A covered stent system

Abstract

This invention provides a covered stent system, including a delivery system and an integrated stent module. The integrated stent module includes a main covered stent with a fenestration. The delivery system includes a fixation component, an outer tube, a bending adjustment component, a beam diameter component, and a tip-end capture component. The bending adjustment component includes a bending adjustment line, which, by pulling the bending adjustment line, can adjust the bending shape of the delivery system to conform to the curvature of the blood vessel and prevent bird-beak phenomenon. The beam diameter component includes a beam diameter lever and a beam diameter wire for radially restraining the stent. The tip-end capture component includes claws and a post-release wire for capturing the proximal end of the stent. The delivery system is configured to: withdraw the outer tube to put the stent in a semi-released state; adjust the bending shape and axial position to align the fenestration with the target blood vessel; release the beam diameter restraint and then release the proximal end of the stent. This invention achieves precise stent positioning, good wall apposition, and convenient branch superselection, significantly improving surgical safety and success rate.

Description

Technical Field

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

[0002] The aortic arch region is composed of the ascending aorta 31, brachiocephalic artery 32, left common carotid artery 33, left subclavian artery 34, and descending aorta 35. (See also: [link to relevant documentation]) Figure 1 As shown.

[0003] Aortic dissection is a serious cardiovascular emergency. Please refer to [link / reference]. Figure 2 As shown, aortic dissection is a disease caused by bleeding within the aortic wall, resulting in damage to the media of the blood vessel, leading to the separation of the vessel walls and the subsequent formation of a true lumen 36 and a false lumen 37 that may be interconnected or not. In most cases, aortic dissection begins with a tear in the intima, through which blood enters the media 38, eventually leading to aortic rupture or re-entry into the true lumen through a second tear in the intima.

[0004] For aortic dissection involving the aortic arch, the current gold standard of treatment is total aortic arch replacement surgery. This surgery is highly invasive, requiring a median thoracotomy followed by removal of the diseased vessel under cardiopulmonary bypass, and subsequent procedures... Figure 3 The artificial blood vessel and the autologous blood vessel are sutured at the five locations shown (41 at the ascending aorta, 42 at the brachiocephalic artery, 43 at the left common carotid artery, 44 at the left subclavian artery, and 45 at the descending aorta).

[0005] However, due to the high mortality and complication rates of surgical total aortic arch replacement, transcatheter endovascular aortic arch repair has become an alternative treatment option in recent years, thanks to advancements in endovascular techniques. This is particularly suitable for patients with high surgical risks or contraindications to surgery. Please refer to... Figure 4 As shown, this technique involves implanting a main covered stent 21 and branch covered stents 22 via a catheter. The main covered stent 21 has openings 2121 corresponding to the branches of the three aortic arch.

[0006] However, transcatheter intravascular aortic arch repair still faces three major technical challenges: first, type Ia endoleak caused by the bird's beak phenomenon; second, the precise positioning of the main covered stent; and third, the overselection of branch vessels.

[0007] (1) Bird beak phenomenon In some patients with aortic arch dissection, the ascending aorta has severe tortuosity, making it prone to non-apposition after the main covered stent is deployed, especially on the lesser curvature side. Please refer to [link to relevant documentation]. Figure 5 As shown, there is a certain gap between the main covered stent and the aorta 5, a phenomenon known as the "beak phenomenon".

[0008] The main dangers of the "bird's beak" phenomenon are: blood may flow into the gap, causing type Ia endoleak, leading to continuous blood entering the false lumen, increasing the risk of reoperation, and potentially even causing rupture of a large blood vessel or recurrent arterial dissection. Furthermore, the bird's beak phenomenon may also lead to decreased stent stability, increasing the risk of stent migration.

[0009] (2) Difficulty in precise positioning The ascending aorta, being close to the heart, is subjected to the high-speed blood flow impact from the left ventricle, resulting in significantly higher arterial impact force and blood flow pressure compared to the distal segment. During peak systolic flow, newly deployed stents experience even stronger blood flow impact. Simultaneously, the morphological and blood flow dynamic changes in the aorta caused by cardiac systole and diastole further increase the positioning instability during stent deployment.

[0010] If the main covered stent 21 is not positioned accurately, it will cause a deviation between the stent fenestration 2121 and the branch artery, which will lead to a series of problems: First, it will increase the difficulty of superselection of the branch artery, and long-term superselection operation may cause plaque to detach from the vessel wall and cause cerebral infarction; second, it may cause stenosis of the branch covered stent, affecting the blood supply to the brain; third, serious positioning deviation may even lead to failure of branch vessel reconstruction, and the patient may need to be converted to open-chest surgery.

[0011] (3) Branch overselection difficulty A normal aortic arch contains three branch vessels. Even if one of the openings 2121 on the main covered stent 21 is aligned with one branch vessel, considering the differences in vascular anatomy among individuals, there may still be axial or circumferential deviations between the other two openings 2121 and the other two branch vessels, thus increasing the difficulty of superselection of branch arteries. Superselection refers to the process by which physicians use guidewires and catheters to enter the target branch vessel from the main trunk. Prolonged superselection procedures may lead to plaque detachment from the vessel wall, causing cerebral infarction.

[0012] In summary, existing transcatheter intravascular aortic arch repair techniques have significant shortcomings in terms of stent apposition, precise positioning, and branch superselection. There is an urgent need for a novel covered stent system that can simultaneously solve these three major technical challenges. Summary of the Invention

[0013] In view of the above-mentioned shortcomings of the prior art, the purpose of the present invention is to provide a film-coated stent system to solve the technical problems of poor stent adhesion leading to bird beak phenomenon, difficulty in precise stent positioning, and difficulty in branch overselection in the prior art.

[0014] To achieve the above and other related objectives, the present invention provides a covered stent system, comprising: Conveying system; and An integrated support module, which is releasably mounted on the delivery system, includes a main film-coated support having at least one window. The conveying system includes: Fixed components; The outer tube is axially slidably sleeved on the outside of the fixing component; A bending adjustment assembly includes a bending adjustment line, the distal end of which is connected to the distal end of the fixing assembly. The bending shape of the conveying system can be adjusted by pulling the bending adjustment line toward the proximal end. A beam diameter assembly includes a beam diameter tie rod and a beam diameter wire, wherein the beam diameter wire is releasably wound between the main body covering support and the beam diameter tie rod for radially binding the main body covering support; The head-end grasping assembly includes a claw and a rear release wire, the claw being slidably mounted on the fixing assembly for releasably grasping the proximal end of the main body covered support.

[0015] In one embodiment of the present invention, the conveying system is configured as follows: First, remove the outer tube, so that the support is in a semi-released state where it is restrained by the beam diameter assembly and its proximal end is captured by the head end capture assembly. In the semi-released state, the bending shape and axial position of the delivery system can be adjusted to align the window with the target blood vessel; After confirming alignment, the restraint of the beam diameter assembly can be released first, and then the head-end grasping assembly can be operated to release the proximal end of the support.

[0016] In one embodiment of the present invention, a pre-embedded guide wire is further included. The pre-embedded guide wire is integrated with the main film-coated support to form the integrated support module. The pre-embedded guide wire has a distal end and a proximal end. The distal end is fixed to the main film-coated support by a pre-embedded guide wire fixing member in the loaded state. Furthermore, the main film-coated support, with the pre-embedded guide wire fixed thereon, is integrally formed into an integrated support module and loaded into the film-coated support delivery system, wherein: In the loading and conveying states: the pre-embedded guide wire and the main film-coated support are radially constrained together in the outer tube; and the pre-embedded guide wire starts from the fixing point of the pre-embedded guide wire and passes through the opening into the internal cavity of the main film-coated support, then extends along the internal cavity towards the proximal end and passes into the fixing component, and finally exits from the proximal end of the film-coated support conveying system.

