Release device for an analysis device for analyzing a sample contained in a cartridge, analysis device, and method for operating an analysis device

Abstract

The invention relates to a release device (108) for an analysis device (100) for analyzing a sample contained in a cartridge (102). The release device (108) is designed to release a fluid (302) located in at least one fluid chamber (113) of a fluid bar (112) inserted into the cartridge (102), and the release device (108) has a penetrating element (116) for penetrating the fluid chamber (113), wherein the penetrating element (116) is shaped so as to carry out a penetrating movement in order to puncture a sealing film (300) of the fluid chamber (113) in order to release the fluid (302) located in the fluid chamber (113), and a force transmission unit (118) which is designed to transmit an actuating force to the penetrating element (116) by means of a transmission movement, said penetrating movement and / or transmission movement having a rotational movement component.

Description

[0001] Description

[0002] title

[0003] Release device for an analytical device for analyzing a sample contained in a cartridge, analytical device and method for operating an analytical device

[0004] State of the art

[0005] The invention relates to a release device for an analytical device for analyzing a sample contained in a cartridge, an analytical device, and a method for operating an analytical device according to the preamble of the independent claims. The present invention also relates to a computer program.

[0006] Microfluidic analysis systems (so-called lab-on-chips, or LoCs for short) enable automated, reliable, fast, compact, and cost-effective processing of patient samples for medical diagnostics. By combining a variety of operations for the controlled manipulation of fluids, complex molecular diagnostic test sequences can be performed in a microfluidic device, also known as a lab-on-chip cartridge. The processing of the lab-on-chip cartridge and the analysis of the patient sample can take place in a compact analysis device. For this purpose, the cartridge can be inserted into the analysis device, whereby the cartridge can be fixed in the analysis device using a so-called clamping process.

[0007] Disclosure of the invention

[0008] Against this background, the approach presented here presents an improved release device for an analytical device for analyzing a sample contained in a cartridge, an improved analytical device, and an improved method for operating an analytical device, as well as a device using this method and, finally, a corresponding computer program according to the main claims. The measures listed in the dependent claims enable advantageous refinements and improvements of the device specified in the independent claim.

[0009] The approach presented can create a possibility to release fluid within a cartridge by force transmission using a reduced number of actuators within an analytical device.

[0010] A release device for an analytical device for analyzing a sample contained in a cartridge is presented, wherein the release device is designed to release fluid located in at least one fluid chamber of a fluid bar inserted in the cartridge. The release device has a penetration element for penetrating the fluid chamber, wherein the penetration element is shaped to execute a penetration movement based on an actuating force in order to pierce a sealing film of the fluid chamber in order to release the fluid located in the fluid chamber. In addition, the release device has a force transmission unit that is designed to transmit the actuating force to the penetration element by means of a transmission movement, wherein the penetration movement and additionally or alternatively the transmission movement have or have a rotational movement component.

[0011] The analysis device can be used, for example, in the field of diagnostics to examine patient samples. The cartridge can be shaped, for example, as a reagent carrier into which the sample is introduced and which can then be fed into the analysis device for sample analysis. A fluid bar having at least one fluid chamber can be introduced or inserted into such a cartridge. These fluid chambers can usually be closed by a sealing film, which can be opened by the release device for an analysis process. Furthermore, such a fluid bar can be adjacent to a protective membrane of the cartridge, which can prevent the fluid from leaking out after the sealing film is opened. The release device can be shaped as a movable part of the analysis device.The penetration element can, for example, be shaped like a pin and penetrate the fluid chamber without damaging the protective membrane. The force transmission unit can, for example, be formed as part of a drive. Advantageously, voltage peaks can be generated using the actuating force, which can be transferred to the penetration element to open the sealing film.

[0012] According to one embodiment, the force transmission unit can be configured to impart a rotational movement to the penetration element about a rotational axis. The rotational axis and thus a pivot point can, for example, extend through the force transmission unit, so that the penetration element can advantageously rotate about the force transmission unit.

[0013] The power transmission unit can be designed as a cam drive, a crank drive, a lever unit, a screw drive, a worm drive, a spur gear, a bevel gear, or a ring gear drive. The ring gear drive can, for example, function or be designed as a planetary gear. This advantageously ensures reliable power transmission.

[0014] Furthermore, the penetration element can have a form-fitting insert element at a free end. The insert element can be shaped like a ball. The insert element can advantageously simplify opening the sealing film. This means, for example, that less force is required to open the sealing film or that a defined opening gap is created when the sealing film is torn. For example, the insert element can also be arranged on the cartridge.

[0015] The penetration element can be designed as a plunger, a pin, or a cam. The penetration element can advantageously be designed as a sliding pin with a rounded end to slide over a protective membrane without damaging it, while being able to apply sufficient force at a point at a free end of the penetration element to pierce the sealing film.

[0016] According to one embodiment, the penetration element can be coated to reduce friction. Additionally or alternatively, the penetration element can be formed in one or more parts. Teflon can advantageously be used as the coating material, which can reduce friction.

[0017] Furthermore, the penetration movement and, additionally or alternatively, the transfer movement can have a linear movement component in addition to the rotational movement component. This means that, for example, if space is limited within the analyzer, a linear movement can also be used to reliably open the sealing film.

[0018] The release device can have at least one further penetration element for penetrating at least one further fluid chamber of the cartridge in order to be able to carry out a further penetration movement, to be able to pierce a further sealing film of the further fluid chambers in order to release fluid located in the further fluid chambers. The force transmission unit can be designed to transmit the actuating force to the further penetration element by means of the transmission movement, wherein the further penetration movement and additionally or alternatively the transmission movement can have a rotational movement component. The two penetration elements can therefore advantageously be coupled to the force transmission unit. The penetration elements can advantageously be designed identically.

[0019] According to one embodiment, the release device can be configured to sequentially pierce the sealing film of the fluid chamber by the penetration element and the further sealing film of the further fluid chamber (900) by the further penetration element. This means that the different fluid chambers can be opened one after the other. Advantageously, the penetration elements can be arranged in different ways for this purpose. This can also advantageously prevent the protective membrane from rupturing.

