Double-cavity dialysis catheter based on end side connection

Abstract

The invention discloses a double-cavity dialysis catheter based on end side connection, and relates to the technical field of medical instruments, the double-cavity dialysis catheter comprises a catheter main body, an artery end catheter and a vein end catheter; a partition wall is arranged in the catheter main body and extends in the length direction of the catheter main body, and the inner space of the catheter main body is divided into a first cavity and a second cavity which are independent from each other by the partition wall; one end of the artery end catheter is connected with one end of the catheter main body, and the internal space of the artery end catheter is communicated with the first cavity; one end of the vein end catheter is connected with one end of the catheter body, the vein end catheter and the artery end catheter are connected to the same end of the catheter body, and the inner space of the vein end catheter is communicated with the second cavity; the vein end catheter is longer than the artery end catheter; an included angle is formed between the vein end catheter and the catheter body. The dialysis catheter is based on end side connection, the hemodynamics is optimized, the pressure gradient and the recirculation rate are reduced, blood vessel wall contact is reduced, long-term blood flow smoothness is achieved, and blood vessel protection is considered.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and particularly relates to a double-lumen dialysis catheter based on end-side connection. Background Art

[0002] Hemodialysis is an important means for treating chronic renal failure, and a stable blood flow needs to be provided by a vascular access catheter during the dialysis process. Currently, the commonly used central venous catheter (CVC) mostly adopts an "end-to-end connection" design, that is, the catheter tip penetrates into the target vein (such as the superior vena cava or the atrium) to ensure blood flow. However, this design has significant defects:

[0003] 1. Narrow side holes or tip channels increase blood flow resistance, and a relatively high pressure gradient (about 1 mmHg / cm or a total pressure of 100 - 200 mmHg) is required for blood extraction and reinfusion, imposing a burden on dialysis equipment and blood vessels;

[0004] 2. The arterial port and venous port of the catheter are close in position, and recirculation is likely to occur, reducing dialysis efficiency;

[0005] 3. The catheter is in extensive contact with the blood vessel wall, and the dynamic friction generated by cardiopulmonary movement will damage the endothelium, form a fibrin sheath, block blood flow, resulting in a decrease in blood flow patency, and thrombolytic agents need to be frequently used or the catheter needs to be replaced.

[0006] Therefore, there is an urgent need for a new type of dialysis catheter to solve the fundamental problems of high pressure gradient, high recirculation rate, and blood vessel damage while ensuring blood flow. Summary of the Invention

[0007] The present application provides a double-lumen dialysis catheter based on end-side connection to solve the problems existing in the above-mentioned prior art.

[0008] The double-lumen dialysis catheter based on end-side connection provided by the present application includes a catheter body, an arterial end catheter, and a venous end catheter. A partition wall is arranged inside the catheter body, the partition wall extends along the length direction of the catheter body, and the internal space of the catheter body is separated into two independent first cavities and second cavities by the partition wall. One end of the arterial end catheter is connected to one end of the catheter body, and the internal space of the arterial end catheter is communicated with the first cavity. One end of the venous end catheter is connected to one end of the catheter body, the venous end catheter is connected to the arterial end catheter at the same end of the catheter body, and the internal space of the venous end catheter is communicated with the second cavity; the length of the venous end catheter is greater than the length of the arterial end catheter; the venous end catheter is arranged at an angle with the catheter body.

[0009] In a specific feasible implementation scheme, the outer diameter of the catheter body is 4 - 5 mm.

[0010] In a specific feasible embodiment, the inner diameter of the first cavity is 1.8 - 2.2 mm, and the inner diameter of the second cavity is 1.8 - 2.2 mm.

[0011] In a specific feasible embodiment, the total length of the catheter body and the venous end catheter is 8 - 10 cm.

[0012] In a specific feasible embodiment, the inner diameter of the venous end catheter is 1.8 - 2.2 mm.

[0013] In a specific feasible embodiment, the included angle between the venous end catheter and the catheter body is α, where 30° ≤ α ≤ 45°.

