identification device

Abstract

Embodiments of the present application provide an identification device, comprising: an identification net basket and a delivery assembly, the identification net basket has a radially outwardly unfolded state and a radially inwardly folded state, in the unfolded state, the identification net basket is adapted to be in close contact with the blood vessel wall of a branch blood vessel to display the morphology of the branch blood vessel. The identification device of the embodiments of the present application can display the position and morphology of the branch blood vessel in real time during the in-situ fenestration process, improve the success rate of in-situ fenestration, and after the fenestration is completed, the identification device can be withdrawn, which can reduce the difficulty of branch blood vessel reconstruction and improve the reconstruction effect.

Description

Technical Field

[0001] This application relates to the field of interventional medical device technology, and more particularly to an identification device. Background Technology

[0002] In situ fenestration is a technique used during endovascular treatment to reconstruct branch arteries, particularly suitable for complex abdominal aortic diseases involving visceral areas or the aortic arch. This technique allows operators to create openings (i.e., "fenestrations") within an already placed covered stent to maintain blood flow to critical branch vessels, thereby preventing complications such as organ ischemia.

[0003] Taking the thoracic and abdominal aortic region as an example, the thoracic and abdominal aorta gives rise to four visceral arteries (caecilia, superior mesenteric artery, left renal artery, and right renal artery). The openings of these visceral arteries are relatively close together, and the spacing and angles between their branches are not clearly defined. Therefore, when endovascular repair is used to treat lesions involving the thoracic and abdominal aorta, there are problems such as requiring too many different sizes of covered stent products, high operational difficulty, and altering the location of branch vessel inlets.

[0004] By applying in situ fenestration technology, the need for visceral artery reconstruction can be met by using only conventional straight covered stents. This can solve the problem of excessive covered stent sizes required for endovascular isolation of the thoracic and abdominal aorta, and the problem of altering the inlet position of branch vessels during reconstruction.

[0005] The biggest challenge of in-situ fenestration is that the location of the branch artery to be fenestrated cannot be accurately displayed during the fenestration process. If in-situ fenestration is performed without real-time confirmation of the location of the branch artery to be fenestrated, it is easy to puncture the aorta or branch artery during the membrane rupture process. Utility Model Content

[0006] In view of this, the embodiments of this application aim to provide an identification device that can improve the success rate of in-situ fenestration, reduce the difficulty of branch vessel reconstruction, and improve the reconstruction effect.

[0007] This application provides an identification device, including: an identification basket having an expanded state that is radially outward and a contracted state that is radially inward, wherein, in the expanded state, the identification basket is adapted to conform to the vessel wall of a branch vessel to display the morphology of the branch vessel.

[0008] In some embodiments, in the deployed state, the circumferential wall of the marking basket forms a passage for the guide wire to pass through, the passage extending through the circumferential wall along the axial direction of the marking basket.

[0009] In some embodiments, in the unfolded state, the circumferential wall of the marking basket is arc-shaped, and two side edges of the circumferential wall are spaced apart along the circumference of the marking basket to form the passage between the two side edges.

[0010] In some embodiments, in the deployed state, the central angle of the circumferential wall of the marking basket is greater than or equal to 270°, and / or, in the deployed state, the diameter of the marking basket is greater than or equal to the diameter of the branch vessel.

[0011] In some embodiments, the marking basket is configured to be formed by winding a sheet-like substrate, wherein the sheet-like substrate is configured as a structure formed by pressing a cylindrical basket.

[0012] In some embodiments, the marking device further includes a delivery assembly for delivering or retrieving the marking basket into or from the branch vessel, the delivery assembly including a catheter and a pusher for moving the marking basket relative to the catheter to release or retrieve the marking basket from or from the distal end of the catheter.

[0013] In some embodiments, the pusher includes a core wire, and the marking basket includes a basket body with a connecting portion disposed near the proximal end of the basket body, the proximal end of the connecting portion being connected to the core wire, wherein, in the unfolded state, the connecting portion gradually narrows in a direction away from the basket body.

[0014] In some embodiments, the connecting portion includes multiple traction wires, the distal end of each traction wire being connected to the basket body and distributed circumferentially along the basket body, and the proximal end of each traction wire being connected to the core wire.

[0015] In some embodiments, the delivery assembly includes a loading tube for constraining the identification basket in the folded state, the loading tube engaging with the conduit to allow the identification basket to enter the conduit via the loading tube.

[0016] In some embodiments, the catheter includes a tube body and a hemostatic valve disposed proximal to the tube body, and the loading tube is configured to be inserted into the hemostatic valve and communicate with the tube body.

