Lower limb blood perfusion shunt cannula

Abstract

The utility model provides a lower limb blood perfusion shunt cannula, which aims to establish a blood passage of a lower limb femoral artery and solve the problem of lower limb artery ischemia, is composed of a multi-layer structure, and comprises a reinforcing tube, a suture lantern ring, a lower limb blood shunt port, a development marking ring, a reducer tube, a joint and a drainage tube, the reinforcing tube and the drainage tube are both made of soft polymer materials and internally provided with spiral steel wire ring supporting layers, flexibility and mechanical strength are ensured, the suture lantern ring is provided with a guide groove, suture efficiency is improved, intubation tube displacement is prevented, the lower limb blood shunting opening directly perfuses oxygenated blood into the lower limb, and the developing marking ring assists a doctor in accurate positioning. Due to the design that the reinforcing tube is bent by 120-150 degrees, clinical operation is facilitated, blood vessel injury is reduced, the surface of the whole cannula is coated with an anti-coagulation coating, the risk of thrombosis is reduced, blood flowing is optimized through the design of the lower limb blood perfusion shunt cannula, and the safety and effectiveness of an operation are improved.

Description

Technical Field

[0001] The present application belongs to the field of medical devices, and specifically relates to a lower limb blood perfusion shunt cannula. Background Art

[0002] Currently, the incidence of cardiovascular diseases is increasing, and heart failure, as the most common cardiovascular disease, poses a serious threat to human health. Venoarterial extracorporeal membrane oxygenation (VA-ECMO), as an effective mechanical circulatory support method, can provide continuous circulatory support for days, months, or even years for patients with circulatory failure due to various reasons that are ineffective with conventional treatment. VA-ECMO maintains blood circulation by draining part of the venous blood from the patient's body to the outside of the body, oxygenating it and then pumping it into the arterial system by a driving pump. Depending on the location of the catheter, VA-ECMO is usually divided into two forms: central catheterization and peripheral catheterization. Compared with central catheterization and other peripheral catheterization methods (such as axillary artery catheterization), femoral artery catheterization has become the most commonly used catheterization method for adult VA-ECMO because of its simple and convenient operation and rapid bedside implementation.

[0003] However, patients receiving VA-ECMO therapy are prone to lower limb ischemia due to inherent hemodynamic instability and the potential for reduced or even interrupted ipsilateral arterial blood flow caused by retrograde arterial cannulation. Furthermore, factors such as the use of high-dose vasoactive drugs, slow blood flow, and endothelial damage can lead to lower limb thrombosis and blockage of distal perfusion cannulas, exacerbating lower limb ischemia. The incidence of ipsilateral lower limb ischemia in patients receiving peripheral VA-ECMO therapy is as high as 10%-70%. Once lower limb ischemia occurs, it significantly increases the patient's mortality rate and seriously affects their quality of life.

[0004] To prevent the above-mentioned serious complications, a 5F or 6F cannula is usually inserted at the distal end of the arterial cannula or a bypass vessel is sutured to ensure adequate oxygen supply. However, this treatment method is time-consuming and requires additional equipment support. Currently, conventional arterial cannulae in clinical practice mainly rely on a small amount of blood flow and collateral circulation around the cannula to supply the distal lower limbs. Even if the patient's lower limb condition is closely observed clinically, when clinical symptoms are obvious, irreversible cell damage may have already occurred, which ultimately causes harm to the patient and affects the prognosis.

[0005] Traditional VA-ECMO cannulas are typically designed as straight-through tubes. This can cause the distal end of the cannula to swing easily when affected by blood flow, leading to intravascular movement. This instability not only affects treatment efficacy but can also hinder blood return to the cannula, further increasing the risk of lower limb ischemia.

