Body fluid sampling device and method

Abstract

A body fluid sampling device and a body fluid sampling method. The device comprises a piercing module, a driving module, a resetting module and a first locking module. The piercing module comprises a piercing member. The driving module comprises a first actuator having a driving potential energy. The first actuator is used to drive the piercing member to move out of a sampling port of a housing in a first direction from a first position to a second position. The resetting module comprises a second actuator having a resetting potential energy. The second actuator is used to drive the piercing member to return to the sampling port in a reverse direction of the first direction from the second position. The first locking module is used to lock the resetting module and unlock the resetting module when the piercing member reaches the second position, so that the second actuator drives the piercing member to return. From the movement of the piercing member to the second position, to the unlocking of the resetting module by the first locking module, to the driving of the piercing member to return by the second actuator, the whole process is linked, which is beneficial to reduce the residence time of the piercing member in the barrier.

Description

Body fluid sampling device and method Technical Field

[0001] The present application relates to the field of medical devices, and in particular to a body fluid sampling device and a body fluid sampling method. Background Art

[0002] Currently, human sampling (such as blood sampling) mainly relies on the help of professional medical staff. With the development of point-of-care (POCT) technology and the change of hospital testing mode in the future, the current blood sampling method will be difficult to meet people's demand for self-service sampling.

[0003] Therefore, there is a need for a simple and easy-to-use blood collection device, so that ordinary people can independently complete blood collection without professional skills. In the related art, there is a device that uses a pressing structure for self-service blood collection. The principle is that the user presses to cause the internal needle to move quickly and penetrate the skin. At this time, the elastic part at the bottom of the needle is elastically compressed. When the user lets go, the bottom elastic part rebounds and pushes the needle to reset, thereby completing the blood collection. However, before the user lets go, the needle will remain in the skin. If the needle stays in the skin for too long, it will cause discomfort and pain to the human body, reducing the user experience.

[0004] Summary of the Invention

[0005] In order to solve the above shortcomings, it is necessary to provide a body fluid sampling device that is simple to use and helps to reduce the residence time of the needle in the skin.

[0006] In addition, it is also necessary to provide a body fluid sampling method applied to the above body fluid sampling device.

[0007] In a first aspect, the present application provides a body fluid sampling device having a bottom surface for contacting a barrier. The body fluid sampling device includes a puncture module, a drive module, a reset module, and a first locking module. The puncture module includes a puncture member. The drive module includes a first actuator having driving potential energy, the first actuator being used to drive the puncture member from a first position, along a first direction, through a sampling port on the bottom surface, and to a second position. The reset module includes a second actuator having reset potential energy, the second actuator being used to drive the puncture member from the second position, along a direction opposite to the first direction, back to the sampling port. The first locking module is used to lock the reset module, and the first locking module is coupled to the second position to unlock the reset module when the puncture member reaches the second position, so that the second actuator releases the reset potential energy and drives the puncture member back. The time between the puncture member passing through the sampling port and returning to the sampling port is defined as T, and T is less than or equal to 5 milliseconds.

[0008] According to a second aspect of the present application, a body fluid sampling device is provided, comprising a bottom surface for contacting a barrier. The body fluid sampling device comprises a puncture module, a drive module, a reset module, and a first locking module. The puncture module comprises a puncture member. The drive module comprises a first actuator having driving potential energy, the first actuator being configured to drive the puncture member from a first position, along a first direction, through a sampling port on the bottom surface, and to a second position. The reset module comprises a second actuator having reset potential energy, the second actuator being configured to drive the puncture member from the second position, along a direction opposite to the first direction, back to the sampling port. The first locking module is configured to lock the reset module. The first locking module is coupled to the second position to unlock the reset module when the puncture member reaches the second position, allowing the second actuator to release the reset potential energy and drive the puncture member back. The time between the puncture member reaching the second position and the start of reverse movement under the drive of the second actuator is defined as t, which is less than or equal to 0.5 milliseconds.

[0009] According to a third aspect of the present application, a body fluid sampling device is provided, comprising a bottom surface for contacting a barrier. The body fluid sampling device comprises a puncturing module, a driving module, a reset module, and a first locking module. The puncturing module comprises a puncturing member. The driving module comprises a first actuator with driving potential energy, configured to drive the puncturing member from a first position, along a first direction, through a sampling port on the bottom surface, and to a second position. The reset module comprises a second actuator with reset potential energy, configured to drive the puncturing member from the second position, along a direction opposite to the first direction, back toward the sampling port. The first locking module is configured to lock the reset module. The first locking module is coupled to the second position to unlock the reset module when the puncturing member reaches the second position, allowing the second actuator to release the reset potential energy and drive the puncturing member back. The time between the puncturing member passing through the sampling port and returning to the sampling port is defined as T, and the time between the puncturing member reaching the second position and beginning to move in the opposite direction under the drive of the second actuator is defined as t, with t / T being less than or equal to 10%.

[0010] A fourth aspect of the present application provides a body fluid sampling method, comprising: applying the bottom surface of a body fluid sampling device to a surface of a barrier, the body fluid sampling device comprising a puncturing module, a driving module, a reset module, and a first locking module, the puncturing module comprising a puncturing member, the driving module comprising a first actuator having driving potential energy, the reset module comprising a second actuator having reset potential energy, and the first locking module being used to lock the reset module; the first actuator driving the puncturing member from a first position to pierce a sampling port on the bottom surface in a first direction, then pierce the barrier and move to a second position; the first locking module unlocking the reset module; and the second actuator driving the puncturing member from the second position to exit the barrier in a direction opposite to the first direction and return to the sampling port. The time between the puncturing member piercing the sampling port and returning to the sampling port is defined as T, and the time between the puncturing member reaching the second position and beginning to move in the opposite direction under the drive of the second actuator is defined as t, with t / T being less than or equal to 10%.

