An integrated dual-catheter navigation catheter sheath system

Abstract

The application discloses an integrated double-adjustable-curve navigation catheter sheath system and relates to the technical field of medical devices. The catheter sheath system comprises a catheter sheath main body, an operation handle, an adjusting assembly and a plugging assembly. The catheter sheath main body is provided with a first cavity, a second cavity, a third cavity and a plurality of perfusion holes in communication with the first cavity. The catheter sheath main body comprises at least a proximal adjustable-curve segment and a distal adjustable-curve segment connected with the proximal adjustable-curve segment. A first adjusting mechanism is connected with the proximal adjustable-curve segment and used for adjusting the bending angle and direction of the proximal adjustable-curve segment. A second adjusting mechanism is connected with the distal adjustable-curve segment and used for adjusting the bending angle and direction of the distal adjustable-curve segment. A first plugging balloon and a second plugging balloon are arranged on the distal end of the catheter sheath main body. The application provides an integrated double-adjustable-curve navigation catheter sheath system, simplifies the operation process, improves the target blood vessel positioning accuracy, and realizes reliable isolation plugging and ablation agent perfusion.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an integrated dual-bend navigation catheter sheath system. Background Technology

[0002] The left atrial oblique vein, also known as the Marshall vein, is the site of alcohol ablation. Marshall vein (VOM) ablation is an effective interventional procedure for treating persistent atrial fibrillation. The core procedure involves precisely infusing anhydrous alcohol into the Marshall vein and its associated myocardial region via a catheter to ablate abnormal electrical conduction pathways.

[0003] Currently, the standard method for achieving this surgical approach is a step-by-step instrumentation procedure: First, a dedicated angiography catheter (such as a JR angiography catheter) is inserted into the right atrium through the inferior vena cava to attempt to locate and select the coronary sinus (CS) ostium. Coronary sinus venography is then performed to initially identify the location of the Marshall vein. Next, a guidewire (such as a Runthrough guidewire) is inserted into the coronary sinus and attempts to penetrate the Marshall vein. Then, an occlusion balloon (such as an OTW balloon) is advanced along the guidewire to the proximal end of the Marshall vein for occlusion. Finally, alcohol is injected into this segment through the central lumen of the balloon or another microcatheter.

[0004] However, this traditional step-by-step procedure has significant drawbacks. Due to the variable location and complex anatomy of the Marshall vein opening, establishing a pathway from the right atrium to the coronary sinus and then to the target vein is extremely difficult, and the manipulation of guidewires and catheters is time-consuming and has an inconsistent success rate. Furthermore, isolation of the target vessel segment typically relies on occlusion of the Marshall vein opening with a single balloon, but this occlusion is often ineffective, with contrast agent easily flowing back into the coronary sinus, affecting the visualization of distal vessels; simultaneously, there is a risk of leakage during alcohol infusion, potentially damaging non-target tissues. In addition, the entire procedure requires frequent exchanges of catheters, guidewires, and balloons, which not only prolongs the procedure time and increases the risk of iatrogenic injuries (such as vascular perforation and dissection), but also increases the complexity and cost of the procedure.

[0005] Therefore, there is an urgent need for an integrated medical device to simplify the procedure of Marshall intravenous alcohol ablation, improve the accuracy of target vessel positioning, and achieve reliable isolation and occlusion and ablation agent infusion. Summary of the Invention

[0006] The main objective of this invention is to provide an integrated dual-bend navigation catheter sheath system, which aims to provide an integrated medical device that simplifies the operation process of Marshall intravenous alcohol ablation, improves the accuracy of target vessel positioning, and achieves reliable isolation and occlusion and ablation agent infusion.

