HK1135301B - System for collecting samples and method for collecting a liquid sample - Google Patents

Description

Sample extraction system and method for extracting liquid sample

Technical Field

The present invention relates to a sample collection system and method for collecting a liquid sample, in particular a body fluid such as blood or interstitial fluid. The sample extraction here comprises the two steps of creating an opening in the skin by the penetration of a lancet, allowing the sample liquid to flow out of the opening, and collecting the sample on a test element, so that the sample can be analyzed on the test element in a test field.

Background

The examination of blood samples or interstitial fluid enables the early and reliable detection of pathological states and the targeted and informed (fundiert) examination of the physical state in clinical diagnostics. Medical diagnosis is always premised on the extraction of a sample from the blood or interstitial fluid of an individual to be examined.

For taking samples, the skin on the finger belly or on the ear lobe of the person to be examined can be perforated by means of a sterile sharp needle, for example, in order to obtain a few microliters or less of blood for analysis in this way. This method is particularly suitable for the analysis of samples immediately after their extraction.

In particular in the field of so-called "Home-Monitoring", i.e. in the case of simple analysis of blood or interstitial fluid by the layperson and in particular in the case of blood extraction processes to be carried out by diabetics regularly several times a day for blood glucose concentration tests, lancets and devices (so-called lancing aids) suitable for lancets are provided, which are able to extract samples with as little pain and reproducibility as possible. Such lancets and apparatuses (lancing aids) are for example the subject of WO-A98/48695, US 4,442,836, US 5,554,166 or WO 2006/013045A 1.

In-person blood glucose measurements, which are today a worldwide method of spread in diabetes examinations, are carried out. The prior art blood glucose devices comprise an analysis device into which a test element (test strip) is inserted. The test element is brought into contact with a drop of sample which has been removed beforehand by means of a penetration aid, for example from the palm of a finger.

For the analysis of liquid samples, such as body fluids like blood or urine, analytical devices are frequently used in which the sample to be analyzed is placed on a test field of a test element and, if necessary, reacted with one or more reagents in the test field before being analyzed. Optical, in particular photometric and electrochemical, analysis of the test element is the most common method for rapidly determining the concentration of an analyte in a sample. Analytical systems with test elements for the analysis of samples are used in the field of analytics, environmental analytics and in particular in the field of medical diagnostics. Test elements for photometric or electrochemical analysis, in particular in the field of blood glucose diagnostics from capillary blood, are of great value.

There are different forms of test elements. For example, substantially square foils, also referred to as Slides, are known, in the middle of which a multi-layered test field is present. The test element to be diagnosed, which is configured as a strip, is referred to as a test strip. In the prior art, test elements are widely described, for example, in documents CA 2311496A 1, US 5,846,837A, US 6,036,919 a or WO 97/02487.

Other multi-layer test elements known from the prior art are analytical tapes with a large number of test fields, which are wound in magazines ready for use in analytical devices. Such cartridges and analytical tapes are described, for example, in documents DE 10332488 a1, DE 10343896 a1, EP 1424040 a1, WO 2004/056269 a1 and US 2006/0002816 a 1.

The large number of system components (lancets, lancing aids, test elements and analysis equipment) requires a lot of space and leads to relatively complex operations. There are also systems with a higher degree of integration and thus simpler handling, in which, for example, the test element is stored in an analysis device and is available for measurement. The next step of the miniaturization process is carried out, for example, by integrating a plurality of functions or functional elements in a single analytical aid (disposable article). For example, the insertion process and the detection of the analyte concentration by the sensor on the test element can be combined in a suitable manner, so that the operating procedure can be significantly simplified.

From US2006/0155317 a 1a lancet device for producing a puncture wound in a skin surface is known, which comprises an integrated test element in the form of a reference element having a lancet and a sample collection unit. The test element is fixedly coupled to the coupling mechanism of the lancet device at one time. In a first position of the coupling mechanism, the lancet of the test element is actuated and a puncturing movement is carried out by means of a coupling rod and a connecting rod. The entire coupling mechanism with the fixedly coupled test element is then moved by a pivoting movement into a second position in which the opening of the sample collection channel of the test element is located above the puncture point for collecting the liquid sample.

This solution known from US2006/0155317 a1 is relatively complex, since the combination of several perpendicular movements of the coupling mechanism and the necessary pivoting movement of the coupling mechanism with the test element fixedly coupled therein and the necessary separate drive for the lancet movement require a high outlay in terms of design. Furthermore, the described solution is technically difficult to expand to the automated sequential use of a large number of test elements (for example from a magazine).

From WO 2005/107596 a2 it is known to provide a tape with a large number of spaced lancets. According to one embodiment, the tape carries not only the lancets but also a plurality of test elements which are each assigned to one of the lancets. The present invention therefore relates to a tape having a plurality of analytical aids arranged at a distance from one another, which can integrate the puncturing process and the sample collection process in a sample collection system.

Disclosure of Invention

The object of the present invention is to provide a sample collection system and a method for collecting a liquid sample, which allow the functions of puncturing a lance of an auxiliary element for analysis and collecting a liquid sample to be integrated into a test element of the auxiliary element for analysis. The object of the invention is, in particular, to achieve a high degree of integration and a construction size that is as small as possible of the sample collection system.

According to the invention, this object is achieved by a sample collection system for collecting a liquid sample and a method for collecting a liquid sample using a sample collection system. The sample extraction system comprises at least one analytical auxiliary element, wherein the analytical auxiliary element comprises a lancet and a test element and the test element has a test field for analyzing the liquid sample. The sample extraction system comprises a coupling element which can be coupled to the lancet successively in a first position of the analytical aid and to the test element in a second position of the analytical aid. Furthermore, the sample extraction system comprises a drive unit for driving the coupling element from a rest position into an offset position, so that the movement of the coupling element is transmitted to the lancet coupled thereto for performing a sample collection movement or to the test element coupled thereto for performing a sample collection movement.

