A multi-lumen multilevel strand venous cannula

Abstract

This invention discloses a multi-hole, multi-level femoral vein cannula, comprising a pre-insertion segment, a post-insertion segment, a transition segment, and a post-drainage segment connected sequentially. The pre-insertion segment is made of a polymer material and has staggered thin-walled drainage holes along its length. The post-insertion segment employs a three-layer composite structure, including a reinforcing metal wire in the middle and polymer material layers wrapped around both sides of the reinforcing metal wire. Multiple sets of reinforcing drainage holes are spaced at intervals along the radial direction of the post-insertion segment, with an even number of holes in each set, located on the same circumference and arranged opposite each other. The post-drainage segment is also made of a polymer material, with an inner and outer diameter larger than that of the post-insertion segment. The transition segment is made of the same material as the post-insertion segment. This invention effectively reduces the recirculation rate, minimizes damage to blood vessels, enables high-flow drainage under low negative pressure, and shortens extubation time, meeting the clinical demand for efficient and safe femoral vein cannulation technology.

Description

Technical Field

[0001] This utility model relates to the field of medical devices, specifically to a multi-hole, multi-level femoral vein cannula. Background Technology

[0002] In the field of modern medicine, femoral vein catheterization is a common medical procedure that plays a crucial role in many medical scenarios, such as extracorporeal membrane oxygenation (ECMO), hemodialysis, and cardiopulmonary bypass surgery.

[0003] Conventional femoral vein catheterization primarily achieves blood drainage through a single or symmetrically arranged drainage port, which can, to some extent, direct the flow of returning blood. However, its practical application has revealed numerous serious problems. Taking femoral-femoral VV-ECMO as an example, the risk of recirculation is extremely high; relevant clinical data indicate that the recirculation rate can reach 60% in some cases. This high recirculation rate significantly reduces the effectiveness of blood drainage, greatly diminishing the therapeutic effect.

[0004] During use, conventional femoral vein catheters are prone to vibration and often adhere closely to the vessel wall. This not only directly damages the vascular endothelium, increasing the potential risk of vascular complications, but also significantly prolongs the extubation time. Clinical observations show that prolonged extubation time due to the catheter adhering closely to the vessel wall exposes patients to a higher risk of infection during treatment, increasing patient suffering and medical costs.

[0005] Furthermore, conventional femoral vein catheterization often relies on high negative pressure to maintain necessary blood flow. However, the application of high negative pressure further increases the risk of vascular collapse. Vascular collapse not only obstructs normal blood drainage but can also trigger a series of serious complications, such as local thrombosis, posing a serious threat to the patient's life and health.

[0006] Compared to conventional femoral vein catheters, multi-level femoral vein catheters feature an improved design. The multi-level side holes disperse drainage pressure, thus reducing the resistance coefficient and negative pressure requirement to some extent. Furthermore, a larger proportion of venous blood is drained from the proximal holes, optimizing blood drainage. However, multi-level femoral vein catheters also have significant drawbacks. When the catheter needs to be withdrawn, the displacement of the multi-level holes can lead to significant recirculation. This means that any adjustments to the catheter position during treatment can severely impact the quality of blood drainage and reduce treatment effectiveness. Additionally, the symmetrical arrangement of the side holes in multi-level femoral vein catheters can easily create localized high pressure at a single point on the vessel wall. Prolonged exposure to this high pressure can damage the vascular endothelium, disrupting the normal physiological structure and function of the blood vessel and increasing the risk of vascular-related diseases.

[0007] CN119235421A discloses an integrated femoral vein catheterization device and its usage method. This technology aims to solve the problem that existing puncture catheters cannot be used minimally invasively and can not be inserted quickly. It has made some progress in terms of the convenience of puncture operation, but it has obvious shortcomings in solving the key problem of recirculation risk and still cannot meet the clinical demand for efficient and safe femoral vein catheterization technology.

[0008] CN110177586B discloses a convertible multi-stage / double-lumen femoral vein cannula. This technology has certain advantages in reducing the number of components required for cardiopulmonary bypass surgery and simplifying surgical procedures, providing a new solution for optimizing surgical processes. However, regrettably, this patent does not give sufficient attention to the risk of recirculation, nor does it effectively improve drainage efficiency. In actual cardiopulmonary bypass surgery and other applications involving femoral vein cannulation, a high risk of recirculation can lead to the mixing of oxygenated and unoxygenated blood, reducing oxygenation efficiency and affecting surgical outcomes and patient recovery. Simultaneously, insufficient drainage efficiency may fail to meet the blood flow requirements during surgery, also hindering the smooth progress of the procedure.

