Covered stent, covered stent conveying system and intervention system

Abstract

The invention provides a covered stent, a covered stent delivery system and an intervention system, the covered stent comprises: a main covered stent having at least one pre-opening; and at least part of the guide wire is located at the pre-opened hole, and the guide wire is in releasable connection with the main covered stent. The covered stent embedded with the guide wire can be assembled into a standardized module in advance before an operation, then the standardized module is pressed, held and loaded in a conveying system, in an interventional operation, the stent is conveyed to a target position of an aortic arch through a femoral artery approach, after the main covered stent is released, the conveying system is withdrawn, the guide wire is disengaged from a side hole of a middle tube and exposed, and the guide wire is released from the side hole of the middle tube. An operator can directly use the exposed guide wire to guide the rapid exchange catheter to enter a branch blood vessel to complete passage establishment without additionally puncturing a carotid artery or a brachial artery, so that the operation time is remarkably shortened, and the stroke risk is reduced.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of covered stent delivery, and particularly relates to a covered stent, a covered stent delivery system and an interventional system. BACKGROUND

[0002] The cause of acute aortic syndrome (AAS) is that under the induction of factors such as hypertension, ulcers, hematomas and dissections of large blood vessels are gradually formed. Since the AAS condition develops extremely rapidly, there is a risk of blood vessel rupture and death at any time, and therefore it is a fatal disease that seriously endangers the life and health of patients.

[0003] For the treatment of AAS, surgical treatment is currently the main method, but surgical treatment has the disadvantages of complex operation, large trauma, many complications, difficult blood vessel anastomosis and hemostasis, long operation time of 5-7 hours, high operation complications, high multiple organ ischemic damage, high average operation mortality of 15-25%, high cost, and few surgical resources. In order to solve the above problems, countries continue to develop interventional stents in the hope of breaking through the pain point, but various methods such as windowing, chimney and mesh stents are not ideal and can only meet the treatment of simple AAS. In summary, it is particularly important to develop an interventional stent for complex conditions, especially for the three branches above the arch.

[0004] For the stent accumulating the branches above the arch, there has been a long-term lack of standardized, simple and fast, and lower risk products in the market. In the prior art, the operator uses multiple descending aortic stents to pre-punch and overlap to treat the three branches above the arch, but this method lacks standardized structure and pre-established guide wire passage, making it particularly difficult to superselect the branch blood vessels. In order to reduce the difficulty of superselection, the above treatment method often needs to make an incision from the upper access (carotid artery / brachial artery) to complete the establishment of the guide wire passage and the use of the delivery system. Some stent systems use a pre-embedded guide wire in the delivery system, some of which reserve a pre-embedded guide wire in the branch part of the stent, make an incision in the brachial artery, guide the catheter from the brachial artery to the femoral artery, and then send the pre-embedded guide wire into the specified branch artery along the catheter; some of the stent systems reserve a pre-embedded guide wire for the innominate artery, but the guide wire needs to be captured in the right brachial artery during the operation to form a complete passage, and the stent system can only realize the function of the pre-embedded guide wire for the innominate artery.

[0005] In summary, the above prior art needs to make an incision in the carotid artery / brachial artery, which increases the operation time, adds new incisions to the patient, and increases the risk of blood vessel plaque shedding. SUMMARY

[0006] In view of the above-mentioned shortcomings of the prior art, the purpose of the present invention is to provide a covered stent, a covered stent delivery system and an interventional system to solve the problem that the prior art requires an incision in the carotid / brachial artery, which increases the operation time, adds new wounds to the patient and increases the risk of plaque detachment in the blood vessel.

[0007] To achieve the above and other related objectives, the present invention proposes a membrane-covered stent with pre-embedded guide wires, comprising: A primary coating support having at least one pre-opening; At least one guidewire, one end of which is at least partially located at the pre-drilled hole and releasably connected to the main overlay support.

[0008] In one embodiment of the present invention, the guidewire is a single strand or a multi-strand type, wherein the multi-strand type guidewire is a multi-line structure formed by folding the same guidewire in half.

[0009] In one embodiment of the present invention, the distal or intermediate section of the guidewire passes through the pre-drilled hole and extends toward the target branch vessel to achieve natural guidance of the branch vessel.

[0010] In one embodiment of the present invention, the main film-coated support is provided with a reinforcing structure around the pre-drilled hole, and the reinforcing structure is at least one of a metal ring, a beam-shaped support ring, or a sunken support structure.

[0011] In one embodiment of the present invention, a developing wire is wound around the metal ring for precisely locating the pre-drilled hole position under image guidance.

[0012] In one embodiment of the present invention, one end of the guidewire is fixed to the reinforcing structure around the membrane, stent ring, or pre-drilled hole of the main covered stent by one or more flexible connectors, wherein the flexible connector is a detachable rope or suture to achieve a releasable connection with the main covered stent.

[0013] In one embodiment of the present invention, the end of the guidewire is configured as a spherical structure.

[0014] In one embodiment of the present invention, the guide wire is made of at least one of nickel-titanium alloy, stainless steel, cobalt-chromium alloy, polypropylene, polylactic acid, polyglycolic acid, polydioxane, polydioxane, and polyethylene terephthalate.

[0015] In one embodiment of the present invention, the pre-opened window has a multi-layer structure.

[0016] The present invention also proposes a covered stent delivery system, comprising: A support conveying system, comprising an inner tube, a middle tube, and an outer tube arranged sequentially from the inside to the outside, wherein the middle tube has at least one side hole along its circumference and the side hole extends along its axial direction; As described in any of the above embodiments, the main covered stent of the covered stent is compressed radially and straightened axially and then housed between the inner tube and the outer tube; The guide wire of the membrane-covered stent is inserted into the side hole of the central tube.

[0017] The present invention also proposes an interventional system for aortic branch reconstruction, comprising: The film-coated stent delivery system as described in any of the above embodiments; A rapid exchange catheter, wherein the tube body of the rapid exchange catheter has at least one side hole in the circumferential direction and the side hole extends in the axial direction; In this process, after the main covered stent is released and the delivery system is withdrawn, the guidewire is exposed outside the body. The rapid exchange catheter connects to the guidewire through its side hole and establishes a rapid exchange pathway, thereby enabling rapid superselection and access establishment of branch vessels.

