Aortic rapid repair stent, stent kit and delivery system

Abstract

The present application discloses an aortic rapid repair stent, a stent kit and a delivery system. The stent of the present invention includes a stent body and a channel surrounded by the stent body, and is characterized in that the stent body has a woven mesh structure, the mesh of the mesh structure is expandable and deformable, and the widest part of the mesh is at least 1 mm when not expanded. The stent of the present invention can quickly alleviate the risk of arterial dissection or aneurysm in the aorta with branched blood vessels by applying a woven, high-elastic mesh with large support force, thereby avoiding the risk of the stent blocking the blood flow of the branched artery on the one hand, and on the other hand, can quickly repair the aorta in advance, reduce the surgical risk and the technical difficulty of the operation, thereby winning precious treatment time for the patient.

Description

Technical Field

[0001] The present invention relates to a stent placed in the aorta, in particular a stent placed in the aortic arch and abdominal aorta for treating aortic dissection or aortic aneurysm. Background Art

[0002] The arterial wall is composed of a tightly fitted intima, media, and adventitia. When the arterial wall is locally damaged, the strong impact of arterial blood flow gradually causes the media to peel away, allowing blood to enter between the media and adventitia, creating two lumens: a true and a false lumen. The most common cause of this is aortic dissection. Aortic dissection weakens the arterial wall, leaving it at risk of rupture. Once a dissection ruptures, it can lead to death within minutes.

[0003] An aortic aneurysm is an abnormal dilation of the aorta, and a ruptured aortic aneurysm can be fatal.

[0004] Therefore, early diagnosis and timely treatment of aortic dissection and aortic aneurysm are very necessary.

[0005] For aortic dissection and aortic aneurysm involving the aortic arch, descending aorta, and / or abdominal aorta, stents can be used to isolate the damaged area. The advantages of stenting are minimal trauma, minimal bleeding, rapid recovery, and low mortality. Compared with traditional open surgery, stenting reduces the incidence of perioperative complications.

[0006] The convex side of the aortic arch, from the heart, has three major branches: the brachiocephalic trunk (also known as the innominate artery, which branches into the right common carotid artery and right subclavian artery), the left common carotid artery, and the left subclavian artery. The abdominal aorta has many more branches, such as the middle adrenal artery, renal arteries, celiac trunk, superior mesenteric artery, inferior mesenteric artery, inferior phrenic artery, lumbar artery, and median sacral artery. It branches into the left and right iliac arteries at its terminal end.

[0007] During stent placement surgery, important branch arteries, particularly the brachiocephalic trunk, left common carotid artery, left subclavian artery, left and right renal arteries, and celiac artery, must not be blocked by the stent, as this can cause serious complications or even death to the patient. Therefore, conventional practice involves creating holes in the aortic stent corresponding to important branch arteries and aligning the holes with the branch arteries before releasing the stent. This increases the difficulty of the procedure and requires highly experienced surgeons to perform. Furthermore, if the placement is inaccurately positioned or the stent shifts during release, occluding a critical branch vessel can have serious consequences.

[0008] In addition, the relative position of the branch arteries varies from person to person, especially the relative position of the branch arteries on the abdominal aorta is often different for different people. This requires the position of the branch blood vessels on the aorta of each patient to be measured in advance and customized with the stent manufacturer. Even so, due to movement or different postures, the position of the blood vessels will shift. During surgery, the specific position of the blood vessels may deviate from the opening position of the customized stent. To avoid this situation, experienced surgeons will make holes in the stent during surgery (pre-windowing or in situ windowing). However, this practice is often not recognized by stent manufacturers, and there is also a greater risk of deviation.

[0009] Current treatments for aortic dissection and aortic aneurysm face the following challenges: First, aortic dissection causes the true aortic lumen to concave inward, while aortic aneurysm causes the true aortic lumen to protrude outward, leading to issues with the blood supply to the false lumen of some branches of the aortic dissection. Second, as mentioned above, stent therapy can present difficulties in aligning the branches or complicate the surgical procedure.

[0010] Because aortic dissection or aortic aneurysm can rupture at any time, and branch arteries cannot be blocked for long periods of time, early surgery and rapid intraoperative stent placement are crucial for patients. While stenting offers numerous advantages for treating aortic dissection, it remains difficult, risky, and inefficient in performing the surgery.

[0011] Although numerous improvement plans have been proposed to solve one or more of the above problems, due to the presence of many important branch arteries in the aortic arch and abdominal aorta, the stents that need to be placed are complex in structure and large in number, resulting in the operation time still not being effectively shortened. Summary of the Invention

[0012] In view of this, the main purpose of the present invention is to provide a stent that, once placed, can greatly alleviate the risk of arterial dissection or aneurysm in the aortic arch and / or abdominal aorta, and does not have the risk of blockage of branch arteries due to surgery, thereby buying time for treatment.

[0013] To this end, a first aspect of the present invention provides a stent comprising a stent body and a channel enclosed by the stent body, wherein the stent body has a woven mesh structure, the meshes of the mesh structure are expandable and deformable, and the widest part of the meshes is at least 1 mm when not expanded.

[0014] The stent body of this invention features a highly elastic, woven mesh structure with highly elastic, expandable meshes. This provides support to the treatment area without obstructing blood flow. Furthermore, because each mesh can expand and deform, subsequent branch stent placement is facilitated without the need for accurate positioning of branch vessels, ensuring smooth blood flow throughout each branch artery during surgery.

