Interventional catheter and control method of interventional system for promoting obstruction and opening

Abstract

The invention discloses an interventional catheter and a control method of an interventional system for promoting obstruction and opening, and is applied to the field of medical instruments, the interventional imaging catheter comprises: a catheter body provided with a first cavity and a second cavity; an inner cavity of the bag body can be expanded or contracted; an imaging probe is arranged at the far end of the imaging assembly, and the imaging probe is arranged at the far end of the second cavity; the first cavity channel is provided with a first outlet and a second outlet, the first outlet and the second outlet are formed in the two sides of the bag body respectively, and the guide wire is arranged in the first cavity channel and extends out of one of the first outlet and the second outlet; the second cavity is filled with a liquid medium, and the capsule body and the imaging assembly are in liquid communication with the second cavity asynchronously. According to the interventional catheter provided by the invention, one of the first outlet and the second outlet can face the intima of a blood vessel under the guiding action of the bag body, so that the positioning precision and efficiency of a guide wire puncture position can be remarkably improved.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to an interventional catheter and a control method of an interventional system for promoting the opening of obstructions. Background Art

[0002] Chronic total occlusion (CTO) refers to a lesion in which the coronary artery is completely occluded and has been occluded for more than 3 months. It is characterized by high recurrence and reocclusion rates and is difficult to treat. It is the biggest challenge currently facing coronary interventional treatment and is known as the "last bastion that has not been conquered."

[0003] Among the related technologies, there are three main methods for CTO interventional treatment: antegrade wire upgrade (AWE), retrograde (Retrograde), and antegrade dissection re-entry (ADR) technology. In some complex clinical situations, when using medical devices to attempt to traverse chronic total occlusion (CTO) lesions in an antegrade manner and then reopen the blood vessels, it is often difficult, complicated, or even impossible to achieve. In view of this, ADR technology is more efficient and is becoming mainstream. This technology can construct a subintimal pathway around the occlusion site, that is, to open a channel between the two layers of tissue of the vascular intima and adventitia at the occlusion site, and then re-enter the actual lumen of the blood vessel distal to the occlusion site through the opened channel, hoping to achieve vascular recanalization in this way.

[0004] However, interventional catheters using ADR technology usually rely on X-ray images to determine the true and false lumens of the blood vessels and the exit of the puncture guidewire. This not only requires the operator to have rich clinical experience, but also increases the risk of X-ray exposure. In addition, the relevant interventional catheters are equipped with multiple channels with different functions, which limits the size of the catheter and cannot be made smaller, resulting in larger tears in the subintimal tunnel of the blood vessel. In addition, the relevant interventional catheters lack guidance and flexibility for readjustment, resulting in poor puncture positioning accuracy.

[0005] Therefore, how to improve the one-time success rate of puncture without increasing the size of the interventional catheter is a technical problem that those skilled in the art currently need to solve. Summary of the Invention

[0006] The purpose of the present invention is to provide an interventional catheter and a control method for an interventional system for promoting the opening of blockages, which can effectively reduce the size of the catheter body, reduce the degree of tearing of the subintimal tunnel of the blood vessel, and accurately position the puncture of the guide wire.

[0007] To achieve the above object, the present invention provides the following technical solutions:

[0008] An interventional catheter, comprising:

[0009] The catheter body is provided with a first lumen and a second lumen extending in the same direction and separated from each other;

[0010] a balloon connected to the distal end of the catheter body, wherein the inner cavity of the balloon can expand or contract;

[0011] An imaging assembly, wherein the distal end of the imaging assembly is provided with an imaging probe, and the imaging probe is disposed in the distal end of the second cavity;

[0012] The first lumen has a first outlet and a second outlet, the first outlet and the second outlet are respectively arranged on both sides of the balloon, and the guide wire is placed in the first lumen and extends out of one of the first outlet or the second outlet;

[0013] The second lumen is filled with a liquid medium, and the capsule and the imaging probe asynchronously establish liquid communication with the second lumen.

[0014] On the other hand, a response member is disposed in the second cavity, and the response member is connected between the second cavity and the capsule;

[0015] The gap between the imaging probe and the second cavity is filled with liquid medium, and the response component allows the liquid medium to flow from the second cavity into the inner cavity of the balloon under a critical value, so that the liquid medium fills the gap and expands the balloon.

[0016] On the other hand, the interventional catheter includes a guiding state, an anchoring state and a puncture state. When the imaging probe is activated and the response member has not reached a critical value, the interventional catheter is in the guiding state. When the response member reaches a critical value to gradually expand the balloon, the interventional catheter is in the anchoring state. When the balloon is expanded and the guide wire is extended from the first outlet or the second outlet, the interventional catheter is in the puncture state.

[0017] On the other hand, the catheter body is provided with a water outlet micro-hole connecting the second cavity and the inner cavity of the capsule, and the response component is a micro-pressure film, which blocks the water outlet micro-hole;

[0018] The micro-pressure film deforms when the pressure applied is greater than a preset critical value, so as to allow the liquid medium to flow from the second cavity to the inner cavity of the capsule.

[0019] In another aspect, the imaging probe is an ultrasonic transducer;

[0020] The imaging component can drive the ultrasonic transducer to rotate and / or move in the second cavity to obtain image information to indicate the axial extension position and radial extension direction of the guide wire.

[0021] On the other hand, the capsule presents a flat structure when filled with liquid medium, and the capsule is a flexible capsule that can conformably deform to present a subcircular shape.

