Insertion needle structure and inserter

Abstract

This disclosure provides a needle implantation structure for accommodating and partially implanting a biosensor under the skin of a living organism. The needle implantation structure includes a needle tip and a needle body. The needle body is integrally connected to the needle tip and has an accommodating space for accommodating the biosensor. The needle body includes a base wall, two side walls, two sloping sections, and two arc-shaped connecting sections. The two side walls are located on opposite sides of the base wall, and are at least partially non-parallel, with each side wall being at least partially straight. The two sloping sections are located on opposite sides of the base wall, each connecting the side wall and the needle tip and generally forming a convex arc shape. Each arc-shaped connecting section connects the side wall and the base wall, and also connects the sloping section and the base wall. The needle tip extends from the base wall and the two arc-shaped connecting sections. This needle implantation structure allows for smoother insertion into the skin of a living organism.

Description

Technical Field

[0001] This disclosure relates to a needle implantation structure and implantation device, and more particularly to a needle implantation structure and implantation device for use in biosensor implantation. Prior Technology

[0002] Monitoring blood glucose levels is crucial for diabetic patients. In addition, patients with other chronic diseases also need to monitor specific physiological parameters such as blood lipids and cholesterol levels daily to track their condition and facilitate subsequent treatment. Generally, these physiological parameters require further analysis by drawing bodily fluids from the patient. For example, a blood glucose meter uses a needle to puncture the skin and extract blood for analysis to determine blood glucose levels.

[0003] However, in order to improve the accuracy and timeliness of monitoring, some companies have proposed implanting biosensors under the skin. These biosensors can acquire the physiological parameters to be analyzed at any time. Then, in conjunction with a signal processor, these physiological parameters are transmitted to the cloud or back-end monitoring system, providing a larger amount of more real-time analytical data and avoiding the discomfort and infection risks of multiple invasive fluid extractions.

[0004] Biosensors can be implanted under the skin using an implantation device. This device may include a needle, within which the biosensor is placed. The needle punctures the skin to create a tiny opening, allowing the biosensor to enter and implant under the skin. If the opening is too large or uneven, it can lead to poor wound healing. Therefore, improving the smoothness of the needle implantation process, and consequently the smoothness of the opening formed on the skin, has become a key objective for related industries. Summary of the Invention

[0005] To address the aforementioned issues, this disclosure provides a needle implantation structure and implantation device, whose structural configuration can effectively improve the smoothness of the needle implantation structure when inserted into the skin of a living organism.

[0006] According to one embodiment of this disclosure, a needle implantation structure is provided, which is formed by bending a flat plate for accommodating a biosensor and partially implanting the biosensor under the skin of a human. The needle implantation structure includes a needle tip and a needle body. The needle body and needle tip are integrally connected and have an accommodating space for accommodating the biosensor. The needle body includes a base wall, two side walls, two sloping sections, and two arc-shaped connecting sections. The two side walls are located on opposite sides of the base wall, and are at least partially non-parallel, with each side wall being at least partially straight. The two sloping sections are located on opposite sides of the base wall, each sloping section connecting the side wall and the needle tip and generally forming a convex arc shape. Each arc-shaped connecting section connects the side wall and the base wall, and connects the sloping section and the base wall. The needle tip extends from the base wall and the two arc-shaped connecting sections.

[0007] According to the needle-planting structure of the aforementioned embodiment, each sidewall may have a first inner edge and a first outer edge, each first inner edge is adjacent to the receiving space, each first outer edge is far from the receiving space, and each first inner edge is arc-shaped.

[0008] According to the needle implantation structure of the aforementioned embodiment, each first outer edge can be 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.

[0009] According to the needle implantation structure of the aforementioned embodiment, the plate may have a thickness T1, satisfying the relationship 20%≤R11 / T1≤50%.

[0010] According to the needle-planting structure of the aforementioned embodiment, each slope segment may include a second inner edge and a second outer edge, each second inner edge is connected to each first inner edge, each second outer edge is connected to each first outer edge, and each second inner edge is arc-shaped.

[0011] According to the needle implantation structure of the aforementioned embodiment, each second outer edge may be at least partially straight and tilted in a direction away from the receiving space.

[0012] According to the needle implantation structure of the aforementioned embodiment, the needle tip may include two sides respectively connected to two arc-shaped connecting segments, the two sides intersecting to form a tip, each side including a needle tip upper edge and a needle tip lower edge. The needle tip upper edge is arc-shaped and connected to each of the second inner edges, and the needle tip lower edge is connected to each of the second outer edges.

[0013] According to the needle implantation structure of the aforementioned embodiment, the lower edge of the needle tip may be planar, and each second outer edge is at least partially planar.

[0014] According to the needle-planting structure of the aforementioned embodiment, each sidewall can extend upward from each arc connecting segment, each sidewall includes a first segment and a second segment, each first segment is connected to each slope segment, and each second segment includes a plane, and the two planes are not parallel.

[0015] According to the needle-planting structure of the aforementioned embodiment, each sidewall may include a first section and a second section. Each first section is connected to each slope section. Each second section includes an upright part and a curved part. Each upright part extends upward from each arc connecting section. Each curved part extends upward and inward from each upright part. Each upright part includes a plane, and the two planes are parallel.

[0016] According to the needle implantation structure of the aforementioned embodiment, the biosensor may have a widest part, which has a maximum width in a width direction of the needle implantation structure. The height between the bottom wall and the widest part along a height direction of the needle implantation structure is H1, and the height of the upright part in the height direction of the needle implantation structure is H2, satisfying the relationship H1>H2.

[0017] According to the needle implantation structure of the aforementioned embodiment, the biosensor may have a widest portion, which has a maximum width in a width direction of the needle implantation structure, and a wall opening is formed between the two second segments, the width of the wall opening in the width direction of the needle implantation structure being less than the maximum width.

