Device and method for sampling and analysing body fluids

The invention relates to a device and a corresponding The method by which the sample of body fluid, for example, Blood, as well as the quantitative or qualitative analysis contained therein Components can be performed.

In clinical diagnosis is the examination of body fluids, in particular blood, an important way to health to verify a patient. The most common tests are doing performed in the Homecare segment with capillary blood from the patient. For Such applications, especially for the determination of the glucose level in the Blood, use the patient Einstechhilfen to slightly injure the skin and to obtain a small drop of blood. This blood is then in the Rule applied to a test strip with the help of a measuring instrument is evaluated. To simplify this complex procedure and the to minimize pain to the patient, are a number of methods and Technologies have been developed. An attempt was made several steps perform with a single device, and also to study the reduce required amount of blood.

Handling is improved with compact devices where the lancing device and the measuring unit are integrated in one device. Such devices are in US 6,352,514, EP 1362551, EP 1360934, EP 1360933, WO 03/088834 and WO 02/101359 described. The US 6352514 and EP 1360933 describe the use of lancet and test strip into individual Sensor units, while from the other writings respective assembly apparent with numerous lancets and sensor units.

A measuring unit with an unspecified test element is made of EP 1287785 is known, a measurement unit with an electric sensor is in US 6,607,658 described, and from EP 1,342,448 is one on an optical Measurement based unit known.

The disadvantages of the known lancing devices, sensor systems and integrated Devices can be summarized as follows: There are relatively large amounts of body fluid, usually blood, needed the sting is painful, the manufacturing cost of corresponding devices are high, the devices are large, heavy and have a high energy demand, hygiene and comfort are improvable.

The object of the present invention is a device and a corresponding method with which the sampling of a Body fluid, such as blood, and the quantitative analysis is to improve constituents contained can be performed, so that the Comfort for the user at low cost is as large as possible.

The object is achieved by a device according to the Claim 1 and a corresponding method.

The device for sampling and analysis of body fluids, thereby is intended, in particular of blood, comprising a handpiece having a pneumatic Driving means receives, and a magazine with at least one Sensor unit, each having a microneedle that firmly with an elastic Diaphragm is connected and contains at least one sensor system. The Hand part and the magazine are advantageously releasably together connected. A conveyor mechanism pushes a first sensor unit from the Magazine on the function body and biases the pneumatic Driving means before the start sampling after its initiation. The at least one sensor unit is packed sterile in the magazine, and a Conveyor system allows the sequential, automated introduction of Sensor units from the magazine to the function body. The Driving means is connected to the sensor unit from the magazine, the se the feature point is, in the manner in interaction that pneumatic drive device via a compressed air space a some pressure on the elastic membrane for insertion of the microneedle exerts on a skin surface for withdrawing body fluid. Subsequently, the pressure on the elastic membrane is reduced. By the Retraction of the membrane in the original form is within the Sensor unit a vacuum is produced and bodily fluid from the Injection site actively transported to at least one sensor system. in the Sensor system by certain components of the body fluid a physical or chemical property change of the sensor system causes.

Advantages of the device according to the invention are a small required amount of body fluid, usually blood, further painless Stinging. The integration of lancing units and sensor units into the Apparatus for single use guarantees to a maximum Hygiene, the additional integration of the measuring unit makes the application very comfortable and easy. With the use of a magazine In addition, other disadvantages overcome: The number of manual Operating steps in the sampling and analysis is reduced, and by the predetermined arrangement of the sensor units in the magazine is a confusion-free operation of the sensor units ensured. weight and Energy consumption of the entire apparatus are also low.

Preferred embodiments of the invention are subject of Subclaims.

The drive means for inserting the microneedle and subsequent Suction of body fluid is based on a simple mechanical Principle is easy to handle and less prone to interference. with a corresponding design of the interior space of the sensor unit, the required sample amount can be optimally reduced to body fluid. The Using a microneedle with a suction support to Promoting blood outlet keeps the pain this low. Especially is low, the detachable connection of handle and magazine, as is characterized it is possible that sensor units in the magazine, or the Magazine with the sensor units perform as sterile disposable. A cost-effective way is for example in the production as Molded part.