[0009] In summary, the core challenge of current femoral vein catheterization technology lies in how to effectively reduce recirculation rates, minimize vascular damage, and shorten extubation time while meeting high flow requirements. This is not only a crucial need for improving treatment outcomes and ensuring patient safety, but also an important direction for the further development of femoral vein catheterization technology. Existing conventional femoral vein catheterization, multi-level femoral vein catheterization, and related patent technologies such as CN119235421A and CN110177586B cannot comprehensively and effectively solve these problems, urgently requiring an innovative femoral vein catheterization technology to improve the current situation. Utility Model Content

[0010] To address the aforementioned issues, this invention discloses a multi-hole, multi-level femoral vein catheter, overcoming several problems existing in the prior art.

[0011] This invention is implemented as follows: a multi-hole multi-level femoral vein cannula includes an insertion front section, an insertion rear section, a gradient connecting section, and a drainage rear section connected in sequence.

[0012] The front section is made of polymer material and has thin-walled drainage holes arranged in a staggered manner along its length.

[0013] The insertion rear section adopts a three-layer composite structure, including a middle reinforcing metal wire and a polymer material layer wrapped on both sides of the reinforcing metal wire. Multiple sets of reinforcing drainage holes are opened in the radial direction along the length direction of the insertion rear section, with a certain spacing. Each set of reinforcing drainage holes has an even number of holes, located on the same circumference and arranged opposite to each other. The inner and outer diameters of the insertion front section and the insertion rear section are the same.

[0014] The drainage section is made of polymer material, with an inner and outer diameter larger than that of the insertion section.

[0015] A gradient connecting section connects the insertion section and the drainage section. The inner and outer diameters of the front end of the gradient connecting section are the same as those of the insertion section, and the inner and outer diameters of the rear end of the gradient connecting section are the same as those of the drainage section. The material is the same as that of the insertion section.

[0016] Furthermore, the polymer material is polyvinyl chloride or polyurethane, and the reinforcing wire is stainless steel.

[0017] Furthermore, the outer diameter of the insertion front section is 2.6-10.5mm, the inner diameter is 1.6-10.3mm, the length is 30.0-150.0mm, the diameter of the thin-walled drainage hole is 0.5-5.0mm, and the total number of holes is 6-66.

[0018] Furthermore, each circumferential surface of the insertion front section has only one thin-walled drainage hole.

[0019] Furthermore, the outer diameter of the inserted rear section is 2.6-10.5 mm, the inner diameter is 1.6-10.3 mm, the length is 120.0-700.0 mm, the diameter of the enhanced drainage hole is 0.5-5.0 mm, and the total number of holes is 10-80.

[0020] Furthermore, each even number of the reinforced drainage holes is opened on an annular metal ring, and the annular metal ring is connected to the reinforcing metal wires on both sides as a whole.

[0021] Furthermore, the reinforcing metal wire is a spiral steel wire with a pitch of 0.01-3.0 mm.

[0022] Furthermore, the cross-section of the reinforcing wire is circular or flat square.

[0023] Furthermore, the outer diameter of the drainage section is 7.0-19.0 mm, the inner diameter is 6.0-13.0 mm, and the length is 50.0-400.0 mm.

[0024] Furthermore, the length of the gradient connecting section is 20-500mm.

[0025] The advantages and technical effects of this utility model are as follows: Through the unique structural design of the insertion front section, insertion rear section, transition section and drainage rear section, the recirculation rate is effectively reduced, damage to blood vessels is reduced, high flow drainage can be achieved under low negative pressure, and the extubation time is shortened, thus meeting the clinical demand for efficient and safe femoral vein catheterization technology. Attached Figure Description

[0026] Figure 1 This is a schematic diagram of the multi-hole, multi-stage femoral vein cannula of this utility model;

[0027] Figure 2 This is a schematic diagram of the structure of the rear section of the multi-hole multi-stage femoral vein cannula of this utility model;

[0028] In the diagram: 1-Insert front section; 2-Insert rear section; 3-Gradual connecting section; 4-Drainage rear section; 101-Thin-walled drainage hole; 201-Reinforced drainage hole; 202-Reinforced metal wire; 203-Annular metal ring; 204-Inner polyurethane layer; 205-Outer polyurethane layer. Detailed Implementation

[0029] To make the objectives, technical solutions, and advantages of this utility model clearer, the present utility model will be further described in detail below with reference to the accompanying drawings. It should be understood that the specific embodiments described herein are merely illustrative of the present utility model and are not intended to limit the scope of the present utility model.

