Pen provided with protective sleeve and used for detecting analyzed substance in sample

By designing a test sample pen with a protective cover, the problem of separation of sampling and detection in home self-tests is solved, a convenient and efficient detection process is achieved, and the accuracy and user experience of the test results are improved.

CN222762171UActive Publication Date: 2025-04-15VIVACHEK BIOTECH HANGZHOU
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Patent Information

Application Number
CN202421031686.6
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-05-11
Publication Date
2025-04-15
Estimated Expiration
2034-05-11

AI Technical Summary

Technical Problem

In the prior art, sampling and testing need to be carried out separately during home self-testing, which cannot meet the user's convenience needs, and the feces sample detection steps are complex, the risk of pollution is high, and the user experience is poor.

Method used

A pen for detecting sample with protective sleeve is designed, including a pen holder, a protective sleeve and a pen cap. The protective sleeve prevents the pen holder from inserting into the pen cap, ensuring that sampling and inspection are carried out on the same equipment, and the design of the protrusion and reflux chamber to achieve the static and pre-treatment of the samples, improving the accuracy of the detection results.

Benefits of technology

It enables users to select the type of sample to be tested at will and complete the inspection step by step, reducing the need for users to learn different detection methods, improving the convenience and accuracy of detection, and reducing the risk of pollution.

✦ Generated by Eureka AI based on patent content.

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Abstract

The utility model provides a pen with a protective sleeve for detecting an analyzed substance in a sample, which comprises a pen holder, the protective sleeve and a pen cap, and the protective sleeve prevents the pen holder from being inserted into the pen cap; the protective sleeve comprises a cavity wall, a cavity and a safety position, the cavity is defined by the cavity wall, and the safety position protrudes out of the first end of the cavity wall. According to the utility model, various sampling detection devices are integrated, and a small and portable one-step detection pen is provided, so that a user can select the type of a sample to be detected at will and complete detection in one step, and the user does not need to learn to adopt different detection methods according to different samples to be detected under the condition that the sampling device is isolated before being used.
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Description

Technical Field

[0001] The utility model relates to the field of in vitro diagnosis, in particular to a pen with a protective cover for detecting analyzed substances in a sample. Background Art

[0002] The technology of using the principle of immune binding reaction to detect whether the analyte exists in the sample is widely used in various fields, including detecting the analyte in saliva, blood, urine, serum, sweat, feces, wastewater and other samples to monitor the health of humans, animals, plants, and the environment. The fundamental principle of this detection technology is based on the specific binding performance between immune molecules, such as antibodies and antigens, haptens / antibodies, biotin and anti-biotin, etc.

[0003] Saliva and urine are used as samples for disease detection. Since sampling is non-invasive and convenient, they are widely used in epidemic virus detection, drug abuse screening, etc.

[0004] Using blood as a sample for disease detection and applying immunochromatography technology, a variety of different diagnostic reagents have been developed and applied in different disease detection fields, such as: detection of tumor markers, early prediction of cardiovascular diseases, screening and detection of infectious diseases, etc. Blood is a more commonly used sample source, especially fingertip blood, because it is minimally invasive and rapid, and has been widely adopted by various platforms.

[0005] Using feces as a sample for disease detection still needs to be carried out in hospitals due to the relatively complicated testing steps. Even if there are personal home testing products, the testing needs to be completed in steps, which has a high risk of contamination and a poor user experience.

[0006] In the prior art, when the above samples are used for home self-testing, in order to isolate the sampling device and protect the sampling device from contamination, sampling and testing are generally required to be performed separately, which cannot meet the user's demand for testing convenience. Summary of the invention

[0007] In order to solve the problems of the prior art, the utility model provides a pen with a protective cover for detecting analyzed substances in a sample, comprising a pen body, a protective cover, and a pen cap. The protective cover prevents the pen body from being inserted into the pen cap; the protective cover comprises a cavity wall, a cavity body and a safety position, the cavity body is surrounded by the cavity wall, and the safety position is arranged at the first end of the cavity wall.

