The present disclosure relates to devices and methods for extracting liquid from a pierceable liquid storage container, such as a blood collection tube.
Point-of-care diagnostic devices are typically used for carrying out diagnostic tests, such as immunoassays, on a biological sample (such as whole blood, blood serum or blood plasma). In order to carry out such diagnostic tests, the biological sample needs to be transferred to the diagnostic device. The diagnostic device is subsequently inserted into an analyser device (or instrument), which controls the movement of fluids (e.g. biological samples, reagents, buffer solutions, etc.) within the diagnostic device and conducts measurements of biomarkers, in order to conduct the diagnostic test.
Biological samples such as whole blood or blood plasma are typically collected from a subject using a pierceable liquid storage container such as a blood collection tube, also commonly referred to as a venous blood tube or as a Vacutainer (RTM). Existing systems for extracting liquid samples from blood collection tubes involve coupling the blood collection tube to the diagnostic device, and subsequently inserting the diagnostic device and coupled blood collection tube into the analyser device. Diagnostic tests can take several minutes to perform, meaning that any remaining quantity of biological sample within the blood collection tube cannot be used until the diagnostic device has been removed from the analyser device, following completion of the diagnostic test. Accordingly, a drawback of such existing systems is that a biological sample within a blood collection tube cannot be utilised until a particular diagnostic test has been completed.
Some existing systems include a needle that is configured to pierce a septum of a blood collection tube. A drawback of such existing systems is that there is a risk of injury to the user. In addition, there is a risk of contamination if the user injures themselves on the needle after it has been used for extracting blood from the blood collection tube.
Accordingly, there exists a need for devices for extracting liquid from a liquid storage container that can be safely and easily used by a user.
This summary introduces concepts that are described in more detail in the detailed description. It should not be used to identify essential features of the claimed subject matter, nor to limit the scope of the claimed subject matter.
According to one aspect of the present disclosure, there is provided a liquid extraction device for extracting liquid from a liquid storage container, the liquid extraction device comprising: a receptacle configured to receive a portion of the liquid storage container; a liquid storage container interface housed within the receptacle, wherein the liquid storage container interface is configured to provide a fluidic connection to a volume of liquid within the liquid storage container when the liquid storage container is connected to the liquid storage container interface; and a safety mechanism actuatable from a first safety mechanism configuration to a second safety mechanism configuration, wherein the safety mechanism is configured to conceal the liquid storage container interface when the safety mechanism is in the first safety mechanism configuration, and wherein the safety mechanism is configured to reveal the liquid storage container interface when the safety mechanism in the second safety mechanism configuration.
By concealing the liquid storage container interface (e.g. a piercing element such as a needle) when the safety mechanism is in the first safety mechanism configuration, the liquid storage container interface is not exposed, meaning that the user cannot injure themselves on the liquid storage container interface when the safety mechanism is in the first safety mechanism configuration.
The liquid storage container interface may comprise at least one needle configured to provide the fluidic connection to the volume of liquid within the liquid storage container.
The liquid extraction device may further comprise a resiliently deformable element configured to be deformed when the safety mechanism is actuated from the first safety mechanism configuration to the second safety mechanism configuration; wherein the resiliently deformable element is configured to bias the safety mechanism away from the second safety mechanism configuration towards the first safety mechanism configuration.
The resiliently deformable element ensures that the liquid storage container interface (e.g. a piercing element such as a needle) is re-concealed after the safety mechanism has been actuated to the second safety mechanism configuration. For example, if the liquid extraction device comprises a needle configured to extract blood from a blood collection tube, re-concealing the needle ensures that a user cannot injure themselves on a needle that has been in contact with potentially contaminated blood. This reduces the contamination risk for the user.
The safety mechanism may comprise a release mechanism configured to engage a portion of the receptacle when the safety mechanism is in the first safety mechanism configuration. The release mechanism ensures that the safety mechanism needs to be actively released in order to actuate it from its first configuration to its second configuration, thereby reducing the risk of accidentally exposing the needle. The release mechanism may be configured to permit actuation of the safety mechanism from the first safety mechanism configuration to the second safety mechanism configuration when the release mechanism is disengaged from the portion of the receptacle.
The release mechanism may comprise at least two clips, wherein the release mechanism is configured to be disengaged from the portion of the receptacle when a force is simultaneously applied to each of the at least two clips. By using two clips to which forces must be simultaneously applied, the release mechanism is more difficult to operate using a user's finger, reducing the risk of a user actuating the safety mechanism using their finger. The at least two clips may be configured to be actuated by an annular force profile, for example, a cap of a blood collection tube.
The liquid extraction device may further comprise a blocking element configured to: prevent actuation of the safety mechanism from the first safety mechanism configuration to the second safety mechanism configuration when the liquid extraction device is in a first orientation; and permit actuation of the safety mechanism from the first safety mechanism configuration to the second safety mechanism configuration when the liquid extraction device is in a second orientation different to the first orientation.
