Visual bending vascular covered stent windowing device and method

Abstract

The application discloses a visual bending vascular covered stent windowing device and method, which comprises a flexible bending pipe body, a control handle, an image acquisition part and a guide wire channel. The distal end of the flexible bending pipe body is provided with a working end. The control handle is connected with the flexible bending pipe body, and the control handle can control the flexible bending pipe body to form bidirectional bending. The image acquisition part can acquire real-time images inside the blood vessel. The guide wire channel is provided for the guide wire, and the guide wire can extend to the target branch blood vessel from the working end. The puncture assembly is slidably arranged in the flexible bending pipe body, and the puncture assembly is provided with a puncture needle. The side of the working end is provided with a puncture outlet, and the puncture needle can extend out of the puncture outlet to pierce the covering film of the vascular covered stent. The visual component can enable the operator to intuitively observe the internal structure of the blood vessel during the movement and alignment of the working end, so that the bending part can accurately control the bending of the working end, and the traditional two-dimensional image cannot accurately position the opening position of the branch blood vessel branch, and the precise windowing of the covered stent branch is realized.

Description

Technical Field

[0001] This invention belongs to the field of medical devices, and in particular relates to a visually adjustable vascular covered stent fenestration device and method. Background Technology

[0002] A standard covered stent is an interventional medical device that covers the surface of a metal stent with membrane materials such as polytetrafluoroethylene (PTFE) or polyester (PET). It combines the support of metal with the insulating function of membrane and is mainly used to isolate blood flow from impacting the blood vessel wall and to close ruptures or fistulas.

[0003] When a lesion is close to a vital branch vessel, using a standard covered stent can cause vascular closure, leading to organ ischemia and complex aortic disease. In such cases, a "fenestration" is needed to place a smaller stent in the branch vessel at the branch location, allowing normal blood flow to the branch vessel. Simply put, "fenestration" aims to preserve or restore blood flow to the branch artery in the stent-covered area while simultaneously sealing the lesion. It is primarily used in the following scenarios: 1. Abdominal aortic aneurysm (AAA): Primarily refers to pararenal or proximal renal aneurysms. When the aneurysm is closely attached to or even involves important blood vessels supplying the kidneys and intestines (such as the renal artery and superior mesenteric artery), resulting in insufficient proximal anchorage; 2. Thoracic aortic aneurysm (TAA): When the aneurysm involves the aortic arch and it is necessary to preserve the "supraclavicular three branches" (innominate artery, left common carotid artery, and left subclavian artery) that supply blood to the brain and upper limbs; 3. Aortic dissection: When the dissection opening is close to the opening of the left subclavian artery, due to insufficient anchoring zone, the stent needs to be moved forward, which may cover the branches, or the true lumen is severely compressed and the blood supply to the branches needs to be guaranteed.

[0004] In all three scenarios above, if a standard covered stent blocks a branch vascular access in that segment of the blood vessel, precise fenestration of the covered stent is necessary. In minimally invasive aortic surgery, the "fenestration" technique for covered stents currently falls into two main categories: pre-fenestration outside the body and in-situ fenestration inside the body. In addition, there are some innovative and specialized branch techniques. Simply put, one is "pre-fabricated" outside the body, and the other is "made on-site" inside the body.

[0005] Pre-fenestration: Pre-operative "customization". During the procedure, the surgeon trims the window at the corresponding position on the covered stent based on pre-operative measurements ("on-the-job modification"), and then aligns the stent "window" with the target vessel for release. Pre-formed windows are more precise and can effectively eliminate the risks of pre-fenestration and endoleak, but if the alignment fails, it may close branch vessels, and it requires a very high level of manual dexterity and three-dimensional spatial awareness from the surgeon.

[0006] In-situ fenestration: "Opening up" inside the body. First, a standard covered stent is implanted into the aorta (which may temporarily cover the branch vessels). Then, using energy such as a puncture needle, laser, or radiofrequency, a hole is precisely punctured / burned from inside the branch vessel to create a hole in the membrane covering the branch opening. The hole is then expanded with a balloon, and a small stent is implanted to restore blood flow. The biggest advantage is its flexibility.

