Vascular anastomat assembly

Abstract

A vascular anastomat assembly (1), comprising an application apparatus (100) and a vascular interface assembly (200) releasably connected to the application apparatus (100). The application apparatus (100) comprises a piercing assembly (40) movably arranged within a rod portion (22) of a handle (10), the piercing assembly (40) comprising a piercing portion to pierce a vascular wall, and the piercing portion being movable between a retraction position and an extension position; and a cutting assembly (20) movably arranged within a sheath (30) of the handle (10), the cutting assembly (20) being movable between a retraction position and a cutting position for cutting an incision on the vascular wall. The vascular interface assembly (200) comprises a main body portion (212); a clamping member (230) arranged at a distal end portion of the main body portion (212), the clamping member (230) being capable of being triggered to be in an open state; a flange (221) arranged at a periphery of the main body portion (212); and a trigger member (220), the trigger member (220) being configured to trigger the clamping member (230), such that the clamping member (230) is in the open state to clamp the vascular wall between the clamping member (230) and the flange (221) in a sealing manner.

Description

Vascular anastomosis assembly Technical Field

[0001] The present invention relates to the technical field of vascular surgery, and in particular to a vascular anastomosis device assembly used in artificial vascular synchronous anastomosis surgery. Background Art

[0002] As is well known, aortic bypass surgery is a common procedure for treating localized aortic lesions. The procedure involves using an artificial blood vessel as a vascular substitute to connect the proximal and distal ends of the lesioned vessel, creating a bypass. This allows blood to bypass the lesion and reach the distal end, restoring blood supply to the distal end, thereby alleviating distal ischemic symptoms and saving the patient's life. Currently, this procedure requires the use of a known scalpel. First, a longitudinal incision is made in the aortic sidewall, which has been clamped by a sidewall clamp. A surgical needle and sutures are then used to anastomose the artificial blood vessel ends to the incision. However, this conventional procedure is complex, prone to bleeding, highly invasive, risky, and difficult to perform.

[0003] To address these issues, a combined machine has been developed that can create an incision in the aorta and install a prosthesis. The combined machine generally operates as follows: first, an incision is made in the aorta, then a clamping mechanism is inserted into the incision. At the appropriate moment, the clamping mechanism is triggered to clamp the inner and outer walls of the incision, thereby achieving anastomosis between the incision and the prosthesis.

[0004] However, this type of combined machinery currently has problems such as complex clamping wall structure and inconvenient clamping wall operation. Summary of the Invention

[0005] According to one embodiment of the present application, a vascular anastomosis device assembly is provided, comprising an application device and a vascular interface assembly, wherein the vascular interface assembly is releasably connected to the application device so as to be detached from the application device during the anastomosis process, thereby sealingly retaining the vascular wall. This structure allows for rapid and safe bridging and drainage of blood vessels without the need for blood flow obstruction or complex procedures such as suturing the vessel wall, making it suitable for minimally invasive surgery and avoiding excessive wounds.

[0006] According to one embodiment, the application device includes: a handle; a hollow sheath extending from the handle; a piercing assembly movably disposed within the sheath of the handle, the piercing assembly including a piercing portion for piercing a blood vessel wall, the piercing portion being movable between a retracted position and an extended position; and a cutting assembly movably disposed within the sheath of the handle, the cutting assembly being movable between a retracted position and a cutting position, wherein in the extended position, the cutting assembly can be rotated relative to the handle by a predetermined angle to cut an incision in the blood vessel wall. Thus, the application device can be manipulated by a single physician to conveniently cut an incision in the blood vessel wall and release the vascular interface assembly into the incision, completing the operation of the vascular anastomosis assembly.

[0007] In one embodiment, the vascular interface assembly is releasably disposed at a distal portion of the application device and comprises: a main body; an artificial blood vessel extending from a proximal end of the main body; a retainer disposed at a distal portion of the main body, the retainer being triggerable to be in an open state; a flange disposed on an outer periphery of the main body; and a triggering member configured to trigger the retainer so that the retainer is in an open state to seal the blood vessel wall between the retainer and the flange, wherein when the vascular interface assembly is mounted on the application device, in an extended position, the piercing portion of the piercing assembly is extended distally out of the vascular interface assembly, and the cutting assembly is extended distally out of the vascular interface assembly. Thus, by providing a releasable vascular interface assembly, a doctor can also select vascular interface assemblies of different sizes according to the patient's needs, thereby facilitating surgical operations.

[0008] The vascular anastomosis device assembly of the present application does not require vascular incision, suturing, or other procedures, nor does it require blood flow obstruction. It can achieve rapid anastomosis with blood vessels, establish a bypass (bridge), and is also suitable for minimally invasive surgery. The device is quick and easy to operate, reduces surgical risks, and has a significant improvement on existing surgical procedures. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings of the embodiments of the present invention. The drawings are only used to illustrate some embodiments of the present invention, but not to limit all embodiments of the present invention thereto.

[0010] FIG1 shows a perspective view of a vascular anastomosis assembly according to the present application;

[0011] FIG2 is an exploded perspective view of the vascular anastomosis assembly shown in FIG1 ;

[0012] FIG3 is a partially cutaway view of the application device with the vascular interface assembly removed;

[0013] FIG4 is an exploded perspective view of the handle;

[0014] FIG5 is a perspective view showing a sheath portion;

[0015] FIG6 is a perspective view showing a cutting assembly;

[0016] FIG7 is a perspective view showing one embodiment of a cutting head;

[0017] FIG8 is a perspective view showing another embodiment of a cutting head;

[0018] FIG9A is a perspective view showing yet another embodiment of a cutting head;

[0019] FIG9B is a perspective view showing yet another embodiment of a cutting head;

[0020] FIG10 is a perspective view showing a piercing assembly;

[0021] 11A-11E are views illustrating different embodiments of a piercing tip of a piercing assembly;

[0022] FIG12 is an overall perspective view showing a vascular interface assembly;

[0023] FIG13 is an exploded perspective view showing a vascular interface assembly;

[0024] FIG14 is a perspective view showing a trigger member;

[0025] FIG14A is a perspective view showing another embodiment of a trigger member;

[0026] FIG14B is a perspective view showing another embodiment of a trigger member;

[0027] FIG14C is a perspective view showing a screw sleeve engaged with a trigger member;

[0028] 15 is a perspective view showing the vascular interface assembly in the clamping member is in an open state, wherein the artificial blood vessel portion is omitted;

[0029] FIG15A is a perspective view of an assembly employing the cutting head of FIG9B;

[0030] FIG16 is a perspective view showing another embodiment of the clamping member;

[0031] FIG17 is a perspective view showing yet another embodiment of the clamping member;

[0032] FIG18 is a view showing another embodiment of the main body portion of the vascular interface assembly; and

[0033] 19 to 23 show views of a vascular interface assembly of an inclined insertion-type vascular anastomosis assembly and its components. DETAILED DESCRIPTION

[0034] In order to make the purpose, technical solution and advantages of the technical solution of the present invention clearer, the technical solution of the embodiment of the present invention will be clearly and completely described below in conjunction with the drawings of specific embodiments of the present invention. The same figure marks in the drawings represent the same components. It should be noted that the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the described embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0035] Unless otherwise defined, the technical or scientific terms used herein shall have the ordinary meaning understood by persons of ordinary skill in the field to which the invention belongs. The words "first", "second" and similar terms used in the patent application specification and claims of the present invention do not indicate any order, quantity or importance, but are only used to distinguish different components. Similarly, words such as "one" or "a" do not necessarily indicate a quantity limitation. Words such as "include" or "comprising" mean that the elements or objects preceding the word include the elements or objects listed after the word and equivalents, without excluding other elements or objects. Words such as "connect" or "connected" are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect.