[0015] The widest part of the mesh may have a width of 1 to 5 mm, preferably 2 to 3 mm.

[0016] According to one embodiment, the stent body can be woven from wires with a diameter of 0.05 to 0.5 mm, preferably 0.1 to 0.4 mm. The wires can be made of a material selected from metal, medical polymers, or biodegradable materials.

[0017] Examples of metal materials include, but are not limited to, shape memory alloys (such as Nitinol) and cobalt-chromium alloys. Examples of medical polymers include, but are not limited to, nylon, polyester, polytetrafluoroethylene, polyacrylates, and polyolefins. The stent material of the present invention is preferably a nickel-titanium alloy.

[0018] According to one embodiment, the mesh, after expansion, allows a stent delivery device having an outer diameter of at least 4.8 mm to pass through.

[0019] The stent of the present invention can have a length of 10 to 500 mm, preferably 100 to 300 mm, and a diameter of 25 to 55 mm in the deployed state. Stents of the present invention having the aforementioned length and diameter ranges are suitable for treating any part of the aorta. The specific dimensions may vary depending on the specific treatment site.

[0020] According to one embodiment, the stent body of the stent of the present invention at least partially comprises a coated area and a non-coated area, wherein when the stent is released in a treatment site, the non-coated area at least corresponds to a site having a branched artery.

[0021] The coated stent can have a rapid relief effect, especially for aortic aneurysms, and also has a better effect on the repair of aortic dissection.

[0022] According to one embodiment, the film may also have a developing function.

[0023] Since there is no coating at the portion corresponding to the branch artery, the coated stent of the present invention is also easy to deploy and can be placed quickly and simply to ensure blood supply to the branch artery during surgery.

[0024] The membrane of the coating area can be formed of a biocompatible polymer, and the present invention is not particularly limited thereto. Preferably, the membrane can be formed of a material selected from polytetrafluoroethylene, polyester, and polyurethane. Preferably, the membrane is polyurethane, in particular, formed of thermoplastic polyurethane.

[0025] The film may have a thickness of 0.01 to 0.3 mm, preferably 0.05 to 0.1 mm.

[0026] According to one specific embodiment, the stent has a proximal end and a distal end, wherein the proximal end has a diameter that gradually decreases from 40-55 mm to 30-38 mm, while the distal end has a generally constant diameter of 28-38 mm. This embodiment of the stent is more suitable for treating aortic arch conditions. The gradually decreasing diameter of the proximal end conforms to the human anatomy and can better support the aorta on the cardiac side.

[0027] In this embodiment, the proximal end portion may have a length of 10 to 100 mm, preferably 10 to 20 mm. The distal end portion may have a length in a wide range of 20 to 300 mm, preferably 40 to 60 mm, depending on actual needs.

[0028] According to another embodiment, the stent is suitable for the visceral vascular area from the ascending aorta to the abdominal aorta including the aortic arch, and the stent has a coated area at least on the greater curvature side of the aortic arch, provided that after the stent is released, at least the area corresponding to the branch artery on the greater curvature side has a non-coated area.

[0029] Since there is no coating at the portion corresponding to the branch artery, the coated stent of the present invention is also easy to deploy and can be placed quickly and simply to ensure blood supply to the brain during surgery.

[0030] Specifically, the length of the stent with the coating portion is 10 to 300 mm. The area of ​​the coating can be determined based on the specific treatment needs. According to a preferred embodiment, the stent further has a developing mark on the greater curvature side to facilitate stent positioning.

[0031] A second aspect of the present invention provides a stent kit, which includes the stent described above and at least one branch stent.

[0032] The branch stent in the stent kit of the present invention is not particularly limited and can be any suitable branch stent commonly used.

[0033] The stent kit of the present invention reduces the risk of arterial rupture by pre-positioning the aforementioned stent at the aortic treatment site, thereby buying time for further stent placement. Therefore, in addition to the branch stent, the stent kit of the present invention may further include other stents for the aortic treatment site. These stents can be any conventionally used suitable stents. For example, but not limited to, stents for bifurcated sub-channels of the abdominal aorta, stents for iliac artery branches to maintain patency of the internal iliac artery (IBD), etc.

[0034] A third aspect of the present invention provides a stent delivery system, comprising a delivery catheter and the above-mentioned stent, wherein the stent is retained in the delivery catheter in a releasable delivery configuration.

[0035] The stent delivery system of the present invention has no particular limitation on the structure of the delivery catheter. Any suitable delivery catheter can be used to deliver the stent of the present invention, thereby forming a stent delivery system together with the stent of the present invention.

[0036] According to one embodiment, the delivery catheter has a proximal end, a distal end, and a hollow lumen extending therebetween, the stent being releasably retained in the hollow lumen of the proximal end of the delivery catheter in a delivery configuration, wherein the delivery catheter comprises at least one set of a first guidewire opening, a second guidewire opening, and a slit corresponding to at least one opening of the stent, wherein:

[0037] The first guidewire opening is provided on the delivery catheter wall corresponding to the delivery configuration maintained at

[0038] an opening in the stent in the delivery catheter;

[0039] The second guidewire opening is provided at the distal end of the delivery catheter, and

[0040] The slit is provided along the longitudinal direction of the delivery catheter between the first guide wire opening and the delivery catheter.

[0041] on the wall of the delivery catheter between the proximal ends of the catheter; and

[0042] The stent delivery system further includes at least one guidewire tube, which is movably and removably disposed in the hollow cavity of the delivery catheter and extends between the first guidewire opening and the second guidewire opening.

