Connecting stent, connecting device and arteriovenous fistulation device

Abstract

The present application relates to a connecting stent, a connecting device, and an arteriovenous fistulation device. A first positioning element (1200) is provided at a proximal end of a stent body of a stent main body (1100), and the first positioning element (1200) radially protrudes relative to the surface of the stent body of the stent main body (1100) in the radial direction; and a second positioning element (1300) is provided at a distal end of the stent body of the stent main body (1100), and the second positioning element (1300) radially protrudes relative to the surface of the stent body of the stent main body (1100) in the radial direction.

Description

Connecting stent, connecting device and arteriovenous fistula device

[0001] Related applications

[0002] This application claims priority to Chinese patent application filed on November 18, 2024, application number 2024116524477, entitled "Connecting stent, connecting device and arteriovenous fistula device", the entire contents of which are incorporated herein by reference. Technical Field

[0003] This application relates to the field of medical device technology, and in particular to connecting stents, connecting devices, and arteriovenous fistula creation devices. Background Technology

[0004] Vascular repair surgery and arteriovenous fistula recanalization surgery mainly involve the anastomosis and repair of various morphologies of blood vessels of different sizes. The commonly used vascular anastomosis method in clinical practice is end-to-side anastomosis of veins and arteries. Based on the characteristics of vascular tissue, in order to reduce long-term intravascular lesions, the anastomosis process requires thorough treatment of both the intima and adventitia. This is routinely done manually by the surgeon, but the suturing technique demands a high level of skill, and the suturing results vary among surgeons. Surgeons proficient in microsurgical anastomosis of small-sized blood vessels require at least 3 to 5 years of practical training and experience. Even highly experienced surgeons may make suturing errors. These human-caused errors can indirectly lead to complications such as intravascular proliferation and infection, and directly affect the long-term patency rate of the blood vessel.

[0005] Regarding the opening of autogenous arteriovenous fistulas, it is generally believed in the field that the quality of vascular suturing directly affects the long-term patency rate. Manual suturing is an open surgery, and open fistula surgery is more invasive to patients, does not conform to the minimally invasive concept, and leaves a wound of about 5cm on the patient's skin, posing a certain risk of infection. Manual suturing is also time-consuming, with the vascular suturing process generally taking more than 30 minutes, easily causing fatigue and depletion of the surgeon's energy, as a significant amount of time and energy is spent on vascular suturing and repair. Moreover, manual suturing techniques require a high level of surgical experience; the suturing quality and effect vary among different surgeons, potentially leading to a lower long-term patency rate due to improper suturing. Summary of the Invention

[0006] According to various embodiments of this application, this application provides a connecting stent, a connecting device, and an arteriovenous fistula creation device.

[0007] This application provides a connecting bracket, the connecting bracket comprising:

[0008] The support body is configured as a cylindrical frame, having an internal space and a proximal opening and a distal opening connecting the internal space, and the support body has deformation capability, capable of switching between an expanded state and a contracted state;

[0009] A first positioning element is disposed at the proximal end of the frame of the support body. At least a portion of the element structure protrudes radially relative to the frame surface of the support body along the radial direction of the support body, for locking the proximal end of the support body and the first target position.

[0010] A second positioning element is disposed at the far end of the frame of the support body. At least a portion of the element structure protrudes radially relative to the frame surface of the support body along the radial direction of the support body, for locking the far end of the frame of the support body and the second target position.

[0011] In one embodiment, the first positioning element is an annular element disposed around the proximal opening at the proximal end of the frame, and the annular portion of the first positioning element protrudes radially relative to the frame surface of the support body along the radial direction of the support body.

[0012] In one embodiment, the first positioning element is configured as a first annular plate, the inner end of the first annular plate is connected to the proximal end of the frame, and the surface of the first annular plate is configured as a plane.

[0013] In one embodiment, the first positioning element is configured as a first annular plate, the inner end of the first annular plate is connected to the proximal end of the frame, and the surface of the first annular plate is configured as a curved surface.

[0014] In one embodiment, the second positioning element is an annular element disposed around the proximal opening at the proximal end of the frame, and the annular portion of the second positioning element protrudes radially relative to the frame surface of the support body along the radial direction of the support body.

[0015] In one embodiment, the second positioning element is configured as a second annular plate, the inner end of which is connected to the far end of the frame, and the surface of the second annular plate is configured as a plane.

[0016] In one embodiment, the second positioning element is configured as a second annular plate, the inner end of which is connected to the far end of the frame, and the surface of the second annular plate is configured as a curved surface.