[0008] Furthermore, the pen cap includes a chamber portion, and a vertical distance L between the safety position and the second end of the cavity wall is smaller than a length K of the chamber portion of the pen cap.

[0009] Particularly, the pen holder comprises a sampling head, and the sampling head is sealed in a space formed by the protective cover and the pen holder.

[0010] Furthermore, the pen body includes a protrusion, and the pen cap includes a backflow chamber, and the diameter of the protrusion is equivalent to the inner diameter of the backflow chamber.

[0011] Furthermore, the pen cap also includes a third chamber, and the inner diameter of the third chamber gradually decreases to present a funnel shape.

[0012] In addition, the pen cap also includes a storage chamber, and the storage chamber is detachably connected to the pen cap.

[0013] Furthermore, the pen cap includes a chamber outlet, the storage chamber includes a storage chamber inlet, and the inner diameter of the chamber outlet is greater than or equal to the inner diameter of the storage chamber inlet.

[0014] Furthermore, the pen cap includes a convex strip or a groove, and the storage chamber is connected to the pen cap via the convex strip or the groove.

[0015] In addition, the pen cap includes a yoke portion, the storage chamber includes surrounding wings, the storage chamber is connected to the pen cap through the surrounding wings, and the yoke portion is located in a slit formed by the surrounding wings.

[0016] Furthermore, the pen barrel and the protective cover form a first separate package, and the pen cap forms a second separate package.

[0017] The beneficial effects of the utility model include: 1. It integrates a variety of sampling and testing devices to provide a compact and portable one-step testing pen, so that users can freely choose the type of sample to be tested and complete the test in one step. Under the condition that the sampling device is isolated before use, users do not need to learn to use different testing methods according to the different samples to be tested. 2. The sample to be tested is not directly received by the test paper after sampling, but due to the interaction between the protrusion and the reflux chamber, the sample to be tested is allowed to stand and is further pre-processed in one step before being received by the test paper, so that the test result is more accurate. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 A cross-sectional view of a pen used for detecting an analyte in a sample according to the present invention.

[0019] Figure 2 One of the cross-sectional views of the sampling head of the pen for detecting the analyte in the sample according to the present invention.

[0020] Figure 3 One of the cross-sectional views of the pen cap of the pen for detecting an analyte in a sample according to the present invention.

[0021] Figure 4 The second cross-sectional view of the pen cap of the pen for detecting the analyzed substance in the sample according to the present invention.

[0022] Figure 5 The second cross-sectional view of the sampling head of the pen for detecting the analyzed substance in the sample of the present invention.

[0023] Figure 6The third cross-sectional view of the sampling head of the pen for detecting the analyzed substance in the sample of the present invention.

[0024] Figure 7 The fourth cross-sectional view of the sampling head of the pen for detecting the analyzed substance in the sample of the present invention.

[0025] Pen holder 1; pen cap 2; protective cover 3; cavity wall 33; cavity wall first end 331; cavity wall second end 332; cavity body 30; safety position 31; sampling head 11; chamber 211; chamber entrance 2114; chamber exit 2115; pen cap bottom 220; sealed space 300; sampling head 11; protrusion 1132; first channel 112; first channel entrance 1121; sampling head top 1111; protruding platform 1131; sampling head side wall 1112; second channel 114; second channel entrance 1141; first chamber 2111; second chamber 2112; third chamber 2113; backflow chamber starting end 21 01; reflux chamber termination end 2102; yoke 212; storage chamber 221; storage chamber opening 2211; storage chamber bottom 2212; sealing sheet 2216; one of the convex strips 214; two of the convex strips 226; one of the grooves 227; two of the grooves 213; chamfer 2261; buffer chamber 115; first end 1123 of the water absorbing member; second end 1124 of the water absorbing member; sampling hole 1114; sampling hole opening 1117; sampling hole bottom 1118; filter membrane 1126; surrounding wing 224; slit 225; water absorbing member 1122; first end 1123 of the water absorbing member; second end 1124 of the water absorbing member. Implementation Example 1