[0007] However, both external and internal fenestration techniques have significant drawbacks. External fenestration requires precise placement of the stent branch into the branch vessel, demanding extremely high surgical skill and presenting a high level of surgical difficulty. Internal fenestration, performed under DSA two-dimensional imaging, involves placing the stent and creating the fenestration. The surgeon must first place the covered stent at the desired vessel site under 2D imaging, then locate the circumferential branch of the vessel before performing the puncture and fenestration. However, locating the branch in a 360° circumferential direction under 2D imaging is difficult and risky; inaccurate positioning can lead to puncturing the vessel wall instead of the branch, resulting in vessel rupture. Summary of the Invention

[0008] The technical objective of this invention is to provide a visually adjustable vascular stent fenestration device and method to solve the technical problem in the prior art that the fenestration position of the stent cannot be accurately confirmed.

[0009] To solve the above problems, the technical solution of the present invention is as follows: A visually adjustable vascular stent fenestration device includes: A flexible adjustable bend, with a working end provided at the far end of the flexible adjustable bend; A control handle is connected to the proximal end of a flexible adjustable bend, and a bending adjustment element is provided on the control handle. The bending adjustment element is configured to control the distal end of the flexible adjustable bend to form at least two bends in opposite directions. A visualization component, integrated into the working end, includes an image acquisition unit whose field of view covers the front of the working end and at least part of the peripheral area, and is configured to acquire real-time images of the inside of blood vessels. The guidewire channel is set through the control handle, the flexible adjustable bend body and the working end. The guidewire channel is configured to allow the guidewire to be inserted. The guidewire can extend from the working end and extend into the target branch blood vessel to fix the fenestration device. The puncture assembly is slidably disposed within a flexible adjustable curved tube. The distal end of the puncture assembly is provided with a puncture needle, and the side of the working end is provided with a puncture outlet corresponding to the puncture needle. The puncture needle can extend through the puncture outlet under the control of the control handle to puncture the covering of the corresponding vascular covered stent. The visualization component is also configured to provide real-time images during the movement and alignment of the working end toward the branch orifice of the target branch vessel, in order to assist the operator in controlling the bending component to bend the working end. Furthermore, the direction in which the puncture needle extends from the puncture site is opposite to the direction in which the guidewire extends from the working end into the target branch blood vessel.

[0010] The puncture needle includes a proximal pushing section and a distal flexible puncture section. The distal flexible puncture section is made of a metal material with elastic recovery properties, so that the puncture needle can pass through the working end along a preset curved path and extend out through the puncture outlet.

[0011] The outer diameter of the puncture needle is smaller than the minimum gap between adjacent metal skeletons in the vascular endovascular stent graft, so that the puncture needle can avoid the metal skeleton when puncturing the graft.

[0012] The control handle is equipped with a puncture seat, which is connected to the puncture assembly. The puncture seat is set in the direction of the puncture outlet to drive the puncture needle to extend through the puncture outlet.

[0013] The flexible adjustable bend includes a snake-bone tube segment at the distal end and a braided tube segment at the proximal end, with the snake-bone tube segment covered by a flexible elastic tube.

[0014] The flexible adjustable bend also includes at least two traction wires. The at least two traction wires extend along the axial direction of the flexible adjustable bend and are fixed at different circumferential positions of the snake bone pipe segment. The bending component bends the snake bone pipe segment in different directions by pulling different traction wires.

[0015] The working end includes a guidewire outlet and a puncture outlet. The guidewire outlet is located in the front end region of the working end, and the puncture outlet is located in the side region of the working end. The axial direction of the puncture outlet is opposite to that of the axial direction of the guidewire outlet.

[0016] A further preferred embodiment includes a rinsing channel, which is connected to the working end, and the outlet of the rinsing channel is positioned facing the image acquisition unit to deliver rinsing liquid to the image acquisition area.

[0017] The flushing channel and the guide wire channel are connected at the working end and share the same outlet.

[0018] The working end is equipped with a rinsing tank, which is located on the outlet side of the rinsing channel and extends in the direction toward the visualization component to guide the rinsing liquid to the image acquisition area.

[0019] The image acquisition unit includes a light source and a lens, with the light source located on at least one side of the lens to provide illumination.