[0017] The marking device in this application embodiment can display the location and shape of branch vessels in real time during the window opening process, improving the success rate of window opening. Moreover, the marking device can be retracted after the window opening is completed, which can reduce the difficulty of branch vessel reconstruction and improve the reconstruction effect. Attached Figure Description

[0018] Figure 1This is a schematic diagram of the marking device according to an embodiment of this application, wherein the marking basket is in a retracted state; Figure 2 This is a schematic diagram of the identification basket in the unfolded state according to an embodiment of this application; Figure 3 This is a schematic diagram of the identification basket in the unfolded state according to another embodiment of this application; Figure 4 for Figure 3 A schematic diagram of the axial projection of the net basket in the unfolded state; Figure 5 This is a schematic diagram illustrating the usage scenario of the identification basket according to an embodiment of this application; Figure 6 This is a schematic diagram of the manufacturing process of the identification basket according to an embodiment of this application; Figure 7 This is a schematic diagram of the identification basket in the unfolded state according to another embodiment of this application; Figure 8 This is a schematic diagram of the catheter structure according to an embodiment of this application; Figure 9 This is a schematic diagram of the loading tube according to an embodiment of this application.

[0019] Explanation of reference numerals in the attached figures 1. Identification basket; 1a. Through port; 11. Basket body; 12. Connecting part; 121. Traction wire; 2. Delivery assembly; 21. Catheter; 211. Tube body; 212. Hemostatic valve; 213. Side tube; 22. Pushing element; 221. Core wire; 23. Loading tube; X. Guide wire; Y. Sheet-shaped substrate; Z. Cylindrical basket. Detailed Implementation

[0020] To make the objectives, technical solutions, and advantages of this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the scope of this application.

[0021] The specific technical features described in the specific embodiments can be combined in any suitable manner without contradiction. For example, different combinations of specific technical features can form different embodiments and technical solutions. To avoid unnecessary repetition, the various possible combinations of the specific technical features in this application will not be described separately.

[0022] In the following description, the terms "first," "second," etc., are used merely to distinguish different objects and do not indicate that the objects have the sameness or relationship. It should be understood that the directional descriptions "above," "below," "outside," and "inside" refer to the orientation under normal use conditions, while "left" and "right" refer to the left and right directions shown in the corresponding diagrams, which may or may not be the left and right directions under normal use conditions.

[0023] It should be noted that the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Unless otherwise specified, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes that element. "A plurality of" means two or more.

[0024] In the description of the embodiments of this application, the technical terms "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "circumferential", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing the embodiments of this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed, operated or used in a specific orientation. Therefore, they should not be construed as limitations on the embodiments of this application.

[0025] In the description of the embodiments of this application, unless otherwise expressly specified and limited, technical terms such as "installation," "connection," "joining," and "fixing" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in the embodiments of this application according to the specific circumstances.

[0026] In the description of the embodiments of this application, unless otherwise expressly specified and limited, the technical term "contact" should be interpreted broadly, and can be direct contact, contact through an intermediate medium layer, contact between two contacting parties with substantially no interaction force, or contact between two contacting parties with interaction force.

[0027] In the description of the embodiments of this application, the distal end refers to the end that is far away from the operator during actual use, and the proximal end refers to the end that is close to the operator during actual use.

[0028] Embodiments of this application provide an identification device, with reference to Figures 1-9 The marking device includes a marking basket 1.

[0029] Reference Figure 1 and Figure 2 The marking basket 1 has an expanded state that extends radially outward and a contracted state that retracts radially inward. In the expanded state, the marking basket 1 is adapted to fit against the vessel wall of the branch vessel to display the morphology of the branch vessel.

[0030] The label basket 1 refers to a basket-like structure that can be developed in an image captured by an imaging device, including but not limited to X-ray imaging devices, MRI imaging devices, ultrasound imaging devices, etc. The label basket 1 can be configured to be made entirely of a developing material (e.g., a non-transmissive material) so that the label basket 1 can be developed, or the label basket 1 can be provided with developing marks so that the label basket 1 can be developed.

[0031] Reference Figure 1 The identification basket 1 has a radially inwardly contracted state, and the identification basket 1 can be delivered to the branch vessel in the contracted state. After reaching the branch vessel, refer to Figure 2 The identification basket 1 can be released and switched to the deployed state, thereby fitting against the vessel wall of the branch vessel.

[0032] The marking basket 1 can be configured as a self-expanding structure. Here, self-expanding specifically means that the marking basket 1 can remain in a contracted state under the action of external force, and automatically expand to an unfolded state under the action of its own restorative force after the external force is removed. As an example, the marking basket 1 can be made of shape memory materials such as shape memory alloys to achieve self-expansion.