[0020] The penetration element and the further penetration element can be arranged with an angular offset of 5 to 15 degrees, in particular 10 degrees, from each other. Advantageously, the angular offset can be used to control the force acting on the protective membrane, for example, without a feedback loop. This also means that damage to the membrane can be prevented. Advantageously, the angular offset can be used to achieve a time offset during the penetration of the penetration elements into adjacent fluid chambers, so that the force required to open the fluid chambers can be reduced. This can also reduce a force peak.

[0021] Furthermore, the force transmission unit can be coupled to an actuating element for actuation by a user or to a drive unit for providing the actuating force. This means that the actuating element can be actuated manually by the user, for example. In this case, the actuating element can be designed as a lever, a button, or a rotary knob, for example. The drive unit can also be electrically controlled, for example, or can trigger or provide the actuating force through an impulse.

[0022] Furthermore, an analytical device for analyzing a sample contained in a cartridge is presented, wherein the analytical device comprises a coupling device for coupling to the cartridge and a release device in a previously mentioned variant. The release device is connected to the coupling device or arranged adjacent to it.

[0023] The analyzer can be used, for example, in diagnostics. The approach presented here can advantageously reduce the size of the analyzer.

[0024] Furthermore, a method for operating an analytical device in a previously mentioned variant is presented, wherein the method comprises a step of transmitting an actuating force by means of a transmission movement to a penetration element using the force transmission unit in order to release a fluid located in a fluid chamber, and a step of executing a penetration movement using the penetration element based on the actuating force in order to penetrate the fluid chamber and pierce a sealing film of the fluid chamber. The penetration movement and, additionally or alternatively, the transmission movement have or have a rotational movement component.

[0025] This method can be implemented, for example, in software or hardware or in a mixed form of software and hardware, for example in a control unit.

[0026] The approach presented here further provides a device configured to perform, control, or implement the steps of a variant of a method presented here in corresponding devices. This embodiment of the invention in the form of a device also allows the problem underlying the invention to be solved quickly and efficiently.

[0027] For this purpose, the device can have at least one computing unit for processing signals or data, at least one memory unit for storing signals or data, at least one interface to a sensor or an actuator for reading sensor signals from the sensor or for outputting data or control signals to the actuator, and / or at least one communication interface for reading or outputting data embedded in a communication protocol. The computing unit can be, for example, a signal processor, a microcontroller, or the like, wherein the memory unit can be a flash memory or a magnetic storage unit.The communication interface can be designed to read in or output data wirelessly and / or via a wired connection. A communication interface that can read in or output wired data can, for example, read this data electrically or optically from a corresponding data transmission line or output it to a corresponding data transmission line. In the present case, a device can be understood as an electrical device that processes sensor signals and, depending on them, outputs control and / or data signals. The device can have an interface that can be implemented in hardware and / or software. In a hardware implementation, the interfaces can, for example, be part of a so-called system ASIC, which contains a wide variety of functions of the device.However, it is also possible for the interfaces to be separate integrated circuits or at least partially comprised of discrete components. In a software-based implementation, the interfaces can be software modules that, for example, exist on a microcontroller alongside other software modules.

[0028] Also advantageous is a computer program product or computer program with program code that can be stored on a machine-readable carrier or storage medium such as a semiconductor memory, a hard disk memory or an optical memory and is used to carry out, implement and / or control the steps of the method according to one of the embodiments described above, in particular when the program product or program is executed on a computer or a device.

[0029] Examples of the approach presented here are shown in the drawings and explained in more detail in the following description. It shows:

[0030] Fig. 1 is a schematic sectional view of an embodiment of an analysis device;

[0031] Fig. 2 is a schematic sectional view of an embodiment of an analysis device;

[0032] Fig. 3 is a schematic representation of a fluid bar in a cartridge;

[0033] Fig. 4 is a schematic representation of a fluid lock in a cartridge; Fig. 5 is a schematic representation of an embodiment of a release device;

[0034] Fig. 6 is a schematic representation of an embodiment of a release device;

[0035] Fig. 7 is a schematic representation of an embodiment of a release device;

[0036] Fig. 8 is a schematic representation of embodiments of release devices;

[0037] Fig. 9 is a schematic representation of an embodiment of a release device;

[0038] Fig. 10 is a schematic representation of an embodiment of a release device;

[0039] Fig. 11 is a schematic representation of an embodiment of a release device;

[0040] Fig. 12 is a schematic representation of an embodiment of a release device;

[0041] Fig. 13 is a schematic representation of a fluid chamber;

[0042] Fig. 14 is a schematic representation of a plurality of insert elements for a release device;

[0043] Fig. 15 is a schematic representation of an embodiment of a release device;

[0044] Fig. 16 is a schematic representation of an embodiment of a release device; Fig. 17 is a schematic representation of an embodiment of a release device;

[0045] Fig. 18 is a schematic representation of an embodiment of a release device;

[0046] Fig. 19 is a schematic representation of an embodiment of a release device;

[0047] Fig. 20 is a schematic representation of an embodiment of a release device;

[0048] Fig. 21 is a schematic representation of an embodiment of a movement pattern of a release device;

[0049] Fig. 22 is a schematic representation of an embodiment of a release device; and

[0050] Fig. 23 is a flowchart of an embodiment of a method for operating a release device.

[0051] In the following description of advantageous embodiments of the present invention, the same or similar reference numerals are used for the elements shown in the various figures and having a similar effect, whereby a repeated description of these elements is omitted.

[0052] Fig. 1 shows a schematic representation of an embodiment of an analysis device 100. The analysis device 100 is designed to analyze input samples, allowing, for example, PCR tests to be performed. For this purpose, a cartridge 102, for example, with a plastic housing and a microfluidic network for processing the sample, can be inserted into a receiving area 104 of the analysis device 100. In one embodiment, the analysis device 100 optionally further comprises a display with a touch function, by means of which settings for the desired analysis process can be manually entered, merely by way of example. Furthermore, the display is designed merely by way of example to display analysis results.

