MXPA00005160A - Analytic measuring device with a puncturing aid - Google Patents

Abstract

The invention relates to a system for determining the presence or the content of an analyte in blood. The system comprises a measuring device (1) for measuring and displaying the change of a characteristic property of a test element, said property being correlated to the analyte, and comprises a puncturing aid (2) for obtaining the blood from a body part of a testee. The invention is characterized in that the measuring device (1) and the puncturing aid (2) are directly connected to one another in a detachable manner. The invention also relates to the utilization of such a system for determining the presence or the content of an analyte in blood.

Description

INSTRUMENT FOR ANALYTICAL QUANTIFICATION WITH DEVICE OF PUNCTURE WITH LANCETA The invention concerns a system and its use to determine the presence or content of a substance to be analyzed in the blood, wherein the system comprises a quantification instrument for quantifying and visualizing the change of a property characteristic of an analysis element that is correlates with the substance to be analyzed and has to do with a lancet puncture device to obtain blood from a body region from a person to be analyzed.

The determination of the content of a substance to be analyzed in particular in the blood, for example glucose or lactate, requires the collection of an adequate amount of sample (blood) and the provision of an adequate quantification system for the substance to be analyzed. In addition to medical practices and laboratories, medical amateurs increasingly carry out such determinations for their own use. The quantification systems that are REF .: 120393 designed to be used by the same people to analyze are widely distributed for the determination and monitoring of blood sugar values ie the blood glucose content in the case of diabetics also to determine other parameters such as content of lactate or cholesterol level.

Conventional quantification systems usually contain elements of analysis in the form of so-called analysis strips that, together with appropriate quantification instruments, allow the determination of one or more substances to be analyzed in the blood. In addition, generally the user also requires a lancet which is used to puncture the skin of particular bodily regions, for example the finger cushion or the ear lobe and thereby obtain blood to be used for quantification. Several manufacturers offer lancing devices for comfortable collection of blood and insert the lancets into the skin in a controlled and guided manner in order to control the depth of the puncture and minimize pain.

Since the user requires several separate components (analysis elements, quantification instrument, lancet puncture device, lancets, etc.), in order to quantify a substance to be analyzed in the blood, it must be loaded with it for external analysis For example when traveling or for sports, it is especially the diabetics, who also have to carry insulin and a syringe, consider it desirable to reduce the individual components that they must have with them.

Therefore there has not been a lack of several attempts to reduce the number of individual components. One solution is to pack the necessary components such as the quantification instrument, the lancet puncture device, lancet and the test strips in a common carrying case. However, these are usually bulky and for example too large and too heavy to be held in a jacket or shirt pocket.

Another solution is to integrate as many of the aforementioned components as possible into a single instrument. An example of this is the integration of a storage system of analysis strips in a quantification instrument as described in US Pat. No. 5,489,414 or US Pat. No. 5,645,798.

The systems in which the lancet puncturing device and the quantization instrument have been amalgamated in a single instrument are described, for example, in US Pat. No. 5,029,583 and in US Pat. No. 4,637,403. Although these integrated systems essentially solve the problem of reducing the number of individual components that one has to carry, the management of such integrated systems for blood collection is unsatisfactory since the systems are generally uncomfortable and comparatively heavy and therefore, make it difficult point accurately at a lancet puncture site.

The aim of the present invention is to eliminate the disadvantages of the prior art. In particular, the goal is to find a system that combines the quantification instrument and the lancet puncture device that allows accurate aiming at the lancet puncture site with a general reduction in the number of individual components that one has to load.

The object is achieved by the subject of the invention as characterized in the patent claims.

The invention is concerned with a system for determining the presence of the content of a substance to be analyzed in the blood comprising a quantification instrument to quantify and visualize the change of a property characteristic of an element of analysis that correlates with the substance to be analyzed and a lancet puncturing device for obtaining blood from a body region of a person to be analyzed characterized in that the quantization instrument and lancet lancing device are directly connected to one another in a detachable manner.

The invention also concerns the use of the system according to the invention to determine the presence or content of a substance to be analyzed in the blood.

Finally, the invention concerns the individual components of the system according to the invention, that is, a lancet puncture device and a quantization instrument which are suitable for a direct connection removable one with the other.

The system according to the invention is suitable for determining the presence of the content of a substance to be analyzed in the blood. The determination of the content of a substance to be analyzed can for example be used for the qualitative diagnosis of an infection (for example with viruses such as HIV or HCV) or for the qualitative determination of a particular state of the body (for example, pregnancy, heart attack) . The determination of the content of a substance to be analyzed can be used to monitor the course of a disease or response to therapy and provides more detailed information on the state of a person's body analyzed. Examples of this are the quantification of blood glucose, the concentration of lactate or cholesterol in the blood and such things. The system according to the invention preferably allows the determination of a parameter. The simultaneous determination of various parameters is also possible in another embodiment of the system according to the invention.

