Intravascular stent and stent system

By designing a vascular stent system, the combination of main stent, single stent and guiding elements is used to solve the problems of complex operation and branch occlusion in acute Stanford A type of aortic dissection surgery, simplifying and improving the operation and safety, and is suitable for a variety of anatomical morphology.

CN119632724APending Publication Date: 2025-03-18SHANGHAI MICROPORT ENDOVASCULAR MEDTECH (GRP) CO LTD
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Patent Information

Application Number
CN202311209358.0
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2023-09-18
Publication Date
2025-03-18

AI Technical Summary

Technical Problem

In the treatment of acute Stanford A type aortic dissection, the surgical operation is complex, the number of anastomosis is large, the risk of bleeding is high, and the single stent is difficult to accurately locate when released without X-ray, resulting in occlusion of branches and cannot be applied to the anatomical morphology of different patients.

Method used

A vascular stent system is designed, including a body stent, a single stent and a guide element. The body bracket has a branch window and a guide channel, and the single branch bracket is in communication with the body bracket. The guide element is used to build a bracket guidance path and simplify the guidance and implantation of the branch bracket.

Benefits of technology

By simplifying surgical operations, reducing the number of anastomosis, reducing bleeding risks, and improving the safety and efficiency of the surgery, it is suitable for the anatomical form of different patients without customization, and solves the problem of difficulty in stocking.

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Abstract

The invention relates to an intravascular stent and a stent system.The main body stent is provided with a main body channel penetrating in the first axial direction, the side wall of the main body stent is provided with a single window and a branch window, the single window and the branch window are communicated with the main body channel, and the single stent is provided with a single channel penetrating in the second axial direction; the single branch channel of the single branch stent is communicated with the single branch window of the main body stent, the guide element is provided with a guide channel, the guide element is arranged in the main body channel of the main body stent, and the guide channel is used for constructing a stent guide path capable of being connected with the branch window in the main body channel. The stent guiding path is constructed in the main body channel of the main body stent by utilizing the guiding element, so that the main body channel and the branch window can conveniently guide the branch stent to be guided and implanted in an operation based on the establishment of the stent guiding path, and a branch blood vessel blood flow path is established; the structure for implanting the branch stent in a targeted manner based on the anatomical form of the patient in the operation can be highly matched with the actual anatomical form of the patient.
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Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a vascular stent and a stent system. Background Art

[0002] The main pathological change of acute Stanford type A aortic dissection is the tearing of the aortic intima, which causes blood to rush into the space between the intima and elastic layer, or between the elastic layer and the adventitia, forming a true or false lumen. This situation can cause severe complications such as massive bleeding, pericardial tamponade, and poor perfusion of important organs leading to functional failure, with a high mortality rate. Surgery is an effective means of treating Stanford type A aortic dissection. The commonly used surgical procedure is total aortic arch replacement combined with stent elephant trunk surgery. During this procedure, the aortic arch and its branch vessels are freed, the stent-graft is introduced into the aortic arch and the true lumen of the descending aorta, the distal end of the four-branch graft is anastomosed with the descending thoracic aorta and the proximal end of the stent-graft, and the blood flow perfusion of the descending thoracic aorta is restored after venting, the anastomosis of the left common carotid artery and the four-branch graft is completed, and the four-branch graft is anastomosed end-to-end with the ascending aorta graft. After venting, the blocking clamp is opened, the heart is resuscitated and rewarmed, and finally the left subclavian artery, innominate artery and the remaining four-branch graft are anastomosed to complete the operation.

[0003] In this procedure, the artificial blood vessels need to be anastomosed one by one with the autologous aortic vessels and branch arterial vessels. There are many anastomoses, the process is complicated, the surgical trauma and difficulty are large, and the risk of bleeding is high. If the surgical operation can be simplified, the number of anastomoses can be reduced, the difficulty of the operation can be reduced, and the amount of bleeding can be reduced, it will greatly increase the benefits to patients. At present, the main way to reduce the difficulty of surgery, the number of anastomoses and bleeding is the integrated single-branch stent technology. However, this method cannot accurately locate and introduce the single-branch stent because it is released without X-rays. The single-branch stent is easy to deviate or fall out of the branch blood vessels, resulting in branch occlusion. Therefore, it has high requirements on the morphology and angle of the patient's supra-aortic branch blood vessels, and the instrument needs to be highly matched with the patient's anatomical morphology. The problem is that the anatomical morphology of different patients varies greatly, which is bound to be difficult to stock, and it cannot be applied to patients with acute aortic dissection. Summary of the invention

[0004] Based on this, it is necessary to provide a vascular stent and a stent system to address the above-mentioned technical problems.

[0005] The present application provides a vascular stent, the vascular stent comprising:

[0006] A main body bracket, wherein the main body bracket has a main body channel penetrating along a first axial direction, and a branch window is formed on a side wall of the main body bracket, and the branch window is connected to the main body channel;

[0007] A single-branch bracket, wherein the single-branch bracket has a single-branch channel penetrating along the second axial direction, the single-branch bracket is arranged on the side wall of the main body bracket, and the single-branch channel is connected to the main body channel;

[0008] A guiding element is provided with a guiding channel, and the main body bracket is used to construct a bracket guiding path which can be connected to the branch window through the guiding channel.

