A vascular end-to-end telescopic intraluminal anastomat

Abstract

The present application belongs to the technical field of medical devices, and discloses a blood vessel end-to-end telescopic intraluminal anastomat, which comprises a main handle, a guide rod connected to the front end of the main handle, and an anastomosis head installed at the front end of the guide rod; an anastomosis assembly, which comprises a curved nail forming structure and a plurality of anastomosis nails, the plurality of anastomosis nails are arranged on the anastomosis head in a circumferential direction, the curved nail forming structure is arranged outside the blood vessels to be anastomosed, the anastomosis nails pass through the blood vessel wall from inside to outside of the blood vessels to be anastomosed, and enter the curved nail forming structure to complete bending and fixation; the blood vessels to be anastomosed comprise a first blood vessel and a second blood vessel, the second blood vessel extends into the first blood vessel, the anastomosis nails are arranged across the edge of the broken end of the second blood vessel, so that one side of the nail foot of the anastomosis nail passes through the first blood vessel and the second blood vessel, and the other side of the nail foot passes through the first blood vessel. The present application can realize rapid and uniform circumferential fixation of the broken end of the blood vessel, shorten the anastomosis time, improve the anastomosis quality, and is suitable for the fields of vascular surgery, organ transplantation and microsurgery, and is especially suitable for anastomosis reconstruction of the superior and inferior vena cava of liver transplantation.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and in particular relates to a vascular end-to-end endovascular anastomosis device. Background Technology

[0002] Vascular anastomosis is a fundamental procedure in vascular surgery, cardiac surgery, organ transplantation, and microsurgery. Its main purpose is to achieve a reliable connection between two blood vessels and restore blood flow.

[0003] Currently, the most commonly used method for vascular anastomosis in clinical practice is manual suture anastomosis. During the procedure, the surgeon uses suture needles and sutures to continuously or intermittently suture the severed ends of the blood vessel, thereby completing vascular reconstruction. This method has a wide range of applications, but it requires a high level of surgical experience, the operation time is relatively long, and the quality of the anastomosis is greatly affected by human factors.

[0004] To improve the efficiency of vascular anastomosis, researchers both domestically and internationally have developed various mechanical vascular anastomosis devices. These include vascular couplers, vascular clamping anastomoses, and suture assist devices. These devices primarily use ring-shaped clips, clamping structures, or connecting rings to fix the blood vessel, which can reduce suture time to some extent.

[0005] In addition, the circular anastomosing device, widely used in gastrointestinal surgery, employs a ring of metal staples to achieve tissue connection. This type of device uses a drive mechanism to propel the staples through the tissue, and the anvil causes the staples to plastically deform, thus forming a stable connection structure. This technique has been widely applied in esophageal, gastrointestinal, and colorectal anastomosis surgeries.

[0006] However, existing vascular anastomosis techniques still have the following shortcomings: (1) Traditional manual suturing requires needle insertion and knot tying, which is complicated and takes a long time to complete; (2) Most existing mechanical vascular anastomosis devices adopt the direct docking method of vascular ends, which has high requirements for vascular size matching; (3) Some devices require the blood vessel ends to be everted and fixed, which is complicated and not suitable for small-diameter blood vessels. (4) Existing technologies rarely use overlapping connection of blood vessel ends, making it difficult to form a long connection area; (5) Existing vascular anastomosis devices cannot easily achieve rapid circumferential fixation of vascular tissue by drawing on the mature circular anastomosis staple technology; (6) There is still room for improvement in the existing equipment in terms of standardization, consistency and rapid fit.

[0007] Therefore, there is an urgent need for a vascular end-to-end endovascular anastomosis device to solve the above problems. Summary of the Invention

[0008] The purpose of this invention is to provide a vascular end-to-end endovascular anastomosis device to solve the problems existing in the prior art, and it is applicable to scenarios such as anastomosis and reconstruction of the superior and inferior vena cava in liver transplantation and reconstruction of vascular transplantation.