The blocking element ensures that the safety mechanism is actuated when the liquid extraction device is in a desired orientation (e.g. a substantially vertical orientation), and cannot be actuated when the liquid extraction device is not in the desired orientation. For example, permitting actuation of the safety mechanism when the liquid extraction device is in a vertical orientation ensures that the needle is in fluidic connection with a volume of blood within a blood collection tube.
The blocking element may be configured to engage a portion of the receptacle to prevent actuation of the safety mechanism from the first safety mechanism configuration to the second safety mechanism configuration when the liquid extraction device is in the first orientation. The second orientation may be a substantially vertical orientation.
The liquid extraction device may further comprise a liquid extraction mechanism actuatable from a first liquid extraction mechanism configuration to a second liquid extraction mechanism configuration, wherein the liquid extraction mechanism is configured to provide a pressure difference between a volume of gas in the liquid storage container and the liquid extraction outlet, when the liquid extraction mechanism is actuated from the first liquid extraction mechanism configuration to the second liquid extraction mechanism configuration.
By providing a pressure difference between a volume of gas in the liquid storage container (e.g. blood collection tube) and the liquid extraction outlet, liquid can be forced out of the liquid storage container by the pressure difference.
The safety mechanism may be configured to actuate the liquid extraction mechanism from the first liquid extraction mechanism configuration to the second liquid extraction mechanism configuration. Therefore, a single continued user action is required to both actuate the safety mechanism and the liquid extraction mechanism, thereby providing increased ease of use. The liquid extraction mechanism may be actuatable from the first liquid extraction mechanism configuration to the second liquid extraction mechanism configuration once the safety mechanism has been actuated to the second safety mechanism configuration.
The liquid extraction device may further comprise an first engagement mechanism configured to prevent actuation of the liquid extraction mechanism from the first liquid extraction mechanism configuration in a direction opposite to the direction of actuation from the first liquid extraction mechanism configuration to the second liquid extraction mechanism configuration. This prevents the liquid extraction mechanism from being pulled out of the first liquid extraction mechanism configuration.
The liquid extraction device may further comprise a second engagement mechanism configured to retain the liquid extraction mechanism in the second liquid extraction mechanism configuration once the liquid extraction mechanism has been actuated to the second liquid extraction mechanism configuration. The second engagement mechanism may provide an audible click when engaged. This allows a user to establish that the liquid extraction device has been actuated to a configuration in which liquid is extracted.
The safety mechanism may comprise an aperture; wherein the liquid storage container interface does not extend through the aperture in the safety mechanism when the safety mechanism is in the first safety mechanism configuration; and wherein the liquid storage container interface extends through the aperture in the safety mechanism when the safety mechanism is in the second safety mechanism configuration.
The safety mechanism may comprise: an actuatable platform having an aperture; wherein the actuatable platform is movable from a first configuration, in which the blood collection tube interface does not extend through the aperture, to a second configuration, in which the blood collection tube interface extends through the aperture. The actuatable platform may further comprise a cap configured to cover the aperture. The liquid storage container interface may be configured to open the cover when the actuatable platform is moved from the first configuration to the second configuration. The actuatable platform may be prevented from moving from the first configuration to the second configuration when a force is applied to the cover to move the actuatable platform.
The safety mechanism may comprise: an upper portion and a lower portion, wherein the upper portion and the lower portion cooperate to define the recess; wherein the lower portion is actuatable from a first position, in which the upper portion and the lower portion cooperate to prevent the blocking element from moving into the recess under gravity, to a second position, in which the upper portion and the lower portion are displaced apart, thereby enlarging the recess and allowing the blocking element to move into the recess under gravity.
The upper portion may comprise one or more holes, each of the one or more holes extending through the upper portion, and the lower portion may comprise one or more elongate elements (or protrusions), each of the one or more elongate elements configured to extend through a corresponding one of the one or more holes; wherein when the lower portion is in the first position, the one or more elongate elements extend through the one or more holes such that the ends of the one or more elongate elements protrude above an upper surface of the upper portion; and wherein the lower portion is actuatable from the first position to the second position by application of a force to the ends of the one or more elongate elements.
According to another aspect of the present disclosure, there is provided a liquid handling apparatus comprising: a liquid handling device comprising one or more conduits; and a liquid extraction device according to any of the above paragraphs; wherein the liquid extraction device is in fluidic communication with at least one of the one or more conduits.
The liquid handling device may be suitable for use in carrying out a diagnostic test. The liquid extraction device may be integrated within the liquid handling device. Alternatively, the liquid extraction device may be attachable to the liquid handling device. For example, the liquid extraction device may be removably attachable to the liquid handling device.
Specific embodiments are described below by way of example only and with reference to the accompanying drawings, in which:
Implementations of the present disclosure are explained below with particular reference to extracting liquid from a blood collection tube. It will be appreciated, however, that the implementations described herein may also be used to extract liquid from other sealed liquid storage containers into which a liquid collection interface (such as a needle) may be inserted.