[0007] To achieve the above objectives, this invention proposes an integrated dual-bend navigation catheter sheath system, comprising: The catheter sheath body has a first cavity, a second cavity, a third cavity, and a plurality of irrigation holes communicating with the first cavity. The first cavity is used to deliver liquid ablative agent, the second cavity is used to fill with fluid, and the third cavity is used to fill with fluid. The catheter sheath body includes at least a proximal adjustable bend and a distal adjustable bend connected to the proximal adjustable bend. An operating handle is connected to the proximal end of the catheter sheath body; The adjustment assembly includes a first adjustment mechanism and a second adjustment mechanism, respectively disposed on the operating handle. The first adjustment mechanism is connected to the proximal adjustable bend segment and is used to adjust the bending angle and direction of the proximal adjustable bend segment; the second adjustment mechanism is connected to the distal adjustable bend segment and is used to adjust the bending angle and direction of the distal adjustable bend segment; and An occlusion assembly includes a first occlusion balloon and a second occlusion balloon, which are spaced apart and disposed on the distal end of the catheter sheath body to establish an isolation occlusion zone. The infusion port is located between the first occlusion balloon and the second occlusion balloon. The first occlusion balloon communicates with the second cavity, and the second occlusion balloon communicates with the third cavity.

[0008] Optionally, the first adjustment mechanism includes a first control element and a first transmission mechanism, and the second adjustment mechanism includes a second control element and a second transmission mechanism; the first control element and the second control element are respectively disposed on the operating handle, and the first transmission mechanism and the second transmission mechanism extend from the inside of the operating handle to the inside of the catheter sheath body; the proximal end of the first transmission mechanism is connected to the first control element, and the distal end of the first transmission mechanism is connected to the proximal adjustable bend; the proximal end of the second transmission mechanism is connected to the second control element, and the distal end of the second transmission mechanism is connected to the distal adjustable bend.

[0009] Optionally, the first control element and / or the second control element is a knob or a slider.

[0010] Optionally, the first transmission mechanism and / or the second transmission mechanism are wire drawing mechanisms.

[0011] Optionally, the maximum bending angle of the proximal adjustable bending segment is greater than the maximum bending angle of the distal adjustable bending segment.

[0012] Optionally, the radial dimension of the proximal adjustable bend is greater than the radial dimension of the distal adjustable bend.

[0013] Optionally, the radial dimension of the first occlusion balloon in the inflated state is greater than the radial dimension of the second occlusion balloon in the inflated state; The first occlusion balloon is used to occlude within the main coronary sinus, and the second occlusion balloon is used to occlude at a predetermined location within the left atrial oblique vein.

[0014] Optionally, the first occlusion balloon and the second occlusion balloon are made of compliant or semi-compliant polymer materials.

[0015] Optionally, the integrated dual-bend navigation catheter sheath system further includes a first interface, a second interface, and a third interface, wherein the first interface, the second interface, and the third interface are respectively disposed on the operating handle; The first interface is connected to the proximal end of the first cavity and is used for connecting an external infusion device and allowing guidewire passage; the second interface is connected to the second cavity and is used for connecting an external filling device; and the third interface is connected to the third cavity and is used for connecting an external filling device.

[0016] Optionally, the integrated dual-bend navigation catheter sheath system further includes a fourth channel for delivering a guidewire, and the first channel for delivering contrast agent and liquid ablation agent.

[0017] In the technical solution of this invention, the integrated dual-adjustable-bend navigation catheter sheath system includes a catheter sheath body, an operating handle, an adjustment assembly, and an occlusion assembly; the catheter sheath body has a first cavity, a second cavity, a third cavity, and a plurality of infusion holes communicating with the first cavity, the first cavity being used to deliver liquid ablative agent, the second cavity being used to fill with fluid, and the third cavity being used to fill with fluid; the catheter sheath body includes at least a proximal adjustable bend and a distal adjustable bend connected to the proximal adjustable bend; the operating handle is connected to the proximal end of the catheter sheath body; the adjustment assembly includes a first adjustment mechanism and a second adjustment mechanism, the first adjustment mechanism... The first adjustment mechanism and the second adjustment mechanism are respectively located on the operating handle. The first adjustment mechanism is connected to the proximal adjustable bend and is used to adjust the bending angle and direction of the proximal adjustable bend. The second adjustment mechanism is connected to the distal adjustable bend and is used to adjust the bending angle and direction of the distal adjustable bend. The occlusion assembly includes a first occlusion balloon and a second occlusion balloon. The first and second occlusion balloons are spaced apart and located at the distal end of the catheter sheath body to establish an isolation and occlusion zone. The infusion port is located between the first and second occlusion balloons. The first occlusion balloon communicates with the second cavity, and the second occlusion balloon communicates with the third cavity. It can be understood that this invention provides an integrated medical device. This integrated dual-adjustable-bend navigation catheter sheath system, through the setting of an infusion cavity structure, a dual-adjustable-bend structure, and an occlusion structure, allows navigation, target vessel isolation and occlusion, and ablation agent infusion to all be completed by this device without frequent device switching, greatly simplifying the operation process, effectively improving the accuracy of target vessel positioning, and achieving reliable isolation and occlusion and ablation agent infusion.

