An antithrombotic dialysis catheter

Abstract

The application discloses an anti-thrombus dialysis catheter and relates to the technical field of hemodialysis catheters. The application is unique in design, can effectively reduce platelet adhesion and protein deposition during self-hemodialysis, and effectively prevents thrombus formation. In addition, the application can automatically inject normal saline or other preset solutions into the catheter during non-dialysis, ensuring that the catheter is continuously cleaned and kept unobstructed. Not only does it prevent blockage caused by blood reflux, but it also reduces the risk of infection caused by improper catheter maintenance, greatly improving the safety and efficiency of the dialysis process. It improves the treatment experience of patients and greatly improves the safety and comfort of patients.

Description

Technical Field

[0001] This invention relates to hemodialysis catheter technology, and more particularly to an antithrombotic dialysis catheter. Background Technology

[0002] As the core lifeline for maintenance hemodialysis patients, the antithrombotic properties and long-term patency of venous catheters directly determine the clinical treatment outcome. Current mainstream antithrombotic catheter technologies mostly employ an internal balloon structure (such as a double-lumen catheter combined with a balloon catheter design). The balloon inflates to compress the lumen, achieving physical isolation and thus reducing blood contact with the catheter's inner wall.

[0003] However, the insertion of a balloon into a venous catheter increases catheter wall thickness, reduces the effective inner diameter (15%-20%), and the nested structure creates microgaps, exacerbating the risk of infection and thrombosis. Simultaneously, the nested structure of the balloon catheter and the double-lumen catheter creates microgaps, becoming a high-risk area for protein deposition and bacterial colonization. Furthermore, the localized high pressure (typically 300-500 mmHg) exerted by the balloon during inflation on the vascular endothelium or catheter wall can easily cause endothelial detachment 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 balloon can lead to insufficient blood flow and the high pressure expansion of the balloon can directly damage the vascular endothelium or the inner wall of the catheter, thereby stimulating and triggering platelet activation.

[0005] The above-mentioned technical problems are solved by the following technical solution: The present invention proposes an antithrombotic dialysis catheter, which includes a catheter unit, including a pump head, a connector disposed at the bottom of the pump head, a flexible tube disposed inside the connector, and a venous catheter embedded inside the flexible tube;

[0006] The sealing unit includes an airbag disposed around the periphery of the hose, a clamp disposed on the outside of the hose, an indwelling tube disposed on the inside of the clamp, and a sealing assembly and a drainage assembly disposed around the indwelling tube.

[0007] The indwelling catheter contains multiple sets of elastic diaphragms, which can block the venous catheter.

[0008] In a preferred embodiment of the antithrombotic dialysis catheter of the present invention: the venous catheter is a double-lumen catheter, which is used for blood drawing and blood return during dialysis respectively;

[0009] The tubing is hollow inside, and the venous catheter is inserted at the axis of the tubing and the indwelling tube.

[0010] The venous catheter includes an elastic balloon connecting both sides of the venous catheter.

[0011] In a preferred embodiment of the antithrombotic dialysis catheter of the present invention: the indwelling catheter 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.

[0012] In a preferred embodiment of the antithrombotic dialysis catheter of the present invention: the clamp includes multiple sets of clamps that are clamped to the periphery of the connecting end, and clamping rings disposed on the periphery of the clamps.

[0013] In a preferred embodiment of the antithrombotic dialysis catheter of the present invention: the connecting end includes a sealing portion and a drainage portion protruding from the end of the sealing portion.

[0014] In a preferred embodiment of the antithrombotic dialysis catheter of the present invention: the occlusion assembly includes a clamping ring sleeved on the periphery of the connecting end, multiple sets of elastic coils disposed on the periphery of the bottom of the clamping ring, a steel wire fixedly connected to the bottom of each set of elastic coils, and an occlusion member fixedly connected to the bottom of the steel wire.

[0015] The sealing element comprises a linear array of spring clips.

[0016] In a preferred embodiment of the antithrombotic dialysis catheter of the present invention: the indwelling catheter is uniformly divided into multiple groups of chambers by the elastic diaphragm;

[0017] The elastic diaphragm is attached to the outer wall of the venous catheter.

[0018] In a preferred embodiment of the antithrombotic dialysis catheter of the present invention: the spring clip assembly is embedded in the cavity.

[0019] After the airbag fills the hose with gas, it can lower the spring assembly to the bottom of the chamber.

[0020] In a preferred embodiment of the antithrombotic dialysis catheter of the present invention: after the spring plate group blocks the bottom of the chamber, the elastic diaphragm bends and squeezes the venous catheter.

