Guiding system for patent foramen ovale interventional closure device guide wire

Abstract

The application provides a guide system for patent foramen ovale (PFO) interventional closure device guide wire, which comprises a sheath tube dilator assembly, a guide tube component, a first guide wire and a second guide wire; the sheath tube dilator assembly comprises a fixed sheath tube component and a dilator component, the tube structure of the dilator component is arranged in the tube structure of the fixed sheath tube component; the sheath tube dilator assembly has an operation part for controlling the movement of the distal end of the sheath tube dilator assembly to the fossa ovalis of the atrial septum; the tube structure of the guide tube component is rotatably and slidably arranged in the tube structure of the dilator component, and the distal end of the guide tube component is used for entering the PFO tunnel from the fossa ovalis of the atrial septum, thereby establishing a left atrial passage. The application can significantly improve the success rate and efficiency of the operation, and effectively solves the guide wire passing difficulty problem caused by the small size, adhesion or anatomical variation of the PFO tunnel by using the step-by-step strategy of first mechanically expanding the PFO tunnel by using the guide tube component and then exploring the path by using the second guide wire.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of interventional medical devices, and in particular to a guide system for a patent foramen ovale interventional occluder guide wire. BACKGROUND

[0002] The foramen ovale is a normal physiological passage on the interatrial septum of the heart during the fetal period, allowing blood to flow from the right atrium to the left atrium. After birth, with the establishment of pulmonary circulation, the left atrial pressure rises, and the foramen ovale of most people will functionally close and form an anatomical closure within 1 year. If the foramen ovale is still not closed at the age of > 3 years, it is called patent foramen ovale (PFO). Although most PFO patients are asymptomatic, there is a significant correlation between PFO and clinical conditions such as cryptogenic stroke, migraine, decompression disease, etc.

[0003] Percutaneous interventional occlusion has become the preferred method for treating PFO. One of the core steps of the surgery is to establish a stable delivery channel from the peripheral vein (such as the femoral vein) through the inferior vena cava, right atrium, and PFO tunnel to the left atrium, so as to facilitate the subsequent delivery and release of the occluder. Currently, a multi-purpose catheter (MP catheter) or a guide catheter combined with a guide wire is routinely used in clinical practice to attempt to pass through the PFO.

[0004] However, the existing technology has significant limitations in actual application, such as insufficient support and positioning difficulty, poor passability, etc. For patients with special anatomical structures, such as those with aortic root dilation leading to a twisted change in the anatomical position of the interatrial septum, the conventional MP catheter is difficult to stably adhere to the oval fossa area, and the head end thereof cannot maintain stable coaxiality with the PFO tunnel opening, making it difficult to send in the guide wire. For complex PFOs with small oval foramen openings or tissue adhesion in the tunnel, the conventional catheter is insufficient in flexibility and support to open the tunnel, and the guide wire has a large resistance to pass through, which increases the operation time and operation difficulty, and even fails.

[0005] To overcome the above difficulties, some solutions use an interatrial septum puncture sheath combined with a puncture needle. The puncture needle is placed in the sheath, and its overall rigidity is used to try to open the PFO tunnel. However, this solution has inherent risks: first, the inner sheath front end of the interatrial septum puncture sheath and the puncture needle tip are relatively sharp, and even if they are not actively exposed, they are extremely easy to stab the heart tissue, such as the atrial wall or the aortic root, during operation, causing serious complications such as cardiac tamponade; second, the contact point between the sheath opening and the interatrial septum is a surface, not a guide point, and the opening shape is not conducive to the guide wire sliding into the small PFO tunnel, and the operation accuracy is poor.

[0006] Therefore, there is an urgent need for a new guide system that can provide strong and stable support to open the complex PFO tunnel, ensure accurate and safe operation, and avoid damage to the heart structure. SUMMARY

[0007] In view of this, the embodiments of the present application provide a guide system for an interventional closure device guide wire for patent foramen ovale, so as to eliminate or improve one or more defects in the prior art.

[0008] The present application provides a guide system for an interventional closure device guide wire for patent foramen ovale, the guide system comprising: a sheath tube dilator assembly, a guide tube component, a first guide wire and a second guide wire; wherein the sheath tube dilator assembly comprises a fixed sheath tube component and a dilator component, the tube structure of the dilator component is arranged to be inserted into the tube structure of the fixed sheath tube component; the first guide wire is used to guide the distal end of the sheath tube dilator assembly to reach the superior vena cava, and after the distal end of the sheath tube dilator assembly reaches the superior vena cava, the first guide wire is completely withdrawn from the tube of the dilator component; the sheath tube dilator assembly has an operation part for controlling the movement of the distal end of the sheath tube dilator assembly to the oval fossa of the atrial septum; the tube structure of the guide tube component is arranged to be rotatably and slidably inserted into the tube structure of the dilator component, the distal end of the guide tube component can be extended from the distal end of the dilator component, and the distal end of the guide tube component is used to enter the PFO tunnel from the oval fossa of the atrial septum, thereby establishing a left atrial passage; after the left atrial passage is established, the distal end of the second guide wire is extended from the distal end of the guide tube component and enters the left atrium; the second guide wire is also used to guide the distal end of at least one of the fixed sheath tube component, the dilator component and the guide tube component to pass through the PFO tunnel and enter the left atrium; after the distal end of the sheath tube dilator assembly enters the left atrium, the second guide wire is completely withdrawn from the tube of the guide tube component; at least one of the fixed sheath tube component, the dilator component and the guide tube component is retained in the left atrium, so that the guide wire for the release sheath of the closure device enters the left atrium from the retained component.

[0009] In some embodiments, the tube structure of the guide tube component comprises: a main body section located in the middle section, a curved section located at the distal end, the main body section being adjacent to the curved section; the curved section is inwardly deflected by no more than 90° relative to the main body section, and the curved section extends in an arc direction or a straight line direction; the inner wall, the middle layer or the outer wall of the tube of the curved section is provided with a metal braid layer; the tube of the curved section is formed with an enhanced visualization ring; the part of the tube near the end of the curved section is provided in a tapered structure with gradually tapered outer diameter.