[0014] In a specific feasible embodiment, the other end of the venous end catheter is provided with an arc-shaped chamfer, and the radius of the chamfer is 0.5 - 1 mm.

[0015] In a specific feasible embodiment, the length difference between the arterial end catheter and the venous end catheter is 10 - 15 mm.

[0016] In a specific feasible embodiment, the inner diameter of the arterial end catheter is 1.8 - 2.2 mm.

[0017] In a specific feasible embodiment, the other end of the arterial end catheter is flared.

[0018] In a specific feasible embodiment, a positioning ring is sleeved outside the catheter body, and the positioning ring can slide relative to the catheter body; at least part of the surface of the positioning ring is a rough surface; the dimension of the positioning ring along the length direction of the catheter body is 5 - 10 mm.

[0019] In a specific feasible embodiment, the inner wall of the catheter body is provided with a first installation groove and a second installation groove, the first installation groove and the second installation groove respectively extend along the length direction of the catheter body, and the first installation groove and the second installation groove are spaced apart in the circumferential direction of the catheter body; the partition wall is inserted into the first installation groove and the second installation groove.

[0020] In a specific feasible embodiment, the cross-section of the first installation groove along the radial direction of the catheter body is U-shaped, and the cross-section of the second installation groove along the radial direction of the catheter body is U-shaped; the end face of the partition wall inserted into the first installation groove is U-shaped, and the end face of the partition wall inserted into the second installation groove is U-shaped.

[0021] Compared with the prior art, the beneficial effects of the present application are:

[0022] The dual-chamber dialysis catheter based on end-side connection provided by the present application. The arterial catheter can utilize the relatively wide blood flow channel at the junction of the tributary vein and the target vein to achieve multi-directional blood flow convergence, mimicking natural blood flow convergence, reducing the resistance of blood drawn out by the arterial catheter. At the same time, the venous catheter arranged at an angle to the catheter body can point to the downstream of the target vein and can perform backflow along the flow, reducing the resistance of blood backflow from the venous catheter to the vein. The arterial catheter and the venous catheter work together to reduce the pressure gradient;

[0023] The length of the venous catheter is greater than that of the arterial catheter, and the venous catheter is arranged at an angle to the catheter body, which can pull the blood extraction path and the blood backflow path farther apart, control the recirculation rate at a lower level, and improve the dialysis efficiency;

[0024] The end-side connection method can be adopted. On the one hand, it can utilize the wide blood flow channel at the junction to draw out blood and perform backflow along the flow by pointing to the downstream of the target vein, which can ensure smooth blood flow for a relatively long time. On the other hand, it can take into account blood vessel protection, reduce contact with the blood vessel wall, reduce endothelial damage, and reduce the risk of forming a fibrin sheath and thrombus. Description of the Drawings

[0025] Figure 1 Shows a schematic structural diagram of the dual-chamber dialysis catheter based on end-side connection provided by the embodiment of the present application;

[0026] Figure 2 Shows a schematic cross-sectional view of the catheter body of the dual-chamber dialysis catheter based on end-side connection provided by the embodiment of the present application along its radial direction;

[0027] Figure 3 Shows a schematic cross-sectional view of the catheter body of the dual-chamber dialysis catheter based on end-side connection provided by the embodiment of the present application after removing the partition wall.

[0028] Reference Signs:

[0029] 1 - Catheter Body; 11 - First Chamber; 12 - Second Chamber; 13 - First Installation Groove; 14 - Second Installation Groove; 2 - Arterial Catheter; 3 - Venous Catheter; 4 - Partition Wall; 5 - Positioning Ring; 6 - Tributary Vein; 7 - Target Vein. Detailed Embodiments

[0030] To make the objectives, technical solutions, and advantages of this application clearer, the embodiments of this application will be further described in detail below in conjunction with the accompanying drawings. However, the exemplary embodiments can be implemented in various forms and should not be construed as limited to the embodiments set forth herein. Identical reference numerals in the figures denote identical or similar structures, and thus their repeated description will be omitted. The words expressing positions and directions described in the embodiments of this application are illustrative examples based on the accompanying drawings, but can be changed as needed, and all such changes are included within the scope of protection of this application. The accompanying drawings of the embodiments of this application are only used to illustrate the relative positional relationship and do not represent the actual scale.