[0053] The analysis device 100 comprises a coupling device 106 for coupling to the cartridge 102, wherein the coupling device 106 is shown only schematically in this exemplary embodiment. Furthermore, the analysis device 100 comprises a release device 108, which is connected to the coupling device 106 or arranged adjacent to it. According to this exemplary embodiment, the cartridge 102 comprises a housing element 110 with a plurality of chambers and a fluid lock 112 with at least one fluid chamber 113, against which a protective membrane 114 of the cartridge 102 rests.

[0054] The release device 108 has a penetration element 116 for penetrating the fluid chamber 113, wherein the penetration element 116 is shaped to perform a penetration movement to pierce a sealing film of the fluid chamber 113 in order to release the fluid located in the fluid chamber 113. Furthermore, the release device 108 has a force transmission unit 118, which is designed to transmit an actuating force to the penetration element 116 by means of a transmission movement. The penetration movement and / or the transmission movement has or have a rotational movement component. According to the illustration in Fig. 1, both the penetration element 116 and the force transmission unit 118 rotate, for example, clockwise so that the penetration element 116 can penetrate the fluid chamber 113. The release device 108 is described in more detail in at least one of the following figures.

[0055] In other words, an optionally manual clamping mechanism is described in an analysis device 100, also called an analyzer, which can be used in conjunction with a lab-on-chip system. The space freed up by the elimination of, for example, a pneumatic piston in a pneumatic clamping variant or the electric motor in an electronic version can be used directly. A lever or button as an actuating element for actuation can, for example, be relocated through a housing opening of the analysis device 100. The cartridge 102 is processed in the analysis device 100 so that various molecular biological detection reactions can be implemented. The system is, for example, an analyzer-cartridge combination, wherein the analysis device 100 contains the components necessary for processing and the cartridge 102 contains the fluids required for the chemical reaction.The approach described here makes it possible to release the fluids either manually or by means of a drive, thus optionally eliminating the need for actuators.

[0056] Fluid bars such as the fluid bar 112 of the cartridge 102 typically comprise at least one plastic reservoir or fluid chamber 113, which is sealed, for example, by a longitudinally perforated metal foil. The reservoirs are available in various sizes, for example, 350 microliters and 650 microliters, which are typically combined into a triple reservoir. The volume indicates the actual fluid volume available in the reservoir. The cartridge 102 is a sandwich structure consisting of several layers: a pneumatic layer, the protective membrane 114, and a fluidic layer. The fluidic layer contains the recesses or cartridge reservoirs into which the fluid bar 112 is inserted before the cartridge 102 is welded.Such a fluid lock 112 is inserted, for example, into fluidic layer tanks during a manufacturing process of the cartridge 102 and then welded to the protective membrane 114, which can be realized and / or designated, for example, as a membrane made of thermoplastic polyurethane (TPU). The release of the liquids contained in the fluid lock 112 occurs through the volume displacement of at least one penetration element 116 of the release device 108, which penetrates into the cartridge 102 during the coupling of the analyzer 100 to the cartridge 102. Fig. 1 shows an example of such a cartridge 102 with an integrated fluid lock 112. During the clamping process, the plunger, i.e., the penetration element 116, first strikes the protective membrane 114, which is elastically and plastically deformed and presses against the sealing film. When a critical force is exceeded by the penetration element 116, the sealing foil tears open and releases the fluid contained therein.

[0057] Fig. 2 shows a schematic sectional view of an embodiment of an analysis device 100, which, for example, corresponds to or at least resembles the analysis device described in Fig. 1. According to this embodiment, the analysis device 100 also has a release device 108, which, however, may differ in its design from the release device 108 described in Fig. 1. According to this embodiment, the force transmission unit 118 has the rotational movement component, and the penetration element 116 has a preferably linear movement component.

[0058] In other words, Fig. 2 shows an opening process in which the penetration unit 116, also referred to as a plunger, penetrates the cartridge 102, strongly plastically deforms the protective membrane 114, tears open the sealing film, and partially empties the medium contained therein into the cartridge tank or fluidic layer tank. The medium is retained in the tanks, for example, by an actively switched diaphragm valve on the cartridge 102, which is initially pressurized. The fluid lock 112 is located upside down in the cartridge tank in the clamped state, which means that one lock top is at the bottom in the sketch. Release is achieved by mechanical displacement of the medium, by penetration of the penetration element 116 into the cartridge 102 and the resulting tearing of the films through force transmission.

[0059] The breaking of the fluid lock 112 is realized or can be realized, for example, by manual mechanisms. This has the advantage that additional actuators in the analyzer can be dispensed with, thus enabling cost reduction. Modifications to the analyzer 100 are primarily envisaged in relation to current analyzers, although the effectiveness of the modifications can also be amplified by additional modifications to the cartridge 102. The modifications to the analyzer 100 include, for example, mechanisms that essentially function as force transmissions and / or force deflections and open the sealing foil of the fluid lock 112 without disrupting the protective membrane 114, as described in more detail in at least one of the following figures.

[0060] For example, after inserting the cartridge 102, the sealing film is opened by a lever mechanism, a cam drive, which can be implemented as a single part or as an assembly, or by a more complex mechanism to achieve high strokes and thus deformations of the sealing film. For example, a user of the analysis device 100 actuates a lever or button. Furthermore, the sealing film can optionally be opened using the principle of a planetary gear using a ring gear drive, which achieves more complex curves of the opening pin that cannot be achieved with conventional cams due to the narrow width of the fluid locks. More precisely, the principle of moving a movable wheel in a stationary ring gear is adapted so that the resulting trochoid has its maximum deflection in the fluid lock 112 and thereby stretches and tears the film.In summary, local voltage peaks are generated, which opens the protective film and allows the fluid to escape.

[0061] Fig. 3 shows a schematic representation of a partial section of a cartridge with an integrated fluid lock 112, as described in at least one of Figures 1 to 2. A basic opening process of a fluid chamber 113, also referred to as a tank, which is a component of the fluid lock 112, is illustrated in Figures 3 to 4. The fluid lock 112 has at least one fluid chamber 113, which is opened by the release device, as described in at least one of Figures 1 to 2. More precisely, the at least one fluid chamber 113 is opened by the penetration element 116 of the release device, wherein the penetration element 116 is shown in simplified form as a plunger according to this exemplary embodiment.

