Kit of reconstitutable reagents
By designing a resolvable reagent kit, independent sealing and environmental contact-free resolvation of lyophilized reagents were achieved, solving the contamination problem during the resolvation process of lyophilized reagents and improving the accuracy of test results and ease of operation.
Patent Information
- Application Number
- CN202211544963.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2022-12-04
- Publication Date
- 2026-01-23
- Estimated Expiration
- 2042-12-04
AI Technical Summary
Existing lyophilized reagents are easily contaminated during the reconstitution process, leading to reduced accuracy of test results and cumbersome operation procedures.
Design a reconstituteable reagent kit comprising a kit body, a piston assembly, and a push-down device. The piston assembly is designed to allow for independent sealing of the two reagents, and the push-down device is used to detach the container from the stopper, enabling environmental-free reconstitution of the reagents.
This ensures that the reagent reconstitution process is not contaminated by the external environment, improves the accuracy of test results, simplifies the operation process, and reduces the risk of contamination.
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Figure CN115743912B_ABST
Abstract
Description
Technical Field
[0001] This invention belongs to the field of formulation box design, specifically relating to a reagent kit for resolvable reagents. Background Technology
[0002] Because biological agents can maintain their biological activity well in the lyophilized state, lyophilized reagent products are widely used. However, the application of lyophilized reagents requires reconstitution, which involves aliquoting the lyophilized reagent into containers, adding reconstitution solution, and then using a pipette to remove the reconstituted lyophilized reagent for application. This process is not only cumbersome but also highly susceptible to contamination of the biological agent under substandard environmental conditions, thus reducing the accuracy of test results. Therefore, designing a reagent kit that facilitates reconstitution, minimizes the risk of contamination during the process, and is easy to store, produce, and transport has become an urgent requirement. Summary of the Invention
[0003] Therefore, the technical problem to be solved by the present invention is to provide a reagent kit for resolvable reagents, so as to overcome the shortcomings of the prior art in which the resolvation of lyophilized reagents by pipetting may be contaminated, resulting in reduced accuracy of detection results and cumbersome operation procedures.
[0004] To address the aforementioned problems, this invention provides a reagent kit for resolvable reagents, comprising a kit body having a receiving through-hole. A sealing element is detachably connected to a first end of the receiving through-hole, and a piston assembly is connectable to a second end of the receiving through-hole. A first reagent is placed in the space between the piston assembly and the sealing element. The piston assembly includes a piston, and a receiving element is connected to a stopper located within the receiving through-hole. A second reagent is placed in the receiving element. The kit further includes a pushing device capable of detaching the receiving element from the stopper. After the receiving element detaches from the stopper, the second reagent in the receiving element can be resolvable with the first reagent.
[0005] In some embodiments, the receiving member includes a first gasket and a second gasket, the first gasket and the second gasket being spaced apart on the piston along the axial direction of the piston, the first gasket being located on the side of the second gasket away from the first reagent, and the second reagent being received in the gap between the first gasket and the second gasket.
[0006] In some embodiments, the piston is a rubber stopper, and a blind cavity is formed on the end of the stopper facing the first reagent, with the first gasket and the second gasket interference-fitted into the blind cavity.
[0007] In some embodiments, the push-down device includes a piercing needle having a push-away position that pierces the piston and disengages the receiving member from the plunger, the piercing needle being in the push-away position when it is necessary to reconstitute the first reagent with the second reagent.
[0008] In some embodiments, the pushing device further includes a booster plate disposed at the tail of the puncture needle.
[0009] In some embodiments, the piercing needles are at least two in number, and the at least two piercing needles are evenly spaced around the piston in a circumferential manner.
[0010] In some embodiments, the booster plate has a gap retaining ring on its end face facing the piston, which is removed from the end face of the piston when it is necessary to disengage the receiving member from the plunger.
[0011] In some embodiments, the gap retaining ring is disposed around the outside of the puncture needle and is connected to the booster plate via a slit.
[0012] In some embodiments, the first gasket is made of a rigid material.
[0013] In some embodiments, the first reagent is a liquid reagent and the second reagent is a dry powder reagent.
[0014] This invention provides a reagent kit for resolvable reagents. When the container is in its initial state, i.e., when the container is connected to the piston plunger, the second reagent and the first reagent are in separate spaces, achieving the purpose of separate and independent sealing of the two reagents to be resolvable. This state is particularly easy to preserve, produce, and transport. When it is necessary to resolvate the two reagents, the pusher detaches the container from the plunger. As the container falls, the second reagent inside will come into contact with the first reagent to complete the resolvation. This resolvation process does not involve the transfer of reagents to the external environment, completely eliminating the risk of formulation contamination and ensuring the accuracy of subsequent test results. The resolvation process is simple and convenient to operate. Attached Figure Description
[0015] Figure 1 This is a schematic diagram of the structure of a resolvable reagent kit according to an embodiment of the present invention. The container is in its initial state in this state.