[0022] On the other hand, the balloon includes a first balloon and a second balloon, the first balloon and the second balloon are respectively located on both sides of the catheter body, and the first balloon, the second balloon, the first cavity and the second cavity are arranged in parallel, and the thickness of the balloon is not greater than the dimension of the catheter body along the arrangement direction perpendicular to the first cavity and the second cavity.

[0023] On the other hand, the balloon is connected to one side of the catheter body, the balloon, the first cavity and the second cavity are arranged in parallel, and the thickness of the balloon is not greater than the dimension of the catheter body along the arrangement direction perpendicular to the first cavity and the second cavity.

[0024] On the other hand, the distal end of the catheter body is provided with a puncture section, the first outlet and the second outlet are staggered in the axial direction of the first lumen of the puncture section, and the capsule is connected to the puncture section in parallel.

[0025] On the other hand, a development mark is provided between the first outlet and the second outlet, or a development mark is provided near the first outlet and the second outlet respectively.

[0026] The present invention also provides the following technical solution: a method for controlling an interventional system for promoting the opening of an obstruction, wherein the interventional system includes an interventional catheter and a guidewire, including:

[0027] axially moving the interventional catheter to the target area, establishing fluid communication between the imaging probe and the second lumen, and turning on the imaging probe to acquire an image of the tissue;

[0028] Identifying an image of the target tissue that matches the intended target tissue, further establishing fluid communication between the balloon and the second lumen to inflate the balloon at the current position, with the balloon driving one of the first outlet and the second outlet toward the target tissue and the other away from the target tissue;

[0029] The imaging component drives the imaging probe to move relative to the second cavity to a position roughly flush with one of the first outlet or the second outlet, and observes through the imaging probe whether the guide wire extended from the outlet and the target tissue are on the same side of the imaging probe. If they are on the same side, the guide wire continues to be pushed; if they are not on the same side, the guide wire is retracted into the first cavity and controlled to be extended from the other outlet.

[0030] The interventional catheter and the control method of the interventional system provided by the present invention are as follows: the second lumen is used for inserting the imaging probe, and the imaging probe is used to establish liquid communication with the second lumen, that is, the gap between the imaging probe and the second lumen is filled with a liquid medium to help the imaging probe obtain an image of the occluded part in the blood vessel, so that the desired guidewire puncture position can be selected distal to the occluded part without relying on X-rays, thereby reducing the risk of X-ray exposure; the balloon and the imaging probe are set to establish liquid communication with the second lumen asynchronously, so that after the catheter body moves to the desired position distal to the occluded part, the balloon is further controlled to establish liquid communication with the second lumen, so that the liquid in the second lumen is used to provide both liquid medium for the imaging probe and filling medium for the balloon. The asynchronous establishment of liquid communication makes it possible to have two different functions without adding a new channel, thereby not increasing the size of the interventional catheter, which is beneficial to reducing the risk of tearing of the subintimal channel of the blood vessel and reducing harm to the patient. At the same time, setting the balloon to inflate later than activating the imaging probe facilitates the operator to first obtain images using the imaging probe, freely adjust the overall position of the interventional catheter to the desired guidewire puncture position, and then inflate the balloon, thereby avoiding the movement resistance and wear and tear risks caused by moving the catheter while the balloon is inflated. Furthermore, the first lumen has a first outlet and a second outlet located on either side of the balloon. Due to the constraint of the vascular interlayer, the balloon is restricted from expanding within the cylindrical interlayer, causing the first and second outlets to face toward or away from the true lumen as the balloon expands. As a result, one of the first and second outlets will inevitably face the vascular intima. The imaging probe only needs to be used to determine whether the guidewire exits from the first or second outlet facing the intima. The coordinated use of the imaging probe, balloon, and dual outlets provides critical guidance and operational flexibility for identifying the true lumen, selecting the puncture position, and guiding and readjusting the puncture direction. This interventional catheter can reduce operational risks and significantly improve the positioning accuracy and efficiency of the guidewire puncture position, thereby increasing the first-time success rate of puncture. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or related technologies, the following briefly introduces the drawings required for use in the embodiments or related technical descriptions. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0032] Figure 1 This is a structural schematic diagram of a specific embodiment of the catheter body and the balloon in the interventional imaging catheter provided by the present invention;

[0033] Figure 2 for Figure 1 A schematic diagram of the arrangement structure of the response component on the second cavity is shown;

[0034] Figure 3 for Figure 1 Schematic diagram of the arrangement structure of the water outlet microholes on the second cavity;

[0035] Figure 4-1 Schematic diagram of the structure of the bilateral capsule in the anchored state;

[0036] Figure 4-2 This is a schematic diagram of the structure of the capsule in the guiding state;

[0037] Figure 4-3 Schematic diagram of the structure of a unilateral capsule in the anchored state;

[0038] Figure 5-1 It is a cross-sectional view of the bilateral sacs and the catheter body;

[0039] Figure 5-2 It is a cross-sectional view of a unilateral balloon and a catheter body;

[0040] Figure 6-1 for Figure 1 A schematic diagram of a first structure of the catheter body is shown;

[0041] Figure 6-2 for Figure 1 A second structural schematic diagram of the catheter body is shown;

[0042] Figure 6-3 for Figure 1 A third structural schematic diagram of the catheter body is shown;

[0043] Figure 7 This is a structural schematic diagram of a specific embodiment of the interventional catheter provided by the present invention;

[0044] Figure 8 for Figure 7 A schematic diagram of the structure of a signal connector in an interventional catheter is shown;

[0045] Figure 9 for Figure 7 A schematic structural diagram of a signal connector in an interventional catheter from another perspective;

[0046] Figure 10 for Figure 7 A schematic diagram of the structure of the signal connector and external equipment in the interventional catheter shown;

[0047] Figure 11 Flow chart of a control method for promoting the opening of an interventional system for blocking provided by the present invention;

[0048] Figure 12A cross-sectional view of the interventional system provided by the present invention for promoting the opening of blockages using an interventional catheter.

