Surgery – Instruments – Cutting – puncturing or piercing
Patent
1997-06-05
1998-03-24
Buiz, Michael
Surgery
Instruments
Cutting, puncturing or piercing
606182, 128770, A61B 1732
Patent
active
057307539
DESCRIPTION:
BRIEF SUMMARY
FIELD OF INVENTION
The present invention relates to an assembly which is mounted onto an injector (or a projector) which ejects (or projects) a lancet (a needle for blood collection) from which a pricking element protrudes, and the assembly adjusts a pricking depth of the pricking element into an object to be pricked.
BACKGROUND ART
Diabetes is classified into insulin dependent diabetes mellitus (IDDM) and non-insulin dependent diabetes mellitus(NIDDM). It is said to be desirable that a patient of IDDM has to measure his/her blood sugar concentration several times a day, and even a patient of NIDDM has to measure his/her blood sugar concentration several times a week.
Search carried out by WHO shows results that a remainder of life of a diabetes patient who self-controls his/her blood sugar concentration to surely keep at a given level while his/her blood sugar concentration is frequently measured and referred to is clearly longer than that of a patient who does not control so.
In order to measure a blood sugar concentration using commercially available test paper for blood sugar concentration measurement, blood has to be collected in an amount between several microliters and 20 .mu.l depending on a performance of the paper. For such collection, a lancet and an injector which ejects the lancet are used, and blood is usually collected from a finger tip.
A commercially available lancet has a needle as a pricking element of which diameter is 0.8 mm (20 gauge), 0.65 mm (23 gauge), 0.5 mm (25 gauge) or 0.4 mm (28 gauge), and its pricking depth into a skin is in the range between about 2.3 mm and 3 mm.
The diabetes patients range over the infant, the adult and the old or the male and the female, and over various human races, on which a skin thickness of the finger tip from which the blood is collected depends. However, as the lancet used for the blood collection, those having the above mentioned pricking elements are often used. By the way, a manufacturer who produces an apparatus for blood sugar concentration measurement usually sells, in addition to the test paper, a lancet and an injector which ejects (or projects) the lancet.
In order to adapt to different skin thicknesses of a patient or to change an amount of blood to be collected, there have been only provided two types of cap elements which are so constructed that they are mounted onto an end of the conventional injector: one of which has a thicker end surface (or thick wall) having an opening (for shallower pricking); and the other of which has a thinner end surface (or thin wall) having an opening (for deeper pricking). Then, the pricking depth can be changed by replacing the cap with the other. Thus, the depth may be very roughly changed, for example 0.4 mm or 0.7 mm.
Therefore, the following have occurred: The infants having a thin skin has to be pricked through a longer depth than necessary everyday so that their fingers have been considerably damaged. On the other hand, the adult male who has a relatively thick skin cannot collect an effective amount of blood.
In order to solve the above problems, Boehringer Mannheim GmbH (Germany) has sold "Softclix (registered trade mark)" as a blood collection assembly since 1993 which can adjust the pricking depth of the pricking element of the lancet step-wise using a single cap element.
The assembly can adjust the pricking depth of the pricking element of the lancet in multi steps (six steps) by rotating the cap element which is mounted onto an end of an injector body. An adjustable span in six steps total is about 1.2 mm and thus one step can change the depth by 0.2 mm.
Known assemblies such as "Softclix" have good mechanisms for locking a spring as an elastic element which ejects the lancet and for releasing the locked state so as to eject the lancet. However, those mechanisms are complicated and thus the number of parts becomes large, so that the known assemblies are expensive compared with injectors which have been sold before.
As to "Softclix", no stop means for stopping the ejected lancet is provide
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APLS Co., Ltd.
Buiz Michael
Reip David O.
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