Antithrombotic dialysis catheter

Abstract

The invention discloses an anti-thrombus dialysis catheter, and relates to the technical field of hemodialysis catheters. The self-hemodialysis device is unique in design, can effectively reduce the phenomena of platelet adhesion and protein deposition in the self-hemodialysis process, and effectively prevents thrombosis. In addition, normal saline or other preset solutions can be automatically injected into the catheter in the non-dialysis period, and it is ensured that the interior of the catheter is continuously clean and kept unobstructed. The problem of blockage caused by blood backflow is solved, the risk of infection caused by improper maintenance of the catheter is reduced, and the safety and efficiency of the dialysis process are greatly improved. The treatment experience of the patient is improved, and meanwhile, the use safety and comfort of the patient are also greatly improved.

Description

Technical Field

[0001] The present invention relates to hemodialysis catheter technology, in particular to an anti-thrombotic hemodialysis catheter. Background Art

[0002] As the core lifeline for maintenance hemodialysis patients, venous catheters' anti-thrombotic properties and long-term patency directly determine clinical treatment outcomes. Current mainstream anti-thrombotic catheter technologies often utilize an internal balloon (such as a dual-lumen catheter combined with a balloon catheter design). This balloon inflates and compresses the catheter lumen to achieve physical isolation, reducing blood contact with the catheter's inner wall.

[0003] However, the built-in balloon in an intravenous catheter increases catheter wall thickness, reducing the effective inner diameter (15%-20%). The nested structure creates microgaps, increasing the risk of infection and thrombosis. Furthermore, the nested structure between the balloon catheter and the double-lumen catheter creates microgaps, creating high-risk areas for protein deposition and bacterial colonization. Furthermore, the localized high pressure (typically 300-500 mmHg) exerted on the vascular endothelium or catheter inner wall during balloon inflation can easily cause endothelial denudation or lumen deformation, activating the platelet adhesion cascade. Summary of the Invention

[0004] Therefore, the technical problem to be solved by the present invention is that the existing intravenous catheter with a built-in balloon may lead to insufficient blood flow and the high-pressure expansion of the balloon may directly damage the vascular endothelium or the inner wall of the catheter, thereby stimulating platelet activation.

[0005] The above technical problem is solved by the following technical solution: The present invention provides an anti-thrombotic dialysis catheter, which includes a catheter unit, including a pump head, a connector provided at the bottom of the pump head, a hose provided inside the connector, and a venous catheter built into the inside of the hose; The blocking unit includes an air bag provided around the hose, a clamping tube provided outside the hose, an indwelling tube provided inside the clamping tube, and a blocking component and a drainage component provided around the indwelling tube; The indwelling tube is internally provided with multiple sets of elastic diaphragms, and the elastic diaphragms can block the intravenous catheter.

[0006] In a preferred embodiment of the anti-thrombotic dialysis catheter of the present invention: the venous catheter is a double-lumen catheter, which is used for drawing blood and returning blood during dialysis; The interior of the hose is hollow, and the intravenous catheter is built into the axis of the hose and the indwelling tube. The intravenous catheter includes an elastic balloon connected at both sides of the intravenous catheter.

[0007] In a preferred embodiment of the anti-thrombotic dialysis catheter of the present invention, the indwelling tube includes a connecting end connected to the end of the flexible tube, a tube body disposed at the bottom of the connecting end, and a needle tip disposed at the end of the tube body.

[0008] In a preferred embodiment of the anti-thrombotic dialysis catheter of the present invention, the clamping tube includes a plurality of clamping plates clamped around the connecting end, and a clamping ring provided around the clamping plates.

[0009] In a preferred embodiment of the anti-thrombotic dialysis catheter of the present invention, the connecting end includes a blocking portion and a drainage portion protruding from the end of the blocking portion.

[0010] In a preferred embodiment of the anti-thrombotic dialysis catheter of the present invention, the blocking assembly includes a clamping ring sleeved around the connecting end, a plurality of groups of elastic coils disposed around the bottom of the clamping ring, a steel wire fixedly connected to the bottom of each group of elastic coils, and a blocking member fixedly connected to the bottom of the steel wire. The blocking member includes a linear array of spring pieces.