[0009] In one embodiment, the vascular stent comprises:

[0010] A branch bracket has a branch channel penetrating along a third axial direction, and the branch bracket is used to be guided out from the branch window along the bracket guide path.

[0011] In one embodiment, the side wall of the main body support has a concave area that is recessed radially inwardly along the main body support, and the concave area is used to accommodate at least a portion of the branch support guided out from the branch window.

[0012] In one embodiment, the guide element is connected to the side wall of the main support, and the guide channel is directly connected to the branch window; and / or,

[0013] The guide element is disposed in the main body channel of the main body support; and / or,

[0014] The concave area and the branch window correspond to each other in a first axial direction of the main body support.

[0015] In one embodiment, a reserved anastomotic portion is provided at the distal end of the main support; and / or,

[0016] The single-branch support and the main body support are formed as an integral structure; and / or,

[0017] The guiding element is integrally formed with the main support; and / or,

[0018] The main body support adopts a variable diameter cylindrical support.

[0019] In one embodiment, the guide element is arranged in the main body channel of the main body support; and / or,

[0020] The guiding element is located in the proximal direction of the branch window in the first axial direction of the main body stent; and / or,

[0021] The guide element is located in the proximal region of the main body support; and / or,

[0022] The guiding element is a support structure, and the guiding element has a contracted state and an expanded state, and is used to contract or expand along with the main support; and / or,

[0023] The main support has a bendable section, and the single-branch support and the branch window are located on the large bend side of the bendable section.

[0024] In one embodiment, the vascular stent comprises:

[0025] a guide tube, the guide tube being used to pass through the guide channel and the branch window along the stent guide path; and / or,

[0026] a guide wire, the guide wire being used to pass through the guide channel and the branch window along the stent guide path; and / or,

[0027] An artificial blood vessel has a blood vessel channel that runs through the blood vessel axis, the artificial blood vessel is connected to the proximal end of the main support, and the blood vessel channel is communicated with the main channel.

[0028] In one embodiment, a limiting portion is provided at the distal end of the guide wire.

[0029] In one embodiment, the number of the branch windows is two, the single-branch stent and the two branch windows are distributed along the first axial direction on the main stent in the direction from the proximal end to the distal end, the number of the guide elements is two, and the two guide channels are used to construct two independent stent guide paths in the main channel that can respectively connect the two branch windows.

[0030] The present application provides a support system, the support system comprising:

[0031] The vascular stent;

[0032] A conveying device is connected to the vascular stent and is used to convey the vascular stent.

[0033] In the above-mentioned vascular stent and stent system, since the main stent is equipped with a guiding element, and a stent guiding path is constructed in the main stent by using the guiding element, the main channel and the branch window can be conveniently used to guide the guidance and implantation of the branch stent during the operation based on the establishment of the stent guiding path, so as to establish a branch vascular blood flow path. This structure of targeted implantation of branch stents based on the patient's anatomical morphology during the operation can be highly adapted to the patient's actual anatomical morphology, and there is no need to anastomose the single-split stent and the single-split window on the operating table. Therefore, the number of anastomoses required during the operation can be reduced, the surgical operation can be simplified, the difficulty of the operation can be reduced, no customization is required, and the problem of difficulty in stocking stents can be solved. It is suitable for patients with acute aortic dissection. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 A schematic diagram of the structure of a support system provided in one embodiment of the present application.

[0035] Figure 2 A schematic diagram of the structure of a vascular stent provided in one embodiment of the present application.

[0036] Figure 3 A schematic diagram of a concave area provided for one embodiment of the present application.

[0037] Figure 4a A schematic cross-sectional view of a vascular stent provided in accordance with an embodiment of the present application.

[0038] Figure 4b A schematic cross-sectional view of a vascular stent provided in accordance with another embodiment of the present application.

[0039] Figures 5 to 8 A schematic diagram of the use status of a vascular stent provided in one embodiment of the present application.

[0040] Figure Number:

[0041] 10. Descending aorta; 20. Ascending aorta;

[0042] 10a, innominate artery; 10b, left common carotid artery; 10c, left subclavian artery;

[0043] 100. Vascular stent; 200. Delivery device;

[0044] 1000, main stent; 2000, single-branch stent; 3000, guide element; 4000, artificial blood vessel; 5000, branch stent; 6000, guide tube; 7000, guide wire;

[0045] 1000a, single split window; 1000b, branch window; 1000c, bendable segment; 1000c1, small bend side; 1000c2, large bend side; 1000d, concave area;

[0046] 7000a, limit part. DETAILED DESCRIPTION

[0047] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0048] In the description of the present application, it should be understood that if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application.

[0049] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0050] In this application, unless otherwise clearly specified and limited, if the terms "installed", "connected", "connected", "fixed" and the like appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to the specific circumstances.