[0036] In the following description and claims, directional terminology is used, where "proximal," "proximal direction," "proximal end," etc., refer to the side or direction closer to a medical practitioner, such as a physician, when the vascular stapler assembly is being used by the medical practitioner, such as a physician, while "distal," "distal direction," "distal end," etc., refer to the side or direction toward or closer to the affected area or patient being treated or processed. Furthermore, in the following description and claims, "longitudinal" generally refers to the length of the component or feature being described, while the circumferential or circumferential direction refers to the direction surrounding the longitudinal direction.

[0037] When localized lesions develop in arteries or veins, bypass surgery—the so-called arterial bypass—is often necessary to bypass the lesion and restore blood supply. However, such bypass surgeries involve complex procedures, such as thoracotomy, vascular incision, and drainage, resulting in large incisions and slowing postoperative recovery. These procedures are complex, require a high level of surgical experience and skill, and are lengthy, presenting significant challenges for both surgeons and patients.

[0038] According to the present application, a vascular stapler assembly is provided that can rapidly bridge an artificial blood vessel to a large blood vessel, such as the aorta or vein, avoiding major trauma or incision to the patient. This simplifies the surgical procedure, shortens the operative time, and reduces the difficulty of the surgical operation for the surgeon. Furthermore, the vascular stapler assembly of the present application allows for flexible selection of the vessel bridging location based on surgical needs, without being restricted by distance.

[0039] According to the present disclosure, a vascular stapler assembly is provided, comprising an application device and a vascular interface assembly, wherein the vascular interface assembly is releasably engaged with the application device so that the vascular interface assembly can be installed within an incision in a blood vessel by operating the application device. The vascular interface assembly can be sealingly secured to the blood vessel incision and is provided with an artificial blood vessel, thereby achieving bridging of the blood vessels.

[0040] The application device may include a cutting assembly, which can be operated to form an incision in the blood vessel, and then the blood vessel interface assembly can be placed in the formed incision by further operating the application device. Thus, the entire surgical process can be completed only by operating the application device, and the entire process is simplified.

[0041] Advantageously, before making the incision, the vessel wall is pierced by a piercing assembly to provide a fixed point for subsequent cutting operations. The piercing assembly can be accommodated in an application device and can be extended from the application device when needed to pierce the vessel.

[0042] Preferably, the piercing assembly comprises a sharp tip, which is useful for piercing the vessel wall. In addition, the piercing assembly also comprises a barb structure that can hold the vessel wall, thereby providing a fixed point for the cutting operation and taking out the cut vessel wall after the subsequent cutting operation is completed.

[0043] The vascular access assembly, for example, includes a hollow cylindrical body portion adapted to fit within the incision formed in the vessel wall by the cutting assembly. To achieve sealing and securement, the vascular access assembly clamps onto the vessel wall around the incision. To achieve this, the vascular access assembly may include a retaining member on the distal portion of the cylindrical body and a flange on the proximal portion, which cooperate to clamp onto the vessel wall. To further enhance sealing, a sealing and hemostatic structure, such as a hemostatic pad, may be provided on the distal end surface of the flange.

[0044] In order to facilitate the insertion of the vascular interface assembly into the incision in the vascular wall, when applying, the clamping member is in a retracted position, that is, retracted within the cylindrical main body of the vascular interface assembly, and after the vascular interface assembly is inserted into the incision, for example, when the flange abuts against the outside of the vascular wall, the clamping member is triggered to switch to the open position by the operation of the applying device, thereby clamping the vascular wall. This opening can be achieved by means of the elasticity of the clamping member itself, or by other opening mechanisms, and the present application has no restrictions on this. As an example, the opening mechanism includes, for example, an eccentric cam, which biases the clamping member to the open position by the drive of the applying device.

[0045] In order to maintain the retaining member in a retracted position when the vascular interface assembly is deployed in the incision in the vascular wall, a retaining element can be provided, for example, surrounding the retaining member to thereby restrict the retaining member from expanding. Furthermore, the retaining member can be released from its restraint by operation of the application device. However, it should be understood that the retaining element is not essential and can be omitted if the retaining member is expanded by the expansion mechanism.

[0046] As an advantageous embodiment, the retaining element and the flange can be provided in one piece, thereby simplifying the structure of the entire vascular interface assembly.

[0047] The vascular interface assembly can be attached with an artificial blood vessel at the proximal side, thereby bridging the artificial blood vessel to the target blood vessel through the vascular interface assembly. The artificial blood vessel can be clamped by a hemostat or the like and opened when needed, such as when connecting to another section of artificial blood vessel or to another blood vessel.

[0048] Thus, the vascular anastomosis device assembly of the present application can easily achieve vascular connection. For example, it can achieve the connection between a bypass vessel and a main vessel to overcome, for example, localized lesions and blockages in the main vessel. It can also be used to treat other conditions and achieve vascular bridging. Because the entire operation can be performed by operating the application device, the surgical process is simplified, the technical requirements for the doctor or operator are lower, the implementation difficulty is low, the operation time is shortened, the surgical trauma caused is minimized, and the patient's pain and recovery time are reduced.

[0049] The vascular anastomosis assembly according to the present application is described in detail below with reference to the accompanying drawings, wherein Figure 1 shows a perspective view of the vascular anastomosis assembly according to the present application, Figure 2 is an exploded perspective view of the vascular anastomosis assembly shown in Figure 1, Figure 3 is a partial cross-sectional view of the application device 100 without the vascular interface assembly 200, and Figure 4 is an exploded perspective view of the handle 10.

[0050] As shown in Figures 1 and 2, the vascular stapler assembly 1 according to the present application includes an application device 100 and a vascular interface assembly 200. The vascular interface assembly 200 is releasably coupled to the application device 100 so as to pass through the incision made in the vascular wall by the application device 100. As shown in Figure 2, the application device 100 includes a handle 10, through which a doctor or operator can operate the vascular stapler assembly 1; a sheath 30 extending from the distal end of the handle 10; a cutting assembly 20 slidably accommodated in an interior space formed by the handle 10 and the sheath 30; and a piercing assembly 40 slidably accommodated in the interior space.

[0051] As shown in more detail in FIG. 4 , the handle 10 is generally composed of two halves 11 and 12, each of which is formed from a polymer material, such as by injection molding, 3D printing, or the like. The handle halves 11 and 12 are essentially mirror images, and therefore, only the housing half 11 is described in detail. The interior of the housing half 11 includes a plurality of partitions 15 and 16 to increase the strength of the housing and to form positioning portions for the sheath 30, cutting assembly 20, and piercing assembly 40. Furthermore, each handle half 11 and 12 also defines a mounting hole 18, for example, to allow the two handle halves 11 and 12 to be assembled together using screws. However, the present disclosure is not limited thereto, and other combinations or fastening methods, such as bonding, welding, etc., may be employed. Furthermore, although not shown in the figures, the handle 10 may be provided with markings to indicate or indicate an operating position or direction.