[0033] Reference Figure 2 In its deployed state, the marking basket 1 is roughly cylindrical. The diameter of the marking basket 1 in its deployed state can be approximately the same as, or slightly larger than, the diameter of the branch vessel to be reconstructed. This allows the marking basket 1 to fit closely to the vessel wall of the branch vessel in its deployed state. Of course, in some other embodiments, the marking basket 1 can also be set to a universal size (i.e., adaptable to the size of most branch vessels requiring reconstruction) to improve its versatility.

[0034] The delivery component 2 is used to deliver or retrieve the identification basket 1 into or from the branch vessel. Specifically, retrieving from the branch vessel means that the delivery component 2 can return the identification basket 1 to the retracted state and back into the delivery component 2 when the identification basket 1 is in the unfolded state and in contact with the vessel wall of the branch vessel.

[0035] The specific structure of the delivery component 2 is not limited, as long as it can realize the delivery and retrieval of the identification basket 1. Those skilled in the art can refer to the relevant technology in the field to specifically set the delivery component 2. The relevant parts below will also describe the optional structure of the delivery component 2, which will not be repeated here.

[0036] It is understandable that when opening a window in situ from the main vessel to the branch vessel, the position must be very precise. Any deviation in position may lead to perforation of the vessel wall of the main vessel or the branch vessel, which could result in serious adverse events.

[0037] Due to factors such as the stent delivery system, the covered stent, and respiration, the location of branch vessels cannot be reproduced using image fusion techniques such as preoperative CTA images during in-situ fenestration. Taking the aortic stent with a covered stent as an example, before the fenestration is completed after the aortic covered stent is released, the covered stent will cause blood flow in the branch vessels, so the location of the branch vessels cannot be displayed by contrast agents.

[0038] In this embodiment, after the identification basket 1 is attached to the vessel wall of the branch vessel, the outer contour of the identification basket 1 in the image is roughly the inner contour of the branch vessel. In this way, the operator can observe the position and shape of the branch vessel in real time in the image, thereby improving the success rate of the window opening operation and reducing the difficulty of the window opening operation.

[0039] Furthermore, it is understandable that after the fenestration procedure, reconstruction of the branch vessel is usually required. If the marker basket 1 remains within the branch vessel, it will interfere with the subsequent reconstruction work and increase the difficulty of reconstruction. Moreover, the stent used for reconstructing the branch vessel will overlap with the marker basket 1 after implantation, reducing the flexibility of the reconstructed vessel and making it easier to damage the branch vessel. In addition, the mutual friction between the basket and the stent will aggravate stent fatigue damage and affect the lifespan of the stent.

[0040] In this embodiment, after the fenestration operation is completed, the marker basket 1 can be retrieved from the branch vessel without leaving it inside the branch vessel. This reduces the difficulty of branch vessel reconstruction and improves the reconstruction effect.

[0041] In some embodiments, refer to Figure 1 and Figure 2The marking device includes a delivery component 2, which is used to deliver or retrieve the marking basket 1 into or from the branch blood vessel. Specifically, retrieving from the branch blood vessel means that the delivery component 2 can return the marking basket 1 to the retracted state and back into the delivery component 2 when the marking basket 1 is in the unfolded state and in contact with the blood vessel wall of the branch blood vessel.

[0042] The specific structure of the delivery component 2 is not limited, as long as it can realize the delivery and retrieval of the identification basket 1. Those skilled in the art can refer to the relevant technology in the field to specifically set the delivery component 2. The relevant parts below will also describe the optional structure of the delivery component 2, which will not be repeated here.

[0043] It should be noted that in some other embodiments, the marking device may not include the delivery component 2, and the delivery and retrieval of the marking basket 1 may be accomplished by means of an external structure (such as the conduit used when delivering the main support).

[0044] In some embodiments, refer to Figure 3 and Figure 4 In the unfolded state, the circumferential wall of the marking basket 1 forms a passage 1a for the guide wire to pass through, and the passage 1a extends through the circumferential wall along the axial direction of the marking basket 1.

[0045] Here, "penetrating the circumferential wall along the axial direction of the marking basket 1 through the opening 1a" specifically means that the opening 1a extends from one end of the circumferential wall of the marking basket 1 along the axial direction to the other end, and forms notches at both ends in the circumferential direction. In other words, the circumferential wall is formed as a discontinuous structure in the circumferential direction of the marking basket 1.

[0046] Here, the guidewire specifically refers to the instrument (such as a membrane rupture needle) that guides the procedure during in-situ fenestration. The specific structure and usage of the guidewire can be found in the relevant technology in this field, and will not be elaborated here.