[0020] Specifically, the guidewire channel includes a guidewire cavity located at the working end and a guidewire channel inlet located at the control handle; wherein, the cross-section of the guidewire cavity is elliptical.

[0021] The working end has a smooth transition section on its outer periphery to reduce the risk of damage to the blood vessel wall during its movement within the blood vessel.

[0022] A method for fenestrating a visually adjustable vascular stent graft, utilizing the aforementioned visually adjustable vascular stent graft fenestration device, includes the following steps: The working end of the fenestration device is inserted into the target blood vessel via a vascular access. The visualization component of the windowing device acquires real-time images of the inside of the blood vessel, and identifies the location of the branch opening of the target branch blood vessel based on the real-time images. The bending element of the window opening device is controlled to bend and align the working end toward the branch opening of the target branch blood vessel; The guidewire is extended from the working end through the guidewire channel of the fenestration device and extended into the target branch blood vessel to locate the working end; The puncture assembly of the fenestration device is controlled so that the puncture needle extends from the side of the working end and punctures the vascular stent covering the branch orifice of the target branch vessel in a direction opposite to the direction of guidewire extension, thereby forming a fenestration.

[0023] In the process of identifying the branching point of the target branch blood vessel through the visualization component, flushing fluid is delivered to the image acquisition area of ​​the visualization component through the flushing channel of the window opening device.

[0024] Because the present invention adopts the above technical solution, it has the following advantages and positive effects compared with the prior art: This invention utilizes a visualization component integrated into the working end to acquire real-time images of the blood vessel interior, with a field of view covering the area in front of the working end and at least part of its peripheral region. This allows the operator to visually observe the internal structure of the blood vessel while moving and aligning the working end towards the branch opening of the target branch blood vessel, thereby precisely controlling the bending element to adjust the working end. Combined with the flexible, adjustable bending tube body providing at least two opposite bending directions, this device can accurately align the working end with the branch opening, avoiding the inability to accurately locate the branch opening position under traditional two-dimensional imaging, thus achieving precise fenestration of the covered stent branch.

[0025] This invention features a guidewire channel. After precise alignment via a visualization component, the guidewire extends from the working end into the target branch vessel, thereby firmly fixing the entire fenestration device in the predetermined position. This ensures that the working end will not shift during subsequent puncture procedures, greatly improving the stability and reliability of the operation and providing a solid foundation for precise puncture.

[0026] In this invention, the exit direction of the puncture needle as it extends from the puncture outlet is opposite to the extension direction of the guidewire from the working end into the target branch vessel. In actual operation, the guidewire first enters the branch vessel for guidance and fixation, and then the puncture needle extends from the side of the working end, puncturing from the outside of the covered stent towards the inside of the stent, thereby puncturing the covered stent. Because the puncture needle remains within the vessel lumen and towards the stent covered stent, the risk of puncturing the vessel wall due to inaccurate positioning, as seen in traditional in vivo fenestration techniques, is completely avoided. This fundamentally eliminates serious complications such as vessel perforation and significantly improves the safety of the procedure. Attached Figure Description

[0027] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the invention.

[0028] Figure 1 This is an overall structural diagram of a visually adjustable vascular stent fenestration device according to the present invention; Figure 2 This is a front view of a visually adjustable vascular stent fenestration device according to the present invention; Figure 3 For based on Figure 2 Enlarged schematic diagram of part A; Figure 4 This is a side view of a visually adjustable vascular stent fenestration device according to the present invention; Figure 5 For based on Figure 4 Enlarged schematic diagram of part B; Figure 6 This is a schematic diagram illustrating a specific implementation of the present invention; Figure 7 For based on Figure 6 Enlarged schematic diagram of part C.

[0029] Explanation of reference numerals in the attached figures 1: Guidewire lumen; 2: Irrigation tank; 3: Light source; 4: Lens; 5: Snake-bone tube segment; 5.1: Rubber tube; 6: Braided tube segment; 7: Control handle; 8: Adjusting element; 9: Cable; 10: Puncture seat; 11: Puncture tube; 11.1: Puncture channel interface; 12: Plug; 13: Guidewire channel inlet; 14: Connecting tube; 15: Working end; 16: Puncture needle; 17: Stent membrane; 18: Covered stent; 19: Aortic vessel; 20: Guidewire; 21: Branch vessel. Detailed Implementation

[0030] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the specific implementation methods of the present invention will be described below with reference to the accompanying drawings. Obviously, the drawings described below are merely some embodiments of the present invention. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without any creative effort.