[0026] A pen with a protective cover for detecting substances to be analyzed in a sample, comprising a pen cap 2, a protective cover 3 and a pen body 1. The pen body comprises an air vent for maintaining the air pressure balance inside and outside the pen body, and a test paper is contained in the pen body. Before use, the protective cover prevents the pen body from being inserted into the pen cap; when in use, the protective cover between the pen body and the pen cap is removed, the sample to be tested is taken with the pen body, and then the pen body is inserted into the pen cap, so that the pen body moves toward the pen cap, the pen body and the pen cap are gradually tightened after cooperating with each other, and the air vent gradually discharges gas, and the pen body has been completely inserted into the pen cap when tightened. In this process, parts of the pen cap and the pen body contact each other and cause the sample to be tested to flow in the opposite direction of the movement of the pen body, and the test can be completed after waiting for a certain period of time, and the test results can be observed through the pen body. The operation is very simple and easy to understand.

[0027] like Figure 1As shown, (a) is an exploded cross-sectional view of the pen for analyzing substances in the sample, and (b) is a complete cross-sectional view of the pen for analyzing substances in the sample. The pen body includes a sampling head, and a protective cover is arranged on the sampling head. The protective cover can prevent the pen body and the pen cap from contacting each other before the user uses it. When the protective cover is put on the sampling head and the pen cap is put on the protective cover, the pen body and the pen cap can be prevented from contacting each other before the user uses it. The protective cover includes a cavity wall 33, a cavity 30 and a safety position 31. The cavity is surrounded by the cavity wall. The first end 331 of the cavity wall is an open end, and the second end 332 of the cavity wall is a closed end. The safety position is arranged to protrude from the first end of the cavity wall. When the protective cover is put on the pen body and the combination is inserted into the pen cap, the safety position contacts the pen cap but does not enter the pen cap, thereby achieving the purpose of preventing the pen body and the pen cap from contacting each other. The protective cover is mounted on the sampling head, and the cavity of the protective cover accommodates the sampling head therein. A sealed space is formed between the protective cover and the pen body. The sampling head is sealed in the sealed space formed by the protective cover and the pen body, so that the protective cover isolates the fluid connection between the outside of the pen body and the outside of the pen body, and of course isolates the flow connection between the pen body and the pen cap.

[0028] like Figure 3 As shown, the pen cap includes a chamber 211 and a bottom surface 220 of the pen cap. The chamber 211 includes a first chamber (reflux chamber), a chamber inlet 2114 and a chamber outlet 2115. The length of the chamber is K, that is, the length from the chamber inlet to the chamber outlet is K. Figure 1 As shown, when the protective cover is put on the pen barrel and then on the pen cap, the safety position of the protective cover contacts and is supported on the entrance of the chamber, and the second end of the cavity wall does not exceed the exit of the chamber, that is, the vertical distance L between the safety position and the second end of the cavity wall is less than the length K of the chamber.

[0029] For the convenience of packaging, the pen body and the protective cover are packaged together to form a first separate package, and the pen cap is packaged separately to form a second separate package. In this way, after the pen body, the protective cover and the pen cap are produced separately, only the process step of putting the protective cover on the pen body needs to be added, and there is no need to add the process step of putting the pen cap on the protective cover. Example 2

[0030] like Figure 1 As shown, the pen holder includes a sampling head 11 and a protrusion 1132. The sampling head is used to collect samples to be tested. The protrusion can be set on the sampling head or on other positions of the pen holder. When the protective sleeve is put on the pen holder, the sampling head is accommodated in the cavity, and the protrusion contacts the cavity wall, thereby ensuring that the protective sleeve does not fall off the pen holder. A sealed space is formed between the pen holder and the protective sleeve, and the sampling head is sealed in the space formed by the protective sleeve and the pen holder. Figure 2As shown, the sampling head includes a first channel 112 for transmitting the sample to be tested. The first channel is a hollow channel that allows the fluid inside the pen body to communicate with the fluid outside the pen body. The first channel inlet 1121 can be located at any position of the sampling head, such as Figure 2 (a) is located at the top of the sampling head 1111, or as shown in Figure 2 (b), located on the protruding platform 1131 of the sampling head, or as Figure 2 (c) is located on the side wall 1112 of the sampling head. In another embodiment, as shown in Figure 2 As shown in (d), the sampling head includes a second channel 114, the first channel entrance is at the top of the sampling head, and the second channel entrance 1141 is on the protruding platform. In some embodiments, the diameter of the first channel is between 0.1-2 mm, which is calculated based on the properties of the raw materials forming the first channel, the properties of the liquid sample, and the required sample volume. The basic raw material of the first channel can be the same as the other parts of the sampling head, except that a hydrophilic coating is applied to the first channel; or the raw material of the first channel is different from the other parts of the sampling head, and is glass, quartz, or polymers that can be used to make capillaries. More preferably, the diameter of the first channel is between 0.1-1.7 mm, which can be calculated based on the properties of the raw materials of the first channel, the properties of the blood sample, and the required sample volume.

