TW202106253A - Biologically sensing insertion device, and its actuator and insertion method - Google Patents

Abstract

The invention discloses an inserter for subcutaneously inserting a biological sensor, including a housing and an actuator, wherein the actuator includes an insertion boss, an insertion spring, a retraction boss, and a retraction spring. Via the bias of the insertion spring, the insertion boss moves downward to subcutaneously insert the biological sensor into skin; the engagement between the insertion and the retraction bosses is released, and the retraction boss moves upward to remove an insertion needle from the biological sensor via the bias of the retraction spring; and an electrode is retained under the skin to continuously transmit electronic signals to the biological sensor. The present invention at least have advantages of: accelerating insertion/retraction speed, reducing users’ pain, precisely fabricating the biological sensor and the transducer, and guaranteeing two actuations being sequentially completed.

Description

Biosensing implantation device, implantation needle unit and implantation method thereof

The invention relates to a biosensing implantation device, its implantation needle unit and implantation method.

In order to know the physiological parameters of an individual, current medical institutions or individuals usually take or collect samples of the individual’s body fluids, blood, urine, feces, etc., and use instruments or test papers to detect the content of specific molecules in these samples to confirm The physiological parameters of the individual are used to diagnose whether the individual suffers from a specific disease or whether the individual’s disease is alleviated or cured. However, the method of collecting samples is mostly a single act. For example, in order to monitor the blood glucose value of a diabetic patient, it is necessary to collect subcutaneous blood with a disposable blood sampling needle on a regular basis and one after another according to the doctor's advice. However, long-term and successive blood sampling also causes patient discomfort. Forgetting to collect blood will also interrupt the monitoring record, and purchasing a large number of disposable blood sampling needles will cause the patient's economic burden. Therefore, in order to solve the inconvenience of extracting or collecting individual physiological samples in the prior art, there is an urgent need to develop novel and advanced technologies.

In view of the shortcomings of the prior art, the applicant in this case, after careful experimentation and research, and with a spirit of perseverance, finally conceived this case, which can overcome the shortcomings of the previous technology. The following is a brief description of the case.

In order to solve the problem that the prior art cannot continuously extract or collect the physiological sample of the individual and continuously measure the value of the physiological sample, the present invention discloses a biosensing implant device for implanting a biosensor under the skin. During the implantation process, the electrode is implanted under the skin of the individual to allow the biosensor to continuously receive the electrical signal from the electrode. The electrical signal is transmitted to the biosensor coupled to the biosensor through the circuit of the biosensor. The sensor, the calculation unit of the sensor calculates the physiological parameter value indicated by the electrical signal, transmits it to the electronic device of the individual or the medical institution in a wireless manner, and presents it on the display of the electronic device. The biosensor can continuously and uninterruptedly receive electrical signals without the need for repeated needle implantation and needle withdrawal, which will reduce the individual's risk of infection and allow individuals or physicians to know the continuous changes in physiological sample values.

To this end, the present invention discloses a biosensing implant device comprising: a housing with a first raised shoulder, a top cover, a plurality of protruding positioning portions, and a limit extending from the top cover on the inside of the housing Column; a firing seat, set in the housing, including a hollow body with a channel, and the two ends of the hollow body are respectively connected to the grasping portion, a first base, a positioning on the first base Part, and a second raised shoulder on the bottom plate in the first base; a needle implanting part, including a needle seat, a holding seat, an implant seat, and connecting the needle seat and extending through An implantation needle of the implant base, wherein the implantation needle has an electrode; and an implantation needle unit, including: an implantation needle holder, which is accommodated in the first base and includes a safety buckle , A first buckle and a buckle part, and the first buckle and the safety buckle respectively abut the limit post and the first convex shoulder when assembled; a needle planting spring, both ends of which Respectively press against the top cover and the bottom wall of the implant needle seat; a needle extraction seat is accommodated in the implant needle seat and includes a clamping member and a second buckle. The clamping member is assembled during assembly. Disposed in the hollow body and used to clamp the needle holder, the second buckle and the buckle portion of the needle implant holder are mutually engaged, and the top of the needle extraction seat is engaged with the first buckle; And a needle withdrawing spring, the two ends of which are respectively pressed against The needle extraction base and the needle implant base; wherein, when the housing is pressed to perform a firing process, the positioning member of the firing base sequentially forms a positioning relationship with the plurality of protruding positioning portions of the housing.

The present invention also discloses a method for implanting a biosensing implant device, including: providing a sensor housing: the sensor housing has a positioning buckle, a positioning device, and a sensor inside, and the sensor is formed by the positioning buckle and the positioning device Positioning relationship; to provide a biosensing implant device: the biosensing implant device includes: a housing, a pre-fire seat, a firing seat with a grasping part, a needle implant with a clamping part, and a needle implant and extraction unit, The needle planting and extracting unit includes: a needle planting seat with a safety buckle, a needle planting spring, a needle withdrawing seat, and a needle withdrawing spring; grasp the sensor: engage the housing in the sensor housing, and press the housing to release Positioning device, the grasping part grasps the sensor; pre-fire: press down the shell so that the grasping part is flush with the bottom surface of the pre-fire seat; press down firing: press down the shell again, the needle implanting seat Being pushed down causes the safety buckle to retract from the safety buckle relationship with the first raised shoulder, and at the same time the clamping portion releases the biosensor, so that the biosensor is combined with the sensor, The implanting needle seat drives the implanting needle part to pass through the bottom of the sensor; and retracting the implantation needle: when the implanting needle seat is out of the limit relationship with the limit post, the return elastic force of the needle withdrawing spring is used to make the withdrawal The needle seat is withdrawn instantly, and the down-press firing is completed.