The flow of fluids between the chambers is controlled by an external pump 120 that is configured to apply a positive or negative pressure to the main chamber 104 via a pump conduit 122. The positive or negative pressure dispenses or aspirates fluid from one chamber to another, depending on which of the valves 114 is opened. For example, to aspirate reagent from the reagent chamber 106 to the main chamber 104 (e.g. for mixing with a sample), the valve 114 between the reagent chamber 106 and the main chamber 104 is opened, and a negative pressure is applied to the main chamber 104 by the pump 120.
The liquid extraction device 200 is in fluidic communication with the cartridge 100 via an inlet conduit 14. As explained in further detail below, the liquid extraction device 200 is configured to extract a liquid sample (e.g. blood) from a pierceable liquid storage container (e.g. a blood collection tube, not shown in
The sample can then be combined with one or more reagents in the main chamber 104 by aspirating a reagent from the reagent chamber 106 to the main chamber 104. In order to mix the sample and reagent together, the solution may be repeatedly transferred between the main chamber 104 and the mixing chamber 108. The solution may then be dispensed to the measurement chamber 112, where an electrochemical measurement is carried out on the solution, using the sensor 116. Any waste solution from the main chamber 104 or the measurement chamber 112 may be transferred to the waste chamber 110.
The liquid extraction device 200 comprises a receptacle in the form of a cylinder 202 (or tube) in which a pierceable liquid storage container, such as a blood collection tube, is received. The liquid extraction device 200 also includes an actuatable liquid extraction mechanism in the form of a piston 204 that is actuatable within the cylinder 202 from a first liquid extraction mechanism configuration to a second liquid extraction mechanism configuration. In
The piston 204 includes a sealing element in the form of an O-ring seal 210 configured to provide a seal between the piston 204 and the cylinder 202. The cylinder 202 includes a recess 212 configured to compromise the O-ring seal 210 by allowing air to flow around the O-ring seal 210, when the piston 204 is in the second configuration shown in
The liquid extraction device 200 includes a liquid storage container interface (e.g. a blood collection tube interface) in the form of a needle 206 that is fixedly attached to the piston 204. The needle 206 is configured to pierce a liquid storage container (e.g. by piercing a septum of a blood collection tube). The needle 206 comprises a liquid extraction outlet 208 through which liquid extracted from the blood collection tube can flow.
The cylinder 202 also comprises an outlet 216 that allows liquid to be removed from the liquid extraction device 200 once it has been extracted from the blood collection tube. The outlet 216 is in fluidic communication with the inlet conduit 14, thereby allowing liquid to be transferred from the liquid extraction device 200 to the cartridge 100.
In the first liquid extraction mechanism, the piston 204 is located above the outlet 216 in the cylinder 202 (i.e. further from an end wall 218 of the cylinder 202 than shown in
Together, the piston 204 and the cylinder 202 define a chamber. After connection of a blood collection tube to the needle 206, the volume of the chamber is reduced as the piston 204 is actuated from the first liquid extraction mechanism configuration to the second liquid extraction mechanism configuration. Once the piston 204 is actuated beyond the outlet 216, the reduction in volume of the chamber results in an increase in pressure of the air within the chamber, because the chamber is sealed by the O-ring seal 210. The increase in air pressure within the chamber forces air through the needle 206 and into the blood collection tube, which increases the pressure of a volume of gas within the blood collection tube. The increase in the pressure of air within the chamber and the blood collection tube continues as the piston 204 is actuated towards the second configuration.
Once the piston 204 is in the second configuration, the O-ring seal 210 is aligned with the recess 212 and is consequently compromised, meaning that the pressurised air within the chamber can flow around the O-ring seal 210. This reduces the pressure at the liquid extraction outlet 208, which is in fluidic communication with the chamber, thereby providing a pressure difference between the volume of gas within the blood collection tube, and the liquid extraction outlet 208. This difference in pressure forces liquid out of the blood collection tube via the needle 206, around the O-ring seal 210, and out of the liquid extraction device 200 via the outlet 216.
The liquid extraction device 200 comprises a safety mechanism 250 that is actuatable from a first safety mechanism configuration (shown in
The cartridge 100 further comprises a sample adequacy control chamber 24 that provides a visual indication to a user that a sufficient amount of liquid has been extracted from the liquid storage container (e.g. blood collection tube). In particular, the sample adequacy control chamber 24 may provide a visual indication that a volume of liquid sufficient for a particular diagnostic test has been extracted. As shown, for example, in
The sample adequacy control chamber 24 forms part of a first flow path that is in fluidic communication with an inlet conduit 14 (which receives fluid extracted using the liquid extraction device 200). The cartridge 100 also includes a metering chamber 16 configured to store a specific volume of liquid. The first flow path includes the metering chamber 16, a connector conduit 22 providing a fluidic connection between the metering chamber 16 and the sample adequacy control chamber 24, the sample adequacy control chamber 24, and a vented waste chamber 44 in fluidic communication with the sample adequacy control chamber 24. The cartridge 100 further comprises a second flow path comprising an outlet conduit 43 extending from an outlet port in the metering chamber 16. The outlet conduit 43 allows liquid to be aspirated into the main chamber 104 of the cartridge 100. Alternative implementations may not include the metering chamber 16 or the connector conduit 22, in which case the outlet conduit 43 extends from an outlet port in a sample adequacy control chamber that is configured to meter a specific volume of liquid.
