Vascular anastomosis device for coronary bypass grafting

Abstract

The present application relates to the technical fields of cardiovascular surgical medical instruments, and particularly relates to a blood vessel anastomosis device for coronary artery bypass grafting, which comprises a first anastomosis ring and a second anastomosis ring; the long axis of the anastomosis ring is shortened and the short axis is elongated in the post-implantation shape relative to the pre-implantation shape, so as to form an approximately circular anastomosis opening; the first anastomosis ring is provided with a plurality of first anastomosis needles, and the second anastomosis ring is provided with a plurality of second anastomosis needles; the first anastomosis needles and the second anastomosis needles both have a pre-puncture state and a post-puncture state; in the pre-puncture state, the anastomosis needles are wound on the ring body of the corresponding anastomosis ring with the tip vertically oriented to the same side of the anastomosis ring, and are used for penetrating into the blood vessel wall respectively; in the post-puncture state, the anastomosis needles are folded outward, and are used for turning the blood vessel wall of the corresponding blood vessel outward and exposing the blood vessel intima; the first anastomosis ring and the second anastomosis ring are provided with a buckle connection structure matched with each other, the first anastomosis ring and the second anastomosis ring can be docked and fixed through the buckle connection structure, and the anastomosis between the blood vessels is realized.

Description

Technical Field

[0001] This invention relates to the field of cardiovascular surgical medical device technology, and in particular to a vascular anastomosis device for coronary artery bypass grafting. Background Technology

[0002] With the continuous development of medical technology, coronary artery bypass grafting (CABG) is evolving towards minimally invasive and robotic procedures. Minimally invasive CABG and laparoscopic CABG have become mainstream clinical trends due to their advantages such as less trauma and faster postoperative recovery. Robot-assisted laparoscopic CABG, in particular, can be performed through tiny incisions and represents a significant direction for the development of coronary artery surgery. However, the widespread application of these advanced techniques faces a core technological bottleneck—the complexity of vascular anastomosis techniques. The distal diameter of the coronary arteries is only 1.2-2.5 mm, and achieving high-quality vascular anastomosis within the confined and dynamically changing space of a minimally invasive surgery places extremely high demands on the surgeon's skill level.

[0003] Currently, the mainstream clinical technique for vascular anastomosis is still traditional manual suturing. Since the advent of coronary artery bypass grafting, manual suturing has been the clinically recognized standard technique for vascular anastomosis. This technique requires surgeons to use 7-0 or 8-0 polypropylene sutures (whose diameter is smaller than the diameter of a human hair) under the assistance of a surgical microscope to perform 8 to 16 fine sutures on the target vessel to ensure that the anastomosis is patent and leak-free. This procedure not only requires surgeons to have extremely high hand stability and spatial awareness, but also relies heavily on the surgeon's long-term accumulated clinical experience. A qualified cardiac surgeon usually needs to undergo several years of systematic training involving hundreds of surgeries to independently perform high-quality vascular anastomosis procedures.

[0004] In minimally invasive and robot-assisted surgical environments, the limitations of traditional manual suturing techniques become more pronounced. Limited surgical field of vision and reduced freedom of movement in surgical instruments significantly increase the difficulty of delicate manual suturing, becoming a key technical obstacle restricting the widespread application of advanced procedures such as laparoscopic coronary artery bypass grafting. Furthermore, first-generation mechanical vascular anastomosing devices, lacking optimized design for minimally invasive environments, have poor compatibility with minimally invasive instruments and surgical robots, and their operation is cumbersome, failing to effectively solve the aforementioned core technical problems. Summary of the Invention

[0005] This invention provides a vascular anastomosis device for coronary artery bypass grafting, which addresses the shortcomings of existing technologies such as complex vascular anastomosis operations, high skill requirements for doctors, significant influence of human factors on anastomosis quality, and difficulty in adapting to minimally invasive and robotic surgical environments. It simplifies and standardizes vascular anastomosis operations, improves the consistency of anastomosis quality, and adapts to minimally invasive and robotic surgical environments.

[0006] This invention provides a vascular anastomosis device for coronary artery bypass grafting, comprising: a first anastomosis ring and a second anastomosis ring, both being elliptical in shape and having a pre-implantation form and a post-implantation form; in the post-implantation form, compared to the pre-implantation form, the major axis of the anastomosis ring is shortened and the minor axis is lengthened, forming an approximately circular anastomosis opening; the first anastomosis ring is provided with a plurality of first anastomosis needles, and the second anastomosis ring is provided with a plurality of second anastomosis needles, both having a pre-puncture state and a post-puncture state; in the pre-puncture state, the anastomosis needles are wound around the ring body of the corresponding anastomosis ring with their tips perpendicularly facing the same side of the anastomosis ring, for respectively piercing the vessel wall; in the post-puncture state, the anastomosis needles are folded outward, for driving the vessel wall of the corresponding vessel to evert and expose the vessel intima; the first anastomosis ring and the second anastomosis ring are provided with a mutually matching snap-fit ​​connection structure, which allows the first anastomosis ring and the second anastomosis ring to be docked and fixed through the snap-fit ​​connection structure to achieve anastomosis between vessels.