[0017] In one embodiment, the connection bracket includes:

[0018] A support membrane covering the surface of the frame.

[0019] In one embodiment, the scaffold membrane is made of a biocompatible material.

[0020] In one embodiment, the connection bracket includes:

[0021] A first puncture element is connected to at least one of the first positioning element and the proximal end of the frame.

[0022] In one embodiment, the puncture tip of the first puncture element is directed from the proximal end of the stent body toward the distal end of the stent body.

[0023] In one embodiment, the first puncture element is a linear element.

[0024] In one embodiment, the first puncture element is a curved element.

[0025] In one embodiment, the connection bracket includes:

[0026] The second puncture element is connected to at least one of the second positioning element and the distal end of the frame.

[0027] In one embodiment, the puncture tip of the second puncture element is directed from the distal end of the stent body toward the proximal end of the stent body.

[0028] In one embodiment, the second puncture element is a linear element.

[0029] In one embodiment, the second puncture element is a curved element.

[0030] In one embodiment, the support body is a straight cylindrical body, the plane of the proximal opening is perpendicular to the central axis of the support body, and the plane of the distal opening is perpendicular to the central axis of the support body.

[0031] In one embodiment, the support body is a straight cylindrical body; wherein the central axis of the support body forms an angle with respect to the plane containing the proximal opening.

[0032] In one embodiment, the central axis of the support body is at an angle relative to the plane containing the distal opening.

[0033] In one embodiment, the support body is a curved cylindrical body, and the plane of the proximal opening is parallel to the plane of the distal opening.

[0034] In one embodiment, the main body of the support is a curved cylinder, and the plane where the proximal opening is located is at an angle to the plane where the distal opening is located.

[0035] In one embodiment, the radial profile coverage area of ​​the support body remains consistent in the axial direction of the support body.

[0036] In one embodiment, the radial profile coverage area of ​​the support body changes in the axial direction of the support body.

[0037] In one embodiment, the support body is a straight cylindrical body with a diameter of 2mm to 10mm and a length of 10mm to 50mm.

[0038] In one embodiment, the support body is a straight cylindrical body, and the diameter of the support body changes in the axial direction, with the diameter of the proximal opening of the support body being larger than the diameter of the distal opening of the support body.

[0039] This application provides a connecting device for conveying the connecting bracket, the connecting device comprising:

[0040] First external catheter;

[0041] The first inner catheter is movably inserted into the inner cavity of the first outer catheter. The inner cavity of the first inner catheter is used to movably insert a branch guidewire. The interlayer space between the first outer catheter and the first inner catheter is used to accommodate the connecting support.

[0042] This application provides an arteriovenous fistula stomoplasty device for delivering the connecting stent, the arteriovenous fistula stomoplasty device comprising:

[0043] The connecting device;

[0044] A puncture device for delivering a branched guidewire, the branched guidewire being used to form a delivery path for the connecting device.

[0045] In one embodiment, the puncture device includes:

[0046] Second external catheter;

[0047] The intermediate multi-lumen tube is movably inserted into the inner cavity of the second external catheter, and the intermediate multi-lumen tube has a first inner channel and a second inner channel;

[0048] The second internal catheter is movably inserted into the first internal channel;

[0049] The inner core tube is movably inserted into the second inner channel. The inner cavity of the inner core tube is used to movably insert the main guide wire, which is used to form the delivery path of the puncture device.

[0050] Details of one or more embodiments of this application are set forth in the following drawings and description, and other features, objects and advantages of this application will become apparent from the specification, drawings and claims. Attached Figure Description

[0051] To more clearly illustrate the technical solutions in the embodiments of this application or the conventional technology, the drawings used in the description of the embodiments or the conventional technology will be briefly introduced below. Obviously, the drawings described below are only embodiments of this application. For those skilled in the art, other drawings can be obtained based on the disclosed drawings without creative effort.

[0052] Figure 1 is a schematic diagram of the puncture device provided in some embodiments of this application entering a vein.

[0053] Figure 2 is a schematic diagram of the puncture device provided in some embodiments of this application passing through the vessel wall of the stoma vein and stoma artery.

[0054] Figure 3 is a schematic diagram of the branched guidewire passing through the vessel wall of the stoma vein and stoma artery provided in some embodiments of this application.

[0055] Figure 4 is a schematic diagram of a connecting device provided in some embodiments of this application for delivering a connecting stent between a vein and an artery.

[0056] Figure 5 is a three-dimensional structural diagram of the connecting bracket provided in some embodiments of this application.

[0057] Figure 6 is a three-dimensional structural diagram of the connecting bracket provided in some other embodiments of this application.

