Interventional catheter for subintimal puncture and interventional system

Abstract

The present application relates to the technical field of medical devices, and discloses an intervention catheter for subintimal puncture and an intervention diagnosis and treatment system, the intervention catheter comprising: a guide wire lumen extending along the axial direction of the catheter body is arranged in the catheter body; the guide wire lumen comprises a first section and a second section; a puncture outlet is arranged on the side surface of the catheter body, the puncture outlet is located at the joint of the first section and the second section, and is in communication with the guide wire lumen; the joint of the first section and the second section is provided with a target shape and / or a target component for guiding the puncture guide wire to pass out of the puncture outlet. The present application reduces the difficulty of puncture, increases the efficiency of puncture, solves the problem that the guide wire is difficult to pass through the occlusion section in the related art, and improves the opening rate of occlusive lesions.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an interventional catheter and interventional diagnostic and treatment system for subendoscopic puncture. Background Technology

[0002] CTO (Chronic Total Occlusion) refers to chronic total occlusion of the coronary arteries, typically caused by atherosclerosis leading to gradual narrowing of the blood vessels and eventually complete occlusion. CTO accounts for approximately 20-30% of coronary artery disease patients. Patients may not experience obvious chest pain or tightness, or they may experience frequent angina or heart failure. Prolonged ischemia can lead to severe damage to cardiac function and increase the risk of malignant cardiovascular events.

[0003] One of the main treatment methods for CTO lesions is interventional therapy, which requires selecting an appropriate guidewire to penetrate or bypass the occluded lesion. However, in related techniques, it is difficult for the guidewire to pass through the occluded segment, resulting in a low success rate. Summary of the Invention

[0004] In view of this, the present invention provides an interventional catheter and interventional diagnostic and treatment system for subendoscopic puncture, in order to solve the problems of difficulty in guidewire passing through the occluded segment and low success rate of opening in related technologies.

[0005] In a first aspect, the present invention provides an interventional catheter for subendoscopic puncture, the interventional catheter comprising: a catheter body;

[0006] The catheter body includes a guidewire lumen extending axially along the catheter body; the guidewire lumen includes a first segment and a second segment;

[0007] The catheter body has a puncture outlet on its side, which is located at the junction of the first segment and the second segment and communicates with the guidewire lumen.

[0008] The junction of the first segment and the second segment is provided with a target shape and / or target component for guiding the puncture guide wire out of the puncture outlet.

[0009] In a second aspect, the present invention provides an interventional diagnostic and treatment system for subendoscopic puncture, comprising any of the interventional catheters for subendoscopic puncture described in the first aspect above.

[0010] In one alternative implementation, the system further includes: an imaging device;

[0011] The imaging device includes an imaging probe and a processor;

[0012] The processor is configured to execute an image recognition method, the image recognition method comprising:

[0013] Acquire the target image obtained by the imaging probe; the target image includes a tomographic image of the interventional catheter;

[0014] The target object in the target image is identified using a semantic segmentation network based on edge block results to obtain a segmentation mask of the target object, wherein the target object includes at least one of the following: the indicator lumen, guidewire lumen, and outer ring of the interventional catheter.

[0015] The interventional catheter and interventional diagnostic and treatment system for subendoscopic puncture provided in this invention propose an interventional catheter in which a working guidewire and a puncture guidewire are used in combination, which reduces the difficulty of puncture, increases the efficiency of puncture, solves the problem of guidewire passing through the occluded segment in related technologies, and improves the opening rate of occluded lesions. Attached Figure Description

[0016] To more clearly illustrate the technical solutions in the specific embodiments or related technologies of the present invention, the drawings used in the description of the specific embodiments or related technologies will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0017] Figure 1 This is one of the partial structural schematic diagrams of the catheter body according to an embodiment of the present invention;

[0018] Figure 2 This is a second schematic diagram of a portion of the structure of the catheter body according to an embodiment of the present invention;

[0019] Figure 3 This is a third schematic diagram of a portion of the structure of the catheter body according to an embodiment of the present invention;

[0020] Figure 4 This is a fourth schematic diagram of a portion of the structure of the catheter body according to an embodiment of the present invention;

[0021] Figure 5 This is the fifth partial structural schematic diagram of the catheter body according to an embodiment of the present invention;

[0022] Figure 6 This is a partial structural schematic diagram of the catheter body according to an embodiment of the present invention;

[0023] Figure 7 This is the seventh partial structural schematic diagram of the catheter body according to an embodiment of the present invention;

[0024] Figure 8 This is the eighth partial structural schematic diagram of the catheter body according to an embodiment of the present invention;

[0025] Figure 9 This is a partial structural schematic diagram of the catheter body according to an embodiment of the present invention;

[0026] Figure 10 This is one of the schematic cross-sectional views of the catheter body at the puncture exit position according to an embodiment of the present invention;

[0027] Figure 11 This is a second schematic cross-sectional view of the catheter body at the puncture exit position according to an embodiment of the present invention;

[0028] Figure 12 This is the third schematic cross-sectional view of the catheter body at the puncture exit position according to an embodiment of the present invention;

[0029] Figure 13 This is the fourth schematic cross-sectional view of the catheter body at the puncture exit position according to an embodiment of the present invention;

[0030] Figure 14 This is one of the schematic diagrams of the reinforcing section of the catheter body according to an embodiment of the present invention;

[0031] Figure 15 This is a second schematic diagram of the reinforcing section of the catheter body according to an embodiment of the present invention;

[0032] Figure 16 This is a schematic diagram of using a catheter to open a completely occluded lesion area according to an embodiment of the present invention;

[0033] Figure 17 This is one of the schematic diagrams of the overall structure of the catheter according to an embodiment of the present invention;

[0034] Figure 18 This is a schematic diagram illustrating the use of a catheter to open a severely occluded lesion area according to an embodiment of the present invention;

[0035] Figure 19 This is a second schematic diagram of the overall structure of the catheter according to an embodiment of the present invention;

[0036] Figure 20 This is the third schematic diagram of the overall structure of the catheter according to an embodiment of the present invention;

[0037] Figure 21 This is a schematic diagram of a novel Y-type interface according to an embodiment of the present invention;

[0038] Figure 22 This is the fourth schematic diagram of the overall structure of the catheter according to an embodiment of the present invention;

[0039] Figure 23 This is a schematic diagram of a semantic segmentation network based on edge block results according to an embodiment of the present invention;

[0040] Figure 24This is a schematic diagram of the identification result of the guidewire lumen, the indicator lumen, and the outer ring of the catheter according to an embodiment of the present invention;

[0041] Figure 25 This is a schematic diagram of a blood identification model according to an embodiment of the present invention;

[0042] Figure 26 This is a schematic diagram of true cavity identification according to an embodiment of the present invention. Detailed Implementation

[0043] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0044] There are two interventional treatment methods for CTO lesions: one is to directly penetrate the occluded lesion with a guidewire, and the other is to bypass the occluded lesion, such as the antégrade dissection re-entry (ADR) technique. ADR utilizes the subendothelial space to bypass the difficult-to-pass occluded portion and then re-enter the true lumen. The specific steps of the ADR technique include: using a special guidewire and instruments, starting from the proximal end of the vessel, advancing through the subendothelial space; when reaching the distal end of the occluded segment, using a specific device to guide the guidewire back into the true lumen of the vessel. This invention provides an interventional catheter for subendothelial puncture, specifically for guiding the guidewire back into the true lumen of the vessel.

