A double pre-pressed blood sample collection device and its use method

Abstract

The present invention provides a double pre-stressed blood sample collection device, including: a sealing cover, a bottom cover, a top cover, a piston rod, a microneedle holder, a microneedle, a first spring, a second spring, and a one-button unlocking mechanism; the microneedle holder is launched under the action of the second spring, and the second pair of bosses are used to limit the microneedle holder after launching; there are two pairs of spring buckles on the periphery of the microneedle holder, wherein the first pair of spring buckles pre-stress the first spring launched by the microneedle on the groove inside the piston rod to form a second layer of pre-stress. The two springs used in the device of the present invention are double pre-stressed to form a double pre-stressed structure; it can be unlocked by just gently triggering, one-button operation, simple and convenient operation; after the trigger plate is unlocked, the piston rod automatically forms a continuous and stable vacuum negative pressure to achieve continuous blood collection; the entire device allows users, especially the elderly and children, to collect blood samples at home without pressing, only unlocking operation.

Description

Technical Field

[0001] The present invention relates to the field of medical and health clinical testing technology, and in particular to a blood collection device for receiving blood samples from subjects and a method for using the device. Background Art

[0002] With the continuous advancement of biotechnology, information technology and medical equipment manufacturing technology, many tests that originally needed to be performed in hospitals can now be completed through portable devices or home testing instruments. For example, blood glucose monitors, blood pressure monitors, electrocardiographs and other devices have been widely used in homes, allowing people to monitor their health status at home.

[0003] In modern society, people pay more and more attention to health, and the demand for disease prevention and early detection is growing. Home testing can provide people with a more convenient means of health monitoring, which helps to achieve early detection and timely intervention of diseases, thereby improving treatment effects and quality of life.

[0004] Home blood sample collection allows people to complete the blood collection operation at home without having to go to the hospital to wait in line, saving time and transportation costs. For those chronic disease patients who need to monitor their health status regularly, home blood collection can reduce the trouble of frequent visits to the hospital and improve the convenience of life.

[0005] After collecting blood samples at home, they can be quickly tested and analyzed, and test results can be obtained in a timely manner. This is especially important for some diseases or health problems that require emergency treatment, and can buy patients valuable treatment time. At the same time, home blood collection can be carried out in a private environment, protecting the privacy of patients. Some patients may experience psychological pressure because they are worried about exposing their health status when drawing blood in the hospital, and home blood collection can effectively alleviate this psychological burden.

[0006] When blood is collected in a hospital, the main collection techniques are: 1. Multi-needle puncture collection technology, vacuum blood collection tubes provide vacuum suction to supplement suction; 2. Use multi-needle puncture, use the internal soft rubber airbag recovery force to provide negative pressure, and absorb blood samples; at the same time, professional medical staff will operate and guide to ensure the safety, accuracy and standardization of the blood collection process. In a home environment, without the assistance of professional technicians, ordinary people may find it difficult to correctly master blood collection techniques and operating specifications, increasing the risk of blood collection failure or accidents.

[0007] The elderly and children are the most difficult groups to collect blood samples from at home. Due to the deterioration of physical functions, mobility problems, and decreased vision, the elderly may have difficulty accurately finding blood vessels, controlling the amount of blood collected, and treating wounds after blood collection; children may be afraid of pain and refuse to cooperate, making the blood collection process more difficult. In addition, the elderly and children may also have difficulties in preserving and handling samples after blood collection, affecting the accuracy of the test results.

[0008] After years of technical research and development, the applicant has made breakthrough innovations in home blood sample collection and applied for an invention patent (application number is CN202411036196.X, the invention name is a blood collection device and its use method). However, the applicant found that in the absence of family assistance, the elderly and children still face difficulties in collecting blood samples at home. How to improve the safety, accuracy and convenience of home blood collection and meet people's growing health needs is still a technical problem in home blood sample collection. Summary of the invention

[0009] The present invention aims to provide a double-preloaded blood sample collection device and a method of using the same. The two springs used in the device are both preloaded to form a double-preloaded structure. The two springs used in the device are both preloaded to form a double-preloaded structure. After the trigger plate is unlocked, the piston rod automatically forms a continuous and stable vacuum negative pressure to achieve continuous blood collection. The entire device allows users, especially the elderly and children, to collect blood samples at home without pressing, only requiring an unlocking operation.