[0031] To keep the drawings concise, only the parts relevant to the invention are shown schematically in each figure, and they do not represent the actual structure of the product. Furthermore, for ease of understanding, in some figures, only one of components with the same structure or function is shown schematically, or only one is labeled. In this document, "one" can mean not only "only one" but also "more than one".

[0032] The following detailed description, in conjunction with the accompanying drawings and specific embodiments, provides a visually adjustable vascular covered stent 18 fenestration device and method according to the present invention. The advantages and features of the present invention will become clearer from the following description and claims.

[0033] Example 1

[0034] See Figures 1 to 5 This embodiment provides a visually adjustable vascular stent fenestration device, which mainly includes: a flexible adjustable tube body, a control handle 7, a visualization component, a guidewire channel, and a puncture component.

[0035] like Figures 1 to 3 As shown, in this embodiment, the front end of the control handle 7 is connected to the proximal end of the flexible adjustable bend, while the distal end of the flexible adjustable bend is provided with a working end 15. The outer periphery of the working end 15 has a smooth transition portion with a diameter of 2.8-3.5 mm to reduce the risk of damage to the vessel wall during movement within the blood vessel. This diameter range balances device passability with minimizing vascular trauma, making it suitable for commonly used access vessels such as the femoral artery. The control handle 7 is a handheld component; the operator must hold the control handle 7 during implementation and manipulate the bending adjustment element 8 located on the control handle 7 to control the distal end of the flexible adjustable bend to form at least two bends in opposite directions. The bending adjustment element 8 can be in the form of a knob or a push rod for easy one-handed operation.

[0036] Specifically, the flexible adjustable bend tube body comprises a snake-bone tube segment 5 (near the working end 15) at the distal end and a braided tube segment 6 (near the control handle 7) at the proximal end, connected together. Furthermore, a flexible elastic tube, preferably a rubber tube 5.1, covers the snake-bone tube segment 5. A connecting tube 14 provides a transition connection between the working end 15 and the snake-bone tube segment 5. Further, to enable bending of the flexible adjustable bend tube body, at least two traction wires are included. These two traction wires extend axially along the flexible adjustable bend tube body and are fixed at different circumferential positions on the snake-bone tube segment 5. The operator can adjust the bending element 8 to pull different traction wires, allowing the snake-bone tube segment 5 (with a segmental structure and external flexible elastic tube) to achieve bidirectional bending by adjusting its length (greater than 4 cm). The segmental structure of the snake-bone tube segment 5 provides precise control of the bending angle, while the external rubber tube 5.1 ensures sealing and smoothness.

[0037] See Figure 2 and Figure 6 To secure the control handle 7 during implementation of this embodiment, a guidewire channel and a matching guidewire 20 are provided. Specifically, the guidewire channel sequentially passes through the control handle 7, the flexible adjustable bend, and the working end 15. The guidewire 20 can be inserted into the guidewire channel. The guidewire 20 enters through the guidewire channel inlet 13 below the control handle 7, passes through the flexible adjustable bend, and then extends from the guidewire lumen 1 of the working end 15, extending at least 20mm into the target branch vessel to secure the fenestration device. The length of the guidewire 20 extending into the branch vessel is sufficient to resist the displacement force caused by subsequent puncture operations, ensuring device stability. Preferably, the guidewire lumen 1 has an elliptical cross-section, maximizing the channel space and achieving a maximum channel cross-sectional area with the smallest tip outer diameter, allowing for the insertion of the largest guidewire 20 and meeting the maximum irrigation flow rate. The elliptical design provides a larger flow area than a circular cross-section for the same outer diameter, facilitating the passage of the guidewire 20 and fluid flushing.