[0058] Figure 7 is a schematic planar structure diagram of a first type of straight-shaped connecting bracket provided in some embodiments of this application.

[0059] Figure 8 is a schematic diagram of the planar structure of a second straight-shaped connecting bracket provided in some embodiments of this application.

[0060] Figure 9 is a schematic diagram of the planar structure of the first type of inclined connecting bracket provided in some embodiments of this application.

[0061] Figure 10 is a schematic diagram of the planar structure of a second type of inclined connecting bracket provided in some embodiments of this application.

[0062] Figure 11 is a schematic plan view of the first type of arched connecting bracket provided in some embodiments of this application.

[0063] Figure 12 is a schematic plan view of the connecting bracket of the second arched structure provided in some embodiments of this application.

[0064] Figure 13 is a schematic diagram of the planar structure of a straight connecting stent provided in some embodiments of this application, positioned between a vein and an artery.

[0065] Figure 14 is a schematic diagram of the planar structure of the oblique connecting stent provided in some embodiments of this application, which is positioned between a vein and an artery.

[0066] Figure 15 is a schematic diagram of the planar structure of the arched connecting stent provided in some embodiments of this application, which is positioned between a vein and an artery.

[0067] Figure 16 is a three-dimensional structural schematic diagram of a straight connecting stent provided in some embodiments of this application, positioned between a vein and an artery.

[0068] Figure 17 is a three-dimensional sectional view of the straight connecting stent structure shown in Figure 16 positioned between a vein and an artery.

[0069] Figure 18 is a three-dimensional structural diagram of the oblique connecting stent provided in some embodiments of this application, positioned between a vein and an artery.

[0070] Figure 19 is a three-dimensional sectional view of the oblique structure connecting stent shown in Figure 18 positioned between a vein and an artery.

[0071] Figure 20 is a three-dimensional structural schematic diagram of the arched connecting stent provided in some embodiments of this application, positioned between a vein and an artery.

[0072] Figure 21 is a three-dimensional sectional view of the arched connecting stent, as shown in Figure 20, positioned between the vein and the artery.

[0073] Reference numerals: 10, vein; 20, artery; 100, first target location; 200, second target location; 1000, connecting stent; 2000, connecting device; 3000, puncture device; 1100, stent body; 1200, first positioning element; 1300, second positioning element; 1400, stent membrane; 1500, first puncture element; 1600, second puncture element; 2100, first external catheter; 2200, first internal catheter; 2300, branch guidewire; 2101, first guide tip; 3100, second external catheter; 3200, intermediate multi-lumen tube; 3300, second internal catheter; 3400, puncture inner core tube; 3500, main guidewire; 3101, second guide tip; 3201, first internal channel; 3202, second internal channel; 3401, tip structure. Detailed Implementation

[0074] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0075] To more clearly describe the structure of the vascular closure device, the term "distal" is defined herein as the end furthest from the target object (closer to the operator) during the surgical procedure, and "proximal" is defined as the end closest to the target object (farthest from the operator) during the surgical procedure. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in this application's specification is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0076] Referring to Figure 1, this application provides an arteriovenous fistula creation device for delivering a connecting stent 1000 between a vein 10 and an artery 20 in the body. After the connecting stent 1000 is delivered to a predetermined position between the vein 10 and the artery 20, it can connect the vein 10 and the artery 20 and form a through blood flow channel between the vein 10 and the artery 20, thereby realizing the arteriovenous fistula creation operation in the body through the connecting stent 1000.

[0077] Figures 1 to 4 illustrate the process of arteriovenous fistula (AGF) creation using the aforementioned AGF device. The AGF device includes a connecting device 2000, a puncture device 3000, and a connecting stent 1000 for delivery into the body. As shown in Figure 1, the AGF device first uses the main guidewire 3500 to create a delivery path for the puncture device 3000, allowing it to enter the vein 10 along the main guidewire 3500 until it reaches the predetermined position (i.e., the fistula area) within the vein 10. As shown in Figure 2, the puncture device 3000 is then aligned with the fistula artery 20 and passes through the vessel walls of both the fistula vein 10 and the fistula artery 20, delivering the branch guidewire 2300 from the vein 10 into the artery 20.