[0043] According to one embodiment, when the stent is held in the hollow lumen of the delivery catheter in the delivery configuration, the guidewire tube can extend from the corresponding first guidewire opening through the corresponding opening on the stent into the inner space of the stent and further extend to the second guidewire opening.

[0044] According to one embodiment, the guide wire tube can pass through the corresponding first guide wire opening and / or the second guide wire opening when needed.

[0045] In the stent placement method described in detail below, the guidewire tube can be removed through the corresponding second guidewire opening after the guidewire is positioned at the desired treatment site, thereby facilitating subsequent stent release.

[0046] The stent delivery system of this embodiment, combined with the stent design of the present invention, can achieve rapid stent placement and reduce the risk of blockage of branch vessels during stent placement, thereby gaining valuable treatment time for patients.

[0047] According to the present invention, the wire guide tube may have an outer diameter of 2 to 6 mm and an inner diameter of 1.7 to 5.8 mm.

[0048] According to one embodiment, the delivery catheter may also have a third guidewire opening provided at the distal end of the delivery catheter, and the third guidewire opening is configured to allow a guidewire to pass through the hollow cavity of the delivery catheter through the third guidewire opening and guide the stent delivery system to the treatment site.

[0049] In the stent placement method described in detail below, a guidewire that has been previously positioned at the treatment site may have one end outside the patient's body passed into the delivery catheter and out through the third guidewire opening, thereby guiding the stent delivery system to the treatment site.

[0050] Furthermore, a pushing rod is coaxially arranged in the hollow cavity of the delivery catheter, and the pushing rod is configured to be operably connected to the delivery catheter so as to completely or partially release the stent when the pushing rod is manipulated.

[0051] According to a specific embodiment, the slit is configured to have a slit width that allows the wire guide tube to pass through.

[0052] As described in detail below in the stent placement method, when releasing the stent, the delivery catheter moves relative to the stent, while the guidewire for positioning the branch vessel can remain in the slit, thereby remaining relatively fixed relative to the stent and the branch vessel.

[0053] The delivery catheter of the stent delivery system of the present invention may further include an inner catheter, and the stent may be arranged in the space between the delivery catheter and the inner catheter.

[0054] A fourth aspect of the present invention further provides a method for treating or preventing aortic dissection or aortic aneurysm, comprising the step of placing the stent of the present invention at a treatment site of the aorta.

[0055] The method further comprises the step of placing a further aortic stent and / or branch stent into at least one branch artery at the treatment site.

[0056] The treatment site is any artery with branched arteries. The artery can be a blood vessel, a lymphatic vessel, etc. The treatment site of the present invention particularly refers to a blood vessel, in particular, the aortic arch or the abdominal aorta.

[0057] According to one embodiment of the stent delivery system, the stent placement method comprises the following steps:

[0058] guiding the stent delivery system to the treatment site via a first guidewire;

[0059] Extending a second guidewire from the first guidewire opening through the guidewire tube and guiding the stent delivery system so that the first guidewire opening on the delivery catheter is substantially aligned with the branch vessel at the treatment site;

[0060] at least partially releasing the stent (and optionally, substantially aligning the uncoated region of the released stent with the opening of the branch vessel in the main vessel), and withdrawing the guidewire through a second guidewire opening;

[0061] Under the guidance of the second guidewire, the branch stent delivery system is passed through the hollow cavity of the delivery catheter and one mesh of the stent to place the branch stent into the branch vessel;

[0062] The first guidewire and the delivery catheter are withdrawn from the patient.

[0063] According to a specific embodiment, the first and / or second guidewire can be introduced into the stent delivery system through an adjustable bend catheter, a catcher (or snare), or a single-bend catheter.

[0064] According to one embodiment, after the first guidewire opening is substantially aligned with the branch vessel at the treatment site, the guidewire tube can be moved so that the guidewire tube passes through the first guidewire opening and partially enters and remains in the branch vessel. This ensures that the guidewire remains in the branch vessel when the stent is released.

[0065] According to a specific embodiment, the stent can be gradually partially released during the placement process so that branch stents are placed one by one during the release process; or the stent can be released all at once so that branch stents are placed one by one after the stent is completely released.

[0066] After the placement of each branch stent is completed, the corresponding second guidewire and the delivery system of the branch stent are withdrawn.

[0067] According to the method of the present invention, the guidewire can be guided into the delivery catheter or guidewire tube in the same direction as the stent delivery system is introduced into the human body, or can be guided into the delivery catheter or guidewire tube in the opposite direction from the stent delivery system is introduced into the human body.

[0068] According to one embodiment, before finally withdrawing the first guidewire and the delivery catheter from the patient's body, the positions of the stent and all branch stents are finally confirmed, for example, by using a medical imaging device.