[0006] Therefore, this application proposes a lower limb blood perfusion shunt cannula, aiming to address the existing problems of lower limb ischemia and insufficient cannula stability. By optimizing the cannula's structural design, improving its stability in the body, and improving distal blood supply through a shunt device, the incidence of lower limb ischemia can be effectively reduced, thereby improving patient prognosis. Utility Model Content

[0007] The present application provides a lower limb blood perfusion shunt cannula, which improves hemodynamics through precise blood perfusion, effectively prevents lower limb ischemia caused by surgery, and maintains the continuity and uniformity of blood flow.

[0008] A lower limb blood perfusion shunt cannula, comprising:

[0009] The lower limb blood perfusion shunt cannula is provided with a connector, a reducer, a reinforcement tube and a drainage tube from the proximal end to the distal end; the reinforcement tube, the reducer and the drainage tube are all hollow structures and are used to establish a blood access to the femoral artery of the lower limb;

[0010] The reinforcing tube is covered with a suture ring made of a polymer material, and an inner concave guide groove is provided on the inner side of the suture ring for guiding the suture thread to pass along a predetermined path;

[0011] The drainage tube is provided with at least one drainage tube side hole, and the drainage tube side hole is used to allow blood to flow to surrounding tissues.

[0012] According to one embodiment of the present application, a lower limb blood diversion port is provided at the bottom of the reinforcement tube for directly supplying blood to the lower limbs.

[0013] According to one embodiment of the present application, the lower limb blood perfusion shunt cannula further includes a developing marker ring, which is arranged in the proximal direction of the lower limb blood shunt port to provide a clear image under imaging technology.

[0014] According to one embodiment of the present application, the reinforcement tube has a bending radius of 120° to 150° to adapt to the anatomical structure of the femoral artery and reduce damage to the inner wall of the blood vessel.

[0015] According to one embodiment of the present application, the lower limb blood perfusion shunt cannula also includes a blood return monitoring tube and a blood return monitoring tube. The blood return monitoring tube and the blood return monitoring tube are slender hollow structures and are arranged on both sides of the reinforced tube. The distal opening of the blood return monitoring tube is connected to the lower limb blood shunt port and is used to monitor blood flow. The distal opening of the blood return monitoring tube does not enter the femoral artery along with the lower limb blood perfusion shunt cannula and is used to monitor the depth of the lower limb blood perfusion shunt cannula entering the femoral artery.

[0016] According to one embodiment of the present application, the reinforcement tube and the drainage tube adopt a multi-layer structure, and are sequentially provided with a first flexible layer, a support layer, and a second flexible layer from the inside to the outside. The first flexible layer and the second flexible layer are made of polymer material, and the support layer is composed of a spiral steel wire ring.

[0017] The beneficial effects of the present application are: the lower limb blood perfusion shunt cannula provided by the present application not only provides precise blood perfusion to prevent lower limb ischemia, but also enhances the positioning accuracy and safety of the operation by strengthening the bending design of the tube and the development markings. The introduction of the anticoagulant coating significantly reduces the risk of thrombosis, and the flexible and highly compliant multi-layer structure enables the cannula to move smoothly in the blood vessel, reducing damage to the blood vessel wall, while further improving the stability of the operation, optimizing the patient's surgical experience, accelerating the postoperative recovery process, and improving the overall success rate of treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following briefly introduces the drawings required for describing the embodiments. Obviously, the drawings described below are only some embodiments of the present application. Those skilled in the art can also derive other drawings based on these drawings without inventive work, among which:

[0019] Figure 1 This is a schematic structural diagram of a lower limb blood perfusion shunt cannula of the present application;

[0020] Figure 2 This is a cross-sectional schematic diagram of a lower limb blood perfusion shunt cannula of the present application;

[0021] Figure 3 is a schematic diagram of a cross section of the intubation AA reinforcement tube of the present application;

[0022] Figure 4 This is a schematic diagram of the cross section of the reinforced tube where the lower limb blood shunt port of the cannula BB of the present application is located.

