A catheter closure device

Abstract

A catheter sealing device comprises: a sealing plug, which comprises an elastomer composed of foamed polyurethane and a coating made of ePTFE wrapped on the surface of the elastomer, wherein the elastomer penetrates into the micropores of the coating to strengthen the connection strength between the two, and a core shaft for supporting is arranged inside the elastomer; a catheter, which is connected to the sealing plug and is provided with a flushing hole for flushing a hemodialysis catheter; a joint, which is connected to the catheter and is provided with a rotary valve for opening and closing the joint; a delivery shaft, which is inserted into the catheter and is pulled out after the delivery is completed; a hemostatic valve, which is slidably sleeved on the catheter and is provided with a side branch for passing liquid; the distal end of the sealing plug is a conical structure for guiding the sealing plug, and the side surface of the sealing plug is wavy for reducing the friction between the sealing plug and the inner wall of the hemodialysis catheter.

Description

Technical Field

[0001] The invention patent relates to the field of medical devices, and in particular to a catheter sealing device. Background Art

[0002] The lifeline of hemodialysis patients is vascular access. Stable and reliable vascular access is the basic guarantee for hemodialysis patients to undergo hemodialysis. With the aging of the population, the increasing dialysis age of maintenance hemodialysis patients, and the increased incidence of hypertension, diabetes, obesity, autoimmune diseases, etc., it is becoming increasingly difficult to establish autologous fistulas. Temporary dialysis catheters and semi-permanent dialysis catheters, as a type of long-term hemodialysis access, will inevitably be used clinically for a long time. According to statistics, during clinical use, 40% of catheter failures are attributed to venous thrombosis and fibrin sheath formation, and approximately 17%-33% of catheters are forced to be removed due to thrombosis. The complications of thrombosis lead to insufficient flow rate, prolonged dialysis time, and increased costs, which seriously affect the quality of life of patients.

[0003] Clinically, after dialysis, a sealing fluid is used to seal the dialysis catheter to prevent blood clots from forming inside the dialysis catheter or external bacteria from entering the dialysis catheter. However, since the catheter is located in the blood vessel and immersed in the blood, the sealing fluid will gradually diffuse and flow into the circulatory system during the blood circulation process, causing the concentration of the sealing fluid to decrease, and there is still a risk of thrombosis in the catheter. Therefore, a device is needed to isolate the catheter from the blood to prevent the formation of thrombosis in the catheter. Summary of the invention

[0004] The object of the present invention is to overcome the above disadvantages and provide a catheter sealing device.

[0005] The technical solution adopted by the present invention is as follows:

[0006] A catheter sealing device, characterized in that it includes: a sealing plug, the sealing plug includes an elastomer composed of foamed polyurethane and a coating made of ePTFE material wrapped on the surface of the elastomer, the elastomer penetrates into the micropores of the coating to strengthen the connection strength between the two, a core shaft for supporting is arranged inside the elastomer, and the elastomer can be compressed to at least one third of its original volume; a catheter, the catheter is connected to the sealing plug, and the catheter is provided with a flushing hole for flushing a hemodialysis catheter; a connector, the connector is connected to the catheter, and the connector is provided with a rotary valve for opening and closing the connector; a delivery shaft, the delivery shaft is inserted into the catheter, and when the delivery is completed, the delivery shaft is pulled out; a hemostatic valve, the hemostatic valve is slidably sleeved on the catheter, and the hemostatic valve is provided with a side branch for passing liquid.

[0007] The distal end of the sealing plug is a conical structure for guiding the sealing plug, and the side surface of the sealing plug is wavy for reducing the friction between the sealing plug and the inner wall of the hemodialysis catheter.

[0008] Preferably, the flushing hole is arranged at one end of the catheter close to the sealing plug.

[0009] Preferably, the catheter and the sealing plug are connected together through the core shaft.

[0010] Preferably, the surface of the coating is coated with heparin.

[0011] Preferably, the length of the sealing plug is 1 cm-3 cm.