[0011] A fifth aspect of the present application provides a body fluid sampling method, comprising: driving a drive shaft in a body fluid sampling device to drive a puncture member through a sampling port in a puncture direction to puncture a barrier, the body fluid sampling device having a bottom surface in contact with the barrier, the sampling port being located on the bottom surface; the drive shaft driving the puncture member to further move to a second position to trigger a reset module, the reset module releasing pre-stored reset potential energy and driving the drive shaft in a reset direction opposite to the puncture direction to withdraw the puncture member from the barrier and return to the sampling port. The time between the puncture member passing through the sampling port and returning to the sampling port is defined as T, the time between the puncture member reaching the second position and starting to move in the opposite direction under the drive of the second actuator is defined as t, and t / T is less than or equal to 10%.

[0012] The present application has a simple structure and is easy to operate. By attaching the body fluid sampling device to the surface of the barrier, the sampling and collection of body fluids can be completed without the help of professional medical personnel. During the puncture process, the first actuator releases the compression potential energy and drives the puncture member of the puncture module to move along the first direction. When the puncture member moves along the first direction to the second position, it triggers the first locking module to unlock the reset module, thereby triggering the second actuator to release the compression potential energy and drive the puncture member to return in the opposite direction of the first direction. From the movement of the puncture member to the second position, to the first locking module unlocking the reset module, and then to the second actuator driving the puncture member to return, the entire process is linked, and there is no need for external force from the user to press the puncture member to pass through the sampling port, so there is no need for the user to remove the external force to make the puncture member return. The above-mentioned linkage process is conducive to reducing the residence time of the puncture member in the barrier, thereby reducing the discomfort and pain caused by the puncture and improving the user experience. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] FIG1 is a schematic structural diagram of a body fluid sampling device provided in one embodiment of the present application.

[0014] FIG2 is a cross-sectional view of the body fluid sampling device shown in FIG1 along the cutting line II-II.

[0015] FIG3 is a cross-sectional view of the body fluid sampling device shown in FIG2 after the puncture member reaches the second position along the first direction.

[0016] FIG4 is a cross-sectional view of the body fluid sampling device shown in FIG3 after the first locking module is unlocked.

[0017] FIG5 is a cross-sectional view of the puncture member of the body fluid sampling device shown in FIG4 after returning in the opposite direction of the first direction.

[0018] FIG. 6 is a graph showing the relationship between the speed of the puncture member of the body fluid sampling device shown in FIG. 2 and time.

[0019] FIG7 is a flow chart of a body fluid sampling method provided in one embodiment of the present application.

[0020] FIG8 is a flow chart of a body fluid sampling method provided in another embodiment of the present application.

[0021] FIG9 is a photograph obtained by using a high-speed camera to capture the entire movement process of the puncture member of the body fluid sampling device according to one embodiment of the present application.

[0022] Explanation of Main Component Symbols: Puncture module 10 Puncture member 11 Fixing seat 12 Driving module 20 First actuator 21 Driving shaft 22 Resetting module 30 Second actuator 31 Shaft seat 32 First locking module 40 Moving block 41 Third actuator 42 Second locking module 50 Bracket 60 Accommodating space 61 Housing 70 Bottom surface 71 Body fluid sampling device 100 First elastic member 210 First flange 220 Pushing portion 320 Second elastic member 310 Second flange 321 Slot 410 Step portion 621 Sampling port 710 Engaging depth H Active stroke L First position P1 Second position P2 First direction X Second direction Y Third direction Z

[0023] The following specific implementation methods will further illustrate the present application in conjunction with the above-mentioned drawings. DETAILED DESCRIPTION

[0024] The technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments.

[0025] It should be noted that when a component is considered to be "disposed on" another component, it may be directly disposed on the other component or there may be a central component; when a component is considered to be "mounted on" another component, it may be directly mounted on the other component or there may be a central component. The term "and / or" as used herein includes all and any combinations of one or more of the relevant listed items.

[0026] Please refer to Figures 1 and 2. One embodiment of the present application provides a body fluid sampling device 100, which can be used to pierce a barrier (e.g., human skin) to collect body fluids from the human body, such as blood samples or interstitial fluid samples. The body fluid sampling device 100 includes a shell 70, a puncture module 10, a drive module 20, a reset module 30, and a first locking module 40. The puncture module 10, the drive module 20, the reset module 30, and the first locking module 40 are all arranged in the shell 70. The shell 70 has a bottom surface 71 for contacting the barrier, and a sampling port 710 is provided on the bottom surface 71. For simplicity, Figures 1 and 2 only show the bottom surface 71 of the shell 70, and do not show the rest of the shell 70.

[0027] The puncture module 10 includes at least one puncture member 11. The figure shows that there are multiple puncture members 11. The puncture member 11 is used to penetrate the sampling port 710 along the first direction X (i.e., the puncture direction) under the action of a driving force, thereby puncturing the barrier. In some embodiments, the puncture module 10 may further include a fixing seat 12 for fixing the puncture member 11. When the above-mentioned driving force acts on the fixing seat 12, the fixing seat 12 drives the puncture member 11 to move along the first direction X and penetrate the sampling port 710. Among them, the puncture member 11 can be a solid needle body made of metal material. For example, the puncture member 11 can be a microneedle. It can be understood that a flow channel (not shown) can also be provided in the shell 70, and the body fluid flowing out after the barrier is punctured can flow into the flow channel. This part is a prior art and will not be repeated here.

