Closed-type disease diagnosis cartridge
The sealed disease diagnostic cartridge addresses the challenges of POC systems by providing a rapid, simultaneous, and contamination-free solution for molecular and immunodiagnostic tests through its innovative design and cover mechanism.
Patent Information
- Application Number
- PCT/KR2024/016412
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-12-19
- Filing Date
- 2024-10-25
- Publication Date
- 2025-06-26
AI Technical Summary
Current Point-Of-Care (POC) systems for molecular and immunodiagnosis are cumbersome, time-consuming, and vulnerable to contamination due to the multiple steps and exposure required for sample collection and testing.
A sealed disease diagnostic cartridge with a main body, a chamber array, and a cover member that includes a syringe tip and a cover mechanism to prevent foreign substance penetration, allowing for simultaneous molecular and immunodiagnostic functions while maintaining containment.
The cartridge enables rapid and simultaneous performance of molecular and immunodiagnostic tests while effectively preventing contamination and leakage of infectious agents, thus enhancing emergency preparedness and reducing in-hospital infections.
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Figure KR2024016412_26062025_PF_FP_ABST
Abstract
Description
Sealed disease diagnostic cartridge
[0001] The technical idea of the present disclosure relates to a disease diagnosis cartridge, and more specifically, to a sealed disease diagnosis cartridge.
[0002] Existing molecular diagnostics or immunodiagnostics equipment was designed to automatically or semi-automatically test large volumes of samples. These equipment was deployed in hospital systems primarily equipped with large equipment, making it difficult to test small numbers of samples, limiting emergency preparedness.
[0003] Accordingly, there is a recent trend toward introducing point-of-care (POC) systems for testing small numbers of samples. POC systems perform real-time molecular or immunological diagnostics on-site, with random access testing to minimize nosocomial infections.
[0004] Overseas, the demand for POC systems is increasing in areas with limited access to hospitals, and especially in the US and Europe, having POC systems is more cost-competitive than having large-scale equipment-equipped testing centers.
[0005] However, these POC systems also require numerous steps and a long time from specimen collection to test result confirmation. POC testing requires specimen collection, extraction reagent dispensing, nucleic acid extraction, PCR reagent dispensing, sealing and centrifugation, PCR amplification, and analysis. While this time has been reduced compared to large-scale automated equipment, it still requires considerable time.
[0006] In addition, the POC system requires collecting samples on-site and performing molecular or immune diagnosis in real time, and thus is relatively vulnerable to contamination by infectious agents compared to in-hospital diagnosis.
[0007] The technical idea of the present disclosure is to provide a cartridge that can rapidly perform molecular diagnosis and immunodiagnosis while preventing contamination by infectious agents.
[0008] A sealed disease diagnosis cartridge (10) for preventing foreign substance penetration according to an embodiment of the present disclosure may include a main body (100) that accommodates a syringe tip (110), a chamber array (200) that is composed of a plurality of types of chambers and is connected to the main body (100) so that one end of the syringe tip (110) is positioned in an opening of the chamber, and a cover member that is connected to at least one of the main body (100) and the chamber array (200) and is provided so as to be openable and closable.
[0009] According to one embodiment, the chamber array (200) may be configured to be mounted on the main body (100) so that the contents of the chambers can be discharged or introduced into the chambers through one end of the syringe tip (110) through the openings of the chambers.
[0010] According to one embodiment, the cover member may include a first cover member (310) that is connected to the main body (100) and can be opened and closed so that the other end of the syringe tip (110) can be exposed to the outside.
[0011] According to one embodiment, the main body (100) may be characterized in that a curved guide groove (120) is formed to guide the rotation of the first cover member (310) so that the first cover member (310) can be rotated and covered in the other end direction of the syringe tip (110), and a straight guide groove (130) is formed to guide the straight movement of the first cover member (310) so that the first cover member (310) can move linearly in the other end direction of the syringe tip (110).
[0012] According to one embodiment, the cover member may include a second cover member (320) that is disposed between the main body (100) and the chamber array (200) and opens and closes so that the openings of the chambers can be exposed toward the inside of the main body (100).
