A chimeric combined vascular anastomosis device based on biodegradable material

Abstract

This invention discloses a chimeric vascular anastomosis device based on biodegradable materials, comprising a recipient end and a donor end, both of which are annular structures, and their sizes are adapted to the recipient and donor blood vessels, respectively. A chimeric structure is formed between adjacent ends of the recipient and donor ends, and the recipient and donor blood vessels are held in place by the chimeric structure. Elastic locking units for locking the relative positions of the recipient and donor ends are distributed along their circumference on the outer sides of the recipient and donor ends. When the elastic locking units are engaged and connected, a radial limiting force is applied to the adventitia layer of the blood vessel between their adjacent surfaces. The advantages of this invention compared to existing technologies are: it provides a chimeric vascular anastomosis device based on biodegradable materials that solves the problems of vascular wall necrosis and permanent foreign body retention caused by rigid compression in existing technologies.

Description

Technical Field

[0001] This invention relates to vascular anastomosis devices, specifically a chimeric vascular anastomosis device based on biodegradable materials. Background Technology

[0002] Organ transplantation is a complex surgical procedure that transplants a healthy organ from one person into a patient's body, with the aim of replacing an organ that has lost its function due to disease. With continuous improvements in organ transplantation surgical techniques and perioperative care, the survival rate and quality of life of organ transplant patients have significantly improved. Organ transplantation technology has become a recognized effective means of treating various end-stage organ diseases.

[0003] In liver transplantation surgery, the most difficult and technically demanding part after the removal of the diseased liver and the implantation of the new liver is the anastomosis and reconstruction of the superior vena cava above the liver and the inferior vena cava below the liver in the classic surgical procedure. This is of decisive significance to the success rate of the operation and postoperative recovery.

[0004] Because the receptor ends of the superior and inferior vena cava are difficult to leave long and are prone to retraction, and their diameter varies from 1 to 3 cm, existing instruments cannot be used for anastomosis.

[0005] Currently, the most common method in the world is still manual continuous eversion suture. Due to the limited space, deep location, difficulty in operation, and time-consuming and laborious, it takes an average of 35 to 45 minutes. This results in a long hepatic absence period during the operation, which has a significant impact on vital organs such as the heart, lungs, and kidneys. Furthermore, quality control is affected by the surgeon's skill, making it prone to complications such as intraoperative and postoperative bleeding and postoperative anastomotic stenosis. This is the most critical part of the difficulty in liver transplantation surgery.

[0006] Therefore, developing a vascular anastomosis device that can securely lock the blood vessel while avoiding excessive compression and damage to the vessel wall, and which can ultimately be absorbed by the body without the need for secondary removal, is a technical challenge that urgently needs to be solved in clinical practice. Summary of the Invention

[0007] The technical problem to be solved by the present invention is to overcome the above-mentioned technical defects and provide a biodegradable material-based interlocking vascular anastomosis device that solves the problems of vascular wall necrosis and permanent foreign body retention caused by rigid compression in the prior art.

[0008] To solve the above-mentioned technical problems, the technical solution provided by the present invention is: a chimeric combined vascular anastomosis device based on biodegradable materials, comprising a recipient end and a donor end, wherein both the recipient end and the donor end are annular structures, and the sizes of the recipient end and the donor end are adapted to the recipient end blood vessel and the donor end blood vessel, respectively. A chimera structure is formed between the adjacent ends of the recipient end and the donor end, and the recipient end blood vessel and the donor end blood vessel are held together by the chimera structure. The outer sides of the recipient end and the donor end are also provided with elastic snap-fit ​​units along their circumferential direction for locking the relative positions of the recipient end and the donor end. When the elastic snap-fit ​​unit snaps and connects, a radial limiting force is applied to the adventitia of the blood vessel between its adjacent surfaces.

[0009] Preferably, the fitting structure includes a groove at one end and a corresponding boss at the other end.

[0010] Preferably, the cross-sections of the groove and the boss are arranged in an isosceles trapezoidal pattern, and the outer end face of the boss is arrayed with a plurality of anti-detachment cones along its circumferential direction; The inner groove surface of the groove is fitted with an anti-detachment groove in the recessed part of the anti-detachment top cone.