[0069] The stent of the present invention utilizes a braided, expandable mesh that allows for rapid placement in the aorta with branching vessels, thereby rapidly alleviating the risk of arterial dissection or aneurysm and avoiding the risk of the stent blocking blood flow in the branching arteries, thus saving time for further treatment. Furthermore, the stent's high compliance, high-strength, highly elastic mesh, and optional localized coating structure enable rapid, preemptive aortic repair, reducing surgical risk and technical complexity, thereby saving patients valuable treatment time. BRIEF DESCRIPTION OF THE DRAWINGS

[0070] Figure 1 A schematic diagram of a bracket according to an embodiment of the present invention;

[0071] Figure 2 A schematic diagram of a bracket according to another embodiment of the present invention;

[0072] Figure 3 A schematic diagram of a bracket according to another embodiment of the present invention;

[0073] Figure 4 A partial enlarged view of a stent according to an embodiment of the present invention;

[0074] Figure 5 Based on Figure 4 A schematic diagram of the stent of the illustrated embodiment being placed at a treatment site;

[0075] Figure 6 is a schematic diagram of a stent delivery system that can be used to place a stent according to the present invention;

[0076] Figure 7 for Figure 6 A partial top view of the outer catheter of the stent delivery system shown having a first guidewire opening; and

[0077] Figure 8 For use Figure 6 Schematic diagram of the process of placing a stent at a treatment site using a stent delivery system. DETAILED DESCRIPTION

[0078] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the embodiments of the present invention and the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. In the absence of conflict, the technical solutions described in the embodiments of the present invention can be implemented in any combination. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0079] Throughout this specification, unless otherwise specified, the terms used herein should be understood as having the same meaning as commonly used in the art. Therefore, unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. In the event of any conflict, the present specification shall take precedence.

[0080] The same reference numerals in the drawings refer to the same components. The shapes and sizes of the components in the schematic drawings are for illustration only and should not be considered to reflect the actual shapes, sizes and absolute positions.

[0081] It should be noted that, in the present invention, the terms "comprises", "includes" or any other variations thereof are intended to cover non-exclusive inclusion, so that a method or apparatus comprising a series of elements includes not only the elements explicitly stated, but also other elements not explicitly listed, or also includes elements inherent to the implementation of the method or apparatus.

[0082] It should be noted that the terms "first, second, and third" as used herein are merely used to distinguish similar objects and do not represent a specific ordering of the objects. It is understood that the terms "first, second, and third" may interchangeably represent a specific order or precedence, where appropriate. It should be understood that the terms "first, second, and third" may interchangeably represent objects, where appropriate, such that the embodiments of the present invention described herein may be implemented in an order other than that illustrated or described herein.

[0083] To more clearly describe the structure of the delivery system of the present invention, the terms "proximal end," "proximal tip," "distal end," and "distal tip" are commonly used in the field of interventional medicine. The "distal end" refers to the end (segment) farther from the heart during the surgical procedure, while the "proximal end" refers to the end (segment) closer to the heart during the surgical procedure.

[0084] According to a first aspect of the present invention, a bracket is provided. Figure 1 , which shows a schematic diagram of a stent 10 in a released state according to an embodiment of the present invention. The stent 10 comprises a stent body 11 and a channel 12. The stent body 11 is a mesh structure woven from stent material.

[0085] The stent material can be metal, such as shape memory alloys (e.g., nitinol) or cobalt-chromium alloys; medical polymers, such as nylon, polyester, polytetrafluoroethylene, polyacrylates, and polyolefins; or bioderived or biodegradable materials. The present invention does not particularly limit the stent material; any suitable conventional material can be used. A preferred material for the stent of the present invention is nickel-titanium alloy.

[0086] The mesh structure constituting the stent body 11 of the present invention can be woven from the threads or lines of the above-mentioned stent material according to conventional methods, so that the stent 10 is self-expandable or capsule-expandable.

[0087] The diameter of the wire used to braid the stent may be 0.05-0.5 mm, preferably 0.1-0.4 mm.

[0088] The widest dimension l of the mesh of the mesh structure of the support body 11 (see Figure 4 , in which a partially enlarged stent is shown) is 1 to 5 mm, preferably 2 to 3 mm, and more preferably 2.5 mm.

[0089] The stent body 11 of the stent of the present invention is entirely composed of a mesh structure with highly elastic meshes, wherein the mesh structure is woven so that each mesh can expand and deform.

[0090] Because the stent of the present invention has the above-mentioned structure, when released at the treatment site, on the one hand, it can play a supporting role on the blood vessel wall, quickly repair the damage that causes aortic dissection, and allow blood flow to pass mainly through the true artery cavity; on the other hand, because the stent as a whole is composed of a mesh structure with expandable mesh holes, it will not cause any blockage of the branch artery, and the branch stent can be further introduced into the branch artery through the mesh holes. Therefore, after expansion, the mesh holes of the stent body 11 of the present invention can at least allow a delivery system with an outer diameter of 14f (about 4.8mm) to pass through, so as to arrange the branch stent in the branch artery. A portion of the branch stent is retained in the channel of the stent 10 of the present invention, and the mesh holes can also play a role in fixing the branch stent.

[0091] Figure 2A stent 20 according to another embodiment of the present invention is shown. The stent 20 also has a stent body 21 and a channel 22 surrounded by the stent body 21. In this embodiment, the stent body 21 has a proximal end 28 and a distal end 29. The proximal end 28 has a diameter that gradually decreases from the proximal end to the distal end, that is, the diameter D1 of the proximal end gradually changes to D2. D1 may be in the range of 40 mm to 55 mm, and D2 may be in the range of 28 mm to 38 mm. Preferably, D1 may be in the range of 45 mm to 55 mm, and D2 may be in the range of 30 mm to 35 mm. The length of the proximal end 28 may be in the range of 10 to 30 mm, preferably 20 mm. The distal end 29 has a substantially constant diameter D2, and its length may be in the range of 20 mm to 300 mm, preferably 40 to 60 mm.

