INSERTION NEEDLE STRUCTURE AND INSERTER

An insertion needle structure includes a needle sharp and a needle body. The needle body is integrally connected to the needle sharp and has a receiving space for receiving the biosensor. The needle body includes a base wall, two side walls, two slope sections and two curved connecting sections. The side walls are located at two sides of the base wall, respectively, the side walls are at least partially nonparallel, and each of the side walls is at least partially flat. Each of the slope sections is connected between each of the side walls and the needle sharp, and each of the slope sections is curved. Each of the curved connecting sections is connected between each of the side walls and the base wall and between each of the slope sections and the base wall. The needle sharp extends from the base wall and the curved connecting sections.

BACKGROUND

Technical Field

The present disclosure relates to an insertion needle and an inserter. Particularly, the present disclosure relates to an insertion needle and an inserter applied for inserting a biosensor.

Description of Related Art

Glucose monitor inside the body is very important for diabetes patients. In addition, the specific physiological parameters, such as blood fatty and the content of cholesterol, of the patients with the chronic illness have to be daily monitored for tracking the illness condition, thereby assisting the latter treatment. Generally, such physiological parameters are obtained by extracting the body fluid of the patient for further analysis, and, for example, a conventional glucose meter employs a needle to pierce the skin surface of the human body to extract the blood for analyzing the value of the glucose.

However, in order to improve the accuracy and immediacy of the monitor, a biosensor which can be implanted underneath the skin surface of the human body is developed. Through the biosensor, real-time physiological parameters can be obtained. The physiological parameters can be sent to the cloud or the back-end monitoring system in association with the signal processer, and numerous and immediate analyzed data can be provided, which prevents the discomfort and the risk of infection caused by invasive extractions of the body fluid.

The biosensor can be implanted underneath the skin surface of the human body by an inserter. The inserter can include an insertion needle, and the biosensor can be received in the insertion needle. By using the insertion needle to pierce the skin surface of the human body to form a small aperture, the biosensor can enter the aperture so as to be implanted underneath the skin surface of the human body. If the aperture is too large or non-smooth, the aperture, i.e., the wound, cannot heal quickly. Hence, how to improve the structure of the insertion needle to lower the burrs and increase the insertion smoothness for increasing the flatness of the aperture formed on the skin surface of the human body or the organism becomes a pursued target for practitioners.

SUMMARY

According to one aspect of the present disclosure, an insertion needle structure which is formed by bending a flat blank and is configured for receiving and allowing a biosensor to be partially implanted underneath a skin surface of an organism includes a needle sharp and a needle body. The needle body is integrally connected to the needle sharp and has a receiving space for receiving the biosensor. The needle body includes a base wall, two side walls, two slope sections and two curved connecting sections. The two side walls are located at two sides of the base wall, respectively, the two side walls are at least partially nonparallel, and each of the two side walls is at least partially flat. The two slope sections are located at the two sides of the base wall, respectively, each of the slope sections is connected between each of the side walls and the needle sharp, and each of the slope sections is curved. The two curved connecting sections are located at the two sides of the base wall, and each of the curved connecting sections is connected between each of the side walls and the base wall and between each of the slope sections and the base wall. The needle sharp extends from the base wall and the curved connecting sections.

According to still yet another aspect of the present disclosure, an inserter includes a cover having a main space, an inserting module disposed within the main space of the cover and including the abovementioned insertion needle structure, and a removing module including a base and the biosensor. The base is detachably limited within the inserting module. The biosensor is detachably assembled with the base and at least a part thereof is received in the receiving space of the insertion needle structure. When the cover is pressed downward, the inserting module is driven to allow the insertion needle structure to move downward so as to carry the biosensor to implant underneath the skin surface of the organism for conducting a measurement of a physiological signal inside the organism.

DETAILED DESCRIPTION

It will be understood that when an element (or mechanism or module) is referred to as being “disposed on”, “connected to” or “coupled to” another element, it can be directly disposed on, connected or coupled to another element, or it can be indirectly disposed on, connected or coupled to another element, that is, intervening elements may be present. In contrast, when an element is referred to as being “directly disposed on”, “directly connected to” or “directly coupled to” another element, there are no intervening elements present.

In addition, the terms first, second, third, etc. are used herein to describe various elements or components, these elements or components should not be limited by these terms. Consequently, a first element or component discussed below could be termed a second element or component.