[0021] In a preferred embodiment of the antithrombotic dialysis catheter of the present invention: the drainage assembly includes a branch tube disposed around the drainage portion and a control valve disposed at the end of the branch tube.

[0022] The beneficial effects of this invention are as follows: This invention forms a double seal through the sealing unit and the internal elastic balloon of the venous catheter. During dialysis, the venous catheter is sealed by air pressure conduction; during non-dialysis periods, the internal elastic balloon expands to provide an auxiliary seal, and this dual action significantly reduces the risk of blood reflux. This invention allows for the injection of saline or other pre-set solutions into the catheter during non-dialysis periods, ensuring continuous cleanliness and patency of the catheter interior. This not only prevents blockage caused by blood backflow but also reduces the risk of infection due to improper catheter maintenance, greatly improving the safety and efficiency of the dialysis process. Attached Figure Description

[0023] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings of the embodiments of the present invention will be briefly described below. Obviously, the drawings described below only relate to some embodiments of the present invention and are not intended to limit the present invention. Wherein:

[0024] Figure 1 A schematic diagram of the overall structure of the antithrombotic dialysis catheter of the present invention is shown;

[0025] Figure 2 An exploded view of the sealing unit structure of the present invention is shown;

[0026] Figure 3 It shows Figure 1 Enlarged view of the ductus venosus tip structure at point A;

[0027] Figure 4 A partial cross-sectional three-dimensional structural diagram of the sealing unit of the present invention is shown;

[0028] Figure 5 It shows Figure 4 Enlarged view of the sealing component structure at point B;

[0029] Figure 6 It shows Figure 4 Enlarged view of the chamber structure at point C;

[0030] Figure 7 A schematic diagram of the internal cross-sectional structure of the cavity of the present invention is shown.

[0031] In the diagram: 1. Catheter unit; 2. Occlusion unit; 11. Pump head; 12. Connector; 13. Tube; 14. Intravenous catheter; 21. Balloon; 22. Clamp; 23. Indwelling tube; 24. Occlusion assembly; 25. Drainage assembly; 141. Elastic balloon; 231. Connecting end; 232. Tube body; 233. Needle tip; 221. Clamping plate; 222. Clamping ring; 241. Clamping ring; 242. Elastic coiled wire; 243. Steel wire; 244. Occlusion component; 251. Branch tube; 252. Control valve; 2311. Occlusion part; 2312. Drainage part; 2441. Spring assembly; N. Diaphragm; M. Chamber. Detailed Implementation

[0032] To enable those skilled in the art to better understand the present invention, the present invention will be further described in detail below with reference to specific embodiments and accompanying drawings.

[0033] The terminology used in this invention is that which is currently widely used in the art in consideration of the function of the invention; however, these terms may vary according to the intent of those skilled in the art, precedent, or new technology in the art. Furthermore, specific terms may be chosen by the applicant, and in such cases, their detailed meanings will be described in the detailed description of the invention. Therefore, the terms used in this specification should not be construed as simple names, but rather based on their meanings and the overall description of the invention.

[0034] Reference Figures 1 to 7 This embodiment provides an antithrombotic dialysis catheter, including a catheter unit 1, including a pump head 11, a connector 12 disposed at the bottom of the pump head 11, a flexible tube 13 disposed inside the connector 12, and a venous catheter 14 embedded inside the flexible tube 13;

[0035] The sealing unit 2 includes an airbag 21 that extends through the periphery of the hose 13, a clamp tube 22 that is disposed on the outside of the hose 13, an indwelling tube 23 disposed on the inside of the clamp tube 22, and a sealing assembly 24 and a drainage assembly 25 disposed around the indwelling tube 23.

[0036] The indwelling catheter 23 contains multiple sets of elastic diaphragms N, which can block the venous catheter 14.

[0037] In this embodiment, the catheter unit 1 is a venous catheter that can maintain the patient's hemodialysis needs. The pump head 11 controls the internal venous catheter 14 to deliver blood. The venous catheter 14 is a double-lumen catheter, with one end for blood aspiration and the other for blood return. The venous catheter 14 is fitted into the lumen of the flexible tube 13, which is then fixedly connected to the port of the pump head 11 via a connector 12.

