Implant needle structure and implant device

Abstract

The present invention provides a needle implant structure for accommodating a biosensor and partially implanting it under the skin of a living body. The needle implant structure includes a needle tip and a needle body that are integrally connected. The needle body has a storage space for accommodating the biosensor and includes a bottom wall, two side walls and two slope sections. The two side walls are respectively located on two sides of the bottom wall, and each side wall has a first inner edge adjacent to the storage space and a first outer edge away from the storage space. The two slope sections are respectively located on two sides of the bottom wall, and each slope section is connected between the side wall and the needle tip and includes a second inner edge and a second outer edge, respectively connecting the first inner edge and the first outer edge. Among them, the first inner edge, the second inner edge, the first outer edge and the second outer edge are arc-shaped, the arc radius of the first inner edge is R11, and the arc radius of the first outer edge is R12, satisfying R11>R12. Thereby, the burr degree of the needle implant structure is reduced.

Description

Technical Field

[0001] The present invention relates to an implant needle structure and an implant device, and more particularly to an implant needle structure and an implant device for biosensor implantation. Background Art

[0002] Monitoring glucose levels is crucial for diabetics. Patients with other chronic diseases also require daily monitoring of specific physiological parameters, such as blood fat and cholesterol levels, to track their condition and facilitate subsequent treatment. Generally, these physiological parameters require analysis of the patient's body fluids. For example, existing blood glucose meters use a needle to puncture the skin, draw blood, and analyze it to determine blood glucose levels.

[0003] However, to facilitate more accurate and timely monitoring, some industry practitioners have proposed implanting biosensors under the human skin. These biosensors can obtain the physiological parameters to be analyzed at any time. These biosensors are then used with signal processors to transmit these physiological parameters to a cloud or back-end monitoring system, providing a larger amount of more timely analytical data while avoiding the discomfort and infection risks of multiple invasive fluid extractions.

[0004] Biosensors can be implanted beneath the human skin via an implant device. The implant device may include an implant needle, into which the biosensor is placed. The implant needle punctures the skin to create a tiny opening, allowing the biosensor to enter through the opening and be implanted beneath the skin. If the opening is too large or uneven, it can be difficult to heal the opening (wound). Therefore, improving the structure of the implant needle to reduce its burrs, improve the smoothness of the implant process, and thereby enhance the smoothness of the opening formed on the human skin or biological surface has become a goal of relevant industry practitioners. Summary of the Invention

[0005] In order to solve the above problems, the present invention provides a needle implant structure and an implantation device, which, through its structural configuration, can effectively improve the smoothness of the needle implant structure when inserted into the skin surface of a living body.

[0006] According to one embodiment of the present invention, there is provided a needle implant structure, which is formed by bending a flat plate and is used to accommodate a biosensor and implant the biosensor portion under the skin of a living organism. The needle implant structure includes a needle tip, a needle body, and a reinforcement portion. The needle body is integrally connected to the needle tip and has a receiving space for accommodating the biosensor, and the needle body includes a bottom wall, two side walls, and two slope sections. The two side walls are respectively located on two sides of the bottom wall, and each side wall has a first inner edge and a first outer edge. Each first inner edge is adjacent to the receiving space, and each first outer edge is away from the receiving space. The two slope sections are respectively located on two sides of the bottom wall, and each slope section is connected between each side wall and the needle tip and is generally convex arc-shaped. Each slope section includes a second inner edge and a second outer edge. Each second inner edge is connected to each first inner edge, and each second outer edge is connected to each first outer edge. The reinforcement portion is disposed in at least one section of a reinforcement block, the reinforcement block being defined as the needle tip and the portion of the needle body adjacent to the needle tip, and the reinforcement portion is formed by forming at least one concave structure and / or a convex structure in the at least one section. Each first inner edge, each second inner edge, each first outer edge, and each second outer edge is arc-shaped, the arc radius of each first inner edge being R11, and the arc radius of each first outer edge being R12, satisfying the relationship R11>R12. The flat plate elastically deforms during separation from a sheet by punching to form each first outer edge and each second outer edge. The flat plate has a thickness T1, satisfying the relationship 20%≤R11 / T1≤50%.

[0007] The arc-shaped first inner edge, second inner edge, first outer edge, and second outer edge facilitate smooth puncture of the skin, thereby enhancing the smoothness of the opening. Furthermore, the relationship of R11 > R12 prevents scratching of the biosensor within the accommodating space. Furthermore, the reinforcement increases the structural strength of the needle tip, preventing it from bending and deforming due to stress during implantation.

[0008] According to the aforementioned embodiment of the implant needle structure, the reinforcement portion may include a groove extending from the needle tip toward the bottom wall of the needle body.

[0009] According to the aforementioned embodiment of the needle implant structure, the reinforcement portion may include a rib extending from the needle tip toward the bottom wall of the needle body.

[0010] According to the aforementioned embodiment of the implant needle structure, the needle tip may include two sides connected to two sloped sections, the two sides intersecting to form a pointed end, and each side including an upper needle tip edge and a lower needle tip edge. The upper needle tip edge is arc-shaped and connected to the second inner edge; the lower needle tip edge is arc-shaped and connected to the second outer edge. The arc radius of each upper needle tip edge is R31, and the arc radius of each lower needle tip edge is R32, satisfying the relationship R31>R32.

[0011] According to the needle implant structure of the aforementioned embodiment, the flat plate can be elastically deformed when being separated from the sheet by punching to form the lower edge of each needle tip.

[0012] According to the needle implant structure of the aforementioned embodiment, a needle tip length L1 can be defined as the distance between the tip and an end position of each side along the length direction, and an extended length L2 can be defined as the distance between the tip and an end position of each slope section along the length direction, satisfying the relationship L1 / L2≤15%.