[0028] Furthermore, the body fluid sampling device 100 may also include a second locking module 50 for locking the puncture module 10. For example, when the body fluid sampling device 100 is not in use, the second locking module 50 can secure the fixing base 12 to prevent the puncture member 11 from extending out of the sampling port 710 and causing unnecessary damage to the human body if the user misoperates the body fluid sampling device 100. When the body fluid sampling device 100 needs to be used to collect body fluid, the second locking module 50 can unlock the fixing base 12, allowing the fixing base 12 to drive the puncture member 11 to move along the first direction X and pass through the sampling port 710. In some embodiments, the second locking module 50 is a slider that is slidably disposed within the housing 70 along a second direction Y that is perpendicular to the first direction X. The slider is used to support the surface of the fixing base 12 provided with the puncture member 11 in the first direction X, thereby locking the fixing base 12 in the first direction X. When the slider slides along the second direction Y until it is separated from the fixing base 12, the slider can unlock the fixing base 12. The slider can slide under the triggering of an external force to release the lock on the fixing seat 12, which is not limited in this application. For example, the user can operate the relevant buttons on the shell 70 to control the sliding of the slider.

[0029] The driving module 20 is fixed to the puncture module 10. The driving module 20 includes a first actuator 21. When the body fluid sampling device 100 is not in use, the first actuator 21 is in a state of having driving potential energy. The first actuator 21 is used to release the driving potential energy and provide the above-mentioned driving force to drive the puncture member 11 from the first position P1, through the sampling port 710 along the first direction X, pierce the barrier and move to the second position P2. As shown in Figure 2, the first position P1 can be understood as the initial position of the puncture member 11, that is, the position of the puncture member 11 when the body fluid sampling device 100 is not in use. The puncture member 11 in the initial position is completely accommodated in the shell 70, thereby avoiding unnecessary damage caused by accidental touch by the user. As shown in Figure 3, the second position P2 can be understood as the extreme position that the puncture member 11 can reach along the first direction X after piercing the barrier, that is, the maximum depth that the puncture member 11 can puncture. The first position P1 and second position P2 marked in Figures 2 and 3 correspond to the positions of the tip of the puncture member 11. It will be understood that the above marking method is only an example, and the first position P1 and second position P2 may also correspond to positions of other parts of the puncture member 11. Figure 2 exemplifies the position of the first position P1. It will be understood that the first position P1 only needs to be located on the side of the bottom surface 71 so that the tip of the puncture member 11 does not protrude from the housing 70 when the body fluid sampling device 100 is not in use. For example, the first position P1 may also be located within the sampling port 710.

[0030] Furthermore, the drive module 20 may also include a drive shaft 22 fixed to the puncture module 10. For example, the drive shaft 22 may be fixed to the fixing base 12. The first actuator 21 includes a first elastic member 210 that is sleeved on the outside of the drive shaft 22. A first flange 220 is provided on the outer periphery of the drive shaft 22. The first elastic member is located on the side of the first flange 220 facing away from the fixing base 12, and one end of the first elastic member 210 elastically abuts against the first flange 220. Therefore, the first elastic member 210 can push the first flange 220 to move in the first direction X, thereby driving the puncture member 11 to move in the first direction X from the first position P1. In some embodiments, the first elastic member 210 is a pre-compressed helical cylindrical spring, but may also be other types of elastic structures suitable for compressing and providing driving force to the puncture member 11.

[0031] The reset module 30 includes a second actuator 31. When the body fluid sampling device 100 is not in use, the second actuator 31 has reset potential energy. As shown in Figures 4 and 5, the second actuator 31 is used to release the reset potential energy and drive the puncture member 11 from the second position P2, returning in the direction opposite to the first direction X (i.e., the reset direction) and exiting the barrier, and then further returning to the housing 70 through the sampling port 710, thereby completing the collection operation. The puncture member 11 can return to the first position P1 after returning, or it can deviate from the first position P1, which is not limited in this application.

[0032] Furthermore, the reset module 30 may also include a shaft seat 32 that is coupled to the drive shaft 22, and the second actuator 31 includes a second elastic member 310 that is sleeved over the shaft seat 32. In some embodiments, the shaft seat 32 may extend inward near the bottom of the fixing base 12 to form a push portion 320. The first flange 220 is configured to abut against the push portion 320, thereby enabling the shaft seat 32 to be coupled to the drive shaft 22. As shown in FIG2 , when the body fluid sampling device 100 is not in use, the first flange 220 and the push portion 320 may be spaced a certain distance apart in the first direction X. As shown in FIG3 , when the puncture module 10 is unlocked, the first elastic member 210 releases its compressed potential energy and pushes the first flange 220 of the drive shaft 22 in the first direction X, thereby driving the puncture member 11 to move in the first direction X from the first position P1. During this process, the first flange 220 first contacts the push portion 320, which then drives the shaft seat 32 in the first direction X through the push portion 320. Therefore, the shaft seat 32 and the drive shaft 22 are linked in the first direction X. When the second elastic member 310 releases its compressed potential energy and drives the shaft seat 22 back in the direction opposite to the first direction X, during this process, the abutting portion 320 of the shaft seat 32 drives the first flange 220 to move in the direction opposite to the first direction X, thereby driving the piercing member 11 in the direction opposite to the first direction X through the drive shaft 22. Therefore, the shaft seat 32 and the drive shaft 22 are linked in the direction opposite to the first direction X. In some embodiments, the second elastic member 310 is a pre-compressed helical cylindrical spring, but may also be other types of elastic structures suitable for compressing and providing driving force to the piercing member 11.

