Patent Application
20240016429
The present invention is directed to a hand-operated actuator mechanism, to a piercing device comprising said actuator mechanism, to a testing device comprising said piercing device and to methods for operating the actuator mechanism and the testing device.
US 2012/0227697A1 describes systems and methods for delivering to and/or receiving fluids or other materials, such as blood or interstitial fluid, from subjects, e.g. from the skin. In a particular embodiment, when an actuator is actuated by a user, a piercing element is engaged and driven toward the skin.
It is an object to provide an improved or alternative piercing device.
According to the invention, a hand-operated actuator mechanism is provided. The actuator mechanism is configured for driving an external piercing element with a predetermined force. The actuator mechanism comprises a mounting element, a trigger element and a piercing element carrier. The piercing element carrier can be operatively connected to the piercing element.
According to a first aspect of the actuator mechanism, the trigger element is connected to the mounting element via at least one first breakable connection element, i.e. a connection element that is designed to break in a controlled manner when a predetermined force is applied. The trigger element further comprises or is connected to a pushing member that can be pushed with a human finger. Via the pushing element a force can be exerted on the trigger element. The first breakable connection element is configured to break if a predetermined pushing finger force is pushingly applied to said pushing member. Thus, the force that is need to break the first breakable connection element defines the force acting on the piercing element.
Preferably, the piercing element carrier is connected to the trigger element via at least one second breakable connection element. The second breakable connection is designed to break in a controlled manner when a second predetermined force is applied. The piercing element carrier is movable between an initial position wherein the first and the second breakable connection elements are unbroken, and a stop position wherein an abutment stops a movement of the piercing element carrier.
Applying a force on the pushing member in a longitudinal direction causes a stress in the material of the first breakable connection element, e.g. tensile and/or shear stress. The first breakable connection element is advantageously configured to break upon application of the predetermined pushing finger force. Once the first breakable connection element is broken, the trigger element and the piercing element carrier are free to move independently of the mounting element in at least the longitudinal direction. The free-moving part of the actuator mechanism, which includes at least the trigger element and the piercing element carrier is accelerated with an acceleration that depends primarily on the predetermined pushing force needed to break the first breakable connection element and on the mass of the accelerated objects, for instance the trigger element, the pushing element, the piercing element carrier, and external piercing element and the finger.
Due to the first breakable connection element, a predefined piercing force can be achieved and safety is increased since the actuator can only be used once in its intended form thus ensuring a single-use operation.
In the following, embodiments of the actuator mechanism of the first aspect of the invention are described.
In a preferred embodiment of the actuator mechanism, that further increases the safety, the second breakable connection element is configured to be broken when the piercing element carrier reaches the stop position. This enables a separation of the trigger element from the piercing element carrier so that a further actuation of the pushing member is uncoupled from the piercing element carrier, thus ensuring that no further force can be transferred from the actuator to the piercing element carrier.
In order to further increase the safety, an embodiment of the actuator mechanism further comprises an elastic element that is arranged to act on the piercing element carrier for returning the piercing element carrier form the stop position in the direction of the initial position. Thus, the elastic element is configured to exert a retraction force for driving the piercing carrier element towards the initial position. In an embodiment wherein the second breakable connection is configured to be broken when the piercing element carrier reaches the stop position, the piercing element carrier is advantageously driven towards the initial position independently on whether further pushing finger force is applied on the pushing member, thus guaranteeing a retraction of the piercing element carrier. Suitable elastic elements include, but are not limited to, coil springs, which can be conical, or more preferably cylindrical, or strips such as metal or plastic strips, elastics bands such as rubber bands, etc.
In an embodiment, the abutment (that is arranged to stop the movement of the piercing element carrier once the first breakable connection element is broken) is a non-movable element, with respect to the mounting element. In a preferred alternative embodiment, the abutment is the elastic element in its stressed or compressed state, for instance a helical spring in its fully compacted, solid state. The application of the predetermined pushing finger force on the pushing element in the longitudinal direction causes the breakage of the first breakable connection element and an acceleration of the trigger element and the piercing carrier element, which are linked by the second breakable connection element, towards the stop position. This accelerated movement is carried out against the elastic element, which is moved away from its initial position, storing elastic potential energy and decelerating the trigger element and the piercing carrier element until it stops. Thus, the elastic strip or band in a stressed state or the coil spring in the compressed state acts as the abutment that stops the movement of the piercing element carrier.
