Cuvettes for body fluid analysis

Abstract

A cuvette for bodily fluid analysis is disclosed. The cuvette comprises a sampling cavity with a fluid inlet, a sample analysis cavity, and a discharge cavity in fluid communication with the sampling cavity and the sample analysis cavity. The discharge cavity has an outlet to an exterior of the cuvette. The cuvette is configured to transfer bodily fluid from the sampling cavity to the sample analysis cavity through the discharge cavity when centrifugal force is applied to the cuvette. The sample analysis cavity is configured to provide a first capillary force, the first capillary force being greater than the capillary force in the discharge cavity. The sample analysis cavity is configured for separating and analyzing a bodily fluid sample.

Description

[Technical Field]

[0001] The present disclosure relates to the field of bodily fluid analysis, such as blood analysis. The present disclosure relates to a cuvette for drawing up a bodily fluid sample and providing the bodily fluid sample for analysis. The present disclosure relates to a method for determining one or more biological parameters of a sample of a bodily fluid. [Background technology]

[0002] A cuvette is a small container designed to hold a liquid sample, such as a bodily fluid sample, for spectrophotometric / photometric measurements in which a beam of light may be passed through the sample in the cuvette to determine a particular property of the sample, such as measuring the sample's absorbance, transmittance, fluorescence intensity, fluorescence polarization, fluorescence lifetime, or reflectance. These measurements may be performed by an analytical device such as a spectrophotometer.

[0003] Typically, each characteristic to be determined requires a respective cuvette with a corresponding bodily fluid sample. Therefore, large volumes of bodily fluid may be required to analyze multiple characteristics. Furthermore, each sample is typically analyzed independently. Therefore, there is a significant time delay between receiving the blood sample and providing the analysis, which can delay necessary patient care.

[0004] Typical cuvettes used for body fluid analysis may be susceptible to spillage of body fluids when the cuvette is manipulated, particularly when the cuvette is removed from the analytical instrument and subsequently processed, such as after analysis of a blood sample, which may result in reduced availability of the analytical instrument because time may have to be spent cleaning the instrument from the spilled body fluids between analytical runs.

[0005] Therefore, there is a need for new approaches that allow for accurate and fast body fluid analysis. Summary of the Invention [Problem to be solved by the invention]

[0006] Therefore, a need exists for a cuvette that reduces, mitigates, or addresses existing drawbacks, provides improved ease of use, improved analytical quality, and reduces the time required to perform body fluid analysis. [Means for solving the problem]

[0007] A cuvette for analyzing bodily fluids is disclosed. The cuvette includes a sampling cavity with a fluid inlet, a sample analysis cavity, and a discharge cavity in fluid communication with the sampling cavity and the sample analysis cavity. The discharge cavity has an outlet to the exterior of the cuvette. The cuvette is configured to transfer bodily fluid from the sampling cavity to the sample analysis cavity through the discharge cavity when a force, such as centrifugal force, is applied to the cuvette. The sample analysis cavity is configured to provide a first capillary force, the first capillary force being greater than a second capillary force provided by the discharge cavity. The sample analysis cavity is configured to separate and analyze a bodily fluid sample.

[0008] A method for determining one or more biological parameters of a sample of a bodily fluid is disclosed. The method includes introducing the sample of the bodily fluid into a sampling cavity of a cuvette disclosed herein. The method includes applying a force, such as centrifugal force, to the cuvette, thereby promoting transfer of the bodily fluid from the sampling cavity to a sample analysis cavity via an ejection cavity. The method includes determining one or more biologically relevant parameters of the sample.

[0009] It is an advantage of the present disclosure that the cuvette allows for measurement of characteristics, such as gap depth, of the sample analysis cavity of the cuvette containing the bodily fluid sample before starting analysis of the bodily fluid sample. By providing two cavities in the cuvette, for example, a sampling cavity for drawing up and holding the sample and a sample analysis cavity for performing analysis of the sample, measurements can be performed on the empty sample analysis cavity before transporting the bodily fluid sample to the sample analysis cavity. By measuring the characteristics of the empty sample analysis cavity, the analyzer can be calibrated for each cuvette before analyzing the bodily fluid sample, which can improve the quality of the analysis.

[0010] Furthermore, by providing a cuvette having a sample analysis cavity with a first capillary force greater than the second capillary force in the discharge cavity, the bodily fluid sample is prevented from leaking from the sample analysis cavity. This ensures that a predetermined volume of bodily fluid remains in the sample analysis cavity and can be used for analysis. This can improve the quality of the analysis and reduce the volume of bodily fluid required for analysis. Furthermore, preventing bodily fluid from leaking from the sample analysis cavity reduces leakage of bodily fluid outside the cuvette, which may contaminate the surroundings of the cuvette, such as an analyzer, during centrifugation of the cuvette or upon removal from the analyzer, or upon placement of the cuvette. This can reduce the time required to clean the analyzer, which reduces downtime between analysis sessions and allows the analyzer to be used more efficiently.

[0011] Additionally, the present disclosure provides a cuvette that is easy and cost-effective to manufacture.

[0012] Furthermore, a cuvette according to the present disclosure has the advantage that the same bodily fluid sample and cuvette can be used to analyze multiple different biological parameters of the bodily fluid sample, thereby providing faster and more accurate results.

[0013] The above and other features and advantages of the present disclosure will become readily apparent to those skilled in the art from the following more detailed description of exemplary embodiments of the present disclosure, with reference to the accompanying drawings. [Brief explanation of the drawings]

[0014] [Figure 1] FIG. 1 is a perspective view of an example cuvette according to the present disclosure. [Figure 2] 1 is a schematic diagram of an example cuvette disclosed herein. [Figure 3] 1 is a schematic diagram of an example cuvette including a cut line showing a cross-section of an example cuvette disclosed herein. [Figure 4] 4A and 4B are a first schematic cutaway view and a first schematic cross-sectional view of an example cuvette taken along section line AA as disclosed herein; [Figure 5] 5A and 5B are a second schematic cutaway view and a second schematic cross-sectional view of an example cuvette taken along section line BB as disclosed herein; [Figure 6] FIG. 10 is a third schematic cross-sectional view of an example cuvette taken along section line CC as disclosed herein. [Figure 7] FIG. 10 is a fourth schematic cross-sectional view of an example cuvette taken along section line DD as disclosed herein. [Figure 8] 1 is a schematic diagram of an example cuvette with a designator according to the present disclosure. [Figure 9] 1 is a schematic diagram of an example cuvette according to the present disclosure. [Figure 10] 1 is a flow diagram illustrating an example method for determining one or more biological parameters of a bodily fluid according to the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0015] Various exemplary embodiments and details are described hereinafter with reference to the figures, when relevant. It should be noted that the figures may or may not be drawn to scale, and that elements of similar structure or function are indicated by similar reference numerals throughout the figures. It should also be noted that the figures are intended only to facilitate the description of the embodiments. The figures are not intended as an exhaustive description of the present disclosure or as limitations on the scope of the present disclosure. Moreover, the illustrated embodiments need not have all aspects or advantages shown. An aspect or advantage described in connection with a particular embodiment is not necessarily limited to that embodiment and may be implemented in any other embodiment even if not so shown or explicitly described.

[0016] A cuvette for body fluid analysis, such as blood analysis, is disclosed. The cuvette is configured to draw a body fluid sample, such as a blood, plasma, serum, and / or urine sample, and provide the body fluid sample for analysis, such as to an analytical device. In the example herein, the cuvette is particularly adapted for drawing a sample of whole blood. The analytical device may be configured to centrifuge the body fluid sample and determine biological parameters of the body fluid sample. The cuvette includes a sampling cavity with a fluid inlet for drawing, e.g., acquiring, the body fluid sample, a sample analysis cavity for analyzing the body fluid sample, and a discharge cavity.

[0017] The discharge cavity is in fluid communication with the sampling cavity and the sample analysis cavity, allowing bodily fluid to flow from the sampling cavity to the sample analysis cavity via the discharge cavity. The sampling cavity and the sample analysis cavity are not in direct fluid communication with each other. Therefore, in order for the bodily fluid sample to move from the sampling cavity to the sample analysis cavity, the bodily fluid sample must flow through the discharge cavity.

[0018] The cuvette is configured to transfer a body fluid sample from the sampling cavity to the sample analysis cavity via the discharge cavity when a force, such as a centrifugal force, is applied to the cuvette. In one or more example cuvettes, the cuvette is configured to transfer a body fluid sample from the sampling cavity to the sample analysis cavity via the discharge cavity while centrifugal force is applied to the cuvette, for example, during a single centrifugation step. In one or more example cuvettes, the cuvette has a first interface that fluidically connects the discharge cavity to the sampling cavity. The first interface can be configured to allow the body fluid sample to flow through the first interface when a centrifugal force that overcomes the capillary force of the sampling cavity, such as a third capillary force, is applied to the cuvette. In one or more example cuvettes, the cuvette has a second interface that fluidically connects the discharge cavity to the sample analysis cavity. The second interface may be configured to allow the body fluid sample to flow from the discharge cavity to the sample analysis cavity through the second interface and may prevent flow from the sample analysis cavity to the discharge cavity. In one or more example cuvettes, the body fluid sample may automatically flow through the second interface, for example, because a first capillary force in the sample analysis cavity is greater than a second capillary force provided by the discharge cavity. In one or more example cuvettes, the cuvette lacks any means, such as a capillary channel and / or a siphon, configured to draw the body fluid sample away from the sample analysis cavity.