[0031] like Figure 3 As shown in (a), the reflux chamber of the pen cap includes a reflux chamber starting end 2101 and a reflux chamber ending end 2102. The reflux chamber is used to contact with the protrusion of the pen body to form a sealing contact surface. It is the key to promote the sample to be tested to flow from the pen cap to the pen body. The inner diameter of the reflux chamber is equivalent to the diameter of the protrusion, so that when the pen body is inserted into the pen cap and the protrusion is in the reflux chamber, the protrusion can always contact the reflux chamber and always form a sealing contact surface. The length of the reflux chamber can be designed differently according to the required amount of liquid to be tested. It can be equal to the length of the chamber or less than the length of the chamber. Specifically, in the first case, Figure 3 As shown in (a), the chamber portion only includes the first chamber 2111, which is the backflow chamber. The inner diameter of the first chamber is equivalent to the diameter of the protrusion, so that when the pen holder is inserted into the pen cap, the protrusion and the inner wall of the first chamber have sliding friction, and in this process, the protrusion moves in the first chamber. In the second case, as Figure 3As shown in (b), the chamber portion includes a first chamber 2111 and a third chamber 2113. The inner diameter of the first chamber is larger than that of the third chamber. The first chamber is a reflux chamber, and the third chamber is a non-reflux chamber. The inner diameter of the first chamber is equivalent to the diameter of the protrusion, so that when the pen holder is inserted into the pen cap, the protrusion and the inner wall of the first chamber will have sliding friction, and during this process, the protrusion moves in the first chamber. The third chamber transitions to the first chamber, and the diameter of the third chamber gradually decreases in the direction away from the first chamber and presents a funnel shape. The third chamber can limit the end point of the pen holder movement and prevent the pen holder from continuing to move downward. In the third case, as Figure 3 As shown in (c), the chamber portion includes a first chamber 2111 and a second chamber 2112, the inner diameter of the second chamber is larger than the inner diameter of the first chamber, the second chamber is a non-reflux chamber, the first chamber is a reflux chamber, the inner diameter of the second chamber is larger than the diameter of the protrusion, the inner diameter of the first chamber is smaller than the inner diameter of the second chamber, and is equal to the diameter of the protrusion, so that when the pen body is inserted into the pen cap, the protrusion first passes through the second chamber but does not contact the second chamber, then passes through the first chamber, contacts the first chamber and moves in the first chamber. In the fourth case, as Figure 3 As shown in (d), the chamber portion includes a first chamber 2111, a second chamber 2112 and a third chamber 2113 connected in series, the first chamber is a backflow chamber, the second chamber and the third chamber are non-backflow chambers, the inner diameter of the second chamber is larger than the inner diameter of the first chamber and larger than the inner diameter of the third chamber, the inner diameter of the first chamber is equivalent to the diameter of the protrusion, so that when the pen holder is inserted into the pen cap, the protrusion first passes through the second chamber but does not contact the second chamber, then passes through the first chamber, contacts the first chamber and moves in the first chamber. The third chamber transitions to the first chamber, and the third chamber can limit the end point of the pen holder movement and prevent the pen holder from continuing to move. Example 3

[0032] like Figure 4 As shown, the pen cap includes a yoke portion 212, which extends from the outer wall of the chamber portion toward a direction away from the regurgitation chamber.