The analytical aid element is in this respect a special device which combines the two functions of puncturing by a lancet and sample collection, in particular the three functions of puncturing, sample collection and the provision of a chemical test agent for the analysis of a sample. The auxiliary elements for the analysis of the present invention include lancets and test elements. The test element has a test field for analyzing the liquid sample. The test field is in this case a restricted area of the test element in which the liquid sample is located during its analysis, for example, electrochemically or photometrically. The test field can comprise a chemical detection agent which reacts with the sample and thereby causes an effect (for example a color change) which can be evaluated in the analysis, in particular depending on the concentration of the analyte in the sample. In such test zones, for example, the concentration of glucose in a body fluid, such as blood or interstitial fluid, can be analyzed.

For example, a single strip-shaped analytical aid or a plurality of analytical aids arranged on a strip can be used for the invention. The possibility of using not only a single analytical auxiliary element but also a large number of such auxiliary elements is a significant advantage of the sample extraction system according to the invention over the disclosed systems, such as the system disclosed from US2006/0155317 a 1.

According to a preferred embodiment of the invention, a large number of analytical aids are used, for example, which are arranged on the analytical tape. Alternatively, however, the sample extraction system can also be configured in other ways for using a large number of analytical aids. For example, a large number of analytical auxiliary elements can be accommodated on a conveyor belt, wherein the concept of conveyor belt should be understood in a broad sense and can include almost any mechanical connection between adjacent analytical auxiliary elements or a carrier on which lancets and test elements are arranged, such as a link chain, a film connection or another connection. As an alternative, the analytical aids can also be accommodated in cartridges such as rod cartridges, column cartridges (Reihenmagazin), cartridge cartridges or sawtooth cartridges. Furthermore, the analytical aids can also be received on a test element disk, for example a circular test element disk. Such test element trays are known in principle and can, for example, have a plastic, paper or ceramic carrier, which in turn has test elements, for example in the form of lancets arranged in the region of the outer edge and, for example, a chemical test agent zone. The lancet and the chemical test agent region can, for example, be arranged alternately on the test element disk on the circumferential side, the test element disk being rotated stepwise successively relative to the coupling element, so that the lancet can be coupled successively in the first position and the chemical test agent region can be coupled successively in the second position. However, other technical embodiments for using a large number of analytical aids can also be implemented.

The sample extraction system according to the invention comprises a coupling element which can be coupled to the lancet in the first position of the analytical auxiliary element and to the test element in the second position of the analytical auxiliary element. For this purpose, the analytical auxiliary element can be automatically or manually transferred from the first position into the second position. The sample collection system according to the invention preferably comprises, for the automated transport, a transport device for transporting the analytical auxiliary element from the first position into the second position relative to the coupling element arranged in the rest position. If the analytical aids are arranged on an analytical tape which is wound on a reel in a magazine, such a transport device can, for example, rotate the reel for winding the analytical tape by a specific angle of rotation until the next test element or the next lancet is in the desired position relative to the coupling element.

In the present invention, the coupling element is coupled to the lancet needle in the first position and to the test element in the second position. The sample extraction system according to the invention thus differs from known sample extraction systems, for example from the system disclosed in US2006/0155317 a1, in that a fixed initial coupling between the coupling element and the test element is carried out and the coupling state is subsequently maintained, wherein the relative position between the coupling element and the test element is no longer changed.

In particular, the coupling can be carried out such that first the same coupling element is coupled to the lancet in the first position, then the puncturing movement can be carried out, then the coupling element is decoupled and moved into the second position, and then the coupling element is coupled to the test element, and then a sample collection movement can be carried out by the test element. The coupling element can then be decoupled from the test element. It is therefore advantageous to use the same coupling element for coupling to the lancet and to the test element.

If the coupling element is coupled to a lancet, its intended movement from a rest position (undeflected position) into its deflected position causes the lancet to likewise perform a movement, i.e., a puncturing movement. If the coupling element is coupled to the test element, its intended movement from the rest position into the displaced position causes the test element to likewise execute a movement, i.e. a sample collection movement. The sample collection system according to the invention is thus also different from known sample collection systems, such as the system disclosed in US2006/0155317 a1, in which the lancet is driven not by the movement of the coupling element, but by the movement of a coupling rod and a connecting rod that are separate from the coupling element, although the entire coupling element is displaced for the subsequent sample collection.

In the present invention, the lancet or test element can be coupled to the coupling element in any manner known to those skilled in the art that ensures that movement of the coupling element from its rest position to its displaced position results in a puncturing movement of the lancet or in a sample collection movement of the test element. If a plurality of analytical auxiliary elements, i.e. a plurality of lancets and test elements, are arranged on a common carrier, e.g. an analytical tape or carrier tape, the offset can alternatively be carried out in both cases (i.e. the offset of the lancets in the first position and/or the offset of the test elements in the second position) in such a way that the carriers are offset together, so that the position of the lancets or test elements relative to the carrier does not change or changes only slightly, or the offset of the lancets or test elements can be carried out in such a way that the carrier remains substantially stationary and only the lancets or test elements are offset. Of course, the offset position may also be different for the lancet and the test element. For example, for the puncturing movement of the lancet, a different offset (e.g., puncturing depth) can be used than for the sample collection movement of the test element, in which only a slight offset is required. The offset movements may also differ, for example, in their speed.

Coupled here directly or indirectly via other components. For example, the coupling element can engage the auxiliary element to be analyzed in a corresponding position and lift it up by a defined distance when it is moved into the offset position.

An active coupling can be understood here to mean a coupling in which the coupling element is coupled to the analytical auxiliary element in such a way (for example by a force-fitting and/or form-fitting coupling, for example by clamping of the lancet or test element or by a microstructure having barbs which also pull back the lancet or test element when the coupling element is pulled back) that a return movement of the lancet or test element from the deflected position into the rest position is also guided and driven by the coupling element. In general, it is possible in particular to use grippers with a specific surface structure or gripper surfaces made of suitable materials for coupling to the auxiliary elements of the analysis. In contrast, in passive coupling, the coupling element pushes or pushes the analytical auxiliary element, such as the lancet or test element, into an offset position. The analytical aid element should then be moved back into the rest position by an additional drive element, for example by a spring, which is tensioned when the lancet or test element is deflected and acts on the lancet or test element when it is relaxed, so that the lancet or test element is moved back into the rest position. The spring can also be a component of the test element itself, for example a carrier strip of the test element, which exerts a spring action by means of its internal stress.

Furthermore, the sample collection system according to the invention comprises a drive unit which drives the coupling element from the rest position into the displaced position. The drive unit provides, in particular, energy for moving the coupling element and means for transmitting the energy to the coupling element.