[0092] This embodiment of the stent is suitable for treating lesions in the aortic arch, where the vessels are thicker near the heart and taper away from the heart. The stent structure of this embodiment conforms to human anatomy and is quick and simple, minimizing arch manipulation time and reducing the risk of cerebral complications. The evenly distributed, highly elastic mesh allows the branch stent to quickly select the appropriate mesh for deployment, reducing manipulation of the arteries above the arch and protecting cerebral blood vessels.

[0093] Further references Figure 3 , which shows a partially coated stent 30. The stent 30 is mainly used in the aortic arch and has the same Figure 2 The stent 20 shown has a generally similar structure: a stent body 31 formed of a mesh structure encloses a channel 32. The stent body 31 includes a proximal end 38, a first distal end 39a, and a second distal end 39b. The second distal end 39b generally corresponds to the location of the three branching arteries of the aortic arch. A membrane 33 is provided on the side of the second distal end 39b corresponding to the greater curvature of the aortic arch. An uncoated area 34 is retained in the center of the membrane 33. When the stent 30 is deployed in the aortic arch, this uncoated area 34 covers the openings of the three branching arteries in the aortic arch.

[0094] Because the stent body of the present invention is formed from a highly elastic mesh structure, the uncoated region 34 provides an open blood channel to all branch arteries. The provision of such an integrally open area, such as the uncoated region 34, during stent placement makes it easy to align the uncoated region 34 with the opening of the branch artery on the greater curvature, thereby expediting stent placement.

[0095] From the above Figures 1 to 3The stent of the illustrated embodiment of the present invention can be quickly placed without the need to align the openings on the stent with each branch artery one by one as in existing stents, thereby greatly reducing the difficulty of the operation and gaining time for patient treatment.

[0096] Figure 3 The embodiment shown here is one in which only a portion (the greater curvature side) of a stent segment (the second distal end 39b) is coated. The stent of the present invention can be coated in sections or entirely, excluding the portion corresponding to the branch artery. The coating region and area can be determined based on the treatment site, therapeutic purpose, and other factors. For example, a substantially fully coated stent is more advantageous for treating aortic aneurysms.

[0097] The membrane 33 used in the stent of the present invention can be any suitable membrane used for coating stents. Examples include, but are not limited to, polytetrafluoroethylene, polyester, polyurethane (such as thermoplastic polyurethane), etc. Preferably, thermoplastic polyurethane membrane is used.

[0098] The thickness of the film is not particularly limited, but is usually 0.01 to 0.3 mm, preferably 0.05 to 0.1 mm.

[0099] The size of the uncoated area 34 varies depending on the treatment site, as long as it can expose the opening of the branch artery and can be easily and quickly located. Generally speaking, in order to reduce the difficulty of the operation, the size of the uncoated area 34 can be set to be relatively large. Or in some cases, the area corresponding to the branch artery is not coated at all. The shape of the uncoated area 34 is not particularly limited, and can be, for example, rectangular, elliptical, circular, etc. For the aortic arch area, the uncoated area 34 can have a length of approximately 20 to 40 mm and a corresponding central angle of approximately 120° to approximately 180°.

[0100] Figure 4 A partial enlarged view of a stent according to one embodiment is shown. In this embodiment, a stent 40 is provided with a branch channel 45 in a channel 42. One end of the branch channel 45 opens into a (uncoated) mesh 46 on the stent body 41, and the other end opens into the interior of the channel 42 of the stent 40.

[0101] See further Figure 5 , which shows Figure 4The figure shows a partial enlarged view of a stent 40 placed in a treatment site 90. The treatment site 90 has a branch artery 91. The stent 40 has been released in the site 90. The branch channel 45 is configured so that one end opens into the mesh 46, and the mesh 46 is generally near the opening of the branch artery 91. The branch stent 80 has been placed in the branch artery 91, and the other end is retained in the branch channel 45. The branch channel 45 does not need to be completely aligned with the branch artery 91, as long as it is generally near the opening of the branch artery 91. By expanding the mesh 46, the mesh can be roughly aligned with the branch artery 91, thereby facilitating the placement of the branch stent and helping to stabilize the branch stent.

[0102] The branch channels 45 can be woven from any of the above-mentioned stent materials, and can expand to a certain extent along with the expansion of the mesh 45 .

[0103] The stent of the present invention is suitable for early placement during surgical treatment of aortic dissection and aortic aneurysm, rapidly reducing the risk of aortic rupture and buying patients time for further treatment. Therefore, the present invention also provides a stent kit. The stent kit includes the aforementioned stent of the present invention and at least one branch stent.

[0104] Depending on the treatment objective, the stent kit of the present invention may further include other stents for the aortic treatment area. Examples include: a stent for the bifurcated sub-channels of the abdominal aorta, which facilitates subsequent placement of stents for the left and right common iliac arteries within the sub-channels after release; and a stent for the iliac artery bifurcation (IBD) to maintain patency of the internal iliac artery.

[0105] The stent of the present invention, as well as each stent in a stent kit, can be placed using any suitable stent delivery system according to conventional methods.

[0106] According to one specific embodiment, the stents and stent kits of the present invention can be placed using the stent delivery system described below.

[0107] refer to Figure 6 , which shows a perspective schematic diagram of a stent delivery system 100 according to a specific embodiment of the present invention. The stent delivery system can be used to place the stent of the present invention and can be used to place the stent of the present invention in a stent kit and position each branch stent. It should be understood by those skilled in the art that the stent of the present invention can be placed by any suitable conventional stent delivery system, and is not limited to this embodiment.