[0047] As mentioned above, once the marker basket 1 is deployed, it will closely adhere to the vessel wall of the branch vessel. This means that after the guidewire enters the branch vessel, it will be located within the cavity formed by the circumferential wall of the marker basket 1. If the circumferential wall of the marker basket 1 forms a closed annular structure (i.e., a continuous and uninterrupted structure in the circumferential direction of the marker basket 1), the guidewire will be constrained within the cavity formed by the circumferential wall of the marker basket 1 and will be retrieved along with the marker basket 1 during retrieval. This will require the guidewire to be re-implanted during subsequent reconstruction of the branch vessel, affecting the reconstruction efficiency.

[0048] In this embodiment, the circumferential wall of the identification basket 1 forms an axially penetrating through-hole 1a, thus, referring to... Figure 5The guidewire Z can move from inside the lumen formed by the circumferential wall to outside the lumen through the through port 1a, so that the guidewire Z remains in the branch vessel after the marker basket 1 is retrieved. In this way, the guidewire does not need to be re-implanted during branch vessel reconstruction (e.g., when delivering a stent into the branch vessel after fenestration), which improves reconstruction efficiency and reduces reconstruction difficulty.

[0049] In some embodiments, refer to Figure 3 and Figure 4 In the unfolded state, the circumferential wall of the marking basket 1 is arc-shaped, and the two side edges of the circumferential wall are spaced apart along the circumference of the marking basket 1, thereby forming a passage 1a between the two side edges.

[0050] In this embodiment, the circumferential wall is set as an arc-shaped structure, which helps the marking basket 1 to fit better with the blood vessel wall in the unfolded state, thereby more accurately marking the location and shape of the branch blood vessels.

[0051] In some embodiments, refer to Figure 6 At least a portion of the identification basket 1 is configured to be formed by winding a sheet-like substrate Y, wherein the sheet-like substrate Y is configured as a structure formed by pressing a cylindrical basket Z.

[0052] For example, refer to Figure 2 and Figure 3 The net basket 1 includes a net basket body 11 and a connecting part 12 disposed near the proximal end of the net basket body 11, or, refer to Figure 5 The net basket 1 includes a net basket body 11 and two connecting parts 12 disposed at the near end or far end of the net basket body 11.

[0053] In this embodiment, only the basket body 11 may be configured to be formed by winding a sheet-like substrate Y, and the connecting part 12 may be connected to the basket body 11 after the basket body 11 is manufactured. Alternatively, both the basket body 11 and the connecting part 12 may be configured to be formed by winding a sheet-like substrate Y, that is, the basket 1 as a whole may be configured to be formed by winding a sheet-like substrate Y.

[0054] Reference Figure 6 In the actual preparation process, a cylindrical mesh basket Z can be prepared first. Here, the cylindrical mesh basket Z specifically refers to a mesh basket structure (such as a vascular stent) with a circumferential wall forming a closed ring structure, which is well known to those skilled in the art. The cylindrical mesh basket Z can be a woven mesh basket (a mesh basket with a mesh-like circumferential wall formed by weaving a filamentous structure) or a cut mesh basket (a mesh basket formed by cutting a cylindrical structure).

[0055] Next, pressure can be applied to the tubular basket Z to compress it into a sheet-like substrate Y.

[0056] Next, the sheet substrate Y is wound into a marking basket 1. For example, the sheet substrate Y can be wound from its two ends along its length (or width) towards the middle. In this way, the two ends of the sheet substrate Y along its length (or width) will form the two side edges of the circumferential wall of the marking basket 1. After being wound to a suitable curvature and shaped, the marking basket 1 of this embodiment can be obtained.

[0057] In this embodiment, the identification basket 1 of this structural form can be manufactured using conventional molds and / or processing equipment (e.g., automated braiding machines) in the art, without the need for new mold making and / or replacement of processing equipment, which helps reduce manufacturing costs. Furthermore, in this embodiment, the two side edges of the circumferential wall of the identification basket 1 are formed into a relatively smooth structure, which helps improve safety during use. Moreover, in this embodiment, the circumferential wall of the identification basket 1 is formed into a double-layer structure, which helps improve the support performance, structural strength, and adhesion to the vessel wall of the branch vessel when the identification basket 1 is deployed, thereby improving its identification capability.

[0058] In some embodiments, alternatively, at least a portion of the identification basket 1 is configured to be formed by cutting a cylindrical substrate.

[0059] Similarly, in this embodiment, the identification basket 1 may include a basket body 11 and a connecting portion 12. Only the basket body 11 may be formed by cutting a cylindrical base, and the connecting portion 12 may be attached to the basket body after the basket body 11 is manufactured. Alternatively, both the basket body 11 and the connecting portion 12 may be formed by cutting a cylindrical base.

[0060] In this embodiment, the specific implementation of the cutting can refer to the cutting of the net basket in the relevant technology of the art. The difference is that in this embodiment, in addition to cutting to form a notch on the circumferential wall of the conventional net basket (the notch is mainly used to realize the folding and unfolding of the net basket), it is also necessary to further cut to form a passage 1a.