[0013] According to another embodiment of the present invention, there is provided a needle implant structure, which is formed by bending a flat plate and is used to accommodate a biosensor and partially implant the biosensor under the skin of a living body. The needle implant structure includes a needle tip and a needle body. The needle body is integrally connected to the needle tip and has a receiving space for accommodating the biosensor, and the needle body includes a bottom wall, two side walls and two slope sections. The two side walls are respectively located on two sides of the bottom wall, and each side wall has a first inner edge and a first outer edge. Each first inner edge is adjacent to the receiving space, and each first outer edge is away from the receiving space. The two slope sections are respectively located on two sides of the bottom wall, and each slope section is connected between each side wall and the needle tip and is generally convex arc-shaped. Each slope section includes a second inner edge and a second outer edge. Each second inner edge is connected to each first inner edge, and each second outer edge is connected to each first outer edge. Among them, each first inner edge, each second inner edge, each first outer edge and each second outer edge are arc-shaped, the arc radius of each first inner edge is R11, and the arc radius of each first outer edge is R12, satisfying the relationship R11>R12, and the flat plate elastically deforms when being separated from a sheet by punching to form each first outer edge and each second outer edge, and the flat plate has a thickness T1, satisfying the relationship 20%≤R11 / T1≤50%.

[0014] According to the implant needle structure of the aforementioned embodiment, the relationship of 3≤R11 / R12≤10 can be satisfied.

[0015] According to the needle implant structure of the aforementioned embodiment, the needle tip may include two side edges respectively connected to two slope sections, the two side edges intersect to form a tip, and a needle tip length L1 may be defined as the distance between the tip and an end position of each side edge along the length direction, and an extended length L2 may be defined as the distance between the tip and an end position of each slope section along the length direction, satisfying the relationship L1 / L2≤15%.

[0016] According to another embodiment of the present invention, there is provided a needle implant structure, which is formed by bending a flat plate and is used to accommodate a biosensor and implant the biosensor portion under the skin of a living body. The needle implant structure includes a needle tip and a needle body. The needle body is integrally connected to the needle tip and has a receiving space for accommodating the biosensor, and the needle body includes a bottom wall, two side walls and two slope sections. The two side walls are respectively located on two sides of the bottom wall, and each side wall has a first inner edge and a first outer edge. Each first inner edge is adjacent to the receiving space, and each first outer edge is away from the receiving space. The two slope sections are respectively located on two sides of the bottom wall, and each slope section is connected between each side wall and the needle tip. Each slope section includes a second inner edge and a second outer edge. Each second inner edge is connected to each first inner edge, and each second outer edge is connected to each first outer edge. Among them, each first inner edge, each second inner edge, each first outer edge and each second outer edge are arc-shaped, the arc radius of each first inner edge is R11, and the arc radius of each first outer edge is R12, satisfying the relationship R11>R12, and satisfying the relationship 3≤R11 / R12≤10, and the flat plate has a thickness T1, satisfying the relationship 20%≤R11 / T1≤50%.

[0017] According to the implant needle structure of the aforementioned embodiment, the arc radius of each second inner edge may be R21, and the arc radius of each second outer edge may be R22, satisfying the relationship of R11 = R21 and R12 = R22.

[0018] According to the aforementioned embodiment of the implant needle structure, the needle tip may include two sides connected to two sloped sections, the two sides forming an angle and intersecting to form a pointed tip, and each side including an upper edge and a lower edge. The upper edge of the needle tip is arc-shaped and connected to the second inner edge; the lower edge of the needle tip is arc-shaped and connected to the second outer edge. The arc radius of each upper edge of the needle tip is R31, and the arc radius of each lower edge of the needle tip is R32, satisfying the relationship R31>R32.

[0019] According to the implant needle structure of the aforementioned embodiment, the angle may be between 20 degrees and 40 degrees.

[0020] According to the needle implant structure of the aforementioned embodiment, the needle body may further include two arc connecting sections, each arc connecting section is connected between each side wall and the bottom wall, and connected between each slope section and the bottom wall, and each arc connecting section has an arc connecting section height T2 along a height direction of the needle implant structure, satisfying the relationship T2 / T1≥1.5.

[0021] According to the implant needle structure of the aforementioned embodiment, the needle body may further include a connecting surface parallel to a width direction of the implant needle structure and connected between each first inner edge and each first outer edge.

[0022] According to the implant needle structure of the aforementioned embodiment, each first inner edge can be directly connected to each first outer edge.

[0023] According to the aforementioned embodiment of the needle implant structure, a burr height of the flat plate when separated from a sheet by punching may be less than or equal to 0.02 mm.

[0024] According to the aforementioned embodiment of the needle implant structure, the flat plate may form a polished surface when being separated from a sheet by punching, and the polished surface has a height T3, satisfying the relationship of T3 / T1≥50%.

[0025] According to another embodiment of the present invention, an implant device is provided, which includes a cover body, an implant module and a detachable module. The cover body has a main space; the implant module is arranged in the main space of the cover body and includes an implant needle structure as described in the above embodiment; the detachable module includes a base and a biosensor. The base is detachably limited in the implant module; the biosensor is detachably assembled on the base and at least partially accommodated in the accommodating space of the implant needle structure. When the cover body is pressed down, the implant module is driven to cause the implant needle structure to move downward to drive the biosensor to be implanted under the skin of the organism to measure a physiological signal in the organism. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 A perspective view of an implant needle structure according to a first embodiment of the present invention is shown;

[0027] Figure 2 Draw Figure 1 A schematic front view of the implant needle structure of the first embodiment is shown;

[0028] Figure 3 Draw Figure 1 A schematic side view of the implant needle structure of the first embodiment is shown;

[0029] Figure 4 Draw Figure 1 A schematic top view of the implant needle structure of the first embodiment is shown;

[0030] Figure 5 Drawing for bending Figure 1 A schematic top view of a flat plate of the needle implant structure of the first embodiment is shown;

[0031] Figure 6 FIG2 is a perspective view showing an implant needle structure according to a second embodiment of the present invention;

[0032] Figure 7 Draw Figure 6 A schematic front view of the implant needle structure of the second embodiment is shown;

[0033] Figure 8 Draw Figure 6 Another perspective schematic diagram of the implant needle structure of the second embodiment is shown;

[0034] Figure 9FIG2 is a perspective view showing an implant needle structure according to a third embodiment of the present invention;

[0035] Figure 10 Draw Figure 9 Another perspective schematic diagram of the implant needle structure of the third embodiment is shown;

[0036] Figure 11 Draw Figure 9 A schematic front view of the implant needle structure of the third embodiment is shown;