[0051] In the present application, unless otherwise clearly specified and limited, if there is a description that a first feature is "above" or "below" a second feature, etc., or similar descriptions appear, it may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "above" and "above" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. The first feature being "below", "below" and "below" the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0052] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. If an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. If any, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are for illustrative purposes only and do not represent the only implementation method.

[0053] In order to more clearly describe the structure of the vascular stent 100 and the stent system, the term "distal end" is defined herein to mean the end away from the operator during the surgical operation, and the term "proximal end" is defined herein to mean the end close to the operator during the surgical operation. Unless otherwise defined, all technical and scientific terms used in this application have the same meanings as those commonly understood by those skilled in the art to which this application belongs. The terms used in this specification are only for the purpose of describing specific embodiments and are not intended to limit this application.

[0054] See also Figure 1 As shown, the present application provides a stent system, which includes a vascular stent 100 and a delivery device, which is connected to the vascular stent 100 and is used to deliver the vascular stent 100. The delivery device includes a main delivery device 200 and a branch delivery device, the main delivery device 200 can be used to deliver the main stent 1000, and the branch delivery device can be used to deliver the branch stent 5000. Those skilled in the art can select an adapted device to deliver the main stent 1000 and the branch stent 5000 according to the needs, and there is no limitation on this.

[0055] For example Figure 1 As shown, the main stent 1000 in the vascular stent 100 is mounted on the catheter (not shown) of the main delivery device 200, and the main delivery device 200 is used to deliver the main stent 1000 to a predetermined position in the body. Then, the branch delivery device is used to deliver the branch stent 5000 to a predetermined position in the body. Those skilled in the art can select the appropriate main delivery device 200 and branch delivery device according to the specific structure of the vascular stent 100 and the intraoperative delivery requirements, and no limitation is made here. For more information about the vascular stent 100, see Figure 1 and Figure 2As shown, a vascular stent 100 provided in one embodiment of the present application includes a main stent 1000, a single-branch stent 2000 and a guiding element 3000, the main stent 1000 has a main channel passing through along a first axial direction, a single-branch window 1000a and a branch window 1000b are provided on the side wall of the main stent 1000, the single-branch window 1000a and the branch window 1000b are connected to the main channel, the single-branch stent 2000 has a single-branch channel passing through along a second axial direction, the single-branch channel of the single-branch stent 2000 is connected to the single-branch window 1000a of the main stent 1000, the guiding element 3000 has a guiding channel, the guiding element 3000 is arranged on the main stent 1000, and the main channel is used to construct a stent guiding path that can be connected to the branch window 1000b through the guiding channel.

[0056] The guide element 3000 may be disposed outside the main stent 1000 or inside the main channel of the main stent 1000. Those skilled in the art may select the form of the guide element 3000 and the specific location when it is disposed on the main stent 1000 according to actual needs, as long as a guide channel can be formed for the branch stent 5000 to be smoothly implanted along the stent guide path. This needs to be specifically determined according to the needs during the operation and is not limited here. Figure 2 As shown, the guide element 3000 can be selectively disposed in the main channel of the main stent 1000, so that the guide channel can construct a stent guide path that can be connected to the branch window 1000b in the main channel.

[0057] The guide element 3000 can be connected to the side wall of the main support 1000. In this case, the guide element 3000 is located at the side wall of the main support 1000 where the branch window 1000b is opened, so that the guide channel can be directly connected to the branch window 1000b, and the two can be completely sealed or the sealing degree can be adjusted according to the needs. The guide element 3000 can be connected to the branch window 1000b at the end or directly assembled inside the branch window 1000b, which is not limited here. The guide element 3000 and the main support 1000 can be detachably matched or directly used as an integrated structure.

[0058] The guide element 3000 can be selectively connected to the side wall of the main support 1000, so that the guide element 3000 and the branch window 1000b are both located on the outer wall of the main support 1000 to form a support guide path. Figure 1 and Figure 2As shown, the guiding element 3000 can also be located in a more proximal direction relative to the branch window 1000b in the first axial direction of the main support 1000. Along the first axial direction, in the relative positions of the main support 1000 and the branch window 1000b, the main support 1000 is closer to the proximal direction, and the branch window 1000b is closer to the distal direction.

[0059] The structures of the main stent 1000 and the single-branch stent 2000 can be constructed into matching shapes according to the actual implantation environment of the target blood vessel, so that the main stent 1000 and the single-branch stent 2000 can be suitable for implantation into the target blood vessel and form a stable implantation in their respective target blood vessels. For example, the main stent 1000 can be used for implantation into the aortic arch and descending aorta 10 in the body, and the single-branch stent 2000 can be used for implantation into any one of the innominate artery 10a, the left common carotid artery 10b or the left subclavian artery 10c.

[0060] Therefore, the main stent 1000 and the single-branch stent 2000 can be constructed as a cylindrical stent structure according to the actual implantation environment of each artery. Moreover, the main stent 1000 and the single-branch stent 2000 can also be set as a variable diameter structure according to needs. For example, the main stent 1000 is a variable diameter cylindrical stent whose diameter changes at different positions along the first axial direction instead of remaining unchanged.