[0078] As shown in Figure 3, after the branch guidewire 2300 is delivered from the vein 10 to the artery 20, the puncture device 3000 can be withdrawn from the body, leaving only the delivered branch guidewire 2300 between the vein 10 and the artery 20. The branch guidewire 2300 forms a delivery path for the connecting device 2000 between the vein 10 and the artery 20, allowing the connecting device 2000 to enter the artery 20 along the branch guidewire 2300. As shown in Figure 4, the connecting device 2000 can then release the connecting stent 1000 between the vein 10 and the artery 20, positioning the connecting stent 1000 between them. The space within the connecting stent 1000 connects the vein 10 and the artery 20, completing the arteriovenous fistula operation.

[0079] In one embodiment, as shown in FIG4, a connecting device 2000 provided in this application may include a first outer conduit 2100 and a first inner conduit 2200. The first inner conduit 2200 is movably inserted into the inner cavity of the first outer conduit 2100, and the inner cavity of the first inner conduit 2200 is used to movably insert a branch guidewire 2300. Before the connecting bracket 1000 is delivered, the connecting bracket 1000 can be retracted and assembled in the interlayer space between the first outer conduit 2100 and the first inner conduit 2200, as shown in FIG4. The proximal end of the first outer conduit 2100 may also be provided with a first guide head 2101 to facilitate the delivery of the connecting device 2000. The first guide head 2101 may be tapered.

[0080] Once the branch guidewire 2300 is fully delivered, forming a delivery path between the vein 10 and artery 20 for the connecting device 2000 to be delivered into the body, the entire connecting device 2000 can then be guided from the vein 10 to the artery 20 along the branch guidewire 2300, thus achieving delivery into the body. The first guide head 2101 facilitates the advancement of the connecting device 2000 within the body. When the connecting device 2000 crosses the vein 10 and artery 20 along the branch guidewire 2300, presenting the delivery state shown in Figure 4, the first external catheter 2100 of the connecting device 2000 can then move distally for retraction. As the first external catheter 2100 retracts, the connecting stent 1000 is gradually exposed, allowing for its release. Once the first external catheter 2100 is fully exposed above the connecting stent 1000, the connecting stent 1000 can expand and be released between the vein 10 and the artery 20, and is positioned between the vein 10 and the artery 20. The internal space of the connecting stent 1000 connects the vein 10 and the artery 20, completing the arteriovenous fistula operation.

[0081] As shown in Figures 1 and 2, in one embodiment, the puncture device 3000 may include a second external catheter 3100, an intermediate multi-lumen tube 3200, a second internal catheter 3300, and a puncture inner core tube 3400. The main function of the puncture device 3000 is to deliver the branch guidewire 2300, which forms a delivery path for the connecting device 2000 between the vein 10 and the artery 20, preparing for the delivery and release of the connecting device 2000 to the connecting stent 1000.

[0082] Referring to Figures 1 and 2, the intermediate multi-lumen tube 3200 is movably inserted into the inner lumen of the second external catheter 3100. The intermediate multi-lumen tube 3200 has a first inner channel 3201 and a second inner channel 3202, both of which, as shown in Figure 2, extend through both ends of the intermediate multi-lumen tube 3200. The second internal catheter 3300 is movably inserted into the first inner channel 3201, and the puncture inner core tube 3400 is movably inserted into the second inner channel 3202. The proximal end of the puncture inner core tube 3400 can also be configured with a puncture-friendly tip structure 3401, used to align with the direction of the stoma artery 20 and pass through the vessel wall of the stoma vein 10 and the stoma artery 20. The tip structure 3401 at the proximal end of the puncture inner core tube 3400 can be pre-bent at a certain angle, such as a pre-bent at 45°, to facilitate puncture of the vessel wall.

[0083] The inner cavity of the puncture inner tube 3400 is used for the movable insertion of the main guidewire 3500. Therefore, after the puncture inner tube 3400 passes through the vessel walls of the stoma vein 10 and stoma artery 20, the branch guidewire 2300 can be delivered from the vein 10 to the artery 20 along the inner cavity of the puncture inner tube 3400. The proximal end of the second external catheter 3100 may also be provided with a second guide head 3101 to facilitate the delivery of the puncture device 3000. The second guide head 3101 may be tapered.