[0033] Specifically, a second flange 321 may be protruding from the outer periphery of the shaft seat 32. The second elastic member 310 is located on the side of the second flange 321 that is closer to the fixing seat 12, and one end of the second elastic member 310 elastically abuts against the second flange 321. Therefore, the second elastic member 310 can act on the second flange 321, thereby pushing the shaft seat 32 back in the direction opposite to the first direction X via the second flange 321. Furthermore, as the first flange 220 drives the shaft seat 32 to move in the first direction X via the abutting portion 320, the second elastic member 310 may be further compressed.

[0034] The first locking module 40 is used to lock the reset module 30. Specifically, as shown in Figure 2, when the body fluid sampling device 100 is not in use, the first locking module 40 can lock the shaft seat 32 in the first direction X. When the piercing member 11 begins to move in the first direction X from the first position P1, the first locking module 40 still locks the shaft seat 32 in the first direction X. Therefore, the second elastic member 310, via the second flange 321, does not push the shaft seat 32 in the direction opposite to the first direction X. As shown in Figures 3 to 5, the first locking module 40 is coupled to the second position P2. In this application, "coupled" refers to the mutual relationship between the first locking module 40 and the second position P2. Therefore, when the piercing member 11 reaches the second position P2, the first locking module 40 releases the lock on the shaft seat 32, allowing the second actuator 31 to release the reset potential energy and drive the piercing member 11 to exit the barrier in the direction opposite to the first direction X and return to the housing 70 through the sampling port 710.

[0035] FIG6 shows a graph showing the relationship between the movement speed of the puncture member 11 and time without puncturing the barrier. First, the puncture member 11 starts from the initial position along the first direction X, passes through the sampling port 710, and then reaches the second position P2. In the process of reaching the second position P2 from the initial position, the speed v1 of the puncture member 11 increases; when reaching the second position P2, the speed v1 of the puncture member 11 decreases to zero in a very short time, and the puncture member 11 rebounds slightly near the second position P2. Within a very short period of time after the rebound, the puncture member 11 begins to move in the opposite direction of the first direction X and the speed v2 increases until it returns to the housing 70 through the sampling port 710. It should be understood that the speeds v1 and v2 in this embodiment are only used for schematic representation and are not used to limit the speed of the puncture member 11 moving in different directions. The time point when the puncture member 11 starts to move along the first direction X is defined as t0 (t0 may coincide with the coordinate origin), the time point when it passes through the sampling port 710 is defined as t1, the time point when it reaches the second position P2 is defined as t2, the time point when it starts to return in the opposite direction of the first direction X under the drive of the second actuator 31 is defined as t3, and the time point when it returns to the housing 70 through the sampling port 710 is defined as t4.

[0036] In the present application, the time it takes for the puncture member 11 to pass through the sampling port 710 and return to the housing 70 is T (i.e., the time from t1 to t4), and T is less than or equal to 5 milliseconds. Therefore, the time it takes for the puncture member 11 to pass through the sampling port 710 and return to the housing 70 is relatively short, so when the body fluid sampling device 100 is used to pierce a barrier for body fluid sampling, it is beneficial to reduce the residence time of the puncture member 11 within the barrier. It is understood that when the elastic coefficient of the first elastic member 210 or the second elastic member 310 changes, the weight of the relevant modules in the device can be set at the same time to offset the influence of the elastic coefficient, thereby ensuring that the above-mentioned time T will not change due to unilateral adjustment of the elastic coefficient.

[0037] In some embodiments, the time from when the piercing member 11 reaches the second position P2 to when it begins to move in the opposite direction under the drive of the second actuator 31 is defined as t (i.e., the time from t2 to t3), and t is less than or equal to 0.5 milliseconds. Therefore, the time from when the piercing member 11 reaches the second position P2 to when it begins its return journey is relatively short, which is also beneficial for reducing the residence time of the piercing member 11 within the barrier when the body fluid sampling device 100 is used to pierce a barrier for body fluid sampling. In this application, "beginning to move in the opposite direction" refers to the start of regular continuous movement in the opposite direction under the drive of the second actuator 31, which does not include the small rebound of the piercing member 11 near the second position P2.

[0038] In some embodiments, the time between the piercing member 11 reaching the second position P2 and the start of reverse movement under the drive of the second actuator 31 is defined as t (i.e., the time from t2 to t3), and t / T is less than or equal to 10%. When the body fluid sampling device 100 is used to puncture a barrier, the ratio of the time between the piercing member 11 reaching the second position P2 and the start of reverse movement under the drive of the second actuator 31 to the time between the piercing member 11 passing through the sampling port 710 and returning to the housing 70 is also approximately less than or equal to 10%. Therefore, the time between the piercing member 11 reaching the second position P2 and the start of its return journey under the drive of the second actuator 31 accounts for a relatively small proportion, which also helps to reduce the residence time of the piercing member 11 within the barrier.