[0018] The integrated dual-bend navigation catheter sheath system of the present invention simplifies the surgical procedure and shortens the operation time. It integrates the three major functions of navigation, occlusion and irrigation into a single instrument, avoiding the complicated steps of exchanging catheters, guidewires and balloons multiple times during the operation, so that the operation can be completed in one go and significantly shorten the overall operation time.

[0019] The integrated dual-bending navigation catheter sheath system of this invention improves the accuracy of target vessel localization. Its dual-segment design, featuring a large proximal bend and a fine distal bend, better adapts to the complex anatomical path of the right atrium-coronary sinus-Marshall vein, significantly improving the success rate of Marshall vein retrieval and superselection. The proximal and distal adjustable segments employ independent control systems, enabling, for the first time, the establishment of a complex path from the atrium to the target branch vein using a single device.

[0020] The integrated dual-bend navigation catheter sheath system of this invention significantly improves surgical safety and effectiveness. This invention employs dual-balloon occlusion, with the first and second occlusion balloons independently controllable. The first occlusion balloon occludes the coronary sinus, effectively preventing contrast agent backflow and ensuring clear visualization of distal vessels (including small branches), aiding in surgeon decision-making. The second occlusion balloon occludes the target vessel (VOM). Simultaneously, the reliable isolation zone formed between the two balloons ensures that the ablation agent is confined to the target area, allowing for full ablation while effectively protecting non-target tissues (such as the coronary sinus and right coronary artery), avoiding serious complications caused by alcohol leakage. This invention uses a conformal balloon; the compliant balloon design adapts to irregular vessel walls, achieving tight occlusion while reducing the risk of vascular injury. Attached Figure Description

[0021] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.

[0022] Figure 1 This is a schematic diagram of an embodiment of the integrated dual-bend navigation catheter sheath system of the present invention; Figure 2 This is a schematic diagram of another embodiment of the integrated dual-bend navigation catheter sheath system of the present invention; Figure 3 This is a cross-sectional view of the catheter sheath body in another embodiment of the integrated dual-bend navigation catheter sheath system of the present invention; Figure 4 This is a schematic diagram of the distal isolation and sealing section of the catheter sheath body in another embodiment of the integrated dual-bend navigation catheter sheath system of the present invention; Figure 5 This is a schematic diagram of the integrated dual-bend navigation catheter sheath system of the present invention in application; Figure 6 This is a partial schematic diagram of the integrated dual-bend navigation catheter sheath system of the present invention in application.

[0023] Explanation of icon numbers: 100. Catheter sheath body; 200. Operating handle; 310. First adjustment mechanism; 320. Second adjustment mechanism; 410. First occlusion balloon; 420. Second occlusion balloon; 100a. First cavity; 100b. Second cavity; 100c. Third cavity; 100d. Fourth cavity; 100a1. Infusion port; 110. Proximal adjustable bend; 120. Distal adjustable bend; 201. First interface; 202. Second interface; 203. Third interface; 204. Fourth interface.

