TWM659071U - Physiological sensing device - Google Patents

Abstract

A physiological sensing device includes a needle body and a biochemical sensor. Starting from the tip, the needle body includes an insertion part and a spreading part that are connected to each other. The insertion part further includes a first insertion part and a second insertion part that are connected to each other. The expansion part includes a cushion part connected to the second insertion part and an enlarge part connected to the cushion part.

Description

Physiological sensing devices

This invention relates to a technical field of monitoring body fluids, and in particular provides a physiological sensing device.

In recent years, the use of testing or monitoring human body fluids to determine physical characteristics has become a very important aspect for modern people. The aforementioned human body fluids are, for example, glucose, lactic acid or glycosylated hemoglobin (HbA1c). Taking diabetes as an example, real-time and periodic monitoring of blood sugar concentration in body fluids is necessary for diabetic patients. Therefore, automated monitoring of body fluids has become one of the development directions in recent years.

Diabetes is a common chronic medical disease among modern people. According to the data report of the International Diabetes Federation in 2021, the incidence of diabetes has reached 9.3% worldwide. Diabetes is a disease caused by insufficient secretion of insulin. The causes of diabetes include obesity, stress, bad eating habits, genetic factors and other factors.

Diabetic patients often experience high and low blood sugar levels. If a patient is in a low blood sugar state for a long time and does not get enough carbohydrates, it may cause the diabetic patient to lose consciousness or even die. Therefore, it is very important to detect when a diabetic patient is in a low blood sugar state in time.

In order to improve the accuracy and timeliness of blood sugar measurement, researchers have been working on developing continuous glucose monitoring (CGM) systems in recent years, allowing users to continuously monitor their blood sugar status and provide timely treatment and emergency response measures. Therefore, the improvement of continuous glucose monitoring systems has always been a goal that relevant industry players and researchers have been pursuing.

Traditionally, due to poor structural design, physiological sensing devices may wear out biochemical sensors during operation, resulting in inaccurate subsequent measurements. Therefore, a physiological sensing device with an improved structure is needed.

The physiological sensing device of the invention comprises a biochemical sensor and a needle body, wherein the needle body comprises an insertion part and an extension part connected from the needle tip in sequence, the insertion part further comprises a first insertion part and a second insertion part connected, the extension part further comprises a buffer part connected to the second insertion part and an expansion part connected to the buffer part; the needle body is formed by bending a plate inwardly based on a symmetry axis and forming a groove, and the biochemical sensor is provided In the groove, a first angle θ1 is formed between a line connecting a starting point and an end point of an edge of the first insertion portion and the symmetry axis, a second angle θ2 is formed between a line connecting a starting point and an end point of an edge of the second insertion portion and the symmetry axis, a third angle θ3 is formed between a line connecting a starting point and an end point of an edge of the buffer portion and the symmetry axis, and a fourth angle θ4 is formed between a line connecting a starting point and an end point of an edge of the expansion portion and the symmetry axis.

In at least one embodiment of the present invention, the needle body further includes an inner shell forming a groove, and the inner shell accommodates the biochemical sensor.

In at least one embodiment of the present invention, the inner shell includes a first surface and a second surface that are opposite to each other and parallel; in a first direction perpendicular to the axis of symmetry, the distance between the first surface and the second surface is greater than the width of the biochemical sensor.

In at least one embodiment of the present invention, the fourth angle θ4 is greater than the third angle θ3, the third angle θ3 is greater than the second angle θ2, and the second angle θ2 is greater than the first angle θ1.

In at least one embodiment of the present invention, the shape of the biochemical sensor is different from the shape of the inner shell.

In at least one embodiment of the present invention, the first surface has a first length in a second direction perpendicular to the first direction and the axis of symmetry, and the second surface has a second length in the second direction; the sum of the length from the lowest point of the bottom of the inner shell along the second direction to the bottom edge of the first surface and the first length is greater than or equal to the height of the biochemical sensor along the second direction; the sum of the length from the lowest point of the bottom of the inner shell along the second direction to the bottom edge of the second surface and the second length is greater than or equal to the height of the biochemical sensor along the second direction.

In at least one embodiment of the present invention, the first length is equal to the second length.

In at least one embodiment of the present invention, the first angle θ1, the second angle θ2, the third angle θ3 and the fourth angle θ4 are all sharp angles.

In at least one embodiment of the present invention, the sum of the first angle θ1 and the second angle θ2 is between 0° and 90°, the sum of the second angle θ2 and the third angle θ3 is between 0° and 90°, and the sum of the third angle θ3 and the fourth angle θ4 is between 0° and 90°.

In at least one embodiment of the present invention, at least one of the edge of the first insertion portion, the edge of the second insertion portion, the edge of the buffer portion, and the edge of the expansion portion is an arc edge.