The present invention also discloses a method for implanting a biosensing implant device, including: providing a sensor housing, wherein the sensor housing includes a recess and a positioning buckle, a plurality of positioning pieces and a sensor in the recess. The sensor It is buckled and held by the positioning buckle and the plurality of positioning pieces to be set toward a specific orientation; a biosensing implant device is provided, and the biosensing implant device includes: a housing, and a first part of the inner wall of the housing A protruding shoulder and a plurality of protruding positioning portions, a limit stop extending from a top cover of the housing, a pre-firing seat, a firing seat including a grasping part and a first base, in A positioning piece on the first base has a clamping seat and a plant The needle, a biosensor held by the holder, and a needle implantation and extraction unit, the implantation and extraction needle unit includes: a needle implantation base with a safety buckle, a needle implantation spring, and a needle extraction unit Seat and a needle-drawing spring; engage the housing in the sensor housing, and press down the housing to release the positioning relationship between the positioning member and one of the plurality of protruding positioning portions, so that the grasping portion can grasp the Sensor; continue to press down on the shell to perform a pre-fire action, so that the bottom of the gripping portion and the bottom of the pre-fire seat are on the same level; continue to press down on the shell to perform a press-on firing action, where the implant The needle holder is pushed down to retract the safety buckle to release a buckling relationship with the first raised shoulder, and at the same time, the holder releases the biosensor so that the biosensor and The sensor is combined, and the implant needle holder drives the implant needle out of the bottom of the sensor; and when the implant needle holder is out of a limit relationship with the limit post, the return elastic force of the needle withdrawal spring is used to make the The needle holder is instantly withdrawn, and the down-pressing and firing action is completed.

The present invention also discloses a needle implantation unit for a biosensing implant device, wherein the biosensing implant device is used to implant an electrode of a biosensor under the skin, and the biosensing implant device It includes a housing, and the planting and extracting needle unit includes: a planting needle holder, which is arranged in the housing and includes a safety buckle and a first buckle; a needle planting spring adapted to the needle planting base; The needle holder is buckled in the needle planting holder by the first buckle and includes a clamping piece and a second buckle. The clamping piece is used for clamping a needle holder and a clamp assembled with the needle holder The holder is used to hold the biosensor, and an implant needle passes through the biosensor, and the implant needle has an electrode connected to the biosensor at one end; and a needle drawing spring, and The needle withdrawal seat is adapted, wherein when the housing is pressed by an external force, the safety buckle is released to trigger the needle implant spring to generate a first bias, and the needle implant seat and the needle withdrawal seat are driven from A first position moves along the axial direction of the housing to a second position, so that the holder releases the biosensor, installs the biosensor to a sensor, and inserts the implant needle Subcutaneously of a body; and when the biosensor is installed on the sensor, the second buckle is released and the needle is implanted The seat is released to trigger the needle drawing spring to generate a second bias, the needle drawing seat is driven to move from the second position in the opposite direction to the axial direction to a third position and disengage from the first buckle, so that the The implanted needle is pulled away from the biosensor instantaneously to accommodate the electrode under the skin.

1. 101‧‧‧Biosensing implant device

2, 102‧‧‧Shell

3‧‧‧Inner wall

4. 104‧‧‧Top cover

5. 105‧‧‧Limiting post

6‧‧‧The first raised shoulder

7‧‧‧Percussion seat

8‧‧‧Hollow body

9‧‧‧Channel

10‧‧‧Grabbing Department

11‧‧‧First Pedestal

12‧‧‧Bottom plate

13‧‧‧Second raised shoulder

14‧‧‧Needle implant

15‧‧‧Needle seat

16‧‧‧Clamping seat

17, 117‧‧‧Implant needle

18‧‧‧electrode

19‧‧‧Needle extraction unit

20‧‧‧Needle Planter

21‧‧‧Safety buckle

22‧‧‧First buckle

23‧‧‧Needle Planting Spring

24, 124‧‧‧Needle extraction seat

25‧‧‧Clamping parts

26‧‧‧Second buckle

27、127‧‧‧Needle withdrawal spring

28‧‧‧Second Base

29‧‧‧Third Pedestal

30‧‧‧Cap body

31‧‧‧Implant

32‧‧‧ Zhoubi

33‧‧‧Cross Track

33a‧‧‧First track

33b‧‧‧Second track

33c‧‧‧Third track

33d‧‧‧Fourth track

34a‧‧‧The first virtual line

34b‧‧‧Second Virtual Line

35、135‧‧‧Lip

36‧‧‧Pre-strike starter

37‧‧‧Spine

38‧‧‧ feet

39‧‧‧Groove

40‧‧‧Sensor box

41‧‧‧Neck

42‧‧‧Guide

43‧‧‧Concave

44‧‧‧The third raised shoulder

45‧‧‧Positioning Department

45a‧‧‧First positioning part

45b‧‧‧Second positioning part

45c‧‧‧The third positioning part

46‧‧‧Boycott Department

47‧‧‧Positioning piece

48‧‧‧Snap part

49‧‧‧Concave

50‧‧‧Biosensor

51‧‧‧Positioning buckle

52a‧‧‧First positioning piece

52b‧‧‧Second positioning piece

52c‧‧‧The third positioning piece

54‧‧‧Sensor housing

60‧‧‧Sensor

70‧‧‧Specific location

104a‧‧‧File Department

D1‧‧‧First direction

D2‧‧‧Second direction

P‧‧‧First position

Q‧‧‧Second position

R‧‧‧third position

The above-mentioned objects and advantages of the present invention will become more immediately apparent to those with ordinary knowledge in the technical field after referring to the following detailed description and accompanying drawings.