[0011] Preferably, the elastic snap-fit ​​unit includes an elastic inclined wall and an inclined pressure head; Several anti-slip protrusions are provided between the adjacent surfaces of the elastic inclined wall and the inclined pressure head, and a barbed arm is formed at the free end of the inclined pressure head. When the elastic inclined wall is engaged with the inside of the inclined pressure head, the barbed arm abuts against the end wall of the elastic inclined wall.

[0012] Preferably, the inclination angle of the elastic inclined wall is 30° to 60°.

[0013] Preferably, a clearance gap is formed between the interlocking structures and between the elastic snap-fit ​​units, and the size of the clearance gap is greater than or equal to the thickness of the vessel wall after the vessel everts.

[0014] Preferably, the vascular anastomosis device is made of bioabsorbable or biodegradable materials.

[0015] Preferably, the vascular anastomosis device is made of a biocompatible titanium alloy.

[0016] The advantages of this invention compared with the prior art are as follows: In this invention, the unique elastic snap-fit ​​and clearance gap design restricts the fixation force to the tough vascular adventitia, avoiding ischemic necrosis of the fragile intima and muscle layer, and significantly reducing the risk of postoperative thrombosis and anastomotic stenosis. The trapezoidal interlocking structure is self-guiding, and the elastic snap-fit ​​unit achieves one-click self-locking, which greatly shortens the operation time and reduces the time of vascular occlusion. The invention uses biodegradable materials, and the device disappears automatically after the blood vessel has healed, without the need for a second surgery to remove it, making it especially suitable for children and young patients. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of a chimeric and modular vascular anastomosis device based on biodegradable materials.

[0018] Figure 2This is a second-view structural schematic diagram of a chimeric and modular vascular anastomosis device based on biodegradable materials.

[0019] As shown in the figure: 1. Recipient end, 2. Donor end, 3. Groove, 4. Boss, 5. Anti-detachment top cone, 6. Anti-detachment groove, 7. Elastic inclined wall, 8. Inclined pressure head, 9. Hook arm. Detailed Implementation

[0020] The present invention will now be described in further detail with reference to the accompanying drawings.

[0021] Combined with appendix Figure 1-2 As shown, 1. A chimeric vascular anastomosis device based on biodegradable materials includes a recipient end 1 and a donor end 2, both of which are annular structures. The sizes of the recipient end 1 and the donor end 2 are adapted to the blood vessels of the recipient end 1 and the donor end 2, respectively. A chimeric structure is formed between adjacent ends of the recipient end 1 and the donor end 2, and the blood vessels of the recipient end 1 and the donor end 2 are held together by the chimeric structure. Elastic snap-fit ​​units for locking the relative positions of the recipient end 1 and the donor end 2 are also distributed along their circumferential direction on the outer side of the recipient end 1 and the donor end 2. When the elastic snap-fit ​​units snap and connect, a radial limiting force is applied to the adventitia layer of the blood vessel between their adjacent surfaces.

[0022] In use, the fitting structure includes a groove 3 at one end and a corresponding boss 4 at the other end. The cross-sections of the groove 3 and the boss 4 are arranged in an isosceles trapezoidal shape, and the outer end face of the boss 4 is arrayed with a plurality of anti-detachment cones 5 along its circumferential direction; the inner groove surface of the groove 3 is provided with an anti-detachment groove 6 in the inner recess of the anti-detachment cone 5.

[0023] The elastic snap-fit ​​unit includes an elastic inclined wall 7 and an inclined pressure head 8; several anti-slip protrusions are provided between the adjacent surfaces of the elastic inclined wall 7 and the inclined pressure head 8, and a barb arm 9 is formed at the free end of the inclined pressure head 8; when the elastic inclined wall 7 snaps into the inside of the inclined pressure head 8, the barb arm 9 abuts against the end wall of the elastic inclined wall 7, and the inclination angle of the elastic inclined wall 7 is 30°~60°.

