Connecting support, connecting device and arteriovenous fistula ostomy device

Abstract

The invention belongs to the technical field of medical instruments, and relates to a connecting stent, a connecting device and an arteriovenous fistula fistulization device.A first positioning element is arranged at the near end of a stent body, and at least one part of element structure of the first positioning element protrudes in the radial direction of the stent body relative to the surface of the stent body in the radial direction of the stent body; the second positioning element is arranged at the far end of the stent body, and at least one part of element structure of the second positioning element protrudes in the radial direction of the stent body relative to the surface of the stent body in the radial direction of the stent body. The connecting stent is conveyed between a vein blood vessel and an artery blood vessel, based on the structural design of the connecting stent, the connecting stent can be fixed between the vein and the artery, and the space in the stent body of the connecting stent is used as a blood supply channel between the vein and the artery, so that the interventional fistulization operation of arteriovenous fistula is simply and efficiently realized; the operation difficulty is reduced while the operation time is shortened, and the problem that the manual suturing effect is inconsistent is solved.

Description

Technical Field

[0001] 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

[0002] 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.

[0003] 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

[0004] Therefore, it is necessary to provide a connecting stent, a connecting device, and an arteriovenous fistula creation device to address the aforementioned technical problems.

[0005] This application provides a connecting bracket, the connecting bracket comprising:

[0006] 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;

[0007] 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.

[0008] 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.

[0009] 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 entire circumference of the first positioning element protrudes radially relative to the frame surface of the frame body along the radial direction of the frame body; and / or,

[0010] 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.

[0011] In one embodiment, the first positioning element is configured as a first annular plate, the inner annular 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 or a curved surface.

[0012] And / or, 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 or a curved surface.

[0013] In one embodiment, the connection bracket includes:

[0014] A support membrane body, the support membrane body covering the surface of the support body; and / or,

[0015] A first puncture element, the first puncture element being connected to at least one of the first positioning element and the proximal end of the frame; and / or

[0016] The second puncture element is connected to at least one of the second positioning element and the distal end of the frame.

[0017] In one embodiment, the scaffold membrane is made of a biocompatible material; and / or,

[0018] The puncture tip of the first puncture element extends from the proximal end of the stent body toward the distal end of the stent body; and / or,

[0019] The puncture tip of the second puncture element extends from the distal end of the stent body toward the proximal end of the stent body; and / or,

[0020] The first puncture element is a linear element or a curved element; and / or,

[0021] The second puncture element is a linear element or a curved element.

[0022] 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.

[0023] Alternatively, 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, and / or, the central axis of the support body forms an angle with respect to the plane containing the distal opening;

[0024] Alternatively, the main body of the support is a curved cylindrical body, and the plane where the proximal opening is located is parallel to the plane where the distal opening is located.

[0025] Alternatively, the main body of the support is a curved cylinder, and the plane where the proximal opening is located has an angle with the plane where the distal opening is located;

[0026] Alternatively, in the axial direction of the support body, the radial profile coverage area of ​​the support body remains consistent;

[0027] Alternatively, the radial profile coverage area of ​​the support body changes in the axial direction of the support body.

[0028] In one embodiment, the support body is a straight cylindrical body with a diameter of 2 mm to 10 mm and a length of 10 mm to 50 mm; and / or,

[0029] 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.

[0030] This application provides a connecting device for conveying the connecting bracket, the connecting device comprising:

[0031] First external catheter;

[0032] 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.

[0033] This application provides an arteriovenous fistula stomoplasty device for delivering the connecting stent, the arteriovenous fistula stomoplasty device comprising:

[0034] The connecting device;

[0035] A puncture device for delivering a branched guidewire, the branched guidewire being used to form a delivery path for the connecting device.

[0036] In one embodiment, the puncture device includes:

[0037] Second external catheter;

[0038] 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;

[0039] The second internal catheter is movably inserted into the first internal channel;

[0040] 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.