According to the invention, the movement of the coupling element from the rest position into the displaced position, which is driven by the drive unit, and the return thereof into the rest position is transmitted to the lancet coupled thereto for carrying out the puncturing movement or to the test element coupled thereto for carrying out the sample collection movement.

The puncturing movement is in this respect a controlled movement in which the lancet is moved forward and then back again by a specific stroke. In this case, the tip of the lancet can project, for example, from an opening in the housing of the sample collection system according to the invention by a predetermined length, wherein this length determines the penetration depth and, for example, penetrates into the skin of a finger pad of a patient in order to produce a skin opening. The speed of the puncturing movement is preferably controlled in such a way that a low-pain puncturing is ensured.

The sample collection movement is in this respect a specific movement in which the test element, in particular the test element contained on the analysis tape, is moved forward and then back again by a specific stroke. This movement is preferably slower than the puncturing movement. In the sample collection movement, a sample collection site (for example, the inlet of a capillary for delivering a sample to the test field of the test element or the test field itself) can project by a specific distance from an opening provided for this purpose in the housing of the sample extraction system according to the invention, so that the sample can come into contact with the sample collection site and be transferred thereto.

The invention further relates to a method for extracting a liquid sample in a sample extraction system by means of at least one analytical auxiliary element, wherein the analytical auxiliary element comprises a lancet and a test element and the test element has a test field for analyzing the liquid sample. In the method, the coupling element of the sample extraction system is coupled to the lancet in the first position of the analytical aid and to the test element in the second position of the analytical aid. The drive unit drives the coupling element from the rest position into the displaced position, so that the movement of the coupling element is transmitted to a lancet coupled thereto for carrying out a puncturing movement or to a test element coupled thereto for carrying out a sample collection movement.

The present invention enables a sample extraction system to be constructed simply and at low cost. The installation space of the sample extraction system according to the invention is kept to a small extent by using the same coupling element for moving the lancet needle (carrying out the puncturing stroke) and subsequently the test element (collecting the sample to be analyzed).

In addition, the coupling elements are coupled individually one after the other to the auxiliary element of the evaluation, as a result of which the coupling mechanism and the drive unit can be significantly technically simplified. No separate drive means for driving the lancet needles is required, which likewise reduces the design expenditure considerably.

According to a preferred embodiment of the invention, the drive unit comprises a mechanical energy store which can output its own energy to the coupling element for moving it into the displaced position, and a motor which can optionally be used to charge the mechanical energy store. In order to achieve a puncture that is as painless as possible, the lancet should be accelerated so much that it penetrates the body part at high speed during the puncturing movement. For this purpose, a mechanical energy accumulator is preferably provided, the energy stored in which can be converted at least partially into kinetic energy of the lancet. After the puncturing movement has been carried out, the energy accumulator is largely or completely discharged. The motor can then supply the mechanical energy accumulator with energy for the next penetration movement. But loading may also be performed manually. An example of an accumulator for a preferred mechanism is a spring that is expanded or compressed by the patient, such as by a motor or manually, to load and relax in order to transfer energy to the lancet. Mechanical accumulators are distinguished by high extraction speeds.

The motor provided for charging the mechanical energy store is preferably an electric motor (in particular a dc motor, brushless external rotor motor) or a Shape Memory Alloy drive ("Shape Memory Alloy Actuator").

Preferably, the drive unit of the sample collection system according to the invention comprises a mechanical motion converter, wherein the coupling element is coupled to the mechanical energy store via the mechanical motion converter. The mechanical movement converter is a device which, in addition, converts the energy released by the energy accumulator mechanically into a desired movement of the coupling element, which movement leads to a puncturing movement of the lancet needle. The mechanical movement converter transfers the energy of the mechanical energy store to the coupling element, which causes the coupling element to move from its rest position into an offset position and back again into the rest position, so that the lancet needle coupled to the coupling element executes a puncturing movement. The drive unit of the sample collection system according to the invention and particularly preferably the mechanical motion converter are preferably designed such that, during the application of the mechanical energy storage, the drive unit or the mechanical motion converter transfers energy (for example of the motor) to the coupling element for carrying out a sample collection movement by the test element. In particular, the mechanical motion converter can simultaneously transmit a loading motion (for example, a tensioning motion for a tensioning spring) driven by the motor or the patient manually for loading the energy accumulator to the coupling element for carrying out a sample collection motion by the test element. In this way, only a single motor or a single operating step of the patient is required for the puncturing movement or for the preparation of the puncturing movement and for the sample collection movement, which in turn saves space for the sample extraction system according to the invention. Time can also be saved by this combination of the functions.

One possible embodiment of this variant is an electric motor which is provided for tensioning a spring which acts as a mechanical energy accumulator. The energy released by the tensioned spring is transmitted via the mechanical motion converter to a coupling element coupled to the lancet needle. The coupling element is thereby moved from a rest position into an offset position and back into the rest position, whereby the lancet needle performs a puncturing movement. The analytical auxiliary element is then transported from the first position into a second position in which the test element is coupled to the coupling element. The motor then tensions the spring (charges the mechanical energy store), wherein the tensioning movement driven by the motor is simultaneously transmitted via the mechanical movement transducer to the coupling element coupled to the test element. The coupling element is thereby moved from the rest position into the offset position and back again, whereby the test element executes a sample collection movement. The spring is then tensioned again and is ready to drive another puncturing movement. This preferred embodiment of the invention is therefore based on the following: the movement for loading the mechanical energy store (for example, a tension spring) is used as the available movement, that is to say for carrying out the sample collection movement by means of the test element.

Furthermore, the invention relates to a method for extracting a liquid sample in a sample extraction system, comprising the following method steps:

the liquid sample is collected on an analytical auxiliary element, which comprises a lancet and a test element having a test field for analyzing the liquid sample, the sample collection movement being performed by driving a coupling element (for example manually or by means of a motor) coupled to the test element through the test element, and

simultaneously charging a mechanical energy accumulator (for example manually or by means of a motor) with energy for driving the puncturing movement of the lancet needle coupled to the coupling element,

wherein the coupling element, which is coupled in series to the lancet and to the test element, moves from a rest position into an offset position and executes a return movement both in the puncturing movement and in the sample collection movement.