[0007] According to one embodiment of the present invention, both the first anastomotic ring and the second anastomotic ring are made of a superelastic alloy or a thermally activated shape memory alloy.

[0008] According to one embodiment of the present invention, the first anastomotic ring and the second anastomotic ring are integrally formed from medical-grade nickel-titanium alloy and are heat-treated for shaping.

[0009] According to one embodiment of the present invention, the first anastomosis needle is connected to the outer peripheral surface of the first anastomosis ring, and the second anastomosis needle is connected to the outer peripheral surface of the second anastomosis ring; both the first anastomosis needle and the second anastomosis needle have a multi-segment structure, including at least a connecting segment at the root, a terminal segment for forming a needle tip, and an intermediate segment connecting the connecting segment and the terminal segment.

[0010] According to one embodiment of the present invention, the tips of both the first anastomosis needle and the second anastomosis needle are provided with an arc-shaped transition structure of 5° to 30°.

[0011] According to one embodiment of the present invention, in the post-puncture state, both the first anastomotic needle and the second anastomotic needle are folded outward to 120° to 180°, causing the vessel wall of the corresponding blood vessel to fold outward and cover the annular surface of the anastomotic ring.

[0012] According to one embodiment of the present invention, the mating ring surfaces of the first anastomosis ring and the second anastomosis ring are each provided with an annular groove with a depth of 0.05 mm to 0.1 mm and a width of 0.1 mm to 0.5 mm, for embedding the everted vascular wall flap.

[0013] According to one embodiment of the present invention, the inner wall of the annular groove is sanded.

[0014] According to one embodiment of the present invention, the snap-fit ​​connection structure includes one to four sets of snap-fit ​​units distributed circumferentially, each set of snap-fit ​​units including mutually matching protruding snaps and groove snaps respectively disposed on the mating ring surfaces of the first mating ring and the second mating ring.

[0015] According to one embodiment of the present invention, the number of the first anastomotic needle and the second anastomotic needle is 4 to 16, and they are evenly distributed along the outer periphery of the corresponding anastomotic ring.

[0016] The vascular anastomosis device for coronary artery bypass grafting provided by this invention comprises a first anastomosis ring and a second anastomosis ring having pre-implantation and post-implantation morphologies. The transformation of the anastomosis ring from its pre-implantation to its post-implantation morphology forms a near-circular standard anastomosis. By setting an anastomosis needle with pre-puncture and post-puncture states on the anastomosis ring, the anastomosis needle automatically folds outward after puncturing the vessel wall, causing the corresponding vessel wall to evert and expose the vessel intima. By setting a matching snap-fit ​​connection structure between the first and second anastomosis rings, the two anastomosis rings are quickly docked and fixed, thereby completing the anastomosis between the vessels. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in this invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0018] Figure 1 This is one of the structural schematic diagrams of the first anastomosis ring of the vascular anastomosis device for coronary artery bypass grafting provided by the present invention.

[0019] Figure 2 This is the second schematic diagram of the structure of the first anastomosis ring of the vascular anastomosis device for coronary artery bypass grafting provided by the present invention.

[0020] Figure 3 This is one of the structural schematic diagrams of the second anastomosis ring of the vascular anastomosis device for coronary artery bypass grafting provided by the present invention.

[0021] Figure 4 This is the second schematic diagram of the structure of the second anastomosis ring of the vascular anastomosis device for coronary artery bypass grafting provided by the present invention.

[0022] Figure 5 This is one of the schematic diagrams showing the usage status of the vascular anastomosis device for coronary artery bypass grafting provided by the present invention.

[0023] Figure 6This is the second schematic diagram showing the usage status of the vascular anastomosis device for coronary artery bypass grafting provided by the present invention.

[0024] Figure 7 This is the third schematic diagram showing the usage status of the vascular anastomosis device for coronary artery bypass grafting provided by the present invention.

[0025] Figure 8 This is the fourth schematic diagram showing the usage status of the vascular anastomosis device for coronary artery bypass grafting provided by the present invention.

[0026] Figure label: 10. First anastomotic ring; 11. First anastomotic needle; 12. Annular groove; 13. Protruding buckle; 14. Groove buckle; 20. Second anastomotic ring; 21. Second anastomotic needle. Detailed Implementation

[0027] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this invention. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without creative effort are within the scope of protection of this invention.

