CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a U.S. National phase based on, and claiming priority to, PCT/EP2015/081459, filed on Dec. 30, 2015 entitled “NEEDLE HUB AND IV CATHETER SYSTEM COMPRISING SUCH NEEDLE HUB,” which is based on and claims priority to Swedish Patent Application No. 1550001-0, filed on Jan. 2, 2015, each of which is hereby incorporated by reference in its entirety.

FIELD OF THE INVENTION

The present invention pertains to an IV catheter system, comprising a needle hub, a catheter hub with a catheter connected distally of a catheter hub body, said catheter hub body having a catheter extending laterally from the catheter hub body, wherein the catheter is in fluid communication with an inner catheter hub body cavity and the lumen of the catheter, and a needle shield assembly. The invention also pertains to a needle hub for cooperation with such catheter hub into an IV catheter system.

BACKGROUND OF THE INVENTION

Catheters, particularly intravascular (IV) catheters, are used for infusing fluid, such as normal saline solution, various medicaments and total parenteral nutrition, into a patient, withdrawing blood from a patient or monitoring various parameters of the patient's vascular system. Peripheral IV catheters tend to be relatively short, and typically are on the order of about two inches or less in length. The most common type of IV catheter is an over-the-needle peripheral IV catheter.

As its name implies, an over-the-needle catheter is mounted over an introducer needle having a sharp distal tip. At least the distal portion of the catheter tightly engages the outer surface of the needle to prevent peelback of the catheter and thus facilitates insertion of the catheter into the blood vessel. The catheter and the introducer needle are assembled so that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle facing up away from the patient's skin.

The catheter and introducer needle assembly is inserted at a shallow angle through the patient's skin into a blood vessel. There are many techniques for inserting such a catheter and introducer needle assembly into a patient. In one insertion technique, the introducer needle and catheter are inserted completely into the blood vessel together. In another technique, the introducer needle is partially withdrawn into the catheter after the initial insertion into the blood vessel. The catheter is then threaded over the needle and inserted completely into the blood vessel.

The clinical utilization of a pointed hollow needle mounted inside a flexible catheter tube is well known in the medical art for the introduction of a catheter. In such a medical instrument, the catheter tube is positioned tightly around the needle in such a way as to allow the needle to slide and telescope along the length of the catheter tube. Before use, the tip of the needle is protruding slightly through the opening of the catheter tube to allow facile penetration through the skin. Upon puncturing of the skin and introduction of the needle, the distal end of the catheter tube is simultaneously brought into place inside the desired target body cavity of the patient, such as the inside of a blood vessel, for example a vein. The needle has then done its duty in assisting the introduction of the catheter and is withdrawn by being pulled backwards through the catheter. Upon release of the needle, the catheter is set in its intended working mode extending over a lengthier period of time and including, for example, periodical administration or infusion of fluids or medications in liquid form, the collection of blood samples and the like.

With regard to over-the-needle catheters, there are mainly two major alternatives. The first one, the open IV catheter system, comprises luer through which the needle is withdrawn after insertion of the catheter into the blood vessel, which is connectable to blood withdrawal or infusion means, as well as an optional port for the same purpose. The second one, the closed IV catheter system, comprises a septum in an catheter hub through which the needle is withdrawn after insertion of the catheter into the blood vessel, closing off the “needle channel” from the environment, and instead has an extension tube extending laterally from the catheter hub, wherein the extension tube is in fluid communication with the catheter hub cavity and the lumen of the catheter positioned in the blood vessel. These two alternatives are accompanied with different problems and benefits.

In recent years, there has been great concern over the contamination of clinicians with a patient's blood and a recognition that “blood contaminated sharps” must be disposed to avoid an accidental needle stick. This concern has arisen because of the advent of currently incurable and fatal diseases, such as Acquired Immunosuppressive Deficiency Syndrome (“AIDS”), hepatitis, etc., which can be transmitted by the exchange of body fluids from an infected person to another person.

As a result of the problem of accidental needlesticks by “blood contaminated sharps”, various needle shields have been developed for use in conjunction with intravenous catheters.

In the field of medicine, such as within the field of devices for infusion and injection, it is known to arrange needle tip shielding devices on the injection or infusion needle, said shielding device having the ability to snap in front of the needle tip upon withdrawal of the needle. These needle tip shielding devices have historically been manufactured in stainless steel. After the manufacturing and packing of the devices for infusion and injection, the devices are sterilized for hygienic reasons.

Such a needle tip shielding device is for example disclosed in EP1003588. However, needle tip shielding devices will, when being arranged in for example a catheter hub, scratch and tear the polymeric catheter hub lumen, resulting in a major risk of flushing plastic material into the blood stream of the patient. Additionally, the manufacturing of such shielding devices of stainless steel is cumbersome and costly, since several punching and bending stations have to be used. Additionally, due to the metal sheet of such device, there is a high risk of “drawer effect” on the needle shaft.

A softer needle shielding device could be used to avoid such scratching. For instance, a plastic needle shield would not scratch the plastic of the catheter hub. However, the softer material characteristics of such a needle shield could also create the risk of it being able to slide over the stopper close to the needle tip, and off the needle.

Hence, a soft needle shield assembly with decreased risk of undue needle shield assembly release with regard to a IV catheter system, is desired.

SUMMARY OF THE INVENTION

Accordingly, the present invention preferably seeks to mitigate, alleviate or eliminate one or more of the above-identified deficiencies in the art and disadvantages singly or in any combination and solves at least the above mentioned problems by providing: an IV catheter system comprising a catheter hub, said catheter hub comprising: a tubular catheter, having a lumen, attached to a catheter hub body at its proximal end, with a catheter hub cavity in fluid communication with the lumen of the tubular catheter; a needle hub, said needle hub comprising: a needle extending distally from a needle hub body, said needle having a bulge and a high friction surface at its distal end zone; a needle shield comprising at least one resilient arm extending distally from a base plate, said base plate having a through hole for receiving the needle there through; wherein the needle hub is arranged in the catheter hub, such that the needle is slidingly arranged through the lumen of said catheter, such that the needle may be withdrawn proximally from the catheter hub; wherein the needle shield is arranged in the catheter hub cavity in a retained manner through cooperation between the needle shield and an inner wall of the catheter hub in said catheter hub cavity, and onto the needle, such that the at least one arm rests upon and is spring loaded by the needle, and the needle is slidingly arranged within the through hole of the base plate, in an assembled state; and wherein the outer diameter of the needle bulge is larger than the inner diameter of the through hole of the base plate when the needle hub is withdrawn from the catheter hub to release the needle shield from the catheter hub and the at least one arm will cover the tip of the needle in a released state: and such needle hub.

Advantageous features of the invention are defined in the dependent claims.