According to a preferred embodiment of the invention, the mechanical motion converter has a slide plate with a slide groove, in which an engagement element arranged on the coupling element engages. In this case, the mechanical energy store and, if appropriate, the motor are preferably coupled to the slide body via a drive element, so that the energy of the mechanical energy store is transmitted to the slide body for moving the slide body in a first direction relative to the coupling element, and during the application of the mechanical energy store energy (for example of the motor) can be transmitted to the slide body for moving the slide body in a second direction opposite to the first direction relative to the coupling element. The slide body can thus be moved in one direction by the energy store and in the other direction, for example manually or by a motor. In contrast, the coupling element is positionally fixed in the displacement direction of the slide body, but can be moved perpendicular to the displacement direction from the rest position into the offset position. The engagement element of the coupling element is guided along the slide groove as the slide body moves, which serves as a control curve for the deflection of the coupling element perpendicular to the movement of the slide body. The link is designed as a symmetrical structure with a highest point arranged between two lowest points, so that the coupling element moves in the forward movement of the slide body and in the return movement thereof both through a movement path from a rest position to a position of maximum offset and back into the rest position. The forward movement of the slide body is driven, for example, by a spring and the return movement is driven, for example, by an electric motor when the spring is again tensioned. After the forward movement and before the backward movement, the lancet is decoupled from the coupling element and the test element, in particular the test element contained on the analytical tape, is coupled to the coupling element.

According to a further preferred embodiment of the invention, the mechanical motion converter is designed as a link drive, wherein the link drive has a link and a drive rotor which interact with the coupling element in such a way that a rotary motion of the drive rotor can be converted into a linear motion of the coupling element.

The drive rotor (e.g. drive shaft) can thus be rotated in one direction by the mechanical energy store (e.g. helical spring) and in the other direction (e.g. by a motor). Upon rotation of the drive rotor, the rotational movement is converted by the connecting rod into a linear movement of the coupling element. The angle of rotation is selected in such a way that the coupling element passes through the movement path from the rest position into the position of maximum deflection and back again into the rest position both in the forward rotation and in the return rotation of the drive rotor. In this case, the forward rotation is driven, for example, by a helical spring and can be performed rapidly. The return rotation can be driven, for example, by an electric motor or manually when the helical spring is again tensioned and can be performed slowly.

To illustrate the two concepts of "fast" and slow, the lancing time can be taken into account, for example, in the "fast" lancet movement. For example, the lancet movement can be so fast that a puncturing time of about 2 to 3 milliseconds is required for the last millimeters of the stroke. This means that the velocity is about 0.66 m/s in a time of 2 to 3 milliseconds in a total lift of 2 mm. Typically, the velocity may preferably be between about 0.2 m/s and about 5 m/s, wherein the velocity is preferably between 0.5 m/s and 1 m/s. For "slow" sample collection movement, a total lift of, for example, about 17 mm may be performed in a time of 1 to 2 seconds, which results in a velocity of about 0.85 mm/sec to about 1.7 mm/sec. It is generally preferred that the velocity be in the range of about 0.5 mm/sec to about 5 mm/sec. The dwell time at the peak of the amplitude in such a movement is, for example, in the range of 0.5 seconds, preferably in the range of 0.2 seconds to 2 seconds.

After the forward rotation has been performed and before the return rotation has been performed, the lancet is decoupled from the coupling element and the test element is coupled to the coupling element (or at least is ready for coupling).

The drive unit of the sample collection system according to the invention preferably comprises a drive element which performs at least the following three functions:

1. the energy of the energy accumulator is transmitted as kinetic energy to the coupling element and thus to the lancet needle which can be coupled thereto for carrying out the puncturing movement,

2. the energy of the motor or the energy applied manually by the user is transferred as kinetic energy to the coupling element and thus to the test element that can be coupled thereto, in particular to the test element contained on the analysis strip, for carrying out a sample collection movement, and

3. the energy of the motor or the energy applied manually by the user is transmitted to the mechanical energy storage device for charging the mechanical energy storage device.

In the embodiment variant with a slide, for example, a tappet (Mitnehmer) is used as the drive element, which moves in one direction when the spring (mechanical energy accumulator) expands and in the other direction when driven manually by the user or by the motor, tensions the spring when driven manually by the user or by the motor, and moves the slide body in both movements (by the spring and by the user/motor).

In the embodiment variant with a link drive, a drive rotor can be used as the drive element, which rotates in one rotational direction when the spring (mechanical energy store) is relaxed and in the other direction when driven manually by the user or by a motor, and tensions the spring when rotated manually by the user or by the motor and moves the link and thus the coupling element in both rotations (by the spring and the motor).

Furthermore, the invention relates to a sample extraction system for extracting a liquid sample, comprising a lancet, a housing and a drive unit for driving the lancet such that the lancet can at least partially protrude from the housing for performing a puncturing movement. The drive unit comprises a mechanical energy store which can output its own energy to the lancet needle in order to perform the puncturing movement, and a motor which is optionally used to charge the mechanical energy store. The drive unit comprises a mechanical motion converter, wherein the lancet is coupled to the mechanical energy accumulator by the mechanical motion converter and the mechanical motion converter comprises a link drive. The connecting rod drive has a connecting rod and a drive rotor which interact with the lancet in such a way that a rotary movement of the drive rotor can be converted into a linear movement of the lancet.

Furthermore, the mechanical motion converter or the motor can be coupled to a further system function of the sample collection system or of an evaluation system containing the sample collection system, which is independent of the mechanical energy store. The system function of the mechanical-independent energy store may be, for example, at least one function selected from the group of functions of carrying out a sample collection movement of the test element, delivering an auxiliary element for analysis with a lancet, delivering a test element, and delivering a test element magazine. According to this embodiment, for example, the motor is used as a combined drive. In the case of a combined drive, the (preferably electrically operated) motor on the one hand charges the mechanical energy storage device and at the same time drives another system function offset in time or independent of this. In the case of the sample collection system according to the invention described above, this is the system function of the test element for carrying out the sample collection movement.