[0024] In practical applications, clearance gaps are formed between the interlocking structures and between the elastic snap-fit ​​units. The size of the clearance gap is greater than or equal to the thickness of the vessel wall after the vessel everts.

[0025] In one embodiment: Vascular anastomosis devices are made using bioabsorbable or biodegradable materials.

[0026] In one embodiment: The vascular anastomosis device is made of biocompatible titanium alloy.

[0027] In specific implementation of the present invention, Both the recipient end 1 and the donor end 2 are annular structures. In practical applications, the device can be manufactured in various specifications and models according to the different diameters of the blood vessels to be anastomosed, such as the aorta, veins, or microvessels, to ensure that the inner diameter of the recipient end 1 is compatible with the outer diameter of the recipient blood vessel, and the outer diameter of the donor end 2 is compatible with the outer diameter of the donor blood vessel.

[0028] In this embodiment, the entire device is integrally molded using medical-grade poly-L-lactic acid (PLLA) or polycaprolactone (PCL) and other bioabsorbable / degradable materials through precision injection molding. It has good biocompatibility and can be gradually hydrolyzed into carbon dioxide and water and metabolized by the human body after completing the vascular healing task in the body, thus avoiding permanent foreign body retention.

[0029] Both the recipient end 1 and the donor end 2 are annular structures, each with an outer diameter of 20 mm, an inner diameter of 12 mm, and a height of 5 mm. An interlocking structure is formed between adjacent end faces of the recipient end 1 and the donor end 2. Specifically, the center of the interlocking end face of the recipient end 1 has a groove 3 with an isosceles trapezoidal cross-section, and the center of the interlocking end face of the donor end 2 has a corresponding boss 4 with an isosceles trapezoidal cross-section. Multiple anti-detachment cones 5 are evenly distributed in a circumferential array on the outer end face of the boss 4, with a height of 0.3 mm. Correspondingly, six anti-detachment grooves 6, matching the positions of the anti-detachment cones 5, are recessed into the bottom of the inner groove surface of the groove 3. Multiple sets of elastic locking units are evenly distributed circumferentially on the outer walls of the recipient end 1 and the donor end 2. Each set of elastic locking units includes an elastic inclined wall 7 located on the outer side of the recipient end 1 and an inclined pressure head 8 located on the outer side of the donor end 2. The elastic inclined wall 7 is a cantilever beam structure, with its root connected to the ring body and its free end extending outward. The free end of the inclined pressure head 8 forms a barbed arm 9, the end of which is rounded. Several tiny anti-slip protrusions are provided on the inner surface of the elastic inclined wall 7 and the contact surface of the inclined pressure head 8. When the device is locked, the barbed arm 9 hooks onto the end wall of the elastic inclined wall 7 and abuts against it.

[0030] In the fitting area between the groove 3 and the boss 4 of the interlocking structure and in the contact area between the barb arm 9 of the elastic snap-fit ​​unit and the blood vessel, there are reserved clearances. The height of the clearance is designed to be 1.2mm, which is greater than the thickness of the double-layer tube wall after the conventional blood vessel eversion. This ensures that the device only applies radial limiting force to the adventitia of the blood vessel in the locked state, without compressing the vascular muscle layer and intima.

[0031] In liver transplantation surgery, taking the superior and inferior vena cava as an example, the operation is as follows: Following the original surgical requirements, the superior and inferior vena cava and the inferior vena cava are blocked respectively, and the diseased liver is removed. The recipient end 1 and donor end 2 of the vascular anastomosis device of this invention are placed in the recipient's superior and inferior vena cava and the donor's superior and inferior vena cava, respectively. The vessel walls of the recipient's superior and inferior vena cava are folded outwards and fitted around the groove 3 of the recipient end 1 and the protrusion 4 of the donor end 2, so that the intima faces the center of the lumen and the adventitia adheres to the surface of the device. Holding both ends, the protrusion 4 of the donor end 2 is inserted into the groove 3 of the recipient end 1. At this time, the anti-dislodgement cone 5 slides into the anti-dislodgement groove 6 to complete the initial centering and locking. Continuing axial pushing, the oblique pressure head 8 compresses the elastic oblique wall 7, causing deformation, until it reaches the predetermined position. The elastic oblique wall 7 rebounds instantly, and the barbed arm 9 engages and locks, producing a "click" sound, completing the vascular anastomosis. Due to the existence of the clearance gap, the vessel wall is not flattened, and blood flow is unobstructed. Once the fastening is completed, the anastomosis of the donor and recipient blood vessels is considered finished.