[0062] In Fig. 3, the penetration element 116 is shown in a resting state. This means that the penetration element 116 is not touching the fluid lock 112 and thus the protective membrane 114. A sealing foil 300, which closes the fluid chamber 113 of the lock 112, is also shown untouched. A fluid 302 is also shown in the fluid chamber 113, which reacts with a sample contained in the cartridge, thereby enabling analysis of the sample.

[0063] More specifically, the following figures illustrate further variants and designs for opening the at least one fluid chamber 113, also referred to as a fluid tank. All variants can be integrated, for example, into a complete clamping mechanism of the analyzer or combined with an existing analyzer, for example, by pneumatically pre-tensioning a manifold to release an insertion shaft.

[0064] Fig. 4 shows a schematic representation of a partial section of a cartridge with an integrated fluid lock 112, as described in at least one of Figures 1 to 2. As mentioned in Fig. 3, only a basic opening process of a fluid chamber 113 of the fluid lock 112 using the release device, as described, for example, in at least one of Figures 1 to 2, is illustrated here. In Fig. 4, the penetrating element 116 is arranged in the fluid chamber 113 for this purpose. By the penetration of the penetrating element 116, the sealing film 300 is pierced and the fluid 302 is displaced from the fluid chamber 113. Leakage of the fluid 302 is prevented, for example, by a valve unit and by the protective membrane 114 of the cartridge. In Fig. 4, the elastic protective membrane 114 is shown stretched by the penetrating element 116.

[0065] Fig. 5 shows a schematic representation of an embodiment of a release device 108, as described in at least one of Figures 1 to 4. The release device 108 is also designed here to open the fluid chamber 113 of the fluid lock 112. Here, too, the release device 108 has the penetration element 116 and the force transmission unit 118. The penetration element 116 is shaped to perform a penetration movement to penetrate the fluid chamber 113 in order to pierce the sealing film 300 of the fluid chamber 113 in order to release the fluid 302 located in the fluid chamber 113. The force transmission unit 118 is shaped to transmit an actuating force to the penetration element 116 by means of a transmission movement, wherein the penetration movement and / or the transmission movement has or have a rotational movement component.

[0066] As shown in Fig. 5, both the penetration element 116 and the force transmission unit 118 are rotatable clockwise about a rotational axis. Alternatively, the direction of rotation can also be counterclockwise. This allows stress peaks to be generated locally at a free end of the penetration element 116 without damaging the elastic protective membrane 114, which is achieved, for example, by a rounded end of the penetration element 116. For example, the force transmission unit 118 is designed as a cam drive, a crank drive, a lever unit, a screw drive, or a ring gear drive.

[0067] According to the embodiment shown in Fig. 5, however, the force transmission unit 118 is designed as a cam drive. Due to the rotational movement of the force transmission unit 118, the penetration element 116 is pressed onto the protective membrane 114 and deforms it. The direction of rotation is symbolically represented by a directional arrow 500. For this purpose, the penetration element 116 is shaped as a cam according to this embodiment. In an alternative embodiment, the penetration element 116 can be designed as a tappet or as a pin. Only optionally is the penetration element 116 coated to reduce friction, for example with Teflon. Furthermore, the penetration element 116 can be formed, for example, in one piece or in multiple pieces.

[0068] In other words, the penetration element 116, for example, is manually rotated by a user as a sliding pin or cam around a fixed point. This allows the penetration element to slide along the protective membrane 114 in a pneumatic layer recess of the cartridge and, as a function of the angle, adjusts itself, thereby stretching the sealing film 300. The resulting local tension in the sealing film 300 causes it to tear open and the fluid 302 to be released. The penetration element 116 exerts a sliding movement on the protective membrane 114, which is also referred to below as TPU or TPU membrane. Depending on the coefficient of friction, shearing is induced in the TPU 114 or in the contact. However, this can be minimized by a suitable material pairing, such as when using the penetration element 116 as a Teflon tappet or as a coated tappet.Alternatively, it is conceivable to construct the penetration element 116 in several parts such that a ball or roller and / or at least one ball or roller cap is integrated into the plunger tip to further minimize friction. In principle, the TPU 114 is characterized by very high tear resistance, so that the sliding stress in combination with the low penetration depth of the

[0069] Penetrating element 116 is uncritical

[0070] Since the effect of breaking open by rolling is possibly restricted by the geometric limitations of the components involved, i.e. a rolling movement takes up space in both the longitudinal and transverse directions, a purely linear movement can also be translated or brought about via a crank drive. In addition to reducing the necessary movement space of the mechanism, such a translation has the advantage that a piston element not only performs the task of opening the fluid chamber 113 but also improves the fluid displacement function. In addition, the force and speed can be designed over the angle of rotation by adjusting the parameters crank arm length, for example R, to tappet length, for example L. Here, for example, breaking open, where a high force is initially required and a low speed is gentle on the diaphragm, can be designed to be advantageous for the diaphragm load.