A preferred embodiment of the device is that the Handle a measuring unit with display for the determination of the sensor system caused by exposure to certain components of the body fluid physical or chemical property changes contains. The Measurement unit determined from these property changes to Concentration value of a component to be determined of the body fluid, which is then displayed on the display. In this way it is possible in perform a single process, a sampling, the desired Analysis value to determine and display directly to the user.

Similarly, the storage of measured values ​​is possible. The user can previously stored readings call by pressing a button. In a specific embodiment, the result also via transponder or the like are passed to a second device. This second device For example, an automatic syringe or a pump for his administration of appropriate drugs such as insulin. It may be this includes a display device, for example a mobile phone, a Wristwatch, a PC or PDA (<u>P</u>ersonal <u>D</u>igital <u>A</u>ssistant) act.

Since an analysis of body fluids inexpensive, reliable and fast is to take place, are optical methods of measurement of the sensor system, in particular fluorescence spectroscopic measurement methods, especially advantageous. In the Fluorescence measurement can use a minimum area at Sensor System , whereby the production of the sensor units is inexpensive. In a preferred embodiment is a method of detection the FRET method (<u>F</u>luorescence <u>R</u>esonance <u>e</u>nergy <u>T</u>ransfer) used.

The releasable connection between the hand part and the magazine is in advantageously carried out as quickly snap connection. That can for example, be a plug, clamping, snap or adhesive bond. It is important in any case that the loosening and preparing the compound quickly and easily done and a connecting handle and magazine a stable device performs.

For better hygiene and ease of handling, it is provided that a plurality of sensor units are packed in a magazine and in a Operation are inserted into the machine. then from the magazine for each examination a sensor unit by the actuation of a pushed conveyor mechanism on the function and location of the Measurement process prepared. This automation by Conveying mechanism is important because the sensor system of the Sensor unit in a precise position relative to the optical measuring unit of the Handset should be located.

In a further embodiment it is provided that the handle section a comprising adjusting for variable determination of the penetration depth of the microneedle. This is especially advantageous noticeable when the puncture depth be individually adapted to the injection site on the skin soil. It depends strong from the point of puncture on whether the skin surface there thicker or thinner and whether the blood vessels are deeper or less deep.

The penetration depth may be electrically, as in the example by use of a Electric motor, or be determined by a mechanical governor. The electrically controlled adjustment is performed using a ± button, wherein the set value is read on a multi-function display.

Moreover, it is possible that a second adjusting member on the handle for variable determination of the infeed rate is appropriate. To this Way is an individual adjustment possible to the pain possible to keep low. The infeed rate can also be electrically connected Help a ± button set and read on a multi-function display will.

It is also possible for an electronic or mechanical Setting the aspiration of body fluid by means of a third setting member.

The funding mechanism for changing the sensor unit and biasing the Pricking device can simultaneously be used for electric power generation will. Upon actuation of the handle is determined by the movement of the Conveying mechanism a small dynamo rotated. Of this Dynamo electric energy generated, for example, in a battery get saved. The recovered energy can be used for the implementation of Measurement and display the measurement result on the display used will. The power of the battery is used above all for storage and Retrieving the measured data and for setting and storing the Piercing parameters.

The invention is illustrated by way of example with reference to the following drawings.

Show it:

<dl tsize="13"><dt>Fig. 1 a), b)</dt><dd>two schematic representations of the invention Device with magazine in a longitudinal section, in Fig. 1a) in the biased state and in Figure 1b) during the puncture.</dd><dt>FIG. 2a), b)</dt><dd>two schematic illustrations of a sensor unit in the Cross-section, in Fig. 2a) at rest and in Fig. 2b) at the puncture; </dd><dt>Fig. 3</dt><dd>a view of the device from the front with setting keys and Display;</dd><dt>FIG. 4a) -d)</dt><dd>four schematic representations of an inventive Device in longitudinal section in a time sequence that the illustrate functional principle of the device;</dd><dt>Fig. 5</dt><dd>a schematic representation of an inventive Device in longitudinal section with an alternative arrangement the sensor units in the magazine;</dd><dt>Fig. 6</dt><dd>a schematic representation of an inventive Device in longitudinal section with a further arrangement of the Sensor units in the magazine;</dd><dt>Fig. 7</dt><dd>a schematic representation of an inventive Device in longitudinal section with an alternative arrangement the sensor units in the magazine.</dd></dl>