[0023] Figure 5 It is a schematic diagram of the structure of the reinforcement tube and drainage tube of the present application;

[0024] in:

[0025] 1. Reinforcement tube; 2. Suture ring; 3. Lower limb blood shunt port; 4. Development marker ring; 5. Reducer; 6. Connector; 7. Drainage tube; 8. Side hole of drainage tube; 9. No-return blood monitoring tube; 10. Return blood monitoring tube; 12. First flexible layer; 13. Support layer; 14. Second flexible layer; 15. Distal end of no-return blood monitoring tube; 16. Distal end of return blood monitoring tube. DETAILED DESCRIPTION

[0026] In order to make the above-mentioned objects, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. It will be understood that the specific embodiments described herein are only used to explain the present application, rather than to limit the present application. It should also be noted that, for ease of description, only some, rather than all, structures related to the present application are shown in the accompanying drawings. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0027] In this application, unless otherwise specified or limited, the terms "mounted," "connected," "connected," "fixed," etc., should be interpreted broadly. For example, these terms may refer to fixed connections, removable connections, or integration; mechanical connections or electrical connections; direct connections or indirect connections through an intermediary; and internal communication between two components or interaction between two components, unless otherwise specified. Those skilled in the art will understand the specific meanings of these terms in this application based on the specific circumstances.

[0028] This application provides a lower limb blood perfusion shunt cannula for establishing a lower limb femoral artery blood access. Figure 1 The lower limb blood perfusion shunt cannula includes a reinforcement tube 1, a suture collar 2, a lower limb blood shunt port 3, a development marker ring 4, a reducer 5, a connector 6, a drainage tube 7, and a drainage tube side hole 8. The connector 6, the reducer 5, the reinforcement tube 1, and the drainage tube 7 are sequentially arranged from the proximal end to the distal end, all of which are hollow structures. The suture collar 2 is wrapped around the reinforcement tube 1 and is made of a transparent elastic material such as medical silicone or polyvinyl chloride. A guide groove is designed in the concave part of the suture collar 2 to make it easier for the suture to pass along the predetermined path, thereby improving the suture efficiency. At the same time, due to the good elasticity of the suture collar 2, it can fit tightly against the reinforcement tube 1 when fixed, and can be easily adjusted in position when necessary, thereby preventing the lower limb blood perfusion shunt cannula from displacement and falling off.

[0029] A drainage tube 7 is disposed at the distal end of the lower limb blood perfusion shunt cannula. At least one drainage tube side hole 8 is disposed on the surface of the drainage tube 7. This drainage tube side hole 8 allows blood to flow from the interior of the lower limb blood perfusion shunt cannula to surrounding tissues or return to the vascular system, ensuring continuity and uniformity of blood flow while assisting in shunting blood to the lower limbs and improving lower limb arterial ischemia. A lower limb blood shunt port 3 is disposed at the bottom of the reinforcement tube 1. This circular or elliptical hole allows oxygenated blood to be directly perfused into the lower limbs, regulating blood flow in the lower limbs, improving hemodynamics, and directly supplying blood to the lower limbs, preventing lower limb ischemia caused by blood flow interruption. The developing marker ring 4 is set in the proximal direction of the lower limb blood shunt port 3, close to the lower limb blood shunt port 3, and is used to mark the entrance of the lower limb blood shunt port 3 to help the doctor confirm whether the lower limb blood shunt port 3 has completed entering the blood vessel, avoiding too deep or too shallow intubation. During the operation, the developing marker ring 4 is used as a positioning reference. Under X-ray or other imaging technology, the developing marker ring 4 can provide clear images to guide the doctor to adjust the depth and direction of the intubation, ensure that the shunt port is correctly placed in the blood vessel, and evaluate the direction and speed of blood flow.

