Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-09-23
2003-10-07
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S170010
Reexamination Certificate
active
06629956
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to parenteral fluid transfer apparatus having a body member through which fluids are parenterally delivered to and/or withdrawn from a patient (human or animal) through venipuncture or the like. More particularly, this invention is directed to such apparatus having a needle and a self-blunting mechanism.
2. Related Art
For reasons which have received wide publicity, there is substantial demand for self-blunting venipuncture products which may be employed by healthcare workers with minimal risk of incurring accidental needle-stick wounds. A highly successful venipuncture product of this nature is sold under the trademark PUNCTUR-GUARD® by Bio-Plexus, Inc. of Vernon, Conn. The PUNCTUR-GUARD® blood collection needle assembly is manufactured in accordance with the teachings of U.S. Pat. No. 4,828,547, issued on May 9, 1989 to Carl R. Sahi et al, the disclosure of which is hereby incorporated herein by reference. In the PUNCTUR-GUARD® product, a tubular blunting member is disposed within the bore of a needle, i.e., a needle cannula having a conventional beveled tip suitable for penetrating tissue to initiate venipuncture. The blunting member and needle combination of the syringe is initially in an insertion configuration, in which the tissue puncture tip of the needle extends beyond the blunt tip of the blunting member, so normal penetration of the needle into tissue is not affected. The user takes a conventional finger and thumb grip on the barrel finger rest and plunger thumb rest to manipulate the needle. After venipuncture has been achieved, but prior to removal of the needle from the patient, the user advances the syringe plunger relative to the needle by applying thumb and finger pressure to the thumb and finger rests, thus advancing the blunting member so that the tip of the blunting member extends beyond the tissue-penetrating tip of the needle. In this extended configuration of the blunting member and needle combination, the needle tip is effectively blunted to thereby prevent accidental needle-stick wounds upon or after removal of the needle from the patient. Such an arrangement offers the advantages of being economical, reliable and simple in construction and in use.
Another known, commercially available device that makes use of a self-blunting needle assembly is a blood collection needle. The needle assembly comprises a needle cannula mounted in a hub. The hub is configured to engage a standard blood collection tube holder. The assembly comprises a blunting component that comprises a hub having a tubular member extending therethrough. One portion of the tubular member (referred to as the blunting member) extends from the blunting component hub, terminates with a blunt end, and is configured to be slidably received within the needle cannula. The other end of the tubular member extends from the blunting component hub in the opposite direction and terminates with a puncture tip for puncturing the seal on a conventional blood collection vial. The blunting component hub slidably engages the needle component hub and is movable from a retracted position in which the blunt end of the tubular member is within the needle cannula, placing the assembly in a sharpened, insertion configuration, to an extended position in which the blunt end of the tubular member extends beyond the tip of the needle cannula, thus blunting the needle and placing the assembly in a blunted configuration. A groove and detent arrangement between the needle hub and the blunting component hub secures the assembly in the blunted configuration. The assembly is secured in the holder in the insertion configuration. The user grasps the collection tube holder to insert the needle cannula into a patient's vein. Then, a blood collection tube is inserted into the holder and the puncture tip of the tubular member penetrates the seal on the vial, permitting blood to flow into the tube. To blunt the needle, the user pushes the collection vial further into the holder, causing the seal to bear upon the blunting component hub and to advance the blunting component into the extended position to blunt the needle assembly.
The art shows attempts to reduce the accidental needle-stick danger associated with the use of other medical sharps as well, often by the use of exterior sheathing devices such as that of McCormick et al, U.S. Pat. No. 5,176,655. Other medical sharps devices employing needle-sheathing devices are illustrated by Dombrowski et al U.S. Pat. No. 4,790,828; Dombrowski et al U.S. Pat. No. 4,978,344; Vaillancourt U.S. Pat. No. 4,804,371; and Karczmer U.S. Pat. No. 4,795,432.
U.S. Pat. No. 4,627,841 to Dorr, issued on Dec. 9, 1986, discloses an infusion needle having a needle mounted in a hub and a hollow blunting member mounted in a hub and being telescopically received within the needle. A spring pulls the hubs together, causing the forward end of the blunting member to extend beyond the needle tip. The rearward end of the blunting member is secured to a tube or other fluid flow device. The device comprises wings that carry wedges and that are folded towards each other to provide a haft by which the user manipulates the needle. When the wings are folded towards each other, the wedges are driven between the needle hub and the blunting member hub, thereby separating the hubs by overcoming resistance of the spring and causing the blunting member to retract into the needle.
SUMMARY OF THE INVENTION
Generally, the present invention overcomes the above-discussed and other deficiencies and disadvantages of the prior art by providing novel and improved parenteral fluid flow apparatuses for subcutaneous delivery of fluids to, and/or withdrawal of fluids from, a patient.
One broad aspect of the present invention provides a needle apparatus comprising a cannula component comprising a needle cannula and a blunting member. The needle cannula has a longitudinal axis, a puncture tip, and a needle passageway therethrough, and the blunting member has a blunt end. The needle cannula and the blunting member are disposed telescopically one within the other and are configured for movement (i) from an insertion configuration in which the puncture tip of the needle cannula extends beyond the blunt end of the blunting member, (ii) to a blunted configuration in which the blunt end of the blunting member extends beyond the puncture tip to blunt the apparatus. There is a haft connected to the cannula for use in manipulating the cannula component, and an oblique motion deployment means for moving the apparatus from the insertion configuration to the blunted configuration independently of the function of the haft means.
A needle apparatus in accordance with the present invention may have a fluid flow passageway therethrough and may comprise a needle component having a needle component passageway therethrough and comprising a hub portion and a needle cannula, the needle cannula having a longitudinal axis and being joined to, and extending from, the hub portion and having a proximal end and a puncture tip. There is also a blunting component comprising a blunting member having a proximal end and a blunt distal end, the blunting component being dimensioned and configured to be received in the needle component passageway. The blunting component and the needle component are movable relative to each other from an insertion configuration, in which the puncture tip of the needle cannula extends beyond the blunt end of the blunting member, to a blunted configuration, in which the blunt distal end of the blunting member protrudes beyond the puncture tip of the needle cannula, thus blunting the needle cannula. There is an oblique motion deployment means for moving the apparatus from the insertion configuration to the blunted configuration, and a haft connected to the needle component for use in manipulation of the needle cannula without moving the apparatus from the insertion configuration to the blunted configuration.
According to one aspect of the invention, the o
Biancardi Gregory F.
Holdaway Richard G.
Kearns Richard S.
Polidoro John M.
Sahi Carl R.
Casler Brian L.
Knobbe Martens Olson & Bear LLP
Maynard Jennifer
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