CN108355225B

CN108355225B - Venous catheter with double anti-backflow valves and preparation method thereof

Info

Publication number: CN108355225B
Application number: CN201810067063.7A
Authority: CN
Inventors: 张海军; 段翠海; 刘光; 李宜玮; 王新坤; 侯文博; 周超; 尹玉霞; 鲁守涛
Original assignee: Shandong Branden Medical Devices Co Ltd
Current assignee: Shandong Branden Medical Devices Co Ltd
Priority date: 2018-01-24
Filing date: 2018-01-24
Publication date: 2021-04-27
Anticipated expiration: 2038-01-24
Also published as: CN108355225A

Abstract

The invention relates to a venous catheter with double anti-backflow valves and a preparation method thereof, belonging to the field of medical instruments and medical materials. The venous catheter with the double anti-reflux valves is composed of a catheter and a connecting pipe, wherein the side wall of the head end of the catheter is provided with a longitudinal opening, a high-elasticity gasket is designed at the pipe seat of the connecting pipe, a notch is designed on the gasket to play a second valve role, and a double-valve structure is formed at the near end and the far end to play a double anti-reflux role. The valve is made of polyurethane, silicon rubber, thermal elastomer or other elastic high polymer materials. The venous catheter with the double anti-backflow valves can form a positive and negative pressure control system in vitro, between two valves and in vivo so as to better adjust and control the state of the catheter during transfusion, blood drawing and standing and meet different use requirements. The invention can be used for infusing chemotherapy drugs through veins, can effectively solve the problem of reflux in the process of catheter placement, reduces the problems of thrombus and catheter blockage caused by reflux, and prolongs the catheter placement time of the catheter.

Description

Venous catheter with double anti-backflow valves and preparation method thereof

Technical Field

The invention belongs to the field of medical instruments and medical materials, and particularly relates to a venous catheter with double anti-backflow valves and a preparation method thereof.

Background

Intravenous catheters are the main method for establishing venous access, are used as main instruments for establishing venous channels for chemical drug therapy, venous eutrophication therapy, critical patient rescue and the like, and have been widely applied in recent years. For example, a transvenous catheter is a deep vein catheterization method in which the catheter tip is placed in the superior vena cava from a peripheral venipuncture.

Although intravenous catheters provide many benefits to patients, they have associated complications after placement in the body, such as venous infections, venous thrombosis, catheter detachment or breakage, catheter blockage, mechanical phlebitis, and the like. Catheter blockage and thrombosis due to blood or drug reflux are among the more serious complications. In order to solve the problems of the catheter, the invention provides an intravenous catheter with a double anti-reflux valve, and a valve structure is respectively arranged at the far end and the near end of the catheter, so that the blood reflux can be effectively prevented and the related complications can be reduced.

US 4671769 discloses an intravenous catheter which is slit along the central axis in the wall of the catheter, the slit being symmetrical on both sides, the slit being in a natural closed position when no blood is withdrawn and no medical fluid is infused. When the medical staff draws back blood, the inner cavity of the catheter forms negative pressure, and two sides of the catheter cutting seam are simultaneously concave; when medical staff infuses the liquid medicine, the inner cavity of the catheter forms positive pressure, and the cutting seam protrudes outwards, thereby playing the role of a valve. Patent CN 206534923U has disclosed a prevent through periphery central venous catheter against current, mainly includes PICC pipe, connecting seat and extension pipe, and this patent has increased a Y type needleless connector that can prevent against current, is designed with the check valve in the Y type needleless connector, prevents that the medicine from flowing backwards. Patent CN201481988U discloses a medical catheter with a multi-directional valve, which solves the blood backflow situation of the catheter in clinical use.

The paper "analysis and countermeasure of the three-way valvular peripheral central venous catheter catheterization complication cause" of Tianqing et al is published in journal of nursing science, 2006, 21(15), statistics is carried out on the three-way valvular peripheral central venous catheter catheterization complication in the literature, and complications of related infection, phlebitis and blockage after blood return exist after catheterization. PA Zerla et al, "Open-vs Closed-Tip valve modified personal Catheters and Midlines: Finding from a valve Access Database" published in Journal of the Association for valve Access, 2015,20 (3), compares the Open-ended and valve-shaped Catheters, and counts 1341 patients with ducted Catheters, indicating that valve-shaped Catheters cause fewer complications and have a low probability of replacement relative to the need for ducted replacement.

The venous catheter related in the above-mentioned published patent and published literature is a single valve type structure, which plays the role of preventing backflow, the invention relates to a design of double backflow-preventing valve, through designing a valve respectively at the front end and the back end of the catheter, thereby forming positive and negative pressure control systems in vitro, between two valves, and in vivo, better adjusting and controlling the state of the catheter during transfusion, blood drawing and standing to meet different use requirements. Especially for long-term catheterization, the design of the double-valve can reduce the long-term reflux phenomenon and prolong the catheterization time.