[0033] The pen cap also includes a storage chamber 221 , which includes a storage chamber opening 2211 and a storage chamber bottom surface 2212 . The storage chamber stores a buffer solution for mixing with the collected sample to be tested to form a mixed sample. The opening of the storage chamber is sealed with a sealing sheet 2216 .

[0034] The storage chamber is detachably connected to the pen cap. Generally, the storage chamber is connected to the pen cap by threads, or Figure 4 As shown in (b), the storage chamber is connected to the pen cap by a snap, or as Figure 4 As shown in (a), the storage chamber is connected to the pen cap by interference fit. Figure 4As shown in (b), the inner wall of the yoke is provided with one of the convex strips 214 or the outer wall of the storage chamber is provided with the second convex strip 226, and the outer wall of the storage chamber is provided with one of the grooves 227 or the inner wall of the yoke is provided with the second groove 213, or the above four exist at the same time. Of course, it is also possible that the outer wall of the yoke is provided with one of the convex strips or the inner wall of the storage chamber is provided with the second convex strip, and the inner wall of the storage chamber is provided with one of the grooves or the outer wall of the yoke is provided with the second groove, or the above four exist at the same time. After the yoke and the storage chamber are aligned in the upper and lower positions shown in the figure, relative forces are applied to the yoke and the storage chamber. In the process of the groove and the convex strip approaching each other, the non-concave part on the yoke or the storage chamber will squeeze the convex strip, causing the convex strip to deform slightly, so that the convex strip enters the groove, and the yoke and the storage chamber are snapped together. In addition, the convex strip can be provided with a chamfer, for example, the convex strip has a chamfer 2261, so that the convex strip and the groove can be smoothly snapped together under the action of the squeezing force. The yoke may be an elastic structure, so that the deformation of the yoke increases as the groove and the convex strip approach each other, making it easier to buckle into the groove. Figure 4 As shown in (a), the storage chamber includes a surrounding wing 224 and a slit 225. The width of the slit is equivalent to the width of the yoke. After the yoke is inserted into the slit and moves a certain distance relative to the storage chamber, the yoke stays in the slit due to the pressure squeezed by the surrounding wing and the outer wall of the storage chamber. The yoke and the storage chamber are tightly connected together. The thickness of the yoke at the end away from the reflux chamber can be less than the thickness of the yoke at the end close to the reflux chamber, so that a buffering effect can be given to the squeezing effect between the yoke and the slit.

[0035] When the storage chamber is connected to the pen cap, the sealing sheet of the storage chamber opening and the chamber outlet are in contact, and the sealing sheet seals the storage chamber opening and the chamber outlet at the same time. That is to say, when the sealing sheet has not been punctured, the sealing sheet is the temporary bottom surface of the pen cap, and when the sealing sheet is punctured, the storage chamber bottom surface is the pen cap bottom surface. The inner diameter of the chamber outlet is greater than or equal to the inner diameter of the storage chamber opening to ensure that the mixed sample flows smoothly without leakage after the sealing sheet is punctured. During detection, the sampling head punctures the sealing sheet, and the sampling head enters the storage chamber to mix the collected sample to be tested with the buffer solution in the storage chamber. Example 4

[0036] like Figure 5 As shown, a buffer chamber 115 is provided at the junction of the first channel and the second channel, and the buffer chamber is located in the sampling head. Since the buffer chamber is relatively large in volume, it is more conducive to the mixing of the sample to be tested and the buffer solution. Furthermore, the buffer chamber includes a guide groove (not shown) for guiding the flow of the sample, which helps the sample to be tested or the mixed sample to flow along a predetermined track and then be received by the test paper. In other embodiments, even if the second channel does not exist, the middle part of the first channel may also include a buffer chamber, and the buffer chamber further includes a guide groove. Example 5

