Microfluidic cartridge for processing fluids and lid for covering a non-functional part of a microfluidic cartridge

Abstract

The present approach relates to a microfluidic cartridge for processing fluids. The cartridge is designed to be evaluable in an analytical device and comprises a base body with a functional part as an interface to an evaluation device of the analytical device. The cartridge further comprises a non-functional part in which at least one pre-storage chamber for pre-storing at least one reagent, a sample chamber for receiving and / or pre-storing sample material, and preferably a mixing chamber for mixing the reagent and the sample material are arranged. The cartridge also comprises a lid (130) for covering the non-functional part. The lid (130) preferably has a circumferential edge (305) for placement on the base body. The cartridge also comprises a sealing element (300) for watertightly sealing the edge (305) of the lid (130) with respect to the base body.

Description

State of the art

[0001] The present approach is based on a microfluidic cartridge for processing fluids and a lid for covering a non-functional part of a microfluidic cartridge according to the class of the independent claims.

[0002] 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. Processing of the lab-on-chip cartridge and analysis of the patient sample can be performed in a compact analyzer. Disclosure of the invention

[0003] Against this background, the approach presented here proposes a microfluidic cartridge for processing fluids and a lid for covering a non-functional part of the microfluidic cartridge according to the main claims. Advantageous embodiments emerge from the respective subclaims and the following description.

[0004] By using a lid with a sealing element, leakage of liquids from a non-functional part of the microfluidic cartridge can be prevented. This can prevent damage to an analytical device used to evaluate the cartridge.

[0005] A microfluidic cartridge for processing fluids is presented, which is designed to be evaluable in an analytical device. The cartridge comprises a base body with a functional part as an interface to an evaluation device of the analytical device and a non-functional part in which at least one pre-storage chamber for pre-storing at least one reagent, a sample chamber for receiving and / or pre-storing sample material, and preferably a mixing chamber for mixing the reagent and the sample material are arranged. The pre-storage chamber and / or sample chamber can also be designed as a mixing chamber. The cartridge further comprises a lid for covering the non-functional part, wherein the lid has a, in particular circumferential, edge for placement on the base body. The cartridge also comprises a sealing element for watertightly sealing the edge of the lid relative to the base body.

[0006] A microfluidic cartridge can be understood as a cartridge from the field of microfluidics, for example for clinical diagnostics or in-vitro diagnostics.

[0007] Such a cartridge can be analyzed, i.e., evaluated, in an analytical device, particularly a biochemical analyzer. Examining the fluids in the cartridge, particularly using an evaluation device of the analytical device, can enable diagnoses for a variety of diseases. For example, the cartridge can be used for rapid PCR tests.

[0008] The base body of the cartridge with the functional part and the non-functional part can be shaped according to known microfluidic cartridges.

[0009] When installed, the lid can prevent liquids such as reagents or sample material from leaking from the non-functional part. In other words, liquids that may occur due to improper use of the cartridge by the user or cartridge defects in the non-functional part can be retained under the lid. Improper use can occur if too much sample material is pipetted into the sample chamber. Cartridge defects can occur, for example, due to delamination.

[0010] According to one embodiment, the lid and the sealing element can be formed as a single piece. This offers the advantage of easy handling.

[0011] For example, the lid and the sealing element can be formed as a two-component injection-molded part. This offers the advantage that the lid and the sealing element can be manufactured cost-effectively and quickly as a single component, for example, using a two-component injection molding process.

[0012] Alternatively, the sealing element can be formed separately from the lid. According to such an embodiment, the lid and the sealing element can be manufactured separately from each other.

[0013] The sealing element can have a Shore hardness of 5 to 20. This allows the sealing element to be very soft and thus provide a high sealing effect.

[0014] The sealing element can be shaped to change color upon contact with a liquid, and preferably comprise a, preferably irreversible, hydrochromic dye for this purpose. This allows the user to determine whether the cartridge has previously come into contact with a liquid. Thus, the user can determine, particularly after processing, i.e., a test run, that the sealing material was wetted with liquid before or during the test run.

[0015] Advantageously, contact with moisture or liquid can be indicated both from the inside and the outside.

