WO2017042825A2

WO2017042825A2 - Intravenous catheter with a secured mechanism to avoid reverse flow of the blood

Info

Publication number: WO2017042825A2
Application number: PCT/IN2015/000410
Authority: WO
Inventors: Neeraj Gupta
Original assignee: Neeraj Gupta
Priority date: 2015-09-08
Filing date: 2015-11-05
Publication date: 2017-03-16
Also published as: WO2017042825A3

Abstract

The present invention provides an intravenous catheter with a secured mechanism for prevention of reverse flow of blood. The mechanism consists of a one way valve with slit or groove in its convex portion that is securely inserted within the catheter hub. The construction of one way valve allows flow of fluid in only one direction with the help of gravity infusion pressure and prevents flow of fluid in the opposite direction.

Description

INTRAVENOUS CATHETER WITH A SECURED MECHANISM TO AVOID REVERSE FLOW OF THE BLOOD

Field of invention

The present invention relates to the field of medical devices. More specifically, the present invention relates to an intravenous catheter with a secured mechanism to avoid reverse flow of the blood by means of one way valve.

Background of invention

Catheters have been used by mankind since ancient times. Ancient Syrians made catheters out of reeds. Ancient Greeks used hollow metal tubes that they inserted through the urethra into the urinary bladder to empty it. In modern medicine, catheter use was first described by Dr. N. B. Sornborger who patented the syringe and catheter in 1868.

Intravenous catheters have also been in existence since many years. Intravenous catheters are venous devices used to infuse medication or fluids directly into a vein or draw blood samples for testing. Intravenous catheters are introduced into vein using a needle and fixed to the patient's skin with an adhesive tape.

One drawback associated with the use of over-needle intravenous catheters is that once the needle is withdrawn from the catheter, there is an open channel for the blood to flow through the catheter and spill out of the catheter hub. The blood may be contaminated and this may lead to risk of infection for the healthcare worker.

Additionally, spillage of blood leads to unhygienic conditions for the patient as well as in the healthcare space where the catheter is applied and blood spillage is currently a major problem during administration of IV catheter.

Following are the current methods being used to avoid blood spillage but there are risks and drawbacks associated with each: • Manual pressure is applied on the vein before withdrawal of needle to stop the flow of blood but this method requires either two hand technique with correct skill or two operators may be required. Still the flow of blood may not be stopped.

• A closed system intravenous catheter is used in which the flow of blood is stopped by having a dead stopper in the path of the blood flow and a side port is provided at an angle to the catheter in order allow air escape for flashback visualization and to allow infusion of fluid. However these products are bulky, complicated to use and more expensive than standard products. Further, additional training is required to be given to healthcare workers for use of these products.

The catheter space may be blocked by a mandrel or obturator which requires proper skill and training and that further makes the product complicated and expensive.

An additional swabb able valve or one-way valve is attached or integrated with the catheter which makes the product bulky and expensive and requires an additional training for healthcare worker for easy operation of the product with this valve.

US 4360024 discloses catheter having hub portion and bore. Incorporation of the hub inside the catheter is either through separate molding or as a one piece molding. Back flow of blood is prevented by advert closure of the bore and manual pressure is required to fix the bore inside the catheter.

US 4952207 discloses IV catheter having catheter and hub assembly along with a needle and hub assembly with a self-locating needle guard. This patent has not disclosed any alternative for prevention of back flow of blood.

US 5154703 discloses bloodless catheter assembly prevents the backflow of blood through the catheter by utilization of a self-closing valve carried in a hollow catheter housing to one end of which a catheter is fixed so as to provide a fluid passage through the catheter and catheter housing and a hollow needle is held in the catheter housing downstream and pointed at the valve element. The valve element of this invention is movable in nature.

US 6213978 discloses intravenous catheter having hub and a cannula with bore, cylindrical housing chamber and a fluid flow tube and a needle. The technology of this invention did not provide any valve type of feature, although removal of blunt cannula leaves the septum of injection site sealed.

US6699221 discloses over-the-needle catheter having hub, cannula and a septum seal within the hub of the catheter in which needle passes through the septum seal into the catheter.

US7666166 discloses intravenous catheter having a body, a catheter, a retractable needle system, an axially movable valve which moves between a first position in which the valve is substantially flush with the distal end of the body and a second position in which the valve is entirely disposed within the body. As the valve is movable in nature, it may not provide any promising mechanism for prevention of back flow of blood.

Although many designs of valve are provided for prevention of back flow of blood in prior, but the designs of these valve are very complex and require additional skill and training on the part of the healthcare worker. Another drawback with these types of the designs is that they are based on single activation which allows the flow of blood in one direction and once the valve is activated flow can occur in both directions. Since the catheter is connected multiple times to the intravenous fluid line during its usage which means that the blood path may be closed or open multiple times. These types of valve designs are vulnerable during the time when the blood path is open in subsequent infusions.