[0052] As shown in Figures 3 and 4 and in conjunction with Figure 5, Figure 5 shows a perspective view of the sheath 30. The sheath 30 is made of, for example, metal and includes an elongated body 31. The distal end of the elongated body 31 is formed with at least one protrusion 33 along the circumference. The protrusion 33 releasably engages with the vascular access assembly 100, which will be described in detail below. A shoulder 32 is also formed proximal to the protrusion 33. This shoulder serves as a mounting and positioning portion for the vascular access assembly 200, which will be described below, and can push the vascular access assembly during implantation. In addition, a plurality of notches 34 are formed in the body 31. These notches 34 engage with the snaps 19 in the handle half 11 to secure the sheath 30 to the handle. Although not shown, the body 31 of the sheath 30 is hollow to accommodate the cutting assembly and the piercing assembly, as will be described in detail below.

[0053] FIG6 shows a cutting assembly 20. The cutting assembly 20 includes a hollow shaft 22, a cutting head 24 disposed at the distal end of the hollow shaft 22, and a stopper 21 disposed at the proximal end of the hollow shaft 22. The stopper 21 is removably secured to the proximal end of the shaft 22 and includes a stopper 25 having a diameter greater than that of the hollow shaft 22 and an arm 26 extending from the stopper 25. Although FIG6 shows the stopper 21 as including two arms 26 extending in opposite directions, the present invention is not limited thereto and may include multiple arms or even a single arm. Referring again to FIG3 , the shaft 22 is slidably received within the hollow body 31 of the sheath 30, with the cutting head 24 extending out of the distal end of the hollow body 31. Furthermore, the arm 26 of the stopper 21 extends outside the handle 10 through a slit 17 formed in the handle 10 and engages the operating ring 13. An operating ring 13 is slidably mounted on the outer periphery of the handle 10. By longitudinally moving the operating ring 13 along the outer periphery of the handle 10, the longitudinal movement of the cutting assembly 20 inside the handle 10 can be controlled. A biasing element (not shown) is also provided, such as a coil spring. One end of the coil spring abuts against the partition 16 inside the handle 10, and the other end abuts against the stop 25 of the baffle 21. This biases the cutting assembly 20 proximally, i.e., biases the cutting assembly 20 into a retracted position. As shown in FIG1 , in the retracted position, the cutting head is retracted into the vascular interface assembly 200.

[0054] The cutting head 24 can be integrally formed with the stem 22 or formed separately and then secured together by welding, riveting, or the like. Alternatively, the cutting head 24 can be detachably connected to the stem 22, such detachable connection being achieved, for example, by a threaded connection, a snap fastener, a pin, a snap ring, or the like. Thus, if the blade of the cutting head 24 becomes less sharp after repeated use, the cutting head 24 can be replaced. Alternatively, the cutting head 24 can be provided with different types of blades to accommodate different cutting requirements.

[0055] As shown in FIG4 , the slit 17 in the handle is formed into an L-shape, comprising a longitudinally extending portion and a circumferentially extending portion. Thus, by inserting the arm 26 of the baffle 21 through the slit 17, the slit 17 guides the longitudinal movement of the cutting assembly when the operating ring 13 operates the cutting assembly. Furthermore, when the arm 26 moves to the circumferentially extending portion of the slit, the slit 17 allows the operating ring 13 to rotate the cutting assembly. This circumferentially extending portion, for example, ranges from 60 to 120 degrees, thereby allowing the cutting head 24 at the distal end of the cutting assembly to rotate a specific angle to perform the cutting operation. As shown in FIG4 , the circumferentially extending portion of the slit 17 can be formed to extend clockwise from the longitudinally extending portion, thereby allowing the cutting head 24 to rotate clockwise. However, the present application is not limited to this. Combining the circumferentially extending portion with the longitudinally extending portion can allow the cutting head 24 to rotate in either the clockwise, counterclockwise, or both directions for cutting. Preferably, markings (not shown) are provided on the handle to indicate the rotation angle of the cutting head 24.

[0056] As shown in Figures 3 and 6 to 9, the cutting head may include a cylindrical main body 23 and a plurality of blades 24 fixed to the main body 23. The blades 24 may be fixed to the main body 23 by, for example, welding, riveting, bonding, etc. Compared with the technical solution of integrally forming the main body 23 and the blades 24, by first forming the blades and then fixing them to the main body 23, the blade forming process and the formation of the blade edges can be simplified.

[0057] Figures 7 to 9A illustrate three optional blade configurations. As shown in Figure 7, blade 24 has a cutting edge extending obliquely in one direction. This blade allows the cutting head to rotate in only one direction for cutting. Figure 8 shows a blade 24' with cutting edges extending obliquely in two directions, allowing the cutting head to rotate in both directions for cutting. Figure 9A shows a blade 24" with a curved cutting edge. This blade 24" resembles a scalpel in shape. Compared to the oblique cutting edge shown in Figures 7 and 8, the curved cutting edge generates greater tangential force and forward thrust during cutting, allowing tissue to be penetrated more quickly. Compared to a traditional straight cutting edge, this allows the blade to penetrate the tissue more easily, reducing operating force and improving cutting efficiency. Furthermore, in addition to the curved cutting edge, this blade 24" can also have a cutting edge on the other side to enhance puncture effectiveness, for example, making it easier to puncture a blood vessel before initiating cutting. Furthermore, as described above, if the cutting head 22 is detachable, multiple cutting heads with different blades can be provided, allowing for customized cutting heads tailored to the surgical procedure or cutting location.

[0058] Although the above describes a structure in which a blade is formed separately and attached to a main body and various forms of the blade, the present disclosure is not limited thereto. FIG. 9B shows another cutting head applicable to the present disclosure.

[0059] As shown in FIG9B , a blade 24 ″′ can be formed on the distal edge of the cylindrical body 23, thereby constituting a cylindrical knife. The blade can be a complete circle, but the present disclosure is not limited thereto. The blade can also include multiple blade portions (not shown) in the circumferential direction. These blade portions are regularly distributed around the circumference and have gaps between them.

[0060] FIG. 10 shows a perspective view of the piercing assembly 40 , and FIG. 11 shows an enlarged view of the distal end of the piercing assembly 40 .

[0061] As shown in FIG10 , the piercing assembly 40 includes a shaft 43, a button 41 and a shoulder 42 disposed at the proximal end of the shaft 43, and a sharp tip 44 disposed at the distal end of the shaft 43. The shaft 43 is inserted into the hollow shaft 22 of the cutting assembly. As shown in FIG3 , the button 41 extends from the proximal end of the handle, and the shoulder 42 engages the handle's tip opening to prevent the button 41 from being dislodged. Furthermore, although not shown, a biasing device, such as a compression spring, is provided between the handle's partition 15 and the shoulder 42 of the button 41 to bias the piercing assembly 40 toward its retracted position, in which the tip 44 of the piercing assembly 40 is housed within the cutting head of the cutting assembly. Thus, by pressing the button 41, the tip 44 of the piercing assembly can be extended beyond the distal end of the cutting assembly, thereby piercing the target blood vessel wall. As shown in FIG11A , the tip 44 includes a piercing blade 45 constituting the tip and a barb 46. When viewed longitudinally, the piercing blade 45 and the barbed portion 46 generally form a cross shape, but the present application is not limited thereto; other piercing tips and barbs may be formed. The piercing tips and barbs allow the piercing tip to penetrate the blood vessel wall by pressing the button 41. Upon release of the pressure on the button 41, the piercing assembly moves to a retracted position under the action of a spring, and can move the blood vessel wall via the barbs, as will be described later. Preferably, the button 41 is provided with markings to indicate the degree or direction in which the button 41 has been depressed.

