Covered stent windowing device

Abstract

The invention provides a covered stent windowing device which comprises a sheathing canal, the sheathing canal comprises an adjustable bending section and a main body section, the adjustable bending section is arranged at the far end of the main body section, and a side hole is formed in the side wall, close to the adjustable bending section, of the far end of the main body section; the puncture assembly is arranged in the sheath tube and extends in the axis direction of the sheath tube; in a working state, at least part of the far end of the puncture assembly penetrates out of the side hole, and a window is formed in the covered stent. According to the scheme, various problems caused by the fact that the puncture assembly stretches out of the far-end port of the sheathing canal to conduct windowing operation are effectively avoided, the windowing position of the puncture assembly on the covered stent can be accurately positioned, the windowing position precision and the windowing success rate are improved, the use difficulty of an operator is reduced, and the windowing operation process does not need to be repeatedly adjusted.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a covered stent fenestration device. Background Technology

[0002] Aortic endovascular stent grafts, with their advantages of minimal invasiveness and rapid recovery, have become the main routine interventional treatment for aortic dissection and aortic aneurysm. However, when dissections and aneurysms involve important branches of the aorta, significant limitations arise, as the endovascular stent graft can obstruct blood flow to the branch vessels. For these complex lesions, fenestration techniques for endovascular stent grafts have emerged. The greatest challenge in this type of procedure lies in precisely perforating the endovascular stent graft at the branch vessel orifice under limited imaging conditions. In practice, using existing instruments presents numerous problems, including the stent graft not being placed at the branch vessel orifice, the inability to insert the instrument into the branch vessel, the need for multiple positioning and adjustments, the long procedure time, and even the risk of intraoperative bleeding due to damage to the vessel wall during perforation; and the risk of multiple perforations leading to endoleaks.

[0003] The complexity of fenestration surgery varies depending on the extent of arterial dissection or aneurysm affecting other branches, as there are currently no suitable instruments for rapid fenestration at any location, resulting in a variety of complex solutions. Common fenestration methods include: in situ retrograde fenestration, in situ fenestration, external fenestration, and a combination of external and in situ fenestration. Fenestration puncture instruments include, but are not limited to, puncture needles and laser cables. The simplest method is in-situ retrograde fenestration, which is only applicable when the aortic arch involves the left subclavian artery branch. The puncture instrument is inserted from the brachial artery, and the fenestration is performed from the outside of the covered stent. The operation is relatively simple, but it is difficult to maintain the center. Another method is when the abdominal aorta involves important organ branches, and it is impossible to insert the instrument from the branch vessels. In this case, the in-situ fenestration can only be performed in the abdominal aorta, inside the covered stent. Due to limitations of imaging and the instrument itself, it is difficult to puncture accurately, and it takes 1-2 hours and multiple punctures to successfully insert the branch vessels. Another method is external fenestration, which involves releasing the covered stent outside the body before the operation, manually fenestrating the covered stent and adding contrast markers, and then re-entering it into the delivery system for further release. Modifying the covered stent device itself is difficult and takes more than 2 hours. There is also the problem of inaccurate external fenestration, which may not be able to align with the branch vessel opening after insertion. The most complicated case is arterial dissection or aneurysm involving the four branches of the abdominal aorta, which requires a combination of external and in situ fenestration. For example, 2-3 holes are opened externally and 1-2 holes are opened in situ internally. The operation is extremely complicated and time-consuming, usually more than 10 hours, which is also a great challenge for doctors.

[0004] Currently, stent graft fenestration is a highly complex and risky procedure, requiring extensive experience to perform. Therefore, for over a decade, this technique has been limited to a few large central hospitals and specialized doctors, preventing its widespread adoption. In most regions, hospitals only consider cases involving aortic branches as contraindications for stent graft placement, leaving many patients without treatment and facing the life-threatening risk of massive bleeding.

[0005] Therefore, there is an urgent need for a fenestration instrument that can solve one or more of the following problems: applicable to various conditions of the thoracic aorta-abdominal aorta-iliac artery segment, arterial dissection, aneurysm involving important branches; capable of in situ or retrograde fenestration in vivo, accurately locating vascular branch sites, and achieving successful membrane puncture in one attempt; significantly shortening operation time and reducing patient and doctor suffering; relatively simple to operate, requiring only routine intraoperative procedures, suitable for various hospitals, and widely applicable. Summary of the Invention

[0006] To overcome at least one of the many problems in related technologies, the present invention provides a film-covered support window opening device, comprising: The sheath includes an adjustable bend section and a main body section. The adjustable bend section is located at the distal end of the main body section, and a side hole is provided on the side wall of the distal end of the main body section near the adjustable bend section. A puncture assembly, wherein the puncture assembly is disposed within the sheath and extends along the axial direction of the sheath; In the working state, the distal end of the puncture component at least partially protrudes through the side hole and opens a window on the covered support.

[0007] In some optional embodiments, the film-covered bracket window opening device further includes a bending handle; In operation, the bending handle controls the bending shape of the adjustable section and makes it at least partially abut against the covered stent or at least partially abut against the branch blood vessel, so as to provide positioning support for the fenestration process of the puncture component.

[0008] In some optional embodiments, the hardness of the material used to manufacture the adjustable bending section is less than the hardness of the material used to manufacture the main body section.