[0037] Figure 12 Draw Figure 9 A schematic top view of the implant needle structure of the third embodiment is shown;

[0038] Figure 13 Draw Figure 9 A schematic side view of the implant needle structure of the third embodiment is shown;

[0039] Figure 14 A perspective view of an implant needle structure according to a fourth embodiment of the present invention is shown;

[0040] Figure 15 Draw Figure 14 A schematic front view of the implant needle structure of the fourth embodiment is shown;

[0041] Figure 16 Draw Figure 14 A schematic side view of the implant needle structure of the fourth embodiment is shown;

[0042] Figure 17 Drawing for bending Figure 14 A schematic top view of a flat plate of the needle implant structure of the fourth embodiment is shown;

[0043] Figure 18 FIG2 is a front cross-sectional perspective view of an implant needle structure according to a fifth embodiment of the present invention;

[0044] Figure 19 Drawing for bending Figure 18 A schematic top view of a flat plate of the needle implant structure of the fifth embodiment is shown;

[0045] Figure 20 A perspective schematic diagram of an implant needle structure according to a sixth embodiment of the present invention is shown;

[0046] Figure 21 A perspective schematic diagram of an implant needle structure according to a seventh embodiment of the present invention is shown;

[0047] Figure 22 Draw Figure 21 A side view schematic diagram of the implant needle structure of the seventh embodiment is shown;

[0048] Figure 23 FIG2 is a perspective view showing an implant needle structure according to an eighth embodiment of the present invention;

[0049] Figure 24 A schematic exploded perspective view of an implant device according to a ninth embodiment of the present invention is shown; and

[0050] Figure 25 Draw Figure 24 A partial cross-sectional schematic diagram of the implant device according to the ninth embodiment is shown.

[0051] The description of the accompanying drawings is as follows:

[0052] 1000, 2000, 3000, 4000, 5000, 6000, 7000, 8000, 9430: needle structure

[0053] 1100, 2100, 3100, 4100, 6100, 7100: needle body

[0054] 1110, 4110: side wall

[0055] 1111, 4111, 5111: first inner edge

[0056] 1112, 4112, 5112: first outer edge

[0057] 1120, 4120: Slope section

[0058] 1121: Second inner edge

[0059] 1122: Second outer edge

[0060] 1130, 2130, 3130: bottom wall

[0061] 1140: Arc connection segment

[0062] 1150: Connection surface

[0063] 1200, 2200, 3200, 4200, 6200, 7200, 8200: needle tip

[0064] 1210: Side

[0065] 1211: upper edge of the needle tip

[0066] 1212: lower edge of needle tip

[0067] 1220: Cutting Edge

[0068] 2300, 6300: Groove

[0069] 3310, 7310: ribs

[0070] 3320, 7320: groove

[0071] 8300: Bump

[0072] 9000: Implantable Devices

[0073] 9100: hood

[0074] 9200: Top cover

[0075] 9300: bottom cover

[0076] 9400: Implantation Module

[0077] 9410: Needle implant

[0078] 9420: Needle implant auxiliary seat

[0079] 9500: Remove module

[0080] 9510: Base

[0081] 9520: Biosensor

[0082] 9530: Sensor holder

[0083] 9600: Fixing parts

[0084] B1, B4, B5: Flat panel

[0085] B11, B41: needle tip

[0086] B12: R corner

[0087] B13: Wing

[0088] B14: Bottom wall

[0089] I1: Centerline

[0090] L1: needle tip length

[0091] L2: Extended length

[0092] S1: Accommodation space

[0093] T1: thickness

[0094] T2: Arc connecting segment height

[0095] X: width direction

[0096] Y: length direction

[0097] Z: height direction

[0098] θ: angle DETAILED DESCRIPTION

[0099] The following describes embodiments of the present invention with reference to the accompanying drawings. For clarity, many practical details are included in the following description. However, the reader should understand that these practical details are not intended to limit the present invention. In other words, in some embodiments of the present invention, these practical details are not essential. Furthermore, to simplify the drawings, some conventional structures and components are depicted in a simplified schematic manner; and repeated components may be represented using the same or similar numbers.

[0100] Furthermore, terms such as "first," "second," and "third" are used herein to describe different elements or components and do not limit the elements / components themselves. Therefore, a "first element / component" may also be referred to as a "second element / component." Furthermore, the combinations of elements / components / mechanisms / modules described herein are not generally known, conventional, or existing in the art. Whether the elements / components / mechanisms / modules are readily achievable by one of ordinary skill in the art cannot be determined based on the existing nature of the elements / components / mechanisms / modules themselves.

[0101] See also Figure 1 and Figure 2 ,in Figure 1 FIG. 1 is a perspective view of an implant needle structure 1000 according to the first embodiment of the present invention. Figure 2 Draw Figure 1 The front view of the implant needle structure 1000 of the first embodiment is shown. The implant needle structure 1000 is formed by a flat plate B1 (shown in FIG. Figure 5) is bent and is used to accommodate a biosensor (not shown in the first embodiment) and partially implant the biosensor under the skin of an organism. The implant needle structure 1000 includes a needle tip 1200 and a needle body 1100. The needle body 1100 and the needle tip 1200 are integrally connected. The needle body 1100 includes a bottom wall 1130, two side walls 1110, and two sloped sections 1120. The two side walls 1110, the two sloped sections 1120, and the bottom wall 1130 define a receiving space S1 for receiving the biosensor. The two side walls 1110 are respectively located on two sides of the bottom wall 1130. Each side wall 1110 has a first inner edge 1111 and a first outer edge 1112. Each first inner edge 1111 is adjacent to the receiving space S1, and each first outer edge 1112 is away from the receiving space S1. Two sloped sections 1120 are located on either side of the bottom wall 1130, each connected between the side walls 1110 and the needle tip 1200. Each sloped section 1120 includes a second inner edge 1121 and a second outer edge 1122. Each second inner edge 1121 is connected to each first inner edge 1111, and each second outer edge 1122 is connected to each first outer edge 1112. Each first inner edge 1111, each second inner edge 1121, each first outer edge 1112, and each second outer edge 1122 are arc-shaped. The arc radius of each first inner edge 1111 is R11, and the arc radius of each first outer edge 1112 is R12, satisfying the relationship R11>R12.