[0019] A bodily fluid sample, such as a bodily fluid sample introduced into a cuvette via a sampling cavity, can be separated within the sample analysis cavity by further applying centrifugal force as the bodily fluid sample enters the sample analysis cavity. For example, red blood cells can be separated and removed from a whole blood sample, or disturbing elements can be separated and removed from a urine sample. In other words, the bodily fluid sample can be separated and analyzed within the same cavity, such as within the sample analysis cavity. The sample analysis cavity can also act as a centrifugal cavity in one or more example methods.

[0020] In one or more example cuvettes, the sample analysis cavity is the innermost cavity of the cuvette, whereby the separated bodily fluid is disposed within the innermost cavity of the cuvette, which reduces the risk of the separated bodily fluid being contaminated by contact with the outside of the cuvette.

[0021] In one or more example cuvettes, the first interface and the second interface are disposed at an angle relative to each other. The first interface may be disposed along a first axis, such as along the longitudinal axis of the cuvette. The second interface may be disposed along a second axis, such as along the transverse axis of the cuvette. The first interface and the second interface may be disposed, for example, substantially perpendicular to each other. Substantially perpendicular may be understood herein as being disposed at an angle within a range of 80 to 100 degrees, such as within a range of 85 to 95 degrees, relative to each other. However, other angles are also contemplated. The second interface may be disposed, in one or more example cuvettes, substantially perpendicular to the longitudinal direction of the cuvette, such as substantially perpendicular to the direction of centrifugal force applied to the cuvette.

[0022] The sample analysis cavity is configured to provide a first capillary force, which is greater than a second capillary force provided by the discharge cavity. The first capillary force may be achieved by the height and / or width of the sample analysis cavity and is less than the capillary force achieved by the height and / or width of the discharge cavity. The height of the sample analysis cavity and the discharge cavity may be viewed herein as the distance between the first and second inner surfaces of each cavity in the vertical direction of the cuvette, as defined in FIG. 1 . By decreasing the distance between the inner surfaces of the cavities, the capillary force of the cavity may be increased. By configuring the sample analysis cavity to have a greater capillary force than the discharge cavity, i.e., the first capillary force is greater than the second capillary force, transport of the body fluid sample from the discharge cavity to the sample analysis cavity may be increased, while transport of fluid from the sample analysis cavity to the discharge cavity may be prevented. As such, the cuvette can be configured to prevent the bodily fluid sample from leaving the sample analysis cavity after the centrifugal force is removed, thereby ensuring that the entire volume of the bodily fluid sample remains in the sample analysis cavity after the centrifugal force is removed from the cuvette. The entire volume may be viewed herein as at least 90%, such as 95%, 96%, 97%, 98%, 99%, or 100%, of the volume of the bodily fluid acquired by the sampling cavity.

[0023] The discharge cavity has an opening to the exterior of the cuvette, which may be referred to herein as a discharge opening. The discharge opening may form an outlet through which air may be discharged from the sample analysis cavity to the exterior of the cuvette via the discharge cavity when the sample analysis cavity is filled with a bodily fluid sample. The cuvette may be configured to transfer air from the sampling cavity to the exterior of the cuvette via the discharge cavity and / or through the sampling cavity when bodily fluid is introduced into, e.g., drawn up by, the sampling cavity.

[0024] The discharge opening may be located at a first end of the cuvette in one or more example cuvettes. The discharge opening may cover the entire width of the discharge cavity, such that all sides of the discharge cavity are open to the exterior of the cuvette.

[0025] In one or more example cuvettes, the discharge opening is an opening through the outer wall of the cuvette. The discharge opening can extend across a portion or the entire width of the discharge cavity. The opening allows air to escape from any cavity, such as the discharge cavity, sampling cavity, and / or sample analysis cavity, through the discharge cavity to the exterior of the cuvette when the cavity is filled with a body fluid sample. In one or more example cuvettes, the outlet of the discharge cavity to the exterior of the cuvette is located at a first end of the cuvette, such as at a first longitudinal end of the cuvette.

[0026] In one or more example cuvettes, the sampling cavity has an opening through the outer wall of the cuvette, which opening may be referred to herein as a sampling opening. The sampling opening may extend across a portion of or the entire width of the sampling cavity. The sampling opening may allow air to escape from the sampling cavity as the sampling cavity draws up, e.g., fills with, the bodily fluid sample. In one or more example cuvettes, the sampling opening of the sampling cavity relative to the exterior of the cuvette is located at a first end of the cuvette. Thus, the sampling opening and the discharge opening may be located at the same end of the cuvette.

[0027] In one or more example cuvettes, a drain opening and / or a sampling opening extending across the entire width of each cavity can allow for the removal of shaping tools used during cuvette manufacturing, which can expedite cuvette manufacturing, potentially reducing the time and cost to manufacture the cuvette.

[0028] The sampling cavity may be configured to provide a third capillary force. The third capillary force may be greater than the second capillary force in the discharge cavity. Configuring the cuvette so that the third capillary force is greater than the second capillary force may prevent automatic transport of the bodily fluid sample from the sampling cavity. Automatic transport herein refers to transport without applying an external force, such as centrifugal force, to the cuvette. A greater capillary force in the sampling cavity may be achieved by having the sampling cavity have a height that is less than the height of the discharge cavity. The height of the cavity may be viewed herein as the distance between the two parallel inner surfaces of each cavity. The third capillary force of the sampling cavity may be the same as or different from the first capillary force. Because the cuvette is configured to prevent automatic transport of the bodily fluid from the sampling cavity, the sampling cavity may be filled with the sample in several steps without acquiring excess fluid. Therefore, if the sampling cavity is not filled properly, more fluid may be drawn into the sampling cavity to fill it. Therefore, if it is noted that the inlet cavity is not completely filled with fluid, the cuvette can again come into contact with the fluid to be sampled, which will cause more fluid to be drawn into the inlet cavity by capillary action within the sampling cavity. Thus, a predefined sample volume corresponding to the volume of the sampling cavity can always be collected.

[0029] In one or more example cuvettes, the cuvette is comprised of a main body member, such as a unitary main body member, having an inner wall that defines a sampling cavity, a sample analysis cavity, and a discharge cavity within the body. A unitary body member may be seen herein as meaning that the cuvette is made in one integral piece, for example, by molding or casting. By making the cuvette as a unitary piece, the cuvette does not include any joints / joints through which bodily fluids may leak from the cuvette during centrifugation. This may reduce contamination of the outside of the cuvette and the analytical device, which reduces the time required between analyses to clean and prepare the analytical device to receive another cuvette.

[0030] The sampling cavity, sample analysis cavity, and discharge cavity may be disposed within a main body member of the cuvette. The main body member of the cuvette may be made of a material having low absorbance for radiation at wavelengths used during analysis of the bodily fluid sample. In one or more example cuvettes, the material of the cuvette may be a plastic such as polystyrene (PS), polymethylmethacrylate (PMMA), or polycarbonate (PC).

[0031] The centrifugal force applied to the cuvette can overcome the third capillary force that holds the bodily fluid sample in the sampling cavity. Therefore, the bodily fluid sample can leave the sampling cavity through the discharge cavity and enter the sample analysis cavity. The sample analysis cavity can be offset from the sampling cavity in the longitudinal direction of the cuvette. This allows the centrifugal force to urge the bodily fluid sample toward and into the sample analysis cavity.

[0032] In one or more example cuvettes, the sample analysis cavity has, e.g., is configured to provide, a greater capillary force than any adjacent cavity, such as the ejection cavity. An adjacent cavity may be viewed herein as a cavity in direct fluid communication with the sample analysis cavity. In other words, the sample analysis cavity may not be in direct fluid communication with a cavity that has a greater capillary force than the sample analysis cavity itself.

[0033] The cuvette can be configured to transfer air from the sample analysis cavity to the exterior of the cuvette through the discharge cavity when centrifugal force is applied to the cuvette. When a bodily fluid sample enters the sample analysis cavity, air within the sample analysis cavity can escape from the sample analysis cavity to the exterior of the cuvette through the second interface and the discharge opening, thereby ensuring proper filling of the sample analysis cavity.