[0010] A double pre-pressurized blood sample collection device, characterized in that it includes: a sealing cover 01, a bottom cover 02, a top cover 03, a piston rod 04, a microneedle support 06, a microneedle 07, a first spring 08, a second spring 09, and a one-key unlocking mechanism.

[0011] The bottom cover 02 serves as a skeleton to support the sealing cover 01, and forms a male and female buckle with the top cover 03 to form a seal; a support ring is provided inside the bottom cover 02, and a guide groove is provided on the inner side to provide a guide device for the piston rod 04. At the same time, there are two pairs of bosses, of which the first pair of inclined bosses 021 is used to deform the spring top of the microneedle holder 06 so that it is separated from the inner limiting surface of the piston rod, and then the microneedle holder 06 is launched under the action of the second spring 09, and the second pair of bosses 022 is used to limit the microneedle holder 06 after it is launched.

[0012] The piston rod 04 is provided with a groove 042, and the microneedle holder can be clamped inside the groove 042; a small boss 043 is also provided at the bottom of the piston rod 04; the piston rod 04 has the function of pre-stressing the first spring 08, and after the first spring 08 is pre-stressed, the piston rod 04 is clamped by the one-key unlocking mechanism to form a first layer of pre-stressing.

[0013] The microneedle holder 06 is used to install the microneedle 07. It has a guide groove on its surface, which can guide the sliding inside the piston rod 04. There are two pairs of spring buckles on the circumference. The first pair of spring buckles pre-presses the first spring 08 launched by the microneedle on the groove 042 inside the piston rod 04 to form a second layer of pre-pressure.

[0014] Furthermore, a double pre-pressurized blood sample collection device is provided, wherein a one-button unlocking mechanism is used to lock and unlock the piston rod; its specific structure may include but is not limited to the following specific structures: a trigger plate 10 and a third spring 12, which are used to release the restriction on the piston rod 04.

[0015] Furthermore, a double pre-pressurized blood sample collection device is provided, wherein a one-button unlocking mechanism is installed in a guide groove formed by the top cover 03 and the outer cover 13 .

[0016] Furthermore, in a double pre-pressed blood sample collection device, the one-key unlocking mechanism further includes a button cap 11, which is optionally mounted on the trigger plate 10 for the user to press.

[0017] Furthermore, the double pre-pressurized blood sample collection device also includes a sealing ring 05 , which is arranged between the piston rod 04 and the top cover 03 .

[0018] Furthermore, in a double pre-compression blood sample collection device, a guide groove 0131 is provided inside the outer cover 13, which forms a sealing guide groove together with the guide groove 031 of the top cover 03, and limits the trigger plate 10 to slide up and down in the guide groove.

[0019] A method for using a double pre-pressurized blood sample collection device comprises the following steps:

[0020] Put the blood collection tube 14 on the sample bleeding port of the sealing cover 01 to form a seal with the sealing cover 01;

[0021] The user presses the one-button unlocking mechanism, and the piston rod 04 moves upward under the preload of the first spring 08, driving the microneedle holder 06 to move upward. The first pair of spring buckles of the microneedle holder 06 are pressed by the first pair of inclined bosses 021 of the bottom cover 02 and deform inward, leaving the end surface of the groove 042 of the piston rod 04. The microneedle holder is ejected under the preload of the first spring 08, and the microneedle 07 punctures the skin. When it moves a fixed distance, it is limited by the second pair of bosses 022 on the bottom cover 02, completing the entire puncture action;

[0022] The piston rod 04 continues to move upward to the first position under the action of the first spring 08, the small boss 043 pushes the fired microneedle holder 06 back from the skin, and the piston rod 04 continues to move upward to form negative pressure;

[0023] Under the effect of negative pressure, blood will flow out when the skin is pierced by the needle, and after the blood is collected, it will flow into the blood collection tube 14.