[0024] The realization of the objective, functional features and advantages of the present invention will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation

[0025] 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 a part of the embodiments of the present invention, and not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0026] It should be noted that all directional indications (such as up, down, left, right, front, back, etc.) in the embodiments of the present invention are only used to explain the relative positional relationship and movement of each component in a certain specific posture (as shown in the figure). If the specific posture changes, the directional indication will also change accordingly.

[0027] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances. In the description of this invention, the terms "proximal end" and "distal end" refer to near and far relative to the operator. When using this invention, the end closer to the operator is the "proximal end," that is, the end where the operator is located, and the end farther from the operator is the "distal end."

[0028] Furthermore, the use of terms such as "first" and "second" in this invention is for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined with "first" or "second" may explicitly or implicitly include at least one of those features. The word "and / or" throughout the text means including three parallel solutions; for example, "A and / or B" includes solution A, solution B, or a solution that simultaneously satisfies A and B. The technical solutions of the various embodiments can be combined with each other, but this must be based on the ability of those skilled in the art to implement them. When the combination of technical solutions is contradictory or impossible to implement, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection claimed by this invention.

[0029] The left atrial oblique vein, also known as the Marshall vein, is the site of alcohol ablation. Marshall vein (VOM) ablation is an effective interventional procedure for treating persistent atrial fibrillation. The core procedure involves precisely infusing anhydrous alcohol into the Marshall vein and its associated myocardial region via a catheter to ablate abnormal electrical conduction pathways.

[0030] Currently, the standard method for achieving this surgical approach is a step-by-step instrumentation procedure: First, a dedicated angiography catheter (such as a JR angiography catheter) is inserted into the right atrium through the inferior vena cava to attempt to locate and select the coronary sinus (CS) ostium. Coronary sinus venography is then performed to initially identify the location of the Marshall vein. Next, a guidewire (such as a Runthrough guidewire) is inserted into the coronary sinus and attempts to penetrate the Marshall vein. Then, an occlusion balloon (such as an OTW balloon) is advanced along the guidewire to the proximal end of the Marshall vein for occlusion. Finally, alcohol is injected into this segment through the central lumen of the balloon or another microcatheter.

[0031] However, this traditional step-by-step procedure has significant drawbacks. Due to the variable location and complex anatomy of the Marshall vein opening, establishing a pathway from the right atrium to the coronary sinus and then to the target vein is extremely difficult, and the manipulation of guidewires and catheters is time-consuming and has an inconsistent success rate. Furthermore, isolation of the target vessel segment typically relies on occlusion of the Marshall vein opening with a single balloon, but this occlusion is often ineffective, with contrast agent easily flowing back into the coronary sinus, affecting the visualization of distal vessels; simultaneously, there is a risk of leakage during alcohol infusion, potentially damaging non-target tissues. In addition, the entire procedure requires frequent exchanges of catheters, guidewires, and balloons, which not only prolongs the procedure time and increases the risk of iatrogenic injuries (such as vascular perforation and dissection), but also increases the complexity and cost of the procedure.

[0032] To address these issues, this invention proposes an integrated dual-bend navigation catheter sheath system.

[0033] Reference Figures 1 to 6 In some embodiments of the present invention, the integrated dual-adjustable-bend navigation catheter sheath system includes a catheter sheath body 100, an operating handle 200, an adjustment assembly, and an occlusion assembly; the catheter sheath body 100 is provided with a first cavity 100a, a second cavity 100b, a third cavity 100c, and a plurality of irrigation holes 100a1 communicating with the first cavity 100a. The first cavity 100a is used to deliver liquid ablative, the second cavity 100b is used to fill with fluid, and the third cavity 100c is used to fill with fluid; the catheter sheath body 100 includes at least a proximal adjustable bend 110 and a distal adjustable bend 120 connected to the proximal adjustable bend 110; the operating handle 200 is connected to the proximal end of the catheter sheath body 100; the adjustment assembly includes a first adjustment mechanism 310 and a second adjustment mechanism 320, the first adjustment... Mechanism 310 and the second adjustment mechanism 320 are respectively disposed on the operating handle 200. The first adjustment mechanism 310 is connected to the proximal adjustable bend 110 and is used to adjust the bending angle and direction of the proximal adjustable bend 110. The second adjustment mechanism 320 is connected to the distal adjustable bend 120 and is used to adjust the bending angle and direction of the distal adjustable bend 120. The occlusion assembly includes a first occlusion balloon 410 and a second occlusion balloon 420. The first occlusion balloon 410 and the second occlusion balloon 420 are spaced apart and disposed on the distal end of the catheter sheath body 100 to establish an isolation occlusion zone. The infusion port 100a1 is located between the first occlusion balloon 410 and the second occlusion balloon 420. The first occlusion balloon 410 is connected to the second cavity 100b, and the second occlusion balloon is connected to the third cavity 100c.