[0011] In a preferred embodiment of the anti-thrombotic dialysis catheter of the present invention: the indwelling tube is evenly divided into multiple groups of chambers by the elastic diaphragm; The elastic diaphragm is attached to the outer wall of the venous catheter.

[0012] In a preferred embodiment of the anti-thrombotic dialysis catheter of the present invention, the shrapnel group is built into the chamber. After the air bag injects gas into the interior of the hose, the shrapnel group can be sunk to the bottom of the chamber.

[0013] In a preferred embodiment of the anti-thrombotic dialysis catheter of the present invention, after the shrapnel group blocks the bottom of the chamber, the elastic diaphragm bends and squeezes the venous catheter.

[0014] In a preferred embodiment of the anti-thrombotic dialysis catheter of the present invention, the drainage assembly includes a branch pipe extending through the periphery of the drainage portion, and a control valve disposed at the end of the branch pipe.

[0015] The beneficial effects of the present invention are as follows: the present invention forms a double seal through the occlusion unit and the built-in elastic balloon of the venous catheter. During dialysis, the venous catheter is sealed by air pressure conduction; during the non-dialysis period, the built-in elastic balloon is expanded to provide auxiliary sealing. This dual action significantly reduces the risk of blood reflux. The present invention can inject physiological saline or other preset solutions into the catheter during the non-dialysis period to ensure that the interior of the catheter is continuously clean and unobstructed. Not only does it prevent blockage caused by blood backflow, it also reduces the risk of infection caused by improper catheter maintenance, greatly improving the safety and efficiency of the dialysis process. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings of the embodiments of the present invention. Obviously, the drawings described below only relate to some embodiments of the present invention and are not intended to limit the present invention. Among them: Figure 1 The figure shows the overall structure of the anti-thrombotic dialysis catheter of the present invention; Figure 2 Shows an explosion schematic diagram of the plugging unit structure of the present invention; Figure 3 Shown Figure 3 A magnified view of the structure of the venous catheter tip; Figure 4 A schematic diagram of a partially cutaway three-dimensional structure of a plugging unit according to the present invention is shown; Figure 5 Shown Figure 4 A magnified view of the plugging component structure at position B; Figure 6 Shown Figure 4 An enlarged view of the chamber structure at position C in FIG. Figure 7 A schematic diagram of the internal cross-sectional structure of the chamber of the present invention is shown.

[0017] In the figure: 1. catheter unit; 2. blocking unit; 11. pump head; 12. connector; 13. hose; 14. intravenous catheter; 21. airbag; 22. clamp tube; 23. indwelling tube; 24. blocking assembly; 25. drainage assembly; 141. elastic balloon; 231. connecting end; 232. tube body; 233. needle tip; 221. splint; 222. snap ring; 241. clamping ring; 242. elastic coil; 243. steel wire; 244. blocking piece; 251. branch pipe; 252. control valve; 2311. blocking part; 2312. drainage part; 2441. shrapnel group; N. diaphragm; M. chamber. DETAILED DESCRIPTION

[0018] In order to enable those skilled in the art to better understand the present invention, the present invention is further described in detail below with reference to specific embodiments and the accompanying drawings.

[0019] The terms used in the present invention are those commonly used in the art in view of the functions of the present invention, but these terms may vary according to the intentions of those skilled in the art, precedents, or new technologies in the art. In addition, specific terms may be selected by the applicant, and in such cases, their detailed meanings will be described in the detailed description of the present invention. Therefore, the terms used in the specification should not be understood as simple names, but rather as the meanings of the terms and the overall description of the present invention.

[0020] Reference Figures 1 to 7 This embodiment provides an anti-thrombotic dialysis catheter, comprising a catheter unit 1, including a pump head 11, a connector 12 disposed at the bottom of the pump head 11, a hose 13 disposed inside the connector 12, and a venous catheter 14 built into the inside of the hose 13; The occlusion unit 2 includes an airbag 21 extending through the circumference of the hose 13, a clamping tube 22 disposed outside the hose 13, an indwelling tube 23 disposed inside the clamping tube 22, and a occlusion assembly 24 and a drainage assembly 25 disposed around the indwelling tube 23. The indwelling tube 23 has multiple sets of elastic diaphragms N built in, and the elastic diaphragms N can block the venous catheter 14.

