Blood vessel anastomat assembly

Abstract

The present application relates to a vascular stapler assembly comprising: an application device comprising a piercing assembly movably disposed within a rod portion of a handle, the piercing assembly comprising a piercing portion to pierce a vascular wall, and a vascular interface assembly releasably connected to the application device, the piercing part can move between a retraction position and an extension position; and a cutting assembly movably disposed within the sheath portion of the handle, the cutting assembly movable between a retracted position and a cutting position for cutting an incision in a blood vessel wall. The vascular interface assembly includes: a body portion; the clamping piece is arranged at the far end part of the main body part, and the clamping piece can be triggered to be in an open state; the flange is arranged on the periphery of the main body part; the triggering piece is constructed to trigger the clamping piece, so that the clamping piece is in an open state, and the blood vessel wall is clamped between the clamping piece and the flange in a sealed mode.

Description

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] Figure 1 shows a perspective view of a vascular anastomosis assembly according to the present application;

[0011] Figure 2 It shows Figure 1 An exploded perspective view of a vascular stapler assembly is shown;

[0012] Figure 3 is a partially cutaway view of the application apparatus with the vascular interface assembly removed;

[0013] Figure 4 This is an exploded perspective view of the handle;

[0014] Figure 5 is a perspective view showing a sheath;

[0015] Figure 6 is a perspective view showing a cutting assembly;

[0016] Figure 7 is a perspective view showing one embodiment of a cutting head;

[0017] Figure 8 is a perspective view showing another embodiment of a cutting head;

[0018] Figure 9A is a perspective view showing yet another embodiment of a cutting head;

[0019] Figure 9B is a perspective view showing yet another embodiment of a cutting head;

[0020] Figure 10 is a perspective view showing a piercing assembly;

[0021] Figure 11A is an enlarged perspective view showing a piercing tip of the piercing assembly;

[0022] Figure 11B are three views showing another piercing tip of the piercing assembly;

[0023] Figure 11C are three views showing yet another piercing tip of the piercing assembly;

[0024] Figure 12 is an overall perspective view showing a vascular interface assembly;

[0025] Figure 13 is an exploded perspective view showing a vascular interface assembly;

[0026] Figure 14 is a perspective view showing a trigger member;

[0027] Figure 14A is a perspective view showing another embodiment of a trigger member;

[0028] Figure 15 is a perspective view showing the vascular interface assembly in a state where the clamp is in an expanded state, wherein the artificial blood vessel portion is omitted;

[0029] Figure 15A It is adopted Figure 9B A perspective view of the components of the cutting head

[0030] Figure 16 is a perspective view showing another embodiment of a clamp; and

[0031] Figure 17 is a perspective view showing still another embodiment of a clamp. DETAILED DESCRIPTION

[0032] 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.

[0033] 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.

[0034] 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.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] 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.

[0039] 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.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] The vascular anastomosis device 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 a vascular anastomosis assembly according to the present application, Figure 2 It shows Figure 1 An exploded perspective view of a vascular anastomosis assembly is shown. Figure 3 is a partially cutaway view of the application device 100 with the vascular interface assembly 200 removed, Figure 4 is an exploded perspective view of the handle 10 .

[0048] like Figure 1and 2 As shown, the vascular anastomosis 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 fitted to the application device 100 to pass through the incision set in the vascular wall by the application device 100. Figure 2 As shown, the application device 100 includes a handle 10, through which a doctor or operator can operate the vascular anastomosis assembly 1; a sheath 30 extending from the distal end of the handle 10; a cutting assembly 20 slidably accommodated in an internal space formed by the handle 10 and the sheath 30; and a piercing assembly 40 slidably accommodated in the internal space.

[0049] like Figure 4 As shown in more detail in the figure, the handle 10 is generally composed of two halves 11 and 12, and the two handle halves 11 and 12 are formed of a polymer material such as by injection molding, 3D printing, etc. The handle halves 11 and 12 are basically mirror images, and therefore, only the shell half 11 is described in detail. The interior of the shell half 11 includes a plurality of partitions 15 and 16 to increase the strength of the shell and form positioning parts for the sheath 30, the cutting assembly 20 and the piercing assembly 40. In addition, each handle half 11 and 12 is also formed with a mounting hole 18 to combine the two handle halves 11 and 12 together, for example, by screws. However, the present disclosure is not limited to this, and other combinations or fastening methods can be used, such as bonding, welding, etc.