[0061] Similarly, the single-branch stent 2000 can also select a similar variable diameter cylindrical stent according to the needs, and the purpose of this variable diameter design is to make the main stent 1000 and the single-branch stent 2000 more suitable for the shape of the target blood vessel. Those skilled in the art can select the corresponding stent structure of the main stent 1000 and the single-branch stent 2000 to be implanted in different arterial environments according to the needs, and no limitation is made here.

[0062] Continue reading Figure 1 and Figure 2As shown, the side wall of the main support 1000 is provided with a single-branch window 1000a and a branch window 1000b, wherein the single-branch window 1000a is used to assemble the single-branch support 2000, and one of the ports of the single-branch support 2000 can be connected with the single-branch window 1000a, so that the single-branch channel of the single-branch support 2000 is connected with the main channel of the main support 1000, and can allow fluid to pass through. The single-branch window 1000a can be constructed according to the port shape of the single-branch support 2000, such as a circular window or an elliptical window, etc., which is not limited here. The single-branch stent 2000 and the main stent 1000 can adopt a split structure. When surgery is required, the single-branch stent 2000 and the main stent 1000 can be assembled and connected in advance, so that the single-branch channel of the single-branch stent 2000 is connected with the main channel of the main stent 1000 to meet the blood flow. Alternatively, the single-branch stent 2000 and the main stent 1000 can also be directly adopted as an integrated molding structure, so that the single-branch stent 2000 and the main stent 1000 are always connected, and the single-branch channel of the single-branch stent 2000 is always connected with the main channel of the main stent 1000, thereby reducing the number of operating steps.

[0063] Continue reading Figure 1 and Figure 2 As shown, the branch window 1000b can be used to guide the branch bracket 5000 to the corresponding target environment. Moreover, when the branch bracket 5000 is led out from the branch window 1000b, the branch window 1000b can stabilize the assembly of the branch bracket 5000 by limiting the branch bracket 5000, or can directly fix the branch bracket 5000 by forming a connection with the branch bracket 5000. Technical personnel in this field can choose the way to stabilize the branch bracket 5000 with the branch window 1000b according to actual needs.

[0064] In some of the embodiments, the vascular stent 100 includes a branch stent 5000, which is a stent structure separate from the main stent 1000 before surgery. The branch stent 5000 is implanted into the target environment only after the main stent 1000 and the single-branch stent 2000 are implanted into the target environment. The branch stent 5000 has a branch channel that passes through along the third axial direction. After the branch stent 5000 is implanted, it can be connected with the main channel of the main stent 1000 by means of the branch window 1000b, thereby constructing a channel for fluid flow.

[0065] The implantation process of the branch stent 5000 requires a guiding element 3000 pre-set in the main channel. The guiding element 3000 has a guiding channel. Therefore, after the guiding element 3000 is set in the main channel of the main stent 1000, the guiding channel can be used to construct a stent guiding path in the main channel that can be connected to the branch window 1000b. The stent guiding path is actually a path connecting the guiding channel and the branch window 1000b. The proximal end of the branch stent 5000 can be fixed by relying on the guiding element 3000, for example, by anchoring, and the airtightness of the connection position needs to be ensured. For example, the proximal end of the branch stent 5000 is sealed and connected to the guiding element 3000.

[0066] After the branch stent 5000 is implanted, it can be connected to the guide element 3000 by using a variety of relative matching structures. In some implementations, the proximal end of the branch stent 5000 and the guide element 3000 at least partially overlap in the axial direction and are sleeved with each other. For example, the proximal end of the branch stent 5000 is sleeved in the guide channel of the guide element 3000, and for another example, the proximal end of the branch stent 5000 is sleeved on the outer peripheral surface of the guide element 3000.

[0067] Regarding the axial relative position of the branch bracket 5000 and the guiding element 3000, the present application only needs to ensure the stable combination of the branch bracket 5000 and the guiding element 3000. The following description will be made by taking the proximal end of the branch bracket 5000 as an example of being sleeved in the guiding channel of the guiding element 3000. For example, the proximal end of the branch bracket 5000 protrudes from the end of the guiding element 3000. For another example, the proximal end of the branch bracket 5000 is flush with the end of the guiding element 3000. While ensuring the connection strength between the branch bracket 5000 and the guiding element 3000, the volume of the branch bracket 5000 entering the main channel is reduced, thereby reducing the resistance to the fluid in the main channel and improving stability. For another example, the proximal end of the branch bracket 5000 is located in the guiding channel of the guiding element 3000. Those skilled in the art can choose a suitable matching method according to actual needs, which is not limited here.

[0068] In the construction of the stent guiding path, components such as a wire or a catheter for guidance can be connected between the guiding channel and the branch window 1000b as needed, which is not limited here. Therefore, the stent guiding path has the function of guiding the branch stent 5000 to the branch window 1000b. The purpose is to be able to guide the branch stent 5000 from the main channel of the main stent 1000 to the branch window 1000b along the stent guiding path during the operation, and then smoothly implant it into the target environment corresponding to the branch window 1000b, such as the innominate artery 10a, the left common carotid artery 10b or the left subclavian artery 10c.