[0041] 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 to the space between the vein and the artery. After releasing the membrane-covered connecting stent, based on the structural design of the above-mentioned connecting stent, the connecting stent can be fixed between the vein and the artery. The space inside the connecting stent is used as the blood supply channel between the vein and the artery, which can realize the interventional fistula creation operation of arteriovenous fistula in a simple and efficient way, shorten the operation time and reduce the operation difficulty, and solve the problem of inconsistent results of manual suturing. Attached Figure Description

[0042] Figure 1 This is a schematic diagram of a puncture device inserted into a vein according to one embodiment of this application.

[0043] Figure 2 This is a schematic diagram of a puncture device provided in one embodiment of the present application passing through the vessel walls of a stoma vein and a stoma artery.

[0044] Figure 3This is a schematic diagram of a branched guidewire passing through the vessel walls of the stoma vein and stoma artery, according to one embodiment of this application.

[0045] Figure 4 This is a schematic diagram of a connecting device provided in one embodiment of the present application for delivering a connecting stent between a vein and an artery.

[0046] Figure 5 This is a three-dimensional structural diagram of a connecting bracket provided in one embodiment of this application.

[0047] Figure 6 This is a three-dimensional structural diagram of a connecting bracket provided in another embodiment of this application.

[0048] Figure 7 This is a schematic diagram of the planar structure of a first straight-shaped connecting bracket provided in one embodiment of this application.

[0049] Figure 8 This is a schematic diagram of the planar structure of a second straight-shaped connecting bracket provided in one embodiment of this application.

[0050] Figure 9 This is a schematic diagram of the planar structure of a first type of inclined connecting bracket provided in one embodiment of this application.

[0051] Figure 10 This is a schematic diagram of the planar structure of a second type of inclined connecting bracket provided in one embodiment of this application.

[0052] Figure 11 This is a schematic diagram of the planar structure of a first arched connecting bracket provided in one embodiment of this application.

[0053] Figure 12 This is a schematic diagram of the planar structure of a second arched connecting bracket provided in one embodiment of this application.

[0054] Figure 13 This is a schematic diagram of a planar structure for positioning a straight connecting stent between a vein and an artery, according to one embodiment of this application.

[0055] Figure 14 This is a schematic diagram of a planar structure for positioning a slanted connecting stent between a vein and an artery, according to one embodiment of this application.

[0056] Figure 15 This is a schematic diagram of the planar structure of the arched connecting stent provided in one embodiment of the present application, positioned between a vein and an artery.

[0057] Figure 16 This is a three-dimensional structural diagram of a straight connecting stent provided in one embodiment of the present application, positioned between a vein and an artery.

[0058] Figure 17 For example Figure 16 A three-dimensional sectional view showing the straight connecting stent positioned between a vein and an artery.

[0059] Figure 18 This is a three-dimensional structural diagram of a connecting stent with an oblique structure provided in one embodiment of this application, positioned between a vein and an artery.

[0060] Figure 19 For example Figure 18 A three-dimensional sectional view showing the oblique structure connecting the stent positioned between the vein and the artery.

[0061] Figure 20 This is a three-dimensional structural diagram of an arched connecting stent positioned between a vein and an artery, according to one embodiment of this application.

[0062] Figure 21 For example Figure 20 The diagram shows a three-dimensional sectional view of the arched connecting support positioned between a vein and an artery.

[0063] Icon labels:

[0064] 10. Vein; 20. Artery;

[0065] 100, First target location; 200, Second target location;

[0066] 1000, connecting bracket; 2000, connecting device; 3000, puncture device;

[0067] 1100, Stent body; 1200, First positioning element; 1300, Second positioning element; 1400, Stent membrane; 1500, First puncture element; 1600, Second puncture element;

[0068] 2100, First external catheter; 2200, First internal catheter; 2300, Branch guidewire;

[0069] 2101, First guide head;

[0070] 3100, Second external catheter; 3200, Intermediate multi-lumen tube; 3300, Second internal catheter; 3400, Puncture inner core tube; 3500, Main guidewire;

[0071] 3101, Second guide head; 3201, First inner channel; 3202, Second inner channel; 3401, Tip structure. Detailed Implementation

[0072] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0073] In the description of this application, it should be understood that if terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0074] Furthermore, where the terms "first" and "second" appear, these terms are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, where the term "multiple" appears, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0075] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., 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, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0076] In this application, unless otherwise expressly specified and limited, the use of descriptions such as "above" or "below" the second feature indicates that the first and second features are in direct contact or indirect contact via an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. Similarly, "below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0077] It should be noted that if an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. If an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. If so, the terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application are for illustrative purposes only and do not represent the only possible implementation.