[0016] According to a further embodiment, the cartridge may comprise an absorbent material arranged in a space between the non-functional part and the lid. This allows liquids to be trapped under the lid, providing additional leakage protection.

[0017] The lid can be shaped like a shell. The shell shape of the lid can correspond exactly or approximately to the external shape of the non-functional part. This is advantageous because the lid can be attached to the non-functional part in a watertight, precise, and secure manner, covering the latter.

[0018] The lid may have at least one ventilation channel. The ventilation channel can be used to prevent negative pressure in the cartridge and, optionally, to equalize pressure between the cartridge and the surrounding area, particularly during pumping of liquid from the cartridge.

[0019] The lid can have a closure for the sample chamber. Opening the closure makes the sample chamber accessible. This allows the user to insert sample material into the sample chamber. The lid allows the sample chamber to be closed simply, user-friendly, and reliably after the sample material has been inserted. If the closure is simply located in a corner of the lid, for example, user comfort can be further increased by allowing the user to easily access the lid to open or close it.

[0020] According to one embodiment, the base body can be formed as a stack of a fluid layer, a membrane, a pneumatic layer, and a sealing membrane. The fluid layer can comprise a fluidic channel system, and the pneumatic layer can comprise a pneumatic channel system, which can be formed as part of a microfluidic network of the cartridge. The network can comprise fluidic microchannels and pneumatically controllable microfluidic elements. This embodiment allows for an advantageous mode of operation or functionality of the cartridge.

[0021] Furthermore, a lid for covering a non-functional part of a microfluidic cartridge for processing fluids is presented. The cartridge is designed to be evaluable in an analysis device. Furthermore, the cartridge comprises a base body with a functional part as an interface to an evaluation device of the analysis device and a non-functional part in which at least one pre-storage chamber for pre-storing at least one reagent, a sample chamber for pre-storing sample material, and a mixing chamber for mixing the reagent and the sample material are arranged. The lid comprises a, in particular circumferential, edge for placement on the base body and a sealing element for watertightly sealing the edge of the lid with respect to the base body.

[0022] The lid and sealing element can be designed as a single or two-piece unit. Optionally, the sealing element can be molded to change color upon contact with moisture or a liquid.

[0023] The approach presented here is explained in more detail below using the attached drawings. They show: Fig. 1 a schematic representation of an analysis device and a microfluidic cartridge according to an embodiment; Fig. 2 a schematic representation of a microfluidic cartridge according to an embodiment; Fig. 3 a schematic representation of a lid of a microfluidic cartridge according to an embodiment; Fig. 4 a schematic representation of a part of a microfluidic cartridge according to an embodiment; and Fig. 5 a schematic representation of a part of a microfluidic cartridge according to an embodiment.

[0024] In the following description of advantageous embodiments of the present approach, 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.

[0025] Fig. Figure 1 shows a schematic representation of an analysis device 100 and a microfluidic cartridge 105 according to one embodiment. The analysis device 100 has an input shaft, and the microfluidic cartridge 105 is inserted into the analysis device 100 via the input shaft. The microfluidic cartridge 105 is used, for example, for processing fluids and can be evaluated in the analysis device 100.

[0026] The microfluidic cartridge 105 has a base body 112 and a lid 130. The base body 112 is divided into a functional part 114 and a non-functional part 116. The functional part 114 and the non-functional part 116 are directly adjacent to one another.

[0027] The functional part 114 is designed as an interface to an evaluation device 140 of the analysis device 100. For example, the evaluation device 140 is designed to apply pressure to pneumatic connections of the functional part 114 and to optically evaluate fluid located in an evaluation chamber, for example.114

[0028] The non-functional part 116 of the cartridge 105 is shaped to store reagents and at least one sample.

[0029] The lid 130 is placed on the base body 112 and covers the non-functional part 116. The lid 130 is used to retain fluid escaping from the non-functional part 116. For this purpose, a sealing element is used, via which a circumferential edge of the lid 130 is sealed against the base body 112. The sealing element is, for example, a rubber seal or a soft edge region of the edge of the lid 130.

[0030] According to one embodiment, the lid 130 is placed onto the base body 112 of the cartridge 105 for ease of manufacture. The lid 130 is connected to the rest of the cartridge 105 in a watertight manner.