In an embodiment, the elastic element, such as a coil spring, is further arranged and configured to break the second breakable connection elements when the stop position is reached. For instance, the elastic element is arranged so that in applies a breaking force on the second breakable connection element when the stop position is reached. In an alternative embodiment, the actuator mechanism further comprises a non-movable breaking element that is configured to break the second breaking connection element. In an embodiment, the coil spring, preferably a cylindrical coil spring is arranged as a guide for an external piercing element attachable to the piercing element carrier to ensure that the piercing element moves in a longitudinal direction of the coil spring and preferably inside the coils. In an embodiment where the diameter of the coil spring is smaller than the dimensions of the piercing carrier element, the actuator mechanism includes an additional breaking element arranged to be in contact and to break the second breakable connection element.
In a particular embodiment of the actuator mechanism, which may include any of the technical features described above, the first breakable connection is adapted to be broken upon exertion of a pushing finger force of 20-100 N on the pushing member. Preferably, the pushing finger force necessary to break the first breakable connection element is between 30 and 80 N and more preferably between 35 and 55 N. The actual value of the predetermined pushing finger force that is to be applied for breaking the first breakable connection element can be selected in dependence on the application or the intended user. For example, predetermined pushing finger forces between 50 and 100 N provides an increase safety feature that prevents an accidental activation by children. Actuator mechanism intended for use by elderly people may advantageously require less pushing finger force than those intended to you by younger adults.
According to a second aspect of the present invention, a piercing device is described. The piercing device comprises a peripheral support structure forming an inner volume. It also comprises a hand-operated actuator mechanism in accordance with any of embodiments of the first aspect of the invention, wherein the mounting element of the actuator mechanism is connected to the peripheral support structure.
Preferably, the abutment and/or the elastic element is connected to the peripheral support structure.
An embodiment of the piercing element comprises a piercing element connected to the piercing element carrier. In an alternative embodiment, the piercing element carrier comprising connecting means for connecting an external piercing element. Suitable piercing element include, but are not limited to, lancets, needles, hollow needles, trocars and catheters.
In a preferred embodiment of the piercing device, the piercing element is arranged to remain within the inner volume at the initial position and to protrude from the inner volume at the stop position. This reduces the risk of accidental damage by the piercing element before the pushing member is actuated.
Preferably, the piercing device is a hand-held device. In a particular embodiment, the peripheral support structure has a cylindrical shape defined by a height value and a diameter value, and wherein the diameter value is larger than the height value. Preferably, the height of the peripheral support structure is smaller than 5 cm, more preferably smaller than 3 cm and even more preferably smaller than 2.5 cm. The diameter of the peripheral support structure is preferably smaller than 5 cm.
According to a third aspect of the present invention, a testing device is described. The testing device comprises a piercing device according to any of the embodiments of the piercing device of the second aspect of the present invention. The testing device further comprises a fluid sample receiving unit for receiving a fluid sample for testing and at least one fluid transport element having an input end fluidly connected to the fluid sample receiving unit. The fluid transport element is arranged and configured to transport a fluid away from the input end. The testing device also comprises at least one testing unit in fluidic communication with the fluid transport element. The testing unit comprises a respective reacting material configured to react in a predetermined manner to a pre-specified analyte or property of the fluid.
In an embodiment, the fluid sample receiving unit is or comprises a piercing element. In another embodiment, the fluid sample receiving unit comprises connection means for attaching an external piercing element. In another embodiment, the sample fluid receiving unit is an interface for receiving a fluid sample.
In a preferred embodiment, the testing device is a device suitable for performing a lateral flow assay. Also known as lateral flow immunochromatographic assays. These assays are typically intended to detect the presence of a target substance in a fluid sample and are widely used in medical diagnostics for home testing, point of care testing, or laboratory use.
In a particular embodiment, the fluid transport element is a capillary wick or other capillary bed having the capacity of transporting a fluid spontaneously, for instance by capillary effect. Alternatively, the fluid transport element is a micro-fluidic system. In another embodiment, the fluid transport element includes both a capillary bed or wick and a micro-fluidic system.
In an embodiment, each of the testing units comprises a different reacting material configured to react in a pre-specified manner to a respective pre-specified analyte. Alternatively, two or more of the testing units comprise one or more test portions having a given reacting material with a same or a respective different sensitivity, either in order to improve the accuracy of testing assembly or in order to enable a semi-quantitative evaluation of the given analyte.
In a preferred embodiment, that can be arranged as a hand-held testing device with reduced dimensions, the fluid transport element has, in a planar state, a center line length, a width and a thickness that is shorter than the center line length and the width. Also, a width direction of the fluid transport element extends at an angle smaller than 90° with respect to a normal of a support plane defined by the peripheral support structure. In this particular embodiment, the fluid transport element is curved, resulting in a shortest distance between two opposite longitudinal ends of the fluid transport element being shorter than the center line length in the planar state.