[0017] In one embodiment of the present invention, when the outer tube is removed and the main film-coated support is in a semi-released state bound by the beam diameter assembly: The distal end of the pre-embedded guidewire is held on the main film-covered bracket by the pre-embedded guidewire fixing member, and its main body is held to pass through the opening and extend proximally along the internal cavity into the fixing component.

[0018] In one embodiment of the present invention, after the main covered stent is completely released and the covered stent delivery system is removed from the body: The distal end of the pre-embedded guidewire is held on the main covered stent by the pre-embedded guidewire fixation member. Its main body is held through the opening and then extends distally along the internal cavity of the main covered stent, finally exiting from the distal end of the main covered stent and extending outside the body, thereby forming a guide track from outside the body through the internal cavity of the main covered stent, through the opening and pointing to the opening of the target branch blood vessel.

[0019] In one embodiment of the present invention, the bending assembly further includes a bending diameter adjustment wire, which is wound around the main film-coated support and the diameter adjustment rod, and constrains the bending line therein to limit the spatial position of the bending line during the bending process.

[0020] In one embodiment of the present invention, the bending assembly further includes a bending ring, which is sleeved on the bundle diameter wire, and the bending line passes through the bending ring to constrain the path of the bending line.

[0021] In one embodiment of the invention, the bending line passes through part or all of the bundle diameter wire to constrain the path of the bending line using the bundle diameter wire.

[0022] In one embodiment of the present invention, the bending line is made of metal and has a coating on its surface.

[0023] In one embodiment of the present invention, the bending line includes an inner metal core and a polymer material layer covering the outer surface of the inner metal core, wherein the outer surface of the polymer material layer is provided with a coating.

[0024] In one embodiment of the present invention, the fixing component includes: A conical head is disposed at the distal end of the fixing component, and its outer surface has a hydrophilic coating; The claw head receiver has several blind holes for receiving the beam diameter pull rod of the beam diameter assembly and the claw wire of the head end grasping assembly. A chuck with several through holes for the passage of the jaw wires; The inner core tube is a cylindrical, thin-walled tube with an internal lumen for the passage of the guide wire. The middle tube is sleeved outside the inner core tube and has several through holes for the passage of the bending line, the diameter tie rod and the rear release wire.

[0025] In one embodiment of the present invention, the beam diameter assembly further includes an anti-torsion structure disposed on the beam diameter tie rod and aligned axially with the opening of the main body film-coated bracket; the anti-torsion structure is used to radially constrain the beam diameter tie rod and the inner core tube to prevent the main body film-coated bracket from circumferentially rotating.

[0026] In one embodiment of the present invention, the beam diameter assembly further includes an anti-drift structure, which is disposed on the small bend side of the proximal end and / or distal end of the main body film-coated support; the anti-drift structure is an annular closed-loop structure, used to sleeve and constrain the beam diameter wire to prevent the beam diameter wire from drifting out of the main body film-coated support after being unconstrained.

[0027] In one embodiment of the present invention, the head-end grasping assembly further includes a claw wire, which is a U-shaped metal wire, with its distal end fixed to the claw and its proximal end slidably passing through the through hole of the chuck and fixed to the rear release wire; The post-release wire is configured such that when the post-release wire is pulled proximally, it causes the claw wire and the claw to move proximally, thereby releasing the proximal end of the main covered stent.

[0028] In one embodiment of the present invention, the main film-coated support includes: The proximal support is a wavy support ring, part of which is fixed to the membrane and part of which is free from the membrane, for use in conjunction with the head-end capture assembly; The coating is a cylindrical thin film structure with the aforementioned openings on it; At least one other support, a corrugated support ring, is fixed to the membrane to provide radial support force.

[0029] In one embodiment of the present invention, the number of waves of the proximal end support is greater than or equal to the number of claw wires of the head end grasping assembly.

[0030] In one embodiment of the present invention, the number of waves in the proximal stent is twice the number of the claw wires.

[0031] In one embodiment of the present invention, in the semi-released state, the diameter of the main body covering support bound by the beam diameter assembly is 20% to 60% of the fully extended diameter.

[0032] Compared with the prior art, the present invention has the following beneficial effects: Effectively preventing the "bird's beak" phenomenon and reducing the risk of endoleaks: This invention incorporates a bending adjustment component, with the distal end of the bending adjustment line connected to the distal end of the fixation component. The surgeon can actively adjust the curvature of the delivery system by pulling the bending adjustment line proximally, conforming it to the natural shape of curved blood vessels such as the aortic arch. This active bending adjustment design ensures that the main covered stent adheres tightly to the lesser curvature of the blood vessel after deployment, fundamentally eliminating the gap formed by the "bird's beak," effectively preventing type Ia endoleaks, and reducing the reoperation rate and the risk of vascular rupture.

[0033] Achieving precise positioning and ensuring accurate alignment of the fenestration with the branch vessel: This invention achieves a step-by-step, controllable release process of "partial release - adjustment - complete release" through the coordinated design of the bundle diameter component and the tip-end grasping component. After the external catheter is removed, the stent is in a semi-restrained state (approximately 20%-60% of its fully deployed diameter) bound by the bundle diameter component. Partial blood flow can pass through the stent lumen, significantly reducing the impact force of blood flow and providing the surgeon with a valuable adjustment window. In this state, the surgeon can easily adjust the axial position of the delivery system and ensure circumferential alignment of the fenestration with the branch vessel through the anti-torsion structure. After confirming the position is correct, the bundle diameter restraint is first released to allow the stent body to unfold, and then the proximal end of the stent is controllably released using the tip-end grasping component, effectively preventing "forward jump" displacement of the stent at the moment of release. This design ensures precise alignment of the fenestration with the branch vessel opening, ensuring blood supply to the brain and reducing the risk of surgical failure.

[0034] This invention significantly simplifies branch superselection, shortens surgical time, and reduces complications: Through a pre-embedded guidewire design, the pre-embedded guidewire and the main covered stent are integrated into a single integrated stent module. In the loaded state, the pre-embedded guidewire passes through the fenestration and extends proximally along the internal lumen of the stent into the delivery system. After the stent is fully released, the pre-embedded guidewire extends distally along the internal lumen of the stent to the outside, forming a ready-made guide track from outside the body, through the internal lumen of the stent, through the fenestration, and towards the opening of the target branch vessel. The surgeon only needs to push the catheter along the pre-embedded guidewire to quickly complete superselection, completely avoiding the time-consuming and high-risk repeated trial-and-error operations of traditional procedures. This design significantly shortens branch superselection time, reduces the risk of cerebral infarction caused by plaque detachment, and improves the overall surgical success rate and long-term patency.

[0035] Multiple safety features reduce the risk of vascular injury: This invention provides various bending wire restraint schemes (bending wire bundle, bending ring, and threading wire bundle), which can effectively restrict the spatial position of the bending wire during the bending process, preventing sharp bending wires from cutting or damaging the vessel wall and stent cover. At the same time, the anti-drift structure prevents the wire bundle from drifting out of the stent after being unrestrained, avoiding it becoming a foreign object or affecting stent apposition.

[0036] Highly controllable and with a short learning curve: The step-by-step release logic of this invention is clear and the operation steps are well-defined. The surgeon can adjust the position and angle at will in the semi-release state without having to perform high-risk operations under high-speed blood flow impact, which reduces the dependence of the surgery on the surgeon's operating skills and shortens the learning curve. Attached Figure Description

[0037] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0038] Figure 1 This is a schematic diagram of a normal aorta.