[0102] Thus, since each first inner edge 1111, each second inner edge 1121, each first outer edge 1112, and each second outer edge 1122 are all arc-shaped, they facilitate smooth puncture of the skin surface of a living organism, thereby improving the smoothness of the opening formed in the skin surface. Furthermore, due to the relationship R11 > R12, scratching of the biosensor located in the accommodation space S1 can be avoided. The details of the implant needle structure 1000 will be described in detail later.

[0103] The needle implant structure 1000 is a three-dimensional structure. If the thickness is not considered, the bottom wall 1130 is located on the plane formed by the length direction Y and the width direction X, and the side wall 1110 and the slope section 1120 are located on the plane formed by the length direction Y and the height direction Z. One of the side walls 1110 and one of the slope sections 1120 are located on one side of the center line I1 of the needle implant structure 1000, and the other side wall 1110 and the other slope section 1120 are located on the other side of the center line I1 of the needle implant structure 1000, and are arranged symmetrically with each other.

[0104] The needle body 1100 may further include two arc connecting sections 1140, each arc connecting section 1140 being connected between each side wall 1110 and the bottom wall 1130, and between each slope section 1120 and the bottom wall 1130. That is to say, the bottom wall 1130 located on the plane in the length direction Y and the width direction X is smoothly and indirectly connected to the side wall 1110 and the slope section 1120 located on the plane in the length direction Y and the height direction Z through the arc connecting section 1140, thereby forming a U-shaped cross-section. Furthermore, each arc connecting section 1140 has an arc connecting section height T2 along the height direction Z of the needle implant structure 1000, and the flat plate B1 has a thickness T1 (which is equivalent to the thickness of the bottom wall 1130 and is indicated at Figure 2 When this relationship is met, the bending resistance of the needle tip 1200 is increased, thereby improving the puncture performance. In addition, the puncture force can be reduced, thereby helping to reduce pain.

[0105] Each needle body 1100 may further include a connecting surface 1150, which is parallel to the width direction X of the needle implant structure 1000 and connected between each first inner edge 1111 and each first outer edge 1112. In other words, the inner and outer peripheral surfaces of the side wall 1110 may both be straight surfaces, and the first inner edge 1111 and the first outer edge 1112 both have an R angle of 90 degrees, but the arc radii R11 and R12 of the R angles are different in size, such as Figure 2 , and are connected to each other by a connecting surface 1150. The second inner edge 1121 and the second outer edge 1122 can also be connected to each other by a connecting surface 1150. The side wall 1110 can have a substantially uniform height. The aforementioned height refers to the distance in the height direction Z from the intersection of the arc connecting section 1140 and the side wall 1110 to the connecting surface 1150. The height of the starting position of the slope section 1120 is approximately zero and gradually increases along the length direction Y. Therefore, the height of the ending position of the slope section 1120 is approximately equal to the height of the side wall 1110 so as to be connected to each other. In the first embodiment, except for the starting position and the ending position of the slope section 1120, the slope of the height of the slope section 1120 can be approximately constant.

[0106] See also Figure 3 and Figure 4 , and see also Figure 1 and Figure 2 ,in Figure 3 Draw Figure 1 The schematic side view of the needle implant structure 1000 of the first embodiment is shown. Figure 4 Draw Figure 1The diagram shows a top view of the needle implant structure 1000 according to the first embodiment. The needle tip 1200 may include two side edges 1210 connected to the two slope sections 1120, respectively. The two side edges 1210 are arranged at an angle θ and intersect to form a tip 1220. Each side edge 1210 includes a needle tip upper edge 1211 and a needle tip lower edge 1212. Each needle tip upper edge 1211 is in an arc shape and connected to each second inner edge 1121; each needle tip lower edge 1212 is in an arc shape and connected to each second outer edge 1122. The arc radius of each needle tip upper edge 1211 is R31, and the arc radius of each needle tip lower edge 1212 is R32, satisfying the relationship R31>R32, and the angle θ may be between 20 degrees and 40 degrees.

[0107] Specifically, the needle tip 1200 is generally triangular in shape. Without considering thickness, the needle tip 1200 is located on a plane formed by the length direction Y and the width direction X. Each side 1210 is indirectly connected to the sloped section 1120 via an arcuate connecting section 1140, and the tip 1220 is located on the centerline I1. It should be noted that the arcuate connecting section 1140 smoothly connects to each side 1210 and the sloped section 1120. Therefore, the height of the arcuate connecting section 1140 in the height direction Z also gradually decreases toward the side 1210 along the length direction Y. Each arcuate connecting section 1140 may further include a third inner edge (not labeled) and a third outer edge (not labeled). Each needle tip upper edge 1211 is indirectly connected to the second inner edge 1121 via the third inner edge, and each needle tip lower edge 1212 is indirectly connected to the second outer edge 1122 via the third outer edge.

[0108] Furthermore, a needle tip length L1 can be defined as the distance along the length direction Y between the tip 1220 and an end point of each side 1210, and an extension length L2 can be defined as the distance along the length direction Y between the tip 1220 and an end point of each sloped section 1120, satisfying the relationship L1 / L2 ≤ 15%. The end point of each side 1210 is the intersection of the side 1210 and the arc connecting section 1140, and the end point of the sloped section 1120 is the intersection of the sloped section 1120 and the sidewall 1110. When the relationship L1 / L2 ≤ 15%, or even L1 / L2 ≤ 8%, is satisfied, the smoothness of the opening expansion after the needle tip 1200 penetrates the skin of a living organism is improved, thereby facilitating the placement of a biosensor.

[0109] See also Figure 5 , and see also Figures 1 to 4 ,in Figure 5 Drawing for bending Figure 1The figure shows a top view of a flat plate B1 of the implant structure 1000 according to the first embodiment. Flat plate B1 can be a metal plate, which is bent to form the implant structure 1000. Therefore, the thickness T1 of flat plate B1 is the thickness of the bottom wall 1130, the side wall 1110, the sloped section 1120, and the arcuate connecting section 1140. By giving flat plate B1 a radiused angle of twice its thickness T1, the arcuate connecting section 1140 having a height T2 of the arcuate connecting section can be formed.