[0024] Furthermore, after the skin is punctured by the microneedle 07, a wound surface is formed, and blood will flow along the wound to the inside of the sealing cover (01).

[0025] Beneficial effects:

[0026] Compared with the prior art, the present invention has the following beneficial effects:

[0027] 1. One-button trigger operation: The trigger plate of the blood collection device is cleverly designed. Just a light trigger can unlock the spring, allowing the piston rod to form a continuous and stable vacuum negative pressure by itself, achieving a continuous and stable blood collection process. This one-button operation is simple and convenient, and easy for users to master.

[0028] 2. Connection between home blood collection and medical testing: The device is designed for home environments, allowing patients to easily collect blood samples and providing a basis for preliminary screening at home. The collected blood samples can be sent directly to the hospital for professional testing, effectively alleviating the pressure on the hospital's blood collection window and optimizing the allocation of medical resources.

[0029] 3. Piston-type negative pressure source and puncture adaptability: The piston-type vacuum negative pressure source can provide negative pressure continuously and stably to ensure the smoothness of the blood collection process. The blood collection needle and the needle holder are connected by a movable rod and a cap, which has good adaptability and can fit the skin slope closely during puncture, further ensuring the accuracy of puncture and the effect of blood collection.

[0030] The dual-pre-pressurized blood sample collection device provided by the present invention provides a safe, convenient and efficient solution for home blood sample collection, especially for the elderly and children, due to its innovative design and excellent functions, which helps to promote the development of home medical testing and improve people's health management level. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 The figure is a schematic structural diagram of a double pre-pressurized blood sample collection device of the present invention.

[0032] Figure 2A-2B It is a schematic structural diagram of the bottom cover of the present invention.

[0033] Figure 3 It is a schematic structural diagram of the top cover of the present invention.

[0034] Figures 4A-4B It is a structural schematic diagram of the piston rod of the present invention.

[0035] Figure 5A-5B Schematic diagram of the structure of the microneedle holder of the present invention.

[0036] Figure 6A-6BIt is a schematic structural diagram of the outer cover of the present invention.

[0037] Figure 7 This is a schematic diagram of one-key unlocking of the present invention.

[0038] Figure 8 This is a schematic diagram of the state of the device when blood sampling is completed.

[0039] Fig. 9 This is a schematic diagram of the state of the device for microneedle skin puncture of the present invention.

[0040] Fig.10 Schematic diagram of the microneedle emission state of the present invention. DETAILED DESCRIPTION

[0041] Aspects of the present disclosure are not limited in application to the details of construction and arrangement of components set forth in the following description or shown in the accompanying drawings. For example, illustrative embodiments related to piercing the skin and receiving blood released from the pierced skin are discussed below, but aspects of the present disclosure are not limited to use with devices that pierce the skin and / or receive blood. Other embodiments may be employed, for example, devices that receive other body fluids without piercing, and aspects of the present disclosure may be practiced or performed in a variety of ways. Furthermore, the wording and terminology used herein is for descriptive purposes and should not be considered limiting.

[0042] According to the attached Figure 1-6B As shown in the figure, a double pre-pressurized blood sample collection device includes: a sealing cover 01, a bottom cover 02, a top cover 03, a piston rod 04, a sealing ring 05, a microneedle support 06, a microneedle 07, a first spring 08, a second spring 09, a trigger plate 10, a button cap 11, a third spring 12, and an outer cover 13.