[0018] The pre-embedded guidewire-covered stent of the present invention can be pre-assembled into a standardized module before surgery, then crimped and loaded into the delivery system. During interventional surgery, the stent is delivered to the target location in the aortic arch via a femoral artery approach. After the covered stent is released, the delivery system is withdrawn, allowing the guidewire to dislodge and be exposed from the side port of the central catheter. The operator can then directly use the exposed guidewire to guide the rapid exchange catheter into the branch vessel to establish access. It has the following beneficial effects: This invention can significantly shorten the operation time and improve the efficiency of operation. This invention realizes "instant placement and selection" of branch vessels, reducing the guidewire superselection time of the traditional technique from an average of more than 30 minutes to less than 5 minutes, greatly improving the efficiency of operation and reducing the patient's X-ray exposure time and anesthesia risk.

[0019] This invention can reduce trauma and complications. The entire treatment is performed through the femoral artery, avoiding carotid or brachial artery incisions, thus reducing patient trauma, bleeding risk and postoperative infection probability.

[0020] This invention can reduce the risk of stroke. This invention does not involve the operation of the brachial artery, carotid artery, or brachiocephalic artery, effectively avoiding cerebral infarction caused by plaque detachment and improving surgical safety.

[0021] This invention is compatible with existing system structures and is easy to industrialize. Without changing the main structure of the existing film-coated stent and the basic configuration of the delivery system, this invention can achieve functional upgrades simply by adding pre-opened windows, integrating pre-embedded guide wires, and optimizing the design of the side holes in the central tube. It has good engineering compatibility and industrialization prospects. Attached Figure Description

[0022] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with this application and, together with the description, serve to explain the principles of this application. It is obvious that the drawings described below are merely some embodiments of this application, and those skilled in the art can obtain other drawings based on these drawings without any inventive effort.

[0023] Figure 1 This is a schematic diagram of a conveying system in one embodiment of the present invention.

[0024] Figure 2 This is a schematic diagram of the film-coated stent in Embodiment 1 of the present invention.

[0025] Figure 3 for Figure 2 A top view of the membrane-covered stent.

[0026] Figure 4 This is a schematic diagram of a single-strand guidewire in one embodiment of the present invention.

[0027] Figure 5 This is a schematic diagram of a double-stranded guidewire in one embodiment of the present invention.

[0028] Figure 6 This is a schematic diagram of a film-coated stent with a double-stranded guidewire in one embodiment of the present invention.

[0029] Figure 7 This is a schematic diagram of the cooperation between the single-strand guide wire and the conveying system in Example 1.

[0030] Figure 8 This is a schematic diagram of the intervention system in one embodiment of the present invention.

[0031] Figure 9 This is a schematic diagram of the intervention system in another embodiment of the present invention.

[0032] Figure 10 This is a schematic diagram of the film-coated stent in Embodiment 2 of the present invention.

[0033] Figure 11 for Figure 10 A top view of the membrane-covered stent.

[0034] Figure 12 This is a schematic diagram of the cooperation between the single-strand guide wire and the conveying system in Example 2.

[0035] Figure 13 This is a schematic diagram of the film-coated stent in Embodiment 3 of the present invention.

[0036] Figure 14 This is a schematic diagram of the cooperation between the double-stranded guide wire and the conveying system in Example 2.

[0037] Figure 15 This is a schematic diagram of the intervention system in Embodiment 3 of the present invention. Detailed Implementation

[0038] 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. 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. In the absence of conflict, the following embodiments and features in the embodiments can be combined with each other.

[0039] It should be noted that the illustrations provided in the following embodiments are only schematic representations of the basic concept of the present invention. The drawings only show the components related to the present invention and are not drawn according to the actual number, shape and size of the components in the actual implementation. In the 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.

[0040] In the following description, numerous details are explored to provide a more thorough explanation of embodiments of the invention. However, it will be apparent to those skilled in the art that embodiments of the invention may be practiced without these specific details. In other embodiments, well-known structures and devices are shown in block diagram form rather than in detail to avoid obscuring embodiments of the invention.

[0041] For ease of description, the technical terms used in the text are explained below: Superselective insertion refers to the technique of precisely inserting a guidewire or catheter into the terminal small blood supply branch of the lesion or a specific target vessel under the real-time guidance of imaging equipment.

[0042] Lower access: Lower access refers to the procedure of establishing a device delivery channel by puncturing the femoral artery, so that interventional devices such as catheters, guidewires, and stents can reach the target vascular area through this path.

[0043] Proximal end: Arteries originating from the heart gradually branch into capillaries, and then gradually converge into veins that return to the heart. The end of any segment of the blood vessel that is closest to the heart is called the proximal end.

[0044] Distal end: Arteries originating from the heart gradually branch into capillaries, and then gradually converge into veins that return to the heart. The end of any segment of the blood vessel furthest from the heart is called the distal end.

[0045] Axial axis: Blood vessels, interventional stents, etc. are all roughly cylindrical. If they are regarded as cylinders, then the axis of rotation of the cylinder is defined as the axial axis.

[0046] Radial: "Radial" is perpendicular to "axial", that is, the direction of the radius or diameter of the end face circle of a cylinder. The radial direction is perpendicular to the axial direction in space.

[0047] Circumferential direction: "Circumferential direction" refers to the circumferential direction, which, together with "axial direction" and "radial direction", forms the three orthogonal directions of cylindrical coordinates.

[0048] Please see Figure 1 As shown, traditional surgical procedures are highly invasive and risky. Existing interventional techniques, when dealing with complex lesions involving supra-aortic branches, generally suffer from difficulties in superselecting branch vessels, complex procedures, and long operation times. They often require establishing an upper access route via carotid or brachial artery puncture to assist guidewire positioning, which not only increases patient trauma but also carries the secondary risk of plaque detachment leading to stroke. Therefore, this invention proposes a covered stent, a covered stent delivery system, and an interventional system to achieve interventional treatment of aortic syndrome via an all-lower access route. This allows for rapid superselection of branch vessels and access establishment after the aortic covered stent is deployed, avoiding the additional trauma and stroke risks associated with establishing a guidewire access via peripheral vessels (including the carotid and brachial arteries).

