WO2021257041A1 - Robotic mechanism unit intended to be used in in-vitro diagnostic tests and analysis - Google Patents

Robotic mechanism unit intended to be used in in-vitro diagnostic tests and analysis Download PDF

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Publication number
WO2021257041A1
WO2021257041A1 PCT/TR2021/050631 TR2021050631W WO2021257041A1 WO 2021257041 A1 WO2021257041 A1 WO 2021257041A1 TR 2021050631 W TR2021050631 W TR 2021050631W WO 2021257041 A1 WO2021257041 A1 WO 2021257041A1
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Prior art keywords
unit
robotic mechanism
robotic
mechanism according
analyses
Prior art date
Application number
PCT/TR2021/050631
Other languages
French (fr)
Inventor
Ahmet Ali ŞEN
Original Assignee
Intecro Roboti̇k Otomasyon Arge Mühendi̇sli̇k Maki̇ne Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇
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Application filed by Intecro Roboti̇k Otomasyon Arge Mühendi̇sli̇k Maki̇ne Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ filed Critical Intecro Roboti̇k Otomasyon Arge Mühendi̇sli̇k Maki̇ne Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇
Priority to DE212021000370.2U priority Critical patent/DE212021000370U1/en
Publication of WO2021257041A1 publication Critical patent/WO2021257041A1/en

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/0099—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor comprising robots or similar manipulators
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N2035/00178—Special arrangements of analysers
    • G01N2035/00306—Housings, cabinets, control panels (details)