[0039] In the present application, when the puncture module 10 is unlocked, the first actuator 21 releases the driving potential energy and drives the puncture member 11 of the puncture module 10 to move in the first direction X. When the puncture member 11 moves in the first direction X to a designated position, namely the second position P2, the first locking module 40 is triggered to unlock the reset module 30, thereby triggering the second actuator 31 to release the reset potential energy and drive the puncture member 11 back into the housing 70 in the opposite direction of the first direction X. The entire process from the puncture member 11 moving to the second position P2, to the first locking module 40 unlocking the reset module 30, and then to the second actuator 31 driving the puncture member 11 back is coordinated. There is no need for the user to press the puncture member 11 to penetrate, and therefore no need for the user to remove the external force to return the puncture member 11. This coordinated process helps reduce the time the puncture member 11 remains within the barrier, thereby reducing the discomfort and pain caused by the puncture and improving the user experience.

[0040] As shown in Figures 2 and 3, in some embodiments, the end of the first elastic member 210 facing away from the first flange 220 can be elastically supported against the first locking module 40. That is, the first elastic member 210 can be elastically supported between the first locking module 40 and the first flange 220. Considering that both the first elastic member 210 and the second elastic member 310 are in a compressed state, the compression potential energy of the first elastic member 210 generates a thrust in the first direction X on the first flange 220, which in turn generates a thrust in the first direction X on the abutting portion 320 of the shaft seat 32 through the first flange 220. Simultaneously, the compression potential energy of the second elastic member 310 generates a thrust in the opposite direction on the second flange 321 of the shaft seat 32, which in turn generates a thrust in the opposite direction on the first flange 220 through the abutting portion 320. Therefore, the elastic coefficient of the first elastic member 210 is set to be greater than the elastic coefficient of the second elastic member 310. Therefore, after the second locking module 50 releases the lock on the puncture module 10, the compression potential energy of the first elastic member 210 is sufficient to resist the compression potential energy of the second elastic member 310, so that the puncture member 11 can move smoothly along the first direction X to the second position P2.

[0041] Furthermore, as shown in FIG4 , the first locking module 40 is movably disposed relative to the first elastic member 210, such that the first locking module 40 can be separated from the first elastic member 210 when the piercing member 11 reaches the second position P2. Therefore, during the process in which the second elastic member 310 drives the piercing member 11 from the second position P2 in a direction opposite to the first direction X, the end of the first elastic member 210 facing away from the first flange 220 no longer elastically abuts against the first locking module 40, i.e., the first locking module 40 releases its constraint on the end of the first elastic member 210. Therefore, during the process in which the second elastic member 310 drives the piercing member 11 in its return motion, the movement of the shaft seat 32 and the drive shaft 22 is no longer restricted by the compressive potential energy of the first elastic member 210, thereby preventing the piercing member 11 from being unable to return due to the action of the first elastic member 210, which has a larger elastic coefficient, on the drive shaft 22 and shaft seat 32.

[0042] As shown in FIG2 , in some embodiments, the body fluid sampling device 100 further includes a bracket 60, which is fixed in position within the body fluid sampling device 100. For example, the bracket 60 can be secured to the housing 70 using fasteners such as screws. The bracket 60 supports the drive module 20 and the reset module 30. In the first direction X, the bracket 60 is positioned between the first locking module 40 and the second locking module 50. The shaft seat 32 is movably disposed within the bracket 60 along the first direction X. The shaft seat 32 has a predetermined range of motion within the bracket 60 along the first direction X, such that the piercing member 11 is stopped at the second position P2. Specifically, the bracket 60 defines a receiving space 61, within which at least a portion of the drive module 20 and at least a portion of the reset module 30 are disposed. A stepped portion 621 is formed on the inner sidewall of the receiving space 61. When the body fluid sampling device 100 is not in use, a gap is formed between the stepped portion 621 and the second flange 321 in the first direction X. This gap represents the travel of the shaft seat 32 within the bracket 60 along the first direction X. As shown in FIG3 , when the first elastic member 210 pushes the first flange 220 of the drive shaft 22 to move in the first direction X, the first flange 220 may first contact the push portion 320, thereby driving the shaft seat 32 to move in the first direction X through the push portion 320. When the shaft seat 32 moves to the point where the step 621 contacts the second flange 321, the drive shaft 22 stops moving, causing the piercing member 11 to stop at the second position P2. As shown in FIG6 , due to the rigid stop of the step 621, the velocity v1 of the piercing member 11 is reduced to zero in a very short time when it reaches the second position P2.