[0108] Stent delivery system 100 includes a delivery catheter 120 and a stent 110 of the present invention. Delivery catheter 120 includes an outer catheter 130 and a push rod 170 coaxially arranged along a longitudinal axis XX. Outer catheter 130 has a proximal end 131 and a distal end 132, and a hollow cavity 133 extending therebetween. Hollow cavity 133 has a proximal end 138 and a distal end 139. Push rod 170 is coaxially arranged with outer catheter 130 along longitudinal axis XX.

[0109] The stent 110 is releasably retained in the delivery configuration within the proximal end 138 of the hollow body 133 of the outer catheter 130 . Figure 6 The entire mesh structure of the stent 110 is not shown in the figure, and only the uncoated mesh structure 114 of the portion designed to correspond to the branch blood vessels is shown as an example. Figure 6 The other parts of the stent 110 shown in FIG. 1 may have a mesh structure identical to the mesh structure 114 or a partial or full coating.

[0110] According to some embodiments, a mechanism (not shown) for preventing the stent 110 from moving, such as a bump, may be provided on the inner wall of the proximal end 138 of the outer catheter 130 or at an appropriate position of the push rod 170, but is not limited thereto.

[0111] The stent 110 may be a stent having any of the aforementioned structures. In this embodiment, the stent 110 has an uncoated region 114 .

[0112] In addition, a first guidewire opening 134 is provided on the wall of the proximal end of the outer catheter 130 relative to the uncoated region 114 of the stent 110. According to the stent placement method described in detail below, a guidewire for guiding the delivery system of the branch stent can pass through the opening to locate the branch artery.

[0113] Similar to conventional delivery systems, the outer catheter 130 can be moved relative to the push rod 170 along the X-axis by manipulating the push rod 170, thereby releasing the stent 110. Figure 8 In Figures A to C), after the delivery system 100 is guided to the treatment site 90 by the first guide wire 181 and the uncoated area 114 of the stent 110 is roughly aligned with the branch artery 91 by the second guide wire 182, the push rod 170 is manipulated to move the proximal end 138 of the outer catheter 130 toward the proximal end 131, so that the proximal end 138 of the outer catheter 130 is separated from the distal end 139, thereby releasing the stent 110 from its distal end.

[0114] In this embodiment, a slit 136 is provided on the outer catheter wall on one side of the first guidewire opening 132 in the direction of movement of the outer catheter 130 when releasing the stent 110, so that when the outer catheter 130 is moved to release the stent 110, the second guidewire 182 that has been positioned in the branch artery can remain in the branch artery 91 as the stent 110 is released.

[0115] Figure 7 Shown Figure 6 FIG. 1 is a partial top view of the proximal end 138 of the outer catheter 130 of the stent delivery system 100. Figure 7 As shown, when releasing the stent, outer catheter 130 moves along the X-axis as indicated by the arrow. Its wall has a first guidewire opening 134. A slit 136 is provided parallel to the X-axis on the side of first guidewire opening 134 opposite to the direction of movement of outer catheter 130 (i.e., the side near the distal end). The width d of slit 136 is sufficient to allow at least the second guidewire to move within the slit.

[0116] According to another embodiment, in contrast to the embodiment described above, when releasing stent 110, outer catheter 130 is moved toward distal end 132, with proximal end 131 moving away from delivery system head 160, thereby releasing stent 110 from its proximal end. In this embodiment, slit 136 may be provided on the side of first guidewire opening 134 near the proximal end.

[0117] According to other embodiments, the stent of the present invention may also be released from its middle portion, such as described in Chinese patent application CN110353866A, the entire content of which is incorporated herein by reference.

[0118] The stent release method applicable to the present invention may be any existing suitable method. Those skilled in the art may reasonably set the position of the slit according to specific circumstances to complete the stent placement process described in detail below.

[0119] See also Figure 6 , the stent delivery system 100 also has a guide wire tube 150. The guide wire tube 150 has two open ends 151 and 152, and a cavity extending between the two ends. The guide wire tube 150 is arranged in the hollow cavity 133 of the outer catheter 130. One end 151 thereof extends through the inner cavity of the stent 110 from a mesh of its uncoated area 114, but remains inside the cavity 133 of the outer catheter 130. The other end 152 of the guide wire tube 150 extends from the distal end 132 of the outer catheter 130. The end of the distal end 132 can be provided with a second guide wire opening 135. In this embodiment, the other end 152 of the guide wire tube 150 extends outside the outer catheter 130 through the second guide wire opening 135.

[0120] The guidewire tube 150 of the present invention is movable within the hollow cavity 133 of the outer catheter 130 and can be removed from the stent delivery system 100 through the second guidewire opening 135.

[0121] See further Figure 8 In the figure A, when positioning the branch artery 91 by the second guidewire 182, the second guidewire 182 is introduced from the first guidewire opening 134 of the outer catheter 130 of the delivery system 100, passes through one end 151 of the guidewire tube 150, and exits from the other end 152 thereof. After positioning, the guidewire tube 150 can be moved so that the guidewire tube 150 extends from the first guidewire opening 134 and partially enters the branch artery 91, so as to further stably maintain the second guidewire in the branch artery (see Figure 8 B~C) in the above.

[0122] In this case, the width d of the slit 136 may be set to allow the guide wire tube 150 to move in the slit.

[0123] See also Figure 8 In Figures C to E, when the stent is fully or partially released so that the uncoated area 114 of the stent 110 is substantially located at the branch artery, the guidewire tube 150 can be withdrawn through the second guidewire opening 135 while still keeping the second guidewire 182 in the branch artery 91. Subsequently, the branch stent delivery system 80 is introduced into the branch artery 91 via the second guidewire 182, and the branch stent 70 is released.