[0039] Figure 2 This is a schematic diagram of aortic dissection.

[0040] Figure 3 This is a schematic diagram of a total arch replacement surgery.

[0041] Figure 4 This is a schematic diagram of transcatheter intravascular aortic arch repair implantation.

[0042] Figure 5 This is a diagram of a bird's beak.

[0043] Figure 6 This is a cross-sectional view of the film-coated support delivery system in this invention.

[0044] Figure 7 for Figure 6 Enlarged diagram of point B in the middle.

[0045] Figure 8 for Figure 6 Enlarged diagram of point C in the middle.

[0046] Figure 9 This is a schematic diagram of the fixing component in this invention.

[0047] Figure 10 for Figure 9 Enlarged diagram of point A in the middle.

[0048] Figure 11 for Figure 9 Enlarged diagram of point B in the middle.

[0049] Figure 12 This is a schematic diagram of the beam diameter assembly in this invention.

[0050] Figure 13 This is a schematic diagram of the head-end capture component in this invention.

[0051] Figure 14 This is a schematic diagram of the pre-embedded guide wire assembly in this invention.

[0052] Figure 15 A schematic diagram for aligning the left common carotid artery and the fenestration.

[0053] Figure 16 This is a schematic diagram illustrating the first step of releasing the outer tube after its retraction.

[0054] Figure 17 A schematic diagram illustrating the bending process by pulling the bending line.

[0055] Figure 18 Example 1 shows the morphology of the bending line in a blood vessel, that is, a schematic diagram of the bending line being constrained by the bending bundle diameter wire.

[0056] Figure 19 Example 2 shows the morphology of the bending line in a blood vessel, that is, a schematic diagram of the bending line being constrained by the bending ring.

[0057] Figure 20 Example 3 shows the morphology of the bending line in a blood vessel, that is, a schematic diagram of the bending line being constrained by a portion of the bundle diameter wire.

[0058] Figure 21 This diagram illustrates the second step of releasing the pull rod after retracting it.

[0059] Figure 22 This is a schematic diagram illustrating the final release of the main film-coated scaffold after the retraction and release filaments.

[0060] Figure 23 A schematic diagram illustrating the superselection process performed by delivering the conduit along the pre-embedded guide wire.

[0061] Figure 24 A schematic diagram of a branched covered stent implanted. Detailed Implementation

[0062] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

[0063] It should be noted that the illustrations provided in this embodiment are only schematic representations of the basic concept of the present invention. Therefore, the drawings only show the components relevant to the present invention, and are not drawn according to the number, shape and size of the components in actual implementation. In actual implementation, the form, quantity and proportion of each component can be arbitrarily changed, and the layout of the components may also be more complex.

[0064] This embodiment provides a covered scaffold system. Please refer to [link / reference]. Figures 6 to 8 As shown, it includes a conveying system 1 and an integrated support module.

[0065] The integrated support module is releasably loaded into the delivery system 1. The integrated support module includes a main film-coated support 21 having at least one opening 2121.

[0066] The conveying system 1 includes a fixing component 11, an outer tube 12, a bending component 13, a beam diameter component 14, and a head-end capture component 15.

[0067] The fixation assembly 11 remains relatively fixed during stent release, providing a track for axial movement of other movable components. The fixation assembly 11 includes a conical head 111, a claw head receiver 112, a chuck 113, an inner core tube 114, and a central tube 115. The conical head 111, located at the distal end of the fixation assembly 11, has a streamlined conical design and a hydrophilic coating on its outer surface to reduce the risk of injury when the delivery system passes through tortuous blood vessels. The claw head receiver 112 has several blind holes 1121 for receiving the bundle diameter pull rod 141 and the claw wire 152. The chuck 113 has several through holes 1131 for the passage of the claw wire 152. The inner core tube 114 is a cylindrical thin-walled tube with an internal lumen for the passage of a guidewire. The middle tube 115 is sleeved outside the inner core tube 114, and has several through holes 1151 for passing through the bending line 131, the diameter tie rod 141 and the rear release wire 153.

[0068] The outer tube 12 is axially slidably fitted onto the outside of the fixation assembly 11. The outer tube 12 is used to constrain the integrated stent module within its lumen, protecting the stent and preventing damage to the blood vessel during delivery. The first release of the main covered stent 21 can be completed when the outer tube 12 is withdrawn proximally.

[0069] The bending adjustment component 13 includes a bending adjustment line 131. The distal end of the bending adjustment line 131 is connected to the distal end of the fixation component 11. Specifically, the bending adjustment line 131 is a double-stranded line formed by folding a single thread in half, with the folded end passing through the claw wire 152 between the claw head receiver 112 and the chuck 113. By pulling the bending adjustment line 131 proximally, the bending shape of the delivery system 1 can be adjusted to better conform to the natural shape of curved blood vessels such as the aortic arch, thereby optimizing the wall adhesion of the main covered stent 21 after release and reducing the occurrence of the bird's beak phenomenon. The bending adjustment line 131 is made of metal with a coating on its surface. Specifically, the bending adjustment line 131 can be made of stainless steel, nickel-titanium alloy, or other metal materials with good mechanical properties and biocompatibility. The metal bending adjustment line 131 has high tensile strength and fatigue resistance, and can withstand repeated traction during surgery without breaking or plastic deformation.

[0070] Furthermore, the bending line 131 includes an inner metal core and a polymer material layer covering the outer surface of the inner metal core, and the outer surface of the polymer material layer is provided with a coating.

[0071] Specifically, the internal metal core material can be made of stainless steel, nickel-titanium alloy, or other metallic materials to provide sufficient tensile strength and fatigue resistance. A polymer material layer, such as polytetrafluoroethylene, polyimide, or polyurethane, coats the outer surface of the internal metal core. This polymer material layer improves the biocompatibility of the bending line 131, reducing mechanical irritation to the blood vessel wall; it also provides a good adhesion substrate for the coating.

[0072] The beam diameter assembly 14 includes a beam diameter tie rod 141 and a beam diameter wire 142. The beam diameter wire 142 is releasably wound between the main body coating support 21 and the beam diameter tie rod 141 for radially binding the main body coating support 21. The beam diameter tie rod 141 is made of metal, and the beam diameter wire 142 is made of polymer material. Figure 12 An example of a winding method is shown, in which the left end of the bundle diameter wire 142 is fixed to the film-coating bracket 21 by a knot and wound around the main film-coating bracket 21 and the bundle diameter tie rod 141 in a certain way, and the right end is fixed to the bundle diameter tie rod 141 by a knot.

[0073] The head-end gripping assembly 15 includes a claw 151 and a rear release wire 153. The claw 151 is slidably mounted on the fixing assembly 11 for releasably gripping the proximal end of the main body coating support 21. The head-end gripping assembly 15 also includes a claw wire 152, which is a U-shaped metal wire. Its distal end is fixed to the claw 151, and its proximal end slidably passes through the through hole 1131 of the chuck 113 and is fixed to the rear release wire 153. By retracting the rear release wire 153, the claw 151 and the claw wire 152 can be retracted, completing the unlocking and release of the proximal end of the main body coating support 21.

[0074] The main membrane support 21 includes a proximal support 211, a membrane 212, and at least one other support 213. The proximal support 211 is a corrugated support ring, partially fixed to the membrane 212 and partially free from the membrane 212, for engagement with the head-end grasping assembly 15. The membrane 212 is a cylindrical thin film structure with openings 2121. The other support 213 is a corrugated support ring, fixed to the membrane 212, for providing radial support force.