[0012] Preferably, the elastomer is hydrogel or silica gel. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 A catheter closure device of the present invention;

[0014] Figure 2 To seal the plug;

[0015] Figure 3 The present invention shows a state of a catheter sealing device when it is inserted into a hemodialysis catheter. DETAILED DESCRIPTION

[0016] The following embodiments of the present invention are described in further detail in conjunction with the accompanying drawings and examples. The following examples are used to illustrate the present invention, but are not intended to limit the scope of the present invention.

[0017] A catheter sealing device, characterized in that it comprises: a sealing plug 100, wherein the sealing plug 100 comprises an elastic body 120 composed of foamed polyurethane and a coating 110 of ePTFE material wrapped on the surface of the elastic body 120, wherein the elastic body 120 penetrates into the micropores of the coating to strengthen the connection strength between the two, and a core shaft 130 is arranged inside the elastic body 120 for supporting, and the elastic body 120 can be compressed to at least one third of the original volume. The elasticity of the sealing plug 100 is mainly provided by the foamed polyurethane, so that when the sealing plug 100 enters the hemodialysis catheter, the shape can be changed arbitrarily to adapt to the cavity of the dialysis catheter and improve the sealing performance. The elastomer 120 generally has a large friction coefficient. When the elastomer 120 enters the hemodialysis catheter, it will generate a strong pressure on the inner wall of the tube due to compression. At this time, the friction between the elastomer 120 and the inner wall of the tube will be very large, which will make it difficult to push the catheter sealing device of the present invention and even damage the product. Therefore, it is necessary to reduce the friction between the sealing plug 100 and the inner wall of the tube. In the present invention, a layer of expanded polytetrafluoroethylene (ePTFE) is sleeved on the surface of the elastomer 120 to reduce the friction. Expanded polytetrafluoroethylene is made of polytetrafluoroethylene resin through special processing methods such as stretching, and has a mesh structure formed by connecting fine fibers. These fine fibers form countless pores. When making the sealing plug 100, an ePTFE membrane 110 is used to wrap the liquid polyurethane foaming agent. After the foamed polyurethane is formed, part of the polyurethane will penetrate into the pores of the ePTFE membrane 110, thereby strengthening the connection strength between the ePTFE membrane 110 and the foamed polyurethane, so that during the pushing process of the sealing plug 100, the ePTFE membrane 110 and the foamed polyurethane bracket are not easily separated.

[0018] In another embodiment, the material of the elastomer 120 is hydrogel or silicone. When the elastomer 120 is hydrogel, the hydrogel is wrapped in the ePTFE membrane 110, and the volume is small before encountering the liquid, and it may pass smoothly in the hemodialysis catheter. When the sealing plug 100 is placed in the expected position, the hydrogel will be affected by the blood and expand, thereby blocking the catheter port. When the elastomer 120 is silicone, the silicone is wrapped in the ePTFE membrane 110. Because the silicone is elastic, the sealing plug 100 can adapt to the lumen of the hemodialysis catheter when entering the hemodialysis catheter, thereby blocking the catheter port.

[0019] A supporting mandrel 130 is also provided inside the elastic body 120. Because the elastic body 120 is not hard enough and cannot provide sufficient force in the axial direction, a mandrel 130 needs to be provided inside the elastic body 120 to push the elastic body 120. The mandrel 130 is provided with a plurality of small holes so that the elastic body 120 can penetrate therein, thereby improving the connection strength between the mandrel 130 and the elastic body 120.

[0020] The distal end of the sealing plug 100 is a conical structure, which is used to guide the sealing plug 100 to prevent the sealing plug 100 from being damaged when inserted into the hemodialysis catheter, and it can also facilitate the insertion of the sealing plug 100. The proximal end of the sealing plug 100 is provided with an arc chamfer to facilitate the withdrawal of the sealing plug 100 out of the dialysis catheter. The side of the sealing plug is a wavy structure, which can reduce the contact area between the side of the sealing plug and the inner wall of the hemodialysis catheter, thereby reducing the friction between the two and making the push smoother. The length of the sealing plug 100 is 1-3cm.

[0021] When the sealing plug 100 is sealing, the distal end will be exposed to the blood, which may cause the risk of thrombosis, so a heparin coating with anti-coagulation function is coated on the surface of the ePTFE membrane 110 .