[0062] The piercing blade 45 can be formed separately and fixed to the piercing tip by welding, bonding, etc., thereby simplifying the manufacturing process. In addition, the entire piercing tip can be fixed together with the rod 43, or it can be detachably connected, for example, by a thread, a buckle, etc., so that the piercing tip can be replaced.

[0063] Figures 11B and 11C illustrate two alternative embodiments of piercing blades. Figure 11B shows views of one embodiment of a three-piece piercing blade 45', with (a) showing a side view, (b) showing a top view, and (c) showing a perspective view. As shown in Figure 11B, the piercing blade 45' is composed of three identical pieces and is fixed to the shaft 43. Each piece includes a piercing portion 45'-1 and a tail portion 45'-2. The piercing portion 45'-1 forms a cutting edge at its distal end edge, and the tail portion 45'-2 extends outward from the end of the piercing portion 45'-1 at an angle greater than 100 degrees, preferably greater than 120 degrees. The tail portion 45'-2 has a concave, generally flat portion 45'-3 formed at the proximal end of the tail portion 45'-2, thereby forming a shape similar to an aircraft wing.

[0064] Figure 11C shows views of an embodiment of a four-piece puncture blade 45", wherein (a) is a side view, (b) is a top view, and (c) is a perspective view. As can be seen from Figure 11C, the puncture blade 45" includes a main blade portion 45"-1 and a positioning blade 45"-2. The main blade portion 45"-1 includes a piercing portion 45"-1A and a symmetrically arranged tail portion 45"-1B. Similar to Figure 11B, the tail portion 45"-1B also includes a concave, generally flat portion 45"-1C at its proximal end. The positioning blade 45"-2 includes a generally triangular shape, the distal edge of which can form a cutting edge portion 45"-2A, and the proximal end of which forms a slightly concave flat portion 45"-2B. The positioning blades 45"-2 can be symmetrically arranged on both sides of the main blade portion 45"-1, thereby forming a cross in the top view as shown in (b) in Figure 11C.

[0065] FIG11D illustrates another embodiment of a puncture blade 45D according to the present application. This puncture blade 45D includes a generally inverted conical main portion 45D-3, formed with mutually perpendicular slits 45D-4. The main blade portion 45D-1 and the positioning blade 45D-2 are embedded in and extend from this slit 45D-4. The cylindrical main portion 45D-3 allows the puncture blade 45D to more securely hold the blood vessel when it penetrates and retracts. Alternatively, the main portion may be formed with three slits spaced 120 degrees apart, each with a blade embedded in it. The three identical blades can then be used to more securely hold the blood vessel by using the circular planar surface of the main portion as the positioning surface (which has a larger area). FIG11E shows a puncture blade 45E according to yet another embodiment. In the puncture blade 45E shown in FIG11E , an inverted conical main body portion 45E-3 is cut away at three portions of the circumference, thereby forming three corners, and a slit 45E-4 is formed at each corner, and three substantially identical blades 45E-1 are embedded in the slit 45E-4, thereby reducing the overall size of the puncture blade 45E and achieving an effect similar to that of the puncture blade 45D.

[0066] The structure of the vascular access assembly 200 will be described below with reference to Figures 12 to 15 . Figure 12 shows a perspective view of the vascular access assembly 200, with the retaining element in a retracted state; Figure 13 shows an exploded view of the vascular access assembly 200; Figure 14 shows a perspective view of the trigger element 220; and Figure 15 shows a schematic diagram of the retaining element in an extended state. As shown in Figures 12 and 13 , the vascular access assembly 200 includes, for example, a cylindrical main body 212, an artificial blood vessel 211 connected to the proximal end of the main body 212, and a trigger element 220 disposed around the outer circumference of the main body 212. The main body 212 can be formed by winding and welding a thin-walled material or by directly machining a tubular material, and has a diameter ranging from 5 mm to 20 mm. The thin-walled material can be, for example, stainless steel, nickel-titanium alloy, or other biocompatible material, and has a wall thickness ranging from approximately 0.1 to 2 mm, for example, 0.2 mm. The main body 212 may have a plurality of small holes 215 formed in its proximal portion to facilitate connection to the artificial blood vessel 211, for example, by suturing or gluing. Furthermore, a plurality of protrusions 213 are formed circumferentially in the middle of the main body 212. These protrusions 213 serve as guides and limiters for the trigger 220. At the distal end of the main body 212, a plurality of retaining members 230 are formed circumferentially by laser cutting or other means. These retaining members 230 are made elastic, for example, by heat treatment and shaping, and thus can be opened by their own elasticity.

[0067] An L-shaped slot 214 is formed at the proximal end of the main body portion 212. The slot 214 includes a longitudinal extension extending from the proximal edge of the main body portion 212 to the distal end and a circumferential extension extending a specific length from the distal end of the longitudinal extension. The slot 214 cooperates with the protrusion 33 of the sheath portion 30 (see FIG5 ). Thus, when the protrusion 33 is located within the circumferential extension of the slot 214, the vascular interface assembly is connected to the application device. As the sheath portion 30 rotates relative to the vascular interface assembly, the protrusion 33 can rotate to align with the longitudinal extension of the slot 214, thereby releasing the vascular interface assembly from the application device. The protrusion and L-shaped slot thus constitute a release mechanism, but it should be understood that the present application is not limited to this and may include other types of release mechanisms, such as a quick-release buckle structure. Release of the release mechanism does not necessarily require rotation of the application device and can also be achieved by providing a dedicated release device.

[0068] But slit 214 also can take other forms, for example, as shown in Figure 18, slit 214B is formed as straight incision form, and the application is not limited to this.In addition, as shown in Figure 18, clamping piece 230 also can be formed as petal shape, so that better clamping is held on the blood vessel inner wall.

[0069] As shown in Figures 12 and 14 , the trigger member 220 is movable longitudinally around the main body 212 and includes a cylindrical portion and a flange portion 221 extending radially from the cylindrical portion. Multiple (three shown) grooves 222 are formed at intervals on the inner circumference of the trigger member 220. These grooves 222 engage with protrusions 213 on the main body 212. As the trigger member 220 moves along the main body 212, the protrusions 213 guide the movement of the trigger member 220 and limit its range of movement, preventing it from being disengaged from the main body 212. Multiple notches (three shown) are formed on the outer circumference of the flange portion 221. These notches are designed to engage with corresponding surgical tools to adjust the position of the trigger member 220.

[0070] Therefore, when the trigger member 220 is in the distal position, the trigger member 220 will surround the clamping member 230, thereby preventing the clamping member 230 from opening by its own elastic force. As the trigger member 220 moves toward the proximal direction, the trigger member 220 will let go of the clamping member 230, thereby releasing the obstruction to the clamping member 230, and the clamping member 230 will open by its own elastic force. Therefore, when the vascular interface assembly 200 is placed in the incision in the vascular wall, the opened clamping member 230 will be supported on the inner side of the vascular wall. Since the outer diameter of the flange portion 221 is larger than the outer diameter of the main body portion 212, when the main body portion 212 is inserted into the incision in the blood vessel wall, the flange portion 221 will abut against the outside of the blood vessel wall; at the same time, since the inner diameter of the flange 221 is smaller than the outer diameter after the clamp is popped open, the flange portion 221 abutting against the outside of the blood vessel wall and the popped-open clamp 230 can form a fixation and seal for the blood vessel, clamping the blood vessel wall between the clamp 230 and the flange portion 221 (see Figure 15). The blood in the blood vessel can flow into the artificial blood vessel through the hollow space of the main body portion 212 of the blood vessel interface assembly.