[0110] Flat plate B1 can be manufactured, for example, by stamping, particularly by punching. When manufacturing flat plate B1, a stamping die is first used to process the area on a sheet where the needle tip 1200 is to be formed (i.e., needle tip portion B11). The stamping die is then used to further process the area to be punched, such as by shaving, to define the contour and enhance the sharpness of needle tip 1200. Consequently, the height of a burr on flat plate B1 when separated from the sheet by punching can be less than or equal to 0.02 mm. Flat plate B1 can also form a polished surface when separated from the sheet by punching. The polished surface can have a height T3 (not shown) that satisfies the relationship T3 / T1 ≥ 50% with respect to the thickness T1 of flat plate B1, specifically T3 / T1 ≥ 70%, and more specifically T3 / T1 ≥ 90%. Through the aforementioned manufacturing process, the contour of flat plate B1 can be a continuous, well-proportioned, and well-cut edge, thereby reducing the need for subsequent surface finishing and burr removal steps.

[0111] In the first embodiment, the arc radius of each first inner edge 1111 is R11, the arc radius of each second inner edge 1121 can be R21, the arc radius of each needle tip upper edge 1211 can be R31, the arc radius of each first outer edge 1112 is R12, the arc radius of each second outer edge 1122 can be R22, and the arc radius of each needle tip lower edge 1212 can be R32, satisfying the relationship R11=R21=R31 and R12=R22=R32, and the first outer edge 1112, the second outer edge 1122 and the needle tip lower edge 1212 can be formed by elastic deformation of the flat plate B1 when it is separated from the sheet by punching. Specifically, during stamping, the area to be punched on the sheet undergoes elastic deformation, followed by plastic deformation, and finally complete tearing, resulting in a flat plate B1 completely separated from the sheet. Thus, viewed from the side, flat plate B1 can be formed into a die roller area and a shearing area due to conventional stamping. The die roller area itself is an arc-shaped area produced by elastic deformation and requires no further processing, so it can directly serve as the first outer edge 1112, the second outer edge 1122, and the lower edge 1212 of the needle tip, satisfying the relationship of 20% ≤ R11 / T1 ≤ 50%. The shearing area is a region produced by plastic deformation, and its relatively smooth finish generally accounts for approximately 30% to 50% of the thickness T1 of flat plate B1. However, the present invention can increase the finish to greater than or equal to 50%, or even greater than or equal to 70%, through stamping die processing (e.g., scraping). Furthermore, at least a portion of the remaining burrs can be rounded to form a first inner edge 1111, a second inner edge 1121, and a needle tip upper edge 1211, satisfying the relationship 3 ≤ R11 / R12 ≤ 10. This reduces the planar area of ​​the cut edge of flat plate B1 and eliminates any remaining fine burrs. The resulting bent implant structure 1000 can also reduce friction with the skin during implantation.

[0112] The flat plate B1 may include a needle tip portion B11, a bottom wall portion B14, two rounded corner portions B12, and two wings B13. The needle tip portion B11 is generally triangular in shape, the bottom wall portion B14 is elongated and integrally connected to the needle tip portion B11, and the width of the bottom wall portion B14 is equivalent to the widest part of the needle tip portion B11. Each rounded corner portion B12 is integrally connected to the bottom wall portion B14 and has a hypotenuse extending from the needle tip portion B11. Each wing portion B13 is integrally connected to the rounded corner portion B12 and has a hypotenuse extending from the rounded corner portion B12 (with the same slope as the hypotenuse extending from the needle tip portion B11) and a straight edge connecting the hypotenuse. After the flat plate B1 is bent, the needle tip portion B11 forms a needle tip 1200, the rounded corner portion B12 forms a circular arc connecting section 1140, and the wings B13 form side walls 1110 and sloped sections 1120, thus completing the needle implant structure 1000.

[0113] See also Figure 6 、 Figure 7 and Figure 8 ,in Figure 6FIG. 1 is a perspective view of an implant needle structure 2000 according to a second embodiment of the present invention. Figure 7 Draw Figure 6 The schematic front view of the needle implant structure 2000 of the second embodiment is shown. Figure 8 Draw Figure 6 Another three-dimensional schematic diagram of the needle implant structure 2000 of the second embodiment is shown. The needle implant structure 2000 is similar to the needle implant structure 1000 of the first embodiment and includes a needle tip 2200 and a needle body 2100, but the difference is that the needle implant structure 2000 may further include a reinforcement portion (not marked), and the reinforcement portion is provided along the length direction Y of the needle implant structure 2000 on at least one of the needle tip 2200 and the needle body 2100. Specifically, the needle tip 2200 and the portion of the needle body 2100 adjacent to the needle tip 2200 can be defined as a reinforcement block, and the reinforcement portion is provided in at least one section of the reinforcement block, and the reinforcement portion can be achieved by forming at least one concave structure and / or a convex structure in at least one section. As shown in FIG. Figures 6 to 8 As shown, the reinforcement portion includes a groove 2300 extending from the needle tip 2200 toward the bottom wall 2130 of the needle body 2100. The groove 2300 may be located on the first surface of the needle tip 2200 facing the accommodating space (not shown in the second embodiment) and the first surface of the bottom wall 2130 facing the accommodating space, and the groove 2300 may be located on the centerline I1. During the manufacturing process, the groove 2300 may be first formed in the needle tip portion (not shown in the second embodiment) and the bottom wall portion (not shown in the second embodiment) of a flat plate (not shown in the second embodiment). The depth of the groove 2300 is no greater than the thickness of the flat plate. After the flat plate is bent, the needle implant structure 2000 with the groove 2300 is formed. The second surface of the needle tip 2200 and the second surface of the bottom wall 2130 facing the accommodating space remain smooth. Specifically, groove 2300 is formed by pressing down from the first surface of the needle tip portion and the first surface of the bottom wall portion of the flat plate. It should be noted that during manufacturing, groove 2300 extends at most to the portion of the bottom wall portion adjacent to the needle tip portion. At this point, the density of the material of needle tip 2200 increases after being pressed, and the strength of needle tip 2200 can be increased. This can help improve the bending resistance of implant structure 2000, and in particular, prevent needle tip 2200 from bending and deforming due to stress during implantation. In other embodiments, the groove can also be formed by cutting away a portion of material, and the reinforcement portion can also include multiple grooves and can be located only at the needle tip, without being limited to the above disclosure.