[0071] To further increase the local stress increase of the sealing film 300 and better define the tear-open behavior, the effect can be enhanced by insert elements, also referred to as cutting elements, as described, for example, in at least one of Figures 13 to 14, which are introduced into the cartridge during the manufacturing process. The cutting elements can be used as inserted parts or, to better define the relative direction and position to the fluid bar 112, can be firmly connected to the sealing film 300. This is achieved by adhesives or form-fitting (clips). The geometry of the cutting edge can be designed in a geometrically variable manner and adapted to the specific application.The best results when breaking open the fluid chamber 113 are achieved when the sealing film 300 tears and opens over as large an area as possible, for example, to allow air to enter the fluid chamber 113 to prevent the formation of a vacuum and to ensure a steady outflow of the entire fluid content into the cartridge tank. The geometries should not exceed the width of the sealing film 300 in order to achieve a good shearing and tearing of the film 300. The outflow of the fluid 302 is primarily gravity-driven in this functional principle. The principle of the cam drive is explained here using a single tank, i.e., a single fluid chamber 113. When using a three-chamber cartridge, a camshaft can be used as an embodiment.In order to distribute the force peaks over the angle of rotation and thus minimize the maximum force required to open the fluid chamber 113, the cam tips should be offset from one another by at least 10 degrees. The maximum offset should be selected so that, for example, the cams 116 are evenly distributed over the circumference of the camshaft. The force distribution and thus the feedback for the user can be optimized by selecting the geometry of the cams. The force transmission unit 118, which is designed as a shaft, for example, is formed as a single part or as one of several, for example homogeneous, identical parts that are arranged offset by a defined angle. This releases the fluids 302 at staggered times. By using identical parts, further cost potential can be exploited and individual designs of cams can be easily implemented.The idea behind the mechanism is to minimize the forces so that the fluid chambers 113 can be easily opened manually. According to estimates of the opening forces using plungers that operate according to the displacement principle and require an opening force of approximately 60 to 80 Newtons per tank, the force can be reduced, for example, to less than 30 Newtons, by a significantly smaller contact area on the membrane and less stretching of the TPU membrane. Possible maximum operating forces, achieved by a user using their finger, for example, are in the range of 50 Newtons. Recommended values ​​are approximately 10 percent. This would allow a gear ratio of approximately 6 to achieve an actuation force of 30 Newtons.

[0072] Fig. 6 shows a schematic representation of an embodiment of a release device 108, as described in at least one of Figures 1 to 5. Here, too, the release device 108 is designed to open the fluid chamber 113 of the fluid lock 112. For example, the release device 108 shown in Fig. 6 corresponds to the release device described in Fig. 5. In Fig. 6, however, the penetration element 116 is shown rotated so that it touches the protective membrane 114 and slightly deforms it. In this case, however, the sealing film 300 is still unopened. This means that Fig. 6 shows a state before the sealing film 300 is pierced. Here, too, the release device 108 is designed as a cam drive and performs a rotary movement.

[0073] Fig. 7 shows a schematic representation of an embodiment of a release device 108, as described in at least one of Figures 1 to 6. For example, the release device 108 shown in Fig. 7 corresponds to the release device described in Figures 5 and 6. In Fig. 7, only the sealing film 300 is shown broken. The protective membrane 114 is also shown deformed, so that the fluid 302 located in the fluid chamber 113 is released but does not penetrate into the interior of the analyzer.

[0074] Fig. 8 shows a schematic representation of embodiments of release devices 108. More specifically, Fig. 8 shows three partial images A, B, C, each showing an embodiment of a release device 108. First, common features of all partial images A, B, C are described, followed by a description of features of the individual partial images A, B, C in which the release devices 108 differ.

[0075] According to this exemplary embodiment, each of the release devices 108 has the penetration element 116 and the force transmission unit 118, as described, for example, in at least one of Figures 1 to 7. Furthermore, each of the release devices 108 according to this exemplary embodiment has at least one further penetration element 800 for penetrating at least one further fluid chamber in order to carry out a further penetration movement in order to pierce a further sealing film of the further fluid chamber in order to release fluid located in the further fluid chamber. The force transmission unit 118 is designed to transmit the actuating force to the further penetration element 800 by means of the transmission movement. In this case, too, the further penetration movement and / or the transmission movement has / have a rotational movement component.According to this exemplary embodiment, the release device 108 has an additional penetration element 802 in each of the partial images A, B, and C. The penetration elements 116, 800, 802 are designed identically for each partial image A, B, and C. The release device 108, and in this case also the force transmission unit 118, is likewise shaped in each partial image A, B, and C in order to sequentially pierce the sealing film of the fluid chamber by the penetration element 116, the further sealing film of the further fluid chamber by the further penetration element 800, and an additional sealing film of an additional fluid chamber by the additional penetration element 802. This occurs, for example, with a time offset or at an angle. The angular offset is, for example, between 5 and 15 degrees, in particular 10 degrees. This means that the penetration elements 116, 800, 802 are arranged on the force transmission unit 118 offset from one another by 10 degrees, for example.

[0076] In partial image A, the penetration element 116 has an angular offset from the further penetration element 800, and the further penetration element 800 also has an angular offset from the additional penetration element 802, so that the penetration element 116 and the additional penetration element 802 have the greatest angular offset from one another. This means that during a rotational movement, first the penetration element 116, then the further penetration element 800, and finally the additional penetration element 802 each penetrate into a fluid chamber and pierce a corresponding sealing film. Furthermore, according to this exemplary embodiment, the further penetration element 800 is arranged between the penetration element 116 and the additional penetration element 802.According to this exemplary embodiment, the force transmission unit 118 is formed in several parts, such that a first section is coupled to the penetration element 116, a second section is coupled to the further penetration element 800, and a third section is coupled to the additional penetration element 802. For this purpose, the force transmission unit 118 comprises, for example, a shaft.

[0077] In partial image B, the penetration elements 116, 800, 802 also exhibit the angular offset, which corresponds to partial image A. However, the force transmission unit 118 is designed as a single piece according to this exemplary embodiment. Alternatively, the penetration element 116 is arranged or can be arranged between the further penetration element 800 and the additional penetration element 802, so that the penetration element 116 and the additional penetration element 802 exhibit the greatest angular offset. The penetration elements 116, 800, 802 are, for example, formed integrally with the force transmission unit 118.

[0078] The release device 108 shown in partial image C is also similar to the release devices from partial images A and B. According to this exemplary embodiment, the penetration elements 116, 800, 802 are arranged relative to one another as in partial image A, and the force transmission unit 118 is designed, for example, in multiple parts. According to this exemplary embodiment, the penetration elements 116, 800, 802 additionally each have a form-fitting and / or material-fitting insert element 804, 806, 808 arranged or arrangeable at their free ends. According to this exemplary embodiment, each of the insert elements 804, 806, 808 is designed as a ball that is rotatably arranged, here, for example, clockwise. Alternatively, at least one insert element 804, 806, 808 can also be shaped as a cutting element or as a mandrel.

[0079] Fig. 9 shows a schematic representation of an embodiment of a release device 108, as described, for example, in partial image A of Fig. 8. Fig. 9 also includes partial image A and partial image B. Partial image A in Fig. 9 therefore corresponds to partial image A from Fig. 8, with the release device 108 being shown in a top view of an end face. The release device 108 of partial image B in Fig. 9 is similar to the release device of partial image A from Fig. 9, but the release device 108 is shown in a side view.