FIG.1shows a three-dimensional schematic view of an insertion needle structure1000according to a first embodiment of the present disclosure.FIG.2shows a front view of the insertion needle structure1000of the first embodiment ofFIG.1. Please refer toFIGS.1and2, the insertion needle structure1000which is formed by bending a flat blank B1(shown inFIG.5) and is configured for receiving and allowing a biosensor (not shown in the first embodiment) to be partially implanted underneath a skin surface (not shown) of an organism includes a needle sharp1200and a needle body1100. The needle body1100is integrally connected to the needle sharp1200and includes a base wall1130, two side walls1110, and two slope sections1120. A receiving space S1for receiving the biosensor is defined by the two side walls1110, the two slope sections1120, and the base wall1130. The two side walls1110are located at two sides of the base wall1130, respectively. Each of the side walls1110has a first inner edge1111and a first outer edge1112. The first inner edge1111is near the receiving space S1, and the first outer edge1112faces away from the receiving space S1. The two slope sections1120are located at the two sides of the base wall1130, respectively. Each of the slope sections1120is connected between each of the side walls1110and the needle sharp1200. Each of the slope sections1120has a second inner edge1121connected to the first inner edge1111, and a second outer edge1122is connected to the first outer edge1112. Each of the first inner edges1111, each of the second inner edges1121, each of the first outer edges1112and each of the second outer edges1122are curved. R11represents a radius of each of the first inner edges1111, R12represents a radius of each of the first outer edges1112, and a condition of R11>R12is satisfied.

Therefore, because each of the first inner edges1111, each of the second inner edges1121, each of the first outer edges1112and each of the second outer edges1122are curved, the insertion needle structure1000is favorable for smoothly piercing the skin surface of the organism, which can increase the flatness of the aperture formed on the skin surface of the organism. Moreover, through the condition of R11>R12, damage of the biosensor inside the receiving space S1can be avoided. The details of the insertion needle structure1000will be described hereinafter.

The insertion needle structure1000is a three-dimensional structure. Without considering the thickness, the base wall1130is located on a plane formed by a length direction Y and a width direction X of the insertion needle structure1000, and the side walls1110and the slope sections1120are located on the plane formed by the length direction Y and a height direction Z of the insertion needle structure1000. One of the side walls1110and one of the slope sections1120are located on one side of the central axis I1of the insertion needle structure1000, and the other one of the side walls1110and the other one of the slope sections1120are located on the other side of the central axis I1of the insertion needle structure1000. The two side walls1110are aligned symmetrically, and the two slope sections1120are aligned symmetrically.

The needle body1100can further include two curved connecting sections1140, and each of the curved connecting sections1140is connected between each of the side walls1110and the base wall1130and between each of the slope sections1120and the base wall1130. In other words, the base wall1130located on the plane formed by the length direction Y and the width direction X can be smoothly connected to the side walls1110and the slope sections1120on the plane formed by the length direction Y and the height direction Z so as to form a cross-section being U-shaped. Furthermore, each of the curved connecting sections1140has a height thereof represented by T2along the height direction Z of the insertion needle structure1000, the flat blank B1has a thickness represented by T1which is identical to the thickness of the base wall1130and is marked onFIG.2, and a condition of T2/T1≥1.5 is satisfied. When the condition is satisfied, the anti-bending capability of the needle sharp1200can be increased to enhance the piercing capability, and the piercing force can be decreased to lower the piercing pain.

The needle body1100can further include a connecting surface1150which is parallel to the width direction X of the insertion needle structure1000and connected between each of the first inner edges1111and each of the first outer edges1112. In other words, the inner surface and the outer surface of the side wall1110can be vertical. The radius angle of the first inner edge1111and the radius angle of the first outer edge1112are both 90 degrees, but the radius of the first inner edge1111and the radius of the first outer edge1112are different. As shown in the enlarged schematic view inFIG.2, the first inner edge1111and the first outer edge1112are connected to each other via the connecting surface1150. The second inner edge1121and the second outer edge1122can also be connected via the connecting surface1150. The side wall1110can have a substantially uniform height which is defined by the distance from the intersection between the curved connecting section1140and the side wall1110to the connecting surface1150along the height direction Z. The height of the starting position of the slope section1120is substantially equal to zero, the height of the slope section1120is incrementally increased along the length direction Y, and the height of the stop position of the slope section1120is substantially equal to the height of the side wall1110, thereby allowing the slope section1120to be smoothly connected to the side wall1110. In the first embodiment, in addition to the starting position and the stop position, a slope of the height of the slope section1120is constant.

