CN115877025A - In vitro analysis diagnosis detection device and card box valve control assembly - Google Patents

Abstract

The invention relates to an in vitro analysis diagnosis detection device and a card box valve control assembly. When the gas circuit control assembly works in a first working state, the second joint is controlled to be communicated with the pressure control mechanism, and the fourth joint is communicated with the atmospheric environment; when the gas circuit control assembly works in a second working state, the second joint is controlled to be communicated with the atmospheric environment, and the fourth joint is communicated with the pressure control mechanism. Switch the action through gas circuit control assembly, can realize that the first gas pocket of reagent card box communicates through first trachea and pressure control mechanism, also can realize that the second gas pocket of reagent card box communicates through second trachea and pressure control mechanism, can provide power according to the technology demand of reagent card box and promote sample liquid and shift between the cavity, and the overall structure of card box valve control assembly is comparatively simplified simultaneously.

Description

In vitro analysis diagnosis detection device and card box valve control assembly

Technical Field

The invention relates to the technical field of in-vitro analysis and diagnosis, in particular to an in-vitro analysis and diagnosis detection device and a card box valve control assembly.

Background

The quick detection pathogen POCT (Point-of-care testing) integrated instrument system based on PCR (polymerase chain reaction) technology is suitable for analyzing sample types such as nasopharyngeal swabs, sputum, urine, feces, cervical/vaginal swabs, blood, cerebrospinal fluid, skin, wound swabs and the like, adding a body fluid sample into a disposable reagent card box, putting the card box into the instrument system, and performing nucleic acid amplification, detection, calculation and result printing output. The instrument and the reagent are suitable for single or multiple detection of DNA or RNA of pathogens infecting human bodies.

In the field of biotechnology, nucleic acid extraction by a centrifugal column method or a magnetic bead method generally requires four steps of lysis, binding, washing, elution, and the like, followed by steps of nucleic acid molecule hybridization, polymerase chain reaction, molecule detection, and the like. The molecular detection technology is developed towards the direction of accuracy, convenience, sensitivity, automation and integration. However, due to the technical complexity of molecular detection itself, there are few fully automated instrument platforms from sample to result, and the structure of an instrument system for realizing automatic transfer of a sample liquid, for example, from a sample chamber to a pretreatment chamber, from a pretreatment chamber to a mixing chamber, or from a mixing chamber to a PCR chamber, is complicated.

Disclosure of Invention

In view of the foregoing, there is a need to overcome the deficiencies of the prior art by providing an in vitro diagnostic testing device and a cartridge valve control assembly that facilitates the transfer of sample fluid between chambers while also being structurally simplified.

The technical scheme is as follows: a cartridge valve control assembly, the cartridge valve control assembly comprising: a rack for housing a reagent cartridge; the reagent card box comprises a first pressing assembly, a second pressing assembly and a clamping assembly, wherein the first pressing assembly comprises a first driving mechanism, a first air pipe and a second air pipe, the first driving mechanism is arranged on the bracket and drives the first air pipe and the second air pipe to move, a first joint is arranged at one end of the first air pipe, a second joint is arranged at the other end of the first air pipe, a third joint is arranged at one end of the second air pipe, a fourth joint is arranged at the other end of the second air pipe, and when the first driving mechanism drives the first air pipe and the second air pipe to move to a first position, the first joint and the third joint are respectively used for being in butt joint communication with a first air hole and a second air hole of the reagent card box; the gas path control assembly is communicated with the second joint, the fourth joint and the pressure control mechanism respectively; the gas circuit control assembly is provided with a first working state and a second working state; when the gas circuit control assembly works in the first working state, the gas circuit control assembly is used for controlling the second connector to be communicated with the pressure control mechanism, and the fourth connector is communicated with the atmospheric environment; and when the gas circuit control assembly works in the second working state, the gas circuit control assembly is used for controlling the second joint to be communicated with the atmospheric environment, and the fourth joint is communicated with the pressure control mechanism.

When the detection work of the sample liquid in the reagent card box is required, the reagent card box is arranged in the bracket, the first driving mechanism moves the first air pipe and the second air pipe to the first position, so that the first joint is communicated with the first air hole in an opposite way, and the third joint is communicated with the second air hole in an opposite way; when the gas circuit control assembly works in a first working state, the first gas hole is in butt joint communication with the pressure control mechanism through the first gas pipe, the second gas hole is communicated with the atmospheric environment through the second gas pipe, and the suction force provided by the pressure control mechanism acts on the reagent card box, so that the sample liquid in the reagent card box is transferred between the chambers; similarly, when the air channel control assembly works in a second working state, the second air hole is in butt joint communication with the pressure control mechanism through the second air pipe, the first air hole is communicated with the atmospheric environment through the first air pipe, and the suction force provided by the pressure control mechanism acts on the reagent card box, so that the sample liquid in the reagent card box is transferred between the chambers. So, switch the action through gas circuit control assembly, can realize that the first gas pocket of reagent card box communicates through first trachea and pressure control mechanism, also can realize that the second gas pocket of reagent card box communicates through second trachea and pressure control mechanism, can provide power according to reagent card box's technology demand and promote sample liquid and shift between the cavity, and the overall structure of card box valve control assembly is comparatively simplified simultaneously.

In one embodiment, the first joint and the third joint are both vacuum chucks.

In one embodiment, the first compression assembly further comprises a first mounting plate; the first air pipe and the second air pipe are both arranged on the first mounting plate; the first driving mechanism is connected with the first mounting plate and drives the first mounting plate to move.

In one embodiment, the first compression assembly further comprises a first resilient member; the first air pipe is connected with the first mounting plate through the first elastic piece.

In one embodiment, a first guide through hole is formed in the first mounting plate, the first air pipe is movably arranged in the first guide through hole, a first step is arranged on the hole wall of the first guide through hole, a second step is arranged on the outer wall of the first air pipe, and two ends of the first elastic piece are correspondingly abutted against the first step and the second step respectively.

In one embodiment, the first compression assembly further comprises at least one first compression member; at least one first pressing piece is arranged on the first mounting plate; the first compressing member is used for compressing or loosening the first valve of the reagent card box.