[0009] In some optional embodiments, the puncture assembly includes a delivery catheter and a hollow puncture needle placed within the delivery catheter, wherein both the distal end of the delivery catheter and the hollow puncture needle have a pre-bent shape; or, The puncture assembly includes a hollow puncture needle, which has a pre-bent shape; or, The puncture assembly includes a delivery catheter and a solid puncture needle placed within the delivery catheter, wherein both the distal end of the delivery catheter and the solid puncture needle have a pre-bent shape; or, The puncture assembly includes a delivery catheter and a laser cable placed inside the delivery catheter, the distal end of which has a pre-bent shape.

[0010] In some optional embodiments, the hollow or solid puncture needle is made of metal and is pre-bent and shaped.

[0011] In some optional embodiments, the distal end of the delivery catheter has a tapered outer contour, and the distal end of the delivery catheter is transitionally connected to the outer surface of the solid puncture needle through the tapered shape, so that the delivery catheter follows the solid puncture needle through the covered stent during the fenestration process.

[0012] In some optional embodiments, the puncture assembly includes a delivery catheter and a hollow puncture needle disposed within the delivery catheter, wherein the distal end of the delivery catheter is controllably bendable, and the distal end of the hollow puncture needle is at least partially flexible; or, The puncture assembly includes a delivery catheter and a solid puncture needle placed within the delivery catheter, wherein the distal end of the delivery catheter is controllably bendable, and the distal end of the solid puncture needle is at least partially flexible; or, The puncture assembly includes a delivery conduit and a laser cable placed inside the delivery conduit, the distal end of which can be controlled to be bent.

[0013] In some alternative embodiments, the hollow puncture needle, which is at least partially flexible, and the solid puncture needle, which is at least partially flexible, are made of a metallic material and are at least partially heat-treated so that the stiffness of that portion is less than the stiffness of the other portions of the puncture needle.

[0014] In some optional embodiments, the proximal end of the adjustable bend and the distal end of the side hole are spaced apart, with the space being greater than 0 mm and less than 10 mm.

[0015] In some optional embodiments, the film-covered bracket window opening device includes a pull wire assembly for controlling the bending state of the adjustable bend. The pull wire assembly is disposed inside the sheath tube and is positioned opposite to the side hole.

[0016] In some optional embodiments, the interior of the sheath is at least partially provided with a reinforcing layer, and the side holes are at least partially provided on the reinforcing layer.

[0017] In some optional embodiments, the sheath is provided with a side hole, and the side hole is at least partially provided on the side hole. The side hole is provided with a receiving groove to at least partially accommodate the pull wire assembly.

[0018] In some optional embodiments, a reinforcing layer is provided inside the sheath, and the distal and proximal ends of the side hole are respectively connected to the reinforcing layer.

[0019] In some optional embodiments, the side hole is provided with a notch or groove, and the sheath is at least partially embedded in the notch or groove to enhance the connection strength between the side hole and the sheath.

[0020] In some optional embodiments, a developing element is further included, wherein the developing element is disposed near the distal and proximal ends of the side hole; or, the developing element is disposed on the side hole element and distributed around the side hole.

[0021] The technical solution of the present invention has the following advantages or beneficial effects: This invention utilizes a side hole penetrating the sidewall of the distal end of the sheath to allow the puncture component to extend through the side hole and perform fenestration on the covered stent. This effectively avoids various problems associated with extending the puncture component from the distal end of the sheath for fenestration, such as complex operation and inaccurate positioning. Because the side hole is located in the sidewall, the operator only needs to adjust the side hole to the target position and then independently control the puncture component. The interaction between the two operations and the involved devices is minimized, ensuring that deformation or bending of the distal end of the sheath does not affect the shape or movement of the puncture component extending from the side hole. Ultimately, this allows for precise positioning of the puncture component on the covered stent, reducing the operator's difficulty and eliminating the need for repeated adjustments and fenestration.

[0022] When the adjustable bend of the present invention is positioned along the target position, at least one side abuts against the covered stent or against the branch vessel, thereby reducing or eliminating the displacement of the distal end of the sheath at the target position in the vessel, thereby improving the positioning accuracy between the side hole and the covered stent, and ultimately enabling the puncture assembly to open a window at the desired position of the covered stent.

[0023] The pull wire assembly is disposed inside the sheath and is positioned opposite to the side hole; this opposite arrangement ensures that the pull wire assembly can pull the adjustable bend away from the side hole and bend it, so that the side hole is fully retained and aligned with the film-coated support side.

[0024] The developing element of the present invention is an additional developing unit, which is disposed on the side hole element and distributed around the side hole; thereby enabling precise monitoring of the position of the side hole.

[0025] In this invention, the side hole of the sheath and the distal outlet of the sheath form a blood flow channel. After the covered stent is released, blood flows in from the distal end of the sheath and then out from the side hole, ensuring that the branch vessels maintain unobstructed blood flow during the membrane rupture and fenestration process. Attached Figure Description