1(A) and 1(B) are respectively the first and second cross-sectional schematic diagrams of the biosensing implant device of the present invention.

Figure 2(A) is a side view of the sensor packaging box of the present invention.

Figure 2(B) is a perspective view of the sensor packaging box of the present invention.

3(A) and 3(B) are respectively the first and second cross-sectional schematic diagrams of the grasping sensor of the biosensing implant device of the present invention.

4(A) and 4(B) are respectively the first and second cross-sectional schematic diagrams of the biosensing implant device of the present invention positioned at a specific position on the skin and releasing the safety buckle structure.

Figures 5(A) and 5(B) are respectively the first and second cross-sectional schematic diagrams of the biosensing implant device of the present invention to activate the pre-percussion seat.

6(A) and 6(B) are respectively the first and second cross-sectional schematic diagrams of the firing needle implantation unit of the biosensing implant device of the present invention.

7(A) and 7(B) are respectively the first and second cross-sectional schematic diagrams of the release needle holder of the biosensing implant device of the present invention.

8(A) and 8(B) are respectively the first and second cross-sectional schematic diagrams of the biosensing implant device of the present invention separated from the biosensor.

Figure 9 is a perspective view of the percussion seat of the present invention.

Figure 10 is a three-dimensional top view of the percussion seat of the present invention.

Figure 11 is a top view of the percussion seat of the present invention.

Figure 12(A) is a three-dimensional view of the needle implant of the present invention set on the firing base.

Figure 12(B) is a top view of the needle implant of the present invention set on the firing base.

Figure 13(A) is a first cross-sectional schematic view of another biosensing implant device of the present invention.

Figure 13(A) is a second cross-sectional schematic diagram of another biosensing implant device of the present invention.

The invention proposed in this case will be fully understood by the following examples, so that those with ordinary knowledge in the technical field can complete it. However, the implementation of this case is not limited by the following examples. Those with ordinary knowledge in the field can still deduce other embodiments based on the spirit of the disclosed embodiments, and these embodiments should all fall within the scope of the present invention.

The biosensing implant device of the present invention is shown in the first and second cross-sections in Figures 1(A) to 1(B), 3(A) to 8(B), 13(A) to 13(B) The schematic diagram shows the three-dimensional mechanical structure, (A) shows the first cross-section, (B) shows the second cross-section, and the first and second cross-sections are two cross-sections at 90 degrees. Unless otherwise specified, for example, in order to consider the directionality of specific components, the biosensing implant device of the present invention exhibits bilateral symmetry in the first section and the second section.

Please refer to Figures 1(A) and 1(B), which are respectively the first and second cross-sectional schematic diagrams of the biosensing implant device of the present invention. In Figures 1(A) and 1(B), the biosensing implant device 1 includes a housing 2, a firing base 7, a needle implant 14, a needle implanting unit 19, and a prefire base 36. The housing 2 includes an inner wall 3, a top cover 4 adjacent to the inner wall 3, and a limit post 5 extending from the top cover 4. The inner wall 3 is provided with a first raised shoulder 6 (Figure 1(A)) and First position The portion 45a, the second positioning portion 45b, the third positioning portion 45c (Figure 1(B)), and the housing 2 are provided with a ridge 37 downwardly along the first raised shoulder portion 6. The number of the protruding positioning portions 45 (for example, the first to third positioning portions (45a-45c)) may be plural.

Please also refer to Figs. 1(A), 1(B), 9 and 10 together. The firing seat 7 provided in the housing 2 includes a hollow body 8 (Fig. 10) through which a channel 9 penetrates, and a hollow body 8 The two ends are respectively connected to the grasping portion 10, the positioning member 47 (Figure 1(B)), the first base 11, and the second raised shoulder 13 on the bottom plate 12 in the first base 11, respectively. The aforementioned components of the firing seat 7 may be integrally formed; or may be composed of two structures, the first structure is the first base 11, the second structure is composed of the hollow body 8 and the grasping portion 10, the first and the second The structure is adapted to each other. The firing base 7 also includes two legs 38 extending downward from the edge of the first base 11, which have grooves 39 longitudinally arranged along the legs 38, and the grooves 39 are adapted to fit with the ridge 37 of the housing 2. It is equipped to allow the first base 11 to move longitudinally in the housing 2. The leg 38 also has a resisting portion 46 provided with lateral protrusions.

Please continue to refer to Figures 1(A) and 1(B). The needle implant 14 of the biosensing implant device 1 is arranged in the housing 2. The needle implant 14 includes a needle seat 15 for holding the biosensing device The clamping base 16 of the device 50, the implant base 31, and the implant needle 17 extending from the needle base 15 and passing through the implant base 31 and the biosensor 50. Wherein, the needle holder 15 has a neck 41 for the needle holder 24 to clamp, the implant needle 17 passing through the implant holder 31 and the biosensor 50 exposes its needle tip, the implant needle 17 has an electrode 18 inside, and is implanted Four guide rails 42 are provided on the seat 31 (Figures 12(A) and 12(B)).