[0049] Reference numerals:

[0050] Catheter body 1; first lumen 11; first outlet 111; second outlet 112; second lumen 12; response member 121; water outlet micropore 122; first water outlet micropore 1221; second water outlet micropore 1222; distal end 13; proximal end 14; third lumen 15; capsule 2; first capsule 21; second capsule 22; imaging assembly 3; imaging probe 31; signal connector 32; coaxial port 321; signal core needle 3211; non-coaxial port 322; drive shaft 33; cavity connector 4; first connection port 41; second connection port 42; third connection port 43; external device 5. DETAILED DESCRIPTION

[0051] The core of the present invention is to provide an interventional imaging catheter and system, which can significantly improve positioning efficiency and enhance the accuracy of guidewire puncture positioning.

[0052] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0053] In order to enable those skilled in the art to better understand the present application, the present application is further described in detail below in conjunction with the accompanying drawings and specific embodiments. With respect to the distal end and proximal end in the specific embodiments, the distal end refers to the part of the corresponding component away from the operator, usually the end where the component enters the patient's body or the surgical area, and the proximal end refers to the part of the corresponding component close to the operator, usually the end held or operated by the operator. For a single component, the end closer to the operator is the proximal end, and the end farther away from the operator is the distal end. Furthermore, the end closest to the operator is the proximal end, and the end farther away from the operator is the distal end. Unless otherwise specified, the following description should be given priority for understanding and will not be repeated.

[0054] In addition, it should be noted that the connection mentioned in this application includes both direct connections between systems, components, and parts, and indirect connections between systems, components, and parts through a medium. Those skilled in the art should not understand this as a limitation but should adapt it according to specific needs, which does not exceed the scope of protection of this application.

[0055] During the entire interventional imaging catheterization process, external angiography is required, and there is a certain chance of penetrating the vessel wall, which brings considerable difficulty and risk to the operation. Intravascular ultrasound (IVUS) has been increasingly used in coronary artery surgery, greatly facilitating the treatment of coronary artery lesions. If IVUS can be used, the position of the puncture guidewire can be more accurately determined, helping doctors to better adjust the guidewire exit position, improving the first-time success rate of the puncture, and helping to reduce the use of contrast agents and radiation time during the procedure.

[0056] In this embodiment, please refer to Figure 1 , interventional imaging catheters include:

[0057] The catheter body 1 is provided with a first lumen 11 and a second lumen 12 extending in the same direction and separated from each other. The distance between the first lumen 11 and the second lumen 12 should not be too large, otherwise the size of the catheter body 1 will be too large. The first lumen 11 and the second lumen 12 can be close to each other and separated from each other.

[0058] The balloon 2 is connected to the distal end 13 of the catheter body 1, and the inner cavity of the balloon 2 can expand or contract; the distal end 13 of the catheter body 1 refers to the end of the catheter body 1 inserted into the subintimal tunnel of the blood vessel; specifically, the balloon 2 can be fixedly connected to the catheter body 1;

[0059] Imaging assembly 3, wherein an imaging probe 31 is provided at the distal end of imaging assembly 3, and imaging probe 31 is disposed within the distal end of second lumen 12. The distal end of imaging assembly 3 refers to the side of driving shaft 33 of imaging assembly 3 facing away from external device 5. The distal end of second lumen 12 is aligned with distal end 13 of catheter body 1;

[0060] The first lumen 11 has a first outlet 111 and a second outlet 112, and the first outlet 111 and the second outlet 112 are respectively arranged on both sides of the balloon 2, so that the two face in opposite directions, and the guide wire is placed in the first lumen 11 and extends out from one of the first outlet 111 or the second outlet 112; in a specific embodiment, the balloon 2 is arranged in a first direction of the catheter body 1, and the balloon 2 is constrained by the subintimal tunnel when filled with liquid and expands in the cylindrical space, the first direction is perpendicular to the extension direction of the catheter body 1, the first lumen 11 and the second lumen 12 are arranged along the first direction, the directions of the first outlet 111 and the second outlet 112 are both parallel to the second direction, and the first outlet 111 and the second outlet 112 are opposite to each other, and the first direction, the second direction and the extension direction of the catheter body 1 are perpendicular to each other;

[0061] The second lumen 12 is filled with liquid medium, and the capsule 2 and the imaging probe 31 asynchronously establish liquid communication with the second lumen 12 .

[0062] It should be noted that the balloon 2 and the imaging probe 31 establish liquid communication with the second cavity 12 asynchronously, which means that the time when the balloon 2 and the imaging probe 31 start to establish communication with the liquid is different, wherein the imaging probe first establishes liquid communication with the second cavity 12, that is, the gap between the imaging probe 31 and the second cavity 12 is filled with liquid medium. When the trigger condition is met, the balloon 2 will establish liquid communication with the second cavity 12, and the imaging probe 31 will be surrounded by the liquid medium in the second cavity 12 alone. It is transformed into the imaging probe 31 being surrounded by the liquid medium while the balloon 2 is also filled and expanded by the liquid medium. The balloon 2 and the imaging probe 31 share the same cavity and work in an orderly manner, which avoids the increase in catheter size while ensuring the flexibility of operation.