[0034] In this embodiment, the catheter sheath body 100 is a slender, flexible, and kink-resistant polymer tube extending from the proximal end (operating end) to the distal end (interventional end). It contains a centrally located inner lumen and multiple side lumens located lateral to the inner lumen, forming a first channel 100a, a second channel 100b, and a third channel 100c. The first channel 100a can be used to deliver guidewires, contrast agents, or liquid ablatives (such as anhydrous alcohol). Alternatively, the catheter sheath body 100 may also form a fourth channel 100d, such as... Figure 3 As shown, the contrast agent and liquid ablation agent can be delivered through the fourth cavity 100d, while the first cavity 100a serves only as a guidewire cavity for delivery. Here, the number and size of cavities within the catheter sheath body 100 are not limited.

[0035] This integrated dual-bend navigation catheter sheath system employs a dual-segment adjustable bending structure. At the distal intervention portion of the catheter sheath, an axially arranged distal adjustable bending segment 120 and a proximal adjustable bending segment 110 are provided. The proximal adjustable bending segment 110 is positioned relatively posteriorly, closer to the operating handle 200. It is primarily used for large-angle bending within the right atrium to align and guide the distal end of the catheter sheath into the coronary sinus ostium. The distal adjustable bending segment 120 is located at the very end of the catheter sheath. It is primarily used for finer, smaller-angle bending after entering the coronary sinus to guide the distal end of the catheter sheath into the target branch vessel, the Marshall vein. In this embodiment, the maximum bending angle of the proximal adjustable bending segment 110 is greater than that of the distal adjustable bending segment 120, and the radial dimension of the proximal adjustable bending segment 110 is greater than that of the distal adjustable bending segment 120. The distal adjustable bending section 120 and the proximal adjustable bending section 110 can be made of different materials or structures to achieve different adjustable bending angles, and there are no specific limitations.

[0036] In this embodiment, the operating handle 200 is connected to the proximal end of the catheter sheath body 100, and integrates two independent adjustment mechanisms, which are respectively connected to the corresponding bending section through a transmission mechanism built into the wall of the catheter sheath body 100. The operator can precisely control the bending direction and angle of the corresponding bending section through the two adjustment mechanisms, thereby achieving flexible navigation.

[0037] In this embodiment, two independently inflatable and deflated balloons are disposed along the bearing on the outer wall of the catheter sheath. The first occlusion balloon 410, located between (or near) the proximal adjustable bend 110 and the distal adjustable bend 120, is larger in size and designed for occlusion within the main coronary sinus. The second occlusion balloon 420, located at the end of the distal adjustable bend 120 or proximal to it, is smaller in size and designed for occlusion at a predetermined location within the Marshall vein. In this embodiment, the radial dimension of the first occlusion balloon 410 in its inflated state is larger than that of the second occlusion balloon 420 in its inflated state; the first occlusion balloon 410 is used for occlusion within the main coronary sinus, and the second balloon 420 is used for occlusion at a predetermined location within the left atrial oblique vein.

[0038] The first occlusion balloon 410 and the second occlusion balloon 420 can be inflated via independent inflation ports on the operating handle 200, allowing them to conform to the morphology of the vessel wall and thus achieve non-invasive occlusion. Through the coordinated operation of the two balloons, a sealed, isolated chamber specifically for the infusion of chemical ablation agents can be created within the Marshall vein, fundamentally solving the problems of ablation agent leakage and insufficient perfusion of the target area.