[0009] To achieve the above objectives, the present invention provides the following solution: The present invention provides a vascular end-to-end endovascular anastomosis device, comprising: The main handle has a guide rod connected to its front end, and a matching head is installed at the front end of the guide rod. The anastomosis assembly includes a bent stud forming structure and a plurality of anastomotic studs. The plurality of anastomotic studs are arranged circumferentially on the anastomosis head. The bent stud forming structure is located on the outside of the blood vessel to be anastomosed. The anastomotic studs pass through the blood vessel wall from the inside to the outside of the blood vessel to be anastomosed and enter the bent stud forming structure to complete the bending and fixing. The vessels to be anastomosed include a first vessel and a second vessel. One end of the second vessel extends into the first vessel. The anastomotic staple is arranged across the cut edge of the second vessel, such that one side of the staple passes through the first and second vessels, and the other side of the staple passes through the first vessel.

[0010] Preferably, the bent nail forming structure includes an annular base, on which a plurality of forming grooves are provided circumferentially, and the plurality of forming grooves correspond one-to-one with the plurality of matching nails.

[0011] Preferably, the forming groove includes a first forming groove and a second forming groove, wherein the first forming groove is adapted to the pin foot of the anastomosis staple that passes through both the first and second blood vessels, and the second forming groove is adapted to the pin foot of the anastomosis staple that passes through the first blood vessel.

[0012] Preferably, the depth of the first forming groove is greater than the depth of the second forming groove.

[0013] Preferably, it also includes multiple staple cartridges, which are fixedly connected to the anastomosis head at equal intervals along the circumference. Each staple cartridge is provided with a guide groove, and the anastomosis staples are slidably connected to the guide groove. A staple pusher block is provided at the end of the staple cartridge, and the staple pusher block is used to push the anastomosis staples out of the staple cartridge.

[0014] Preferably, the staples are metal staples.

[0015] Preferably, the anastomotic staple has a U-shaped structure.

[0016] Preferably, the number of anastomotic staples is 8-24.

[0017] Preferably, the cut ends of the first blood vessel and the cut ends of the second blood vessel are joined together to form an axially overlapping area, and the anastomosis head is located inside the overlapping area.

[0018] Preferably, the overlap length is 5-20 mm.

[0019] Compared with the prior art, the present invention has the following advantages and technical effects: By employing an anastomotic staple structure positioned across the vessel ends, the second vessel end is pressed and fixed to the inner wall of the first vessel, reducing vessel end migration and blood flow erosion. A circumferential staple structure, formed by endovascular puncture and shaping on the outer side of the vessel, achieves stable fixation of the overlapping vessel area, creating a continuous mechanical fixation interface and minimizing local blood flow disturbance. Multiple staples are evenly distributed circumferentially, ensuring uniform circumferential stress and improving the stability of the anastomosis structure. After anastomosis, the instruments can be withdrawn as a whole, leaving only the individual staple structures, facilitating vascular reconstruction. This invention enables rapid and uniform circumferential fixation of vessel ends, shortens anastomosis time, and improves anastomosis quality, making it applicable to vascular surgery, organ transplantation, and microsurgery. Attached Figure Description

[0020] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1 This is a schematic diagram of the overall structure of the present invention; Figure 2 This is a schematic diagram of the overall structure of the bent nail forming structure of the present invention; Figure 3 This is a schematic diagram of the disassembled state of the bent nail forming structure of the present invention; Figure 4 This is a schematic diagram of the distribution of the anastomotic staples in this invention; Figure 5 This is a schematic diagram of the push state of the anastomosis staple of the present invention; The components include: 1. Main handle; 2. Guide rod; 3. Anastomosis head; 4. Anastomosis staples; 5. Bent staple forming structure. Detailed Implementation