Definitions

  • the invention relates to the robotic mechanism intended to be used in all kinds of in vitro diagnostic tests and analyses such as microbiological analyses, molecular diagnosis, forensic medicine, food and drug. Thanks to the use of the robotic mechanism, the in vitro human factor is deactivated and high accuracy, fast and efficient analyses are provided.
  • the laboratory a French-based word, can be defined lexically as "the place where various research, examination and experiments are performed and the tools, materials and devices required for these are present".
  • SARS-CoV-2 coronavirus
  • PCR polymerase chain reaction
  • test method it is operated by determining whether the person has been infected recently.
  • serological test antibodies produced by the immune system against the virus in the blood are checked.
  • PCR polymerase chain reaction
  • Serious risks may occur for the operator performing the test in case of performing dangerous tests such as the new type of coronavirus (SARS-CoV-2). It is possible that the operator performing the process can be infected by viruses, as well as different microorganisms on the user can infect the test environment and affect the test results.
  • SARS-CoV-2 new type of coronavirus
  • the invention aims to create a robotic mechanism that can be operated autonomously in an analysis chamber completely isolated from the external environment, enabling the application of all kinds of in vitro diagnostic tests and analyses with the help of at least one robotic mechanism.
  • the robotic mechanism subject to the invention can be operated automatically with the data sets defined for itself. In this way, the human need for the application of in vitro diagnostic tests and analyses can be completely eliminated.
  • test and analysis processes without human ingenuity allows for high precision processes (approximately 10 times) and much faster process (5-10 times), while on the other hand, indisputably it allows keeping the process repeatability at a very high level (99.99%). This situation provides a great advantage especially for instant and rapid response to rapidly spreading diseases such as the COVID 19 pandemic.
  • Another important advantage is that the robotic mechanism can be operated 24/7 without any interruption.
  • FIG. 1 Front perspective view of the robotic mechanism unit intended to be used in all kinds of in vitro diagnostic tests and analyses
  • FIG. 1 Front detailed perspective view of the robotic mechanism unit intended to be used in all kinds of in vitro diagnostic tests and analyses,
  • a filtered cell (18) isolated from the external environment contains; sample entry unit (1), tube unit (2), solution input and storage unit (3), sample preparation unit (4), pipettor unit (5), tube decapper unit (6), medical waste bin (7), sample waiting unit (8), reader unit (9), vortex device (10), centrifuge device (11), PCR Device (12), robotic element (13) and sterilization unit (17).
  • the isolated chamber was formed as a filtered cell (18) in the form of a box, as shown in Figure 1.
  • the filtered cell (18) contains a hepa filter in order to separate the air inside the cell from the outside air.
  • the sample entry unit (1) is used to place the taken samples into the robotic mechanism. According to the embodiment shown in Figure 1, the robotic mechanism unit was equipped with 2 sample entry units (1).
  • Consumables such as standard tube, plate, and solution can be loaded into the system via the material input cover formed on one of the side walls of the filtered cell (18).
  • the tube unit (2) contains the tubes needed during the test preparation process.
  • the solution input and storage unit (3) contains the solutions to be used for the test. According to the preferred embodiment of the invention, solutions are stored at -20°C in the solution input and storage unit (3).
  • the sample preparation unit (4) is the section where the robotic element (13) performs the sample preparation process.
  • the pipettor unit (5) defines the unit used in the processes of taking samples and preparing the solution.
  • the tube decapper unit (6) is the unit that enables the lids of the tubes to be opened and closed.
  • the section where they are disposed of is defined as the medical waste bin (7).
  • the sample waiting unit (8) is the area where the samples that need to wait during the test preparation process are kept.
  • the reader unit (9) defines the unit that scans the labels on the tubes and solutions. Within the preferred embodiment of the invention, the reader unit (9) is in the form of a barcode reader.
  • the robotic element (13) defines the unit operating in the isolated chamber.
  • the robotic element (13) has at least 2 arms. Within the embodiment described in Figure 1, the robotic element (13) consists of 2 arms.
  • the robotic element (13) was designed with 13 axis.
  • the robotic element (13) consisting of 2 arms has the holder unit (15) and/or the camera unit (16) on at least its one arm.
  • the holder unit (15) is in the form of a gripper.
  • the sterilization unit (17) is used to sterilize the inside of the filtered cell (18).
  • the sterilization unit (17) is in the form of a UV-C source and is located on walls of the filtered cell (18).
  • the inside of the filtered cell (18) is sterilized by the UV-C source, which acts as the sterilization unit (17).
  • the robotic elements (13) located within the robotic mechanism unit, which is the subject of the invention, were formed in such a way that they can work in cooperation with each other and/or independently.
  • each arm belonging to the robotic element (13) can also contain the holder unit (15) and the camera unit (16) thereon. In this way, the whole process can be monitored in real time and the control of the processes is carried out.
  • the filtered cell (18) was associated with at least one screen (14).
  • the sample preparation process and test results can be displayed simultaneously on the screen (14).
  • More than one robotic mechanism unit which is the subject of the invention, can be operated depending on a single software.
  • a single admin can monitor and direct the data of all units over the common software.
  • the embodiment of the robotic mechanism unit which is the subject of the invention, used for molecular diagnosis is operated as follows, and it consists of the following process steps:

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  • Engineering & Computer Science (AREA)
  • Robotics (AREA)
  • Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

The invention relates to the robotic mechanism intended to be used in all kinds of in vitro diagnostic tests and analyses such as microbiological analyses, molecular diagnosis, forensic medicine, food and drug analyses. Thanks to the use of the robotic mechanism, the in vitro human factor is minimized and high accuracy, fast and efficient analyses are provided.