[0045] This embodiment provides an interventional catheter for subendoscopic puncture, which can be used to treat chronic total occlusion and also to treat lesions with severe occlusion. Figure 1 and Figure 2 This is a schematic diagram of the structure of an interventional catheter for subendoscopic puncture according to an embodiment of the present invention, as shown below. Figure 1 and Figure 2 As shown, the interventional catheter for subendoscopic puncture includes:

[0046] Catheter body 1;

[0047] The catheter body 1 includes a guidewire lumen 11 extending along the axial direction of the catheter body, and the guidewire lumen 11 includes a first segment and a second segment;

[0048] The guidewire cavity is used to accommodate the guidewire, which can be one, two, or more.

[0049] The catheter body has a puncture outlet 13 on its side. The puncture outlet 13 is located at the junction of the first segment and the second segment and communicates with the guidewire lumen 11. The junction of the first segment and the second segment is close to the distal inlet 111 of the guidewire lumen 11. The first segment is the proximal segment of the guidewire lumen 11, and the second segment is the distal segment of the guidewire lumen 11. That is to say, the second segment is shorter in length.

[0050] The junction of the first segment and the second segment is provided with a target shape and / or target component for guiding the puncture guide wire 4 out of the puncture outlet 13.

[0051] Specifically, the main body of the catheter can be a polymer material, such as polyether block amide (Pebax), nylon, thermoplastic polyurethane (TPU), ML21, TR55, polypropylene (PP), high-density polyethylene (HDPE), polyethylene (PE), Pick, etc.

[0052] The catheter body can be designed in three sections: the first section is a double-lumen tube (imaging lumen 15, guidewire lumen 11), the second section is a triple-lumen tube (imaging lumen 15, guidewire lumen 11, and indicator lumen 14), and the third section is a single-lumen tube (guidewire lumen 11). The three sections can be connected together by heat fusion, laser welding, or adhesive bonding. The second section is cut or heat-fused to form a puncture outlet 13.

[0053] Alternatively, the catheter body can be a two-section design, with the first section being a three-lumen design and the second section a single-lumen design; the two sections are connected together by heat fusion, laser welding, or adhesive; the first section is cut and heat-fused to create a puncture outlet 13, which is as follows: Figure 2 As stated above.

[0054] The interventional catheter provided in this embodiment of the invention can be used in conjunction with a guidewire. For example, the guidewire is initially used as a guiding guidewire. The distal inlet of the catheter body is inserted into the proximal end of the guidewire until the guidewire exits from the proximal inlet of the guidewire lumen. The catheter body is then guided to the subintimal space of the vascular lesion area, that is, the space between the intima and media of the blood vessel. Then, part of the guidewire is withdrawn until the distal end of the guidewire reaches near the puncture outlet 13. Finally, the guidewire is advanced distally so that it exits from the puncture outlet 13 and punctures the vascular intima to enter the true lumen of the blood vessel.

[0055] The interventional catheter provided in this embodiment of the invention can also be used in conjunction with two guidewires, such as a puncture guidewire and a working guidewire (also called a guiding guidewire). The distal inlet 111 of the guidewire lumen 11 serves as the inlet of the working guidewire 2, and the proximal inlet of the guidewire lumen serves as the inlet of the puncture guidewire 4. In actual treatment of chronic total occlusion, the distal end of the working guidewire 2 first enters the subendothelial space of the blood vessel, and then the proximal end of the working guidewire 2 is inserted through the distal inlet 111 of the interventional catheter. The interventional catheter enters the subendothelial space of the blood vessel along the working guidewire 2. That is, the working guidewire 2 and the puncture guidewire 4 work separately. The working guidewire 2 first reaches the subendothelial space of the lesion area, and then the proximal end of the working guidewire 2 is inserted through the distal inlet 111 of the guidewire lumen 11 of the catheter to guide the catheter to the subendothelial space of the lesion area. After that, the working guidewire 2 is withdrawn, and finally the puncture guidewire 4 is inserted through the proximal inlet of the catheter, reaches the puncture outlet 13, and then exits to puncture the vascular intima and enter the true lumen 26 of the blood vessel.

[0056] The interventional catheter for subendothelial puncture provided in this invention reduces the difficulty of vascular endarterial puncture, increases puncture efficiency, solves the problem of guidewire difficulty in passing through occluded segments in related technologies, and improves the opening rate of occluded lesions.

[0057] In some optional embodiments, the puncture outlet 13 also serves as the outlet for the working guidewire 2. In this case, the first segment of the guidewire lumen 11 from the proximal inlet to the puncture outlet 13 (i.e., the junction of the first and second segments) can be called the proximal lumen or the puncture lumen, where only the puncture guidewire 4 passes. The second segment of the guidewire lumen 11 from the distal inlet 111 to the puncture outlet 13 (i.e., the junction of the first and second segments) can be called the working guidewire lumen, where only the working guidewire 2 passes. In other embodiments, the working guidewire 2 can enter the interventional catheter from the distal inlet 111, and then, instead of exiting from the puncture outlet 13, continue along the first segment of the guidewire lumen 11, finally exiting from the proximal inlet of the guidewire lumen 11.

[0058] Some optional implementations, such as Figure 1 As shown, the target shape includes the curved shape of the catheter body. The curved shape is formed by a pre-bending process. The vertex of the curved shape is located at or near the puncture outlet. The bending direction of the curved shape is radially opposite to the puncture outlet 13.

[0059] That is to say, the main body of the catheter includes a curved section 12, and the puncture outlet 13 is located in the curved section.

[0060] In this embodiment of the invention, a curved section is added to the catheter body through a catheter pre-bending process, so that it will always remain curved during use and will not easily straighten. Thus, after the puncture guidewire 4 enters from the proximal inlet of the guidewire lumen 11, it can easily pass through the puncture outlet 13, increasing the efficiency of puncture.

[0061] Some optional implementations, such as Figure 2 As shown, the target shape includes a slope 17 and / or an inverted slope 18;

[0062] The first side of the longitudinal section of the puncture outlet 13 is a slope, and the second side of the longitudinal section of the puncture outlet 13 is an inverted slope; the first side is the side close to the distal end of the guidewire cavity 11, and the second side is the side away from the distal end of the guidewire cavity 11.

[0063] In this embodiment of the invention, by designing the puncture outlet 13 as a ramp, the probability that the puncture guidewire 4 will exit through the puncture outlet 13 after entering from the proximal entrance of the guidewire cavity 11 can be increased, and the probability that the puncture guidewire 4 will continue to travel distally along the second segment of the guidewire cavity 11 after crossing the puncture outlet 13 can be reduced.

[0064] The sloping design of the puncture outlet 13 can be combined with the design of the catheter body having a curved section in the above embodiment. That is, a curved section is set at or near the puncture outlet 13, and the side of the puncture outlet 13 is set as a slope.

[0065] Specifically, the angle of the slope or inverted slope is between 10° and 60°. To ensure that the puncture guidewire 4 can successfully penetrate the vascular intima, the puncture outlet 13 is designed with an angle of 10° < angle < 60°. The purpose is to allow the puncture guidewire 4 to be smoothly pushed into the true lumen 26 of the blood vessel while penetrating the intima. An angle > 10° is intended to allow for easier penetration of the intima. When the angle is < 10°, the puncture guidewire 4 may not be able to successfully penetrate the intima and enter the true lumen due to the small puncture angle. In addition, if the puncture angle is too small, the puncture guidewire 4 may exit directly from the entrance of the working guidewire 2 during puncture, resulting in puncture failure. When the angle is > 60°, the puncture guidewire 4 may come into contact with the intima of the true lumen after penetrating the intima, causing puncture of the intima or subendothelial dissection.