[0069] See also Figure 2 As shown, in the present application, the single-branch bracket 2000 can be pre-assembled on the main bracket 1000 to connect the single-branch channel of the single-branch bracket 2000 with the single-branch window of the main bracket 1000.

[0070] In the above-mentioned stent, the single-branch stent 2000 is pre-assembled in the main stent 1000, and there is no need to temporarily anastomose the single-branch stent 2000 and the single-branch window 1000a during surgery, thereby reducing the number of anastomoses required during surgery. 、 Simplify surgical procedures and reduce surgical difficulty.

[0071] In addition, since a guiding element 3000 is pre-installed in the main stent 1000, and a stent guiding path is constructed in the main channel of the main stent 1000 by using the guiding element 3000, the main channel and the branch window 1000b can be conveniently used to guide the guidance and implantation of the branch stent 5000 during surgery based on the establishment of the stent guiding path, so as to establish a branch blood vessel blood flow path. This structure of targeted implantation of the branch stent 5000 based on the patient's anatomical morphology during surgery can be highly adapted to the patient's actual anatomical morphology and match aortic arches with different anatomical morphologies without the need for customization, thereby solving the problem of difficult stocking. It is suitable for patients with acute aortic dissection.

[0072] In one embodiment, the vascular stent 100 includes an artificial blood vessel 4000, which has a vascular channel that runs through the vascular axis, the artificial blood vessel 4000 is connected to the proximal end of the main stent 1000, and the vascular channel is connected to the main channel, and the artificial blood vessel 4000 can be used for the proximal end of the main stent 1000 to be anastomosed with the ascending aorta 20. In addition, a reserved anastomosis portion is provided at the distal end of the main stent 1000, and the reserved anastomosis portion can be used for the distal end of the main stent 1000 to be anastomosed with other instruments in a secondary operation, for example, the reserved anastomosis portion can be used to anastomose with the artificial blood vessel 4000. The reserved anastomosis portion can be constructed using a variety of structures suitable for anastomosis, for example, the main stent 1000 has a film, so that the apex of the main stent 1000 is not sutured against the edge of the film, and a part of the end of the film is reserved for anastomosis, wherein the length of the reserved anastomosis portion can be limited to the range of 0 mm to 20 mm. For example, the length of the reserved anastomotic portion may range from 2 mm to 15 mm, and is used for anastomosis with the stent graft 4000 in a secondary operation. Those skilled in the art may make specific arrangements based on demand, and no limitation is made here.

[0073] The main stent 1000 has a bendable section 1000c, and the bendable section 1000c has good flexibility. The bendable section 1000c of the main stent 1000 is formed with a small curved side 1000c1 and a large curved side 1000c2. The small curved side 1000c1 refers to the side of the main stent 1000 facing away from the branch blood vessels on the arch after the main stent 1000 is implanted in the human body, and the large curved side 1000c2 refers to the side of the main stent 1000 facing the branch blood vessels on the arch after the main stent 1000 is implanted in the human body.

[0074] The following will be described in conjunction with the accompanying drawings. Figure 2 As shown, the bendable section 1000c of the main support 1000 causes the section of the main support 1000 to bend downward as shown in FIG2 , so that the lower part of the bend section 1000c is a small bend side 1000c1 and the upper part is a large bend side 1000c2.

[0075] In some embodiments, the single-branch stent 2000 and the branch window are located on the large curved side 1000c2 of the bendable section. The single-branch stent 2000 being located on the large curved side 1000c2 of the bendable section can be understood as the single-branch window 1000a corresponding to the single-branch stent 2000 being located on the large curved side 1000c2 of the bendable section. That is, the single-branch window 1000a and the branch window 1000b can be selectively located on the large curved side 1000c2 of the main stent 1000, so that the single-branch stent 2000 and the branch stent 5000 are also assembled on the large curved side 1000c2 of the main stent 1000.

[0076] It can be understood that the above-mentioned arrangement of the single-branch bracket 2000 and the branch window 1000b on the main bracket 1000 is only a partial example. The single-branch bracket 2000 and the branch window 1000b can also be arranged in other areas on the main bracket 1000. For example, the branch window 1000b can be arranged in other areas of the main bracket 1000 (for example, the back side of the bendable segment 1000c, and other segments in the main bracket 1000). The specific arrangement method can be adaptively adjusted according to specific usage requirements and is not specifically limited here.

[0077] Continue reading Figure 3 As shown, the main support 1000 may also have a concave area 1000d, and the corresponding area of ​​the main support 1000 is concave inward along the radial direction, and the concave area 1000d may be a regular shape or an irregular shape and concave inward along the radial direction of the main support 1000. The function of the concave area 1000d is to accommodate the branch support 5000 derived from the branch window 1000b.

[0078] See also Figure 3As shown, the guiding element 3000 is connected to the main support 1000, and the guiding channel is directly connected to the branch window 1000b. The branch support 5000 can directly enter the branch window 1000b from the guiding element 3000 and be led out. The concave area 1000d and the branch window 1000b can correspond to each other in the first axial direction of the main support 1000, so that after the branch support 5000 is led out from the branch window 1000b, a part of the section of the branch support 5000 can pass through the concave area 1000d, and the branch support 5000 can be accommodated to a certain extent by means of the concave characteristics of the concave area 1000d.