[0018] According to the needle-planting structure of the aforementioned embodiment, the two first sections can be parallel to each other, and the wall opening formed between the two first sections in a width direction of the needle-planting structure is larger than the wall opening formed between the two second sections.

[0019] According to the aforementioned embodiment of the needle implantation structure, it may further include an assembly body and a connecting body. The assembly body is connected to a needle implantation component of an implantation device, and the connecting body is connected between the assembly body and the needle body. The assembly body includes two parallel straight walls and two connecting walls. Each connecting wall is connected between each straight wall and each side wall, and each connecting wall is at least partially inclined from each straight wall toward each side wall.

[0020] The needle implantation structure according to the aforementioned embodiment may further include a reinforcing portion disposed in at least one segment of a reinforcing block. The reinforcing block is defined as the portion of the needle tip and needle body adjacent to the needle tip. The reinforcing portion is formed by forming at least one concave structure and / or one convex structure in the aforementioned at least one segment to prevent the needle tip from bending and deforming under stress during an implantation process.

[0021] According to the needle implantation structure of the aforementioned embodiment, the reinforcing part may include a groove that extends from the needle tip toward the bottom wall of the needle body, and one cross-section of the groove is V-shaped or U-shaped.

[0022] According to the needle implantation structure of the aforementioned embodiment, the reinforcing part may include a rib that extends from the needle tip toward the bottom wall of the needle body.

[0023] According to the needle implantation structure of the aforementioned embodiment, each arc connecting segment may have an arc connecting segment height T2 along a height direction of the needle implantation structure, and the plate has a thickness T1, satisfying the relationship T2 / T1≥1.5.

[0024] According to another embodiment of this disclosure, an implantation device is provided, comprising a cover, an implantation module, and a removal module. The cover has a main space; the implantation module is disposed in the main space of the cover and includes a needle implantation structure as described in the previous embodiment; the removal module includes a base and a biosensor. The base is detachably located within the implantation module; the biosensor is detachably mounted on the base and at least partially housed in the receiving space of the needle implantation structure. When the cover is pressed down, the implantation module is driven to displace the needle implantation structure downwards, thereby implanting the biosensor under the skin of a living organism to measure a physiological signal within the organism. Simple Explanation of the Diagram

[0025] Figure 1 illustrates a perspective view of an implantation needle structure according to one of the first embodiments of this disclosure; Figure 2 shows a cross-sectional view of the needle-planting structure of the first embodiment in Figure 1 along the cutting line 2-2; Figure 3 shows a cross-sectional view of the needle-planting structure of the first embodiment in Figure 1 along the cutting line 3-3; Figure 4 shows a top view of the needle implantation structure of the first embodiment in Figure 1; Figure 5 shows a side view of the needle implantation structure of the first embodiment in Figure 1; Figure 6 shows a top view of a flat plate used to bend and form the needle implantation structure of the first embodiment in Figure 1; Figure 7 illustrates a three-dimensional schematic diagram of an implantation needle structure according to one of the second embodiments of this disclosure; Figure 8 shows a cross-sectional view of the needle-planting structure of the second embodiment in Figure 7 along the cutting line 8-8; Figure 9 shows a cross-sectional view of the needle-planting structure of the second embodiment in Figure 7 along the cutting line 9-9; Figure 10 shows a top view of the needle implantation structure of the second embodiment in Figure 7; Figure 11 shows a side view of the needle implantation structure of the second embodiment in Figure 7; Figure 12 illustrates a three-dimensional schematic diagram of an implantation needle structure according to one of the third embodiments of this disclosure; Figure 13 shows a cross-sectional view of the needle-planting structure of the third embodiment in Figure 12 along the cutting line 13-13; Figure 14 shows a top view of the needle implantation structure of the third embodiment in Figure 12; Figure 15 shows a side view of the needle implantation structure of the third embodiment in Figure 12; Figure 16 illustrates a three-dimensional schematic diagram of an implantation needle structure according to one of the fourth embodiments of this disclosure; Figure 17 shows a cross-sectional view of the needle-planting structure of the fourth embodiment in Figure 16 along the cutting line 17-17; Figure 18 shows a top view of the needle implantation structure of the fourth embodiment in Figure 16; Figure 19 shows a side view of the needle implantation structure of the fourth embodiment in Figure 16; Figure 20 illustrates a cross-sectional schematic diagram of an implantation needle structure according to one of the fifth embodiments of this disclosure; Figure 21 illustrates a three-dimensional schematic diagram of an implantation needle structure according to one of the sixth embodiments of this disclosure; Figure 22 shows a front view of the needle implantation structure of the sixth embodiment in Figure 21; Figure 23 illustrates a three-dimensional schematic diagram of an implantation needle structure according to one of the seventh embodiments of this disclosure; Figure 24 illustrates another perspective view of the needle implantation structure of Embodiment 7 in Figure 23; Figure 25 shows a front view of the needle implantation structure of the seventh embodiment in Figure 23; Figure 26 illustrates a three-dimensional exploded view of an implantation device according to one of the eighth embodiments of this disclosure; and Figure 27 shows a partial cross-sectional schematic diagram of the implantation device of the 8th embodiment in Figure 26. Implementation

[0026] The embodiments of this disclosure will now be described with reference to the drawings. For clarity, many practical details will be described in the following description. However, the reader should understand that these practical details should not be used to limit this disclosure. That is, in some embodiments of this disclosure, these practical details are not essential. Furthermore, for the sake of simplicity, some conventional structures and elements will be shown in the drawings in a simple schematic manner; and repeated elements may be represented by the same or similar designations.