[0066] In other embodiments where the first side of the longitudinal section of the puncture outlet 13 is not set as a slope, and the second side of the longitudinal section of the puncture outlet 13 is not set as the inverted slope, the angle between the puncture guidewire 4 and the catheter when it exits the puncture outlet 13 can be between 10° and 60° by designing the target component.

[0067] In some optional embodiments, the guidewire lumen includes a proximal inlet and a distal inlet, wherein the first opening of the first segment is the proximal inlet and the second opening of the first segment is at the junction; the first opening of the second segment is the distal inlet and the second opening of the second segment is at the junction;

[0068] like Figure 3 and Figure 4 As shown, the second opening of the first segment is higher than the second opening of the second segment. Here, "the second opening of the first segment is higher than the second opening of the second segment" means that the second opening of the first segment is closer to the side of the catheter body from which the guidewire 4 passes compared to the second opening of the second segment.

[0069] In this embodiment of the invention, by setting the outlet of the puncture guidewire 4 (i.e. the second opening of the first segment of the guidewire cavity 11) higher than the opening of the guidewire cavity 11 on the other side of the puncture outlet, the probability of the puncture guidewire 4 passing through the catheter body from the puncture outlet is increased, and the probability of the puncture guidewire 4 continuing to enter the second segment of the guidewire cavity 11 and passing through the distal inlet 111 is reduced, thereby improving the puncture efficiency.

[0070] The design of the opening position of the guidewire lumen 11 provided in this embodiment of the invention can be combined with the above-mentioned bending design of the catheter body and the sloping design of the side of the puncture outlet 13.

[0071] Additionally, in some embodiments, the second opening of the first section of the guidewire lumen is designed to be higher than the second opening of the second section, which can be like... Figure 3 and Figure 4 Similarly, a section near the second opening of the first segment can be designed with a curved shape to make the second opening of the first segment higher than the second opening of the second segment. The first segment, except for the section near the second opening, is flush with the second segment. Alternatively, the entire first segment of the guidewire cavity 11 can be designed to be higher than the second segment, thus also achieving the goal of making the second opening of the first segment of the guidewire cavity higher than the second opening of the second segment. That is, either only the second opening of the first segment of the guidewire cavity 11 can be designed to be higher than the second opening of the second segment, or the entire first end of the guidewire cavity 11 can be designed to be higher than the second segment.

[0072] Other alternative implementations, such as Figure 3 As shown, the target shape includes a groove 20 located at the junction, and the groove 20 extends along the radial direction of the conduit body;

[0073] The opening of the first section of the guide wire cavity 11 at the junction is located on the first sidewall of the groove, and the opening of the second section of the guide wire cavity at the junction is located on the second sidewall of the groove.

[0074] In this embodiment of the invention, the groove 20 design increases the distance between the first and second segments of the guidewire cavity 11, increasing the probability that the puncture guidewire 4 will pass through the catheter body and reducing the probability that the puncture guidewire 4 will continue to enter the second segment of the guidewire cavity 11 and pass through the distal inlet 111, thereby improving the puncture efficiency.

[0075] Specifically, the length of the groove 20 along the axial direction of the catheter body can be 1-10 mm. This length avoids the problem of the puncture guidewire 4 being difficult to pass through the opening of the groove 20 due to an excessively narrow opening, and also avoids the problem of the interventional catheter becoming difficult to deliver along the working guidewire 2 due to an excessively short second section of the guidewire lumen 11. Specifically, if the second section of the guidewire lumen 11 is too short, that is, the corresponding catheter body part is too short, the support part becomes shorter when the interventional catheter is delivered along the working guidewire 2, thus making it difficult to deliver the interventional catheter along the working guidewire 2. In addition, when the diameter of the catheter body is 1.08 mm, the depth of the groove 20 can be 0.2-0.5 mm. This depth of the groove 20 avoids the problem of the puncture guidewire 4 and working guidewire 2 being unable to pass or having difficulty passing through due to an insufficiently exposed opening of the guidewire lumen 11, and also avoids the problem of the groove 20 being too deep, resulting in insufficient catheter material and wrinkles at the groove 20 when the catheter is delivered along the working guidewire 2.

[0076] For example, the length of the groove 20 can be 4 mm, and the depth of the groove 20 can be 0.45 mm. In addition, a tantalum ring 16 can be provided on the catheter body, specifically on the first side of the groove 20. The first side of the groove 20 is the side away from the distal inlet 111. The distance between the top of the first side of the groove 20 and the tantalum ring 16 is 5 mm, and the distance between the top of the first side of the groove 20 and the distal side of the indicator cavity 14 is 6 mm. The distal sides of the indicator cavity 14 and the imaging cavity 15 can be flush. The distance between the distal side of the indicator cavity 14 and the distal inlet 111 of the guidewire cavity 11 can be 4 mm.

[0077] In addition, such as Figure 3 As shown, the groove 20 design provided in this embodiment of the invention can be combined with the design in the above embodiment where the opening positions of different segments of the guidewire cavity 11 are not aligned at the joint. Specifically, based on the groove 20 design, the following design is added: the opening of the guidewire cavity 11 on the first sidewall of the groove 20 is higher than the opening of the guidewire cavity 11 on the second sidewall of the groove 20. The groove 20 design can also be combined with the catheter body bending design in the above embodiment.

[0078] Regarding tantalum ring 16, such as Figure 1 and Figure 2As shown, a tantalum ring 16 can be placed near the proximal end of the puncture outlet 13 on the catheter body, and then another tantalum ring 16 can be placed near the distal inlet 111 of the guidewire lumen 11. The tantalum ring 16 placed near the puncture outlet 13 can guide the guidewire 4 to remain near the puncture outlet 13 with the assistance of a digital subtraction angiography (DSA) device. The tantalum ring 16 placed near the distal inlet 111 of the guidewire lumen 11 can guide the catheter to the target location (e.g., the lesion location) with the assistance of a DSA device.

[0079] In some optional embodiments, the target component includes a blocking member disposed on the inner wall of the guidewire cavity 11, the blocking member being used to prevent the puncture guidewire 4 from entering the target opening, the target opening being the opening of the second segment of the guidewire cavity 11 at the junction, the second segment being the distal segment.

[0080] In this embodiment of the invention, the design of the target component can be combined with the target shape design, opening position design, etc., in the above embodiments, as long as there is no conflict. The following description only provides examples of combined designs and does not list them all.

[0081] The following example illustrates the blocking component.

[0082] In some optional embodiments, the blocking element includes a protrusion 19, the top of which is flush with or close to the bottom surface of the puncture outlet 13.

[0083] In this embodiment of the invention, by setting the height of the protrusion 19 to be relatively high, the puncture guidewire 4 can more easily pass through the puncture outlet 13 when it travels from the proximal entrance of the guidewire cavity 11 to the puncture outlet 13 (i.e., the junction of the first and second segments) because the opening leading to the second segment of the guidewire cavity 11 is completely or nearly completely blocked by the protrusion 19, and thus it is not easy to enter the second segment of the guidewire cavity 11, thereby improving the puncture efficiency.

[0084] The protrusion 19 can be made of polymer or metal materials by hot melting, or by polymer casting, or by laser welding or glue bonding. Its function is to provide an upward guiding force during the advancement of the puncture guide wire 4 in the guide wire cavity 11 so that the puncture guide wire 4 can pass smoothly through the puncture outlet 13.