[0032] The procedures for the inferior vena cava and portal vein under the liver are similar, requiring only the use of vascular anastomosis devices that match the size of the inferior vena cava and portal vein.

[0033] After 3-6 months, the vascular anastomosis device is gradually degraded and absorbed by the human body, the recipient blood vessel and the donor blood vessel heal together, the device disappears completely, and there is no foreign body residue.

[0034] The contents not described in detail in this specification are existing technologies known to those skilled in the art.

[0035] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0036] The present invention and its embodiments have been described above. This description is not restrictive, and the accompanying drawings are only one embodiment of the present invention; the actual structure is not limited thereto. In conclusion, if those skilled in the art are inspired by this description and design similar structures and embodiments without departing from the spirit of the invention, such designs should fall within the protection scope of the present invention.

Claims

1. A chimeric vascular anastomosis device based on biodegradable materials, comprising a recipient end (1) and a donor end (2), characterized in that: Both the receptor end (1) and the donor end (2) are ring structures, and the size of the receptor end (1) and the donor end (2) are adapted to the blood vessels of the receptor end (1) and the donor end (2), respectively. A chimera structure is formed between the adjacent ends of the recipient end (1) and the donor end (2), and the blood vessels of the recipient end (1) and the donor end (2) are held together by the chimera structure. Elastic snap-fit ​​units for locking the relative positions of the recipient end (1) and the donor end (2) are also distributed along their circumferential direction on the outer side of the recipient end (1) and the donor end (2). When the elastic snap-fit ​​unit snaps and connects, a radial limiting force is applied to the adventitia of the blood vessel between its adjacent surfaces.

2. The chimeric combined vascular anastomosis device based on biodegradable materials according to claim 1, characterized in that: The fitting structure includes a groove (3) at one end and a corresponding boss (4) at the other end.

3. The chimeric combined vascular anastomosis device based on biodegradable materials according to claim 2, characterized in that: The groove (3) and the boss (4) are arranged in a uniform isosceles trapezoidal cross section, and the outer end face of the boss (4) is arrayed with a number of anti-detachment cones (5) along its circumferential direction. The inner groove surface of the groove (3) is provided with an anti-detachment groove (6) in the recess of the anti-detachment top cone (5).

4. The chimeric combined vascular anastomosis device based on biodegradable materials according to claim 1, characterized in that: The elastic snap-fit ​​unit includes an elastic inclined wall (7) and an inclined pressure head (8); Several anti-slip protrusions are provided between the adjacent surfaces of the elastic inclined wall (7) and the inclined pressure head (8), and a barbed arm (9) is formed at the free end of the inclined pressure head (8). When the elastic inclined wall (7) engages with the inside of the inclined pressure head (8), the hook arm (9) abuts against the end wall of the elastic inclined wall (7).

5. The chimeric combined vascular anastomosis device based on biodegradable materials according to claim 4, characterized in that: The inclination angle of the elastic inclined wall (7) is 30°~60°.

6. The chimeric combined vascular anastomosis device based on biodegradable materials according to claim 3 or 5, characterized in that: A clearance gap is formed between the interlocking structures and between the elastic snap-fit ​​units, and the size of the clearance gap is greater than or equal to the thickness of the vessel wall after the vessel everts.

7. The chimeric combined vascular anastomosis device based on biodegradable materials according to claim 1, characterized in that: The vascular anastomosis device is made of bioabsorbable or biodegradable materials.

8. The chimeric combined vascular anastomosis device based on biodegradable materials according to claim 1, characterized in that: The vascular anastomosis device is made of biocompatible titanium alloy.

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