Surgery – Instruments – Cutting – puncturing or piercing
Utility Patent
1999-11-10
2001-01-02
Buiz, Michael (Department: 3731)
Surgery
Instruments
Cutting, puncturing or piercing
C606S182000
Utility Patent
active
06168606
ABSTRACT:
BACKGROUND AND SUMMARY OF THE INVENTION
Single-use lancets for drawing capillary blood reduce the risk of HIV, hepatitis and other bloodborne diseases. Typically, the needle of these devices is driven into the patient's skin by a small spring which is cocked by the technician just prior to use. The safety cap with its attachment keeps the end of the lancet sterile and, since it can be used as a kind of pushrod, it is also employed by the user to cock the device. When pulled off, the needle is exposed and the device, having been cocked, is ready for use. Such a device is described in U.S. Pat. No. 5,487,748 to Marshall.
A disadvantage of the Marshall device is the ease with which it can be recocked using the same pushrod-type needle cap. The needle cap can simply be replaced over the end of the lancet and pushed inward to once again cock the spring of the lancet. While such an action is unlikely by a professional blood drawer, it is nevertheless an undesirable feature of a lancet constructed in this fashion.
The safety cap of the present invention positively cannot be used to recock a spring-driven lancet. The safety cap to be described uses a thin plastic fiber to pull off the needle cap and because of its flexibility no significant compressive force can be exerted through it to cock the device. In this design, the spring is cocked during assembly before closure of the case. A precooked device is preferable from the point of view of the user because it avoids the necessity of pushing in a pushrod to cock the lancet, therefore saving time and avoiding repetitious pressure against the user's finger. If the device is indeed precooked during the manufacturing process, the trigger mechanism must be secure enough to avoid accidental firing, especially during shipping and handling. In a precooked lancet device, plastic creep can be a problem so construction must be rugged enough to withstand over time the considerable pressure of the cocked spring.
Ideally, the trigger should be comfortable to the user's hand and should be intuitive in its use. To keep costs low, the trigger should be preferably molded with the body of the device so that no separate parts are required.
The trigger for a spring-driven lancet may be at the end of the device as described by Sullivan in U.S. Pat. No. 5,147,375 or Crossman in U.S. Pat. No. 5,100,427. A second method, in which the trigger is pinched between the thumb and index finger, is described in 5,487,748. In the relatively flat Marshall device, the trigger has a rocker-like action and projects 5 to 6 millimeters above the body, making it prone to accidental firing.
The trigger mechanism of the present invention has an up and down motion and is formed as a part of the body which reduces cost. There is a comfortable concave shape to its upper surface for the tip of the finger, and it projects only about a millimeter above the general surface of the body to reduce the risk of accidental triggering. The contact surfaces are fairly broad, which reduces the problem of long-term plastic creep if it is stored in the cocked position. The design has been optimized for an automatic assembly process so that, when the trigger is made as part of the clamshell body, closure of the body will always correctly align the top and bottom halves of the trigger.
A primary object of the invention is to provide a single-use lancet device having a removable safety cap protecting the needle tip wherein the safety cap cannot be utilized to recock and reuse the lancet device.
A further object of the invention is to provide a pre-cocked single-use lancet device.
Another object of the invention is to provide a single-use precooked lancet device with a rugged trigger design which prevents accidental firing of the device during shipping and handling.
Another object of the invention is to provide a single-use lancet capable of using a chisel tip needle for pediatric use.
Other objects and advantages will become apparent from the following description and drawings, wherein:
REFERENCES:
patent: 4889117 (1989-12-01), Stevens
patent: 4994068 (1991-02-01), Hufnagle
Decker Lance G.
Harding John D.
Levin Paul D.
Buiz Michael
Johnsonbaugh Bruce H.
King Anthony S.
Palco Labs, Inc.
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