Please refer to Figures 2(A) and 2(B), which are respectively a side view and a three-dimensional view of the sensor packaging box of the present invention. The sensor packaging box 40 is combined with the biological sensing implant device 1 so that the biological sensing implant device 1 grabs the sensor 60 in the sensor packaging box 40. In Figures 2(A) and 2(B), the sensor package 40 has a sensor housing 54. The recess 49 of the sensor housing 54 has a sensor 60, a first positioning piece 52a, a second positioning piece 52b, and a third positioning piece. 52c, and a positioning buckle extending from one surface of the first positioning piece 52a 51. The sensor 60 is arranged on the second positioning piece 52b and is buckled and held by the positioning buckle 51 to be arranged in a specific orientation. In addition, the second positioning piece 52b may have a convex structure to fit with the opposite concave structure (not shown) on the sensor 60. The third positioning piece 52c is disposed between the first positioning piece 52a and the sensor housing 54 and is arranged substantially in parallel with the first positioning piece 52a. When the housing 2 of the biosensing implant device 1 intends to grab the sensor 60 in the sensor packaging box 40, the height of the third positioning piece 52c prevents the housing 2 from entering the recess 49 too deep and jamming.

Please refer to Figures 10, 11, 12(A) and 12(B) together. The channel 9 of the hollow body 8 of the firing seat 7 has a peripheral wall 32. , Second, third and fourth tracks (33a, 33b, 33c, 33d, see Figure 10). In detail, the first to fourth rails (33a, 33b, 33c, 33d) are arranged on the arc-shaped surface of the peripheral wall 32 and are arranged in pairs. Wherein, when viewing the longitudinal direction from the top view of FIG. 11, the first track 33a is arranged opposite to the first virtual line 34a and the third track 33c, and the second track 33b is opposite to the fourth track 33d through the second virtual line 34b. Configuration, the first and second virtual lines (34a, 34b) intersect in a cross shape, wherein the four guide rails 42 of the implant base 31 and the first to fourth rails (33a, 33b, 33c, 33d) are adapted to form a cross rail 33 , The cross track 33 prevents the needle implant 14 from deflection during the implantation process, and greatly improves the stability of the implantation. Furthermore, through the precise positioning of the tracks 33a to 33d, the implant base 31 can assist the biosensor 50 and the sensor 60 to be accurately combined.

Furthermore, at the bottom of the channel 9 of the hollow body 8, a third raised shoulder 44 is provided beside the track (33a, 33b, 33c, 33d) of the peripheral wall 32, which has an inclined surface. When the biosensor 50 clamped by the clamping base 16 enters the bottom of the channel 9, the clamping base 16 presses against the inclined surface of the third raised shoulder 44 to release the biosensor 50, so that the biosensor 50 and The sensor 60 is combined.

As mentioned above, the biosensor 50 includes a circuit and one end is connected to the biosensor The electrode 18 of the object sensor 50 (Figure 1(B)). The electrode 18 is usually an elongated body made of a soft material. Except that one end of the electrode 18 is connected to the biosensor 50, the elongated body and the other end of the electrode 18 are set in the implantation needle 17 through the tip of the implantation needle 17. The electrode 18 is held under the skin by the traction of the implant needle 17. In addition, the aforementioned implant base 31 has at least one positioning protrusion (not shown) on the side facing the biosensor 50, and the biosensor 50 has at least one positioning protrusion on the side facing the implant base 31. At least one positioning recess (not shown) correspondingly configured. The position and number of at least one positioning convex point on the implant base 31, the position and number of at least one positioning concave point on the biosensor 50, and the mutual fit between the positioning convex point and the positioning concave point are used to confirm The biosensor 50 clamped by the holder 16 is arranged in a specific direction, so that the biosensor 50 is also installed to the sensor 60 in a specific direction to prevent the biosensor 50 from being installed in any direction The sensor 60 cannot be activated.

The needle implantation and withdrawal unit 19 includes a needle implantation base 20, a needle implantation spring 23, a needle withdrawal base 24 and a needle withdrawal spring 27. The needle implant base 20 is accommodated in the first base 11 and includes a safety buckle 21, a buckle portion 48 and a first buckle 22. When the needle planter 20 moves upward relative to the downward movement of the housing 2 in the housing 2, the outwardly arranged inclined surface on the safety buckle 21 will disengage and abut against the first convex shoulder 6, making it elastic The safety buckle 21 is squeezed toward the center of the first base 11 to release the safety buckle mechanism of the needle implant base 20. The first buckle 22 will abut against the limit post 5 during the assembly process of the biosensing implant device 1, so that the needle withdrawal seat 24 buckled by the first buckle 22 is constrained between the two limit posts 5 Space movement. In addition, the needle implant base 20 further includes a second base 28 and a third base 29 surrounded by the second base 28, and the safety buckle 21 is disposed on the outside of the second base 28.

The needle planting spring 23 in the planting needle unit 19 is a compression spring, which is carried on the second base 28, and its two ends are respectively pressed against the top cover 4 and the bottom wall of the needle planting base 20 and present a pre-compressed energy storage. The state is preferably a partially compressed energy storage state. In a specific embodiment, the diameter of the needle implant spring 23 exceeds the distance between the two limit posts 5, because The needle-planting spring 23 is not blocked by the limit post 5.

The needle withdrawal seat 24 is accommodated in the implant needle seat 20 and includes a cap body 30, a clamping member 25 extending from the cap body 30, and a second buckle 26, wherein the clamping member 25 is disposed in the assembly during assembly Part of it extends into the hollow body 8 and is used to clamp the neck 41 of the needle holder 15; and the second buckle 26 is arranged along the edge of the cap body 30 and abuts against the edge of the third base 29, and The two buckles 26 and the buckle portion 48 of the needle implant base 20 are mutually engaged, and the top of the needle withdrawal seat 24 is engaged with the first buckle 22. It is worth noting that the second buckle 26 is the same as the safety buckle 21, and the buckle mechanism can be released by the design of the inclined surface and the opposite shoulder structure.