[0022] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0023] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0024] Reference Figures 1-5 The present invention provides a vascular end-to-end endovascular anastomosis device, comprising: The main handle 1 has a guide rod 2 connected to its front end, and a matching head 3 is installed at the front end of the guide rod 2. The anastomosis assembly includes a bent stud forming structure 5 and multiple anastomotic studs 4. The multiple anastomotic studs 4 are arranged circumferentially on the anastomosis head 3. The bent stud forming structure 5 is located on the outside of the blood vessel to be anastomosed. The anastomotic studs 4 pass through the blood vessel wall from the inside to the outside of the blood vessel to be anastomosed and enter the bent stud forming structure 5 to complete the bending and fixing. The vessels to be anastomosed include a first vessel and a second vessel. One end of the second vessel extends into the first vessel. The anastomosing staple 4 is arranged across the edge of the broken end of the second vessel, such that one side of the staple 4 passes through the first and second vessels, and the other side of the staple 4 passes through the first vessel.

[0025] As an optional implementation, the bent nail forming structure 5 includes an annular base with multiple forming grooves circumferentially formed on the annular base, and the multiple forming grooves correspond one-to-one with multiple matching nails 4.

[0026] In one embodiment of the present invention, the bent nail forming structure 5 is an annular structure, including an annular base, a plurality of first forming grooves and a plurality of second forming grooves. The plurality of first forming grooves and the plurality of second forming grooves are arranged circumferentially on the annular base and correspond one-to-one with the nail feet on both sides of the plurality of matching nails 4.

[0027] As an optional implementation, the forming groove includes a first forming groove and a second forming groove. The first forming groove is adapted to the pin of the anastomosis staple 4 that passes through the first blood vessel and the second blood vessel simultaneously, and the second forming groove is adapted to the pin of the anastomosis staple 4 that passes through the first blood vessel.

[0028] In one embodiment of the present invention, one side of the anastomotic staple 4 passes through two layers of vessel walls in the overlapping area, while the other side passes through only a single layer of the first vessel wall. The bridge portion of the anastomotic staple 4 crosses the edge of the second vessel and presses against the free edge of the second vessel's broken end.

[0029] As an optional implementation, the depth of the first forming groove is greater than the depth of the second forming groove.

[0030] In one embodiment of the present invention, the depth of the first forming groove is greater than the depth of the second forming groove to compensate for the forming differences caused by different tissue thicknesses. As an optional implementation, it also includes multiple staple cartridges, which are fixedly connected to the anastomosis head 3 at equal intervals along the circumference. The staple cartridges are provided with guide grooves, and the anastomosis staples 4 are slidably connected to the guide grooves. A pusher block is provided at the end of the staple cartridge, which is used to push the anastomosis staples 4 out of the staple cartridge.

[0031] In one embodiment of the present invention, a drive ring and a pusher block are further included. The drive ring is sleeved on the guide rod 2 and can slide along the axial direction of the guide rod 2. The pusher block is disposed between the drive ring and the anastomotic staple 4. One end of the pusher block abuts against the distal end face of the drive ring, and the other end abuts against the back of the anastomotic staple 4. When the drive ring moves axially to the distal end, it pushes the pusher block to move radially outward, and the pusher block then pushes the anastomotic staple 4 to pass through radially outward. In use, by pressing the drive button on the main handle 1, the drive ring moves axially to the distal end along the guide rod 2.

[0032] As an optional implementation, the staple 4 is a metal staple.

[0033] In one embodiment of the present invention, the anastomotic staple 4 can be made of a shape memory alloy (such as nickel-titanium alloy). The anastomotic staple 4 is mounted on the anastomotic head 3 in a temporary form at low temperature. After penetrating the blood vessel wall, it undergoes a phase transition under body temperature and returns to a preset bent shape, thereby completing tissue fixation. At this time, the bent staple forming structure 5 can be simplified and used only as a temporary positioning and guiding structure.

[0034] As an optional implementation, the anastomotic staple 4 has a U-shaped structure.

