIG. 1) in the lesion Z in the normal state, estimated from the flow path diameters before and after the lesion Z.

[0058] Next, the control unit 21 selects the suction operation of the suction catheter 1 based on the extracted length information and flow path diameter information of the lesion Z (see S3 in FIG. 3). Specifically, the control unit 21 of this embodiment controls the suction operation of the suction catheter 1 by comparing the length L of the lesion Z and the flow path blockage rate extracted from the image data with preset thresholds.

[0059] The control unit 21 selects either the first suction mode or the second suction mode based on the length information and flow path diameter information of the lesion Z of the blood vessel BV. The first suction mode is an operation mode in which a constant suction pressure is maintained inside the suction catheter 1, as shown in FIG. 6A. The second suction mode is an operation mode in which the suction pressure inside the suction catheter 1 is repeatedly changed between high and low, as shown in FIGS. 6B to 6D. By using such first and second suction modes, it becomes easier to realize a suction operation according to the condition of the lesion Z.

[0060] More specifically, the control unit 21 of this embodiment selects the first suction mode when the length L of the lesion Z is equal to or less than a predetermined value as a threshold (hereinafter referred to as the "length threshold") and the flow path blockage rate in the lesion Z is equal to or less than a predetermined value as a threshold (hereinafter referred to as the "blockage threshold") (see S4-1 in FIG. 3). That is, as shown in FIG. 6A, the control unit 21 controls the suction so as to maintain a constant suction pressure p0. In other words, the control unit 21 selects the first suction mode when it is determined that the state of the lesion Z is in the third quadrant state shown in FIG. 4. Here, the length threshold in this embodiment is 7 mm as an example, but is not limited to this value, and the length threshold can be set appropriately. Also, the blockage threshold in this embodiment is 50% as an example, but is not limited to this value, and the blockage threshold can be set appropriately. FIG. 5 shows a lesion Z with a length L of 3 mm and a flow path blockage rate of 30% as an example of the lesion Z determined to be in the third quadrant state.

[0061] On the other hand, the control unit 21 selects the second suction mode in any one of the following cases (1) to (3). (1) The length L of the lesion Z is longer than the length threshold (7 mm in this embodiment) and the flow path blockage rate in the lesion Z is equal to or less than the blockage threshold (50% in this embodiment). (2) The length L of the lesion Z is equal to or less than the length threshold (7 mm in this embodiment) and the flow path blockage rate in the lesion Z is greater than the blockage threshold (50% in this embodiment). (3) The length L of the lesion Z is greater than the length threshold (7 mm in this embodiment) and the flow path blockage rate in the lesion Z is greater than the blockage threshold (50% in this embodiment).

[0062] The above-mentioned case (1) means that the state of the lesion Z is in the second quadrant of Fig. 4. The above-mentioned case (2) means that the state of the lesion Z is in the fourth quadrant of Fig. 4. The above-mentioned case (3) means that the state of the lesion Z is in the first quadrant of Fig. 4.

[0063] Thus, in this embodiment, when at least one of the following conditions is satisfied: the length L of the lesion Z is longer than 7 mm, and the flow path blockage rate in the lesion Z is greater than 50%, the control unit 21 selects the second suction mode. That is, as shown in Figs. 6B to 6D, the control unit 21 controls suction so as to repeatedly vary the strength of the suction pressure. In other words, the control unit 21 selects the second suction mode when it is determined that the state of the lesion Z is in any of the first, second, and fourth quadrants shown in Fig. 4. By selecting the second suction mode in which the strength of the suction pressure is repeatedly varied, foreign matter such as a thrombus Y (see Fig. 1) on the inner wall of the blood vessel BV is more likely to be deformed or destroyed than when the first suction mode is selected. Therefore, the efficiency of suction of foreign matter can be improved. In this embodiment, the blood flow is stopped by the balloon 14 (see Fig. 1) and pulse suction is performed in the second suction mode, causing the blood vessel BV to repeatedly contract and expand. This can promote the deformation and destruction of foreign matter such as thrombus Y (see FIG. 1), and can more efficiently remove the foreign matter.