[0038] The tubing 13 can serve as a protective tube for the venous catheter 14, and a sealing unit 2 is also mounted on the outside of the tubing 13. By pumping gas into the tubing 13, the outer wall of the venous catheter 14 is squeezed and compressed together to achieve the need to seal the venous catheter 14. This avoids the local high pressure on the vascular endothelium or the inner wall of the catheter caused by balloon inflation, which could lead to endothelial peeling or lumen deformation, and activates the platelet adhesion cascade reaction.

[0039] It should be noted that the end of the tubing 13 is connected to the indwelling catheter 23, and the venous catheter 14 is also inserted into the needle hole of the indwelling catheter 23. A set of clamps 22 are attached to the periphery of the indwelling catheter 23, which can effectively protect the end structure of the indwelling catheter 23. In addition, a set of airbags 21 are connected to one side of the tubing 13, which can squeeze air into the tubing 13. Because the tubing 13 has poor toughness and the venous catheter 14 has good dilatancy, the air pumped into the tubing 13 cannot cause the tubing 13 to expand. Instead, it can only act on the venous catheter 14 inside the indwelling catheter 23 along the path of the tubing 13, causing it to collapse.

[0040] Specifically, the diameter of the tubing 13 is actually quite small, just enough to accommodate the intravenous catheter 14 and leave some space.

[0041] Medical silicone with low elastic modulus and a thickness of 0.8 mm and tensile strength ≥8 MPa can be selected. Its inner diameter is 1.2-1.5 mm larger than the outer diameter of the intravenous catheter 14, forming an annular air gap channel.

[0042] In this embodiment, three sets of blocking components 24 are also installed around the indwelling tube 23. When the air bag 21 does not pump in gas, the blocking components 24 cannot block the venous catheter 14. Then, the medication can be injected into the venous catheter 14 through the three sets of drainage components 25 that are also connected around the indwelling tube 23, so as to reduce thrombus formation and reduce platelet adhesion and protein deposition.

[0043] In addition, three sets of diaphragms N are heat-fused to the inner wall of the indwelling tube 23. The diaphragms N have good dilatation properties, so the diaphragms N can simultaneously squeeze the outer venous catheter 14 through air pressure changes, thereby achieving the function of blocking the venous catheter 14.

[0044] In summary, this invention achieves a double seal through the sealing unit 2 and the built-in elastic balloon 141 in the venous catheter 14. During dialysis, the venous catheter 14 is sealed by air pressure conduction; during non-dialysis periods, the built-in elastic balloon 141 expands to provide an auxiliary seal, and this dual action significantly reduces the risk of blood reflux. This invention can automatically inject saline or other preset solutions into the catheter during non-dialysis periods, ensuring continuous cleanliness and patency of the catheter interior. This not only prevents blockage caused by blood backflow but also reduces the risk of infection due to improper catheter maintenance, greatly improving the safety and efficiency of the dialysis process.

[0045] Reference Figure 3 As an optional embodiment, the venous catheter 14 is a double-lumen catheter, which is used for blood draw and blood return during dialysis, respectively;

[0046] The inner part of the tubing 13 is hollow, and the intravenous catheter 14 is inserted at the axis of the tubing 13 and the indwelling catheter 23.

[0047] Furthermore, the venous catheter 14 includes an elastic balloon 141 connecting both sides of the venous catheter 14.

[0048] In this embodiment, the venous catheter 14 is a double-lumen catheter, used for blood aspiration and blood return during dialysis, respectively. One end of the venous catheter 14 is also equipped with an elastic balloon 141. One lumen of the venous catheter 14 is the aspiration lumen / arterial lumen, with a relatively large inner diameter, typically ≥3.0 mm. The proximal opening is located 1-2 cm posterior to the catheter tip to ensure the lumen does not collapse during high-flow aspiration. During dialysis, blood is drawn from the patient's venous system at a flow rate of 200-400 mL / min and transported to the dialysis machine for purification.

[0049] The other lumen is the venous lumen for blood return, with an inner diameter slightly smaller than the blood collection lumen by about 2.5-3.0 mm. Its wall is designed with a flexible corrugated structure to buffer blood flow pulsations, and the distal opening is located at the catheter tip to reduce the impact of blood flow on the vessel wall. Blood purified by the dialysis machine can be returned to the patient at a matched flow rate, forming a closed-loop circulatory system. The two lumens are physically isolated throughout, preventing the mixing of unpurified and purified blood. The recirculation rate is <5%, significantly better than the >15% recirculation rate of single-lumen catheters.

[0050] The elastic balloon 141 is existing technology and can occlude the venous catheter 14 through expansion. The occlusion effect can be relatively weak, but a small diameter should be selected to avoid local high pressure on the vascular endothelium or the inner wall of the catheter during expansion. In addition, the occlusion unit 2 provides dual protection to prevent backflow.