[0034] In one or more example cuvettes, the sampling cavity and the sample analysis cavity have equal volumes, such as substantially equal volumes, such that a predefined volume of a bodily fluid sample can be acquired by the sampling cavity and the same volume of fluid can be separated and / or analyzed in the sample analysis cavity.

[0035] The volume of the sampling cavity can be in the range of 10-100 microliters (μL) or 20-60 microliters (μL), such as in the range of 30-50 μL, such as in the range of 30-40 μL, such as in the range of 30-35 μL, such as 32 μL. The volume of the sample analysis cavity can be in the range of 10-100 microliters (μL), such as in the range of 20-60 microliters (μL), such as in the range of 30-50 μL, such as in the range of 30-40 μL, such as in the range of 30-35 μL, such as 32 μL.

[0036] In one or more example cuvettes, the sample analysis cavity has a substantially uniform elongated shape extending in a first direction between a first end and an opposing second end of the cuvette. The first and second ends of the cuvette may be located at opposite longitudinal ends of the cuvette. The first direction may be parallel to an intended direction of centrifugal force applied to the cuvette, such as the direction of centrifugal force applied to the cuvette when the cuvette is analyzed using an analytical instrument configured to receive the cuvette.

[0037] In one or more example cuvettes, the overall length of the cuvette, such as the longitudinal extension of the cuvette as defined in Figure 1, can be in the range of 30 to 50 mm or 36 to 44 mm, such as in the range of 38 to 42 mm, for example, in the range of 39 to 40 mm. The overall length can be measured from the tip of a first longitudinal end of the cuvette to the second longitudinal end of the cuvette.

[0038] In one or more example cuvettes, the overall width of the cuvette, including the lateral extension of the cuvette as defined in Figure 1, can be in the range of 15 to 28 mm or 18 to 24 mm, such as in the range of 19 to 23 mm, for example, in the range of 20 to 22 mm. In one or more example methods, the width of the cuvette can be 21 mm.

[0039] In one or more example cuvettes, the overall width of the cuvette, such as the vertical extension of the cuvette as defined in FIG. 1, can be in the range of 1.9 to 2.4 mm, such as in the range of 2.0 to 2.3 mm, for example in the range of 2.1 to 2.2 mm.

[0040] In one or more example cuvettes, the sample analysis cavity can have a length in the longitudinal direction of the cuvette, e.g., the X-direction extension, as defined in FIG. 1, within the range of 10-20 mm, e.g., 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, or 20 mm, and / or within any range limited by the dimensions discussed in this paragraph.

[0041] In one or more example cuvettes, the sample analysis cavity can have a width, such as the lateral, e.g., Y-direction extension of the cuvette as defined in FIG. 1, of 2 to 7 mm, e.g., 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, or 7 mm, and / or any range limited by the dimensions discussed in this paragraph.

[0042] In one or more example cuvettes, the sample analysis cavity can have a height, such as the vertical, e.g., Z-direction extension of the cuvette as defined in Figure 1, in the range of 0.2 to 0.7 mm, e.g., 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, or 0.7 mm, and / or any range limited by the dimensions discussed in this paragraph. In one or more example cuvettes, the height of the sample analysis cavity can be 0.5 mm, e.g., 500 μm.

[0043] In one or more example cuvettes, the sampling cavity can have a length, such as an average length, in the range of 5-15 mm, e.g., 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, or 15 mm, and / or any range bounded by the dimensions discussed in this paragraph. The length of the sampling cavity can be viewed as its extension in a vertical direction, such as in the X direction of the cuvette as defined in FIG. 1.

[0044] In one or more example cuvettes, the sampling cavity can have a width, such as an extension in a lateral direction, such as in the Y direction of the cuvette as defined in FIG. 1, such as an average width, in the range of 5 to 15 mm, e.g., 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, or 15 mm, and / or any range limited by the dimensions discussed in this paragraph.

[0045] In one or more example cuvettes, the sampling cavity can have a height in the vertical, e.g., Z-direction extension of the cuvette as defined in Figure 1, within a range of 0.2-0.7 mm, e.g., 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, or 0.7 mm, and / or any range limited by the dimensions discussed in this paragraph. In one or more example cuvettes, the height of the sampling cavity can be within a range of 200-700 μm, e.g., 500-650 μm, e.g., 592 μm or 575 μm.

[0046] In one or more example cuvettes, the ejection cavity can have a length, such as an extension in a vertical direction, such as in the X direction of the cuvette as defined in FIG. 1, within a range of 5 to 10 mm, e.g., 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm, and / or within any range limited by the dimensions discussed in this paragraph.

[0047] In one or more example cuvettes, the ejection cavity can have a width, such as an extension in the Y direction of the cuvette as defined in FIG. 1, within a range of 3 to 8 mm, e.g., 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, or 8 mm, and / or any range limited by the dimensions discussed in this paragraph.

[0048] In one or more example cuvettes, the ejection cavity can have a height in the vertical, e.g., Z-direction, extension of the cuvette as defined in Figure 1 within the range of 0.4 to 2 mm, e.g., 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, or 2.0 mm, and / or any range limited by the dimensions discussed in this paragraph. In one or more example cuvettes, the height of the ejection cavity can be 1 mm, e.g., 1000 μm.

[0049] In one or more example cuvettes, the body member includes a tip. The sampling cavity can be located at the tip of the body member, such that the inlet of the sampling cavity is located at the tip of the cuvette. By locating the inlet at the tip of the cuvette, filling of the sampling cavity with the bodily fluid sample can be facilitated because the tip allows for precise positioning of the inlet of the sampling cavity in the blood sample being drawn up.

[0050] In one or more example cuvettes, the sampling cavity, such as the inner surface of the sampling cavity, is configured to slope toward the sample analysis cavity. By providing a slope to the sample analysis cavity, transport of the bodily fluid sample from the sampling cavity to the sample analysis cavity can be improved. The sampling cavity can be configured to slope outward toward the opening to further facilitate removal of the shaping tool after shaping the cuvette.

[0051] In one or more example cuvettes, the cuvette, such as the sample analysis cavity of the cuvette, is reagent-free. When the cuvette is reagent-free, analysis of a bodily fluid sample, such as a blood sample, can be performed by directly measuring hemoglobin (Hb) derivatives contained in the body. In the case of blood, the hemoglobin derivative can be, for example, reduced hemoglobin (Hb), e.g., deoxyhemoglobin (reduced), oxyhemoglobin (HbO2), methemoglobin (met-Hb), carboxyhemoglobin (HbCO), or other types of hemoglobin. Different hemoglobin derivatives can have different absorbances at different wavelengths, and therefore, optical components such as a photometer and algorithms for determining blood parameters can be configured to compensate for interference caused by different hemoglobin derivatives at different wavelengths. Creating reagent-free cuvettes reduces the cost of manufacturing the cuvette and also reduces the time it takes to manufacture the cuvette. By making the cuvette reagent-free, the number of cavities in the cuvette can be reduced. This is because no reaction between the separated blood and the reagents needs to occur. This can reduce the complexity of the cuvette, which facilitates its manufacture and use. Furthermore, by making the cuvette without reagents, the cuvette becomes insensitive to air humidity, which allows the cuvette to be shipped without sealed packaging. This has the advantage that the labor and cost for producing the cuvette can be reduced.

[0052] In one or more example cuvettes, the walls of the sampling cavity are coated with a wetting agent, which can aid in wicking the blood sample into the sampling cavity.

[0053] In one or more example cuvettes, the sample analysis cavity can include a reagent configured to react with the bodily fluid sample. The reagent can be disposed on an inner surface of the sample analysis cavity so that it contacts the bodily fluid sample when it enters the sample analysis cavity. The reagent can be applied to the sample analysis cavity during manufacturing of the cuvette. Different reagents can be provided within the cavity depending on the analysis to be performed, thereby allowing the cuvette to be adapted for analysis of different biological parameters of the bodily fluid and for different types of bodily fluid. When the bodily fluid sample is blood, the reagent can react different hemoglobin derivatives to become the same derivative, thereby reducing interference at different wavelengths, which can facilitate the analysis procedure of the blood sample.

[0054] In one or more example cuvettes, the cuvettes may include a unique identifier for identifying each respective cuvette. The unique identifier may be a visual identifier, such as a barcode or QR code, or a digital identifier, such as a radio frequency identification (RFID) tag. The unique identifier may be used to identify the cuvette used for a particular bodily fluid sample and / or analysis. In one or more example cuvettes, the identifier may be identified by an analytical device, and measurements from the analytical device may be automatically stored along with the cuvette's unique identifier.