[0021] In this embodiment, catheter unit 1 is a venous catheter that supports a patient's hemodialysis needs. A pump head 11 controls an internal venous catheter 14 for blood delivery. Venous catheter 14 is a dual-lumen catheter, with one end for blood withdrawal and the other for blood return. Venous catheter 14 is sheathed within the lumen of a flexible tube 13, which is fixedly connected to a port on pump head 11 via a connector 12.

[0022] The hose 13 can serve as a protective tube for the intravenous catheter 14, and a sealing unit 2 is also installed on the outside of the hose 13. By pumping gas into the hose 13, the outer wall of the intravenous catheter 14 is squeezed and collapsed together to achieve the need to block the intravenous catheter 14, thereby avoiding local high pressure on the vascular endothelium or the inner wall of the catheter during balloon inflation, causing endothelial denudation or lumen deformation, and activating the platelet adhesion cascade reaction.

[0023] It's important to note that the end of the flexible tube 13 is connected to an indwelling tube 23, with the intravenous catheter 14 also contained within the pinhole of the indwelling tube 23. A set of clamping tubes 22 are secured around the periphery of the indwelling tube 23, effectively protecting the end structure of the indwelling tube 23. Furthermore, a set of airbags 21 are connected to one side of the flexible tube 13, which squeeze and inject gas into the flexible tube 13. Due to the poor toughness of the flexible tube 13 and the good dilatation of the intravenous catheter 14, gas pumped into the flexible tube 13 cannot expand the flexible tube 13 and instead flows along the path of the flexible tube 13, ultimately acting on the intravenous catheter 14 within the indwelling tube 23, causing it to collapse.

[0024] Specifically, the diameter of the hose 13 is actually smaller, as long as it can accommodate the intravenous catheter 14 and leave some space.

[0025] A low elastic modulus medical silica gel with a thickness of 0.8 mm and a tensile strength of ≥8 MPa can be selected. The inner diameter of the silica gel is 1.2-1.5 mm larger than the outer diameter of the intravenous catheter 14 to form an annular air gap channel.

[0026] In this embodiment, three groups of blocking components 24 are also set up on the peripheral side of the indwelling tube 23. When the airbag 21 does not pump gas into the blocking components 24, the blocking components 24 cannot block the venous catheter 14. Then, through the three groups of drainage components 25 that are also connected to the peripheral side of the indwelling tube 23, drugs can be injected intravenously into the venous catheter 14 in the human body to reduce thrombosis and reduce platelet adhesion and protein deposition.

[0027] In addition, three groups of diaphragms N are hot-melt-connected on the inner wall of the indwelling tube 23 . The diaphragms N have good dilatation properties, and thus the diaphragms N can squeeze the outer venous catheter 14 at the same time through changes in air pressure, thereby achieving the effect of blocking the venous catheter 14 .

[0028] In summary, the present invention forms a double seal through the blocking unit 2 and the built-in elastic balloon 141 of the venous catheter 14. During dialysis, the venous catheter 14 is sealed by air pressure conduction; during the non-dialysis period, the built-in elastic balloon 141 expands to provide auxiliary sealing. The dual action significantly reduces the risk of blood reflux. The present invention can automatically inject physiological saline or other preset solutions into the catheter during the non-dialysis period to ensure that the inside of the catheter is continuously clean and unobstructed. It not only prevents blockage problems caused by blood backflow, but also reduces the risk of infection caused by improper catheter maintenance, greatly improving the safety and efficiency of the dialysis process.

[0029] Reference Figure 3 As an optional embodiment, the venous catheter 14 is a double-lumen catheter, which is used for drawing blood and returning blood during dialysis; The interior of the hose 13 is hollow, and the intravenous catheter 14 is built into the axis of the hose 13 and the indwelling tube 23. The intravenous catheter 14 includes an elastic balloon 141 connected at both sides of the intravenous catheter 14 .