[0071] Although the trigger member 220 is described in the above embodiment as being translated along the main body 212 by the engagement of the groove 222 with the protrusion 213, the present disclosure is not limited thereto. As shown in FIG14A , a threaded engagement may also be employed. As shown in FIG14A , the trigger member 220A includes an internal thread 222A, and correspondingly, an external thread (not shown) or protrusion is formed on the outer periphery of the main body 212 to engage with the internal thread of the trigger member 220A. A notch 223A is formed on the outer periphery of the trigger member 220A. Thus, after being assembled to the main body 212, as shown in FIG15A , the notch 223A can be engaged by a tool, and the trigger member 220A can be rotated so that the trigger member 220A rotates along the external thread on the outer periphery of the main body 212 and moves axially, thereby being rotated to a position where the retaining member 230 is released. The trigger member 220A can then be rotated in the opposite direction so that the trigger member 220A presses against the outside of the blood vessel, thereby more effectively compressing the blood vessel and preventing blood leakage.

[0072] Figure 14B shows another embodiment of the trigger member. As shown in Figure 14B, the periphery of the trigger member 220B is formed with ribs 223B, so that the doctor or assistant can grasp the periphery of the trigger member 220B and twist the trigger member 220B during surgery.

[0073] Optionally, a screw sleeve 224B can be fixedly connected to the periphery of the main body part 212, as shown in Figure 14C, and the screw sleeve 224B can be fixed to the periphery of the main body part 212, for example, by welding or bonding, or the screw sleeve 224B can be formed integrally with the main body part 212, and a thread 225B is formed on the periphery of the screw sleeve 224B to cooperate with the internal threaded hole of the trigger member 220A or 220B, so that the trigger member 220A or 220B can be moved along the axial direction of the main body part 212 by screwing the trigger member 220A or 220B.

[0074] The trigger 220A or 220B can be twisted away from the holder 230 on the screw sleeve 224B, thereby releasing the holder 230, and when the holder 230 is held in place, the trigger 220A or 220B can be twisted in reverse, thereby making the flange portion 221 of the trigger 220A or 220B press on the outer wall of the blood vessel. However, the application is not limited to this, and the trigger and the flange portion can be separate elements, that is, a pressure ring (not shown) is also provided between the trigger 220A or 220B and the holder, and the pressure ring is roughly annular and moves axially along the periphery of the main body in association with the trigger 220A or 220B. Preferably, the pressure ring only moves axially and does not rotate, and this is for example achieved by the slit of the pressure ring cooperating with the stop pin on the periphery of the main body.

[0075] To further enhance the seal between the vascular interface assembly and the vascular incision, a hemostatic member and / or sealing member 240 can optionally be provided on the surface of the flange 221 facing the vascular wall. The sealing member can include, for example, a hemostatic felt, a gauze pad, etc. Furthermore, a sealing material or sealing member can also be provided on the surface of the trigger member 220A facing the blood vessel to further improve the sealing effect.

[0076] Figures 16 and 17 show two alternative embodiments of the clip 230. As shown in Figures 16 and 17, the clip 230 can have a rounded free end, thereby reducing damage to the blood vessel wall when clipped on the blood vessel wall and preventing displacement or falling off from the blood vessel after implantation.

[0077] Although the above description describes that the clamping member 230 is formed integrally with the main body 212 and is cut out from the main body 212 by, for example, laser cutting, the present application is not limited thereto, and other clamping members 230 may be used. For example, the clamping member may be formed separately and connected to the main body by, for example, welding, etc. The clamping member 230 may be made of, for example, a material such as a memory alloy and thus may be deployed to an open state by relying on its own elasticity. However, the present application is not limited thereto, and other methods may be used to deploy the clamping member 230 to an open state, such as an eccentric cam, high-pressure gas or liquid push, etc. In this case, the trigger member may be a mechanism or element that applies or actuates the eccentric cam, high-pressure gas or liquid, etc.

[0078] In the above description, the flange 221 is provided on the trigger member 220. The flange portion 221 may be integrally formed with the trigger member 220, or the flange portion 221 and the trigger member 220 may be formed separately and then joined together by welding, bonding, etc. However, the present application is not limited thereto, and the flange portion 221 does not necessarily have to be formed together with the trigger member. The flange portion 221 may be formed separately on the main body portion 212, and the trigger member 220 may be separately sleeved on the main body portion 212, and the trigger member 220 may be driven by a driving mechanism such as a pull rope or a pull rod.

[0079] Next, the operation of the vascular anastomosis assembly according to the present application will be briefly described with reference to FIG. 1 .

[0080] Step 1: Prepare the vascular anastomosis assembly. In the initial state, the vascular interface assembly 200 is connected to the application device 100 and the artificial blood vessel is sheathed outside the sheath 30. In this state, the trigger member 220 is in its distal position, thereby surrounding the clamping member 230 to prevent the clamping member from opening.

[0081] Step 2: When the vascular anastomosis assembly is aligned with a target placement position of the blood vessel, preferably, the blood vessel is pulled to facilitate the piercing and cutting of the piercing assembly and the cutting assembly;

[0082] Step 3: Place the distal end of the vascular anastomosis assembly against the vessel wall and press the button 41, thereby moving the puncture assembly to the extended position, in which the puncture tip of the puncture assembly pierces and penetrates the vessel wall;

[0083] Step 4: After releasing the button 41, the operating ring 13 is moved downward along the outer circumference of the handle to move the cutting head 23 of the cutting assembly to the extended position. In this extended position, the cutting blade 24 of the cutting head 23 penetrates the blood vessel wall. As the extended position is reached, the operating ring 13 can drive the cutting assembly to rotate, thereby causing the cutting blade 24 to cut an incision in the blood vessel wall. In the case of using a cylindrical knife as shown in FIG. 9B , it is not necessary to rotate the cutting assembly, and the incision is directly cut, thereby improving the cutting effect and the shape integrity of the incision.

[0084] Step 5: After the incision is made, the barbs or tail fins on the piercing tip pull the cut portion of the blood vessel wall out of the incision and store it in the cutting head 23, while the distal end of the blood vessel interface assembly is simultaneously inserted into the incision. By using the wing-shaped tail fins as shown in Figures 11B and 11C, the positioning effect of the piercing blade assembly on the blood vessel can be improved. Thus, with the cooperation of the piercing assembly and the cutting assembly, the blood vessel incision can be formed more easily and efficiently.