[0124] The guide wire tube 150 can be a flexible tube made of any suitable material, with an outer diameter in the range of 2 to 6 mm and an inner diameter in the range of 1.7 to 5.8 mm. Examples of usable materials include, but are not limited to, stainless steel, pebax (nylon elastomer), PTFE, and PU.

[0125] According to other embodiments, delivery conduit 120 also can further have an inner conduit (not shown) that is coaxially arranged with outer conduit, thereby makes support can remain in the space between described outer conduit and the inner conduit.Wire guide tube is then arranged in the hollow cavity of inner conduit accordingly.When delivery system 100 had inner conduit, inner conduit was also provided with the opening that was convenient to wire guide tube through corresponding to outer conduit.Alternatively, inner conduit also can have the slit that is convenient to wire guide tube and keeps its position in the release support process.

[0126] According to other embodiments, the stent delivery system 100 of the present invention may further include a sheath; or the inner catheter may be used as the pushing device, and the pushing rod 170 may be omitted.

[0127] The stent of the present invention can have an outer diameter of about 25 to 55 mm and a length of about 10 to 500 mm in the deployed configuration. Therefore, the delivery catheter (e.g., outer catheter) of the stent delivery system of the present invention typically has an outer diameter of about 4 to 10 mm (i.e., 12 to 30 Fr) and a length of about 400 to 1000 mm.

[0128] The above describes several specific embodiments of the stent and stent delivery system of the present invention, but the embodiments of the present invention are not limited thereto. Those skilled in the art should know that stent structures suitable for arteries of different shapes or locations in the prior art can be used for the stent of the present invention; in addition, by configuring the structure and connection method of the inner catheter, outer catheter, push rod and / or sleeve, a variety of stent release forms can be formed. Any release form and corresponding delivery system structure that is conducive to the positioning and placement of the stent, as long as it is consistent with the spirit of the present invention, is within the scope of protection of the present invention.

[0129] A simple placement method for the stent according to the present invention involves simply introducing the stent into the treatment site in the blood vessel using a conventional delivery system and then releasing it. Because the stents of the present invention are constructed of an expandable mesh structure or have a large uncoated area corresponding to the branch vessels, even if subsequent treatment requires the placement of a branch stent in a branch vessel, there is no need to worry about whether the area corresponding to the branch vessel has an opening. The branch stent can be placed by simply expanding the mesh openings in the branch vessel.

[0130] The following combination Figure 8 The following describes in detail a method for placing the stent and branched stent of the present invention at a treatment site, particularly at a site with branched arteries, using the stent delivery system of the present invention.

[0131] In general, Figure 8 The invention specifically illustrates a method for using a stent delivery system comprising a coated stent and a mechanism for facilitating the positioning of a second guidewire (the mechanism particularly comprises first and second guidewire openings and slits provided on an outer catheter, and a guidewire tube). The stent placement method of the invention can quickly complete the positioning of the stent, reduce the difficulty of the operation, speed up the operation process, and reduce the risk of the operation. Figure 8 As shown, which schematically shows the Figure 6 The stent delivery system is shown during stent placement.

[0132] See also Figure 8 A in FIG. 1 schematically shows a treatment site 90 in which there is a branch artery 91. A first guide wire 181 has been positioned at the treatment site 90, and a second guide wire 182 has been positioned at the branch artery 91. Figure 8As shown in A in the figure, the first guide wire 181 has been introduced into the hollow cavity 133 of the outer catheter 130 through the head 160 of the stent delivery system 100 and passed out from the distal end 132 of the outer catheter 130; and the second guide wire 182 has also been introduced into the guide wire tube 150 through the first guide wire opening 134 of the outer catheter 130 and passed out from the distal end.

[0133] like Figure 8 As shown in FIG. 1B , stent delivery system 100 is guided to treatment site 90 via first and second guidewires 181 and 182, with first guidewire opening 134 of outer catheter 130 generally aligned with branch artery 91. At this point, uncoated region 114 of stent 110, still held in the delivery configuration within hollow cavity 133 of outer catheter 130, is also generally aligned with branch artery 91. Because uncoated region 114 is significantly larger than the opening of the branch artery, it is sufficient to align the first guidewire opening generally with the branch artery 91, significantly reducing the difficulty of the procedure.

[0134] As described above, by operating the pushing rod 170 of the stent delivery system 100, the outer catheter 130 is pushed toward the proximal end 131, so that the proximal end 138 thereof is away from the distal end 139 and moves toward the proximal end, thereby releasing the stent 110 from its distal end toward its proximal end ( Figure 8 C).

[0135] According to a specific embodiment, after the stent delivery system 100 is guided to a suitable position, the guidewire tube 150 can be moved so that one end 151 thereof passes through the second guidewire opening 134 along the second guidewire and partially enters the branch artery 91, so as to ensure that the second guidewire 182 is always kept in the branch artery 91 during the process of releasing the stent. Figure 8 C in Figure 1). This further ensures that the stent is released at the desired, predetermined location.

[0136] Since a slit 136 is pre-set on the side of the second guidewire opening 134 of the outer catheter 130 near the distal end, when the outer catheter 130 moves toward the proximal end, the second guidewire 182 or the guidewire tube 150 can enter the slit 136 and remain stationary relative to the branch artery.