[0010] In some embodiments, the guide tube component further includes a Y-type valve disposed near the proximal end of its tube body structure, wherein the main channel of the Y-type valve is coaxial with the tube body structure of the guide tube component, and the branch channels of the Y-type valve intersect with the extended axis of the tube body structure of the guide tube component; the guide tube component further includes a sealing hemostatic valve disposed near the proximal end of the main channel of the Y-type valve; a guide ramp is provided at the joint between the main channel of the Y-type valve and the tube body structure of the guide tube component;

[0011] The guide tube component also includes a curved directional indicator disposed on the Y-type valve.

[0012] In some embodiments, the distal end of the tube structure of the fixed sheath component has a first bend; the fixed sheath component further includes: a hemostatic valve disposed at the proximal end of its tube structure, a side branch connected to the hemostatic valve, and a three-way valve, wherein the hemostatic valve has an expander inlet and outlet coaxial with the tube structure of the fixed sheath component.

[0013] In some embodiments, the distal end of the tube structure of the expander component is formed with a second bend; the expander component also includes a Luer connector disposed near the proximal end of its tube structure.

[0014] In some embodiments, a portion of the first bent section near its end is configured as a tapered structure with a gradually tapering outer diameter and an inner diameter matching the outer diameter of the middle section of the tube body structure of the expander component; a portion of the second bent section near its end is configured as a tapered structure with a gradually tapering outer diameter and an inner diameter matching the outer diameter of the middle section of the tube body structure of the guide tube component.

[0015] In some embodiments, the distal ends of the first guidewire and / or the second guidewire are formed with hook-shaped bends.

[0016] In some embodiments, the guidance system further includes: a occluder release sheath guide wire, the distal end of which has a helical bend.

[0017] In some embodiments, the first guidewire is a 0.032-inch coated guidewire, the second guidewire is a 0.014-inch ultrafine guidewire, and the diameter of the tube structure of the fixed sheath component is set to 8.5F.

[0018] This invention significantly improves surgical success rate and efficiency. By employing a step-by-step strategy of first mechanically opening the PFO tunnel using a guide tube component, and then exploring with a second guidewire, it effectively solves the problem of guidewire passage difficulties caused by the small size, adhesion, or anatomical variations of the PFO tunnel. This guidance system has clear logic and standardized procedures, greatly reducing repeated trial operations, shortening surgical time, and improving the success rate of interventional treatment for complex PFO cases.

[0019] Additional advantages, objects, and features of the invention will be set forth in part in the description which follows, and will also become apparent in part to those skilled in the art upon studying the description, or may be learned by practice of the invention. The objects and other advantages of the invention can be realized and obtained by means of the structures specifically pointed out in the description and drawings.

[0020] Those skilled in the art will understand that the objectives and advantages achievable with the present invention are not limited to those specifically described above, and that the above and other objectives achievable with the present invention will become clearer from the following detailed description. Attached Figure Description

[0021] The accompanying drawings, which are included to provide a further understanding of the invention and form part of this application, are not intended to limit the scope of the invention. The components in the drawings are not drawn to scale but are merely illustrative of the principles of the invention. For ease of illustration and description of certain parts of the invention, corresponding portions in the drawings may be enlarged, i.e., may appear larger relative to other components in an exemplary device actually manufactured according to the invention.

[0022] Figure 1 This is a schematic diagram of the assembled structure of the fixed sheath component, dilator component, and guide tube component of the guide wire guidance system for the patent foramen ovale interventional occluder in one embodiment of the present invention.

[0023] Figure 2 This is a schematic diagram of the structural components of a guidance system according to an embodiment of the present invention. Figure 2 a) is a structural schematic diagram of the fixed sheath component; Figure 2 b) is a schematic diagram of the structure of the expander component; Figure 2 c) is a schematic diagram of the structure of the first guidewire; Figure 2 (d) is a schematic diagram of the second guidewire; Figure 2 e) is a schematic diagram of the guide tube component; Figure 2 f) is a schematic diagram of the structure of the guide wire used in the release sheath of the occluder.

[0024] Figure 3 A schematic diagram of the distal mating structure after the assembly of the fixed sheath assembly, the expander assembly, and the guide tube assembly.

[0025] Figure 4 This is a three-dimensional structural diagram of the guide tube component.

[0026] Figure 5 The diagram shows a cross-sectional view of the guide tube component, a three-dimensional view of the proximal end, and a magnified view of the distal end.

[0027] Figures 6-1 to 6-7This is a schematic diagram illustrating the operation of the guidance system at different stages in an embodiment of the present invention.

[0028] Figure label:

[0029] 10. First guide wire; 11. First hook-shaped bend;

[0030] 20. Expander assembly; 21. Second bending section; 22. Distal end of expander assembly; 23. Luer joint;

[0031] 30. Fixing the sheath assembly; 31. Fixing the outer sheath to the narrow end; 32. Fixing the distal end of the sheath assembly; 33. Hemostatic valve; 34. Lateral branch; 35. Three-way valve;

[0032] 40. Second guidewire; 41. Second hook-shaped bend;

[0033] 50. Guide tube assembly; 51. Bent section; 53. Main body section; 54. Y-type valve; 55. Sealing hemostatic valve; 56. Sub-channel; 57. Enhanced imaging ring; 58. Distal end of guide tube assembly; 59. Bent directional indicator; 60. Thick tube guide ramp; 61. Thin tube guide ramp; 62. Metal braided mesh layer;

[0034] 80. Left atrium; 81. Superior vena cava; 82. PFO tunnel; 83. Inferior vena cava; 84. Right atrium; 85. Atrial septum, foramen ovale;

[0035] 90. Plugging device release sheath guide wire; 91. Helical bend section. Detailed Implementation

[0036] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the embodiments and accompanying drawings. Here, the illustrative embodiments and descriptions of this invention are used to explain the invention, but are not intended to limit the invention.

[0037] It should also be noted that, in order to avoid obscuring the invention with unnecessary details, only the structures and / or processing steps closely related to the solution according to the invention are shown in the accompanying drawings, while other details that are not closely related to the invention are omitted.

[0038] It should be emphasized that the term "including / comprises" as used herein refers to the presence of a feature, element, step, or component, but does not exclude the presence or addition of one or more other features, elements, steps, or components.

[0039] It should also be noted that, unless otherwise specified, the term "connection" in this article can refer not only to a direct connection, but also to an indirect connection involving an intermediary.