In addition to the needle implantation spring 23, the present invention also provides a needle withdrawal spring 27, which is also a compression spring, is arranged around the clamping member 25, and the two ends are respectively pressed against the needle withdrawal seat 24 and the needle implant seat 20. In detail, the two ends of the needle withdrawal spring 27 abut against the top wall of the top cap body 30 and the bottom wall of the needle implant base 20 respectively.

Please refer to Figures 2(A) to 8(B). First, after removing the upper cover (not shown) of the sensor packaging box 40, the housing 2 of the biosensing implant device 1 is placed in the sensor packaging box 40. The concave portion 43, at this time, the grasping portion 10 will first abut the positioning buckle 51 on the first positioning piece 52a to form an action of preparing to grasp the sensor 7. Then, press the housing 2 slightly downwards, and the legs 38 of the firing seat 7 are resisted by the first positioning piece 52a and deform slightly inwardly (see Figure 3(A)), formed by the resisting portion and the first positioning piece 52a Resisting the relationship, avoiding false firing before the grasping portion 10 of the trigger 7 is completely grasped before the sensor 7. At this time, the positioning member 47 of the firing device 7 is positioned on the first positioning portion 45a of the housing 2 (see section 3(B) Figure). Continue to press down on the housing 2 again to release the buckling relationship between the grabbing portion 10 and the positioning buckle 51, so that the grabbing portion 10 can grab the sensor 60. At this time, the positioning member 47 of the trigger 7 is displaced upward to be positioned on the housing The second positioning portion 45b of 2 (see Fig. 4(B)) completes the action of the trigger 7 to take the sensor 60 out of the sensor packaging box 40.

Please refer to Figures 4(A) and 4(B), which are ejected from the sensor box 40 The biosensing implant device 1 has clamped the sensor 60, and then presses down on the housing 2 (for example, the housing 2 can be placed on a specific position 70) to push the pre-firing base 36 to move downward, so that the bottom surface of the pre-firing base 36 It is aligned at the bottom of the grasping part 10 to form a pre-fire action. At this time, the adhesive substance (not shown) coated on the bottom of the sensor 60 is attached to the specific position 70. It is worth noting that during the pre-firing action, the safety buckle 21 and the first protruding shoulder 6 have a safety buckle relationship to avoid direct firing during the pre-firing action. With the pre-fire action, the user or operator of the biosensing implant device 1 can first search for a suitable specific location 70 on the user’s skin. When the specific location 70 is determined, the user or operator will The pre-firing base 36 and the sensor 60 of the implant device 1 are arranged at a specific position 70 and aligned with the specific position 70.

Please refer to Figures 5(A) to 6(B) for the continuous action representation. When a downward pressure is applied to the housing 2 at a specific position 70 (as indicated by the arrow), the needle implant holder 20 is pushed downward The safety buckle 21 is retracted away from the safety buckle relationship with the first raised shoulder 6, and at the same time, when the biosensor 50 clamped by the holding seat 16 enters the bottom of the channel 9, the holding seat 16 will abut The biosensor 50 is released to the inclined surface of the third convex shoulder 44, and the biosensor 50 is combined with the sensor 60 (see Figure 6(A)), and the needle implant base 20 and the needle withdrawal base 24 are one And move the implant needle 17 downwards and out of the sensor 60 to complete the action of pressing down and firing. At this time, the positioning member 47 of the firing seat 7 moves upward to be positioned at the third positioning portion 45c of the housing 2 (see Section 6(B) )Figure).

Please refer to the continuous action diagrams in Figures 6(A) to 7(B). At the moment when the pressing down firing action is completed, because the first buckle 22 of the needle implanting seat 20 has completely broken away from the resisting relationship with the limit post 5 ( See Fig. 6(A)), and the return elastic force of the needle withdrawal spring 27, so that the second buckle 26 releases the buckling relationship of the second raised shoulder 13 (see Fig. 6(B)), making the needle planting seat 20 rebounds up instantly, the implant needle 17 is pulled away from the biosensor 50, the electrode 18 is placed under the skin (see Figures 7(A) and 7(B)), the sensor 60 and the biosensor 50 are left on the skin , The withdrawal of the implant needle 17 is completed.

During the firing process, the upwardly-moving pre-fire seat 36 pushes the implantation needle unit 19 upwards, so that the safety buckle 21 abuts the first raised shoulder 6 (see Figure 5(A)). At this time, the positions of the needle implanting seat 20 and the needle withdrawal seat 24 in the housing 2 are the first position P. The safety buckle 21 presses against the first raised shoulder 6 to trigger the needle implant spring 23 in the stored energy state to generate a first bias, which drives the needle seat 15 in the channel 9 to move downward in the direction of the sensor 60 (ie, The first direction D1).

Please refer to FIGS. 6(A) and 6(B). Then, the needle holder 15 moves toward the sensor 60 and the needle implant holder 20 and the needle withdrawal holder 24 touch the bottom plate 12 of the first base 11 and stop. At this time, the position of the needle implant base 20 and the needle withdrawal base 24 in the housing 2 is the second position Q, the biosensor 50 has been installed to the sensor 60, and the implant needle 17 has been inserted under the user's skin . In addition, the holder 16 abuts against the inclined surface of the third raised shoulder 44 to prepare or release the biosensor 50.