To overcome above mentioned problems, present invention provides a simple, cost effective and easy to use solution by designing a catheter with one way valve which effectively blocks the reverse flow of blood and prevents blood spillage. Object of invention

The main object of present invention is to provide an intravenous catheter to avoid reverse flow of blood.

Another object of present invention is to provide an intravenous catheter with a novel one way valve design which is responsible for prevention of reverse flow of blood by mechanism of slit or groove present on convex portion of said one way valve.

Summary of invention

The catheter apparatus of present invention avoids back flow of blood from one way valve or vein. The catheter comprises of catheter tube, catheter hub, one way valve, and needle hub and flashback chamber.

The catheter tube is a thin tube made up of medical grade material having wide range of function. The catheter hub is made up of biocompatible material which is rigid in nature which holds the one way valve securely and the position of the valve is fixed along the axis of the catheter hub. The one way valve is a dome shape flexible body made up of rubber, silicone or any other suitable material which facilitates easy penetration of the needle through it and effective re-sealing is achieved once the needle is removed. The slit or groove is an important part of the one way valve and present on convex portion of one way valve which prevents the reverse flow of blood. Flash chamber is a portion of needle hub where blood is collected and provides a visual inspection of bold collected.

A needle and needle hub assembly along with a flashback chamber is inserted into catheter hub through the valve. Brief description of the drawings

FIG. l shows diagrammatic view of three representative types of intravenous catheter with catheter tube, catheter hub, one way valve, needle hub and flashback chamber. FIG. 2 shows cross-sectional view of the catheter hub and valve assembly where mutual fitments and locations of the components are highlighted.

FIG.3 shows diagrammatic view of convex surface of valve with Y shaped slit having three sides.

F1G.4 shows diagrammatic view of concave surface of valve with Y shaped slit having three sides.

FIG.5shows diagrammatic view of convex surface of valve with cross shaped slit having four sides.

FIG.6shows diagrammatic view of concave surface of valve with cross shaped slit having four sides.

Detail description of invention

The development of flexible intravenous catheters has greatly increased the comfort of patients during intravenous administration of medicinal fluids. The catheter also prevents unwanted puncture of the vein. The catheter is snugly nested about a sharp needle which can be inserted into the vein. After insertion of sharp needle, catheter remains in place for connection with the fluid source, but once the needle is withdrawn from the catheter, there is an open channel for the blood to flow through the catheter and spill out from the catheter hub. The blood may be contaminated and this may lead to risk of infection for the healthcare worker and spillage of blood leads to unhygienic conditions for the patient as well as in the healthcare space where the catheter is applied.

The present invention discloses an intravenous catheter which avoids reverse flow of the blood and thereby avoids spillage of blood. More specifically, the present invention incorporates one way valve feature which prevents back flow of blood.

Referring FIG. l , intravenous catheter of present invention mainly comprise of following:

1 ) Catheter tube 2) Catheter hub

3) One way valve

4) Needle and needle hub assembly

5) Flashback chamber

Referring to FIG. 1, construction and working of intravenous catheter of present invention is described as following:

Catheter tube 2 is a thin tube of catheter serving wide range of function. Catheter hub 3 is a body having a distal end, a central section and a proximal end made up of biocompatible material which is rigid in nature. The catheter hub 3 has an undercut or depression in the internal diameter. The projection or collar on the one way valve 6 will fit into this undercut and therefore catheter hub 3 holds the one way valve 6 securely and the position of the one way valve 6 is fixed along the axis of the catheter hub 3. When the needle 1 is inserted through the one way valve 6, certain force of friction is applied to this one way valve 6 that leads to shifting of the one way valve 6 within the catheter hub 3. Because of presence of above mentioned collar and undercut which resist the force and prevent shifting of one way valve even when force is applied.

An additional rigid catheter holder may be used in order to provide easy press fitting between the catheter 2 and the catheter hub 3. The catheter 2 may be affixed with the catheter holder 4 by using an adhesive or by press fitting. Thumb stop 10 is located between one way valve 6 and needle hub 7 next to port cap 1 1.

One way valve 6 is a dome shaped flexible body made up of rubber or silicone or any other suitable flexible plastic which facilitates easy penetration of the needle 1 and has a projection or collar all along the circumference of the dome. The flexibility of the one way valve 6 ensures that the collar fits with the undercut in the catheter hub 3 and further allows the needle to pass through the slit of the one way valve 6 without piercing or damaging the one way valve 6. This one way valve 6 is inserted inside the catheter hub 3 and extends towards the needle hub 7. As the one way valve 6 is made up of rubber or silicone, effective resealing is achieved once the needle 1 is removed. The location of the one way valve 6 with respect to the opening of the catheter hub is defined in a way that any standard 6% male luer connector may be inserted into the catheter hub without touching or displacing the one way valve. One such standard 6% male luer connector 9 is also defined in the figures.

