manually operated actuator mechanism

Abstract

The invention relates to a manually operated actuator mechanism (500) for driving a piercing element (502) with increased safety. The actuator mechanism comprises a mounting element (504) connected to a trigger element (506) by a first breakable connection element (510). The actuator mechanism further comprises a piercing element carrier (508) connected to the trigger element by a second breakable connection element (514). The trigger element (506) further comprises a push member (512) which can be pushed with a human finger. The first breakable connection element is configured to break by means of a predetermined pushing finger force (F) pushing said push member (512). The piercing element carrier is movable between an initial position, in which the first breakable connection element (510) and the second breakable connection element (514) are not broken, and a stop position, in which a base (516) prevents movement of the piercing element carrier (508).

Description

[0001] The present invention relates to a manually operated actuator mechanism, a puncture device including the actuator mechanism, a test device including the puncture device, and a method for operating the actuator mechanism and the test device.

[0002] US 2012 / 0227697 A1 describes systems and methods for delivering fluids or other materials (such as blood or interstitial fluid) to and / or receiving them from a test subject (e.g., skin). In one particular embodiment, a puncture element is engaged and driven toward the skin when a user actuates the actuator.

[0003] The objective of this invention is to provide an improved or alternative puncture device.

[0004] According to the present invention, a manually operated actuator mechanism is provided. This actuator mechanism is configured to drive an external puncture element with a predetermined force. The actuator mechanism includes a mounting element, a triggering element, and a puncture element carrier. The puncture element carrier can be operably connected to the puncture element.

[0005] According to a first aspect of the actuator mechanism, a trigger element is connected to an mounting element via at least one first detachable connecting element (i.e., a connecting element designed to disconnect in a controlled manner upon application of a predetermined force). The trigger element also includes or is connected to a push member capable of being pushed by a human finger. Force can be applied to the trigger element via this push member. The first detachable connecting element is configured to disconnect if a predetermined pushing finger force is applied to the push member in a pushing manner. Therefore, the force required to disconnect the first detachable connecting element defines the force acting on the puncture element.

[0006] Preferably, the puncture element carrier is connected to the trigger element via at least one second disconnectable connection element. This second disconnectable connection element is designed to disconnect in a controlled manner upon application of a second predetermined force. The puncture element carrier is movable between an initial position and a stop position, in which the first and second disconnectable connection elements are not disconnected, and in the stop position, the base prevents movement of the puncture element carrier.

[0007] A force is applied to the actuating member in the longitudinal direction, resulting in stresses, such as tensile and / or shear stresses, in the material of the first detachable connecting element. The first detachable connecting element is advantageously configured to disconnect upon application of a predetermined actuating finger force. Once the first detachable connecting element disconnects, the triggering element and the puncture element carrier move freely, at least in the longitudinal direction, independently of the mounting element. The freely moving portion of the actuator mechanism (which includes at least the triggering element and the puncture element carrier) is accelerated with an acceleration that depends primarily on the predetermined thrust required to disconnect the first detachable connecting element and on the mass of the accelerated object (e.g., the triggering element, the actuating element, the puncture element carrier, and the external puncture element and finger).

[0008] Because the first detachable connecting element enables a predetermined puncture force, and because the actuator can only be used once in its predetermined form, thus ensuring a single-use operation, safety is improved.

[0009] An embodiment of the actuator mechanism according to a first aspect of the present invention is described below.

[0010] In a preferred embodiment of the actuator mechanism, safety is further enhanced by a second disconnectable connection element configured to disconnect when the puncture element carrier reaches the stop position. This allows the trigger element to detach from the puncture element carrier, thereby disengaging further actuation of the member from the puncture element carrier, thus ensuring that no further force is transmitted from the actuator to the puncture element carrier.

[0011] To further enhance safety, one embodiment of the actuator mechanism also includes an elastic element arranged to act on the puncture element carrier to return the puncture element carrier from the stop position in the direction of the initial position. Thus, the elastic element is configured to apply a retraction force to drive the puncture element carrier toward the initial position. In one embodiment (where a second disconnectable connection element is configured to disconnect when the puncture element carrier reaches the stop position), the puncture element carrier is advantageously driven toward the initial position regardless of whether further pushing force is applied to the pushing member, thereby ensuring the retraction of the puncture element carrier. Suitable elastic elements include, but are not limited to: coil springs (which may be conical, or more preferably cylindrical), or strips such as metal or plastic strips, elastic bands such as rubber bands, etc.

[0012] In one embodiment, the base (arranged to prevent movement of the puncture element carrier once the first disconnectable connecting element is disconnected) is a non-movable element relative to the mounting element. In a preferred alternative embodiment, the base is an elastic element in its compressed or compressed state, such as a coil spring in its fully compacted, solid state. A predetermined pushing force is applied to the pushing element in the longitudinal direction, which causes the first disconnectable connecting element to disconnect and causes the triggering element and the puncture element carrier (which are connected by a second disconnectable connecting element) to accelerate toward a stopping position. This accelerating motion is against the elastic element, which is removed from its initial position, stores elastic potential energy, and decelerates the triggering element and the puncture element carrier until they come to a stop. Thus, the elastic strip or band (in the compressed state) or the coil spring (in the compressed state) serves as the base, preventing movement of the puncture element carrier.

[0013] In one embodiment, an elastic element (such as a coil spring) is further arranged and configured to disconnect the second disconnectable connection element upon reaching a stop position. For example, the elastic element is arranged such that a disconnecting force is applied to the second disconnectable connection element upon reaching the stop position. In an alternative embodiment, the actuator mechanism further includes a non-movable disconnecting element configured to disconnect the second disconnectable connection element. In one embodiment, the coil spring (preferably a cylindrical coil spring) is arranged as a guide for an external puncture element attached to the puncture element carrier to ensure that the puncture element moves in the longitudinal direction of the coil spring, and preferably within the spring coil. In embodiments where the diameter of the coil spring is smaller than the size of the puncture element carrier, the actuator mechanism includes an additional disconnecting element arranged to contact and disconnect the second disconnectable connection element.

[0014] In a particular embodiment of the actuator mechanism, the actuator mechanism may include any of the above-described technical features, wherein the first disconnectable connecting element is adapted to be disconnected when a push finger force of 20N to 100N is applied to the push member. Preferably, the push finger force required to disconnect the first disconnectable connecting element is between 30N and 80N, and more preferably between 35N and 55N. The actual value of the predetermined push finger force (which is to be applied to disconnect the first disconnectable connecting element) can be selected according to the application or the intended user. For example, a predetermined push finger force between 50N and 100N provides an increased safety feature that prevents accidental activation by a child. Advantageously, an actuator mechanism intended for use by an older person may require a smaller push finger force compared to an actuator mechanism intended for use by a younger person.

[0015] According to a second aspect of the invention, a puncture device is described. The puncture device includes a peripheral support structure that forms an internal volume. The puncture device also includes a manually operated actuator mechanism according to any embodiment of the first aspect of the invention, wherein mounting elements of the actuator mechanism are connected to the peripheral support structure.

[0016] Preferably, the base and / or elastic element are connected to the peripheral support structure.

[0017] One embodiment of the puncture element includes a puncture element connected to a puncture element carrier. In an alternative embodiment, the puncture element carrier includes a connection device for connecting an external puncture element. Suitable puncture elements include, but are not limited to, lancets, needles, hollow needles, cannulas, and catheters.

[0018] In a preferred embodiment of the puncture device, the puncture element is arranged to remain within the internal volume in the initial position and extend out of the internal volume in the stop position. This reduces the risk of accidental injury from the puncture element before the actuating member is actuated.