In one embodiment, the cartridge valve control assembly further comprises a second hold down assembly; the second pressing assembly comprises a second driving mechanism, a second mounting plate and at least one second pressing piece; the second driving mechanism is arranged on the bracket, and at least one second pressing piece is arranged on the second mounting plate; the second driving mechanism is connected with the second mounting plate and used for driving the second mounting plate to be close to or far away from the support.

In one embodiment, the cartridge valve control assembly further comprises a slide rail assembly; the sliding rail assembly comprises a fixed frame arranged on the bracket, a first sliding rail and a second sliding rail which are arranged on the fixed frame, a first sliding block which is arranged on the first sliding rail in a sliding manner, a second sliding block which is arranged on the second sliding rail in a sliding manner, a first connecting plate connected with the first sliding block, and a second connecting plate connected with the second sliding block; the first connecting plate is connected with the first mounting plate, and the second connecting plate is connected with the second mounting plate.

In one embodiment, the cartridge valve control assembly further comprises a first sensor and a first trigger member in inductive engagement with the first sensor; the first sensor is arranged on the bracket, and the first trigger piece is arranged on the first mounting plate or the first connecting plate; the card box valve control component also comprises a second sensor and a second trigger piece in inductive fit with the second sensor; the second sensor is arranged on the bracket, and the second trigger piece is arranged on the second mounting plate or the second connecting plate.

In one embodiment, the first pressing assembly further includes at least one second elastic member mounted on the first mounting plate, at least one of the first pressing members and at least one of the second elastic members are disposed in one-to-one correspondence, and the first pressing member is connected to the first mounting plate through the second elastic member;

the second pressing component further comprises at least one third elastic piece arranged on the second mounting plate, the at least one second pressing piece and the at least one third elastic piece are arranged in a one-to-one correspondence mode, and the second pressing piece is connected with the second mounting plate through the third elastic piece.

In one embodiment, a first accommodating chamber and a second guide through hole communicated with the first accommodating chamber are arranged in the first mounting plate, the second elastic member is arranged in the first accommodating chamber, one end of the first pressing member is positioned in the first accommodating chamber and connected with the second elastic member, the first pressing member is movably arranged in the second guide through hole, and the other end of the first pressing member extends out of the second guide through hole and is used for pressing or loosening a first valve of the reagent card box;

the inside second that is equipped with of second mounting panel holds the room and with the second holds the third guide through hole that the room is linked together, the third elastic component is located the second holds indoorly, the one end that the second compressed tightly is located the second holds the inside of room and with the third elastic component links to each other, the second compress tightly the piece set up movably in the third guide through hole, the other end that the second compressed tightly stretches out the outside of third guide through hole and is used for compressing tightly or unclamping the second valve of reagent card box.

An in vitro analysis diagnosis detection device comprises the card box valve control component.

When the in-vitro analysis, diagnosis and detection device needs to detect sample liquid in the reagent card box, the reagent card box is arranged in the bracket, the first driving mechanism moves the first air pipe and the second air pipe to the first position, so that the first joint is communicated with the first air hole in a butt joint way, and the third joint is communicated with the second air hole in a butt joint way; when the gas circuit control assembly works in a first working state, the first gas hole is communicated with the pressure control mechanism in a butt joint mode through the first gas pipe, the second gas hole is communicated with the atmosphere environment through the second gas pipe, and the suction force provided by the pressure control mechanism acts on the reagent card box, so that sample liquid in the reagent card box is transferred between the chambers; similarly, when the air channel control assembly works in a second working state, the second air hole is in butt joint communication with the pressure control mechanism through the second air pipe, the first air hole is communicated with the atmospheric environment through the first air pipe, and the suction force provided by the pressure control mechanism acts on the reagent card box, so that the sample liquid in the reagent card box is transferred between the chambers. So, switch the action through gas circuit control assembly, can realize that the first gas pocket of reagent card box communicates through first trachea and pressure control mechanism, also can realize that the second gas pocket of reagent card box communicates through second trachea and pressure control mechanism, can provide power according to reagent card box's technology demand and promote sample liquid and shift between the cavity, and the overall structure of card box valve control assembly is comparatively simplified simultaneously.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this application, illustrate embodiments of the invention and, together with the description, serve to explain the invention and not to limit the invention.

In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed to be used in the description of the embodiments will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

FIG. 1 is a schematic view of a cartridge valve control assembly according to an embodiment of the present invention;

FIG. 2 is a schematic view of another embodiment of a cartridge valve control assembly;

FIG. 3 is a schematic view of a view angle structure of the cassette valve control assembly with the gas path control assembly and the pressure control mechanism hidden therein according to an embodiment of the present invention;

FIG. 4 is a schematic view of another perspective structure of the cassette valve control assembly with the gas path control assembly and the pressure control mechanism hidden therein according to an embodiment of the present invention;

FIG. 5 is a schematic view of a reagent cartridge according to an embodiment of the present invention;

FIG. 6 is a perspective view of a first mounting plate according to an embodiment of the present invention;

FIG. 7 is a view of the first mounting plate from another perspective in accordance with one embodiment of the present invention;

FIG. 8 is a further perspective view of the first mounting plate of one embodiment of the present invention;

FIG. 9 is a cross-sectional view at B-B of FIG. 8;

FIG. 10 is a perspective view of a second mounting plate according to an embodiment of the present invention;

FIG. 11 is a perspective view of the slide rail assembly according to an embodiment of the present invention;

FIG. 12 is a schematic view of another embodiment of a slide rail assembly according to the present invention;

FIG. 13 is a perspective view of a bracket of the cartridge valve control assembly in accordance with one embodiment of the present invention;

FIG. 14 is a view of another perspective of the carriage of the cartridge valve control assembly in accordance with one embodiment of the present invention;

fig. 15 is an enlarged schematic view of the guide plate of fig. 14 after it is hidden and at a.