[0085] Step 6: When the flange 221 of the trigger member 220 of the vascular interface assembly is against the outside of the vascular wall at the incision, the vascular interface assembly is continued to be inserted. Since the flange 221 is blocked by the vascular wall, as the main body of the vascular interface assembly is inserted inward, the trigger member 220 slides on the main body of the vascular interface assembly, thereby moving to its proximal position, releasing the blocking effect on the clamping member 230. The clamping member 230 is expanded to the open position under the action of its own elastic force, thereby clamping the vascular wall between the clamping member 230 and the flange 221. The flange 221 is provided between the trigger member 220A and the flange 221, and the incision of the blood vessel is sealed by means of the two or further by means of a sealing member provided on the flange 221, so that the blood vessel is connected with the artificial blood vessel. In the case of the trigger member 220A, the trigger member 220A can be twisted with an external tool so that the trigger member 220A releases the obstruction of the clamping member 230 to allow the clamping member 230 to open. After the clamping member 230 is opened, the trigger member 220A is rotated in the opposite direction so that the trigger member 220A abuts against the outer wall of the blood vessel, thereby improving the blood vessel sealing effect.

[0086] Step 7: After the vascular interface assembly is in place, turn the handle so that the protrusion 33 on the sheath 30 disengages from the L-shaped slot 214 of the main body of the vascular interface assembly, thereby releasing the vascular interface assembly and removing the application device, thereby completing the implantation of the vascular interface assembly.

[0087] Typically, an artificial blood vessel can be clamped with a hemostatic forceps to prevent blood from flowing out. The artificial blood vessel can then be connected to a target device when needed to perform the corresponding treatment. For example, in a bypass surgery, the vascular anastomosis assembly of the present application can be used to implant a vascular interface assembly at two locations on either side of the necrotic or blocked portion of the blood vessel, and then the respective artificial blood vessels can be connected to bypass the necrotic or blocked portion.

[0088] After the vascular access assembly is implanted, the application device can be sterilized again and a new vascular access assembly can be installed to perform a new operation, thereby saving costs.

[0089] Although an embodiment of inserting and implanting the anastomosis device substantially perpendicular to the blood vessel wall is described above with reference to Figures 1 to 18 , the present application is not limited thereto. As shown in Figures 19 to 22 in combination with Figures 1 to 18 , a brief description of an obliquely implantable vascular anastomosis device assembly is given below.

[0090] FIG19 shows an overall view of the obliquely implantable vascular stapler assembly 1C. As shown in FIG19 , the obliquely implantable vascular stapler assembly 1C differs from the vertically implantable vascular stapler assembly 1 described above only in the vascular interface assembly. Both employ the same application apparatus, and therefore, the following primarily describes the structure of the vascular interface assembly.

[0091] FIG20 shows a schematic diagram of a vascular interface assembly 200C. As shown in FIG20 to FIG23 , the vascular interface assembly includes a main body portion 212C. As shown in FIG21 , the main body portion 212C is generally cylindrical and differs from the main body portion 212B shown in FIG18 in that its distal end portion is formed into an inclined surface A. Similarly, the main body portion 212C includes, for example, a petal-shaped retaining member 230C and a slot 214C formed in the proximal end portion.

[0092] A limit pin 213C is provided on the outer circumference of the main body 212C. A pressure ring 215C, shown in FIG22 , is positioned around the outer circumference of the main body 212C and is capable of axial movement along the main body 212C. A limit groove 216C is provided on the inner circumference of the pressure ring 215C. This limit groove 216C cooperates with the limit pin 213C on the main body 212C to limit the range of axial movement of the pressure ring 215C along the main body 212C, allowing the pressure ring 215C to move only axially and not rotate. Prior to implantation, the pressure ring 215C is positioned around the outer side of the retaining member 230C, thereby restricting the opening of the retaining member 230C. Similarly, the pressure ring 215C is provided with an inclined surface B at its distal end. The inclination angle of the inclined surface B can be the same as that of the inclined surface A, for example, within a range of 20 to 70 degrees, preferably within a range of 60 to 70 degrees.

[0093] On the periphery of main part 212C, also be fixed with nut sleeve 217C, for example, this nut sleeve 217C can be fixed on the periphery of main part 212C by welding or bonding.As shown in figure 23, nut sleeve 217C is fixed on the periphery of main part 212C and forms external thread 218C on the periphery of this nut sleeve 217C.Triggering member 220C is similar to the triggering member 220B shown in Figure 14 B, is threadedly connected to the periphery of nut sleeve 217C and along with rotation and moves axially along nut sleeve (main part), and the rotation of triggering member 220C drives the axial movement of pressure ring 215C simultaneously and does not rotate.

[0094] When implanting the vascular interface assembly, the entire vascular anastomosis device assembly can be inserted into the blood vessel at an angle, and an opening is cut into the blood vessel wall using the cutting head, while the main body 212C is inserted into the opening formed in the blood vessel wall. As the trigger 220C is turned, the pressure ring 215C is driven proximally with the movement of the trigger 220C, thereby releasing the retaining member 230. After the retaining member 230 is released and retained on the inner wall of the blood vessel, the trigger 220C is turned again in the opposite direction, thereby driving the pressure ring 215C, causing the pressure ring 215C to press against the outer wall of the blood vessel, thereby pressing the vascular interface assembly against the blood vessel wall, completing the surgery.

[0095] As can be seen from the above description, the vascular anastomosis assembly of the present application can implant the vascular interface assembly into the incision of the blood vessel wall only by operating the handle. The entire process does not require incision, suturing, etc. Therefore, the vascular anastomosis assembly provided by the present application can not only be used under open-chest conditions, but also can be used for minimally invasive interventional surgery, simplifying the surgical procedure. In addition, the materials of the above-mentioned various components can be medical materials or biocompatible materials, and the present invention has no restrictions. In addition, in order to prevent accidental trauma, the various components can be appropriately chamfered to avoid unnecessary sharp edges.

[0096] Although the above description uses a button to operate the piercing assembly and an operating ring to operate the cutting assembly, the present application is not limited thereto and other structures may be employed. In addition, the present application is not limited to manual operation of the above components and may employ, for example, an electric, pneumatic, or hydraulic structure. For example, the handle may include a motor to drive the piercing assembly or the cutting assembly to switch between a retracted position and an extended position.

[0097] Although the number of multiple clamps, multiple bosses or multiple protrusions is shown in the above description and illustrations, it is understood that these are exemplary and those skilled in the art can increase or decrease them as needed without impairing the effect or purpose of the present application.

[0098] Therefore, according to the present disclosure, the following technical solutions are provided:

[0099] Solution 1. A vascular anastomosis assembly, comprising:

[0100] An application device, the application device comprising:

[0101] handle;

[0102] a hollow sheath extending from the handle;

[0103] a piercing assembly movably disposed within the sheath portion of the handle, the piercing assembly comprising a piercing portion for piercing a blood vessel wall, the piercing portion being movable between a retracted position and an extended position;

[0104] a cutting assembly movably disposed within the sheath portion of the handle, the cutting assembly being movable between a retracted position and a cutting position, wherein the cutting assembly is capable of rotating relative to the handle by a predetermined angle to cut an incision in a blood vessel wall; and

[0105] A vascular access assembly is releasably disposed at the distal end of the application device and comprises:

[0106] Main body;

[0107] a vascular prosthesis extending from a proximal end of the body portion;

[0108] a latch provided at a distal end portion of the main body portion, the latch being capable of being triggered to be in an open position;

[0109] a flange provided on the outer periphery of the main body portion; and

[0110] A triggering member is configured to trigger the clamping member so that the clamping member is in an open position to seal the blood vessel wall between the clamping member and the flange.

[0111] Option 2. The vascular anastomosis assembly of Option 1, wherein the applying device further comprises a first biasing device that biases the piercing assembly to its retracted position.