The second flow path (which includes the outlet conduit 43) provides a higher hydraulic resistance than the first flow path (which includes the sample adequacy control chamber 24, and optionally the metering chamber 16 and the outlet conduit 22). This means that the flow rate of liquid through the first flow path is higher than the flow rate through the second flow path. The higher flow rate through the first flow path means that liquid flows into the sample adequacy control chamber 24 to provide the visual indication that a sufficient volume of liquid has been received, without filling the outlet conduit 43.
The outlet 216 of the liquid extraction device 200 shown in
The liquid extraction device 300 also comprises a piston 304 that is moveable within the cylinder 302 from a first configuration to a second configuration. Attached to the piston 304 is a liquid storage container interface (e.g. needle 306) that provides a path for air to flow into the liquid storage container, and provides a path for liquid (e.g. blood) to flow out of the liquid storage container.
In contrast to the liquid extraction device 200 shown in
It will be appreciated that these attachment mechanisms are not specific to the locations of the outlet in the cylinder of the liquid extraction device. In particular, the liquid extraction device 300 shown in
Various implementations of liquid extraction devices that may be used to extract a liquid sample (e.g. blood) from a pierceable liquid storage container (e.g. a blood collection tube) will now be described in greater detail with reference to
An example of a blood collection tube that may be used with the implementations described herein is shown schematically in
The liquid extraction device 400 further comprises an actuatable liquid extraction mechanism in the form of a piston 600 that is moveable within the cylinder 500 from a first liquid extraction mechanism configuration to a second liquid extraction mechanism configuration. The piston 600 comprises a liquid storage container interface, such as a blood collection tube interface, shown in
The liquid extraction device 400 further comprises an actuatable safety mechanism 700 that is actuatable within the cylinder 500 from a first safety mechanism configuration to a second safety mechanism configuration. The safety mechanism 700 is configured to conceal the liquid storage container interface (i.e. needle 620) when the safety mechanism 700 is in the first safety mechanism configuration, and to reveal the liquid storage container interface when the safety mechanism 700 is in the second safety mechanism configuration.
The safety mechanism 700 comprises two spherical blocking elements 718. At least one of the blocking elements 718 prevents actuation of the safety mechanism 700 from the first safety mechanism configuration to the second safety mechanism configuration when the liquid extraction device 400 is in a first orientation (such as a horizontal orientation). The at least one of the blocking elements 718 also permits actuation of the safety mechanism 700 from the first safety mechanism configuration to the second safety mechanism configuration when the liquid extraction device 400 is in a second orientation (such as a vertical orientation).
The liquid extraction device 400 further comprises a resiliently deformable element, shown in
As shown in
The cylinder 500 further comprises a second cylinder portion 520 that defines a second cylindrical interior volume 524. The second cylindrical interior volume 524 extends from the first cylindrical interior volume 514. The cross-sectional area of the second cylindrical interior volume 524 is smaller than the cross-sectional area of the first cylindrical interior volume 514, such that the second cylindrical interior volume 524 is narrower than the first cylindrical interior volume 514.
An annular flange 506 is disposed within the cylinder 500 and joins the first cylindrical interior volume 514 to the second cylindrical interior volume 524. The annular flange 506 acts as an end wall for the first cylindrical interior volume 514.
As best shown in
The third cylinder portion 530 protrudes from the annular flange 506 in a direction opposite to the direction in which the second cylinder portion 520 extends. The diameter of the third cylinder portion 530 is smaller than the diameter of the first cylindrical interior volume 514, meaning that there is an annular gap between the exterior surface 538 of the side wall 532 of the third cylinder portion 530, and the interior surface 516 of the side wall 512 of the first cylinder portion 510. The height of the side wall 532 of the third cylinder portion 530 is smaller than the height of the side wall 512 of the first cylinder portion 510, such that the third cylinder portion 510 only protrudes part way into the first cylindrical interior volume 514.
Returning to
Also shown in
The second projection 544 includes two apertures, shown in
The first opening 542, second opening 546 and cutout 548 are provided at different heights, meaning that the distance from the annular flange 506 to the first opening 542, the distance from the annular flange 506 to the second opening 546, and the distance from the annular flange 506 to the cutout 548 are all different. Specifically, the distance from the annular flange 506 to the cutout 548 in the second projection 544 is greater than the distance from the annular flange 506 to the first opening 542 in the first projection 540, and the distance from the annular flange 506 to the first opening 542 in the first projection 540 is greater than the distance from the annular flange 506 to the second opening 546 in the second projection 544.
The cylinder 500 further comprises an outlet 550 that allows liquid extracted from a liquid storage container (e.g. a blood collection tube) using the liquid extraction device 400 to be removed from the liquid extraction device 400. The outlet 550 is in fluidic communication with the second cylinder portion 520 and extends through a side wall of the second cylinder portion 520 to provide a fluidic connection to the second cylindrical interior volume 524.