[0031] The lid 130 prevents reagents and sample material from leaking into the functional part 114, also referred to as the functional area of ​​the cartridge 105. This significantly reduces the risk of damage and contamination of the analyzer 100 by liquids. Causes for leaking liquids include improper use by the user, such as pipetting in too much sample material, or cartridge defects, such as delamination.

[0032] According to one embodiment, the cover 130, designed as a cartridge cover with an integrated seal, retains liquids under the cover 130 and prevents them from flowing into the functional area. This prevents damage to the interfaces of the analyzer 100, for example, a heater on top or an optics, or damage to the electronics and mechanics of the analyzer 100. Fig. Figure 2 shows a schematic representation of a microfluidic cartridge 105 according to an embodiment. This is an example of a representation of the individual components of the Fig. 1 shown microfluidic cartridge 105.

[0033] The cartridge 105 comprises the base body 112, which is formed as a stack of a fluid layer 205, a membrane 210, a pneumatic layer 215, and a sealing membrane 220. According to one embodiment, the fluid layer 205, the membrane 210, the pneumatic layer 215, and the sealing membrane 220 are arranged one above the other and are firmly connected to one another during assembly of the cartridge.

[0034] Optionally, the base body 112 comprises a microarray 230, also referred to as a µArray, and a reagent bar 225, which is arranged on an underside of the fluid layer 205. Optionally, the base body 112 comprises a silica membrane (not shown) and a lyophilisate (not shown).

[0035] The base body 112 comprises the functional part 114 and the non-functional part 116. The non-functional part 116 is covered using the lid 130. When assembled, the lid 130 conceals the non-functional part 116 of the cartridge 105.

[0036] Arranged in the non-functional part 116 are a pre-storage chamber 235 for pre-storing at least one reagent, a sample chamber 240 for receiving and / or pre-storing sample material, and a mixing chamber 245 for mixing the reagent and the sample material. According to one embodiment, the mixing chamber 245 is arranged between the pre-storage chamber 235 and the sample chamber 240. To prevent a negative pressure, for example, when pumping liquids out of the cartridge 105, these chambers 235, 240, 245 optionally have so-called vents (not shown), i.e., ventilation channels. The sample chamber 240 can be closed by a closure 250 for the sample chamber 240, which is arranged on the lid 130.

[0037] According to one embodiment, the cover 130, for example a white cover 130, can be placed on the cartridge 105. The outlets of the aforementioned or additional ventilation channels are also located under the cover 130. The cover 130 also has a ventilation channel in the form of a vent. A label (not shown) and an RFID (cover with label / RFID) (not shown) are optionally arranged on the cover 130.

[0038] According to one embodiment, the lid 130 is attached during the final step of manufacturing the cartridge 105 before packaging. The lid 130 covers the non-functional part 116 of the cartridge 105. The reagent storage chambers 235, a mixing chamber 245, and the sample chamber 240 are located there. To prevent negative pressure when pumping out liquids, these chambers 235, 240, and 245 have a ventilation channel. The outlets of the ventilation channels are also located under the lid 130.

[0039] Fig. 3 shows a schematic representation of a lid 130 of a microfluidic cartridge according to an embodiment. This is an exemplary embodiment of the Fig. 2 shown lid.

[0040] The lid 130 comprises a sealing element 300 for watertightly sealing the peripheral edge 305 of the lid 130 with respect to the base body (not shown) of the microfluidic cartridge. Thus, the peripheral edge 205 is sealed with respect to the base body when the peripheral edge 305 is placed onto the base body.

[0041] According to one embodiment, the sealing element 300, which may also be referred to as a sealing lip or integrated sealing lip, is formed separately from the cover 130. For example, the sealing element 300 is designed as a plug-on sealing element 300, also called a seal.

[0042] According to a further embodiment, the cover 130 and the sealing element 300 are formed as a single piece. Here, the cover 130 and the sealing element 300 are optionally formed as a two-component injection-molded part.

[0043] In cartridge production, no additional assembly step is optionally required, as the cartridge remains a single component. Various common materials can be used for the sealing element 300, in particular a plastic, preferably an elastomer. Optionally, the sealing element 300 should be as soft as possible and can also be referred to as a soft sealing material or a sealing lip. The sealing element 300 has an exemplary hardness of 5 to 20 Shore.