[0027] Furthermore, the terms "first," "second," and "third" used in this article are merely used to describe different components or parts, and do not impose any restrictions on the components / parts themselves. Therefore, the first component / part can also be referred to as the second component / part. Moreover, the combinations of components / parts / mechanisms / modules in this article are not combinations generally known, conventional, or conventional in this field. Whether the components / parts / mechanisms / modules themselves are conventional cannot be used to determine whether their combination relationships are easily accomplished by those with ordinary knowledge in the technical field.

[0028] Please refer to Figures 1, 2, and 3, wherein Figure 1 shows a perspective view of an implant needle structure 1000 according to one embodiment of the present disclosure, Figure 2 shows a cross-sectional view of the implant needle structure 1000 of the first embodiment of Figure 1 along section line 2-2, and Figure 3 shows a cross-sectional view of the implant needle structure 1000 of the first embodiment of Figure 1 along section line 3-3. The implant needle structure 1000 is formed by bending a flat plate B1 (shown in Figure 6) for accommodating a biosensor 1520 and partially implanting the biosensor 1520 under the skin of a living organism, and the implant needle structure 1000 includes a needle tip 1200 and a needle body 1100. The needle body 1100 and needle tip 1200 are integrally connected. The needle body 1100 includes a bottom wall 1130, two side walls 1110, two slope sections 1120, and two arc-shaped connecting sections 1140. The two side walls 1110, two slope sections 1120, two arc-shaped connecting sections 1140, and the bottom wall 1130 define an accommodating space S1 for accommodating the biosensor 1520. The two side walls 1110 are located on both sides of the bottom wall 1130, and the two side walls 1110 are at least partially non-parallel, and each side wall 1110 is at least partially straight. The two slope sections 1120 are located on both sides of the bottom wall 1130, and each slope section 1120 connects to each side wall 1110 and the needle tip 1200. Each arc-shaped connecting section 1140 connects to each side wall 1110 and the bottom wall 1130, and also connects to each slope section 1120 and the bottom wall 1130. Among them, the needle tip 1200 extends from the bottom wall 1130 and the two circular arc connecting sections 1140.

[0029] In this way, the structure of the sidewalls 1110, which is at least partially non-parallel and at least partially straight, can help improve the smoothness of the insertion of the needle structure 1000 into the skin of a living organism.

[0030] The needle-planting structure 1000 is a three-dimensional structure. Ignoring thickness, the base wall 1130 lies on the plane formed by the length direction Y and the width direction X. The base wall 1130 can be smoothly and indirectly connected to the side wall 1110 and the slope section 1120 via an arc-shaped connecting section 1140. One side wall 1110, one arc-shaped connecting section 1140, and one slope section 1120 are located on one side of the centerline I1 of the needle-planting structure 1000, while the other side wall 1110, another arc-shaped connecting section 1140, and another slope section 1120 are located on the other side of the centerline I1, arranged symmetrically.

[0031] Each arc-shaped connecting segment 1140 has an arc-shaped connecting segment height T2 along the height direction Z of the needle implantation structure 1000, and the plate B1 has a thickness T1 (which is equivalent to the thickness of the bottom wall 1130 and is shown in Figure 3). The two can satisfy the relationship T2 / T1≥1.5. When this relationship is satisfied, the bending resistance of the needle tip 1200 increases, thereby improving the puncture performance. At the same time, the puncture force can be reduced, which helps to reduce pain.

[0032] Furthermore, the sidewall 1110 can have a generally uniform height. The aforementioned height refers to the distance in the height direction Z from the junction of the arc connecting segment 1140 and the sidewall 1110 to the top of the sidewall 1110. The height of the starting position of the slope segment 1120 is approximately zero and gradually increases along the length direction Y. Therefore, the height of the ending position of the slope segment 1120 is approximately equal to the height of the sidewall 1110, so that they can be connected to each other. In the first embodiment, except for the starting and ending positions of the slope segment 1120, the slope of the height of the slope segment 1120 can be approximately constant.

[0033] As shown in Figures 1 to 3, each sidewall 1110 extends upward from each arc connecting segment 1140. Each sidewall 1110 includes a first segment 1110a and a second segment 1110b. Each first segment 1110a connects to each slope segment 1120, and each second segment 1110b includes a plane, and the planes are not parallel.

[0034] Specifically, each sidewall 1110 can be divided into two interconnected segments, namely, the first segment 1110a and the second segment 1110b. Each first segment 1110a does not curve inwards; that is, it lies on the plane formed by the length direction Y and the height direction Z. Therefore, the two planes of the two first segments 1110a are parallel to each other and respectively connect to two slope segments 1120, which are also located on the planes of the length direction Y and the height direction Z. Each second segment 1110b curves straight inwards from the arc connecting segment 1140; therefore, the two planes of the two second segments 1110b are not parallel to each other, meaning that the extension line of the arc connecting segment 1140 forms an angle in the height direction Z. Furthermore, a wall opening with a width W1 can be formed between the two first sections 1110a in the width direction X of the needle implantation structure 1000, and another wall opening with a width W2 can be formed between the two second sections 1110b in the width direction X of the needle implantation structure 1000, wherein the width W1 is greater than the width W2.

[0035] The implantation structure 1000 may further include an assembly body 1300 and a connecting body 1400. The assembly body 1300 is connected to an implantation needle component of an implantation device. The connecting body 1400 is connected between the assembly body 1300 and the needle body 1100. The assembly body 1300 includes two parallel straight walls 1310. The connecting body 1400 includes two connecting walls 1410, each connecting wall 1410 connecting between each straight wall 1310 and each side wall 1110. Each connecting wall 1410 is at least partially inclined from each straight wall 1310 toward each side wall 1110. An opening with a width equal to the width W1 can be formed between the two straight walls 1310 in the width direction X of the implantation structure 1000, so that each connecting wall 1410 can be partially inclined toward each side wall 1110.