Disclosure of Invention

The venous catheter with the double anti-backflow valves is characterized in that a vertical opening is designed on the side wall of the front end of the catheter, and the length of the opening is 5-15 mm. The back end of the conduit is additionally provided with a connecting pipe, and a high-elasticity gasket is designed in the middle of a pipe seat of the connecting pipe.

The high-elasticity gasket is designed with a cutting slit which can be a- (X) -shaped cutting slit, an x-shaped cutting slit or other shapes with three-way valve function.

The thickness of the high-elasticity gasket is 0.5-1.0 mm.

The number of the cutting seams is 1-3.

The ground connecting pipe mainly comprises a pipe seat, an extension pipe and a fixed wing, and is connected by the connecting pipe after the pipe is arranged in the human body to form a complete transfusion and blood drawing channel.

The ground pipe seat consists of an upper pipe seat and a lower pipe seat, and the middle of the ground pipe seat is provided with a high-elasticity gasket which is connected together through a buckle type structure.

The materials used by the ground conduit, the extension pipe and the high-elasticity gasket are polyurethane, silicon rubber, thermal elastomer or other high polymer materials with elasticity.

The connecting pipe seat and the fixing wings can be made of medical grade plastics such as polycarbonate, ABS and the like.

The venous catheter with the double anti-backflow valves can form a positive and negative pressure control system between the two valves in vitro and in vivo, and can better adjust and control different use requirements of the catheter during transfusion, blood drawing and standing.

The venous catheter with the double anti-reflux valves is suitable for peripheral veins, and can also be used in the fields of jugular veins, central veins, subclavian veins, femoral veins and the like which need venous transfusion.

Another object of the present invention is to provide a method of making the above-described venous catheter with a dual anti-reflux valve:

the method comprises the steps of firstly preparing a connecting pipe, wherein a pipe seat of the connecting pipe is formed by injection molding, and the pipe seat can be divided into three parts, namely an upper pipe seat, a lower pipe seat and a high-elasticity gasket. The upper tube seat is designed with a standard luer interface, which is convenient for later transfusion and tube sealing. The lower pipe seat is connected with the extension pipe, a high-elasticity gasket is arranged in the middle of the pipe seat, the upper pipe seat and the lower pipe seat are connected together through a physical clamping structure, and the gasket is fixed to form a first heavy backflow prevention valve. The extension tube is a transparent tube, which is convenient for observation during transfusion and blood drawing.

Then extruding the catheter, closing the head end of the catheter, and making a vertical incision on the side wall of the head end of the catheter to form a second heavy valve structure. When in use, the catheter is placed into a blood vessel of a human body and is connected with the connecting pipe to form a finished infusion and blood drawing passage.

The invention provides a venous catheter protected by double valves, wherein in positive pressure, a valve at the position of a connecting pipe seat is inwards opened, and a valve at the head end of the catheter is outwards opened to finish infusion; when the negative pressure is generated, the valve at the position of the connecting pipe seat is opened outwards, and the valve at the head end of the catheter is opened inwards to finish blood drawing; when the catheter is kept, the two valves are closed, the valve at the position of the connecting pipe seat is mainly used for preventing air from entering, and the catheter can effectively prevent medicine reflux and blood from entering the catheter, so that the incidence rate of related infection and thrombus is reduced. The design can further improve the catheter placement time of the catheter and reduce the occurrence probability of complications after catheter placement; the activity limit of the patient is further reduced, and the life quality level of the patient is improved.

Drawings

FIG. 1 is a schematic view of a venous catheter with a dual anti-reflux valve

FIG. 2 is a schematic view of a catheter implanted in a human body

FIG. 3 is a schematic view of a connecting tube

FIG. 4 is a schematic view showing the basic structure of a connecting tube socket

FIG. 5 is a schematic view of an "-" shaped notch shim

FIG. 6 is a schematic view of an "x" shaped notched gasket

FIG. 7 is a schematic view of a multi-slit gasket

Wherein: 1, a catheter; 11, vertically cutting a seam; 2, connecting pipes; 21 tube seat; 22 an extension tube; 23 fixing wings; 24 high-elasticity gaskets; 25 shim slitting.

Detailed Description

In order to make the invention more comprehensible, preferred embodiments are described in detail below with reference to the accompanying drawings. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Further, it should be understood that various changes or modifications of the present invention may be made by those skilled in the art after reading the teaching of the present invention, and such equivalents may fall within the scope of the present invention as defined in the appended claims.