When the biosensor 50 is mounted on the sensor 60, the second buckle 26 abuts against the second raised shoulder 13 (refer to Figure 6(B)), triggering the needle drawing spring 27 to generate a second bias, and driving the drawing The needle holder 24 moves upwards in the opposite direction to the sensor 60 (see the second direction D2 in Figures 7(A) and 7(B)), so that the implant needle 17 is withdrawn from the biosensor 50 and the electrode 18 is placed under the skin. The procedure of implanting the biosensor 50 under the skin is completed (see Figure 7(A)).

The bias of the needle withdrawal spring 27 causes the needle withdrawal seat 24 to break through the restriction of the first buckle 21 and move upward. Therefore, the position of the needle withdrawal seat 24 in the housing 2 stays at the third position R (see Section 7( B)Picture). The third position R in Figure 7(B) is for illustration only. The third position R may be the same or different from the first position P, for example, a position as high as the first position P, but lower than the first position P的 position, a position higher than the first position P. As long as the tip of the implant needle 17 is finally located at a position where the user or operator will not touch the tip (to avoid injury to the user or operator), the length of the implant needle 17 and the implant needle 17 are taken into consideration. The needle holder 24 clamps the position after the upward movement, and the third position R can be defined. In a specific embodiment, the third position R is when the needle holder 24 is pressed against the top cover 4 of the housing 2. In a specific embodiment, the tip of the implant needle 17 is located at a position slightly higher than the position of the lip 35, and this position can be calculated to obtain the third position R.

Please refer to FIGS. 8(A) and 8(B). The operator or user removes the biosensing implant device 1 and presents the state where the biosensor 50 is implanted subcutaneously through the electrode 18. The biosensor 50 continuously receives the electric signal from the electrode 18, and the electric signal is transmitted to the sensor 60 combined with the biosensor 50 through the circuit of the biosensor 50, and the arithmetic unit of the sensor 60 calculates the electric signal The indicated physiological parameter values are wirelessly transmitted to the user or the electronic device of the medical institution and displayed on the display of the electronic device.

Please refer to FIGS. 13(A) and 13(B), which are schematic diagrams of the first cross-section and the second cross-section of another biosensing implant device of the present invention. In the biosensing implant device 101 of FIGS. 13(A) and 13(B), the top cover 104 of the housing 102 extends with a stop 104a having a thickness or height, which is arranged on two limit posts 105, when the needle withdrawal seat 124 rebounds upward by the return elastic force of the needle withdrawal spring 127, it does not contact the top cover 104 of the housing 102, but determines the withdrawal by the thickness or height of the stopper 104a. The rebound stroke and path distance of the needle seat 124, as long as the needle tip of the implant needle 117 is finally located at a position where the user or operator will not touch the needle tip (to avoid injury to the user or operator), for example, consider the implant needle The length of the 117 and the position where the implant needle 117 is clamped by the needle holder 124 to move upward, or the needle tip of the implant needle 117 is higher than the position of the lip 135.

In a specific embodiment, the needle implant 14 of the present invention can be integrated with the needle implant base 20 to form a needle implant mechanism, and the needle withdrawal base 24 can be used as a needle withdrawal mechanism coupled to the needle implant mechanism. When the needle planting mechanism and the housing 2 are in a first relative position (the needle planting mechanism is a distance from the housing 2), the needle planting mechanism implants the biosensor 50 into a specific position of the user's skin; and when the needle is withdrawn When the mechanism and the needle implant mechanism are in a second relative position (that is, the position of the needle withdrawal mechanism causes the implant needle 17 to retract into the housing 2 without causing the user or operator to touch the implant needle 17 and be injured, and The needle planting mechanism stays below the needle drawing mechanism), planting The needle mechanism is separated from the biosensor 50.

In another specific embodiment, when the needle planting mechanism is in the firing position in the housing 2, the needle planting spring releases its spring compression kinetic energy to drive the needle planting mechanism, and the needle planting mechanism combines the biosensor 50 and the sensor 60, And the biosensor 50 is implanted in a specific location.

In another specific embodiment, the needle planting spring and the needle planting mechanism provided on the needle planting mechanism are both in the unactuated first energy storage state, and both the needle ejecting spring and the needle ejecting mechanism provided on the needle planting mechanism In the second state of energy storage that has not been activated. After the needle planting spring and the needle drawing spring release their compression kinetic energy, the needle drawing mechanism, the needle planting mechanism and the housing are in a relative position, and the needle implanting spring and the needle drawing spring are in the released state at the same time. Among them, the relative position means that the needle tip of the implant needle is located in the lip of the housing, and the position of the needle implant mechanism in the housing is far from the top cover; and the released state means that the needle implant spring and the needle withdrawal spring are in a relaxed state.

In another specific embodiment, the pre-firing base 36 of the present invention can be used as a position selection element to maintain a predetermined distance between the biosensor and a specific position on the skin. When the user confirms that the specific location is where he wants to be able to continuously monitor physiological parameters, the location selection component allows the user to operate the implantation needle unit with confidence.

The advantages of the present invention are as follows:

1. The needle implant spring and the needle withdrawal spring are set to a pre-compressed state: the needle implant spring is in a pre-compressed state to reduce the resistance when artificially pressing the biosensing implant device, and the needle spring is in a pre-compressed state for biosensing The implantation device immediately withdraws the implant needle at the moment when the firing action is completed. In addition, the actions of implanting and drawing the needle are completed synchronously by pressing down on the biosensing implant device, and the speed of implanting and drawing the needle is very fast and easy to operate.