Description

ROBOTIC MECHANISM UNIT INTENDED TO BE USED IN IN-VITRO
DIAGNOSTIC TESTS AND ANALYSIS
Technical Field
The invention relates to the robotic mechanism intended to be used in all kinds of in vitro diagnostic tests and analyses such as microbiological analyses, molecular diagnosis, forensic medicine, food and drug. Thanks to the use of the robotic mechanism, the in vitro human factor is deactivated and high accuracy, fast and efficient analyses are provided.
State of the Art
The laboratory, a French-based word, can be defined lexically as "the place where various research, examination and experiments are performed and the tools, materials and devices required for these are present".
In the laboratory environment, many different analyses can be performed for clinical laboratory tests, bacteria, HIV, influenza, hlnl, toxic substance detection, species identification, respiratory tract viruses, etc. in the medical, drug, food, agriculture, livestock sectors.
These analyses performed in the laboratory environment are performed by operating different difficult, repetitive and sensitive operations such as adding, removing, mixing and dispersing samples and reagents.
With the COVID 19 epidemic emerging today, the importance of such laboratory analyses is increasing. Revealing the infected people will provide an important advantage to prevent or slow down the epidemic.
There are two main methods to test for Covid-19 caused by the new type of coronavirus (SARS-CoV-2). One of them is the molecular diagnostic test to detect the existing infection, and the other is the serological test, that is, the blood test, which reveals recent infection.
In the samples taken for the molecular diagnostic test, which is the first way to understand whether a person has Covid-19, genetic sequences specific to the new type of coronavirus are sought. For this purpose, samples taken with swabs from the nose or nasal passages or saliva samples are used.
When the taken samples reach the laboratory, parts of the genome are amplified by polymerase chain reaction (PCR) to enable gene analysis. At the end of the process, if 2 genes specific to the new type of coronavirus are found, it means that the person is infected and the result is reported as positive.
In the other test method, it is operated by determining whether the person has been infected recently. In this method, called serological test, antibodies produced by the immune system against the virus in the blood are checked.
During the COVID 19 epidemic, molecular diagnostic tests come to the forefront with their high accuracy, speed and efficiency.
However, polymerase chain reaction (PCR) processes, which are the basis of molecular diagnostic tests, must be performed by experienced personnel who are experts in their field under sensitive environmental conditions. The processing steps of the ongoing process require high attention and operational precision. Therefore, the success of a validated PCR process depends on the precision and reproducibility of the personnel performing the process.
The fact that such processes can only be carried out by competent personnel increases the cost of the process on the one hand, and causes the number of processes to be limited by the number of competent personnel on the other hand.
Especially in the current pandemic period, the cost of molecular diagnostic processes and the capacity to apply the processes become even more important.
Performing molecular diagnostic tests with human ingenuities within the current technique also constitutes an important impediment in terms of standardization of tests. While the process precision of the very experienced operator may be higher, the process precision of the less experienced operator may be lower. Again, since the same operator cannot perform all tests with the same precision, standardization may not be possible even among the tests performed by the same operator.
Serious risks may occur for the operator performing the test in case of performing dangerous tests such as the new type of coronavirus (SARS-CoV-2). It is possible that the operator performing the process can be infected by viruses, as well as different microorganisms on the user can infect the test environment and affect the test results.
Another technical obstacle that arises as a result of performing such tests by human ingenuity is the possibility of making mistakes due to the application being made by humans. On the other hand, performing the tests by humans significantly increases the total processing time, reduces the reproducibility of the test and decreases its quality.
It takes months to acquire and/or transfer sets of expertise and experience through human ingenuity. Especially when more specialist operators are needed to contend with the instantaneous risks such as the current COVID 19 pandemic process, it will be very difficult to intervene in the pandemic as it will take a long time to train specialist operators. Therefore, it is very important that trained personnel perform the maximum number of tests at a high accuracy rate.
Again, the consequences of errors caused by intensive human factor use can be very serious. These can include:
• Unnecessary treatment,
• Treatment complications,
• Failure to provide appropriate treatment,
• Delay in correct diagnosis,
• Additional and unnecessary test for diagnosis.
These results lead to increased costs and often insufficient patient output due to time loss and personnel effort.
In order to eliminate these problems caused by human factor during laboratory analyses, applications that allow at least some of the process steps applied during the analyses to be performed with the help of machines have started to emerge.
However, the aforementioned applications are not suitable for all processes to be performed automatically by robotic mechanisms in an isolated environment. Since performing only one of the process steps in conditions that are not isolated by human ingenuity will cause technical problems such as the risk of infection of the operator, the increase in the cost/duration of the total test time, and the use of an experienced operator, it will continue to cause negativity such as test processes that are operated entirely by human ingenuity.
Problems That Invention Aims To Solve
The invention aims to create a robotic mechanism that can be operated autonomously in an analysis chamber completely isolated from the external environment, enabling the application of all kinds of in vitro diagnostic tests and analyses with the help of at least one robotic mechanism.
The robotic mechanism subject to the invention, can be operated automatically with the data sets defined for itself. In this way, the human need for the application of in vitro diagnostic tests and analyses can be completely eliminated.
In this way, more sensitive, more accurate, more tests can be performed by easing the personnel workload without the need for an increase in the number of specialist personnel working in diagnostic processes.