[0038] like Figure 4 and Figure 5 As shown, a visualization component is integrated on the working end 15. This visualization component includes an image acquisition unit whose field of view covers the front and at least part of the peripheral area of ​​the working end 15, in order to acquire real-time images of the inside of the blood vessel after the working end 15 enters the blood vessel. Specifically, the image acquisition unit includes a light source 3 and a lens 4. The light source 3 is disposed on at least one side of the lens 4 for providing illumination. The light source 3 can be an LED lamp bead, and the lens 4 is a miniature high-definition camera. Both are packaged in the front end of the working end 15 without adding extra volume.

[0039] Preferably, to further enable the image acquisition unit to acquire clearer images, this embodiment also includes a rinsing channel. This rinsing channel is connected to the working end 15, and its outlet faces the image acquisition unit to deliver rinsing fluid (physiological saline) to the image acquisition area. More preferably, this rinsing channel is connected to the guidewire channel at the working end 15 and shares the same outlet, allowing both the guidewire 20 and physiological saline to pass through to rinse the field of view. In actual operation, positioning is first completed using the guidewire 20, and then the rinsing mode is switched, without the need for additional channels. Preferably, a rinsing tank 2 is also provided at the working end 15. The rinsing tank 2 is located on the outlet side of the rinsing channel, and extends towards the visualization component to guide the rinsing fluid to the image acquisition area. That is, the guiding structure of the rinsing tank 2 ensures that the fluid preferentially rinses the area in front of the lens 4, improving rinsing efficiency.

[0040] See Figure 6 and Figure 7 In this embodiment, the visualization component provides real-time images during the movement and alignment of the working end 15 toward the branch opening of the target branch blood vessel, in order to assist the operator in controlling the bending component 8 to bend the working end 15.

[0041] See Figures 3 to 7 In this embodiment, the puncture assembly is slidably disposed within a flexible adjustable curved tube. The puncture assembly includes a puncture needle 16 at its distal end and a puncture tube 11 connected to the puncture needle 16. A puncture outlet corresponding to the puncture needle 16 is provided on the side of the working end 15, allowing the puncture needle 16 to extend through the puncture outlet under the control of the control handle 7 to puncture the covering of the corresponding vascular stent graft 18. The axial direction of the puncture outlet is opposite to the axial direction of the guidewire lumen 1. Furthermore, the needle exit direction of the puncture needle 16 when it extends through the puncture outlet is opposite to the extension direction of the guidewire 20 extending from the guidewire lumen 1 of the working end 15 into the target branch vessel. This opposite design allows the guidewire 20 to enter the branch vessel forward for fixation, while the puncture needle 16 punctures the stent graft 18 backward without interfering with each other. The puncture needle 16 remains within the aortic lumen, avoiding accidental damage to the vessel wall.

[0042] Specifically, the puncture needle 16 includes a proximal pushing section and a distal flexible puncture section. The distal flexible puncture section is made of a metal material with elastic recovery properties, allowing the puncture needle 16 to pass through the working end 15 along a preset bending path and extend through the puncture outlet. The flexible puncture section can be made of nickel-titanium alloy or stainless steel spring wire, which has good elasticity and fatigue resistance. The proximal pushing section is connected to the puncture tube 11. Under the action of the puncture tube 11, the proximal pushing section is pushed, thereby allowing the puncture needle 16 to extend from the puncture outlet. Furthermore, the outer diameter of the puncture needle 16 is smaller than the minimum gap size between adjacent metal skeletons in the vascular graft stent 18. The diameter of the puncture needle 16 is preferably 0.3-0.6 mm, so that the puncture needle 16 can avoid the metal skeleton when puncturing the graft. This size design ensures both puncture sharpness and avoids interference with the stent wires.

[0043] Preferably, the control handle 7 has a puncture channel interface 11.1, from which a puncture tube 11 extends and connects to a puncture seat 10. The other end of the puncture tube 11 is connected to a puncture needle 16. The puncture seat 10 is oriented to correspond to the direction of the puncture outlet. The operator pushes the puncture seat 10 to drive the puncture needle 16 out through the puncture outlet. The push-pull stroke of the puncture seat 10 matches the extension length of the puncture needle 16, providing a clear operational feel.