[0013] According to one embodiment, when the second cover member (320) is open, the syringe tip (110) may be configured to be accessible to the chambers, and when the second cover member (320) is closed, access to the chambers for the syringe tip (110) may be blocked.
[0014] According to one embodiment, the opening and closing of the second cover member (320) may be determined according to the direction in which the chamber array (200) slides based on a designated position.
[0015] According to one embodiment, the second cover member (320) may have a groove (322) formed diagonally with respect to the sliding direction, and a protrusion formed on the chamber array (200) may be fitted into and connected to the groove (322) formed on the second cover member (320), and the second cover member (320) may be moved in the diagonal direction corresponding to the moving direction of the protrusion.
[0016] The cartridge according to an exemplary embodiment of the present disclosure is an all-in-one cartridge that can simultaneously perform the functions of a molecular diagnostic cartridge and an immunodiagnostic cartridge, while effectively preventing an infectious agent from leaking out of the cartridge.
[0017] The effects that can be obtained from the exemplary embodiments of the present disclosure are not limited to the effects mentioned above, and other effects not mentioned can be clearly derived and understood by those skilled in the art to which the exemplary embodiments of the present disclosure pertain from the following description. In other words, unintended effects resulting from implementing the exemplary embodiments of the present disclosure can also be derived by those skilled in the art from the exemplary embodiments of the present disclosure.
[0018] FIG. 1 is a drawing illustrating a cartridge according to an embodiment of the present disclosure.
[0019] Figure 2 is a drawing illustrating a first cover member according to one embodiment.
[0020] FIG. 3 is a drawing illustrating a configuration of a chamber array for moving a second cover member according to one embodiment.
[0021] FIG. 4 is a drawing illustrating an embodiment in which a second cover member is mounted on a chamber array according to one embodiment.
[0022] FIG. 5 is a drawing illustrating an embodiment in which a chamber array is opened and closed while a second cover member is mounted on the chamber array according to one embodiment.
[0023] FIG. 6a is an embodiment showing a state in which the second cover member is open according to one embodiment, and FIG. 6b is an embodiment showing a state in which the second cover member is closed according to one embodiment.
[0024] FIGS. 7 to 9 are drawings illustrating an embodiment in which the main body and chamber array of the cartridge are sealed according to one embodiment.
[0025] Hereinafter, various embodiments of the present disclosure will be described in conjunction with the accompanying drawings. Various embodiments of the present disclosure may have various modifications and various embodiments, and thus specific embodiments are illustrated in the drawings and described in detail in connection therewith. However, this is not intended to limit the various embodiments of the present disclosure to specific embodiments, but should be understood to include all modifications and / or equivalents or alternatives falling within the spirit and technical scope of the various embodiments of the present disclosure. In connection with the description of the drawings, similar reference numerals have been used for similar components.
[0026] In various embodiments of the present disclosure, it should be understood that terms such as “include” or “have” are intended to specify the presence of a feature, number, step, operation, component, part, or combination thereof described in the specification, but do not preclude the possibility of the presence or addition of one or more other features, numbers, steps, operations, components, parts, or combinations thereof.
[0027] In various embodiments of the present disclosure, the expression "or" includes any and all combinations of the words listed together. For example, "A or B" may include A, may include B, or may include both A and B.
[0028] The expressions "first," "second," "first," or "second" used in various embodiments of the present disclosure may describe various components of the various embodiments, but do not limit those components. For example, the expressions do not limit the order and / or importance of the components, and may be used to distinguish one component from another.
[0029] When it is said that a component is "connected" or "connected" to another component, it should be understood that the component may be directly connected or connected to the other component, but that new components may also exist between the component and the other component.
[0030] In the embodiments of the present disclosure, terms such as "module," "unit," "part," etc. are terms used to refer to components that perform at least one function or operation, and such components may be implemented as hardware or software, or a combination of hardware and software. In addition, a plurality of "modules," "units," "parts," etc. may be integrated into at least one module or chip and implemented as at least one processor, except in cases where each needs to be implemented as a separate, specific hardware.