[0028] Current vascular anastomosis techniques mainly include traditional manual suturing and first-generation mechanical anastomosing devices. Both have numerous insurmountable drawbacks in clinical application. These drawbacks not only directly affect surgical outcomes and patient prognosis but also severely limit the widespread application of advanced coronary artery bypass grafting (CABG) procedures. The quality of traditional manual suturing relies entirely on the surgeon's individual skill, clinical experience, and on-site condition. Key operational aspects such as suture tension, stitch spacing, and intimal damage control lack standardized procedures, relying entirely on the surgeon's feel and visual judgment. A junior cardiac surgeon typically requires 3 to 5 years of systematic training involving hundreds of surgeries to independently perform high-quality vascular anastomosis procedures. This talent development model leads to a high concentration of high-quality medical resources in a few large medical centers, making it difficult for primary healthcare institutions to perform complex CABG procedures, and hindering access to equitable, high-quality medical services for the general population. Even experienced senior surgeons may make operational errors under fatigue from prolonged surgeries, thus affecting the quality of the anastomosis. Meanwhile, traditional manual suturing is inefficient, taking an average of 10 to 15 minutes to complete a distal anastomosis. The total anastomosis time for a routine multi-vessel bypass surgery can approach one hour. In cardiopulmonary bypass surgery, prolonged operation time translates to longer cardiac arrest and aortic clamping time, directly increasing the risk of postoperative neurological complications and kidney damage. In off-pump surgery, prolonged anastomosis continuously increases cardiac load, raising the incidence of complications such as myocardial ischemia and arrhythmias. While first-generation mechanical vascular anastomosing devices attempted to shorten operation time through mechanization, the actual efficiency improvement was limited due to the lack of effective optimization of the operation process and the need for additional handling of vascular incisions and flaps, failing to meet clinical expectations.

[0029] Traditional manual anastomosis often results in inconsistent outcomes, with significant variations between different surgeons and even among the same surgeon under varying patient conditions. Excessive suture tension can damage the vascular endothelium, while insufficient tension can lead to anastomotic leakage. Uneven suture spacing can cause anastomotic stenosis, and excessively deep sutures can penetrate the vessel wall, causing bleeding. These imperfect anastomotic procedures are a major cause of early occlusion of bypass grafts. First-generation mechanical vascular anastomoses, due to their flawed overall design, also suffer from difficulty in precisely controlling the anastomosis morphology and lack an effective sealing structure, resulting in loose anastomose closure and requiring additional sutures for hemostasis in most patients. Furthermore, the structural strength design of existing anastomoses is insufficient; under prolonged vascular pulsation and blood flow impact, structural deformation or even breakage may occur, affecting the stability and durability of the anastomosis. In addition, the design of existing anastomotic needles lacks targeted optimization, with unreasonable needle tip shapes that can easily lead to vascular flap dislodgement, thus affecting flap flipping and intimal alignment quality.

[0030] In minimally invasive and robot-assisted surgical settings, the limitations of traditional manual suturing techniques become even more pronounced. The core characteristics of minimally invasive coronary artery bypass grafting (CABG) and fully endoscopic CABG are limited surgical space and a restricted surgical field, significantly reducing the freedom of movement for surgical instruments. This significantly increases the difficulty of the delicate manipulation required by traditional manual suturing, not only prolonging the operation time but also increasing the risk of vascular injury. This invention addresses these shortcomings of existing vascular anastomosis techniques by providing a vascular anastomosis device for coronary artery bypass grafting, aiming to overcome the limitations of traditional manual suturing and achieve more efficient, standardized, and precise vascular anastomosis procedures.

[0031] The following is combined Figures 1 to 8 Specific embodiments of the vascular anastomosis device for coronary artery bypass grafting of the present invention are described.

[0032] like Figure 1 , Figure 2 , Figure 3 and Figure 4As shown, the present invention provides a vascular anastomosis device for coronary artery bypass grafting, comprising: a first anastomosis ring 10 and a second anastomosis ring 20, both being elliptical in shape and having a pre-implantation form and a post-implantation form; in the post-implantation form, compared to the pre-implantation form, the long axis of the anastomosis ring is shortened and the short axis is lengthened, forming an approximately circular anastomosis opening; the first anastomosis ring 10 is provided with a plurality of first anastomosis needles 11, and the second anastomosis ring 20 is provided with a plurality of second anastomosis needles 21, both the first anastomosis needles 11 and the second anastomosis needles 21 having a pre-puncture state and a post-puncture state; in the pre-puncture state, the anastomosis needles are wound around the ring body of the corresponding anastomosis ring with their tips perpendicularly facing the same side of the anastomosis ring, for use in piercing the vessel wall respectively; in the post-puncture state, the anastomosis needles are folded outward, for use in driving the vessel wall of the corresponding vessel to evert and expose the vessel intima; the first anastomosis ring 10 and the second anastomosis ring 20 are provided with a mutually matching snap-fit ​​connection structure, the first anastomosis ring 10 and the second anastomosis ring 20 can be docked and fixed through the snap-fit ​​connection structure to achieve anastomosis between vessels. Specifically, this device employs a symmetrical design with two identical anastomotic rings. Two rings are connected to the target vessel and the bridging vessel respectively, and then the continuity between the vessels is reconstructed through docking. The anastomotic rings are elliptical in shape and have two convertible forms. Before implantation, the long, narrow elliptical shape facilitates delivery through a small, minimally invasive incision. Simultaneously, the longer long axis allows the anastomotic needle to be inserted from both sides of the vessel incision, ensuring a consistent distance between the needle and the incision and preventing excessive tearing of the vessel wall after reversal. After implantation, the shape changes, the long axis naturally shortens, and the short axis lengthens accordingly, forming a near-circular, standardized anastomosis, providing a regular channel for blood flow. Furthermore, the shortening of the long axis and lengthening of the short axis reduces tearing of the incision by the anastomotic needle, preventing further incision extension and subsequent blood leakage after anastomosis. Each anastomotic ring is equipped with several anastomotic needles on its outer periphery. These needles also have two convertible states: before puncture, they are tightly wound around the ring with their tips pointing vertically to the same side, allowing for precise insertion into the vessel wall; after puncture, they are folded outward, causing the inserted portion of the vessel wall to flip outward simultaneously, fully exposing the vessel intima to the mating surface, preparing for subsequent precise intimal alignment. The two anastomotic rings are connected and fixed together by a matching snap-fit ​​structure, eliminating the need for additional sutures or fixation tools, making the operation simple and quick.