[0084] When it is necessary to deliver the branch guidewire 2300, under the guidance of subtraction angiography (DSA), the main guidewire 3500 can be extended through the vein 10 to cover the stoma area. For example, the main guidewire 3500 can be delivered through the cephalic vein. The location of the access route can be determined according to the actual clinical situation and is not limited here. Then, as shown in Figure 1, the main guidewire 3500 is inserted into the lumen of the second inner catheter 3300, so that the proximal end of the second inner catheter 3300 is introduced along the distal end of the main guidewire 3500. From there, the puncture device 3000 is inserted along the main guidewire 3500. The puncture device 3000 is advanced along the main guidewire 3500 with the aid of the second inner catheter 3300, so that the puncture core tube 3400 of the puncture device 3000 is delivered to the stoma area of ​​the vein 10, while maintaining... The direction of the puncture inner core tube 3400 is aligned with the direction of the stoma artery 20. Then, the second external catheter 3100 is withdrawn. The puncture inner core tube 3400 is released by withdrawing the second external catheter 3100. Since the proximal end of the puncture inner core tube 3400 has a pre-bent design, the pre-bent design of the proximal end of the puncture inner core tube 3400 can be restored to the pre-bent state after the puncture inner core tube 3400 is released. At this time, it is ensured that the puncture inner core tube 3400 is aligned with the wall of the stoma vein 10 and the wall of the stoma artery 20.

[0085] At this point, the inner core tube 3400 is pushed upwards externally, as shown in Figure 2, so that it passes through the walls of the stoma vein 10 and stoma artery 20. The branch guidewire 2300 is then pushed upwards along the lumen of the inner core tube 3400, allowing it to be delivered into the artery 20 and cover the stoma area. The inner core tube 3400 is then withdrawn, and the intermediate multi-lumen tube 3200 is pushed upwards, retracting the inner core tube 3400 into the second inner channel 3202 of the intermediate multi-lumen tube 3200. Finally, the entire puncture device 3000 is withdrawn, leaving only the branch guidewire 2300 in the vein 10 and artery 20 as the delivery path for the connecting device 2000, thus completing the use of the puncture device 3000.

[0086] During the use of the connecting device 2000, a suitable connecting stent 1000 can be selected according to the size characteristics of the blood vessel. Under the guidance of ultrasound and subtraction angiography (DSA), the connecting device 2000 is inserted into the artery 20 via the pre-reserved branch guidewire 2300 through the vein 10, so that the connecting stent 1000 can cover the fistula area, as shown in Figure 4. The proximal end of the connecting stent 1000 is located in the artery 20, and the distal end of the connecting stent 1000 is located in the vein 10. The connecting stent 1000 can be fitted with a stent membrane 1400 to become a covered stent, thereby enabling blood to flow from the artery 20 to the vein 10, completing the opening of the arteriovenous fistula vascular access.

[0087] The outer diameter of the puncture device 3000 can be designed in different specifications such as 4F, 5F, and 6F, and the effective length of the puncture device 3000 can be designed between 10cm and 30cm. The outer diameter of the connecting device 2000 can be designed in different specifications such as 4F, 5F, and 6F, and the effective length of the connecting device 2000 can be designed between 10cm and 30cm.

[0088] As shown in Figures 5 and 6, this application provides a connecting stent 1000, which includes a stent body 1100, a first positioning element 1200, and a second positioning element 1300. The stent body 1100 is configured as a cylindrical frame, having an internal space and proximal and distal openings connecting the internal space. The cylindrical frame can be configured as a cylinder, elliptical cylinder, etc., as needed, and is not limited here. The stent body 1100 has deformability, capable of switching between an expanded and contracted state. The stent body 1100 is made of a metallic material, such as nickel-titanium metal, which has superelasticity. The connecting stent 1000 also includes a stent membrane 1400, which covers the surface of the frame, thereby constructing the connecting stent 1000 as a metal-coated stent. The stent membrane 1400 is made of a biocompatible material, such as expanded polytetrafluoroethylene (PTFE) or medical-grade silicone, which have good biocompatibility. When the support body 1100 is cylindrical, the diameter of the support body 1100 can be designed to be 2mm to 10mm, and the length of the support body 1100 can be designed to be 10mm to 50mm.

[0089] The main body of the stent 1100 can be designed with different structures, as shown in Figures 7 to 12. Figures 7 to 10 show the design structure of the straight cylindrical body of the stent 1100 (including the straight structure shown in Figures 7 and 8, and the oblique structure shown in Figures 9 and 10). Figures 11 to 12 show the design structure of the curved cylindrical body of the stent 1100 (also known as the arched structure). Figures 13 to 15 show the stent 1100 with three different design structures forming a fistula between the artery 20 and the vein 10. Figures 16 to 21 show the stent 1100 with three different design structures forming a fistula between the artery 20 and the vein 10 in three-dimensional view and corresponding sectional view.