[0043] As shown in FIG2 , the first locking module 40 may further include a slot 410. A portion of the shaft seat 32 (e.g., the end of the shaft seat 32 away from the push portion 320) engages with the slot 410, allowing the first locking module 40 to lock the reset module 30. In some embodiments, the first locking module 40 includes two movable blocks 41 arranged in the third direction Z and a third actuator 42 elastically abutting between the two movable blocks 41. Each movable block 41 is provided with a slot 410. Therefore, when a portion of the shaft seat 32 engages with the slot 410, the relative position of the two movable blocks 41 is fixed. As shown in FIG3 and FIG4 , when the end of the shaft seat 32 is disengaged from the slot 410, the third actuator 42 pushes the two movable blocks 41 away from each other along the third direction Z. At this point, the first locking module 40 releases its lock on the reset module 30, allowing the second actuator 31 to drive the piercing member 11 out of the barrier in a direction opposite to the first direction X. Because the two moving blocks 41 require a certain amount of time to release the lock on the reset module 30, as shown in FIG6 , there is a short time delay between the slight rebound of the piercing member 11 near the second position P2 and the start of the return movement of the piercing member 11 in the opposite direction of the first direction X under the drive of the second actuator 31. In the first direction X, the engagement depth of the shaft seat 32 (i.e., the depth of the shaft seat 32 inserted into the engagement slot 410) is H, and the movable travel of the shaft seat 32 within the bracket 60 is L, where L is greater than H. The movable travel of the shaft seat 32 within the bracket 60 is greater than the engagement depth of the shaft seat 32, so that the piercing member 11 reaches and stops at the second position P2 only after the first locking module 40 releases the lock on the reset module 30, thereby ensuring that the first locking module 40 releases the lock on the reset module 30 when the piercing member 11 reaches the second position P2. In some embodiments, the third actuator 42 is a pre-compressed helical cylindrical spring. The third actuator 42 may also be other types of elastic structures suitable for compressing and providing driving force to the moving block 41 .

[0044] Please refer to Figure 7, which is a flow chart of a body fluid sampling method provided in one embodiment of the present application. According to different needs, the order of the steps of the above method can be changed, and some steps can be omitted or combined. The above method includes the following steps:

[0045] In step S1 , the body fluid sampling device 100 is applied to a barrier surface.

[0046] In step S2 , the first actuator 21 drives the piercing member 11 from the first position P1 to pierce the barrier along the first direction X and move to the second position P2 .

[0047] In some embodiments, an external force is introduced to unlock the puncture module 10 or the drive module 20, so that the first actuator 21 releases the pre-stored driving potential energy and drives the drive shaft 22 to move along the first direction X.

[0048] In step S3 , the first locking module 40 unlocks the reset module 30 .

[0049] In step S4 , the second actuator 31 drives the piercing member 11 to exit the barrier from the second position P2 in the opposite direction of the first direction X.

[0050] The time from when the puncture member 11 passes through the sampling port 710 to when it returns to the housing 70 through the sampling port 710 is T, and the time from when the puncture member 11 reaches the second position P2 to when it starts to move in the opposite direction under the drive of the second actuator 31 is t, and t / T is less than or equal to 10%.

[0051] Please refer to Figure 8, which is a flow chart of a body fluid sampling method provided in another embodiment of the present application. According to different needs, the order of the steps of the above method can be changed, and some steps can be omitted or combined. The above method includes the following steps:

[0052] In step S1 ′, the driving shaft 22 in the body fluid sampling device 100 drives the puncture member 11 along the puncture direction to pass through the sampling port 710 to puncture the barrier. The body fluid sampling device 100 has a bottom surface 71 in contact with the barrier, and the sampling port 710 is provided on the bottom surface 71 .

[0053] In some embodiments, an external force is introduced to unlock the first actuator 21 , causing the first actuator 21 to release pre-stored driving potential energy and drive the driving shaft 22 to move along the first direction.

[0054] In step S2', the drive shaft 22 drives the puncture member 11 to further move to the second position P2 to trigger the reset module 30. The reset module 30 releases the pre-stored reset potential energy and drives the drive shaft 22 along the reset direction opposite to the puncture direction to withdraw the puncture member 11 from the barrier and return to the sampling port 710.

[0055] In some embodiments, the drive shaft 22 drives the shaft seat 32 to release the first locking module 40, so that the first locking module 40 releases the lock on the reset module 30. Then, the reset module 30 releases the pre-stored reset potential energy to drive the shaft seat 32 and the drive shaft 22 to move in the reset direction.

[0056] The present application is described below through specific examples. Those skilled in the art should understand that the body fluid sampling method described in this application is only an example, and any other suitable device and method are within the scope of this application.

[0057] Example 1

[0058] Connect a high-speed camera (model FASTCAM Mini AX200) to a microscope, place the body fluid sampling device 100 shown in Figures 1 and 2 on its side on the microscope platform, place a light source above the microscope platform, and the light output direction of the light source is perpendicular to the movement direction of the puncture member 11. The direction of the microscope objective lens is also perpendicular to the movement direction of the puncture member 11.

[0059] The puncture module 10 is unlocked by an external force. Without puncturing any barrier, the first actuator 21 releases its driving potential energy and drives the puncture member 11 of the puncture module 10 in the first direction X. When the tip of the puncture member 11 passes through the sampling port 710 along the first direction X and moves to the second position P2, the first locking module 40 releases the lock on the reset module 30, thereby triggering the second actuator 31 to drive the tip of the puncture member 11 from the second position P2 back into the housing 70 through the sampling port 710 in the opposite direction of the first direction X. The entire movement of the puncture member 11 was captured using the high-speed camera. The capture parameters are shown in Figure 9. Frames 6567 to 6747 (a total of 181 images) capture the entire process from the tip of the puncture member 11 passing through the sampling port 710 to its return to the housing 70. Figure 9 shows frame 6615, which shows the tip of the puncture member 11 near the second position P2.

[0060] Record the time point t0 when the puncture member 11 starts to move in the first direction X, the time point t1 when it passes through the sampling port 710, the time point t2 when it reaches the second position P2, the time point t3 when it starts to return in the opposite direction of the first direction X under the drive of the second actuator 31, and the time point t4 when it returns to the housing 70 through the sampling port 710. Then, based on the above time points, calculate the time length T from the puncture member 11 passing through the sampling port 710 to returning to the housing 70 (i.e., the time length from t1 to t4), and calculate the time length t from the puncture member 11 reaching the second position P2 to the time it starts to move in the opposite direction under the drive of the second actuator 31 (i.e., the time length from t2 to t3).