In addition, therefore, sample extraction systems with a combined drive are proposed, in which the drive (for example a motor, in particular an electric motor) is coupled to a plurality of system functions. In this case, it is preferred that one of these system functions is the belt transport of an analysis belt with at least one auxiliary element for the analysis. Such a tape transport is preferably carried out in such a way that the analysis tape is moved relative to the housing of the sample collection system and/or relative to the housing of the tape cassette of the sample collection system. Furthermore, the combined drive is used for coupling to at least one further system function. These at least two system functions of the sample extraction system can be selected again, for example, from the group of system functions mentioned above. Furthermore, the concept of the combined drive can also be implemented independently of the previously mentioned preferred features of the proposed sample extraction system, but can preferably be combined with the preferred embodiments of the sample extraction system described above.

The invention further relates to a sample extraction system for extracting a liquid sample, comprising at least one analytical auxiliary element having a lancet and a test element, and a mechanical energy store (e.g. a spring) which can output energy to the lancet for carrying out a puncturing movement. The sample extraction system comprises a transmission element which is coupled to the mechanical energy store and to the evaluation auxiliary element in such a way that a movement of the transmission element simultaneously transmits energy to the mechanical energy store for loading the mechanical energy store and driving a movement of the test element. The sample extraction system can have a number of features of the sample extraction systems described thus far.

The invention also relates to a method for extracting a liquid sample in a sample extraction system by means of at least one analytical auxiliary element, comprising a lancet and a test element, and to a system for carrying out the method according to the invention. The movement of the transmission element of the sample extraction system for charging the mechanical energy accumulator with energy for driving the puncturing movement of the lancet needle serves at the same time for driving the movement of the test element.

The transmission element according to the invention is a specific element for transmitting energy to the energy store of the machine for charging the energy store of the machine. This is, for example, a device for tensioning a spring provided as a mechanical energy accumulator. The loaded mechanical energy store can then output energy for driving the puncturing movement of the lancet of the analytical aid. If the mechanical energy store is, for example, a spring, the spring can output energy to the lancet needle by relaxing itself for carrying out the puncturing movement.

In order to charge the mechanical energy accumulator, at least one component of the transmission element is moved. The component part performs, for example, a linear translational movement or a rotational movement. This movement transfers energy to the mechanical energy store (for example, tensions a spring). The movement of the component parts of the transmission element additionally and preferably independently of the application of the mechanical energy store causes a movement of the test element, for example a sample collection movement, by means of which a liquid sample is collected on the test field of the test element. For example, a movement of a further component of the transmission is generated from a movement of a component of the transmission, which in turn drives a movement of the test element.

The invention also relates to a method for extracting a liquid sample in a sample extraction system by means of at least one analytical auxiliary element, comprising a lancet and a test element, and to a system for carrying out said method. The movement of the transmission element of the sample extraction system for charging the mechanical energy accumulator with energy for driving the puncturing movement of the lancet needle serves at the same time for driving the movement of the test element.

The transmission element can comprise, for example, a link drive or a slide body with a slide groove in the sample collection system according to the invention and/or in the method according to the invention.

In the case of a link drive, for example, the rotary movement of the drive rotor is used to tension the spring (to load the mechanical energy store). The drive rotor can be rotated, for example, by a motor or manually by a user. The link mounted on the driving rotor is moved by the rotational movement of the driving rotor. This movement of the linkage (independent of the tension of the spring) in turn drives the movement of the test element (e.g., sample collection movement).

In the case of a slide, for example, a translational movement of the slide body is used to tension the spring (to charge the mechanical energy store). The slide body can be moved for this purpose, for example, by a motor or manually by the user. The sliding groove present in the slide body and thus also the engagement element engaged in the sliding groove are entrained by the translational movement of the slide body. This movement of the engagement element (guided by the slide channel) in turn drives (independently of the tensioning of the spring) a movement of the test element (for example a sample collection movement).

Furthermore, the transmission element can transmit the energy of the mechanical energy store to the lancet needle by a first movement for carrying out the puncturing movement and simultaneously transmit the energy for loading the mechanical energy store by a second movement and drive the movement of the test element.

In the case of a link drive, for example, a rotary movement of the drive rotor in one direction can be used to tension a spring (to charge a mechanical energy store) and a rotary movement of the drive rotor in the other direction (when the spring is relaxed — to discharge the mechanical energy store) can be transmitted via the link to the lancet for carrying out a puncturing movement.

In the case of a slider, for example, a translational movement of the slider body in one direction is used to tension a spring (to charge a mechanical energy store) and a translational movement of the slider body in the other direction (when the spring is relaxed — to discharge the mechanical energy store) is transmitted via the runner and the engagement element to the lancet for carrying out the puncturing movement.

The invention further relates to an analysis system for analyzing a liquid sample, comprising a sample extraction system according to the invention and a measuring device.

The analysis system can be designed for performing an electrochemical and/or photometric analysis.

In photometric analytical systems, the test element comprises a reagent system whose reaction with the analyte leads to a change (color change) that can be detected photometrically. The reagent is usually located in the test field of the test element, the color of the reagent varying depending on the concentration. This color change can be quantitatively determined by reflectance photometry with the aid of a measuring device.

Electrochemical test elements comprise an electrochemical reagent system, the reaction of which with the analyte influences the voltage applied between the two poles of the test element and/or the current intensity flowing at a specific voltage between the two poles of the test element. In this case, the voltage or current intensity is therefore a physically measurable variable which is determined by a corresponding measuring device integrated in the analytical system and designed as a voltage or current measuring device, and whose change correlated with the concentration of the analyte is converted into analytical data (analyte concentration).

The invention further relates to the use of the sample collection system according to the invention for collecting a blood sample and to the use of the analysis system according to the invention for analyzing the glucose content in a body fluid.

Drawings

The invention is explained in detail below with the aid of the figures. Wherein:

FIGS. 1A to 1F show the movement sequence in a first embodiment of the sample collection system according to the invention with a slide, and

fig. 2A to 2F show the movement sequence in a second, schematically illustrated embodiment of a sample collection system according to the invention with a link drive.

Detailed Description

Fig. 1A schematically shows the initial state of a first embodiment of a sample collection system according to the invention.

The sample collection system comprises an analytical aid 1, wherein this relates to an analytical aid 1 arranged on an analytical tape 2. Only one section is shown from the analysis strip 2. The analytical aid 1 comprises a lancet needle 3 and a test element 4. The test element 4 then has a test field 5 for analyzing a liquid sample, in particular for analyzing a blood sample. The analysis belt 2 can be moved further in a transport direction 6 by means of a transport device (not shown). The lancet needles 3 are arranged on the analytical auxiliary element 1 perpendicular to the transport direction 6.