[0075] In this embodiment, the conveying system 1 is configured to release according to the following steps: First, the outer tube 12 is removed, leaving the stent 21 in a semi-released state, bound by the bundle diameter assembly 14 and with its proximal end held by the apical grappling assembly 15. Specifically, while keeping the fixation assembly 11 stationary in the blood vessel, the outer tube 12 is withdrawn proximally. At this point, the main covered stent 21 is no longer bound by the outer tube 12, but remains radially bound by the bundle diameter wire 142 of the bundle diameter assembly 14, and its proximal stent 211 is still held by the clasps 151 of the apical grappling assembly 15. In this semi-released state, some blood flow can pass through the lumen of the main covered stent 21, reducing the impact of blood flow on the delivery system 1.

[0076] Understandably, the outer tube 12 binds the main covered stent 21 within its lumen, enabling the main covered stent 21 to be delivered to the designated location without damaging the blood vessels along the route. Secondly, when it moves proximally (i.e., in the external direction, and the opposite direction is distal, i.e., in the direction of the conical head 111) along the axis of the fixation component, the main covered stent 21 can be released for the first time. At this point, the main covered stent 21 is no longer bound by the outer tube 12, but is still bound by the bundle diameter component 14, and its proximal stent 211 is still bound by the head-end capture component 15.

[0077] After the outer tube 12 is retracted, the bundle diameter assembly 14 still binds the main covered stent 21. At this time, the main covered stent 21 is in a semi-bound state, with its diameter larger than the inner diameter of the outer tube 12 but smaller than its fully deployed diameter. Optionally, the diameter in the semi-bound state is 20% to 60% of the fully deployed diameter. In this semi-bound state, some blood flow can pass through the lumen of the main covered stent 21, thereby reducing the impact force of blood flow on the covered stent delivery system 1, making the stent less prone to displacement during subsequent deployment. At the same time, in this state, the axial position of the covered stent delivery system 1 can still be adjusted to increase the positioning accuracy of the main covered stent 21 after deployment.

[0078] Secondly, in the semi-released state, the curvature and axial position of the delivery system 1 can be adjusted to align the fenestration 2121 with the target vessel. Specifically, by pulling the bending line 131 proximally, the distal end of the delivery system 1 is bent to adapt to the shape of curved vessels such as the aortic arch; at the same time, since the blood flow impact force is reduced in the semi-released state, the operator can easily fine-tune the axial position of the delivery system 1 to ensure that the fenestration 2121 is precisely aligned with the branch vessel opening.

[0079] Understandably, the distal end of the bending line 131 is bound between the claw head receiver 112 and the chuck 113 by the claw wire 152. By pulling its proximal end, the bending degree of the covered stent delivery system 1 can be adjusted during the release of the main covered stent 21, so that it fits the bending shape of the aortic arch better, thereby optimizing the wall adhesion of the main covered stent 21 after release and reducing the occurrence of bird beak phenomenon.

[0080] Finally, after confirming alignment, the restraints on the beam diameter assembly 14 can be released first, and then the head-end grasping assembly 15 can be operated to release the proximal end of the stent 21. Specifically, the beam diameter lever 141 is pulled back proximally to release the restraints on the main covered stent 21 by the beam diameter wire 142, allowing the main body of the main covered stent 21 to expand radially and adhere tightly to the vessel wall; then, the release wire 153 is pulled back proximally, causing the claws 151 and claw wire 152 to retract, releasing the proximal stent 211 of the main covered stent 21, so that the main covered stent 21 is completely separated from the delivery system 1, completing the complete release.

[0081] Understandably, after confirming the bending angle and position of the covered stent delivery system 1, the pull rod 141 is pulled towards the proximal end to complete the second release of the main covered stent 21. At this time, the main covered stent 21 has been fully deployed, except that its proximal stent 211 is still restrained by the head-end grasping component 15.

[0082] By retracting the release wire 153, the claw 151 and the claw wire 152 can be retracted, thereby unlocking the proximal stent 211 of the main covered stent 21, completely separating the main covered stent 21 from the covered stent delivery system 1, and finally releasing the main covered stent 21.

[0083] In this embodiment, the covered stent system further includes a pre-embedded guide wire 161. The pre-embedded guide wire assembly 16 consists of the pre-embedded guide wire 161 and the pre-embedded guide wire fixing member 162.

[0084] The pre-embedded guide wire 161 is integrated with the main film-coated support 21 to form the integrated support module. The pre-embedded guide wire 161 has a distal end and a proximal end, and its distal end is fixed to the main film-coated support 21 by a pre-embedded guide wire fixing member 162 in the loaded state. There is at least one pre-embedded guide wire 161, which is made of metal. There is at least one pre-embedded guide wire fixing member 162, which is made of polymer material, and it fixes the pre-embedded guide wire 161 to the main film-coated support 21 by a knotting structure.

[0085] Furthermore, the integrated support module formed by the main film-coated support 21 and the pre-embedded guide wire 161 fixed thereon is loaded into the film-coated support conveying system 1. Specifically: In the loading and conveying states, the pre-embedded guide wire 161 and the main film-coated support 21 are radially constrained within the outer tube 12; and the pre-embedded guide wire 161 starts from its fixing point with the main film-coated support 21, passes through the opening 2121 into the internal cavity of the main film-coated support 21, then extends along the internal cavity towards the proximal end and passes through the fixing component 11, and finally exits from the proximal end of the film-coated support conveying system 1.

[0086] When the main film-coated support 21 is loaded into the film-coated support delivery system 1, one end of the pre-embedded guide wire 161 is fixed to the main film-coated support 21 by the pre-embedded guide wire fixing member 162, then passes through a window 2121 on the main film-coated support 21, enters the internal cavity of the main film-coated support 21, and exits from the distal end of the main film-coated support 21 to enter the through hole 1151 in the central tube 115 of the film-coated support delivery system 1.

[0087] This design ensures that the pre-embedded guide wire 161 is safely constrained within the conveying system along with the support during the conveying process, without interfering with the conveying operation, while also providing a pre-laid track for the superselection operation after release.

[0088] In this embodiment, the state of the pre-embedded guidewire in a semi-released state is defined. When the outer tube 12 is removed and the main film support 21 is in a semi-released state bound by the diameter assembly 14, the distal end of the pre-embedded guidewire 161 is held on the main film support 21 by the pre-embedded guidewire fixing member 162, and its main body remains in a state of passing through the opening 2121 and extending proximally along the internal cavity into the fixing assembly 11.

[0089] Specifically, in this semi-released state, the path of the pre-embedded guide wire 161 remains consistent with that in the loaded state. The pre-embedded guide wire 161 originates from its fixing point with the main film-coated support 21, passes through the opening 2121, extends proximally along the internal cavity of the main film-coated support 21, and remains inserted into the fixing assembly 11, exiting from the proximal end of the delivery system 1. This state ensures that the pre-embedded guide wire 161 will not interfere with the release and position adjustment of the support during subsequent bending and positioning operations, while also preparing for the formation of a guide track after release. The pre-embedded guide wire fixing member 162 provides stable fixing force during this process, preventing accidental slippage of the pre-embedded guide wire 161.

[0090] In this embodiment, the state and function of the pre-embedded guide wire are defined after the support is fully released and the delivery system is withdrawn.

[0091] After the main covered stent 21 is fully released and the covered stent delivery system 1 is removed from the body, the distal end of the pre-embedded guidewire 161 is held on the main covered stent 21 by the pre-embedded guidewire fixation member 162. Its main body remains through the opening 2121 and then extends distally along the internal cavity of the main covered stent 21, eventually exiting from the distal end of the main covered stent 21 and extending outside the body, thereby forming a guide track from outside the body through the internal cavity of the main covered stent 21, through the opening 2121 and pointing to the opening of the target branch vessel.