[0063] The interventional catheter utilizes the setting of the second lumen 12 for inserting the imaging probe 31, and the imaging probe 53 establishes liquid communication with the second lumen 12, that is, the gap between the imaging probe 53 and the second lumen 12 is filled with a liquid medium, and the imaging probe 31 is used to obtain the occlusion site in the blood vessel, and then the required guidewire puncture position is selected according to the occlusion site without relying on X-rays, thereby reducing the risk of X-ray exposure; by arranging the capsule 2 and the imaging component 3 to establish liquid communication with the second lumen 12 asynchronously, when the catheter body 1 moves to the subintimal tunnel, the blood vessel is identified. The catheter is inserted into the obstruction site and further moved to the desired guidewire puncture site. Then, the liquid communication between the balloon 2 and the second lumen 12 is established by controlling the liquid in the second lumen 12 to enter the balloon 2, so that the balloon 2 is filled. The liquid communication is established asynchronously, so that there is no need to add a new channel when having two different functions, thereby not increasing the size of the interventional catheter, which is beneficial to reducing the risk of tearing the subintimal channel of the blood vessel and reducing harm to the patient. At the same time, it is set to make the expansion of the balloon 2 later than the start-up of the imaging probe 31, which is beneficial for the operator to obtain the image of the occlusion site through the imaging probe 31 first. For example, more specifically, information such as the length of the occluded part and the blockage situation can be obtained, so as to allow the operator to make a comprehensive judgment and select a suitable puncture position for the guidewire to return to the true lumen, leaving time for the operator to freely adjust the overall position of the interventional catheter to the desired guidewire puncture position during this period, and then expand the balloon 2, thereby avoiding the movement resistance and the risk of vascular wear and tear caused by moving the catheter in the expanded state of the balloon 2; further, the first cavity 11 has a first outlet 111 and a second outlet 112 respectively arranged on both sides of the balloon 2, which will be limited due to the constraint of the vascular dissection. The balloon 2 expands within the tubular interlayer, causing the first outlet 111 and the second outlet 112 to face the true lumen or away from the true lumen as the balloon 2 expands, so that one of the first outlet 111 and the second outlet 112 faces the endothelium of the blood vessel. It is only necessary to use the imaging probe 31 to determine whether the guidewire passes through the first outlet 111 or the second outlet 112 facing the endothelium. The coordinated use of the imaging probe 31, the balloon 2, and the dual outlets provides key guidance and execution flexibility for the identification of the true lumen, the selection of the puncture position, and the guidance and readjustment of the puncture direction. This interventional catheter can significantly improve the positioning accuracy and efficiency of the guidewire puncture position and increase the success rate of the puncture in one go.

[0064] In some embodiments, a response member 121 is provided in the second cavity 12, and the response member 121 is connected between the second cavity 12 and the capsule 2. Specifically, Figure 2 As shown, the second cavity 12 may be provided with a water outlet micro-hole 122 and other structures, and the response member 121 is provided on the water outlet micro-hole 122;

[0065] The gap between the imaging probe 31 and the second cavity 12 is filled with liquid medium. The response member 121 allows the liquid medium to flow from the second cavity 12 to the inner cavity of the capsule 2 at a critical value, so that the liquid medium fills the gap and expands the capsule 2 at the same time. At this time, the capsule 2 and the imaging component 3 establish liquid communication with the second cavity 12 at the same time.

[0066] Specifically, in addition to the micro-pressure film, the response component 121 can also be a bellows. The bellows can be axially extended or shortened under the action of pressure. The extended bellows has a larger gap, which can allow the liquid medium to leak from the second cavity 12 into the inner cavity of the balloon 2; in addition, the response component 121 can also be a branch cavity at the distal end of the imaging probe 31 and connected to the second cavity 12, which is smaller than the second cavity 12, or a branch cavity with a small size and a tortuous arrangement, thereby extending the length of the liquid flow to the balloon 2 or reducing the flow speed, so that the balloon 2 lags behind the expansion of the imaging probe 31. The time difference obtained can facilitate the movement of the catheter as a whole in the interlayer, and select a suitable position at the distal end of the occluded section for puncture, and then anchor the distal end 13 of the catheter at this position through the expansion of the balloon 2.

[0067] In some embodiments, the interventional catheter includes a guiding state, an anchoring state, and a puncture state; specifically, when the imaging probe 31 is activated and the response member 121 does not reach a critical value, the interventional catheter is in the guiding state. In the guiding state, no liquid medium flows into the balloon 2, such as Figure 4-2 As shown, the balloon 2 surrounds the circumference of the catheter body 1; when the response member 121 reaches the critical value to gradually expand the balloon 2, the interventional catheter is in an anchored state. In the anchored state, the balloon 2 gradually unfolds toward the first direction, and under the constraint of the blood vessel's own structure, the balloon 2 gradually adheres to the endothelium of the blood vessel; when the balloon 2 expands and the guide wire extends from the first outlet 111 or the second outlet 112, the interventional catheter is in a puncture state. In the puncture state, since the balloon 2 has adhered to the endothelium of the blood vessel, the direction of the catheter body 1 is constrained at this time. Since the directions of the first outlet 111 and the second outlet 112 are both parallel to the second direction, and the first outlet 111 and the second outlet 112 are opposite to each other, in the puncture state, one of the first outlet 111 and the second outlet 112 will inevitably face the endothelium of the blood vessel.

[0068] In some embodiments, the imaging probe 31 is an ultrasound transducer. In other embodiments, the imaging probe 31 may also be an OCT imaging probe.