[0051] Reference Figures 1-7 As an optional embodiment, the indwelling tube 23 includes a connecting end 231 connected to the end of the flexible tube 13, a tube body 232 disposed at the bottom of the connecting end 231, and a needle tip 233 disposed at the end of the tube body 232.

[0052] In one embodiment provided in this application, the clamp 22 includes multiple sets of clamping plates 221 that are snapped onto the periphery of the connecting end 231, and snapping rings 222 disposed on the periphery of the clamping plates 221.

[0053] In one embodiment provided in this application, the connection end 231 includes a blocking part 2311 and a draining part 2312 protruding from the end of the blocking part 2311.

[0054] In this embodiment, the end connection 231 of the indwelling tube 23 is sealed and connected to the end of the tubing 13 so that the gas in the tubing 13 can smoothly enter the indwelling tube 23. The middle part of the indwelling tube 23 is the tube body 232, which can be inserted into the patient's vein. The needle tip 233 at the end of the indwelling tube 23 can be inserted into the vein.

[0055] Specifically, the end connection 231 of the indwelling catheter 23 is divided into a blocking part 2311 and a drainage part 2312. The blocking part 2311 can be fitted with a blocking component 24, while the drainage part 2312 can be fitted with a drainage component 25; the drainage component 25 is located at the bottom of the blocking component 24, so that the blocking component 24 does not prevent the drainage component 25 from injecting medication into the periphery of the venous catheter 14.

[0056] Preferably, the three sets of clamps 221 are connected together by snap-fit, so that they can be clamped around the periphery of the connecting end 231 to enhance the connection strength between the connecting end 231 and the hose 13.

[0057] Two sets of snap rings 222 are also snapped onto the outside of the clamping plate 221, and the snap rings 222 clamp the periphery of the clamping plate 221.

[0058] In one embodiment provided in this application, the sealing component 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 sealing member 244 fixedly connected to the bottom of the steel wire 243.

[0059] The sealing element 244 includes a linear array of spring clips 2441.

[0060] In this embodiment, the occlusion component 24 can control the occlusion of the venous catheter 14 and the cleaning effect of the drainage component 25 on the medication.

[0061] The sealing assembly 24 consists of a clamping ring 241 snapped onto the end face of the connecting end 231, an elastic coiled wire 242 vertically connected to the bottom surface of the clamping ring 241, a steel wire 243 at the bottom of the elastic coiled wire 242, and a sealing member 244 inside the indwelling tube 23.

[0062] The clamping ring 241 is fixedly attached to the end face of the connecting end 231. Three sets of fixing platforms are left on the 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.

[0063] The steel wire 243 passes through the clamp 221 and the side wall of the indwelling tube 23, and finally connects to the inside of the indwelling tube 23. The bottom of the steel wire 243 is connected to the sealing element 244, which is composed of a linear array of spring pieces 2441. The spring pieces 2441 are composed of several spring pieces. The spring pieces are highly elastic, so they can fit tightly into the cavity of the indwelling tube 23, ensuring that the indwelling tube 23 is in a completely sealed state. The spring pieces are vortex-shaped, so that the gas has a large driving force when passing through the spring pieces.

[0064] In one embodiment provided in this application, the indwelling tube 23 is uniformly divided into multiple chambers M by an elastic diaphragm N;

[0065] The elastic diaphragm N is attached to the outer wall of the venous catheter 14.

[0066] In one embodiment provided in this application, the spring assembly 2441 is embedded within the chamber M.

[0067] After the airbag 21 fills the hose 13 with gas, the spring assembly 2441 can be lowered to the bottom of the chamber M.

[0068] In one embodiment provided in this application, after the spring assembly 2441 blocks the bottom of the chamber M, the elastic diaphragm N bends and compresses the venous catheter 14.

[0069] In this embodiment, as Figure 7 As shown, the diaphragm N is arc-shaped under normal conditions, and all three groups are tangent to the outer wall of the venous catheter 14. In addition, with the intervals between the three groups of diaphragms N, the indwelling tube 23 is divided into three rhomboid chambers M. The diaphragm N at the port of the indwelling tube 23 is cut with an arc opening to facilitate the smooth entry of the spring assembly 2441 into the chamber M.

[0070] In one embodiment provided in this application, the drainage assembly 25 includes a branch pipe 251 disposed around the drainage portion 2312, and a control valve 252 disposed at the end of the branch pipe 251.