[0055] In one or more example cuvettes, such as when the bodily fluid is blood, the cuvette can include an indicator for indicating the hematocrit level of the bodily fluid sample. The indicator can be disposed along the periphery of the sample analysis cavity. In one or more example cuvettes, the indicator for indicating the hematocrit level of the bodily fluid sample can be disposed to partially or completely overlap the sample analysis cavity. The hematocrit level indicator can be added to the cuvette because the cuvette can be configured to perform separation of the bodily fluid sample, such as plasma separation of a blood sample. The sampling cavity is configured to extract a precise bodily fluid volume, and the cuvette is configured to transport the entire sample from the sampling cavity to the sample analysis cavity. A known volume of the bodily fluid can thereby be provided in the sample analysis cavity. Accordingly, a measurement line can be added within the cuvette to provide a visual indication of the hematocrit level. The measurement line can be added by one or more of laser welding, etching, and engraving on the cuvette, or during the cuvette molding procedure. After centrifugation, when the operator extracts the cuvette from the analyzer, a visual indication of the hematocrit level can be read based on the hematocrit level indicator on the cuvette. The hematocrit level indicator on the cuvette has the advantage of being able to provide an indication for diseases such as anemia or polycythemia.

[0056] The cuvette can be a disposable cuvette, for example a cuvette configured for single use, such that it is disposable and can be used once for an analysis and then discarded.

[0057] Additionally, a method of manufacturing a cuvette is disclosed. The cuvette can be configured to draw up and analyze a bodily fluid sample. The method includes providing a cuvette base material forming the cuvette. The material can be a plastic material with low absorbance for radiation at wavelengths used during analysis, such as polystyrene (PS), polymethyl methacrylate (PMMA), or polycarbonate (PC). The method includes shaping the cuvette from the cuvette base material using at least one shaping tool. The shaping tool is positioned to extend into the cuvette base material to form the cuvette. The cuvette can have a sampling cavity with a fluid inlet, a sample analysis cavity, and an exhaust cavity in fluid communication with the sampling cavity and the sample analysis cavity. The method includes withdrawing the shaping tool through an outer wall of the cuvette. The shaping tool can be withdrawn through an outlet of the sampling cavity and / or the exhaust cavity in one or more example methods.

[0058] In one or more example methods, the method includes attaching an indicator to the cuvette to indicate the hematocrit level of the bodily fluid sample. In one or more example methods, shaping the cuvette is performed by, e.g., using injection molding. The indicator may be attached to the cuvette during the injection molding process, such as using a negative imprint on a molding tool, or may be attached by, e.g., using one or more of laser welding, etching, and engraving. A negative imprint may be viewed herein as the inverse shape of a molded part, such as the indicator.

[0059] A shaping tool for forming a cuvette is disclosed. The shaping tool may be configured for insertion into a cuvette base material to form a cavity in the base material. The shaping tool may be further configured to be withdrawn from the cuvette base material once the cavity has been formed. The shaping tool includes a sampling cavity portion having an inverted shape of the sampling cavity of the cuvette. The shaping tool includes a sample analysis cavity portion having an inverted shape of the sample analysis cavity of the cuvette. The shaping tool includes an ejection cavity portion having an inverted shape of the ejection cavity of the cuvette, the ejection cavity portion being connected to the sampling cavity portion and the sample analysis cavity portion. The sampling cavity portion and the sample analysis cavity portion are not directly connected to each other.

[0060] In one or more example shaping tools, the sampling cavity portion, the sample analysis cavity portion, and the ejection cavity portion are disposed on a common shaping core, such as on a single shaping core.

[0061] In one or more example shaping tools, the shaping tool can include a first shaping core and a second shaping core, wherein one or more of the sampling cavity portion, the sample analysis cavity portion, and the discharge cavity portion are disposed on the first shaping core, and one or more of the sampling cavity portion, the sample analysis cavity portion, and the discharge cavity portion are disposed on the second shaping core.

[0062] In one or more example shaping tools, the thickness of the ejection cavity portion is greater than the thickness of the sampling cavity portion. In one or more example shaping tools, the thickness of the ejection cavity portion is greater than the thickness of the sample analysis cavity portion.

[0063] A method for determining one or more biological parameters of a bodily fluid sample is disclosed. The method includes introducing the bodily fluid sample into a sampling cavity of a cuvette disclosed herein. The method includes applying a centrifugal force, such as a first centrifugal force, to the cuvette, thereby promoting transfer of the bodily fluid from the sampling cavity to the sample analysis cavity via the discharge cavity. In one or more example methods, the method includes applying a second centrifugal force once the bodily fluid sample enters the sample analysis cavity, thereby separating the bodily fluid sample contained in the sample analysis cavity. The method includes determining one or more biological parameters of the bodily fluid sample. Determining the one or more biological parameters of the bodily fluid sample can be performed while the bodily fluid sample is in the sample analysis cavity.

[0064] In the following, the cuvette of the present disclosure will be described in further detail with reference to the figures. The figures are schematic in nature and simplified for clarity, showing only details that are helpful in understanding the present disclosure, while other details are omitted. The same reference numerals are used throughout for identical or corresponding parts.

[0065] FIG. 1 shows a perspective view of a cuvette 1 according to one or more examples of the present disclosure. The cuvette 1 comprises a sampling cavity 2, a discharge cavity 3, and a sample analysis cavity 4. Throughout this document, the cuvette will be described with reference to the coordinate system disclosed in FIG. 1 , where the X-axis defines a vertical direction spanning the length of the cuvette 1 (e.g., between a first vertical end 6 and a second vertical end 7 of the cuvette 1), the Y-axis defines a horizontal direction spanning the width of the cuvette 1, and the Z-axis defines a vertical direction spanning the height of the cuvette 1. The major plane of the cuvette 1 discussed herein is a plane extending in the vertical and horizontal directions of the cuvette 1. A plane perpendicular to the major plane may be referred to herein as one or more of a plane extending in the vertical and vertical directions of the cuvette 1 and a plane extending in the horizontal and vertical directions of the cuvette 1. The cuvette 1 may have a longer extension in the vertical and horizontal directions compared to the vertical direction and may therefore be referred to as having a flat shape or being a flat cuvette.

[0066] FIG. 2 illustrates a cuvette 1 according to one or more examples of the present disclosure. The cuvette 1 includes a sampling cavity 2, a sample analysis cavity 4, and a discharge cavity 3. The sampling cavity 2 includes a fluid inlet 22 for collecting a bodily fluid sample. The cuvette 1 has a main body member 10 including a base portion 11. The base portion 11 can be solid and configured to be touched by an operator during handling of the cuvette without interfering with the results of an analysis of the bodily fluid. In a cuvette according to one or more examples, the base portion 11 of the main body member 10 can have a different surface texture than the main body member 10 in the area of ​​the sampling cavity 2 and / or the sample analysis cavity 4. Providing the base portion 11 with a different surface texture can provide the operator of the cuvette with a visual indication of the areas that can be touched without interfering with the analysis results. For example, the surface in the area of ​​the sampling cavity 2 and / or the sample analysis cavity 4 can be transparent, while the surface of the base portion 11 can be frosted. The outer shape of the cuvette 1 may be configured so that the cuvette 1 can only be positioned in one way within an analytical device. In one or more example cuvettes 1, the outer shape of the cuvette 1 is asymmetrical. The main body member 10 may include a mounting element 5 that may be configured to mate the cuvette holder to an analytical device. The mounting element 5 may be arranged so that the cuvette 1 can only be positioned in one way within an analytical device. In the example cuvette 1 shown in FIG. 2, the mounting element 5 may be shaped as a recess in the outer surface of the cuvette 1. As such, the mounting element 5 may be configured to mount the cuvette 1 to an analytical device, such as to a rotatable member of the analytical device. In one or more example cuvettes, the outer shape of the cuvette 1 in the area of ​​the sample analysis cavity 4 may be recessed, for example, lower than the surrounding area of ​​the outer surface of the cuvette 1. In other words, the outer surface of the cuvette 1 may be lower in the area of ​​the sample analysis cavity 4 than in the area of ​​the base portion 11 of the cuvette 1.Thereby, the outer surface in the area of ​​the sample analysis cavity 4 can be protected from being contaminated, eg scratched, when the cuvette is handled or placed on a contaminated and / or rough surface.

[0067] The sampling cavity 2, sample analysis cavity 4, and discharge cavity 3 may be disposed within, e.g., formed within, a main body member 10 of the cuvette 1. The cuvette 1 may consist of a single main body member 10, such as an integral part, with inner walls defining the sampling cavity 2, sample analysis cavity 4, and discharge cavity 3 within the main body member 10. The main body member 10 of the cuvette 1 may be made of a material that has low absorbance for radiation at wavelengths used during analysis of bodily fluid samples. The main body member 10 may be made of a plastic, such as polystyrene (PS), polymethyl methacrylate (PMMA), or polycarbonate (PC).