[0061] After multiple tests, the time T from the puncture member 11 passing through the sampling port 710 to returning to the shell 70 through the sampling port 710 is within 5 milliseconds, the time t from the puncture member 11 reaching the second position P2 to starting to move in the opposite direction under the drive of the second actuator 31 is within 0.5 milliseconds, and t / T is less than or equal to 10%.

[0062] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present application and are not intended to limit the present application. Although the present application has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solutions of the present application may be modified or replaced by equivalents without departing from the spirit and scope of the technical solutions of the present application.

Claims

1. A body fluid sampling device having a bottom surface for contacting a barrier, characterized in that, The body fluid sampling device includes: A puncture module including a puncturing member; A driving module including a first actuator having driving potential energy, the first actuator being configured to drive the puncturing member to penetrate through the sampling port on the bottom surface in a first direction from a first position and move to a second position; A reset module including a second actuator having reset potential energy, the second actuator being configured to drive the puncturing member to return to the sampling port in the opposite direction of the first direction from the second position; and A first locking module for locking the reset module, the first locking module being coupled to the second position to unlock the reset module when the puncturing member reaches the second position, so that the second actuator releases the reset potential energy and drives the puncturing member to return. The duration between the puncturing member penetrating through the sampling port and returning to the sampling port is defined as T, and T is less than or equal to 5 milliseconds.

2. The body fluid sampling device according to claim 1, wherein The duration between the puncturing member reaching the second position and starting to move in the opposite direction under the drive of the second actuator is defined as t, and t is less than or equal to 0.5 milliseconds.

3. The body fluid sampling device according to claim 1, wherein The duration between the puncturing member reaching the second position and starting to move in the opposite direction under the drive of the second actuator is defined as t, and t / T is less than or equal to 10%.

4. The body fluid sampling device according to claim 1, characterized in that The driving module further includes a drive shaft fixed to the puncture module, a first flange protruding from the outer periphery of the drive shaft, and the first actuator includes a first elastic member sleeved outside the drive shaft and elastically abutted between the first locking module and the first flange; the first locking module is movably arranged relative to the first elastic member to be separated from the first elastic member when the puncturing member reaches the second position.

5. The body fluid sampling device according to claim 4, wherein, The reset module further includes a shaft seat linked to the drive shaft, the second actuator includes a second elastic member sleeved outside the shaft seat, the elastic coefficient of the first elastic member is greater than that of the second elastic member, the body fluid sampling device further includes a bracket, the position of the bracket in the body fluid sampling device is fixed, the shaft seat is movably arranged in the bracket in the first direction, and the shaft seat has a predetermined movement stroke in the bracket in the first direction, so that the puncturing member is stopped at the second position.

6. The body fluid sampling device according to claim 5, wherein, The first locking module includes a card slot, a part of the shaft seat is engaged in the card slot to lock the reset module by the first locking module. In the first direction, the engagement depth of the shaft seat is H, and the movement stroke of the shaft seat is L, and L > H.

7. The body fluid sampling device according to claim 1, wherein, It further includes a second locking module for pre-locking the puncture module or the driving module, and the second locking module is configured to receive an external force to unlock the puncture module or the driving module, so that the first actuator releases the driving potential energy.

8. A body fluid sampling device having a bottom surface for contacting a barrier, characterized in that, The body fluid sampling device includes: A puncture module including a puncturing member; A driving module including a first actuator having driving potential energy, the first actuator being configured to drive the puncturing member to penetrate through the sampling port on the bottom surface in a first direction from a first position and move to a second position; A reset module, including a second actuator having a reset potential energy, the second actuator being configured to drive the puncturing member to return from the second position to the sampling port in the opposite direction of the first direction; and A first locking module for locking the reset module, the first locking module being coupled to the second position to unlock the reset module when the puncturing member reaches the second position, so that the second actuator releases the reset potential energy and drives the puncturing member to return. Define the time duration from when the puncturing member reaches the second position to when it starts to move in the opposite direction under the drive of the second actuator as t, and t is less than or equal to 0.5 milliseconds.

9. The body fluid sampling device according to claim 8, characterized in that The drive module further includes a drive shaft fixed to the puncturing module, a first flange protruding from the outer periphery of the drive shaft, and the first actuator includes a first elastic member sleeved outside the drive shaft and elastically abutted between the first locking module and the first flange; the first locking module is movably arranged relative to the first elastic member to separate from the first elastic member when the puncturing member reaches the second position.

10. The body fluid sampling device according to claim 9, wherein, The reset module further includes a shaft seat linked to the drive shaft, the second actuator includes a second elastic member sleeved outside the shaft seat, the elastic coefficient of the first elastic member is greater than that of the second elastic member, the body fluid sampling device further includes a bracket, the position of the bracket in the body fluid sampling device is fixed, the shaft seat is movably arranged in the bracket along the first direction, and the shaft seat has a predetermined moving stroke in the bracket along the first direction, so that the puncturing member is stopped at the second position.

11. The body fluid sampling device according to claim 10, wherein The first locking module includes a card slot, and a part of the shaft seat is engaged with the card slot to lock the reset module by the first locking module. Along the first direction, the engagement depth of the shaft seat is H, and the moving stroke of the shaft seat is L, and L > H.