[0044] Preferably, the tail of the control handle 7 is also connected to a cable 9 and a plug 12. The cable 9 has built-in power cord and signal cord, which can be connected to an external power source and a display to provide power support and image display for this embodiment, respectively.

[0045] Example 2

[0046] See Figures 6 to 7 This embodiment provides a method for fenestrating a visually adjustable vascular stent graft, utilizing the visually adjustable vascular stent graft fenestration device as described in Embodiment 1, including the following steps: A puncture is routinely performed in the common femoral artery at the groin to establish an entry point accessible to the fenestration device. Then, with the aid of DSA imaging, the working end is inserted into the vessel through the entry point, with the puncture needle 16 positioned inside the working end. Following the vessel route, using the bending adjustment mechanism 8 of the fenestration device and in conjunction with DSA imaging, the device reaches the branch point of the branch vessel 21 requiring stent fenestration. DSA provides overall path navigation, while the bending adjustment function helps the working end navigate through tortuous vessels.

[0047] Since DSA is a two-dimensional imaging device, it cannot clearly identify the location of the branch opening in a circumferential direction. Therefore, the image acquisition unit at the working end 15 is used to observe and locate the branch opening. Because of the blood in the blood vessel, even with a light source, the lens view remains blurry. At this point, saline solution is injected through the guidewire channel inlet 13 to flush away the blood in front of the lens. Continuous flushing with saline solution maintains a clear field of view, facilitating precise operation.

[0048] Once the branch opening of tributary vessel 21 is observed, the working end 15 is bent to hold the guidewire lumen 1 against the branch vessel, and the guidewire 20 is inserted through the guidewire channel inlet 13. The guidewire 20 is advanced along the guidewire channel until it extends out from the working end and is successfully inserted into the branch vessel. This completes the location of the branch vessel opening, and the device is stably fixed using the guidewire 20. The guidewire insertion depth should be at least 20 mm to ensure that subsequent operations do not result in displacement.

[0049] Next, following the standard procedure for placing the covered stent 18, the covered stent 18 is placed at the lesion site in the aortic vessel 19 requiring treatment. The direction of the guidewire and branch opening is observed through the image acquisition unit. The handle is rotated so that the exit direction of the puncture needle 16 is opposite to the direction of the guidewire 20. After determining the exit direction of the puncture needle 16, the puncture seat 10 is quickly pushed forward until the puncture needle 16 punctures the stent membrane 17, thus completing the accurate positioning and puncture of the branch opening, creating a fenestration.

[0050] The embodiments of the present invention have been described in detail above with reference to the accompanying drawings, but the present invention is not limited to the above embodiments. Even if various changes are made to the present invention, if these changes fall within the scope of the claims of the present invention and their equivalents, they shall still fall within the protection scope of the present invention.

Claims

1. A visually adjustable vascular stent fenestration device, characterized in that, include: A flexible adjustable bend, wherein a working end is provided at the distal end of the flexible adjustable bend; A control handle is connected to the proximal end of the flexible adjustable bend, and the control handle is provided with a bending adjustment component, which is configured to control the distal end of the flexible adjustable bend to form at least two bends in opposite directions. A visualization component is integrated into the working end. The visualization component includes an image acquisition unit. The field of view of the image acquisition unit covers the front and at least part of the peripheral area of ​​the working end and is configured to acquire real-time images of the inside of blood vessels. A guidewire channel is provided through the control handle, the flexible adjustable bend body and the working end. The guidewire channel is configured to allow the guidewire to pass through. The guidewire can extend from the working end and extend into the target branch blood vessel to fix the fenestration device. The puncture assembly is slidably disposed within the flexible adjustable curved tube. The distal end of the puncture assembly is provided with a puncture needle, and the side of the working end is provided with a puncture outlet corresponding to the puncture needle. The puncture needle can extend through the puncture outlet under the control of the control handle to puncture the covering of the corresponding vascular covered stent. The visualization component is also configured to provide real-time images during the movement and alignment of the working end toward the branch opening of the target branch blood vessel, so as to assist the operator in controlling the bending component to bend the working end. Furthermore, the direction in which the puncture needle extends from the puncture outlet is opposite to the direction in which the guidewire extends from the working end into the target branch blood vessel.