FIG.3shows a side view of the insertion needle structure1000of the first embodiment ofFIG.1.FIG.4shows a top view of the insertion needle structure1000of the first embodiment ofFIG.1. Please refer toFIGS.3and4with reference toFIGS.1and2. The needle sharp1200can include two slants1210connected to the two slope sections1120, respectively, and the two slants1210intersect at a needle tip1220with an angle θ. Each of the slants1210includes a needle sharp top edge1211being curved and connected to one of the two second inner edges1121, and a needle sharp bottom edge1212being curved and connected to one of the two second outer edges1122. R31represents a radius of each of the needle sharp top edges1211, R32represents a radius of each of the needle sharp bottom edges1212, and a condition of R31>R32is satisfied. Moreover, the angle θ is within a range from 20 degrees to 40 degrees.

To be more specific, the needle sharp1200is substantially triangle-shaped, and, without considering the thickness, the needle sharp1200is located at the plane formed by the length direction Y and the width direction X. Each of the slants1210is indirectly connected to the slope section1120via the curved connecting section1140, and the needle tip1220is located at the central axis I1. Please be noted that, the curved connecting section1140is smoothly connected to the side wall1110and the slope section1120, and therefore the height of the curved connecting section1140in the height direction Z is incrementally decreased toward the slant1210along the length direction Y. Each of the curved connecting sections1140can further include a third inner edge (not labeled) and a third outer edge (not labeled), each of the needle sharp top edges1211is indirectly connected to the second inner edge1121via the third inner edge, and each of the needle sharp bottom edges1212is indirectly connected to the second outer edge1122via the third outer edge.

Moreover, L1represents a needle sharp length defined by a distance along the length direction Y between the needle tip1220and a stop position of each of the slants1210, L2represents an expanding length defined by a distance along the length direction Y between the needle tip1220and a stop position of each of the slope sections1120, and a condition of L1/L2≤15% is satisfied. The stop position of each of the slants1210is defined as the intersection between the slant1210and the curved connecting section1140. The stop position of the slope section1120is defined as the intersection between the slope section1120and the side wall1110. As the condition of L1/L2≤15% is satisfied, particularly L1/L2≤8%, the smoothness for expanding the aperture formed by insertion of the needle sharp1200into the skin surface of the organism can be increased, thereby favorable for implanting the biosensor.

FIG.5shows a top view of a flat blank B1used for being bended and forming the insertion needle structure1000of the first embodiment ofFIG.1. Please refer toFIG.5with reference toFIGS.1to4, the flat blank B1can be made of a metal board, and the flat blank B1can be bended to form the insertion needle structure1000. Consequently, the thickness T1of the flat blank B1is identical to the thickness of the base wall1130, and is identical to the thickness of each of the side wall1110, the slope sections1120and the curved connecting sections1140. Moreover, through the configuration that the bending radius of the flat blank B1is equal to the thickness T1, the curved connecting section1140with the height T2can be formed.

The flat blank B1can be formed by a stamping process, especially a cutting process. During the manufacture for forming the flat blank B1, a portion which is defined to form the needle sharp1200, i.e., the needle sharp portion B11, is processed by the stamping mold, and then the area to be cut is continuously processed by the stamping mold for further process such as shaving to define the contour and to enhance the sharpness of the needle sharp1200. As a result, a burr height formed as the flat blank B1stamped from the sheet is smaller than or equal to 0.02 mm. A finishing surface can be formed as the flat blank B1stamped from the sheet, the finishing surface has a depth represented by T3(not shown), and the depth T3of the finishing surface and the thickness T1of the flat blank B1satisfy a condition of T3/T1≥50%, particularly T3/T1≥70%, more particularly T3/T1≥90%. Through the manufacture process, the contour of the flat blank B1can be a continuous and uniform cutting face, and the process for modifying the surface and reducing the burrs can be omitted.