The first cylinder portion 510 includes two ribs 552 on the interior surface 516 of its side wall 512. The ribs 552 extend longitudinally along the interior surface 516. As best shown in
As best shown in
The ribs 552 extend longitudinally along the interior surface 516 in the regions of the interior surface 516 in which the restrictions 556 do not extend. Therefore, the restrictions 556 and ribs 552 do not overlap. As best shown in
As mentioned above with reference to
The piston 600 comprises a first cylindrical piston portion 602 having a diameter less than the diameter of the third cylindrical interior volume 534, such that the first cylindrical piston portion 602 is moveable within the third cylindrical interior volume 534.
The piston 600 further comprises a second cylindrical piston portion 604 having a diameter less than the diameter of the second cylindrical interior volume 524, such that the second cylindrical piston portion 604 is moveable within the second cylindrical interior volume 524. This means that the second cylindrical piston portion 604 is narrower than the second cylindrical interior volume 524, thereby allowing air to flow in the annular gap between the second cylindrical piston portion 604 and the second cylinder portion 520 when the piston 600 is actuated to the position shown in
The piston 600 further comprises an annular flange 606 that joins the first cylindrical piston portion 602 to the second cylindrical piston portion 604. The annular flange 606 of the piston 600 is configured to contact the annular flange 506 of the cylinder 500 when the piston is in the second configuration (i.e. as shown in
Returning to
The piston 600 further comprises a second sealing element in the form of a second O-ring seal 610. The second O-ring seal 610 extends around the circumference of the second cylindrical piston portion 604 and is configured to provide a seal between the second cylindrical piston portion 604 and the interior surface of the second cylinder portion 520. As an alternative to O-ring seals, the first and second sealing elements could be provided in the form of a moulded plastic seal (i.e. moulded together with the piston 600), or an over-moulded rubber seal.
The piston 600 and the cylinder 500 cooperate to define a chamber 650 between the piston 600 and the walls of the cylinder 500. Specifically, the chamber 650 is defined by the annular flange 506 within the cylinder 500, the interior surface 536 of the third cylinder portion 530, the interior surface of the second cylinder portion 520, the second cylindrical piston portion 604, and the annular flange 606 of the piston 600. The chamber 650 is sealed by the first and second O-ring seals 610, 612, which prevent air flow out of the chamber 650 until the piston is actuated to the second configuration (i.e. as shown in
The first cylindrical piston portion 602 comprises a first engagement mechanism that is configured to prevent actuation of the piston 600 from the first liquid extraction mechanism configuration in a direction opposite to the direction of actuation from the first liquid extraction mechanism configuration to the second liquid extraction mechanism configuration. The first engagement mechanism is shown in
The first resiliently deformable clip 612 has a protrusion 616 that extends into the first opening 542. The protrusion 616 includes an angled lower surface that allows the protrusion 616 to be pushed out of the first opening 542 when sufficient force is applied to the piston 600 in the direction of the annular flange 506 (i.e. a downward force in the orientation shown in
The first cylindrical piston portion 602 also comprises a second engagement mechanism that is configured to retain the piston 600 in the second liquid extraction mechanism configuration once the piston 600 has been actuated to the second liquid extraction mechanism configuration. The second engagement mechanism is provided in the form of a second resiliently deformable clip 614 that is configured to engage the cutout 548 in the second projection 544, when the piston 600 is in the first configuration (i.e. as shown in
The second resiliently deformable clip 614 further includes a protrusion 618 that extends into the cutout 648 when the piston 600 is in the first configuration, and extends into the second opening 646 when the piston 600 is in the second configuration. The protrusion 618 has the same construction as the protrusion 616 of the first resiliently deformable clip 612. Specifically, the protrusion 618 includes an angled lower surface that allows the protrusion 618 to be pushed out of the cutout 648 when sufficient force is applied to the piston 600 in the direction of the annular flange 606. The protrusion 618 also includes an upper contact surface that is perpendicular to the axis of movement of the piston 600. The upper contact surface engages the second opening 546 so as to prevent movement of the piston 600 away from the annular flange 506 when the protrusion extends into the second opening 546 (i.e. when the piston 600 is in the second configuration).
Therefore, in the orientation shown in
As shown in
As described with reference to
The second cylindrical piston portion 604 comprises a liquid extraction outlet 626 that allows liquid extracted from the liquid storage container to be removed from the piston 600. The liquid extraction outlet 626 is provided in a side wall of the second cylindrical piston portion 604. The second cylindrical piston portion 604 further comprises an outlet channel 628 providing fluidic communication between the second end 624 of the needle 620 and the liquid extraction outlet 626. When the piston 600 is in the second configuration (i.e. as shown in
Returning to
The safety mechanism 700 is shown in more detail in
The safety mechanism 700 comprises an aperture in the form of a central cylindrical portion 702 through which the needle 620 (in particular, the tip 622 of the needle 620) extends when the safety mechanism 700 is in the second configuration shown in
As best shown in
Two upper flange sections 706 extend from the top of the central cylinder portion 702 (i.e. from the end of the central cylinder portion 702 furthest from the annular flange 506). The upper flange sections 706 extend radially from the top of the central cylinder portion 702 around the same portion of the circumference of the central cylinder portion 702 around which the lower flange sections 704 extend. The distance between the radial extents of the upper flange sections 706 is less than the distance between the restrictions 556, meaning that the upper flange sections 706 also pass within the restrictions 556 as the safety mechanism 700 is actuated from the first configuration to the second configuration.