10. A support; 11. a support plate; 111. a first recess; 112. an inlet and an outlet; 113. an activity room; 12. a guide plate; 121. a first via hole; 122. a second via hole; 20. a first hold-down assembly; 21. a first drive mechanism; 22. a first air pipe; 221. a first joint; 222. a second joint; 223. a second step; 23. a second air pipe; 231. a third joint; 232. a fourth joint; 24. a first mounting plate; 241. a first accommodating chamber; 242. a first guide through hole; 243. a second guide through hole; 244. a first step; 25. a first elastic member; 26. a first pressing member; 27. a second elastic member; 31. a gas circuit control assembly; 32. a pressure control mechanism; 40. a reagent cartridge; 41. a first air hole; 42. a second air hole; 43. a projection; 44. a first valve; 45. a second valve; 46. a sample chamber; 47. a pre-processing chamber; 48. a mixing chamber; 49. a PCR chamber; 50. a limit baffle; 51. a blocking portion; 511. a guide edge; 52. a rotating member; 53. a fourth elastic member; 60. a second hold-down assembly; 61. a second drive mechanism; 62. a second pressing member; 63. a second mounting plate; 70. a slide rail assembly; 71. a fixed mount; 72. a first slide rail; 73. a second slide rail; 74. a first slider; 75. a second slider; 76. a first connecting plate; 77. a second connecting plate; 81. a first sensor; 82. a first trigger; 83. a second sensor; 84. a second trigger; 91. a thermal cracking assembly; 92. a magnetic hybrid assembly.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention more comprehensible, embodiments accompanying figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.

Referring to fig. 1 to 9, fig. 1 and 2 respectively illustrate two different perspective structural diagrams ofbase:Sub>A cassette valve control assembly in an embodiment of the present invention, fig. 3 and 4 respectively illustrate two different perspective structural diagrams of the cassette valve control assembly in an embodiment of the present invention with an air channel control assembly 31 andbase:Sub>A pressure control assembly 32 hidden, fig. 5 illustratesbase:Sub>A schematic structural diagram ofbase:Sub>A reagent cassette 40 in an embodiment, fig. 6 to 8 respectively illustrate three different perspective structural diagrams ofbase:Sub>A first mounting plate 24 in an embodiment of the present invention, and fig. 9 illustratesbase:Sub>A cross-sectional view of fig. 8 atbase:Sub>A-base:Sub>A. According to an embodiment of the present invention, the cartridge valve control assembly includes a bracket 10, a first pressing assembly 20, an air passage control assembly 31 and a pressure control mechanism 32. The rack 10 is used to house a reagent cartridge 40. The first pressing assembly 20 includes a first driving mechanism 21, a first air pipe 22 and a second air pipe 23. The first driving mechanism 21 is disposed on the support 10, and the first driving mechanism 21 drives the first air tube 22 and the second air tube 23 to move. One end of the first air pipe 22 is provided with a first joint 221, the other end of the first air pipe 22 is provided with a second joint 222, one end of the second air pipe 23 is provided with a third joint 231, and the other end of the second air pipe 23 is provided with a fourth joint 232. When the first driving mechanism 21 drives the first air tube 22 and the second air tube 23 to move to the first position, the first connector 221 and the third connector 231 are respectively used for being in butt-joint communication with the first air hole 41 and the second air hole 42 of the reagent cartridge 40. The air path control assembly 31 is respectively communicated with the second connector 222, the fourth connector 232 and the pressure control mechanism 32.

The air path control assembly 31 has a first operating state and a second operating state. When the air channel control assembly 31 works in the first working state, the air channel control assembly is used for controlling the second connector 222 to be communicated with the pressure control mechanism 32, and the fourth connector 232 is communicated with the atmospheric environment; when the air channel control assembly 31 operates in the second operating state, it is used to control the second connector 222 to communicate with the atmosphere, and the fourth connector 232 communicates with the pressure control mechanism 32.

When the detection work of the sample liquid in the reagent cartridge 40 is required, the reagent cartridge 40 is loaded into the bracket 10, the first driving mechanism 21 moves the first air pipe 22 and the second air pipe 23 to the first position, so that the first joint 221 is in butt joint communication with the first air hole 41, and the third joint 231 is in butt joint communication with the second air hole 42; when the air channel control assembly 31 works in the first working state, the first air hole 41 is in butt joint communication with the pressure control mechanism 32 through the first air pipe 22, the second air hole 42 is in communication with the atmosphere through the second air pipe 23, and the suction force provided by the pressure control mechanism 32 acts on the reagent cartridge 40, so that the sample liquid in the reagent cartridge 40 is transferred between the chambers; similarly, when the air channel control assembly 31 operates in the second operating state, the second air hole 42 is in butt communication with the pressure control mechanism 32 through the second air tube 23, the first air hole 41 is in communication with the atmosphere through the first air tube 22, and the suction force provided by the pressure control mechanism 32 acts on the reagent cartridge 40, so that the sample liquid inside the reagent cartridge 40 is transferred between the chambers. Thus, the gas circuit control assembly 31 is used for switching, so that the first gas hole 41 of the reagent card box 40 can be communicated with the pressure control mechanism 32 through the first gas pipe 22, the second gas hole 42 of the reagent card box 40 can be communicated with the pressure control mechanism 32 through the second gas pipe 23, power can be provided according to the process requirements of the reagent card box 40 to push sample liquid to transfer between chambers, and the whole structure of the card box valve control assembly is simplified.

It should be noted that, the reagent cartridge 40 in this embodiment is provided with at least two chambers, a flow path, a first air hole 41 and a second air hole 42, at least two chambers are communicated through the flow path, both the first air hole 41 and the second air hole 42 are communicated with the flow path, and the specific structural form of the flow path is not limited herein, and may be set according to actual requirements.

Referring to fig. 5, specifically, the at least two chambers are, for example, a sample chamber 46, a pretreatment chamber 47, a mixing chamber 48 and a PCR chamber 49, but may be other functional chambers. The specific number of the sample chamber 46, the pretreatment chamber 47, the mixing chamber 48 and the PCR chamber 49 is not limited, and can be set according to actual requirements. In this embodiment, the sample chamber 46 is one for accommodating a sample liquid; the pretreatment chamber 47 is one for performing a pyrolysis treatment on the sample liquid, for example; the mixing chambers 48 are, for example, two chambers for mixing the sample liquid with the lyophilized reagent; the PCR chambers 49 are, for example, two chambers, and are used for performing a polymerase chain reaction and a molecular detection process on the sample liquid.