[0043] The sealing cover 01 is made of soft rubber that fits the skin and forms a sealing surface with the skin under vacuum negative pressure, so that the blood can flow into the blood collection tube 14 through the microchannel after being sucked out. Preferably, the sealing cover 01 uses a self-adhesive rubber material, which can form a stronger intermolecular force. When it is stuck to the skin during use, the adhesive force generated can be more than twice the weight of the blood collector itself, and the adhesive force generated can overcome the negative pressure of -45kpa, ensuring that after one-key unlocking, the double pre-pressurized blood sample collection device is still firmly stuck to the skin.

[0044] Among them, the bottom cover 02 serves as a skeleton to support the sealing cover 01, and at the same time forms a male and female buckle with the sealing cover 01 and the top cover 03 to press the sealing cover 01 to form a seal; the inner side of the support ring arranged inside the bottom cover 02 has a guide groove to provide a guide device for the piston rod 04, and at the same time, there are two pairs of bosses, among which the first pair of inclined bosses 021 is used to deform the spring top of the microneedle support 06 when the microneedle support 06 moves upward, so that it is separated from the inner limiting surface of the piston rod, and then the microneedle support 06 is launched under the action of the second spring 09, that is, the microneedle is launched to puncture the skin; the second pair of bosses 022 is used to limit the microneedle support 06 after it is launched, so that the microneedle is launched to the skin surface at a fixed distance, and also to ensure that the microneedle punctures the skin to a fixed depth.

[0045] The top cover 03 is the outer shell support of the entire double pre-pressed blood sample collection device, and forms a male and female buckle with the bottom cover 02 to press the sealing cover 01 to form a seal, and the guide groove 031 of the trigger plate 10 and the spring support seat 032 are provided on the back thereof.

[0046] Among them, the piston rod 04 is provided with a sealing groove 041 for installing a sealing ring, and a guide boss is provided on its surface to guide the movement inside the sealing cover 01 and the top cover 03. It is provided with a groove 042, and the microneedle holder 06 can be clamped inside the groove 042; a small boss 043 is also provided at the bottom to push the microneedle holder 06 back from the skin after firing; the piston rod 04 also has the function of pre-stressing the first spring 08, and after the first spring 08 is pre-stressed, the end groove 044 of the piston rod 04 is clamped by the trigger plate 10 to form the first layer of pre-stressing.

[0047] The sealing ring 05 forms a sealed cavity between the piston rod 04 and the top cover 03. When the piston rod 04 moves upward, the sealing ring 05 and the top cover 03 form a pressurized air sealing area to improve the sealing performance, and a trace amount of medical silicone oil can be contained inside to improve the sealing performance and make pressing smoother.

[0048] The microneedle holder 06 is used to install the microneedles. The microneedle holder 06 clamps the microneedles by snapping them in place, which has good adaptability. The microneedle holder 06 launches the microneedles and punctures the skin to a fixed distance. The surface of the microneedle holder 06 has a guide groove, which can guide and slide inside the piston rod 04. There are two pairs of spring buckles on its circumference; the first pair of spring buckles pre-press the first spring 08 of the microneedle launch onto the groove 042 inside the piston rod 04 to form a second layer of pre-pressure; the second pair of spring buckles are to support the second pair of bosses 022 after the microneedle is launched, thereby ensuring that the distance of microneedle puncture is a fixed value, that is, the trigger plate 10 is used After the user unlocks and is triggered, the piston rod 04 will be moved upward by the elastic force of the first spring 08, and the microneedle holder 06 will also be lifted upward. When the first pair of spring buckles are pressed tightly by the first pair of inclined bosses 021 of the bottom cover 02 and deform inward to leave the end face of the groove 042 of the piston rod 04, the microneedle holder is ejected under the action of the first spring 08 and the microneedle punctures the skin. When it moves a fixed distance, it is limited by the second pair of bosses 022 on the bottom cover 02, thereby completing the entire puncture action.