[0092] Please see Figure 14As shown, after the main covered stent 21 is released and removed from the delivery system 1, one end of the pre-embedded guidewire 161 is fixed to the main covered stent 21 by the pre-embedded guidewire fixation member 162, passes through the opening 2121, and exits from the distal end along the internal cavity of the stent, and finally exits the human body from the blood vessel entry point.

[0093] The pre-embedded guidewire 161, extending from the body, guides the catheter through the interior of the main covered stent 21, through the fenestration 2121, and into the corresponding branch vessel to complete superselection. Once superselection is complete, the end of the pre-embedded guidewire 161 extending from the body can be pulled to detach it from the main covered stent 21, ultimately allowing the pre-embedded guidewire 161 to be withdrawn from the body. The pre-embedded guidewire fixation element 162 provides stable withdrawal resistance, preventing slippage before use and during superselection, and also preventing stent displacement during withdrawal.

[0094] In one embodiment, the bending assembly 13 further includes a bending diameter wire 132. The bending diameter wire 132 is wound around the main film-coated support 21 and the diameter tie rod 141, and the bending line 131 is constrained therein to limit the spatial position of the bending line 131 during the bending process.

[0095] Specifically, the bending diameter wire 132 is wound around the main film-coating support 21 and the diameter tie rod 141 in a certain manner, and can be used as follows: Figure 12 The winding method is shown, and the bending wire 131 is bound within it. Please refer to... Figure 18 As shown, the bending line 131 can add additional fixing points on the main covered stent 21, thereby changing the shape of the bending line 131 in the blood vessel and preventing the bending line 131 from damaging the blood vessel wall or stent cover during the bending process.

[0096] By adjusting the number and layout of additional fixation points formed by the bending bundle diameter wire 132, the bending line 131 can present a variety of differentiated spatial configurations to adapt to the vascular anatomy characteristics of different patients, thereby further improving the safety and effectiveness of the bending operation.

[0097] In one embodiment, the bending assembly 13 further includes a bending ring 133. The bending ring 133 is sleeved on the bundle diameter wire 142, and the bending line 131 passes through the bending ring 133 to constrain the path of the bending line 131.

[0098] Specifically, the bending ring 133 is nested on the bundle diameter wire 142, and the bending line 131 passes through the bending ring 133, thereby constraining the morphology of the bending line 131 in the blood vessel. (See also...) Figure 19 As shown, by adjusting the number, size and layout of the bending rings 133, the bending line 131 can present a variety of different spatial configurations.

[0099] The setting of the bending ring 133 can effectively prevent the bending line 131 from directly contacting the blood vessel wall during the bending process, avoiding damage to the blood vessel intima from the sharp bending line. At the same time, the bending ring 133 provides a fixed path for the bending line 131, making the bending operation smoother and more controllable.

[0100] In one embodiment, the bending line 131 passes through part or all of the bundle diameter wire 142 to constrain the path of the bending line 131 using the bundle diameter wire 142.

[0101] Specifically, please refer to Figure 20 As shown, the bending wire 131 passes through part or all of the bundle diameter wire 142, using the bundle diameter wire 142 to constrain the bending wire 131, thereby changing the shape of the bending wire 131 in the blood vessel and preventing the bending wire 131 from damaging the blood vessel during the bending process. This solution does not require additional components, directly utilizing the existing bundle diameter wire 142 as the constraint structure for the bending wire 131, simplifying the system structure, reducing manufacturing costs, and simultaneously achieving effective constraint on the bending wire 131.

[0102] Please see Figure 9 , Figure 10 and Figure 11 As shown, in this embodiment, the fixing component 11 includes a conical head 111, a claw head receiving seat 112, a chuck 113, an inner core tube 114, and a middle tube 115.

[0103] A conical tip 111 is disposed at the distal end of the fixation assembly 11, and its outer surface has a hydrophilic coating. The conical tip 111 is coaxial with the inner core tube 114, is made of a polymer, and has a streamlined conical design at its tip. A radiopaque material such as barium sulfate can be added to the conical tip, and its outer surface has a hydrophilic coating. The conical tip 111 is designed to reduce the risk of vascular injury when the covered stent delivery system 1 passes through the tortuous arch.

[0104] The claw head receiver 112 is provided with several blind holes 1121 for receiving the beam diameter pull rod 141 of the beam diameter assembly 14 and the claw wire 152 of the head-end grasping assembly 15. The claw head receiver 112 is coaxial with the inner core tube 114 and has several blind holes 1121 for receiving the beam diameter pull rod 141 and the claw wire 152. Its material can be metal or polymer. The several blind holes 1121 on the claw head receiver 112 are used to receive the beam diameter pull rod 141 and the claw wire 152 to prevent the beam diameter pull rod 141 and the claw wire 152 from damaging blood vessels. At the same time, together with the chuck 113 and the head-end grasping assembly 15, it fixes the proximal stent 211 of the main covered stent 21 when the main covered stent 21 is released, preventing it from shifting during the release process.

[0105] The chuck 113 has several through holes 1131 for the passage of the jaw wires 152. The chuck 113 is coaxial with the inner core tube 114 and has several through holes 1131 for the passage of the jaw wires 152. The material of these through holes can be metal or polymer. The several through holes 1131 on the chuck 113 provide a fixed track for the jaw wires 152.

[0106] The inner core tube 114 is a cylindrical, thin-walled tube with an internal lumen for the passage of a guidewire. Optionally, the inner core tube 114 can be pre-bent to conform to the shape of the aortic arch, and its material can be metal or polymer. The lumen inside the inner core tube 114 allows for smooth passage of the guidewire, ensuring that the covered stent delivery system 1 can be delivered along the guidewire to the designated location and withdrawn from the body along the guidewire after the main covered stent 21 has been deployed.

[0107] The middle tube 115 is sleeved outside the inner core tube 114 and has several through holes 1151 for the passage of the bending line 131, the diameter tie rod 141, and the rear release wire 153. The middle tube 115 is coaxial with the inner core tube 114, and has several through holes 1151 around its central hole for the passage of the bending line 131, the diameter tie rod 141, and the rear release wire 153. (See also...) Figure 8 As shown, its material is a polymer. The middle tube 115, serving as the filler between the inner core tube 114 and the outer tube 12 in the non-stent segment, increases the overall bending resistance of the covered stent delivery system 1, ensuring that the covered stent delivery system 1 does not buckle in curved blood vessels. Simultaneously, the through-hole 1151 near its central aperture provides a fixed track for the bending adjustment wire 131, the bundle diameter lever 141, and the post-release wire 153, preventing them from entangled around the axis of the covered stent delivery system 1 and affecting their corresponding functions.

[0108] In this embodiment, the beam diameter assembly 14 further includes an anti-torsion structure 143. The anti-torsion structure 143 is disposed on the beam diameter tie rod 141 and is axially aligned with the opening 2121 of the main body film support 21. The anti-torsion structure 143 is used to radially constrain the beam diameter tie rod 141 and the inner core tube 114 to prevent the main body film support 21 from rotating circumferentially.

[0109] Specifically, the anti-torsion structure 143 radially binds the diameter tie rod 141 and the inner core tube 114 together through a knotting structure. Since the anti-torsion structure 143 is aligned with the fenestration 2121 in the axial direction, when the diameter tie rod 141 and the inner core tube 114 are radially bound, the main covered stent 21 cannot rotate around the axial direction of the inner core tube 114 in the diameter state, thereby ensuring the circumferential alignment accuracy of the fenestration 2121 and the branch artery.

