HAND OPERATED ACTUATOR MECHANISM
20240016429 · 2024-01-18
Inventors
Cpc classification
A61B5/150732
HUMAN NECESSITIES
A61B5/150755
HUMAN NECESSITIES
A61B5/150908
HUMAN NECESSITIES
A61B5/15113
HUMAN NECESSITIES
A61B5/150847
HUMAN NECESSITIES
International classification
Abstract
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 said 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.
Claims
1. A hand-operated actuator mechanism for driving an external piercing element with a predefined force, the actuator mechanism, comprising: a mounting element; a trigger element; a piercing element carrier for an external piercing element, wherein: the trigger element is connected to the mounting element via a first breakable connection element that is designed to break when a predefined force is applied to the trigger element, said trigger element further comprising or being connected to a pushing member that can be pushed with a human finger and that is arranged to transfer a finger force via the trigger element to the first breakable connection element so as to cause breaking of the first breakable connection element when a pushing finger force pushing said pushing member exceeds a predetermined threshold; and the piercing element carrier is connected to the trigger element and is movable between an initial position wherein the first breakable connection element and a second breakable connection element are unbroken, and a stop position wherein an abutment stops a movement of the piercing element carrier.
2. The actuator mechanism of claim 1, wherein the piercing element carrier is connected to the trigger element via the second breakable connection element, said second breakable connection element being configured to be broken when the piercing element carrier reaches the stop position.
3. The actuator mechanism of claim 1, further comprising an elastic element that is arranged to act on the piercing element carrier for returning the piercing element carrier form from the stop position in the direction of the initial position.
4. The actuator mechanism of claim 3, wherein the abutment is the elastic element in a stressed or compressed state.
5. The actuator mechanism according to claim 1, wherein the first breakable connection element is adapted to be broken upon exertion of a pushing finger force of 20-100 N on the pushing member.
6. A piercing device, comprising: a peripheral support structure forming an inner volume; and a hand-operated actuator mechanism in accordance with claim 1 wherein the mounting element is connected to the peripheral support structure.
7. The piercing device of claim 6, further comprising a piercing element connected to the piercing element carrier, the piercing element being arranged to remain within the inner volume at the initial position and to protrude from the inner volume at the stop position.
8. A testing device, comprising: a piercing device according to claim 6; a fluid sample receiving unit for receiving a fluid sample for testing; at least one fluid transport element having an input end fluidly connected to the fluid sample receiving unit, the at least one fluid transport element arranged and configured to transport a fluid away from the input end; and at least one testing unit in fluidic communication with the at least one fluid transport element, the at least one testing unit comprising a respective reacting material configured to react in a predetermined manner to a pre-specified analyte or property of the fluid.
9. The testing device of claim 8, further comprising 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 at least one fluid transport element and/or to the fluid sample receiving unit.
10. The testing device of claim 9, wherein the flow control means is configured to control a transfer of the buffer solution from the at least one solution chamber to the at least one fluid transport element or/and to the fluid sample receiving unit either: before a fluid sample is transferred to the at least one fluid transport element or/and to the fluid sample receiving unit; or while the fluid sample is being transferred to the at least one fluid transport element or/and to the fluid sample receiving unit; or after the fluid sample has been transferred to the at least one fluid transport element or/and to the fluid sample receiving unit; or any combination thereof.
11. The testing device according to claim 8, further comprising: 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; 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.
12. A method for actuating a hand-operated actuator mechanism for driving an external piercing element, the method comprising: applying a predetermined pushing finger force on a pushing member, thereby breaking a first breakable connection element connecting a mounting element to a trigger element; moving a piercing element carrier connected via a second breakable connection element to the trigger element from an initial position wherein the first and the second breakable connection elements are unbroken, to a stop position wherein an abutment stops a movement of the piercing element carrier.
13. The method of claim 12, further comprising: 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.
14. The method of claim 12, wherein breaking the first breakable connection element requires applying a pushing finger force of 20-100 N.
15. A method for operating a testing device, the method comprising: performing the steps of claim 12; 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 prespecified analyte or property of the fluid.
Description
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[0101] 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.
[0102] 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
[0103] In the exemplary actuator mechanism 100 of
[0104]
[0105] 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
[0106]
[0107] The actuator mechanism 300 of
[0108] 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
[0109] In the actuator mechanism 400 of
[0110] In the example shown in
[0111] 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
[0112]
[0113] 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.
[0114] Preferably, the piercing element 502 is dimensioned and arranged: [0115] a) to remain within the inner volume 503 at the initial position shown in
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[0119] A schematic diagram of an exemplary first and/or second breakable connection element is shown in
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[0121] 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.
[0122] 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.
[0123] 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.
[0124] 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.
[0125] 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.
[0126] This is shown in
[0127] 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
[0128] 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
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[0130] 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: [0131] before a fluid sample is transferred to the at least one fluid transport element or/and to the fluid sample receiving unit; or [0132] while the fluid sample is being transferred to the at least one fluid transport element or/and to the fluid sample receiving unit; or [0133] after the fluid sample has been transferred to the at least one fluid transport element or/and to the fluid sample receiving unit; or [0134] any combination thereof.
[0135] 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.
[0136] 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.
[0137] 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.
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[0139] 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.
[0140] 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.
[0141] 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.
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[0143] 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.
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[0145] 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.
[0146] 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.
[0147] 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.
[0148] 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.