[0078] 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.

[0079] See Figure 1 As shown, 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.

[0080] like Figures 1 to 4 The diagram illustrates the process of performing an arteriovenous fistula (AVC) procedure using the aforementioned AVC device. It is evident that the AVC device includes a connecting device 2000, a puncture device 3000, and a connecting stent 1000 that is delivered into the body. For example... Figure 1As shown, the arteriovenous fistula creation device first needs to use the main guidewire 3500 to form a delivery path for the puncture device 3000, so that the puncture device 3000 first enters the vein 10 along the main guidewire 3500 until the puncture device 3000 enters the predetermined position (i.e., the fistula area) of the vein 10. Figure 2 As shown, at this time, the puncture device 3000 can be used to pass through the vessel wall of the stoma vein 10 and the stoma artery 20 in the direction of the stoma artery 20, and the branch guide wire 2300 can be delivered from the vein 10 to the artery 20.

[0081] like Figure 3 As shown, 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. Figure 4 As shown, at this time, the connecting device 2000 can release the connecting stent 1000 between the vein 10 and the artery 20, so that the connecting stent 1000 is positioned between the vein 10 and the artery 20, and the space inside the connecting stent 1000 connects the vein 10 and the artery 20 to complete the arteriovenous fistula operation.

[0082] In one embodiment, such as Figure 4 As shown, the 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, such as... Figure 4 As shown. The proximal end of the first external conduit 2100 may also be provided with a first guide head 2101 to facilitate delivery by the connecting device 2000. The first guide head 2101 may be in the form of a tapered structure.

[0083] 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, it appears as follows... Figure 4In the indicated delivery state, the first external catheter 2100 of the connecting device 2000 can 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, the connecting stent 1000 expands and releases between the vein 10 and artery 20, and is positioned between them. The internal space of the connecting stent 1000 connects the vein 10 and artery 20, completing the arteriovenous fistula procedure.

[0084] like Figure 1 and Figure 2 As shown, 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.

[0085] See Figure 1 and Figure 2 As shown, the intermediate multi-lumen tube 3200 is movably inserted into the inner cavity of the second outer catheter 3100. The intermediate multi-lumen tube 3200 has a first inner channel 3201 and a second inner channel 3202, both of which are as shown in the figure. Figure 2 The diagram shows the two ends of the multi-lumen tube 3200. A second inner catheter 3300 is movably inserted into the first inner channel 3201, and a 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, for example, pre-bent at a 45° angle, to facilitate puncture of the vessel wall.

[0086] 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.

[0087] When a branch guidewire 2300 needs to be delivered, the main guidewire 3500 can be introduced via venous 10 under the guidance of digital subtraction angiography (DSA) to extend and cover the stoma area. For example, the main guidewire 3500 can be introduced via the cephalic vein. The location of the approach can be determined according to the actual clinical situation and is not limited here. Then, as... Figure 1 As shown, the main guidewire 3500 is inserted into the lumen of the second inner catheter 3300, such that the proximal end of the second inner catheter 3300 is introduced along the distal end of the main guidewire 3500, thereby allowing the puncture device 3000 to be inserted along the main guidewire 3500. The puncture device 3000 advances 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 fistula area of ​​the vein 10, ensuring puncture. The inner core tube 3400 is aligned with the direction of the stoma artery 20. Then, the second external catheter 3100 is withdrawn. The inner core tube 3400 is released by withdrawing the second external catheter 3100. Since the proximal end of the inner core tube 3400 has a pre-bent design, after the inner core tube 3400 is released, the pre-bent design of the proximal end of the inner core tube 3400 can be restored to the pre-bent state. At this time, it is ensured that the inner core tube 3400 is aligned with the wall of the stoma vein 10 and the wall of the stoma artery 20.

[0088] At this point, push the punctured inner core tube upwards at 340° externally, as... Figure 2 As shown, the inner core tube 3400 is passed through the walls of the stoma vein 10 and stoma artery 20, respectively. The branch guidewire 2300 is pushed upwards along the lumen of the inner core tube 3400, delivering it into the artery 20 and covering 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.