The operation of test and analysis processes without human ingenuity allows for high precision processes (approximately 10 times) and much faster process (5-10 times), while on the other hand, indisputably it allows keeping the process repeatability at a very high level (99.99%). This situation provides a great advantage especially for instant and rapid response to rapidly spreading diseases such as the COVID 19 pandemic.
With the use of the robotic mechanism operated entirely by automation, waiting times due to the human factor are eliminated, the time lost for intermediate operation preparations is reduced to zero and the tests required for immune plasma treatment are performed quickly.
Another important advantage is that the robotic mechanism can be operated 24/7 without any interruption.
The use of the robotic mechanism and the almost elimination of the human factor allow the elimination of nearly 90% of especially two-way contamination factors, including all the risks that the expert personnel are exposed to.
On the other hand, it is aimed to eliminate the possibility of making mistakes due to human factor by 90%.
Description of the Figures
Figure 1. Front perspective view of the robotic mechanism unit intended to be used in all kinds of in vitro diagnostic tests and analyses,
Figure 2. Front detailed perspective view of the robotic mechanism unit intended to be used in all kinds of in vitro diagnostic tests and analyses,
Figure 3. Top view of the robotic mechanism unit intended to be used in all kinds of in vitro diagnostic tests and analyses . Description of References in the Figures
I.Sample entry unit 2.Tube unit
3.Solution Input and Storage Unit 4.Sample Preparation Unit
5.Pipettor Unit
6.Tube Decapper Unit
7.Medical Waste Bin
8.Sample Waiting Unit
9.Barcode Reader Unit
10. Vortex Device
II. Centrifuge Device
12. PCR Device
13. Robotic element
14. Screen
15. Holder element
16. Camera unit
17. Sterilization unit
18. Filtered cell
Description of the Invention
A filtered cell (18) isolated from the external environment contains; sample entry unit (1), tube unit (2), solution input and storage unit (3), sample preparation unit (4), pipettor unit (5), tube decapper unit (6), medical waste bin (7), sample waiting unit (8), reader unit (9), vortex device (10), centrifuge device (11), PCR Device (12), robotic element (13) and sterilization unit (17).
The isolated chamber was formed as a filtered cell (18) in the form of a box, as shown in Figure 1. According to the preferred embodiment of the invention, the filtered cell (18) contains a hepa filter in order to separate the air inside the cell from the outside air.
The sample entry unit (1) is used to place the taken samples into the robotic mechanism. According to the embodiment shown in Figure 1, the robotic mechanism unit was equipped with 2 sample entry units (1).
Consumables such as standard tube, plate, and solution can be loaded into the system via the material input cover formed on one of the side walls of the filtered cell (18).
The tube unit (2) contains the tubes needed during the test preparation process.
The solution input and storage unit (3) contains the solutions to be used for the test. According to the preferred embodiment of the invention, solutions are stored at -20°C in the solution input and storage unit (3).
The sample preparation unit (4) is the section where the robotic element (13) performs the sample preparation process.
The pipettor unit (5) defines the unit used in the processes of taking samples and preparing the solution. The tube decapper unit (6) is the unit that enables the lids of the tubes to be opened and closed.
After using pipettor tips, lid, etc., the section where they are disposed of is defined as the medical waste bin (7). The sample waiting unit (8) is the area where the samples that need to wait during the test preparation process are kept. The reader unit (9) defines the unit that scans the labels on the tubes and solutions. Within the preferred embodiment of the invention, the reader unit (9) is in the form of a barcode reader.
The robotic element (13) defines the unit operating in the isolated chamber.
Within the preferred embodiment of the invention, the robotic element (13) has at least 2 arms. Within the embodiment described in Figure 1, the robotic element (13) consists of 2 arms.
Again, according to the embodiment described in Figure 1, the robotic element (13) was designed with 13 axis.
According to the embodiment of the invention shown in Figure 1, the robotic element (13) consisting of 2 arms has the holder unit (15) and/or the camera unit (16) on at least its one arm.
Within the preferred embodiment of the invention, the holder unit (15) is in the form of a gripper.
The sterilization unit (17) is used to sterilize the inside of the filtered cell (18). According to the preferred embodiment of the invention, the sterilization unit (17) is in the form of a UV-C source and is located on walls of the filtered cell (18).
After the test or analysis to be applied is completed, the inside of the filtered cell (18) is sterilized by the UV-C source, which acts as the sterilization unit (17). The robotic elements (13) located within the robotic mechanism unit, which is the subject of the invention, were formed in such a way that they can work in cooperation with each other and/or independently.
According to the preferred embodiment of the invention, each arm belonging to the robotic element (13) can also contain the holder unit (15) and the camera unit (16) thereon. In this way, the whole process can be monitored in real time and the control of the processes is carried out.
Within the preferred embodiment of the invention, the filtered cell (18) was associated with at least one screen (14). The sample preparation process and test results can be displayed simultaneously on the screen (14).
More than one robotic mechanism unit, which is the subject of the invention, can be operated depending on a single software. A single admin can monitor and direct the data of all units over the common software.
Again, traceability was ensured in all processes with the tracking of the reader unit (9).
It can be operated in different programs with different operation formulas pre-loaded on the tracking interface. Again, process steps, data, errors related to all operations can be recorded in real time.
Again, all patient and sample-based records can be safely stored in the database through the common software used and can work in integration with the hospital management system.
The embodiment of the robotic mechanism unit which is the subject of the invention, used for molecular diagnosis is operated as follows, and it consists of the following process steps:
• Entering the sample into the system via the sample entry unit (1),
• Making the samples ready for testing,
• Nucleic acid extraction,
• Delivering the sample to the PCR device,
• Running the PCR device and generating the test result.