[0071] In this embodiment, the branch tube 251 is located at the bottom of the spring assembly 2441, ensuring that when no gas is pumped in, the spring only blocks the upper half of the chamber M, but cannot block the lower half of the chamber M, so that drugs can be injected into the vein and prevent thrombosis.

[0072] Preferably, the control valve 252 can control the demand for external drug pumping into the branch pipe 251, and during the non-blocking period, an anticoagulant such as 0.1% heparin sodium solution is injected through the branch pipe 251 to remove residual blood in the dead corner of the lumen and reduce the amount of fibrin deposition.

[0073] Under normal conditions, the elastic coiled wire 242 is coiled together, and the spring sheet assembly 2441 is sealed in the middle 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 spring sheet assembly 2441 downward, and the elastic coiled wire 242 will be stretched. As the spring sheet assembly 2441 moves downward, it will reach the bottom of the branch tube 251, which not only achieves the purpose of sealing the bottom port of the chamber M, but also achieves the purpose of sealing the drainage agent of the branch tube 251.

[0074] In addition, the pressure on the diaphragm N near its port will increase, causing the section of diaphragm N closer to the port to bulge, so that the three sets of diaphragms expand inward at the same time, the three sets of chambers M expand, thereby reducing the inner diameter of the venous catheter 14, squeezing the inner side of the venous catheter 14, causing it to collapse and close, so that the venous catheter 14 can be blocked without the use of the elastic balloon 141.

[0075] When the airbag 21 releases gas, the previously inflated diaphragm N rebounds, the chamber M contracts, and the inner diameter of the venous catheter 14 rebounds, releasing the closure. At the same time, the elastic coil 242 rebounds, pulling the spring assembly 2441 back to its original position and scraping away any residual medication in the chamber M, allowing it to return to the branch tube 251 or be scraped into the flexible tube 13.

[0076] In summary, this device, through the design of the occlusion unit 2, does not occupy the inner diameter of the lumen and can also reduce the inner diameter of the elastic balloon 141, thereby increasing blood flow and reducing platelet adhesion and protein deposition. During the non-occlusion period, the drainage component 25 injects saline or other preset solutions through the branch tube 251 to ensure continuous cleanliness and patency of the catheter interior, remove residual blood from dead corners of the lumen, and reduce fibrin deposition.

[0077] Finally, it should be noted 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 as long as they do not depart from the scope of the present invention.

Claims

1. An antithrombotic dialysis catheter, characterized in that: include, The catheter unit (1) includes 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) embedded inside the hose (13). The sealing unit (2) includes an airbag (21) that runs through the periphery of the hose (13), a clamp (22) that is disposed on the outside of the hose (13), an indwelling tube (23) that is disposed on the inside of the clamp (22), and a sealing assembly (24) and a drainage assembly (25) disposed on the periphery of the indwelling tube (23). The indwelling catheter (23) has multiple sets of elastic diaphragms (N) inside, which can block the venous catheter (14). The venous catheter (14) is a double-lumen catheter, which is used for blood draw and blood return during dialysis, respectively; The tubing (13) is hollow inside, and the venous catheter (14) is inserted at the axis of the tubing (13) and the indwelling tube (23). The venous catheter (14) includes an elastic balloon (141) connecting both sides of the venous catheter (14). The indwelling tube (23) includes a connecting end (231) connected to the end of the flexible tube (13), a tube body (232) disposed at the bottom of the connecting end (231), and a needle tip (233) disposed at the end of the tube body (232). The clamp (22) includes multiple sets of clamps (221) that are snapped onto the periphery of the connecting end (231), and snap rings (222) disposed on the periphery of the clamps (221). The connection end (231) includes a blocking part (2311) and a draining part (2312) protruding from the end of the blocking part (2311). The sealing 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 sealing member (244) fixedly connected to the bottom of the steel wire (243). The sealing element (244) includes a linear array of spring sheets (2441). The indwelling tube (23) is evenly divided into multiple chambers (M) by the elastic diaphragm (N); The elastic diaphragm (N) is attached to the outer wall of the venous catheter (14); The spring assembly (2441) is built into the chamber (M). After the airbag (21) fills the hose (13) with gas, the spring assembly (2441) can be lowered to the bottom of the chamber (M); After the spring assembly (2441) blocks the bottom of the chamber (M), the elastic diaphragm (N) bends and squeezes the venous catheter (14). The drainage assembly (25) includes a branch pipe (251) extending through the periphery of the drainage section (2312) and a control valve (252) disposed at the end of the branch pipe (251).

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