[0049] Please see Figure 1 , Figure 2 and Figure 3 As shown, the present invention proposes a covered stent 100 with a pre-embedded guide wire 200. The covered stent 100 includes a main covered stent 100, which has at least one pre-opening 102 and at least one guide wire 200. One end of the guide wire 200 is at least partially located at the pre-opening 102 and is releasably connected to the main covered stent. In this embodiment, one end of the guide wire 200 is fixed to the covered stent, the stent ring 101, or the reinforcing structure around the pre-opening 102 of the main covered stent 100 by one or more flexible connectors 201. The flexible connector 201 is a detachable cord or suture that enables the releasable connection with the main covered stent 100.

[0050] Please see Figure 1 , Figure 2 and Figure 3 As shown, one end of the guidewire 200 is fixed to the main membrane support 100 via a releasable connection. The fixing position can be on the membrane, the support ring 101, or the reinforcing structure around the pre-drilled hole 102. The releasable connection can be achieved by a flexible connector 201, which is composed of one or more flexible rope-like materials (such as biodegradable sutures or polymer filaments) to firmly bind the guidewire 200 to the support, but can break or detach under external force, thus achieving controllable release.

[0051] Crucially, one end of the guidewire 200 is at least partially located at the pre-drilled hole 102, meaning its distal or intermediate section passes through the pre-drilled hole 102, allowing the rapid exchange catheter to be oriented towards the corresponding branch vessel. After the main covered stent is deployed, the pre-embedded guidewire 200 can be exposed from the pre-drilled hole 102 as a guiding marker, providing precise guidance for the subsequent rapid exchange catheter 400 to enter the branch vessel.

[0052] Please see Figure 2 , Figure 3 , Figure 4 and Figure 5 As shown in this embodiment, the pre-embedded guidewire 200 of the present invention includes two main structural categories: single-strand type and multi-strand type, which can be used alone or in combination according to clinical needs.

[0053] The single-strand pre-embedded guidewire 200 is a continuous filamentous structure, while the multi-strand pre-embedded guidewire 200 is a parallel multi-line structure formed by folding the same guidewire 200 in half, preferably a double-strand type, i.e., a parallel double-line structure formed by folding the same guidewire 200 in half. The material can be an alloy or a polymer. For example, alloys can be stainless steel, cobalt-chromium alloy, nickel-titanium alloy, etc.; polymers can be polypropylene, polylactic acid, polyglycolic acid, polydioxanone, silk fibroin, or polyethylene terephthalate, etc., suitable for applications requiring partial degradation or reduction of metal residue. Preferably, the single-strand guidewire 200 is made of nickel-titanium alloy, due to its excellent superelasticity, shape memory effect, and biocompatibility, making it suitable for delivery and positioning in complex vascular pathways. The double-strand guidewire 200 is made of polypropylene, due to its good flexibility, creep resistance, and processing performance, suitable for being made into a folded structure and maintaining morphological stability over a long period.

[0054] In this invention, the diameter of the pre-embedded guidewire 200 is 0.1 mm to 0.9 mm, preferably 0.3 mm to 0.6 mm, to balance pushing force and vascular safety, and its effective length is 0.5 m to 2 m, ensuring that it can extend from the femoral artery approach to the branch vessels of the aortic arch and can be effectively restrained and released by the delivery system 300.

[0055] Understandably, the fixation position of the pre-embedded guidewire 200 can be flexibly set according to the stent design and anatomical adaptation requirements. For example, for a single-strand guidewire 200, it can be fixed to the overlay or stent ring 101 of the ascending main segment, arch segment, or descending main segment of the covered stent. Its fixation direction can be any direction, preferably towards the natural physiological direction of the target branch vessel to achieve the best guiding effect. For a dual-strand guidewire 200, it can be fixed to the overlay, crossbeam (i.e., stent connecting rod), or stent ring around the pre-drilled hole 102, using structural anchor points to enhance connection reliability.

[0056] In this embodiment, the end of the pre-embedded guidewire 200 is sphericalized, that is, its end is formed into a smooth spherical structure through heat processing or coating process to prevent scratching the intima during movement in the blood vessel and improve the safety of operation.

[0057] In a complete covered stent system, the number of pre-embedded guidewires 200 can be greater than or equal to one, preferably one to three, corresponding to the brachiocephalic artery, left common carotid artery, and left subclavian artery in the aortic arch, respectively. Single-strand and double-strand pre-embedded guidewires 200 can be used in combination in the same system. For example, a single-strand nickel-titanium guidewire 200 can be used for the relatively straight brachiocephalic artery, while a double-strand polypropylene guidewire 200 can be used for the tortuous left subclavian artery, achieving personalized and modular superselective support.

[0058] Please see Figure 2 , Figure 3 , Figure 4 and Figure 5 As shown, the main covered stent 100 of the present invention has 1 to 3 pre-drilled holes 102 at the arch position to provide blood flow channels for branch vessels and to provide mating sites for subsequent anchoring of branch stents. Each pre-drilled hole 102 is 5 mm to 30 mm in size and 0 to 20 mm in height. The shape of the pre-drilled hole 102 is preferably trapezoidal to provide more operating space and reduce stress concentration. In addition, the pre-drilled holes 102 can also be cylindrical, planar, or multi-layered composite structures, which can be flexibly selected according to anatomical needs and clinical applications.

[0059] Please see Figure 2 , Figure 3 , Figure 4 and Figure 6 As shown, in this embodiment, the arch end of the covered stent may have a sunken structure or a non-sunken structure, with a sunken structure being preferred. The sunken structure is formed by setting a stent ring 101 with a sunken stent structure around the pre-opening 102, so that the middle section of the stent forms a local depression, which not only ensures unobstructed blood supply to the branch vessels, but also reserves operating space for the guidewire 200 to be superselectively operated.

[0060] In this embodiment, a metal ring of equal diameter can be provided on the pre-drilled hole 102 to enhance the mechanical strength of the hole and prevent deformation during or after the operation. The metal ring material can be stainless steel, nickel-titanium alloy, etc., with nickel-titanium alloy being preferred due to its good biocompatibility and shape memory effect.