[0030] In the description of this utility model, it should be noted that the terms "upper", "middle", "lower", "inner", "outer", "both sides", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the purpose of simplifying the description of this utility model and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model.

[0031] In the description of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the terms "installed," "equipped with," and "connected," etc., should be interpreted broadly. For example, "connected" can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be a connection within two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0032] like Figure 1-2 As shown, the multi-hole multi-stage femoral vein cannula of this utility model includes an insertion front section 1, an insertion rear section 2, a gradient connecting section 3, and a drainage rear section 4 connected in sequence.

[0033] The insertion section 1 is made of polymer material and has thin-walled drainage holes 101 arranged in a staggered manner along its length.

[0034] The insertion rear section 2 adopts a three-layer composite structure, including a middle reinforcing metal wire 202 and a polymer material layer wrapped on both sides of the reinforcing metal wire. Multiple sets of reinforcing drainage holes 201 are opened in the radial direction along the length direction of the insertion rear section, with a certain spacing between them. Each set of reinforcing drainage holes 201 has an even number of holes, located on the same circumference and arranged opposite to each other. The inner and outer diameters of the insertion front section 1 and the insertion rear section 2 are the same.

[0035] The drainage section 4 is made of polymer material and has an inner and outer diameter larger than that of the insertion section 2.

[0036] The gradient connecting section 3 connects the insertion rear section 2 and the drainage rear section 4. The inner and outer diameters of the front end of the gradient connecting section 3 are the same as those of the insertion rear section 2, and the inner and outer diameters of the rear end of the gradient connecting section 3 are the same as those of the drainage rear section 4. The material is the same as that of the insertion rear section 2.

[0037] Furthermore, the polymer material is polyvinyl chloride or polyurethane, and the reinforcing wire 202 is stainless steel.

[0038] Furthermore, the outer diameter of the insertion front section 1 is 2.6-10.5 mm, the inner diameter is 1.6-10.3 mm, the length is 30.0-150.0 mm, the diameter of the thin-walled drainage hole 101 is 0.5-5.0 mm, and the total number of holes is 6-66.

[0039] Furthermore, each circumferential surface of the insertion front section 1 has only one thin-walled drainage hole 101.

[0040] Furthermore, the outer diameter of the inserted rear section 2 is 2.6-10.5mm, the inner diameter is 1.6-10.3mm, the length is 120.0-700.0mm, the diameter of the reinforcing drainage hole 201 is 0.5-5.0mm, and the total number of holes is 10-80.

[0041] Furthermore, each even number of the reinforced drainage holes 201 are opened on an annular metal ring 203, and the annular metal ring 203 is connected to the reinforcing metal wires 202 on both sides as a whole.

[0042] Furthermore, the reinforcing metal wire 202 is a spiral steel wire with a pitch of 0.01-3.0 mm.

[0043] Furthermore, the cross-section of the reinforcing metal wire 202 is circular or flat square.

[0044] Furthermore, the outer diameter of the drainage section 4 is 7.0-19.0 mm, the inner diameter is 6.0-13.0 mm, and the length is 50.0-400.0 mm.

[0045] Furthermore, the length of the gradient connecting segment 3 is 20-500mm.

[0046] The staggered arrangement of thin-walled drainage holes 101 in the insertion section 1 of this invention allows blood to enter the cannula from different angles, effectively preventing the formation of local vortices around the cannula and reducing the possibility of recirculation. Simultaneously, the staggered arrangement disperses the pressure of the cannula on the blood vessel wall, reducing the risk of single-point high pressure on the blood vessel wall and minimizing damage to the vascular endothelium.