[0050] like Figure 3 and 4 Shown and combined Figure 5 ,in, Figure 5 A perspective view of the sheath 30 is shown. The sheath 30 is made of, for example, metal and includes an elongated main body 31. The distal end of the elongated main body 31 is formed with at least one protrusion 33 along the circumference. The protrusion 33 releasably engages with the vascular interface assembly 100, which will be described in detail below. A shoulder 32 is also formed proximal to the protrusion 33. The shoulder serves as a mounting and positioning portion for the vascular interface assembly 200, which will be described below, and can push the vascular interface assembly during implantation. Furthermore, a plurality of notches 34 are formed on the main body 31. The notches 34 engage with the snaps 19 in the handle half 11 to secure the sheath 30 to the handle. Although not shown, the main body 31 of the sheath 30 is hollow to accommodate a cutting assembly and a piercing assembly, as will be described in detail below.

[0051] like Figure 6 As shown, Figure 6The cutting assembly 20 is shown. The cutting assembly 20 includes a hollow shaft 22, a cutting head 24 is provided at the distal end of the hollow shaft 22, and a stopper 21 is provided at the proximal end of the hollow shaft 22. The stopper 21 is detachably fixed to the proximal end of the shaft 22 and includes a stopper 25 having a diameter larger than the diameter of the hollow shaft 22 and an arm 26 extending from the stopper 25. Although Figure 6 The baffle 21 is shown to include two arms 26 extending relative to each other, but the present application is not limited thereto and may include multiple or even one arm. Figure 3 , the rod portion 22 is slidably accommodated in the hollow body 31 of the sheath portion 30, and the cutting head 24 extends out of the distal end of the hollow body 31. In addition, the arm 26 of the baffle 21 extends to the outside of the handle through the slit 17 formed on the handle 10 and engages the operating ring 13. The operating ring 13 is slidably sleeved on the outer periphery of the handle 10, and thus, by moving the operating ring 13 longitudinally along the outer periphery of the handle 10, the longitudinal movement of the cutting assembly 20 inside the handle 10 can be manipulated. A biasing element (not shown in the figure) is also provided, which is, for example, a coil spring, one end of which abuts against the partition 16 inside the handle 10, and the other end abuts against the stop portion 25 of the baffle 21, thereby biasing the cutting assembly 20 in the proximal direction, that is, biasing the cutting assembly 20 in the retracted position. As shown in FIG. Figure 1 As shown, in the retracted position, the cutting head is retracted into the vessel interface assembly 200.

[0052] 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.

[0053] like Figure 4 As shown, the slit 17 on the handle is formed into an L shape, including a longitudinally extending portion and a circumferentially extending portion. Thus, by passing the arm 26 of the baffle 21 through the slit 17, when the cutting assembly is manipulated by the operating ring 13, the slit 17 guides the longitudinal movement of the cutting assembly, and when the arm 26 moves to the circumferentially extending portion of the slit, the slit 17 allows the operating ring 13 to drive the cutting assembly to rotate. The circumferentially extending portion is, for example, in the range of 60 to 120 degrees, thereby allowing the cutting head 24 at the distal end of the cutting assembly to rotate a specific angle to achieve the cutting operation. Figure 4As shown, the circumferential extension portion of the slit 17 can be formed to extend in a clockwise direction from the longitudinal extension portion, thereby allowing the cutting head 24 to rotate in a clockwise direction, but the present application is not limited to this. Instead, through the combination of the circumferential extension portion and the longitudinal extension portion, the cutting head can be allowed to rotate in a clockwise direction, a counterclockwise direction, or both directions for cutting.

[0054] like Figure 3 and Figure 6 As shown in Figures 9 and 9, the cutting head may include a cylindrical body 23 and a plurality of blades 24 fixed to the body 23. The blades 24 may be fixed to the body 23 by, for example, welding, riveting, bonding, etc. Compared with the technical solution of integrally forming the body 23 and the blades 24, by first forming the blades and then fixing them to the body 23, the blade forming process and the formation of the blade edges can be simplified.

[0055] like Figures 7 to 9A As shown, Figures 7 to 9A Three optional blade forms are shown. Figure 7 Shown, blade 24 is formed with the cutting edge that extends obliquely in one direction.For this cutting edge, allow cutting head to rotate and cut only in one direction. Figure 8 A blade 24' is shown having cutting edges extending obliquely in two directions, which allows the cutting head to be rotated in two directions to effect cutting. Figure 9A A blade 24" with a curved edge is shown. This blade 24" is similar in shape to a scalpel. Figure 7 and Figure 8 Compared with the inclined blade shown, the curved blade can generate greater tangential force and forward thrust during cutting, allowing the tissue to be pierced more quickly. Compared with the traditional straight blade, it allows the blade to pass through the cut tissue more easily, reduces the operating force, and improves the cutting efficiency. In addition, in addition to the curved blade, this blade 24" can also have a blade on the other side to increase the puncture effect, for example, it can easily puncture the blood vessel and then start cutting. In addition, as mentioned above, when the cutting head 22 is detachable, a variety of cutting heads equipped with different blades can be provided, thereby providing different cutting heads according to the surgical situation or cutting site.