In the first embodiment, the radius of each of the first inner edges1111is represented by R11, the radius of each of the second inner edges1121is represented by R21, and the radius of each of the needle sharp top edges1211is represented by R31. The radius of each of the first outer edges1112is represented by R12, the radius of each of the second outer edges1122is represented by R22, and the radius of each of the needle sharp bottom edges1212is represented by R32. Conditions of R11=R21=R31and R12=R22=R32are satisfied. Moreover, each of the first outer edges1112, each of the second outer edges1122and each of the needle sharp bottom edges1212are formed as the flat blank B1stamped and elastic deformed from the sheet. Precisely, during stamping, the area to be cut will first be elastic deformed, then be plastically deformed, and finally be torn off. Therefore, the flat blank B1which is completely separated from the sheet can be formed. As viewing from the side, a rollover zone and the rest, which is represented by a shear zone, caused by stamping the flat blank B1can be formed. The rollover zone is curved owing to the elastic deformation, and can be used as the first outer edges1112, the second outer edges1122and the needle sharp bottom edges1212without further processes. Consequently, the condition of 20%≤R11/T1≤50% can be satisfied. The shear zone is caused by plastic deformation, and the finishing surface is originally about 30% to 50% of the thickness T1of the flat blank B1. The present disclosure can use the stamping mold and the process such as the shaving to increase the depth of the finishing surface to about more than 50% of the thickness T1or about more than 70% of the thickness T1. Additionally, at least a part of the remained burrs can be rounded to form the first inner edges1111, the second inner edges1121and the needle sharp top edges1211, and a condition of 3≤R11/R12≤10 can be satisfied. As a result, the flat area of the cutting face of the flat blank B1can be decreased and the remained small burrs can be removed. The friction between the insertion needle structure1000bended therefrom and the skin surface of the organism can be lowered during the inserting process.

The flat blank B1can include a needle sharp portion B11, a base wall portion B14, two radius angle portions B12and two wing portions B13. The needle sharp portion B11is substantially triangle-shaped, and the base wall portion B14can be strip-shaped and can be integrally connected to the needle sharp portion B11. A width of the base wall portion B14is equal to the maximum width of the needle sharp portion B11. Each of the radius angle portions B12is integrally connected to the base wall portion B14and has an inclined line extending from the needle sharp portion B11. Each of the wing portions B13is integrally connected to the radius angle portion B12and has an inclined line extending from the radius angle portion B12, which has the same slope of the inclined line extending from the needle sharp portion B11, and a straight line connected to the inclined line. After the flat blank B1is bended, the needle sharp portion B11forms the needle sharp1200, the radius angle portion B12forms the curved connecting section1140, and the wing portion B13forms the side wall1110and the slope section1120, thereby completing the insertion needle structure1000.

FIG.6shows one three-dimensional schematic view of an insertion needle structure2000according to a second embodiment of the present disclosure.FIG.7shows a front view of the insertion needle structure2000of the second embodiment ofFIG.6.FIG.8shows another three-dimensional schematic view of the insertion needle structure2000of the second embodiment ofFIG.6. The insertion needle structure2000is similar to the insertion needle structure1000of the first embodiment and includes a needle sharp2200and a needle body2100. The difference is that the insertion needle structure2000can further include a reinforcing portion (not labeled). The reinforcing portion is disposed at at least one of the needle sharp2200and the needle body2100along the length direction Y. Particularly, a reinforcing area is defined as the needle sharp2200and a part of the needle body2100adjacent to the needle sharp2200. The reinforcing portion is disposed at at least one segment of a reinforcing area. The reinforcing portion is constructed by forming at least one depression structure and/or at least one protrusion structure at the at least one segment. As shown inFIGS.6to8, the reinforcing portion includes a groove2300, and the groove2300extends from the needle sharp2200toward the base wall2130of the needle body2100. The groove2300can be located at a first surface of the needle sharp2200facing toward the receiving space (not labeled in the second embodiment) and at a first surface of the base wall2130facing toward the receiving space, and the groove2300can be positioned at the central axis I1. A cross section of the groove is V-shaped or U-shaped. During the manufacture, the groove2300can be formed on the needle sharp portion (not shown in the second embodiment) and the base wall part (not shown in the second embodiment) of the flat blank (not shown in the second embodiment) first, and the depth of the groove2300is not larger than or equal to the thickness of the flat blank. The insertion needle structure2000having the groove2300can then be formed by bending the flat blank, and a second surface of the needle sharp2200facing away from the receiving space and a second surface of the base wall2130facing away from the receiving space are still smooth surfaces. Precisely, the groove2300is formed by pressing the first surface of the needle sharp portion and the first surface of the base wall portion. Please be noted that, during the manufacture, the groove2300extends no further than the part of the base wall portion adjacent to the needle sharp portion. The material density of the needle sharp2200will be increased after pressing, and the strength of the needle sharp2200can be enhanced, thereby favorable for increasing the anti-bending capability of the insertion needle structure2000and avoiding the needle sharp2200from bending or deforming during the implanting process. In other embodiments, the groove can also be formed by cutting off a part of the material. The reinforcing portion can include a plurality of grooves, the reinforcing portion can only be located on the needle sharp, and the present disclosure is not limited thereto.