2. The visually adjustable vascular stent fenestration device according to claim 1, characterized in that, The puncture needle includes a proximal pushing section and a distal flexible puncture section. The distal flexible puncture section is made of a metal material with elastic recovery properties, so that the puncture needle can pass through the working end along a preset bending path and extend out through the puncture outlet.

3. The visually adjustable vascular stent fenestration device according to claim 2, characterized in that, The outer diameter of the puncture needle is smaller than the minimum gap between adjacent metal skeletons in the vascular covered stent, so that the puncture needle can avoid the metal skeleton when puncturing the covered stent.

4. The visually adjustable vascular stent fenestration device according to claim 1, characterized in that, The control handle is provided with a puncture seat, which is connected to the puncture assembly. The puncture seat is set in the direction corresponding to the puncture outlet to drive the puncture needle to extend through the puncture outlet.

5. The visually adjustable vascular stent fenestration device according to claim 1, characterized in that, The flexible adjustable bend includes a snake-bone tube segment at the distal end and a braided tube segment at the proximal end, the snake-bone tube segment being covered with a flexible elastic tube.

6. The visually adjustable vascular stent fenestration device according to claim 5, characterized in that, The flexible adjustable bend also includes at least two traction wires, which extend along the axial direction of the flexible adjustable bend and are respectively fixed at different circumferential positions of the snake-bone pipe segment. The bending member bends the snake-bone pipe segment in different directions by pulling different traction wires.

7. The visually adjustable vascular stent fenestration device according to claim 1, characterized in that, The working end includes a guidewire outlet and a puncture outlet. The guidewire outlet is located in the front end region of the working end, and the puncture outlet is located in the side region of the working end. The axial direction of the puncture outlet is opposite to the axial direction of the guidewire outlet.

8. The visually adjustable vascular stent fenestration device according to claim 1, characterized in that, It also includes a rinsing channel, which is connected to the working end, and the outlet of the rinsing channel is disposed toward the image acquisition unit to deliver rinsing liquid to the image acquisition area.

9. The visually adjustable vascular stent fenestration device according to claim 8, characterized in that, The flushing channel and the guide wire channel are connected at the working end and share the same outlet.

10. The visually adjustable vascular stent fenestration device according to claim 8, characterized in that, The working end is provided with a rinsing tank, which is located on the outlet side of the rinsing channel and extends in the direction toward the visualization component to guide the rinsing liquid to the image acquisition area.

11. The visually adjustable vascular stent fenestration device according to claim 1, characterized in that, The image acquisition unit includes a light source and a lens, wherein the light source is disposed on at least one side of the lens for providing illumination.

12. The visually adjustable vascular stent fenestration device according to claim 1, characterized in that, The guidewire channel includes a guidewire cavity located at the working end and a guidewire channel inlet located at the control handle; wherein the cross-section of the guidewire cavity is elliptical.

13. The visually adjustable vascular stent fenestration device according to claim 1, characterized in that, The outer periphery of the working end is provided with a smooth transition portion to reduce the risk of damage to the blood vessel wall during the movement of the working end within the blood vessel.

14. A method for fenestrating a visually adjustable vascular stent graft, utilizing the visually adjustable vascular stent graft fenestration device as described in any one of claims 1 to 13, characterized in that, Includes the following steps: The working end of the window opening device is inserted into the target blood vessel via a vascular access. The visualization component of the windowing device acquires real-time images of the inside of the blood vessel, and identifies the location of the branch opening of the target branch blood vessel based on the real-time images. The bending component of the window opening device is controlled to bend and align the working end toward the branch opening of the target branch blood vessel; The guidewire extends from the working end through the guidewire channel of the fenestration device and extends into the target branch blood vessel to locate the working end; Control the puncture assembly of the fenestration device so that the puncture needle extends from the side of the working end and punctures the vascular stent covering the branch orifice of the target branch vessel in a direction opposite to the extension direction of the guidewire, thereby forming a fenestration.

15. The method according to claim 14, characterized in that, During the process of identifying the branching point location of the target branch blood vessel through the visualization component, flushing fluid is delivered to the image acquisition area of ​​the visualization component through the flushing channel of the window opening device.

Images