[0016] Figure 2 for Figure 1 In the reagent kit for resolvable reagents, the container is pushed away from the piston by the push-down device and falls off. In this state, the second reagent will fall down with the container to the first reagent below.
[0017] Figure 3This is a schematic diagram showing the state of the first and second reagents re-dissolving after the container falls onto the first reagent.
[0018] The reference numerals in the attached figures are as follows:
[0019] 1. Reagent kit body; 11. Receptacle opening; 2. Sealing element; 31. Piston; 4. Push-down device; 41. Puncture needle; 42. Push plate; 43. Gap retaining ring; 51. First gasket; 52. Second gasket; 101. First reagent; 102. Second reagent. Detailed Implementation
[0020] See also Figures 1 to 3 As shown in the embodiment of the present invention, a reagent kit for resolvable reagents is provided, including a reagent kit body 1, the reagent kit body 1 having a receiving through hole 11, a sealing member 2 being detachably connected to a first end of the receiving through hole 11, a piston assembly being connected to a second end of the receiving through hole 11, a first reagent 101 being placed in the space between the piston assembly and the sealing member 2, the piston assembly including a piston 31, a receiving member (not labeled in the figure) being connected to a plug in the receiving through hole 11, a second reagent 102 being placed in the receiving member, the reagent kit also including a pushing device 4, the pushing device 4 being able to detach the receiving member from the plug, and when the receiving member is detached from the plug, the second reagent 102 in the receiving member can be resolvated with the first reagent 101.
[0021] In this technical solution, when the container is in its initial state, that is, when the container is connected to the plunger of the piston 31, the second reagent 102 and the first reagent 101 are in independent spaces, achieving the purpose of separately and independently sealing the two reagents to be reconstituted. This state is particularly easy to preserve, produce and transport. When it is necessary to reconstitute the two reagents, the pushing device 4 detaches the container from the plunger. As the container falls, the second reagent 102 inside will come into contact with the first reagent 101 to complete the reconstitution. This reconstitution process does not involve the transfer of reagents to the external environment, completely eliminating the risk of formulation contamination and ensuring the accuracy of subsequent test results. The reconstitution process is simple and convenient to operate.
[0022] In one specific embodiment, the receiving element includes a first gasket 51 and a second gasket 52, which are spaced apart on the piston 31 along the axial direction. The first gasket 51 is located on the side of the second gasket 52 away from the first reagent 101. The second reagent 102 is contained in the gap between the first gasket 51 and the second gasket 52. It is understood that after the first gasket 51 and the second gasket 52 are assembled on the piston, the second reagent 102 should be sealed and stored to ensure that the two reagents do not come into contact when the reagent kit is moved, such as when it is upside down. In a preferred embodiment, the piston 31 is a rubber stopper, and a blind cavity is constructed on the end of the stopper facing the first reagent 101. The first gasket 51 and the second gasket 52 are interference-fitted into the blind cavity. By using the interference fit of the first gasket 51 and the second gasket 52, the deformability and sealing performance of the rubber stopper can be used to ensure the independent and sealed storage of the second reagent 102. At the same time, this structure can easily ensure the separation of the container from the stopper under the action of the pushing device 4. It is understood that after the container is separated, since the second reagent 102 is contained in the gap between the first gasket 51 and the second gasket 52, the first reagent 101 and the second reagent 102 form sufficient contact and reconstitute through this gap, with a large contact area, thereby improving the reconstitution efficiency. It should be noted that the thickness of the first gasket 51 and the second gasket 52 in the container is relatively small (the thickness in the figure is only an example), and after falling, they are located at the bottom of the reagent kit body 1, and will not adversely occupy the mixed solvent formed.
[0023] As a preferred embodiment of the push-down device 4, the push-down device 4 includes a piercing needle 41, which has a push-away position that pierces the piston 31 and disengages the accommodating member from the plug. When it is necessary to reconstitute the first reagent 101 and the second reagent 102, the piercing needle 41 is in the push-away position. When the piercing needle 41 is in the push-away position, the accommodating member will disengage from the plug, thereby achieving the purpose of the push-down device 4 applying force to the accommodating member.
[0024] In some embodiments, the pushing device 4 further includes a pusher plate 42, which is located at the tail of the piercing needle 41, that is, at the end of the piercing needle 41 away from the piston 31. In actual use, the operator can apply force to the pusher plate 42 with their fingers to make the piercing needle 41 pierce the piston 31 and thus push the receiving part. Of course, in other application conditions, a corresponding push rod can also be applied to the pusher plate 42 to achieve the purpose of mechanized operation.