[0019] Preferably, the puncture device is a handheld device. In one particular embodiment, the peripheral support structure has a cylindrical shape defined by a height value and a diameter value, wherein the diameter value is greater than the height value. Preferably, the height of the peripheral support structure is less than 5 cm, more preferably less than 3 cm, and even more preferably less than 2.5 cm. The diameter of the peripheral support structure is preferably less than 5 cm.

[0020] According to a third aspect of the invention, a testing apparatus is described. The testing apparatus includes a puncture device according to any embodiment of the puncture device according to a second aspect of the invention. The testing apparatus further includes: a fluid sample receiving unit for receiving a fluid sample for testing; and at least one fluid delivery element having an input terminal fluidly connected to the fluid sample receiving unit. The fluid delivery element is arranged and configured to deliver fluid away from the input terminal. The testing apparatus also includes at least one testing unit in fluid communication with the fluid delivery element. The testing unit includes a corresponding reactive material configured to react with a pre-specified analyte or fluid property in a predetermined manner.

[0021] In one embodiment, the fluid sample receiving unit is a puncture element or includes a puncture element. In another embodiment, the fluid sample receiving unit includes a connection means for attaching an external puncture element. In yet another embodiment, the sample fluid receiving unit is an interface for receiving fluid samples.

[0022] In a preferred embodiment, the testing device is suitable for performing a lateral flow assay, also known as a lateral flow immunochromatographic assay. These analyses are typically designed to detect the presence of a target substance in a fluid sample and are widely used for home testing, point-of-care testing, or medical diagnostics in laboratories.

[0023] In one particular embodiment, the fluid delivery element is a capillary wick or other capillary bed that has the ability to spontaneously deliver fluid, for example, through capillary action. Alternatively, the fluid delivery element is a microfluidic system. In another embodiment, the fluid delivery element includes both a capillary bed or capillary wick and a microfluidic system.

[0024] In one embodiment, each of the test units includes a different reactive material configured to react with a corresponding pre-specified analyte in a pre-specified manner. Alternatively, two or more test units may include one or more test sections having a given reactive material with the same or correspondingly different sensitivities, thereby improving the accuracy of the testing apparatus or enabling semi-quantitative evaluation of a given analyte.

[0025] In a preferred embodiment, the testing device may be arranged as a handheld testing device with reduced dimensions, wherein the fluid delivery element has a centerline length, width, and thickness in a planar state, the thickness being shorter than the centerline length and width. Furthermore, the width direction of the fluid delivery element extends at an angle of less than 90° relative to the normal of the support plane defined by the peripheral support structure. In this particular embodiment, the fluid delivery element is curved, resulting in a minimum distance between the two opposing longitudinal ends of the fluid delivery element being shorter than the centerline length in the planar state.

[0026] Preferably, the fluid transport element is a capillary bed or capillary core having two flat sides spaced apart by a given thickness of the fluid transport element. In its planar state, the fluid transport element has length, width, and thickness.

[0027] If the fluid transport element is rectangular in its planar state (ignoring its thickness), then the fluid transport element has a given centerline length in the longitudinal direction, a given width in the width direction perpendicular to the longitudinal direction, and a given thickness in the thickness direction perpendicular to both the longitudinal and width directions. The thickness is shorter than the centerline length and the width, i.e., it has a smaller elongation. In the specific case of a rectangular fluid transport element, the length of the fluid transport element and the length of the centerline at the center of the fluid transport element (hereinafter also referred to as the centerline length) are equal to the length of the longitudinal edge of the flat surface of the fluid transport element.

[0028] Alternatively, in a planar state, the edges of the flat sides can be curved (i.e., not straight). This results in the fluid delivery element having a curved shape in its planar state. In this case, the centerline length is the length of the centerline located midway between the longitudinal edges of the fluid delivery element. The centerline length is inherent to the test strip and is independent of the actual state of the fluid delivery element (curved or planar).

[0029] The distance between the longitudinal ends of a planar, curved fluid transport element may be shorter than the length of the centerline.

[0030] To further limit the external dimensions of the fluid transport element—and thus further limit its envelope—the fluid transport element can be arranged to be non-planar, i.e., bent or further curved in a third dimension. This includes, for example: fluid transport elements having straight longitudinal edges arranged in a curved state (e.g., rectangular fluid transport elements that are folded, rolled, or wrapped); fluid transport elements having longitudinal edges that are bent in a flat state; or fluid transport elements having curved longitudinal edges that are folded, rolled, or wrapped (and thus in a curved state).

[0031] In one embodiment of the testing apparatus of the third aspect of the invention, the width direction of the fluid delivery element extends at an angle of less than 90° relative to the normal of the plane defined by the support structure. Therefore, the longitudinal edges of the fluid delivery element are arranged on the support structure, such that other longitudinal edges extend from the support structure. Furthermore, the fluid delivery element is curved, resulting in a minimum distance between the two opposing longitudinal ends of the centerline that is shorter than the length of the centerline in its planar state. This minimum distance is defined here as a length quantity indicating the minimum distance between the proximal end of the fluid delivery element (i.e., the portion of the test strip that contacts or is near the contact with the puncture element or puncture element carrier) and the distal end of the fluid delivery element (where the test unit is arranged or near the distal end).

[0032] It is important to note that a shortest distance between the longitudinal ends of the fluid delivery element that is shorter than the centerline length implies that the test strip is curved, either in its planar configuration, or because the fluid delivery element is arranged non-planarly, or both. A fluid delivery element whose shortest distance between its longitudinal ends is shorter than its centerline length has an effective total extension or envelope that is smaller than the centerline length in its planar configuration. This, in turn, allows the size of the test device to be reduced compared to the minimum size the device would have if the fluid delivery element were arranged in a planar configuration. If the fluid delivery element is curved in a semi-circular shape, the shorter distance between the longitudinal ends can be shorter than the maximum external dimension of the fluid delivery element, which is still smaller than the centerline.

[0033] This advantageous spatial arrangement of the fluid delivery elements within the test apparatus allows for better utilization of space. It also enables a reduction in the overall size of the test apparatus without needing to reduce the centerline length of the fluid delivery elements. This, in turn, leads to improved adaptability and provides enhanced versatility.

[0034] By arranging the fluid delivery element in a curved manner, with its width direction extending at an angle of less than 90° relative to the normal of the plane defined by the support structure (i.e., the fluid delivery element is not arranged parallel to the plane defined by the support structure), the size of the test apparatus can be reduced compared to a typical test apparatus configuration, where the fluid delivery element (e.g., test strip) is typically arranged directly on the support structure in a planar state. Alternatively, longer fluid delivery elements can be used compared to known test apparatuses where the test strip is arranged planarly on the support structure.

[0035] In another embodiment, the testing apparatus additionally or optionally includes: at least one solution chamber containing a corresponding buffer solution; and a flow control device configured to control the transfer of the buffer solution to the fluid delivery element.

[0036] At least one solution chamber is preferably arranged on the support structure. In one particular embodiment, the solution chamber is configured as a cavity in the support structure.

[0037] Certain buffer solutions are advantageously selected to enhance the transfer of fluid samples to the test unit. Other buffer solutions include reagents configured to react with specific analytes in a predetermined manner. In a particular embodiment comprising multiple solution chambers, the different chambers may contain different buffer solutions, which are individually delivered to one or more fluid delivery elements according to the specific requirements of the test apparatus.

[0038] The solution chamber and buffer solution (such as those discussed above) can be used in combination with any of the technical features described according to the foregoing embodiments.

[0039] In one embodiment of the test apparatus of the third aspect of the invention, the flow control device is configured to control the transfer of the buffer solution from the solution chamber to at least one fluid delivery element in the following situations: before the fluid sample is transferred to at least one fluid delivery element; or when the fluid sample is transferred to at least one fluid delivery element; or after the fluid sample has been transferred to at least one fluid delivery element; or any combination of the above.