[0040] In the following description, embodiments of the invention will be illustrated with reference to the accompanying drawings. In the drawings, the same reference numerals represent the same or similar parts, or the same or similar steps.

[0041] In this invention, when describing an instrument (such as a catheter, guidewire, or sheath) or an anatomical structure (such as a limb or blood vessel), "distal" and "proximal" are defined according to their relative position to the operator or the core of the body. The distal end refers to the end of the instrument or body structure furthest from the operator's body or the center of the human torso. The proximal end refers to the end of the instrument or body structure closest to the operator's body or the center of the human torso.

[0042] One aspect of the present invention provides a guidance system for a guidewire in an interventional occlusion device for patent foramen ovale, such as... Figure 1 and Figure 2 As shown, the guidance system includes: a sheath dilator assembly, a guide tube component 50, a first guidewire 10, and a second guidewire 40, etc. These structures form a multi-layered, hierarchical, and synergistic structure. Each component is coaxially nested and plays a different role at different stages of the surgery, working together to complete the entire process from the establishment of venous access to the final formation of the left atrial 80 channel.

[0043] In this embodiment, the sheath expander assembly includes a fixed sheath component 30 and an expander component 20, the tube structure of which is inserted into the tube structure of the fixed sheath component 30. Optionally, the two components can be sealed together at their proximal ends via a structure such as a Luer connector 23, and can be assembled into a single unit during use.

[0044] In this embodiment, such as Figure 6-1 As shown, the first guidewire 10 is used to guide the distal end of the sheath dilator assembly to the superior vena cava 81, and to completely withdraw from the tube of the dilator component 20 after the distal end of the sheath dilator assembly reaches the superior vena cava 81.

[0045] In this embodiment, such as Figure 6-2 As shown, the sheath dilator assembly has an operating section for controlling the distal end of the sheath dilator assembly to move to the fossa ovalis 85 of the atrial septum. The operating section can be a sheath handle or a similar structure, allowing the operator to manipulate the direction and angle of its distal bend, ensuring its tip is stably positioned against the target location in the fossa ovalis 85 of the atrial septum, providing a strong rear support platform for the subsequent operation of the guide tube component 50. At this time, the distal end of the sheath dilator assembly remains in the fossa ovalis 85 of the atrial septum, providing a stable, large-diameter initial working channel for subsequent operations.

[0046] In this embodiment, the guide tube component 50 is rotatably and slidably inserted into the tube structure of the expander component 20, and the distal end 58 of the guide tube component can extend from the distal end 22 of the expander component, while its proximal end can be grasped and operated by the surgeon. Figure 6-3 As shown, the distal end 58 of the guide tube component is used to enter the PFO tunnel 82 from the fossa ovalis 85 of the atrial septum, thereby establishing a passage to the left atrium 80. Specifically, after the sheath assembly is positioned, the rigid or semi-rigid guide tube is pushed forward. Its distal end, with its excellent torque transmission and sufficient support, can accurately penetrate and mechanically open the PFO tunnel 82, forming a temporary, open passage. Furthermore, the tube body of the guide tube component 50 provides a protected, highly coaxial delivery path for the second guidewire 40, ensuring the accuracy of the second guidewire 40's forward direction and direct alignment with the entrance of the opened PFO tunnel 82.

[0047] In this embodiment, such as Figure 6-4 As shown, the second guidewire 40 is used to extend from the distal end 58 of the guide tube component and enter the left atrium 80 after the channel to the left atrium 80 is established; as Figure 6-5 As shown, the second guidewire 40 is also used to guide the distal end of at least one of the fixed sheath component 30, the dilator component 20 and the guide tube component 50 through the PFO tunnel 82 into the left atrium 80.

[0048] like Figure 6-6 As shown, the second guidewire 40 is also used to completely withdraw from the body of the guide tube component 50 after the distal end of the sheath dilator assembly enters the left atrium 80; at least one of the fixed sheath component 30, the dilator component 20, and the guide tube component 50 remains in the left atrium 80, so that the "occluder release sheath guidewire 90" enters the left atrium 80 from the remaining component, such as... Figure 6-7 As shown.

[0049] In this embodiment, at least one of the fixed sheath component 30, the dilator component 20, and the guide tube component 50, guided by the second guidewire 40, enters the left atrium 80 through the PFO tunnel 82. This means that the specific component entering and remaining in the left atrium 80 can be determined based on individual patient differences and surgical requirements. The operation mode can also be overall advancement or stepwise advancement. For example, the distal end 22 of the dilator component enters and remains in the left atrium 80. This can utilize its relatively small profile and stronger rigidity to initially dilate the tortuous or narrow PFO tunnel 82, preparing for the subsequent passage of the fixed sheath. Based on the dilator component 20 entering the left atrium 80 as a guide support, the outer fixed sheath component 30 is then pushed along it, so that its distal end also smoothly passes through the tunnel into the left atrium 80. Optionally, if the material and shape of the distal end 58 of the guide tube component meet the requirements for entering the left atrium 80, the distal end 58 of the guide tube component can also be pushed in and remaining in the left atrium 80 first. This approach is suitable for cases where the tunnel is extremely narrow or where there is high uncertainty regarding initial passage, aiming to confirm the patency of the passage in a minimally invasive manner. In other cases, considering the shape and material configuration of the guide tube component 50, it can also be completely withdrawn, preventing it from entering the left atrium 80.

[0050] In this embodiment, at least one of the fixed sheath component 30, dilator component 20, and guide tube component 50 is retained within the left atrium 80. This means that after the second guidewire 40 successfully enters the left atrium 80 and guides the system forward, it is ultimately necessary to ensure that the distal portion of at least one tubular component with a sufficiently large lumen crosses and is stably positioned on the left side of the PFO tunnel 82 (i.e., the left atrium 80), thereby establishing a safe, stable, and direct working channel to the target position for the subsequent "occluder release sheath guide wire 90". The selection of the retention component can be determined based on the selection of the "occluder release sheath guide wire 90". For example, based on its radial dimension, the inner diameter of the retention component needs to be no greater than the outer diameter of the tubular structure of the "occluder release sheath guide wire 90".