Needle hub 7 is the enlarged base by which a hollow needle 1 is attached to a device. The needle 1 of the intravenous catheter is either press-fitted to a needle hub 7 or it is fixed to a needle hub 7 with the help of an adhesive. The holding force between the needle 1 and the needle hub 7 is sufficient to ensure that the joint can withstand the additional force of friction when the needle 1 is inserted through the one way valve 6. Flash chamber 8 is a portion of needle hub 7 where blood is collected and provides a visual inspection of blood collected in it which indicates that the vein has been successfully punctured.

The slit or groove 5 is an important part of the one way valve 6 and present on convex portion of one way valve 6 which faces the needle hub 7 of the assembly and convex portion forms the outer surface of the one way valve 6.

The slit can be a single line, Y shaped slit with 3 sides, a cross shaped slit with 4 sides or it can also be a star shaped slit with more than 4 sides. The number of sides of the slit will be governed by the diameter of needle 1 which is required to be inserted through the slit to allow sufficient flexibility. Slit allows the passage of needle 1 from the catheter hub 3 to the needle hub 7.

As shown in FIG. 3 & 4, Y shaped slit 5 has three sides on its convex portion.

As shown in FIG. 5 & 6, cross shaped slit 5 has four sides on its convex portion.

The slit or the groove is a single or multiple incisions depending upon the size of the needle 1 to be passed through this slit or groove 5. In accordance with the principles of the present invention, one way valve 6 is inserted inside the catheter hub 3 and extended towards the needle hub 7, which facilitates easy penetration of the needle 1 through it and leads to effective re-sealing after the needle 1 is removed and thereby inhibit reverse flow of blood and avoid blood spillage.

The working mechanism and of catheter and the mechanism for prevention of reverse flow of blood is described below:

When the needle 1 is inserted through the one way valve 6, certain force of friction is applied to this one way valve 6. The slit 5 present on one way valve 6 allows an opening for the needle 1 to go through the one way valve 6 without piercing one way valve 6 while at the same time it allows a reduction in the force of friction that would be applied in absence of the slit. During collection of blood, slit 5 provides seal around the needle 1 to avoid blood flow through the one way valve 6 or side of the needle 1. After withdrawal of needle 1 from the one way valve 6, sides of the slit 5 closes and further slit 5 leads to self sealing of one way valve 6. Again, the sides of slit 5 open up when fluid pressure is applied to the concave part of the one way valve 6 which further allows easy flow of fluid.

When the needle 1 is inserted through the one way valve 6, because of force of friction on one way valve 6 causes shifting of the one way valve 6 which is prevented by presence of collar and undercut on the one way valve 6, even though force is applied and prevent the movement of one way valve 6. Further, when needle 1 is withdrawn from the one way valve 6 leads to closing of slit 5 and easy self sealing is achieved which avoids back flow of blood through the catheter hub 3.

Claims

An intravenous catheter with a secured mechanism to avoid reverse flow of the blood comprising:

a catheter tube which is a thin tube composed of medical grades material; a catheter hub having a distal end, a central section and a proximal end made up of biocompatible material;

a one way valve having dome shaped flexible body made up of rubber or silicone or any other suitable flexible plastic which facilitates easy penetration of the needle;

a needle hub as enlarged base by which a hollow needle is attached to a catheter;

a flashback chamber for collection of blood and provides a visual inspection of collected blood.

The intravenous catheter as claimed in claim 1 , further comprising catheter holder to provide easy press fitting between the catheter and the catheter hub. The intravenous catheter as claimed in claim 1, further comprising thumb stop and port cap on left and right side of one way valve respectively.

The intravenous catheter as claimed in claim 3, wherein the one way valve serves the insertion mechanism for needle and needle hub into catheter hub. The intravenous catheter as claimed in claim 3, wherein the one way valve has slit or groove on its convex portion.

The intravenous catheter as claimed in claim 5, wherein slit or groove present on convex portion of one way valve can be single or multiple incisions depending upon the size of the needle to be passed from said one way valve. The intravenous catheter as claimed in claim 6, wherein the slit or groove present on convex surface of one way valve can be Y shaped having three sides or cross shaped having four sides.

8. The intravenous catheter as claimed in claim 6, wherein the one way valve is fixed at its position with help of projection or collar present on said one way valve which makes its fitting into the undercut or depression provided in catheter hub.

9. The intravenous catheter as claimed in claim 1 , wherein the one way valve prevents reverse flow of blood from catheter hub with the help of slit as the needle is withdrawn from one way valve which leads to closing of slit and self sealing of one way valve.