The sample extraction system comprises a coupling element 7 in the form of a gripper, which coupling element 7 is coupled to the lancet needle (first position of the auxiliary element 1 for analysis) in fig. 1A. Furthermore, the sample extraction system comprises a drive unit 8 for driving the movement of the coupling element 7. The drive unit 8 comprises a spring 9 as a mechanical energy accumulator 10, a motor 11, a slide 12 as a mechanical motion converter 13 and a tappet 14 as a drive element 15 coupling the mechanical energy accumulator 10, the motor 11 and a slide body 16 of the slide 12 to one another. The spring 9 is tensioned (loaded mechanical energy store 10). The slide 12 includes a slide body 16, and the slide body 16 has a slide groove 17. The gate 17 has the shape of a highest point 19 arranged between two lowest points 18 and is designed as a symmetrical structure. The engaging element 34 of the coupling element 7 engages into the sliding groove 17. The coupling element 7 is arranged in a fixed position relative to the possible direction of movement 20 of the slide body 16. The coupling element 7 can be moved only perpendicularly to this movement direction 20 by the sliding groove 17, wherein the engagement element 34 of the coupling element 7 engages in the sliding groove 17. In fig. 1A, the coupling element 7 is shown in its rest position 22.

Fig. 1B shows the sample collection system according to the invention of fig. 1A after triggering of the pricking process.

Upon triggering, the tensioned spring 9 relaxes and the mechanical energy store 10 outputs its stored energy at least partially via the drive element 15 to the slide body 16 as kinetic energy. The slide body 16 is thus moved in a first direction 21 relative to the coupling element 7. In this case, the engagement element 34 of the coupling element 7 moves past the sliding groove 17, as a result of which the coupling element 7 is lifted from the rest position into the offset position 23 shown in fig. 1B. The coupling element 7 reaches the highest point 19 of the slide groove 17. The lancet 3 coupled to the coupling element 7 is thus likewise lifted and, by this movement, penetrates, for example, into a body part of a patient for producing an opening in the skin and taking a blood sample.

Fig. 1C shows the sample collection system according to the invention of fig. 1A and 1B after the puncturing movement has been performed.

After the coupling element 7 has reached the highest point 19 of the slider 17, the slider body 16, as a result of the further relaxation of the spring 9, continues to move relative to the coupling element 7 in the first direction 21. The engaging element 34 of the coupling element 7 continues to move past the slide groove 17 until the spring 9 is completely relaxed. In this state, the coupling element 7 is at the level of the second lowest point 24 of the gate 17, so that it is again in its rest position 22. The lancet needle 3 is now pulled back again and thus its puncturing movement is terminated.

Fig. 1D shows the sample collection system according to the invention of fig. 1A to 1C after the further transport of the analytical auxiliary element.

The transport device (not shown) transports the analytical auxiliary element 1 in the transport direction 6 after the puncturing movement of the lancet 3 relative to the coupling element 7 arranged in the rest position 22 from a first position into a second position, in which the coupling element 7 is coupled to the test element 4. For this purpose, the analytical tape 2 carrying the analytical auxiliary element 1 is advanced (vorspulen) in the transport direction 6 until a desired second position is reached for coupling the test element 4 to the coupling element 7.

Fig. 1E shows the sample collection system according to fig. 1A to 1D in the case of a sample collection movement performed by the test element.

The test element 4 is coupled to the coupling element 7. The motor 11 moves the drive element 15 in a second direction 25 opposite to the first direction 21. Whereby the slide body 16 coupled to the drive element 15 is moved in the second direction 25 relative to the coupling element 7. The engagement element 34 of the coupling element 7 is thereby moved in the opposite direction to fig. 1B over the slide groove 17, thereby lifting the coupling element 7 from the rest position into the offset position 23 shown in fig. 1E. The coupling element 7 reaches the highest point 19 of the slide groove 17. The movement of the coupling element 7 is transmitted to the test element 4 coupled thereto, so that the test element 4 is likewise lifted and brought into contact with, for example, a blood sample on a body part of a patient by this movement for the sample collection.

At the same time, the spring 9 is tensioned by the motor 11 (the mechanical energy storage 10 is charged) by a movement of the drive element 15 in the second direction 25. The energy of the motor 11 is thus simultaneously used for loading the mechanical energy store 10 and for moving the slide body 16 in the second direction 25 relative to the coupling element 7. The slide 12 and the drive element 15 are designed such that, during the loading of the mechanical energy store 10, they transmit the energy of the motor 11 to the coupling element 7 for carrying out a sample collection movement by the test element 4. This is achieved in particular by the design of the coupling of the slide 12, the motor 11 and the mechanical energy store 10 to the drive element 15.

Fig. 1F shows the sample collection system according to the invention of fig. 1A to 1E after a sample collection movement has been carried out.

After the coupling element 7 has reached the highest point 19 of the sliding groove 17, the slide body 16 is moved further in the second direction 25 by the motor 11 relative to the coupling element 7 by means of the drive element 15, wherein at the same time the spring is tensioned further by means of the drive element. The engagement element 34 of the coupling element 7 continues to move past the slide groove 17 until the spring 9 is completely tensioned and the motor 11 is stopped. In this state, coupling element 7 is at the level of first lowest point 26 of gate 17, so that it is again in its rest position 22. The test element 4 is now pulled back again and the sample collection process is thereby terminated. The analysis tape 2 is subsequently transported further in the transport direction 6 by a transport device (not shown) relative to the coupling element 7 until the first position of the next analytical auxiliary element 1 arranged on the analysis tape 2 is reached again. In this first position, as shown in fig. 1F, the lancet needle 3 is coupled to the coupling element 7. The spring 9 is fully tensioned and ready to deliver its energy for another penetration movement.

Fig. 2A schematically shows the second embodiment of the sample collection system according to the invention in its original state.