[0036] As shown in Figure 2, the biosensor 1520 may have a widest portion 1521, which has a maximum width W3 in the width direction X of the needle implantation structure 1000, and the width W2 is smaller than the maximum width W3 of the biosensor 1520. This prevents the biosensor 1520 from separating from the needle implantation structure 1000 in the height direction Z. It should be noted that Figure 2 is only used to show that the biosensor 1520 has a maximum width W3; however, it is clear that an appropriate distance must be maintained between the biosensor 1520 and the sidewall 1110. In the first embodiment, the difference between the biosensor 1520 and the width W1, and the difference between the biosensor 1520 and the width W2, can be between -100 μm and 100 μm.

[0037] Each sidewall 1110 may have a first inner edge 1111 and a first outer edge 1112. Each first inner edge 1111 is adjacent to the accommodating space S1, and each first outer edge 1112 is away from the accommodating space S1. Each first inner edge 1111 is arc-shaped. Further, each first outer edge 1112 may be arc-shaped, with the radius of arc of each first inner edge 1111 being R11 and the radius of arc of each first outer edge 1112 being R12, satisfying the relationship R11>R12.

[0038] Specifically, both the first inner edge 1111 and the first outer edge 1112 have a 90-degree radius (R-angle). The inner and outer circumferential surfaces of the sidewall 1110 can both be planes, and the radii R11 and R12 of the radius (R-angle) are different. In the first embodiment, the first inner edge 1111 can be directly connected to the first outer edge 1112, that is, there is no connecting surface between the first inner edge 1111 and the first outer edge 1112. However, in other embodiments, a connecting surface may be included between the first inner edge and the first outer edge, and this is not a limitation.

[0039] Please refer to Figures 4 and 5, and also to Figures 1 through 3. Figure 4 shows a top view of the needle implantation structure 1000 of the first embodiment in Figure 1, and Figure 5 shows a side view of the needle implantation structure 1000 of the first embodiment in Figure 1. As shown in Figures 1 through 5, each slope segment 1120 may include a second inner edge 1121 and a second outer edge 1122. Each second inner edge 1121 connects to each first inner edge 1111, and each second outer edge 1122 connects to each first outer edge 1112. Each second inner edge 1121 may be arc-shaped, and each second outer edge 1122 may also be arc-shaped.

[0040] The needle tip 1200 may include two sides 1210 connected to two slope sections 1120 respectively. The two sides 1210 intersect at an angle to form a pointed tip 1220. Each side 1210 includes an upper edge 1211 and a lower edge 1212. The upper edge 1211 of each needle tip is arc-shaped and connected to the second inner edge 1121; the lower edge 1212 of each needle tip is arc-shaped and connected to the second outer edge 1122. The radius of the arc of each upper edge 1211 is R31, and the radius of the arc of each lower edge 1212 is R32, satisfying the relationship R31>R32, and the angle can be between 20 degrees and 40 degrees.

[0041] Specifically, the needle tip 1200 is generally triangular, and without considering the thickness, the needle tip 1200 is located on the plane formed by the length direction Y and the width direction X. Each side 1210 is indirectly connected to the slope section 1120 through the arc connecting section 1140, and the tip 1220 is located on the center line I1. It should be noted that the arc connecting section 1140 is smoothly connected to each side 1210 and the slope section 1120. Therefore, the height of the arc connecting section 1140 in the height direction Z also gradually decreases towards the side 1210 along the length direction Y. Each arc connecting section 1140 may further include a third inner edge (not shown) and a third outer edge (not shown). The upper edge 1211 of each needle tip is indirectly connected to the second inner edge 1121 through the third inner edge, and the lower edge 1212 of each needle tip is indirectly connected to the second outer edge 1122 through the third outer edge.

[0042] Please refer to Figure 6, and also to Figures 1 through 5. Figure 6 shows a top view of the plate B1 used to bend and form the pin-planting structure 1000 of the first embodiment in Figure 1. The plate B1 can be a metal plate, which can form the pin-planting structure 1000 after bending. Therefore, the thickness T1 of the plate B1 is the thickness of the bottom wall 1130, as well as the thickness of the side wall 1110, the slope section 1120, and the arc connecting section 1140. By making the plate B1 form an R-angle with a thickness T1, an arc connecting section 1140 with a height T2 can be formed.

[0043] The flat plate B1 can be manufactured, for example, by stamping, particularly by die cutting. When manufacturing the flat plate B1, a stamping die can be used to process the area on a sheet of material where the needle tip 1200 is to be formed (i.e., the needle tip portion B11). Then, the area to be cut is further processed using the stamping die, for example, by shaving, to define the contour and enhance the sharpness of the needle tip 1200. Accordingly, the burr height of the flat plate B1 when it separates from the sheet during stamping can be less than or equal to 0.02 mm, and the flat plate B1 can form a smooth surface when it separates from the sheet during stamping. The smooth surface can have a height T3 (not shown), which satisfies the relationship T3 / T1≥50% with the thickness T1 of the flat plate B1, specifically T3 / T1≥70%, and more specifically T3 / T1≥90%. Through the above process, the contour of the flat plate B1 can be a continuous and uniform cut edge, reducing subsequent surface finishing and burr removal processes.