[0064] Furthermore, in the above cases (1) to (3), the control unit 21 of this embodiment controls the fluctuation of the suction pressure in the second suction mode based on the length information and the flow path diameter information.

[0065] Specifically, the second suction mode of this embodiment includes a low flow rate mode and a high flow rate mode in which the suction flow rate per minute is different. The "low flow rate mode" here means a mode in which the suction flow rate per minute is relatively low among two modes in the second suction mode that have different suction flow rates per minute, and the "high flow rate mode" means a mode in which the suction flow rate per minute is relatively high. The control unit 21 of this embodiment selects the high flow rate mode of the second suction mode when the length L of the lesion Z is longer than the length threshold value (7 mm in this embodiment) and the flow path blockage rate in the lesion Z is equal to or less than the blockage threshold value (50% in this embodiment) based on the length information and the flow path diameter information (see S4-3 in FIG. 3). In other words, the control unit 21 of this embodiment selects the high flow rate mode of the second suction mode when it is determined that the state of the lesion Z is in the second quadrant state shown in FIG. 4. FIG. 5 shows a lesion Z with a length L of 15 mm and a flow path blockage rate of 30% as an example of the lesion Z determined to be in the second quadrant state. As shown by the solid line in Fig. 6C, the high flow mode has the same suction cycle t1 as the low flow mode shown by the dashed line in Fig. 6C, but the suction time w2 in one suction cycle t1 is longer than the suction time w1 in one suction cycle t1 in the low flow mode. As a result, the high flow mode is controlled to have a higher suction flow rate per minute than the low flow mode.

[0066] In this way, when the length L of the lesion Z is long (in this embodiment, when it belongs to the first or second quadrant of FIG. 4), the second suction mode is used to promote deformation, destruction, etc. of foreign matter such as thrombus Y (see FIG. 1) and improve suction efficiency. Here, it is not preferable that the blood flow rate in the blood vessel BV suddenly changes before and after the foreign matter such as thrombus Y (see FIG. 1) is removed from the blood vessel BV. Such a sudden change in blood flow rate is likely to occur when the foreign matter is removed from the lesion Z, which has a high flow path blockage rate. However, when the state of the lesion Z is determined to be in the second quadrant shown in FIG. 4, the flow path blockage rate in the lesion Z is not high, so that the above-mentioned sudden change in blood flow rate is unlikely to occur before and after the foreign matter is removed. Therefore, when the control unit 21 of this embodiment determines that the state of the lesion Z is in the second quadrant shown in FIG. 4, it selects the high flow rate mode, which has a high suction flow rate per minute, as described above, instead of the low flow rate mode, which has a low suction flow rate per minute.

[0067] In contrast, the controller 21 of this embodiment selects the low flow rate mode of the second suction mode when the length L of the lesion Z is equal to or less than the length threshold (7 mm in this embodiment) and the flow path blockage rate in the lesion Z is greater than the blockage threshold (50% in this embodiment) (see S4-2 in FIG. 3). In other words, the controller 21 of this embodiment selects the low flow rate mode of the second suction mode when it determines that the state of the lesion Z is in the fourth quadrant state shown in FIG. 4. FIG. 5 shows a lesion Z with a length L of 5 mm and a flow path blockage rate of 85% as an example of the lesion Z determined to be in the fourth quadrant state.

[0068] In this way, when the length L of the lesion Z is short and the passage blockage rate of the lesion Z is large (in this embodiment, the lesion Z belongs to the fourth quadrant of FIG. 4), the second suction mode can be used to promote deformation, destruction, etc. of foreign matter such as thrombus Y (see FIG. 1) and improve suction efficiency. However, a sudden change in blood flow rate is likely to occur before and after removal of the foreign matter. Therefore, when the control unit 21 of this embodiment determines that the state of the lesion Z is in the fourth quadrant shown in FIG. 4, it selects a low flow rate mode with a low suction flow rate per minute. This allows the foreign matter to be gradually sucked in, suppressing a sudden change in blood flow rate.