[0031] In the following description, specific details are set forth to facilitate an understanding of this application. However, the embodiments of this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar generalizations without departing from the connotation of the embodiments of this application. Therefore, this application is not limited by the specific embodiments disclosed below.

[0032] As a possible application scenario, the dual-lumen dialysis catheter based on end-side connection provided in the embodiments of this application can be applied to hemodialysis, providing a stable blood flow rate for dialysis patients, reducing complications, and having clear medical application value.

[0033] First, refer to Figure 1 , Figure 1 which shows a schematic structural diagram of the dual-lumen dialysis catheter based on end-side connection provided in the embodiments of this application. As Figure 1 shown, the dual-lumen dialysis catheter based on end-side connection provided in the embodiments of this application can include a catheter body 1, an arterial end catheter 2, and a venous end catheter 3. Figure 2 which shows a schematic cross-sectional view of the catheter body of the dual-lumen dialysis catheter based on end-side connection provided in the embodiments of this application along its radial direction. As Figure 2 shown, a partition wall 4 is provided inside the catheter body 1. The partition wall 4 extends along the length direction of the catheter body 1, and the length of the partition wall 4 is the same as the length of the catheter body 1. The internal space of the catheter body 1 is divided into two independent first cavities 11 and second cavities 12 by the partition wall 4.

[0034] One end of the arterial end catheter 2 is connected to one end of the catheter body 1, and the internal space of the arterial end catheter 2 communicates with the first cavity 11. One end of the venous end catheter 3 is connected to one end of the catheter body 1. The venous end catheter 3 is connected to the arterial end catheter 2 at the same end of the catheter body 1, and the internal space of the venous end catheter 3 communicates with the second cavity 12. The length of the venous end catheter 3 can be greater than the length of the arterial end catheter 2, and the venous end catheter 3 and the catheter body 1 can be arranged at an angle.

[0035] The double - lumen dialysis catheter provided by the embodiment of the present application, in practical application, can insert this dialysis catheter into the tributary vein 6 (such as the right internal jugular vein) of the patient, so that the port of the arterial - end catheter 2 (the opening at the end of the arterial - end catheter 2 that is not connected to the catheter body 1) is positioned at the junction of the tributary vein 6 and the target vein 7 (such as the brachiocephalic vein), and penetrates into the target vein 7 for a certain length (such as 2 - 5 mm). Since the venous - end catheter 3 and the catheter body 1 are arranged at an angle, that is, the venous - end catheter 3 is pre - bent, the port of the venous - end catheter 3 (the opening at the end of the venous - end catheter 3 that is not connected to the catheter body 1) can point to the downstream of the target vein 7; connect the port of the catheter body 1 (the opening at the end of the catheter body 1 that is not connected to the arterial - end catheter 2 and the venous - end catheter 3) to the dialysis device, thereby realizing the circulation of blood between the patient and the dialysis device, and thus realizing hemodialysis.

[0036] The special structural design of this dialysis catheter enables it to adopt the end - side connection method, that is, the port of the arterial - end catheter 2 is located at the junction of the tributary vein 6 and the target vein 7. It can utilize the relatively wide blood - flow channel (with a diameter of about 10 - 15 mm) at the junction to achieve multi - directional blood - flow convergence, which can reduce the resistance of blood flowing into the port of the arterial - end catheter 2, making it easier for blood to flow into the arterial - end catheter 2, and thus easier to lead the blood from the vein to the dialysis device through the first cavity 11 of the arterial - end catheter 2 and the catheter body 1. At the same time, the venous - end catheter 3 arranged at an angle with the catheter body 1 points to the downstream of the target vein 7, and can integrate the blood transfused back by the dialysis device into the blood flow along the main blood - flow direction (downstream) of the target vein 7, that is, it can perform a downstream transfusion, which can reduce the transfusion resistance. And, the length of the venous - end catheter 3 is greater than the length of the arterial - end catheter 2, which can pull the blood - leading path and the blood - transfusion path apart, realizing the separation of the blood - leading path and the blood - transfusion path, and can largely avoid the recirculation of the transfused blood.