[0047] The reinforced drainage hole 201 of the insertion section 2 of this invention features an inner polyurethane 204 layer with good biocompatibility, reducing damage to blood components; a middle reinforcing wire layer enhances the structural strength of the cannula, preventing deformation within the body; and an outer polyurethane 205 layer further protects the stainless steel wire and provides a smooth surface, reducing friction against the blood vessel wall. The reinforced drainage hole 201 and the reinforcing wire 202 work together to improve the overall stability of the cannula, reducing vibration within the blood vessel and further minimizing damage to the blood vessel wall. Simultaneously, it ensures high-flow-rate blood drainage under low negative pressure conditions, reducing the risk of vascular collapse due to high negative pressure.

[0048] Example 1

[0049] Reference Figure 1-2 A multi-hole, multi-level femoral vein catheter includes an insertion front section 1, an insertion rear section 2, a gradient connecting section 3, and a drainage rear section 4, made of polyurethane and stainless steel. The insertion front section 1 has staggered thin-walled drainage holes 101 and is made of polyurethane. The insertion rear section 2 adopts a three-layer composite structure, including a middle reinforcing metal wire 202 (stainless steel wire) and inner polyurethane layers 204 and 4 and outer polyurethane layers 205 wrapped on both sides of the reinforcing metal wire.

[0050] Example 2

[0051] As shown in Example 1, a multi-hole multi-level femoral vein cannula structure is prepared by dip-coating process. The multi-hole multi-level femoral vein cannula is made of polyurethane and stainless steel. The outer diameter of the insertion front section 1 is 2.6 mm, the inner diameter is 1.6 mm, and the length is 30.0 mm. The diameter of the thin-walled drainage hole 101 is 0.5 mm, and there are 6 holes arranged in a staggered manner. The insertion section 2 has an outer diameter of 2.6 mm, an inner diameter of 1.6 mm, and a length of 120.0 mm. The reinforcing drainage hole 201 is opened on an annular metal ring, which is connected to the reinforcing metal wires on both sides as a whole. The hole diameter is 0.5 mm and there are 10 holes. The insertion section 2 adopts a three-layer composite structure, including a middle reinforcing metal wire 202 (stainless steel wire) and an inner polyurethane layer 204 and an outer polyurethane layer 205 wrapped on both sides of the reinforcing metal wire. The reinforcing metal wire 202 is a spiral steel wire with a wire diameter of 0.02 mm and a pitch of 0.01 mm. The length of the gradient connecting section 4 is 20 mm (please supplement). The drainage section 4 has an outer diameter of 7.0 mm, an inner diameter of 6.0 mm, and a length of 50.0 mm.

[0052] Example 3

[0053] As shown in Example 1, a multi-hole, multi-level femoral vein cannula structure is prepared using an extrusion process. The cannula is made of polyurethane and stainless steel. The insertion section 1 has an outer diameter of 6.6 mm, an inner diameter of 6.0 mm, and a length of 90.0 mm. The thin-walled drainage holes 101 have a diameter of 2.8 mm and are 36 in number, arranged in a staggered pattern. The insertion section 2 has an outer diameter of 6.6 mm, an inner diameter of 6.0 mm, and a length of 410.0 mm. The reinforcing drainage holes 201 are located on an annular metal ring, which is integrated with the reinforcing metal wires on both sides. The holes have a diameter of 2.8 mm and are 45 in number. The insertion section 2 adopts a three-layer composite structure, including a central reinforcing metal wire 202 (stainless steel wire) and inner polyurethane 204 and outer polyurethane 205 wrapped around the stainless steel wire. The reinforcing metal wire 202 is a spiral steel wire with a diameter of 0.51 mm and a pitch of 1.51 mm. The gradient connecting section 4 has a length of 260mm, and the drainage section 4 has an outer diameter of 13.0mm, an inner diameter of 9.5mm, and a length of 225.0mm.