Preferably, the fluid transport element is a capillary bed or wick that has two flat sides that are spaced apart by the thickness of the given fluid transport element. In a planar state, the fluid transport element has a length, a width and a thickness.
If the fluid transport element is rectangular (neglecting its thickness) in its planar state, then the fluid transport element has a given center line length in a longitudinal direction, a given width in a width direction perpendicular to the longitudinal direction and a given thickness in a thickness direction perpendicular to both the longitudinal direction and the width direction, that is shorter, i.e., has a smaller extension, than the center line length and the width. In this particular case of a rectangular fluid transport element, a length of the fluid transport element and a length of a center line in the middle of the fluid transport element, hereinafter also referred to as center line length, is equal to a length of the longitudinal edges of the fluid transport element's flat surfaces.
Alternatively, the edges of the flat sides may be curved, (i.e. not straight) in the planar state. This results in a fluid transport element having a curved shape in its planar state. In this case, the center line length is the length of a center line located midway between the longitudinal edges of the fluid transport element. The center line length is inherent to the testing strip and independent on an actual state—curved or planar—of the fluid transport element.
The distance between the longitudinal ends of a planar, curved fluid transport element may be shorter than the length of the center line.
To further limit the outer dimensions of the fluid transport element—and thus the envelop of the fluid transport element—the fluid transport element may be arranged non-planar, i.e. bent or further curved in a third dimension. This includes for example fluid transport elements having straight longitudinal edges that are arranged in a curved state (e.g. rectangular fluid transport elements that are folded, curled or wrapped), fluid transport elements with curved longitudinal edges in a flat state, or fluid transport element s with curved longitudinal edges that are folded curled or wrapped and thus in a curved state).
In an embodiment of the testing device of the third aspect of the present invention, a width direction of the fluid transport element extends at an angle smaller than 90° with respect to the normal of the plane defined by the support structure. Thus, a longitudinal edge of the fluid transport element is arranged on the support structure so that the other longitudinal edge extends from the support structure. Also, the fluid transport element is curved, resulting in a shortest distance between two opposite longitudinal ends of the center line being shorter than the center line length in the planar state. The shortest distance is herein defined as a length amount indicative of a minimum distance amount between a proximal end of the fluid transport element (i.e. a section of the testing strip being in contact with or in the vicinity of the piercing element or the piercing element carrier) and a distal end of the fluid transport element at which, or close to which, the testing unit is arranged.
It is noted that a shortest distance between the longitudinal ends of the fluid transport element shorter than a center line length implies that the testing strip is curved, either in its planar state, or because the fluid transport element is arranged non-planar or both. Fluid transport elements wherein the shortest distance between the longitudinal ends is shorter than its center line length have an effective total extension or envelope of the fluid transport element that is smaller than the center line length in the planar state. This, in turn, allows for a size reduction of the testing device in comparison with a minimum size that the assembly would have in case the fluid transport elements were arranged in the planar state. If the fluid transport element is curved in a semi-circular shape, the shorter distance between the longitudinal ends may be shorter that the maximum outer dimension of the fluid transport element while the maximum outer dimension of the fluid transport element is still smaller than the center line.
This advantageous spatial arrangement of the fluid transport element in the testing device enables an improved usage of space within the testing device. It further enables a reduction of a total size of the testing device without a need to reduce the center line length of the fluid transport element. This, in turn, results in an improved applicability and offers an increased versatility.
By arranging the fluid transport element in a curved way and in a way in which the width direction extends at an angle smaller than 90° with respect to the normal of the plane defined by the support structure (i.e. the fluid transport element not being arranged parallel to the plane defined by the support structure), the size of the testing device can be reduced compared to typical testing device configurations, wherein the fluid transport element such as testing strips are usually directly arranged on a support structure in the planar state. Alternatively, longer fluid transport elements can be used when compared to known testing devices wherein the testing strips are arranged in the planar state onto the support structure.
In another embodiment, the testing device additionally or alternatively comprises at least one solution chamber containing a respective buffer solution, and flow control means configured to control a transfer of the buffer solution to the fluid transport element.
The at least one solution chamber is preferably arranged on the support structure. In a particular embodiment, the solution chamber is provided as a cavity in the support structure.
Some buffer solutions are advantageously chosen to enhance the transfer of the fluid sample to the testing unit. Other buffer solutions comprise a reagent that is configured to react with a particular analyte in a predetermined manner. In a particular embodiment comprising a plurality of solution chambers, different solutions chambers may contain different buffer solutions, which are individually transferred to one or more of the fluid transport element in accordance with particular requirements of the testing devices.
Solution chambers and buffer solutions such as those discussed above can be used in combination with any of the technical features described with respect to the previous embodiments.