Claims

1. Invitro Robotic Laborant is a robotic mechanism intended to be used in all kinds of in vitro diagnostic tests and analyses such as microbiological analyses, molecular diagnosis, forensic medicine, food and drug, characterized in that it contains a sample entry unit (1), tube unit (2), solution input and storage unit (3), sample preparation unit (4), pipettor unit (5), tube decapper unit (6), medical waste bin (7), sample waiting unit (8), reader unit (9), vortex device (10), centrifuge device (11), PCR Device (12), robotic element (13) and sterilization unit (17) in a filtered cell (18) isolated from the external environment.
2.A robotic mechanism according to Claim 1, characterized in that it contains a filtered cell (18) equipped with a hepa filter in order to separate the air inside the cell from the outside air.
3.A robotic mechanism according to Claim 1, characterized in that the filtered cell (18) contains a material input cover formed on one of its side walls.
4.A robotic mechanism according to Claim 1, characterized in that it contains a reader unit (9) in the form of a barcode reader.
5.A robotic mechanism according to Claim 1, characterized in that it contains a robotic element (13) consisting of at least 2 arms designed with 13 axis.
6.A robotic mechanism according to Claim 5, characterized in that it contains a robotic element (13) with holder unit
(15) and/or camera unit (16) located on at least one arm.
7.A robotic mechanism according to Claim 6, characterized in that it contains a holder unit (15) in the form of a gripper.
8.A robotic mechanism according to Claim 1, characterized in that it contains a sterilization unit (17) in the form of a UV-C source and located on the walls of the filtered cell (18).
9.A robotic mechanism according to Claim 1, characterized in that it contains a filter cell (18) associated with at least one screen (14).
10. A method of operation of the robotic mechanism intended to be used in all kinds of in vitro diagnostic tests and analyses such as microbiological analyses, molecular diagnosis, forensic medicine, food and drug, characterized in that it includes the following process steps:
• Entering the sample into the system via the sample entry unit (1),
• Making the samples ready for testing,
• Nucleic acid extraction,
• Delivering the sample to the PCR device,
• Running the PCR device and generating the test result.
PCT/TR2021/050631 2020-06-19 2021-06-19 Robotic mechanism unit intended to be used in in-vitro diagnostic tests and analysis WO2021257041A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
DE212021000370.2U DE212021000370U1 (en) 2020-06-19 2021-06-19 Robot mechanism assembly for use in in vitro diagnostic testing and analysis