[0037] This dialysis catheter can achieve the following multiple technical effects:

[0038] The arterial - end catheter 2 can utilize the relatively wide blood - flow channel at the junction of the tributary vein 6 and the target vein 7 to achieve multi - directional blood - flow convergence, mimicking the natural blood - flow convergence, reducing the resistance of blood led out by the arterial - end catheter 2. At the same time, the venous - end catheter 3 arranged at an angle with the catheter body 1 can point to the downstream of the target vein 7, perform a downstream transfusion, and reduce the resistance of blood transfused back from the venous - end catheter 3 to the vein. The combined action of the arterial - end catheter 2 and the venous - end catheter 3 can reduce the pressure gradient;

[0039] The length of the venous - end catheter 3 is greater than the length of the arterial - end catheter 2, and the venous - end catheter 3 is arranged at an angle with the catheter body 1, which can pull the blood - leading path and the blood - transfusion path apart, control the recirculation rate at a relatively low level, and improve the dialysis efficiency;

[0040] The end-side connection method can be adopted. On the one hand, it can utilize the wide blood flow channel at the junction to draw out blood and perform downstream antegrade reinfusion towards the downstream of the target vein 7, so as to ensure smooth blood flow for a relatively long time. On the other hand, it can take into account vascular protection, reduce contact with the vascular wall, reduce endothelial damage, and lower the risk of forming a fibrin sheath and thrombus.

[0041] Overall, based on the end-side connection, this dialysis catheter places the arterial end catheter 2 at the junction of the tributary vein 6 and the target vein 7, and the venous end catheter 3 is pre-bent and points towards the downstream of the target vein 7, optimizing hemodynamics, reducing the pressure gradient and recirculation rate, reducing contact with the vascular wall, achieving long-term blood flow patency and taking into account vascular protection, and solving the problems of high pressure gradient, high recirculation rate and vascular damage existing in hemodialysis therapy.

[0042] In a specific implementation, the catheter body 1 can be made of biocompatible materials such as silicone and polyurethane. The outer diameter of the catheter body 1 can be 4 - 5 mm, the inner diameter of the first cavity 11 can be 1.8 - 2.2 mm, and the inner diameter of the second cavity 12 can be 1.8 - 2.2 mm. The catheter body 1 is connected to a dialysis device, and a blood flow rate of 200 - 350 ml / min can be achieved during hemodialysis.

[0043] The total length of the catheter body 1 and the venous end catheter 3 can be 8 - 10 cm. The length of the venous end catheter 3 can be 3 - 5 cm. The venous end catheter 3 and the catheter body 1 can be connected by a threaded structure, or the venous end catheter 3 and the catheter body 1 can be sleeved and have an interference fit, or the venous end catheter 3 and the catheter body 1 can be integrally formed. The inner diameter of the venous end catheter 3 can be 1.8 - 2.2 mm. The included angle between the venous end catheter 3 and the catheter body 1 is α. Exemplarily, 30° ≤ α ≤ 45°, to realize the pre-bending setting of the venous end catheter 3. The end of the venous end catheter 3 connected to the catheter body 1 has a bent section with a fixed shape, so that the venous end catheter 3 can maintain the included angle α. The other end of the venous end catheter 3 (the end not connected to the catheter body 1) can be provided with a rounded chamfer, and the radius of the chamfer can be 0.5 - 1 mm. The chamfer can be formed by molding. The setting of the chamfer can reduce endothelial damage and also reduce the shear force and turbulence during downstream antegrade reinfusion of blood. The chamfer and the pre-bent venous end catheter 3 act synergistically to further optimize hemodynamics and further ensure long-term blood flow patency.