[0069] The imaging assembly 3 is capable of driving the ultrasonic transducer to rotate and / or move within the second lumen 12 to acquire image information to indicate the axial extension position and radial extension direction of the guidewire. Specifically, the imaging assembly 3 includes a drive shaft 33 and a connector component. The connector component is connected to an external device 5, which drives the drive shaft 33 to rotate. The ultrasonic transducer is mounted at the distal end of the drive shaft 33. The axial extension position of the guidewire includes detecting that the appropriate position is at the distal end of the obstruction segment, and the radial extension direction of the guidewire includes monitoring whether the guidewire is extended in the correct direction toward the end of the intima and the true lumen.

[0070] Specifically, the imaging component 3 can drive the ultrasonic transducer to rotate and / or move in the second cavity 12 in any state of the guiding state, the anchoring state or the puncture state. The imaging probe 31 can rotate without moving, or both rotate and move in the guiding state. There is no restriction on whether the imaging probe 31 is opened or closed in the anchoring state. In the puncture state, the imaging probe 31 can be selected to be roughly flush with one of the first outlet 111 or the second outlet 112 to observe whether the guide wire extends from the flush outlet. If the guide wire is observed to extend from the outlet but not toward the true cavity, it means that the selected outlet is the wrong outlet, so that the guide wire is controlled to withdraw from the outlet, return to the cavity and further push to another outlet to extend, thereby ensuring that the guide wire eventually extends toward the correct outlet without relying on X-ray image guidance, and returns to the true cavity.

[0071] In some embodiments, the catheter body 1 is provided with a water outlet micropore 122 communicating with the second lumen 12 and the inner cavity of the balloon 2, and the response member 121 is a micro-pressure film that covers the water outlet micropore 122;

[0072] The micro-pressure film deforms when subjected to a pressure greater than a preset critical value, so as to allow the liquid medium to flow from the second lumen 12 to the inner cavity of the balloon 2. For example, when the water injection pressure in the second lumen 12 is less than 3atm, the liquid medium only fills the second lumen 12 for the imaging probe to work; when the water injection pressure in the second lumen 12 exceeds 3atm, the micro-pressure film can be opened, and the liquid medium will fill the interior of the balloon 2, filling and expanding the balloon 2; specifically, when the interventional catheter enters the puncture state, that is, when the interventional catheter moves to the desired position, by increasing the liquid pressure in the second lumen 12, the liquid in the second lumen 12 passes through the micro-pressure film and enters the interior of the balloon 2, so that the balloon 2 is filled, thereby playing a good guiding role; after the balloon 2 is filled, the liquid pressure in the second lumen 12 can be restored to the initial pressure. When the guidewire puncture is completed and the interventional catheter needs to be withdrawn, applying a reverse pressure greater than 3atm to the micro-pressure film can cause the liquid in the balloon 2 to flow out to shrink the balloon 2, such as Figure 4-2 shown.

[0073] Specifically, such as Figure 6-1 to Figure 6-3As shown, the cross-section of the catheter body 1 can be waist-shaped, or composed of two quasi-circular shapes. Of course, a third lumen 15 can also be provided in the catheter body 1. The extension direction of the third lumen 15 is parallel to the extension direction of the catheter body 1. The third lumen 15 is used to realize auxiliary functions such as measurement, or the third lumen 15 and the second lumen 12 respectively provide liquid to one of the two balloons 2. When one of the third lumen 15 and the second lumen 12 provides liquid, the unilateral balloon expands. When both provide liquid, the bilateral balloons expand and are fully expanded.

[0074] In some embodiments, see Figure 5-1 and Figure 5-2 When the liquid medium is filled into the bladder 2, the bladder 2 is flat and flexible. The bladder 2 can conform to the shape of a subcircle. Specifically, the subcircle refers to a non-closed annular structure, which can be a curved shape of three-quarters quadrant, two-thirds circumference, or even smaller. Due to the constraint of the vascular interlayer, the expansion of the bladder 2 in the cylindrical interlayer is restricted. By designing the bladder 2 with a flat structure, the bladder 2 gradually adheres to the two sides of the subintimal channel of the blood vessel during the process of filling the liquid medium (such as Figure 12 As shown in the figure, the expansion of the balloon 2 enables the distal end of the catheter to be more stably anchored at this position, and the flat structure of the balloon 2 can expand more conformably in the interlayer, and the shape characteristics of the balloon 2 are used to embrace the endothelium, so that the first outlet 111 and the second outlet 112 are directed toward the true lumen or away from the true lumen as the balloon 2 expands, so that one of the first outlet 111 and the second outlet 112 will face the endothelium of the blood vessel, thereby regulating the direction of the catheter body 1.

[0075] In some embodiments, at least one side of the catheter body 1 is provided with a balloon 2; specifically, Figure 4-1 、 5-1 As shown, the balloon 2 includes a first balloon 21 and a second balloon 22, which are located on either side of the catheter body 1, respectively. The first balloon 21, the second balloon 22, the first lumen 11, and the second lumen 12 are arranged in parallel. The thickness of the balloon 2 in its expanded state is no greater than the dimension of the catheter body 1 along a direction perpendicular to the arrangement of the first lumen 11 and the second lumen 12, that is, the thickness of the balloon 2 is no greater than the dimension of the catheter body 1 along the second direction. This configuration is intended to prevent excessive tearing of the dissection. Furthermore, the dimension h of the catheter body 1 along the second direction can be slightly greater than the inner diameter D1 of the first lumen 11 or the second lumen 12, thereby minimizing the size of the catheter body 1 and further reducing the tearing range of the vascular dissection caused by the catheter body 1.