[0040] Passing a buffer solution to a fluid delivery element before the fluid sample is received or transferred results in the wetting of the capillary bed or capillary core or absorbent material, which in certain embodiments enhances the material’s absorption capacity.

[0041] The buffer solution is delivered to the fluid delivery element during the receipt or transfer of the fluid sample, which increases the volume of the liquid present and the flow rate of the fluid sample, thereby reducing the time required for the fluid sample to reach the test unit.

[0042] After the fluid sample has been received or transferred, the buffer solution is transferred to the fluid delivery element, which in certain embodiments is advantageously used to flush the fluid sample toward the test unit.

[0043] Any variation concerning the transfer of the buffer solution can be used in combination with any of the technical features discussed in the foregoing embodiments of the test apparatus according to the third aspect of the invention.

[0044] In one embodiment of the invention's third aspect, the flow control device may include a soluble material configured to dissolve in a buffer solution at a predetermined dissolution rate and configured such that the buffer solution can flow out of a corresponding solution chamber after a predetermined time span. In another embodiment, the testing device includes a reservoir containing a soluble material, such as a pharmacologically inactive substance like lactose. The soluble material is configured to dissolve upon contact with a predetermined fluid (e.g., bodily fluid). The dissolution of the soluble material is configured to contact a puncture device with a solution chamber. The puncture device is configured to puncture the solution chamber and allow the buffer solution to flow out of the solution chamber in a controlled manner.

[0045] A particular embodiment of the testing apparatus according to a third aspect of the invention additionally or alternatively includes a hollow needle or conduit or a microfluidic connection system filled with a soluble material. The hollow needle or conduit is configured to puncture a solution chamber during operation (e.g., by applying pressure or by actuating the testing apparatus in a predetermined manner). Once the solution chamber is punctured, a buffer solution begins to contact the soluble material. Therefore, by appropriately selecting the soluble material, the amount of the soluble material, and the geometry of the flow control device and the solution chamber, the time span between puncturing the solution chamber and the arrival of the buffer solution at the fluid delivery element can be controlled.

[0046] In another embodiment according to the third aspect, it may also include any technical feature described with reference to any of the foregoing embodiments, the test apparatus further including a window portion that is at least partially transparent in the visible wavelength range and is arranged to allow optical inspection of the test unit from the outside of the test apparatus.

[0047] In one particular embodiment, the window portion is included in the peripheral support structure. In one embodiment, where the testing device includes a reflector element that allows optical inspection of the testing unit from a direction substantially perpendicular to the plane defined by the support structure, the window portion is advantageously arranged such that its projection onto the plane surrounds at least a portion of the reflector element. In an alternative embodiment, the support structure of the testing device has a peripheral wall in a direction substantially perpendicular to the plane, and the window portion is arranged in the peripheral wall at multiple locations to enable direct optical inspection of the testing unit. Yet another embodiment includes corresponding window portions in the upper part of the support structure and in the peripheral wall.

[0048] In a specific embodiment of the testing apparatus of the third aspect of the invention, the window portion is arranged in a recessed region above the peripheral support structure, i.e., not on the peripheral wall. In this embodiment, the window portion may include at least one lens, preferably at least one collimating lens. In one embodiment, the at least one lens is made of glass. In an alternative embodiment, the at least one lens is made of an acrylic compound. Another alternative embodiment may include other transparent materials known to those skilled in the art. In yet another embodiment, the window portion includes an array of microlenses.

[0049] Any variations discussed regarding the window section can be combined with any technical features disclosed in the foregoing embodiments of the test apparatus.

[0050] One embodiment of the test unit—in which the window portion is arranged in a recessed area on the upper part of the peripheral support structure—provides enhanced protection for the window portion by reducing the risk of damage to it (e.g., by accidental scratches). Furthermore, this embodiment is advantageously configured for use in conjunction with a test reading device, including a camera, such as a mobile phone device. In some test reading devices, the camera protrudes from the back plane of its housing. By arranging the window portion in the slightly recessed area, the mobile phone can be placed thereon, maximizing the contact surface between the back of the test reading device and the test device, thereby reducing the risk of incorrect relative positioning. In one embodiment of the test device of the invention, the peripheral support structure may also include a non-slip or anti-slip material configured to increase friction when the test device comes into contact with other objects (such as the test reading device).

[0051] The test reading device may include a processor and a storage unit containing software that enables the test reading device to access a camera, analyze images, and interpret the state of the reactive material in the test section according to a predetermined analysis template. The software may be configured to provide an output signal that includes result data related to the state of the reactive material. The output signal can then be sent directly to a user interface, or via a wired or wireless communication link to a central data processing center, or both.

[0052] In these cases, it is desirable to allow light to enter the test apparatus to illuminate the test unit during the readout phase of its status. Since it is possible that the test readout device blocks the light path from the outside of the test unit through the window portion, one embodiment of the test apparatus preferably also includes a transparent or translucent portion of the peripheral support structure, configured to allow light to penetrate into the interior of the test apparatus.

[0053] Certain specific test reading devices also include a light source, such as a flash unit. Depending on the relative spatial arrangement of the camera and the light source, light from the light source can also enter the test device through a window portion. However, to provide a general solution, independent of a specific type of test reading device—whether the test reading device includes a light source or its relative arrangement with respect to the camera—implementations of the test device include additional window portions on the peripheral wall. Additionally or alternatively, embodiments of the test device also include light guides to direct light from the additional window portions on the peripheral wall to the test unit for illumination. For example, in a particular embodiment of the test unit, the peripheral wall serves as a light guide. In another embodiment of the test device, the additional window portions may additionally or alternatively include a transparent or translucent material, preferably glass or an acrylic compound. In one particular embodiment, matching materials are used to achieve uniform light distribution.

[0054] In another embodiment, the testing device is advantageously configured to read test results and transmit information about those results to an external device. In one embodiment, the testing device further includes an optical sensor arranged and configured to detect light reflected from at least one test unit and convert the detected light into an electrical signal representing the intensity and / or color of the detected light. The testing device also includes: a conversion unit for converting the electrical signal into digital data representing the intensity and / or color of the detected light; and a transmission unit for wirelessly transmitting the digital data to an external device.

[0055] An optical sensor of the testing apparatus is arranged and configured to detect light reflected from at least one testing unit and to provide an electrical signal representing the intensity and / or color of the detected light. The optical sensor can be, for example, a single-pixel photodiode, a CMOS sensor, or a CCD sensor. After converting the detected light into an electrical signal, the electrical signal is provided to a conversion unit. This conversion unit is configured to convert the electrical signal into digital data representing the intensity and / or color of the detected light. The conversion unit can be part of the optical sensor. The conversion unit can also be a separate component of the testing apparatus. Alternatively, the conversion unit can be part of a transmission unit. Preferably, the conversion unit is or includes an analog-to-digital converter (ADC) for converting the electrical signal into digital data representing the intensity and / or color of the detected light. The conversion unit can be configured to convert an 8-bit electrical signal.

[0056] The conversion unit is operatively connected to the transmission unit, for example via a data bus, to provide digital data to the transmission unit.

[0057] Preferably, the transmission unit is configured to wirelessly transmit digital data to an external receiving device using a predetermined wireless communication protocol, such as Bluetooth, Near Field Communication (NFC), Wi-Fi, or RFID. Specifically, the transmission unit may be or may include an NFC chip and NFC coil, or a radio frequency identification (RFID) tag or transponder, or a Wi-Fi integrated circuit chip, or a Bluetooth integrated circuit chip.