[0069] Furthermore, in this embodiment, the controller 21 selects the high flow rate mode from the second suction mode when the length L of the lesion Z is longer than the length threshold (7 mm in this embodiment) and the flow path blockage rate in the lesion Z is greater than the blockage threshold (50% in this embodiment) (see S4-4 in FIG. 3). In other words, in this embodiment, the controller 21 selects the high flow rate mode from the second suction mode when it determines that the state of the lesion Z is in the first quadrant state shown in FIG. 4. In FIG. 5, as an example of the lesion Z determined to be in the first quadrant state, a lesion Z with a length L of 20 mm and a flow path blockage rate of 70% is shown.

[0070] In this way, when the length L of the lesion Z is long and the flow path blockage rate of the lesion Z is large (in this embodiment, the lesion Z belongs to the first quadrant of FIG. 4), the second suction mode can be used to promote deformation, destruction, etc. of foreign matter such as thrombus Y (see FIG. 1) and improve suction efficiency. As described above, when the flow path blockage rate of the lesion Z is large, a sudden change in blood flow rate is likely to occur before and after the removal of the foreign matter. Therefore, from this viewpoint, the low flow rate mode is preferable. However, when the length L of the lesion Z is long, it is more preferable to remove the foreign matter early and restore normal blood flow, rather than the change in blood flow rate before and after the removal of the foreign matter. Therefore, when the control unit 21 of this embodiment determines that the state of the lesion Z is the state of the first quadrant shown in FIG. 4, it does not select the low flow rate mode with a low suction flow rate per minute, but selects the high flow rate mode with a high suction flow rate per minute.

[0071] In this embodiment, the high flow mode selected when the state of the lesion Z belongs to the first quadrant of FIG. 4 is the same as the high flow mode selected when the state of the lesion Z belongs to the second quadrant of FIG. 4, but is not limited to this configuration. The second suction mode may further include another mode in which the suction flow rate per minute is higher than the high flow mode described above. In other words, the second suction mode may include three or more modes in which the suction flow rate per minute is different. In this case, when the length L of the lesion Z is longer than the length threshold value (7 mm in this embodiment) and the flow path blockage rate in the lesion Z is greater than the blockage threshold value (50% in this embodiment), the control unit may select, from the second suction mode, another mode in which the suction flow rate per minute is higher than the low flow mode and the high flow mode described above. In this way, it becomes easier to achieve rapid foreign matter removal. As shown in FIG. 6D, for example, such another mode has the same suction cycle t1 and suction time w2 in one suction cycle t1 as the above-mentioned high flow mode, but its suction pressure p0 is higher than the suction pressure p1 of the high flow mode. As a result, the aspiration flow rate per minute in this other mode is greater than that in the high flow mode described above.

[0072] The control unit 21 of this embodiment may determine the maximum suction pressure in the second suction mode based on at least one of the stiffness information of the normal part of the blood vessel BV and the stiffness information of the thrombus Y (see FIG. 1) in the lesion part Z of the blood vessel BV. That is, the control unit 21 may determine the maximum suction pressure related to the suction flow rate per minute in the second suction mode based on at least one of the stiffness information of the normal part of the blood vessel BV and the stiffness information of the thrombus Y (see FIG. 1) in the lesion part Z of the blood vessel BV. For example, the control unit 21 may determine the degree of deformation of the blood vessel BV in the vicinity of the lesion part Z, and based on the determination result, may determine the maximum suction pressure to be used in the second suction mode by, for example, selecting from a plurality of options. As an example, the control unit 21 gradually increases the suction pressure of the suction catheter 1 and observes the degree of deformation of the inner wall of the normal blood vessel BV. Then, when the degree of deformation increases at a predetermined suction pressure p, the control unit 21 may determine the suction pressure p as the maximum suction pressure when suctioning the lesion Z. On the other hand, when the degree of deformation does not increase even if the suction pressure is increased, the control unit 21 may determine the above-mentioned suction pressure p0 (see FIG. 6A and FIG. 6D) as the maximum suction pressure when suctioning the lesion Z. In this way, the control unit 21 may control the suction pressure used in the second suction mode by determining the degree of deformation as the hardness information of the normal part of the blood vessel BV. Also, the maximum suction pressure in the second suction mode may be determined based on the change information of the suction pressure in the suction catheter 1. Specifically, the suction pressure of the suction flow path 11a of the suction catheter 1 may be measured, an inflection point at which the time rate of change of this pressure change increases rapidly may be obtained, and a value close to this value may be set as the maximum suction pressure. This inflection point is correlated with the point at which the degree of deformation increases.