[0079] As can be seen from the foregoing, after the branch bracket 5000 is led out from the branch window 1000b, the section where the branch bracket 5000 is led out is outside the main bracket 1000. The effect of the concave area 1000d will be described below in conjunction with the accompanying drawings. Figure 6 In the implantation state of the main stent 1000 shown in the figure, the main stent 1000 is inside the blood vessel (for example, the aortic arch between the ascending aorta 20 and the descending aorta 10) and fits with the blood vessel wall. If the branch stent 5000 is led out from the branch window 1000b, the section of the branch stent 5000 led out will be between the outer wall of the main stent 1000 and the blood vessel wall, which will further fill the already scarce space between the main stent 1000 and the blood vessel, and further compress the inner blood vessel wall of the blood vessel. Therefore, by means of the concave area 1000d accommodating a part of the section of the branch stent 5000, the compression of the branch stent 5000 on the blood vessel wall and the outer wall of the main stent 1000 can be alleviated. In addition, after the branch stent 5000 is led out from the branch window 1000b, it can continue to be led out through the space between the concave area 1000d and the blood vessel wall, so as to avoid the branch stent 5000 from being folded or squeezed, and reduce the difficulty of assembling the branch stent 5000.

[0080] It can be understood that the above-mentioned setting method of the concave area 1000d is only a partial example. The concave area 1000d can also be set in other areas on the main bracket 1000. The specific setting method can be adaptively adjusted according to the use requirements of the guiding element 3000 and the branch bracket 5000, and is not specifically limited here.

[0081] In some embodiments, the guide element 3000 is located in the proximal region of the main support 1000, and when the guide element 3000 is disposed in the main channel of the main support 1000, the location of the guide element 3000 cannot affect the fluid flow between the main channel and the branch channel, for example, see Figure 4a and Figure 4b As shown, after the guide element 3000 is located in the main channel of the main support 1000, the guide element 3000 is arranged on a side close to the main channel. Figure 4a and Figure 4bWhat is shown is the arrangement position when there are two guide elements 3000. When the number of guide elements 3000 is one or other number, the guide elements 3000 can still be arranged with reference to this arrangement so that the flow passage between the main channel and the single branch channel can be connected. Among them, the guide element 3000 can be adopted as a variety of structures with a guide channel, for example, the guide element 3000 adopts a cylindrical structure, and the round structure satisfies the construction of the guide channel, or the guide element 3000 can also be adopted as a bracket structure, and the axial direction of the guide element 3000 is roughly the same as the first axial direction of the main bracket 1000. The guide element 3000 has a contracted state and an expanded state, and can be contracted or expanded with the main bracket 1000, and is in a contracted state with a smaller volume before the operation, and is expanded to an expanded state with a larger volume during the operation. Those skilled in the art can set it according to needs, and it is not limited here.

[0082] In one embodiment, the use of the vascular stent 100 needs to be matched with a suitable guide tube 6000 or guide wire 7000. The guide tube 6000 or guide wire 7000 may be included in the subject of the vascular stent 100 and form a complete product with the vascular stent 100. The guide tube 6000 or guide wire 7000 may not be included in the subject of the vascular stent 100, but may be included in the delivery device or in the subject of the stent system. The operator may select at least one of the guide tube 6000 and the guide wire 7000 to match the use of the vascular stent 100 as needed during the operation. Those skilled in the art may select according to the needs, and there is no limitation on this.

[0083] For example, the vascular stent 100 includes a guide tube 6000 or a guide wire 7000. When the main stent 1000 and the single-branch stent 2000 are in a pressed state, the guide tube 6000 or the guide wire 7000 can be pre-buried in the guide channel of the guide element 3000. The guide tube 6000 is used to pass through the guide channel and the branch window 1000b along the stent guide path. The guide wire 7000 is also used to pass through the guide channel and the branch window 1000b along the stent guide path, and then used to construct the stent guide path connecting the guide channel and the branch window 1000b. In one embodiment, a limiting portion 7000a is provided at the distal end of the guide wire 7000. The limiting portion 7000a can be, for example, a spherical member or a boss member with a limiting function.

[0084] In one embodiment, the number of branch windows 1000b and branch stents 5000 can be at least two, for example, the number of branch windows 1000b is two, the single branch window 1000a and the two branch windows 1000b are distributed along the first axial direction on the main stent 1000 from the proximal end to the distal end, the two branch windows 1000b are located in the distal direction of the single branch window 1000a, the number of guide elements 3000 is two, and the two guide channels are used to construct two independent stent guide paths in the main channel that can connect the two branch windows 1000b respectively. In addition, those skilled in the art can set the number and arrangement position of the branch stent 5000 according to needs to meet diverse surgical needs, which is not limited here.