[0026] The accompanying drawings are provided to better understand the invention and are not intended to unduly limit the scope of the invention. Wherein: Figure 1 This is a front view schematic diagram of the film-covered bracket window opening device according to an embodiment of the present invention; Figure 2 It is based on Figure 1 A partial schematic diagram of the front-end main body of the device shown; Figure 3 This is a schematic diagram of a hollow puncture needle and a pre-bent delivery catheter according to an embodiment of the present invention; Figure 4 This is a schematic diagram of a hollow puncture needle without a delivery catheter according to an embodiment of the present invention; Figure 5 This is a schematic diagram of a solid puncture needle and a pre-bent delivery catheter according to an embodiment of the present invention; Figure 6 This is a schematic diagram of a laser optical cable and a pre-bent delivery conduit according to an embodiment of the present invention; Figure 7 This is a schematic diagram of a hollow / solid puncture needle or laser cable combined with an adjustable delivery catheter according to an embodiment of the present invention; Figure 8 This is a schematic diagram of in-situ retrograde fenestration of the aortic approach according to an embodiment of the present invention; Figure 9 This is a schematic diagram of in-situ reverse fenestration of branch vessel access according to an embodiment of the present invention; Figure 10 This is a schematic diagram illustrating the process of maintaining branch vessel flow during the fenestration according to an embodiment of the present invention; Figure 11 This is a schematic diagram of the positioning support during the window opening process according to an embodiment of the present invention; Figure 12 This is a schematic diagram of the adjustable bending section of the sheath tube in an unadjusted state according to an embodiment of the present invention; Figure 13 This is a schematic diagram of the adjustable bending section at the end of the sheath tube in the bending state according to an embodiment of the present invention; Figure 14 This is a schematic diagram of the adjustable bending section in the middle section of the sheath tube in an unadjusted state according to an embodiment of the present invention; Figure 15 This is a schematic diagram of the adjustable bending section in the middle section of the sheath tube according to an embodiment of the present invention. Figure 16This is a partial schematic diagram of the side hole of a component without side holes according to an embodiment of the present invention; Figure 17 This is a partial schematic diagram of the side hole of a component with a side hole according to an embodiment of the present invention; Figure 18 This is a schematic diagram of the first side hole component according to an embodiment of the present invention; Figure 19 This is a schematic diagram of the second side hole component according to an embodiment of the present invention; Figure 20 This is a schematic diagram of the third side hole component according to an embodiment of the present invention; Figure 21 This is a schematic diagram of the fourth side hole component according to an embodiment of the present invention; Figure 22 This is a schematic diagram of the fifth side hole component according to an embodiment of the present invention; Figure 23 This is a schematic diagram of an O-shaped developing ring according to an embodiment of the present invention; Figure 24 This is a schematic diagram of a C-shaped developing ring according to an embodiment of the present invention; Figure 25 This is a schematic diagram of a developing element disposed on a side hole element according to an embodiment of the present invention; Figure 26 This is a schematic diagram of the pre-bending of a rigid puncture needle according to an embodiment of the present invention; Figure 27 This is a schematic diagram of the heat-treated pre-bent portion of the puncture needle according to an embodiment of the present invention; Figure 28 This is a schematic diagram of a puncture needle with a flexible segment according to an embodiment of the present invention; Figure 29 This is a schematic diagram of a hollow puncture needle according to an embodiment of the present invention; Figure 30 This is a schematic diagram of a solid puncture needle according to an embodiment of the present invention. Detailed Implementation

[0027] The following description, in conjunction with the accompanying drawings, illustrates exemplary embodiments of the present invention, including various details to aid understanding. These details should be considered merely exemplary. Therefore, those skilled in the art will recognize that various changes and modifications can be made to the embodiments described herein without departing from the scope and spirit of the invention. Similarly, for clarity and brevity, descriptions of well-known functions and structures are omitted in the following description.

[0028] The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The singular forms “a,” “the,” and “the” used in this application and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the term “and / or” as used herein refers to and includes any or all possible combinations of one or more of the associated listed items.

[0029] It should be understood that although the terms first, second, third, etc., may be used in this application to describe various information, such information should not be limited to these terms. These terms are only used to distinguish information of the same type from one another. For example, without departing from the scope of this application, first information may also be referred to as second information, and similarly, second information may also be referred to as first information. Depending on the context, the word "if" as used herein may be interpreted as "when," "when," or "in response to determination."

[0030] To overcome at least one of the many problems in related technologies, the present invention provides a fenestration device for a covered stent, comprising: a sheath, the sheath comprising an adjustable bend 401 and a main body 402, the adjustable bend being disposed at the distal end of the main body, and a side hole 102 being provided at the distal end of the main body adjacent to the side wall of the adjustable bend; and a puncture assembly disposed within the sheath and extending along the axial direction of the sheath; in the working state, the distal end of the puncture assembly at least partially protrudes through the side hole and fenestrates the covered stent.

[0031] See Figure 1 , Figure 2 and Figure 12 The covered stent fenestration device includes a sheath, which is an adjustable bending sheath (in some embodiments, it may include a dilator, which can be combined with the dilator to form a catheter sheath kit), a delivery catheter 110, a puncture needle 114, a guidewire 105, a Y-valve 113, a torque controller 117, a needle hub 116, a Luer connector 112, a delivery catheter bending handle 111, a hemostatic valve 109, a bending knob 108, a bending handle 107, a three-way valve 106, etc. The guidewire, Y-valve, and torque controller are conventional surgical instruments and are not essential components of the fenestration system; operators can choose to use them as needed.

[0032] The distal end 101 of the sheath is designed for adjustable bending. It works in conjunction with a pull-wire assembly, allowing the operator to change the bending shape and timing of the distal end 101 by manipulating the pull-wire assembly proximally. The distal end of the main body of the sheath has a side hole, which is a through-hole. This side hole allows communication between the sheath's inner lumen and the external environment. During use, the puncture needle assembly or other instruments can be inserted through the side hole. The adjustable bending portion of the distal end of the sheath's side hole plays a role in positioning and maintaining blood flow during surgery. In some embodiments, the distal end 103 of the delivery catheter is a pre-bent catheter. Of course, to flexibly adjust the bending shape of the delivery catheter, it can also be configured as an adjustable-bend catheter. Figure 2 As shown, the proximal end of the delivery conduit is provided with a delivery conduit bending handle 111, and the tail end of the delivery conduit bending handle 111 is connected to a Luer connector, which can be connected to a Y valve, syringe, etc.