In an embodiment of the testing device of the third aspect of the invention, the flow control means is configured to control a transfer of the buffer solution from the solution chamber to at least one of the fluid transport elements either before a fluid sample is transferred to the at least one fluid transport element, or while the fluid sample is being transferred to the at least one fluid transport element, or after the fluid sample has been transferred to the at least one fluid transport element, or any combination thereof.
Transferring the buffer solution to the fluid transport element before the fluid sample is received or transferred causes a wetting of the capillary bed or wick or of an absorbent material, which, in a particular embodiment, enhances an absorption capacity of the material.
Transferring the buffer solution to the fluid transport element while the fluid sample is being received or transferred increases the volume of the liquid present and the flow velocity of the fluid sample and thus reduces the time needed by the fluid sample to reach the testing unit.
Transferring the buffer solution to the fluid transport element after the fluid sample has been received or transferred is advantageously used in a particular embodiment to wash away the fluid sample towards the testing unit.
Any of the variants regarding the transfer of the buffer solution can be used in combination with any of the technical features discussed with regard to any of the previous embodiments of the testing device of the third aspect of the invention.
The flow control means may comprise, in an embodiment in accordance with the third aspect of the invention, a soluble material configured to be dissolved in the buffer solution at a predetermined dissolution rate and configured to enable a flow of the buffer solution away from the respective solution chamber after a predetermined time span. In another embodiment, the testing device comprises a reservoir containing a soluble material, for instance a pharmacologically inactive substance such as for example lactose monohydrate. This soluble material is configured to be dissolved when in contact with a predetermined fluid such as a body fluid. The dissolution of the soluble material is configured to bring in contact a piercing means with the solution chamber. The piercing means is configured to pierce the solution chamber and to allow a controlled flow of the buffer solution out of the solution chamber.
A particular embodiment of a testing device in accordance with the third aspect of the invention additionally or alternatively comprises hollow needles or catheters or microfluidic connection systems filled with the soluble material. The hollow needles or catheters are configured to pierce the solution chamber upon operation (e.g. by applying pressure, or by actuating the testing device in a predetermined manner). Once the solution chamber is pierced, the buffer solution enters in contact with the soluble material. Thus, by a proper choice of the soluble material, its amount, and the geometry of the flow control means and the solution chamber, a time span expanding between piercing the solution chamber and the buffer solution reaching the fluid transport element is controlled.
In another embodiment in accordance with the third aspect, which may also include any of the technical features described with respect to any of the preceding embodiments, the testing device further comprises a window section being at least partially transparent in a visible wavelength range and arranged to allow an optical inspection of the testing unit from outside the testing device.
In a particular embodiment, the window section is included in the peripheral support structure. In an embodiment wherein the testing device comprises a reflector element to allow an optical inspection of the testing unit from a direction substantially perpendicular to the plane defined by the support structure, the window section is advantageously arranged so that its projection onto the plane encloses at least a portion of the reflector element. In an alternative embodiment, the support structure of the testing device has a peripheral wall with in a direction substantially perpendicular to the plane, and the window section is arranged in said peripheral wall at peripheral wall positions that enable a direct optical inspection of the testing units. Yet another embodiment comprises a respective window section in an upper part of support structure and in the peripheral wall.
In a particular embodiment of the testing device of the third aspect of the invention, the window section is arranged in a recessed region of the upper part of the peripheral support structure, i.e. not on the peripheral wall. In this embodiment, the window section may comprise at least one lens, preferably at least a collimating lens. In an 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 comprise other transparent materials known to the person skilled in the art. In yet another embodiment, the window section comprises an array of micro lenses.
Any of the variants discussed with respect to the window section may be combined with any of the technical features disclosed with regard to the previous embodiments of the testing device.
An embodiment of the testing unit wherein the window section is arranged in a recessed region of the upper part of the peripheral support structure offers an increased protection of the window section, by reducing the risk of damaging it, by, for instance, unintended scratching. Further, this embodiment is advantageously configured to be used in combination with a test-reading device comprising a photographic camera such as, for instance, a mobile phone device. In some test-reading devices, the camera protrudes from a backside plane of a housing thereof. By arranging the window section in a slightly recessed region, the mobile phone can be placed thereon, maximizing a contact surface between the back side of the test-reading device and the testing device, thus reducing the risk of an incorrect relative positioning. In an embodiment of the testing device of this invention, the peripheral support structure may also comprise a non-slip or anti-skid material configured to increase the friction of the testing device when in contact with other object such as a test-reading device.
The test-reading device may comprise a processor and a memory unit including a software causing the test-reading device to access the camera, analyze the image and interpret the state of the reacting material of the test portion according to a predetermined analysis template. The software may be configured to provide an output signal that comprises result data pertaining to the state of the reacting material. The output signal can then be directly sent to a user interface or, via a wired or wireless communication link to a centralized data processing center, or both.