[0112] Option 3. The vascular anastomosis assembly of Option 1 or 2, wherein the applying device further comprises a second biasing device that biases the cutting assembly to its retracted position.

[0113] Option 4. A stapler assembly as described in any one of Options 1 to 3, wherein the cutting assembly includes a hollow rod accommodated in the hollow sheath portion of the handle and a cutting head fixed to the distal end of the hollow rod, the cutting head is cylindrical, and a plurality of blades are evenly spaced along the circumferential direction at the distal end of the cylindrical cutting head.

[0114] Option 5. The stapler assembly of Option 4, wherein the blade comprises a cutting edge inclined in one direction.

[0115] Option 6. The stapler assembly of Option 4, wherein the blade includes a cutting edge inclined in two directions.

[0116] Option 7. The stapler assembly of Option 4, wherein the blade comprises a curved cutting edge.

[0117] Option 8. The stapler assembly according to any one of Option 4 to Option 7, wherein the blade is welded to the distal end of the cutting head.

[0118] Option 9. The stapler assembly of Option 4, wherein the diameter of the cutting head is in the range of 5 mm to 20 mm.

[0119] Option 10. The stapler assembly according to Option 4, wherein the distal end edge of the cutting head forms a cutting edge, thereby forming a cylindrical knife, and the cutting edge is preferably formed around the entire circumference of the distal end edge.

[0120] Option 11. The stapler assembly according to any one of Options 4 to 10, wherein the cutting head is disposed within the main body portion of the interface assembly, and an outer diameter of the cutting head is substantially equal to an inner diameter of the main body portion.

[0121] Option 12. A vascular anastomosis assembly as described in Option 4 or 5, wherein the piercing assembly includes a rod portion accommodated in the hollow rod of the cutting assembly, the piercing portion is fixed at the distal end of the rod portion, and the piercing portion includes a blade forming a sharp distal end and a barb extending in a proximal direction.

[0122] Option 13. A vascular anastomosis assembly as described in Option 4 or 5, wherein the blade of the puncture assembly can be a three-piece blade or a four-piece blade, wherein, in the three-piece blade, each blade includes a cutting edge formed at the distal edge and a concave, generally flat portion formed at the proximal end; in the four-piece blade, it includes a main blade portion and positioning blade portions symmetrically arranged on both sides of the main blade portion, and the positioning blade portion includes a cutting edge at the distal edge and a concave, generally flat portion arranged at the proximal end.

[0123] Option 14. The vascular anastomosis assembly according to any one of Options 1 to 13, further comprising a release mechanism that can be actuated to release the vascular interface assembly from the application device.

[0124] Option 15. A vascular anastomosis assembly as described in Option 14, wherein the release mechanism includes a protrusion formed on the circumference of the distal end portion of the rod and a narrow groove formed in the circumferential portion of the main body portion of the vascular interface assembly, and the protrusion fits into the narrow groove.

[0125] Option 16. A vascular anastomosis assembly as described in Option 15, wherein the narrow groove is L-shaped, including a circumferential portion extending along the circumferential portion and a longitudinal portion extending from the circumferential portion to the proximal edge of the main body portion; the protrusion fits into the narrow groove so that the protrusion moves from the circumferential portion to the axial portion by rotating the handle, thereby releasing the vascular interface assembly from the application device.

[0126] Option 17. The vascular anastomosis assembly according to any one of Options 1 to 16, wherein the retaining member is formed integrally with the main body portion, and the retaining member is placed in an open position based on its own elasticity.

[0127] Option 18. The vascular anastomosis assembly according to Option 17, wherein the retaining member comprises a plurality of claws spaced apart around the circumference of the main body portion, and the plurality of claws are in the shape of elongated strips.

[0128] Option 19. The vascular anastomosis assembly according to Option 17, wherein the retaining member includes a plurality of claws spaced apart around the circumference of the main body portion, the plurality of claws having rounded ends.

[0129] Option 20. A vascular anastomosis assembly as described in any one of Options 1 to 19, wherein the trigger member is arranged around the main body portion and is capable of moving longitudinally along the main body portion from a first position to a second position, in the first position, the trigger member surrounds the clamping member to prevent the clamping member from being in an open position, and in the second position, the trigger member releases the blockage of the clamping member.

[0130] Option 21. A vascular anastomosis assembly as described in Option 20, wherein one of the trigger member and the main body portion includes a groove, and the other of the trigger member and the main body portion includes a protrusion, and the groove and the protrusion cooperate to enable the trigger member to move along the main body portion.

[0131] Option 22. A vascular anastomosis assembly as described in Option 20, wherein the trigger member includes an internal thread, the main body portion includes an external thread, and the internal thread of the trigger member engages with the external thread of the main body portion, so that the trigger member rotates and moves around the main body portion.

[0132] Option 23. The vascular anastomosis assembly according to any one of Options 20 to 22, wherein a limit member is provided on the main body portion to limit the movement range of the trigger member.

[0133] Option 24. The vascular anastomosis assembly according to Option 23, wherein the stopper comprises a protrusion arranged on the circumference of the main body portion.

[0134] Option 25. The vascular anastomosis assembly according to any one of Options 1 to 24, wherein the flange and the trigger member are formed into one piece.

[0135] Option 26. The vascular anastomosis assembly according to any one of Options 1 to 25, wherein the handle comprises a button connected to the piercing assembly to overcome the first biasing device and place the piercing assembly in the extended position.

[0136] Option 27. A vascular anastomosis assembly as described in any one of Options 1 to 26, wherein the handle includes an operating ring arranged on its periphery, and the operating ring is connected to the hollow rod of the cutting assembly to overcome the second biasing device to place the cutting assembly in an extended position and rotate the cutting assembly.

[0137] Option 28. The vascular anastomosis assembly according to any one of Options 1 to 27, wherein a hemostatic seal is provided on the distal end surface of the flange.

[0138] Solution 29. A vascular interface assembly for sealingly placing in an incision of a blood vessel, comprising:

[0139] a cylindrical main body portion, wherein the outer diameter of the main body is substantially equal to the diameter of the cutout;

[0140] a vascular prosthesis extending from a proximal end of the body portion;

[0141] a holding member disposed at a distal end portion of the main body portion, the holding member being switchable between a retracted position and an extended position;

[0142] a flange provided at a proximal end of the main body portion, wherein when the retaining member is in an open position, the flange and the retaining member sandwich a blood vessel wall therebetween; and

[0143] A triggering member can be triggered to switch the clamping member to the open position.

[0144] Option 30. The vascular interface assembly of Option 29, wherein the retaining member switches from the retracted position to the expanded position by virtue of its own elasticity.

[0145] Option 31. A vascular interface assembly as described in Option 29 or 30, wherein the trigger member is capable of moving along the main body between a first position and a second position, wherein in the first position, the trigger member surrounds the clamping member to maintain the clamping member in a retracted position, and in the second position, the trigger member is away from the clamping member to allow the clamping member to switch to an open position by its own elasticity.

[0146] Option 32. The vascular interface assembly of any one of Option 29 to Option 31, wherein the trigger member and the flange are formed as one piece.

[0147] Option 33. The vascular interface assembly according to any one of Options 29 to 32, wherein a hemostatic seal is provided on the surface of the flange facing the retainer.

[0148] Option 34. A vascular interface assembly as described in any one of Options 29 to 33, wherein a limit member is provided on the periphery of the main body portion to limit the movement range of the trigger member.