[0080] In part B, in addition to the release device 108, which corresponds to the release device described in part A, a fluid lock 112 with three fluid chambers 113, 900, 902 is also shown, as well as a position of the individual penetration elements 116, 800, 802 relative to the fluid lock 112, which differs due to the angular offset from one another. This means that in partial image B, due to the representation, the further penetration element 800 and the additional penetration element 802 appear smaller than the penetration element 116. In addition, the additional penetration element 802 appears smaller than the further penetration element 800. According to this exemplary embodiment, the force transmission unit 118 also has the plurality of sections 904, 906, 908, wherein a first section 904 is coupled to the penetration element 116, a second section 906 is coupled to the further penetration element 800, and a third section 908 is coupled to the additional penetration element 802 or is formed in one piece.

[0081] Fig. 10 shows a schematic representation of an embodiment of a release device 108, as described, for example, in partial image B of Fig. 8. Fig. 10 also includes a partial image A and a partial image B. Partial image A in Fig. 10 therefore corresponds to partial image B from Fig. 8, wherein the release device 108 is shown in a plan view of an end face.

[0082] The release device 108 of partial image B in Fig. 10 is similar to the release device of partial image A in Fig. 10, but the release device 108 is shown in a side view. Unlike the release device described in Fig. 9, the force transmission unit 118 according to this embodiment is designed as a single piece. The penetration elements 116, 800, 802, for example, are formed integrally with the force transmission unit 118.

[0083] Fig. 11 shows a schematic representation of an embodiment of a release device 108, which is similar, for example, to the release device described in at least one of Figures 1 to 10. According to this embodiment, the penetration element 116 is realized in one piece, and the force transmission unit 118 is made of multiple parts. Furthermore, the penetration element 116 executes the penetration movement, which has a linear movement component. This means that the penetration element 116 moves in a straight line according to this embodiment. The transmission movement of the force transmission unit 118, on the other hand, has a rotational movement component in order to transmit the actuating force to the penetration element 116. The rotational movement component is symbolically represented by a double arrow 1100 according to this embodiment.According to this exemplary embodiment, the force transmission unit 118 has at least one joint 1102 which movably connects two force transmission parts 1104, 1106 of the force transmission unit 118 to one another. A first force transmission part 1104 is rotatably mounted. According to this exemplary embodiment, a second force transmission part 1106 is movably connected to the penetration element 116 by means of a further joint 1108, so that the penetration element 116 is moved linearly into the fluid chamber 113 and in the process pierces the sealing film 300. This means that according to this exemplary embodiment, the penetration movement has a linear movement component and the transmission movement has a rotational movement component, which can be advantageous in particular in the case of a compact analysis device due to the available installation space.In other words, the non-linear relationship between rotary motion and stroke motion is advantageous. For example, with a constant drive torque, the force on the plunger, i.e., on the penetration element 116, is very high near the bottom and top dead centers, and rather low in between. Conversely, the speed of the plunger 116 is low at the bottom and top dead centers, reaching a maximum at a constant rotational speed in between. This is consistent with the high force required to penetrate the sealing film 300 and with the increasingly tensioned protective membrane 114.

[0084] Fig. 12 shows a schematic representation of an embodiment of a release device 108, which corresponds, for example, to the release device described in Fig. 11. However, unlike Fig. 11, the fluid chamber 113 is shown open, and the second force transmission part 1106 is arranged on a common axis with the penetration element 116, which projects into the fluid chamber 113 and pierces, or has pierced, the sealing film 300. Furthermore, the protective membrane 114 is shown deformed.

[0085] Fig. 13 shows a schematic representation of at least one insert element 1300 for a release device. The insert element 1300 is designed to simplify the piercing of the sealing film 300. The insert element 1300 is arranged between the protective membrane 114 and the sealing film 300. Insert elements 1300 are designed, for example, to cause local stress peaks on the sealing film 300. According to this example, the insert element 1300 is designed in a plate-like or mat-like manner.

[0086] Fig. 14 shows a schematic representation of a plurality 1400 of insert elements 1300 for a release device, as described, for example, in at least one of Figures 1 to 12. For illustrative purposes, the plurality 1400 of insert elements 1300 comprises, in particular, six different types of insert elements 1300, each of which is designed differently. This means that the individual insert elements 1300 are each arranged or can be arranged uniformly or in any combination in the release device.

[0087] Each of the insert elements 1300 has a surface structure 1402, which can differ from the surface structures of the other insert elements 1300. For example, the surface structure 1402 is designed as a sphere, a mandrel, or a cutting element, or is H-shaped, knob-like, U-shaped, or triangular, for example. The height of the surface structure 1402 is, for example, between 0.2 mm and 2 mm, advantageously 1 mm, wherein the height is smaller than a difference between the inner cartridge tank height and the outer height of the bars. For example, the insert element 1300 is arranged between the protective membrane of the cartridge and the sealing film of the fluid bar, wherein the surface structure 1402 is oriented toward the sealing film.

[0088] In other words, to increase the local stress peaks on the sealing film during the welding process of the cartridge, additional inserts such as balls, cutting edges and mandrels can be inserted or glued onto the sealing film. These inserts can further facilitate the tearing of the films or can shape their tearing behavior in terms of shape and force, which, for example, improves the force-time curve.

[0089] Fig. 15 shows a schematic representation of an embodiment of a release device 108, which is similar, for example, to a release device described in at least one of Figures 1 to 12. According to this embodiment, the penetration element 116 is designed as a pin whose penetration movement has a linear movement component. The force transmission unit 118 is designed like a rocker and therefore functions as a lever mechanism with the transmission movement having a rotational movement component around a pivot point 1500. According to this embodiment, the force transmission unit 118 is coupled to an actuating element 1502 for actuation by a user. Alternatively, the force transmission unit 118 is coupled or can be coupled to a drive unit for providing the actuating force. The actuating element 1502 is designed as a knob, which is also linearly movable.The actuating element 1502 is connected to the penetration element 116 by means of at least one rod element 1504. The at least one rod element 1504 is therefore also designed as part of the force transmission unit 118.