[0089] 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 stoma area, i.e. Figure 4 As shown, the proximal end of the stent 1000 is located within the artery 20, and the distal end of the stent 1000 is located within the vein 10. The 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, thus completing the opening of the arteriovenous fistula vascular access.

[0090] 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.

[0091] like Figure 5 and Figure 6 As shown, 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 a proximal opening and a distal opening connecting the internal space. The cylindrical frame can be configured as a cylinder, an elliptical cylinder, etc., as needed, and is not limited here. The stent body 1100 has deformation capability, capable of switching between an expanded state and a 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) and medical 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.

[0092] The main body of the support frame 1100 can be designed with different structures, for example... Figures 7 to 12 As shown, Figures 7 to 10 The diagram shows the design structure of the straight cylindrical body of the support body 1100 (including...). Figure 7 and Figure 8 The straight structure shown, and Figure 9 and Figure 10 (The oblique structure shown) Figures 11 to 12 The diagram shows the design structure (also known as an arched structure) of the curved cylindrical body of the support body 1100. Figures 13 to 15 The diagram shows three different stent body structures 1100 used for fistula creation between artery 20 and vein 10. Figures 16 to 21 The diagram shows a three-dimensional schematic diagram and corresponding sectional view of a stent body 1100 with three different designs between an artery 20 and a vein 10.

[0093] like Figure 7 and Figure 8As shown, 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 perpendicular to the central axis of the support body 1100, forming the straight structure described above. Figure 9 and Figure 10 As shown, the support body 1100 is a straight cylindrical body. The central axis of the support body 1100 forms an angle with the plane containing the near-end opening. Alternatively, the central axis of the support body 1100 can also be designed to form an angle with the plane containing the far-end opening, thus creating the oblique structure shown above. Figure 11 and Figure 12 As shown, the main body 1100 of the support is a curved cylinder. The plane where the near end opening is located is parallel to the plane where the far end opening is located, or the plane where the near end opening is located can be set to have an angle with the plane where the far end opening is located, thus forming the arched structure shown above.

[0094] 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 also be designed to vary according to requirements. For example, the diameter of the connecting stent 1000 can be designed as a variable diameter structure according to different blood vessel size characteristics, thereby adapting to the needs of most clinical patients with inconsistent arterial 20 and venous 10 vessel sizes. 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 is larger than the diameter of the distal opening of the stent body 1100. 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 corresponding D2=7 mm, or D1=8 mm and corresponding D2=6 mm, which is not limited here.

[0095] Continue reading Figure 5 and Figure 6 As shown, the first positioning element 1200 is disposed at the proximal end of the support body 1100, and at least a portion of the element structure of the first positioning element 1200 protrudes radially relative to the surface of the support body 1100 along the radial direction of the support body 1100. Therefore, when the support body 1100 connecting the support 1000 is as shown... Figures 13 to 15After the stent body is covered, 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 a component structure that protrudes radially relative to the surface of the stent body to fit tightly against the inner wall of the artery 20.

[0096] The second positioning element 1300 is disposed at the distal end of the frame of the support body 1100, and at least a portion of the element structure of the second positioning element 1300 protrudes radially relative to the frame surface of the support body 1100 along the radial direction of the support body 1100. Therefore, when the support body 1100 connecting the support 1000 is as follows... Figures 13 to 15 After the stent body is covered, 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 a component structure that protrudes radially relative to the surface of the stent body to fit tightly against the inner wall of the vein 10.

[0097] In one embodiment, the first positioning element 1200 may be configured as an annular element, and the annular first positioning element 1200 may be disposed around the proximal opening at the proximal end of the frame, such that... Figure 5 and Figure 6 As shown, the first positioning element 1200 can protrude radially relative to the surface of the stent body 1100 along the radial direction of the stent body 1100, thereby forming close contact with the inner wall of the artery 20 in the circumferential direction, improving the positioning effect. For example, the first positioning element 1200 can be configured as a first annular plate, with the inner end of the first annular plate connected to the proximal end of the stent body. The surface of the first annular plate can be configured as a plane or a curved surface, for example... Figure 5 and Figure 6 As shown, the first annular plate is constructed as a trumpet-shaped curved structure, which is designed to better fit and anchor to the inner surface of the filled 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.