In these cases, it is desirable to allow an entrance of light into the testing device to illuminate the testing unit during a reading phase of the state thereof. Since it is possible that the test-reading device blocks light paths from an exterior of the testing unit through the window section, an embodiment of the testing device preferably comprises further transparent or translucent sections of the peripheral support structure configured to allow light to penetrate inside the testing device.
Some particular test-reading devices further comprise a source of light such as a flash unit. Depending on the relative spatial arrangement of the camera and the source of light, light from the source of light can also enter the testing device through the window section. However, in order to provide a general solution, independently of a particular type of test-reading device, i.e. whether the test-reading device comprises a source of light or its relative arrangement with respect to the camera, an embodiment of the testing device comprises an additional window section at the peripheral wall. Additionally, or alternatively, an embodiment of the testing device further comprises light guiding means to guide the light from the additional window section at the peripheral wall to the testing units for illumination. For instance, in a particular embodiment of the testing unit, the peripheral wall serves as a light guide. In another embodiment of the testing device, the additional window section may additionally or alternatively comprise a transparent or translucid material, preferably glass or an acrylic compound. In a particular embodiment, the material is mated to enable an even distribution of light.
In another embodiment, the testing device is advantageously configured to read the test result and to transfer information pertaining to this test result to an external device. In an embodiment, the testing device further comprises an optical sensor, arranged and configured to detect light reflected from the at least one testing unit and to convert the detected light into an electrical signal representing an intensity and/or a color of the detected light. It further comprises a conversion unit for converting the electrical signal into digital data representing the intensity and/or the color of the detected light, and a transmitter unit for wirelessly transmitting the digital data to the external device.
The testing device's optical sensor is arranged and configured for detecting light reflected from the at least one testing unit, and for providing an electrical signal representing an intensity and/or a color of the detected light. The optical sensor can be, e.g., a single-pixel photodiode or a CMOS-sensor or a CCD-sensor. After converting detected light into an electrical signal, the electrical signal is provided to the conversion unit. The conversion unit is configured for converting the electrical signal into digital data representing the intensity and/or the 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 device. Alternatively, the conversion unit can be part of the transmitter unit. Preferably, the conversion unit is or comprises an analog-to-digital converter (ADC) for converting the electrical signal into digital data representing the intensity and/or the color of the detected light. The conversion unit can be configured for converting the electrical signal with 8-bit.
The conversion unit is operatively connected to the transmitter unit, e.g., via a data bus, for providing digital data to the transmitter unit.
The transmitter unit is configured for wirelessly transmitting the digital data; preferably, to an external receiving device using a predetermined wireless communication protocol such as Bluetooth, near-field communication (NFC) or Wi-Fi or RFID. In particular, the transmitter unit can be or can comprise a NFC-chip and a NFC-coil, or a radio-frequency identification (RFID)-tag or transponder, or a Wi-Fi-integrated circuit chip, or a Bluetooth integrated circuit chip.
A transmitter unit based on a technology such as NFC or RFID not requiring a permanent energy supply is preferred. The energy needed for powering such a transmitter unit is provided by a so-called initiator.
A transmitter unit that is configured for transmitting data via NFC or RFID, preferably, comprises one or more antennas functioning as a radio-frequency (RF) interface for transmitting electromagnetic signals representing digital data by means of electromagnetic induction to one or more further antennas of an external device. Antennas typically comprise one or more coils each having four or five windings.
The initiator can be the external device providing a carrier field that is modulated by the transmitter unit for transmitting digital data. Preferably, for powering the transmitter unit, the transmitter unit draws energy from the external device via the NFC or RFID link. Thus, in particular, in case the transmitter unit is NFC- or RFID-enabled, it is not necessary that the testing device itself comprises an energy storage unit, e.g., a battery, for powering the transmitter unit.
The optical sensor, the conversion unit and the transmitter unit can be arranged as separate components on the peripheral support structure together with any microfluidic components also comprised by the testing device. It is also possible that the optical sensor, the conversion unit and the transmitter unit are be fabricated using electronic packaging, e.g., 3D-packaging. Using 3D-packaging, thus, by stacking the components on top of each other, a compact three-dimensional integrated circuit can be designed. After 3D-packaging the integrated circuit comprising the optical sensor, the conversion unit and the transmitter unit can be mounted onto the peripheral support structure or attached to a cover unit. Alternatively, a chip comprising the optical sensor, the conversion unit and the transmitter can be fabricated using wafer-level packaging (WLP). The optical sensor, the conversion unit and the transmitter unit can also be put into a protective package for integration into the testing device.