[0073] Furthermore, the control unit 21 may determine the maximum suction pressure in the second suction mode based on stiffness information of the thrombus Y (see FIG. 1) in the lesion Z of the blood vessel BV. The stiffness of the thrombus Y in the lesion Z of the blood vessel BV may be measured, for example, by measuring the reaction force generated when the tip of the guidewire is brought into contact with the thrombus Y in the lesion Z under certain conditions (for example, by pressing the tip of the guidewire against the thrombus Y at a certain speed). The control unit 21 may determine the maximum suction pressure according to the reaction force.

[0074] In this embodiment, the control unit 21 creates the difference in the suction flow rate per minute between the low flow rate mode and the high flow rate mode of the second suction mode by varying the suction time in one suction cycle (see "w1" and "w2" in FIG. 6C), but the suction flow rate per minute may be varied by varying the suction pressure. That is, the control unit 21 may control the suction pressure in the second suction mode based on the length information and flow path diameter information of the lesion Z, and may also control the suction pressure in the second suction mode based on at least one of the stiffness information of the normal part of the blood vessel BV and the stiffness information of the thrombus Y in the lesion Z of the blood vessel BV, either separately or in addition to this.

[0075] In this way, after the suction control method of the suction catheter 1 is determined by the control unit 21, the suction control is executed through the suction catheter 1 inserted into the blood vessel BV (see S5 in FIG. 3).

[0076] The suction device and suction system according to the present disclosure are not limited to the specific configurations and processes shown in the above-described embodiments, and various modifications and variations are possible without departing from the scope of the claims.

[0077] The above-mentioned suction system 100 includes an X-ray image processing device 3a and an ultrasonic image processing device 3b as the imaging device 3, but is not limited to this configuration. The method of acquisition of the suction device 2 is not particularly limited as long as it can acquire length information and flow path diameter information of the lesion Z of the blood vessel BV. Therefore, the suction device 2 may include either one of the X-ray image processing device 3a and the ultrasonic image processing device 3b, or may include another imaging device 3. However, by using the X-ray image processing device 3a, image data of the lesion Z can be easily acquired. Furthermore, by using the ultrasonic image processing device 3b in addition to the X-ray image processing device 3a as in the above-mentioned embodiment, the accuracy of identifying the state of the lesion Z can be further improved.

[0078] In addition, in the above-described suction system 100, the control unit 21 of the suction device 2 is configured to extract the length information and flow path diameter information of the lesion Z from the X-ray image data and the ultrasound image data, but is not limited to this configuration. The suction system 100 may include a device including a control unit that extracts the length information and flow path diameter information of the lesion Z from the X-ray image data and the ultrasound image data, separate from the suction device 2. Then, the suction device 2 may obtain the length information and flow path diameter information of the lesion Z from this device.

[0079] Furthermore, the control unit 21 of the above-mentioned suction device 2 extracts the length L of the lesion Z itself from the image data as length information of the lesion Z of the blood vessel BV, but may also extract other information capable of identifying the length L of the lesion Z, such as positional information from which this length L can be calculated.