[0051] Through the orderly cooperation and synergistic effect of the above-mentioned components, the present invention produces significant beneficial effects compared with the prior art, including at least:

[0052] (1) Significantly improves surgical success rate and efficiency. By first using the guide tube component to mechanically open the PFO tunnel 82, and then using the second guide wire 40 to explore, the step-by-step strategy effectively solves the problem of guide wire passage difficulties caused by the small size, adhesion, or anatomical variation of the PFO tunnel 82. The guidance system has clear logic and standardized steps, which greatly reduces repeated trial operations, shortens the operation time, and improves the success rate of interventional treatment for complex PFO cases.

[0053] (2) Greatly enhances operational safety and reduces the risk of complications. This invention completely eliminates the need for atrial septal puncture needles with sharp tips. The distal end 58 of the guide tube component, having an outlet, can be designed with a blunt end structure. Its main function is to open rather than puncture, fundamentally avoiding the risk of accidentally puncturing the atrial wall, aortic root, or pericardium, and greatly reducing the possibility of serious complications such as cardiac tamponade during and after the operation.

[0054] (3) Provides excellent support and coaxiality. The sheath dilator assembly in this invention provides stable rear-end support for the guide tube, while the guide tube component 50 itself transmits the support force forward to the PFO tunnel 82 opening. This design ensures that the instrument tip and the atrial septum maintain optimal coaxiality when the tunnel is opened, creating ideal mechanical conditions and angles for the smooth passage of the second guidewire 40, and the guidewire is not easy to dislodge or bounce.

[0055] (4) Optimize the surgical procedure and reduce dependence on technology. This guidance system breaks down the complex guidewire intervention into several simple and reliable steps, reducing the over-reliance on the surgeon's personal experience and feel, making the surgery easier to learn and master, and facilitating the promotion and popularization of this technology.

[0056] In some embodiments, to improve the ability of the guide tube component 50 to pass through complex anatomical structures and the accuracy of intraoperative operations, the present invention has optimized its tube structure. For example... Figure 2-5 As shown, the guide tube component 50 comprises a main body section 53 located in the middle and a curved section 51 located at the distal end, wherein the main body section 53 is adjacent to the curved section 51. This split design allows different mechanical properties to be assigned to different sections. The main body section 53 primarily provides strong pushing force and torque support, ensuring that force can be effectively transmitted to the distal end. The curved section 51 imparts a specific pre-shaping angle to the guide tube tip, making it easier to penetrate and align with the entrance of the PFO tunnel 82, significantly improving the initial borehole finding and passage success rate.

[0057] Optionally, the main body section 53 may be made of a high-rigidity metallic material, such as stainless steel, nickel-titanium alloy, or similar alloy material. The bent section 51 may be made of a polymer material, such as polyimide or other polymers with suitable flexibility and biocompatibility.

[0058] The high-rigidity metal material provides it with extremely strong longitudinal pushing support and resistance to compression / bending. This ensures that during long-distance pushing, the force can be efficiently and losslessly transferred from the proximal end to the distal end, avoiding the absorption or dispersion of thrust in the middle section of the tube, and effectively solving the common problems of whiplash effect or insufficient thrust in flexible catheters.

[0059] The polymer material endows this section of the catheter with excellent flexibility and malleability. This not only ensures the stability of the pre-set bend, but more importantly, it allows the catheter to conform to anatomical structures and deform flexibly when passing through sensitive structures within the heart (such as the right atrial wall 84 and the tricuspid valve) or entering the PFO tunnel 82, greatly reducing the risk of trauma or irritation to the endocardium and tissues, and improving the safety of the procedure. The combination of the metal main body segment 53 and the polymer bend segment 51 achieves an ideal state of strong proximal support and flexible distal guidance. The operator can confidently apply pushing force and rotational torque, which are precisely transmitted through the rigid main body segment 53. When the force reaches the flexible bend segment 51, it is converted into controllable and gentle head movement, achieving stable and precise control of the catheter tip. The connection between the metal main body segment 53 and the polymer bend segment 51 can be achieved through laser welding, bonding, or mechanical interlocking structures to form a complete and high-performance catheter.

[0060] In some embodiments, the curved segment 51 is deflected inward by no more than 90° relative to the main body segment 53, and the curved segment 51 extends along an arc or a straight line; limiting the deflection angle to within 90° perfectly matches the physiological angle and anatomical morphology of the atrial septum inside the heart. This angle design allows the curved segment 51 to naturally abut against the fossa ovalis 85 region of the atrial septum within the right atrium 84, maintaining optimal coaxiality with the common orientation of the PFO tunnel 82. This eliminates the need for overly complex shaping operations within the cardiac chambers, achieving precise orientation, simplifying surgical procedures, and shortening operation time. As one possible implementation, the curved segment 51 extends along an arc, and its radius of curvature can be set to R3-R7, optionally R5.

[0061] In some embodiments, the inner wall, intermediate layer, or outer wall of the curved segment 51 is provided with a metal braided mesh layer 62. The metal braided mesh layer 62 is a key performance-enhancing structure that greatly improves the bending resistance of the curved segment 51, preventing it from collapsing or twisting when passing through tortuous blood vessels or bending within the heart, thus ensuring the patency of the lumen. Simultaneously, the metal braided mesh layer 62 significantly improves the torque transmission efficiency of the catheter, enabling the distal curved segment 51 to produce a 1:1 instantaneous and precise response when the operator rotates the catheter proximally, achieving precise control over the tip direction.

[0062] In some embodiments, an enhanced radiopaque ring 57 is formed on the tube body of the curved segment 51; optionally, the radiopaque ring may be made of high-density metal materials such as platinum-iridium alloy or gold, which appear as clear, high-brightness markers under X-ray fluoroscopy. This design allows the surgeon to determine the exact position and orientation of the distal end of the guide tube in real time during the procedure, which is crucial for precise positioning within the heart, greatly improving the visualization and safety of the operation, and avoiding the risks that may arise from blind operation.

[0063] In some embodiments, the portion of the curved section 51 near its end is configured as a tapered structure with a gradually tapering outer diameter. The tapered, flexible tip allows for easier passage through interstitial spaces and narrow PFO openings, reducing pushing resistance and acting as a guide; the smoothly transitioning tapered structure minimizes potential damage to fragile tissues such as the endocardium and valves, conforming to the principle of compliant passage of interventional devices; the tapered structure provides a smooth exit for the extension of the second guidewire 40, preventing the guidewire from encountering steps or resistance at the exit point and causing scraping or ejection.