Referring to fig. 6 to 9, in one embodiment, the first connector 221 and the third connector 231 are vacuum chucks. Thus, when the first joint 221 is in butt joint communication with the first air hole 41, the vacuum chuck completely covers the outside of the hole wall of the first air hole 41, and the butt joint sealing performance between the first joint 221 and the first air hole 41 can be ensured; similarly, when the third joint 231 is in butt-joint communication with the second air hole 42, the vacuum chuck can completely cover the outside of the hole wall of the second air hole 42, and the butt-joint sealing performance between the third joint 231 and the second air hole 42 can be ensured.

Referring to fig. 1 and 2, in addition, the air path control component 31 includes, for example, electromagnetic control valves (for example, two in number as illustrated in fig. 1 and 2) and pipes (hidden and not illustrated in fig. 1 and 2). The solenoid control valve is respectively communicated with the second joint 222, the fourth joint 232 and the pressure control mechanism 32 through pipelines. The pressure control mechanism 32 is embodied as a vacuum pump, suction fan, plunger pump, or the like. The solenoid-operated valve is provided with a first operation state and a second operation state, and when the solenoid-operated valve switches the operation states, it enables the first air vent 41 of the reagent cartridge 40 to communicate with the pressure control mechanism 32 through the first air tube 22, and enables the second air vent 42 of the reagent cartridge 40 to communicate with the pressure control mechanism 32 through the second air tube 23. It should be noted that the number of the electromagnetic control valves, the specific structure of the pipeline, and the setting positions of the electromagnetic control valves on the pipeline are not limited herein, and the setting is set according to actual requirements as long as at least the first working state and the second working state can be realized. For example, when one of the two solenoid control valves is actuated, the second connector 222 is communicated with the air pump through a pipeline, or the second connector 222 is communicated with the atmosphere through a pipeline, and the other solenoid control valve is actuated synchronously, the fourth connector 232 is communicated with the atmosphere through a pipeline, or the fourth connector 232 is communicated with the air pump through a pipeline.

In one embodiment, the first compression assembly 20 further includes a first mounting plate 24. The first air pipe 22 and the second air pipe 23 are both disposed on the first mounting plate 24. The first driving mechanism 21 is connected with the first mounting plate 24, and the first driving mechanism 21 drives the first mounting plate 24 to move. Therefore, the first driving mechanism 21 drives the first mounting plate 24 to move, the first mounting plate 24 drives the first air pipe 22 and the second air pipe 23 to move synchronously, and the first joint 221 and the first air hole 41 can be communicated in a butt joint mode, and the third joint 231 and the second air hole 42 can be communicated in a butt joint mode.

In one embodiment, the first compression assembly 20 further includes a first resilient member 25. The first air pipe 22 is connected to the first mounting plate 24 by a first elastic member 25. Thus, when the first joint 221 of the first air tube 22 is in butt joint with the first air hole 41 of the reagent cartridge 40 under the pushing of the first driving mechanism 21, the first elastic member 25 plays a role in buffering, so as to prevent the first joint 221 from damaging the reagent cartridge 40.

In one embodiment, the first mounting plate 24 is provided with a first guiding through hole 242, the first air tube 22 is movably disposed in the first guiding through hole 242, a first step 244 is disposed on a hole wall of the first guiding through hole 242, a second step 223 is disposed on an outer wall of the first air tube 22, and two ends of the first elastic member 25 respectively abut against the first step 244 and the second step 223.

Specifically, the first elastic element 25 is a spring sleeved on the outer wall of the air tube, and two ends of the spring respectively abut against the first step 244 and the second step 223.

It should be noted that the second air tube 23 is mounted on the first mounting plate 24 in a manner similar to that of the first air tube 22, and the description thereof is omitted here.

Referring to fig. 3 and 4, and 13 to 15, further, the card box valve control assembly further includes a limit baffle 50 and a fourth elastic member 53. The bracket 10 includes a support plate 11 and a guide plate 12. One of the side surfaces of the support plate 11 is provided with a first recess 111, the first recess 111 being adapted to accommodate the reagent cartridge 40. The guide plate 12 is provided on one side surface of the support plate 11, and the guide plate 12 is configured to abut against a side surface of the reagent cartridge 40 loaded into the first recess 111. One side wall of the first recess 111 is provided with an inlet/outlet 112, and the other side wall of the first recess 111 is provided with a movable chamber 113. The movable chamber 113 communicates with the first recess 111. The limit baffle 50 is movably arranged in the movable chamber 113, the limit baffle 50 is connected with the wall of the movable chamber 113 through a fourth elastic piece 53, and the limit baffle 50 is provided with a blocking part 51. The blocking portion 51 is used to interfere with the reagent cartridge 40 loaded into the first recess 111. In this way, when the reagent cartridge 40 needs to be tested, the reagent cartridge 40 enters the first recess 111 through the inlet/outlet 112 along the guide plate 12, that is, the guide plate 12 guides the reagent cartridge 40, and the reagent cartridge 40 enters the first recess 111 and then is relatively stable in position under the action of the guide plate 12 and the support plate 11, so that the relative position of the reagent cartridge 40 can be ensured to be relatively accurate, and the reagent cartridge 40 can be aligned with the first pressing member 61, the second pressing member 62, the first joint 221, the second joint 222, the third joint 231, the fourth joint 232, and other components; in addition, under the elastic force of the fourth elastic member 53, the blocking portion 51 of the limiting baffle 50 is pressed against the reagent cartridge 40 at a certain pressure, so that the reagent cartridge 40 cannot easily separate from the inlet/outlet 112, i.e., the reagent cartridge 40 can be stably disposed on the cartridge valve control assembly, thereby ensuring the accuracy of the detection result of the reagent cartridge 40, and the overall structure of the cartridge valve control assembly is simple and reliable.

After the analysis and detection operation of the reagent cartridge 40 is completed, the stopper 50 is driven to move so that the blocking portion 51 is separated from the reagent cartridge 40, and the reagent cartridge 40 is taken out through the inlet/outlet 112.