[0030] In this embodiment, venous catheter 14 is a dual-lumen catheter, used for both blood withdrawal and blood return during dialysis. An elastic balloon 141 is also installed at one end of venous catheter 14. One lumen of venous catheter 14 is the arterial lumen for blood withdrawal, with a larger inner diameter, typically ≥3.0 mm. The proximal opening is located 1-2 cm behind the catheter tip to prevent the lumen from collapsing during high-flow blood withdrawal. During dialysis, blood is drawn from the patient's venous system at a flow rate of 200-400 mL / min and delivered to the dialysis machine for purification.

[0031] The other cavity is the vena cava cavity for blood return, with an inner diameter slightly smaller than the blood withdrawal cavity by approximately 2.5-3.0mm. The tube wall is designed with a flexible corrugated structure to buffer blood flow pulsation, and the distal opening is located at the tip of the catheter to reduce the impact of blood flow impact on the blood vessel wall. The blood purified by the dialysis machine can be returned to the patient's body at a matching flow rate to form a closed-loop circulation system. The two cavities are physically isolated throughout the process to avoid mixing of unpurified blood and purified blood. The recirculation rate is less than 5%, which is significantly better than the recirculation rate of more than 15% of the single-lumen catheter.

[0032] The elastic balloon 141 is a prior art that can be expanded to block the venous catheter 14. The blocking effect can be weaker, but the diameter should be small to avoid local high pressure on the vascular endothelium or the inner wall of the catheter when it is expanded. In addition, the blocking unit 2 plays a dual protection role to prevent backflow.

[0033] Reference Figures 1 to 7 As an optional embodiment, the indwelling tube 23 includes a connecting end 231 connected to the end of the hose 13, a tube body 232 arranged at the bottom of the connecting end 231, and a needle tip 233 arranged at the end of the tube body 232. In one embodiment provided in the present application, the clamping tube 22 includes a plurality of clamping plates 221 clamped on the peripheral side of the connecting end 231 , and a clamping ring 222 provided on the peripheral side of the clamping plates 221 .

[0034] In one embodiment provided in the present application, the connecting end 231 includes a blocking portion 2311 and a drainage portion 2312 protruding from the end of the blocking portion 2311 .

[0035] In this embodiment, the end connection end 231 of the indwelling tube 23 is sealed and connected to the end of the hose 13 so that the gas in the hose 13 can smoothly enter the indwelling tube 23, and the middle part of the indwelling tube 23 is the tube body 232, which can be extended into the patient's vein and can be inserted into the vein through the needle tip 233 at the end of the indwelling tube 23.

[0036] Specifically, the end connection end 231 of the indwelling tube 23 is divided into a blocking portion 2311 and a drainage portion 2312. The blocking portion 2311 can be mounted with the blocking assembly 24, while the drainage portion 2312 can be mounted with the drainage assembly 25. The drainage assembly 25 is located at the bottom of the blocking assembly 24 so that the blocking assembly 24 does not prevent the drainage assembly 25 from injecting medication into the circumference of the intravenous catheter 14.

[0037] Preferably, the three groups of clamps 221 are connected together by snapping together so as to be clamped around the peripheral side of the connecting end 231 , thereby enhancing the connection strength between the connecting end 231 and the hose 13 .

[0038] Two sets of clamping rings 222 are also clamped on the outer side of the clamping plate 221 , and the clamping rings 222 clamp the circumference of the clamping plate 221 .

[0039] In one embodiment provided herein, the blocking assembly 24 includes a clamping ring 241 sleeved around the connecting end 231, multiple sets of elastic coils 242 disposed around the bottom of the clamping ring 241, a steel wire 243 fixedly connected to the bottom of each set of elastic coils 242, and a blocking member 244 fixedly connected to the bottom of the steel wire 243. The blocking member 244 includes a linear array of spring pieces 2441 .

[0040] In this embodiment, the blocking component 24 can control the blocking of the venous catheter 14 and the cleaning of the medicine in the drainage component 25 .

[0041] Among them, the sealing assembly 24 consists of a clamping ring 241 clamped on the end face of the connecting end 231, an elastic coil 242 vertically connected to the bottom surface of the clamping ring 241, a steel wire 243 at the bottom of the elastic coil 242, and a sealing piece 244 on the inside of the retention tube 23.