[0039] Both the first occlusion balloon 410 and the second occlusion balloon 420 can be made of compliant polymer materials such as medical-grade silicone or polyurethane, or semi-compliant polymer materials such as nylon; the choice is not limited here. Compliant balloons can better conform to irregular vessel walls, resulting in superior occlusion, but require more precise control of filling pressure; semi-compliant balloons offer greater dimensional stability and are suitable for more regularly shaped vessels.

[0040] It is understood that the present invention provides an integrated medical device. This integrated dual-bend navigation catheter sheath system, by setting up an infusion cavity structure, a dual-bend structure and a occlusion structure, enables navigation, target vessel isolation and occlusion and ablation agent infusion to be completed by the device. It eliminates the need for frequent device switching, greatly simplifies the operation process, effectively improves the accuracy of target vessel positioning, and achieves reliable isolation and occlusion and ablation agent infusion.

[0041] The integrated dual-bend navigation catheter sheath system of this invention adopts an integrated functional design, integrating three key functions—precise navigation, target vessel isolation and occlusion, and ablation agent infusion—into a single catheter sheath system. This revolutionizes the traditional step-by-step operation and provides a highly efficient and safe integrated solution for arrhythmia ablation.

[0042] To further improve the convenience of the procedure and increase the efficiency of navigation and positioning, the main reference is... Figure 1 In some embodiments, the first adjustment mechanism 310 includes a first control member and a first transmission mechanism, and the second adjustment mechanism 320 includes a second control member and a second transmission mechanism. The first control member and the second control member are respectively disposed on the operating handle 200. The first transmission mechanism and the second transmission mechanism extend from the inside of the operating handle 200 to the inside of the catheter sheath body 100. The proximal end of the first transmission mechanism is connected to the first control member, and the distal end of the first transmission mechanism is connected to the proximal adjustable bend 110. The proximal end of the second transmission mechanism is connected to the second control member, and the distal end of the second transmission mechanism is connected to the distal adjustable bend 120.

[0043] In this embodiment, both the first control element and the second control element can be manually adjusted using a knob or slider (push button), and there is no limitation here.

[0044] In this embodiment, the first and second transmission mechanisms are preferably wire drawing mechanisms, which have small volume and occupy little space. Besides wire drawing, shape memory alloy wires such as nickel-titanium alloys or hydraulic methods can also be used to achieve bending control of the bending section. Ordinary metal wire drawing methods are simple in structure, low in cost, and offer direct control; shape memory alloy wire methods can achieve automatic recovery of a preset shape, but are more expensive and have slightly lower control accuracy.

[0045] In some embodiments, refer to Figures 1 to 3The integrated dual-bend navigation catheter sheath system may further include a first interface 201, a second interface 202, and a third interface 203, which are respectively located on the operating handle 200. The first interface 201 communicates with the proximal end of the first cavity 100a and is used for connecting an external infusion device and allowing the guidewire to pass through. The second interface 202 communicates with the second cavity 100b and is used for connecting an external filling device. The third interface 203 communicates with the third cavity 100c and is used for connecting an external filling device. This arrangement facilitates the delivery of the guidewire, the infusion of ablation agent, and the filling of the first occlusion balloon 410 and the second occlusion balloon 420.

[0046] In addition, such as Figure 2 and Figure 3 As shown, when the catheter sheath body 100 is provided with a fourth cavity 100d, a fourth interface 204 can also be provided on the operating handle 200. The fourth interface 204 is connected to the fourth cavity 100d and is adapted to be connected to the ablation agent container. The fourth cavity 100d is used to deliver contrast agent and liquid ablation agent, while the first cavity 100a is only used as a guidewire cavity for delivering guidewire.