2. The design of the cross track: the combination and design of the cross track and the needle implanting parts improve the stability of the needle implantation process, and the auxiliary biosensor and sensor can be accurate Really combine. In addition, the holder only grabs the biosensor. Since the quality and size of the sensor are smaller than those of the biosensor, the holder is combined with the design and arrangement of the cross track to make the needle implant faster and reduce pain.

3. Double safety buckle mechanism of the needle withdrawal seat: the needle withdrawal spring is in a pre-compressed state. In order to avoid the needle seat rebound before the needle implantation seat is fired, the subsequent firing will be invalid. The double buckle mechanism of the needle withdrawal seat can be used. Effectively avoid this situation from happening.

4. Safety buckle mechanism for the needle implant holder: This system uses the design of the safety buckle to avoid direct firing of the needle implant holder during pre-fire.

5. The sensor packaging box has a safety design of the positioning part: when the biosensing implant device enters the housing of the sensor packaging box to grab the sensor, the positioning part is designed to avoid false firing due to incomplete grabbing of the sensor.

6. The top cover of the housing of the biosensing implant device can be additionally designed with a stop: the height or thickness of this stop can be designed according to actual needs to determine the withdrawal stroke of the needle holder, so that the needle holder is returning There is no need to return to the top cover after bombing.

7. A third raised shoulder is arranged at the bottom of the channel of the hollow body: when the biosensing implant device is pressed down, the holding seat is pressed by the inclined surface of the third raised shoulder, and the holding seat is slightly deformed to release the biological sensing The device combines the biological sensor with the sensor.

8. The inner wall of the housing of the biosensing implant device has a plurality of protruding positioning parts: this provides the biosensing implant device with a positioning function during the pressing process to avoid false firing.

The present invention is really a difficult innovative invention and has deep industrial value, and it is necessary to file an application in accordance with the law. In addition, the present invention can be modified by persons with ordinary knowledge in the relevant technical field, but does not deviate from the scope of protection as claimed in the attached patent scope.

1‧‧‧Biosensing implant device

2‧‧‧Shell

3‧‧‧Inner wall

4‧‧‧Top cover

5‧‧‧Limiting post

6‧‧‧The first raised shoulder

7‧‧‧Percussion seat

8‧‧‧Hollow body

9‧‧‧Channel

11‧‧‧First Pedestal

12‧‧‧Bottom plate

14‧‧‧Needle implant

15‧‧‧Needle seat

16‧‧‧Clamping seat

17‧‧‧Implant needle

18‧‧‧electrode

19‧‧‧Needle extraction unit

20‧‧‧Needle Planter

21‧‧‧Safety buckle

22‧‧‧First buckle

23‧‧‧Needle Planting Spring

24‧‧‧Needle Drawer

25‧‧‧Clamping parts

27‧‧‧Needle withdrawal spring

31‧‧‧Implant

35‧‧‧Lip

36‧‧‧Pre-strike starter

37‧‧‧Spine

38‧‧‧ feet

41‧‧‧Neck

44‧‧‧The third raised shoulder

46‧‧‧Boycott Department

50‧‧‧Biosensor

Claims (11)