[0042] The clamping ring 241 is fixedly connected to the end face of the connecting end 231, and three sets of fixing platforms are left downward on its bottom surface, which can be used to fix and connect three sets of elastic coils 242. When there is no external force, the elastic coils 242 will curl together, so that the steel wire 243 at the bottom of the elastic coils 242 will be pulled upward.

[0043] The steel wire 243 passes through the splint 221 and the sidewall of the indwelling tube 23, ultimately connecting to the inside of the indwelling tube 23. The bottom of the steel wire 243 is connected to the sealing member 244. The sealing member 244 is composed of a linear array of spring fragments 2441. The spring fragment group 2411 is composed of multiple spring fragments. The spring fragments have high elasticity, so they can fit tightly within the lumen of the indwelling tube 23, ensuring that the indwelling tube 23 is completely sealed. The spring fragments are vortex-shaped, so that when gas passes through the spring fragments, it has a strong driving force.

[0044] In one embodiment provided in the present application, the indwelling tube 23 is evenly divided into multiple groups of chambers M by an elastic diaphragm N; The elastic diaphragm N is attached to the outer wall of the venous catheter 14 .

[0045] In one embodiment provided in this application, the spring group 2441 is built into the chamber M. After the airbag 21 injects gas into the interior of the hose 13, the shrapnel group 2441 can be sunk to the bottom of the chamber M.

[0046] In one embodiment provided in the present application, after the spring assembly 2441 blocks the bottom of the chamber M, the elastic diaphragm N bends and squeezes the intravenous catheter 14 .

[0047] In this embodiment, Figure 7 As shown, the diaphragms N are normally arc-shaped, and all three groups are tangent to the outer wall of the intravenous catheter 14. Furthermore, the three groups of diaphragms N separate the indwelling tube 23 into three diamond-shaped chambers M. The diaphragms N at the end of the indwelling tube 23 are sheared with arcs to facilitate the smooth entry of the spring assembly 2441 into the chamber M.

[0048] In one embodiment provided in the present application, the drainage assembly 25 includes a branch pipe 251 extending through the periphery of the drainage portion 2312 , and a control valve 252 disposed at the end of the branch pipe 251 .

[0049] In this embodiment, the branch tube 251 is located at the bottom of the shrapnel group 2441, ensuring that when no gas is pumped in, the shrapnel will only block the upper half of the chamber M and cannot block the lower half of the chamber M, so that the drug can be injected into the vein without causing blood clots.

[0050] Preferably, the control valve 252 can control the demand for external agents to be pumped into the branch tube 251, and in the non-blocking period, an anticoagulant such as 0.1% sodium heparin solution is injected through the branch tube 251 to remove residual blood in the dead corners of the lumen and reduce the amount of fibrin deposition.

[0051] Under normal conditions, the elastic coil 242 is curled together, and the shrapnel group 2441 is blocked in the middle position of the chamber M and above the drainage component 25. When the airbag 21 is squeezed and gas is pumped into the hose 13, the gas will push the shrapnel group 2441 to move downward, and the elastic coil 242 is stretched. As the shrapnel group 2441 moves downward, it will reach the bottom of the branch pipe 251, not only achieving the purpose of blocking the bottom port of the chamber M, but also achieving the purpose of blocking the branch pipe 251 to drain the medicine.

[0052] In addition, the pressure on the diaphragm N near its port will increase, causing the area of ​​the diaphragm N closer to the port to bulge, causing the three groups of diaphragms to expand inward at the same time, and the three groups of chambers M to expand, thereby reducing the inner diameter of the venous catheter 14, squeezing the inner venous catheter 14, causing it to collapse and close, and achieving the goal of blocking the backflow of the venous catheter 14 without using the elastic balloon 141.

[0053] When the balloon 21 releases gas, the previously inflated diaphragm N rebounds, shrinking the chamber M and causing the inner diameter of the intravenous catheter 14 to rebound, releasing the seal. Simultaneously, the elastic coil 242 rebounds, pulling the spring assembly 2441 back into place and scraping any remaining medication from the chamber M back into the branch tube 251 or into the flexible tube 13.