[0114] See also Figure 9 、 Figure 10 、 Figure 11 、 Figure 12 and Figure 13 ,in Figure 9 FIG. 1 is a perspective view of an implant needle structure 3000 according to a third embodiment of the present invention. Figure 10 Draw Figure 9 Another perspective view of the needle implant structure 3000 of the third embodiment is shown. Figure 11 Draw Figure 9 The schematic front view of the needle implant structure 3000 of the third embodiment is shown. Figure 12 Draw Figure 9 The schematic top view of the needle implant structure 3000 of the third embodiment is shown. Figure 13 Draw Figure 9 A schematic side view of a needle implant structure 3000 according to the third embodiment is shown. The needle implant structure 3000 is similar to the needle implant structure 1000 according to the first embodiment and includes a needle tip 3200 and a needle body 3100. However, the difference is that the needle implant structure 3000 may further include a reinforcement portion (not shown). The reinforcement portion includes a rib 3310 extending from the needle tip 3200 toward the bottom wall 3130 of the needle body 3100. Specifically, the reinforcement portion may further include a pressure groove 3320. The pressure groove 3320 is located on a first surface of the needle tip 3200 facing the accommodating space (not shown in the third embodiment) and a first surface of the bottom wall 3130 facing the accommodating space. The pressure groove 3320 is located on the centerline I1, while the rib 3310 is located on a second surface of the needle tip 3200 facing away from the accommodating space and a second surface of the bottom wall 3130 facing away from the accommodating space and on the centerline I1. In other words, the indentation 3320 and the rib 3310 correspond to each other, and during the manufacturing process, the indentation 3320 can be pressed out first on the needle tip portion (not shown in the third embodiment) and the bottom wall portion (not shown in the third embodiment) of the first surface of the flat plate (not shown in the third embodiment), and the depth of the indentation 3320 is greater than the thickness of the flat plate, so the rib 3310 protruding relative to the second surface can naturally be formed. Therefore, after the flat plate is bent, a needle implant structure 3000 with the indentation 3320 and the rib 3310 can be formed. It should be noted that when the flat plate is manufactured, the groove 3320 extends at most to the portion of the bottom wall adjacent to the needle tip, that is, the rib 3310 also extends at most to the portion of the bottom wall adjacent to the needle tip. The groove 3320 of the third embodiment is also manufactured by pressing, and forms a relatively thin but relatively protruding and dense rib 3310. After the needle tip 3200 is pressed, the density of the material increases, and the strength of the needle tip 3200 can be increased, thereby helping to improve the bending resistance of the needle implant structure 3000. However, the manufacturing process is not limited to the above. However, the reinforcement portion is not limited to a groove extending along the length direction of the needle implant structure (such as the groove 2300 of the second embodiment) or a rib (such as the rib 3310 of the third embodiment), and can also be a convex point protruding from the second surface of the needle tip away from the accommodating space, and can be provided only on the needle tip.

[0115] See also Figure 14 、 Figure 15 Figure and Figure 16 ,in Figure 14FIG. 1 is a perspective view of an implant needle structure 4000 according to a fourth embodiment of the present invention. Figure 15 Figure drawing Figure 14 A schematic front view of a needle implant structure 4000 according to a fourth embodiment is shown; Figure 16 Draw Figure 14 A side view schematic diagram of the needle implant structure 4000 of the fourth embodiment is shown. The needle implant structure 4000 is similar to the needle implant structure 1000 of the first embodiment and includes a needle tip 4200 and a needle body 4100. The needle body 4100 includes two slope sections 4120 and two side walls 4110. Each side wall 4110 includes a first inner edge 4111 and a first outer edge 4112. The difference is that each slope section 4120 is generally in the shape of a convex arc. In other words, the front end of the needle body 4100 connecting the needle tip 4200 in the needle implant structure 4000 provided in the fourth embodiment is in the shape of a convex arc. More specifically, the projection line of the height of each slope section 4120 on the plane in the height direction Z and the length direction Y is curved with the convex point facing upward, and the tangent slopes of the slope sections 4120 at different heights are not the same.

[0116] See also Figure 17 , and see also Figures 14 to 16 ,in Figure 17 Drawing for bending Figure 14 The top view of a flat plate B4 of the needle implant structure 4000 of the fourth embodiment is shown. The flat plate B4 is used to bend to form the needle implant structure 4000. Figure 5 The structure is similar to the flat plate B1, but differs in that the bevel extending from the needle tip B41 is curved, and there is no obvious turning point when the bevel turns into a straight edge. This allows the needle tip 4200 of the implant needle structure 4000 to shorten and widen simultaneously, thereby strengthening the structural strength of the needle tip 4200 and making it less prone to bending. The convexly curved slope sections 4120 instantly and smoothly expand the opening when puncturing the skin of a living organism, thereby increasing the smoothness of the implant needle structure 4000 during the implant process, thereby reducing pain and facilitating the placement of the biosensor. In other embodiments, the curvature of each slope section may be increased, but the curvature of each slope section must be designed to take into account the sharpness of the needle tip.

[0117] See also Figure 18 and Figure 19 ,in Figure 18 FIG. 1 is a front cross-sectional perspective view of an implant needle structure 5000 according to a fifth embodiment of the present invention. Figure 19 Drawing for bending Figure 18A schematic top view of a flat plate B5 of the needle implant structure of the fifth embodiment is shown. The needle implant structure 5000 is similar to the needle implant structure 1000 of the first embodiment and includes a first inner edge 5111 and a first outer edge 5112, and each first inner edge 5111 can be directly connected to each first outer edge 5112. In other words, the needle implant structure 5000 does not include the connecting surface 1150 of the first embodiment, but instead allows each first inner edge 5111 to be directly connected to each first outer edge 5112. In addition, the curvature of the oblique edge extending from the needle tip (not indicated in the fifth embodiment) of the flat plate B5 is greater than the curvature of the flat plate B4 of the fourth embodiment, thereby increasing the curvature of each slope section.