[0037] like Figure 6 As shown, the sampling head includes a water absorbing member 1122 arranged around the side wall of the sampling head, the water absorbing member includes a first end 1123 of the water absorbing member and a second end 1124 of the water absorbing member, the middle part of the water absorbing member is hollow, and the sampling head and the water absorbing member are partially connected, for example, the second end 1124 of the water absorbing member is connected to the protruding platform 1131, so that the water absorbing member is fixed on the protruding platform, and after absorbing the liquid, the water absorbing member can be telescopically slid along the side wall 1112 of the sampling head with the protruding platform as a fixed point. Example 6

[0038] like Figure 7 As shown, the sampling head includes at least one sampling hole 1114, which is formed by the inward depression of the side wall of the sampling head, including a sampling hole opening 1117 and a sampling hole bottom surface 1118. The sampling hole is used to collect solid or semi-solid samples, and the inward depression volume is proportional to the required sample volume.

[0039] In other embodiments, Figure 7 As shown in (d), the sampling hole and the first channel entrance are at the same level and have the same opening direction, and the bottom surface of the sampling hole is a filter membrane 1126. At the same time, the filter membrane is also the first channel entrance, that is, the bottom surface of the sampling hole and the first channel entrance coincide. The filter membrane is used to determine the volume of the solid or semi-solid sample on the one hand, and to prevent the solid or semi-solid sample from directly entering the first channel without mixing with the buffer solution on the other hand.

[0040] The terms “first”, “second” and “third” in the present invention are for the purpose of explanation and are only used to distinguish names, and do not represent quantity or order.

[0041] The above specific implementation modes are used to explain the present invention rather than to limit the present invention. Any modification and change made to the present invention within the spirit of the present invention and the protection scope of the claims shall fall within the protection scope of the present invention.

Claims

1. A pen with a protective cover for detecting an analyte in a sample, characterized in that: It comprises a pen holder, a protective cover and a pen cap, wherein the protective cover prevents the pen holder from being inserted into the pen cap; the protective cover comprises a cavity wall, a cavity body and a safety position, wherein the cavity body is surrounded by the cavity wall, and the safety position is arranged at a first end protruding from the cavity wall.

2. A pen for detecting an analyte in a sample with a protective cover according to claim 1, characterized in that: The pen cap comprises a chamber portion, and a vertical distance L between the safety position and the second end of the cavity wall is smaller than a length K of the pen cap chamber portion.

3. The pen for detecting an analyte in a sample with a protective cover according to claim 1, characterized in that: The pen holder comprises a sampling head, and the sampling head is sealed in a space formed by the protective cover and the pen holder.

4. The pen for detecting an analyte in a sample with a protective cover according to claim 3, characterized in that: The pen barrel comprises a protruding portion, and the pen cap comprises a backflow chamber, wherein a diameter of the protruding portion is equivalent to an inner diameter of the backflow chamber.

5. The pen with a protective cover for detecting an analyte in a sample according to claim 4, characterized in that: The pen cap further comprises a third chamber, the inner diameter of which gradually decreases to present a funnel shape.

6. The pen for detecting an analyte in a sample with a protective cover according to claim 4, characterized in that: The pen cap also includes a storage chamber, which is detachably connected to the pen cap.

7. The pen for detecting an analyte in a sample with a protective cover according to claim 6, characterized in that: The pen cap comprises a chamber outlet, the storage chamber comprises a storage chamber inlet, and the inner diameter of the chamber outlet is greater than or equal to the inner diameter of the storage chamber inlet.

8. The pen with a protective cover for detecting an analyte in a sample according to claim 7, characterized in that: The pen cap comprises a convex strip or a concave groove, and the storage chamber is connected to the pen cap via the convex strip or the concave groove.

9. The pen for detecting an analyte in a sample with a protective cover according to claim 7, characterized in that: The pen cap comprises a yoke portion, the storage chamber comprises surrounding wings, the storage chamber is connected to the pen cap via the surrounding wings, and the yoke portion is located in a slit formed by the surrounding wings.

10. A pen for detecting an analyte in a sample with a protective cover according to any one of claims 1 to 9, characterized in that: The pen barrel and the protective cover form a first separate package, and the pen cap forms a second separate package.