[0061] In this embodiment, the marking basket 1 is directly cut from the cylindrical substrate, which helps to improve the structural stability of the marking basket 1 and helps to reduce manufacturing processes and improve manufacturing efficiency.

[0062] In some embodiments, alternatively, the identification basket 1 can also be directly woven. In this embodiment, for example, the circumferential wall of the identification basket 1 may include a mesh portion and a sealing portion. The mesh portion is provided with sealing portions at both ends of the circumferential direction of the identification basket 1. The mesh portion is formed into a mesh-like structure, thereby realizing the folding and unfolding of the identification basket 1. The sealing portion is provided as a rod-like structure with a smooth surface and is formed as the two side edges of the circumferential wall. In this way, the possibility of the side edges of the circumferential wall scratching branch blood vessels is reduced, and the safety of the identification device is improved.

[0063] In some embodiments, in the unfolded state, the central angle of the circumferential wall of the identification basket 1 is greater than or equal to 270°. Here, the central angle of the circumferential wall specifically refers to the large included angle formed between the line connecting the two side edges of the circumferential wall and the center of the circumferential wall in a projection plane perpendicular to the axis of the identification basket 1.

[0064] In this embodiment, the central angle of the circumferential wall is set to be greater than or equal to 270°, which helps to maximize the contact area between the marking basket 1 and the branch blood vessel while forming the passage 1a. This helps to more accurately mark the position and shape of the branch blood vessel, and also helps to reduce the possibility of displacement after the marking basket 1 is released.

[0065] In some embodiments, specifically, the central angle of the circumferential wall of the basket 1 is 270°-350°, such as any value among 270°, 275°, 280°, 285°, 290°, 295°, 300°, 305°, 310°, 315°, 320°, 325°, 330°, 335°, 340°, 345°, and 350°, or any value between two of them.

[0066] By limiting the central angle of the circumferential wall of the marking basket 1 to the range of 270°-350°, it is possible to improve marking accuracy and reduce the possibility of displacement, while reducing the difficulty of the guide wire passing through the passage 1a and improving the success rate of passage.

[0067] In some embodiments, in the unfolded state, the diameter of the identification basket 1 is greater than or equal to the diameter of the branch vessel.

[0068] Here, the diameter of the marking basket 1 specifically refers to its maximum diameter. In this embodiment, the diameter of the marking basket 1 is set to be greater than or equal to the diameter of the branch vessel. That is, the diameter of the marking basket 1 is determined according to the diameter of the branch vessel to be reconstructed. This helps to ensure that the marking basket 1 fits tightly against the vessel wall of the branch vessel after release, thereby improving the accuracy of marking the position and shape of the branch vessel. Furthermore, it helps to reduce the possibility of displacement of the marking basket 1 after release.

[0069] In some embodiments, refer to Figure 1 and Figure 8 The delivery component 2 includes a conduit 21 and a pusher 22, the pusher 22 being used to move the identification basket 1 relative to the conduit 21 to release or retract the identification basket 1 from the distal end of the conduit 21.

[0070] In this embodiment, during delivery, the identification basket 1 is housed within the lumen of catheter 21 and remains in a retracted state under the constraint of catheter 21. After the end of catheter 21 reaches the branch vessel, the pusher 22 can be operated to retract catheter 21 and / or push identification basket 1 forward, thereby removing identification basket 1 from the opening at the end of catheter 21. After losing the constraint of catheter 21, identification basket 1 expands to an unfolded state and adheres to the vessel wall of the branch vessel. After the fenestration is completed, the pusher can be operated to push catheter 21 forward and / or retract identification basket 1, thereby retrieving identification basket 1 back into the lumen of catheter 21, completing the retrieval of identification basket 1.

[0071] In this embodiment, the delivery component 2 with this structural form helps to reduce costs and delivery difficulties.

[0072] In some embodiments, refer to Figure 2 The pusher 22 includes a core wire 221, and the identification basket 1 includes a basket body 11 and a connecting part 12 disposed near the end of the basket body 11. The near end of the connecting part 12 is connected to the core wire 221. In the unfolded state, the connecting part 12 gradually narrows in the direction away from the basket body 11.

[0073] As an example, refer to Figure 2 and Figure 3 In the unfolded state, the main body 11 of the net basket can be roughly formed into a cylindrical structure (a structure with approximately equal diameter along the axial direction). The far end of the main body 11 of the net basket is formed into an open end, and the connecting part 12 is connected to the near end of the main body 11 of the net basket and gradually narrows in the direction away from the main body 11 of the net basket. Here, gradually narrowing specifically means that the diameter gradually decreases. In other words, the connecting part 12 is roughly formed into a conical structure, and the near end is the small end of the conical structure.