[0044] In the first embodiment, the first outer edge 1112, the second outer edge 1122, and the lower edge of the needle tip 1212 can be formed by the elastic deformation of the plate B1 during stamping when it separates from the sheet material. Specifically, during stamping, the area on the sheet material to be cut will first undergo elastic deformation, then plastic deformation, and finally completely tear, thus cutting out the plate B1 that is completely separated from the sheet material. Therefore, viewed from the side, the plate B1 can generally be formed by stamping, such as the die roller area and the shearing area. The die roller area itself is an arc shape generated by elastic deformation and does not require further processing. Therefore, it can be directly used as the first outer edge 1112, the second outer edge 1122, and the lower edge of the needle tip 1212, and satisfy the relationship 20%≤R11 / T1≤50%. The sheared area is the region created by plastic deformation. The smoother, polished surface typically accounts for about 30% to 50% of the thickness T1 of the plate B1. However, this invention discloses that by using a stamping die (such as polishing), the smoothness can be increased to greater than or equal to 50%, or even greater than or equal to 70%. 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 sheared edge of the plate B1 and eliminates residual fine burrs, while the bent needle structure 1000 reduces the friction between the needle and the skin surface of the organism during the needle implantation process.

[0045] The plate B1 may include a needle tip B11, a bottom wall B14, two rounded corner sections B12, and two wing sections B13. The needle tip B11 is generally triangular, and the bottom wall section B14 is elongated and integrally connected to the needle tip B11. The width of the bottom wall section B14 is approximately equal to the widest point of the needle tip B11. Each rounded corner section B12 is integrally connected to the bottom wall section B14 and has a bevel extending from the needle tip B11. Each wing section B13 is integrally connected to the rounded corner section B12 and has a bevel extending from the rounded corner section B12 (with the same slope as the bevel extending from the needle tip B11) and a straight edge connecting the bevels. After the plate B1 is bent, the needle tip B11 forms a needle tip 1200, the rounded corner section B12 forms an arc connecting section 1140, and the wing section B13 forms a side wall 1110 and a slope section 1120, thus completing the needle-planting structure 1000. In other embodiments, the bevel extending from the needle tip of the plate may be curved, and there is no obvious turning point when the bevel turns to the straight edge. This allows the needle tip of the implant structure to be shortened while widening, thereby strengthening the structural strength of the needle tip, making it less prone to bending, and through the convex arc-shaped bevels, the opening expands immediately and smoothly when piercing the skin surface of a living organism, thus increasing the smoothness of the implant structure during the implantation process, reducing the pain of implantation, and also facilitating the placement of biosensors. In addition, the curvature of each bevel can be increased, but the design of the curvature of each bevel must take into account the sharpness of the needle tip.

[0046] Please refer to Figures 7, 8, and 9, where Figure 7 shows a perspective view of a needle implantation structure 2000 according to one of the second embodiments of this disclosure, Figure 8 shows a cross-sectional view of the needle implantation structure 2000 of the second embodiment of Figure 7 along section line 8-8, and Figure 9 shows a cross-sectional view of the needle implantation structure 2000 of the second embodiment of Figure 7 along section line 9-9. The needle implantation structure 2000 is similar to the needle implantation structure 1000 of the first embodiment and includes a needle tip 2200 and a needle body 2100. The needle body 2100 is integrally connected to the needle tip 2200 and includes a bottom wall 2130, two side walls 2110, two slope sections 2120, and two arc connecting sections 2140 (labeled in Figure 11).

[0047] Each sidewall 2110 includes a first section 2110a and a second section 2110b. The structure of each first section 2110a is similar to that of the first section 1110a in the first embodiment, and the first inner edge 2111 and the first outer edge 2112 of each sidewall 2110 are both arc-shaped.

[0048] Each slope segment 2120 may include a second inner edge 2121 and a second outer edge 2122, with each second inner edge 2121 connecting to each first inner edge 2111 and each second outer edge 2122 connecting to each first outer edge 2112. Each second inner edge 1121 may be arc-shaped, and each second outer edge 1122 may be at least partially planar and inclined in a direction away from the accommodating space. In other words, a portion of each slope segment 2120 is cut flat and planar, but another portion adjacent to the sidewall 2110 can remain arc-shaped, thus being partially planar and partially arc-shaped.

[0049] Please refer to Figures 10 and 11, and also to Figures 7 through 9. Figure 10 shows a top view of the needle implantation structure 2000 of the second embodiment in Figure 7, and Figure 11 shows a side view of the needle implantation structure 2000 of the second embodiment in Figure 7. The needle tip 2200 may include two sides 2210 respectively connected to two slope sections 2120. The two sides 2210 are angled and intersect to form a pointed tip 2220. Each side 2210 includes an upper edge 2211 and a lower edge 2212 of the needle tip. Each upper edge 2211 of the needle tip is arc-shaped and connected to each second inner edge 2121; each lower edge 2212 of the needle tip is planar and connected to each second outer edge 2122.

[0050] Please refer to Figures 12, 13, 14, and 15, where Figure 12 shows a perspective view of a needle implantation structure 3000 according to one of the third embodiments of this disclosure; Figure 13 shows a cross-sectional view of the needle implantation structure 3000 of the third embodiment of Figure 12 along section line 13-13; Figure 14 shows a top view of the needle implantation structure 3000 of the third embodiment of Figure 12; and Figure 15 shows a side view of the needle implantation structure 3000 of the third embodiment of Figure 12. The needle implantation structure 3000 is similar to the needle implantation structure 2000 of the second embodiment and includes a needle tip 3200 and a needle body 3100. The needle body 3100 includes two sidewalls 3110 and two slope sections 3120.

[0051] Each sidewall 3110 has a first inner edge 3111 that is arc-shaped, and each sidewall 3110 has a first outer edge 3112 that is planar and inclined in a direction away from the receiving space. Each slope segment 3120 has a second inner edge 3121 that is arc-shaped, and each slope segment 3120 has a second outer edge 3122 that is planar and inclined in a direction away from the receiving space. The needle tip 3200 has a needle tip upper edge 3211 that is arc-shaped, and a needle tip lower edge 3212 that is planar and inclined in a direction away from the receiving space.