[0058] Transmission units based on technologies such as NFC or RFID that do not require a permanent power supply are preferred. The energy required to power such transmission units is provided by a so-called starter.

[0059] A transmission unit configured to transmit data via NFC or RFID preferably includes one or more antennas that function as radio frequency (RF) interfaces to transmit electromagnetic signals representing digital data to one or more other antennas of an external device by means of electromagnetic induction. The antennas typically include one or more coils, each coil having four or five windings.

[0060] The initiator can be an external device that provides a carrier field, which is modulated by a transmission unit for transmitting digital data. Preferably, to power the transmission unit, the transmission unit obtains power from an external device via an NFC or RFID link. Therefore, particularly when the transmission unit is enabled via NFC or RFID, the test apparatus itself does not need to include an energy storage unit, such as a battery, to power the transmission unit.

[0061] Optical sensors, conversion units, and transmission units can be arranged as separate components on a peripheral support structure along with any microfluidic components, which are also included in the test apparatus. Alternatively, the optical sensors, conversion units, and transmission units can be fabricated using electronic packaging (e.g., 3D packaging). Using 3D packaging allows for the design of compact three-dimensional integrated circuits by stacking components on top of each other. After 3D packaging, the integrated circuit including the optical sensors, conversion units, and transmission units can be mounted onto the peripheral support structure or attached to a cover unit. Alternatively, the chip including the optical sensors, conversion units, and transmitters can be fabricated using wafer-level packaging (WLP). The optical sensors, conversion units, and transmission units can also be placed in protective packaging for integration into the test apparatus.

[0062] In some embodiments, the optical sensor, conversion unit, and transmission unit are mounted on a circuit board, which is attached as a module to an external support structure or to a cover unit. The circuit board can be flexible, for example, a flexible substrate made of polyimide (e.g., Kapton), polyetheretherketone (PEEK), liquid crystal polymer (LCP), or FR4. Alternatively, rigid or semi-flexible circuit boards can also be used. In particular, the optical sensor, conversion unit, and transmitter can be integrated onto a thin FR4 substrate. The circuit board can be a printed circuit board (PCB), preferably flexible, such as an FR4 PCB. Alternatively, the printed circuit board can be rigid or semi-rigid.

[0063] It is advantageous to attach at least one of the optical sensor, conversion unit, or transmission unit to the top or periphery of the support structure, because more space is left at the bottom of the support structure, for example, for arranging components of the microfluidic system.

[0064] Specifically, the antenna of the transmission unit can be integrated into the test apparatus using injection molding. In cases where the test apparatus has a cover unit attached to a support structure and thus forming a closed housing, the transmitter's antenna can be integrated into the housing by injection molding, for example, by attaching it to the cover member of the cover unit on the inside. Alternatively, the antenna of the transmission unit can be integrated into the same chip or circuit as the rest of the transmitter electronics, optical sensors, and conversion units. For example, the antenna can be integrated into a PCB.

[0065] Preferably, in another embodiment, the testing apparatus includes an optical device comprising one or more optical elements arranged and configured to guide light reflected from at least one test unit to an optical sensor, and / or to guide light emitted from a light source to at least one test unit. The optical elements can be mirrors, lenses, or waveguides. The optical elements are used to create an optical path that links, for example, at least one test unit to the optical sensor.

[0066] For example, a reflector can be used to guide light reflected from a test unit, and a lens can be used to focus the light reflected from the reflector onto an optical sensor. Alternatively, a waveguide can be used to guide light reflected from at least one test unit to the optical sensor. The waveguide can be shaped at one end to focus light onto the optical sensor.

[0067] In particular, the optical device is advantageous if the test unit and the optical sensor are not aligned, i.e., the test unit is not in the direct field of view of the optical sensor.

[0068] Optical devices are particularly advantageous when the testing apparatus includes more than one test unit (e.g., three test units). In this case, the optical elements of the optical device are preferably configured and arranged to guide light reflected from any of the three test units to an optical sensor. The correspondingly configured optical elements may include three mirrors tilted relative to each other, so that light reflected from any of the test units is guided to the optical sensor upon reflection on one of the three tilted mirrors. Therefore, typically, the optical elements may include multiple reflective surfaces, such as multiple facets, configured and arranged to guide light reflected from one or more test units arranged along the length of a fluid delivery element to the optical sensor. An external receiving device is capable of receiving digital data from the transmission unit, wherein the digital data represents the light intensity and / or color of light reflected from one or more of the multiple test units.

[0069] Generally, the use of optical devices allows for greater freedom in arranging one or more fluid delivery elements and optical sensors within the test setup, such as at the bottom of the peripheral support structure, because it enables the creation of an optical path connecting the test unit and the optical sensor. This optical path can be angled or bendable (e.g., when using waveguides).

[0070] According to a fourth aspect of the present invention, a method for actuating a manually operated actuator mechanism is disclosed, the manually operated actuator mechanism being used to drive an external puncture element, the method comprising:

[0071] - A predetermined pushing force is applied to the pushing member, thereby disconnecting the first detachable connection element that connects the mounting element to the trigger element;

[0072] - The puncture element carrier is moved from an initial position to a stop position, the puncture element carrier being connected to the trigger element via a second disconnectable connection element. In the initial position, the first and second disconnectable connection elements are not disconnected. In the stop position, the base (116) prevents the movement of the puncture element carrier.

[0073] In one particular embodiment, the method further includes: disconnecting a second disconnectable connection element when the puncture element carrier reaches a stop position; and acting on the puncture element carrier to return it from the stop position in the direction of the initial position.

[0074] In another embodiment, disconnecting the first disconnectable connecting element requires applying a pushing finger force of 20N to 100N.

[0075] According to a fifth aspect of the invention, a method for operating a testing apparatus is disclosed. The method includes performing any step of the method according to the fourth aspect, delivering fluid from a puncture element to at least one testing unit via a fluid delivery element, and causing a corresponding reactive material to react with a pre-specified analyte or fluid property in a predetermined manner.

[0076] In one embodiment, the method of the fifth aspect further includes: detecting light reflected from at least one test unit; converting the light into an electrical signal representing the intensity and / or color of the detected light; converting the electrical signal into digital data representing the intensity and / or color of the detected light; and wirelessly transmitting the digital data, preferably using a near-field communication link.

[0077] It should be understood that the manually operated actuator mechanism of claim 1, the puncture device of claim 5, the testing device of claim 10, and the methods for operating the actuator mechanism and the testing device of claims 18 and 21, respectively, have similar and / or identical preferred embodiments, particularly as defined in the dependent claims.

[0078] It should be understood that the preferred embodiments of the present invention can also be any combination of the dependent claims or the above embodiments with the corresponding independent claims.

[0079] These or other aspects of the invention will be apparent or explained with reference to the embodiments described below.

[0080] Figure 1A A schematic diagram of one embodiment of a manually operated actuator mechanism in a non-actuated state is shown.

[0081] Figure 1B It shows that it is in the actuated state. Figure 1A A schematic diagram of an implementation of a manually operated actuator mechanism.

[0082] Figure 2A A schematic diagram of another embodiment of the actuator mechanism in a non-actuated, manually operated state is shown.

[0083] Figure 2B It shows that it is in the actuated state. Figure 2A A schematic diagram of an implementation of a manually operated actuator mechanism.

[0084] Figure 2C It shows the final state. Figure 2A and Figure 2B A schematic diagram of an implementation of a manually operated actuator mechanism.

[0085] Figure 3 A schematic diagram of another embodiment of a manually operated actuator mechanism is shown.

[0086] Figure 4A A schematic diagram of another embodiment of the actuator mechanism in a non-actuated, manually operated state is shown.

