Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Patent
1991-10-01
1994-06-21
Rosenbaum, C. Fred
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
604263, A61M 532
Patent
active
053225171
DESCRIPTION:
BRIEF SUMMARY
1. FIELD OF THE INVENTION
This invention relates to the safe disposal of hypodermic needles by a guard device which protects the needle tip from exposure after use. More particularly, it relates to a tip protector which is storable on the needle and which automatically locks over the end of the needle when slid into position by the user.
2. BACKGROUND TO THE INVENTION
2.1 The dangers of infection from accidental contact with the pointed end of used hypodermic needles has long been recognized and is well documented. For example, refer to Jagger, Hunt, Brand-Elnaggar and Pearson, the New England Journal of Medicine, August, 1988. In most procedures, the greatest avoidable risk of accidental needle puncture, or "needle-stick", occurs during handling of the used needle, when it is generally inserted into a protective sheath for disposal. This action usually requires moving the hand which holds the sheath towards the pointed tip of the needle, and any inaccuracy in this operation raises the possibility of a puncture. The risk of this is greatly increased if the operator is working under stress, such as time-pressure or fatigue, or is handicapped by marginal eyesight or unsteady hands.
2.2 A number of devices have been developed to deal with the general problem of needle-sticks, and reference may be made to U.S. Pat. Nos. 4,747,835 (Sandhaus); 4,735,618 (Hagen); 4,735,617 (Nelson, Fieme); 4,731,059 (Wanderer, Sagsfretter); 4,725,267 (Vaillancourt); 4,720,285 (Pickhard); 4,623,336 (Pedicano, Kane); 4,430,082 (Schwabacher, et el), and 4,755,170 (Golden).
2.3 Some of these, for example Sandhaas, Neison/Flome, and Pedicano/Kane, provide an enlarged conical entry to the protective sheath, so that the resulting larger target reduces the chance of the operator missing the entry. This may be combined with some non-manual means of holding the sheath assembly, further reducing the risk. All of these devices require the operator to divert his attention from his immediate task and to exercise some measure of care in placing the needle into the sheathing device.
2.4 Others of these, for example Hagen and Vaillancourt, aspire to attain the desirable goal of keeping the hands wholly behind the sharpened tip of the needle during the manipulation of the protective device. The Hagen design stores the tip protector around the base of the needle, but in this mode the lateral retaining members are folded in an "arms akimbo" configuration, mending to either side of the needle in a manner which could interfere with the proper manipulation of the syringe and needle during insertion and removal. The Vaillancourt design mounts the tip protector at the distal end of a cylindrical bellows coaxial with the needle, which may be collapsed longitudinally to allow storage of the tip protector at the needle base. This is more compact, but requires care and attention during the needle sheathing action to ensure that the needle is properly located within the protector. Failure to do this could result in the needle becoming exposed again. Both designs appear to offer uncertainty of protection in the event of an impact against the tip of the needle, such as might occur if the latter were dropped. As both designs appear to employ flexed plastic or elastomeric joints or folds for their articulation, operation of the device might encounter significant stiffness, depending upon the desired mechanical strength of this articulation and the length of time over which the device was kept in the stored position prior to use.
2.5 Golden provides for a sealing cover to be placed over a needle tip after being slid down the needle from the base. This tip, made of absorbent material that is not normally stored on the needle prior to use, is not of a dimension that would fit conveniently within a storage cover. The positioning of this cover is either by means of eye judgment, relying on a marker on the needle; or by means of a thickened portion formed near the tip of a specially configured needle. This cover does not, however, fasten, clamp or lock onto the nee
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Sircom Richard C.
Solomon Robert S.
Youssef Yousef M.
French David J.
Rafa Michael
Rosenbaum C. Fred
Sero-Guard Corporation
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