[0035] In one embodiment of the present invention, the anastomotic staple 4 is preferably a U-shaped structure.

[0036] As an alternative implementation, the number of anastomotic staples 4 is 8-24.

[0037] In one embodiment of the present invention, the number of anastomotic staples 4 can be adjusted according to the vessel diameter and anastomosis strength requirements, for example, set to 8, 10, 16, or 24. A higher number of staples results in better uniformity and stability of circumferential fixation, but also increases the operation time and the number of implants. For superior and inferior vena cava anastomosis in liver transplantation, 12 staples are a preferred number that balances anastomosis efficiency and fixation effect.

[0038] As an optional implementation, the ends of the first blood vessel and the ends of the second blood vessel are connected by a sleeve to form an axially overlapping area, and the anastomosis head 3 is located inside the overlapping area.

[0039] In one embodiment of the present invention, the severed end of the second blood vessel is pressed and fixed to the inner wall of the first blood vessel, forming a continuous and smooth blood flow channel. The free edge of the severed end is tightly attached to the vessel wall and is not exposed to the blood flow, which helps to reduce the risk of thrombosis. Each anastomotic staple 4 is evenly distributed circumferentially, and the anastomosis site is subjected to uniform force, which has good mechanical stability.

[0040] As an optional implementation, the overlap length is 5-20 mm.

[0041] In one embodiment of the present invention, the axial length of the overlapping region can be adjusted according to the vessel wall thickness and anastomosis strength requirements, for example, set to 8 mm, 12 mm, or 15 mm. A longer overlapping region results in higher mechanical strength of the anastomosis, but may compress surrounding tissues. 10 mm is a preferred length that balances mechanical strength and clinical safety.

[0042] In one embodiment of the present invention, taking superior and inferior vena cava anastomosis in liver transplantation as an example, the diameters of the donor and recipient vessels are assessed preoperatively based on imaging data. A first vessel with a larger diameter and a second vessel with a smaller diameter are selected. During the operation, the severed end of the second vessel is inserted into the severed end of the first vessel, forming an axially overlapping area. The guide rod 2 and the anastomosis head 3 are then inserted into the overlapping area through the vessel lumen, so that the 12 U-shaped anastomotic staples 4 circumferentially positioned around the severed end of the second vessel are precisely located. Then, the drive button on the main handle 1 is pressed, and the drive ring moves distally along the axial direction of the guide rod 2. The drive ring pushes the pusher blocks to move radially outward, and each pusher block drives the corresponding U-shaped anastomotic staples 4 to simultaneously pass outward from the vessel lumen.

[0043] The anastomotic staple 4 is positioned across the severed end of the second vessel. One side of the staple 4 passes through two layers of vessel wall in the overlapping area, while the other side passes through only a single layer of vessel wall of the first vessel. The bridging portion of the staple 4 crosses the edge of the severed end of the second vessel and presses against the free edge of the severed end of the second vessel.

[0044] After the two pins protrude from the outer wall of the first blood vessel, they enter the corresponding forming grooves on the bending and forming structure 5. Specifically, the pin that penetrates the double-layered tissue enters the first forming groove, while the pin that penetrates the single-layered tissue enters the second forming groove. Because the depth of the first forming groove is greater than that of the second forming groove, although the exposed length of the first pin after protruding from the blood vessel wall is relatively short, guided by the deeper grooves, the first and second pins can simultaneously complete the bending and forming, creating a U-shaped bend with consistent shape.

[0045] After the anastomotic staples 4 are bent and shaped, a 360° circumferential fixation structure is formed in the overlapping area of ​​the blood vessels. At this time, the staple feet of each staple are located on the outer side of the outer wall of the blood vessel, and the staple bridge is closely attached to the cut end of the second blood vessel and the inner wall of the first blood vessel.