Example 1

Referring to fig. 1, the venous catheter with a double anti-reflux valve mainly comprises a catheter 1 and a connecting pipe 2. The main material of the conduit 1 is silicon rubber. The side wall of the head end of the conduit is provided with a vertical opening 11, and the length of the opening is 10 mm. The connecting pipe 2 mainly comprises a pipe seat 21, an extension pipe 22 and a fixed wing 23, wherein a one-shaped opening silicone rubber pad 24 is designed inside the pipe seat, the number of the silicone rubber pads is 1, and the thickness of the silicone rubber pad is 0.5 mm. The vertical opening 11 of the catheter head end and the silicone rubber pad opening 25 jointly form a double valve. When in use, the catheter 1 is placed into a human vein and is connected with the connecting pipe 2 to form a finished infusion and blood drawing path. When the pressure is positive, the valve at the position of the connecting pipe seat is opened inwards, and the valve at the head end of the catheter is opened outwards, so that the transfusion is finished; when the negative pressure is generated, the valve at the position of the connecting pipe seat is opened outwards, and the valve at the head end of the catheter is opened inwards to finish blood drawing; when the catheter is kept in place, the two valves are closed, the valve at the connecting pipe seat is mainly used for preventing air from entering, and the valve at the head end can prevent medicines and blood from entering the catheter.

The preparation method comprises the following steps: firstly, a connecting pipe 2 is prepared, a pipe seat 21 of the connecting pipe is formed by injection molding, and the pipe seat can be divided into three parts, namely an upper pipe seat, a lower pipe seat and a high-elasticity gasket. The upper tube seat is designed with a standard luer interface, which is convenient for later transfusion and tube sealing. The lower tube seat is connected with the extension tube 22, a silica gel gasket is arranged in the middle of the tube seat, the upper tube seat and the lower tube seat are connected together through a physical buckle type structure, and the gasket is fixed to form a first heavy backflow prevention valve. The extension tube 22 is a transparent tube, which is convenient for observation during transfusion and blood drawing.

Then the catheter 1 is extruded out, the head end of the catheter is closed, and a vertical cut 11 is made on the side wall of the head end of the catheter to form a second valve structure. When in use, the catheter is placed into a blood vessel of a human body and is connected with the connecting pipe to form a complete infusion and blood drawing path.

Example 2

The basic structure and method of use of the product are similar to example 1, except that the silicone pad opening is "x" shaped and the thickness of the silicone pad is 1.0mm, as shown in fig. 6.

Example 3

The basic structure and method of use of the product are similar to example 1, except that the number of the silica gel pad "-" shaped openings is 3, as shown in fig. 7.

Example 4

The basic structure and application method of the product are similar to those of example 1, except that the material of the conduit 1 is polyurethane and the material of the high-elasticity gasket is silicon rubber.

Example 5

The basic structure and method of use of the product are similar to example 1, except that the catheter 1 is made of polyurethane and the elastomeric pad is made of polyurethane.

Example 6

The basic structure and application method of the product are similar to those of example 1, except that the material of the conduit 1 is silicone rubber and the material of the high-elasticity gasket is polyurethane.

Claims

1. A peripherally inserted central catheter with dual anti-reflux valves is characterized in that the product consists of a catheter and a connecting pipe, the side wall of the head end of the catheter is provided with a vertical opening, the connecting pipe mainly consists of a pipe seat, an extension pipe and a fixing wing, a high-elasticity gasket is designed at the pipe seat of the connecting pipe, the opening of the high-elasticity gasket is in a shape of- (minus) -shape or (X) -shape or other shapes capable of having the valve function, a second valve is arranged on the gasket at the near end, and the peripherally inserted central catheter can form a positive and negative pressure control system in vitro, between the two valves and in vivo, so that different use requirements of the catheter during transfusion, blood drawing and standing can be better adjusted and controlled;

the length of a vertical opening of the side wall of the head end of the conduit is 5-15 mm;

the number of the openings of the high-elasticity gasket is 1-3, and the thickness is 0.5-1.0 mm.

2. The peripherally inserted central catheter with dual anti-reflux valve of claim 1, wherein the material of the catheter, the connecting tube and the elastomeric gasket is polyurethane, silicone rubber or other elastomeric polymer material.

3. The transveriperipheral central catheter with dual anti-reflux valve as claimed in claim 1 or 2, wherein the connecting tube holder and the fixing wings are made of polycarbonate, ABS or other medical grade plastics.

4. The peripherally inserted central catheter with dual anti-reflux valve of claim 1, wherein the hub of the connecting tube is injection molded and is divided into three sections, an upper hub, a lower hub and a highly elastic spacer; the upper tube seat is designed with a standard Ruhr interface, the lower tube seat is connected with an extension tube, a high-elasticity gasket is arranged in the middle of the tube seats, the upper tube seat and the lower tube seat are connected together through a physical clamping structure, and the gasket is fixed to form a first heavy backflow-preventing valve.

5. The peripherally inserted central catheter with a dual anti-reflux valve of claim 1, wherein after the catheter is extruded, the catheter tip is closed and a vertical slit valve structure is formed in the sidewall of the catheter tip.