It should be noted that the "blocking portion 51" may be a part of the "limit baffle 50", that is, the "blocking portion 51" and the "other part of the limit baffle 50" are integrally formed; or a separate member which can be separated from the other parts of the limit stop 50, that is, the blocking part 51 can be manufactured separately and then combined with the other parts of the limit stop 50 into a whole. As shown in fig. 15, in one embodiment, the "blocking portion 51" is a part of the "limit stop 50" that is integrally formed.

Referring to fig. 14 and 15, further, one end of the limit stop 50 is rotatably connected to the wall of the movable chamber 113 through the rotating member 52. The other end of the limit baffle 50 is connected with the wall of the movable chamber 113 through a fourth elastic member 53, and the other end of the limit baffle 50 is further provided with a blocking part 51.

Referring to fig. 5, 14 and 15, in one embodiment, the blocking portion 51 is provided with a guiding edge 511, and the guiding edge 511 is disposed to be inclined toward the entrance 112. The inclination angle of the guiding edge 511 with respect to the direction in which the reagent cartridge 40 enters and exits the first recess 111 is a, and a is 30 ° to 60 °, but a may be any angle from 0 ° to 90 °, and is not limited herein and may be set according to actual requirements. When the reagent cartridge 40 is inserted into the first concave portion 111 through the inlet/outlet 112, the projection 43 of the reagent cartridge 40 contacts the guiding edge 511, gradually enters the first concave portion 111 under the guiding action of the guiding edge 511, and simultaneously pushes and compresses the fourth elastic member 53 through the guiding edge 511; when the reagent cartridge 40 moves to the proper position, the blocking portion 51 is restored under the action of the fourth elastic member 53 and then is in limit contact with the protruding portion 43 of the reagent cartridge 40, so that the effect of clamping the protruding portion 43 of the reagent cartridge 40 can be achieved, and the reagent cartridge 40 is prevented from being separated from the outlet 112.

The direction in which the reagent cartridge 40 moves into and out of the first recess 111 is indicated by a double-headed arrow S in fig. 15.

Referring to fig. 3, 4, and 6 to 8, fig. 6 to 8 respectively show structural schematic diagrams of the first mounting plate 24 at three different viewing angles according to an embodiment. In one embodiment, the first compression assembly 20 further includes at least one first compression member 26. At least one first compression member 26 is mounted on the first mounting plate 24. The first compression member 26 is used to compress or release the first valve 44 of the reagent cartridge 40. Specifically, the first pressing member 26 is, for example, a thimble, a push rod, or the like, as long as the first valve 44 can be pushed to close the first valve 44, or the first valve 44 can be opened when the first valve 44 is released. The size of the abutting end face of the first pressing member 26 is set to correspond to the size of the first valve 44.

Referring to fig. 3, 4 and 10, in one embodiment, the door control assembly further includes a second pressing member 60 disposed on the supporting plate 11. The second compression assembly 60 includes a second drive mechanism 61, a second mounting plate 63, and at least one second compression member 62. At least one second compression member 62 is mounted on the second mounting plate 63. The second driving mechanism 61 is connected to the second mounting plate 63 for driving the second mounting plate 63 closer to or farther from the stand 10. Thus, the second driving mechanism 61 drives the second mounting plate 63 to move, the second mounting plate 63 drives the second pressing member 62 to move, and the second pressing member 62 can press or release the second valve 45 of the reagent cartridge 40. When the second pressing member 62 presses the second valve 45, the second valve 45 is closed; when the second pressing member 62 releases the second valve 45, the opening of the second valve 45 is achieved.

Referring to FIGS. 6 to 10, in one embodiment, the first mounting plate 24 is provided with the number of the first clamping members 26 not less than the number of the first valves 44 of the reagent cartridge 40, and the second mounting plate 63 is provided with the number of the second clamping members 62 not less than the number of the second valves 45 of the reagent cartridge 40. In this way, when the first driving mechanism 21 drives the first mounting plate 24 to move, all the first valves 44 of the reagent cartridge 40 can be opened or closed; likewise, when the second driving mechanism 61 drives the second mounting plate 63 to move, all the second valves 45 of the reagent cartridge 40 can be opened or closed. For example, the number of the first compressing members 26 in this embodiment is four, wherein three first compressing members 26 are disposed corresponding to three first valves 44 of the reagent cartridge 40, and another first compressing member 26 is also used for compressing or releasing the reagent cartridge 40, but is not compressed at the position where the first valve 44 is disposed, so as to ensure a better compressing effect on the side surface of the reagent cartridge 40. In addition, the number of the second compressing members 62 in this embodiment is, for example, four, and four second compressing members 62 are provided in one-to-one correspondence with the four second valves 45 of the reagent cartridge 40.

As an alternative, for example, the first pressing member 26 of the first pressing assembly 20 and the second pressing member 62 of the second pressing assembly 60 are collectively disposed on the same mounting plate, that is, two mounting plates are not required, and the mounting plate on which the first pressing member 26 and the second pressing member 62 are disposed is driven to move by a driving mechanism. In addition, for example, a third pressing assembly or a fourth pressing assembly, etc. are also provided, and are not limited herein.

The first driving mechanism 21 is, for example, a motor screw driving structure, a cylinder driving structure, a hydraulic cylinder driving structure, an electric cylinder driving structure, a cam driving structure, etc., and is not limited herein, and may be provided according to actual requirements. The second driving mechanism 61 is similar to the first driving mechanism 21, and will not be described in detail.

