Syringe with reciprocating, leak-proof needle guard

Details Syringe with reciprocating, leak-proof needle guard Syringe with reciprocating, leak-proof needle guard

1999-11-01

2003-03-25

Nguyen, Anhtuan T. (Department: 3763)

Surgery

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

Treating material introduced into or removed from body...

Reexamination Certificate

active

06537257

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a device and to method. More specifically, this invention relates to a medical device, in the form an improved syringe for dispensing or, alternatively, collecting of potentially infectious biological fluids; and, to the method for the isolating such fluids within the collection device.
2. Description of the Prior Art
The prior art is replete with various contrivances for use in combination with a syringe
eedle to both protect and isolate the needle, both before and after use, so as to prevent inadvertent injury to a clinician or phlebotomist. In addition, the illicit and multiple use of a syringe
eedle has also been the subject of intense focus because of the prospect of transfer of infectious diseases. In each instance, the expedient suggested has been, with minor variation, essentially the same. The needle is initially isolated from the ambient environment prior to use, and subsequent to use, the needle and/or the barrel of the syringe rendered inoperative (preferably without exposure to the collected fluid or to the injury from the used needle). The following patents are representative of the relevant prior art and, are therefore discussed herein. The following patents are discussed in chronological order of their date of issue and, thus, no significance is to be attached to the order of their discussion.
U.S. Pat. No. 2,704,073 (to Jensen, issued Sep. 21, 1953) describes a unique solution dispensing device in the nature of an ampoule or vial having a conventional end (e.g. septum closure for access of medicant fluid contents) and a reciprocating syringe-like piston assembly fitted into the based of the solution container. This piston is connected to an internally mounted needle which is contained within the vial/ampoule. Upon exertion of pressure on the plunger, the needle is advanced a short distance within the vial until it penetrates the septum (from within the vial). It is then available for placement at the dispensing/administration site. Upon insertion of the needle into the patient, the plunger is then advanced further. The further advancement of the plunger, allows for the contents of the vial to be drawn/forced through a hole in the needle shaft and thereby delivered/dispensed fluid from the exposed end thereof. The continued advancement of the plunger within the vial forces the contents from the vial and through the needle. The obvious disadvantage of this system is that the needle also continues to move relative to and in response to the pressure on the plunger, and thus may inadvertently extend beyond the desired depth of tissue penetration or possibly puncture a blood vessel. Moreover, the design adopted by patentee is apparently only useful in the dispensing of the contents of the vial, as opposed to sample collection, because the position of needle changes in the course of movement of the plunger/ram, as does the accessibility of the fluid channel through the needle into the container.
U.S. Pat. No. 5,002,533 (to Jullien—issued Mar. 26, 1991)—describes a needle guard for use with a hypodermic syringe. The needle guard comprises a retractable tubular member that fits over the syringe barrel. The end of the guard is provided with an end-piece that permits, alternate, opening and closing of an aperture at the end of the guard so as to allow the syringe needle to pass through the aperture in the end of the guard upon the retraction of the guard over the syringe barrel. In one of the embodiments of the Jullien device, the end piece is repositioned over the aperture at the end of the guard upon the extension thereof over the needle. The needle is once again forced forward and into the end-piece and thereby blunted, bent or otherwise rendered inoperative so as to prevent its re-use.
U.S. Pat. No. 5,057,087 (to Harmon—issued Oct. 15, 1991) describes a hypodermic needle safety system in which the exposed needle is protected by a removable protective cap. The removable cap is held in place by friction fitting thereof to the end of an axially movable safety sleeve. In use, the cap is removed and the safety sleeve retracted and locked in place on the syringe barrel. Upon conclusion of use of the syringe, the safety sleeve is extended to once again surround the needle. The extent of extension of the safety sleeve is somewhat more advanced than its initial position prior to use to allow for the coupling/locking engagement thereof to the end of the syringe barrel upon its reinstallation. More specifically, the additional extension/advancement of the safety sleeve causes one or more détentes within the protective sleeve to engage and lock the movable safety sleeve onto the syringe barrel upon its insertion of the sleeve. Thus, the syringe can no longer be re-used, while once again protecting one from exposure to injury and transmission of disease.
In one of the alternative embodiments of the Harnon device a sealant/adhesive is disposed at the interface of the guard and the syringe barrel to effect sealing of the guard to prevent inadvertent discharge of fluids from the syringe.
U.S. Pat. No. 5,125,908 (to Cohen—issued Jun. 30, 1992)—describes a hypodermic syringe with a protective holder. The protective holder comprises a tubular structure fitted to the barrel of a syringe. The syringe operates by dispensing fluids from a needle that extends through an aperture in the end of the protective holder. A rubber plug is fitted onto the end of the needle to protect it from damage during the assembly of the syringe and protective holder. Prior to use, the protective holder is retracted to permit advancement of the needle through the aperture at the end of the holder. In the course of advancement of the needle, the needle penetrates the rubber plug that is displaced relative to the needle tip. The contents of the syringe are then dispensed in the traditional manner. Upon completion of the use thereof, the protective holder is re-positioned over the needle from its retracted position to it original protective position; and, the aperture at the end thereof capped as before. Upon retraction of the needle, the rubber plug is not re-positioned over the end of the needle but rather remains remote from the tip of the needle and the aperture in the end of the protective holder.
U.S. Pat. No. 5,139,490 (to Vetter et al—issued Aug. 18, 1992) describes a hypodermic syringe that is typically pre-filled with a medicinal solution (e.g. insulin). The syringe barrel is capped on the dispensing end thereof with a rubber/elastomer seal; and, is fitted on the opposite end of the syringe barrel with a plunger. Prior to use, a needle is fitted to the dispensing end of the barrel. The needle is double ended and, upon mounting to the syringe, pieces the rubber/elastomer seal with one (the distal) end thereof. The act of mounting of the needle on the syringe barrel, thus, causes the distal end of the needle to puncture the seal on the dispensing end of the syringe barrel and thereby permits the plunger to dispense the contents of the syringe through the needle. Presumably the needle can then be removed and the fluid contents remaining within the syringe resealed for use at a later time. Vetter does not disclose how he disposes of the used needle, and presumably it is not reused but rather discarded in the conventional manner.
U.S. Pat. No. 5,647,849 (to Kalin issued Jul. 15, 1997) describes a self-contained safety syringe similar in concept to the device discussed herein relative to U.S. Pat. No. 5,057,087 (to Harmon). The Kalin device is provided with a safety shield that is slidably mounted on a syringe barrel. The open end of this safety shield is covered with a removable cap (and presumably discarded). When it is time to use the syringe, the cap is pealed off the end of the safety shield and the safety shield retracted over the barrel. In one of the alternative embodiments of this invention, the cap is not separately removed, rather the needle simple punctures this shield upon relative movement of the shield and the nee

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