[0110] This design provides circumferential positioning stability in the stent semi-release state, allowing the operator to be confident that the circumferential position of the fenestration 2121 will not change unexpectedly during adjustment and release, significantly improving the success rate of branch vessel superselection.

[0111] In this embodiment, the beam diameter assembly 14 further includes an anti-drift structure 144. The anti-drift structure 144 is disposed on the small curved side of the proximal end and / or distal end of the main body coating support 21. The anti-drift structure 144 is an annular closed-loop structure, used to sleeve and constrain the beam diameter wire 142 to prevent the beam diameter wire 142 from drifting out to the outside of the main body coating support 21 after being unconstrained.

[0112] Specifically, please refer to Figure 12 As shown, the anti-drift structure 144 is disposed on the small bends of the proximal and distal ends of the main covered stent 21. It is a closed-loop annular structure that passes through the small bends of the bundle wire 142 and constrains it therein. When the bundle wire 142 is released from its restraint, due to the constraint of the anti-drift structure 144, the bundle wire 142 will not unravel and drift out of the main covered stent 21, but will remain between the main covered stent 21 and the vessel wall.

[0113] This design ensures that the bundle wire 142 will not become a foreign body in the blood vessel after it has completed its binding function, thus avoiding interference with blood flow or damage to the blood vessel wall. It also ensures that the bundle wire 142 can be smoothly removed from the body.

[0114] In this embodiment, the head-end grasping assembly 15 also includes a claw wire 152. The claw wire 152 is a U-shaped metal wire, with its distal end fixed to the claw 151 and its proximal end slidably passing through the through hole 1131 of the chuck 113 and fixed to the rear release wire 153.

[0115] The post-release wire 153 is configured such that when the post-release wire 153 is pulled proximally, it drives the claw wire 152 and the claw 151 to move proximally, thereby releasing the proximal end of the main covered stent 21.

[0116] Specifically, please refer to Figure 13 As shown, the claw wire 152 is a U-shaped metal wire, with its distal end fixed to the claw 151 and its proximal end slidably passing through the through hole 1131 of the chuck 113, and its end placed in the blind hole 1121 of the claw head receiving seat 112. The release wire 153 is a U-shaped metal wire with one end longer than the other, and is fixedly connected to the proximal end of the claw wire 152.

[0117] When it is necessary to release the proximal end of the stent, the operator pulls the release wire 153 proximally. The release wire 153 then drives the clasp wire 152 and the clasp 151 to slide proximally along the through hole 1131 of the clasp 113. The clasp 151 disengages from its engagement with the proximal stent 211, completing the unlocking of the proximal stent 211, completely separating the main covered stent 21 from the delivery system 1, and finally completing the release of the main covered stent 21.

[0118] In this embodiment, the main body film-coated support 21 includes the following components: The proximal stent 211 is a corrugated stent ring, partially fixed to the cover 212 and partially free from the cover 212, for engagement with the tip-end grasping assembly 15. The proximal stent 211 is a corrugated stent ring made of metal, preferably nickel-titanium, with the number of waves greater than or equal to the number of claw wires 152, preferably twice the number of claw wires 152. The proximal stent 211 is partially fixed to the cover 212 and partially free from it. When the tip-end grasping assembly 15 is not retracted, the proximal stent 211 secures the proximal end of the main covered stent 21 to the covered stent delivery system 1, preventing displacement of the main covered stent 21; after the tip-end grasping assembly 15 is retracted, it fully unfolds and adheres tightly to the vessel wall.

[0119] The membrane 212 is a cylindrical thin film structure with the aforementioned openings 2121. The membrane 212 is a cylindrical thin film structure made of polymer. The membrane 212 prevents blood flow into the false lumen. Optionally, the membrane 212 has openings 2121 corresponding to branch vessels, which ensure blood supply to the branch vessels and provide a pathway for subsequent reconstruction of the branch vessels.

[0120] At least one of the remaining stents 213 is a corrugated stent ring, fixed to the covering 212, for providing radial support. The remaining stents 213 are corrugated stent rings made of metal, preferably nickel-titanium, and are axially evenly distributed on the covering 212, partially or completely fixed to the covering 212 by sutures or other means. After complete release, the remaining stents 213 provide radial support, ensuring the main covered stent 21 adheres tightly to the inner wall of the blood vessel.

[0121] The number of waves in the proximal support 211 is greater than or equal to the number of claw wires 152 in the head-end grasping assembly 15. Specifically, the proximal support 211 is a wave-shaped support ring with a number of waves greater than or equal to the number of claw wires 152. This design ensures that each claw wire 152 can engage with one wave of the proximal support 211 to achieve stable grasping. When the number of claw wires 152 is less than the number of waves in the proximal support 211, the claws 151 can selectively grasp some waves, still achieving reliable fixation; when the two numbers are equal, each claw wire 152 corresponds to one wave, forming a one-to-one grasping relationship, resulting in more uniform and reliable fixation.

[0122] Preferably, the number of waves on the proximal support 211 is twice the number of claw wires 152. Taking a configuration of 3 claw wires 152 as an example, the proximal support 211 has 6 waves. This preferred ratio ensures reliable capture while providing a more uniform circumferential fixation point for the proximal support 211. When the claws 151 capture every wave, the circumferential force on the proximal support 211 is more balanced, resulting in better wall adhesion after release and facilitating stable maintenance of the support during release.

[0123] In the semi-released state, the main covered stent 21 is bound by the diameter assembly 14 to a diameter of 20% to 60% of its fully deployed diameter. Specifically, when the outer tube 12 is retracted, the diameter assembly 14 still binds the main covered stent 21, at which point the main covered stent 21 is in a semi-bound state, with a diameter larger than the inner diameter of the outer tube 12 but smaller than its fully deployed diameter. Optionally, the diameter in the semi-bound state is 20% to 60% of the fully deployed diameter. In this semi-bound state, some blood flow can pass through the lumen of the main covered stent 21, thereby reducing the impact force of blood flow on the delivery system 1, making the stent less prone to displacement during subsequent release. At the same time, the stent still maintains sufficient radial constraint, facilitating axial and circumferential positional adjustments by the operator. This diameter range is a validated preferred range, ensuring both sufficient blood flow to reduce impact and stability of the stent during adjustment. If the diameter is too large, the blood flow impact force will still be large; if the diameter is too small, the resistance to stent adjustment will increase, which is not conducive to accurate positioning.

[0124] Taking the treatment of aortic dissection involving the aortic arch as an example, the complete surgical steps of this endovascular stent graft system are as follows: Step 1: Please refer to Figure 15 As shown, the main covered stent 21 has a window 2121 and is loaded in the covered stent delivery system 1. The covered stent delivery system 1 delivers the stent along the guide wire 6 to the designated position, that is, the window 2121 is aligned with the left common carotid artery 33.

[0125] Step Two: Please refer to Figure 16As shown, keeping the fixation component 11 in place within the blood vessel, the outer cannula 12 is withdrawn, completing the first step of releasing the main covered stent 21. After release, the position of the main covered stent 21 can be adjusted to maintain alignment between the left common carotid artery 33 and the fenestration 2121. At this time, the main covered stent 21 is still bound by the bundle diameter rod 141 and the bundle diameter wire 142.

[0126] Step 3: Please refer to Figure 17 As shown, while keeping the fixation component 11 in place in the blood vessel, the distal end of the covered stent delivery system 1 is bent downward by pulling the bending line 131, so that its bending shape is closer to the bending shape of the aortic arch.