According to the invention, the quantification instrument of the system quantifies and shows the change of a characteristic property in an analysis element that correlates with the substance to be analyzed. The analysis element can be present in any form that is well known to a person skilled in the art for example in the form of an analysis strip or a tube where the reagents that are required for the detection reaction are present in or about the element of analysis. When ~ one or more substances to be analyzed are present, the analysis element allows the generation of a detectable signal as a characteristic property of the analysis element that correlates with the substance to be analyzed. Examples of this are changes in color in a reactive detection layer that can be quantified photometrically, or electrical currents or changes in potential that can be detected by electrode systems. The signals generated in this way are then quantified and evaluated by the quantization instrument by, for example, comparison with calibration values. The different methods of detection and determination are possible depending on the substance to be analyzed that is going to be examined that differs in the physicochemical principle of detections (for example photometry, electrochemistry) and, on the other hand, in the bio (chemical) interactions that lead to characteristic changes, and detectable (for example, detection by means of enzymatic or immunological reactions, analysis of the nucleic acid sequence).

In addition to the quantification instrument, the system according to the invention contains a lancet puncture device that can be used to obtain a blood sample from a person to be analyzed. For example, lancing devices known to the skilled artisan from EP-B 0 565 970 are sold commercially in various forms by various vendors. They are used in combination with lancets to obtain samples for example from the finger bearing or ear lobe in a comfortable, reproducible and painless way.

In the alleged system, the lancet puncturing device is connected according to the invention to the quantization instrument in a direct and detachable manner. It is understood that by direct connection means part of the lancet puncture device of the quantization instrument, they are not • necessary separate additional devices such as bags, covers, tapes or cases to connect the lancet puncture device and the quantization instrument. In contrast, the quantizing instrument or lancet puncturing device or both components contain an appropriate connection means that preferably equalizes and adjusts to each other and allow a detachable connection of the two components of the system. The possible means of connection are plug connections, connections with clamps, connections using profiled rails, connectes by means of magnets or fastening with Sailboat. The connection is preferably by means of plug connections in which case a connection with the aid of a clasp is particularly preferred.

The connection according to the invention between the lancet puncturing device and the quantization instrument can be easily and quickly detached and closed again and therefore allows the system according to the invention to be handled comfortably which makes it more acceptable among the users Because in a preferred embodiment of the invention it should also be possible to obtain blood from a person of analysis by means of the lancet puncture device in a disassembled state also when connected to the quantization instrument it has been proven that a stable connection is particularly advantageous, that is to say, a connection that resists the shearing forces that are exerted during the operation of the lancet puncturing device. A connection with the aid of a clasp is particularly preferred. Broaches are known in various forms, materials and designs such as for writing utensils such as fountain pens, pens or markers.

Preferably the clasp is especially attached to the lancet puncturing device, especially preferably it has an essentially cylindrical shape, similar to a fountain pen as in EP-B 0 565 970 and the quantification instrument which essentially preferably has the shape of a flat cuboid containing a niche with a corresponding shape and particularly preferably one of its narrow side faces that allows the clip to be held with an exact fit and therefore allows a stable, direct and detachable connection of the lancet puncture device and the quantification instrument. The clasp and the corresponding niche for holding the clasp are preferably configured in such a way that when it reaches the stable connection position, it is perceptible by the user in a tactile or audible manner. The combination of the clasp in the lancet puncture device an essentially complementary niche in the housing of the quantification instrument allows an unambiguous, oriented and guided connection of the components of two systems according to the invention where the play between the puncture device with lancet and the quantization instrument is optimized in order to create a stable connection that resists vibration forces and, on the other hand, can be disassembled easily and quickly. The lancing device particularly preferably terminates essentially resting against the narrow side of the quantizing instrument as results and connection with quantizing instrument.

The lancet puncture and accommodation device of the quantization instrument are preferably designed in such a way that it results in a generally compact form. For example, a niche in the form of a pylon that at least partially encloses the lancing device can be provided in the housing of the quantization instrument. In addition to the compactness of the configuration, this also stabilizes the detachable connection between the lancet puncture device and the quantization instrument.