As best shown in
The safety mechanism 700 further comprises an angled shoulder 710 provided at the join between each upper flange section 706 and its corresponding arc-shaped section 708. The angled shoulders 710 extend around the same circumferential extent as the corresponding upper flange sections 706 and arc-shaped sections 708.
The lower flange sections 704, upper flange sections 706, arc-shaped sections 708 and angled shoulders 710 each extend around the same circumferential extent as the restrictions 556 extending from the interior surface 516 of the side wall 512 of the first cylinder portion 510.
As best shown in
As best shown in
As shown in
The spherical blocking elements 718 of the safety mechanism 700 are each provided in a respective arcuate channel 716. The spherical blocking elements 718 may be, for example, ball bearings. As described in more detail below with reference to
Together, the central cylinder portion 702, end ribs 714, lower flange sections 706, upper flange sections 708 and angled shoulders 710 define two arcuate recesses 740. As shown in
As best shown in
As best shown in
The angled surfaces of the teeth 558 at the open end of the first cylinder portion 502 push the resiliently deformable clips 720 inwards when the safety mechanism 700 is inserted into the cylinder 500 during assembly of the liquid extraction device 400. The teeth 558 also act to retain the safety mechanism 700 in place by preventing upwards movement of the safety mechanism 700 out of the first configuration. In particular, the clips 720 are retained in the gaps between the teeth 558 and the ends of the ribs 552. Accordingly, when the clips 720 are retained in the gaps between the teeth 558 and the ends of the ribs 552, the safety mechanism 700 is retained in the first configuration.
As best shown in
Each lever 724 further comprises a radial portion 728 extending radially inwards from the end of the longitudinal portion 726. The radial portions 728 of the levers 724 extend sufficiently far inwards so that they are contacted by the cap 15 of a blood collection tube 11. Consequently, when a downward force is applied to the blood collection tube 11, the cap 15 simultaneously applies a downward force to each radial portion 728.
The longitudinal portion 726 of each lever 724 is joined to the radial portion 728 at an elbow 730. The elbow contacts the rib 552 over which the U-shaped portion 722 is clipped, and is configured to provide a pivot point against the rib 552 when a downward force is applied to the corresponding radial portion 728.
When the cap 15 of the blood collection tube 11 is pressed against the radial portions 728 of the levers 724, the force applied to each radial portion 728 of the lever 724 causes the lever 724 to pivot about the contact point between the elbow 730 and the rib 552 over which the clip 720 is attached. The pivoting of the lever 724 causes the clip 720 to hinge inwardly about its attachments to the end ribs 714 (as shown, for example, in
Accordingly, the safety mechanism 700 is configured to be unclipped by the application of simultaneous forces to the resiliently deformable clips 720 (specifically, to the radial portions 728 of the levers 724 of the clips 720). The forces may be simultaneously applied to the radial portions 728 by, for example, by application of an annular force profile, such as that applied by a cap 15 of a blood collection tube 11.
The resiliently deformable element (spring 800) of the liquid extraction device 400 is disposed between the annular flange 506 of the cylinder 500 and the lower flange sections 704 of the safety mechanism 700, as shown in
The operation of the safety mechanism 700 will now be described with reference to
When a force is applied to one or more of these elements, the radial portions 728 of the L-shaped levers 724 are not displaced, meaning that the clips 720 are retained in the gaps between the ends of the ribs 552 and the teeth 558. As shown in
Specifically, when a force is applied in this manner, the effective pivot point of each clip 720 against the surface of the corresponding rib 552 is at the base of the U-shaped portion 722, which is almost coincident with the attachment point of the clip 720 to the end ribs 714. The location of this effective pivot point prevents the clips 720 from hinging inwardly about their point of attachment to the end ribs 714.
Further application of the force to the blood collection tube 11 applies a downward force to the radial portions 728 of the levers 724, which causes each lever 724 to pivot about the contact point between the elbow 730 of the lever 724 and the rib 552, as shown in
Further application of the force to the blood collection tube 11 applies a downward force to the safety mechanism 700. This pushes the safety mechanism 700 downwards so that the needle 620 extends through the central cylinder portion 702, as shown in
Continued application of the force to the blood collection tube 11 actuates the safety mechanism 700 to its second configuration, in which safety mechanism 700 contacts the piston 600. Specifically, the base of the central cylinder portion 702 is forced into contact with the top of the first cylindrical piston portion 602, and the spring 800 is further compressed, as shown in
Once in the second configuration, the safety mechanism 700 is configured to actuate the piston 600. Specifically, the safety mechanism 700 transfers the force applied by the user on the blood collection tube 11 to the piston 600. Optionally, the safety mechanism 700 may be configured to unclip the piston 600 (e.g. if the piston 600 includes resiliently deformable clips that are similar to the resiliently deformable clips 720 of the safety mechanism 700).