[0031] Terms defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant technology, and will not be interpreted in an idealized or overly formal sense unless explicitly defined in various embodiments of the present disclosure.
[0032] Hereinafter, embodiments of the present disclosure will be described in detail with reference to the attached drawings.
[0033] FIG. 1 is a drawing illustrating a cartridge (10) according to an embodiment of the present disclosure.
[0034] Referring to FIG. 1, a cartridge (10) according to an embodiment of the present disclosure may be composed of a main body (100), a chamber array (200), and a cover member. The cover member may be composed of parts whose opening and closing can be controlled to selectively allow access to external devices. In addition, the cover member may be controlled to selectively allow access between components within the cartridge (10). For example, some cover members may be configured to allow access between the main body (100) and the chamber array (200) to be controlled.
[0035] The main body (100) may be provided with a syringe tip that mediates a connection between an external device and the chamber array (200). The syringe tip (110) may be provided so as to be connectable to a syringe pump configured as an external device, and the syringe pump may be a device capable of supplying or drawing in a precise amount of fluid through a syringe. That is, in the embodiment of the present disclosure, when the syringe pump is connected to the cartridge (10) through the syringe tip (110), the syringe pump may draw in contents stored in the chamber array (200) or supply contents to the chamber array (200).
[0036] The chamber array (200) may be configured with multiple types of chambers connected together and may be mounted on the lower portion of the main body (100). The chamber array (200) may be removed from the main body (100) in a mounted state depending on the operation of the user or the diagnostic device. The types of chambers may be classified according to the shape of the chamber and / or the type of reagent contained in the chamber.
[0037] For example, the chamber array (200) may be equipped with a sample chamber for sealing a sample solution, a buffer chamber containing a solution for lysis and binding for performing molecular diagnosis by loading a sample solution injected by a syringe tip (110), a mixing chamber, a washing chamber, a buffer chamber containing a solution for elution, and a PCR chamber for performing PCR. In addition, an extraction and freeze-drying chamber for extracting and freeze-drying a target from the sample solution may be further equipped.
[0038] However, the chamber type of the present disclosure is not limited thereto, and may include all kinds of chambers capable of containing reagents or storing contents.
[0039] According to one embodiment, the syringe tip (110) may correspond one-to-one to a chamber of the chamber array (200). Specifically, one end of the syringe tip (110) may be positioned corresponding to an opening of the chamber. At this time, the syringe tip (110) or the chamber array (200) may slide in one direction while being connected to each other. The direction in which the syringe tip (110) or the chamber array (200) slides may be a direction in which the syringe tip (110) moves to be positioned at the opening of an adjacent chamber.
[0040] For example, the syringe tip (110) may be moved in the direction in which the adjacent chamber is located while being positioned within the main body (100). However, the embodiment in which the syringe tip (110) or the chamber array (200) is moved in the cartridge (10) of the present disclosure is not limited thereto, and may include any method in which the syringe tip (110) is moved so that it can be positioned in each of the plurality of chambers configured in the chamber array (200) according to the operation of the user or the diagnostic device.
[0041] Figure 2 is a drawing illustrating a first cover member (310) according to one embodiment.
[0042] Referring to FIG. 2, the first cover member (310) may be mounted on the upper portion of the main body (100) and may be opened and closed by rotating about a certain axis. When the first cover member (310) is opened, the other end of the syringe tip (110) inside the main body (100) may be exposed to the outside. The other end of the syringe tip (110) may have an opening formed in the opposite direction of one end of the syringe tip (110) and connected to the syringe pump. That is, when the first cover member (310) is opened, the syringe tip (110) inside the main body (100) may be exposed to the outside, and when the first cover member (310) is closed, the syringe tip (110) may be prevented from being exposed to the outside.
[0043] According to one embodiment, the first cover member (310) may be formed with a first protrusion (311) and a second protrusion (312), and the first protrusion (311) may be fitted into a curved guide groove (120) formed in the main body (100), and the second protrusion (312) may be fitted into a straight guide groove (130) formed in the main body (100). The first cover member (310) may rotate as the first protrusion (311) moves along the curved guide groove (120). At this time, the center of rotation of the first cover member (310) may be the second protrusion (312), and when the second protrusion (312) is moved to the uppermost end along the straight guide groove (130) and fixed, the first protrusion (311) may move along the curved guide groove (120).