[0127] Optionally, the bending assembly 13 further includes a bending diameter adjustment wire 132, which is wound around the main film-coating support 21 and the diameter adjustment rod 141 in a certain manner, and can be used as follows: Figure 12 The bending line 131 is bound within the main covered stent 21 by a winding method. In this way, the bending line 131 can add additional fixation points on the main covered stent 21, thereby changing the shape of the bending line 131 in the blood vessel and preventing the bending line 131 from damaging the blood vessel during the bending process. Figure 18 This is an example of the morphology of the bending line 131 in a blood vessel after adding additional fixation points. Furthermore, by adjusting the number and layout of the additional fixation points, the bending line can present a variety of different spatial configurations.

[0128] Optionally, the bending assembly 13 also includes a bending ring 133, which is nested on the bundle diameter wire 142. The bending wire 131 passes through the bending ring 133, thereby constraining the shape of the bending wire 131 in the blood vessel and preventing the bending wire 131 from damaging the blood vessel during the bending process. By adjusting the number, size, and layout of the bending rings 133, the bending wire 131 can present a variety of different spatial configurations. Figure 19 This is an example of using the bending ring 133 to control the shape of the bending line 131.

[0129] Optionally, when the bending wire 131 passes through part or all of the bundle diameter wire 142, the shape of the bending wire 131 in the blood vessel can be changed to prevent the bending wire 131 from damaging the blood vessel during the bending process. Figure 20 This is an example of using the bundle diameter wire 142 to control the shape of the bending line 131.

[0130] Step 4: Please refer to Figure 21As shown, while maintaining tension on the bending line 131 to ensure the curvature of the covered stent delivery system 1 closely approximates the curvature of the aortic arch, the bundle diameter lever 141 is retracted proximally, completing the second release of the main covered stent 21. At this point, the main covered stent 21 is fully deployed, except that its proximal stent 211 remains restrained by the apical capture assembly 15. By pulling one side of the proximal end of the bending line 131, it is withdrawn from the blood vessel.

[0131] Step 5: Please refer to Figure 22 As shown, the release wire 153 is withdrawn proximally, which can drive the clasp 151 and clasp wire 152 to withdraw, thereby unlocking the proximal stent 211 of the main covered stent 21, completely separating the main covered stent 21 from the covered stent delivery system 1, and finally releasing the main covered stent 21. The covered stent delivery system 1 is then withdrawn from the blood vessel to the outside, the guidewire is withdrawn, and the implantation of the main covered stent 21 is completed.

[0132] Step Six: Please refer to Figure 23 As shown, catheter 7 is delivered along the pre-embedded guidewire 161 and inserted into the branch vessel to complete the superselection of the branch vessel. Then, the pre-embedded guidewire 161 is withdrawn, and an ultra-stiff guidewire is delivered using catheter 7 to complete the establishment of the branch access.

[0133] Step Seven: Please refer to Figure 24 As shown, a branched covered stent 22 is implanted using the established branched access to reconstruct the corresponding branch vessels. Similarly, the other two branch vessels are reconstructed, thereby completing the reconstruction of the entire aortic arch region.

[0134] Compared with the prior art, the present invention has the following beneficial effects, taking the treatment of aortic arch lesions as an example: 1. The bending assembly effectively prevents the "bird's beak" phenomenon, reducing the risk of internal leakage and reoperation: This invention incorporates a bending adjustment component 13, with its bending adjustment line 131 distally connected to the distal end of the fixation component 11. The surgeon can actively adjust the curvature of the delivery system 1 by pulling the bending adjustment line 131 proximally, conforming it to the natural shape of curved blood vessels such as the aortic arch. This active bending adjustment design ensures that the main covered stent 21 fits tightly against the lesser curvature of the blood vessel after deployment, structurally eliminating the gap formed by the "bird's beak," effectively preventing type Ia endoleaks, and reducing the reoperation rate and the risk of vascular rupture. Simultaneously, by improving the spatial fit between the stent and the vessel wall, the stent's anti-migration ability and long-term stability are further enhanced.

[0135] As a preferred embodiment, when the bending assembly 13 also includes a bending bundle wire 132 or a bending ring 133, the bending line 131 can add additional fixing points or constraint points on the main covered stent 21, thereby changing the course of the bending line 131 in the blood vessel, effectively preventing the bending line 131 from cutting or damaging the blood vessel wall and stent cover during the bending process, and significantly improving the safety of the bending operation.

[0136] II. The beam diameter assembly and the head-end capture assembly work together to achieve precise positioning, ensuring branch blood supply and surgical success rate: This invention, through the coordinated design of the beam diameter component 14 and the head-end grasping component 15, ensures the axial positioning accuracy of the main covered stent 21, enabling the fenestration 2121 to be precisely aligned with the branch vessels of the aortic arch, thereby ensuring uninterrupted blood supply to the brain during surgery. Specifically, the blood flow impact force is significantly reduced in the semi-released state, providing the surgeon with a comfortable adjustment window, allowing for precise positioning without the risk of displacement; final release is performed after confirming the position, avoiding the problems of stent "pre-jumping" or displacement in traditional release methods. This design makes postoperative branch vessel superselection easier, improving the overall surgical success rate, while ensuring long-term patency after implantation of the branch covered stent.

[0137] As a preferred embodiment, when the bundle diameter assembly 14 also includes an anti-torsion structure 143, it can prevent the main covered stent 21 from rotating around the axial direction of the inner core tube 114, thereby improving the circumferential alignment accuracy of the fenestration 2121 of the main covered stent 21 with the branch artery. This design further ensures intraoperative cerebral blood supply, makes postoperative branch vessel superselection easier, improves the overall surgical success rate, and ensures long-term patency after implantation of the branch covered stent.

[0138] III. The pre-embedded guidewire assembly significantly simplifies branch overselection and reduces the incidence of complications: This invention utilizes a pre-embedded guidewire assembly 16 to create a ready-made guide track after stent deployment, which runs from outside the body through the internal cavity of the stent, through the fenestration, and points towards the opening of the target branch vessel. The catheter can then quickly and accurately enter the target branch vessel along this track to perform superselection, significantly reducing superselection operation time and the probability of repeated probing and damage to the vessel wall during surgery. This effectively reduces the incidence of cerebral infarction caused by plaque detachment and improves the overall surgical success rate.

[0139] IV. Multiple safety features reduce the risk of vascular injury: This invention provides various methods for constraining the bending wire, including bending bundle wire 132, bending ring 133, and bending wire 131 passing through bundle wire 142. These methods effectively restrict the spatial position of the bending wire 131 during the bending process, preventing sharp bending wires from cutting or damaging the vessel wall and stent cover. Simultaneously, the anti-drift structure 144 prevents the bundle wire 142 from drifting out of the stent after being released from its restraints, thus avoiding it becoming a foreign body within the vessel or affecting stent apposition. These safety designs reduce the risk of surgery-related vascular injury from multiple angles.

[0140] V. Stepped release logic improves operational controllability and shortens the learning curve: The "partial release-adjustment-full release" step-by-step release logic of this invention is clear and the operation steps are well-defined. The surgeon can easily adjust the position and angle in the partial release state without performing high-risk operations under high-speed blood flow impact. This design significantly reduces the reliance on the surgeon's skill level, shortens the learning curve, and facilitates the clinical promotion and application of this technology.

[0141] In summary, this invention systematically solves the three core challenges of existing transcatheter intravascular aortic arch repair techniques in terms of wall apposition, positioning accuracy, and branch superselection through the synergistic effect of the bending adjustment component, the bundle diameter component, the tip capture component, and the pre-embedded guidewire component, significantly improving the safety, success rate, and long-term efficacy of the procedure.

