Venipuncture assistor

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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Details

C604S116000

Reexamination Certificate

active

06652487

ABSTRACT:

FIELD OF INVENTION
This invention relates to a device for use in venipuncture, i.e., the insertion of a needle into a patient's vein in order to draw blood, or to carry out an intravenous treatment of some type.
BACKGROUND OF INVENTION
In performing a venipuncture, the nurse, medical technician or other qualified person always seeks to accomplish the task of inserting the needle—in order to draw blood, start intravenous fluids, or inject some medication—on the first trial. If the first attempt is not successful and another attempt must be made, the patient's discomfort and anxiety are increased, the chances of infection are increased, and the number of sites available for future venipuncture is further decreased. Hence it is important to make the likelihood of a successful insertion on the first try as great as possible.
In the insertion of a needle into a vein, the needle is positioned directly over the chosen vein at an angle that is selected (1) to avoid pushing the needle completely through the vein and out the opposite side, and (2) to bring the tip of the needle into an appropriate final position so that blood can flow back into the hollow needle, or fluids can flow through the needle into the vein. The vein is surrounded and supported by fatty tissue in the cells that make up the connective tissue, and it lies between the skin and the underlying muscle or bone.
Most persons performing a venipuncture sense the depth of the vein below the skin surface by touch as well as by sight. Another source of information for the person doing the venipuncture is the “feel” of the needle tip as it is inserted in the patient's arm or other body part. The needle is first pressed through the skin, which is felt as one layer, then through the intervening fatty tissue as a second layer, and finally through the wall of the vein, which is felt as a third layer. The angle at which the needle is inserted may be adjusted as the venipuncture proceeds, and will usually be changed at least in the latter part of the procedure so that the tip of the needle will stay within the vein.
During this procedure any extreme lateral movement of the vein as the needle is being inserted must be avoided. However, the vein is often difficult to hold steady, as it tends to roll, or move sideways, entirely out of the path followed by the needle as the needle is pressed into the tissue above the vein. When this happens, the tip of the needle pushes the vein aside, the venipuncture is unsuccessful, and another attempt to insert the needle in the patient's vein must be made.
Sometimes the person inserting the needle will try to use his or her fingers to prevent the vein from rolling out of the path of the needle being inserted. This poses the risk of puncturing a finger with the needle, thereby increasing the chance of the operator getting a blood borne disease such as hepatitis B or HIV.
Various complicated, bulky, or cumbersome instruments have been developed for keeping a vein from moving laterally out of the way of the needle as it is being inserted during venipuncture.
U.S. Pat. No. 1,561,116, issued to Silliman on Nov. 10, 1925, discloses a vein stabilizer that has a flat metal plate (or a similar shape formed of wire) for pressing down upon a portion of a distended vein while an immediately adjacent portion of the vein is contained in an opening that is directed towards the heart.
U.S. Pat. No. 1,824,516, issued to Tyvand on Sep. 22, 1931, discloses a vein retainer comprising a complicated plate structure (which carries a pair of adjustable retaining fingers having downwardly turned ends) that is placed over a vein and held there tightly by an adjustable strap. The two fingers carried by the plate press down against the body surface on both sides of a vein for the entire length of the involved portion of the vein, and a third finger (which, extends downwardly from the plate and is positioned transverse to the path of blood flow) pushes down against the vein and restricts the flow of blood so as to distend the vein.
U.S. Pat. No. 2,103,174, issued to Posada on Dec. 21, 1937, discloses a surgical instrument having a plate that comprises a pair of upwardly bowed legs that are connected by spring means to form an opening between the legs, the spring means being manipulable by pressing down separately with the operator's thumb and index finger applied to the bowed legs in order to narrow the width of the opening that retains the vein, and to confine the vein segment being punctured to cause it to swell up and stand out in bold relief.
U.S. Pat. No. 2,234,961, issued to Canada on Mar. 18, 1941, discloses a mechanism consisting of a tourniquet to which a pivoted metal device is attached. This device has two downsloping legs that can be positioned to press downward at a single narrow location on either side of the vein to be punctured.
U.S. Pat. No. 3,324,854, issued to Weese on Jun. 13, 1967, discloses a vein-stabilizing device that is adapted to be attached to the barrel of a syringe and which includes two leg portions (joined by a connecting member) that initially extend beyond the point of the needle and can be pressed down on both sides of the portion of the vein to be punctured, which causes the connecting member to press down against the vein as well, at a location only a short distance beyond the point at which the needle enters the flesh above the vein.
U.S. Pat. No. 4,314,568, issued to Loving on Feb. 9, 1982, discloses two flat members adjustably hinged (at one end only) to form an opening of variable width between them, with means to lock the members in position to press down on both sides of the vein during venipuncture.
U.S. Pat. No. 4,316,461, issued to Marais et al. on Feb. 23, 1982, discloses a long, flat, rigid rectangular base plate with a medially located opening extending for a part of the length of the plate, and a hood adapted to cover and contact the vein for a part of the length of the opening and exert downward pressure on the vein when the base plate is pressed from above. Once the intravenous needle is introduced. into the vein, the whole assembly is held in place with a pair of straps.
U.S. Pat. No. 4,332,248, issued to DeVitis on Jun. 1, 1982, discloses a device having a parallel pair of downwardly extending leg members for receiving and pressing down around a distended vein, and a third member rigidly positioned with respect to the leg members and adapted to guide a needle at a fixed angle to the vein.
U.S. Pat. No. 4,586,924, issued to Lanning on May 6, 1986, discloses a long, flat plate with a notch at one end which leads to a groove under the plate. When the device is in use, the walls of the groove press down on the vein close to the point of insertion of the needle.
U.S. Pat. No. 5,254,095, issued to Harvey on Oct. 19, 1993, discloses a stabilizer for blood vessels that looks like a shortened, widened forceps and functions similarly. It is formed of two resiliently hinged panels. with their outer edges spaced from each other. Each of the panels has a pair of downwardly extending, narrow legs that taper to thin pointed ends (disclosed as being about the thickness of a slightly dull pencil point) for engaging, and pushing inwardly when the device is manually manipulated, against the skin surrounding the vein for the positioning and stabilizing of the vein into which a needle is to be inserted.
U.S. Pat. No. 5,415,647, issued to Pisarik on May 16, 1995, discloses a vascular immobilizer consisting of a flexible, flat, elongated piece of a clear plastic or plastic-like material with a plurality of grooves on its bottom surface arranged parallel to each other and perpendicular to the longitudinal axis of the device, the grooves being of various calibers and having walls arranged at various angles to squeeze and immobilize a substantial length of the vein in the area into which the needle is to be inserted.
None of these many prior patents which are addressed to problems inherent in a venipuncture procedure discloses or suggests the venipuncture assistor of the pr

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