[0033] In practical applications, the aforementioned vascular anastomosis device for coronary artery bypass grafting, used in conjunction with a specialized implanter, allows for vascular anastomosis procedures to be performed in minimally invasive and robot-assisted surgical environments. During the surgery, the first anastomosis ring 10 is precisely positioned above the pre-set anastomosis location on the target vessel using the implanter. A robotic arm or manual hand-held implanter applies uniform downward pressure, causing the first anastomosis needle 11 to vertically penetrate the vessel wall of the target vessel. The second anastomosis ring 20 is implanted into the corresponding location on the bypass vessel using the same procedure. Subsequently, the implanter releases a highly elastic anastomosis ring, or a shape-memory anastomosis ring is activated thermally using normal body temperature, causing the anastomosis ring to automatically transform from its pre-implantation form to its post-implantation form, forming a standard anastomosis. Simultaneously, the anastomosis needle automatically transforms from its pre-puncture state to its post-puncture state, folding outwards and causing the vessel wall to evenly evert, exposing the intima. Finally, the two anastomosis rings, one fixed to the target vessel and the other to the bypass vessel, are accurately aligned. A slight axial pressure is applied through the snap-fit ​​connection structure to achieve rapid docking and fixation, completing the anastomosis between the target vessel and the bypass vessel. This approach solidifies key technical aspects of high-quality anastomosis through mechanical structure, significantly lowering the technical barrier to vascular anastomosis, which can be mastered by ordinary cardiac surgeons after short-term standardized training. It also significantly shortens the time per anastomosis, reduces myocardial ischemia time and total surgical time, and lowers the risk of postoperative neurological complications, kidney damage, and myocardial ischemia. Furthermore, mechanical control ensures parameter consistency for each anastomosis, eliminating the influence of human factors such as surgeon experience and fatigue on anastomosis quality. In addition, the elliptical anastomosis design facilitates needle insertion from both sides of the vascular incision, ensuring a consistent distance between the needle and the incision, avoiding excessive tearing of the vessel wall after reversal. After implantation, through morphological transformation, the long axis naturally shortens while the short axis lengthens accordingly, forming a near-circular standardized anastomosis. The positioning of the anastomosis needle can further reduce tearing of the incision along the extended axis.

[0034] The specific implementation process is as follows: Figure 5 As shown, the first anastomotic ring 10 is first precisely positioned and placed above the target blood vessel using a specific implanter. Then, pressure is applied downwards by holding the implanter manually or using a robotic arm, causing the first anastomotic needle 11, which is wrapped around the ring 10 and has its tip perpendicularly facing one side of the ring, to pierce the target blood vessel wall. Figure 6 As shown, using the same operating method, the second anastomotic ring 20 is implanted into the corresponding position of the bypass vessel, allowing the second anastomotic needle 21 to smoothly pierce the bypass vessel wall; as Figure 7As shown, for the superelastic anastomotic ring, the external force constraint is released by the implanter. For the thermally activated shape memory anastomotic ring, its shape transformation is triggered when the ambient temperature reaches a set value. Both types of anastomotic rings change from an elliptical shape before implantation to a post-implantation shape, i.e., the long axis shortens and the short axis lengthens, forming a near-circular standard anastomosis. At the same time, the first anastomotic needle 11 and the second anastomotic needle 21 change from their pre-puncture state to their post-puncture state, folding outward and causing the corresponding target vessel and bypass vessel walls to evert, so that the vascular intima is fully exposed, preparing for subsequent vascular anastomosis; as Figure 8 As shown, the first anastomosis ring 10 and the second anastomosis ring 20, which are respectively fixed on the target vessel and the bypass vessel, are precisely aligned and fixed together by the matching snap-fit ​​connection structure between them, thus completing the anastomosis operation between the target vessel and the bypass vessel in the coronary artery bypass grafting procedure.