[0022] One end of the catheter 200 is connected to the sealing plug 100, and a flushing hole 210 is provided on the catheter 200 for flushing the hemodialysis catheter. The flushing hole 210 is provided at one end close to the sealing plug 100, and the flushing hole 210 is square, circular, or a combination of the two. The catheter 200 and the sealing plug 100 are connected together through a mandrel 130, one end of the mandrel 130 is inserted into the elastomer 120, and the other end is inserted into the catheter 200, and the length of the mandrel 130 inserted into the catheter 200 will not block the flushing hole 210, and the mandrel 130 and the catheter 200 are bonded together by glue.

[0023] The other end of the catheter 200 is connected to the joint 300 by glue, and the flushing liquid and the core shaft 130 enter the catheter 200 through the joint. The joint 300 is also provided with a rotary valve 310 for opening and closing the joint. A delivery shaft 400 is inserted into the catheter 200. Since the catheter 200 is relatively soft and lacks strength, it is easy to bend when it is transported into the dialysis catheter. After the delivery shaft 400 is inserted, the anti-bending performance of the catheter can be improved, so that the product can be transported in the dialysis catheter more smoothly. After the product is transported in place, the delivery shaft is withdrawn.

[0024] A hemostatic valve 500 is also slidably sleeved on the catheter 200, and the hemostatic valve 500 is used to prevent blood from flowing back from the dialysis catheter when the sealing plug 100 is inserted. The hemostatic valve 500 is provided with a side branch 510 for passing liquid.

[0025] The use steps of the present invention are:

[0026] When using the present invention, the sealing plug 100 is first inserted into the joint of the hemodialysis catheter 600, and then the joint of the hemostatic valve and the dialysis catheter is tightened, and then the hemostatic buckle of the dialysis catheter is opened, and then the sealing plug 100 is inserted until the desired position is reached. Then, a flushing liquid, such as heparin, is input from the joint of the present invention, and then the flushing liquid flows out from the flushing hole 210 to flush out all the blood in the dialysis catheter, and the flushed blood flows out from the side branch of the hemostatic valve.

[0027] The described embodiments are to be considered in all respects as illustrative only and not restrictive. Therefore, the scope of the present disclosure is indicated by the appended claims rather than by the preceding description. All changes within the equivalent meaning and scope of the claims are included within their scope. The present invention is not limited to the above-described embodiments, which does not mean that the present invention must rely on the above-described embodiments to be implemented. Those skilled in the art should understand that any improvements to the present invention, equivalent replacement of the raw materials selected by the present invention, addition of auxiliary components, selection of specific methods, etc., all fall within the scope of protection and disclosure of the present invention.

Claims

1. A catheter closure device, characterized in that: include: A sealing plug, the sealing plug comprising an elastomer made of foamed polyurethane and a coating made of ePTFE wrapped on the surface of the elastomer, the elastomer permeating into the micropores of the coating to strengthen the connection strength between the two, a core shaft for supporting is arranged inside the elastomer, and the elastomer can be compressed to at least one third of its original volume; A catheter, the catheter is connected to the sealing plug, and the catheter is provided with a flushing hole for flushing the hemodialysis catheter; A connector, the connector is connected to the conduit, and a rotary valve is provided on the connector for opening and closing the connector; A delivery shaft, the delivery shaft is inserted into the catheter, and when the delivery is completed, the delivery shaft is withdrawn; A hemostatic valve, the hemostatic valve is slidably sleeved on the catheter, and the hemostatic valve is provided with a side branch for passing liquid; The distal end of the sealing plug is a conical structure for guiding the sealing plug, and the side surface of the sealing plug is wavy for reducing the friction between the sealing plug and the inner wall of the hemodialysis catheter.

2. A catheter closure device according to claim 1, characterized in that: The flushing hole is arranged at one end of the catheter close to the sealing plug.

3. A catheter closure device according to claim 1, characterized in that: The catheter and the sealing plug are connected together through the core shaft.

4. A catheter closure device according to claim 1, characterized in that: The surface of the film is coated with heparin.

5. A catheter closure device according to claim 1, characterized in that: The length of the sealing plug is 1 cm-3 cm.

6. A catheter closure device according to claim 1, characterized in that: The elastomer is hydrogel or silica gel.

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