12. The body fluid sampling device according to claim 8, wherein, It further includes a second locking module for pre-locking the drive module, and the second locking module is configured to receive an external force to unlock the puncturing module, so that the first actuator releases the drive potential energy.

13. A body fluid sampling device having a bottom surface for contacting a barrier, characterized in that, The body fluid sampling device includes: A puncturing module, including a puncturing member; A drive module, including a first actuator having a drive potential energy, the first actuator being configured to drive the puncturing member to penetrate through the sampling port on the bottom surface and move to the second position along the first direction from the first position; A reset module, including a second actuator having a reset potential energy, the second actuator being configured to drive the puncturing member to return from the second position to the sampling port in the opposite direction of the first direction; and A first locking module for locking the reset module, the first locking module being coupled to the second position to unlock the reset module when the puncturing member reaches the second position, so that the second actuator releases the reset potential energy and drives the puncturing member to return. Define the time duration from when the puncturing member penetrates through the sampling port to when it returns to the sampling port as T, and the time duration from when the puncturing member reaches the second position to when it starts to move in the opposite direction under the drive of the second actuator as t, and t / T is less than or equal to 10%.

14. The body fluid sampling device according to claim 13, wherein The driving module further includes a driving shaft fixed to the puncturing module. A first flange is protruded on the outer periphery of the driving shaft. The first actuator includes a first elastic member sleeved outside the driving shaft and elastically abutted between the first locking module and the first flange. The first locking module is movably arranged relative to the first elastic member to be separated from the first elastic member when the puncturing member reaches the second position.

15. The body fluid sampling device according to claim 14, characterized in that, The reset module further includes a shaft seat linked with the driving shaft. The second actuator includes a second elastic member sleeved outside the shaft seat. The elastic coefficient of the first elastic member is greater than that of the second elastic member. The body fluid sampling device further includes a bracket, whose position in the body fluid sampling device is fixed. The shaft seat is movably arranged in the bracket along the first direction and has a predetermined moving stroke in the bracket along the first direction, such that the puncturing member is stopped at the second position.

16. The body fluid sampling device according to claim 15, characterized in that, The first locking module includes a clamping groove, and part of the shaft seat is clamped in the clamping groove so that the first locking module locks the reset module. Along the first direction, the clamping depth of the shaft seat is H, and the moving stroke of the shaft seat is L, where L > H.

17. The body fluid sampling device according to claim 13, wherein, It further includes a second locking module for pre-locking the driving module. The second locking module is used to receive an external force to release the locking of the puncturing module, so that the first actuator releases the driving potential energy.

18. A method for sampling body fluid, characterized in that, Comprising: Applying the bottom surface of the body fluid sampling device to the barrier surface. The body fluid sampling device includes a puncturing module, a driving module, a reset module and a first locking module. The puncturing module includes a puncturing member. The driving module includes a first actuator having driving potential energy. The reset module includes a second actuator having reset potential energy. The first locking module is used to lock the reset module. The first actuator drives the puncturing member to penetrate out of the sampling port on the bottom surface along the first direction from the first position, then pierce the barrier and move to the second position. The first locking module releases the locking of the reset module. And The second actuator drives the puncturing member to withdraw from the barrier along the reverse direction of the first direction and return to the sampling port from the second position. Define the time period between the puncturing member penetrating out of the sampling port and returning to the sampling port as T, and the time period between the puncturing member reaching the second position and starting to move in the reverse direction under the drive of the second actuator as t. t / T is less than or equal to 10%.

19. The body fluid sampling method according to claim 18, wherein The first actuator drives the puncturing member to penetrate out of the sampling port on the bottom surface along the first direction from the first position, including: Introducing an external force to release the locking of the puncturing module or the driving module, so that the first actuator releases the pre-stored driving potential energy and drives the driving shaft to move along the first direction.

20. A method for sampling body fluid, characterized in that, Comprising: Driving the driving shaft in the body fluid sampling device to drive the puncturing member to penetrate through the sampling port along the puncturing direction to pierce the barrier. The body fluid sampling device has a bottom surface in contact with the barrier, and the sampling port is opened on the bottom surface; and The drive shaft drives the puncturing member to further move to a second position to trigger a reset module, and the reset module releases pre-stored reset potential energy and drives the drive shaft to withdraw the puncturing member from the barrier along a reset direction opposite to the puncturing direction and return to the sampling port; Define the time duration between the puncturing member piercing out of the sampling port and returning to the sampling port as T, and the time duration between the puncturing member reaching the second position and starting to move in the reverse direction under the drive of the reset module as t, and t / T is less than or equal to 10%.

21. The body fluid sampling method according to claim 20, characterized in that, The drive shaft in the drive sampling device drives the puncturing member to extend out of the sampling port along the puncturing direction to pierce the barrier, including: Introduce an external force to release the locking of the first actuator in the body fluid sampling device, and the first actuator releases pre-stored driving potential energy and drives the drive shaft to move along the puncturing direction.

22. The body fluid sampling method according to claim 20, wherein The sampling device includes a first locking module associated with the reset module and a shaft seat coupled between the first locking module and the reset module; The drive shaft drives the puncturing member to further move to the second position to trigger the reset module, including: The drive shaft drives the shaft seat to drive the shaft seat to release the first locking module, and the first locking module releases the locking of the reset module; The reset module releases pre-stored reset potential energy to drive the shaft seat and the drive shaft to move along the reset direction.

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