[0090] As shown in Figures 7 and 8, the support body 1100 is a straight cylindrical body. In this case, the plane containing the proximal opening is perpendicular to the central axis of the support body 1100, and the plane containing the distal opening is also perpendicular to the central axis of the support body 1100, forming the straight structure described above. As shown in Figures 9 and 10, the support body 1100 is a straight cylindrical body, wherein the central axis of the support body 1100 forms an angle with the plane containing the proximal opening. Alternatively, the central axis of the support body 1100 can also be designed to form an angle with the plane containing the distal opening, forming the oblique structure described above. As shown in Figures 11 and 12, the support body 1100 is a curved cylindrical body, where the plane containing the proximal opening is parallel to the plane containing the distal opening, or the plane containing the proximal opening can be set to form an angle as required, forming the arched structure described above.

[0091] In one embodiment, the radial profile coverage area of ​​the stent body 1100 can remain consistent in the axial direction. Alternatively, the radial profile coverage area of ​​the stent body 1100 can be designed to vary according to requirements. For example, the diameter of the connecting stent 1000 can be designed as a variable diameter structure to accommodate the inconsistent sizes of arteries 20 and veins 10 in most clinical patients. When the stent body 1100 is a straight cylindrical body, the diameter of the stent body 1100 can vary in the axial direction. For example, the diameter of the proximal opening of the stent body 1100 can be larger than the diameter of the distal opening. The variation range between the diameters of the proximal and distal openings can be between 1 mm and 2 mm. For example, the diameter of the proximal opening is D1, and the diameter of the distal opening is D2, such as D1 = 8 mm and D2 = 7 mm, or D1 = 8 mm and D2 = 6 mm, which is not limited here.

[0092] Referring again to Figures 5 and 6, the first positioning element 1200 is disposed at the proximal end of the stent body 1100. At least a portion of the element structure of the first positioning element 1200 protrudes radially relative to the surface of the stent body 1100 along the radial direction of the stent body 1100. Therefore, when the stent body 1100 connecting the stent 1000 covers the stenthole area as shown in Figures 13 to 15, the first positioning element 1200 can be used to lock the proximal end of the stent body 1100 and the first target position 100. At this time, the first target position 100 is the inner wall of the artery 20. The first positioning element 1200 locks the proximal end of the stent body and the first target position 100 by using the element structure that protrudes radially relative to the surface of the stent body to fit tightly against the inner wall of the artery 20.

[0093] The second positioning element 1300 is disposed at the distal end of the stent body 1100. At least a portion of the element structure of the second positioning element 1300 protrudes radially relative to the surface of the stent body 1100 along the radial direction of the stent body 1100. Therefore, when the stent body 1100 connecting the stent 1000 covers the stenthole area as shown in Figures 13 to 15, the second positioning element 1300 can be used to lock the distal end of the stent body 1100 and the second target position 200. At this time, the first target position 100 is the inner wall of the vein 10. The second positioning element 1300 locks the distal end of the stent body and the second target position 200 by using the element structure that protrudes radially relative to the surface of the stent body to fit tightly against the inner wall of the vein 10.

[0094] In one embodiment, the first positioning element 1200 can be configured as an annular element. The annular first positioning element 1200 can be positioned around the proximal opening at the proximal end of the stent body, as shown in Figures 5 and 6. The entire circumference of the first positioning element 1200 protrudes radially relative to the surface of the stent body 1100 along the radial direction of the stent body 1100, thereby achieving close contact with the inner wall of the artery 20 in the circumferential direction and improving the positioning effect. For example, the first positioning element 1200 can be configured as a first annular plate, with its inner annular end connected to the proximal end of the stent body. The surface of the first annular plate can be planar or curved. For example, as shown in Figures 5 and 6, the first annular plate is constructed as a trumpet-shaped curved structure. This trumpet-shaped curved structure is designed for better contact and anchoring with the filled inner surface of the blood vessel. The trumpet-shaped curved structure can be formed by heat-setting nickel-titanium metal. Depending on the characteristics of different vascular tissues, the trumpet-shaped curved structure can also be designed with an angle of 30° to 90° with the stent body 1100.

[0095] Referring again to Figures 5 and 6, similarly, the second positioning element 1300 can be configured as an annular element. The second positioning element 1300 can be positioned around the proximal opening at the proximal end of the stent body. In this case, the entire circumference of the second positioning element 1300 protrudes radially relative to the surface of the stent body 1100 along the radial direction of the stent body 1100, thus achieving close contact with the inner wall of the vein 10 in the circumferential direction, improving the positioning effect. For example, the second positioning element 1300 can be configured as a second annular plate, with the inner end of the annular plate connected to the distal end of the stent body. The surface of the second annular plate can be configured as a plane or a curved surface, as shown in Figures 5 and 6. The second annular plate is constructed as a trumpet-shaped curved surface structure, which easily conforms to the vessel wall. The trumpet-shaped curved surface structure can be formed by heat-setting nickel-titanium metal. Depending on the characteristics of different vascular tissues, the trumpet-shaped curved surface structure can also be designed with an angle of 30° to 90° with the stent body 1100.