[0076] In some embodiments, see Figure 4-3 、 5-2The balloon 2 is connected to a single side of the catheter body 1, that is, the balloon 2 is only provided on a single side of the catheter body 1. The balloon 2, the first lumen 11, and the second lumen 12 are provided in parallel. Specifically, the balloon 2, the second lumen 12, and the first lumen 11 are arranged in sequence along the first direction, that is, the balloon 2 is provided close to the second lumen 12, so as to facilitate the liquid medium in the second lumen 12 to enter the balloon 2. The thickness of the balloon 2 is not greater than the dimension of the catheter body 1 along the direction perpendicular to the arrangement of the first lumen 11 and the second lumen 12, that is, the thickness of the balloon 2 is not greater than the dimension of the catheter body 1 along the second direction. The above-mentioned configuration, which adopts the structural characteristics of the single-wing balloon 2, can further reduce the overall size of the catheter body 1 and the balloon 2, and further avoid excessive tearing of the vascular dissection.

[0077] Further, if Figure 3 As shown, the water outlet micropores 122 include a first water outlet micropore 1221 and a second water outlet micropore 1222. The first water outlet micropore 1221 is used to supply liquid to the first capsule 21, and the second water outlet micropore 1222 is used to supply liquid to the second capsule 22. Specifically, the diameter of the first water outlet micropore 1221 and / or the second water outlet micropore 1222 is 0.2-0.6 mm, and the pressure resistance of the micro-pressure film is ≈2 atm, which is used to control the water flow rate. The distal water outlet micropores 122 of the second cavity 12 are connected to the interior of the capsule 2. When multiple capsules 2 are provided, the number of water outlet micropores 122 is the same as the number of capsules 2 and corresponds one to one. The liquid medium first passes through the second cavity 12 and then reaches the interior of the capsule 2. Due to the presence of the micro-pressure film, when the pressure is less than 2 atm, water can only fill the second cavity 12 and cannot enter the interior of the capsule 2 to fill it.

[0078] In some embodiments, the first outlet 111 and the second outlet 112 are staggered in the axial direction of the first cavity 11, and the distance from the first outlet 111 to the proximal end 14 of the catheter body 1 is not equal to the distance from the second outlet 112 to the proximal end 14 of the catheter body 1; with such a setting, if the outlet selected for the first time is incorrect, after exiting the outlet, the operator can push forward or backward at the proximal end 14, and the outlet selected again will not be the previously incorrect outlet, thereby avoiding the erroneous operation of repeatedly entering and exiting the same outlet.

[0079] In some embodiments, a puncture section is provided at the distal end 13 of the catheter body 1, and the capsule 2, the first outlet 111 and the second outlet 112 are all located in the puncture section. The length of the puncture section along the extension direction of the catheter body 1 should be greater than or equal to the length of the capsule 2 along the extension direction of the catheter body 1. This arrangement is to ensure that the first outlet 111 and the second outlet 112 are both close to the position of the capsule 2, which facilitates the subsequent puncture control of the guide wire; further, the projections of the first outlet 111 and the second outlet 112 on the axis of the first lumen 11 are both within the projection range of the capsule 2 on the axis of the first lumen 11. The projection on the axis of the first lumen 11 refers to the projection of the capsule 2 and the first outlet 111 and the second outlet 112 projected on the axis of the first lumen 11 after irradiation in a direction perpendicular to the axis of the first lumen 11. This arrangement can ensure that the positions of the first outlet 111 and the second outlet 112 correspond to the position of the capsule 2. Such an arrangement can prevent the catheter body 1 from being kinked. If the guidewire outlet and the balloon 2 are not arranged in the same puncture section of the catheter body 1, the direction of the balloon 2 may not be able to regulate the correct outlet of the guidewire well.

[0080] In some embodiments, a developing mark is provided between the first outlet 111 and the second outlet 112, or a developing mark is provided on the first outlet 111 and the second outlet 112 respectively; specifically, the developing mark can be a metal developing mark, and the developing mark can be provided near the first outlet 111 and the second outlet 112 respectively, that is, the developing mark is adjacent to the first outlet 111 and the second outlet 112, but not flush with the first outlet 111 or the second outlet 112, which helps to indicate that the imaging probe has moved to the corresponding guidewire outlet without interfering with imaging, and is used to display the position of the first outlet 111 and the second outlet 112, thereby improving the positioning efficiency of the guidewire; of course, only one developing mark can be provided between the first outlet 111 and the second outlet 112, so that the position of the first outlet 111 and the second outlet 112 can be obtained in a timely and accurate manner.

[0081] In some embodiments, as Figure 7 As shown, the apparatus further includes a lumen connector 4, wherein a first connection port 41 of the lumen connector 4 is connected to the catheter body 1; a second connection port 42 of the lumen connector 4 is in communication with the first lumen 11, allowing a guidewire to enter the first lumen 11 through the second connection port 42; and a third connection port 43 of the lumen connector 4 is in communication with the second lumen 12, allowing an imaging probe 31 and a liquid medium to enter the second lumen 12 through the third connection port 43. Specifically, the lumen connector 4 is mounted at the proximal end 14 of the catheter body 1. The lumen connector 4 is used for multi-lumen diversion, and the second connection port 42 is separated from the third connection port 43, thereby facilitating guidewire insertion and facilitating guidewire manipulation by the operator.