[0033] Figure 1 and 2 The puncture assembly shown is disposed within the sheath and extends along the axis of the sheath. It can be operatively moved forward or backward along the lumen of the sheath. In operation, the distal end of the puncture assembly at least partially protrudes through the side hole and creates a window on the covered stent. In practice, the puncture assembly is a membrane-breaking tool, pre-installed in the delivery catheter before use. Before windowing (or membrane breaking), the puncture assembly (such as a puncture needle) does not extend from the delivery catheter. After reaching the target position, the puncture assembly is advanced through the side hole 102 of the sheath to perform the membrane-breaking operation. In practice, the puncture assembly may contain a hollow puncture needle, a solid puncture needle, or a laser cable, etc., without specific limitations. After puncturing the covered stent, a guidewire 105 needs to be inserted and left in the body. For subsequent surgical procedures after windowing, all relevant instruments need to be advanced along the guidewire. As can be seen from the above description, this invention, by creating a side hole penetrating the sidewall at the distal end of the sheath, allows the puncture component to extend from the side hole to perform the fenestration on the covered stent. This effectively avoids various problems associated with the puncture element extending from the distal end of the sheath for fenestration, such as complex fenestration operations and inaccurate positioning. Because a side hole is created in the sidewall, the operator only needs to adjust the side hole to the target position and then independently control the puncture component. The interaction between the two operations and the involved devices is minimized, ensuring that deformation or bending of the distal end of the sheath does not affect the shape or movement of the puncture component extending from the side hole. Ultimately, this allows for precise positioning of the puncture component at the fenestration location on the covered stent, reducing the difficulty of operation and eliminating the need for repeated adjustments and repeated fenestration.

[0034] In some optional embodiments, the covered stent fenestration device further includes a bending adjustment handle 107; in the working state, the bending adjustment knob 108 on the bending adjustment handle controls the bending shape of the adjustable segment and makes it at least partially abut against the covered stent or at least partially abut against the branch vessel (see...). Figure 8 This provides positioning support for the window opening process of the puncture component. Figure 8-11 As shown, when the adjustable bend moves along the inside of the blood vessel to the target position, at least one side of it abuts against the covered stent for positioning, thereby reducing or eliminating the displacement of the distal end of the sheath at the target position within the blood vessel. This improves the positioning accuracy between the side hole and the covered stent, ultimately allowing the puncture assembly to open a window at the desired location on the covered stent. Preferably, as Figure 10 and 11 As shown, the distal end of the sheath is clamped between the covered stent and the blood vessel, further improving the stability of its positioning.

[0035] In some optional embodiments, the hardness of the material used to manufacture the adjustable bending section is lower than the hardness of the material used to manufacture the main body section. In some embodiments, the hardness of the polymer material of the adjustable bending section is 25D-40D, and the hardness of the polymer material of the main body section is 40D-80D. To ensure the rigidity of the side holes during bending, the polymer material at the side hole location is made of high-hardness material, with a hardness not lower than 40D.

[0036] In some optional embodiments, such as Figure 3 The puncture assembly includes a delivery catheter and a hollow puncture needle 104 placed within the delivery catheter. Both the distal section 103 of the delivery catheter and the hollow puncture needle have a pre-bent shape; or, as... Figure 4 As shown, the puncture assembly includes a hollow puncture needle 104, which has a pre-bent shape; or, as... Figure 5 As shown, the puncture assembly includes a delivery catheter and a solid puncture needle 204 placed within the delivery catheter. Both the distal end of the delivery catheter and the solid puncture needle have a pre-bent shape; or, as... Figure 6As shown, the puncture assembly includes a delivery conduit and a laser cable 604 placed within the delivery conduit. The distal end of the delivery conduit has a pre-bent shape. In practice, the delivery conduit can include both non-adjustable and adjustable types. Non-adjustable delivery conduits are simple in structure, low in cost, and easy to operate, but in order for the puncture assembly to pass smoothly through the side hole and be aligned with the target position on the covered stent, one or more components in the puncture assembly need to have a preset bending shape. Commonly used puncture components include hollow puncture needles, solid puncture needles, or laser cables. When the puncture needle is hollow, the guidewire can pass through the puncture needle. The puncture needle has a pre-bent angle, and the delivery conduit is a non-adjustable conduit with a pre-bent angle. The pre-bent structure of the puncture needle and the delivery conduit allows the puncture assembly to be delivered from the sheath side hole. For Figure 4 The catheter-free approach shown only requires a pre-bent puncture needle. Similarly, for a solid puncture needle approach, when the delivery catheter is non-adjustable, both the puncture needle and delivery catheter need to be pre-bent to allow for smooth passage through the side hole. In some hospitals, operating rooms are equipped with laser equipment and laser cables. The instantaneous high temperature of the laser can create a small hole in the covered stent. In this case, the puncture needle described above can be replaced with a laser cable. However, it should be noted that the laser cable needs to be used in conjunction with a delivery catheter, which in this case needs to have a pre-bent shape or be controllably adjustable.

[0037] In some optional embodiments, the hollow or solid puncture needle is made of metallic material and is shaped by pre-bending heat treatment. Preferably, a nickel-titanium alloy is used to make the puncture needle, and its rigidity and toughness are adjusted through heat treatment to obtain the required balanced performance, while simultaneously achieving pre-bending heat treatment shaping. For example, a heat-setting mold can be machined first, with grooves cut into the hot-working mold steel plate, and the distal bending angle at 30-70°. The nickel-titanium tube / rod is then placed and fixed within the groove. A muffle furnace, tubular vacuum furnace, salt bath furnace, or alumina powder furnace is then used, with the temperature adjusted to the range of 510-540°C. After the temperature stabilizes, the nickel-titanium tube / rod and the heat-setting mold are placed in a heat treatment furnace, heated for 5-10 minutes, and then immediately water-cooled; thus obtaining a puncture needle with a pre-bent shape.