[0090] Fig. 16 shows a schematic representation of an embodiment of a release device 108, which is similar, for example, to the release device described in Fig. 15. Also according to this embodiment, the force transmission unit 118 is coupled to the actuating element 1502 by means of a rod element 1504, which is similar to the rod element 1504 described in Fig. 15, and also functions as a lever mechanism. However, the penetration element 116 is designed as a rotatable cam or as part thereof, so that the penetration movement of the penetration element 116, in contrast to Fig. 15, has a rotational movement component around the pivot point 1500.

[0091] In other words, according to this embodiment, the lever induces a rotational movement of the penetration element 116 shaped as a cam, moves it along the TPU, and thus deforms it, which ultimately leads to the tearing open of the sealing film 300.

[0092] In other words, Figures 15 and 16 show two possible designs for a mechanism for releasing the reagents. The leverage effect can further reduce the force required for opening. In the example shown in Fig. 15, a parallel linkage with two rod elements 1504 is used to tear open the sealing film 300. By raising the plunger tip, the local stress peaks can be further increased and the tearing of the film 300 can be facilitated. A simpler design of a parallel linkage would be the implementation of a rocker, e.g., in combination with one or two guides (of the actuating element and / or the penetration element).

[0093] Fig. 17 shows a schematic representation of an embodiment of a release device 108, which is similar, for example, to the release device described in at least one of Figures 1 to 12 and / or 15 to 16. According to this embodiment, the penetration element 116 has a gear 1700 that interacts with a counterpart 1702 of the power transmission unit 118. The counterpart 1702 also has teeth 1704 that mesh with the gear 1700 and thereby rotate it about the pivot point 1500. The penetration element 116 is designed as a cam coupled to the gear 1700. In this case, an actuating force applied by the user to the actuating element 1502 is transmitted to the penetration element 116 by means of a cam drive, so that the penetration element 116 rotates about the pivot point 1500 and thus penetrates the fluid chamber 113. The actuating element 1502 is also formed in Fig. 17 as a button that is linearly movable.

[0094] According to this embodiment, the mode of operation of the release device 108 shown here is comparable to the previous mechanisms. A compressive force or, alternatively, a tensile force from the user moves the penetration element 116 into the TPU 114, which leads to the tearing of the sealing film 300.

[0095] Fig. 18 shows a schematic representation of an embodiment of a release device 108, which is similar, for example, to the release device described in at least one of Figures 1 to 12 and / or 15 to 17. According to this embodiment, a screw drive actuatable by the user is shown. This means that the force transmission unit 118 has a threaded portion 1800 connected to an actuating element 1502, by means of which the pin-like penetration element 116 is moved linearly to pierce the sealing film 300 and penetrate into the fluid chamber 113 to release the fluid 302. To effect this, the user can, for example, rotate the actuating element 1502 clockwise or counterclockwise. This rotation sets the force transmission unit 118 and thus the threaded portion 1800 in motion.The penetration element 116 and the force transmission unit 118 are arranged transversely to one another, in particular perpendicular to one another, so that the movement of the threaded portion 1800 moves the penetration element 116 linearly.

[0096] In a similar way, all types of gears with crossing axes such as bevel gears, helical gears, bevel helical gears or worm gears are conceivable.

[0097] By means of such an arrangement, for example, several penetration elements 116 can be moved to open several fluid chambers 113, as shown for example in Fig. 19.

[0098] In the variant described here, a simple spindle drive moves a crosshead, which, for example, pushes the plunger 116 into the fluid chamber 113. Unlike the previous examples, a rotary movement, performed by the user, for example, can be performed instead of a push or pull movement to release the fluid 302 in the fluid chamber 113. The aim of the design is to configure the mechanism so that the actuating rotation is less than 360 degrees, for ease of use.

[0099] Fig. 19 shows a schematic representation of an embodiment of a release device 108, which corresponds, for example, to the release device 108 described in Fig. 18. In Fig. 19, the fluid lock 112 is also shown in section, so that three fluid chambers 113, 900, 902 are visible. The force transmission unit 118 corresponds to or is similar to the force transmission unit 118 described in Fig. 18, differing only in the perspective view. According to this embodiment, the size of the individual penetration elements 116, 800, 802 is different, so that the protective membrane 114 is not stretched more than necessary and the fluid chambers 113, 900, 902 can be opened one after the other. According to this embodiment, the penetration elements 116, 800, 802 are arranged on a common support element 1900, which is moved uniformly by the force transmission unit 118 in response to a rotational movement of the actuating element 1502.

[0100] A temporal offset between the force maxima when tearing open multiple films 300 is achieved, for example, directly by the selected height of the penetration elements 116, 800, 802 and should, for example, be between 2 and 8 mm. A limit switch can be used to ensure that the subsequent processing of the cartridge is not started until the user has fully actuated the actuating element 1502, also referred to as the operating element, such as a lever, knob, or rotary knob, all the way to the stop. Greater penetration depths of the penetration elements 116, 800, 802 into the fluid chambers 113, 900, 902 compared to the cam drive, as described, for example, in at least one of Figures 5 to 10, can be achieved by more complex curve profiles of the penetration elements 116, 800, 802. A possible variant of this is shown in Figures 20 to 22.

[0101] Fig. 20 shows a schematic representation of an embodiment of a release device 108, which is similar, for example, to the release device described in at least one of Figures 1 to 12 and / or 15 to 19. According to this embodiment, the power transmission unit 118 is designed as a ring gear drive, which has a ring gear 2000 and a planet carrier 2002. According to this embodiment, the planet carrier 2002 in turn has three planets or planet gears 2004, which are designed as gears and engage with the ring gear 2000. According to this embodiment, the carrier element 1900, which is shaped as an opening arm and is similar to the carrier element 1900 in Fig. 19, is arranged on one of the planets 2004. The at least one penetration element is arranged on the carrier element 1900, as described, for example, in Fig. 22.