[0082] In some embodiments, as Figure 8 and Figure 9As shown, the imaging assembly 3 includes a T-shaped piece, two ports of which are colinear with the catheter body 1, and the two ports are respectively connected to a signal connector 32 and a drive shaft 33, and the drive shaft 33 is connected between the signal connector 32 and the imaging probe 31; specifically, the signal connector 32 is provided with a coaxial port 321 coaxial with the drive shaft 33, and a signal core needle 3211 is provided in the port, and the signal core needle 3211 realizes signal transmission with the external device 5; the T-shaped piece is also provided with a non-coaxial port 322 which is coaxial with the drive shaft 33, and the non-coaxial port 322 is provided. The coaxial port 322 is a water injection port, which is used to allow liquid medium to pass into the second cavity 12. Specifically, the liquid medium first enters the interior of the T-shaped piece from the water injection side port, and then passes through the cavity connector 4 to enter the gap between the catheter body 1 and the drive shaft 33. When the balloon 2 needs to be filled, the liquid medium enters the balloon 2 through the response member 121. When the liquid medium enters the balloon 2, the liquid medium in the drive shaft 33 will not decrease, and the total liquid medium capacity in the interventional catheter will increase, thereby avoiding affecting the performance of the imaging probe 31.

[0083] Specifically, the signal interface 32 is rigidly connected to the proximal end 14 of the drive shaft 33, and is axially fixed inside the coaxial port 321. It can rotate and / or move concentrically therein, and at the same time, the drive shaft 33 drives the distal ultrasonic transducer to rotate and / or move synchronously; there is a signal core needle 3211 inside the signal interface for transmitting electrical signals; the non-coaxial port 322 is mainly used for the injection and recovery of physiological saline or heparin water, and the non-coaxial port 322 is communicated with the second cavity 12, and the non-coaxial port 322 and the coaxial port 321 of the proximal end 14 of the catheter are separated by a sealing ring.

[0084] In some embodiments, as Figure 10 As shown, the external device 5 can be a driving component such as a motor. The external device 5 is used to drive the drive shaft 33 to move and / or rotate, and the drive shaft 33 is used to drive the imaging probe 31 to move and / or rotate within the second lumen 12. When the imaging probe is an ultrasonic transducer, the motor can rotate at a high speed of 30 to 100 revolutions per second. At the same time, the ultrasonic excitation signal is transmitted to the transducer through the signal core needle 3211, and the electrical signal is converted into an ultrasonic signal. The ultrasonic signal propagates through the liquid and the sidewall of the catheter body 1, and after contacting the tissue, it is reflected and returned as an ultrasonic signal. The returned ultrasonic signal is converted again into an electrical signal by the ultrasonic transducer, and finally returned to the system for processing into an ultrasonic image.

[0085] In addition to the above-mentioned interventional imaging catheter, the present invention also provides a control method for an interventional system that promotes the opening of blockages using the above-mentioned interventional imaging catheter. The interventional system includes an interventional catheter, a guidewire, and a host. The host is equipped with a processor and a display. The processor sends an electrical signal to the imaging probe 31. The imaging probe 31 converts the electrical signal into an acoustic signal. After signal transmission with the tissue in the blood vessel, it is converted into an electrical signal again and returned to the processor. The processor calculates an image of the tissue and displays it on the display. The interventional system locates the guidewire outlet and true lumen through the image of the interventional catheter, thereby enhancing the accuracy of the puncture guidewire returning to the true lumen.

[0086] For details, please refer to Figure 11 , the control method provided by the present invention includes:

[0087] Step S1: axially moving the interventional catheter to the target area, establishing fluid communication between the imaging probe 31 and the second lumen 12 and turning on the imaging probe 31 to acquire an image of the tissue;

[0088] Step S2: Identifying an image that matches the intended target tissue, further establishing fluid communication between the balloon 2 and the second lumen 12 to inflate the balloon 2 at the current location, thereby temporarily anchoring the distal end 13 of the interventional catheter at the location. The balloon drives one of the first outlet 111 and the second outlet 112 toward the target tissue and the other away from the target tissue.

[0089] Step S3: The imaging component 3 drives the imaging probe 31 to move relative to the second cavity 12 to a position roughly flush with one of the first outlet 111 or the second outlet 112, and observes through the imaging probe 31 whether the guide wire extended from the outlet and the target tissue are on the same side of the imaging probe 31. If they are on the same side, the guide wire continues to be pushed; if they are not on the same side, the guide wire is retracted into the first cavity 11 and controlled to be extended from the other outlet.

[0090] It should be noted that in the application scenario of promoting the opening of blockages, the tissue image and the target tissue image are not the same object. The tissue image can be a circumferential image detected at the dissection position of the blood vessel, and the target tissue image is an image of the true lumen distal to the blockage site.

[0091] This control method uses the imaging probe 31 to acquire an image of the tissue, temporarily anchoring the distal end 13 of the interventional catheter at a location consistent with the desired tissue image. The second lumen 12 is used to provide rotational space and a medium for the imaging probe 31, while also providing fluid for the expansion of the balloon 2. This method fully utilizes the detection accuracy of the imaging probe 31 and improves the positioning accuracy of the guidewire puncture. Furthermore, there is no need to provide separate fluid passage lumens for the imaging probe 31 and the balloon 2, thereby effectively controlling the size of the catheter body 1, reducing the degree of tearing of the subintimal tunnel of the blood vessel, and minimizing harm to the patient. Furthermore, by controlling the imaging probe 31 to move relative to the second lumen 12 to a position substantially flush with either the first outlet 111 or the second outlet 112, it is determined whether the guidewire and the target tissue are on the same side of the imaging probe 31, that is, whether the guidewire exits from the outlet facing the intima. If the guidewire exits from the incorrect position, the guidewire is simply retracted into the first lumen 11 and controlled to exit from the other outlet, significantly improving the positioning accuracy and efficiency of the guidewire puncture.

