Surgery – Diagnostic testing – Liquid collection
Reexamination Certificate
2001-09-26
2003-09-09
Hindenburg, Max F. (Department: 3736)
Surgery
Diagnostic testing
Liquid collection
Reexamination Certificate
active
06616616
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention concerns a system for storing and providing lancets for collecting body fluids, in particular for blood collection, and it concerns a corresponding working process for the system for the purpose of collecting body fluids and in particular for blood collection.
The examination of samples of body fluids and in particular blood samples in clinical diagnostics enables an early and reliable detection of pathological states and a 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 milliliters 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 microliters of blood and sometimes even less is often sufficient for individual analyses which are specific 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 microliters of blood or even amounts of blood in the nanoliter range 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 devices (so-called blood collection instruments, blood lancet devices or 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. Examples of lancets and lancing devices are the commercially available devices (lancing devices) and lancets Glucolet® from the Bayer AG Company and Softclix® from Roche Diagnostics GmbH. Such lancets and devices (lancing devices) are for example the subject matter of EP-A 0 565 970.
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 containing a plurality of lancets (usually in a disordered arrangement and loosely packed). Subsequently the lancing device is prepared for receiving the lancet by for example unscrewing or pulling off a protecting cap to expose the lancet holder of the lancing device. The lancet removed from the pack is manually inserted into the lancet holder of the lancing device and fixed there. Then the protective cover has to be manually removed from the lancet. Subsequently the lancing device is sealed again with its protecting cap. The 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 to collect blood.
The many manual operating steps in conventional lancet systems (lancet and lancing device) are felt to be disadvantageous by the user and are particularly problematic when perception is limited in a hypoglycaemic state. Moreover the user is not prevented from using a once inserted lancet several times for lancing and collecting blood. Multiple use of a lancet must be prevented for hygienic reasons especially when the lancet is used by more than one person which for example may be the case in doctors practices or hospitals or if misuse for example by children cannot be excluded. On the other hand the repeated use of lancets also leads to increasing pain for the user since the lancets are designed for single use and rapidly become blunt when used several times. Furthermore with the lancing devices and lancets of the prior art there is a risk that 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 U.S. Pat. No. 5,514,152, U.S. Pat. No. 5,152,775, U.S. Pat. No. 4,794,926 and U.S. Pat. No. 5,035,704 which store several lancets and can use these individually and in succession for lancing processes. After the lancing process the lancets can be removed individually from the device. Storage in a magazine and the ability to automatically dispense lancets helps to avoid mistakes when placing a lancet in a lancing device. In order to carry out the lancing movement, the lancet in the blood collection device (lancing device) must firstly be moved or deflected in a lancing direction (i.e. it's tip moves towards the body region to be pierced) and subsequently retracted as rapidly as possible into its initial position. In conventional lancet systems such as those described in EP-A 0 565 970 the part of the lancet that faces away from the tip is enclosed as tightly as possible by a lancet holder which is part of the lancing device and is moved in the lancing direction (forwards) as well as back to the starting position (backwards). The forwards and backwards movement is accomplished by a single drive mechanism which is often driven by a spring.
An automatic change of lancets by for example using a lancet magazine is difficult to realise with such a system in which it is necessary to enclose the lancet in a lancet holder. Moreover the lancet must have a lancet body which is adapted to the lancet holder and makes a firm connection between the lancet and holder especially to ensure the backwards movement. Consequently the lancets are often voluminous and their storage in a magazine would lead to large dimensions of the lancet system.
The lancet system described in U.S. Pat. No. 4,794,926 utilizes the elastic force of a leaf spring which is part of the lancet to move the lancet forwards and backwards. However, this propulsion method is unsuitable for essentially needle-like lancets.
A lancet system is known from U.S. Pat. No. 5,578,014 in which the drive of the lancet for the forwards movement operates independently of the drive for the return movement. The return movement is effected by a spring driven plunger which is part of the lancing device and acts on the lancet from behind i.e. on the end facing away from the tip. The return movement is driven by a spring which is incorporated in the lancet. Similar systems are described in U.S. Pat. No. 5,029,583 and DE-A 198 55 465. A disadvantage of this variant is that each lancet has to be equipped with its own spring which makes the manufacturing process complicated and expensive. Moreover it is very difficult to miniaturize the system.
Attempts to reduce the manufacturing costs for such lancets which are mass-produced articles (so-called disposables) often results in the obligatory use of cheap return springs. In this case the material properties are often subject to large variations which also means that there are also considerable variations in the return speeds. This can have a negative impact on the pain sensation during the lancing process.
The object of the invention is therefore to eliminate the disadvantages of the prior art. In particular it is an object of the present invention to provide a system for collecting blood or other body fluids which provides a plurality of lancets in the smallest possible space. This object is achieved by the subject matter of the invention.
SUMMARY OF THE INVENTION
The invention concerns a system for storing and providing lancets to collect a body fluid and in particular for blood collection. The invention also concerns a process for temporarily extending the tip of an essentially needle-shaped lancet from a system for storing and providing lancets to collect body fluids and in particul
Argauer Herbert
Deck Frank
Fritz Michael
Immekus Claudio
List Hans
Brinks Hofer Gilson & Lione
Foreman Jonathan
Hindenburg Max F.
Roche Diagnostics Corporation
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