Referring to fig. 3, 4, 11 and 12, fig. 11 and 12 respectively show two different perspective structural schematic views of the slide rail assembly 70. In one embodiment, the cartridge valve control assembly further comprises a slide rail assembly 70. The slide rail assembly 70 includes a fixing frame 71 installed on the supporting plate 11, a first slide rail 72 and a second slide rail 73 installed on the fixing frame 71, a first slider 74 slidably installed on the first slide rail 72, a second slider 75 slidably installed on the second slide rail 73, a first connecting plate 76 connected to the first slider 74, and a second connecting plate 77 connected to the second slider 75. A first connecting plate 76 is connected to the first mounting plate 24 and a second connecting plate 77 is connected to the second mounting plate 63. Like this, when first actuating mechanism 21 drive first mounting panel 24 removed, first connecting plate 76 drives first slider 74 and removes along first slide rail 72, and the operating stability of first mounting panel 24 is better like this, and then can control the motion stroke of first mounting panel 24 comparatively accurately, and the motion stroke precision of first pressure piece 26 reaches 0.05mm promptly. In addition, due to the high precision of the movement stroke of the first compressing member 26, when the first valve 44 is opened, under the power of the first driving mechanism 21, the first compressing member 26 moves away from the first valve 44 by a distance of, for example, 0.1mm or 0.2mm to release the first valve 44 of the reagent cartridge 40, and at this time, the first compressing member 26 still interferes with the side surface of the reagent cartridge 40 to play a positioning role, so that the reagent cartridge 40 is stably disposed on the rack 10.

Similarly, when the second driving mechanism 61 drives the second mounting plate 63 to move, the second connecting plate 77 drives the second slider 75 to move along the second slide rail 73, so that the operation stability of the second mounting plate 63 is good, and the movement stroke of the second mounting plate 63 can be controlled accurately, that is, the movement stroke precision of the second pressing member 62 reaches 0.05mm.

Specifically, the first mounting plate 24, the second mounting plate 63, the first sliding block 74, the second sliding block 75, the first connecting plate 76, and the second connecting plate 77 are specifically made of, for example, aluminum, copper, iron, stainless steel, wood, plastic, etc., and are not limited herein, and may be set according to actual requirements.

It should be noted that the "first connecting plate 76" may be a part of the "first slider 74", that is, the "first connecting plate 76" and the "other part of the first slider 74" are integrally formed; or a separate member that is separable from the "other portion of the first slider 74", i.e., the "first connecting plate 76" may be separately manufactured and then integrated with the "other portion of the first slider 74".

In one embodiment, the cartridge valve control assembly further comprises a first sensor 81 and a first trigger member 82 in inductive engagement with the first sensor 81. The first sensor 81 is mounted on the bracket 10, and the first trigger 82 is mounted on the first mounting plate 24 or the first connecting plate 76. In this way, the first sensor 81 can sense the moving position of the first trigger 82, and the moving position information of the first mounting plate 24 can be obtained according to the sensing signal of the first trigger 82, so that the moving stroke of the first pressing member 26 can be correspondingly controlled within the preset range.

In addition, the cartridge valve control assembly further includes a second sensor 83 and a second trigger 84 that is in inductive engagement with the second sensor 83. The second sensor 83 is mounted on the support plate 11, and the second triggering member 84 is mounted on the second mounting plate 63 or the second connecting plate 77.

Specifically, the first sensor 81 is a photoelectric switch, a proximity switch, a correlation sensor or other types of sensors, as long as it can sense the moving position of the first trigger 82 and timely feed back the moving position signal of the first trigger 82. The second sensor 83 is similar to the first sensor 81 and will not be described in detail.

In one embodiment, the first compression assembly 20 further includes at least one second resilient member 27 mounted to the first mounting plate 24. The at least one first pressing member 26 is disposed in one-to-one correspondence with the at least one second elastic member 27, and the first pressing member 26 is connected to the first mounting plate 24 through the second elastic member 27. In this way, the first pressing member 26 can avoid damage to the reagent cartridge 40 during contact with the first valve 44 under the buffering action of the second elastic member 27.

Similarly, the second pressing assembly 60 further includes at least one third elastic member mounted on the second mounting plate 63, and the at least one second pressing member 62 is disposed in one-to-one correspondence with the at least one third elastic member. The second pressing member 62 is connected to the second mounting plate 63 through a third elastic member. Likewise, the second presser member 62 can avoid damage to the reagent cartridge 40 during contact with the second valve 45 under the cushioning action of the third resilient member.

Referring to fig. 8 and 9, in one embodiment, the first mounting plate 24 is provided therein with a first accommodating chamber 241 and a second guiding through hole 243 communicated with the first accommodating chamber 241. The second elastic member 27 is disposed in the first accommodating chamber 241, one end of the first pressing member 26 is disposed inside the first accommodating chamber 241 and connected to the second elastic member 27, the first pressing member 26 is movably disposed in the second guide through hole 243, and the other end of the first pressing member 26 protrudes outside the second guide through hole 243 and is used to press or release the first valve 44 of the reagent cartridge 40.

Similarly, the second mounting plate 63 is provided therein with a second accommodating chamber (not shown) and a third guide through-hole (not shown) communicating with the second accommodating chamber. The third elastic piece is arranged in the second accommodating chamber. One end of the second pressing member 62 is located inside the second receiving chamber and connected to the third elastic member, the second pressing member 62 is movably disposed in the third guide through hole, and the other end of the second pressing member 62 protrudes outside the third guide through hole and is used to press or release the second valve 45 of the reagent cartridge 40.

Specifically, the first elastic member 25, the second elastic member 27, the third elastic member and the fourth elastic member 53 are, for example, springs, elastic blocks, etc., and are not limited herein, and may be provided according to actual requirements.

Referring to fig. 13, in one embodiment, the cartridge valve control assembly further comprises a thermal cracking assembly 91, the thermal cracking assembly 91 is disposed on the support plate 11 for performing a thermal cracking process on the liquid in the pre-processing chamber 47 of the reagent cartridge 40. In addition, the cartridge valve control assembly further comprises a magnetic mixing assembly 92, wherein the magnetic mixing assembly 92 is disposed on the support plate 11 and is used for moving the magnetic beads in the mixing chamber 48 of the reagent cartridge 40 up and down, so that the liquid in the mixing chamber 48 is fully mixed to obtain the required mixed liquid.

Referring to fig. 4, in one embodiment, in order to prevent the first pressing member 26 or the air tube from interfering with the guide plate 12 in the process of pressing the reagent cartridge 40 on the side surface, at least one first through hole 121 and at least one second through hole 122 are formed in the guide plate 12, and the at least one first through hole 121 and the at least one first pressing member 26 are disposed in a one-to-one correspondence, so that the first pressing member 26 can pass through; the at least one second through hole 122 is disposed corresponding to the first joint 221 of the first air tube 22 and also corresponding to the third joint 231 of the second air tube 23, and allows the first joint 221 to pass through and the third joint 231 to pass through.