[0054] Example 4

[0055] As shown in Example 1, a multi-hole multi-level femoral vein cannula structure is prepared using an encapsulation process. The multi-hole multi-level femoral vein cannula is made of polyvinyl chloride and stainless steel. The outer diameter of the insertion section 1 is 10.5 mm, the inner diameter is 10.3 mm, and the length is 150.0 mm. The diameter of the thin-walled drainage holes 101 is 5.0 mm, and there are 66 holes arranged in a staggered manner. The insertion section 2 has an outer diameter of 10.5 mm, an inner diameter of 10.3 mm, and a length of 700.0 mm. The reinforcing drainage holes 201 are located on an annular metal ring, which is integrated with the reinforcing metal wires on both sides. The hole diameter is 5.0 mm, and there are 80 holes in total. The insertion section 2 adopts a three-layer composite structure, including a central reinforcing metal wire 202 (stainless steel wire) and inner polyurethane 204 and outer polyurethane 205 wrapped around the stainless steel wire. The reinforcing metal wire 202 is a spiral steel wire with a diameter of 1.0 mm and a pitch of 3.0 mm. The gradient connecting section 4 has a length of 500 mm. The drainage section 4 has an outer diameter of 19.0 mm, an inner diameter of 13.0 mm, and a length of 400.0 mm.

[0056] The above description is only a preferred embodiment of the present utility model and is not intended to limit the present utility model. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present utility model should be included within the protection scope of the present utility model.

Claims

1. A multi-hole, multi-level femoral vein cannula, characterized in that, It includes the insertion front segment (1), the insertion rear segment (2), the gradient connection segment (3), and the drainage rear segment (4) connected in sequence; The insertion section (1) is made of polymer material and has thin-walled drainage holes (101) arranged in a staggered manner along its length. The insertion rear section (2) adopts a three-layer composite structure, including a middle reinforcing metal wire (202) and a polymer material layer wrapped on both sides of the reinforcing metal wire. Multiple sets of reinforcing drainage holes (201) are opened in the radial direction along the length direction of the insertion rear section. Each set of reinforcing drainage holes (201) has an even number of holes, located on the same circumference and arranged opposite to each other. The inner and outer diameters of the insertion front section (1) and the insertion rear section (2) are the same. The drainage section (4) is made of polymer material and has an inner and outer diameter larger than that of the insertion section (2). The gradient connecting section (3) is connected between the insertion rear section (2) and the drainage rear section (4). The inner and outer diameters of the front end of the gradient connecting section (3) are the same as those of the insertion rear section (2), and the inner and outer diameters of the rear end of the gradient connecting section (3) are the same as those of the drainage rear section (4). The material is the same as that of the insertion rear section (2).

2. The multi-hole, multi-level femoral vein cannulation method according to claim 1, characterized in that, The polymer material is polyvinyl chloride or polyurethane, and the reinforcing metal wire (202) is stainless steel.

3. The multi-hole, multi-level femoral vein cannulation method according to claim 1, characterized in that, The outer diameter of the insertion front section (1) is 2.6-10.5 mm, the inner diameter is 1.6-10.3 mm, the length is 30.0-150.0 mm, the diameter of the thin-walled drainage hole (101) is 0.5-5.0 mm, and the total number of holes is 6-66.

4. The multi-hole multi-level femoral vein cannulation according to claim 1 or 3, characterized in that, The insertion front section (1) has only one thin-walled drainage hole (101) on each circumferential surface.

5. The multi-hole, multi-level femoral vein cannulation method according to claim 1, characterized in that, The outer diameter of the inserted rear section (2) is 2.6-10.5 mm, the inner diameter is 1.6-10.3 mm, the length is 120.0-700.0 mm, the diameter of the enhanced drainage hole (201) is 0.5-5.0 mm, and the total number of holes is 10-80.

6. The multi-hole, multi-level femoral vein cannulation method according to claim 1, characterized in that, Each even number of the reinforced drainage holes (201) are opened on an annular metal ring (203), and the annular metal ring (203) is connected to the reinforcing metal wires (202) on both sides as a whole.

7. The multi-hole multi-stage femoral vein cannulation according to claim 1 or 6, characterized in that, The reinforcing metal wire (202) is a spiral steel wire with a pitch of 0.01-3.0 mm.

8. The multi-hole, multi-level femoral vein cannula according to claim 7, characterized in that, The cross-section of the reinforcing metal wire (202) is circular or flat square.

9. The multi-hole, multi-level femoral vein cannula according to claim 1, characterized in that, The outer diameter of the drainage section (4) is 7.0-19.0 mm, the inner diameter is 6.0-13.0 mm, and the length is 50.0-400.0 mm.

10. The multi-hole, multi-level femoral vein cannulation according to claim 1, characterized in that, The length of the gradient connecting section (3) is 20-500mm.

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