[0096] The connecting stent 1000 also includes at least one of a first puncture element 1500 and a second puncture element 1600. The first puncture element 1500 punctures and fixes itself to the wall of the artery 20, and the second puncture element 1600 punctures and fixes itself to the wall of the vein 10. Depending on different clinical needs, a number of the first puncture elements 1500 and the second puncture elements 1600 can be designed in the circumferential direction of the stent body 1100. For example, six to ten first puncture elements 1500 and second puncture elements 1600 can be designed at equal intervals in the circumference. Six or eight first puncture elements 1500 and second puncture elements 1600 can be designed.

[0097] The first puncture element 1500 is connected to at least one of the first positioning element 1200 and the proximal end of the support body, for example, the first puncture element 1500 is connected to the first positioning element 1200. The first puncture element 1500 can be configured as a straight element as shown in Figure 5 or as a curved element as shown in Figure 6. If a certain curvature is set according to the puncture requirements, the curved element can provide a better anchoring effect and is less likely to lose control. The puncture tip of the first puncture element 1500 is directed from the proximal end of the support body 1100 towards the distal end of the support body 1100. For example, when the support body 1100 has a straight cylindrical design structure, the orientation of the puncture tip of the first puncture element 1500 can also be parallel to the central axis of the support body 1100.

[0098] The second puncture element 1600 is connected to at least one of the second positioning element 1300 and the distal end of the support body, for example, the second puncture element 1600 is connected to the second positioning element 1300. The second puncture element 1600 can be configured as a straight element as shown in Figure 5 or as a curved element as shown in Figure 6, such as by setting a certain arc according to the puncture requirements. The puncture tip of the second puncture element 1600 is directed from the distal end of the support body 1100 towards the proximal end of the support body 1100. For example, when the support body 1100 has a straight cylindrical design structure, the orientation of the puncture tip of the second puncture element 1600 can also be parallel to the central axis of the support body 1100.

[0099] It should be noted that when the first puncture element 1500 and the second puncture element 1600 are pre-compressed in the lumen of the first external catheter 2100 by the connecting stent 1000, the endpoints of the first puncture element 1500 and the second puncture element 1600 do not come into contact with the first external catheter 2100 in the radial direction, and do not affect the release of the connecting stent 1000.

[0100] As can be seen from the above, in order to solve the various problems caused by manual suturing in clinical practice, the arteriovenous fistula creation device provided in this application can deliver the above-mentioned connecting stent 1000 to the space between the vein 10 and the artery 20. After releasing the membrane-covered connecting stent 1000, based on the structural design of the above-mentioned connecting stent 1000, the connecting stent 1000 can be fixed between the vein 10 and the artery 20. The space inside the connecting stent 1000 is used as the blood supply channel between the vein 10 and the artery 20, which can realize the interventional fistula creation operation of arteriovenous fistula in a simple and efficient manner, shorten the operation time and reduce the operation difficulty, and solve the problem of inconsistent results of manual suturing.

[0101] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above 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.

[0102] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these modifications and improvements all fall within the scope of protection of this application. Therefore, the scope of protection of this patent application should be determined by the appended claims.