[0061] To further improve intraoperative positioning accuracy, a contrast-enhancing suture, such as platinum or tantalum wire, can be wound around the metal ring to precisely locate the pre-drilled hole 102 under X-ray or DSA imaging. This contrast-enhancing suture design not only improves the safety and accuracy of the surgery but also reduces the need for surgeons to rely on experience for manual positioning.

[0062] In this embodiment, beam-shaped support rings 101 can be provided before and after the pre-drilled hole 102 to enhance the overall support force of the support and ensure the structural stability around the pre-drilled hole 102. The beam-shaped support rings 101 and non-beam-shaped support rings 101 can be used in combination according to specific needs. For example, a beam-shaped support ring 101 can be provided in front of the pre-drilled hole 102, and a non-beam-shaped support ring 101 can be provided behind it to balance the requirements of support force and flexibility.

[0063] In this embodiment, the pre-drilled hole 102 is preferably trapezoidal in shape, with a narrower top and wider bottom, which effectively prevents the edge of the pre-drilled hole 102 from collapsing and provides a stable guiding path for the guide wire 200. Furthermore, the trapezoidal structure allows for adjustment of the upper and lower side lengths according to the actual anatomical situation, further optimizing blood flow and ease of operation. Of course, the pre-drilled hole 102 can also adopt a straight cylindrical, planar, or multi-layered composite structure to adapt to the distribution and direction of different branch vessels. Multi-layered composite structures help improve the success rate of branch vessel reconstruction and reduce additional damage to the aortic wall during surgery.

[0064] Understandably, the pre-embedded guidewire 200 of the present invention can be pre-assembled into a standardized module before surgery, then crimped and loaded into the delivery system 300. During the interventional procedure, the stent is delivered to the target location in the aortic arch via a femoral artery approach. After the main covered stent is released, the delivery system 300 is withdrawn, allowing the guidewire 200 to dislodge and be exposed from the side port of the central tube 302. The operator can directly use the exposed guidewire 200 to guide the rapid exchange catheter 400 into the branch vessel to establish access without additional puncture of the carotid or brachial artery, significantly shortening the operation time and reducing the risk of stroke.

[0065] In summary, by pre-integrating the guidewire 200 with the main covered stent 100 to form an integrated "guidewire 200-stent" assembly, this invention achieves rapid, precise, and safe superselection of branch vessels, providing an innovative solution for the total endovascular treatment of complex aortic diseases.

[0066] Please see Figure 1 , Figure 2 , Figure 3 and Figure 7As shown, the present invention also proposes a covered stent delivery system, which includes a stent delivery system 300 and a main covered stent 100 pre-assembled with a guidewire 200 as described in the above embodiments. The stent delivery system 300 includes an inner tube 301, a middle tube 302, and an outer tube 303 arranged sequentially from the inside to the outside. The middle tube 302 has at least one side hole along its circumference, and the side hole extends along its axial direction. The main covered stent 100 is radially compressed and axially straightened and housed between the inner tube 301 and the outer tube 303. The guidewire 200 passes through the side hole of the middle tube 302. During interventional surgery, the stent is delivered to the target position in the aortic arch via a femoral artery approach. After the main covered stent is released, the delivery system 300 is withdrawn, allowing the guidewire 200 to dislodge from the side hole of the middle tube 302 and be exposed.

[0067] Please see Figure 1 , Figure 2 , Figure 3 and Figure 7 As shown, in this embodiment, the conveying system 300 of the present invention includes several key components, including a conical head, an inner tube 301, a middle tube 302, a reinforcing tube, an outer tube 303, a handle, a rear release mechanism, and connectors, etc., for safely and accurately conveying the main film-coated support 100 to the target position and releasing the support at the appropriate time.

[0068] The conical head is located at the very front of the delivery system 300 and is typically made of a soft and biocompatible polymer material, such as silicone or TPU (thermoplastic polyurethane), to reduce damage to the blood vessel wall and allow for smooth passage through a curved path.

[0069] The outer tube 303 is used to radially constrain the main membrane support 100, keeping it in a compressed state until it reaches the target position. The outer tube 303 can be straight or pre-bent, preferably pre-bent. The material of the outer tube 303 can be a polymer material, such as polytetrafluoroethylene, polyurethane, nylon, polyethylene, polypropylene, polyetheretherketone, polyoxymethylene resin, block polyetheramide resin, fluorinated ethylene propylene, polyvinyl chloride, thermoplastic polyurethane, silicone and related composite materials, or an alloy braided tube, such as stainless steel, nickel-titanium alloy, titanium, etc., or a composite material of the above materials, preferably a block polyetheramide resin-nickel-titanium alloy composite material, to provide excellent radial support and flexibility.

[0070] The central tube 302 is one of the core components of the delivery system 300. It has a central hole for installing the inner tube 301 and at least one side hole for installing the pre-embedded guide wire 200. In this embodiment, the central tube 302 can be straight or pre-bent, preferably pre-bent, to better adapt to the anatomical curve of the aortic arch. The material of the central tube 302 can be selected from polymer materials, such as polytetrafluoroethylene, polyurethane, nylon, polyethylene, polypropylene, polyetheretherketone, polyoxymethylene resin, block polyetheramide resin, fluorinated ethylene propylene, polyvinyl chloride, thermoplastic polyurethane, silicone and related composite materials, or alloy braided tubing, such as stainless steel, nickel-titanium alloy, titanium, etc., or composite materials of the above materials, preferably block polyetheramide resin-nickel-titanium alloy composite material, which has both good flexibility and strength. In this embodiment, the central tube 302 can be configured as a multi-hole through-hole tube structure, that is, it can have multiple side holes, so as to install multiple guide wires 200. Each side hole can install one or more pre-embedded guide wires 200, preferably one, to ensure the operational independence and accuracy of each guide wire 200.

[0071] The inner tube 301 can be made of polyetheretherketone (PEEK) or alloy tubing, such as stainless steel, nickel-titanium alloy, titanium, or alloy braided tubing. Nickel-titanium alloy braided tubing is preferred because it has excellent flexibility and anti-kink properties, which helps to improve the efficiency of pushing force transmission.