Referring again to fig. 1 to 9, in one embodiment, an in vitro diagnostic test device includes a cartridge valve control assembly according to any of the above embodiments.

When the in-vitro analysis, diagnosis and detection device needs to detect the sample liquid in the reagent cartridge 40, the reagent cartridge 40 is loaded into the rack 10, the first driving mechanism 21 moves the first air tube 22 and the second air tube 23 to the first position, so that the first joint 221 is in butt-joint communication with the first air hole 41, and the third joint 231 is in butt-joint communication with the second air hole 42; when the air channel control assembly 31 works in the first working state, the first air hole 41 is in butt joint communication with the pressure control mechanism 32 through the first air pipe 22, the second air hole 42 is in communication with the atmosphere through the second air pipe 23, and the suction force provided by the pressure control mechanism 32 acts on the reagent cartridge 40, so that the sample liquid in the reagent cartridge 40 is transferred between the chambers; similarly, when the air channel control assembly 31 operates in the second operating state, the second air hole 42 is in butt communication with the pressure control mechanism 32 through the second air tube 23, the first air hole 41 is in communication with the atmosphere through the first air tube 22, and the suction force provided by the pressure control mechanism 32 acts on the reagent cartridge 40, so that the sample liquid inside the reagent cartridge 40 is transferred between the chambers. Thus, the gas circuit control assembly 31 is used for switching, so that the first gas hole 41 of the reagent card box 40 can be communicated with the pressure control mechanism 32 through the first gas pipe 22, the second gas hole 42 of the reagent card box 40 can be communicated with the pressure control mechanism 32 through the second gas pipe 23, power can be provided according to the process requirements of the reagent card box 40 to push sample liquid to transfer between chambers, and the whole structure of the card box valve control assembly is simplified.

In one specific embodiment, the method of operating the cartridge valve control assembly comprises the steps of:

and step S10, sample adding. The patient sample is loaded into the sample chamber 46 of the reagent cartridge 40 and the lid of the reagent cartridge 40 is closed and the reagent cartridge 40 is inserted into the rack 10. The limiting baffle 50 has a limiting function, and can prevent the reagent cartridge 40 from falling off from the support 10.

Step S20, after the reagent cartridge 40 is mounted on the support 10, the first compressing assembly 20 and the second compressing assembly 60 work, the first driving mechanism 21 drives the first mounting plate 24 to move close to the support 10, the second driving mechanism 61 drives the second mounting plate 63 to move close to the support 10, so as to realize the butt-joint communication between the first joint 221 and the first air hole 41, the butt-joint communication between the third joint 231 and the second air hole 42, meanwhile, the three first compressing members 26 tightly abut against the three first valves 44 of the reagent cartridge 40 one by one, the other first compressing member 26 abuts against the reagent cartridge 40, and the four second compressing members 62 tightly abut against the four second valves 45 of the reagent cartridge 40 one by one, so as to clamp and fix the reagent cartridge 40.

Step S30, after the reagent cartridge 40 is completely clamped, controlling the air path control assembly 31 to operate in the first operating state, so that the second air hole 42 is communicated with the atmosphere, the first air hole 41 is communicated with the plunger pump, and the plunger pump provides a negative pressure to the first air hole 41 through the reverse movement of the piston, so that the sample liquid in the reagent cartridge 40 moves from the sample chamber to the pre-processing chamber 47.

In step S40, after the sample liquid is filled in the pre-processing chamber 47, the first driving mechanism 21 is controlled to move the first mounting plate 24 such that the first mounting plate 24 drives the first pressing member 26 to be away from the reagent cartridge 40 by a predetermined distance, so as to open the three first valves 44 of the reagent cartridge 40. And meanwhile, the air path control assembly 31 is controlled to work in a second working state, so that the first air hole 41 is communicated with the atmospheric environment, the second air hole 42 is communicated with the plunger pump, and the plunger pump provides negative pressure for the second air hole 42 through the reverse movement of the piston. At this point, the lysed sample fluid is drawn into 2 mixing chambers 48, which reconstitutes the lyophilized reagents therein.

Step S50, driving the first driving mechanism 21 to move a preset distance, so that the three first compressing members 26 tightly abut against the three first valves 44 of the reagent cartridge 40 in a one-to-one correspondence manner, that is, the three first valves 44 are closed, the magnetic mixing component 92 is opened, the magnetic mixing component 92 is periodically powered on and off to generate a periodic magnetic force, the magnetic beads arranged in the mixing chamber 48 are driven to reciprocate up and down, and the redissolved lyophilized reagent and the sample liquid are uniformly mixed.

After the mixing is finished, the second driving mechanism 61 is driven to move for a preset distance, so that the four second pressing members 62 are separated from the four second valves 45, and the four second valves 45 are opened. The second vent 42 is pressurized by the forward motion of the piston in the plunger pump, allowing sample to flow from the mixing chamber 48 into the two PCR chambers 49.

In step S70, the four second pressing members 62 tightly abut against the four second valves 45 while maintaining a predetermined pressure, and the four second valves 45 are closed, so that the PCR chamber of the reagent cartridge 40 is slightly bulged. While the four second valves 45 are closed, the optical window corresponding to the PCR chamber 49 can also be pressed against the front face of the PCR chamber 49 of the reagent cartridge 40. The PCR chamber 49 of the reagent cartridge 40 is slightly bulged due to a certain pressure so as to be closely attached to the PCR optical window for the next operation.

Step S80, the first driving mechanism 21 and the second driving mechanism 61 are reset, the first pressing member 26, the second pressing member 62, the first joint 221 and the third joint 231 loosen the reagent cartridge 40, and the plunger pump is reset.

All possible combinations of the technical features in the above embodiments may not be described for the sake of brevity, but should be considered as being within the scope of the present disclosure as long as there is no contradiction between the combinations of the technical features.

The above examples only show some embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

In the description of the present invention, it is to be understood that the terms "central," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," "circumferential," and the like are used in the orientations and positional relationships indicated in the drawings for convenience in describing the invention and to simplify the description, and are not intended to indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and are not to be considered limiting of the invention.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of the present invention, "a plurality" means at least two, e.g., two, three, etc., unless specifically limited otherwise.