The clip for connecting the lancing device and the quantization instrument can be manufactured from the housing material for the lancing device or the quantization instrument as well as other suitable material. Suitable materials are, for example, metals, alloys or plastics or combinations thereof, for example, metal-coated metals or metallized plastics. The clasp can be a component of the housing which for example is manufactured as a part manufactured by injection in mold or can be a separate component that is, however, permanently connected to the housing.

It has also turned out that the lancet puncture device and the quantization instrument can also be advantageously connected by the conformation of the housing of the quantization instrument. For example, the quantization instrument may contain a flexible gripping cheek on one of the preferably narrow sides of the housing that partially covers the lancet puncturing device and is therefore dependent on removably attaching to the quantization instrument. In this case, it is not necessary to connect the devices to the lancet puncture device to join it to the quantization instrument. In this preferred embodiment of the means for releasably connecting the lancet puncturing device and the quantizing instrument may be an integral component of the housing of the quantization instrument and may for example be incorporated therein during the injection-casting process. However, this means can also be molded as a separate component that is, however, permanently connected to the housing.

The system according to the invention provides the user as a compact system of lancet puncture device and quantification instrument that reduces the number of individual components that the user needs to obtain blood subsequently measuring a blood parameter. An additional advantage is that the user can decide if he wants to use the lancet puncture device connected to the quantization instrument or dismantled from the quantification instrument, which allows a high degree of flexibility in the operation. Moreover, the lancet puncture device can be cleaned in a safe and hygienic manner without risk of damaging the quantification instrument.

The invention is explained in more detail by the following figures 1 to 5.

Figure 1 schematically shows a top view from above of a preferred embodiment of the system according to the invention.

Figure 2 is a schematic top view from the direction A of the system according to the invention shown in Figure 1.

Figure 3 schematically shows the connection mechanism for the lancing device in the quantification instrument of the system according to the invention of Figure 1 based on a partial sectional view.

Figure 4 shows a preferred embodiment of the system according to the invention as an alternative of Figures 1 to 3 based on three partial Figures (A to C).

Figure 5 also shows a preferred embodiment of the system according to the invention as an alternative of Figures 1 to 4 which are also based on three partial Figures (A through C).

The numbers in the Figures indicate: 1 A quantification instrument. 2 A lancing device. 3 A viewer. 4 A functional element for the quantification instrument. 5 A functional element for the lancing device. 6 Connection element 1 (snap). 7 Connection element 2 (complementary niche) 8 A housing wall of the quantization instrument 1. 9 A bra with clamp.

The system shown in Figures 1 to 3 representing a particularly preferred embodiment of the invention is composed of a quantization instrument 1 and a function device with 'lancet 2 which are connected directly and detachably to one another. In this case the lancing device 2 terminates resting essentially against the side of the quantization instrument 1.

The dimensions of the quantization instrument 1 are preferably such that they can be held comfortably in one hand. The lancet puncturing device 2 is essentially in the form of a fountain pen and its size (length, diameter) is essentially matched to the quantization instrument 1 in such a way that protruding or protruding parts are not present for transport and operation of the system.

The quantization instrument 1 contains all the necessary and functional components of which only the viewer 3 and an operator element 4 are shown schematically in Figures 1 and 3. The analysis elements to be quantified with the quantization instrument 1 are inserted in the instrument 1 on the side A in Figure 1 or, alternatively to the instrument 1, can for example be provided by an integrated tank of the analysis tank.

The lancing device 2 also contains all the necessary and functional components of which only a functional element 5 is shown schematically. The lancets for obtaining blood are inserted into the lancing device 2 from side A (Figure 1).

Figure 3 shows a detailed schematic view of the connection elements 1 (snap) 6 and 2 (complementary niche) 7 of which a part of the upper side of the quantization instrument has been left out. The clasp 6 fits exactly into the complementary niche 7 that is formed by the wall of the housing 8 of the quantization instrument 1.

When the lancing device 2 is used, the operator usually dismounts it from the quantization instrument 1 in order to collect the blood as precisely and painlessly as possible. For this purpose a corresponding lancet has to be inserted into the lancing device 2, the lancing device 2 is activated by for example when pulling a spring which subsequently moves to the desired body region such as a finger pad or lobe of the ear from which you try to draw blood. When the functional element 5 is actuated, the lancet punctures the desired body region and therefore the blood is obtained.

Subsequently the blood is applied to the region of application of the sample of an analysis element that is preferably already located in the quantization instrument 1 and at least the application region of the sample of the analysis element is projected onto the instrument of analysis. quantification 1 the quantification in itself begins when the functional element 4 is activated. After the detection reaction has been completed in the analysis element, the quantified value of the determination of the substance to be analyzed appears in the display 3.