[0049] Among them, the microneedle 07 is installed on the microneedle holder 06 to provide the effect of puncturing the skin for blood collection. The first spring 08 is used to form a vacuum in the vacuum chamber to provide continuous power for emptying, and the second spring 09 is used to store power to provide power for microneedle excitation. The trigger plate 10 is installed in the guide groove formed by the top cover 03 and the outer cover 13, and a spring is installed at the bottom to tighten so that the trigger plate can move up and down. The button cap 11 is optionally installed on the trigger plate 10 for the user to press. The third spring 12 pre-presses the trigger plate 10.

[0050] Preferably, the negative pressure range that can be generated by the first spring 08 is -20 to -40 kPa, and the pre-pressure of the second spring 09 emitted by the microneedle is greater than 15 nm.

[0051] Among them, the outer cover 13 is provided with a guide groove 0131 inside, which together with the guide groove 031 of the top cover 03 forms a sealing guide groove, limiting the trigger plate 10 to slide up and down in the guide groove; it also covers the trigger plate 10; when the trigger plate 10 is triggered and unlocked, the piston rod 04 will move in the inner cavity of the outer cover to protect its movement trajectory from external interference.

[0052] The blood collection tube 14 collects the blood sample flowing from the skin after puncture.

[0053] according to Figure 1-10As shown, a method for using a double pre-pressurized blood sample collection device is provided. When using the device, the user needs to put the blood collection tube 14 on the sample bleeding port of the sealing cover 01 to form a seal with the sealing cover 01 . The double-preloaded blood sample collection device is a one-touch trigger type. When the user presses the button cap 11 to unlock it, the trigger plate 10 will move downward, and the piston rod 04 will move upward under the preload of the first spring 08, which will drive the microneedle holder 06 to move upward. The first pair of spring undercuts of the microneedle holder 06 are pressed inward by the first pair of inclined bosses 021 of the bottom cover 02 and deformed, leaving the end face of the groove 042 of the piston rod 04. At this time, the microneedle holder 06 is ejected under the preload of the first spring 08, and the microneedle 07 punctures the skin. When it moves a fixed distance, it is limited by the second pair of bosses 022 on the bottom cover 02 to complete the entire puncture action; at this time, the piston rod 04 continues to move upward to the first position under the action of the spring, and the small boss 043 on the piston rod 04 pushes the microneedle holder 06 back from the skin after being fired. At this time, the piston rod 04 continues to move upward under the action of the spring to form a negative pressure.

[0054] Under the action of negative pressure, a small amount of blood will continue to flow out from the skin pierced by the needle. After the blood is collected, it flows into the blood collection tube 14 along the guide groove edge of the sealing cover 01 under the action of gravity.

[0055] After the skin is punctured by the microneedle 07, a wound surface is formed. After the blood sample seeps out, the blood will remain in place due to its small amount. When the blood reaches a certain volume, it will adsorb together. Due to the difference in hydrophilicity, the blood will flow along the wound and stay in the sealing cover 01.

[0056] The invention provides a double pre-pressure blood sample collection device, and its inventive concept is mainly reflected in three aspects: ① Spring trigger plate and negative pressure cavity: The top of the blood collector is equipped with a spring trigger plate, which is used to press the piston rod in the sealed cavity against the large spring. When the spring trigger plate is unlocked, the piston rod will move up, turning the entire cavity into a negative pressure cavity, and the negative pressure is sufficient to meet the blood suction needs. ② Piston rod and blood collection needle linkage: The piston rod is designed with an inverted structure inside the piston rod, and the blood collection needle is firmly locked in it. As the piston rod moves up, the inverted structure is pushed open, and the blood collection needle is immediately fired, accurately puncturing the skin to complete the blood collection action. The boss structure on the bottom cover ensures the consistency of the puncture distance and guarantees the stability of the puncture effect. ③ Double pre-pressure spring design: Before use, the two springs inside the blood collector are pre-compressed to form a double pre-pressure structure. This provides sufficient power reserve for the blood collector, ensuring that the piston rod can move quickly and forcefully after triggering, forming a stable negative pressure and driving the blood collection needle to puncture accurately.