[0074] The connection method between the main body 11 and the connecting part 12 is not limited. For example, they can be welded, glued, or the two can be formed into an integral structure.

[0075] The core wire 221 is used to cause relative movement between the label basket 1 and the conduit 21, thereby enabling the release or retrieval of the label basket 1. Exemplarily, during delivery, the core wire 221 can be pushed forward and / or the conduit 21 can be retracted, causing the label basket 1 to extend from the distal opening of the conduit 21, after which the label basket 1 will unfold under its own expansion force. During retrieval, the conduit 21 can be pushed forward and / or the core wire 221 can be retracted, after which the label basket 1 will be drawn into the lumen of the conduit 21 under the traction of the connecting part 12.

[0076] In some embodiments, a handle structure may be provided at the proximal end of the core wire 221 to facilitate gripping by the operator.

[0077] In this embodiment, when retrieving the marking basket 1, since the proximal end of the connecting part 12 has a smaller diameter (the proximal end of the connecting part 12 is connected to the core wire 221, and its diameter is approximately the same as the diameter of the core wire 221), that is, the diameter of the proximal end of the connecting part 12 is smaller than the inner diameter of the tube lumen of the conduit 21, it can enter the lumen of the conduit 21 more easily when the marking basket 1 is pulled back. Then, as the marking basket 1 enters the lumen, the end of the connecting part 12 near the basket body 11 will gradually close under the action of the tube wall of the conduit 21, causing the basket body 11 to close, so that the basket body 11 can enter the lumen of the conduit 21 more smoothly, thereby improving the smoothness of the marking basket 1 retrieval.

[0078] It should be noted that the structural form of the identification basket 1 is not limited to this. For example, in some embodiments, the identification basket 1 may also be configured as a lantern-shaped structure. In some embodiments, refer to Figure 7 The net basket 1 of the identification basket 1 can be provided with connecting parts 12 at both the near end and the far end. The pusher 22 includes an inner shaft and an outer shaft. The outer shaft is sleeved on the outside of the inner shaft and the two can move relative to each other. The inner shaft is connected to the connecting part 12 at the far end of the net basket 11, and the outer shaft is connected to the connecting part 12 at the near end of the net basket 11. In this way, the smoothness of the identification basket 1’s retrieval and release is improved.

[0079] In some embodiments, refer to Figure 2 and Figure 3 A connecting part 12 is provided at the near end of the net basket body 11. The connecting part 12 includes multiple traction wires 121. The far end of each traction wire 121 is connected to the net basket body 11 and distributed along the circumference of the net basket body 11. The near end of each traction wire 121 is connected to the core wire 221.

[0080] Here, the proximal end of each traction wire 121 can be connected to the same position of the core wire 221 or to different positions of the core wire 221, without any restriction.

[0081] In this embodiment, by configuring the connecting part 12 to include multiple traction wires 121, it helps to reduce manufacturing costs. Furthermore, this structural form is easy to fold up, which can further improve the smoothness of the identification basket 1 retrieval.

[0082] It should be noted that the structure of the connecting part 12 is not limited to this. For example, in some other embodiments, the connecting part 12 may also be configured as a generally conical mesh structure.

[0083] In some embodiments, refer to Figure 1 and Figure 8 and Figure 9The delivery component 2 includes a loading tube 23 for restraining the identification basket 1 in a folded state. The loading tube 23 is engaged with the conduit 21 so that the identification basket 1 can enter the conduit 21 through the loading tube 23.

[0084] Here, the loading tube 23 is specifically formed as a tubular structure with a diameter that matches the diameter of the marking basket 1 in the folded state and the diameter of the conduit 21. For example, the diameter of the loading tube 23 may be slightly larger than the diameter of the marking basket 1 in the folded state and slightly smaller than the diameter of the conduit 21.

[0085] The insertion and removal of the loading tube 23 and the conduit 21 specifically means that the loading tube 23 can be inserted into the lumen of the conduit 21 or pulled out from the lumen of the conduit 21. It can be understood that when the loading tube 23 is inserted into the lumen of the conduit 21, the lumen of the loading tube 23 is connected to the lumen of the conduit 21. Thus, the marking basket 1 can be moved from the lumen of the loading tube 23 to the lumen of the conduit 21, thereby loading the marking basket 1 into the lumen of the conduit 21.

[0086] It is understandable that the lumen of catheter 21, in addition to delivering the label basket 1, may also be used to deliver other surgical instruments or to perform other functions (such as aspiration, cleaning, etc.). Furthermore, the proximal end of the lumen of catheter 21 may have sealing structures, valve structures, etc., resulting in a relatively narrow proximal end of the lumen. These factors make loading the label basket 1 into the lumen of catheter 21 more difficult. Moreover, the structural strength of the label basket 1 itself is relatively low (mainly because the label basket 1 is designed to be retractable and expandable). Therefore, damage (such as deformation) to the label basket 1 is likely to occur during loading.