In some embodiments, the optical sensor, the conversion unit and the transmitter unit are mounted on a circuit board that is attached as a module onto the peripheral support structure or to a cover unit. The circuit board can be flexible, e.g., a flexible substrate made of polyimide, e.g., Kapton, polyether ether ketone (PEEK), liquid-crystal polymer (LCP), or FR4. Also a rigid or semi-flex circuit board can be used as an alternative. In particular, the optical sensor, the conversion unit and the transmitter can be integrated onto a thin FR4 substrate. The circuit board can be a printed circuit board (PCB) which, preferably, is flexible, e.g., a FR4 PCB. Alternatively, the printed circuit board can be a rigid or semi-rigid printed circuit board.
Attaching at least one of the optical sensor, the conversion unit or the transmitter unit to a top or to a peripheral section of the support structure is of advantage since more space is left on a bottom section of the support structure, e.g., for arranging the components of the microfluidic system.
In particular, an antenna of the transmitter unit can be integrated in the testing device using in-mold manufacturing. In case the testing device has a cover unit attached to the support structure, thus, forming a closed housing, an antenna of the transmitter can be integrated into the housing, e.g., attached on the inside to the lid part of the cover unit by means of in-mold manufacturing. Alternatively, an antenna of the transmitter unit can be integrated into the same chip or in the same circuit as the remaining transmitter electronics, the optical sensor and the conversion unit. For instance, the antenna can be integrated in the PCB.
Preferably, in another embodiment, the testing device comprises an optical arrangement comprising one or more optical elements that are arranged and configured for directing light reflected from the at least one testing unit to the optical sensor and/or for directing light emitted from a light source to the at least one testing unit. An optical element can be a mirror or a lens or a waveguide. The optical elements serve for creating an optical path linking, e.g., the at least one testing unit to the optical sensor.
For example, a mirror can be used for directing light reflected from the testing unit and a lens can be employed for focusing the light reflected from the mirror onto the optical sensor. It is also possible that a waveguide is used for directing the light reflected from the at least one testing unit to the optical sensor. The waveguide can be shaped at its one end for focusing light onto the optical sensor.
An optical arrangement is of advantage, in particular, if the testing unit and the optical sensor are not aligned, i.e., the testing unit is not in the immediate field of view of the optical sensor.
An optical arrangement is also of particular advantage if a testing device comprises more than one testing units, e.g., three testing units. In this case, an optical element of the optical arrangement, preferably, is configured and arranged for directing light reflected from anyone of the three testing units to the optical sensor. An accordingly configured optical element can comprise three mirror surfaces that are inclined to each other in a way that light reflected from anyone of the testing units is directed to the optical sensor upon reflection on one of the three inclined mirror surfaces. Thus, in general, an optical element can comprise a plurality of reflecting surfaces, e.g., a plurality of facets, that are configured and arranged for directing light reflected from one or more testing units that are arranged along the length of one fluid transport element to the optical sensor. An external receiving device can receive the digital data from the transmitter unit wherein the digital data representing light intensity and/or color of the light reflected from one or more of the plurality of testing units.
In general, using an optical arrangement allows to more freely arrange the one or more fluid transport elements and the optical sensor in the testing device, e.g., on the bottom part of the peripheral support structure since light paths can be created connecting testing unit and optical sensor. Such light paths can have an angle or can be curved, e.g., when using waveguides.
According to a fourth aspect of the present invention, a method for actuating a hand-operated actuator mechanism for driving an external piercing element is disclosed, the method comprises:
In a particular embodiment, the method further comprises breaking the second breakable connection element when the piercing element carrier reaches the stop position and acting on the piercing element carrier for returning the piercing element carrier from the stop position in the direction of the initial position.
In yet another embodiment breaking the first breakable connection element requires applying a pushing finger force of 20-100 N.
According to a fifth aspect of the present invention, a method for operating a testing device is disclosed. The method comprises performing the steps of any of the methods of the fourth aspect, transporting a fluid via a fluid transport element from a piercing element to at least one testing unit and reacting a respective reacting material in a predetermined manner to a pre-specified analyte or property of the fluid.
In an embodiment, the method of the fifth aspect also comprises detecting light reflected from at least one testing unit, converting the light into an electrical signal representing an intensity and/or a color of the detected light, converting the electrical signal into digital data representing the intensity and/or the color of the detected light and wirelessly transmitting the digital data, preferably using a near-field communication link.
It shall be understood that the a hand-operated actuator mechanism of claim 1, the piercing 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, in particular, as defined in the dependent claims.
It shall be understood that a preferred embodiment of the present invention can also be any combination of the dependent claims or above embodiments with the respective independent claim.