[0056] Although the above descriptions describe a structure in which a blade is formed separately and attached to a main body and various forms of blades, the present disclosure is not limited thereto. Figure 9B Another cutting head that may be used with the present disclosure is shown.

[0057] like Figure 9BAs shown, 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 to this. It 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.

[0058] Figure 10 A perspective view of the piercing assembly 40 is shown, and FIG11 shows an enlarged view of the distal end of the piercing assembly 40.

[0059] like Figure 10 As shown, the piercing assembly 40 includes a rod 43, a button 41 and a shoulder 42 provided at the proximal end of the rod 43, and a sharp tip 44 provided at the distal end of the rod 43. The rod 43 is inserted into the hollow rod 22 of the cutting assembly. Figure 3 As shown, the button 41 extends from the proximal end of the handle and the shoulder 42 is stuck on the tip opening of the handle to prevent the button 41 from falling out. In addition, although not shown, a biasing device such as a compression spring is provided between the partition 15 of the handle 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 accommodated within the cutting head of the cutting assembly. Thus, by pressing the button 41, the tip 44 of the piercing assembly can be extended out of the distal end of the cutting assembly, thereby piercing the target blood vessel wall. Figure 11A As shown, the tip portion 44 includes a piercing blade 45 and a barb 46, which constitute the tip. When viewed longitudinally, the piercing blade 45 and barb 46 form a roughly cross shape, but the present application is not limited thereto; other piercing tip and barb configurations are possible. With the piercing tip and barb, after the button 41 is pressed, causing the piercing tip to penetrate the blood vessel wall, and upon release of the button 41, the piercing assembly moves to a retracted position under the action of a spring, and can then move the blood vessel wall through the barbs, as will be described later.

[0060] 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.

[0061] Figure 11B and Figure 11C Two alternative embodiments of piercing blades are shown. Figure 11B 1 and 2 show views of an embodiment of a three-piece piercing blade 45', wherein (a) shows a side view, (b) shows a top view, and (c) shows a perspective view. Figure 11BAs shown, the puncture blade 45' is composed of three identical parts and is fixed to the rod 43, each of which includes a puncture portion 45'-1 and a tail portion 45'-2. The puncture portion 45'-1 forms a blade at its distal end edge, and the tail portion 45'-2 extends outward from the end of the puncture portion 45'-1 at an angle greater than 100 degrees, preferably greater than 120 degrees, and forms a concave generally flat portion 45'-3 at the proximal end of the tail portion 45'-2, thereby forming the tail portion into a shape similar to an airplane wing.

[0062] Figure 11C 1 shows a view of an embodiment of a four-piece piercing blade 45", wherein (a) is a side view, (b) is a top view, and (c) is a perspective view. Figure 11C It can be seen that the piercing 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 thereof forms a slightly concave flat portion 45"-2B. The positioning blade 45"-2 can be symmetrically arranged on both sides of the main blade portion 45"-1, so that Figure 11C As shown in (b), it is in the form of a cross in the top view.

[0063] Refer to the following Figures 12 to 15 The structure of the vascular interface assembly 200 is described, wherein: Figure 12 A perspective view of the vascular interface assembly 200 is shown, wherein the retainer is in a retracted state; Figure 13 An exploded view of the vascular interface assembly 200 is shown; Figure 14 A perspective view showing the trigger member 220; Figure 15 Schematic diagram showing the clamping member in the open state. Figure 12 and 13As shown, the vascular interface assembly 200 includes, for example, a cylindrical main body portion 212, an artificial blood vessel 211 connected to the proximal end of the main body portion 212, and a trigger member 220 disposed on the outer circumference of the main body portion 212. The main body portion 212 can be formed by winding and welding a thin-walled material, or can be directly processed from a tubular material, and has a diameter in the range of 5 mm to 20 mm. The thin-walled material can be, for example, stainless steel, nickel-titanium alloy, or other biocompatible materials, and has a wall thickness in the range of approximately 0.1 to 2 mm, for example, 0.2 mm. The main body portion 212 can have a plurality of small holes 215 formed on the proximal portion to facilitate connection to the artificial blood vessel 211, for example, by suturing, gluing, etc. In addition, a plurality of protrusions 213 are formed circumferentially in the middle of the main body portion 212, and the protrusions 213 serve as guides and limiters for the trigger member 220. At the distal end of the main body 212 , a plurality of retaining members 230 are processed along the circumferential direction by laser cutting or other methods. The retaining members 230 are elasticized, for example, by a heat treatment shaping process, and thus can be opened by their own elasticity.