When the piston 600 is in the position shown in
When the piston 600 is in the position shown in
Continued application of a downward force on the blood collection tube 11 applies a downward force to the safety mechanism 700, which in turn applies a downward force to the piston 600, and further compresses the spring 800. As shown in
The downwards movement of the piston 600 reduces the volume of the chamber 650 defined by the piston 600 and the cylinder 500. As shown in
Further downward movement of the piston 600 by continued application of a downward force via the safety mechanism 700 results in a further increase in pressure of the air within the chamber 650 and the blood collection tube 11, until the piston 600 reaches the second configuration, shown in
As shown in
The force exerted by the spring 800 on the safety mechanism 700 continues to force the safety mechanism 700 away from the annular flange 506, until the safety mechanism 700 reaches the position shown in
The operation of the liquid extraction device 400 has been described with reference to extracting liquid from a Vacutainer (RTM) as manufactured by Becton, Dickinson and Company of Franklin Lakes, NJ, USA (indicated in
In particular,
To ensure compatibility with these different types of blood collection tubes, the radial portions 728 of the levers 724 are dimensioned so that they are displaced by the cap of each type of blood collection tube. It will be appreciated that the size of the cylinder 500 and safety mechanism 700 may be adjusted in order to cater for different sizes of blood collection tubes (e.g. containing different sample types).
The safety mechanism 700 also ensures that the blood collection tube 11 is inserted into the liquid extraction device 400 in the correct orientation. As described above, the needle 620 must provide a fluidic connection to the volume of liquid 19 within the blood collection tube 11, in order to extract liquid from the blood collection tube 11. It will be appreciated that if the blood collection tube 11 has a high liquid fill level, then the needle 620 would provide a fluidic connection to the volume of liquid 19 even if the liquid extraction device 400 was in a horizontal orientation.
However, to ensure that the fluidic connection is provided for lower fill volumes, the safety mechanism 700 can only be actuated from its first configuration to its second configuration when the liquid extraction device 400 is in a vertical (or close to vertical) orientation (i.e. when the needle 620 is pointing upwards), as shown in
The spherical blocking elements 718 are free to move under gravity within the arcuate channels 716 defined by the safety mechanism 700 and the interior surface 516 of the first cylinder portion 510. As shown in
It will be appreciated that the cooperation of the blocking elements 718 and the arcuate channels 716 prevents movement of the safety mechanism 700 relative to the cylinder 500 when the liquid extraction device 400 is in other orientations, besides horizontal. In particular, the blocking elements 718 cooperate with the arcuate channels 716 to prevent movement of the safety mechanism in all orientations except orientations close to vertical.
In contrast,
As shown in
Variations or modifications to the systems and methods described herein are set out in the following paragraphs.
As shown in
In operation, a blood collection tube 11 is engaged with the soft sealing overmould 1706 when the safety mechanism 1700 is in the first safety mechanism configuration. A downward force is then applied to the blood collection tube 11 by the user. The annular shape of the cap 15 of the blood collection tube 11 means that a downwards force is applied to the actuatable platform 1702, but not the cap 1708. The downwards force applied to the actuatable platform 1702 brings the needle 1620 into contact with the cap 1708, and results in an upwards force being applied to the cap 1708 by the needle 1620. The upwards force applied by the needle 1620 results in the cap 1708 hinging upwards, thereby allowing the needle 1620 to protrude through the aperture 1704, as shown in
In contrast, when a user applies a downward force to the safety mechanism 1700 using their finger, the force is applied to the cap 1708. The downward force applied to the cap 1708 counteracts any upward force applied to the cap 1708 by the needle 1620, meaning that the needle does not protrude through the aperture 1704 and the user's finger is protected.
Although not shown in
The hinged cap 2708 allows a needle 2620 to pass through an aperture 2704 in the actuatable platform 2702 when an annular force is applied by, for example, a cap 15 of a blood collection tube 11, as shown in
The upper safety mechanism portion 3720 and the lower safety mechanism portion 3710 each include apertures 3726, 3716 that are aligned with one another, such that a needle 3620 can extend through the apertures 3726, 3716 when the safety mechanism 3700 is actuated to the second safety mechanism configuration. The lower safety mechanism portion 3710 is biased upwards by a spring 3800 housed within the cylinder 3500.
The upper safety mechanism portion 3720 and lower safety mechanism portion 3710 cooperate to define a recess 3740 configured to house a spherical blocking element 3718. Specifically, the upper safety mechanism portion 3720 comprises an annular angled shoulder 3722 that defines an upper part of the recess 3740, while the lower safety mechanism portion 3710 comprises an annular flange 3712 that defines a lower part of the recess 3740.