[0085] The cross-section of the protrusion 19 is triangular or arc-shaped. Specifically, as shown in the figure... Figure 5 As shown, the cross-section of the protrusion 19 is triangular or nearly triangular. Figure 6 or Figure 7 As shown, the cross-section of the protrusion 19 is arc-shaped. Figure 6 As shown, the design of setting the protrusion 19 as a blocking element can be combined with the design of the side of the puncture outlet 13 being sloped. Additionally, as... Figure 7 As shown, the design of setting the protrusion 19 as a blocking element can be combined with the curved design of the catheter body and the design of the side of the puncture outlet 13 being sloped. For example... Figure 3 As shown, the design of setting the protrusion 19 as a blocking element can also be combined with the groove 20 design in the above embodiment.

[0086] Other alternative implementations, such as Figure 8 As shown, the blocking member includes a flip cover component 21, the top of which is flush with or close to the bottom surface of the puncture outlet 13.

[0087] The first end of the flip-top component 21 is a free end, and the second end is rotatably connected to the inner wall of the guide wire cavity 11. The first end is the end away from the distal inlet 111, and the second end is the end close to the distal inlet 111.

[0088] In this embodiment of the invention, the blocking member is a movable flip-top component 21. In this embodiment, when the guidewire 4 enters from the proximal inlet of the guidewire cavity 11 and travels to the vicinity of the puncture outlet 13 (i.e., the junction of the first and second sections of the guidewire cavity), it lifts the flip-top component 21. The lifted flip-top component 21 blocks the opening of the guidewire cavity 11 at the other end (i.e., the opening of the second section of the guidewire cavity at the junction), thereby preventing the guidewire 4 from entering the guidewire cavity 11 at the other end (i.e., the second section of the guidewire cavity 11), thus increasing the probability of the guidewire 4 exiting through the puncture site and improving puncture efficiency.

[0089] In some specific embodiments, the flip cover component 21 includes two planes; in a first state, the included angle between the two planes is a target angle; in a second state, the included angle between the two planes is greater than the target angle; and in a third state, the included angle between the two planes is less than the target angle.

[0090] The apex of the included angle between the two planes is the apex of the flip cover component 21;

[0091] The first state is when it is not subjected to force from the working guidewire 2 and not subjected to force from the puncture guidewire 4; the second state is when it is subjected to pressure or thrust from the working guidewire 2; and the third state is when it is subjected to thrust from the puncture guidewire 4.

[0092] Specifically, when the flip-top component 21 is subjected to a force from the puncture guidewire 4, one plane directly in contact with the puncture guidewire 4 moves closer to another plane and causes the other plane to rotate towards the distal inlet 111 of the guidewire cavity 11. When the flip-top component 21 is subjected to a force from the working guidewire 2, since the working guidewire 2 passes from the distal inlet 111 to the proximal inlet of the guidewire cavity 11, the plane directly in contact with the working guidewire 2 is pushed by the working guidewire 2.

[0093] For example, the two planes of the flip cover component 21 can be connected by a spring. Alternatively, the flip cover component 21 as a whole can also be made of a spring-loaded component.

[0094] In other embodiments, such as Figure 8 As shown, the interventional catheter also includes an indicator cavity 14, which is used to assist in locating the puncture exit 13. The puncture exit 13 and the indicator cavity 14 are respectively located on both sides of the guidewire cavity 11, and a communication port is provided between the guidewire cavity 11 and the indicator cavity 14. A flapper component 21 is disposed on the communication port. When the working guidewire 2 passes from the distal inlet 111 of the guidewire cavity 11 to the position of the flapper component 21, the thrust of the working guidewire 2 can press the flapper component 21 into the indicator cavity 14. When the working guidewire 2 enters the puncture exit 13, the flapper component 21 springs back, exits from the indicator cavity 14, and returns to its initial state.

[0095] Specifically, the indicator cavity 14 can be an empty cavity or made of a light-absorbing material that is completely different from the main body of the catheter.

[0096] In addition, the design of the flip-top component 21 described in the above embodiment can be combined with the slope design on the side of the puncture outlet 13, so that the puncture guide wire 4 can enter the puncture outlet 13 more easily and smoothly, increasing the success rate and efficiency of puncture, and reducing the probability of the puncture guide wire 4 becoming kinked or bent.

[0097] Some optional implementations, such as Figure 9 As shown, the blocking element includes a one-way valve 22, the opening direction of which is from the distal inlet 111 to the proximal inlet.

[0098] In this embodiment of the invention, by setting a one-way valve 22, the puncture guidewire 4, when traveling from the proximal inlet to the puncture outlet 13, can only exit from the puncture outlet 13 and cannot enter the guidewire cavity 11 at the other end, i.e., it cannot enter the second section of the guidewire cavity 11, thus ensuring puncture efficiency. Furthermore, it also ensures that the working guidewire 2 can exit from the distal guidewire cavity 11 (i.e., from the outlet of the second section of the guidewire cavity 11 at the junction), thereby exiting from the puncture outlet 13 or from the proximal inlet of the guidewire cavity 11.

[0099] In addition, such as Figure 9As shown, the blocking element can include both the protrusion 19 and the one-way valve 22, that is, the protrusion 19 and the one-way valve 22 can be used together.

[0100] In some optional embodiments, the interventional catheter provided in this invention further includes an imaging chamber 15;

[0101] The imaging cavity 15 is used to house the imaging probe and its signal transmission line. Specifically, the imaging probe can be an optical coherence tomography (OCT) probe. The signal transmission line can be an optical fiber. The imaging probe can acquire images of the catheter and blood vessels at the probe's location in real time. The acquired images can be transmitted to the OCT device's main unit via the signal transmission line and displayed on the screen for observation by the surgical operator.

[0102] In some optional embodiments, when the catheter body includes an imaging marker component and the imaging cavity 15, the relative positional relationship between the imaging marker component and the puncture outlet is fixed, which is used to assist in determining the position of the puncture outlet in the target image, wherein the target image is an image acquired by the imaging probe in the imaging cavity.

[0103] Specifically, the imaging marker component is an indicator cavity 14 or a metal wire. The indicator cavity 14 is imaged as a ring in the target image, while the metal wire is imaged as a fan shape in the target image.

[0104] The target image is an image in the cross-sectional direction of the catheter body, and in this cross-sectional direction, the imaging marker component is located in the sidewall of the puncture site. For example, as... Figure 10 The cross-sectional view shown shows that the cross-section of the puncture exit 13 covers the cross-section of the indicator cavity 14. In this embodiment of the invention, the imaging marker component (indicator cavity 14 or metal wire) consists of two segments, one at the front end of the puncture exit and the other at the rear end of the puncture exit.

[0105] In this embodiment of the invention, an imaging marker component is disposed in the side wall of the puncture outlet 13 along the cross-sectional direction of the catheter body. This allows the puncture outlet 13 to be displayed in real-time at the location of the imaging marker component during optical coherence tomography (OCT) imaging. In other words, the location of the imaging marker component indicates the location of the puncture outlet 13. Therefore, the specific location of the puncture outlet 13 can be observed in real-time as the catheter rotates, facilitating the operator's operation. Furthermore, the design of the catheter itself becomes simpler, reducing the overall design risk of the catheter.

[0106] In some alternative embodiments, in the cross-sectional direction of the catheter body, the imaging marker and the puncture outlet are located on opposite sides of the guidewire lumen.

[0107] For example, such as Figure 11 As shown, the line connecting the indicator cavity 14, the guide wire cavity 11, and the puncture outlet 13 is a straight line, that is, the positions of the indicator cavity 14, the guide wire cavity 11, and the puncture outlet 13 are on a straight line.