These and other aspects of the invention will be apparent from and elucidated with reference to the embodiment described hereinafter.
The trigger element 106 is connected to the mounting element 104 via a first breakable connection elements 110. The trigger element 106 further comprises or is connected to a pushing member 112 that can be pushed with a human finger. In the actuator mechanism, the first breakable connection elements 110 are configured to break if a pushing finger force F that pushes the pushing member 112, particularly in a longitudinal direction L, exceeds a predetermined threshold. In the actuator mechanism 100, the piercing element carrier 108 is connected to the trigger element 106 via a second breakable connection element 114.
Once the first breakable connection elements 110 are broken, the piercing element carrier 108 can move from an initial position to a stop position. The initial position is shown in
In the exemplary actuator mechanism 100 of
In the actuator mechanism 200, the second breakable connection elements 214 are configured to break when the piercing element carrier 208 reaches the stop position shown in
The actuator mechanism 300 of
An alternative embodiment of an actuator mechanism 400 is shown in an initial, non-actuated state, in an intermediate actuated state and in a retracted final state in
In the actuator mechanism 400 of
In the example shown in
In particular, in any of the embodiments of the actuator mechanism described above, it is preferred that the first breakable connection is adapted to be broken upon exertion of a pushing finger force of 20-100 N on the pushing member. More preferably, the pushing finger force is between 35 and 45 N
In an exemplary piercing device, the piercing element carrier comprises attaching means for attaching an external piercing element, such as a lancet, a needle, a hollow needle, a catheter or any other suitable piercing element. In another exemplary piercing device, such as piercing device 550, the piercing element 502 is an integral part of the piercing device and is connected to the piercing carrier element.
Preferably, the piercing element 502 is dimensioned and arranged:
A schematic diagram of an exemplary first and/or second breakable connection element is shown in
Suitable fluid transport elements include, but are not limited to capillary beds, such as capillary wicks, and microfluidic systems. The testing device also includes two testing units 758, 760 in fluidic communication with a respective fluid transport element. The testing units 758, 760 comprising a respective reacting material configured to react in a predetermined manner to a pre-specified analyte or property of the fluid.
The testing units 758, 760 may include a respective conjugate pad that comprises an immobilized conjugate material. The conjugate pad is configured to release the immobilized conjugate material upon contact with the liquid sample. The conjugate material is contained in the conjugate pads, i.e. as colloidal gold, or colored, fluorescent or paramagnetic monodisperse latex particles that have been conjugated to one specific biological component expected to be identified in the liquid sample. This biological component is in some testing devices an antigen and in other testing devices an antibody. The testing unit may include a test line and a control line forming a so-called reaction matrix. The fluid sample, received through the fluid sample receiving unit is transported by capillary action from the fluid sample receiving unit along the capillary wick. At the conjugated pad, the liquid sample releases the conjugate material and a combination of both is further transported towards an absorbent pad located at a distal end of the fluid transport element, such as a testing strip, opposite to a proximal end whereto the fluid sample receiving unit is connected. The absorbent pad is typically configured to act as a sink for the liquid sample, maintaining a flow of the liquid over the capillary wick and preventing a flow of the liquid sample back to or towards the fluid sample receiving unit.
The testing device 790 optionally comprises a window section 757 being at least partially transparent in a visible wavelength range and arranged to allow an optical inspection of the testing unit 760 from outside the testing device 790.
Other testing devices (not shown) comprise a different number of fluid transport elements. Other testing devices (not shown) comprise one or more fluid transport elements having a plurality of testing units.
In testing devices using as a fluid transport element a capillary bed or wick configured to transport a fluid by capillarity effect, the fluid transport element has, in a planar state, a center line length, a width and a thickness that is shorter than the center line length and the width. In order to reduce the size of the testing device, the fluid transport elements of some testing devices are arranged so that a width direction of the fluid transport element extends at an angle smaller than 90° with respect to a normal of a support plane defined by the peripheral support structure. Further, the fluid transport element is curved, resulting in a shortest distance between two opposite longitudinal ends of the fluid transport element being shorter than the center line length in the planar state.
This is shown in
The fluid transport element, for instance the testing strip having a capillary wick, is advantageously arranged in the testing device 790 such that a width direction extends in the Z-direction, as indicated on
Preferably, the peripheral support structure has a flat or planar geometry that defines the support plane. In an alternative testing device, however, the support structure is not flat, but an outer perimeter of the support structure defines the plane. In yet another alternative testing device, neither the support structure nor the outer perimeter directly defines a plane and the plane is defined by averaging the spatial position of at least a part of the support structure or of the outer perimeter
The flow control means 964.1, 964.2 is configured to control a transfer of the buffer solution from the solution chamber to the at least one fluid transport element or/and to the fluid sample receiving unit either:
Transferring the buffer solution to the fluid sample receiving unit or to the fluid transport element before the fluid sample is received or transferred respectively causes a wetting of the capillary wick or the absorbent material that in a particular embodiment enhances an absorption capacity.