In the present invention, unless otherwise expressly stated or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be interconnected within two elements or in a relationship where two elements interact with each other unless otherwise specifically limited. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

In the present invention, unless otherwise expressly stated or limited, the first feature "on" or "under" the second feature may be directly contacting the first and second features or indirectly contacting the first and second features through an intermediate. Also, a first feature "on," "over," and "above" a second feature may be directly or diagonally above the second feature, or may simply indicate that the first feature is at a higher level than the second feature. A first feature "under," "beneath," and "under" a second feature may be directly under or obliquely under the second feature, or may simply mean that the first feature is at a lesser elevation than the second feature.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like as used herein are for illustrative purposes only and do not denote a unique embodiment.

Claims (12)

1. A cassette valve control assembly, comprising:

a rack for housing a reagent cartridge;

the reagent card box comprises a first pressing assembly, a second pressing assembly and a clamping assembly, wherein the first pressing assembly comprises a first driving mechanism, a first air pipe and a second air pipe, the first driving mechanism is arranged on the bracket and drives the first air pipe and the second air pipe to move, a first joint is arranged at one end of the first air pipe, a second joint is arranged at the other end of the first air pipe, a third joint is arranged at one end of the second air pipe, a fourth joint is arranged at the other end of the second air pipe, and when the first driving mechanism drives the first air pipe and the second air pipe to move to a first position, the first joint and the third joint are respectively used for being in butt joint communication with a first air hole and a second air hole of the reagent card box;

the gas path control assembly is communicated with the second joint, the fourth joint and the pressure control mechanism respectively; the gas circuit control assembly is provided with a first working state and a second working state; when the gas circuit control assembly works in the first working state, the gas circuit control assembly is used for controlling the second connector to be communicated with the pressure control mechanism, and the fourth connector is communicated with the atmospheric environment; and when the gas circuit control assembly works in the second working state, the gas circuit control assembly is used for controlling the second joint to be communicated with the atmospheric environment, and the fourth joint is communicated with the pressure control mechanism.

2. The cartridge valve control assembly of claim 1, wherein said first connector and said third connector are vacuum cups.

3. The cartridge valve control assembly of claim 1, wherein said first hold down assembly further comprises a first mounting plate; the first air pipe and the second air pipe are both arranged on the first mounting plate; the first driving mechanism is connected with the first mounting plate and drives the first mounting plate to move.

4. The cassette valve control assembly of claim 3, wherein said first compression assembly further comprises a first resilient member; the first air pipe is connected with the first mounting plate through the first elastic piece.

5. A cartridge valve control assembly according to claim 4, wherein the first mounting plate is provided with a first guiding through hole, the first air tube is movably disposed in the first guiding through hole, a first step is disposed on a wall of the first guiding through hole, a second step is disposed on an outer wall of the first air tube, and two ends of the first elastic member respectively and correspondingly abut against the first step and the second step.

6. The cassette valve control assembly of claim 3, said first compression assembly further comprising at least one first compression member; at least one first pressing piece is arranged on the first mounting plate; the first compressing member is used for compressing or loosening the first valve of the reagent card box.

7. The cartridge valve control assembly of claim 6 further comprising a second hold down assembly; the second pressing assembly comprises a second driving mechanism, a second mounting plate and at least one second pressing piece; the second driving mechanism is arranged on the bracket, and at least one second pressing piece is arranged on the second mounting plate; the second driving mechanism is connected with the second mounting plate and used for driving the second mounting plate to be close to or far away from the support.

8. The cartridge valve control assembly of claim 7 further comprising a slide rail assembly; the sliding rail assembly comprises a fixed frame arranged on the bracket, a first sliding rail and a second sliding rail which are arranged on the fixed frame, a first sliding block which is arranged on the first sliding rail in a sliding manner, a second sliding block which is arranged on the second sliding rail in a sliding manner, a first connecting plate connected with the first sliding block, and a second connecting plate connected with the second sliding block; the first connecting plate is connected with the first mounting plate, and the second connecting plate is connected with the second mounting plate.

9. The cartridge valve control assembly of claim 8 further comprising a first sensor and a first trigger member in inductive engagement with said first sensor; the first sensor is arranged on the bracket, and the first trigger piece is arranged on the first mounting plate or the first connecting plate; the card box valve control component also comprises a second sensor and a second trigger piece in inductive fit with the second sensor; the second sensor is arranged on the bracket, and the second trigger piece is arranged on the second mounting plate or the second connecting plate.

10. The cartridge valve control assembly of claim 7, wherein said first biasing assembly further comprises at least one second resilient member mounted to said first mounting plate, at least one of said first biasing members being disposed in one-to-one correspondence with at least one of said second resilient members, said first biasing member being coupled to said first mounting plate via said second resilient member;

the second pressing component further comprises at least one third elastic piece arranged on the second mounting plate, the at least one second pressing piece and the at least one third elastic piece are arranged in a one-to-one correspondence mode, and the second pressing piece is connected with the second mounting plate through the third elastic piece.

11. The cartridge valve control assembly of claim 10, wherein the first mounting plate has a first receiving chamber and a second guiding through hole communicating with the first receiving chamber, the second elastic member is disposed in the first receiving chamber, one end of the first pressing member is disposed in the first receiving chamber and connected to the second elastic member, the first pressing member is movably disposed in the second guiding through hole, and the other end of the first pressing member extends out of the second guiding through hole and is used for pressing or releasing the first valve of the reagent cartridge;

the inside second that is equipped with of second mounting panel holds the room and with the second holds the third guide through hole that the room is linked together, the third elastic component is located the second holds indoorly, the one end that the second compressed tightly is located the second holds the inside of room and with the third elastic component links to each other, the second compress tightly the piece set up movably in the third guide through hole, the other end that the second compressed tightly stretches out the outside of third guide through hole and is used for compressing tightly or unclamping the second valve of reagent card box.

12. An in vitro diagnostic test device comprising the cartridge valve control assembly of any one of claims 1 to 11.

Images