[0072] Please see Figure 1 , Figure 2 , Figure 3 , Figure 7 , Figure 8 and Figure 9 As shown, the present invention also proposes an interventional system for aortic branch reconstruction, including a covered stent delivery system as described in the above embodiments, and a rapid exchange catheter 400. The rapid exchange catheter 400 has at least one side hole circumferentially opened in its tube body, and the side hole extends axially. After the main covered stent 100 is released and the delivery system is withdrawn, the guidewire 200 is exposed outside the body, and the rapid exchange catheter docks with the guidewire through its side hole to establish a rapid exchange pathway, thereby realizing rapid superselection and access establishment of branch vessels. The pre-embedded guidewire 200 of the present invention can be pre-assembled into a standardized module before the operation, and then pressed and loaded into the delivery system 300. During the interventional procedure, the main covered stent 100 is delivered to the target position through stent delivery and the main covered stent is released. Then the delivery system 300 is withdrawn, so that the guidewire 200 is dislodged from the side hole of the central tube 302 and exposed. The operator can directly use the exposed guidewire 200 to guide the rapid exchange catheter 400 into the branch vessel to complete the access establishment without additional puncture of the carotid or brachial artery, which significantly shortens the operation time and reduces the risk of stroke.

[0073] In this embodiment, the outer diameter of the rapid exchange catheter 400 is 4F to 8F, preferably 6F, to accommodate different sized vascular pathways; the length is 0.5m to 2m, preferably 1.2m, to ensure that it can extend from the femoral artery approach to the branch vessels of the aortic arch. The rapid exchange catheter 400 has several side holes, more than or equal to one, located within a range of 1cm to 199cm from the tip. The diameter of each side hole is 0.1mm to 1mm, preferably 0.5mm, and the shape can be circular, elliptical, or other regular or irregular shapes. Elliptical shapes are preferred to reduce stress concentration and improve the smoothness of guidewire 200 sliding. The circumferential position of the side holes can be arbitrarily set according to actual needs to adapt to different vascular anatomy structures.

[0074] The main body material of the rapid exchange catheter 400 can be a polymer material, such as polytetrafluoroethylene, polyurethane, nylon, polyethylene, polypropylene, polyetheretherketone, polyoxymethylene resin, block polyetheramide resin, fluorinated ethylene propylene, polyvinyl chloride, thermoplastic polyurethane, and silicone; or it can be a metal braided tube, such as stainless steel, nickel-titanium alloy, titanium, etc.; or it can be a polymer-metal braided tube composite material. A block polyetheramide resin-nickel-titanium alloy composite material is preferred to balance flexibility, flexural strength, and delivery efficiency.

[0075] In this embodiment, the tip of the rapid exchange catheter 400 may have a radiopaque area, achieved by wrapping gold, platinum, or tantalum wire or coating, to accurately locate the catheter position under X-ray. Furthermore, the tip may be pre-bent with a bending angle of 15° to 90° and a radius of curvature of 2 mm to 20 mm to adapt to the anatomical course of the aortic arch branches, improving operational flexibility and accuracy.

[0076] In this embodiment, a guide transition tube 401 can be optionally installed on the side hole of the rapid exchange catheter 400 to facilitate the insertion of the guidewire 200. The diameter of the guide transition tube 401 is 0.1 mm–1 mm, preferably 0.3 mm; the length is 1 mm to 2000 mm, preferably 500 mm. The material of the guide transition tube 401 can be a polymer material, such as polytetrafluoroethylene, polyurethane, nylon, polyethylene, polypropylene, polyetheretherketone, polyoxymethylene resin, block polyetheramide resin, fluorinated ethylene propylene, polyvinyl chloride, thermoplastic polyurethane, and silicone, or it can be a metal braided tube, such as stainless steel, nickel-titanium alloy, titanium, etc., or it can be a polymer-metal braided tube composite material, preferably polytetrafluoroethylene, because it has good lubricity and biocompatibility.

[0077] Please see Figure 1 , Figure 2 , Figure 3 , Figure 7 and Figure 8In Embodiment 1, this embodiment provides a covered stent delivery system with a pre-embedded guidewire 200, suitable for treating complex lesions involving the three branches of the aortic arch (brachial artery, left common carotid artery, and left subclavian artery), such as type A aortic dissection or aortic ulcer. The main covered stent 100 is a self-expanding covered stent, composed of a nickel-titanium alloy braided skeleton and an ePTFE covering, and is divided into an ascending aortic segment, an arch segment, and a descending aortic segment along the axial direction. Three pre-drilled openings 102 are provided in the arch segment, corresponding to the brachiocephalic artery, the left common carotid artery, and the left subclavian artery, respectively. The diameters of the three pre-drilled openings 102 are 30mm, 10mm, and 20mm, respectively, and the height is 5mm. The structure is trapezoidal to provide good blood flow channels and reduce edge stress concentration. Two metal rings are provided on each pre-drilled opening 102. The metal rings are made of nickel-titanium alloy and are wound with radiopaque lines, which can clearly show the position and direction of the opening under imaging, facilitating precise intraoperative positioning.

[0078] In this embodiment, three guidewires 200 are configured, all of which are single-stranded structures made of nickel-titanium alloy with a wire diameter of 0.3 mm and an effective length of 1.5 m. The proximal ends of the three pre-embedded guidewires 200 are installed on the greater curvature side of the descending aorta covered by the covered stent. The ends of the pre-embedded guidewires 200 are spherically treated and oriented towards the descending aorta. The distal ends of the guidewires 200 are also spherically treated to form smooth, spherical tips to prevent damage to the vascular intima. The routes of the three guidewires 200 are adapted to the anatomical directions of the brachiocephalic artery (right anterior superior), the left common carotid artery (direct superior), and the left subclavian artery (left posterosuperior), respectively.

[0079] The conveying system 300 includes components such as a conical head, an inner tube 301, a middle tube 302, a reinforcing tube, an outer tube 303, a handle, a rear release mechanism, and connectors. Specifically: the outer tube 303 is a pre-bent structure made of PEBAX and is used to radially constrain the compressed main film-coating support 100; the inner tube 301 is a pre-bent nickel-titanium alloy tube used to support the support and accommodate the central guide wire 200; the middle tube 302 is a straight structure made of PP (polypropylene) and has a central hole for the inner tube 301 to pass through, as well as four side holes. Three pre-embedded guide wires 200 are respectively inserted into the three side holes and are constrained inside the middle tube 302 or attached to its outer wall during conveying; the handle is used to control the outer tube 303 to retract and release the support, and the rear release mechanism is used to release the fixed connection between the support and the inner tube 301.