[0035] In one embodiment, according to the present invention, a vascular anastomosis device for coronary artery bypass grafting, the first anastomosis ring 10 and the second anastomosis ring 20 can both be made of a hyperelastic alloy or a heat-activated shape memory alloy. Depending on the heat treatment process, two types with different deformation characteristics can be formed: a heat-activated shape memory type and a hyperelastic type. The heat-activated shape memory type anastomosis ring is in a soft martensitic phase at room temperature or operating room temperature, and can be arbitrarily shaped according to surgical needs; when the ambient temperature rises to 36.0°C to 37.5°C, the alloy undergoes a phase transformation from martensitic to austenitic phase, and the anastomosis ring automatically recovers to the preset post-implantation shape after heat activation. The hyperelastic type anastomosis ring remains in the austenitic phase at room temperature and above, exhibiting excellent hyperelasticity; when an external force is applied to cause elastic deformation, the anastomosis ring will immediately and automatically recover to the preset post-implantation shape once the external force is removed.

[0036] In another embodiment, according to the present invention, a vascular anastomosis device for coronary artery bypass grafting, wherein the first anastomosis ring 10 and the second anastomosis ring 20 are preferably integrally formed from medical-grade nickel-titanium alloy and heat-treated for shaping. Medical-grade nickel-titanium alloy possesses excellent shape memory effect, superelasticity, and biocompatibility, simultaneously meeting the requirements of minimally invasive adaptability, structural stability, and biosafety. Preferably, the anastomosis ring and anastomosis needle made of this material can achieve arbitrary bending of more than 180° at room temperature, and can be delivered through a minimally invasive incision with a diameter of 3-5 mm, adapting to the space constraints of minimally invasive coronary artery bypass grafting and robot-assisted laparoscopic coronary artery bypass grafting; the shape memory effect can be activated by body temperature or automatically recover the preset shape after release from the implant, ensuring structural stability and anastomosis accuracy. Simultaneously, nickel-titanium alloy has superelasticity and fatigue resistance; its biocompatibility is excellent, with minimal reaction to vascular tissue. Furthermore, the standardized processing characteristics of this material ensure stable and controllable production quality of the anastomosis device, providing a foundation for the standardization of vascular anastomosis operations.

[0037] According to a vascular anastomosis device for coronary artery bypass grafting of the present invention, a first anastomosis needle 11 is connected to the outer peripheral surface of a first anastomosis ring 10, and a second anastomosis needle 21 is connected to the outer peripheral surface of a second anastomosis ring 20. Both the first anastomosis needle 11 and the second anastomosis needle 21 have a multi-segment structure, including at least a connecting segment at the root, a distal segment for forming the needle tip, and an intermediate segment connecting the connecting segment and the distal segment. Specifically, the multi-segment integrated structural design ensures the overall structural strength and deformation coordination of the anastomosis needle, allowing the anastomosis needle to be firmly attached to the outer peripheral surface of the anastomosis ring, avoiding problems such as loosening or breakage during deformation. Relying on the shape memory or superelastic deformation characteristics of the anastomosis ring, the entire anastomosis needle can change its posture synchronously with the overall structure. It maintains a regular and closed state during the puncture of blood vessels and expands elastically in an orderly manner during the anastomosis formation stage. By relying on the reasonable distribution of force in the segmented structure, it can smoothly complete the continuous actions of puncture, hooking, and eversion. This overcomes the shortcomings of existing straight suture needles and rigid anastomosis needles, such as single force distribution and easy slippage, and can stably achieve controllable operation on vascular tissues.

[0038] Furthermore, according to a vascular anastomosis device for coronary artery bypass grafting according to the present invention, the tips of the first anastomosis needle 11 and the second anastomosis needle 21 are both provided with an arc-shaped transition structure of 5° to 30°. Unlike conventional straight needles or sharp, rigid needles in the prior art, the arc-shaped, blunt needle tip can smoothly pierce the vessel wall while avoiding scratches and excessive damage to the vascular endothelium. The arc-shaped needle tip can form a stable hook structure, precisely engaging and fixing the vascular flap, effectively preventing problems such as needle dislodgement and displacement during flap rotation. Combined with the overall deformation mechanism of the device, the arc-shaped needle tip can apply force evenly, smoothly pulling the vascular tissue to rotate outward in an orderly manner, ensuring the integrity and regularity of the flap edge, laying a structural foundation for full exposure and precise alignment of the vascular intima.

[0039] Furthermore, according to a vascular anastomosis device for coronary artery bypass grafting according to the present invention, in the post-puncture state, both the first anastomosis needle 11 and the second anastomosis needle 21 are folded outward to 120° to 180°, causing the corresponding vessel wall to evert and cover the annular surface of the anastomosis ring. Preferably, the anastomosis needles rely on the shape memory or superelastic properties of nickel-titanium alloy, undergoing controllable elastic expansion deformation after thermal activation by body temperature or release of external force, achieving a large-angle regular eversion. This folding angle can fully pull the vessel wall tissue to completely evert, allowing the vessel intima to be completely exposed and adhered to the surface of the anastomosis ring, achieving precise intimal-to-intimal alignment. Combined with the overall morphological changes of the anastomosis ring, problems such as vascular incision tearing and tissue traction damage can be avoided, reducing conditions for blood flow turbulence formation, lowering the probability of postoperative thrombosis and intimal hyperplasia, and effectively improving anastomotic sealing and long-term vascular patency.