[0038] In some optional embodiments, such as Figure 5 As shown, the outer contour of the distal end of the delivery catheter includes a distal segment 103 and a tapered segment 201. The distal end of the delivery catheter is transitionally connected to the outer surface of the solid puncture needle 204 through the tapered segment, so that the delivery catheter follows the solid puncture needle through the covered stent during the fenestration process.

[0039] In some optional embodiments, the puncture assembly includes a delivery conduit and a hollow puncture needle placed within the delivery conduit, the distal end of the delivery conduit being controllably bendable, and the distal end of the hollow puncture needle being at least partially flexible; or, the puncture assembly includes a delivery conduit and a solid puncture needle placed within the delivery conduit, the distal end of the delivery conduit being controllably bendable, and the distal end of the solid puncture needle being at least partially flexible; or, the puncture assembly includes a delivery conduit and a laser cable placed within the delivery conduit, the distal end of the delivery conduit being controllably bendable. Preferably, the delivery conduit is an adjustable conduit, the curvature of which can be adjusted as needed to fine-tune the most suitable puncture angle, thereby achieving the desired window opening effect. The delivery conduit bending handle 111 has a bending knob, and the target bending result can be obtained by rotating the bending knob. The adjustable delivery conduit can be used in conjunction with the hollow puncture needle, solid puncture needle, or laser cable described above. To adapt to and follow the bending deformation of the delivery catheter, at least a portion of the distal end of the puncture needle should be flexible, allowing at least a portion of the distal end of the needle to adaptively bend in accordance with the curvature changes of the adjustable delivery catheter. If it is a laser fiber optic cable, the cable itself is flexible and can deform along with the delivery catheter. Figures 26 to 30 As shown, puncture needles can be classified into hollow puncture needles and solid puncture needles. Hollow puncture needles have a sharp, beveled edge at a 20-60° angle. The inner diameter of a hollow puncture needle is 0.5-1.0 mm, allowing a guidewire of 0.014-0.038″ to pass through. Solid puncture needles, on the other hand, have a long tapered section at the distal end, which smoothly transitions with the long tapered section of the delivery catheter, making it easier for them to pass through the covered stent simultaneously and enter the inner layer of the covered stent. Puncture needles can also be classified by rigidity into fully rigid puncture needles and partially flexible puncture needles. Fully rigid puncture needles are used when the delivery catheter is non-adjustable or pre-bent. The distal end of a fully rigid puncture needle has a pre-bent shape with a bending angle of 20-60° and a bending length of 10-50 mm.

[0040] In some optional embodiments, the hollow puncture needle, which is at least partially flexible, and the solid puncture needle, which is at least partially flexible, are made of a metallic material, and at least part of them are heat-treated so that the stiffness of that part is less than the stiffness of other parts of the puncture needle. For example, the material of the partially flexible puncture needle may be a nickel-titanium alloy. During fabrication, within a 30-80 mm range from the distal end of the puncture needle (see...),... Figure 27The material undergoes localized heat treatment to adjust its phase transformation properties, regulating the Af point within a specific range to 25-40℃. This ultimately gives the adjusted portion a certain degree of flexibility, allowing it to bend along with the adjustable delivery conduit. During fabrication, muffle furnaces, salt bath furnaces, tubular heat treatment furnaces, or alumina powder furnaces can be used. The heat treatment furnace needs modification and the addition of small holes to allow partial insertion of the nickel-titanium alloy tube / rod into the furnace, while the rest remains outside, thus heat-treating only the localized area of ​​the puncture needle. The heat treatment temperature is adjusted to the range of 450-500℃. After temperature stabilization, the distal 80mm portion of the nickel-titanium alloy tube / rod is placed into the heat treatment furnace and heated for 5-60 minutes. It is then immediately water-cooled upon removal. This heat treatment process can be repeated multiple times to achieve the desired flexibility. Figure 28 As shown, another processing method for the locally flexible puncture needle is multi-segment laser welding. The distal needle tip E1 is a rigid solid tube or rod, and the main body segment E2 is a rigid solid tube or rod. There is a single-layer or multi-layer spring tube or steel cable made of multiple strands of metal wire between the needle tip and the main body segment. This segment is flexible, and the length of the flexible segment F is 15-75mm. It can bend with the bend of the adjustable bend delivery catheter.

[0041] The following is combined with Figure 9-11 A schematic diagram illustrating the operation of the device of the present invention is provided. When the lesion involves the three branches of the aortic arch, the fenestration device of the present invention can be inserted from the branch vessel 304 or from the aorta 303. The specific operation steps are as follows: 1) Based on the expected length of the covered stent 302 to be deployed, select the appropriate sheath size with side holes. The distance from the side hole to the distal end of the sheath should be greater than the distance from the branch vessel orifice to one end of the covered stent, ensuring that after the covered stent is deployed, the distal end of the sheath is located outside one end of the covered stent (see [reference]). Figure 10 and 11 This allows the opening at the distal end of the sheath and the side holes to form a blood flow channel during the opening process, without blocking the blood flow in the branch vessels.

[0042] 2) Once the adjustable curved sheath kit with side holes (including the sheath tube and the expander in the sheath tube cavity) is in place, remove the expander.