[0044] In other words, the curved guide groove (120) may be a part of an arc centered on the uppermost point of the straight guide groove (130), and may be moved only when the second protrusion (312) is located at the uppermost point of the straight guide groove (130). Accordingly, when the second protrusion (312) is not located at the uppermost point of the straight guide groove (130), the first cover member (310) cannot be rotated and opened.
[0045] According to one embodiment, the first protrusion (311) may be equipped with a tension spring, and the tension spring may be connected to the side opposite to the side of the main body (100) where the open first cover member (310) is located. That is, the first cover member (310) may be extended when it is open, and may be compressed when it is closed.
[0046] According to the embodiment of FIG. 2, the upper part of the main body (100) can be opened as the first cover member (310) rotates counterclockwise, and the upper part of the main body (100) can be closed as the first cover member (310) rotates clockwise. When the first cover member (310) is closed by rotating clockwise, the second protrusion (312) can be lowered along the straight guide groove (130) by the user or the diagnostic device. When the second protrusion (312) is lowered, the first cover member (310) may not be rotated because the second protrusion (312) is not located at the center of curvature of the curved guide groove (120).
[0047] According to one embodiment, the first cover member (310) may further include a locking button, and the locking button may protrude through a groove formed in the main body (100), and when the locking button is not pressed and protrudes outside the main body (100), the rotation, rise, and fall of the first cover member (310) may be locked. A user or a diagnostic device may press the locking button to release the locking, thereby performing the rotation, rise, and fall of the first cover member (310).
[0048] According to one embodiment, a curved guide groove (120) and a straight guide groove (130) may be formed on a first side of the main body (100), and a groove for accommodating a locking button may be formed on a second side opposite the first side.
[0049] FIG. 3 is a drawing showing the configuration of a chamber array (200) for moving a second cover member (320) according to one embodiment.
[0050] Referring to the perspective view of the main body (100) of FIG. 3, a first cover member (310) may be mounted on the upper portion of the main body (100), and a second cover member (320) and a chamber array (200) may be mounted on the lower portion of the main body (100). The second cover member (320) may be positioned between the chamber array (200) and the main body (100), and when the chamber array (200) is closed by the second cover member (320), the contents contained inside the chamber array (200) may be prevented from escaping into the main body (100).
[0051] According to one embodiment, the chamber array (200) mounted on the lower portion of the main body (100) can slide in the width direction of the main body (100) while mounted. At this time, the chamber array (200) and the second cover member (320) can be connected through a protrusion and a groove (322), and the opening and closing of the second cover member (320) connected to the chamber array (200) can be determined depending on the movement direction of the chamber array (200).
[0052] At this time, a catch groove (210) may be formed in the chamber array (200), and for example, the catch groove (210) may be caught by an internal part of a diagnostic device on which a cartridge (10) is mounted, so that the chamber array (200) may slide in the width direction. That is, after the cartridge (10) is mounted on the diagnostic device, the reagent or contents contained in the chamber array (200) may be introduced or discharged into the chamber array (200) by the operation of the diagnostic device, and then the chamber array (200) may be automatically sealed.
[0053] Accordingly, the cartridge (10) according to the embodiment of the present disclosure can primarily prevent an infectious agent from leaking to the outside by the first cover member (310), and secondarily prevent an infectious agent from leaking from the chamber array (200) by the second cover member (320). However, the cartridge (10) according to the embodiment of the present disclosure may not only be provided with both the first cover member (310) and the second cover member (320), but may also be provided with only one of the first cover member (310) and the second cover member (320) to prevent an infectious agent from leaking.
[0054] FIG. 4 is a drawing illustrating an embodiment in which a second cover member (320) is mounted on a chamber array (200) according to one embodiment.