The sample extraction system comprises analytical aids, this being able to relate to analytical aids 1 individually or arranged on an analytical tape. The analytical aid 1 comprises a lancet needle 3 and a test element 4. The test element 4 has a test field 5 for analyzing a liquid sample, in particular for analyzing a blood sample. The analytical auxiliary element 1 can be moved further in the transport direction 6 by means of a transport device (not shown). The lancet needles 3 are arranged on the analytical auxiliary element 1 perpendicular to the transport direction 6.

The sample extraction system comprises a coupling element 7 in the form of a push rod which is guided by a guide 27 in the direction of the analytical auxiliary element, wherein the coupling element 7 in fig. 2A can be coupled to the lancet needle 3 (first position of the analytical auxiliary element 1). Furthermore, the sample extraction system comprises a drive unit 8 for driving the movement of the coupling element 7. The drive unit 8 comprises a spring 9 as a mechanical energy accumulator 10, a motor 11 and a linkage drive 28 as a mechanical motion converter 13. The spring 9 is tensioned (loaded mechanical energy accumulator 10). The connecting rod drive 28 comprises a connecting rod 29 and a drive rotor 30, which connecting rod 29 and drive rotor 30 interact with the coupling element 7 in such a way that a rotary movement of the drive rotor 30 is converted by the connecting rod 29 into a linear movement 31 of the coupling element 7 (guided by the guide 27). The motor 11 is coupled to the drive rotor 30 in such a way that it can be rotated by a specific angle of rotation when required (in particular to tension the spring 9). The spring 9 is coupled to the drive rotor 30 in such a way that it rotates the drive rotor 30 by a specific angle of rotation when switching from the tensioned state into the relaxed state. The spring 9 outputs the stored energy as kinetic energy to the drive rotor 30 in the process. The drive rotor 30 is coupled to the coupling element 7 via the connecting rod 29. The drive rotor 30 is thus a drive element 15, which drive element 15 couples the motor 11, the mechanical energy store 10 (spring 9) and the coupling element 7 to one another. In fig. 2A, the coupling element 7 is shown in its rest position 22.

Fig. 2B shows the sample collection system according to fig. 2A after triggering of the puncturing operation.

Upon triggering, the tensioned spring 9 relaxes and the mechanical energy accumulator 10 outputs its stored energy at least partially as kinetic energy via the drive rotor 30 to the connecting rod 29. The energy of the spring 9 is transmitted to the drive rotor 30 for this purpose, in order to rotate the drive rotor 30 in a first rotational direction 32, as a result of which the connecting rod 29 is moved in the direction of the auxiliary element 1 to be analyzed. Thereby lifting the coupling element 7 (guided by the guide 27) from the rest position into the offset position 23 shown in fig. 2B. The lancet 3 coupled to the coupling element 7 is thus likewise lifted and, by this movement, penetrates, for example, into a body part of a patient for producing an opening in the skin and taking a blood sample. The lifting of the lancet needle 3 is only schematically illustrated in fig. 2B, wherein the analytical aid 1 actually moves at least partially with the lancet needle 3.

Fig. 2C shows the sample collection system according to fig. 2A and 2B after the puncturing movement has been performed.

After the coupling element 7 has reached the maximum deflection (as shown in fig. 2B), the drive rotor 30 continues to rotate in the first rotational direction 32 as a result of the spring 9 relaxing further, until the spring 9 is substantially completely relaxed. In this state, the rod 29 is pulled back again further from the evaluation aid, so that the coupling element likewise moves back into its rest position 22. The lancet needle 3 is thereby pulled back again and the puncturing movement thereof is thereby ended.

Fig. 2D shows the sample collection system according to fig. 2A to 2C after the further transport of the auxiliary element for the analysis.

After the puncturing movement of lancet 3, a transport device (not shown) transports analytical auxiliary element 1 in transport direction 6 relative to coupling element 7, which is arranged in rest position 22, from a first position into a second position, in which coupling element 7 can be coupled to test element 4.

Fig. 2E shows the sample collection system according to fig. 2A to 2D during the sample collection movement performed by the test element.

The test element 4 is coupled to the coupling element 7. The motor 11 moves the drive rotor 30 (drive element 15) in a second rotational direction 33 opposite to the first rotational direction 32. The connecting rod 29 coupled to the drive rotor 30 is thereby moved again in the direction of the auxiliary element to be evaluated, as a result of which the coupling element 7 is lifted (guided by the guide 27) from the rest position into the offset position 23 shown in fig. 2E. The movement of the coupling element 7 is transmitted to the test element 4 coupled thereto, so that the test element 4 is likewise lifted and brought into contact with, for example, a blood sample on a body part of a patient by this movement for the sample collection. The lifting of the test element 4 is only schematically illustrated in fig. 2E by the lifting of the test field 5, wherein the analytical auxiliary element 1 is actually moved at least partially, preferably completely, with the test element 4.

At the same time, the spring 9 (not shown) is tensioned (the mechanical energy storage device 10 is charged) by the motor 11 by rotating the drive rotor 30 (drive element 15) in a second rotational direction 33. The energy of the motor 11 is thus simultaneously used for charging the mechanical energy store 10 and for moving the connecting rod 29. The drive rotor 30 and the connecting rod 29 are designed in such a way that, during the loading of the mechanical energy accumulator 10, they transmit the energy of the motor 11 to the coupling element 7 for carrying out a sample collection movement by the test element 4. This is achieved in particular by the coupling of the connecting rod 29, the motor 11 and the mechanical energy store 10 to the drive rotor 30 (drive element 15).

Fig. 2F shows the sample collection system according to the invention of fig. 2A to 2E after the sample collection movement has been carried out.

After the maximum deflection of the coupling element 7 has been reached (as shown in fig. 2E), the drive rotor 30 is moved further in the second direction of rotation 33 by the motor 11. The connecting rod 29 is thereby pulled back again until the spring 9 is fully tensioned and the motor 11 is stopped. In this state, the coupling element 7 is again in its rest position 22. The test element 4 is now pulled back again and the sample collection process is thereby terminated. The movement process of fig. 2A to 2F can now be repeated with a new analytical auxiliary element 1.