[0108] In this embodiment of the invention, the imaging marker component and the puncture outlet 13 are positioned on opposite sides of the guidewire lumen 11 in the cross-sectional direction of the catheter body, and are roughly arranged in a straight line. This allows the position of the puncture outlet 13 to be seen in real-time in the OCT imaging when the catheter is imaged. Furthermore, the specific position of the catheter puncture outlet 13 can be observed in real-time as the catheter rotates, which facilitates the operator's operation. At the same time, the design of the catheter itself becomes simpler, reducing the overall design risk of the catheter.

[0109] In some alternative embodiments, in the cross-sectional direction of the catheter body, the imaging cavity 15 and the puncture outlet 13 are located on opposite sides of the guidewire cavity 11.

[0110] For example, such as Figure 12 As shown, the line connecting the imaging cavity 15, the guidewire cavity 11, and the puncture outlet 13 is approximately a straight line, that is, the positions of the imaging cavity 15, the guidewire cavity 11, and the puncture outlet 13 are on a straight line.

[0111] In this embodiment of the invention, by placing the imaging cavity 15 and the puncture outlet 13 on opposite sides of the guidewire cavity 11 and arranging them roughly in a straight line, the position of the puncture outlet 13 can be displayed in real time in the OCT imaging device when the catheter is imaged. Furthermore, the specific position of the catheter puncture outlet 13 can be observed in real time as the catheter rotates, which facilitates the operator's operation. At the same time, the design of the catheter itself becomes simpler, reducing the overall design risk of the catheter.

[0112] In the above embodiments, by designing the relative positions between the imaging marker component (e.g., indicator cavity 14), imaging cavity 15, guide wire cavity 11 and puncture outlet 13, the position of puncture outlet 13 can be directly observed on the image acquired by the imaging probe. Compared with the method of calculating the position of puncture outlet 13 by the position of imaging marker component (e.g., indicator cavity 14) and guide wire cavity 11, the amount of calculation is greatly reduced.

[0113] In other embodiments, the relative positions between the imaging cavity 15, the imaging marker component (e.g., the indicator cavity 14), the puncture exit 13, and the guidewire cavity 11 can be as follows: Figure 13 As shown.

[0114] In some optional embodiments, the imaging marker component extends along the axial direction of the catheter body, covering the puncture outlet 13. That is, from the axial position of the catheter body, the proximal end of the imaging marker component is closer to the proximal inlet of the guidewire lumen 11 than the puncture outlet, and the distal end of the imaging marker component is closer to the distal inlet of the guidewire lumen 11 than the puncture outlet. For example, see [reference needed]. Figure 1 , Figure 2 , Figure 5 , Figure 7 , Figure 8 and Figure 9 The positional relationship between the central indicator cavity 14 and the puncture exit 13. This avoids the problem that the imaging marker component (e.g., the indicator cavity 14) cannot be used to locate the puncture exit 13 due to insufficient length.

[0115] In addition, the metal wires used as imaging markers can also strengthen the main body of the catheter.

[0116] In some optional embodiments, the catheter body includes a reinforcing section 23, the reinforcing section 23 is provided with reinforcing members, and / or the reinforcing section 23 of the catheter body is made of a metallic material;

[0117] The reinforcing member is disposed within the main body of the catheter.

[0118] In this embodiment of the invention, a portion of the catheter body is reinforced. The starting point of the reinforced section 23 is the proximal end of the catheter body, and the ending point generally does not exceed the proximal end of the indicator cavity 14. That is, the reinforced section 23 generally does not cover the indicator cavity 14 to avoid affecting the imaging effect, and thus affecting the guiding effect of the puncture guidewire 4 during puncture.

[0119] Specifically, such as Figure 14 As shown, the reinforcing member can be a spring 24. For example, it can be a metal spring. The imaging cavity 15 and guidewire cavity 11 described above can be located inside the spring 24. If the spring 24 is used as the reinforcing member, then any of the catheter bodies described in the above embodiments can be formed first, then a spring 24 can be wound around the outside of the catheter body, and finally a heat-shrinkable polymer material layer can be wrapped around the outside of the spring 24 and heat-treated to form an interventional catheter including the spring 24 as the reinforcing member. Using the spring 24 as the reinforcing member, the support of the catheter can be significantly improved, the bending resistance can be significantly improved, and the compliance can be significantly enhanced.

[0120] Or, such as Figure 15 As shown, the reinforcing member can be a metal wire 25. For example, it can be a stainless steel guide wire. When using the metal wire 25 as the reinforcing member, the catheter manufacturing process can be as follows: First, a catheter body including a guide wire cavity 11, an imaging cavity 15, an indicator cavity 14, and a reinforcing cavity is formed. Then, the metal wire 25 is assembled into the reinforcing cavity of the catheter body, thus forming a catheter with the metal wire 25 as the reinforcing member. In this embodiment of the invention, when the metal wire 25 is used as the reinforcing member, the manufacturing process is simple, the cost is relatively low, and the support, bending resistance, and catheter compliance are also improved to a certain extent.

[0121] In addition, the reinforced design of the catheter body enhances the overall rigidity of the catheter reinforcement section 23, which allows for better consistency when the catheter is rotated, preventing the puncture outlet 13 from being misaligned with the intima of the blood vessel.

[0122] like Figure 16 As shown, the process of treating CTO using the interventional catheter provided in any of the above embodiments is as follows:

[0123] Guided by the working guidewire 2, the catheter enters the space 28 between the intima and media of the blood vessel, and then crosses the completely narrowed lesion area 27; the catheter body is rotated so that the puncture outlet 13 of the catheter is aligned with the true lumen of the blood vessel 26, and the puncture guidewire 4 is pushed so that the guidewire passes through the intima of the blood vessel and enters the true lumen of the blood vessel 26.

[0124] In some optional embodiments, the proximal inlet of the guidewire lumen is also used to communicate with a fluid aspiration device to aspirate or inject fluid through the puncture outlet. Specifically, the aspiration device can be a syringe or a suction pump. For example, a syringe filled with saline can be connected to the proximal inlet of the guidewire lumen to flush the area at the puncture outlet 13, improving OCT imaging results. Additionally, during the opening of the CTO, blood may enter the vascular dissection; the fluid aspiration device can aspirate the blood from the dissection, thereby preventing the dissection from widening or tearing.

[0125] Specifically, the proximal inlet of the guidewire cavity 11 can be directly connected to the liquid aspiration device, or it can be connected to the liquid aspiration device through other connectors, such as... Figure 17 , Figure 19 , Figure 20 and Figure 21 As shown, the catheter also includes a Y-type interface 29 (also known as an external tube rotating Y-type interface), the Y-type interface 29 includes three ports, the first port of the Y-type interface 29 is used to connect to the proximal end of the catheter body;

[0126] The second port of the Y-type interface 29 is used as the entry point of the puncture guidewire 4. After the puncture guidewire 4 is inserted through the second port of the Y-type interface 29, it enters the guidewire lumen 11 in the catheter body through the first port of the Y-type interface 29.

[0127] In some specific implementation methods, such as Figure 21 As shown, the first port 291 and the second port 292 of the Y-type interface 29 are arranged opposite to each other, and a straight connecting hole is provided between the first port and the second port. In this embodiment of the invention, the first port 291 and the second port 292 of the Y-type interface 29 are arranged opposite to each other and connected by a straight connecting hole, so the puncture guidewire 4 can pass straight from the second port 292 to the first port 291, and then pass into the guidewire lumen of the catheter body.

[0128] The third port 293 of the Y-type interface 29 is used to connect to the Patient Interface Unit (PIU), i.e., the PIU connector 30, as detailed below.