[0085] The main stent 1000, the single-branch stent 2000, the guide element 3000 and the branch stent 5000 may be composed of a coating and a metal stent structure, wherein the coating covers the outside of the metal stent structure, wherein the coating material may be selected from polymer materials such as polyester, polyurethane, polytetrafluoroethylene or expanded polytetrafluoroethylene, the metal stent structure may be selected from metal materials such as nickel-titanium alloy, stainless steel or cobalt-chromium alloy, and the connection method between the metal stent structure and the coating may be selected from suturing or hot melting. The material of the artificial blood vessel 4000 may be selected from polymer materials such as polyester, polyurethane, polytetrafluoroethylene and expanded polytetrafluoroethylene, and the outer surface of the artificial blood vessel 4000 may also be coated with biological materials or non-biological materials such as collagen, gelatin, heparin, etc.

[0086] The main stent 1000, the single-branch stent 2000, the guiding element 3000, the branch stent 5000 and the artificial blood vessel all have their own axes, i.e., the main stent 1000 has an axis along the first axis, the single-branch stent 2000 has an axis along the second axis, the branch stent 5000 has an axis along the third axis, and the artificial blood vessel has an axis along the blood vessel axis.

[0087] When the main stent 1000, the single-branch stent 2000, the guiding element 3000, the branch stent 5000 and the artificial blood vessel are in different forms such as straight or curved, the corresponding axial directions will also show different trajectory forms. For example, when the main stent 1000 is straight, the first axial direction shows a straight trajectory. When the main stent 1000 is bent to different degrees, the first axial direction also shows a corresponding curved trajectory with the complete form of the main stent 1000. The trajectory of each axial direction is not limited to a straight axis, but needs to be determined according to the actual situation. The same is true for the single-branch stent 2000, the guiding element 3000, the branch stent 5000 and the artificial blood vessel, which will not be repeated.

[0088] The main stent 1000 is mainly used to be released in the true lumen of the aortic arch and the descending aorta 10, and the single-branch stent 2000 is mainly used to be released in the innominate artery 10a, the left common carotid artery 10b or the left subclavian artery 10c. With the help of the guide wire 7000 on the delivery device, or with the help of the cooperation of the guide wire 7000 and the guide tube 6000, the branch stent 5000 can be introduced into the branch blood vessel on the arch through the guide channel of the guide element 3000 under direct vision to avoid the entanglement of the guide wire 7000 or the guide tube 6000. The distal end of the bridge branch stent 5000 is positioned by clamping with a vascular clamp or tying with a ligature, and the guide channel realizes good anchoring and airtight connection of the proximal end of the bridge stent. The artificial blood vessel 4000 is anastomosed with the ascending aorta 20 to complete the procedure.

[0089] In a specific embodiment, see Figures 5 to 8 As shown, the main stent 1000 in the multi-branch surgery can open a single-branch window 1000a, connected to a single-branch stent 2000, and two guide elements 3000 are set in the main channel, and two stent guide paths are constructed in the main stent 1000 by using the two guide channels. A reserved anastomosis portion is left at the distal end of the main stent 1000. The main stent 1000 and the single-branch stent 2000 are provided with a pre-buried guide tube 6000 in the pressed and gripped state.

[0090] During the operation, a midline thoracotomy is first performed to longitudinally section the proximal end of the aortic arch. First, two guide wires 7000 are introduced into the left common carotid artery 10b and the left subclavian artery 10c in sequence along the aortic arch from the longitudinal section of the aortic arch. A limiting portion 7000a is provided at the distal end of the guide wire 7000. Sutures are used to bind the distal ends of the left common carotid artery 10b and the left subclavian artery 10c. The limiting portion 7000a of the guide wire 7000 clamps the suture binding position to prevent the guide wire 7000 from coming out. At the same time, the stent is positioned. The pre-buried guide tube 6000 on the conveying device is respectively introduced into the left common carotid artery 10b and the left subclavian artery 10c along the guide wire 7000. The single-branch stent 2000 is introduced into the innominate artery 10a, and the pre-buried guide tube 6000 is withdrawn. At this time, the stent guidance path of the left common carotid artery 10b and the left subclavian artery 10c is completed. Then the main stent 1000 is released, and then the single-branch stent 2000 is released in the innominate artery 10a, and the main delivery device 200 is withdrawn. The two branch stents 5000 are introduced into the left common carotid artery 10b and the left subclavian artery 10c along the two guide wires 7000, respectively, and then the two branch stents 5000 are released, the sutures are untied, the blood flow of the left common carotid artery 10b and the left subclavian artery 10c is restored, and the guide wire 7000 and the branch delivery device are withdrawn. Figure 8 As shown, at this time, the artificial blood vessel 4000, the proximal end of the aortic arch and the distal end of the ascending aorta 20 form an end-to-end anastomosis, completing the operation.

[0091] In another specific embodiment, a single-branch window 1000a can be opened in the main stent 1000 during multi-branch surgery to connect a single-branch stent 2000, and two guide elements 3000 are set in the main channel. The two guide elements 3000 are located in the proximal region of the main stent 1000, and two stent guide paths are constructed in the main stent 1000 using two guide channels. A reserved anastomosis portion is left at the distal end of the main stent 1000. The main stent 1000 and the single-branch stent 2000 are provided with a pre-buried guide wire 7000 in the pressed and gripped state instead of a guide tube 6000.