[0087] Figure 4B It shows that it is in the actuated state. Figure 3 A schematic diagram of an implementation of a manually operated actuator mechanism for A.

[0088] Figure 4C It shows the final state. Figure 3 A and Figure 3 A schematic diagram of an implementation of the manually operated actuator mechanism of B.

[0089] Figure 5A A schematic diagram of one embodiment of the puncture device is shown, in which the manually operated actuator mechanism is in a non-actuated state.

[0090] Figure 5B Showing Figure 5A A schematic diagram of an embodiment of the puncture device, wherein the manually operated actuator mechanism is in an actuated state.

[0091] Figure 5C Showing Figure 5A and Figure 5B A schematic diagram of an embodiment of the puncture device, wherein the manually operated actuator mechanism is in its final state.

[0092] Figure 6A A schematic diagram of another embodiment of a manually operated actuator mechanism in a non-actuated state is shown.

[0093] Figure 6B A schematic diagram of a disconnectable connection element is shown.

[0094] Figure 7 A schematic diagram of one embodiment of the testing apparatus is shown.

[0095] Figure 8A and Figure 8B A set of fluid transport elements are shown in both planar and curved states.

[0096] Figure 9 A schematic diagram of another embodiment of the testing apparatus is shown.

[0097] Figure 10 A schematic diagram of another embodiment of the testing apparatus is shown.

[0098] Figure 11 A flowchart of one embodiment of a method for operating a handheld force control actuator mechanism is shown.

[0099] Figure 12 A flowchart of one implementation of a method for operating a test apparatus is shown.

[0100] Figure 1A A schematic diagram of one embodiment of the manually operated actuator mechanism 100 in a non-actuated state is shown. Figure 1B It shows that it is in the actuated state. Figure 1A A schematic diagram of the same manually operated actuator mechanism 100 is shown. This manually operated actuator mechanism 100 is particularly suitable for driving the external puncture element 102. The actuator mechanism 100 is suitable for integration into a puncture device, as shown in the reference. Figure 5A , Figure 5B and Figure 5C The actuator mechanism includes a mounting element 104, a trigger element 106, and a puncture element carrier 108. An external puncture element 102 is operatively connected to the puncture element carrier 108.

[0101] Trigger element 106 is connected to mounting element 104 via a first detachable connection element 110. Trigger element 106 also includes or is connected to a push member 112, which can be pushed by a human finger. In the actuator mechanism, the first detachable connection element 110 is configured to disconnect if (particularly in the longitudinal direction L) the pushing finger force F pushing the push member 112 exceeds a predetermined threshold. In this actuator mechanism 100, puncture element carrier 108 is connected to trigger element 106 via a second detachable connection element 114.

[0102] Once the first disconnectable connection element 110 is disconnected, the puncture element carrier 108 can move from the initial position to the stop position. The initial position is... Figure 1A The system is displayed in a non-actuated state, wherein the first and second disconnectable connecting elements 110 and 114 are not disconnected. The stop position is... Figure 1B The center is shown in an actuated state, wherein the base 116 prevents the movement of the puncture element carrier 108 in the longitudinal direction.

[0103] exist Figure 1A and Figure 1B In the exemplary actuator mechanism 100, the positions of the base and mounting elements are fixed and therefore constant relative to each other. Once a predetermined pushing force F is applied to the pushing member 112, the first disconnectable connection element 110 is disconnected, and the triggering element and the puncture element carrier are able to move relative to the mounting element between an initial position and a stop position.

[0104] Figure 2A A schematic diagram of another embodiment of the manually operated actuator mechanism 200 in a non-actuated state is shown. Figure 2B It is in an actuated state. Figure 2A A schematic diagram of the manually operated actuator mechanism 200. The following discussion focuses on those features that differ between actuator mechanisms 100 and 200. Similar or identical technical features, or those with similar or identical functions, are indicated using the same numerals, except for the first numeral, which is used for... Figure 1A and Figure 1B The actuator mechanism 100 in the middle is "1" and used for Figure 2A and Figure 2B The actuator mechanism 100 in the middle is "2".

[0105] In the actuator mechanism 200, the second disconnectable connection element 214 is configured to, when the puncture element carrier 208 reaches the... Figure 2BThe stop position shown indicates disconnection. In this particular example, the base 216 is advantageously designed and arranged such that when the puncture element carrier 208, which moves with the trigger element, and / or the second disconnectable connecting element 214 contact the base 216, the second disconnectable connecting element 214 disconnects. The disconnection of the second disconnectable connecting element 214 causes the puncture element carrier 208 to detach from the trigger element 206, see... Figure 2C This ensures that the actuator mechanism can only be used once.

[0106] Figure 3 A schematic diagram of another embodiment of the manually operated actuator mechanism 300 in a non-actuated state is shown. The following discussion focuses on... Figure 3 The actuator mechanism 300 differs from actuator mechanisms 100 and 200 in those features. Similar or identical technical features, or those with similar or identical functions, are indicated using the same numerals, except for the first numeral, which is used for... Figure 3 The actuator mechanism 300 of “3”, and respectively used for Figure 1A , Figure 1B and Figure 2A , Figure 2B The actuator mechanisms 100 and 200 in the middle are “1” and “2”.

[0107] Figure 3 The actuator mechanism 300 also includes an elastic element 318 arranged to act on the puncture element carrier 308 to return the puncture element carrier from the stop position in the direction of the initial position. In this particular actuator mechanism 300, the elastic element is a helical spring that is compressed when the puncture element carrier 308 is pushed in the longitudinal direction by an applied pushing force, and once the force exceeds a predetermined trigger value, the first disconnectable connection element 340 is disconnected. As in the embodiment shown in FIG. 2, the base 316 is configured to disconnect the second disconnectable connection element 314 and disengage the trigger element 306 from the puncture element carrier 308 once the second disconnectable connection element and / or the puncture element carrier 308 contacts the base 316. The spring force of the compressed elastic element 318 causes the puncture element carrier 308 to move away from the stop position in the direction of the initial position.

[0108] An alternative implementation of the actuator mechanism 400 is in Figure 4A , Figure 4B and Figure 4C The states are represented as the initial non-actuated state, the intermediate actuated state, and the final regressed state. The following discussion focuses on the state in which the actuation process occurs. Figure 4A , Figure 4B and Figure 4C The actuator mechanism 400 and Figure 1 to Figure 3The actuator mechanisms 100, 200 and 300 differ from each other in those features. Similar or identical or having similar or identical functions of the technical features are indicated by the same numbers, except for the first number, "4" for actuator mechanism 400, and "1", "2" and "3" for actuator mechanisms 100, 200 and 300 respectively.

[0109] exist Figure 4A , Figure 4B and Figure 4C In the actuator mechanism 400, a fully compressed elastic element 418 serves as a base 416, which is arranged and configured to prevent movement of the puncture element carrier 408. Once the first disconnectable element 410 has disengaged upon application of a predetermined pushing force F, the elastic element 418 is compressed. Once fully compressed, the elastic element 418 prevents movement of the puncture element carrier 408 and thus serves as the base 416. Therefore, in this particular actuator mechanism, the functions of both the base 416 and the elastic element 418 are combined in the elastic element 418, which is arranged in a particularly advantageous position.