[0129] Additionally, the second port of the Y-type interface 29 is also used to connect a liquid aspiration device to extract or inject liquid through the puncture port 13. That is, as... Figure 18 As shown, the puncture outlet 13 can also be used as a suction port or a flushing port. The Y-type interface 29 can be made of polymer materials.

[0130] Other optional specific implementations, such as Figure 22 As shown, the catheter body also includes an indicator lumen 14 extending along the catheter body;

[0131] The catheter also includes a Y-shaped interface; the Y-shaped interface includes four ports, one of which serves as the catheter body connection port, connecting to the proximal end of the catheter body, namely the first port 291 of the Y-shaped interface 29 mentioned above, and another port serves as the suction port 294; the other two ports are the second port 292 and the third port 293.

[0132] The indicator cavity has a third opening and a fourth opening 141. The third opening is located on the proximal end face of the catheter body and is connected to the aspiration port via the Y-shaped interface of the catheter body. The fourth opening 141 is located at the puncture outlet 13. The fourth opening 141 is an open opening through which liquid can be injected into the true lumen of the blood vessel or the dissection, or liquid can be withdrawn from the true lumen of the blood vessel or the dissection.

[0133] The indicator cavity 14 is used to assist in determining the position of the puncture exit in the target image and serves as a suction cavity.

[0134] Specifically, the first port 291 of the Y-type interface 29 (i.e., the catheter body connection port) has three independent interfaces that are connected to the indicator cavity, imaging cavity, and guidewire cavity of the catheter body, respectively. These three interfaces are connected to the second port 292, the third port 293, and the aspiration port 294 of the Y-type interface 29 through three independent cavities within the Y-type interface.

[0135] Unlike the previous embodiment where the guidewire cavity 11 was reused as the suction cavity, in this embodiment of the invention, the indicator cavity is reused as the suction cavity. Accordingly, in this embodiment of the invention, the liquid injection device is connected to the suction port 294 of the Y-type interface 29.

[0136] In addition, such as Figure 22 As shown, the indicator cavity 14, in addition to the portion extending from the proximal end of the catheter body to the puncture outlet (proximal side) as described above, may also include another portion extending from the distal side of the puncture outlet to the distal side of the catheter body. In this embodiment of the invention, the indicator cavity 14 is interrupted when passing the puncture outlet 13.

[0137] In the above embodiments of the present invention, by reusing the guidewire lumen and the indicator lumen as aspiration cavities, the function of aspirating fluid into the true lumen of the blood vessel or the dissection is realized, while avoiding the problem of increasing the size of the catheter body due to the addition of an extra aspiration cavity.

[0138] The catheter provided in this embodiment of the invention can be used not only to open CTO (collapsed endovascular tissue), but also to open severely occluded lesions (such as...). Figure 18 (As shown).

[0139] In other embodiments, such as Figure 17 , Figure 19 As shown, the catheter may also include a Patient Interface Unit (PIU), or PIU connector 30, for connecting the OCT imaging device and the imaging probe within the imaging chamber 15. This allows the images acquired by the imaging probe to be transmitted to the OCT imaging device and displayed on the screen, enabling the surgeon to clearly and intuitively observe the condition within the blood vessel. Specifically, the PIU connector 30 is connected to the third port of the Y-type interface 29, which is connected to the first port of the Y-type interface 29. Thus, the signal transmission line within the imaging chamber 15 of the catheter body can be connected to the PIU connector 30 through the first and third ports of the Y-type interface 29.

[0140] Furthermore, the Y-type connector 29 (first port) is fixedly connected to the proximal end of the catheter body, while the connection to the PIU connector 30 is a rotatable connection. That is, when the Y-type connector 29 is rotated, the catheter body rotates accordingly, while the PIU connector 30 remains relatively stationary. Figure 20As shown, with the reinforcing section 23 on the catheter body, the overall coaxiality of the catheter body is significantly improved when the Y-type connector 29 is rotated. The Y-type connector 29 can be... Figure 17 , Figure 19 and Figure 20 The Y-type interface shown can also be Figure 21 The new Y-type interface shown.

[0141] This embodiment provides an interventional diagnostic and treatment system for subendoscopic puncture, which includes any of the interventional catheters described in the above embodiments.

[0142] When using an interventional catheter to open a completely occluded lesion, it is necessary to locate the position of the puncture outlet 13 and then adjust its position. For example, the position of the puncture outlet 13 can be adjusted by rotating the Y-shaped connector 29 to rotate the catheter body until the direction of the puncture outlet 13 points towards the blood in the blood vessel. Then, the puncture guidewire 4 can be pushed along the direction of the puncture outlet 13 to puncture the intima of the blood vessel and enter the true lumen 26. This process involves two difficulties: first, the identification of the puncture outlet 13, and second, the identification of the true lumen (i.e., the position of the blood).

[0143] This invention proposes artificial intelligence detection methods for the puncture cavity and the true cavity to assist users in the treatment of CTO lesions. Examples of the artificial intelligence detection methods for the puncture cavity and the true cavity (i.e., blood) are given below.

[0144] In some optional embodiments, the interventional diagnostic and treatment system further includes: an imaging device;

[0145] The imaging device includes an imaging probe and a processor; as described in the above embodiments, the imaging device can be an OCT imaging device, and the imaging probe and the processor can be connected by a signal transmission line.

[0146] The processor is configured to execute an image recognition method, the image recognition method comprising:

[0147] The target image acquired by the imaging probe is obtained; the target image includes a tomographic image of the interventional catheter; specifically, the target image can be an image in the cross-sectional direction of the interventional catheter, which, in addition to the tomographic image of the interventional catheter, also includes images of the blood vessel wall and images of the blood inside the blood vessel, etc.

[0148] The target object in the target image is identified using a semantic segmentation network based on edge block results to obtain a segmentation mask of the target object. The target object includes at least one of the indicator lumen 14 of the interventional catheter, the guidewire lumen 11, and the outer ring.

[0149] Since the puncture outlet 13 is not visible in the images acquired by the imaging probe in most cases, it cannot be directly identified. However, in the catheter structure, the position of the puncture outlet 13 relative to the guidewire lumen 11 and the indicator lumen 14 is fixed. Therefore, after identifying the guidewire lumen 11, the indicator lumen 14, and the outer ring of the catheter body, the position of the puncture outlet 13 can be finally located. Because the guidewire lumen 11 and the indicator lumen 14 are elliptical ring structures in OCT imaging, with almost no space in the middle, accurate identification of the boundaries of the guidewire lumen 11 and the indicator lumen 14 is required. Furthermore, the guidewire lumen 11 and the indicator lumen 14 are relatively small in the entire image, representing a difficult target detection problem with limited foreground information. Therefore, this embodiment of the invention proposes a semantic segmentation network based on edge blocks to segment the indicator lumen 14 and the guidewire lumen 11.

[0150] In some optional implementations, during the training process of the edge-block-based semantic segmentation network, the network further divides the segmentation masks of the indicator cavity 14 and the guide wire cavity 11 into blocks, and determines the type of each block according to a pre-set standard. Losses are calculated for different types of blocks, and then weighted and summed. The block types include foreground, background, and mixed blocks, with the mixed block having the largest weight. A mixed block is a block that includes both foreground and background. The edges (i.e., boundaries) of segmented target objects such as the guide wire cavity 11 and the indicator cavity 14 often exist in the mixed block. The key to achieving fine instance segmentation often depends on the segmentation effect at the edges. Therefore, when calculating the segmentation loss, a larger weight is set for the loss of the mixed block, which can enhance the network's learning weight for the edges in the mixed block. This means the network's learning tends to focus on edges, reducing the network's edge recognition error, improving the accuracy of edge recognition, and thus improving the recognition accuracy of the guide wire cavity 11 and the indicator cavity 14.