[0137] After the stent 110 is completely released, the guidewire tube 150 is withdrawn from the second guidewire opening 135. Then, under the guidance of the second guidewire, the branch stent delivery system 80 is introduced into the hollow cavity 133 of the outer catheter 130, and further enters the cavity 113 of the stent 110, and passes through a mesh of the uncoated area 114 to enter the branch artery 91 ( Figure 8 D) in.

[0138] Before introducing the branch stent delivery system 80, the mesh through which the second guide wire 182 passes can be appropriately enlarged to facilitate passage of the branch stent delivery system 80. The method for enlarging the mesh is not particularly limited. For example, the mesh can be enlarged using a balloon or a high-strength stent.

[0139] Finally, Figure 8 As shown in FIG. 8E , the branch stent 70 is released at an appropriate position, and the delivery catheter of the branch stent delivery system 80 and the second guide wire are withdrawn.

[0140] For a treatment site with multiple branch arteries, a stent with multiple openings and a corresponding delivery system provided with multiple guidewire tubes and guidewire openings may be used, or multiple stents each with one opening may be used.

[0141] After all branch stents are placed, the placement positions are optionally reconfirmed through intraoperative angiography, and the stent delivery system 100 and the first guidewire are withdrawn.

[0142] The above describes the stent placement method of the present invention by taking a specific stent placement process as an example. Those skilled in the art will appreciate that other placement methods may be used depending on different treatment sites and the actual conditions of the patient.

[0143] For example, a full stent delivery system can be introduced into the body from the femoral artery, or a branched stent delivery system can be introduced from the supraclavicular artery or the brachial artery. A guidewire can also be introduced into the treatment site from the femoral artery, the supraclavicular artery, or the brachial artery.

[0144] In addition, the stent delivery system and the guide wire can be introduced into the treatment site in the same path or in opposite paths. Figure 8 Different from the manner shown, a guidewire can be introduced into the treatment site from the supraclavicular artery, and a guidewire grasper can be used to introduce the guidewire into the delivery system, but is not limited thereto.

[0145] These deformation methods are well known to those skilled in the art and will not be described in detail here.

[0146] The branch stent delivery system and branch stent suitable for the present invention are not particularly limited. Any conventional and suitable stent delivery system and stent may be used in the branch stent delivery system. The above example uses a guidewire as an example of branch stent placement. Adjustable bend catheters can also be used as branch stent delivery systems.

[0147] The above description is only a preferred embodiment of the present invention and does not limit the patent scope of the present invention. All equivalent structural transformations made by using the contents of the present description and drawings under the inventive concept of the present invention, or direct / indirect application in other related technical fields are included in the patent protection scope of the present invention.

Claims

1. A bracket, comprising a bracket body and a channel surrounded by the bracket body, characterized in that: The stent body has a woven mesh structure, the meshes of the mesh structure are expandable and deformable, and the widest part of the meshes is at least 1 mm when not expanded; the stent body at least partially has a coated area and a non-coated area, and when the stent is released in the treatment area, the non-coated area at least corresponds to the area with the branched artery; The stent is provided with a branch channel in the channel, one end of the branch channel opens to an uncoated mesh on the stent body, and the other end opens to the inside of the channel of the stent; by expanding the mesh, the mesh is roughly aligned with the branch artery; after expansion, the mesh allows a stent delivery device with an outer diameter of at least 4.8 mm to pass through; the mesh can be expanded by a balloon or a high-support stent; the branch channel is woven with stent material and can expand as the mesh expands.

2. The stent according to claim 1, wherein the stent body is woven from wires with a diameter of 0.05 to 0.5 mm, and the wires are made of a material selected from metal, medical polymer or biodegradable material.

3. The bracket according to claim 2, wherein: The stent body is woven from wires with a diameter of 0.1 to 0.4 mm. 4 . The stent according to claim 1 , wherein the stent has a length of 10 to 500 mm and a diameter of 25 to 55 mm in a released state.

5. The bracket according to claim 4, wherein The bracket has a length of 100-300 mm. The bracket according to claim 1 , wherein: The film of the coating area is formed of a bioaffinity polymer.

7. The bracket according to claim 6, wherein: The film of the coating area is formed of one selected from polytetrafluoroethylene, polyester and polyurethane.

8. The bracket according to claim 1, wherein The film of the coating area has a thickness of 0.01 to 0.3 mm.

9. The stent according to any one of claims 1 to 8, wherein: The stent has a proximal end and a distal end, wherein the proximal end has a diameter gradually decreasing from 40-55 mm to 30-38 mm, and the distal end has a substantially constant diameter of 28-38 mm. 10 . The stent according to claim 9 , wherein the proximal end portion has a length of 10 to 100 mm, and the distal end portion has a length of 20 to 300 mm.

11. The stent according to claim 10, wherein the stent is suitable for the visceral vascular area from the ascending aorta to the abdominal aorta including the aortic arch, the stent has a coated area at least on the greater curvature side of the aortic arch, and after the stent is released, the stent has a non-coated area at least on the branch artery corresponding to the greater curvature side.

12. The bracket according to claim 11, wherein The length of the stent with the coating portion ranges from 10 to 300 mm.

13. The bracket according to claim 11, wherein The stent has a development mark on the greater curvature side.

14. A bracket kit, comprising: The bracket according to any one of claims 1 to 13; and At least one branch stent for a branch blood vessel.

15. A stent delivery system comprising a delivery catheter and the stent according to any one of claims 1 to 13, wherein the stent is retained in the delivery catheter in a releasable delivery configuration.

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