[0068] The discharge cavity 3 is in fluid communication with the sampling cavity 2 and the sample analysis cavity 4, thereby allowing bodily fluid to flow from the sampling cavity 2 to the sample analysis cavity 4 via the discharge cavity 3. The discharge cavity 3 may be fluidly connected to the sampling cavity 2 via a first interface 23. The first interface 23 may be disposed along the longitudinal axis of the cuvette 1. The discharge cavity 3 may be fluidly connected to the sample analysis cavity 4 via a second interface 34. The second interface 34 may be disposed along the transverse axis of the cuvette 1. The sampling cavity 2 and the sample analysis cavity 4 are not in direct fluid communication with each other. Therefore, for the bodily fluid sample to move from the sampling cavity 2 to the sample analysis cavity 4, the bodily fluid sample must flow through the discharge cavity 3, such as via the first interface 23 and the second interface 34.

[0069] The sample analysis cavity 4 is configured to provide a first capillary force, which is greater than a second capillary force provided by the discharge cavity 3. This may be achieved by the height of the sample analysis cavity 4 being less than the height of the discharge cavity 3. The second interface 34 may be configured to allow the body fluid sample to flow from the discharge cavity to the sample analysis cavity through the second interface 34, and to prevent flow of the body fluid sample from the sample analysis cavity 4 to the discharge cavity 3. This ensures that the entire volume of the body fluid sample enters and remains within the sample analysis cavity 4.

[0070] The first interface 23 and the second interface 34 may be disposed at an angle a relative to each other. The first interface 23 and the second interface 34 may, for example, be disposed substantially perpendicular to each other.

[0071] The sampling cavity 2 is configured to provide a third capillary force, the third capillary force being greater than the second capillary force. The third capillary force, which is greater than the second capillary force, prevents automatic transport of the body fluid sample from the sampling cavity 2 to the discharge cavity 3. This can be achieved by having the height of the sampling cavity 2 be less than the height of the discharge cavity 3. The third capillary force can be the same as or different from the first capillary force. The first interface 23 can be configured to allow the body fluid sample to flow through the first interface 23 when a centrifugal force that overcomes the third capillary force is applied to the cuvette 1. As such, the cuvette 1 can be configured to transfer the body fluid sample from the sampling cavity 2 to the sample analysis cavity 4 via the discharge cavity 3 when a centrifugal force is applied to the cuvette 1.

[0072] The body fluid sample introduced into the cuvette 1 via the sampling cavity 2 can be separated within the sample analysis cavity 4 by applying a further centrifugal force, for example a second centrifugal force, once the body fluid sample enters the sample analysis cavity 4.

[0073] The discharge cavity 3 has an outlet 31 to the exterior of the cuvette 1. The outlet 31 of the discharge cavity 3 may be located at a first end 6, such as a first longitudinal end, of the cuvette 1. The outlet 31 may be an opening through a first outer wall of the first end 6 of the cuvette 1, the opening extending across the entire width of the discharge cavity 3. This allows all sides of the discharge cavity 3 to be open to the exterior of the cuvette 1. The outlet 31 is configured to allow air to be discharged from the sample analysis cavity 4 to the exterior of the cuvette 1 via the discharge cavity 3 when the sample analysis cavity 4 is filled with a body fluid sample. The outlet 31 covering the entire width of the discharge cavity 3 also allows a shaping tool to be removed from the main body member 10 after the cuvette 1 is manufactured.

[0074] The sampling cavity 2 has an opening 21 through a first outer wall at the first end 6 of the cuvette 1. The opening 21 extends across the entire width of the sampling cavity 2. The opening 21 of the sampling cavity 2 can allow air to escape from the sampling cavity 2 as it draws up, e.g., fills with, a bodily fluid sample. The opening 21 can further allow for the removal of a shaping tool used during the manufacture of the cuvette 1. The opening 21 of the sampling cavity 2 can be located at the same end of the cuvette 1 as the outlet 31. The main body member 10 can include a tip 12. The tip 12 can be located at the first end 6. A sidewall of the first end 6 can include a bend that forms the tip 12. The sampling cavity 2 can be located at the tip 12 of the main body member 10, such that the inlet 22 of the sampling cavity 2 is located at the tip 12 of the cuvette 1. Positioning the inlet 22 at the tip 12 of the cuvette 1 can facilitate filling of the sampling cavity with the bodily fluid sample because the tip 12 allows for precise positioning of the inlet 22 in the bodily fluid sample being drawn up. When the tip 12 is immersed in the bodily fluid sample, capillary forces in the sampling cavity 2 draw the bodily fluid into the sampling cavity 2 through the inlet 22. The inlet 22 can be a section of the opening 21 located at the tip 12 of the cuvette 1. The sampling cavity 2, such as the inner surface 24 of the sampling cavity 2, can be configured to slope toward the sample analysis cavity 4. Providing the sampling cavity 2 with a sloped inner surface 24 can improve transport of the bodily fluid sample from the sampling cavity 2 to the sample analysis cavity 4. The sampling cavity 2, such as the inner surface 24, can be configured to slope outward toward the opening 21, which can facilitate removal of the shaping tool after shaping the cuvette 1.

[0075] The sample analysis cavity 4 may have a substantially uniform elongated shape extending in a first direction from a first end 6 of the cuvette 1 to / to an opposing second end 7 of the cuvette 1. The first end 6 and second end 7 of the cuvette may be located at opposing longitudinal ends of the cuvette 1. The first direction may be parallel to an intended direction of centrifugal force applied to the cuvette, such as the direction of centrifugal force applied to the cuvette when the cuvette 1 is analyzed using an analytical device configured to receive the cuvette 1.

[0076] In one or more example cuvettes, the sample analysis cavity 4 can be offset from the sampling cavity 2 in the longitudinal direction of the cuvette 1. In one or more example cuvettes, the sample analysis cavity 4 can be offset from the sampling cavity 2 in the lateral direction of the cuvette 1. In one or more example cuvettes, the sample analysis cavity 4 can be offset from the sampling cavity 2 in the longitudinal direction of the cuvette 1 and in the lateral direction of the cuvette 1. FIG. 3 illustrates the locations of a first cutting plane AA, a second cutting plane BB, a third cutting plane CC, and a fourth cutting plane DD, which are used for the cross-sectional views of FIGS. 4-7. The cutting plane AA extends in the longitudinal direction of the cuvette through the sampling cavity 2. The cross-sectional view of the cutting plane AA is further described with reference to FIGS. 4A and 4B. The cutting plane BB extends in the longitudinal direction of the cuvette through the discharge cavity 3 and the sample analysis cavity 4. The cross-sectional view of the cutting plane BB is further described with reference to FIGS. 5A and 5B. A cutting plane CC extends laterally of the cuvette 1 through the discharge cavity 3 and the sampling cavity 2. A cross-sectional view of the cutting plane CC is further described with reference to Figure 6. A cutting plane DD extends laterally of the cuvette 1 through the sample analysis cavity 4. A cross-sectional view of the cutting plane DD is further described with reference to Figure 7.

[0077] Figure 4A shows a cutaway view and Figure 4B shows a cross-sectional view of the cuvette 1 through section plane AA. As can be seen in the cutaway view of Figure 4A, the sampling cavity 2 is located at the first end 6 of the cuvette 1 within the main body 11. The sampling cavity 2 has an opening 21 through the outer wall of the cuvette 1 at the first end 6.

[0078] 4B shows a cross section of the cuvette looking towards the tip 12 of the cuvette 1. As can be seen, the opening 21 of the sampling cavity 2 extends across the entire width of the sampling cavity 2 to an inlet 22 located at the tip 12.

[0079] FIG. 5A shows a cutaway view, and FIG. 5B shows a cross-sectional view of the cuvette 1 through the cut plane BB. The discharge cavity 3 is disposed at the first end 6 of the cuvette 1 and extends between the first end 6 and the sample analysis cavity 4. The sample analysis cavity 4 extends longitudinally from the discharge cavity 3 toward the second end 7 of the cuvette 1. As can be seen in the cutaway view of FIG. 5A, the sample analysis cavity 4 is narrower than the discharge cavity 3, e.g., has a lower height than the discharge cavity 3. Because the sample analysis cavity 4 has a lower height than the discharge cavity 3, the first capillary force is greater than the second capillary force. This can increase the transport of the body fluid sample from the discharge cavity 3 through the second interface 34 to the sample analysis cavity 4 because the first capillary force draws the body fluid sample into the sample analysis cavity 4. The first capillary force being greater than the second capillary force further prevents fluid from flowing from the sample analysis cavity 4 back to the discharge cavity 3 .

[0080] The cross-sectional view of Figure 5B shows a cross-section of the cuvette as seen toward the tip 12 of the cuvette 1. As can be seen, the opening 21 of the sampling cavity 2 and the outlet 31 of the discharge cavity 3 are connected so that the first outer wall of the cuvette at the first end 6 is open along the entire length of the sampling cavity 2 and the discharge cavity 3. This allows a shaping tool having a common shaping core for all cavities to be removed through the opening 21 and the outlet 31. A first interface 23 is disposed longitudinally of the cuvette and separates the sampling cavity 2 from the discharge cavity 3.