The Fig. 1a) and 1b) show schematically an inventive device with magazine (6) in a longitudinal section. FIG. 1 a) shows a biased state of the device, and FIG. 1 b) shows the device during the puncture. The device consists of a usable again Hand part 1 and at least one disposable sensor unit 2, consisting of a supply hopper 6 is shifted to the operation site. 7 The Sensor unit 2 is disposable and is sterile in the magazine 6, in a for measuring designed, packed distinctive position. In the Hand part 1 is housed a pneumatic drive means consisting of a piston 8 is represented by the force of a spring 9 in a cylinder 10 is driven downwards. The drive means is operated by a Shutter 11, which is pressed on the handle 1 from the outside by a user can be. Furthermore, in the handle 1, a measuring unit 12, a Light guide 13, an electronic unit 14 for evaluation, a battery 15 and electric motors 16 incorporated for setting the functional parameters. Fig. 1 a) shows the biased state, that is, the spring 9 is made of Shutter 11 is still held in position swamped. Figs. 1 b) illustrates how after shifting the sensor unit 2 from the magazine 6 to the Function point 7 a movable cylinder 17 is moved downward. Here not shown, but it is conceivable as an alternative, the cylinder 10 could also are designed to move. Characterized in that the movable cylinder 17 by is moved downward, is formed by a closed space 18, which the piston 8, the fix arranged cylinder 10, the sensor unit 2 and the moving cylinder 17 is enclosed.

FIG. 2a) and 2b) are two schematic illustrations of a sensor unit 2 in cross section. The Fig. 2a) shows a rest state in which the Sensor unit 2 is not used, and Fig. 2b) shows the timing of the Puncture. When triggered, the plunge-the shutter 11 the piston 8 is moved by the spring 9 downward, whereby the air in the closed space is compressed 18th The pressure thus generated pressed a upper diaphragm 4 of the sensor unit 2 downwards, creating a microneedle 3 is also shifted down in the human skin. Variable provide adjustable openings in the moving cylinder 17 or the piston 8 sure that the pressure in the closed space 18 decreases and the flexible Diaphragm 4 of the sensor unit 2 returns to the original shape. Thereby A negative pressure is formed under the diaphragm 4 of the sensor unit 2, by the Body fluid, eg., Blood, from the puncture site into a capillary 19 of Sensor unit 2 sucks.

The procedures for sampling and analysis of body fluids with the A device according to the invention consists of several steps. In a first step exerts absorbed by the hand part 1 pneumatic Drive device via the compressed air space 18 pressure on the elastic membrane 4 for puncturing the at the elastic membrane 4 fortified microneedle 3 from the skin surface, and the microneedle 3 penetrates the skin surface, shown in Fig. 2b). In the pressure action on the elastic membrane 4, the air under the elastic membrane 4 passed through a vent channel 20 to the outside. To the to secure the flow direction of the air to the outside, is located in Venting channel 20 are not illustrated flap valve. Subsequently, the Pressure reduced to the elastic membrane 4 in space 18th By the Retreat of the membrane 4 into the original shape is inside the Sensor unit 2 generates a negative pressure and body fluid from the Injection site actively transported to at least one sensor system. 5 Before the Sensor system 5 is inserted a filter 21, to certain elements of filter out body fluid. In the sensor system 5 is certain Components of the body fluid, a physical or chemical Property change of the sensor system 5 causes. A characterized induced change in optical parameters is a transparent Window 22 measured. In a next step, the measuring unit 12 determines of the property changes, that is the change of an optical Parameter, the concentration value of a component to be determined and displays it on a display 25th

FIG. 3 is a view of the device from the front with setting buttons 26, 27, 28, 29 and display 25. To operate the instrument, the following Functional elements on the handle 1 arranged: a movable handle 23, a release button 24, a multifunctional display 25, a key M (<u>m</u>emory) 26 and for the storage and retrieval of measured values PS (setting parameters, a key<u>p</u>enetration <u>s</u>peed) 27 for setting the Infeed rate, a PD button (<u>p</u>enetration <u>d</u>epth) 28 for Setting the penetration depth, an SS key (<u>s</u>uction <u>s</u>trength) 29 for Setting the suction and a button 30 for the dropping of the used Sensor unit. Alternatively, the used sensor unit 2 is the Actuating the handle 23 dropped. The handle 23 is ergonomically shaped. For this purpose, remain a patch 31 with a roughened surface and a recess 32 for a comfortable and non-slip hold.