In the other preferred embodiment of the system according to the invention shown in Figure 4 which is composed of a lancing device 2 and of the quantization instrument 1, the detachable connection between these two components of the system is also achieved by a clasp 6 in the lancet puncture device 2 and a corresponding complementary niche 7 in the quantization instrument 1. The niche 7 is located in a side wall of the housing of the quantization instrument that matches the contours of the lancet puncture device in order to stabilize the connection between the quantification instrument 1 and the lancing device 2.

The top view in Figure 4 A shows the locations of the quantization instrument 1 and the lancing device 2 in a connected state. Figure 4B is a section through the plane of the quantization instrument 1 and the lancing device 2 indicated by the arrows in Figure 4 A. This cross-section well shows how the side wall of the quantization instrument housing equals the contour of the lancing device 2.

Figure 4C illustrates how the lancing device 2 engages with the quantization instrument 1. The lancing device 2 is oriented parallel to the quantization instrument 1 with the clasp 6 facing the side of the housing containing the niche 7 which is complementary to the clip 6 and the lancing device is connected to the quantization instrument 1 when the clip 6 is inserted in the niche 7. The clip 6, the niche 7 and the pairing of the side wall of the quantization instrument 1 The lancing device with lancet 2 ensures that the connection is stable but can be disassembled again. The connection is dismounted in the reverse sequence to make the connection.

Figure 5 finally shows an alternative connection mechanism for the lancing device 2 and the quantification device 1. In this case the lancet 2 lancing device does not contain any special device that allows a connection to the quantification instrument but more the connection is made by a special conformation of one of the side walls of the housing of the quantization instrument 1. This wall of the housing contains the bracket 9 which in the preferred embodiment of the lancet puncture device 2 shows that it has a round cross section (Figure 5B and C) that partially surrounds it and maintains it in such a way that it can be easily disassembled. The material from which the clamp holder 9 is made is on the one hand simply flexible so that it can be pressed to hold the lancing device with lancet 2 and on the other hand stiff enough to fix the lancing device with lancet 2 once it has been partially surrounded by clamp 9 and rests against the quantization instrument 1.

Figure 5 A shows in a top view how the lancet puncturing device 2 approaches the quantization instrument 1 and is held by the clamp 9 in the quantization instrument 1. A schematic section through the plane of the instrument quantification 1 and lancet puncture device 2 which is indicated by the arrows in Figure 5 A is shown in Figure 5 B. In this cross section one can easily see how the clip bracket 9 is a component of the wall of the housing of the quantization instrument 1 surrounding the lancing device 2. Figure 5 C is like Figure 5 B in that it is a schematic cross-section through the lancing device 2 and the quantization instrument and in this In this case, the arrows are intended to illustrate how the bracket 9 of the housing of the quantization instrument moves apart when the device The puncture with lancet 2 is inserted.

It is noted that in relation to this date, the best method known by the applicant to carry out the aforementioned invention, is the conventional one for the manufacture of the objects to which it relates. Having described the invention as above, the content of the following claims is claimed as property.

Claims (2)

1. A system for determining the presence or content of a substance to be analyzed in the blood comprising a photometric or electrochemical quantification instrument to quantify and visualize the change of a property characteristic of an analysis element that correlates with the substance to be analyzed and a lancet puncture device of a cylindrical shape, similar to a fountain pen for obtaining blood from a body region of a person to be analyzed, characterized in that the quantification instrument and the lancing device are connected in a direct and detachable manner one with the other so that blood can be obtained from a body region of a person to be analyzed with the aid of a lancing device when connected to the quantization instrument as well as when the lancing device is disassemble the quantification instrument.
2. 2. The system as claimed in claim 1, characterized in that the lancet lancing device is connected directly and detachably to the quantization instrument by means of a brooch. . The system as claimed in claim 1 or 2, characterized in that the lancet lancing device is directly and dismountably connected to one of the sides of the quantization instrument. . The system as claimed in one of claims 1 to 3, characterized in that the devices are present in the quantification instrument as well as in the lancing device that allow the quantification instrument and the lancing device to lanceta connect directly and removable. . The lancing device suitable for a system as claimed in one of claims 1 to 4, characterized according to is designed in such a way that it can be connected directly and removably "to a quantization instrument to quantify and visualize the change of a property characteristic of an element of analysis that correlates with the substance to analyze. . The quantization instrument suitable for a system as claimed in one of claims 1 to 4, characterized in that it is designed so that it can. connect directly and removably to a lancet puncture device to obtain blood from the body region of a person to be analyzed.