[0044] The length difference between the arterial end catheter 2 and the venous end catheter 3 can be 10 - 15 mm. The arterial end catheter 2 and the catheter body 1 can be connected through a threaded structure, or the arterial end catheter 2 and the catheter body 1 can be sleeved and have an interference fit, or the arterial end catheter 2 and the catheter body 1 can be integrally formed. The inner diameter of the arterial end catheter 2 can be 1.8 - 2.2 mm. The other end of the arterial end catheter 2 (the end not connected to the catheter body 1) can be trumpet-shaped, which can further reduce the resistance of blood flowing into the port of the arterial end catheter 2, making it easier for blood to flow into the arterial end catheter 2 and facilitating the extraction of blood from the vein to the dialysis device more conveniently.

[0045] In a specific implementation, a positioning ring 5 can be sleeved outside the catheter body 1. During actual application, the positioning ring 5 is fixed under the patient's skin, for example, 5 - 10 cm away from the skin entrance, to fix this dialysis catheter under the skin and to the tributary vein 6. The positioning ring 5 is slidably connected to the catheter body 1, and the positioning ring 5 can slide relative to the catheter body 1, facilitating the adjustment of the position of this dialysis catheter according to the actual clinical situation. The dimension of the positioning ring 5 along the length direction of the catheter body 1 can be 5 - 10 mm, that is, the width of the positioning ring 5 can be 5 - 10 mm. The positioning ring 5 can be made of materials such as polyester, and at least part of the surface of the positioning ring 5 can be a rough surface, which can promote tissue ingrowth and is beneficial to the position stability of the positioning ring 5, and thus beneficial to the position stability of this dialysis catheter.

[0046] In a possible embodiment, the catheter body 1, the venous end catheter 3, and the arterial end catheter 2 are respectively made of silicone. The outer diameter of the catheter body 1 is 4 mm, and the inner diameters of the first cavity 11 and the second cavity 12 are respectively 1.9 mm. The total length of the catheter body 1 and the venous end catheter 3 is 8 cm. The inner diameter of the venous end catheter 3 is 1.9 mm, the included angle α between the venous end catheter 3 and the catheter body 1 is 45°, and the radius of the chamfer at the end of the venous end catheter 3 is 0.5 mm. The length of the arterial end catheter 2 is 10 mm less than the length of the venous end catheter 3, and the inner diameter of the arterial end catheter 2 is 1.9 mm. The positioning ring 5 is made of polyester, and the width of the positioning ring 5 is 5 mm. During actual application, the port of the arterial end catheter 2 extends 2 mm into the junction of the right internal jugular vein and the brachiocephalic vein, and the venous end catheter 3 points to the downstream of the brachiocephalic vein.

[0047] Figure 3 The cross-sectional schematic diagram after removing the partition wall of the catheter body of the double-chamber dialysis catheter based on end-side connection provided by the embodiment of the present application is shown. As Figure 3As shown, the inner wall of the catheter body 1 may be provided with a first mounting groove 13 and a second mounting groove 14, the first mounting groove 13 and the second mounting groove 14 respectively extending along the length direction of the catheter body 1, and the first mounting groove 13 and the second mounting groove 14 are spaced apart in the circumferential direction of the catheter body 1. The partition wall 4 is inserted into the first mounting groove 13 and the second mounting groove 14 to separate the internal space of the catheter body 1 into a first cavity 11 and a second cavity 12 that are independent of each other. The partition wall 4 is detachably connected to the catheter body 1, so that the partition wall 4 can be removed from the inside of the catheter body 1 according to actual clinical conditions, so that the catheter body 1 becomes a single-cavity structure, so as to increase the flexibility of the application of the dialysis catheter. Exemplarily, when the catheter body 1 of the dialysis catheter is a single-cavity structure, it can be suitable for time-sharing blood outflow and inflow operations.

[0048] In a specific implementation, the cross section of the first mounting groove 13 along the radial direction of the catheter body 1 can be U-shaped, that is, the first mounting groove 13 has a U-shaped opening on the cross section along the radial direction of the catheter body 1. The cross section of the second mounting groove 14 along the radial direction of the catheter body 1 can also be U-shaped. In coordination, the end surface of the partition wall 4 at one end plugged into the first mounting groove 13 is U-shaped, and the end surface of the partition wall 4 at one end plugged into the second mounting groove 14 is U-shaped, so that the position of the partition wall 4 inside the catheter body 1 is relatively stable, and the removal of the partition wall 4 is also relatively convenient.