Claims

A connecting bracket, characterized in that The connecting bracket includes: The support body is configured as a cylindrical frame, having an internal space and a proximal opening and a distal opening connecting the internal space, and the support body has deformation capability, capable of switching between an expanded state and a contracted state; A first positioning element is disposed at the proximal end of the frame of the support body. At least a portion of the element structure protrudes radially relative to the frame surface of the support body along the radial direction of the support body, for locking the proximal end of the support body and the first target position. A second positioning element is disposed at the far end of the frame of the support body. At least a portion of the element structure protrudes radially relative to the frame surface of the support body along the radial direction of the support body, for locking the far end of the frame of the support body and the second target position. The connecting bracket according to claim 1, characterized in that The first positioning element is a ring-shaped element. The first positioning element is disposed around the proximal opening at the proximal end of the frame, and the entire circumference of the first positioning element protrudes radially relative to the frame surface of the support body along the radial direction of the support body. The connecting bracket according to claim 2, characterized in that The first positioning element is configured as a first annular plate, the inner end of the first annular plate is connected to the near end of the frame, and the surface of the first annular plate is configured as a plane. The connecting bracket according to claim 2, characterized in that The first positioning element is configured as a first annular plate, the inner end of the first annular plate is connected to the near end of the frame, and the surface of the first annular plate is configured as a curved surface. The connecting bracket according to claim 1, characterized in that The second positioning element is an annular element, which is disposed around the proximal opening at the proximal end of the frame, and the annular circumference of the second positioning element protrudes radially relative to the frame surface of the support body along the radial direction of the support body. The connecting bracket according to claim 5, characterized in that The second positioning element is configured as a second annular plate, the inner end of the second annular plate is connected to the far end of the frame, and the surface of the second annular plate is configured as a plane. The connecting bracket according to claim 5, characterized in that The second positioning element is configured as a second annular plate, the inner end of the second annular plate is connected to the far end of the frame, and the surface of the second annular plate is configured as a curved surface. The connecting bracket according to claim 1, characterized in that The connecting bracket includes: A support membrane that covers the surface of the frame. The connecting bracket according to claim 8, characterized in that The scaffold membrane is made of a biocompatible material. The connecting bracket according to claim 1, characterized in that The connecting bracket includes: A first puncture element is connected to at least one of the first positioning element and the proximal end of the frame. The connecting bracket according to claim 10, characterized in that The puncture tip of the first puncture element is directed from the proximal end of the stent body toward the distal end of the stent body. The connecting bracket according to claim 10, characterized in that The first puncture element is a linear element. The connecting bracket according to claim 10, characterized in that The first puncture element is a curved element. The connecting bracket according to claim 1, characterized in that The connecting bracket includes: The second puncture element is connected to at least one of the second positioning element and the distal end of the frame. The connecting bracket according to claim 14, characterized in that The puncture tip of the second puncture element is directed from the distal end of the stent body toward the proximal end of the stent body. The connecting bracket according to claim 14, characterized in that The second puncture element is a linear element. The connecting bracket according to claim 14, characterized in that The second puncture element is a curved element. The connecting bracket according to claim 1, characterized in that The main body of the support is a straight cylindrical body. The plane where the proximal opening is located is perpendicular to the central axis of the main body of the support, and the plane where the distal opening is located is perpendicular to the central axis of the main body of the support. The connecting bracket according to claim 1, characterized in that The main body of the support is a straight cylindrical body; wherein, the central axis of the main body of the support has an angle with respect to the plane where the proximal opening is located. The connecting bracket according to claim 1, characterized in that The central axis of the main body of the support is at an angle relative to the plane where the distal opening is located. The connecting bracket according to claim 1, characterized in that The main body of the support is a curved cylinder, and the plane where the proximal opening is located is parallel to the plane where the distal opening is located. The connecting bracket according to claim 1, characterized in that The main body of the support is a curved cylinder, and the plane where the proximal opening is located is at an angle to the plane where the distal opening is located. The connecting bracket according to claim 1, characterized in that In the axial direction of the support body, the radial profile coverage area of ​​the support body remains consistent. The connecting bracket according to claim 1, characterized in that In the axial direction of the support body, the radial profile coverage area of ​​the support body changes. The connecting bracket according to claim 1, characterized in that The main body of the support is a straight cylindrical body with a diameter of 2mm to 10mm and a length of 10mm to 50mm. The connecting bracket according to claim 1, characterized in that The main body of the support is a straight cylindrical body. The diameter of the main body changes in the axial direction, and the diameter of the proximal opening of the main body is larger than the diameter of the distal opening of the main body. A connection device, characterized in that For conveying the connecting bracket as described in any one of claims 1-26, the connecting device comprises: First external catheter; The first inner catheter is movably inserted into the inner cavity of the first outer catheter. The inner cavity of the first inner catheter is used to movably insert a branch guidewire. The interlayer space between the first outer catheter and the first inner catheter is used to accommodate the connecting support. An arteriovenous fistula device, characterized by For delivering the connecting stent as described in any one of claims 1-26, the arteriovenous fistula device comprises: The connecting device as described in claim 27; A puncture device for delivering a branched guidewire, the branched guidewire being used to form a delivery path for the connecting device. The arteriovenous fistula fistula device of claim 28, wherein The puncture device includes: Second external catheter; The intermediate multi-lumen tube is movably inserted into the inner cavity of the second external catheter, and the intermediate multi-lumen tube has a first inner channel and a second inner channel; The second internal catheter is movably inserted into the first internal channel; The inner core tube is movably inserted into the second inner channel. The inner cavity of the inner core tube is used to movably insert the main guide wire, which is used to form the delivery path of the puncture device.

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