Together, the interior surface 3516 of the cylinder 3500, the angled end wall 3562 of the restriction 3556, and the recess 3740 define an annular channel 3716 around which the spherical blocking element 3718 is free to move under gravity.
The lower safety mechanism portion 3710 is actuatable from a first position relative to the upper safety mechanism portion 3720, to a second position relative to the upper safety mechanism portion 3720. To allow the lower safety mechanism portion 3710 to be actuated, the lower safety mechanism portion 3710 comprises one or more protrusions (shown in
When the lower safety mechanism portion 3710 is in the first position, the volume of the recess 3740 is reduced, meaning that the blocking element 3718 cannot be fully housed within the recess 3740. When in this position, shown in
To actuate the lower safety mechanism portion 3710 to the second position, a downward force is applied to the prongs 3714 protruding from the upper safety mechanism portion 3720. The force applied to the prongs 3714 pushes the lower safety mechanism portion 3710 downwards by compressing the spring 3800. The downward movement of the lower safety mechanism portion 3710 opens up the recess 3740, which allows the blocking element 3718 to be fully housed within the recess 3740, as shown in
The blocking element 3718 and annular channel 3716 then cooperate in the same manner as described with reference to
The blocking element 3718 falls into the recess 3740 under gravity such that it is fully housed within the recess 3740 when the liquid extraction device is in an orientation close to vertical, thereby permitting movement of the safety mechanism 3700 within the cylinder 3500. This allows the safety mechanism 3700 to be actuated from its first configuration to its second configuration, thereby revealing the needle, which protrudes through the apertures 3716, 3726.
Although the above implementations are described with reference to extracting liquid from a blood collection tube such as a Vacutainer (RTM), it will be appreciated that the implementations described above are also suitable for extracting liquid from other forms of pierceable liquid storage containers, which may differ in size and/or shape from blood collection tubes. In such cases, the dimensions of the safety mechanism, receptacle and piston may be adapted to the size and shape of the liquid storage container from which liquid is to be extracted. For example, although the above implementations are described with reference to a cylindrical tube in which the blood collection tube 11 is received, it will be appreciated that other cross-sections of tubes, pistons and safety mechanisms may be implemented to allow for extraction of liquid from other liquid storage containers.
Additionally, although the above implementations use a liquid storage container interface (e.g. a blood collection tube interface) in the form of one or more needles, other liquid storage container interfaces may be implemented, provided that they are capable of providing a fluidic connection to a volume of liquid within a liquid storage container (e.g. to the volume of liquid 19 within the blood collection tube 11). The safety mechanisms described herein may reveal and conceal such other liquid storage container interfaces.
Although the safety mechanism 700 is described above as part of a liquid extraction device 400 that comprises an actuatable liquid extraction mechanism, it will be appreciated that the safety mechanism 700 is also compatible with a static liquid extraction mechanism (e.g. a static needle), where liquid is extracted from a liquid storage container (e.g. a blood collection tube) by operation of a pump. Further, it will be appreciated that the safety mechanism 700 described above may be used to protect a user against a needle that is disposed within a receptacle for any other purpose besides extracting liquid from a liquid storage container. That is, the safety mechanism 700 is not limited to being implemented as part of a liquid extraction device.
The term “needle” in the above implementations is not intended to be limited to metal needles, and is intended to cover other piercing elements that are configured to pierce a septum of a blood collection tube, such as piercing elements that are integral with a piston.
Although certain implementations are described above using resiliently deformable elements such as springs, it will be appreciated that other resiliently deformable elements may be implemented.
Although certain implementations use one or more sealing elements attached to a piston, the sealing elements may alternatively be attached to an interior wall of the cylinder. Although the above implementations describe sealing elements in the form of O-ring seals, the sealing elements may alternatively be provided in the form of a moulded plastic seal, or an over-moulded rubber seal.
Finally, although the above implementations are described with reference to a force applied by a user to actuate the liquid extraction mechanism, it will be appreciated that the liquid extraction mechanism may alternatively be actuated without requiring user input (e.g. under control of a motor).
As a general point, although the above implementations are described with reference to extracting liquid for use in a diagnostic test carried out using a cartridge, it will be appreciated that the liquid extraction devices described above are suitable for extracting liquid from a liquid storage container (e.g. a blood collection tube) for a wide range of other purposes.
The singular terms “a” and “an” should not be taken to mean “one and only one”. Rather, they should be taken to mean “at least one” or “one or more” unless stated otherwise. The word “comprising” and its derivatives including “comprises” and “comprise” include each of the stated features, but does not exclude the inclusion of one or more further features.
The above implementations have been described by way of example only, and the described implementations are to be considered in all respects only as illustrative and not restrictive. It will be appreciated that variations of the described implementations may be made without departing from the scope of the invention. It will also be apparent that there are many variations that have not been described, but that fall within the scope of the appended claims.
Filing Document | Filing Date | Country | Kind |
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PCT/EP2022/071431 | 7/29/2022 | WO |
Number | Date | Country | |
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63227154 | Jul 2021 | US |