[0043] 3) Adjust the adjustable bend of the sheath so that it fits against the aortic wall and the side holes face the aorta.

[0044] 4) Insert and release the aortic endovascular stent graft.

[0045] 5) Insert the puncture assembly through the sheath and exit through the side hole.

[0046] 6) Secure the delivery catheter and push the puncture needle to puncture the covered stent; if it is a laser fiber optic cable, use the laser to puncture the covered stent. If it is a solid puncture needle (such as...),... Figure 30If the procedure involves a laser cable (as shown), the delivery catheter must be inserted into the covered stent along the puncture needle.

[0047] 7) If it is a hollow puncture needle (such as...) Figure 29 If the needle is solid, the guidewire is inserted through the puncture needle until it enters the covered stent; if the needle is withdrawn, the guidewire is inserted through the delivery catheter into the covered stent.

[0048] 8) Withdraw the puncture needle and delivery catheter, and insert the balloon catheter through the sheath along the guidewire. Dilate the balloon to enlarge the covered stent window to the expected diameter.

[0049] 9) Withdraw the balloon catheter and insert the branch covered stent for release. The branch covered stent is released from the inside of the aortic covered stent to the branch vessel to form a closed passage.

[0050] 10) Remove all instruments; the surgery is complete.

[0051] For lesions involving the four branches of the abdominal aorta (see...) Figure 8 In this situation, the fenestration device is inserted through the aorta 301. The specific operating steps are as follows: 1) Insert the adjustable curved sheath kit with side holes (including the sheath tube and the expander in the sheath tube lumen), and once in place, remove the expander.

[0052] 2) The adjustable bending sheath can be bent to allow the sheath to be inserted into the branch vessel and positioned so that the side hole faces the aorta.

[0053] 3) Insert and release the aortic endovascular stent graft 302.

[0054] 4) Insert the puncture assembly, consisting of the puncture needle and delivery catheter, through the adjustable curved sheath and out through the side hole.

[0055] 5) Secure the delivery catheter and push the puncture needle to puncture the covered stent; if it is a laser fiber cable, use the laser to puncture the covered stent and insert it. If it is a solid puncture needle or a laser fiber cable, the delivery catheter must also be inserted into the covered stent along the puncture needle.

[0056] 6) If it is a hollow puncture needle, the guidewire is inserted through the puncture needle until it enters the covered stent; if it is a solid puncture needle, the puncture needle is withdrawn and the guidewire is inserted through the delivery catheter into the covered stent.

[0057] 7) Insert the guidewire and simultaneously remove the puncture needle and delivery catheter.

[0058] 8) Insert the balloon catheter through the sheath along the guidewire and dilate the balloon to enlarge the covered stent window to the expected diameter.

[0059] 9) Insert the guidewire, remove the balloon catheter, and then remove the adjustable curved sheath with side holes for later use.

[0060] 10) Insert the snare from another branch vessel, such as the brachial artery or the contralateral femoral artery, and capture the guidewire tip with the snare.

[0061] 11) Pull the guidewire out from the entrance of the other branch vessel.

[0062] 12) Insert the adjustable bend sheath with side holes again along the guidewire from another branch vessel until the tip of the sheath is fixed between the covered stent and the aortic vessel wall.

[0063] 13) Push, pull, and rotate the sheath to position the side holes of the sheath so that they are aligned with the branch vessels.

[0064] 14) Withdraw the guidewire and insert another guidewire through the sheath and out through the side hole of the sheath into the branch vessel.

[0065] 15) Fix the guidewire, withdraw the sheath to the covered stent, and advance the branch covered stent to the branch vessel through the sheath along the guidewire. The branch covered stent is released from the branch vessel to the inside of the aortic covered stent to form a closed passage.

[0066] 16) Remove all instruments; the surgery is complete.

[0067] For cases where the lesion involves all four branches of the abdominal aorta, the operation diagram is as follows: Figure 8 The process is basically the same as shown. The specific operation procedure is as follows: 1) Insert the adjustable curved sheath kit with side holes (including the sheath tube and the expander in the sheath tube lumen), and once in place, remove the expander.

[0068] 2) The adjustable bending sheath can be bent to allow the sheath to be inserted into the branch vessel and positioned so that the side hole faces the aorta.

[0069] 3) Insert and release the aortic endovascular stent graft.

[0070] 4) Insert the puncture needle and delivery catheter assembly through the adjustable curved sheath and exit through the side hole.

[0071] 5) Secure the delivery catheter and push the puncture needle to puncture the covered stent; if it is a laser fiber cable, use the laser to puncture the covered stent and insert it. If it is a solid puncture needle or a laser fiber cable, the delivery catheter must also be inserted into the covered stent along the puncture needle.

[0072] 6) If it is a hollow puncture needle, the guidewire is inserted through the puncture needle until it enters the covered stent; if it is a solid puncture needle, the puncture needle is withdrawn and the guidewire is inserted through the delivery catheter into the covered stent.

[0073] 7) Insert the guidewire and simultaneously remove the puncture needle and delivery catheter.

[0074] 8) Insert the balloon catheter through the sheath along the guidewire and dilate the balloon to enlarge the covered stent window to the expected diameter.

[0075] 9) Withdraw the balloon catheter, then withdraw the guidewire into the sheath, and then withdraw the adjustable curved sheath with side holes. At this point, the covered stent window coincides with the branch vessel orifice.

[0076] 10) Push an adjustable sheath with side holes into the lumen of the covered stent. With the help of the adjustment, send the guidewire out from the main lumen end of the sheath and through the covered stent window into the branch vessel.