[0118] See also Figure 20 ,in Figure 20 A perspective schematic diagram of an implant needle structure 6000 according to a sixth embodiment of the present invention is shown. Implant needle structure 6000 is similar to implant needle structure 4000 of the fourth embodiment and includes a needle tip 6200 and a needle body 6100. However, implant needle structure 6000 may further include a reinforcement portion (not shown), which may include a groove 6300. The structure and manufacturing process of groove 6300 are similar to those of groove 2300 of the second embodiment, and the details are not repeated here.

[0119] See also Figure 21 and Figure 22 ,in Figure 21 FIG. 1 is a perspective view of an implant needle structure 7000 according to a seventh embodiment of the present invention. Figure 22 Draw Figure 21 A side view of a needle implant structure 7000 according to the seventh embodiment is shown. The needle implant structure 7000 is similar to the needle implant structure 4000 according to the fourth embodiment and includes a needle tip 7200 and a needle body 7100. The difference is that the needle implant structure 7000 may further include a reinforcement portion (not shown). The reinforcement portion may include a rib 7310 and a groove 7320. The structure and manufacturing process of the rib 7310 and groove 7320 are the same as the rib 3310 and groove 3320 of the third embodiment, and the details are not repeated here.

[0120] See also Figure 23 ,in Figure 23 A perspective schematic diagram of an implant needle structure 8000 according to the eighth embodiment of the present invention is shown. The implant needle structure 8000 of the eighth embodiment is similar to the implant needle structure 3000 of the third embodiment, differing in that the reinforcement portion is a protrusion 8300 protruding from the second surface of the needle tip 8200, away from the receiving space, and can be provided only on the needle tip 8200. The structure and manufacturing process of the protrusion 8300 are similar to those of the rib 3310 and groove 3320 of the third embodiment, and the details are not repeated here.

[0121] See also Figure 24 and Figure 25 ,in Figure 24 FIG. 1 is a perspective exploded view of an implant device 9000 according to a ninth embodiment of the present invention. Figure 25 Draw Figure 24 FIG2 is a partial cross-sectional view of an implantation device 9000 according to a ninth embodiment of the present invention. The implantation device 9000 comprises a housing 9100 , an implantation module 9400 , and a removal module 9500 .

[0122] The housing 9100 has a main space (not shown); the implant module 9400 is disposed within the main space of the housing 9100 and includes an implant needle structure 9430; the detachable module 9500 includes a base 9510 and a biosensor 9520. The base 9510 is detachably secured within the implant module 9400; the biosensor 9520 is detachably assembled to the base 9510 and at least partially accommodated within the accommodation space of the implant needle structure 9430 (not shown in the ninth embodiment). When the housing 9100 is pressed downward, the implant module 9400 is driven, causing the implant needle structure 9430 to move downward, thereby driving the biosensor 9520 to be implanted beneath the skin of an organism to measure a physiological signal within the organism.

[0123] The implant device 9000 may further include an upper cover 9200, a bottom cover 9300 and two fixing parts 9600. The upper cover 9200 and the bottom cover 9300 are assembled together to form a sealed space to accommodate the cover body 9100, the implant module 9400 and the detachable module 9500. The two fixing parts 9600 are symmetrically inserted into the implant module 9400 to be detachably engaged with the base 9510. Each fixing part 9600 may include a support portion (not shown) to support a sensor fixing seat 9530 of the detachable module 9500, and the sensor fixing seat 9530 carries the biological sensor 9520. The implantation module 9400 may further include an implantation needle component 9410 and an implantation needle auxiliary seat 9420. The implantation needle component 9410 is inserted into the implantation needle auxiliary seat 9420, and the implantation needle structure 9430 is assembled on the implantation needle component 9410. The implantation needle structure 9430 may be any one of the implantation needle structures 1000, 2000, 3000, 4000, 5000, 6000, 7000, and 8000, but is not limited to these.

[0124] During operation, the user can press down the upper cover 9200, causing the cover body 9100 inside the upper cover 9200 to move downward, driving the fixing part 9600 to move laterally, releasing the limit of the fixing part 9600 and the sensor fixing seat 9530 and the base 9510, and by releasing the pre-compression elastic force of the first elastic part (not shown) in the implant module 9400, the implant needle part 9410, the implant needle structure 9430 and the biological sensor 9520 can be implanted under the skin of the organism. At the same time, the sensor fixing seat 9530 is combined with the base 9510, and the biological sensor 9520 remains under the skin of the organism. Then, the pre-compression elastic force of the second elastic part (not shown) of the implant module 9400 is released, and the implant needle part 9410 can be withdrawn, thereby completing automatic needle implantation and needle withdrawal.

[0125] Although the present invention has been disclosed above with reference to the embodiments, they are not intended to limit the present invention. Anyone skilled in the art may make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention shall be determined by the appended claims.

Claims

1. An implant needle structure, formed by bending a flat plate, for accommodating a biosensor and partially implanting the biosensor under the skin of a living organism, characterized in that: The implant structure includes: a needle point; A needle body integrally connected to the needle tip and having a receiving space for accommodating the biosensor, and the needle body comprises: a bottom wall; Two side walls, respectively located on two sides of the bottom wall, each of the side walls having a first inner edge and a first outer edge, each of the first inner edges being adjacent to the accommodating space, and each of the first outer edges being away from the accommodating space; and two slope sections, respectively located on two sides of the bottom wall, each slope section connected between each side wall and the needle tip and generally in a convex arc shape, each slope section including a second inner edge and a second outer edge, each second inner edge connected to each first inner edge, and each second outer edge connected to each first outer edge; and a reinforcement portion disposed in at least one section of a reinforcement block, the reinforcement block being defined as the needle tip and the portion of the needle body adjacent to the needle tip, and the reinforcement portion forming at least one concave structure and / or a convex structure in the at least one section to prevent the needle tip from bending and deforming due to stress during implantation; Among them, each of the first inner edges, each of the second inner edges, each of the first outer edges and each of the second outer edges are arc-shaped, the arc radius of each of the first inner edges is R11, and the arc radius of each of the first outer edges is R12, satisfying the relationship R11>R12, and the flat plate elastically deforms when being separated from a sheet by punching to form each of the first outer edges and each of the second outer edges, and the flat plate has a thickness T1, satisfying the relationship 20%≤R11 / T1≤50%.