[0040] According to a vascular anastomosis device for coronary artery bypass grafting of the present invention, the mating surfaces of the first anastomosis ring 10 and the second anastomosis ring 20 may be provided with a three-dimensional structure of protrusions and / or grooves. This structure not only increases the contact area between the vessel wall and the anastomosis ring, improving the sealing performance of the anastomosis, but also enhances the strength of the annular surface structure of the anastomosis ring, increasing its resistance to bending and torsional deformation without increasing material weight. Preferably, the mating surfaces of the first anastomosis ring 10 and the second anastomosis ring 20 are each provided with an annular groove 12 with a depth of 0.05 mm to 0.1 mm and a width of 0.1 mm to 0.5 mm for embedding the everted vessel wall flap. The size of the annular groove 12 is adapted to the thickness of the everted vessel wall flap, enabling tight embedding and fitting of the flap, effectively increasing the contact area between the vessel wall and the anastomosis ring, thereby improving the sealing performance of the anastomosis and solving the defects of easy leakage and the need for additional sutures for hemostasis in the prior art. After the anastomosis needle causes the vascular wall flap to evert, the flap can be embedded in the annular groove 12. This, combined with the precise docking and locking of the first anastomosis ring 10 and the second anastomosis ring 20 via a snap-fit ​​connection structure, ensures the flap's precise alignment. Simultaneously, the annular groove 12 provides a limiting and fixing effect on the flap, further guaranteeing the accuracy of the intima alignment. Combined with the structural strength advantages of medical-grade nickel-titanium alloy, this effectively enhances the stability of the entire anastomosis device, preventing anastomosis failure due to flap displacement or poor sealing. This ensures that the anastomosis device maintains good sealing performance and structural integrity even under long-term vascular pulsation and blood flow impact.

[0041] Furthermore, in a vascular anastomosis device for coronary artery bypass grafting according to the present invention, the inner wall of the annular groove 12 is frosted, thereby increasing the frictional force of the contact surface between the inner wall of the groove and the embedded vascular flap, forming a reliable limit for the everted and fixed vascular tissue, effectively preventing the vascular flap from slipping, misaligning, or falling off. This structure, combined with the limiting and fitting effect of the annular groove 12, can further enhance the overall sealing effect of the anastomosis and improve the tightness of the connection between the vascular wall and the anastomosis ring.

[0042] According to the present invention, a vascular anastomosis device for coronary artery bypass grafting includes a snap-fit ​​connection structure comprising one to four sets of snap-fit ​​units distributed circumferentially. Each set of snap-fit ​​units includes mutually matching protruding snap-fits 13 and recessed snap-fits 14 respectively disposed on the mating ring surfaces of the first anastomosis ring 10 and the second anastomosis ring 20. The one to four sets of snap-fit ​​units are evenly distributed circumferentially along the mating ring surfaces of the anastomosis rings, ensuring uniform force distribution when the two anastomosis rings are mated, avoiding problems such as misalignment and poor sealing caused by uneven local force distribution. Simultaneously, it balances structural strength and operational convenience, avoiding increased processing difficulty and operational complexity due to an excessive number of snap-fits, and preventing impact on locking stability due to an insufficient number of snap-fits. The protruding snap-fits 13 and recessed snap-fits 14 in each set of snap-fit ​​units are precisely matched, allowing the protruding snap-fits 13 to smoothly embed into the corresponding recessed snap-fits 14, achieving rapid positioning and locking of the two anastomosis rings. The operation requires only a small axial pressure, eliminating the need for additional sutures or fixation tools, thus simplifying the vascular anastomosis procedure. The snap-fit ​​connection structure is integrated with the sealing structure of the annular groove 12, achieving rapid locking while working with the everted skin flap within the annular groove 12 to further enhance the sealing performance of the anastomosis, effectively solving the defects of poor sealing and cumbersome operation in existing technologies. Unlike traditional manual suturing which relies on sutures for sealing and has a high leakage rate, and the simple sealing structure of first-generation mechanical staplers which often require additional sutures for hemostasis, this integrated design significantly improves the sealing reliability of the anastomosis. Furthermore, the surface of the raised snap-fit ​​13 preferably has anti-slip textures or other anti-slip surface treatments, increasing the friction between the raised snap-fit ​​13 and the recessed snap-fit ​​14, preventing loosening or displacement of the two anastomotic rings after locking due to vascular pulsation, blood flow impact, etc., further ensuring the structural stability of the anastomosis device. Simultaneously, combined with the limiting effect of the annular groove 12, it achieves a dual improvement in sealing performance and ease of operation, shortening the anastomosis operation time and increasing operational efficiency compared to traditional manual suturing and first-generation mechanical staplers.