[0151] The main characteristic of semantic segmentation networks based on edge block results is that during training, the segmentation results are divided into blocks, for example, into n×n blocks. The loss for each block is then calculated separately, and finally, a weighted sum is obtained to obtain the total loss. Furthermore, in the weighted summation of the losses for each block, blocks containing edges are assigned larger weights. Specifically, the aforementioned semantic segmentation network based on edge block results includes a mask branch (such as...) Figure 23 The bottom right corner is used to divide the segmentation results into blocks and classify each block based on a pre-set gold standard.

[0152] Furthermore, the semantic segmentation network used to segment the indicator cavity 14 and the semantic segmentation network used to segment the guide wire cavity 11 can be the same network or different networks. If they are the same network, then the sample images of the indicator cavity 14 and the guide wire cavity can be trained together on the same semantic segmentation network. Moreover, the network can simultaneously output the segmentation results of the indicator cavity 14 and the guide wire cavity. If they are different networks, then they need to be trained separately. Even if they are different networks, the network architecture can be the same, only the parameters can be different.

[0153] For example, the underlying network of the edge-block-based semantic segmentation network is a mask-region-based CNN (mask-rcnn). However, the underlying network of the edge-block-based semantic segmentation network is not limited to the mask-rcnn network.

[0154] Regarding maskrcnn, such as Figure 23 As shown, it mainly includes a backbone feature extraction module, a feature pyramid network (FPN), a region proposal network (RPN), a pooling module (RoI Align), and a loss function module, wherein:

[0155] 1) For the backbone feature extraction module, this embodiment of the invention uses a ResNet-50 network with an input image size of 704*704. To improve the robustness of the network, the training set can be augmented by rotating and adjusting the contrast to augment the image by a factor of 10. For the ResNet-50 network structure, 3*3 convolutions are used. Each residual module has 3 convolutional layers and uses max pooling. The activation function is the ReLU activation function.

[0156] 2) For the Feature Pyramid Network, a pyramid structure with 5 scales is established. The input is used as the first scale, and the output of each subsequent scale is used as the input of the next scale. Then, 1*1 convolution is used to extract features from the input. The main purpose of FPN is to upsample high-level features and fuse them with low-level features. The output image of each scale will be reduced by 1 / 2 in both length and width compared to the input image.

[0157] 3) For the region extraction network, an n×n sliding window is used to slide across the shared convolutional feature map and extract features. The middle position of each sliding window corresponds to k anchor boxes. In this embodiment of the invention, 3 scaling ratios × 3 aspect ratios are used, for a total of k = 9 anchor boxes.

[0158] 4) For the pooling module, for each candidate region generated by the RPN, a fixed-size feature vector is extracted from the feature map using the RoIAlign layer. Unlike RoIPooling in Faster R-CNN, RoIAlign uses bilinear interpolation to maintain spatial alignment and avoid quantization errors, which is particularly important for accurate instance segmentation.

[0159] 5) For the loss module, including classification loss L cls Regression loss L box and mask loss L mask For classification loss, softmax loss is used; for regression loss, L1 loss is used; and for mask loss, this embodiment of the invention proposes a three-class Lmask loss function, the specific function of which is:

[0160] L mask =αL foregroud +βL backgroud +γL mixed

[0161]

[0162] Among them, L mask L represents the total loss of the mask. foregroud L backgroud and L mixed The values ​​represent the losses of the foreground, background, and mixed block, respectively. α, β, and γ represent the weighting factors of the three losses. In this embodiment of the invention, α = β = 0.2 and γ = 0.6 are set. By increasing the weighting factor of the mixed block, the boundary recognition accuracy of the guidewire lumen 11, the indicator lumen 14, and the outer ring of the catheter can be improved.

[0163] Figure 24 This is a schematic diagram showing the identification results of the guidewire lumen 11, the indicator lumen 14, and the outer ring of the catheter.

[0164] While the general location of a true cavity can be determined visually, it requires combining information from consecutive frames for accurate identification. Furthermore, the boundaries of a true cavity are often blurred, and its high similarity to surrounding tissue information makes accurate and rapid boundary determination by the naked eye difficult, potentially affecting puncture accuracy. Therefore, automated true cavity identification is necessary to ensure accuracy. Since true cavities are filled with blood, the true cavity identification problem is essentially the detection and identification of blood within the cavity. Blood in CTO-OCT imaging appears as scattered points of varying brightness, making it difficult to visually identify blood in a single image. Information from consecutive frames is required to determine blood location. Therefore, it is necessary to address the information from consecutive frames for effective blood detection. This problem is characterized by significant intra-class variability and the need to consider neighboring frames, which current techniques struggle to effectively solve.

[0165] In some optional embodiments, the image recognition method further includes:

[0166] The target image is identified using a blood recognition model to obtain blood recognition results;

[0167] The target image includes the current frame image acquired by the imaging probe and multiple historical frames consecutive to the current frame image; the blood recognition model includes a static network, a dynamic network, a feature fusion network, and a target detection module. The static network extracts features from the current frame image, and the dynamic network extracts features from the multiple historical frames. The feature fusion network fuses the features extracted by the static network and the features extracted by the dynamic network to obtain fused features. The target detection module performs blood recognition based on the fused features.

[0168] This invention proposes a static and dynamic network framework to address the fluidity of blood in the true cavity. The static network can identify blood based on information from a single frame image, while the dynamic network can identify blood based on information from previous frames. By utilizing the features of static single frames and dynamic multi-frame features, accurate blood identification and localization can be achieved.

[0169] Specifically, such as Figure 25 As shown, for the static network, a YOLO network is first used for feature extraction, where a residual network is used in the backbone and a pyramid structure is used in the neck network to enhance multi-scale feature fusion and contextual information transmission. Then, the head network uses classification loss and regression loss to obtain the final blood detection result. The head network uses a combination of 3x3 and 1x1 convolutions to adjust the number of channels and gradually reduces the feature map size. To reduce the vanishing gradient problem during gradient propagation, this embodiment of the invention uses the Mish activation function, the specific formula of which is:

[0170] f(x) = x * tanh(softplus(x)), where softplus(x) = ln(1 + e^(-x)). x )

[0171] For the dynamic network, the input is the image data of the previous historical frames of the current frame. For all input data, the same feature extraction network as the static network is used to extract features from the image and extract temporal information. Then, the outputs of both the static and dynamic networks are passed as inputs to the Long Short Mixed Module (LSMM). The LSMM serves as the fusion module for the static and dynamic networks, and the fusion model can be represented as follows:

[0172] F fuse =Concat(G short (F t ),G long (F t-1 ),…,G long (F t-iδt ))+F t

[0173] Where F * G represents the output of a static or dynamic network. * (*) indicates a 1x1 convolution operation. Furthermore, LSMM introduces residual connections, which directly add the features of the current frame to the fusion result: F fuse =Concat(*)+F t This ensures that the features of the current frame are not diluted by the features of historical frames during the fusion process, thus enhancing the spatiotemporal consistency of the model.

[0174] The output of the LSMM is finally processed by a Detection Module for target identification (i.e., blood in the true cavity). This Detection Module extracts convolutional features from the LSMM output and then uses classification and regression losses to obtain the final target detection result, thereby identifying blood in the true cavity and locating its position. Figure 26 This is a schematic diagram for identifying a true cavity.

[0175] Although embodiments of the invention have been described in conjunction with the accompanying drawings, those skilled in the art can make various modifications and variations without departing from the spirit and scope of the invention, and such modifications and variations all fall within the scope defined by the appended claims.