[0044] Optionally, the sealing element 300 comprises a material that changes color upon contact with moisture and additionally or alternatively upon contact with a liquid. For example, the material, in particular a plastic as mentioned above, can be mixed with dyes, for example with a hydrochromic dye that changes color upon contact with water or aqueous solutions, in particular an irreversible hydrochromic dye or an irreversible hydrochromic ink, such as that used in urine indicators in diapers. This makes it possible to detect whether the cartridge has ever come into contact with liquid. According to one embodiment, the sealing element 300 enables the detection of contact with moisture from outside the cartridge via a color change.Additionally or alternatively, the sealing element 300 enables the detection of contact with moisture or contact with liquid from within the cartridge, for example from an inside of the lid 130, via a corresponding color change.

[0045] For example, after a run, also called a run or processing, the user can recognize that the sealing element 300 was wetted with liquid before or during the run. A corresponding effect caused by the liquid would, for example, only be detectable on the sealing element 300, also called a seal, and not on the entire cover 130.

[0046] The lid 130 is optionally shaped as a bowl. In Fig. Figure 3 shows a view of the inside of the lid 130. According to one embodiment, the lid 130 has a flat top and a circumferential wall with the circumferential edge 305. The lid 130 is, for example, rectangular in shape with rounded corners.

[0047] The lid 130 includes a ventilation channel 310, also called a vent, to prevent negative pressure, for example, when pumping liquids out of the cartridge. Optionally, the ventilation channel 310 is located at a non-critical location on the lid 130, i.e., in particular, without impairing the functionality of the lid 130. For example, the ventilation channel 310 is routed through the ceiling of the lid 130.

[0048] According to one embodiment, the lid 130 includes the closure 250 for the sample chamber illustrated in Figure 1. The closure 250 allows the sample chamber to be closed after a sample has been introduced.

[0049] Optionally, the lid 130 includes the label, for example on or on an outer side of the lid 130, also called the cover outer side.

[0050] A positioning dome 315 for positioning or aligning the lid 130 on the cartridge base body is optionally arranged on the inside of the lid 130. According to one embodiment, the positioning dome 315 is arranged on a side or in a region of the lid 130 on which or in which the closure 250 for the sample chamber is arranged. According to one embodiment, the positioning dome 315 and the closure 250 for the sample chamber are arranged on a side of the lid 130 facing away from the ventilation channel 310.

[0051] Fig. Figure 4 shows a schematic representation of a section of a microfluidic cartridge according to an embodiment. The fluid layer 205 is shown, for example, as shown in Fig. 2 is described.

[0052] The cartridge includes an absorbent material 400 disposed on a surface of the fluid layer 205 in the region of the non-functional portion 116. According to one embodiment, the absorbent material 400 is disposed adjacent to the functional portion 114. Using the absorbent material 400, liquids can be trapped under the lid to prevent leakage.

[0053] The absorbent material 400 is placed in a space between the Fig. 4, and the non-functional part 116. In other words, the absorbent material 400 is inserted between the lid, also referred to as part 1, and the fluid layer 205, also referred to as part 3. Since only a few tens of microliters to 100 microliters of liquid need be absorbed by the absorbent material 400, the material selection for the absorbent material 400 is optionally very broad. Examples of the absorbent material 400 include absorbent paper, in particular blotting paper, a dry sponge, or desiccant.

[0054] According to one embodiment, the absorbent material 400 is arranged in the non-functional part 116 between and in front of the pre-storage chamber 235, the sample chamber 240, and the mixing chamber 245. According to various embodiments, the absorbent material 400 is either designed as an insert or applied, for example, by spraying, to a surface of the fluid layer 205. The absorbent material 400 is applied, for example, over the entire surface or in the form of individual strips. In a strip-shaped arrangement, one strip, for example, forms a closed frame, and further strips are spaced apart from one another and guided through an area enclosed by the frame.

[0055] According to one embodiment, the absorbent material 400 is inserted into the interior of the lid, also called the cover interior.