[0110] exist Figure 4A , Figure 4B and Figure 4C In the example shown, applying a predetermined pushing force F to the pushing member 412 causes the first disconnectable connecting element 410 to disconnect, resulting in the accelerated movement of the trigger element 406 and compressing the elastic element 418, in this case a coil spring, particularly a helical coil spring. The elastic element 418 is arranged and configured in... Figure 4B The stop position shown prevents movement of the puncture element carrier 408. The upper edge of the helical spring contacts the puncture element carrier 408, and the compressed elastic element 418 (i.e., the helical spring 418 in its fully compressed, solid state) results in a reaction force against the finger force used to drive the trigger element 406. Once this reaction force exceeds the load that the second disconnectable connection element 414 is designed to withstand, the second disconnectable connection element 414 disconnects. The reaction force can, for example, exceed the load that the second disconnectable connection element 414 is designed to withstand when the helical spring is fully compressed or when the spring force is sufficiently large due to the spring compression. Once the second disconnectable element 414 disconnects, the trigger element 406 disengages from the puncture element carrier 408, and the spring force of the elastic element acts on the puncture element carrier 408, causing the puncture element carrier 408 to retract toward the initial position.

[0111] In particular, in any embodiment of the actuator mechanism described above, it is preferred that the first disconnectable connecting element is adapted to disconnect when a pushing finger force of 20N to 100N is applied to the pushing member. More preferably, the pushing finger force is between 35N and 45N.

[0112] Figure 5A , Figure 5B and Figure 5C This is a schematic diagram of an embodiment of a puncture device 550 having a manually operated actuator mechanism 500, showing the device in an initial non-actuated state, an intermediate actuated state, and a final retracted state. The actuator mechanism 500 of this particular puncture device 550 shares with... Figure 4A , Figure 4B and Figure 4C The actuation mechanism 400 has the same features. Therefore, the same numbers are used to indicate these technical features, except for the first number, "5" for the feature of actuator mechanism 500 and "4" for the feature of actuator mechanism 400. The puncture device includes a peripheral support structure 501 that forms an internal volume 503. This peripheral support structure has: a base portion that forms a support plane; and a peripheral wall that is substantially perpendicular to the base portion and is preferably cylindrical. The puncture device 550 also includes a manually operated actuator mechanism 500, such that the mounting element 504 is connected to the peripheral support structure 501, particularly to the peripheral wall.

[0113] In an exemplary puncture device, the puncture element carrier includes an attachment means for attaching an external puncture element, such as a lancet, needle, hollow needle, catheter, or any other suitable puncture element. In another exemplary puncture device (such as puncture device 550), the puncture element 502 is an integrated component of the puncture device and is connected to the puncture element carrier.

[0114] Preferably, the puncture element 502 is sized and arranged as follows:

[0115] a) in Figure 5A The initial position shown remains within the internal volume 503;

[0116] b) In Figure 5B The stop position shown extends from the internal volume 503 after the application of a predetermined pushing force F causes the first disconnectable connecting element 504 to disconnect, thereby disengaging the mounting element 504 from the trigger element 506; and

[0117] c) In Figure 5C The final position of the retraction shown returns to the internal volume. Once the second disconnectable element is disconnected, the retraction motion caused by the elastic energy stored in the elastic element is transmitted to the puncture element carrier.

[0118] Figure 6AA schematic diagram of another embodiment of a manually operated actuator mechanism 600 in a non-actuated state is shown. A mounting element 604 has an annular shape and is configured to attach to or connect to a peripheral support structure of the puncture device, so that it does not move relative to the peripheral support structure independently of the current state of the puncture device. A trigger element 606 is arranged concentrically with the mounting element 604, and is closer to the center point than the mounting element 604. The actuator mechanism includes a puncture element carrier 608 to which an external puncture element 602 is attached. The puncture element carrier 608 is located at the center of the actuator mechanism 600. A plurality of first detachable connection elements 610 connect the mounting element 604 to the trigger element 606. Furthermore, a plurality of second detachable connection elements 614 connect the trigger element 606 to the puncture element carrier 608. In this particular actuator mechanism 600, there are four equally spaced first disconnectable connection elements 610 and four equally spaced second disconnectable connection elements 614. Other actuator mechanisms include different numbers of first and / or second disconnectable connection elements.

[0119] exist Figure 6B The diagram illustrates an exemplary first and / or second detachable connecting element. The connecting element extends along the link direction between the two elements it connects to, namely, from the mounting element to the trigger element and from the trigger element to the puncture element carrier. Figure 6B The diagram shows a cross-section along the link direction. At both ends 650, the connecting element has a larger girth than at the middle portion (where the recess 652 is located). Applying a pushing force or a breaking force causes the first and second disconnectable connecting elements to disconnect at this recessed area. Properly dimensionalning this area and appropriate selection of materials allow for the manufacture of a disconnectable connecting element that disconnects upon application of a pre-specified force. Preferably, the pushing member is configured to apply force to the recessed area of ​​the first disconnectable connecting element, and the base or any other disconnecting element is configured to apply force to the recessed area of ​​the second disconnectable connecting element.

[0120] Figure 7 A schematic diagram of one embodiment of the testing apparatus 790 is shown. The testing apparatus includes a puncture device 750, such as referenced in [reference text]. Figures 5A to 5C The described puncture device includes an actuator mechanism 700 that controls the puncture movement of the puncture element 702 based on a pushing force applied to the pushing member 712. The actuator mechanism can also be configured to control the retraction movement of the puncture element, for example, by referring to... Figure 4B and Figure 4CAs described above, the testing apparatus also includes a fluid sample receiving unit 752 adapted to receive a fluid sample to be tested. This fluid sample receiving unit is fluidly connected to the respective inputs of two fluid delivery elements 754, 756. The fluid delivery elements are arranged and configured to deliver fluid away from the inputs. Suitable fluid delivery elements include, but are not limited to, capillary beds (e.g., capillary wicks) and microfluidic systems. The testing apparatus also includes two test units 758, 760 in fluid communication with the respective fluid delivery elements. Test units 758, 760 include corresponding reactive materials configured to react with pre-specified analytes or fluid properties in a predetermined manner.

[0121] Test units 758 and 760 may include corresponding conjugate pads comprising immobilized conjugate material. The conjugate pads are configured to release the immobilized conjugate material upon contact with a liquid sample. The conjugate material, such as colloidal gold or colored, fluorescent, or paramagnetic monodisperse latex particles, is contained within the conjugate pad and conjugates with a specific biological component to be identified in the liquid sample. This biological component may be an antigen in some test devices and an antibody in others. Test units may include test lines and control lines, forming a so-called reaction matrix. A fluid sample received by a fluid sample receiving unit is transported from the fluid sample receiving unit along a capillary wick by means of capillary action. At the conjugate pad, the liquid sample releases the conjugate material, and the combination of the two is further transported toward an absorbent pad located at the distal end of a fluid delivery element (e.g., a test strip), opposite the proximal end to which the fluid sample receiving unit is connected. The absorbent pad is typically configured as a sink for liquid samples, maintaining the flow of liquid on the capillary wick and preventing the liquid sample from flowing back or toward the fluid sample receiving unit.

[0122] The test apparatus 790 may optionally include a window portion 757 that is at least partially transparent in the visible wavelength range and is arranged to allow optical inspection of the test unit 760 from outside the test apparatus 790.

[0123] Other testing apparatuses (not shown) include varying numbers of fluid delivery elements. Other testing apparatuses (not shown) include one or more fluid delivery elements having multiple test units.

[0124] In test apparatuses using capillary beds or capillary cores (configured to transport fluid via capillary action) as fluid transport elements, the fluid transport elements, in a planar state, have a centerline length, width, and thickness, the thickness being shorter than the centerline length and width. To reduce the size of the test apparatus, some fluid transport elements are arranged such that the width direction of the fluid transport element extends at an angle of less than 90° relative to the normal of the support plane defined by the peripheral support structure. Furthermore, the fluid transport element is curved, resulting in a minimum distance between the two opposing longitudinal ends of the fluid transport element that is shorter than the centerline length in the planar state.