[0098] Continue reading Figure 5 and Figure 6As shown, 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 can protrude radially relative to the surface of the stent body 1100 along the radial direction of the stent body 1100, thereby forming 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 second 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, for example... Figure 5 and Figure 6 As shown, the second annular plate is constructed as a trumpet-shaped curved structure, which easily conforms to the blood vessel wall. The trumpet-shaped curved structure can be formed by heat-setting nickel-titanium metal. Depending on the characteristics of different blood vessel tissues, the trumpet-shaped curved structure can also be designed with an angle of 30° to 90° with the stent body 1100.

[0099] 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. Specifically, six or eight first puncture elements 1500 and second puncture elements 1600 can be designed.

[0100] The first puncture element 1500 is connected to at least one of the first positioning element 1200 and the proximal end of the frame, for example, the first puncture element 1500 is connected to the first positioning element 1200. The first puncture element 1500 can be as follows: Figure 5 The shown is set as a linear element or as... Figure 6 The element shown is a curved shape. If a certain arc is set according to the puncture requirements, the curved element can provide a better anchoring effect and is less likely to slip out of 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, 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.

[0101] The second puncture element 1600 is connected to at least one of the second positioning element 1300 and the distal end of the frame, for example, the second puncture element 1600 is connected to the second positioning element 1300. The second puncture element 1600 can be as follows: Figure 5 The shown is set as a linear element or as... Figure 6 The element shown is a curved shape, with a certain curvature set 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, 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.

[0102] 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.

[0103] 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.

[0104] 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.

[0105] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and 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 all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. 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.

2. The connecting bracket according to claim 1, characterized in that, The first positioning element is an annular element, 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; and / or, 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.

3. 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 or a curved surface. And / or, 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 or a curved surface.

4. The connecting bracket according to claim 1, characterized in that, The connecting bracket includes: A support membrane body, the support membrane body covering the surface of the support body; and / or, A first puncture element, the first puncture element being connected to at least one of the first positioning element and the proximal end of the frame; and / or The second puncture element is connected to at least one of the second positioning element and the distal end of the frame.

5. The connecting bracket according to claim 4, characterized in that, The scaffold membrane is made of a biocompatible material; and / or, The puncture tip of the first puncture element extends from the proximal end of the stent body toward the distal end of the stent body; and / or, The puncture tip of the second puncture element extends from the distal end of the stent body toward the proximal end of the stent body; and / or, The first puncture element is a linear element or a curved element; and / or, The second puncture element is a linear element or a curved element.

6. The connecting bracket according to claim 1, characterized in that, The main body of the support is a straight cylindrical body, the plane of the proximal opening is perpendicular to the central axis of the main body of the support, and the plane of the distal opening is perpendicular to the central axis of the main body of the support. Alternatively, 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, and / or, the central axis of the support body forms an angle with respect to the plane containing the distal opening; Alternatively, the main body of the support is a curved cylindrical body, and the plane where the proximal opening is located is parallel to the plane where the distal opening is located. Alternatively, the main body of the support is a curved cylinder, and the plane where the proximal opening is located has an angle with the plane where the distal opening is located; Alternatively, in the axial direction of the support body, the radial profile coverage area of ​​the support body remains consistent; Alternatively, the radial profile coverage area of ​​the support body changes in the axial direction of the support body.

7. The connecting bracket according to claim 6, characterized in that, The main body of the support is a straight cylindrical body, the diameter of the main body of the support is 2mm to 10mm, and the length of the main body of the support is 10mm to 50mm; and / or, 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.

8. A connecting device, characterized in that, For conveying the connecting bracket as described in any one of claims 1-7, 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.

9. An arteriovenous fistula creation device, characterized in that, For delivering the connecting stent as described in any one of claims 1-7, the arteriovenous fistula ostomy device comprises: The connecting device as described in claim 8; A puncture device for delivering a branched guidewire, the branched guidewire being used to form a delivery path for the connecting device.

10. The arteriovenous fistula creation device according to claim 9, characterized in that, 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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