[0056] The absorbent material 400, which can also be referred to here as a component, can therefore be attached or provided, for example, in at least a lower region of the lid. The absorbent material 400 is optionally prefabricated as an insertable block. This enables, in particular, simple assembly of the absorbent material 400 during the production of the cartridge 105.

[0057] Fig. Figure 5 shows a schematic representation of a portion of a microfluidic cartridge according to an embodiment. The cartridge has, as shown in Figure Fig. 4, the absorbent material 400 is arranged. According to one embodiment, the absorbent material 400 is arranged in the non-functional part 116 between and in front of the pre-storage chamber 235, the sample chamber 240 and the mixing chamber 245. In comparison to the Fig. The absorbent material shown in Figure 4 is Fig. 5 more absorbent material 400 is arranged in the cartridge 105. Thus, more liquid can be absorbed by the absorbent material 400 than by the Fig. 4. According to one embodiment, the absorbent material 400 extends continuously along a boundary region between the non-functional part 116 and the functional part 114. According to one embodiment, the absorbent material 400 has a height that corresponds, for example, to a height across the width of the fluid layer 205 and across an entire height of the pre-storage chamber 235.

[0058] The exemplary embodiments described and shown in the figures are selected only as examples. Different exemplary embodiments can be combined with one another in their entirety or with regard to individual features. Furthermore, one exemplary embodiment can be supplemented by features of another exemplary embodiment.

Claims

[1] Microfluidic cartridge (105) for processing fluids, wherein the cartridge (105) is designed to be evaluable in an analysis device (100), and wherein the cartridge (105) has the following features: a base body (112) with a functional part (114) as an interface (115) to an evaluation device (140) of the analysis device (100) and a non-functional part (116) in which at least one pre-storage chamber (235) for pre-storing at least one reagent, a sample chamber (240) for receiving and / or pre-storing sample material and preferably a mixing chamber (245) for mixing the reagent and the sample material are arranged; a cover (130) for covering the non-functional part (116), wherein the cover (130) has a particularly circumferential edge (305) for placement on the base body (112); and a sealing element (300) for watertight sealing of the edge (305) of the cover (130) relative to the base body (112). [2] Cartridge (105) according to claim 1, wherein the lid (130) and the sealing element (300) are formed in one piece. [3] Cartridge (105) according to claim 2, wherein the lid (130) and the sealing element (300) are formed as a 2-component injection-molded part. [4] Cartridge (105) according to claim 1, wherein the sealing element (300) is formed separately from the lid (130). [5] Cartridge (105) according to one of the preceding claims, wherein the sealing element (300) has a hardness of 5 to 20 Shore. [6] Cartridge (105) according to one of the preceding claims, wherein the sealing element (300) is shaped to change color upon contact with moisture or a liquid. [7] Cartridge (105) according to one of the preceding claims, comprising an absorbent material (400) arranged in a space between the non-functional part (116) and the lid (130). [8] Cartridge (105) according to one of the preceding claims, wherein the lid (130) is shaped as a shell. [9] Cartridge (105) according to one of the preceding claims, wherein the lid (130) has at least one ventilation channel (310). [10] Cartridge (105) according to one of the preceding claims, wherein the lid (130) has a closure (250) for the sample chamber (240). [11] Cartridge (105) according to one of the preceding claims, wherein the base body (112) is formed as a stack of a fluid layer (205), a membrane (210), a pneumatic layer (215) and a sealing membrane (220). [12] A lid (130) for covering a non-functional part (116) of a microfluidic cartridge (105) for processing fluids, wherein the cartridge (105) is designed to be evaluable in an analysis device (100), and wherein the cartridge (105) has a base body (112) with a functional part (114) as an interface (115) to an evaluation device (140) of the analysis device (100) and a non-functional part (116) in which at least one pre-storage chamber (235) for pre-storing at least one reagent, a sample chamber (240) for receiving and / or pre-storing sample material, and preferably a mixing chamber (245) for mixing the reagent and the sample material are arranged, wherein the lid (130) has the following features: a peripheral edge (305) for placement on the base body (112); and a sealing element (300) for watertight sealing of the peripheral edge (305) of the cover (130) relative to the base body (112). [13] Lid (130) according to claim 12, wherein the sealing element (300) is shaped to change color upon contact with moisture or a liquid.

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