[0080] Furthermore, the control unit 21 of the suction device 2 described above extracts the flow path blockage rate as the flow path diameter information of the lesion area Z, but may also extract other information related to the degree of blockage of the flow path, such as the minimum flow path diameter of the lesion area Z.

[0081] Furthermore, the control unit 21 of the suction device 2 described above executes control in which a state in which the suction pressure is zero and a state in which the suction pressures p1 and p0 are repeated in a pulse wave manner as the second suction mode (see Figs. 6B to 6D), but is not limited to this control. As shown in Fig. 7A, the control unit 21 may execute control in which a state in which a low suction pressure p2 and a state in which a suction pressure p1 higher than the suction pressure p2 are repeated in a pulse wave manner as the second suction mode. In other words, there may be no time when the negative pressure state is maintained and the suction pressure becomes zero. However, from the viewpoint of suppressing the sudden change in the blood flow rate before and after the removal of the foreign body described above, it is preferable to provide a time when the suction pressure becomes zero, and conversely, a positive pressure state may be used. In the case of a positive pressure, there is a possibility that a thrombus will move to the peripheral side, so it is preferable to install a thrombus trap mechanism such as a net distal to the lesion Z in advance.

[0082] In the above example, the suction flow rate per minute is controlled by varying the suction pressure ("p" in Fig. 6A to Fig. 6D) and the suction time in one suction cycle ("w" in Fig. 6A to Fig. 6D), but the present invention is not limited to such control. As shown in Fig. 7B, the control unit 21 of the suction device 2 may vary the suction flow rate per minute by varying the suction cycle in the second suction mode. Specifically, in Fig. 7B, the dashed lines indicate control in the low flow mode with the suction pressure p1, the suction time w1 in one suction cycle, and the suction cycle t1. In Fig. 7B, the solid lines indicate control in the high flow mode with the suction pressure p1, the suction time w1 in one suction cycle, and the suction cycle t2. In this way, the suction flow rate per minute may be varied by varying the suction cycle. The suction flow rate per minute may be varied by varying two or more of the suction pressure, the suction time in one suction cycle, and the suction cycle.

[0083] 6B to 6D, the control unit 21 of the suction device 2 described above is configured to apply a suction pressure in a rectangular wave shape in the second suction mode, but is not limited to this configuration. As shown in Figures 7C and 7D, the control unit 21 may be configured to apply a suction pressure in a triangular wave shape (see Figure 7C) or a sine wave shape (see Figure 7D).

[0084] Furthermore, in addition to the configuration of the above-described embodiment, the aspiration system 100 may have a mechanism for locally administering a thrombolytic drug to a foreign body such as a thrombus Y (see FIG. 1) in a lesion Z. This may improve the efficiency of destroying the foreign body such as the thrombus Y. [Industrial Applicability]

[0085] The present disclosure relates to aspiration devices and aspiration systems. [Explanation of symbols]

[0086] 1: Suction catheter 2:Suction device 3: Imaging device 3a: X-ray image processing device 3b: Ultrasound image processing device 4: Ultrasound catheter 5: Motor drive unit 11: Catheter body 11a: Suction channel 11a1: Suction port 11b: Guide wire insertion hole 11b1: Distal opening 11b2: Proximal opening 12: Hub 13: Covering tube 14: Balloon 21: Control unit 22: Storage part 23: Input / output section 24: Suction pump 31a: Control unit 31b: Control unit 32a: Storage section 32b: Storage section 33a: Input / output section 33b: Input / output section 34a: Imaging section 80: Medical tubes 100: Suction system A: Longitudinal direction of the suction catheter A1: Distal direction A2: Proximal direction BV: Blood vessel D0: Normal flow path diameter of the lesion area L: Length of the lesion Y: Thrombus Z: Lesion

Claims

1. A suction device connectable to a suction catheter and capable of generating a negative pressure within the suction catheter, comprising: An aspiration device comprising a control unit that selects either a first suction mode in which a constant suction pressure is maintained inside the suction catheter, or a second suction mode in which the strength of the suction pressure inside the suction catheter is repeatedly varied based on length information of the diseased part of the blood vessel and flow path diameter information.