[0080] During the procedure, the system is delivered to the target location in the aortic arch via the femoral artery approach. Rotating the handle retracts the outer cannula 303, causing the main covered stent to expand and deploy automatically, securing itself to the aortic wall. Pulling the release mechanism separates the stent from the inner cannula 301. Subsequently, the middle cannula 302 is retracted, and the three pre-embedded guidewires 200 can be controllably slid out from the side holes of the middle cannula 302 and exposed near the orifices of each branch vessel, naturally pointing towards the target vessel.

[0081] The rapid exchange catheter 400, used to establish branch vessel access, has an outer diameter of 7F and a length of 1.5m. A guide transition tube 401 is detachably mounted on its side port. The guide transition tube 401 has a side port with a diameter of 0.5mm. The guide transition tube 401 has a length of 500mm, a diameter of 0.5mm, and is made of polytetrafluoroethylene. In use, the exposed pre-embedded guidewire 200 is inserted from the proximal end of the guide transition tube 401, passes through the lumen to the distal end, and then the guide transition tube 401 is removed, forming the guidewire 200 access. The operator fixes the pre-embedded guidewire 200 and maintains axial tension, and pushes the rapid exchange catheter 400 along the guidewire 200 into the target branch vessel to complete the access establishment.

[0082] This embodiment achieves three-branch vascular reconstruction via the entire femoral artery approach through an integrated design of pre-embedded guidewire 200, trapezoidal pre-opening window, and rapid exchange catheter 400, without the need for carotid or brachial artery puncture. It significantly shortens the superselection time of guidewire 200 from the traditional >30 minutes to <5 minutes, reducing the risk of stroke and improving the safety and efficiency of the operation.

[0083] Please see Figure 1 , Figure 9 , Figure 10 , Figure 11 and Figure 12 In Example 2, the basic structure of this example is similar to that of Example 1, but the design has been optimized for clinical scenarios where some branch vessels are anatomically offset or only two vessels need to be reconstructed. The focus is on the adjustment of the pre-drilled hole 102 structure, the guide wire 200 layout and the delivery system 300 material to improve the system's adaptability and operational flexibility.

[0084] The main covered stent 100 is still a self-expanding covered stent, composed of a nickel-titanium alloy braided skeleton and an ePTFE covering. Three pre-drilled openings 102 are provided in the arch segment, corresponding to the brachiocephalic artery, left common carotid artery, and left subclavian artery, respectively, with diameters of 15 mm, 10 mm, and 13 mm, and a height of 10 mm. Unlike Embodiment 1, the pre-drilled openings 102 employ a multi-layered composite structure: the lower layer is a trapezoidal structure to provide blood flow pathways and reduce edge stress; the upper layer is a straight cylindrical structure to enhance the rigidity of the opening and prevent collapse. This composite structure balances hemodynamic performance and mechanical stability. Each pre-drilled opening 102 is provided with a metal ring made of nickel-titanium alloy, wound with radiopaque lines for precise intraoperative positioning of the opening. Furthermore, a beam-shaped stent ring 101 is provided around the pre-drilled openings 102 to enhance the overall support of the stent arch segment, ensuring good apposition and opening morphology even on the curved aortic arch.

[0085] This embodiment uses two guidewires 200, both single-stranded, made of nickel-titanium alloy, with a wire diameter of 0.4 mm and an effective length of 2 m to accommodate longer delivery paths. The two guidewires 200 are fixed to the proximal and distal ends of the covered stent, respectively. The proximal guidewire 200 is angled at 30° after fixation, meaning its extension direction is deflected 30° relative to the stent axis to adapt to the specific anatomical course of the brachiocephalic artery or left common carotid artery, improving guidance accuracy. The distal end of the guidewire 200 is also spheroidized to ensure biocompatibility.

[0086] The delivery system 300 has also been adjusted in terms of structure and materials: the outer tube 303, inner tube 301, and middle tube 302 are all straight structures, which are suitable for scenarios where the lesion is relatively flat or where the surgeon prefers straight tube operation; the outer tube 303 is made of a composite material of block polyether amide resin and stainless steel braided mesh, which has both flexibility and radial support force, effectively preventing the stent from expanding unexpectedly during delivery; the inner tube 301 is made of stainless steel alloy, providing stable axial pushing force; the middle tube 302 is made of nylon, with a central hole for the inner tube 301 to pass through, and three side holes, with two pre-embedded guide wires 200 passing through the two side holes respectively, which are constrained inside the middle tube 302 during delivery.

[0087] The surgical procedure is similar to that in Example 1: the stent is delivered to the target location via the femoral artery approach, the outer tube 303 is withdrawn to release the main covered stent, the release mechanism is pulled to separate the stent from the inner tube 301, and then the middle tube 302 is withdrawn so that the two pre-embedded guide wires 200 can be controlled to be exposed from the side holes of the middle tube 302, naturally pointing to the corresponding branch vessels.

[0088] The rapid exchange catheter 400 has an outer diameter of 6F and a length of 1.1m, suitable for establishing medium-length access routes. A guide transition tube 401 is detachably installed on the side port. The guide transition tube 401 has an elliptical side port with a diameter of 0.9mm and a mating length of 20mm. It is made of polyethylene and features good lubricity and flexibility. The short length design facilitates quick installation and removal. In use, the exposed pre-embedded guidewire 200 is inserted into the side port of the rapid exchange catheter 400 through the guide transition tube 401. After removing the guide transition tube 401, the catheter is pushed along the guidewire 200 into the target branch vessel.

[0089] This embodiment achieves precise adaptation to specific anatomical structures by adopting a two-stage pre-drilled hole 102 structure, a dual-positioning guidewire 200 layout, and a straight composite delivery system 300. It is especially suitable for cases where branch vessels deviate, the lesion range is limited, or the surgeon prefers straight tube operation, demonstrating the modularity and customizability advantages of the system of this invention.

