Patent Description:
The closest state of the art showing such a method and device is <CIT>. Another example can be found in <CIT>.

With the development of medicine, biotechnology and various related technologies, tests for detecting various molecular indicators such as blood cells, genes, proteins, antigens, and pathogens in predetermined biological samples such as urine and blood have been widely practiced. The test process is generally performed by collecting a sample, reacting the collected sample with a predetermined reagent suitable for a target indicator, and analyzing and observing the changes that occur. Through this, it is possible to perform qualitative and/or quantitative analysis of various molecular indicators included in the sample and obtain the information on diagnosis, progression, or prognosis of a disease based on the analysis.

Meanwhile, devices capable of processing a large amount of lateral flow type diagnostic cartridges are currently being used. When the user mounts the consumables required for diagnosis on the diagnostic device and puts the sample into the diagnostic device, the diagnostic device automatically performs the entire procedures through a predetermined algorithm for collecting the sample, mixing the collected sample with the detection buffer (DB) to perform pretreatment, and dispensing the sample into the cartridge for measurement so that the diagnosis result may be stored in the memory, transmitted to the outside through the communication unit, or displayed on the display device. Such a diagnostic device needs to further increase the throughput per hour.

The present invention is aimed at providing a method for increasing the throughput of a diagnostic device for transporting a lateral flow type diagnostic cartridge with a conveyor belt, and a diagnostic device using the same.

The objective of the present invention is not limited to the above-mentioned objective, and other objectives of the present invention not mentioned above will be clearly understood by those skilled in the art from the following description.

An aspect of the present invention provides a method for controlling a diagnostic device according to the main claim.

Preferred embodiments of the method are subject of claims <NUM>-<NUM>.

Another aspect of the present invention provides a diagnostic device according to claim <NUM>.

According to the present invention described above, the reading timing of the second cartridge may be later than the reading timing of the first cartridge.

Preferably, the second slot is adjacent to the first slot.

Preferably, the step (c) of mounting the second cartridge includes mounting the second cartridge in the second slot located at the rear of the first slot without driving the conveyor belt in a reverse direction if the first cartridge has been discharged from the conveyor belt.

Preferably, the method of the present invention further includes a step of: (f) transporting the first cartridge to the sample dispensing position by driving the conveyor belt in the forward direction.

Another aspect of the present invention provides a diagnostic device for processing lateral flow type cartridges comprises: a conveyor belt having a plurality of cartridge slots for mounting the cartridges; a measuring unit for reading the reaction result in the cartridge; a cartridge ejecting unit for ejecting the cartridge mounted on a magazine to the conveyor belt; a control unit for controlling driving of the conveyor belt and the cartridge ejecting unit, wherein the control unit mounts a first cartridge in a first slot of the conveyor belt by driving the cartridge ejecting unit; transports the first cartridge to a measuring unit by driving the conveyor belt when a predetermined time for incubation has elapsed from the time of mounting the first cartridge; mounts a second cartridge in a second slot located at the rear of the first slot by driving the conveyor belt in a reverse direction so as to drive a cartridge ejecting unit if the first cartridge being incubated is present on the conveyor belt; and discharges the first cartridge that has been read, from the conveyor belt.

According to the present invention described above, the throughput per hour of the diagnostic device can be increased by controlling the position and time to eject the cartridge to the conveyor belt in the diagnostic device that transports the lateral flow type diagnostic cartridge to the conveyor belt.

These embodiments are illustrative for the purpose of illustrating the present invention, and is not intended to limit the scope of the present invention.

<FIG> illustrates the configuration of a diagnostic device <NUM> according to an embodiment of the present invention. <FIG> is a conceptual diagram illustrating the overall structure and operation of the diagnostic device <NUM> shown in <FIG>. As shown in <FIG> and <FIG>, the diagnostic device <NUM> includes a sample transporting unit <NUM>, a magazine station <NUM>, a cartridge transporting unit <NUM>, a main buffer station <NUM>, a sub-buffer station <NUM>, a tip station <NUM>, an optical measuring unit <NUM>, and a tip discharging unit <NUM>. The sample transporting unit <NUM> includes a sample input station <NUM>, a sample mixing unit <NUM>, and a sample discharge station <NUM>.