List of reference numerals

1 auxiliary element of analysis

2 analytical tape

3 pricking pin

4 test element

5 test area

6 direction of conveyance

7 coupling element

8 drive unit

9 spring

10 mechanical energy accumulator

11 Motor

12 skateboard

13 mechanical motion converter

14 tappet

15 drive element

16 skateboard body

17 chute

18 lowest point

19 highest point

20 direction of movement of the skateboard body

21 first direction

22 rest position

23 off-set position

24 second lowest point

25 second direction

26 first lowest point

27 guide device

28-bar linkage driving device

29 connecting rod

30 drive rotor

31 linear motion

32 first direction of rotation

33 second direction of rotation

34 engaging element

Claims (20)

1. Sample extraction system for extracting a liquid sample, comprising a plurality of analytical auxiliary elements (1), wherein the analytical auxiliary elements (1) comprise a lancet (3) and a test element (4) and the test element (4) has a test field (5) for analyzing the liquid sample, wherein the sample extraction system comprises a coupling element (7), and further comprising a drive unit (8) for moving the coupling element (7) from a rest position (22) into an offset position (23),

it is characterized in that the preparation method is characterized in that,

the coupling element (7) can be coupled to the lancet needle (3) in succession in the first position of the analytical auxiliary element (1) and to the test element (4) in the second position of the analytical auxiliary element (1), and

the drive unit (8) is designed to move the coupling element (7) from a rest position (22) into an offset position (23) in order to transmit the movement of the coupling element (7) to the lancet (3) coupled thereto for carrying out a puncturing movement or to the test element (4) coupled thereto for carrying out a sample collection movement.

2. Sample extraction system according to claim 1, characterized by a transport device for transporting the analytical aid (1) from the first position into the second position relative to the coupling element (7) arranged in the rest position (22).

3. Sample extraction system according to claim 1, characterized in that the drive unit (8) comprises a mechanical energy accumulator (10), which mechanical energy accumulator (10) is capable of outputting its own energy to the coupling element (7) for moving the latter into the offset position (23).

4. Sample extraction system according to claim 2, characterized in that the drive unit (8) comprises a mechanical energy accumulator (10), which mechanical energy accumulator (10) is capable of outputting its own energy to the coupling element (7) for moving the latter into the offset position (23).

5. Sample collection system according to claim 3, wherein the mechanical energy accumulator (10) is a spring (9).

6. Sample collection system according to claim 4, characterized in that the mechanical energy accumulator (10) is a spring (9).

7. Sample extraction system according to one of claims 3 or 6, characterized in that the drive unit (8) comprises a motor (11) for charging the mechanical energy accumulator (10).

8. Sample extraction system according to one of claims 3 to 6, characterized in that the drive unit (8) is designed such that it transfers energy to the coupling element (7) during the loading of the mechanical energy store (10) for carrying out a sample collection movement by means of the test element (4).

9. Sample extraction system according to one of claims 3 to 6, characterized in that the drive unit (8) comprises a mechanical motion converter (13) and that the coupling element (7) is connected to the mechanical energy accumulator (10) via the mechanical motion converter (13).

10. Sample extraction system according to claim 9, characterized in that the mechanical movement converter (13) is designed such that it transmits the energy of the mechanical energy store (10) to the coupling element (7) for carrying out a puncturing movement with the lancet needle (3).

11. Sample extraction system according to claim 9, characterized in that the mechanical motion converter (13) has a slide body (16) with a guide groove (17), in which guide groove (17) an engagement element (34) arranged on the coupling element (7) engages.

12. Sample extraction system according to claim 10, characterized in that the mechanical motion converter (13) has a slide body (16) with a guide groove (17), in which guide groove (17) an engagement element (34) arranged on the coupling element (7) engages.

13. Sample extraction system according to claim 11, characterized in that the mechanical energy accumulator (10) and the motor (11) are connected to the slide body (16) via a drive element (15) so that energy of the mechanical energy accumulator (10) is transmitted to the slide body (16) for moving the slide body (16) in a first direction (21) relative to the coupling element (7), and energy of the motor (11) is transmitted to the slide body (16) during loading of the mechanical energy accumulator (10) for moving the slide body (16) in a second direction (25) opposite to the first direction relative to the coupling element (7).

14. Sample extraction system according to claim 9, characterized in that the mechanical motion converter (13) is designed as a link drive (28), wherein the link drive (28) has a link (29) and a drive rotor (30), wherein the link (29) and the drive rotor (30) interact with the coupling element (7) in such a way that a rotary motion of the drive rotor (30) can be converted into a linear motion (31) of the coupling element (7).

15. Sample extraction system according to claim 10, characterized in that the mechanical motion converter (13) is designed as a link drive (28), wherein the link drive (28) has a link (29) and a drive rotor (30), wherein the link (29) and the drive rotor (30) interact with the coupling element (7) in such a way that a rotary motion of the drive rotor (30) can be converted into a linear motion (31) of the coupling element (7).

16. Sample extraction system according to claim 14, characterized in that the mechanical energy accumulator (10) and the motor (11) are connected to the drive rotor (30) such that energy of the mechanical energy accumulator (10) can be transmitted to the drive rotor (30) for rotating the drive rotor (30) in a first rotational direction (32), and energy of the motor (11) can be transmitted to the drive rotor (30) during loading of the mechanical energy accumulator (10) for rotating the drive rotor (30) in a second rotational direction (33) opposite to the first rotational direction.

17. Sample extraction system according to claim 15, characterized in that the mechanical energy accumulator (10) and the motor (11) are connected to the drive rotor (30) such that energy of the mechanical energy accumulator (10) can be transmitted to the drive rotor (30) for rotating the drive rotor (30) in a first rotational direction (32), and energy of the motor (11) can be transmitted to the drive rotor (30) during loading of the mechanical energy accumulator (10) for rotating the drive rotor (30) in a second rotational direction (33) opposite to the first rotational direction.

18. Sample extraction system as claimed in any one of claims 1 to 6, characterized by a plurality of analytical aids (1), wherein the plurality of analytical aids (1) is received in the sample extraction system in at least one of the following ways:

a large number of analytical auxiliary elements (1) are received on the analytical tape (2),

-a number of auxiliary elements (1) for analysis are received on the conveyor belt,

a number of analytical auxiliary elements (1) are received in the magazine,

-a number of analytical auxiliary elements (1) are received on the test element tray.

19. The sample extraction system of claim 18, wherein the cartridge is a rod, column, cartridge, or zigzag cartridge.

20. The sample collection system of claim 18, wherein said test element disk is a circular test element disk.