[0049] The above are only specific implementation methods of the present application, but the protection scope of the present application is not limited to the above embodiments. Obviously, those skilled in the art can make various changes and modifications to the present application without departing from the scope and spirit of the present application. If these changes and modifications fall within the scope of the claims of the present application and their equivalent technologies, the intention of the present application also includes these changes and modifications.

Claims

1. A double-lumen dialysis catheter based on end-to-side connection, characterized in that: It includes a catheter body, an arterial end catheter and a venous end catheter; A partition wall is provided in the catheter body, the partition wall extends along the length direction of the catheter body, and the internal space of the catheter body is divided into a first cavity and a second cavity which are independent of each other by the partition wall; One end of the arterial end catheter is connected to one end of the catheter body, and the internal space of the arterial end catheter is in communication with the first cavity; One end of the venous end catheter is connected to one end of the catheter body, the venous end catheter and the arterial end catheter are connected to the same end of the catheter body, the internal space of the venous end catheter is connected to the second cavity; the length of the venous end catheter is greater than the length of the arterial end catheter; the venous end catheter is arranged at an angle to the catheter body.

2. The double-lumen dialysis catheter based on end-to-side connection according to claim 1, characterized in that: The outer diameter of the catheter body is 4-5 mm.

3. The double-lumen dialysis catheter based on end-to-side connection according to claim 1, characterized in that: The inner diameter of the first cavity is 1.8-2.2 mm, and the inner diameter of the second cavity is 1.8-2.2 mm.

4. The double-lumen dialysis catheter based on end-to-side connection according to claim 1, characterized in that: The total length of the catheter body and the venous end catheter is 8-10 cm.

5. The double-lumen dialysis catheter based on end-to-side connection according to claim 1, characterized in that: The inner diameter of the venous catheter is 1.8-2.2 mm.

6. The double-lumen dialysis catheter based on end-to-side connection according to claim 1, characterized in that: The angle between the venous end catheter and the catheter body is α, wherein 30°≤α≤45°.

7. The double-lumen dialysis catheter based on end-to-side connection according to claim 1, characterized in that: The other end of the venous catheter is provided with an arc-shaped chamfer, and the radius of the chamfer is 0.5-1 mm.

8. The double-lumen dialysis catheter based on end-to-side connection according to claim 1, characterized in that: The length difference between the arterial end catheter and the venous end catheter is 10-15 mm.

9. The double-lumen dialysis catheter based on end-to-side connection according to claim 1, characterized in that: The inner diameter of the arterial end catheter is 1.8-2.2 mm.

10. The double-lumen dialysis catheter based on end-to-side connection according to claim 1, characterized in that: The other end of the arterial catheter is trumpet-shaped.

11. The double-lumen dialysis catheter based on end-to-side connection according to claim 1, characterized in that: The outer part of the catheter body is sleeved with a positioning ring, and the positioning ring can slide relative to the catheter body; At least part of the surface of the positioning ring is a rough surface; The dimension of the positioning ring along the length direction of the catheter body is 5-10 mm.

12. The double-lumen dialysis catheter based on end-to-side connection according to claim 1, characterized in that: The inner wall of the catheter body is provided with a first mounting groove and a second mounting groove, the first mounting groove and the second mounting groove respectively extend along the length direction of the catheter body, and the first mounting groove and the second mounting groove are spaced apart in the circumferential direction of the catheter body; The partition wall is inserted into the first installation groove and the second installation groove.

13. The double-lumen dialysis catheter based on end-to-side connection according to claim 12, characterized in that: The cross section of the first mounting groove along the radial direction of the catheter body is U-shaped, and the cross section of the second mounting groove along the radial direction of the catheter body is U-shaped; The end surface of one end of the partition wall plugged into the first installation groove is U-shaped, and the end surface of one end of the partition wall plugged into the second installation groove is U-shaped.

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