When a sensor (not shown) senses that a sample rack <NUM> equipped with ten sample containers has been inserted, the sample input station <NUM> transports the sample rack <NUM> in the A and B directions by operating the drive unit <NUM>. The sample information reader <NUM> reads the barcode of the sample rack <NUM> transported through the sample input station <NUM> so as to check the sample type, and reads the barcode of the container containing the sample so as to check patient information. The sample information reader <NUM> may be implemented with a camera. In this case, it is possible to recognize handwritten patient information. The sample mixing unit <NUM> rotates the sample container mounted on the sample rack <NUM> when a sample required to be mixed has been transported after the sample information reader <NUM> reads. The sample discharge station <NUM> operates the driving unit to transport the sample rack <NUM> in the C and D directions so as to discharge the sample that has been measured.

The main buffer station <NUM> is the place on which the detection buffer (DB) contained in the container is mounted. In this embodiment, four sets of twenty-five detection buffers can be mounted. The sample collected from the sample rack <NUM> is mixed with the detection buffer in the corresponding buffer container so that pre-processing may be performed. If the item to measure requires two buffers, another buffer is mounted at sub-buffer station <NUM>.

<FIG> depicts an example of a lateral flow type diagnostic cartridge <NUM> used in the diagnostic device shown in <FIG>. <FIG> illustrates the configuration of a magazine <NUM> in which the diagnostic cartridge shown in <FIG> will be mounted. <FIG> depicts a magazine <NUM> shown in <FIG> in which the cartridge <NUM> has been mounted.

The diagnostic cartridge <NUM> is printed with a cartridge barcode <NUM> that indicates the item to measure and the manufacturing lot. The pretreated sample is introduced into the dispensing hole <NUM>. The reaction result of the sample is measured through the measurement window <NUM>.

Up to <NUM> diagnostic cartridges <NUM> are mounted on the magazine <NUM>, for example. A barcode <NUM> printed on the magazine <NUM> indicates the item to measure and the manufacturing lot of the mounted diagnostic cartridge <NUM>. The magazine <NUM> has an ejecting unit inlet <NUM> and a cartridge ejection port <NUM> which face each other at the bottom of the magazine <NUM>.

The magazine <NUM> may be formed of a transparent or translucent material so that the mounted cartridge <NUM> can be identified. In addition, quantity indicators <NUM> may be made so that the number of the mounted cartridges <NUM> can be easily identified.

When the incubated diagnostic cartridge <NUM> is transported by the cartridge transporting unit <NUM>, the optical measuring unit <NUM> scans the reaction result from the measurement window <NUM> of the diagnostic cartridge <NUM> while mainly moving in the I direction. In order to accurately scan the reaction result, the optical measuring unit <NUM> performs two-dimensional scanning in which it moves in the I direction (or front-rear direction) and in the transporting direction (or left-right direction) of the diagnostic cartridge <NUM>.

The cartridge scanned by the optical measuring unit <NUM> is transported by the cartridge transporting unit <NUM> and discharged from the cartridge discharging unit (not shown).

The tip station <NUM> has one hundred twenty tips mounted on a tip rack. The tip is discharged through the tip discharging unit <NUM> after the tip is used for sample collection, mixing of the sample and buffer, dispensing of the mixed solution, etc..

<FIG> illustrates the configuration of a magazine station <NUM> of the diagnostic device shown in <FIG>. As shown in <FIG>, the magazine station <NUM> includes a magazine holder <NUM>, a magazine barcode reader <NUM>, and a cartridge ejecting unit <NUM>.

The magazine barcode reader <NUM> recognizes the barcode <NUM> printed on the magazine <NUM>. The cartridge ejecting unit <NUM> moves in the E direction and is put into the ejecting unit inlet <NUM> so that the cartridge <NUM> can be ejected through the cartridge ejection port <NUM>. The magazine holder <NUM> controls the barcode recognition position and the cartridge ejection position by transporting the magazine <NUM> in the F direction (shown in <FIG>).