[0064] At the proximal end of the main body portion 212, an L-shaped slot 214 is formed. The slot 214 includes a longitudinal extension portion extending from the proximal edge of the main body portion 212 to the distal end and a circumferential extension portion extending a specific length in the circumferential direction from the distal end of the longitudinal extension portion. The slot 214 cooperates with the protrusion 33 of the sheath portion 30 (see FIG. Figure 5 ), whereby, 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 thereto 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.

[0065] like Figure 12 and 14As shown, trigger member 220 is longitudinally movable around 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 trigger member 220. These grooves 222 engage with protrusions 213 on main body 212. As trigger member 220 moves along main body 212, protrusions 213 guide the movement of trigger member 220 and limit its range of motion, preventing it from disengaging from main body 212. Multiple notches (three shown) are formed on the outer circumference of flange portion 221. These notches are designed to engage with corresponding surgical tools to adjust the position of trigger member 220.

[0066] 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 221 is larger than the outer diameter of the main body 212, when the main body 212 is placed in the incision in the blood vessel wall, the flange 221 will abut against the outer side of the blood vessel wall; at the same time, since the inner diameter of the flange 221 is smaller than the outer diameter of the clamping member after it is ejected, the flange 221 abutting against the outer side of the blood vessel wall and the ejected clamping member 230 can form a fixation and seal on the blood vessel, sandwiching the blood vessel wall between the clamping member 230 and the flange 221 (see FIG. Figure 15 ) The blood in the blood vessel can flow into the artificial blood vessel through the hollow space of the main part 212 of the blood vessel interface component.

[0067] Although in the above embodiment, it is described that the triggering member 220 moves along the main body portion 212 by the cooperation between the groove 222 and the protrusion 213. However, the present disclosure is not limited thereto. Figure 14A As shown, threaded fitting can also be used. Figure 14A As shown, the trigger member 220A includes an internal thread 222A, and correspondingly, an external thread (not shown) is formed on the outer periphery of the main body portion 212, and a notch 223A is formed on the outer periphery of the trigger member 220A. Thus, after being assembled on the main body portion 212, as shown in FIG. Figure 15A As shown, by engaging the notch 223A with a tool, the trigger member 220A can be rotated, causing the trigger member 220A to rotate along the external thread on the outer periphery of the main body portion 212 and move axially, thereby rotating to a position where the retaining member 230 is released. The trigger member 220A can then be rotated in the opposite direction, causing the trigger member 220A to press against the outside of the blood vessel, thereby more effectively compressing the blood vessel and preventing blood leakage.

[0068] 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.

[0069] Figure 16 and 17 Two alternative embodiments of the holder 230 are shown. Figure 16 and 17 As shown, the clamping member 230 may have a rounded free end, thereby reducing damage to the blood vessel wall when clamped on the blood vessel wall and preventing displacement or falling off from the blood vessel after implantation.

[0070] 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 laser cutting, etc., the present application is not limited to this, and other clamping members 230 can be used. For example, the clamping member can be formed separately and connected to the main body by welding, etc. The clamping member 230 can be made of a material such as a memory alloy and can thus be expanded to an open state by relying on its own elasticity. However, the present application is not limited to this, and other methods can also be used to expand the clamping member 230 to the open state, such as an eccentric cam, high-pressure gas or liquid. In this case, the trigger member can be a mechanism or element that applies or actuates the eccentric cam, high-pressure gas or liquid.

[0071] In the above description, the flange 221 is provided on the trigger member 220. The flange 221 can be formed integrally with the trigger member 220, or the flange 221 and the trigger member 220 can be formed separately and then joined together by welding, bonding, etc. However, the present application is not limited to this, and the flange does not necessarily need to be formed together with the trigger member. The flange 221 can be formed separately on the main body 212, and the trigger member 220 can be separately sleeved on the main body 212, and the trigger member 220 can be driven by a driving mechanism such as a pull rope, a pull rod, etc.

[0072] Below, refer to Figure 1 The operation of the vascular anastomosis assembly according to the present application is briefly described.

[0073] 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.