Claims

1. An interventional catheter for subendoscopic puncture, characterized in that, include: Catheter body; The catheter body includes a guidewire lumen extending axially along the catheter body; The guidewire cavity includes a first section and a second section; The catheter body has a puncture outlet on its side, which is located at the junction of the first segment and the second segment and communicates with the guidewire lumen. The junction of the first segment and the second segment is provided with a target shape and / or target component for guiding the puncture guide wire out of the puncture outlet.

2. The catheter according to claim 1, characterized in that, The puncture exit also serves as the exit of the working guidewire. The guidewire lumen includes a proximal inlet and a distal inlet. The distal inlet serves as the entry point of the working guidewire, and the proximal inlet serves as the entry point of the puncture guidewire.

3. The catheter according to claim 1, characterized in that, The guidewire lumen includes a proximal inlet and a distal inlet, wherein the first opening of the first segment is the proximal inlet and the second opening of the first segment is at the junction; the first opening of the second segment is the distal inlet and the second opening of the second segment is at the junction. The second opening of the first segment is higher than the second opening of the second segment.

4. The catheter according to claim 1, characterized in that, The target shape includes a groove located at the junction, and the groove extends along the radial direction of the conduit body; The opening of the first section of the guidewire cavity at the junction is located on the first sidewall of the groove, and the opening of the second section of the guidewire cavity at the junction is located on the second sidewall of the groove.

5. The catheter according to any one of claims 1-4, characterized in that, The target shape includes a slope and / or an inverted slope; The first side of the longitudinal section of the puncture outlet is a slope, and the second side of the longitudinal section of the puncture outlet is an inverted slope; the first side is the side closer to the distal end of the guidewire lumen, and the second side is the side farther away from the distal end of the guidewire lumen.

6. The catheter according to claim 1, characterized in that, The target component includes a blocking member disposed on the inner wall of the guidewire cavity. The blocking member is used to prevent the puncture guidewire from entering the target opening. The target opening is the opening of the second segment of the guidewire cavity at the junction, and the second segment is the distal segment.

7. The catheter according to claim 6, characterized in that, The blocking element includes a protrusion, the top of which is flush with or close to the bottom surface of the puncture outlet.

8. The catheter according to claim 6, characterized in that, The blocking component includes a flip-top component, the top of which is flush with or close to the bottom surface of the puncture outlet. The first end of the flip-top component is a free end, and the second end is rotatably connected to the inner wall of the guide wire cavity. The first end is the end away from the far end of the guide wire cavity, and the second end is the end close to the far end of the guide wire cavity.

9. The catheter according to claim 8, characterized in that, The flip cover component includes two planes; in a first state, the included angle between the two planes is a target angle; in a second state, the included angle between the two planes is greater than the target angle; and in a third state, the included angle between the two planes is less than the target angle. The apex of the included angle between the two planes is the top of the flip cover component; The first state is when there is no force from the working guidewire and no force from the puncture guidewire; the second state is when there is pressure or thrust from the working guidewire; and the third state is when there is thrust from the puncture guidewire.

10. The catheter according to any one of claims 6-9, characterized in that, The blocking element includes a one-way valve, the opening direction of which is from the distal inlet of the guidewire cavity to the proximal inlet.

11. The catheter according to claim 1, characterized in that, The catheter body also includes an imaging marker component and an imaging cavity. The relative positional relationship between the imaging marker component and the puncture outlet is fixed, which is used to help determine the position of the puncture outlet in the target image. The target image is an image acquired by the imaging probe in the imaging cavity. The target image is an image in the cross-sectional direction of the catheter body. In the cross-sectional direction of the catheter body, the imaging marker is located in the side wall of the puncture outlet, or the imaging marker and the puncture outlet are located on opposite sides of the guidewire lumen, or the imaging cavity and the puncture outlet are located on opposite sides of the guidewire lumen.

12. The catheter according to claim 11, characterized in that, The imaging marker component extends along the axial direction of the catheter body and covers the puncture exit.

13. The catheter according to claim 11 or 12, characterized in that, The imaging marker component is an indicator cavity or a metal wire; The metal wire is also used to reinforce the catheter body.

14. The catheter according to any one of claims 1-4, 6-9, and 11-12, characterized in that, The catheter body includes a reinforcing section, the reinforcing section is provided with reinforcing members, and / or the reinforcing section of the catheter body is made of metal material; The reinforcing member is disposed within the main body of the catheter.

15. The catheter according to any one of claims 1-4, 6-9, and 11-12, characterized in that, The proximal inlet of the guidewire lumen is also used to communicate with a liquid aspiration device to extract or inject liquid through the puncture outlet.

16. The catheter according to claim 1, characterized in that, The target shape includes the curved shape of the catheter body, which is formed by a pre-bending process. The apex of the curved shape is located at or near the puncture outlet, and the bending direction of the curved shape is radially opposite to the puncture outlet.

17. The catheter according to claim 1, characterized in that, Also includes: A Y-type interface, wherein the Y-type interface includes three ports; The first port is used to connect to the proximal end of the catheter body; The second port is used as the inlet for the puncture guidewire; The first port and the second port are arranged opposite to each other, and a straight connecting hole is provided between the first port and the second port.

18. The catheter according to claim 1, characterized in that, The catheter body also includes an indicator lumen extending along the catheter body; The catheter also includes a Y-shaped interface; the Y-shaped interface includes four ports, one of which serves as a connection port to the catheter body, connecting to the proximal end of the catheter body, and another port serves as a suction port. The indicator cavity has a third opening and a fourth opening. The third opening is located on the proximal end face of the catheter body and communicates with the aspiration port via the Y-shaped interface of the catheter body connection port. The fourth opening is located at the puncture exit. The indicating cavity is used to assist in determining the position of the puncture exit in the target image and serves as a suction cavity.

19. An interventional diagnostic and treatment system for subendoscopic puncture, characterized in that, Including the interventional catheter for subendoscopic puncture as described in any one of claims 1-18.

20. The system according to claim 19, characterized in that, Also includes: Imaging equipment; The imaging device includes an imaging probe and a processor; The processor is configured to execute an image recognition method, the image recognition method comprising: Acquire the target image obtained by the imaging probe; the target image includes a tomographic image of the interventional catheter; The target object in the target image is identified using a semantic segmentation network based on edge block results to obtain a segmentation mask of the target object, wherein the target object includes at least one of the following: the indicator lumen, guidewire lumen, and outer ring of the interventional catheter.

21. The system according to claim 20, characterized in that, During the training process of the edge-block-based semantic segmentation network, the edge-block-based semantic segmentation network further divides the segmentation mask of the segmented target object into blocks, and judges the type of each block according to a pre-set standard. The loss of each type of block is calculated separately and then summed with weights. The types of blocks include foreground, background and mixed blocks, and the mixed block has the largest weight value.

22. The system according to claim 21, characterized in that, The underlying network of the semantic segmentation network based on edge blocks is a masked region convolutional neural network.

23. The system according to any one of claims 20-22, characterized in that, The image recognition method further includes: The target image is identified using a blood recognition model to obtain blood recognition results; The target image includes the current frame image acquired by the imaging probe and multiple historical frames consecutive to the current frame image; the blood recognition model includes a static network, a dynamic network, a feature fusion network, and a target detection module. The static network extracts features from the current frame image, and the dynamic network extracts features from the multiple historical frames. The feature fusion network fuses the features extracted by the static network and the features extracted by the dynamic network to obtain fused features. The target detection module performs blood recognition based on the fused features.

Images