[0092] The interventional imaging catheter and control method provided in the present application connects the medium cavity of the ultrasonic transducer to the interior of the capsule 2 through the response component 121, thereby solving the problem that the ultrasonic transducer or OCT probe requires a liquid medium for energy transfer and the problem that the capsule 2 needs to be filled with liquid. There is no need for a separate water injection cavity, thereby controlling the size of the catheter body 1 to a smaller range.

[0093] The various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the various embodiments can be referenced to each other.

[0094] The above describes in detail the interventional imaging catheter provided by the present invention. Specific examples are used herein to illustrate the principles and implementation methods of the present invention. The description of the above examples is intended only to facilitate understanding of the method and core concepts of the present invention. It should be noted that those skilled in the art may make various improvements and modifications to the present invention without departing from the principles of the present invention, and such improvements and modifications fall within the scope of protection of the present invention.

Claims

1. An interventional catheter, characterized in that: include: The catheter body is provided with a first lumen and a second lumen extending in the same direction and separated from each other; A balloon body connected to the distal end of the catheter body, wherein the inner cavity of the balloon body can expand or contract; An imaging component, wherein an imaging probe is disposed at the distal end of the imaging component, and the imaging probe is disposed at the distal end of the second cavity; The first cavity has a first outlet and a second outlet, the first outlet and the second outlet are respectively arranged on two sides of the capsule, and the guide wire is placed in the first cavity and extends out from one of the first outlet or the second outlet; The second cavity is filled with a liquid medium, and the capsule and the imaging probe asynchronously establish liquid communication with the second cavity.

2. The interventional catheter according to claim 1, characterized in that: A response member is disposed in the second cavity, and the response member is connected between the second cavity and the capsule; The gap between the imaging probe and the second cavity is filled with liquid medium, and the response member allows the liquid medium to flow from the second cavity to the inner cavity of the capsule at a critical value, so that the liquid medium fills the gap and expands the capsule at the same time.

3. The interventional catheter according to claim 2, characterized in that: The interventional catheter includes a guiding state, an anchoring state and a puncture state. The interventional catheter is in the guiding state when the imaging probe is activated and the response member has not reached a critical value. The interventional catheter is in the anchoring state when the response member reaches a critical value to gradually expand the balloon. The interventional catheter is in the puncture state when the balloon is expanded and the guide wire is extended from the first outlet or the second outlet.

4. The interventional catheter according to claim 2, characterized in that: The catheter body is provided with a water outlet micro-hole connecting the second cavity and the inner cavity of the capsule, and the response component is a micro-pressure film, and the micro-pressure film covers the water outlet micro-hole; The micro-pressure film is deformed when the pressure is greater than a preset critical value to allow the liquid medium to flow from the second cavity to the inner cavity of the capsule.

5. The interventional catheter according to claim 1, characterized in that: The imaging probe is an ultrasonic transducer; The imaging component can drive the ultrasonic transducer to rotate and / or move in the second cavity to obtain image information to indicate the axial extension position and radial extension direction of the guide wire.

6. The interventional catheter according to claim 1, characterized in that: The capsule presents a flat structure when filled with a liquid medium, and the capsule is a flexible capsule that can conformably deform to present a subcircular shape.

7. The interventional catheter according to claim 6, characterized in that: The balloon includes a first balloon and a second balloon, the first balloon and the second balloon are respectively located on both sides of the catheter body, and the first balloon, the second balloon, the first cavity and the second cavity are arranged in parallel, and the thickness of the balloon is not greater than the dimension of the catheter body along a direction perpendicular to the arrangement of the first cavity and the second cavity.

8. The interventional catheter according to claim 6, characterized in that: The balloon is connected to one side of the catheter body, the balloon, the first cavity and the second cavity are arranged in parallel, and the thickness of the balloon is not greater than the dimension of the catheter body along a direction perpendicular to the arrangement of the first cavity and the second cavity.

9. The interventional catheter according to claim 1, characterized in that: A puncture section is provided at the distal end of the catheter body, the first outlet and the second outlet are staggered in the axial direction of the first cavity of the puncture section, and the capsule is connected to the puncture section in parallel.

10. The interventional catheter according to claim 1, characterized in that: A development mark is provided between the first outlet and the second outlet, or a development mark is provided near the first outlet and the second outlet, respectively.

11. A control method for an interventional system for promoting blockage opening, characterized in that: The interventional system comprises an interventional catheter and a guidewire, wherein the interventional catheter is as described in any one of claims 1 to 10, comprising: Axially moving the interventional catheter to the target area, establishing fluid communication between the imaging probe and the second lumen and turning on the imaging probe to obtain an image of the tissue; Identify an image of the target tissue that meets the expectation, further establish liquid communication between the balloon and the second cavity to expand the balloon at the current position, and the balloon drives one of the first outlet and the second outlet toward the target tissue and the other away from the target tissue; The imaging component drives the imaging probe to move relative to the second cavity to a position roughly flush with one of the first outlet or the second outlet, and observes through the imaging probe whether the guide wire extended from the outlet and the target tissue are on the same side of the imaging probe. If they are on the same side, the guide wire continues to be pushed; if not, the guide wire is retracted into the first cavity and controlled to be extended from the other outlet.

Images