[0087] In this embodiment, the delivery component 2 includes a loading tube 23, which can protect the identification basket 1 during the loading process, improve the smoothness of loading the identification basket 1 into the corresponding lumen of the conduit 21, and reduce the possibility of damage to the identification basket 1 during the loading process.

[0088] Of course, in some other embodiments, the delivery component 2 may not include the loading tube 23, and the identification basket 1 may be directly inserted into the lumen of the conduit 21.

[0089] In some embodiments, refer to Figure 8 The catheter 21 includes a tube body 211 and a hemostatic valve 212 disposed at the proximal end of the tube body 211. The loading tube 23 is configured to be able to insert the hemostatic valve 212 and communicate with the tube body 211.

[0090] Here, the hemostatic valve 212 is used to seal the proximal end of the tube body 211, thereby reducing the possibility of blood flowing out from the proximal end of the catheter 21. The specific structural form of the hemostatic valve 212 is not limited, as long as it can achieve the above function.

[0091] In this embodiment, a hemostatic valve 212 is provided at the proximal end of the catheter 21, which can improve the reliability of the marking device. Furthermore, the marking basket 1 is loaded by means of the loading tube 23 and the hemostatic valve 212, so that the hemostatic function can be achieved while taking into account the convenience and reliability of loading the marking basket 1.

[0092] Of course, in some other embodiments, catheter 21 may not include the hemostatic valve 212 described above.

[0093] In some embodiments, refer to Figure 4 The catheter 21 may include a side tube 213 that communicates with the tube body 211. In this embodiment, the lumen of the tube body 211 is mainly used for the guide wire and the marking basket 1 to pass through, while the lumen of the side tube 213 can be used to perform other functions, such as aspiration, cleaning, delivery of other surgical instruments, etc.

[0094] The number of side tubes 213 can be one or more, without limitation. The connection method between the side tube 213 and the tube body 211 is not limited. As an example, the tube body 211, the hemostatic valve 212, and the side tube 213 can be connected by a multi-port valve.

[0095] The embodiments of this application also provide an operation method for an identification device, which is applicable to the identification device described in any of the above embodiments. The operation method for the identification device includes the following steps.

[0096] Step S101: Deliver the identification basket 1 to the proximal end of the branch vessel.

[0097] Step S102: Deliver the main stent to the main vessel connected to the branch vessels.

[0098] Step S103: Under the marking of the basket 1, perform in-situ fenestration on the main stent to create a window through which the main stent leads to the branch vessels.

[0099] Step S104: Retrieve the identification basket 1 from the branch vessel.

[0100] Step S105: After the identification basket 1 is retrieved, the branch vessels are reconstructed via the branch stent through the window.

[0101] For example, in step S101, the identification basket 1 can be delivered to the proximal end of the branch vessel by means of the delivery component 2 or an external structure. Here, delivering the identification basket 1 to the proximal end of the branch vessel specifically means delivering the identification basket 1 to a position where the proximal end of the identification basket 1 is close to the proximal end of the branch vessel, and releasing the identification basket 1 so that the identification basket 1 fits against the vessel wall of the branch vessel.

[0102] In step S102, the specific implementation of delivering the main stent to the main blood vessel connected to the branch blood vessel can be referred to the relevant technology in this field, and will not be repeated here.

[0103] The main support in step S102 can be a bare support or a covered support, and those skilled in the art can choose according to actual usage requirements.

[0104] It should be noted that in step S102, the delivery of the main support can be achieved by the delivery component 2 of the marking device or by a separate delivery device, and there is no limitation on this.

[0105] In step S103, as mentioned above, the identification basket 1 can be visualized in the image to identify the location and shape of the branch vessels. The operator can use the image to deliver the fenestration instrument to the position corresponding to the identification basket 1 to achieve fenestration. The specific fenestration method can be referred to the relevant technology in this field, and will not be described in detail here.

[0106] After the window opening operation is completed, in step S104, the identification basket 1 is retrieved from the branch blood vessel. The specific retrieval method can be referred to the relevant section above, and will not be repeated here.

[0107] In step S105, after the identification basket 1 is retrieved, the branch vessels are reconstructed via the window.

[0108] Here, the branch stent can be a bare stent or a covered stent. For example, both the main stent and the branch stent are covered stents, and the diameter of the main stent is larger than the diameter of the branch stent. In other words, the main stent is a large-diameter covered stent, and the branch stent is a small-diameter covered stent.

