Surgery – Instruments – Cutting – puncturing or piercing
Reexamination Certificate
1999-09-03
2004-08-31
Ngo, Lien Tm (Department: 3727)
Surgery
Instruments
Cutting, puncturing or piercing
C206S438000
Reexamination Certificate
active
06783537
ABSTRACT:
RELATED APPLICATION
This application claims priority from Application No. 198 40 8560 filed Sep. 7, 1998, in the Federal Republic of Germany, incorporated herein by this reference.
BACKGROUND AND SUMMARY
The invention concerns a system which is suitable for obtaining a body fluid, in particular blood, from a body region of a person to be examined, wherein the system contains a lancing device, two or several lancets and a lancet magazine for storing two or several lancets. The invention additionally concerns a lancing device, lancets and a lancet magazine which are suitable for use in a system according to the invention and it concerns a special method for removing a lancet from a lancet magazine.
The examination of blood samples in clinical diagnostics enables an early and reliable detection of pathological states and the specific and well-founded monitoring of body states. Medical blood diagnostics always requires the collection of a blood sample from an individual to be examined. Whereas several millilitres of blood are collected from a person to be examined by venipuncture for analysis in hospitals and by physicians in private practice in order to carry out many laboratory tests, nowadays only a few microlitres of blood are often sufficient for individual analyses which are specifically for one parameter. Such small amounts of blood do not require venipuncture. On the contrary it is sufficient to obtain blood by pushing a sterile, sharp lancet through the skin e.g. into the finger pad or earlobe of the person to be examined in order to collect a few microlitres of blood for the analysis. This method is particularly suitable when it is possible to carry out the analysis of the blood sample immediately after the blood collection.
Lancets and corresponding instruments (so-called blood withdrawal instruments, blood lancet devices or—as they are referred to in the following—lancing devices) which enable a substantially pain-free and reproducible blood collection are available especially in the so-called home-monitoring field i.e. where medical laymen themselves carry out simple analyses of the blood especially for the regular blood collection by diabetics which has to be carried out several times daily to monitor the blood glucose concentration. Furthermore the use of lancets with lancing devices which lower the psychological threshold when lancing one's own body is of particular importance for children affected by diabetes who depend on regular blood glucose tests. Examples of lancets and lancing devices are the commercially available instruments and lancets Glucolet® from the Bayer AG Company and Softclix® from the Boehringer Mannheim GmbH. Such lancets and instruments are for example the subject matter of EP-A 0 565 970, U.S. Pat. No. 4,442,836 or U.S. Pat. No. 5,554,166.
In the systems that are available at present the lancets for use in lancing devices are usually provided in a loose form. For each lancing process the user manually removes a lancet from a pack, for example a cardboard box or a tube loosely filled with a plurality of lancets in a disordered arrangement. Subsequently the lancing device is prepared for holding the lancet for example by unscrewing or pulling off a protecting cap whereby the lancet holder of the lancing device is exposed. The lancet holder serves on the one hand to hold the lancets, on the other hand it guides the lancet in the actual lancing process. The lancet removed from the pack is manually inserted into the lancet holder of the lancing device and immobilized there. Then the protective cover which surrounds the lancet tip and protects this and the user, must be manually removed from the lancet. Subsequently the lancing device is sealed again with its protecting cap. The protecting cap ensures that the lancet is no longer accessible from outside. It usually has an opening through which the lancet tip can pass during the actual lancing process. Finally the lancing device is tensioned and is available for the lancing process for drawing blood.
The many manual operating steps are felt to be disadvantageous by the user and are particularly problematic when perception is limited in a hypoglycaemic state. Moreover the user will be encouraged to use a once inserted lancet several times for lancing and drawing blood. This is unacceptable for hygienic reasons and the repeated use of lancets also leads to increasing pain for the user since the lancets are designed as disposable articles and rapidly become blunt. Furthermore with the lancing devices and lancets of the prior art there is a risk that lancing devices will be used with lancets that do not fit or that the lancets will be inserted improperly into the lancing devices. Furthermore a user can be accidentally injured when the lancets and lancing devices are used improperly.
There have therefore been no lack of attempts to eliminate the said disadvantages. Lancing devices are known from the US patent documents U.S. Pat Nos. 3,030,959, 4,794,926, 5,035,704 and 5,152,775 in which several lancets are stored and which can use these individually and in succession for lancing processes. Lancets that are linked together are known from U.S. Pat No. 5,514,152 and WO 98/14125 which lancets can be inserted together in a type of lancing device. However, the designs proposed in these documents can only partially solve the said problems and themselves cause some new disadvantages such as a complicated construction of the lancing device and/or lancets, lack of hygiene and/or sterility and inadequate user convenience.
The object of the invention is to eliminate the disadvantages of the prior art. In particular it is an object of the present invention to reduce the number of manual operating steps required to insert a lancet into a lancing device and thus to increase the operating convenience for the user. Furthermore an object of the invention is to ensure that the lancet can be inserted in the lancing device without mistakes and to increase the safety for the user when using the lancing device and lancet especially in hypoglycaemic states.
The object is achieved by the subject matter of the invention as characterized in the patent claims.
The invention concerns a system that is suitable for collecting a body fluid, in particular blood from a body region of a person to be examined containing a lancing device which is suitable for holding a lancet, a lancet magazine for storing two or several lancets which has a transport device for the lancets and an opening into which the lancing device can be inserted to remove a lancet from the lancet magazine, and two or several lancets.
The system according to the invention is suitable for collecting a body fluid, in particular blood from a person to be examined. In this process the lancet that is held, guided and driven by the lancing device pierces the skin of this person to a defined puncture depth and thus forms a tiny wound. A drop of the body fluid, in particular blood of usually a few microlitres up to a maximum of 100 microlitres volume collects on the surface of the wound. The body fluid is preferably used immediately after the collection for a diagnostic examination. However, the body fluid sample can also be used for a later examination.
In particular the system according to the invention can be used to collect capillary blood from a body region such as e.g. a finger pad or an earlobe. The system can be used by the person to be examined himself, for example a diabetic who wishes to determine his blood glucose content and also by a third person e.g. a doctor or a nurse to collect blood samples from a patient.
The system according to the invention contains a lancing device, lancets and a lancet magazine whose form and function are matched to one another to achieve an optimal interaction between the individual system components. The individual components and their interaction is elucidated in more detail in the following.
Lancet Magazine
The central component of the system according to the invention is a lancet magazine. It serves to hold, store and provide th
Kintzig Hans
Kuhr Hans-Juergen
Bose McKinney & Evans LLP
Ngo Lien Tm
Roche Diagnostics GmbH
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