[0052] Please refer to Figures 16, 17, 18, and 19, where Figure 16 shows a perspective view of a needle implantation structure 4000 according to one of the fourth embodiments of this disclosure; Figure 17 shows a cross-sectional view of the needle implantation structure 4000 of the fourth embodiment of Figure 16 along section line 17-17; Figure 18 shows a top view of the needle implantation structure 4000 of the fourth embodiment of Figure 16; and Figure 19 shows a side view of the needle implantation structure 4000 of the fourth embodiment of Figure 16. The needle implantation structure 4000 is similar to the needle implantation structure 2000 of the second embodiment and includes a needle tip 4200 and a needle body 4100. The needle body 4100 includes two sidewalls 4110 and two slope sections 4120.

[0053] Each sidewall 4110 has a first inner edge 4111 and a first outer edge 4112 that are both arc-shaped, and each sidewall 4110 further includes a connecting surface 4150 connecting the first inner edge 4111 and the first outer edge 4112. Each slope segment 4120 has a second inner edge 4121 that is arc-shaped, and each slope segment 4120 has a second outer edge 4122 that is at least partially planar and inclined in a direction away from the receiving space. The needle tip 4200 has an upper edge 4211 that is arc-shaped, and a lower edge 4212 that is planar and inclined in a direction away from the receiving space.

[0054] Please refer to Figure 20, which illustrates a cross-sectional schematic diagram of an implantation needle structure according to one of the fifth embodiments of this disclosure. In the fifth embodiment, the second section (not shown in the fifth embodiment) of each sidewall (not shown in the fifth embodiment) includes an upright portion 5110a and a curved portion 5110b. Each upright portion 5110a extends upward from each arcuate connecting section (not shown in the fifth embodiment), and each curved portion 5110b extends upward and inward from each upright portion 5110a. Each upright portion 5110a includes a plane, and the planes are parallel. Specifically, each second section extends upward at least a portion and then bends inward to form the upright portion 5110a and the curved portion 5110b. The base wall (not shown in the fifth embodiment) and the widest part 5521 of the biosensor 5520 have a height H1 along the height direction Z of the needle implantation structure, and the upright part 5110a has a height H2 along the height direction Z of the needle implantation structure, satisfying the relationship H1>H2. Therefore, the upright part 5110a can have sufficient height to accommodate the biosensor 5520.

[0055] Please refer to Figures 21 and 22, where Figure 21 shows a perspective view of an implantation needle structure 6000 according to one of the sixth embodiments of this disclosure, and Figure 22 shows a front view of the implantation needle structure 6000 of the sixth embodiment shown in Figure 21. The implantation needle structure 6000 is similar to the implantation needle structure 1000 of the first embodiment and includes a needle tip 6200 and a needle body 6100, but the implantation needle structure 6000 may further include a reinforcing portion (not shown), which is disposed in at least one segment of a reinforcing block. The reinforcing block is defined as the portion of the needle tip 6200 and the needle body 6100 adjacent to the needle tip, and the reinforcing portion is formed by forming at least one concave structure and / or one convex structure in the aforementioned at least one segment to prevent the needle tip 6200 from bending and deforming under stress during an implantation process.

[0056] As shown in Figures 21 and 22, the reinforcing portion may include a groove 6300 extending from the needle tip 6200 toward the bottom wall 6130 of the needle body 6100, and one cross-section of the groove 6300 is V-shaped. In other embodiments, the cross-section may be U-shaped, but is not limited thereto. Specifically, the groove 6300 may be located on the first surface of the needle tip 6200 toward the receiving space (not shown in the 6th embodiment) and the first surface of the bottom wall 6130 toward the receiving space, and the groove 6300 may be located on the centerline I1. During the manufacturing process, grooves 6300 can be made on the needle tip (not shown in the sixth embodiment) and the bottom wall (not shown in the sixth embodiment) of the plate (not shown in the sixth embodiment). The depth of the grooves 6300 is not greater than the thickness of the plate. After the plate is bent, a needle-planting structure 6000 with grooves 6300 can be formed. The second surface of the needle tip 6200 away from the receiving space and the second surface of the bottom wall 6130 away from the receiving space are still smooth surfaces.

[0057] More specifically, the groove 6300 is formed by pressing down on the first surface of the needle tip and the first surface of the bottom wall of the flat plate. It must be noted that during fabrication, the groove 6300 extends at most to the portion of the bottom wall adjacent to the needle tip. In this case, the density of the material at the needle tip 6200 increases after being compressed, and the strength of the needle tip 6200 can be increased. This helps to improve the bending resistance of the implantation structure 6000, and in particular, it can prevent the needle tip 6200 from bending and deforming under stress during implantation. In other embodiments, the groove can also be formed by cutting away part of the material, and the reinforcing portion can also include multiple grooves, and may only be located at the needle tip, not limited to the above disclosure.

[0058] Please refer to Figures 23, 24, and 25, where Figure 23 illustrates a perspective view of a needle implantation structure 7000 according to one of the seventh embodiments of this disclosure, Figure 24 illustrates another perspective view of the needle implantation structure 7000 of the seventh embodiment of Figure 23, and Figure 25 illustrates a front view of the needle implantation structure 7000 of the seventh embodiment of Figure 23. The needle implantation structure 7000 is similar to the needle implantation structure 1000 of the first embodiment and includes a needle tip 7200 and a needle body 7100. However, the difference is that the needle implantation structure 7000 may further include a reinforcing portion (not shown), which may include a rib 7310 extending from the needle tip 7200 toward the bottom wall 7130 of the needle body 7100.