2. 2. The suction device according to claim 1, wherein the control unit selects the first suction mode when the length of the lesion as the length information is equal to or less than a predetermined value and the flow path blockage rate at the lesion as the flow path diameter information is equal to or less than a predetermined value.

3. The control unit is When the length of the lesion is longer than the predetermined value and the flow path blockage rate at the lesion is equal to or less than the predetermined value, When the length of the lesion is equal to or less than the predetermined value and the flow path blockage rate at the lesion is greater than the predetermined value, and When the length of the lesion is longer than the predetermined value, and the flow path blockage rate in the lesion is greater than the predetermined value, The suction device according to claim 2 , further comprising: a second suction mode selected.

4. The suction device according to claim 3 , wherein the control unit controls a variation in the suction pressure in the second suction mode based on the length information and the flow path diameter information.

5. The second suction mode includes a low flow rate mode and a high flow rate mode having different suction flow rates per minute, The suction device according to claim 4 , wherein the control unit selects the high flow rate mode of the second suction mode when the length of the lesion is longer than the predetermined value and the flow path blockage rate in the lesion is equal to or less than the predetermined value.

6. The suction device according to claim 5 , wherein the control unit selects the low flow rate mode of the second suction mode when the length of the lesion is equal to or less than the predetermined value and a flow path blockage rate in the lesion is greater than the predetermined value.

7. The second suction mode includes a low flow rate mode and a high flow rate mode having different suction flow rates per minute, The suction device according to claim 4 , wherein the control unit selects the low flow rate mode of the second suction mode when the length of the lesion is equal to or less than the predetermined value and a flow path blockage rate in the lesion is greater than the predetermined value.

8. The suction device according to any one of claims 5 to 7, wherein the control unit selects the high flow rate mode from the second suction mode when the length of the lesion is longer than the predetermined value and the flow path blockage rate in the lesion is greater than the predetermined value.

9. The second suction mode includes another mode in which the suction flow rate per minute is greater than that of the high-flow mode, The suction device according to any one of claims 5 to 7, wherein the control unit selects the other mode from the second suction mode when the length of the lesion is longer than the predetermined value and the flow path blockage rate in the lesion is greater than the predetermined value.

10. 10. The suction device according to claim 5, wherein the control unit determines a maximum suction pressure in the second suction mode based on at least one of hardness information of a normal portion of the blood vessel and hardness information of a thrombus in the diseased portion of the blood vessel.

11. The suction device according to claim 5 , wherein the control unit determines a maximum suction pressure in the second suction mode based on information about a change in the suction pressure in the suction catheter.

12. The suction device according to claim 1 , wherein the control unit extracts the length information and the flow path diameter information based on imaging data of the blood vessel obtained from an imaging device.

13. A suction catheter that is inserted into a blood vessel; a suction device connectable to the suction catheter and capable of generating negative pressure within the suction catheter; The suction system includes a control unit that selects either a first suction mode in which a constant suction pressure is maintained inside the suction catheter, or a second suction mode in which the strength of the suction pressure inside the suction catheter is repeatedly varied based on length information of the diseased part of the blood vessel and flow path diameter information.

14. an imaging device capable of imaging the blood vessel; 14. The suction system according to claim 13, wherein the control unit extracts the length information and the flow path diameter information from the imaging data of the blood vessel acquired from the imaging device, and selects either the first suction mode or the second suction mode based on the extracted length information and the flow path diameter information.

15. The aspiration system according to claim 14 , wherein the imaging device includes at least one of an X-ray imaging device that images the blood vessels contrast-enhanced from outside the living body, and an ultrasound imaging device that images the blood vessels from inside the blood vessels using ultrasound.

Images