[0064] In the foregoing embodiments, the guide tube component 50 of the present invention, through its unique structural design, integrates excellent guidance, superior support and flexural strength, precise control, and outstanding visibility, making it particularly suitable for handling PFO closure cases with complex anatomical structures and high operational difficulty. The present invention creatively proposes to introduce a rigid guide tube component 50 within the sheath dilator assembly, which has a curved section 51 at its distal end and a pre-embedded metal braided mesh layer 62 in the distal tube wall. This metal braided mesh layer 62 can serve as a support wire, improving the rigidity and torsional transmission performance of the tube body, giving the tube body sufficient rigidity to open the PFO tunnel 82, establish a channel, and allow the second guidewire 40 to smoothly enter the left atrium 80. The sheath dilator assembly is guided along the second guidewire 40 into the left atrium 80. At this point, the second guidewire 40 is withdrawn and replaced with an ultra-rigid guidewire to perform a standard atrial septal closure operation.

[0065] In some embodiments, to improve the ease of operation, safety, and visibility of the guide tube component 50 during surgery, such as... Figure 5 As shown, the guide tube component 50 also includes a Y-type valve 54 located near the proximal end of its tube structure. The main channel of the Y-type valve 54 is coaxial with the tube structure of the guide tube component 50, ensuring a smooth instrument delivery path; the branch channel 56 (side arm) of the Y-type valve 54 intersects with the extended axis of the tube structure of the guide tube component 50, and can be used as a liquid injection channel, such as for injecting physiological saline for flushing, or for injecting contrast agents.

[0066] In some embodiments, such as Figure 5As shown, the guide tube component 50 also includes a sealing hemostatic valve 55 located proximal to the main channel of the Y-type valve 54. Specifically, the sealing hemostatic valve 55 is made of materials such as elastic silicone and has a slit in its center. When no instrument (such as a guidewire) passes through, the valve is closed, effectively preventing blood from flowing back out of the catheter and maintaining a clean surgical environment. When an instrument (such as the second guidewire 40) passes through, the slit of the valve tightly wraps around the instrument, forming a dynamic seal. This allows the instrument to move freely while maximally preventing air from entering and blood from leaking out, greatly reducing the risk of air embolism and surgeon blood exposure.

[0067] In some embodiments, such as Figure 5 As shown, a guide ramp is provided at the interface between the main channel of the Y-type valve 54 and the tube structure of the guide tube component 50. For example, when the surgeon inserts the thin second guidewire 40 from the proximal port of the Y-type valve 54 to the distal end, the ramp naturally guides the guidewire tip into the center of the main channel, greatly avoiding the risk of the guidewire tip encountering sharp edges at this critical interface, resulting in jamming, skipping, or even damage to the outer coating or tip of the guidewire, thus ensuring smooth and undamaged guidewire delivery. Optionally, the guide ramp may include a thick tube guide ramp 60 and a thin tube guide ramp to accommodate the multi-tube connection structure of the tube structure of the guide tube component 50.

[0068] In some embodiments, such as Figure 5 As shown, the guide tube component 50 also includes a bend orientation mark 59 disposed on the Y-type valve 54. This mark is aligned with the planar orientation of the bend section 51 at the distal end of the guide tube. This design provides a crucial visual reference. During surgery, the surgeon needs to rotate the guide tube component 50 proximally to adjust the orientation of the distal bend within the heart. Since the guide tube component 50 is not visible inside the body, this mark allows the surgeon to quickly and visually determine the current orientation of the distal bend externally without relying on fluoroscopy. This significantly simplifies the procedure, reduces adjustment time, and minimizes unnecessary fluoroscopy, thereby improving the efficiency and accuracy of the surgery.

[0069] In some embodiments, such as Figure 1 and Figure 2 As shown, the distal end of the tube structure of the fixed sheath component 30 has a first bend. This first bend can be configured as a specific arc-shaped bend, with its bending angle and curvature calculated to match the classic anatomical path from the inferior vena cava 83-right atrium 84 entrance to the interatrial septum fossa ovalis 85. When the fixed sheath is pushed into the cardiac region, this first bend allows its distal tip to automatically face and stably abut against the fossa ovalis region, greatly simplifying the surgeon's adjustment of the sheath's orientation, improving the efficiency and accuracy of initial positioning, and providing an ideal angle and stable platform for the subsequent precise operation of the guide tube component 50.

[0070] In other embodiments, the distal end of the tube structure of the fixed sheath component 30 may also be formed as a linear structure to simplify the structure.

[0071] In some embodiments, such as Figure 1 and Figure 2 As shown, the fixed sheath assembly 30 further includes: a hemostatic valve 33 disposed near its proximal end of the tube structure, a side branch 34 connected to the hemostatic valve 33, and a three-way valve 35. The hemostatic valve 33 has an expander inlet and outlet coaxial with the tube structure of the fixed sheath assembly 30. This coaxial design ensures that the expander assembly 20 and the guide tube assembly 50 can be smoothly and unobstructedly inserted and withdrawn. The hemostatic valve 33 provides a dynamic seal throughout the process, preventing blood backflow through the sheath, and is a key structure for maintaining a sterile operating environment and ensuring patient safety.

[0072] In some embodiments, such as Figure 1 and Figure 2 As shown, the distal end of the tube structure of the dilator component 20 has a second bent section 21; the second bent section 21 complements and supports the first bent section of the fixed sheath component 30. When the dilator is inserted into the fixed sheath, the bent sections of both fit together, jointly restoring and reinforcing the preset curvature of the distal end of the fixed sheath. This ensures consistent guidance and excellent shape retention during the push-out process, effectively resisting the tortuosity of blood vessels and the impact of blood flow within the heart, thereby more reliably guiding the distal end of the sheath dilator assembly to the fossa ovalis of the interatrial septum 85.

[0073] In the aforementioned embodiments, the first bent section of the fixed sheath component 30, the second bent section 21 of the expander component 20, and the bent section 51 of the guide tube component 50 are combined in a coaxial nesting manner to provide graded and progressive guiding support force, and can also achieve a larger range of adjustment and precise positioning through multi-level adjustment.