FIG. 4a) to d) are four schematic representations of a A device according to the invention in longitudinal section in a time sequence that the Operating principle of the device illustrate. By the pressing of the Handle 23 are placed four different movements in transition:<dl tsize="2" compact="compact"><dt>1.</dt><dd>A sensor unit 2 is from the magazine 6 to the function point 7 postponed</dd><dt>. 2</dt><dd>the movable cylinder 17 is moved upward,</dd><dt>. 3</dt><dd>the spring 9 of the pneumatic driving device is biased and</dd><dt>. 4</dt><dd>a non-imaged dynamo is set in rotation.</dd></dl>

FIG. 4a) shows the initial state of the device with the back usable hand part 1 and designed to be disposable Sensor units 2, preferably before use in a sterile package be stored in the magazine. 6 The movable cylinder 17 and the piston 8 are in their lower position, and an already used Sensor unit 2 has been ejected earlier. Therefore, at Function stop 7 no sensor unit 2. In Fig. 4b) to slight Pressing the handle 23 of the movable cylinder 17 by an arm 33 upwards and a sensor unit 2 in the direction of function point 7 is displaced. At the same time a further mechanism by the handle 23 is operated, the of a rack 34, a gear segment 35, a first lever arm 36 and a second lever arm 37 consists. The gear segment 35 and the Lever arm 36 are rigidly interconnected and have a common fixed axis of rotation at the point of clash. The translation of Movement is dimensioned such that upon complete depression of the Handle 23 according to FIG. 4c) of the second lever arm 37 of the piston 8 with the Guide bar 38 moves up to the highest point, allowing the spring 9 is biased and the trigger 11 can hold the drive means, as shown in Fig. 4d). Shortly before the highest position of the piston 8 in Fig. 4c) already reaches the sensor unit 2, the function point 7. If the piston 8 has reached its uppermost position in Fig. 4d), its holder 39 is the shutter 11 is retained and the lever arm 33 of the moving cylinder 17 clamped out, whereby the movable cylinder 17 not by a Shown spring is displaced downward. Thereby, the space 18 closed below the cylinder. 8 Thus, the device for the measurement prepared. The rack 34 is placed in the FIG. 4c) and 4d), a small Gear 40 in rotation. The gear 40 is not shown with a Dynamo connected, the rotation generated by the current and a Power supply unit, for example a battery charging. The Power supply unit, the power of a complete measurement sequence produce.

In Figs. 5 to 7 are schematic representations of an apparatus in Longitudinal section with various alternative arrangements of the sensor units 2 shown in the magazine. 6 FIG. 5 shows three parallel hinges 41 2 mounted thereon sensor units, in each case six sensor units per band 41. In Fig. 6 the tape 41 is attached on it with the Sensor units 2 folded several times in the magazine 6. FIG. 7 shows a Solution in which the tape 41 with the fixed thereon sensor units 2 for Large part along the inner wall of the magazine 6 is located. From the Fig. 1 is a Another form of accommodation of the sensor units 2 in the magazine 6 announced wherein the sensor units 2 are stacked. The magazine 6 can after the opening of a magazine compartment of the bottom of the handle section 1 are inserted, which corresponds to the pictured in Figs. 1, 5 and 6 Variants, or by opening the rear cover of the handset 1 are inserted, according to the variant in Fig. 7.

The handpiece 1 may be formed symmetrically to the plane shown, so that an exchange of the front cover with the set buttons 26, 27, 28, 29 and the display 25 with the rear cover is possible. So could the Device with asymmetrically molded handle 23 for left-handers also good in the hand.