[0081] FIG. 6 shows a cross-sectional view of the cuvette 1 through the cross section CC. As discussed above, the height of the sampling cavity 3 is lower than the height of the discharge cavity 3. Because the sampling cavity 2 has a lower height than the discharge cavity 3, the third capillary force in the sampling cavity 2 is greater than the second capillary force. This prevents the bodily fluid sample in the sampling cavity 2 from automatically flowing from the sampling cavity 2 to the discharge cavity 3. The sampling cavity 2 and the discharge cavity 3 may be connected by a first interface 23. The first interface 23 may have a lower height, such as an extension in the Z direction, than both the sampling cavity 2 and the discharge cavity 3. Therefore, the first interface may have a fourth capillary force. The fourth capillary force may be greater than the second and third capillary forces. Therefore, the first interface 23 can be an area adjacent to the sampling cavity 2 that has a very narrow thickness to further ensure that there is no capillary transport from the sampling cavity 2 to the discharge cavity 3. Therefore, the first interface 23 can act as a lock that prevents the body fluid sample from flowing from the sampling cavity 2 to the discharge cavity 3. A centrifugal force can be applied to the cuvette 1 to transport the body fluid sample to the discharge cavity 3. When the centrifugal force applied to the cuvette 1 overcomes the third capillary force, the body fluid sample can leave the sampling cavity 2 through the first interface 23 and enter the discharge cavity 3, from which the body fluid sample can enter the sample analysis cavity 4.

[0082] FIG. 7 shows a cross-sectional view of the cuvette 1 through the section plane DD. As can be seen in FIG. 7, comparing that cross-sectional view with the cross-sectional view CC of FIG. 6, the cross-sectional area of ​​the sample analysis cavity 4, such as its height and width, is smaller than the cross-sectional area of ​​the discharge cavity 3, thereby causing the sampling cavity 2 to have a greater capillary force than the discharge cavity 3. In other words, the discharge cavity 3 has a larger cross-sectional area in a plane perpendicular to the main plane of the cuvette 1, such as in a plane spanning the Y and Z axes, than the sampling cavity 2 and / or the sample analysis cavity 4. Furthermore, the smaller height and narrower width of the sample analysis cavity 4 compared to the height and width of the discharge cavity 3 allows portions of a shaping tool furthest within the main body member 11 of the cuvette 1 during manufacturing, such as the portion that molds the sample analysis cavity 4, to be removed through a wider outer section of the cuvette 1, such as through the wider discharge cavity 3.

[0083] FIG. 8 illustrates a cuvette 1 according to one or more examples of the present disclosure. The cuvette 1 can include an indicator 13 for indicating the hematocrit level of the bodily fluid sample. The indicator 13 can be disposed along the periphery of the sample analysis cavity 4. The cuvette 1 can be configured to perform a separation of the bodily fluid sample, such as plasma separation of a blood sample, and thus the hematocrit level indicator can be added to the cuvette 1. In one or more example cuvettes, the cuvette is configured to perform a separation of the bodily fluid sample within the sample analysis cavity 4. In other words, the blood sample can be separated and analyzed within the sample analysis cavity 4. The sampling cavity 2 is configured to extract a precise bodily fluid volume, and the cuvette 1 is configured to transport the entire sample from the sampling cavity 2 to the sample analysis cavity 4. A known volume of the bodily fluid can thereby be provided to the sample analysis cavity 4. Thus, the indicator 13 may comprise a measurement line added to the main body member 10 of the cuvette 1 to provide a visual indication of the hematocrit level. The indicator may be added by laser welding on the cuvette or during the molding procedure of the cuvette.

[0084] FIG. 9 illustrates a cuvette 1 according to one or more examples of the present disclosure. The example cuvette 1 according to FIG. 9 includes a sampling cavity 2, a sample analysis cavity 4, and a discharge cavity 3. The discharge cavity 3 is in fluid communication with the sampling cavity 2 and the sample analysis cavity 4, such that bodily fluid can flow from the sampling cavity 2 to the sample analysis cavity 4 via the discharge cavity 3. The discharge cavity 3 may be fluidly connected to the sampling cavity 2 via a first interface 23. The first interface 23 may be disposed along the longitudinal axis of the cuvette 1. The discharge cavity 3 may be fluidly connected to the sample analysis cavity 4 via a second interface 34. The second interface 34 may be disposed along the transverse axis of the cuvette 1. The sampling cavity 2 and the sample analysis cavity 4 are not in direct fluid communication with each other. The sample analysis cavity 4 is configured to provide a first capillary force, which is greater than the second capillary force provided by the discharge cavity 3. This can be achieved by having a height, such as a gap depth, of the sample analysis cavity 4 that is less than the height, such as a gap depth, of the discharge cavity 3. In the example cuvette 1 of FIG. 9 , the width of the discharge cavity 3 at the second interface 34 is equal to the width of the sample analysis cavity 4, so that the inner distal sidewall 32 of the discharge cavity 3 facing the first interface 23 is flush with the inner distal sidewall 42 of the sample analysis cavity 4. Distal may be viewed herein as being furthest outward from the sampling cavity 2. By positioning the inner distal sidewall 32 of the discharge cavity 3 flush with the inner distal sidewall 42 of the sample analysis cavity 4, a nook or corner can be eliminated at the transition between the discharge cavity 3 and the sample analysis cavity 4. This provides better fluid flow between the discharge cavity 3 and the sample analysis cavity 4, reducing the risk of bodily fluid being trapped in the discharge cavity 3 and not reaching the sample analysis cavity 4. Thereby, a larger portion of the bodily fluid sample introduced into the cuvette 1 via the sampling cavity can be used for analysis of the bodily fluid in the sample analysis cavity, which may improve the results of the analysis.As in the case of the example cuvettes disclosed in Figures 2 to 8, the height of the discharge cavity 3 is greater than the height of the sample analysis cavity 4, so that the capillary force of the sample analysis cavity 4 is greater than the capillary force of the discharge cavity 3. The example cuvette 1 of Figure 9 further comprises a mounting element 5 for mounting the cuvette 1 to an analysis device.

[0085] FIG. 10 discloses a method 100 for determining one or more biological parameters of a bodily fluid sample, such as a bodily fluid sample. The method includes introducing S102 the bodily fluid sample into a sampling cavity of a cuvette disclosed herein. The method includes applying S104 a centrifugal force, such as a first centrifugal force, to the cuvette, thereby promoting transfer of the bodily fluid from the sampling cavity to the sample analysis cavity via the discharge cavity. In one or more example methods, the method includes applying S105 a second centrifugal force once the bodily fluid sample enters the sample analysis cavity, thereby separating the bodily fluid sample contained in the sample analysis cavity. As such, the bodily fluid sample may be separated within the sample analysis cavity. The method includes determining S106 one or more biological parameters of the bodily fluid sample. Determining the one or more biological parameters of the bodily fluid sample may be performed while the bodily fluid sample is in the sample analysis cavity.

[0086] It should be noted that the features described in the embodiments illustrated in Figures 1-10 are not limited to these particular embodiments. As such, any features of the cuvette and components included therein and described in connection with Figures 2-7, such as the dimensions of the cuvette and / or cavity, are equally applicable to the cuvette described in connection with Figures 1 and 8, and vice versa.

[0087] Embodiments of the products (cuvette, manufacturing method, shaping tool, and method for determining one or more biological parameters of a sample of a bodily fluid) according to the present disclosure are set forth in the following clauses:

[0088] Clause 1. A cuvette for body fluid analysis, comprising: a sampling cavity with a fluid inlet; a sample analysis cavity; an exhaust cavity in fluid communication with the sampling cavity and the sample analysis cavity, the exhaust cavity having an outlet to an exterior of the cuvette; the cuvette is configured to transfer bodily fluid from the sampling cavity to the sample analysis cavity through the discharge cavity when centrifugal force is applied to the cuvette; the sample analysis cavity is configured to provide a first capillary force; The cuvette, wherein the first capillary force is greater than a second capillary force provided by the ejection cavity.

[0089] Clause 2. The cuvette of clause 1, wherein the cuvette is configured to transfer air from the sample analysis cavity to an exterior of the cuvette via the exhaust cavity when centrifugal force is applied to the cuvette.

[0090] Clause 3. The cuvette of clause 1 or 2, wherein the cuvette is configured to transfer air from the sampling cavity to the outside of the cuvette via the exhaust cavity when bodily fluid is introduced into the sampling cavity.

[0091] Clause 4. The cuvette of any one of clauses 1 to 3, wherein the cuvette is configured to prevent the bodily fluid from leaving the sample analysis cavity after the centrifugal force is removed.

[0092] Clause 5. The cuvette of any one of clauses 1 to 4, wherein the sampling cavity and the sample analysis cavity have the same volume.