[0090] Please seeFigure 1 , Figure 13 , Figure 14 and Figure 15 In Embodiment 3, this embodiment is similar to Embodiment 1 in basic architecture, but it has been optimized to meet the clinical needs of enhancing the support of the guidewire 200 and improving the adaptability of the rapid exchange catheter 400. The main differences are: the adoption of a straight pre-drilled structure 102, the configuration of a double-strand pre-embedded guidewire 200, the guidewire 200 being fixed to a beam-shaped stent ring 101, the multi-side hole layout of the central tube 302 of the delivery system 300, and the rapid exchange catheter 400 being equipped with a dual-side hole design, which further improves the guiding stability and operational compatibility of the system.

[0091] The main covered stent 100 is a self-expanding covered stent, composed of a nickel-titanium alloy braided skeleton and an ePTFE covering. Three pre-drilled holes 102 are provided in the arch segment, corresponding to the brachiocephalic artery, left common carotid artery, and left subclavian artery, respectively, with diameters of 18 mm, 11 mm, and 20 mm and a height of 7 mm. Unlike the trapezoidal structure of Embodiment 1, the pre-drilled holes 102 in this embodiment adopt a straight cylindrical structure, i.e., the hole wall is perpendicular to the stent axis, featuring simple structure, high processing precision, and stable hole morphology, suitable for cases with regular branch vessel openings and clear blood flow directions. Two metal rings, made of nickel-titanium alloy, are provided on each pre-drilled hole 102, wound with radiopaque lines for precise intraoperative positioning of the opening location and direction. Furthermore, a beam-shaped stent ring 101 is provided around the pre-drilled holes 102 to enhance local structural rigidity, prevent stent deformation on the curved aortic arch, and ensure that the pre-drilled holes 102 remain aligned with the target branch vessels.

[0092] This embodiment uses three guidewires 200, all of which are double-stranded. The guidewires 200 are made of polypropylene, with a diameter of 0.8 mm and an effective length of 2 m. Polypropylene has good flexibility, creep resistance, and biocompatibility, making it suitable for fabricating folded structures and maintaining morphological stability in vivo over a long period. The three double-stranded guidewires are respectively fixed to the beam-shaped support rings 101 corresponding to each pre-drilled hole 102, and are releasablely connected via polypropylene sutures. This fixing method makes full use of the support structure anchor points, enhancing connection reliability while avoiding perforation damage to the membrane.

[0093] The delivery system 300 adopts a pre-bent design to adapt to the natural curvature of the aortic arch: the outer tube 303 is made of a composite material of PEBAX and nickel-titanium braided mesh, which has excellent flexibility, flexural strength and radial support; the inner tube 301 is made of PEEK, which has high strength, low coefficient of friction and good pushing performance; the middle tube 302 is made of polyethylene, with a central hole for the inner tube 301 to pass through and seven side holes for installing pre-embedded guide wires 200. The three guide wires 200 are guide wire 210, guide wire 220 and guide wire 230. The two strands of guide wires 210, 220 and 230 are respectively passed through one side hole, that is, each double-strand guide wire 200 occupies two side holes (double wires pass through side by side), and the three guide wires 200 occupy a total of 6 side holes. The pre-bent structure of the middle tube 302 ensures coordinated advancement with the outer tube 303 and inner tube 301, reducing torque loss.

[0094] During the procedure, after the main covered stent is released, the central tube 302 is retracted, and the double-stranded pre-embedded guidewire 200 is controllably exposed from the side hole of the central tube 302. Its parallel double-line structure provides stronger axial support, which is conducive to the stable pushing of the subsequent rapid exchange catheter 400.

[0095] The rapid exchange catheter 400 has an outer diameter of 6F and a length of 1.1m, suitable for establishing access to medium-distance branch vessels. A guide transition tube 401 is detachably installed on the side port. Unlike the previous two embodiments, this embodiment's guide transition tube 401 has two side ports: one with a diameter of 0.8mm closer to the heart and one with a diameter of 0.9mm further to the heart. The guide transition tube 401 is made of polytetrafluoroethylene, 20mm in length and 1mm in diameter, possessing excellent lubricity and rigidity, facilitating the insertion and rapid removal of the guidewire 200. In use, the exposed double-stranded pre-embedded guidewire 200 can be inserted into either side port, or one side port can be selectively used for single-vessel superselection, allowing for flexible operation.

[0096] This embodiment significantly enhances the mechanical stability and operational flexibility of the guidewire 200 system by employing a dual-strand polypropylene guidewire 200, a beam-shaped stent ring 101 for fixation, a multi-side-hole central tube 302 design, and a dual-side-hole rapid exchange catheter 400. It is particularly suitable for complex interventional scenarios where branch vessels are tortuous, require high support force for pushing, or require multiple path selection, further expanding the clinical applicability of the technical solution of this invention.

[0097] This invention provides a covered stent system with a pre-embedded guidewire 200 and its interventional method. By pre-integrating the guidewire 200 into the main covered stent 100 and coordinating it with a dedicated delivery system 300 and a rapid exchange catheter 400, it achieves endovascular and subluminal access treatment for complex aortic arch lesions. Compared with the prior art, this invention has the following outstanding innovative features and technical advantages: The entire procedure utilizes a lower access route, avoiding upper access puncture. Specifically, this invention employs a femoral artery approach to complete the main covered stent deployment and branch vessel reconstruction, eliminating the need for upper access via carotid or brachial artery punctures, thus avoiding additional damage to the vessels of the upper limbs and head and neck. Traditional upper access punctures easily disturb atherosclerotic plaques in the carotid or subclavian arteries, leading to plaque detachment and stroke. This invention completely avoids such procedures, significantly reducing the risk of intraoperative stroke, and is particularly suitable for elderly patients with severe arteriosclerosis.