[0046] Subsequently, the curved staple forming structure 5 is removed from the outside of the blood vessel, leaving only 12 U-shaped anastomotic staples 4 independently on the outer wall of the blood vessel, achieving a stable connection between the first and second blood vessels. After the anastomosis is completed, the severed end of the second blood vessel is pressed and fixed to the inner wall of the first blood vessel, forming a continuous and smooth blood flow channel.

[0047] Testing showed that vascular anastomosis using this invention takes approximately 5 minutes, significantly shorter than traditional manual suturing. Furthermore, the tensile strength and sealing performance of the anastomosis meet clinical requirements.

[0048] The bent staple forming structure 5 can be detachable. After the anastomotic staple is bent and formed, the bent staple forming structure 5 is separated from the anastomotic head 3 by a snap or thread connection and is withdrawn from the outside of the blood vessel and the inside of the blood vessel lumen, respectively.

[0049] In the description of this invention, it should be understood that the terms "longitudinal", "lateral", "up", "down", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., 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 invention, and are not intended to 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 invention.

[0050] The embodiments described above are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. A vascular end-to-end endovascular anastomosis device, characterized in that, include: The main handle (1) has a guide rod (2) connected to its front end, and a matching head (3) is installed at the front end of the guide rod (2). The anastomosis assembly includes a bent stud forming structure (5) and multiple anastomotic studs (4). The multiple anastomotic studs (4) are arranged circumferentially on the anastomosis head (3). The bent stud forming structure (5) is located on the outside of the blood vessel to be anastomosed. The anastomotic studs (4) pass through the blood vessel wall from inside to outside the blood vessel to be anastomosed and enter the bent stud forming structure (5) to complete the bending and fixing. The vessels to be anastomosed include a first vessel and a second vessel. One end of the second vessel extends into the first vessel. The anastomosis staple (4) is arranged across the cut edge of the second vessel, such that one side of the staple (4) passes through the first vessel and the second vessel, and the other side of the staple (4) passes through the first vessel.

2. The endovascular anastomosis device with end-to-end laparoscopic arrangement according to claim 1, characterized in that: The bent nail forming structure (5) includes an annular base, and multiple forming grooves are provided on the annular base along the circumferential direction. The multiple forming grooves correspond one-to-one with the multiple matching nails (4).

3. The endovascular anastomosis device with end-to-end laparoscopic arrangement according to claim 2, characterized in that: The forming groove includes a first forming groove and a second forming groove. The first forming groove is adapted to the pin foot of the anastomosis staple (4) that passes through both the first blood vessel and the second blood vessel. The second forming groove is adapted to the pin foot of the anastomosis staple (4) that passes through the first blood vessel.

4. The endovascular anastomosis device with end-to-end overlapping as described in claim 3, characterized in that: The depth of the first forming groove is greater than the depth of the second forming groove.

5. The endovascular anastomosis device with end-to-end vascular cladding as described in claim 1, characterized in that: It also includes multiple staple cartridges, which are fixedly connected to the anastomosis head (3) at equal intervals along the circumference. A guide groove is provided in the staple cartridge, and the anastomosis staple (4) is slidably connected to the guide groove. A pusher block is provided at the end of the staple cartridge, and the pusher block is used to push the anastomosis staple (4) out of the staple cartridge.

6. The endovascular anastomosis device with end-to-end overlapping as described in claim 5, characterized in that: The staple (4) is a metal staple.

7. The endovascular anastomosis device with end-to-end overlapping as described in claim 5, characterized in that: The anastomotic staple (4) has a U-shaped structure.

8. The endovascular anastomosis device with end-to-end overlapping as described in claim 5, characterized in that: The number of the anastomotic staples (4) is 8-24.

9. The endovascular anastomosis device with end-to-end overlapping as described in claim 1, characterized in that: The cut ends of the first blood vessel and the cut ends of the second blood vessel are connected by a sleeve to form an axially overlapping area, and the anastomosis head (3) is located inside the overlapping area.

10. A vascular end-to-end endovascular anastomosis device according to claim 9, characterized in that: The overlap length is 5-20 mm.

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