[0055] Referring to FIG. 4, a groove (322) may be formed in the second cover member (320) in a diagonal direction with respect to the sliding direction of the chamber array (200). The sliding direction of the chamber array (200) may be in the width direction of the main body (100), and the diagonal direction may be a direction rotated by a predetermined angle in the width direction with respect to the width direction of the main body (100).
[0056] The protrusion formed on the chamber array (200) is connected by being fitted into the groove (322) formed on the second cover member (320), and when the chamber array (200) slides, the second cover member (320) can move in a diagonal direction corresponding to the movement direction of the protrusion.
[0057] When the second cover member (320) is covered over the chamber array (200), the syringe tip (110) may be positioned at a pre-designated position, and a cavity (321) corresponding to the thickness of the syringe tip (110) may be formed in the second cover member (320).
[0058] That is, a reagent or content can be introduced or discharged through one end of the syringe tip (110), and after the introduction / discharge operation is completed, one end of the syringe tip (110) can be seated at a position where a seating groove (220) of a predetermined depth is dug to prevent the intrusion of external foreign substances. After one end of the syringe tip (110) is seated in the seating groove (220), the chamber array (200) can be covered by the second cover member (320), but if a cavity (321) corresponding to the thickness of the syringe tip (110) is not formed in the second cover member (320), the movement of the second cover member (320) by the syringe tip (110) may be incomplete.
[0059] In addition, if the introduction / dispensing operation through the syringe tip (110) is not completed, the second cover member (320) must not cover the chamber array (200) so that the introduction / dispensing operation can be continuously performed. Accordingly, in the second cover member (320) of the present disclosure, a cavity (321) is positioned at a position corresponding to the seating groove (220) where the syringe tip (110) will be positioned after the introduction / dispensing operation is completed, thereby preventing the second cover member (320) from being unintentionally covered by the chamber array (200).
[0060] Accordingly, the second cover member (320) of the present disclosure forms a cavity (321) corresponding to the thickness of the syringe tip (110), thereby preventing the infection source from leaking from the chamber array (200) while the syringe tip (110) is seated in the chamber array (200).
[0061] FIG. 5 is a drawing showing an embodiment in which the chamber array (200) is opened and closed while the second cover member (320) is mounted on the chamber array (200) according to one embodiment, FIG. 6a is an embodiment showing an open state of the second cover member (320) according to one embodiment, and FIG. 6b is an embodiment showing a closed state of the second cover member (320) according to one embodiment.
[0062] Referring to FIG. 5, when the injection / dispensing operation of a reagent or contents through the syringe tip (110) is completed, the syringe tip (110) can be moved to a designated position where a groove is formed. At this time, the user or the diagnostic device can adjust the chamber array (200) so that the second cover member (320) can cover the opening of the chamber array (200).
[0063] For example, the diagnostic device can fasten a fastening member that engages with a fastening groove (210) formed at the bottom of the chamber array (200) to the fastening groove (210), and the fastening member can slide the chamber array (200) in the -x direction by moving in the -x direction.
[0064] At this time, the protrusion formed in the chamber array (200) may be inserted into a groove (322) formed in the second cover member (320). The groove (322) may be formed at a predetermined angle toward the front of the main body (100) based on the direction in which the chamber array (200) slides.
[0065] The second cover member (320) must move in the +y direction to cover the chamber array (200), but the chamber array (200) slides in the -x direction, so there is a side where the movement direction is not aligned. Accordingly, the groove (322) of the present disclosure can extend in a direction between the -x direction and the +y direction, and accordingly, the movement of the chamber array (200) in the -x direction can be converted into the movement of the second cover member (320) in the +y direction.
[0066] Referring to FIG. 6a, the second cover member (320) is positioned toward the rear of the main body (100) so that the syringe tip (110) can be positioned in the chamber array (200), and referring to FIG. 6b, the second cover member (320) is positioned toward the front of the main body (100) so that the source of infection can be prevented from leaking from the chamber array (200).
[0067] FIGS. 7 to 9 are drawings illustrating an embodiment in which the main body (100) and chamber array (200) of the cartridge (10) are sealed according to one embodiment.