[0074] In the aforementioned embodiments, the present invention, through the combination of the fixed sheath component 30, the dilator component 20, and the guide tube component 50, achieves multi-directional adjustment capability of the tip outlet, including vertical adjustment, anterior-posterior adjustment, proximal-rear adjustment, and 360-degree adjustment of the outlet angle. This combination also enables a coarse-to-precise positioning process. First, the composite bend of the fixed sheath and dilator completes macroscopic positioning, roughly guiding the system tip to the fossa region. Then, the dilator is withdrawn, leaving only the fixed sheath as a stable channel. Finally, the controllable bend section 51 of the guide tube performs microscopic positioning, precisely locating and engaging the PFO tunnel 82 within the fossa region. This process significantly improves the success rate of locating and navigating the PFO in complex anatomical environments. For cases involving aortic root dilation or other conditions leading to cardiac anatomy distortion, a single bend may not be effective. The multi-angle, multi-rigidity combination options provided by the three components offer the operator more strategic choices. The operator can adapt to abnormal anatomical angles by rotating the entire system or rotating the guide tube individually, utilizing different bend combinations to solve the problem of conventional catheters failing to achieve proper engagement. The rigid composite sheath structure prevents unstable swaying of the small catheter during the pushing process; and when the guide tube finally passes through, the composite sheath at its proximal end acts as a strong back support to prevent it from accidentally rushing forward and causing damage, making the operation of opening the PFO tunnel 82 more controllable and safer.

[0075] In some embodiments, such as Figure 1 and Figure 2 As shown, the dilator component 20 also includes a Luer connector 23 located proximal to its tubular structure. The Luer connector 23 is a standardized threaded locking interface. Through this connector, the proximal end of the dilator component 20 can be quickly, securely, and tightly connected to the dilator inlet / outlet on the proximal hemostatic valve 33 of the fixed sheath component 30. This connection method prevents accidental disengagement during operation, ensuring the integrity and stability of the system.

[0076] In some embodiments, such as Figure 3 As shown, the portion of the tube near the end of the first bend is configured as a tapered structure with a gradually tapering outer diameter, and the middle section's outer diameter matches the inner diameter of the tube body structure of the dilator component 20; the tapering of the outer diameter forms a soft, smooth tapered tip. This design greatly reduces the stimulation, friction, and potential damage to the tube wall, especially sensitive areas such as the atrial inlet and valves, when the fixed sheath travels within the blood vessel, conforming to the principle of non-invasive passage of interventional devices.

[0077] Furthermore, such as Figure 3As shown, the portion of the second bending section 21 near its end is configured as a tapered structure with a gradually tapering outer diameter and an inner diameter matching the outer diameter of the middle section of the guide tube component 50. This design provides a highly coaxial and stable guide channel. When the guide tube needs to be operated with precision through its distal bending section 51, this structure ensures the accuracy of its movement trajectory and prevents unpredictable deviations within the expander head, greatly enhancing the precision and controllability of the operation.

[0078] In some embodiments, such as Figure 2 As shown, the distal ends of the first guidewire 10 and / or the second guidewire 40 are formed with hook-shaped bends. When the first guidewire 10 is used to establish the initial path, this rounded, pre-bent first hook-shaped bend 11 greatly reduces the risk of its tip piercing the vessel wall or weak structures such as the atrial appendage when it advances within blood vessels (such as the subclavian vein or superior vena cava 81), achieving non-invasive passage and significantly improving the safety of the initial step. When the second guidewire 40 enters the left atrium 80 through the guide tube component 50, its distal second hook-shaped bend 41 can also avoid scratching the atrial wall of the left atrium 80.

[0079] In some embodiments, such as Figure 2 As shown, the guidance system further includes an occluder release sheath guidewire 90, the distal end of which has a helical bend 91. The helical bend 91 is an extremely flexible and elastic region. When this guidewire unfolds within the left atrium 80, its soft helical tip contacts the atrial wall, transforming the point-like impact force into a planar, elastic buffering force. This fundamentally eliminates the possibility of the occluder release sheath guidewire 90 impinging on the atrial wall, leading to the most serious complications such as cardiac perforation or cardiac tamponade.

[0080] In some embodiments, the first guidewire 10 is configured as a 0.032-inch coated guidewire. The first guidewire 10 is responsible for initial safe navigation and possesses sufficient rigidity and pushing force to easily guide a relatively large sheath dilator assembly safely through large vessels such as the femoral vein and inferior vena cava 83, resisting the natural tortuosity of the vessels to reach the spacious and safe area of ​​the superior vena cava 81, avoiding vascular injury. The hydrophilic coating or other lubricating coating on the surface significantly reduces the coefficient of friction between the guidewire and the vessel wall, as well as between the guidewire and the catheter lumen. This makes the pushing process smoother, reduces pushing resistance, and minimizes the risk of damage to the vascular intima during operation.

[0081] In some embodiments, the second guidewire 40 is configured as a 0.014-inch ultrafine guidewire. The extremely fine diameter of the second guidewire 40 provides great flexibility, allowing it to easily pass through the small, tortuous, or adhered PFO tunnel 82, which is initially opened by a rigid guide tube, serving as a pioneer guidewire to enter the left atrium 80. The ultrafine and flexible tip, even when moving inside the heart, poses a very low risk of mechanical stimulation and potential damage to the endocardium and atrial wall, ensuring a high degree of safety in this delicate step of exploring and traversing the PFO.

[0082] In some embodiments, the tube body structure of the fixed sheath component 30 has a tube diameter of 8.5F, which is sufficient to allow most mainstream PFO plug delivery systems to pass through smoothly, ensuring that the final plugging operation can be completed in a standard manner.

[0083] Another aspect of the present invention provides a method for guiding a guidewire in an interventional occlusion device for patent foramen ovale, the method being implemented based on the aforementioned guidance system, the method comprising:

[0084] Step 10: After femoral vein puncture, if Figure 6-1 As shown, the first guidewire 10 is controlled to pass from the femoral vein through the inferior vena cava 83, the right atrium 84 and reach the superior vena cava 81.

[0085] Step 20: After the first guidewire 10 reaches the superior vena cava 81, control the sheath dilator assembly to reach the superior vena cava 81 under the guidance of the first guidewire 10.

[0086] Step 30: After the distal end 22 of the dilator component reaches the superior vena cava 81, the first guidewire 10 is withdrawn from the dilator component 20.