[0109] Specific methods for reconstructing branch vessels can be found in relevant techniques in this field, and will not be elaborated here.

[0110] It is understandable that when opening a window in situ from the main vessel to the branch vessel, the position must be very precise. Any deviation in position may lead to perforation of the vessel wall of the main vessel or the branch vessel, which could result in serious adverse events.

[0111] Due to factors such as the stent delivery system, the covered stent, and respiration, the location of branch vessels cannot be reproduced using image fusion techniques such as preoperative CTA images during in-situ fenestration. Taking the aortic stent with a covered stent as an example, before the fenestration is completed after the aortic covered stent is released, the covered stent will cause blood flow in the branch vessels, so the location of the branch vessels cannot be displayed by contrast agents.

[0112] In this embodiment, the marker basket 1 adheres closely to the vessel wall of the branch vessel after delivery. Utilizing the radiopaque nature of the marker basket 1 (or other radiopaque features), the image formed by the marker basket 1 or its markings can be clearly seen under fluoroscopy. Based on the shape of the marker basket 1, the morphology of the corresponding segment of the branch vessel can be determined, thus guiding the location and morphology of the branch vessel for fenestration within the stent. This improves the success rate of fenestration and reduces the possibility of scratching the main or branch vessel during the fenestration process. Furthermore, after fenestration, the marker basket 1 is retracted through the window without interfering with subsequent branch vessel reconstruction, reducing the difficulty of branch vessel reconstruction and improving reconstruction results.

[0113] In some embodiments, as mentioned above, the identification basket 1 has a through-port 1a. In this embodiment, the operation of the identification device further includes, in the step of retrieving the identification basket 1 from the branch vessel via the window, deflecting the guidewire out of the identification basket 1 through the through-port 1a to leave the guidewire within the branch vessel. Thus, when reconstructing the branch vessel in step S105, it is not necessary to re-implant the guidewire; instead, the branch vessel can be reconstructed directly using the guidewire left within it in the aforementioned steps, which helps improve the reconstruction efficiency of grouped vessels.

[0114] The above embodiments are merely illustrative of the technical solutions of this application and are not intended to limit it. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. These modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this application, and all should be covered within the scope of this application. In particular, as long as there is no structural conflict, the various technical features mentioned in the embodiments can be combined in any way.

Claims

1. An identification device, characterized in that, The identification device includes: The marking basket has an expanded state that extends radially outward and a contracted state that retracts radially inward, wherein, in the expanded state, the marking basket is adapted to conform to the vessel wall of a branch vessel to display the morphology of the branch vessel.

2. The marking device according to claim 1, characterized in that, In the unfolded state, the circumferential wall of the marking basket forms a passage for the guide wire to deflect out, the passage extending through the circumferential wall along the axial direction of the marking basket.

3. The marking device according to claim 2, characterized in that, In the unfolded state, the circumferential wall of the marking basket is arc-shaped, and the two side edges of the circumferential wall are spaced apart along the circumference of the marking basket to form the passage between the two side edges.

4. The marking device according to claim 3, characterized in that, In the unfolded state, the central angle of the circumferential wall of the marking basket is greater than or equal to 270°, and / or, In the deployed state, the diameter of the identification basket is greater than or equal to the diameter of the branch vessel.

5. The marking device according to claim 3, characterized in that, At least a portion of the identification basket is configured to be formed by winding a sheet-like substrate, wherein the sheet-like substrate is configured as a structure formed by pressing a cylindrical basket.

6. The marking device according to any one of claims 1-5, characterized in that, The marking device further includes a delivery assembly for delivering or retrieving the marking basket into or from the branch vessel, the delivery assembly including a catheter and a pusher for moving the marking basket relative to the catheter to release or retrieve the marking basket from or from the distal end of the catheter.

7. The marking device according to claim 6, characterized in that, The pusher includes a core wire, and the marking basket includes a basket body with a connecting portion disposed near the proximal end of the basket body. The proximal end of the connecting portion is connected to the core wire, wherein, in the unfolded state, the connecting portion gradually narrows in a direction away from the basket body.

8. The marking device according to claim 7, characterized in that, The connecting part includes multiple traction wires, the distal end of each traction wire is connected to the main body of the net basket and distributed along the circumference of the main body of the net basket, and the proximal end of each traction wire is connected to the core wire.

9. The marking device according to claim 6, characterized in that, The delivery assembly includes a loading tube for securing the marking basket in the folded state, the loading tube engaging with the conduit to allow the marking basket to enter the conduit via the loading tube.

10. The marking device according to claim 9, characterized in that, The catheter includes a tube body and a hemostatic valve disposed at the proximal end of the tube body, and the loading tube is configured to be able to be inserted into the hemostatic valve and communicate with the tube body.

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