[0047] The operation method and workflow of this integrated dual-bend navigation catheter sheath system can be referred to as follows: (1) Establish the initial path Under X-ray guidance, the catheter sheath body 100 of the catheter sheath system is introduced from the femoral vein or jugular vein puncture site and delivered to the right atrium along the vascular pathway. By adjusting the first control element on the operating handle 200, the proximal adjustable bend 110 is bent to a suitable angle, thereby guiding the distal end of the catheter sheath body 100 smoothly into the coronary sinus ostium.

[0048] (2) Fine navigation to the target vessel Once the distal end of the catheter sheath body 100 enters the coronary sinus, the catheter sheath body 100 is pushed forward while the second control element is operated to precisely bend the distal adjustable bend 120. Under real-time angiographic guidance, this bend is used to insert and position the distal end of the catheter sheath body 100 to the opening and proximal segment of the target Marshall vein.

[0049] (3) Establish isolation and containment zones First, using the second interface 202 on the operating handle 200, a suitable amount of a mixture of contrast agent and saline is injected into the first occlusion balloon 410 using a syringe to inflate it. The first occlusion balloon 410 inflates within the coronary sinus and blocks the main coronary sinus trunk, preventing subsequent contrast agent or alcohol from flowing back into the right atrium.

[0050] Then, using the third interface 203 on the operating handle 200, the second occlusion balloon 420 is inflated with a syringe, causing it to expand and occlude the Marshall vein proximal to the coronary sinus. At this point, the segment of the Marshall vein located between the two balloons is defined as a closed isolation zone.

[0051] (4) Targeted perfusion ablation The guidewire is withdrawn through the central working lumen of the catheter sheath body 100, i.e., the first cavity 100a, and then anhydrous alcohol is injected directly into the isolation area. Because the first occlusion balloon 410 occludes the coronary sinus and the second occlusion balloon 420 occludes the distal end of the Marshall vein, the anhydrous alcohol is precisely confined within the isolation area, which can fully immerse the target tissue while completely preventing alcohol leakage into the coronary sinus or systemic circulation.

[0052] (5) Postoperative management After ablation, the first occlusion balloon 410 and the second occlusion balloon 420 are aspirated, and the entire catheter sheath system is removed from the body.

[0053] The integrated dual-bend navigation catheter sheath system of the present invention simplifies the surgical procedure and shortens the operation time. It integrates the three major functions of navigation, occlusion and irrigation into a single instrument, avoiding the complicated steps of exchanging catheters, guidewires and balloons multiple times during the operation, so that the operation can be completed in one go and significantly shorten the overall operation time.

[0054] The integrated dual-bending navigation catheter sheath system of this invention improves the accuracy of target vessel localization. Its dual-segment design, featuring a large proximal bend and a fine distal bend, better adapts to the complex right atrium-coronary sinus-Marshall vein anatomical path, significantly improving the success rate of Marshall vein retrieval and superselection. The proximal adjustable segment 110 and the distal adjustable segment 120 employ independent control systems, enabling, for the first time, the establishment of a complex path from the atrium to the target branch vein using a single device.

[0055] The integrated dual-bend navigation catheter sheath system of this invention significantly improves surgical safety and effectiveness. This invention employs dual-balloon occlusion, with the first occlusion balloon 410 and the second occlusion balloon 420 being independently controllable. The first occlusion balloon 410 occludes the coronary sinus, effectively preventing contrast agent backflow and ensuring clear visualization of distal vessels (including small branches), aiding in surgeon decision-making. The second occlusion balloon 420 occludes the target vessel (VOM). Simultaneously, the reliable isolation zone formed between the two balloons ensures that the ablation agent is confined to the target area, allowing for full ablation while effectively protecting non-target tissues (such as the coronary sinus and right coronary artery), avoiding serious complications caused by alcohol leakage. This invention uses a conformal balloon; the compliant balloon design adapts to irregular vessel walls, achieving tight occlusion while reducing the risk of vascular injury.

[0056] The above description is merely an optional embodiment of the present invention and does not limit the patent scope of the present invention. Any equivalent structural transformations made using the contents of the present invention's specification and drawings under the inventive concept of the present invention, or direct / indirect applications in other related technical fields, are included within the patent protection scope of the present invention.