FIG.9shows one three-dimensional schematic view of an insertion needle structure3000according to a third embodiment of the present disclosure.FIG.10shows another three-dimensional schematic view of the insertion needle structure3000of the third embodiment ofFIG.9.FIG.11shows a front view of the insertion needle structure3000of the third embodiment ofFIG.9.FIG.12shows a top view of the insertion needle structure3000of the third embodiment ofFIG.9.FIG.13shows a side view of the insertion needle structure3000of the third embodiment ofFIG.9. The insertion needle structure3000is similar to the insertion needle structure1000of the first embodiment and includes a needle sharp3200and a needle body3100. The difference is that the insertion needle structure3000can further include a reinforcing portion (not labeled). The reinforcing portion includes a rib3310, and the rib3310extends from the needle sharp3200toward the base wall3130of the needle body3100. To be more specific, the reinforcing portion can further include a pressed depression3320, the pressed depression3320can be located at a first surface of the needle sharp3200facing toward the receiving space (not labeled in the third embodiment) and at a first surface of the base wall3130facing toward the receiving space, and the pressed depression3320can be positioned at the central axis I1. The rib3310is located at a second surface of the needle sharp3200facing away from the receiving space and at a second surface of the base wall3130facing away from the receiving space, and the rib3310can be positioned at the central axis I1. In other words, the pressed depression3320and the rib3310correspond to each other. During the manufacture, the pressed depression3320can be formed on the first surfaces of the needle sharp portion (not shown in the third embodiment) and the base wall part (not shown in the third embodiment) of the flat blank (not shown in the third embodiment) first, and the depth of the pressed depression3320is larger than the thickness of the flat blank, thereby automatically forming the rib3310protruding from the second surface. The insertion needle structure3000having the pressed depression3320and the rib3310can then be formed by bending the flat blank. Please be noted that, during the manufacture, the pressed depression3320extends no further than the part of the base wall portion adjacent to the needle sharp portion, and the rib3310extends no further than the part of the base wall portion adjacent to the needle sharp portion correspondingly. In the third embodiment, the pressed depression3320is pressed by the same pressing method, and the protruding rib3310which is thinner and has higher material density can be formed. Hence, the material density of the needle sharp3200will be increased after pressing, and the strength of the needle sharp3200can be enhanced, thereby favorable for increasing the anti-bending capability of the insertion needle structure3000. The manufacturing process of the present disclosure is not limited thereto. Moreover, the reinforcing portion is not limited to the groove, e.g., the groove2300in the second embodiment, or the rib, e.g., the rib3310in the third embodiment, the reinforcing portion can be a projection protruding from the second surface of the needle sharp facing away from the receiving space, and the reinforcing portion can be only disposed at the needle sharp.

FIG.14shows a three-dimensional schematic view of an insertion needle structure4000according to a fourth embodiment of the present disclosure.FIG.15shows a front view of the insertion needle structure4000of the fourth embodiment ofFIG.14.FIG.16shows a side view of the insertion needle structure4000of the fourth embodiment ofFIG.14. The insertion needle structure4000is similar to the insertion needle structure1000and includes a needle sharp4200and a needle body4100. The needle body4100includes two slope sections4120and two side walls4110, and each of the side walls4110includes a first inner edge4111and a first outer edge4112. The difference is that each of the slope sections4120is curved. In other words, the front end of the needle body4100of the insertion needle structure4000in the fourth embodiment connected to the needle sharp4200is curved. More particularly, a projected line generated by projecting the height of each of the slope sections4120onto the plane formed by the height direction Z and the length direction Y is a curved line with its convex vertex facing upward. The tangent slopes of different height positions of the slope section4120are different.

FIG.17shows a top view of a flat blank B4used for being bended and forming the insertion needle structure4000of the fourth embodiment ofFIG.14. Please refer toFIG.17with reference toFIGS.14to16, the flat blank B4is used for being bended and forming the insertion needle structure4000. The flat blank B4is similar to the flat blank B1of the first embodiment. The difference is that the inclined line extending from the needle sharp portion B41is curved, and no obvious inflection point is presented at the intersection between the inclined line and the straight line. Therefore, the needle sharp4200of the insertion needle structure4000is shortened while the width thereof is increased, thereby increasing the structural strength of the needle sharp4200to avoid bending of the needle sharp4200. Moreover, through the curved slope sections4120, the aperture formed by piercing the skin surface of the organism can be smoothly expanded, and the smoothness of the implanting process can be increased. As a result, the piercing pain can be lowered, which facilitates for implanting the biosensor. In other embodiments, the curve of each of the slope sections can be increased, but the sharpness should be taken into consideration while modifying the curve of each of the slope sections.