[0149] Option 35. The vascular interface assembly according to Option 34, wherein the stopper is a protrusion formed on the outer periphery of the main body portion.

[0150] From the foregoing description, it will be apparent to those of ordinary skill in the art that, while the methods and apparatus described herein constitute exemplary embodiments of the present disclosure, the present invention is not limited to these specific embodiments, and changes may be made to such embodiments without departing from the scope of the present invention as defined by the claims. Additionally, it will be understood that the present invention is defined by the claims, and that this does not mean that any limitation or element describing the exemplary embodiments set forth herein will be incorporated into the interpretation of any claim element unless such limitation or element is expressly stated. Likewise, it will be understood that not all of the noted advantages or objects of the invention disclosed herein need be met in order to fall within the scope of any claim, because the invention is defined by the claims and because there may be inherent and / or unforeseen advantages of the claimed invention even though they may not have been explicitly discussed herein.

Claims

1. A vascular anastomosis assembly, comprising: An application device, the application device comprising: handle; a hollow sheath extending from the handle; a piercing assembly movably disposed within the sheath portion of the handle, the piercing assembly comprising a piercing portion for piercing a blood vessel wall, the piercing portion being movable between a retracted position and an extended position; a cutting assembly movably disposed within the sheath portion of the handle, the cutting assembly being movable between a retracted position and a cutting position, wherein the cutting assembly is capable of rotating relative to the handle by a predetermined angle to cut an incision in a blood vessel wall; and A vascular access assembly is releasably disposed at the distal end of the application device and comprises: Main body; a vascular prosthesis extending from a proximal end of the body portion; a latch provided at a distal end portion of the main body portion, the latch being capable of being triggered to be in an open position; a flange provided on the outer periphery of the main body portion; and A triggering member is configured to trigger the clamping member so that the clamping member is in an open position to seal the blood vessel wall between the clamping member and the flange.

2. The vascular anastomosis assembly according to claim 1, wherein: The applying means further comprises first biasing means and / or second biasing means, wherein the first biasing means biases the piercing assembly into its retracted position and the second biasing means biases the cutting assembly into its retracted position.

3. The stapler assembly according to claim 1 or 2, wherein: The cutting assembly includes a hollow rod accommodated in the hollow sheath portion of the handle and a cutting head fixed at the distal end of the hollow rod, the cutting head is cylindrical, and a plurality of blades are evenly spaced along the circumferential direction at the distal end of the cylindrical cutting head, the blades including a blade selected from at least one of the following: a blade inclined in one direction, a blade inclined in two directions, a curved blade or a cylindrical blade.

4. The stapler assembly according to claim 3, wherein: The cutting head is disposed in the main body portion of the interface assembly, and the outer diameter of the cutting head is substantially equal to the inner diameter of the main body portion.

5. The vascular anastomosis assembly according to any one of claims 1 to 4, wherein: The piercing assembly includes a rod portion accommodated in the hollow rod of the cutting assembly, the piercing portion is fixed to the distal end of the rod portion, and the piercing portion includes a blade forming a sharp distal end and a barb extending in a proximal direction. The blade of the puncture assembly can be a three-piece blade or a four-piece blade, wherein, in the three-piece blade, each blade includes a cutting edge formed at the distal edge and a concave generally flat portion formed at the proximal end; in the four-piece blade, it includes a main blade portion and positioning blade portions symmetrically arranged on both sides of the main blade portion, wherein the positioning blade portion includes a cutting edge at the distal edge and a concave generally flat portion arranged at the proximal end; or The puncture portion includes an inverted conical main body portion, the main body portion includes a plurality of slits in a circumferential direction, and a blade is embedded in each slit.

6. The vascular anastomosis assembly according to any one of claims 1 to 5, further comprising a release mechanism, which can be actuated to release the vascular interface assembly from the application device, in particular, the release mechanism comprises a protrusion formed on the circumference of the distal end portion of the rod portion and a preferably L-shaped narrow groove formed in the circumferential portion of the main body portion of the vascular interface assembly, the protrusion fitting into the narrow groove.

7. The vascular anastomosis assembly according to any one of claims 1 to 6, wherein: The clamping member is formed integrally with the main body portion, and the clamping member is placed in an open position due to its own elasticity.

8. The vascular anastomosis assembly according to claim 7, wherein: The clamping member includes a plurality of claws spaced apart around the circumference of the main body portion, and the plurality of claws are in the shape of an elongated strip or a shape with rounded ends or a petal shape.

9. The vascular anastomosis assembly according to any one of claims 1 to 8, wherein: The trigger is disposed around the main body portion and is movable longitudinally along the main body portion from a first position to a second position, wherein the trigger surrounds the clamp to prevent the clamp from being in the open position and the trigger releases the clamp from being prevented from being in the open position.

10. The vascular anastomosis assembly according to claim 9, wherein: One of the trigger member and the main body portion includes a groove, and the other of the trigger member and the main body portion includes a protrusion, and the groove and the protrusion cooperate to move the trigger member along the main body portion.

11. The vascular anastomosis assembly according to claim 9, wherein: The trigger member includes an internal thread, and the main body portion includes an external thread. The internal thread of the trigger member is engaged with the external thread of the main body portion, so that the trigger member rotates and moves around the main body portion.

12. The vascular anastomosis assembly according to claim 10 or 11, wherein: A pressure ring is also provided, which is operatively provided at the distal end of the trigger member so as to move along the main body portion with the trigger member but not to rotate.

13. The vascular anastomosis assembly according to any one of claims 1 to 12, wherein: The distal end of the main body portion is formed to be inclined, and the distal end surface of the pressure ring or the trigger member is formed to be inclined, and the inclination angle is in the range of 20 to 70 degrees, preferably in the range of 60 to 70 degrees.

14. A vascular interface assembly for sealingly placing in an incision of a blood vessel, comprising: a cylindrical main body portion, wherein the outer diameter of the main body is substantially equal to the diameter of the cutout; a vascular prosthesis extending from a proximal end of the body portion; a holding member disposed at a distal end portion of the main body portion, the holding member being switchable between a retracted position and an extended position; a flange or a pressure ring provided at the proximal end of the main body portion, wherein when the clamp is in the open position, the flange or the pressure ring and the clamp clamp the blood vessel wall therebetween; as well as A triggering member can be triggered to switch the holding member to the open position preferably by relying on its own elasticity.

15. The vascular interface assembly of claim 14, wherein: The trigger member is movable along the main body between a first position and a second position. In the first position, the clamping member is held in the retracted position. In the second position, the clamping member is allowed to elastically switch to the expanded position.

16. The vascular interface assembly according to claim 14 or 15, wherein: The trigger member and the flange or pressure ring form one piece, or the flange or pressure ring moves with the trigger member.

17. The vascular interface assembly according to any one of claims 14 to 16, wherein: A limiting member is provided on the outer periphery of the main body portion to limit the movement range of the trigger member or the pressure ring.

18. The vascular interface assembly according to any one of claims 14 to 17, wherein: The distal end surface of the main body portion is formed to be inclined, and the inclination angle is in the range of 20 degrees to 70 degrees, preferably in the range of 60 degrees to 70 degrees.

19. The vascular interface assembly of claim 18, wherein: The distal end surface of the pressure ring is formed to be inclined, and the inclination angle is in the range of 20 degrees to 70 degrees, preferably in the range of 60 degrees to 70 degrees.

Images