[0087] Step 40: As Figure 6-2 As shown, the movement of the sheath dilator assembly is controlled, and the position of the enhanced imaging ring 57 of the distal end 22 of the dilator component is observed under X-ray. Its rotation and forward / backward / upward / downward positions are controlled to position the distal end 22 of the dilator component in the fossa ovalis 85 of the atrial septum. In this step, the positioning of the distal end 22 of the dilator component in the fossa ovalis 85 can be determined by observing two jumps.

[0088] Step 50: After the distal end 22 of the dilator component is positioned in the fossa ovalis 85 of the interatrial septum, the distal end 58 of the guide tube component is controlled to enter from the proximal end of the dilator component 20, and the distal end 58 of the guide tube component is controlled to extend from the distal end 22 of the dilator component, as follows. Figure 6-3 As shown, a portion of the distal end 22 of the dilator component enters the PFO tunnel 82, thereby establishing a channel to the left atrium 80.

[0089] In this step, the curved section 51 of the distal end 58 of the guide tube component is inserted through the Luer connector 23 of the dilator component 20. After pushing the curved section 51 fully into the hollow cavity of the dilator, the main body section 53 continues until the curved section 51 reaches the fossa ovalis 85 of the interatrial septum. At this point, noticeable resistance can be felt by hand. Continue pushing the main body section 53 with force. Utilizing its own high rigidity and supported by the second bending section 21 of the dilator component 20, the curved section 51 pushes open the distal end 22 of the dilator component and extends completely. At this point, the enhanced imaging ring 57 can be clearly observed under X-ray. Then, the Y-type valve 54 can be rotated to adjust the orientation of the main body section 53 and the curved section 51, ultimately allowing the curved section 51 of the guide tube to enter the PFO tunnel 82. Figure 6-4 As shown, an 80-channel was established in the left atrium.

[0090] Step 60: After the left atrial 80 channel is established, control the distal end of the second guidewire 40 to enter from the proximal end of the guide tube component 50, and control the distal end of the second guidewire 40 to extend from the distal end 58 of the guide tube component and enter the left atrial 80, as follows. Figure 6-5 As shown.

[0091] Step 70: After the distal end of the second guidewire 40 has penetrated the left atrium 80 a first predetermined distance, the guide tube component 50 is withdrawn from the left atrium 80, and the distal end 32 of the fixed sheath component and the distal end 22 of the dilator component are guided to enter the left atrium 80 along the second guidewire 40. The first predetermined distance refers to the length of the second guidewire 40 after successfully passing through the PFO tunnel 82, extending it further into the left atrium 80. This distance needs to ensure that a sufficiently long guidewire remains within the left atrium 80 to provide a stable and reliable path for subsequent sheath system advancement. If the insertion is too short, the guidewire may dislodge. This distance is designed to avoid excessive guidewire insertion, which could cause the distal end to enter and irritate sensitive structures such as the pulmonary veins or left atrial appendage, thereby reducing the risk of arrhythmia or cardiac wall damage. For example, this "first predetermined distance" can be set to 5-10 cm, and needs to be adjusted according to the patient's atrial size.

[0092] Step 80: After the distal end 32 of the fixed sheath component and the distal end 22 of the dilator component have extended into the left atrium 80 a second predetermined distance, as follows... Figure 6-6As shown, the second guidewire 40 is retracted along the tube structure of the dilator component 20, while the fixed sheath component 30 and the dilator component 20 remain stationary. The second predetermined distance referred to here is the length by which the distal end of the fixed sheath component 30 and the dilator component 20 (or a combination thereof) continues to advance within the left atrium 80 after being pushed through the PFO tunnel 82 under the guidance of the second guidewire 40. This distance must ensure that the distal end of the sheath is completely and stably positioned within the left atrium 80 and away from the opening of the PFO tunnel 82, thereby establishing a secure working channel for the entry of the occluder delivery sheath. If the entry is too shallow, the tip of the sheath may become stuck in the tunnel or retract into the right atrium 84. This distance must strictly avoid excessive insertion of the distal end of the sheath to prevent it from impacting or rubbing against the posterior wall, top, or pulmonary vein opening of the left atrium 80; this is crucial to preventing catastrophic complications such as cardiac perforation. Optionally, the "second predetermined distance" can be shorter than the "first predetermined distance," with an empirical value of approximately 2-4 centimeters, based on the principle of "just past the tunnel entrance."

[0093] Step 90: After the second guidewire 40 is fully retracted, control the occluder to release the sheath guidewire 90 so that the distal end of the guidewire 90 enters from the proximal end of the sheath dilator assembly.

[0094] Step 100: After the helical bend 91 at the distal end of the guidewire 90 of the occluder release sheath is fully inserted into the left atrium 80, withdraw the sheath dilator assembly, as follows: Figure 6-7 As shown, the intervention of the guide wire 90 is achieved through the release sheath of the occluder to facilitate the subsequent standard atrial septum occluder implantation procedure.

[0095] In another preferred embodiment, during the withdrawal phase of the second guidewire 40, the dilator component 20 and the guide tube component 50 can be withdrawn together. At this time, only the distal end 32 of the fixing sheath component remains in the left atrium 80. Its proximal end remains outside the patient's body, and its lumen forms the final working channel from outside the body directly to the left atrium 80.

[0096] The methods and procedures for closure of atrial septal defects are common knowledge in internal medicine diagnosis and treatment techniques. The details are as follows, using the Amplatzaer occluder as an example:

[0097] 1. Preoperative preparation: Complete preoperative examinations and obtain surgical consent, etc.;

[0098] 2. Routine disinfection and draping; anesthesia: local anesthesia for older children and adults, intravenous anesthesia for children;

[0099] 3. Femoral vein puncture for right heart catheterization; heparinization: initial intravenous bolus of heparin 100U / kg. If the procedure exceeds 1 hour, administer half the initial heparin dose.