[0057] The above embodiments are only specific descriptions of feasible implementation methods of the present invention, and are not intended to limit the scope of patent protection of the present invention. As long as it involves the core inventive concept of the present invention and one of the technical means for realizing the inventive concept, it belongs to the object of this patent protection.

Claims

1. A double pre-pressed blood sample collection device, characterized in that: include: Sealing cover, bottom cover, top cover, piston rod, microneedle holder, microneedle, first spring, second spring, one-key unlocking mechanism; The bottom cover has two pairs of bosses, wherein the first pair of inclined bosses is used to deform the top of the spring of the microneedle holder so that it is separated from the inner limiting surface of the piston rod, and then the microneedle holder is launched under the action of the second spring, and the second pair of bosses is used to limit the microneedle holder after it is launched; The piston rod is provided with a groove, and the microneedle holder can be clamped inside the groove; a small boss is also provided at the bottom of the piston rod; the piston rod has the function of pre-compressing the first spring, and after the first spring is pre-compressed, the piston rod is clamped by the one-key unlocking mechanism to form a first layer of pre-compression; There are two pairs of spring undercuts on the peripheral side of the microneedle support, wherein the first pair of spring undercuts pre-compresses the first spring emitted by the microneedle onto the groove inside the piston rod to form a second layer of pre-compression.

2. A dual pre-pressure blood pressure sample collection device according to claim 1, characterized in that: The bottom cover serves as a framework to support the sealing cover, and forms a male and female buckle with the top cover to form a seal.

3. A dual preload blood pressure sample collection device according to any one of claims 1 or 2, characterized in that: A support ring is arranged inside the bottom cover, and a guide groove is arranged inside the bottom cover to provide a guide device for the piston rod.

4. A dual preload blood pressure sample collection device according to any one of claims 1 or 2, characterized in that: The microneedle holder is used to install the microneedles and has guide grooves on its surface.

5. A dual preload blood pressure sample collection device according to any one of claims 1 to 4, characterized in that: The one-button unlocking mechanism is used to lock, unlock and release the piston rod.

6. A dual preload blood pressure sample collection device according to any one of claims 1 to 4, characterized in that: The one-button unlocking mechanism is installed in a guide groove formed by the top cover and the outer cover.

7. A dual preload blood pressure sample collection device according to any one of claims 1 to 4, characterized in that: The one-key unlocking mechanism includes a button cap for a user to press.

8. The dual pre-pressure blood pressure sample collection device according to claim 1, characterized in that: It also includes a sealing ring, which is arranged between the piston rod and the top cover.

9. A dual pre-pressure blood pressure sample collection device according to claims 5-7, characterized in that: The outer cover is provided with a guide groove inside, which forms a sealing guide groove together with the guide groove of the top cover, and limits the trigger plate to slide up and down in the guide groove.

10. A method for using a double pre-pressurized blood sample collection device, comprising the following steps: Put the blood collection tube on the sample bleeding port of the sealing cover to form a seal with the sealing cover; The user presses the one-button unlocking mechanism, and the piston rod moves upward under the preload of the first spring, driving the microneedle holder to move upward. The first pair of spring buckles of the microneedle holder are pressed tightly by the first pair of inclined bosses on the bottom cover and deform inward, leaving the groove end surface of the piston rod. The microneedle holder is ejected under the preload of the first spring, and the microneedle punctures the skin. When it moves a fixed distance, it is limited by the second pair of bosses on the bottom cover, completing the entire puncture action. The piston rod continues to move upward to the first position under the action of the first spring, the small boss pushes the fired microneedle holder back from the skin, and the piston rod continues to move upward to form negative pressure; Under the action of negative pressure, blood will flow out when the skin is pierced by the needle. After the blood is collected, it will flow into the blood collection tube.

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