Compact needle point shield

Details Compact needle point shield Compact needle point shield

1999-09-24

2001-05-01

Yasko, John D. (Department: 3763)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

C604S198000, C604S264000

Reexamination Certificate

active

06224569

ABSTRACT:

BACKGROUND OF THE INVENTION
The subject invention relates to a catheter and introducer needle assembly that includes a needle shield that will safely shield the sharp distal tip of the introducer needle after the needle has been used to insert the catheter into a patient.
Catheters, particularly intravascular (IV) catheters, are used for infusing fluid, such as normal saline solution, various medicaments and total parenteral nutrition, into a patient or withdrawing blood from a patient. Peripheral IV catheters tend to be relatively short, and are on the order of about one and one-half inches 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. 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 peripheral blood vessel, i.e a smaller blood vessel that is not connected directly to the heart but is one of the branches of the central blood vessels that is directly connected to the heart. In order to verify proper placement of the assembly in the blood vessel, the clinician confirms that there is flashback of blood in the needle and in a flashback chamber located at the proximal end of the needle, which is typically formed as part of the needle hub. Once proper placement is confirmed, the clinician applies pressure to the blood vessel by pressing down on the patient's skin over the distal tip of the introducer needle and the catheter. This finger pressure occludes further blood flow through the introducer needle. The clinician withdraws the introducer needle, leaving the catheter in place, and attaches a fluid handling device to the catheter hub. Once the introducer needle is withdrawn from the catheter, it is a “blood contaminated sharp” and must be properly handled.
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 immediately disposed. This concern has arisen because of the advent of currently incurable and fatal diseases, such as Acquired Immunosuppressive Deficiency Syndrome (“AIDS”), which can be transmitted by the exchange of body fluids from an infected person to another person. Thus, contact with the body fluid of an AIDS infected person must be avoided. As noted above, if an introducer needle has been used to place a catheter in the vein of an AIDS infected person, the introducer needle is a vehicle for the transmission of the disease. Although clinicians are aware of the need to properly handle “blood contaminated sharps”, unfortunately in certain medical environments, such as emergency situations or as a result of inattention or neglect, needlesticks with contaminated introducer needles still occur.
As a result of the problem of accidental needlesticks by “blood contaminated sharps”, various needle shields have been developed. Generally, such needle shields work for their intended purpose but could be improved. For example, some needle shields are bulky, difficult to use or require special features or techniques to be operative.
SUMMARY OF THE INVENTION
It is therefore an object of this invention to provide a needle shield that is compact.
It is another object of this invention to provide a needle shield that is simple and easy to use.
It is still another object of this invention to provide a needle shield that requires no special features or technique to be operative.
The catheter and introducer needle assembly with needle shield of this invention includes a catheter having a distal end and a proximal end connected to the distal end of a catheter hub. The introducer needle has a sharp distal tip and a proximal end connected to the distal end of a needle hub. A flashback chamber is defined in the needle hub. Typically a vented plug is located in the open proximal end of the flashback chamber to allow air to escape from the flashback chamber when blood enters the flashback chamber from the introducer needle. The catheter is coaxially disposed over the introducer needle so the sharp distal tip of the introducer needle is distal of the distal end of the catheter. The introducer needle also defines, along a distal portion thereof, an enlarged diameter portion.
The needle shield includes a main body portion defining a main chamber into which the introducer needle extends, a proximal opening and a distal opening. The proximal opening has a diameter sufficient to allow the proximal portion of the introducer needle to extend therethrough but that is too small to allow the enlarged diameter portion of the introducer needle to pass therethrough. Thus, the enlarged diameter portion of the needle in cooperation with the size of the proximal opening prevents unwanted proximal movement of the introducer needle with respect to the needle shield once the introducer needle has been withdrawn into the needle shield after use. Alternatively, a separate telescoping element may be disposed in the needle shield to cooperate with the enlarged diameter portion of the introducer needle to prevent unwanted proximal movement of the introducer needle. A movable transverse barrier adjacent to the distal opening to the needle shield flexes out of the way to allow the introducer needle to be withdrawn proximally into the main chamber. Once the sharp distal tip of the needle has been withdrawn proximal of the distal opening, the transverse barrier returns to its unbiased position covering the distal opening to prevent unwanted distal movement of the introducer needle and to capture the sharp distal tip of the needle in the main chamber.
The needle shield is sized so that it fits snugly within the catheter hub. There should be an interference fit between the outside of the needle shield and the inside of the catheter hub so that the needle shield cannot be easily removed from the catheter hub. Conversely, the interference fit should not be so tight as to cause difficulty in removing the needle shield from the catheter hub when desired.


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