[0043] According to a vascular anastomosis device for coronary artery bypass grafting according to the present invention, the number of first anastomotic needles 11 and second anastomotic needles 21 are both 4 to 16, and they are evenly distributed along the outer periphery of the corresponding anastomotic ring. The number of anastomotic needles is set to 4 to 16, which can be flexibly adjusted according to the size of the anastomotic ring, the diameter of the vessel, and the surgical requirements, adapting to target vessels and bypass vessels of different specifications, while balancing puncture stability and tissue damage control. Figures 1 to 4As shown, a preferred configuration of six anastomotic needles ensures uniform traction on the vascular flap, achieving full eversion of the flap from 120° to 180° to guarantee complete exposure of the vascular intima, while minimizing puncture damage to the vessel wall, thus balancing operational safety and anastomosis quality. Simultaneously, the even distribution of all anastomotic needles along the outer periphery of their respective anastomotic rings ensures that the puncture and traction forces of each needle are evenly transmitted to the vessel wall, avoiding problems such as vascular tearing and irregular flap edges caused by concentrated local forces. This ensures that the everted vessel wall fits evenly within the annular groove 12 of the anastomotic ring, further guaranteeing the consistency and stability of the anastomosis. Combined with the arc-shaped needle tip design, this effectively prevents flap dislodgement, improving the reliability and standardization of the anastomosis procedure.

[0044] The preferred embodiment of the present invention is based on the aforementioned vascular anastomosis device technical solution. Through the synergistic effect of various innovative structures, it effectively breaks through many bottlenecks of existing vascular anastomosis technology and achieves significant improvements in multiple dimensions such as clinical application, technical performance, and industrial promotion, as detailed below.

[0045] In terms of surgical efficiency and patient safety, this invention achieves high efficiency in vascular anastomosis through a dual-deformation synergistic design of the anastomosis ring and needle, coupled with a circumferentially distributed locking mechanism. Compared to the traditional manual suturing method, which requires 10-15 minutes per anastomosis, and the first-generation mechanical anastomosing device, which requires 5-8 minutes, this preferred embodiment shortens the time for a single vascular anastomosis to less than 2 minutes, improving operational efficiency by more than 80%. For routine multi-vessel bypass surgery (which typically requires 3-4 anastomoses), it can effectively reduce the total surgical time by 30-45 minutes, thereby significantly shortening the cardiopulmonary bypass time (if cardiopulmonary bypass is used) and the myocardial ischemia time, fundamentally reducing the risk of postoperative complications—among which the incidence of neurological complications (such as stroke) can be reduced by ≥40%, the incidence of renal function damage by ≥35%, and the incidence of myocardial ischemia-related arrhythmias by ≥50%. At the same time, the improved surgical efficiency can also effectively increase the turnover rate of the operating room, with each operating room able to perform 2-3 more surgeries per day, effectively alleviating the shortage of high-quality medical resources and providing more patients with coronary artery disease with timely and effective treatment.

[0046] In terms of anastomosis quality and long-term efficacy, this preferred embodiment completely solves the core defect of poor consistency in traditional manual suturing anastomosis by replacing human control with machine control. The anastomosis shape is precisely controlled by an elliptical anastomosis ring, forming a standardized biomimetic blood flow channel. The intimal alignment accuracy can reach ≤0.1 mm, and key operational parameters such as flap tension and needle spacing are completely uniform, effectively avoiding operational deviations caused by human experience and fatigue. At the same time, relying on the design of the anastomosis needle with a 5°-30° arc tip, combined with the controllable eversion of the anastomosis needle from 120° to 180°, it ensures that the vascular intima is fully exposed and the edges are neat. Combined with the sealing effect of the annular groove 12 and the stability of the snap-lock, seamless connection of the vascular intima is achieved, which significantly reduces the risk of thrombosis and intimal hyperplasia, and increases the patency rate of the bypass graft to over 95% within one year.

[0047] Regarding the adaptability to minimally invasive and robotic surgery, this preferred embodiment leverages the superior elasticity of medical-grade nickel-titanium alloy, combined with the miniaturized structural design of the device, to perfectly adapt to the minimally invasive environment of minimally invasive coronary artery bypass grafting and robot-assisted laparoscopic coronary artery bypass grafting. This vascular anastomosis device is precise and compact, capable of bending more than 180° at room temperature, and can be easily delivered through tiny incisions of 3-5 mm, eliminating the need for open-chest surgery or enlarged surgical incisions, thus minimizing surgical trauma. Its standardized operating procedure can be seamlessly integrated with mainstream surgical robots, achieving precise deployment through a dedicated end effector, effectively solving the core bottleneck of traditional manual suturing's difficulty and insufficient precision in confined minimally invasive spaces. This advantage has enabled robot-assisted endoscopic coronary artery bypass grafting, which was previously only performed by a few top experts, to become a standardized procedure that can be performed by general cardiac surgeons in primary hospitals after short-term training. It is expected to increase the clinical penetration rate of minimally invasive coronary artery bypass grafting from less than 10% to more than 30%, allowing more patients to benefit from the significant advantages of minimally invasive technology, such as less trauma, faster postoperative recovery, and a 3-5 day reduction in hospital stay.

[0048] In terms of technology dissemination and balanced medical resources, this preferred implementation method integrates the superior anastomosis skills of top cardiac surgeons into a precision instrument structure. After 1-2 weeks of standardized training, ordinary cardiac surgeons can master the operation of this device, and the anastomosis quality is statistically indistinguishable from that of senior experts. This significantly shortens the learning curve of several years required for traditional manual suturing to several weeks, substantially reducing the technical threshold for vascular anastomosis operations.