[0100] 4. The guidewire, positioned 90°, is inserted through the right atrium, ASD, left atrium, and right superior pulmonary vein into the delivery sheath. The appropriate occluder is then advanced along the sheath to the left atrium. Under fluoroscopic and echocardiographic monitoring, the left atrial surface is opened and withdrawn. After slight resistance is felt, the right atrial surface is opened. Once the position and morphology of the occluder are satisfactory under fluoroscopic and echocardiographic monitoring, and no residual shunt is observed, the delivery sheath is repeatedly pushed and pulled with slight force. Repeated echocardiography and fluoroscopy confirm occluder fixation. The occluder is then released by rotating the handle. The sheath is removed, the puncture site is pressure-bandaged, and a saline bag is applied for local compression for 4-6 hours. The patient can ambulate 24 hours later.

[0101] 5. Postoperative management:

[0102] (1) If necessary, antibiotics may be used continuously for 3 days to prevent infection. If there are signs of infection, the use may be extended.

[0103] (2) Repeat cardiac X-ray and electrocardiogram examinations on the 3rd day after surgery to observe the position of the occluder and whether there is any residual shunt;

[0104] (3) Aspirin tablets should be taken orally for 3-6 months (5 mg / kg / day for children);

[0105] (4) Routine follow-up at 1 month, 3 months, 6 months and 1 year after surgery.

[0106] In this invention, features described and / or illustrated for one embodiment may be used in the same or similar manner in one or more other embodiments, and / or combined with or in place of features of other embodiments.

[0107] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, various modifications and variations of the embodiments of the present invention are possible. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A guidance system for a guidewire in an interventional occlusion device for patent foramen ovale, characterized in that, The guidance system includes: a sheath dilator assembly, a guide tube component (50), a first guide wire (10), and a second guide wire (40); The sheath expander assembly includes a fixed sheath component (30) and an expander component (20), wherein the tube structure of the expander component (20) is used to pass through the tube structure of the fixed sheath component (30); The first guidewire (10) is used to guide the distal end of the sheath dilator assembly to the superior vena cava (81) and to completely withdraw from the tube of the dilator component (20) after the distal end of the sheath dilator assembly reaches the superior vena cava (81); the distal end of the first guidewire (10) is formed with a hook-shaped bend. The sheath dilator assembly has an operating part for controlling the distal end of the sheath dilator assembly to move to the fossa ovalis of the interatrial septum (85). The tube structure of the guide tube component (50) is rotatably and slidably inserted into the tube structure of the dilator component (20). The distal end (58) of the guide tube component can extend from the distal end (22) of the dilator component. The distal end (58) of the guide tube component is used to enter the PFO tunnel (82) from the interatrial septal fossa (85), thereby establishing a channel for the left atrium (80). The second guidewire (40) is used to extend from the distal end (58) of the guide tube component and enter the left atrium (80) after the passage in the left atrium (80) is established; the second guidewire (40) is also used to guide the distal ends of the fixed sheath component (30) and the dilator component (20) through the PFO tunnel (82) into the left atrium (80); the distal end of the second guidewire (40) is formed with a hook-shaped bend; The second guidewire (40) is also used to completely withdraw from the tube body of the guide tube component (50) after the distal end of the sheath dilator assembly has entered the left atrium (80); The distal ends of the fixed sheath assembly (30) and the dilator assembly (20) remain in the left atrium (80) so that the occluder release sheath guide wire (90) enters the left atrium (80) from the dilator assembly (20).

2. The guidance system for the guidewire of the patent foramen ovale interventional occlusion device according to claim 1, characterized in that, The tube structure of the guide tube component (50) includes: a main body section (53) located in the middle section and a curved section (51) located at the far end, wherein the main body section (53) and the curved section (51) are adjacent to each other. The curved segment (51) is deflected inward by no more than 90° relative to the main body segment (53), and the curved segment (51) extends along an arc or a straight line. The inner wall, middle layer or outer wall of the curved section (51) is provided with a metal woven mesh layer (62). An enhanced imaging ring (57) is formed on the tube body of the curved section (51). The portion of the pipe near the end of the curved section (51) is configured as a tapered structure with a gradually tapering outer diameter.

3. The guidance system for the guidewire of the interventional occlusion device for patent foramen ovale according to claim 2, characterized in that, The guide tube component (50) also includes a Y-type valve (54) disposed near the end of its tube structure. The main channel of the Y-type valve (54) is coaxial with the tube structure of the guide tube component (50), and the branch channel (56) of the Y-type valve (54) intersects with the extension line of the axis of the tube structure of the guide tube component (50). The guide tube component (50) also includes a sealing hemostatic valve (55) located at the proximal end of the main channel of the Y-type valve (54). The main channel of the Y-type valve (54) and the pipe body structure of the guide tube component (50) are provided with a guide ramp; The guide tube component (50) also includes a curved directional mark (59) disposed on the Y-type valve (54).

4. The guidance system for the guidewire of the interventional occlusion device for patent foramen ovale according to claim 1, characterized in that, The distal end of the tube structure of the fixed sheath component (30) has a first bent section; The fixed sheath assembly (30) further includes: a hemostatic valve (33) disposed near the proximal end of its tube structure, a side branch (34) connected to the hemostatic valve (33), and a three-way valve (35), wherein the hemostatic valve (33) has an expander inlet and outlet coaxial with the tube structure of the fixed sheath assembly (30).

5. The guidance system for the guidewire of the patent foramen ovale interventional occlusion device according to claim 4, characterized in that, The distal end of the tube structure of the expander component (20) has a second bend (21). The expander component (20) also includes a Luer connector (23) located near the end of its tube structure.

6. The guidance system for the guidewire of the patent foramen ovale interventional occlusion device according to claim 5, characterized in that, The portion of the pipe near the end of the first bending section is configured as a tapered structure with a gradually tapering outer diameter and an inner diameter matching the outer diameter of the middle section of the pipe body structure of the expander component (20). The second bending section (21) near the end is configured as a tapered structure with a gradually tapering outer diameter and an inner diameter matching the outer diameter of the middle section of the tube structure of the guide tube component (50).

7. The guidance system for the guidewire of the patent foramen ovale interventional occlusion device according to claim 1, characterized in that, The guidance system further includes: a occluder release sheath guide wire (90), the distal end of which is formed with a helical bend (91).

8. The guidance system for the guidewire of the patent foramen ovale interventional occlusion device according to claim 1, characterized in that, The first guidewire (10) is a 0.032-inch coated guidewire, the second guidewire (40) is a 0.014-inch ultrafine guidewire, and the diameter of the tube structure of the fixed sheath component (30) is set to 8.5F.

Images