2. The needle implant structure according to claim 1, characterized in that: The reinforcing portion includes a groove extending from the needle tip toward the bottom wall of the needle body.

3. The needle implant structure according to claim 1, characterized in that: The reinforcing portion includes a rib extending from the needle tip toward the bottom wall of the needle body.

4. The needle implant structure according to claim 1, wherein: The needle tip includes two side edges connected to the two slope sections, the two side edges intersecting to form a tip, and each side edge includes: an upper edge of the needle tip, which is arc-shaped and connected to the second inner edge; and a needle tip lower edge in an arc shape and connected to the second outer edge; The arc radius of the upper edge of each needle tip is R31, and the arc radius of the lower edge of each needle tip is R32, satisfying the relationship of R31>R32.

5. The needle implant structure according to claim 4, characterized in that: The plate is elastically deformed when being separated from the sheet by punching to form the lower edge of each needle tip.

6. The needle implant structure according to claim 4, characterized in that: A needle tip length L1 is defined as the distance between the tip and an end position of each side along a length direction, and an extended length L2 is defined as the distance between the tip and an end position of each slope section along the length direction, satisfying the relationship L1 / L2≤15%.

7. An implant needle structure, formed by bending a flat plate, for accommodating a biosensor and partially implanting the biosensor under the skin of a living organism, characterized in that: The implant structure includes: a needle point; and A needle body integrally connected to the needle tip and having a receiving space for accommodating the biosensor, and the needle body comprises: a bottom wall; Two side walls, respectively located on two sides of the bottom wall, each of the side walls having a first inner edge and a first outer edge, each of the first inner edges being adjacent to the accommodating space, and each of the first outer edges being away from the accommodating space; and two slope sections, respectively located on two sides of the bottom wall, each slope section connected between each side wall and the needle tip and generally in a convex arc shape, each slope section including a second inner edge and a second outer edge, each second inner edge connected to each first inner edge, and each second outer edge connected to each first outer edge; Among them, each of the first inner edges, each of the second inner edges, each of the first outer edges and each of the second outer edges are arc-shaped, the arc radius of each of the first inner edges is R11, and the arc radius of each of the first outer edges is R12, satisfying the relationship R11>R12, and the flat plate elastically deforms when being separated from a sheet by punching to form each of the first outer edges and each of the second outer edges, and the flat plate has a thickness T1, satisfying the relationship 20%≤R11 / T1≤50%.

8. The needle implant structure according to claim 7, wherein: The relationship of 3≤R11 / R12≤10 is satisfied.

9. The needle implant structure according to claim 7, wherein: The needle tip includes two side edges respectively connected to the two slope sections, and the two side edges intersect to form a tip, and a needle tip length L1 is defined as the distance between the tip and an end position of each side edge along a length direction, and an extended length L2 is defined as the distance between the tip and an end position of each slope section along the length direction, satisfying the relationship L1 / L2≤15%.

10. An implant needle structure, formed by bending a flat plate, for accommodating a biosensor and partially implanting the biosensor under the skin of a living organism, characterized in that: The implant structure includes: a needle point; and A needle body integrally connected to the needle tip and having a receiving space for accommodating the biosensor, and the needle body comprises: a bottom wall; Two side walls, respectively located on two sides of the bottom wall, each of the side walls having a first inner edge and a first outer edge, each of the first inner edges being adjacent to the accommodating space, and each of the first outer edges being away from the accommodating space; and two slope sections, respectively located on two sides of the bottom wall, each slope section connected between each side wall and the needle tip, each slope section including a second inner edge and a second outer edge, each second inner edge connected to each first inner edge, and each second outer edge connected to each first outer edge; Among them, each of the first inner edges, each of the second inner edges, each of the first outer edges and each of the second outer edges are arc-shaped, the arc radius of each of the first inner edges is R11, and the arc radius of each of the first outer edges is R12, satisfying the relationship R11>R12, and satisfying the relationship 3≤R11 / R12≤10, and the flat plate has a thickness T1, satisfying the relationship 20%≤R11 / T1≤50%.

11. The needle implant structure according to claim 10, wherein: The arc radius of each second inner edge is R21, and the arc radius of each second outer edge is R22, satisfying the relationship of R11 = R21 and R12 = R22.

12. The needle implant structure according to claim 10, wherein: The needle tip includes two side edges connected to the two slope sections, the two side edges are angled and intersect to form a tip, and each side edge includes: an upper edge of the needle tip, which is arc-shaped and connected to the second inner edge; and a needle tip lower edge in an arc shape and connected to the second outer edge; The arc radius of the upper edge of each needle tip is R31, and the arc radius of the lower edge of each needle tip is R32, satisfying the relationship of R31>R32.

13. The needle implant structure according to claim 12, wherein: The angle is between 20 degrees and 40 degrees.

14. The needle implant structure according to claim 10, wherein: The needle body also includes two arc connecting sections, each of which is connected between the side wall and the bottom wall, and between the slope section and the bottom wall, and each of which has an arc connecting section height T2 along a height direction of the needle implant structure, satisfying the relationship T2 / T1≥1.

5.

15. The needle implant structure according to claim 10, wherein: The needle also includes: A connecting surface is parallel to a width direction of the needle implant structure and connected between each of the first inner edges and each of the first outer edges.

16. The needle implant structure according to claim 10, wherein: Each of the first inner edges is directly connected to each of the first outer edges.

17. The needle implant structure according to claim 10, wherein: The height of a burr edge of the plate when separated from a blank by punching is less than or equal to 0.02 mm.

18. The needle implant structure according to claim 10, wherein: The plate forms a polished surface when being separated from a blank by punching. The polished surface has a height T3, and satisfies the relationship of T3 / T1≥50%.

19. An implant device, characterized in that Include: A cover body having a main space; an implantation module, disposed in the main space of the cover and comprising an implantation needle structure as claimed in claim 10; and A disassembly module comprising: a base, detachably restrained in the implant module; and a biosensor detachably mounted on the base and at least partially accommodated in the accommodation space of the implant needle structure; The cover is pressed downward, and the implantation module is driven to move the implantation needle structure downward to drive the biosensor to be implanted under the skin of the organism to measure a physiological signal in the organism.

Images