[0025] As a preferred embodiment, there are at least two piercing needles 41, which are evenly spaced around the piston 31 in the circumference. The at least two piercing needles 41 can apply force to the accommodating member in a relatively balanced circumference, thereby ensuring that the accommodating member can smoothly detach and fall.
[0026] In one feasible embodiment, the pusher 4 can be configured to exist independently of the reagent kit body 1, and the pusher 4 is only used when the pusher is needed. This approach is obviously cumbersome. In a preferred embodiment, a gap retaining ring 43 is provided on the end face of the pusher plate 42 facing the piston 31. The gap retaining ring 43 is removed from the end face of the piston 31 when it is necessary to disengage the container from the plunger. Specifically, the gap retaining ring 43 can be annular and supported between the end face of the pusher plate 42 and the reagent kit body 1 to prevent the pusher plate 42 from being moved along the axial direction of the reagent kit body 1 toward the container. This function is obviously effective when the first reagent 101 and the second reagent 102 do not need to be reconstituted. When the two need to be reconstituted, the gap retaining ring 43 is removed to release the constraint on the axial movement of the pusher plate 42.
[0027] In some embodiments, the gap retaining ring 43 is disposed around the outside of the puncture needle 41 and is connected to the booster plate 42 through a dummy cut. The aforementioned dummy cut is a dummy cut device used to achieve a dummy connection between the gap retaining ring 43 and the booster plate 42, so that when it is necessary to remove the constraint of the gap retaining ring 43, it can be easily pulled off.
[0028] In some embodiments, the first gasket 51 is made of a rigid material, such as PP, PC or other rigid plastics, to ensure that it is not punctured by the puncture needle 41.
[0029] As a preferred embodiment, the first reagent 101 is a liquid reagent and the second reagent 102 is a dry powder reagent, specifically a solid lyophilized reagent. That is, the second reagent 102 is stored in the container, which facilitates the assembly of the container and the plug.
[0030] It will be readily understood by those skilled in the art that the aforementioned advantageous methods can be freely combined and superimposed without conflict.
[0031] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention. The above are merely preferred embodiments of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the technical principles of the present invention, and these improvements and modifications should also be considered within the protection scope of the present invention.
Claims
1. A reagent kit for resolvable reagents, characterized in that, The kit includes a reagent body (1), which has a receiving through-hole (11). A sealing member (2) is detachably connected to a first end of the receiving through-hole (11), and a piston assembly is connectable to a second end of the receiving through-hole (11). A first reagent (101) is placed in the space between the piston assembly and the sealing member (2). The piston assembly includes a piston (31), which is connected to a receiving member on a plunger inside the receiving through-hole (11). A second reagent (102) is placed in the receiving member. The kit also includes a push-down device (4) that can detach the receiving member from the plunger. After the receiving component is detached from the plunger, the second reagent (102) in the receiving component can be re-dissolved with the first reagent (101); the receiving component includes a first gasket (51) and a second gasket (52), the first gasket (51) and the second gasket (52) are assembled on the plunger at intervals along the axial direction of the piston (31), the first gasket (51) is located on the side of the second gasket (52) away from the first reagent (101), the second reagent (102) is contained in the gap between the first gasket (51) and the second gasket (52), and the first gasket (51) and the second gasket (52) are independent and not connected to each other.
2. The reagent kit according to claim 1, characterized in that, The piston (31) is a rubber stopper, and a blind hole cavity is constructed on the end of the stopper facing the first reagent (101). The first gasket (51) and the second gasket (52) are interference-fitted into the blind hole cavity.
3. The reagent kit according to claim 1, characterized in that, The push-down device (4) includes a piercing needle (41) having a push-away position that pierces the piston (31) and disengages the receiving member from the plug. The piercing needle (41) is in the push-away position when it is necessary to reconstitute the first reagent (101) and the second reagent (102).
4. The reagent kit according to claim 3, characterized in that, The pushing device (4) also includes a booster plate (42), which is disposed at the tail of the piercing needle (41).
5. The reagent kit according to claim 4, characterized in that, The piercing needle (41) has at least two needles, which are evenly spaced around the piston (31) in the circumferential direction.
6. The reagent kit according to claim 4, characterized in that, The booster plate (42) has a gap retaining ring (43) on its end face facing the piston (31), and the gap retaining ring (43) is removed from the end face of the piston (31) when it is necessary to disengage the receiving member from the plunger.
7. The reagent kit according to claim 6, characterized in that, The gap retaining ring (43) is arranged around the outside of the puncture needle (41) and is connected to the booster plate (42) through a slit.
8. The kit according to any one of claims 1 to 7, characterized in that, The first gasket (51) is made of a rigid material.
9. The reagent kit according to claim 1, characterized in that, The first reagent (101) is a liquid reagent, and the second reagent (102) is a dry powder reagent.
Citation Information
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