[0030] Furthermore, the reinforced tube 1 is designed with a bend radius of 120° to 150°. This precise bend angle not only makes the cannula easier to operate clinically, but also, through its unique curved design, allows for more precise positioning of the femoral artery. This design significantly reduces friction and damage to the inner wall of the femoral artery, lowering the risk of damage to the vessel wall while ensuring smooth and even blood flow.

[0031] See also Figure 2 Two slender hollow return blood vessels are provided on both sides of the reinforcement tube 1, namely the non-return blood monitoring tube 9 and the return blood monitoring tube 10. The two return blood vessels are closely attached to the two sides of the reinforcement tube 1, and their inner lumen diameters are much smaller than the main lumen of the reinforcement tube 1. Among them, the distal end 16 opening of the return blood monitoring tube 10 is directly connected to the lower limb blood shunt port 3, allowing blood to be monitored and extracted through the return blood monitoring tube 10, thereby confirming whether the lower limb blood shunt port 3 is correctly located in the arterial blood vessel. At the same time, the distal end 15 opening of the contralateral non-return blood monitoring tube is located 5-6 cm horizontally from the distal end 16 of the return blood monitoring tube, and deliberately does not enter the femoral artery, so as to assist in judging the depth and position of the lower limb blood perfusion shunt cannula by failing to extract blood, thereby effectively controlling the depth and stability of the lower limb blood perfusion shunt cannula in the femoral artery, preventing the cannula from falling off or shifting, and improving the accuracy and safety of the operation.

[0032] Among them, see Figures 3 to 5Both the reinforcement tube 1 and the drainage tube 7 adopt a multi-layer structure design, in which the first flexible layer 12 and the second flexible layer 14 are located in the inner layer and the outer layer respectively, providing softness and adaptability. The first flexible layer 12 and the second flexible layer 14 are mainly made of soft polymer materials, such as polyurethane. The material has good flexibility and biocompatibility and can adapt to the natural curvature and pressure changes of blood vessels. The supporting layer 13 in the middle is composed of a spiral steel wire ring, which is mainly made of medical stainless steel, nickel-titanium alloy or other biocompatible metal materials. These materials provide the necessary support and strength while maintaining flexibility, allowing the cannula to navigate smoothly in the blood vessel, enhancing the strength and stability of the lower limb blood perfusion shunt cannula, preventing the pipeline from bending during surgery, ensuring smooth blood flow and smooth cannulation. This design not only improves the durability and reliability of the cannula, but also helps to reduce damage to blood vessels and ensure the safety and effectiveness of the operation. The inner and outer surfaces of the lower limb blood perfusion shunt cannula that are in direct contact with blood are coated with an anticoagulant coating, which may contain a specific proportion of anticoagulant drugs, such as heparin, to ensure that the drug components are evenly released during the use of the cannula. At the same time, the anticoagulant coating material has good biocompatibility and can continue to exert an anticoagulant effect throughout the entire use cycle of the cannula, thereby reducing the risk of thrombosis due to long-term implantation.

[0033] See also Figure 4 , provides a detailed cross-sectional view of the reinforcement tube 1 where the lower extremity blood shunt port 3 is located, clearly showcasing its multi-layered internal structural design. From the outside in, the second flexible layer 14, the outermost layer, is made of a soft material to adapt to the natural curvature and pressure fluctuations of the blood vessel while minimizing damage to the vessel wall. The support layer 13, located in the middle, utilizes a spiral steel wire loop structure to provide the necessary mechanical strength and support for the reinforcement tube, ensuring its shape and structural stability during advancement within the vessel. The wire loops are spirally wound around the middle layer of the reinforcement tube. This spiral structure maintains a certain degree of rigidity while allowing for a certain degree of bending and stretching, adapting to the natural shape and movement of the blood vessel. The innermost layer is the first flexible layer 12, also made of a soft material, ensuring smooth blood flow, reducing friction between blood and the vessel wall, and lowering the risk of thrombosis. The first and second flexible layers 12, 14 work together to provide a soft interface, allowing the reinforcement tube 1 to move smoothly within the vessel while minimizing the risk of thrombosis. The support layer 13 maintains the shape and structural integrity of the reinforcement tube 1, maintaining its position and orientation even when the vessel path changes.