[0077] 11) The branch covered stent is inserted through the sheath along the guidewire into the branch vessel. The branch covered stent is released from the branch vessel to the inside of the aortic covered stent to form a closed passage.

[0078] 12) Remove all instruments; the surgery is complete.

[0079] In some optional embodiments, the proximal end of the adjustable bend and the distal end of the side hole are spaced apart, the interval being greater than 0 mm and less than 10 mm. For example... Figure 12 and 13 In the illustrated embodiment, the sheath mainly comprises an adjustable bend 401 and a main body 402. The inner diameter of the sheath ranges from 1.7mm to 3mm (5Fr-9Fr). The side hole on the sheath is approximately elliptical, with its major axis along the axial direction of the sheath. The width of the minor axis of the side hole is essentially the same as the inner diameter of the sheath, thus ensuring that the passage of instruments within the side hole is consistent with the passage of the sheath's inner lumen. Preferably, the length of the major axis of the side hole is 1.2-3 times the length of the minor axis. In some embodiments, the length of the adjustable bend of the sheath is 15-50mm, and the side hole is spaced apart from the proximal end of the adjustable bend by a distance D. The distal starting point of distance D is shown below. Figure 12 Reference line 403 is used, with the reference point near the proximal end selected as the distal end of the side hole, and the interval distance D is 0-10mm. In some other embodiments, the distance between the side hole and the distal end face of the sheath is 15-300mm. Under this setting, the side hole remains essentially undeformed in the bending state, such as... Figure 13 As shown, this ensures that the instrument inside the sheath can pass smoothly through the side hole. In some other embodiments, the adjustable bend can be located in the middle of the sheath, meaning that both the distal and proximal ends of the adjustable bend are connected to non-adjustable bends. For example... Figure 14 As shown, the portion between the two reference boundaries 404 is the adjustable bending section, while the portions beyond the far and near ends of the boundaries are non-adjustable bending sections. The bending state is as follows: Figure 15 As shown. Figure 14 and 15 As shown, when the distal end of the adjustable bending section of the sheath is provided with a non-adjustable bending section, the non-adjustable bending section is a highly compliant section with a polymer material hardness between 50A and 35D. The internal reinforcement structure is mainly spring-based, thereby achieving axial flexibility and circumferential compressive strength.

[0080] In some optional embodiments, such as Figure 16 and 17 As shown, the covered stent fenestration device includes a pull wire assembly 503, which controls the bending state of the adjustable section. The pull wire assembly is disposed inside the sheath and is positioned opposite to the side hole. In practice, the adjustable section of the sheath is typically bent by the pull wire assembly. To fully expose the side hole for the puncture component to pass through, the side hole is oriented on the opposite side of the adjustable bending direction; that is, the pull wire assembly in the bending assembly is positioned on the side without the side hole. This relative arrangement ensures that the pull wire assembly pulls the adjustable section away from and bends it away from the side hole, thus fully preserving and aligning the side hole towards the covered stent side.

[0081] In some optional embodiments, the interior of the sheath is at least partially provided with a reinforcing layer, and the side holes are at least partially disposed on the reinforcing layer. For example... Figure 16 and 17 As shown, one structural configuration of the side hole 102 is formed by drilling a hole in the side wall of the sheath. In some embodiments, the sheath wall comprises a PTFE liner 501, a reinforcing layer 506, and a polymer material layer 505. The reinforcing layer is a metal braided wire, a spring, or a combination of braided wire and a spring. During the drilling process, the hole needs to penetrate the liner, the reinforcing layer, and the polymer material layer. Preferably, the reinforcing layer and the polymer material layer are mixed together.

[0082] In some optional embodiments, such as Figure 17 As shown, a side hole 504 is provided inside the sheath, and the side hole is at least partially provided on the side hole component; the side hole component is provided with a receiving groove to at least partially accommodate the pull wire assembly. To ensure that the side hole has sufficient strength to guarantee the passage of instruments within the sheath, a metal material is chosen to make the side hole component. Figure 17 As shown, the side hole component has a relatively short axial length, and its two ends are respectively connected to the braided or spring-like reinforcing layer of the sheath tube. Preferably, the sheath tube reinforcing layer can be welded to the side hole component to increase the connection strength. Preferably, in addition to having a side hole, the side hole component has a groove 601 on the opposite side of the side hole, which provides space for the pull wire assembly to pass through.

[0083] In some optional embodiments, the side hole member is provided with a notch or groove, and the sheath is at least partially embedded in the notch or groove to enhance the connection strength between the side hole member and the polymer material. For example... Figures 19 to 22 As shown, the side hole component is provided with multiple notches or grooves. When it is integrally formed with the polymer material by hot melting, the polymer material can fully contact the notches or grooves, increase the contact area, and thus improve the connection strength between the two.

[0084] In some optional embodiments, such as Figure 16 and 17 As shown, it also includes a developing element 502, which is positioned near the distal and proximal ends of the side hole, meaning the developing element is not positioned on the side hole element. For example... Figure 23 As shown in Figure 24, the developing element can be an O-shape 701 or a C-shape 702 (the opening of the C-shape faces the same direction as the side hole), and is respectively disposed at both ends of the side hole to monitor the position of the side hole. For example, the position of the side hole can be obtained by monitoring the developing element with an X-ray machine. Optionally, the side hole element itself can be developed, for example, made of materials such as stainless steel or nickel-titanium alloy. Of course, the side hole element of this type has weak developability. Preferably, the side hole element can be further made of materials with high developability such as tungsten, tantalum, platinum, gold, or platinum alloy. Preferably, the developing element is an additional developing unit, disposed on the side hole element, and distributed around the side hole; thereby enabling precise monitoring of the position of the side hole. Figure 25 As shown, multiple mounting holes 801 are provided around the side holes, and metal wires 802, such as those made of tantalum, platinum, gold, or platinum alloys, can be wound into the mounting holes. Alternatively, developing material 803 can be embedded or welded into the mounting holes.