[0059] Specifically, the reinforcement may further include a groove 7320, which is located on the first surface of the needle tip 7200 facing the receiving space (not shown in the 7th embodiment) and the first surface of the bottom wall 7130 facing the receiving space, and the groove 7320 is located on the center line I1. The protruding rib 7310 is located on the second surface of the needle tip 7200 away from the receiving space and the second surface of the bottom wall 7130 away from the receiving space and is located on the center line I1. In other words, the groove 7320 and the rib 7310 correspond to each other. During the manufacturing process, the groove 7320 can be pressed out on the needle tip (not shown in the 7th embodiment) and the bottom wall (not shown in the 7th embodiment) of the first surface of the plate (not shown in the 7th embodiment). The depth of the groove 7320 is greater than the thickness of the plate, so the rib 7310 protruding relative to the second surface can be formed. Therefore, after the plate is bent, the needle implantation structure 3000 with the groove 7320 and the rib 7310 can be formed.

[0060] It should be noted that during the fabrication of the flat plate, the groove 7320 extends at most to the portion of the bottom wall near the needle tip, and the rib 7310 also extends at most to the portion of the bottom wall near the needle tip. The groove 7320 in the seventh embodiment is also formed by pressing, resulting in a thinner but relatively protruding and dense rib 7310. After being compressed, the density of the material at the needle tip 7200 increases, and the strength of the needle tip 7200 can be increased, thereby helping to improve the bending resistance of the needle implantation structure 7000. However, the manufacturing process is not limited to the above. Furthermore, the reinforcing portion is not limited to a groove (e.g., the groove 6300 in the sixth embodiment) or a rib (e.g., the rib 7310 in the seventh embodiment) extending along the length of the needle implantation structure. It can also be a protrusion extending from the second surface of the needle tip away from the receiving space, and can be provided only at the needle tip.

[0061] Please refer to Figures 26 and 27, where Figure 26 shows an exploded perspective view of an implantation device 8000 according to one of the eighth embodiments of this disclosure, and Figure 27 shows a partial cross-sectional view of the implantation device 8000 of the eighth embodiment shown in Figure 26. The implantation device 8000 includes a cover 8100, an implantation module 8400, and a removal module 8500.

[0062] The cover 8100 has a main space (not shown); the implantation module 8400 is disposed in the main space of the cover 8100 and includes a needle implantation structure 8430; the detachment module 8500 includes a base 8510 and a biosensor 8520. The base 8510 is detachably located in the implantation module 8400; the biosensor 8520 is detachably disposed in the base 8510 and at least partially housed in the receiving space of the needle implantation structure 8430 (not shown in the 8th embodiment). When the cover 8100 is pressed down, the implantation module 8400 is driven to displace the needle implantation structure 8430 downward, thereby driving the biosensor 8520 to be implanted under the skin of a living organism to measure a physiological signal within the organism.

[0063] The implantation device 8000 may further include an upper cover 8200, a bottom cover 8300, and two fixing members 8600. After the upper cover 8200 and the bottom cover 8300 are fitted together, they form a sealed space to accommodate the cover 8100, the implantation module 8400, and the removal module 8500. The two fixing members 8600 are symmetrically inserted into the implantation module 8400 to detachably fit the base 8510. Each fixing member 8600 may include a support (not shown) to support a sensor fixing seat 8530 of the removal module 8500, and the sensor fixing seat 8530 carries a biosensor 8520. The implantation module 8400 may further include a needle implantation component 8410 and a needle implantation auxiliary seat 8420, with the needle implantation component 8410 passing through the needle implantation auxiliary seat 8420, and the needle implantation structure 8430 assembled on the needle implantation component 8410. The needle implantation structure 8430 may be any one of the needle implantation structures 1000, 2000, 3000, 4000, 6000, and 7000, and is not limited thereto.

[0064] During operation, the user can press down the top cover 8200, causing the cover 8100 inside the top cover 8200 to move downwards, driving the fixing member 8600 to move laterally, releasing the limiting position of the fixing member 8600, the sensor fixing seat 8530, and the base 8510. By releasing the pre-compression elastic force of the first elastic member (not shown) in the implantation module 8400, the implantation needle 8410, the implantation needle structure 8430, and the biosensor 8520 can be implanted under the skin of the organism. At the same time, the sensor fixing seat 8530 is attached to the base 8510, and the biosensor 8520 remains under the skin of the organism. Then, by releasing the pre-compression elastic force of the second elastic member (not shown) in the implantation module 8400, the implantation needle 8410 can be pulled back, thus completing the automatic implantation and removal of needles.

[0065] Although this disclosure has been presented above with reference to embodiments, it is not intended to limit this disclosure. Anyone skilled in the art may make various modifications and refinements without departing from the spirit and scope of this disclosure. Therefore, the scope of protection of this disclosure shall be determined by the appended claims.

[0066] 1000, 2000, 3000, 4000, 6000, 7000, 8430: Needle implantation structure 1100, 2100, 3100, 4100, 6100, 7100: Needle body 1110, 2110, 3110, 4110: Side walls 1110a, 2110a: First section 1110b, 2110b: Second section 1111,2111,3111,4111: First inner edge 1112,2112,3112,4112: First outer edge 1120, 2120, 3120, 4120: Slope sections 1121,2121,3121,4121: Second inner edge 1122,2122,3122,4122: Second outer edge 1130, 2130, 6130, 7130: Bottom wall 1140, 2140: Arc-shaped connecting section 1200, 2200, 3200, 4200, 6200, 7200: Needle tip 1210, 2210: Side 1211,2211,3211,4211: Upper edge of the needle tip 1212,2212,3212,4212: Lower edge of the needle tip 1220, 2220: Cutting edge 1300: Assembly Main Body 1310: Flat wall 1400: Connecting Body 1410: Connecting Wall 1520, 5520, 8520: Biosensors 1521,5521: Widest part 4150: Connecting surface 5110a: Erect part 5110b: Bend 6300: Trench 7310: Convex Rib 7320: Groove 8000: Implantable device 8100: Cover 8200: Top Cover 8300: Bottom Cover 8400: Implant Module 8410: Needle-implanting component 8420: Needle Insertion Auxiliary Seat 8500: Unloading Module 8510: Base 8530: Sensor Mount 8600: Fastener B1: Flat Panel B11: Needle tip B12: R corner B13: Wing B14: Bottom wall section H1, H2: Height I1: Centerline S1: Storage space T1: Thickness T2: Height of the arc connection segment W1, W2: Width W3: Maximum width X: Width direction Y: Length direction Z: Height direction