[0093] Clause 6. A cuvette according to any one of clauses 1 to 5, wherein the sampling cavity is configured to provide a third capillary force, the third capillary force being greater than the second capillary force provided by the discharge cavity.

[0094] Clause 7. A cuvette according to any one of clauses 1 to 6, wherein the sample analysis cavities have substantially identical elongated shapes extending in a first direction from a first end of the cuvette to an opposing second end.

[0095] Clause 8. The cuvette of clause 7, wherein the outlet of the discharge cavity to the exterior of the cuvette is located at the first end of the cuvette.

[0096] Clause 9. A cuvette as described in any one of clauses 1 to 8, wherein the cuvette has a first interface fluidly connecting the discharge cavity to the sampling cavity, and the first interface is configured to allow the bodily fluid sample to flow through the first interface when a centrifugal force is applied to the cuvette that overcomes the third capillary force.

[0097] Clause 10. A cuvette as described in clause 9, wherein the cuvette has a second interface fluidly connecting the discharge cavity to the sample analysis cavity, the second interface being configured to allow the bodily fluid sample to flow through the second interface.

[0098] Clause 11. A cuvette according to clause 9 or 10, wherein the discharge cavity has a larger cross-sectional area in a plane perpendicular to a main plane of the cuvette than the sampling cavity and / or the sample analysis cavity.

[0099] Clause 12. A cuvette according to clause 11, wherein the cross section of the discharge cavity has a width and / or height, in a plane perpendicular to the main plane of the cuvette, that is wider and / or taller than the cross section of the sampling cavity and / or the sample analysis cavity.

[0100] Clause 13. The cuvette according to any one of clauses 9 to 12, wherein the first interface and the second interface are disposed at an angle relative to each other.

[0101] Clause 14. A cuvette according to any one of clauses 1 to 13, wherein the cuvette consists of a single body member having inner walls defining the sampling cavity, the sample analysis cavity, and the discharge cavity within the body.

[0102] Clause 15. The cuvette of clause 14, wherein the body member has a tip, and the sampling cavity is disposed at the tip of the body member.

[0103] Clause 16. The cuvette according to any one of clauses 1 to 15, wherein the sampling cavity is configured to be inclined towards the sample analysis cavity.

[0104] Clause 17. The cuvette of any one of clauses 1 to 16, wherein the sample analysis cavity is reagent-free.

[0105] Clause 18. The cuvette of any one of clauses 1-17, wherein the cuvette includes an indicator for indicating the hematocrit level of the bodily fluid sample.

[0106] Clause 19. The cuvette of clause 18, wherein the indicator is positioned along the periphery of the sample analysis cavity.

[0107] Clause 20. The cuvette of any one of clauses 1 to 19, wherein the discharge cavity has an opening through an outer wall of the cuvette, the opening extending across the entire width of the discharge cavity.

[0108] Clause 21. A cuvette according to any one of clauses 1 to 20, wherein the sampling cavity has an opening through the outer wall of the cuvette, the opening extending across the entire width of the sampling cavity.

[0109] Clause 22. A method of manufacturing a cuvette for drawing up a body fluid sample and analyzing said body fluid sample, comprising: providing a cuvette base material forming the cuvette; shaping a cuvette from the cuvette base material using at least one shaping tool, the shaping tool being disposed to extend into the cuvette base material to form the cuvette, the cuvette comprising: a sampling cavity with a fluid inlet; a sample analysis cavity; a shaping step having an ejection cavity in fluid communication with the sampling cavity and the sample analysis cavity; withdrawing the shaping tool through the outer wall of the cuvette; A method comprising:

[0110] Clause 23. The method of clause 22, wherein said method includes the step of affixing an indicator on said cuvette to indicate the hematocrit level of the bodily fluid sample.

[0111] Clause 24. The method according to clause 23, wherein the step of attaching the indicator is performed by laser welding.

[0112] Clause 25. The method according to any one of clauses 22 to 24, wherein the step of shaping the cuvette is carried out by injection molding.

[0113] Clause 26. A shaping tool for forming a cuvette, the shaping tool being configured for insertion into a cuvette base material to form a cavity in said base material, and further configured for withdrawal from said cuvette base material once said cavity has been formed; a sampling cavity portion having an inverted shape of the sampling cavity of the cuvette; a sample analysis cavity portion having an inverted shape of the sample analysis cavity of the cuvette; an ejection cavity portion having an inverted shape of the ejection cavity of the cuvette; Equipped with A shaping tool, wherein the discharge cavity portion is connected to the sampling cavity portion and the sample analysis cavity portion.

[0114] Clause 27. The shaping tool of clause 26, wherein the sampling cavity portion, the sample analysis cavity portion, and the discharge cavity portion are disposed on a common shaping core.

[0115] Clause 28. A shaping tool according to clause 26 or 27, wherein the thickness of the discharge cavity portion is greater than the thickness of the sampling cavity portion and / or the sample analysis cavity portion.

[0116] Clause 29. A method for determining one or more biological parameters of a sample of a body fluid, comprising: - introducing (S102) a sample of bodily fluid into said sampling cavity of a cuvette according to any one of clauses 1 to 21; - applying (S104) centrifugal force to the cuvette, thereby facilitating transfer of the bodily fluid from the sampling cavity to the sample analysis cavity via the discharge cavity; - determining one or more biological parameters of said sample (S106); A method comprising:

[0117] The use of the terms "first," "second," "third," and "fourth," "primary," "secondary," "tertiary," etc. is included to identify particular elements and not to imply any particular order. Furthermore, the use of the terms "first," "second," "third," and "fourth," "primary," "secondary," "tertiary," etc. does not indicate any order or importance; rather, the terms "first," "second," "third," and "fourth," "primary," "secondary," "tertiary," etc. are used to distinguish one element from another. Note that the terms "first," "second," "third," and "fourth," "primary," "secondary," "tertiary," etc. are used herein and elsewhere merely for labeling purposes and are not intended to indicate any particular spatial or temporal ordering. Furthermore, the labeling of a first element does not imply the presence of a second element, and vice versa.

[0118] It will be noted that the word "comprising" does not necessarily exclude the presence of other elements or steps than those listed.

[0119] It should be noted that the word "a" or "an" preceding an element does not exclude the presence of a plurality of such elements.