[0054] In summary, the device utilizes occlusion unit 2, which does not occupy the inner diameter of the lumen and can also reduce the inner diameter of elastic balloon 141, thereby increasing blood flow and reducing platelet adhesion and protein deposition. During the non-occlusion phase, drainage assembly 25 injects saline or other pre-set solutions through branch tube 251, ensuring continuous cleaning and patency of the catheter interior, removing residual blood from blind spots in the lumen, and reducing fibrin deposition.

[0055] Finally, it should be pointed out that the methods and devices described in detail above are merely embodiments, and those skilled in the art can modify these embodiments in different ways without departing from the scope of the present invention.

Claims

1. An anti-thrombotic dialysis catheter, characterized by: include, A catheter unit (1) comprising a pump head (11), a connector (12) disposed at the bottom of the pump head (11), a hose (13) disposed inside the connector (12), and a venous catheter (14) built into the inside of the hose (13); A blocking unit (2) comprising an air bag (21) provided on the circumference of the hose (13), a clamping tube (22) provided on the outside of the hose (13), a retention tube (23) provided on the inside of the clamping tube (22), and a blocking component (24) and a drainage component (25) provided on the circumference of the retention tube (23); The indwelling tube (23) is built with multiple sets of elastic diaphragms (N), and the elastic diaphragms (N) can block the venous catheter (14).

2. The anti-thrombotic dialysis catheter according to claim 1, characterized in that: The venous catheter (14) is a double-lumen catheter, which is used for drawing blood and returning blood during dialysis; The interior of the hose (13) is hollow, and the intravenous catheter (14) is built into the axis of the hose (13) and the indwelling tube (23). The venous catheter (14) includes an elastic balloon (141) connected to both sides of the venous catheter (14).

3. The anti-thrombotic dialysis catheter according to claim 2, characterized in that: The indwelling tube (23) comprises a connecting end (231) connected to the end of the hose (13), a tube body (232) arranged at the bottom of the connecting end (231), and a needle tip (233) arranged at the end of the tube body (232).

4. The anti-thrombotic dialysis catheter according to claim 3, characterized in that: The clamping tube (22) comprises a plurality of clamping plates (221) clamped on the peripheral side of the connecting end (231), and a clamping ring (222) arranged on the peripheral side of the clamping plates (221).

5. The anti-thrombotic dialysis catheter according to claim 4, characterized in that: The connecting end (231) comprises a blocking portion (2311) and a drainage portion (2312) protruding from the end of the blocking portion (2311).

6. The anti-thrombotic dialysis catheter according to claim 5, characterized in that: The blocking assembly (24) comprises a clamping ring (241) sleeved on the peripheral side of the connecting end (231), a plurality of groups of elastic coils (242) arranged on the peripheral side of the bottom of the clamping ring (241), a steel wire (243) fixedly connected to the bottom of each group of the elastic coils (242), and a blocking member (244) fixedly connected to the bottom of the steel wire (243); The blocking member (244) comprises a linear array of spring fragments (2441).

7. The anti-thrombotic dialysis catheter according to claim 6, characterized in that: The indwelling tube (23) is evenly divided into multiple groups of chambers (M) by the elastic diaphragm (N); The elastic diaphragm (N) is attached to the outer wall of the venous catheter (14).

8. The anti-thrombotic dialysis catheter according to claim 7, characterized in that: The shrapnel group (2441) is built into the chamber (M). After the air bag (21) injects gas into the interior of the hose (13), the shrapnel group (2441) can be sunk to the bottom of the chamber (M).

9. The anti-thrombotic dialysis catheter according to claim 8, characterized in that: After the shrapnel group (2441) blocks the bottom of the chamber (M), the elastic diaphragm (N) bends and squeezes the venous catheter (14).

10. The anti-thrombotic dialysis catheter according to claim 9, characterized in that: The drainage assembly (25) comprises a branch pipe (251) extending through the periphery of the drainage portion (2312), and a control valve (252) disposed at the end of the branch pipe (251).

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