[0068] Referring to FIG. 7, the main body (100) of the cartridge (10) according to one embodiment may further include a sample inlet (140). The sample inlet (140) may be connected to a tube facing the chamber so that a sample is injected into at least some of the plurality of chambers.
[0069] Referring to Fig. 8, a film (150) may be attached to one side of the cartridge (10) body (100) according to one embodiment. The film (150) may be sealed through heat fusion to prevent external foreign substances from entering the body (100).
[0070] Referring to FIG. 9, the chamber array (200) according to one embodiment may be sealed with a waterproof tape (160). For example, when the chamber array (200) is removed from the main body (100) of the cartridge (10), the waterproof tape (160) may be attached to the upper portion of the chamber array (200), and leakage of an infectious agent may be prevented by the waterproof tape (160).
[0071] As described above, exemplary embodiments have been disclosed in the drawings and specification. While specific terminology has been used to describe embodiments herein, it is intended solely to illustrate the technical concept of the present disclosure and is not intended to limit the scope of the present disclosure as defined in the claims. Therefore, those skilled in the art will understand that various modifications and equivalent embodiments are possible. Therefore, the true technical protection scope of the present disclosure should be defined by the technical concept of the appended claims.
Claims
1. In a sealed disease diagnosis cartridge (10) that prevents the source of infection from leaking to the outside, A body (100) accommodating a syringe tip (110); A chamber array (200) composed of multiple types of chambers and connected to the main body (100) such that one end of the syringe tip (110) is positioned in the opening of the chamber; and A cover member connected to at least one of the above main body (100) and the above chamber array (200) and capable of being opened and closed A sealed diagnostic cartridge (10) comprising:
2. In paragraph 1, A sealed diagnostic cartridge (10) characterized in that the chamber array (200) is configured to be mounted on the main body (100) so that the contents of the chamber can be discharged or introduced into the chamber through one end of the syringe tip (110) through the openings of the chambers.
3. In paragraph 1, The above cover member, A first cover member (310) that is connected to the main body (100) and can be opened and closed so that the other end of the syringe tip (110) can be exposed to the outside. A sealed diagnostic cartridge (10) characterized by including a.
4. In paragraph 3, The above main body (100) is A sealed diagnostic cartridge (10) characterized in that a curved guide groove (120) is formed to guide the rotation of the first cover member (310) so that the first cover member (310) can be rotated and covered in the other end direction of the syringe tip (110), and a linear guide groove (130) is formed to guide the linear movement of the first cover member (310) so that the first cover member (310) can move linearly in the other end direction of the syringe tip (110).
5. In paragraph 4, The above first cover member (310) is A locking button protruding through a groove formed in the above body (100) Including, A sealed diagnostic cartridge (10) characterized in that when the locking button is not pressed and protrudes outside the main body (100), the rotation, rise, and fall of the first cover member (310) can be locked, and when the locking button is pressed, the locking is released, thereby allowing at least one of the rotation, rise, and fall of the first cover member (310) to be performed.
6. In paragraph 1, The above cover member, A second cover member (320) that is positioned between the main body (100) and the chamber array (200) and opens and closes so that the openings of the chambers can be exposed toward the inside of the main body (100). A sealed diagnostic cartridge (10) characterized by including a.
7. In paragraph 6, A sealed diagnostic cartridge (10) characterized in that when the second cover member (320) is open, the syringe tip (110) is configured to be accessible to the chambers, and when the second cover member (320) is closed, access to the chambers for the syringe tip (110) is blocked.
8. In paragraph 6, A sealed diagnostic cartridge (10) characterized in that the opening and closing of the second cover member (320) is determined according to the direction in which the chamber array (200) slides based on a designated position.
9. In paragraph 8, The second cover member (320) has a groove (322) formed diagonally with respect to the sliding direction. A sealed diagnostic cartridge (10) characterized in that the protrusion formed on the chamber array (200) is connected by being fitted into a groove (322) formed on the second cover member (320), and the second cover member (320) moves in the diagonal direction corresponding to the movement direction of the protrusion.
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