[0120] While features have been illustrated and described, it will be understood that the features are not intended to limit the claimed disclosure, and it will be apparent to those skilled in the art that various changes and modifications can be made without departing from the scope of the claimed disclosure. Accordingly, the specification and drawings are to be regarded in an illustrative rather than a restrictive sense. The claimed disclosure is intended to cover all alternatives, modifications, and equivalents. <Additional Notes> [Form 1] 1. A cuvette for body fluid analysis, comprising: a sampling cavity with a fluid inlet; a sample analysis cavity; an exhaust cavity in fluid communication with the sampling cavity and the sample analysis cavity, the exhaust cavity having an outlet to an exterior of the cuvette; the cuvette is configured to transfer bodily fluid from the sampling cavity to the sample analysis cavity via the discharge cavity when centrifugal force is applied to the cuvette; the sample analysis cavity is configured to provide a first capillary force; the first capillary force is greater than a second capillary force provided by the ejection cavity; A cuvette, wherein the sample analysis cavity is configured for separating and analyzing the bodily fluid sample. [Form 2] A cuvette according to claim 1, wherein the cuvette is configured to transfer air from the sample analysis cavity to the outside of the cuvette via the exhaust cavity when centrifugal force is applied to the cuvette. [Form 3] A cuvette according to aspect 1 or 2, wherein the cuvette is configured to transfer air from the sampling cavity to the outside of the cuvette via the exhaust cavity when bodily fluid is introduced into the sampling cavity. [Form 4] 4. The cuvette of any one of aspects 1 to 3, wherein the cuvette is configured to prevent the bodily fluid from leaving the sample analysis cavity after the centrifugal force is removed. [Form 5] 5. The cuvette according to any one of the first to fourth aspects, wherein the sampling cavity and the sample analysis cavity have the same volume. [Form 6] A cuvette described in any one of forms 1 to 5, wherein the sampling cavity is configured to provide a third capillary force, the third capillary force being greater than the second capillary force provided by the discharge cavity. [Form 7] A cuvette according to any one of the first to sixth aspects, wherein the sample analysis cavity has a substantially uniform elongated shape extending in a first direction from a first end of the cuvette to an opposing second end. [Form 8] 8. The cuvette of claim 7, wherein the outlet of the discharge cavity to the exterior of the cuvette is located at the first end of the cuvette. [Form 9] A cuvette as described in any one of forms 1 to 8, wherein the cuvette has a first interface fluidly connecting the discharge cavity to the sampling cavity, and the first interface is configured to allow the bodily fluid sample to flow through the first interface when a centrifugal force that overcomes the third capillary force is applied to the cuvette. [Form 10] A cuvette as described in form 9, wherein the cuvette has a second interface fluidly connecting the discharge cavity to the sample analysis cavity, the second interface being configured to allow the bodily fluid sample to flow through the second interface. [Form 11] 11. The cuvette of claim 9 or 10, wherein the discharge cavity has a larger cross-sectional area, in a plane perpendicular to a major surface of the cuvette, than the sampling cavity and / or the sample analysis cavity. [Form 12] A cuvette according to claim 11, wherein the cross-section of the discharge cavity has a width and / or height, in a plane perpendicular to the main plane of the cuvette, that is wider and / or taller than the cross-section of the sampling cavity and / or the sample analysis cavity. [Form 13] 13. The cuvette of any one of embodiments 9 to 12, wherein the first interface and the second interface are disposed at an angle relative to each other. [Form 14] 14. The cuvette of any one of claims 1 to 13, wherein the cuvette is comprised of a unitary body member having inner walls defining the sampling cavity, the sample analysis cavity, and the discharge cavity within the body. [Form 15] 15. The cuvette of claim 14, wherein the body member has a tip, and the sampling cavity is disposed at the tip of the body member. [Form 16] 16. The cuvette of any one of aspects 1 to 15, wherein the sampling cavity is configured to be inclined toward the sample analysis cavity. [Form 17] 17. The cuvette of any one of the preceding embodiments, wherein the sample analysis cavity is reagent-free. [Form 18] 18. The cuvette of any one of the preceding embodiments, wherein the cuvette includes an indicator for indicating a hematocrit level of the bodily fluid sample. [Form 19] 19. The cuvette of claim 18, wherein the indicator is disposed along the periphery of the sample analysis cavity. [Form 20] 20. The cuvette of any one of the preceding embodiments, wherein the discharge cavity has an opening through an outer wall of the cuvette, the opening extending across the entire width of the discharge cavity. [Form 21] 21. The cuvette of any one of embodiments 1 to 20, wherein the sampling cavity has an opening through the outer wall of the cuvette, the opening extending across the entire width of the sampling cavity. [Form 22] 1. A method of manufacturing a cuvette for drawing up and analyzing a bodily fluid sample, comprising: providing a cuvette base material forming the cuvette; shaping a cuvette from the cuvette base material using at least one shaping tool, the shaping tool being positioned to extend into the cuvette base material to form the cuvette, the cuvette comprising: a sampling cavity with a fluid inlet; a sample analysis cavity; a shaping step having an ejection cavity in fluid communication with the sampling cavity and the sample analysis cavity; withdrawing the shaping tool through the outer wall of the cuvette; A method comprising: [Form 23] 23. The method of claim 22, further comprising attaching an indicator onto the cuvette to indicate the hematocrit level of the bodily fluid sample. [Form 24] 24. The method of claim 23, wherein the step of attaching the indicator is performed by laser welding. [Form 25] 25. The method of any one of aspects 22 to 24, wherein the step of shaping the cuvette is performed by injection molding. [Form 26] a shaping tool for forming a cuvette, the shaping tool being configured for insertion into a cuvette base material to form a cavity in the base material, and further configured for withdrawal from the cuvette base material once the cavity has been formed; a sampling cavity portion having an inverted shape of the sampling cavity of the cuvette; a sample analysis cavity portion having an inverted shape of the sample analysis cavity of the cuvette; an ejection cavity portion having an inverted shape of the ejection cavity of the cuvette; Equipped with A shaping tool, wherein the discharge cavity portion is connected to the sampling cavity portion and the sample analysis cavity portion. [Form 27] 27. The shaping tool of claim 26, wherein the sampling cavity portion, the sample analysis cavity portion, and the ejection cavity portion are disposed on a common shaping core. [Form 28] 28. The shaping tool of claim 26 or 27, wherein the thickness of the ejection cavity portion is greater than the thickness of the sampling cavity portion and / or the sample analysis cavity portion. [Form 29] 1. A method for determining one or more biological parameters of a sample of a bodily fluid, comprising: - introducing (S102) a sample of a bodily fluid into the sampling cavity of the cuvette according to any one of aspects 1 to 21; - applying (S104) centrifugal force to the cuvette, thereby facilitating transfer of the bodily fluid from the sampling cavity to the sample analysis cavity via the discharge cavity; - separating the body fluid sample in the sample analysis cavity by applying a further centrifugal force once the body fluid sample has entered the sample analysis cavity (S105); - determining (S106) one or more biological parameters of the bodily fluid sample during or after applying the centrifugal force; A method comprising:

Claims

1. 1. A cuvette for body fluid analysis, comprising: a sampling cavity with a fluid inlet; a sample analysis cavity; an exhaust cavity in fluid communication with the sampling cavity and the sample analysis cavity, the exhaust cavity having an outlet to an exterior of the cuvette; the cuvette is configured to transfer bodily fluid from the sampling cavity to the sample analysis cavity via the discharge cavity when centrifugal force is applied to the cuvette; the sample analysis cavity is configured to provide a first capillary force; the first capillary force is greater than a second capillary force provided by the ejection cavity; A cuvette, wherein the sample analysis cavity is configured for separating and analyzing a bodily fluid sample.

2. 10. The cuvette of claim 1, wherein the cuvette is configured to transfer air from the sample analysis cavity to an exterior of the cuvette via the exhaust cavity when centrifugal force is applied to the cuvette.

3. 3. The cuvette of claim 1, wherein the cuvette is configured to transfer air from the sampling cavity to an exterior of the cuvette via the exhaust cavity when a bodily fluid is introduced into the sampling cavity.

4. 3. The cuvette of claim 1 or 2, wherein the cuvette is configured to prevent the body fluid from leaving the sample analysis cavity after the centrifugal force is removed.

5. 3. The cuvette of claim 1, wherein the sampling cavity and the sample analysis cavity have the same volume.

6. 3. The cuvette of claim 1, wherein the sampling cavity is configured to provide a third capillary force, the third capillary force being greater than the second capillary force provided by the discharge cavity.

7. 3. The cuvette of claim 1, wherein the sample analysis cavity has a substantially uniform elongated shape extending in a first direction from a first end of the cuvette to an opposing second end.

8. 8. The cuvette of claim 7, wherein the outlet of the discharge cavity to the exterior of the cuvette is located at the first end of the cuvette.

9. A cuvette as described in claim 6, wherein the cuvette has a first interface fluidly connecting the discharge cavity to the sampling cavity, and the first interface is configured to allow the bodily fluid sample to flow through the first interface when a centrifugal force that overcomes the third capillary force is applied to the cuvette.

10. 10. The cuvette of claim 9, wherein the cuvette has a second interface fluidly connecting the discharge cavity to the sample analysis cavity, the second interface being configured to allow the bodily fluid sample to flow through the second interface.

11. 10. The cuvette of claim 9, wherein the discharge cavity has a larger cross-sectional area in a plane perpendicular to a main plane of the cuvette than the sampling cavity and / or the sample analysis cavity.

12. 12. The cuvette of claim 11, wherein the cross section of the discharge cavity has a width and / or height, in a plane perpendicular to the main plane of the cuvette, that is wider and / or taller than the cross section of the sampling cavity and / or the sample analysis cavity.

13. 11. The cuvette of claim 10, wherein the first interface and the second interface are disposed at an angle relative to one another.

14. 3. The cuvette of claim 1, wherein the cuvette is comprised of a unitary body member having inner walls defining the sampling cavity, the sample analysis cavity, and the discharge cavity within the body.

15. 15. The cuvette of claim 14, wherein the body member includes a tip, and the sampling cavity is disposed at the tip of the body member.

16. 3. The cuvette of claim 1, wherein the sampling cavity is configured to slope toward the sample analysis cavity.

17. 3. The cuvette of claim 1 or 2, wherein the sample analysis cavity is reagent-free.

18. 3. The cuvette of claim 1 or 2, wherein the cuvette includes an indicator for indicating the hematocrit level of the bodily fluid sample.

19. 20. The cuvette of claim 18, wherein the indicator is disposed along the periphery of the sample analysis cavity.

20. 3. A cuvette according to claim 1 or 2, wherein the ejection cavity has an opening through an outer wall of the cuvette, the opening extending across the entire width of the ejection cavity.

21. 3. A cuvette according to claim 1 or 2, wherein the sampling cavity has an opening through an outer wall of the cuvette, the opening extending across the entire width of the sampling cavity.

22. 1. A method for determining one or more biological parameters of a sample of a bodily fluid, comprising: - introducing (S102) a sample of bodily fluid into the sampling cavity of a cuvette according to claim 1 or 2; applying (S104) a centrifugal force to the cuvette, thereby facilitating the transfer of the bodily fluid from the sampling cavity to the sample analysis cavity via the discharge cavity; - separating the body fluid sample in the sample analysis cavity by applying a further centrifugal force once the body fluid sample has entered the sample analysis cavity (S105); - determining (S106) one or more biological parameters of the body fluid sample during or after application of the centrifugal force; A method comprising:

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