A biosensing implant device includes: a housing with a first convex shoulder, a top cover, a plurality of protruding positioning portions, and a limit post extending from the top cover; and a firing seat, Is arranged in the housing and includes a hollow body with a passage, a grasping portion respectively connected to the two ends of the hollow body, a first base, a positioning member on the first base, and a A second raised shoulder on the bottom plate in a base; a needle implant member, including a needle seat, a holding seat, an implant seat, and a needle seat connected to the needle seat and extending through the implant seat An implantation needle, wherein the implantation needle has an electrode; and an implantation needle unit, including: a implantation needle holder, which is accommodated in the first base and includes a safety buckle and a first buckle And a buckle, and the first buckle and the safety buckle respectively abut against the limit post and the first convex shoulder when assembled; and a needle planting spring, the two ends of which respectively abut against the top cover And the bottom wall of the implant needle seat; a needle extraction seat is accommodated in the implant needle seat and includes a clamping piece and a second buckle, the clamping piece is arranged in the hollow body during assembly and Used to clamp the needle seat, the second buckle and the buckle part of the needle planting seat are mutually engaged, and the top of the needle extraction seat is engaged with the first buckle; and a needle withdrawal spring, Its two ends are respectively pressed against the needle extraction base and the needle implant base; wherein, when the housing is pressed to perform the firing process, the positioning member of the firing base is formed in sequence with the plurality of protruding positioning parts of the housing Positioning relationship. According to the biosensing implant device described in claim 1, wherein the needle implant base further includes a second base, and the needle implant spring is carried on the second base. The biosensing implant device according to item 2 of the scope of patent application, wherein the safety buckle is arranged on the outer side of the second base, and the implant needle seat further includes a third base surrounded by the second base. The base, and the second buckle abuts against the buckle portion of the third base. The biosensing implant device according to the first item of the scope of patent application, wherein the needle withdrawal base further includes a cap body, the clamping member extends from the cap body, and the second buckle is arranged on the cap body The outer side and the needle drawing spring are sleeved between the cap body and the clamping piece. The biosensing implant device according to item 4 of the scope of patent application, wherein the needle withdrawing spring abuts against the top wall of the cap body and the bottom wall of the implant needle holder respectively, and the hollow body further includes a third convex The shoulder portion is arranged at the bottom of the channel and is configured to press against an inclined surface of the third raised shoulder when the biosensor enters the bottom of the channel and is combined with a sensor. Take out the biological sensor. The biosensing implant device according to claim 1, wherein the implant base has at least one positioning convex point, and the biosensor has at least one positioning convex point on the implant base. At least one corresponding positioning recess is arranged. The biosensing implant device according to item 6 of the scope of patent application, wherein the channel has a peripheral wall, and the peripheral wall has a first, a second, a third, and a first, a second, and a third that are equally arranged along the longitudinal direction of the hollow body A fourth track, where viewed from the longitudinal direction, the first track is arranged opposite to the third track with a first virtual line, and the second track is arranged opposite to the fourth track with a second virtual line, The first and the second virtual lines intersect in a cross shape so that the first to the fourth rails form a cross rail, and the implant base includes the first, the second, the third and the fourth rails Adapted four guide rails. The biosensing implant device according to item 1 of the scope of patent application, wherein the housing further includes a lip, and the biosensing implant device further includes A pre-cock seat partially exposed to the lip, and the pre-cock seat is used by a user to determine the position of the biosensor to be implanted under the skin of a body. A method for implanting a biosensing implant device includes: providing a sensor housing: the sensor housing has a positioning buckle, a positioning device, and a sensor, and the positioning buckle and the positioning device form a positioning relationship with the sensor; providing A biosensing implant device: the biosensing implant device includes: a housing, a pre-firing base, a firing base with a grasping part, a needle implant with a clamping part, a implant and aspiration needle unit, and the implant and aspiration needle The unit includes: a needle planting seat with a safety buckle, a needle planting spring, a needle withdrawing seat and a needle withdrawing spring; grab the sensor: engage the housing in the sensor housing, press the housing to release the positioning device, the The grasping part grabs the sensor; pre-fire: press down the shell so that the grasping part is flush with the bottom surface of the pre-fire seat; press down firing: press down the housing again, and the needle implant seat is pushed down The pressure causes the safety buckle to retract from the safety buckle relationship with the first raised shoulder, and at the same time, the clamping portion releases the biosensor, so that the biosensor is combined with the sensor, and the needle implant The seat drives the needle implant to pass through the bottom of the sensor; and withdraw the implant needle: when the implant needle seat is out of the limit relationship with the limit post, the elastic force of the needle withdrawal spring is used to make the needle withdrawal seat instantly withdraw Back, the depressing firing is complete. A method for implanting a biosensing implant device includes: providing a sensor housing, wherein the sensor housing includes a concave portion, a positioning buckle, a plurality of positioning pieces and a sensor in the concave portion, and the sensor is supported by the positioning card The buckle and the plurality of positioning pieces are buckled and held in a specific orientation; a biosensing implant device is provided, and the biosensing implant device includes: a housing, and a first convex shoulder on the inner wall of the housing Part and a plurality of protruding positioning parts, a limit stop extending from a top cover of the housing, a pre-firing seat, including a grasping part and a A firing seat of the first base, a positioning member on the first base, a needle implant member having a holding seat, a biosensor held by the holding seat, and a implant Needle unit, the needle planting and extracting unit includes: a needle planting seat with a safety buckle, a needle planting spring, a needle withdrawing seat and a needle withdrawing spring; the housing is connected to the sensor housing, and the housing is pressed down The housing is used to release the positioning relationship between the positioning member and one of the plurality of protruding positioning portions, so that the grasping portion can grasp the sensor; continue to press down the housing to perform a pre-fire action, so that the grasping portion The bottom is on the same level as the bottom of the pre-percussion seat; continue to press down on the housing to perform a press-percussion action, wherein the needle implant seat is pushed down to retract the safety buckle to release the first protrusion A buckle relationship of the shoulder, and the holding base releases the biosensor, so that the biosensor is combined with the sensor, and the implant needle holder drives the implant needle to pass through the bottom of the sensor; and When the needle implanting seat is out of a limit relationship with the limiting post, the needle ejecting seat is instantly retracted by the elastic force of the needle ejecting spring to complete the pressing and firing action. A needle implantation unit for a biosensing implant device, wherein the biosensing implant device is used to implant one electrode of a biosensor under the skin, and the biosensing implant device includes a housing , The needle planting and extracting unit includes: a needle planting seat, which is arranged in the housing and includes a safety buckle and a first buckle; a needle planting spring, which is adapted to the needle planting seat; The first buckle is buckled in the needle implanting seat and includes a clamping member and a second buckle. The clamping member is used for clamping a needle seat, and a clamping seat assembled with the needle seat is used for The biosensor is clamped, and an implanted needle passes through the biosensor. The implanted needle has an electrode connected to the biosensor at one end; and a needle-drawing spring, and the needle-drawing seat adaptation, Wherein, when the housing is pressed by an external force, the safety buckle is released to trigger the needle planting spring to generate a first bias, and the needle planting base and the needle drawing base are driven to follow the housing from a first position. The axial movement of the body to a second position allows the holder to release the biosensor to install the biosensor to a sensor and insert the implant needle into the subcutaneous of a body; and When the biosensor is installed on the sensor, the second buckle is released and the needle implant holder is released to trigger the needle withdrawal spring to generate a second bias, and the needle withdrawal holder is driven from the second position Move to a third position opposite to the axial direction and detach from the first buckle, so that the implant needle is instantly drawn away from the biosensor to accommodate the electrode under the skin.

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