[0085] The specific embodiments described above do not constitute a limitation on the scope of protection of this invention. Those skilled in the art, after considering the specification and practicing the technical solutions disclosed in this application, will readily conceive of other embodiments of this disclosure. This application is intended to cover any variations, uses, or adaptations of this disclosure that follow the general principles of this disclosure and include common knowledge or customary technical means in the art not disclosed in this disclosure. The specification and embodiments are considered exemplary only, and the true scope and spirit of this disclosure are indicated by the following claims.

[0086] It should be understood that this disclosure is not limited to the precise structures described above and shown in the accompanying drawings, and various modifications and changes can be made without departing from its scope. The scope of this disclosure is limited only by the appended claims.

Claims

1. A film-coated support window opening device, characterized in that: include: The sheath includes an adjustable bend section and a main body section. The adjustable bend section is located at the distal end of the main body section, and a side hole is provided on the side wall of the distal end of the main body section near the adjustable bend section. A puncture assembly, wherein the puncture assembly is disposed within the sheath and extends along the axial direction of the sheath; In the working state, the distal end of the puncture component at least partially protrudes through the side hole and opens a window on the covered support.

2. The film-coated bracket window opening device according to claim 1, characterized in that, The aforementioned film-coated bracket window opening device also includes a bending adjustment handle; In operation, the bending handle controls the bending shape of the adjustable section and makes it at least partially abut against the covered stent or at least partially abut against the branch blood vessel, so as to provide positioning support for the fenestration process of the puncture component.

3. The film-coated bracket window opening device according to claim 1, characterized in that, The hardness of the material used to manufacture the adjustable bending section is less than the hardness of the material used to manufacture the main body section.

4. The film-coated bracket window opening device according to claim 1, characterized in that, The puncture assembly includes a delivery catheter and a hollow puncture needle placed within the delivery catheter, wherein both the distal end of the delivery catheter and the hollow puncture needle have a pre-bent shape; or, The puncture assembly includes a hollow puncture needle, which has a pre-bent shape; or, The puncture assembly includes a delivery catheter and a solid puncture needle placed within the delivery catheter, wherein both the distal end of the delivery catheter and the solid puncture needle have a pre-bent shape; or, The puncture assembly includes a delivery catheter and a laser cable placed inside the delivery catheter, the distal end of which has a pre-bent shape.

5. The film-coated bracket window opening device according to claim 4, characterized in that, The hollow or solid puncture needle is made of metal and is pre-bent and shaped.

6. The film-coated bracket window opening device according to claim 4, characterized in that, The distal end of the delivery catheter has a tapered outer contour, and the distal end of the delivery catheter is connected to the outer surface of the solid puncture needle through the tapered shape, so that the delivery catheter follows the solid puncture needle through the covered stent during the fenestration process.

7. The film-coated bracket window opening device according to claim 1, characterized in that, The puncture assembly includes a delivery catheter and a hollow puncture needle placed within the delivery catheter. The distal end of the delivery catheter is controllably bendable, and the distal end of the hollow puncture needle is at least partially flexible; or, The puncture assembly includes a delivery catheter and a solid puncture needle placed within the delivery catheter, wherein the distal end of the delivery catheter is controllably bendable, and the distal end of the solid puncture needle is at least partially flexible; or, The puncture assembly includes a delivery conduit and a laser cable placed inside the delivery conduit, the distal end of which can be controlled to be bent.

8. The film-coated bracket window opening device according to claim 7, characterized in that, The hollow puncture needle, which is at least partially flexible, and the solid puncture needle, which is at least partially flexible, are made of metallic material and are at least partially heat-treated so that the stiffness of that part is less than the stiffness of the other parts of the puncture needle.

9. The film-coated bracket window opening device according to claim 1, characterized in that, The adjustable bend is spaced apart from the proximal end to the distal end of the side hole, with the interval being greater than 0 mm and less than 10 mm.

10. The film-coated bracket window opening device according to claim 1, characterized in that, The film-covered bracket window opening device includes a pull wire assembly, which is used to control the bending state of the adjustable bending section; The pull wire assembly is disposed inside the sheath tube and is positioned opposite to the side hole.

11. The film-coated bracket window opening device according to claim 1, characterized in that, The sheath has at least a partially reinforced layer inside, and the side holes are at least partially located on the reinforced layer.

12. The film-coated bracket window opening device according to claim 10, characterized in that, The sheath is provided with a side hole, and the side hole is at least partially provided on the side hole. The side hole is provided with a receiving groove to at least partially accommodate the pull wire assembly.

13. The film-coated bracket window opening device according to claim 12, characterized in that, The sheath is provided with a reinforcing layer, and the distal and proximal ends of the side hole are respectively connected to the reinforcing layer.

14. The film-coated bracket window opening device according to claim 12, characterized in that, The side hole is provided with a notch or groove, and the sheath is at least partially embedded in the notch or groove to enhance the connection strength between the side hole and the sheath.

15. The film-coated support window opening device according to any one of claims 1 to 14, characterized in that, It also includes a developing element, which is disposed near the distal and proximal ends of the side hole; or, the developing element is disposed on the side hole element and distributed around the side hole.

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