[0102] According to this embodiment, the actuating element 1502 is coupled to the force transmission unit 118 via a belt or chain 2006 in order to set the carrier element 1900 together with the at least one penetration element in motion and thus open the at least one fluid chamber 113. In this variant, a rotary actuation is also possible instead of a linear actuating element 1502.

[0103] In this embodiment, a maximum deflection of an opening arm or penetration element from the center of the ring gear 2000 is achieved via planetary gears 2004 moving in a fixed ring gear 2000.

[0104] Fig. 21 shows a schematic representation of an embodiment of a movement pattern 2100 of a release device, as described, for example, in Fig. 20. The movement pattern 2100 describes a deflection that is determined by the selected radius of the movable planets described in Fig. 20 and the distance of the opening arm 1900 and / or the penetration element from the orbit 2104 of the planets. A resulting trochoid 2108, which describes a trajectory of the penetration element, is shown in Fig. 21 as an example.

[0105] Fig. 22 shows a schematic representation of an embodiment of a release device 108, which, for example, corresponds to or is similar to the release device described in Fig. 20. In Fig. 22, the release device 108 is shown only from a different perspective, so that the force transmission unit 118 is shown at least partially as a sectional view. Here, the carrier element 1900 is connected to one of the planets 2004. According to this embodiment, three penetration elements 116, 800, 802 are arranged on the carrier element, as described, for example, in Fig. 19. The penetration elements 116, 800, 802 have different angular positions or orientations relative to the carrier element 1900.

[0106] According to this embodiment, a transverse view of the mechanism is shown, in which three fluid chambers 113, 900, 902 can be opened. To reduce the maximum required force, an angular offset of the opening elements can be selected here, for example, at a tip of the opening arms that slide along the TPU. Due to the steep flanks of the resulting trajectory, the expected shear of the TPU is even smaller in this embodiment compared to the cam drive. Fig. 23 shows a flow diagram of an embodiment of a method 2300 for operating a release device, as described and / or mentioned in at least one of Figures 1 to 22.The method 2300 comprises a step 2302 of transmitting an actuating force by means of a transmission movement to a penetration element using the force transmission unit in order to release a fluid located in a fluid chamber, and a step 2304 of executing a penetration movement using the penetration element due to the actuating force in order to penetrate into the fluid chamber in order to pierce a sealing film of the fluid chamber, wherein the penetration movement and / or the transmission movement has or have a rotational movement component.

[0107] If an embodiment includes an “and / or” connection between a first feature and a second feature, this is to be read as meaning that the

[0108] Embodiment according to one embodiment has both the first feature and the second feature and according to another embodiment has either only the first feature or only the second feature.

Claims

Claims 1. A release device (108) for an analysis device (100) for analyzing a sample contained in a cartridge (102), wherein the release device (108) is designed to release fluid (302) located in at least one fluid chamber (113) of a fluid bar (112) inserted in the cartridge (102), wherein the release device (108) has the following features: a penetration element (116) for penetrating the fluid chamber (113), wherein the penetration element (116) is shaped to execute a penetration movement due to an actuating force in order to pierce a sealing film (300) of the fluid chamber (113) in order to release the fluid (302) located in the fluid chamber (113); and a force transmission unit (118) which is designed to transmit the actuating force to the penetration element (116) by means of a transmission movement, wherein the penetration movement and / or the transmission movement has or have a rotational movement component.

2. Release device (108) according to claim 1, wherein the force transmission unit (118) is shaped to set the penetration element (116) in a rotational movement about a rotation axis.

3. Release device (108) according to one of the preceding claims, wherein the force transmission unit (118) is formed as a cam drive, a crank drive, a lever unit, a screw drive, a worm drive, a spur gear screw drive, a bevel drive or a ring gear drive.

4. Release device (108) according to one of the preceding claims, wherein the penetration element (116) has a form-fitting insert element (804, 806, 808) at a free end, wherein the insert element (804, 806, 808) is designed as a ball.

5. Release device (108) according to one of the preceding claims, wherein the penetration element (116) is formed as a plunger, a pin or a cam 6. Release device (108) according to one of the preceding claims, wherein the penetration element (116) is coated to reduce friction and / or is formed in one or more parts.

7. Release device (108) according to one of the preceding claims, wherein the penetration movement and / or the transfer movement has a linear movement component in addition to the rotational movement component.

8. Release device (108) according to one of the preceding claims, with at least one further penetration element (800) for penetrating at least one further fluid chamber (900) of the cartridge (102) in order to carry out a further penetration movement in order to pierce a further sealing film (300) of the further fluid chamber (900) in order to release fluid located in the further fluid chamber (900), wherein the force transmission unit (118) is designed to transmit the actuating force to the further penetration element (800) by means of the transmission movement, wherein the further penetration movement and / or the transmission movement has a rotational movement component.

9. Release device (108) according to claim 8, which is shaped to sequentially pierce the sealing film (300) of the fluid chamber (113) by the penetrating element (116) and the further sealing film (300) of the further fluid chamber (900) by the further penetrating element (800).

10. Release device (108) according to one of claims 8 to 9, wherein the penetration element (116) and the further penetration element (800) are arranged with an angular offset of 5 to 15 degrees, in particular 10 degrees, from one another.

11. Release device (108) according to one of the preceding claims, wherein the force transmission unit (118) is coupled to an actuating element (1502) for actuation by a user or to a drive unit for providing the actuating force.

12. An analysis device (100) for analyzing a sample contained in a cartridge (102), the analysis device (100) comprising: a coupling device (106) for coupling to the cartridge (102); and a release device (108) according to any one of the preceding claims, wherein the release device (108) is connected to or arranged adjacent to the coupling device (106).

13. A method (2300) for operating an analysis device according to claim 12, wherein the method (2300) comprises the following steps: Transmitting (2302) an actuating force by means of a transmission movement to a penetration element (116) using the force transmission unit (118) in order to release a fluid (302) located in a fluid chamber (113); and Carrying out (2304) a penetration movement using the penetration element (116) due to the actuating force to penetrate into the fluid chamber (113) to pierce a sealing film (300) of the fluid chamber (113), wherein the penetration movement and / or the transmission movement has or has a rotational movement component.

Images