The cartridge transporting unit <NUM> is composed of a conveyor belt, and has a plurality of cartridge slots 109a. One cartridge <NUM> is seated in one cartridge slot 109a by the cartridge ejecting unit <NUM>. The control unit (not shown) drives the cartridge transporting unit <NUM> in the G direction (or the forward direction) so as to transport the cartridge <NUM> seated in the cartridge slot 109a to the dispensing position.

<FIG> illustrates a configuration for sample pre-processing and dispensing in the diagnostic device <NUM> shown in <FIG>. <FIG> illustrates a configuration of a dispensing module <NUM> of the diagnostic device <NUM> shown in <FIG>. <FIG> depicts a tube container <NUM> for containing a detection buffer in the diagnostic device <NUM> shown in <FIG>.

The detection buffer <NUM> is a solution required for pretreatment of a sample. The buffer tube <NUM> is a container for containing the detection buffer <NUM>. The opening of the buffer tube <NUM> is sealed with sealing paper <NUM>. The sealing paper <NUM> is an aluminum-based paper and is attached to buffer tube <NUM>. The sealing paper <NUM> is punctured by a tip (not shown) while the sample is being pre-processed.

Dispensing module <NUM> consists of an adapter <NUM> and a syringe pump <NUM> connected to each other through a tube <NUM>. The adapter <NUM> is connected to a driving unit (not shown) that moves in the Z-axis direction, and the lower part of the adapter <NUM> is formed in a shape for easy attachment and detachment of the tip used for sample dispensing. The syringe pump <NUM> sucks and discharges the sample or mixed solution.

The dispensing module driving unit <NUM> moves the dispensing module <NUM> in the X and Y directions. When the cartridge <NUM> is transported to the dispensing position by the cartridge transporting unit <NUM>, the dispensing module <NUM> is moved to the tip station <NUM> by the dispensing module driving unit <NUM>, and the dispensing module <NUM> moves the adapter <NUM> in the Z direction to insert the tip to the lower part of the adapter <NUM>. Next, the dispensing module <NUM> is moved to the sample rack <NUM> by the dispensing module driving unit <NUM>, and a sample is collected at the tip inserted into the adapter <NUM> by the syringe pump <NUM>, and the sample is discharged to the buffer tube <NUM> mounted on the buffer station <NUM>. The dispensing module <NUM> sucks the mixture of the sample and the detection buffer from the buffer tube <NUM> and dispenses it into the dispensing hole <NUM> of the cartridge <NUM>.

The cartridge transporting unit <NUM> is maintained at a constant temperature for incubation. If there is a cartridge in which the incubation is completed, the control unit (not shown) drives the cartridge transporting unit <NUM> in the forward direction so as to measure the reaction result in the cartridge and transports the cartridge to the optical measuring unit <NUM>.

<FIG> illustrates a configuration of a measuring unit <NUM> and a cartridge discharging unit <NUM> of the diagnostic device <NUM> shown in <FIG>. The optical measuring unit <NUM> scans the reaction result through the measurement window <NUM> of the cartridge <NUM> while moving the sensor unit in the I direction (shown in <FIG>).

The cartridge outlet <NUM> is located in front of the optical measuring unit <NUM>. That is, when the cartridge scanned by the optical measuring unit <NUM> is transported in the forward direction, it reaches the cartridge discharge unit <NUM> and falls, and is collected in a cartridge collecting container (not shown). Therefore, the cartridges must be scanned by the optical measuring unit <NUM> in the order they are inserted into the slots of the cartridge transporting unit <NUM>. The scan time is determined by the dispensing time and the incubation reaction time. If the item to measure is different, its incubation reaction time is also different. Therefore, the dispensing time or the cartridge insertion time must be determined so that the scanning time of the cartridge located in the rear may not precede that of the cartridge located in the front.

Hereinafter, the operation of the diagnostic device <NUM> will be described.