[0074] 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;

[0075] 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;

[0076] Step 4: After releasing the button 41, move the operating ring 13 downward along the outer periphery 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 making an incision in the blood vessel wall. Figure 9B In the case of the cylindrical cutter shown, it is not necessary to rotate the cutting assembly, but the cut is made directly, thereby improving the cutting effect and the shape integrity of the cut;

[0077] Step 5: After the incision is made, the barbs or tail fins on the piercing tip are pierced to pull the cut blood vessel wall portion out of the incision and store it in the cutting head 23, and at the same time, the distal end of the blood vessel interface assembly is inserted into the incision; Figure 11B and 11C The wing-shaped tail portion shown can improve the positioning of the piercing blade assembly on the blood vessel, thereby making it easier and more efficient to form an incision in the blood vessel under the cooperation of the piercing assembly and the cutting assembly;

[0078] 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 part of the vascular interface assembly is inserted inward, the trigger member 220 slides on the main part 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 flanges 221 are connected to each other, and the flanges 221 are connected to each other, or further connected to the flanges 221 to seal the incision of the blood vessel, so that the blood vessel and the artificial blood vessel are connected. 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 opens, 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.

[0079] 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.

[0080] 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.

[0081] 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.

[0082] 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.

[0083] 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.

[0084] 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.

[0085] Therefore, according to the present disclosure, the following technical solutions are provided:

[0086] Solution 1. A vascular anastomosis assembly, comprising:

[0087] An application device, the application device comprising:

[0088] handle;

[0089] a hollow sheath extending from the handle;

[0090] 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;

[0091] 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

[0092] A vascular access assembly is releasably disposed at the distal end of the application device and comprises:

[0093] Main body;

[0094] a vascular prosthesis extending from a proximal end of the body portion;

[0095] 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;

[0096] a flange provided on the outer periphery of the main body portion; and

[0097] 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.

[0098] 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.

[0099] 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.

[0100] 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.

[0101] Option 5. The stapler assembly of Option 4, wherein the blade comprises a cutting edge inclined in one direction.

[0102] Option 6. The stapler assembly of Option 4, wherein the blade includes a cutting edge inclined in two directions.

[0103] Option 7. The stapler assembly of Option 4, wherein the blade comprises a curved cutting edge.

[0104] 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.

[0105] 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.

[0106] 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.

[0107] 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.

[0108] 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.

[0109] 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.

[0110] 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.

[0111] 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.

[0112] 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.

[0113] 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.

[0114] 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.

[0115] 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.

[0116] 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.

[0117] 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.

[0118] 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.

[0119] Option 23. The vascular anastomosis assembly as described in any one of Options 20 to 23, wherein a limit member is provided on the main body portion to limit the movement range of the trigger member.

[0120] 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.

[0121] 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.

[0122] 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.

[0123] 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.

[0124] 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.

[0125] Solution 29. A vascular interface assembly for sealingly placing in an incision of a blood vessel, comprising:

[0126] a cylindrical main body portion, wherein the outer diameter of the main body is substantially equal to the diameter of the cutout;

[0127] a vascular prosthesis extending from a proximal end of the body portion;

[0128] 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;

[0129] 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

[0130] A triggering member can be triggered to switch the clamping member to the open position.

[0131] 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.

[0132] 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.

[0133] 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.

[0134] 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.

[0135] 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.

[0136] 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.

[0137] 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 at 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 holding member provided at a distal end portion of the main body portion, the holding member being capable of being triggered to be in an open state; a flange provided on the outer periphery of the main body portion; and a triggering member configured to trigger the clamping member so that the clamping member is in an open state to seal the blood vessel wall between the clamping member and the flange; Wherein, when the vascular interface assembly is mounted on the application device, in the extended position, the piercing portion of the piercing assembly extends in the distal direction outside the vascular interface assembly, and the cutting assembly extends in the distal direction outside the vascular interface assembly.

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

4. The stapler assembly according to any one of claims 1 to 3, wherein: The blade is fixed to the distal end of the cutting head.

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 at the distal end of the rod portion, and the piercing portion includes a blade forming a sharp distal end and barbs extending toward the proximal direction.

6. The vascular stapler assembly according to any one of claims 1 to 5, further comprising a release mechanism that can be actuated to release the vascular interface assembly from the application device.

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 state due to its own elasticity.

8. The vascular anastomosis assembly according to any one of claims 1 to 7, wherein: The flange is formed in one piece with the trigger member.

9. 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 provided at a distal end portion of the main body portion, the holding member being switchable between a retracted state and an expanded state; a flange provided at the proximal end of the main body portion, wherein when the clamp is in an open state, the flange and the clamp clamp the blood vessel wall therebetween; as well as A triggering member can be triggered to switch the holding member to an open state.

10. The vascular interface assembly according to claim 9, wherein: The clamping member switches from the contracted state to the expanded state by virtue of its own elasticity.

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