Claims

1. An integrated dual-bend navigation catheter sheath system, characterized in that, include: The catheter sheath body has a first cavity, a second cavity, a third cavity, and a plurality of irrigation holes communicating with the first cavity. The first cavity is used to deliver liquid ablative agent, the second cavity is used to fill with fluid, and the third cavity is used to fill with fluid. The catheter sheath body includes at least a proximal adjustable bend and a distal adjustable bend connected to the proximal adjustable bend. An operating handle is connected to the proximal end of the catheter sheath body; The adjustment assembly includes a first adjustment mechanism and a second adjustment mechanism, which are respectively disposed on the operating handle. The first adjustment mechanism is connected to the proximal adjustable bend and is used to adjust the bending angle and direction of the proximal adjustable bend; the second adjustment mechanism is connected to the distal adjustable bend and is used to adjust the bending angle and direction of the distal adjustable bend. as well as An occlusion assembly includes a first occlusion balloon and a second occlusion balloon, which are spaced apart and disposed on the distal end of the catheter sheath body to establish an isolation occlusion zone. The infusion port is located between the first occlusion balloon and the second occlusion balloon. The first occlusion balloon communicates with the second cavity, and the second occlusion balloon communicates with the third cavity.

2. The integrated dual-bend navigation catheter sheath system as described in claim 1, characterized in that, The first adjustment mechanism includes a first control element and a first transmission mechanism, and the second adjustment mechanism includes a second control element and a second transmission mechanism. The first control element and the second control element are respectively disposed on the operating handle. The first transmission mechanism and the second transmission mechanism extend from the inside of the operating handle to the inside of the catheter sheath body. The proximal end of the first transmission mechanism is connected to the first control element, and the distal end of the first transmission mechanism is connected to the proximal adjustable bend. The proximal end of the second transmission mechanism is connected to the second control element, and the distal end of the second transmission mechanism is connected to the distal adjustable bend.

3. The integrated dual-bend navigation catheter sheath system as described in claim 2, characterized in that, The first control element and / or the second control element is a knob or a slider.

4. The integrated dual-bend navigation catheter sheath system as described in claim 2 or 3, characterized in that, The first transmission mechanism and / or the second transmission mechanism are wire drawing mechanisms.

5. The integrated dual-bend navigation catheter sheath system as described in claim 1, characterized in that, The maximum bending angle of the proximal adjustable bending section is greater than the maximum bending angle of the distal adjustable bending section.

6. The integrated dual-bend navigation catheter sheath system as described in claim 1 or 5, characterized in that, The radial dimension of the proximal adjustable bend is greater than the radial dimension of the distal adjustable bend.

7. The integrated dual-bend navigation catheter sheath system as described in claim 1, characterized in that, The radial dimension of the first occlusion balloon in its inflated state is greater than that of the second occlusion balloon in its inflated state; The first occlusion balloon is used to occlude within the main coronary sinus, and the second occlusion balloon is used to occlude at a predetermined location within the left atrial oblique vein.

8. The integrated dual-bend navigation catheter sheath system as described in claim 1, characterized in that, The first occlusion balloon and the second occlusion balloon are made of compliant or semi-compliant polymer materials.

9. The integrated dual-bend navigation catheter sheath system as described in claim 1, characterized in that, The integrated dual-bend navigation catheter sheath system further includes a first interface, a second interface, and a third interface, which are respectively located on the operating handle; The first interface is connected to the proximal end of the first cavity and is used for connecting an external infusion device and allowing guidewire passage; the second interface is connected to the second cavity and is used for connecting an external filling device; and the third interface is connected to the third cavity and is used for connecting an external filling device.

10. The integrated dual-bend navigation catheter sheath system as described in claim 1, characterized in that, The integrated dual-bend navigation catheter sheath system also includes a fourth channel for delivering a guidewire, while the first channel is used to deliver contrast agent and liquid ablation agent.

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