FIG.18shows a front section view of an insertion needle structure5000according to a fifth embodiment of the present disclosure.FIG.19shows a top view of a flat blank B5used for being bended and forming the insertion needle structure5000of the fifth embodiment ofFIG.18. The insertion needle structure5000is similar to the insertion needle structure1000and includes two first inner edges5111and two first outer edges5112, and each of the first inner edges5111is directly connected to each of the first outer edges5112. In other words, the connecting surface1150of the first embodiment is omitted, and each of the first inner edges5111is allowed to be directly connected to each of the first outer edges5112. In addition, the curve formed by the inclined line extending from the needle sharp portion (not labeled) of the flat blank B5is larger than that of the flat blank B4in the second embodiment, and the curve of the slope section can be increased.

FIG.20shows a three-dimensional schematic view of an insertion needle structure6000according to a sixth embodiment of the present disclosure. The insertion needle structure6000is similar to the insertion needle structure4000of the fourth embodiment and includes a needle sharp6200and a needle body6100. The difference is that the insertion needle structure6000can further include a reinforcing portion (not labeled). The reinforcing portion can include a groove6300whose manufacture process and structure are identical to that of the groove2300of the second embodiment, and the details will not be mentioned.

FIG.21shows a three-dimensional schematic view of an insertion needle structure7000according to a seventh embodiment of the present disclosure.FIG.22shows a side view of the insertion needle structure7000of the seventh embodiment ofFIG.21. The insertion needle structure7000is similar to the insertion needle structure4000of the fourth embodiment and includes a needle sharp7200and a needle body7100. The difference is that the insertion needle structure7000can further include a reinforcing portion (not labeled). The reinforcing portion can include a rib7310and a pressed depression7320whose manufacture processes and structures are identical to that of the rib3310and the pressed depression3320of the third embodiment, and the details will not be mentioned.

FIG.23shows a three-dimensional schematic view of an insertion needle structure8000according to an eighth embodiment of the present disclosure. The insertion needle structure8000is similar to the insertion needle structure3000of the third embodiment. The difference is that the reinforcing portion is a projection8300protruding from the second surface of the needle sharp8200facing away from the receiving space, and the projection8300is only located on the needle sharp8200. The manufacture process and structure of the projection8300are identical to that of the rib3310and the pressed depression3320of the third embodiment, and the details will not be mentioned.

FIG.24shows an exploded three-dimensional schematic view of an inserter9000according to a ninth embodiment of the present disclosure.FIG.25shows a partial section view of the inserter9000of the ninth embodiment ofFIG.24. The inserter9000includes a cover9100, an inserting module9400and a removing module9500.

The cover9100has a main space (not labeled). The inserting module9400is disposed within the main space of the cover9100and includes an insertion needle structure9430. The removing module9500can include a base9510and a biosensor9520. The base9510is detachably limited within the inserting module9400. The biosensor9520is detachably assembled with the base9510and at least a part thereof is received in the receiving space (not shown in the ninth embodiment) of the insertion needle structure9430. When the cover9100is pressed downward, the inserting module9400is driven to allow the insertion needle structure9430to move downward so as to carry the biosensor9520to be implanted underneath a skin surface of an organism for conducting a measurement of a physiological signal inside the organism.

The inserter9000can further include an upper cap9200, a lower cap9300and two fixing member9600. A sealing space for receiving the cover9100, the inserting module9400and the removing module9500is formed after the upper cap9200is engaged with the lower cap9300. The two fixing member9600is symmetrically inserted into the inserting module9400to be detachably coupled to the base9510. Each of the fixing members9600can include a supporting portion (not shown) for supporting a biosensor bracket9530, and the biosensor bracket9530is configured to carry the biosensor9520. The inserting module9400can further include an insertion needle member9410and an insertion needle supporting socket9420. The insertion needle member9410is inserted into the insertion needle supporting socket9420, and the insertion needle structure9430can be assembled with the insertion needle member9410. The insertion needle structure9430can be any one of the insertion needle structures1000,2000,3000,4000,5000,6000,7000and8000, and the present disclosure is not limited thereto.

During the operation, the user can press the upper cap9200downward to allow the cover9100inside the upper cap9200to move downward, which causes the fixing member9600to horizontally move so as to release the restriction between the fixing member9600, the biosensor bracket9530and the base9510. Moreover, through release of the prepressing elasticity of a first elastic member (not shown) inside the inserting module9400, the insertion needle member9410, the insertion needle structure9430and the biosensor9520can be implanted underneath the skin surface of the organism. Meanwhile, the biosensor bracket9530is assembled with the base9510, and the biosensor9520is remained under the skin surface of the organism. After release of the prepressing elasticity of a second elastic member (not shown) inside the inserting module9400, the insertion needle member9410can be retraced, thereby completing automatically implanting and retracing the insertion needle member9410.