In the test preparation of diagnostic device <NUM>, the test buffer for the item to measure is mounted on the buffer station <NUM>, and the magazine <NUM> is mounted on the magazine station <NUM>. Also, whether or not there are enough tips in a tip station <NUM> must be checked for measurement. The item information of the mounted magazine which has been read through the barcode <NUM> is stored in the memory of the diagnostic device <NUM>.

After the sample is loaded in a sample rack suitable for the type of sample container, the sample rack <NUM> is put into the sample input station <NUM>. The barcode of the sample rack <NUM> transported by the sample input station <NUM> is read by the sample information reader <NUM> to confirm the type of the sample container. While transporting the sample rack <NUM> in the B direction (shown in <FIG>) by the sample input station <NUM>, the number of samples is identified by the sample information reader <NUM>. In addition, the patient information attached to the sample container is read by the sample information reader <NUM> and stored in the memory.

Next, dispensing module <NUM> inserts the tip into the lower part of adapter <NUM> and it should be checked. When the dispensing module <NUM> is transported to the sample collection location, the sample is collected as much as necessary according to the item to measure. The collected sample is transported to the buffer stations <NUM> and <NUM> for pre-treatment, mixed with a buffer, and pre-treated.

The cartridge is ejected from the magazine in which the cartridge of the item to measure is mounted among several magazines. The ejected cartridge is inserted into the cartridge slot 109a of the cartridge transporting unit <NUM> and transported to the dispensing position. The mixture of sample and detection buffer is sucked by the dispensing module <NUM> and dispensed into cartridge <NUM> at the dispensing position.

The cartridge <NUM> waits in cartridge transporting unit <NUM> for the incubation reaction time and then is transported to the optical measurement location for measurement. When the optical measuring unit <NUM> moves with scanning the cartridge <NUM> and then the scanned information is transmitted, the control unit calculates the diagnosis result by internal operation. The controller stores the calculated diagnostic result in the memory of the diagnostic device <NUM> or displays it on the display. In addition, the control unit can transmit the calculated diagnostic result to the outside through LAN, RS232C, WIFI, etc..

<FIG> is a flowchart of a control method used by a control unit for forward driving of a cartridge transporting unit <NUM> in the diagnostic device shown <NUM> in <FIG>. The cartridge transporting unit <NUM> includes a conveyor belt.

When the test starts, the cartridge transporting unit <NUM> is initialized (S902), and it is checked whether the sample processing is possible (S904). If any cartridge is being scanned by the optical measuring unit <NUM>, it waits until scanning is completed (S906). If the sample processing is possible, the sample is pre-processed through the dispensing module <NUM> (S908).

Next, the cartridge <NUM> mounted on the magazine <NUM> is injected into the slot (109a) of the cartridge transporting unit <NUM> by the cartridge ejecting unit <NUM> (S910), and the control unit drives the cartridge transporting unit <NUM> in the forward direction to transport cartridge <NUM> to the dispensing position (S912).

After the dispensing module <NUM> dispenses the mixture of the sample and the detection buffer, the control unit waits for the incubation reaction (S914). It is determined whether the next sample processing is possible while the control unit is waiting for the incubation reaction (S904). When the incubation reaction is completed (S916), the control unit drives the cartridge transporting unit <NUM> in the forward direction to transport the cartridge to the optical measuring unit <NUM> so that optical scanning may be possible (S918). The optical measuring unit <NUM> scans the reaction result in the cartridge <NUM> and stores it in a memory (not shown) (S920).

Next, it is determined whether there is any cartridge in which the reaction is taking place on the cartridge transporting unit <NUM> (S922). If there is any cartridge in which the reaction is taking place on the cartridge transporting unit <NUM>, the control unit waits until the reaction is completed (S914). If there is no cartridge in which the reaction is taking place on the cartridge transporting unit <NUM>, the conveyor belt is initialized and the testing is terminated (S924).

According to the control method shown in <FIG>, the cartridge transporting unit <NUM> is driven in the forward direction to transport the cartridge <NUM> in which the incubation reaction is completed to the scan position of the optical measuring unit <NUM>, and another cartridge is inserted into the cartridge slot of the cartridge transporting unit <NUM>. Accordingly, an empty slot is created between the current cartridge and its previous cartridge inserted immediately before. Therefore, the number of the cartridges in which the incubation reaction takes place is limited in the cartridge transporting unit <NUM>.