[0092] During the operation, a median thoracotomy is first performed, and the proximal end of the aortic arch is longitudinally sectioned. First, two pre-buried guide wires 7000 are sequentially introduced into the innominate artery 10a and the left common carotid artery 10b along the aortic arch from the longitudinal section of the aortic arch. The distal ends of the innominate artery 10a and the left common carotid artery 10b are clamped with surgical forceps. The pre-buried guide wires 7000 on the main delivery device 200 are preferentially introduced into the innominate artery 10a and the left common carotid artery 10b. At this time, the stent guidance path of the innominate artery 10a and the left common carotid artery 10b is completed, and the single-branch stent 2000 is introduced into the left subclavian artery 10c. Then the main stent 1000 is released, and then the single-branch stent 2000 is released in the left subclavian artery 10c, and the main delivery device 200 is withdrawn, and the pre-buried guide wires 7000 remain in the innominate artery 10a and the left common carotid artery 10b. The two branch stents 5000 are introduced into the innominate artery 10a and the left common carotid artery 10b respectively along the two pre-buried guide wires 7000, and then the two branch stents 5000 are released, the surgical forceps are removed, the blood flow of the innominate artery 10a and the left common carotid artery 10b is restored, and the pre-buried guide wires 7000 and the branch delivery device are withdrawn. The artificial blood vessel 4000, the proximal end of the aortic arch and the distal end of the ascending aorta 20 are anastomosed end to end, and the operation is completed.

[0093] In the vascular stent 100 provided in the present application, the single-branch stent 2000 can be used for implantation into any one of the innominate artery 10a, the left common carotid artery 10b or the left subclavian artery 10c. Therefore, in addition to the two specific embodiments given above, those skilled in the art can also refer to the above two specific embodiments and select other different specific embodiments to perform the operation according to actual surgical needs, which is not limited here.

[0094] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0095] The above-described embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be construed as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent application shall be subject to the attached claims.

Claims

1. A vascular stent, characterized in that: The vascular stent comprises: A main body support, wherein the main body support has a main body passage extending through the main body along a first axial direction, and a branch window is formed on a side wall of the main body support, wherein the branch window is connected to the main body passage; A single-branch bracket, wherein the single-branch bracket has a single-branch channel penetrating along the second axial direction, the single-branch bracket is arranged on the side wall of the main body bracket, and the single-branch channel is connected to the main body channel; A guiding element is provided with a guiding channel, and the main body bracket is used to construct a bracket guiding path which can be connected to the branch window through the guiding channel.

2. The vascular stent according to claim 1, characterized in that: The vascular stent comprises: A branch bracket has a branch channel penetrating along a third axial direction, and the branch bracket is used to be guided out from the branch window along the bracket guide path.

3. The vascular stent according to claim 2, characterized in that: The side wall of the main body support has a concave area that is concave inwardly along the radial direction of the main body support, and the concave area is used to accommodate at least a portion of the branch support guided out from the branch window.

4. The vascular stent according to claim 3, characterized in that: The guide element is connected to the side wall of the main support, and the guide channel is directly connected to the branch window; and / or, The guide element is disposed in the main body channel of the main body support; and / or, The concave area and the branch window correspond to each other in a first axial direction of the main body support.

5. The vascular stent according to claim 1, characterized in that: A reserved anastomotic portion is provided at the distal end of the main support; and / or, The single-branch support and the main body support are formed as an integral structure; and / or, The guiding element is integrally formed with the main support; and / or, The main body support adopts a variable diameter cylindrical support.

6. The vascular stent according to claim 1, characterized in that: The guide element is arranged in the main body channel of the main body support; and / or, The guiding element is located in the proximal direction of the branch window in the first axial direction of the main body stent; and / or, The guide element is located in the proximal region of the main body support; and / or, The guiding element is a support structure, and the guiding element has a contracted state and an expanded state, and is used to contract or expand along with the main support; and / or, The main support has a bendable section, and the single-branch support and the branch window are located on the large bend side of the bendable section.

7. The vascular stent according to claim 1, characterized in that: The vascular stent comprises: a guide tube, the guide tube being used to pass through the guide channel and the branch window along the stent guide path; and / or, a guide wire, the guide wire being used to pass through the guide channel and the branch window along the stent guide path; and / or, An artificial blood vessel has a blood vessel channel that runs through the blood vessel axis, the artificial blood vessel is connected to the proximal end of the main support, and the blood vessel channel is communicated with the main channel.

8. The vascular stent according to claim 7, characterized in that: A limiting portion is arranged at the distal end of the guide wire.

9. The vascular stent according to claim 1, characterized in that: The number of the branch windows is two, the single-branch stent and the two branch windows are distributed along the first axial direction on the main stent in the direction from the proximal end to the distal end, the number of the guide elements is two, and the two guide channels are used to construct two independent stent guide paths in the main channel that can respectively connect the two branch windows.

10. A support system, characterized in that: The support system comprises: The vascular stent according to any one of claims 1 to 9; A conveying device is connected to the vascular stent and is used to convey the vascular stent.