[0125] This is Figure 8A and Figure 8B The diagram illustrates an exemplary set of fluid delivery elements 856 in geometry, which are in the form of test strips and preferably include capillary wicks. Figure 2A In this setup, three test strips form a group of test strips. Each individual test strip has a corresponding test unit 860. Each test strip in... Figure 8A The test strip is planar and has a centerline length L in the longitudinal direction, a width W in the width direction perpendicular to the longitudinal direction, and a thickness d in the thickness direction perpendicular to both the longitudinal and width directions. The thickness d is shorter than the centerline length L and the width W, meaning it has a smaller range of extension. Figure 2B The diagram shows the shortest distance between two opposite longitudinal ends of the test strip's centerline, or in other words, the effective extension or envelope R of the test strip, when the distance is shorter than the distance between the two ends of the test strip's centerline. Figure 2A The test strip in a planar configuration is shown with a centerline length L. In this particular example, the shortest distance between the two opposing longitudinal ends of the test strip corresponds to the effective extension range R. In another exemplary configuration (not shown), where the test strip is bent into, for example, a circle, the shortest distance between the two opposing longitudinal ends disappears, and the effective extension corresponds to the diameter of the formed circle, i.e., π / L. In any case, both the shortest distance and the effective extension range are shorter than the centerline length of the test strip.

[0126] Fluid delivery elements (e.g., test strips with capillary cores) are advantageously arranged in the test apparatus 790 such that the width direction extends in the Z direction, as... Figure 7 As shown above. The supporting plane is the portion of the outer supporting structure located in the XY plane, such as... Figure 7 As shown in the diagram, the outer walls of the outer support structure also extend substantially along the Z-direction.

[0127] Preferably, the peripheral support structure has a flat or planar geometry that defines a support plane. However, in alternative testing apparatuses, the support structure is not flat, but its outer perimeter defines the plane. In yet another alternative testing apparatus, neither the support structure nor its outer perimeter directly defines the plane; the plane is defined by averaging the spatial position of at least a portion of the support structure or its outer perimeter.

[0128] Figure 9 A schematic representation of a test apparatus 990 is shown. For clarity, features related to the actuator mechanism are not shown in this figure. The test apparatus 990 includes a fluid sample receiving unit 952 arranged on a support structure defining a support plane XY. The support structure 953 has an opening 955 for receiving a fluid sample. The test apparatus 990 also includes a solution chamber 962 containing a buffer solution; and a flow control device 964.1 configured to control the transfer of the buffer solution to the fluid sample receiving unit 952. Alternatively or additionally, some test apparatuses include a flow control device 964.2 that controls the transfer of the buffer solution directly to the fluid delivery element 954 (as shown by the dashed line). Some test apparatuses include multiple solution chambers and a flow control device that controls the transfer of corresponding solutions (which can be the same or different or a combination thereof) to the fluid sample receiving unit or to one or more fluid delivery elements (particularly preferably test strips including capillary wicks). The buffer solution is advantageously selected to enhance the delivery of the fluid sample along the capillary wick of the test strip.

[0129] Flow control devices 964.1 and 964.2 are configured to control the transfer of buffer solution from the solution chamber to at least one fluid delivery element and / or to the fluid sample receiving unit in any of the following situations:

[0130] -Before the fluid sample is transferred to at least one fluid delivery element and / or to the fluid sample receiving unit; or

[0131] -When a fluid sample is transferred to at least one fluid delivery element and / or to a fluid sample receiving unit; or

[0132] -After the fluid sample has been transferred to at least one fluid delivery element and / or has been transferred to the fluid sample receiving unit; or

[0133] - Any combination of the above situations.

[0134] Passing the buffer solution to the fluid sample receiving unit or fluid delivery element before the fluid sample is received or transferred results in the wetting of the capillary wick or absorbent material, which in certain embodiments enhances absorption capacity.

[0135] When a liquid sample is received or transferred, a buffer solution is passed to the fluid sample receiving unit or fluid delivery element. This increases the volume of the liquid present and the flow rate of the liquid sample, thereby reducing the time required for the liquid sample to reach the test section of the test strip.

[0136] After the liquid sample is received or transferred, the buffer solution is passed to the fluid sample receiving unit or fluid delivery element, which in certain embodiments is advantageously used to flush the liquid sample toward the test section.

[0137] Figure 10 A schematic diagram of another embodiment 1000 of the testing apparatus is shown. (As shown) Figure 9 In the case of test apparatus 990, the actuator mechanism is not explicitly shown for clarity. Test apparatus 1000 includes a puncture element 1002, such as a lancet. Other suitable puncture elements include, but are not limited to, needles, hollow needles, cannulas, or catheters. Other test apparatuses (not shown) do not include puncture elements. Test apparatus 1000 includes: a peripheral support structure 1004, which includes a support structure 1006 defining a support plane XY; and a cover unit 1008 having a peripheral wall. The lancet is a specific, non-limiting example of a puncture element and is connected to a fluid sample receiving unit 1010. The test apparatus also includes two fluid delivery elements, specifically two test strips 1012.1 and 1012.2 with capillary wicks, and each fluid delivery element includes corresponding test units 1014.1 and 1014.2.

[0138] The testing apparatus 1000 also includes an optical sensor 1018 configured to detect impeding light reflected by testing units 1014.1 and 1014.2, and to convert the detected light into an electrical signal representing the intensity and / or color of the impeding light. The optical sensor 1018 is connected to a conversion unit 1020. The conversion unit 1020 is configured to convert the electrical signal into digital data representing the intensity and / or color of the detected light. In this particular testing apparatus, the conversion unit 1020 is an analog-to-digital converter and is comprised of the optical sensor 1018. The testing apparatus 1000 also includes a power management unit 1016, which includes a voltage regulator circuit.

[0139] Alternatively, the conversion unit 1020 can be a separate component, arranged on the support structure 1006 and operatively connected to the optical sensor 1018. For example, the optical sensor 111 and the transmission unit 1022 (which has an RF interface) can be arranged on the support structure 1006. Using one or more mirrors (not shown), also arranged on the support structure 1006, light reflected from the test units 1014.1 and 1014.2 can be guided to the optical sensor. Using the mirrors, an optical path linking the test units 1014.1 and 1014.2 and the optical sensor 1018 can be created. Alternatively, the optical sensor 1018, the transmission unit 1022 (which has an RF interface), and finally the power management unit 1016 can be arranged on a circuit board, such as a flexible PCB. This circuit board can be arranged on the support structure 1006. Using optical elements, such as mirrors, an optical path from the test units 1014.1 and 1014.2 to the optical sensor 1018 arranged on the circuit board can be created. The circuit board can also be attached to the inner surface of the cover unit 1008, which faces the support structure 1006. Preferably, the optical sensor 1018 is arranged such that if the circuit board is attached to the inner surface of the cover unit 1006, the optical sensor also faces the support structure. Because the test units 1014.1 and 1014.2 face the sidewalls of the test apparatus 1000, preferably, the optical elements are arranged and configured to redirect light reflected from the test units 1014.1 and 1014.2 at approximately 90° toward the optical sensor 111. Additionally, one or more light sources, such as LEDs, may be included, arranged and configured to illuminate the test units 1014.1 and 1014.2. These one or more light sources can be arranged on the support structure 1006, on the circuit board, or directly onto the inner surface of the cover unit 1008.

[0140] The transmission unit 1022 is connected to the power management unit 10016 and the conversion unit 1020. The transmission unit 1022 is configured to wirelessly transmit digital data, representing the intensity and / or color of detected light, for example, according to a predetermined wireless communication protocol. Preferably, in the testing apparatus 1000, the transmission unit 1022 is configured to transmit digital data via a near-field communication link.