<FIG> is a flowchart of a control method used by a control unit for reverse driving of a cartridge transporting unit <NUM> in the diagnostic device <NUM> shown in <FIG>.

When the test starts, the cartridge transporting unit <NUM> is initialized (S1002), and the sample is pre-processed by the dispensing module <NUM> (S1004).

Next, it is determined whether there is any cartridge in which reaction is taking place on the cartridge transporting unit <NUM> (S1006). If there is any cartridge in which reaction is taking place in the cartridge transporting unit <NUM>, the slot position of the last inserted cartridge is looked for (S1008). The position of the slot of the rear adjacent to the slot of the last cartridge is calculated (S1010). In this way, cartridges can be inserted without making any empty slots. Next, the control unit drives the cartridge transporting unit <NUM> in the reverse direction (H direction) so that the slot at the position calculated in step S1010 may be at the position where the cartridge is ejected from the magazine <NUM> (S1012), and the cartridge is inserted into the slot (S1014). If there is no cartridge in which the reaction is taking place in the cartridge transporting unit <NUM>, the cartridge is directly inserted without driving the cartridge transporting unit <NUM> in the reverse direction (S1014). If the cartridge is not moved back to be inserted into the slot, an unread cartridge may be dislodged while another cartridge is inserted.

Next, the cartridge transporting unit <NUM> is driven in the forward direction to move the cartridge to the dispensing position. After the dispensing module <NUM> dispenses the mixture of the sample and the detection buffer, the control unit waits for the incubation reaction (S1018). The next sample is processed while the control unit is waiting for the incubation reaction (S1004). When the incubation reaction is completed (S1020), the control unit drives the cartridge transporting unit <NUM> in the forward direction to transport the cartridge to the optical measuring unit <NUM> so that optical scanning may be possible (S1022). The optical measuring unit <NUM> scans the reaction result in the cartridge <NUM> and stores it in a memory (not shown) (S1024).

Next, it is determined whether there is any cartridge in which the reaction is taking place on the cartridge transporting unit <NUM> (S1026). If there is any cartridge in which the reaction is taking place on the cartridge transporting unit <NUM>, the control unit waits until the reaction is completed (S1018). If there is no cartridge in which the reaction is taking place on the cartridge transporting unit <NUM>, the conveyor belt is initialized and the testing is terminated (S1028).

According to the control method shown in <FIG>, the cartridge transporting unit <NUM> is driven in the forward direction so that the cartridge <NUM> in which the incubation reaction is completed may be scanned with the optical measuring unit <NUM>, and then the cartridge transporting unit <NUM> is driven in the reverse direction so that no empty slot may be created between the current cartridge and its previous cartridge inserted immediately before. Therefore, the number of the cartridges in which the incubation reaction takes place may be more in the cartridge transporting unit <NUM> compared to the control method shown in <FIG> so that the throughput in a diagnostic device <NUM> may be increased.

Claim 1:
A method for controlling a diagnostic device that transports cartridges (<NUM>) with a conveyor belt (<NUM>) including steps of:
(a) mounting a first cartridge (<NUM>) in a first slot (109a) of the conveyor belt (<NUM>);
(b) performing an incubation reaction on the first cartridge;
(c) transporting the first cartridge (<NUM>) in a forward direction (G) to a measuring unit (<NUM>) when a predetermined time for incubation has elapsed from the time of mounting the first cartridge;
(d) mounting a second cartridge (<NUM>) in a second slot (109a);
(e) reading a reaction result in the first cartridge (<NUM>); and
(f) discharging the first cartridge (<NUM>) that has been read, from the conveyor belt (<NUM>),
characterized in that
during step (d) the second cartridge (<NUM>) is mounted in said second slot (109a) located at the rear of the first slot (109a) by driving the conveyor belt (<NUM>) in a reverse direction (H) if the first cartridge being incubated is present on the conveyor belt.