FIG.26shows a three-dimensional schematic view of an insertion needle structure10000according to a tenth embodiment of the present disclosure.FIG.27shows a cross-sectional view of the insertion needle structure10000of the tenth embodiment ofFIG.26taken along line27-27.FIG.28shows a cross-sectional view of the insertion needle structure10000of the tenth embodiment ofFIG.26taken along line28-28.FIG.29shows a top view of the insertion needle structure10000of the tenth embodiment ofFIG.26.FIG.30shows a side view of the insertion needle structure10000of the tenth embodiment ofFIG.26. The insertion needle structure10000is similar to the insertion needle structure1000of the first embodiment and includes a needle sharp10200and a needle body10100. The needle body10100is integrally connected to the needle sharp10200and includes a base wall10130, two side walls10110, two slope sections10120, and two curved connecting sections10140. The needle body10100is for receiving a biosensor10520.

Each of the side walls10110extends upward from each of the curved connecting sections10140. Each of the side walls10110has a first section10110aand a second section10110b,and each of the first sections10110ais connected to each of the slope sections10120. Each of the second sections10110bincludes a flat surface, and the two flat surfaces are nonparallel.

Precisely, each of the side walls10110is divided into two sections, i.e., the first section10110aand the second section10110b,and each of the first sections10110ais close to the slope sections10120. Each of the first sections10110ais not bended inward, and therefore two flat surfaces of the two first sections10110aare parallel. Each of the second sections10110bis bended inward from each of the curved connecting sections10140, and the flat surfaces of the two second sections10110bare not parallel. A wall aperture is formed between the two first sections10110aand has a width W1along the width direction X. Another wall aperture is formed between the two second sections10110band has a width W2along the width direction X. The width W1is larger than the width W2.

The insertion needle structure10000may further include an assembling body10300and a connecting body10400. The assembling body10300is connected to an insertion needle member of an inserter, the connecting body10400is connected between the assembling body10300and the needle body10100. The assembling body10300has two flat walls10310parallel to each other, the connecting body10400has two connecting walls10410, each of the two connecting walls10410is connected between each of the flat walls10310and each of the side walls10110, and each of the two connecting walls10410is partially inclined from each of the flat walls10310toward each of the side walls10110. A width of a wall aperture between the flat walls10310along the width direction X is equal to the width W1, and therefore the two connecting walls10410are partially inclined toward the side walls10110.

As shown inFIG.27, the biosensor10520has a widest portion10521having a maximum width W3along the width direction X of the insertion needle structure10000, the width W2is smaller than the maximum width W3of the biosensor10520. Therefore, the biosensor10520may not separate from the insertion needle structure10000in the height direction Z. It should be noted thatFIG.27is only used to illustrate that the biosensor10520has the maximum width W3; however, a gap between the biosensor10520and each of the side walls10110is necessary. Additionally, a difference between the maximum width W3of the biosensor10520and the width W1of the wall aperture, as well as a difference between the maximum width W3of the biosensor10520and the width W2of the wall aperture, is in the range of-100um to100um.

Each of the side walls10110may have a first inner edge10111and a first outer edge10112, and each of the first inner edges10111is curved. Moreover, each of the first outer edges10112is curved. R11represents a radius of each of the first inner edges10111, R12represents a radius of each of the first outer edges10112, and a condition of R11≥R12is satisfied. In the tenth embodiment, each of the first inner edges10111is directly connected to each of the first outer edges10112, that is, no connecting surface is connected between the first inner edge10111and the first outer edge10112. However, in other embodiments, a connecting surface may be connected between the first inner edge and the first outer edge.

As shown inFIGS.26to30, each of the slope sections10120has a second inner edge10121connected to the first inner edge10111, and a second outer edge10122connected to the first outer edge10112. Each of the second inner edges10121is curved, and each of the second outer edges10122is curved. The needle sharp10200includes two slants10210connected to the two curved connecting sections10140, respectively, and the two slants10210intersect at a needle tip10220. Each of the slants10210includes a needle sharp top edge10211being curved and connected to each of the two second inner edges10121, and a needle sharp bottom edge10212being curved and connected to each of the second outer edges10122.