Claims

1. An implantation needle structure, formed by bending a flat plate, for accommodating a biosensor and partially implanting the biosensor under the skin of a living organism, the implantation needle structure comprising: a needle tip; and a needle body integrally connected to the needle tip and having an accommodating space for accommodating the biosensor, wherein the needle body comprises: a base wall; two side walls located on opposite sides of the base wall, the two side walls being at least partially non-parallel and each side wall being at least partially straight; two sloping sections located on opposite sides of the base wall, each sloping section connecting the side wall and the needle tip and generally forming a convex arc; and two arc-shaped connecting sections connecting the side wall and the base wall, and connecting the sloping section and the base wall; wherein... The needle tip extends from the bottom wall and the two circular arc connecting sections.

2. The needle implantation structure as described in claim 1, wherein, Each sidewall has a first inner edge and a first outer edge, each first inner edge being adjacent to the receiving space, each first outer edge being away from the receiving space, and each first inner edge being arc-shaped.

3. The needle implantation structure as described in claim 2, wherein, Each of the first outer edges is arc-shaped, each of the first inner edges has an arc radius of R11, and each of the first outer edges has an arc radius of R12, satisfying the relationship that R11 > R12.

4. The needle implantation structure as described in claim 3, wherein, The plate has a thickness T1, which satisfies the relationship 20%≤R11 / T1≤50%.

5. The needle implantation structure as described in claim 2, wherein, Each slope segment includes a second inner edge and a second outer edge, each second inner edge is connected to each first inner edge, each second outer edge is connected to each first outer edge, and each second inner edge is arc-shaped.

6. The needle implantation structure as described in claim 5, wherein, Each of the second outer edges is at least partially straight and tilted in a direction away from the receiving space.

7. The needle implantation structure as described in claim 5, wherein, The needle tip includes two sides that are respectively connected to two arc-shaped connecting segments. The two sides meet to form a tip. Each side includes: an upper edge of the needle tip, which is arc-shaped and connected to each of the second inner edges; and a lower edge of the needle tip, which is connected to each of the second outer edges.

8. The needle implantation structure as described in claim 7, wherein, The lower edge of the needle tip is planar, and each of the second outer edges is at least partially planar.

9. The needle implantation structure as described in claim 1, wherein, Each sidewall extends upward from each of the arc connecting segments, each sidewall includes a first segment and a second segment, each first segment is connected to each of the slope segments, and each second segment includes a plane, and the two planes are not parallel.

10. The needle implantation structure as described in claim 1, wherein, Each sidewall includes a first section and a second section. Each first section is connected to each slope section. Each second section includes a vertical portion and a curved portion. Each vertical portion extends upward from each arc connecting section. Each curved portion extends upward and inward from each vertical portion. Each vertical portion includes a plane, and the two planes are parallel.

11. The needle implantation structure as described in claim 10, wherein, The biosensor has a widest part, which has a maximum width in a width direction of the needle implantation structure. The height between the bottom wall and the widest part along a height direction of the needle implantation structure is H1, and the height of the upright part in the height direction of the needle implantation structure is H2, satisfying the relationship H1 > H2.

12. The needle implantation structure as described in claim 10, wherein, The biosensor has a widest portion, which has a maximum width in a width direction of the needle implantation structure, and a wall opening is formed between the two second segments, the width of which in the width direction of the needle implantation structure is less than the maximum width.

13. The needle implantation structure as described in claim 10, wherein, The two first sections are parallel to each other, and the wall opening formed between the two first sections in a width direction of the needle-planting structure is larger than the wall opening formed between the two second sections.

14. The needle implantation structure as described in claim 1 further includes an assembly body and a connecting body, the assembly body being connected to a needle implantation component of an implantation device, the connecting body being connected between the assembly body and the needle body, the assembly body including two parallel straight walls, the assembly body including two connecting walls, each connecting wall being connected between each straight wall and each side wall, and each connecting wall being at least partially inclined from each straight wall toward each side wall.

15. The needle implantation structure as described in claim 1 further includes a reinforcing portion disposed in at least one segment of a reinforcing block, the reinforcing block being defined as the portion of the needle tip and the needle body adjacent to the needle tip, and the reinforcing portion being formed by forming at least one concave structure and / or one convex structure in the at least one segment to prevent the needle tip from bending and deforming under stress during an implantation process.

16. The needle implantation structure as described in claim 15, wherein, The reinforcement includes a groove that extends from the needle tip toward the bottom wall of the needle body, and a cross-section of the groove is V-shaped or U-shaped.

17. The needle implantation structure as described in claim 15, wherein, The reinforcement includes a rib that extends from the needle tip toward the bottom wall of the needle body.

18. The needle implantation structure as described in claim 1, wherein, Each of the arc connecting segments has an arc connecting segment height T2 along a height direction of the needle implantation structure, and the plate has a thickness T1, satisfying the relationship T2 / T1≥1.

5.

19. An implantation device comprising: a cover having a main space; an implantation module disposed in the main space of the cover and including a needle implantation structure as described in claim 1; and a detachment module comprising: a base detachably located within the implantation module; and a biosensor detachably disposed on the base and at least partially housed in the housing space of the needle implantation structure; wherein pressing down on the cover drives the implantation module to displace the needle implantation structure downwards to implant the biosensor under the skin of an organism to measure a physiological signal within the organism.

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