[0142] The above embodiments are merely illustrative of the principles and effects of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by those skilled in the art without departing from the spirit and technical concept disclosed in the present invention should still be covered by the claims of the present invention.

Claims

1. A covered scaffold system, characterized in that, include: Conveying system (1); as well as An integrated support module is releasably mounted on the delivery system (1), the integrated support module comprising a main film-coated support (21) having at least one window (2121); The conveying system (1) includes: Fixed component (11); The outer tube (12) is axially slidably sleeved on the outside of the fixing component (11); The bending assembly (13) includes a bending line (131), the far end of which is connected to the far end of the fixing assembly (11). The bending shape of the conveying system (1) can be adjusted by pulling the bending line (131) towards the near end. The beam diameter assembly (14) includes a beam diameter tie rod (141) and a beam diameter wire (142), the beam diameter wire (142) being releasably wound between the main body covering support (21) and the beam diameter tie rod (141) for radially binding the main body covering support (21); The head-end gripping assembly (15) includes a claw (151) and a rear release wire (153). The claw (151) is slidably disposed on the fixing assembly (11) for releasably gripping the proximal end of the main body covering support (21).

2. The covered scaffold system according to claim 1, characterized in that, The conveying system (1) is configured as follows: First, remove the outer tube (12) so that the support (21) is in a semi-released state where it is restrained by the beam diameter assembly (14) and its proximal end is captured by the head end capture assembly (15). In the semi-released state, the bending shape and axial position of the delivery system (1) can be adjusted so that the opening (2121) is aligned with the target blood vessel; After confirming alignment, the restraint of the beam diameter assembly (14) can be released first, and then the head end grasping assembly (15) can be operated to release the proximal end of the support (21).

3. The covered scaffold system according to claim 2, characterized in that, It also includes a pre-embedded guide wire (161), which is integrated with the main body film-coated bracket (21) to form the integrated bracket module. The pre-embedded guide wire (161) has a distal end and a proximal end, and its distal end is fixed to the main body film-coated bracket (21) by a pre-embedded guide wire fixing member (162) in the loaded state. Furthermore, the main film-coated support (21), with the pre-embedded guide wire (161) fixed thereon, is integrally formed into an integrated support module and loaded into the film-coated support delivery system (1), wherein: In the loading and transporting states: the pre-embedded guide wire (161) and the main film-coated support (21) are radially constrained together in the outer tube (12); and the pre-embedded guide wire (161) starts from its fixing point with the main film-coated support (21), passes through the opening (2121) and enters the internal cavity of the main film-coated support (21), then extends along the internal cavity towards the proximal end and passes through the fixing component (11), and finally exits from the proximal end of the film-coated support transport system (1).

4. The covered scaffold system according to claim 3, characterized in that, When the outer tube (12) is removed and the main film-coated support (21) is in a semi-released state bound by the beam diameter assembly (14): The distal end of the pre-embedded guide wire (161) is held on the main body covering bracket (21) by the pre-embedded guide wire fixing member (162), and its main body part is held to pass through the opening (2121) and extend proximally along the internal cavity into the fixing assembly (11).

5. The covered scaffold system according to claim 3, characterized in that, After the main covered stent (21) is completely released and the covered stent delivery system (1) is removed from the body: The distal end of the pre-embedded guidewire (161) is held on the main covered stent (21) by the pre-embedded guidewire fixation member (162). Its main body is held through the opening (2121) and then extends to the distal end along the internal cavity of the main covered stent (21), and finally exits from the distal end of the main covered stent (21) and extends outside the body, thereby forming a guide track from outside the body through the internal cavity of the main covered stent (21), through the opening (2121) and pointing to the opening of the target branch blood vessel.

6. The covered scaffold system according to claim 1, characterized in that, The bending assembly (13) further includes a bending diameter wire (132), which is wound around the main film support (21) and the diameter tie rod (141) and constrains the bending line (131) therein to limit the spatial position of the bending line (131) during the bending process.

7. The covered stent system according to claim 1, characterized in that, The bending assembly (13) further includes a bending ring (133), which is sleeved on the bundle diameter wire (142), and the bending line (131) passes through the bending ring (133) to constrain the path of the bending line (131).

8. The covered scaffold system according to claim 1, characterized in that, The bending line (131) passes through part or all of the bundle diameter wire (142) to constrain the path of the bending line (131) using the bundle diameter wire (142).

9. The covered stent system according to claim 1, characterized in that, The bending line (131) is made of metal and has a coating on its surface.

10. The covered scaffold system according to claim 1, characterized in that, The bending line (131) includes an inner metal core and a polymer material layer covering the outer surface of the inner metal core, and the outer surface of the polymer material layer is provided with a coating.

11. The covered scaffold system according to claim 1, characterized in that, The fixing component (11) includes: A conical head (111) is disposed at the distal end of the fixing component (11), and its outer surface has a hydrophilic coating; The claw head receiving base (112) is provided with a plurality of blind holes (1121) for receiving the beam diameter pull rod (141) of the beam diameter assembly (14) and the claw wire (152) of the head end grasping assembly (15). A chuck (113) is provided with several through holes (1131) for the passage of the chuck claw wires (152); The inner core tube (114) is a cylindrical thin-walled tube, and its internal lumen is used to pass through the guide wire; The middle tube (115) is sleeved outside the inner core tube (114) and has several through holes (1151) for passing through the bending line (131), the diameter tie rod (141) and the rear release wire (153).

12. The covered stent system according to claim 11, characterized in that, The beam diameter assembly (14) further includes an anti-torsion structure (143), which is disposed on the beam diameter tie rod (141) and is axially aligned with the opening (2121) of the main body film support (21); the anti-torsion structure (143) is used to radially constrain the beam diameter tie rod (141) and the inner core tube (114) to prevent the main body film support (21) from circumferentially rotating.

13. The covered stent system according to claim 1, characterized in that, The beam diameter assembly (14) further includes an anti-drift structure (144), which is disposed on the small curved side of the proximal end and / or distal end of the main body film-coated support (21). The anti-drift structure (144) is an annular closed-loop structure used to sleeve and constrain the beam diameter wire (142) to prevent the beam diameter wire (142) from drifting out to the outside of the main body film-coated support (21) after being unconstrained.

14. The covered stent system according to claim 11, characterized in that, The head-end grasping assembly (15) also includes a claw wire (152), which is a U-shaped metal wire. Its distal end is fixed to the claw (151), and its proximal end can slide through the through hole (1131) of the chuck (113) and be fixed to the rear release wire (153). The post-release wire (153) is configured such that when the post-release wire (153) is pulled proximally, it causes the claw wire (152) and the claw (151) to move proximally, thereby releasing the proximal end of the main body covered stent (21).

15. The covered stent system according to claim 1, characterized in that, The main film-coated support (21) includes: The proximal support (211) is a wavy support ring, part of which is fixed to the membrane (212) and part of which is free from the membrane (212) for use in conjunction with the head-end capture assembly (15); The membrane (212) is a cylindrical thin film structure with the window (2121) provided on it; At least one other support (213), which is a corrugated support ring, is fixed to the membrane (212) to provide radial support force.

16. The covered stent system according to claim 15, characterized in that, The number of waves in the proximal end support (211) is greater than or equal to the number of claw wires (152) in the head end grasping assembly (15).

17. The covered stent system according to claim 16, characterized in that, The number of waves in the proximal stent (211) is twice the number of the claw wires (152).

18. The covered scaffold system according to claim 2, characterized in that, In the semi-released state, the diameter of the main film-coated support (21) bound by the beam diameter assembly (14) is 20% to 60% of the fully extended diameter.

Images