FIG.31shows a three-dimensional schematic view of an insertion needle structure11000according to an eleventh embodiment of the present disclosure.FIG.32shows a cross-sectional view of the insertion needle structure11000of the eleventh embodiment ofFIG.31taken along line32-32.FIG.33shows a cross-sectional view of the insertion needle structure11000of the eleventh embodiment ofFIG.31taken along line33-33.FIG.34shows a top view of the insertion needle structure11000of the eleventh embodiment ofFIG.31.FIG.35shows a side view of the insertion needle structure11000of the eleventh embodiment ofFIG.31. The insertion needle structure11000is similar to the insertion needle structure10000of the tenth embodiment and includes a needle sharp11200and a needle body11100. The needle body11100is integrally connected to the needle sharp11200and includes a base wall11130, two side walls11110, two slope sections11120, and two curved connecting sections11140.

Each of the side walls11110includes a first section11110aand a second section11110b,the structure of the side walls11110is similar to the structure of the side walls10110of the tenth embodiment, and a first inner edge11111and a first outer edge11112of each of the side walls11110are curved.

Each of the slope sections11120has a second inner edge11121connected to the first inner edge11111, and a second outer edge11122connected to the first outer edge11112. Each of the second inner edges11121is curved, and each of the second outer edges11122is partially flat and inclined in a direction away from the receiving space. In other words, a part of each of the slope sections11120is cut to be flat, and another part of each of the slope sections11120near each of the side walls11110remains being curved.

The needle sharp11200includes two slants11210connected to the two curved connecting sections11140, respectively, and the two slants11210intersect at a needle tip11220. A needle sharp top edge11211of each of the slants11210is curved, and a needle sharp bottom edge11212is flat to connect to the flat second outer edge11122of each of the slope sections11120.

FIG.36shows a three-dimensional schematic view of an insertion needle structure12000according to a twelfth embodiment of the present disclosure.FIG.37shows a cross-sectional view of the insertion needle structure12000of the twelfth embodiment ofFIG.36taken along line37-37.FIG.38shows a top view of the insertion needle structure12000of the twelfth embodiment ofFIG.36.FIG.39shows a side view of the insertion needle structure12000of the twelfth embodiment ofFIG.36. The insertion needle structure12000is similar to the insertion needle structure11000of the eleventh embodiment and includes a needle sharp12200and a needle body12100. The needle body12100includes two side walls12110and two slope sections12120.

A first inner edge12111of each of the side walls12110is curved, and a first outer edge12112of each of the side walls12110is flat and inclined in a direction away from the receiving space. A second inner edge12121of each of the slope sections12120is curved, and a second outer edge12122of each of the slope sections12120is flat and inclined in a direction away from the receiving space. A needle sharp top edge12211is curved, and a needle sharp bottom edge12212is flat and inclined in a direction away from the receiving space.

FIG.40shows a three-dimensional schematic view of an insertion needle structure13000according to a thirteenth embodiment of the present disclosure.FIG.41shows a cross-sectional view of the insertion needle structure13000of the thirteenth embodiment ofFIG.40taken along line41-41.FIG.42shows a top view of the insertion needle structure13000of the thirteenth embodiment ofFIG.40.FIG.43shows a side view of the insertion needle structure13000of the thirteenth embodiment ofFIG.40. The insertion needle structure13000is similar to the insertion needle structure11000of the eleventh embodiment and includes a needle sharp13200and a needle body13100. The needle body13100includes two side walls13110and two slope sections13120.

A first inner edge13111and a first outer edge13112of each of the side walls13110are curved, and a connecting surface13150is connected therebetween. A second inner edge13121of each of the slope sections13120is curved, and a second outer edge13122of each of the slope sections13120is partially flat and inclined in a direction away from the receiving space. A needle sharp top edge13211is curved, and a needle sharp bottom edge13212is flat and inclined in a direction away from the receiving space.

FIG.44shows a cross-sectional view of an insertion needle structure according to a fourteenth embodiment of the present disclosure, and it is noted thatFIG.44is a cross-sectional surface. In the fourteenth embodiment, the second section of each of the side walls includes a straight portion14110aand a bending portion14110b.Each of the straight portions14110aextends upward from each of the curved connecting sections, and each of the bending portions14110bextends upward and inward from each of the straight portions14110a. Each of the straight portions14110ahas a flat surface, and the two flat surfaces are parallel. Precisely, each of the second sections extends upward for at least a portion and then is bended inward to form the straight portion14110aand the bending portion14110b.A height between a bottom of the base wall and a widest portion14521of a biosensor14520along the height direction Z of the insertion needle structure is represented by H1. A height of the straight portion14110aalong the height direction Z is represented by H2, and a condition of H2>H1is satisfied. Therefore, the straight portion14110ais high enough to receive the biosensor14520.