[0098] The pre-embedded guidewire 200 module design of the main covered stent 100 achieves access sharing and zero additional operations. Specifically, the pre-embedded guidewire 200 is embedded in the side hole of the central tube 302 of the delivery system 300 during delivery, sharing the same vascular access with the main covered stent. There is no need to establish a separate guidewire 200 channel or perform independent puncture, which greatly simplifies the surgical procedure. After the main covered stent is released, only the delivery system 300 needs to be withdrawn to allow the pre-embedded guidewire 200 to be controllably exposed from the side hole of the central tube 302, realizing an integrated operation of "stent release and guidewire 200 placement". There is no need for additional steps of pushing or exchanging the guidewire 200, reducing the complexity and time of operation.

[0099] The pre-embedded guidewire 200 has self-positioning capabilities. Specifically, one end of the pre-embedded guidewire 200 is fixed near the pre-drilled hole 102 of the main covered stent 100. After the main covered stent is accurately released and adheres to the wall, the distal end of the guidewire 200 naturally points to the corresponding branch vessel opening, achieving automatic orientation and spatial positioning. There is no need to use a catcher, guiding catheter, or other auxiliary instruments to position or catch the guidewire 200, reducing the high dependence on complex instruments and the doctor's experience and improving the standardization of the surgery.

[0100] The free end of the pre-embedded guidewire 200 is controllable, supporting precise movement of the rapid exchange catheter 400. Specifically, the free end of the exposed pre-embedded guidewire 200 can be manually controlled by the operator to maintain axial tension, serving as a guide track for the rapid exchange catheter 400. When the rapid exchange catheter 400 is pushed along the pre-embedded guidewire 200, it can achieve stable, precise, and low-resistance entry into branch vessels, significantly improving the success rate and safety of access establishment.

[0101] The modular pre-embedded guidewire 200 design is adaptable to multi-branch reconstruction needs. Specifically, the number of pre-embedded guidewires 200 can be flexibly configured according to clinical needs, for example, 1 to 3 wires, corresponding to different branches of vessels such as the brachiocephalic artery, left common carotid artery, and left subclavian artery. It supports the combined use of single-strand and double-strand guidewires 200, as well as the selection of different materials and fixation methods, forming a modular and customizable treatment plan suitable for various complex lesions such as type A dissection, aortic ulcer, and intramural hematoma.

[0102] In summary, this invention can significantly shorten the operation time and improve the efficiency of operation. This invention realizes "immediate placement and selection" of branch vessels, reducing the guidewire superselection time of the traditional technique from an average of more than 30 minutes to less than 5 minutes, greatly improving the efficiency of operation and reducing the patient's X-ray exposure time and anesthesia risk.

[0103] This invention can reduce trauma and complications. The entire treatment is performed through the femoral artery, avoiding carotid or brachial artery incisions, thus reducing patient trauma, bleeding risk and postoperative infection probability.

[0104] This invention can reduce the risk of stroke. This invention does not involve the operation of the brachial artery, carotid artery, or brachiocephalic artery, effectively avoiding cerebral infarction caused by plaque detachment and improving surgical safety.

[0105] This invention is compatible with existing system structures and is easy to industrialize. Without changing the main structure of the existing main film-coated support 100 and the basic configuration of the delivery system 300, this invention can achieve functional upgrades simply by adding pre-drilled holes 102, integrating pre-embedded guide wires 200 and optimizing the side hole design of the central tube 302. It has good engineering compatibility and industrialization prospects.

[0106] This invention can promote the standardization of interventional therapy. It transforms the manual superselective procedure, which is highly dependent on the doctor's experience, into a standardized process of pre-implantation guidance and rapid exchange, thereby lowering the surgical threshold and facilitating the promotion of the technology in primary hospitals.

[0107] 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 membrane-covered stent with pre-embedded guide wires, characterized in that, include: A primary coating support having at least one pre-opening; At least one guidewire, which is at least partially located at the pre-drilled opening and releasably connected to the main overlay support.

2. The membrane-covered stent with pre-embedded guide wires according to claim 1, characterized in that, The guidewire can be single-strand or multi-strand, wherein the multi-strand guidewire is a multi-line structure formed by folding the same guidewire in half.

3. The membrane-covered stent with pre-embedded guide wires according to claim 1, characterized in that, The distal or intermediate section of the guidewire passes through the pre-drilled hole and extends toward the target branch vessel.

4. The membrane-covered stent with pre-embedded guide wires according to claim 1, characterized in that, The main film-coated support has a reinforcing structure around the pre-drilled hole, and the reinforcing structure is at least one of a metal ring, a beam-shaped support ring, or a sunken support structure.

5. The membrane-covered stent with pre-embedded guide wires according to claim 4, characterized in that, The metal ring is wound with developing lines to accurately locate the pre-drilled hole position under image guidance.

6. The membrane-covered stent with pre-embedded guide wires according to claim 1, characterized in that, One end of the guidewire is fixed to the membrane, stent ring, or reinforcing structure around the pre-drilled hole of the main covered stent via one or more flexible connectors. The flexible connectors are detachable ropes or sutures that enable a releasable connection with the main covered stent.

7. The membrane-covered stent with pre-embedded guide wires according to claim 1, characterized in that, The end of the guidewire is configured with a spherical structure.

8. The membrane-covered stent with pre-embedded guide wires according to claim 1, characterized in that, The guide wire is made of at least one of the following materials: nickel-titanium alloy, stainless steel, cobalt-chromium alloy, polypropylene, polylactic acid, polyglycolic acid, polydioxane, polydioxane, and polyethylene terephthalate.

9. A film-coated stent delivery system, characterized in that, include: A support conveying system, comprising an inner tube, a middle tube, and an outer tube arranged sequentially from the inside to the outside, wherein the middle tube has at least one side hole along its circumference and the side hole extends along its axial direction; The covered stent as described in any one of claims 1 to 8, wherein the main covered stent of the covered stent is compressed radially and straightened axially and then housed between the inner tube and the outer tube; The guide wire of the membrane-covered stent is inserted into the side hole of the central tube.

10. An interventional system for aortic branch reconstruction, characterized in that... ， The film-coated stent delivery system as described in claim 9; A rapid exchange catheter, wherein the tube body of the rapid exchange catheter has at least one side hole in the circumferential direction and the side hole extends in the axial direction; in, After the main covered stent is released and the delivery system is withdrawn, the guidewire is exposed in vitro, and the rapid exchange catheter docks with the guidewire through its side holes to establish a rapid exchange pathway.

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