[0141] Figure 11A flowchart illustrating an embodiment of a method 1100 for actuating a manually operated actuator mechanism for driving an external puncture element is shown. The method includes: in step 1102, applying a predetermined pushing force to a pushing member; thereby, in step 1104, disconnecting a first detachable connection element connecting a mounting element to a trigger element. Method 1100 further includes, in step 1106, moving a puncture element carrier from an initial position to a stop position, the puncture element carrier being connected to the trigger element via a second detachable connection element, wherein in the initial position the first and second detachable connection elements are not disconnected, and in the stop position the base prevents movement of the puncture element carrier.

[0142] A particular variant of method 1100 further includes, in step 1108, disconnecting the second detachable connecting element when the puncture element carrier reaches the stop position, and in step 1110, acting on the puncture element carrier to return it from the stop position in the direction of the initial position. Preferably, disconnecting the first detachable connecting element requires applying a pushing finger force of 20N to 100N.

[0143] Figure 12 A flowchart illustrating an embodiment of a method 1200 for operating a test apparatus is shown. The method includes performing... Figure 11 The method 1100 includes the following steps. The method further includes, in step 1202, delivering fluid from the puncture element to at least one test unit via a fluid delivery element. The method further includes, in step 1204, a corresponding reactive material reacts with a pre-specified analyte or fluid property in a predetermined manner.

[0144] A particular variant of method 1200 further includes: in step 1206, detecting light reflected from at least one test unit; in step 1208, converting the light into an electrical signal representing the intensity and / or color of the detected light; in step 1210, converting the electrical signal into digital data representing the intensity and / or color of the detected light; and in step 1212, wirelessly transmitting the digital data, preferably via a near-field communication link.

[0145] In summary, the present invention relates to a manually operated actuator mechanism that drives a puncture element with improved safety. The actuator mechanism includes a mounting element connected to a trigger element via a first detachable connection element. The actuator mechanism also includes a puncture element carrier connected to the trigger element via a second detachable connection element. The trigger element further includes a push member capable of being pushed by a human finger. The first detachable connection element is configured to disengage by a predetermined pushing finger force applied to the push member. The puncture element carrier is movable between an initial position in which the first and second detachable connection elements are not disengaged, and in the stop position in which a base prevents movement of the puncture element carrier.

[0146] In the claims, the word "comprising" does not exclude other elements or steps, and the indefinite article "a" or "an" does not exclude a plurality.

[0147] A single unit can perform the functions of multiple items recounted in the claims. The fact that certain measures are only recounted in different dependent claims does not mean that a combination of these measures cannot be used advantageously.

Claims

1. A manually operated actuator mechanism for driving an external puncture element (102) with a predetermined force, the actuator mechanism comprising: - Mounting components (104); -Trigger element (106); - A puncture element carrier (108) for external puncture elements, wherein - The trigger element (106) is connected to the mounting element (104) via a first detachable connection element (110), the first detachable connection element (110) being designed to disconnect when a predetermined force is applied to the trigger element. The trigger element (106) also includes or is connected to a push member (112), the push member being actuable by a human finger and arranged to transmit finger force to the first detachable connection element via the trigger element, thereby causing the first detachable connection element to disconnect when the finger force (F) pushing the push member (112) exceeds a predetermined threshold; and wherein - The puncture element carrier (108) is connected to the trigger element (106) and is movable between an initial position and a stop position, in which the second disconnectable connection element (114) and the first disconnectable connection element (110) are not disconnected, and in the stop position, the base (116) prevents the movement of the puncture element carrier (108).

2. The actuator mechanism according to claim 1, wherein, The puncture element carrier (108) is connected to the trigger element (106) via a second disconnectable connection element (214), which is configured to disconnect when the puncture element carrier (208) reaches the stop position.

3. The actuator mechanism according to claim 1 or 2, further comprising an elastic element (318) arranged to act on the puncture element carrier (308) to cause the puncture element carrier to return from the stop position in the direction of the initial position.

4. The actuator mechanism according to claim 3, wherein, The base (416) is an elastic element (418) under pressure or compression.

5. The actuator mechanism according to claim 1 or 2, wherein, The first disconnectable connection element is adapted to disconnect when a pushing finger force of 20N to 100N is applied to the pushing member.

6. A puncture device (550), the puncture device comprising: -External support structure (501), which forms an internal volume (503); - A manually operated actuator mechanism according to any one of the preceding claims, wherein the mounting element is connected to the peripheral support structure (501).

7. The puncture device (550) according to claim 6, further comprising a puncture element (502) connected to the puncture element carrier (508), the puncture element (502) preferably being arranged to be held in the internal volume (503) at the initial position and to extend from the internal volume (503) at the stop position.

8. A testing apparatus (790), the testing apparatus comprising: - The puncture device (750) according to claim 6 or 7; - Fluid sample receiving unit (752), which receives a fluid sample for testing; - At least one fluid delivery element (754, 756), the at least one fluid delivery element having an input end fluidly connected to the fluid sample receiving unit, the fluid delivery element being arranged and configured to deliver fluid from the input end; as well as - At least one test unit (758, 760) is in fluid communication with the fluid delivery element, the test unit comprising a corresponding reactive material configured to react with a pre-specified analyte or fluid property in a predetermined manner.

9. The testing apparatus (990) according to claim 8, further comprising: At least one solution chamber (962) contains a corresponding buffer solution; And a flow control device (964.1, 954.2) configured to control the transfer of the buffer solution to the fluid delivery element and / or to the fluid sample receiving unit.

10. The testing apparatus (990) according to claim 9, wherein, The flow control devices (964.1, 964.2) are configured to control the transfer of the buffer solution from the solution chamber (962) to the at least one fluid delivery element (954) and / or to the fluid sample receiving unit (952) in any of the following situations: -Before the fluid sample is transferred to the at least one fluid delivery element and / or to the fluid sample receiving unit; or -During the period when the fluid sample is transferred to the at least one fluid delivery element and / or to the fluid sample receiving unit; or -After the fluid sample has been transferred to the at least one fluid delivery element and / or has been transferred to the fluid sample receiving unit; or - Any combination of the above situations.

11. The testing apparatus according to any one of claims 8 to 10, wherein the testing apparatus further comprises: - An optical sensor is arranged and configured to detect light reflected from the at least one test unit and convert the detected light into an electrical signal representing the intensity and / or color of the detected light. - A conversion unit, configured to convert the electrical signal into digital data, the digital data representing the intensity and / or color of the detected light, and - A transmission unit, which is used for wirelessly transmitting the digital data.

12. A method for actuating a manually operated actuator mechanism according to claim 1, the manually operated actuator mechanism being used to drive an external puncture element, the method comprising: - A predetermined pushing force is applied to the pushing member, thereby disconnecting the first disconnectable connecting element, which connects the mounting element to the trigger element; - The puncture element carrier is moved from an initial position to a stop position, the puncture element carrier being connected to the trigger element via a second disconnectable connection element. In the initial position, the first disconnectable connection element and the second disconnectable connection element are not disconnected. In the stop position, the base (116) prevents the movement of the puncture element carrier.

13. The method according to claim 12, further comprising: - When the puncture element carrier reaches the stop position, the second disconnectable connection element is disconnected; - The puncture element carrier is acted upon to return the puncture element carrier from the stop position in the direction of the initial position.

14. The method according to claim 12 or 13, wherein, Disconnecting the first disconnectable connection element requires applying a pushing finger force of 20N to 100N.

15. A method of operating a testing apparatus, the method comprising: - Perform the steps of any one of claims 12 to 14; - Fluid is delivered from the puncture element to at least one test unit via a fluid delivery element; - To cause the corresponding reactive material to react with a pre-specified analyte or fluid property in a predetermined manner.

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