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2020/09555A TR202009555A2 (en) 2020-06-19 2020-06-19 Robotic mechanism unit in vitro diagnostic tests and analysis
TR2020/09555 2020-06-19

Publications (1)

Publication Number Publication Date
WO2021257041A1 true WO2021257041A1 (en) 2021-12-23

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US11568958B2 (en) 2017-12-29 2023-01-31 Clear Labs, Inc. Automated priming and library loading device

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US5656493A (en) * 1985-03-28 1997-08-12 The Perkin-Elmer Corporation System for automated performance of the polymerase chain reaction
DE10017802A1 (en) * 2000-04-10 2001-10-11 Bilatec Ges Zur Entwicklung Bi Laboratory robot, useful for automated isolation of nucleic acid, includes orientation device to ensure proper alignment between robotic arm and unit being transported
WO2005009202A2 (en) * 2003-05-12 2005-02-03 Isis Pharmaceuticals, Inc. Automatic identification of bioagents
US20120052560A1 (en) * 2010-08-31 2012-03-01 Canon U.S. Life Sciences, Inc. System and method for serial processing of multiple nucleic acid assays
US20130128035A1 (en) * 2011-11-07 2013-05-23 Beckman Coulter, Inc. Robotic arm
AU2015261711A1 (en) * 2010-10-29 2015-12-17 Thermo Fisher Scientific Oy Automated system for sample preparation and analysis

Patent Citations (6)

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Publication number Priority date Publication date Assignee Title
US5656493A (en) * 1985-03-28 1997-08-12 The Perkin-Elmer Corporation System for automated performance of the polymerase chain reaction
DE10017802A1 (en) * 2000-04-10 2001-10-11 Bilatec Ges Zur Entwicklung Bi Laboratory robot, useful for automated isolation of nucleic acid, includes orientation device to ensure proper alignment between robotic arm and unit being transported
WO2005009202A2 (en) * 2003-05-12 2005-02-03 Isis Pharmaceuticals, Inc. Automatic identification of bioagents
US20120052560A1 (en) * 2010-08-31 2012-03-01 Canon U.S. Life Sciences, Inc. System and method for serial processing of multiple nucleic acid assays
AU2015261711A1 (en) * 2010-10-29 2015-12-17 Thermo Fisher Scientific Oy Automated system for sample preparation and analysis
US20130128035A1 (en) * 2011-11-07 2013-05-23 Beckman Coulter, Inc. Robotic arm

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11568958B2 (en) 2017-12-29 2023-01-31 Clear Labs, Inc. Automated priming and library loading device
US11581065B2 (en) 2017-12-29 2023-02-14 Clear Labs, Inc. Automated nucleic acid library preparation and sequencing device

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DE212021000370U1 (en) 2023-01-12
TR202009555A2 (en) 2020-07-21

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