Transferring the buffer solution to the fluid sample receiving unit or to the fluid transport element while the liquid sample is being received or transferred increases the volume of the liquid present and the flow velocity of the liquid sample and thus reduces the time needed by the liquid sample to reach the test portion of the testing strip.
Transferring the buffer solution to the fluid sample receiving unit or to the fluid transport element after the liquid sample is received or transferred is advantageously used in particular embodiment to wash away the liquid sample towards the test portion.
The testing device 1000 further comprises an optical sensor 1018 that is configured for detecting impeding light that is reflected by the testing units 1014.1 and 1014.2, and for converting the detected light into an electrical signal representing the intensity and/or the color of the impeding light. The optical sensor 1018 is connected to a conversion unit 1020. The conversion unit 1020 is configured for converting an electrical signal into digital data representing an intensity and/or a color of the detected light. The conversion unit 1020 is, in a particular testing device, an analog-to-digital converter and is comprised by the optical sensor 1018. The testing device 1000 also comprises a power management unit 1016 comprising voltage stabilizing circuitry.
Alternatively, the conversion unit 1020 can be a separate component that is arranged on the support structure 1006 and operatively connected to the optical sensor 1018. For example, the optical sensor 111, and a transmitter unit 1022 having an RF-interface can be arranged on the support structure 1006. Light reflected from the testing units 1014.1 and 1014.2 can be directed to the optical sensor using one or more mirrors also arranged on the support structure 1006 (not shown). Using mirrors, a light path can be created linking the testing units 1014.1 and 1014.2 and the optical sensor 1018. It is also possible that the optical sensor 1018, the transmitter unit 1022 having an RF-interface, and eventually also the power management unit 1016 are arranged on a circuit board, e.g., a flexible PCB. The circuit board can be arranged on the support structure 1006. Using optical elements such as mirrors a light path can be created from the testing units 1014.1 and 1014.2 to the optical sensor 1018 that is arranged on the circuit board. The circuit board can also be attached to the inner surface of the cover unit 1008, the inner surface facing 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 likewise faces the support structure. Since the testing units 1014.1 and 1014.2 face the sidewalls of the testing device 1000, preferably, an optical element is arranged and configured to redirect light reflected from testing units 1014.1 and 1014.2 about 90° towards the optical sensor 111. Further comprised can be one or more light sources, e.g., LEDs, that are arranged and configured for illuminating testing units 1014.1 and 1014.2. The one or more light sources can be arranged on the support structure 1006, or on a circuit board, or directly to the inner surface of the cover unit 1008.
The transmitter unit 1022 is connected to the power management unit 10016 and to the conversion unit 1020. The transmitter unit 1022 is configured to wirelessly transmit digital data representing the intensity and/or color of the detected light, e.g., in accordance with a predetermined wireless communication protocol. Preferably, in the testing device 1000, the transmitter unit 1022 is configured to transmit the digital data via a near-field communication link.
A particular variant of the method 1100 also includes, in a step 1108, breaking the second breakable connection element when the piercing element carrier reaches the stop position, and, in a step 1110, acting on the piercing element carrier for returning the piercing element carrier from the stop position in the direction of the initial position. Preferably, breaking the first breakable connection element requires applying a pushing finger force of 20-100 N.
A particular variant of the method 1200 also includes, in a step 1206, detecting light reflected from at least one testing unit, in a step 1208, converting the light into an electrical signal representing an intensity and/or a color of the detected light, in a step 1210, converting the electrical signal into digital data representing the intensity and/or the color of the detected light, and in a step 1212 wirelessly transmitting the digital data, preferably via a near-field communication link.
In summary, the invention is related to a hand-operated actuator mechanism for driving a piercing element with increased safety. The actuator mechanism comprises a mounting element connected to a trigger element by a first breakable connection element. It also comprises a piercing element carrier connected to the trigger element by a second breakable connection element. The trigger element further comprises a pushing member that can be pushed with a human finger. The first breakable connection element is configured to be broken by means of a predetermined pushing finger force pushing the pushing member. The piercing element carrier being movable between an initial position wherein the first and the second breakable connection elements are unbroken, and a stop position wherein an abutment stops a movement of the piercing element carrier.
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.
A single unit may fulfill the functions of several items recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage.
| Number | Date | Country | Kind |
|---|---|---|---|
| 20204788.2 | Oct 2020 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2021/080179 | 10/29/2021 | WO |