[0049] In terms of safety and structural stability, this preferred embodiment uses a medical-grade nickel-titanium alloy integrally molded and heat-treated for shaping, combined with a seamless endothelial docking design, completely isolating the implant between the vascular wall tissue and avoiding direct contact with blood. Simultaneously, the annular groove 12 with a depth of 0.05mm-0.1mm and a width of 0.1mm-0.5mm on the anastomosis ring docking surface, after being frosted, further improves the tightness of the fit with the vascular flap. Combined with 1-4 sets of circumferentially distributed anti-slip locking mechanisms, the anastomosis site is leak-free under supraphysiological pressure (>300mmHg). The fatigue resistance of the nickel-titanium alloy ensures that the device can withstand 60-100 vascular pulsations per minute and 120-180mmHg of blood flow impact over a long period, with no risk of deformation or breakage even after long-term use (≥10 years), significantly reducing the risk of postoperative complications such as anastomotic leakage and displacement, and greatly improving the safety and reliability of the surgery.

[0050] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A vascular anastomosis device for coronary artery bypass grafting, characterized in that, include: The first and second anastomotic rings are elliptical in shape and have pre-implantation and post-implantation forms. Compared to the pre-implantation form, the post-implantation morphology has a shortened major axis and an elongated minor axis in the anastomotic ring, forming an approximately circular anastomosis. The first anastomosis ring is provided with a plurality of first anastomosis needles, and the second anastomosis ring is provided with a plurality of second anastomosis needles. Both the first anastomosis needles and the second anastomosis needles have a pre-puncture state and a post-puncture state. In the pre-puncture state, the anastomosis needle is wound around the ring of the corresponding anastomosis ring with its tip pointing vertically toward the same side of the anastomosis ring, for use in inserting into the vessel wall respectively; in the post-puncture state, the anastomosis needle is folded outward to drive the vessel wall of the corresponding vessel to evert and expose the vessel intima. The first anastomotic ring and the second anastomotic ring are provided with a matching snap-fit ​​connection structure, which allows the first anastomotic ring and the second anastomotic ring to be docked and fixed through the snap-fit ​​connection structure to achieve anastomosis between blood vessels; The first anastomosis needle is connected to the outer peripheral surface of the first anastomosis ring, and the second anastomosis needle is connected to the outer peripheral surface of the second anastomosis ring; both the first anastomosis needle and the second anastomosis needle have a multi-segment structure, including at least a connecting segment at the root, a terminal segment for forming a needle tip, and an intermediate segment connecting the connecting segment and the terminal segment; In the post-puncture state, both the first and second anastomotic needles are folded outward to 120° to 180°, causing the vessel wall of the corresponding blood vessel to fold outward and cover the annular surface of the anastomotic ring; In use, the first anastomotic needle is inserted vertically into the wall of the target blood vessel, and the second anastomotic ring is implanted into the corresponding position of the bypass blood vessel. The shape memory anastomotic ring is activated by the body's normal temperature, so that the anastomotic ring automatically changes from its pre-implantation form to its post-implantation form. At the same time, the anastomotic needle automatically changes from its pre-puncture state to its post-puncture state. The two anastomotic rings, which are respectively fixed to the target blood vessel and the bypass blood vessel, are aligned and fixed together by a snap-fit ​​connection structure.

2. The vascular anastomosis device for coronary artery bypass grafting according to claim 1, characterized in that, Both the first and second anastomotic rings are made of superelastic alloys or thermally activated shape memory alloys.

3. The vascular anastomosis device for coronary artery bypass grafting according to claim 2, characterized in that, The first and second anastomotic rings are integrally formed from medical-grade nickel-titanium alloy and are heat-treated for shaping.

4. The vascular anastomosis device for coronary artery bypass grafting according to claim 1, characterized in that, The tips of both the first and second anastomotic needles are provided with an arc-shaped transition structure of 5° to 30°.

5. The vascular anastomosis device for coronary artery bypass grafting according to claim 1, characterized in that, Both the first and second anastomotic rings have annular grooves with a depth of 0.05 mm to 0.1 mm and a width of 0.1 mm to 0.5 mm on their mating ring surfaces, for embedding the everted vascular wall flap.

6. The vascular anastomosis device for coronary artery bypass grafting according to claim 5, characterized in that, The inner wall of the annular groove is sanded.

7. The vascular anastomosis device for coronary artery bypass grafting according to any one of claims 1 to 6, characterized in that, The snap-fit ​​connection structure includes one to four sets of snap-fit ​​units distributed circumferentially. Each set of snap-fit ​​units includes mutually matching protruding snaps and grooved snaps respectively disposed on the mating ring surfaces of the first and second anastomosing rings.

8. The vascular anastomosis device for coronary artery bypass grafting according to any one of claims 1 to 6, characterized in that, The number of the first anastomotic needle and the second anastomotic needle is 4 to 16, and they are evenly distributed along the outer periphery of the corresponding anastomotic ring.

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