Adjustable endcap for lancing device

Surgery – Instruments – Cutting – puncturing or piercing

Reexamination Certificate

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Details

C606S182000

Reexamination Certificate

active

06451040

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates generally to blood monitoring devices, and, more particularly, to an adjustable endcap for lancing devices used to lance a finger or other areas of the body to harvest blood for monitoring.
BACKGROUND OF THE INVENTION
It is often necessary to quickly obtain a sample of blood and perform an analysis of the blood sample. One example of a need for painlessly obtaining a sample of blood is in connection with a blood glucose monitoring system where a user must frequently use the system to monitor the user's blood glucose level.
Those who have irregular blood glucose concentration levels are medically required to regularly self-monitor their blood glucose concentration level. An irregular blood glucose level can be brought on by a variety of reasons including illness such as diabetes. The purpose of monitoring the blood glucose concentration level is to determine the blood glucose concentration level and then to take corrective action, based upon whether the level is too high or too low, to bring the level back within a normal range. The failure to take corrective action can have serious implications. When blood glucose levels drop too low—a condition known as hypoglycemia—a person can become nervous, shaky, and confused. That person's judgment may become impaired and they may eventually faint. A person can also become very ill if their blood glucose level becomes too high—a condition known as hyperglycemia. Both conditions, hypoglycemia and hyperglycemia, are potentially life-threatening emergencies.
One method of monitoring a person's blood glucose level is with a portable, hand-held blood glucose testing device. In order to check the blood glucose level with the testing device, a drop of blood is obtained from the fingertip using a lancing device. A typical lancing device contains a needle lancet to puncture the skin. Some of these lancing devices have no means of adjusting the depth of penetration of the lancet. These lancing devices cannot accommodate different skin thicknesses which impacts the amount of blood that can be drawn. In addition, these devices cannot accommodate differences in pain tolerances of the person whose blood is being drawn.
Although there are adjustable lancing devices, these devices typically adjust the position of a structural element that engages a lancet holder thereby limiting the travel of the lancet. These are cumbersome to adjust and are subject to rapid deterioration. Other adjustable lancing devices have multiple parts resulting in high costs, and complicated adjustment procedures.
SUMMARY OF THE INVENTION
The present invention is an endcap for a lancing device that adjusts the penetration depth of a lancet in a lancing device allowing the lancing device to be adjusted to accommodate skin thickness and pain tolerance of the person on whom the lancing device is used. The endcap contains adjustment structure and is adapted to fit on an existing lancing device thus reducing the cost.
The endcap of the present invention consists of only two parts, a basecap and a twistcap. Because there are fewer parts than prior art adjustable lancing devices, the cost is reduced and the assembly and use of the endcap of the present invention are simplified. The basecap includes a central post on which the twistcap is mounted. The lancet of the lancing device when triggered, extends through the basecap, across the distance between the basecap and the twistcap, and through and beyond the twistcap. The end of the twistcap is the portion of the endcap that is pressed against the skin of the person from whom blood is to be drawn. The twistcap includes external helical tracks into which fingers on the basecap extend. To adjust the endcap, a user merely needs to twist or rotate the twistcap and the interaction of the fingers and helical tracks moves the twistcap relative to the basecap. The distance the lancet of the lancing device extends beyond the basecap is constant. Therefore, by adjusting the distance between the basecap and twistcap by twisting the basecap, the distance the lancet extends out of the twistcap and into a user's finger is adjusted. Consequently, the user of a lancing device that has an endcap of the present invention can easily adjust the depth of penetration of the lancet merely by rotating or twisting the endcap. There are stops that can be felt and heard by a user as the twistcap is rotated. These stops correspond to different penetration depths and are provided by detents on the central post of the basecap and detent slots on the inside of the twistcap.


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Internet website; Softclix Lancet Device, Mar. 14, 2000, 3 pgs.
Internet website; Soft Touch Lancet Device, Mar. 14, 2000, 2 pgs.
Pictures of Lancets, date unknown (at least prior to Feb. 28, 2000), 1 pg.

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