[0034] Figure 5The spatial layout and interrelationship of the multi-layer structure of the reinforcement tube 1 and the drainage tube 7 are shown. The curved design of the reinforcement tube 1 not only takes into account the anatomical structure of the blood vessels, but also can be optimized for specific surgical approaches to achieve more precise intravascular positioning. The design of the lower limb blood diversion port 3 ensures that blood can be effectively diverted to the lower limbs while avoiding turbulence and blood retention. The drainage tube 7 is connected to at least one drainage tube side hole 8, which is responsible for effectively transporting blood from the surgical area to the whole body or specific parts. In addition, the design of the blood return monitoring tube 10 allows doctors to monitor blood flow and ensure hemodynamic stability during surgery.

[0035] The above description is only an implementation method of the present application and does not limit the patent scope of the present application. Any equivalent structure or equivalent process transformation made using the contents of the description and drawings of this application, or directly or indirectly applied in other related technical fields, are also included in the patent protection scope of the present application.

Claims

1. A lower limb blood perfusion shunt cannula, characterized by: The lower limb blood perfusion shunt cannula is provided with a connector, a reducer, a reinforcement tube and a drainage tube in sequence from the proximal end to the distal end; the reinforcement tube, the reducer and the drainage tube are all hollow structures and are used to establish a blood access to the femoral artery of the lower limb; The reinforcing tube is covered with a suture ring, which is made of a polymer material. The inner side of the suture ring is provided with an inner concave guide groove for guiding the suture thread to pass along a predetermined path; The drainage tube is provided with at least one drainage tube side hole, and the drainage tube side hole is used to allow blood to flow to surrounding tissues.

2. The lower limb blood perfusion shunt cannula according to claim 1, characterized in that: The bottom of the reinforcement tube is provided with a lower limb blood diversion port for directly supplying blood to the lower limbs.

3. The lower limb blood perfusion shunt cannula according to claim 2, characterized in that: The lower limb blood perfusion shunt cannula further includes a developing marker ring, which is arranged in the proximal direction of the lower limb blood shunt port and is used to provide a clear image under imaging technology.

4. The lower limb blood perfusion shunt cannula according to claim 1, characterized in that: The reinforcement tube has a bending radius of 120° to 150° to adapt to the anatomical structure of the femoral artery and reduce damage to the inner wall of the blood vessel.

5. The lower limb blood perfusion shunt cannula according to claim 2, characterized in that: The lower limb blood perfusion shunt cannula also includes a blood return monitoring tube and a blood return monitoring tube. The blood return monitoring tube and the blood return monitoring tube are slender hollow structures and are arranged on both sides of the reinforcement tube. The distal opening of the blood return monitoring tube is connected to the lower limb blood shunt port for monitoring blood flow. The distal opening of the blood return monitoring tube does not enter the femoral artery along with the lower limb blood perfusion shunt cannula, and is used to monitor the depth of the lower limb blood perfusion shunt cannula entering the femoral artery.

6. The lower limb blood perfusion shunt cannula according to claim 1, characterized in that: The reinforcement tube and drainage tube adopt a multi-layer structure, and are sequentially provided with a first flexible layer, a support layer, and a second flexible layer from the inside to the outside. The first flexible layer and the second flexible layer are made of polymer materials, and the support layer is composed of a spiral steel wire ring.

7. The lower limb blood perfusion shunt cannula according to claim 1, characterized in that: The inner and outer surfaces of the lower limb blood perfusion shunt cannula that are in direct contact with blood are coated with an anticoagulant coating. The anticoagulant coating material has good biocompatibility and can continuously exert an anticoagulant effect throughout the entire use cycle of the cannula to reduce the risk of thrombosis during long-term implantation.

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