In at least one embodiment of the present invention, the edge of the first insertion portion, the edge of the second insertion portion, the edge of the buffer portion, and the edge of the expansion portion are all arc edges.

In at least one embodiment of the present invention, the arc radius of the edge of the first insertion portion is between 5.5 mm and 6 mm; the arc radius of the edge of the second insertion portion is between 10 mm and 10.8 mm.

In at least one embodiment of the present invention, the arc radius of the edge of the buffer portion is between 19.35 mm and 20 mm; and the arc radius of the edge of the expansion portion is between 0.2 mm and 2.4 mm.

The physiological sensing device provided by this invention can reduce the contact area between the needle and the biochemical sensor, reduce the wear of the biochemical sensor, and improve the accuracy of blood sugar measurement.

In order to fully understand the purpose, features and effects of this invention, the invention is described in detail through the following specific embodiments and the attached drawings.

In this invention, "a" or "an" is used to describe the units, elements and components described herein. This is only for convenience of explanation and to provide a general meaning to the scope of this invention. Therefore, unless it is obvious that it is otherwise intended, such description should be understood to include one, at least one, and the singular also includes the plural.

In this work, the terms "include", "including", "have", "contain" or any other similar terms are intended to cover non-exclusive inclusions. For example, an element, structure, product or device containing multiple elements is not limited to those listed herein, but may include other elements that are not expressly listed but are generally inherent to the element, structure, product or device. In addition, unless expressly stated to the contrary, the term "or" refers to an inclusive "or" rather than an exclusive "or"

A physiological sensing device of the invention includes a needle body and a biochemical sensor. The needle body includes an insertion portion and a spreading portion connected from the needle tip in sequence, the insertion portion further includes a first insertion portion and a second insertion portion connected, and the spreading portion further includes a buffer portion connected to the second insertion portion and an expansion portion connected to the buffer portion. The needle body is formed by bending a plate inwardly based on a symmetry axis and forming a groove, and the biochemical sensor is arranged in the groove.

As shown in FIG. 1 , a physiological sensing device 10 includes a needle body 12 and a biochemical sensor 18. The needle body 12 also includes an outer shell 14 and an inner shell 16. The inner shell 16 forms a groove to accommodate the biochemical sensor 18.

As shown in FIG. 1 , the inner shell 16 includes a first side 22 and a second side 24 extending along the symmetry axis (i.e., the y direction) of the needle body 12 bending, the first side 22 extending longitudinally along the x direction to form a first surface 26, the second side 24 extending longitudinally along the x direction to form a second surface 28, and the first surface 26 and the second surface 28 are opposite to each other and parallel. In addition, the first surface 26 and the second surface 28 are not connected to each other, and the distance between the first surface 26 and the second surface 28 along the z direction is greater than the width of the biochemical sensor 18 along the z direction. Compared with the first surface 26 and the second surface 28 being flat surfaces, the inner shell 16 may have a curved surface to connect the first side 22 of the first surface 26 and the second side 24 of the second surface 28, but the present invention is not intended to be limited to this.

As further shown in FIG. 1 , the first surface 26 has a first length H1 in the x-direction, and the second surface 28 has a second length H2 in the x-direction, and the first length H1 is equal to the second length H2, that is, the ratio of the first length H1 to the second length H2 is 1:1. In another embodiment, the first length and the second length are not equal. In addition, the inner shell 16 of the needle body 12 has a longitudinal length Hc along the x-direction, and the longitudinal length Hc is defined as the distance from the lowest point of the inner shell 16 in the x-direction to the bottom edge of the first surface 26 (i.e., the first side 22) or the bottom edge of the second surface 28 (i.e., the second side 24).

In particular, since the distance from the highest point to the lowest point of the inner shell 16 in the x-direction of the present invention needs to be greater than or equal to the length W of the biochemical sensor 18 in the x-direction, the biochemical sensor 18 can be kept in the groove formed by the inner shell 16. In other words, the sum of the first length H1 of the first surface 26 and the longitudinal length Hc of the inner shell 16 is greater than or equal to the length W of the biochemical sensor 18 in the x-direction. In another embodiment, the sum of the second length H2 of the second surface 28 and the longitudinal length Hc of the inner shell 16 is greater than or equal to the length W of the biochemical sensor 18. Thus, when the biochemical sensor 18 is encapsulated in the needle body 12 in this way, the abrasion caused by the biochemical sensor 18 directly contacting the skin during the process of the needle body 12 being inserted into the human body is reduced.

In addition, in order to improve the frictional contact between the biochemical sensor 18 and the inner housing 16, which causes the electrode surface 20 to be worn and causes subsequent measurement errors, when the shape of the biochemical sensor 18 is square, there are at most two contact points between the inner housing 16 and the biochemical sensor 18, which can minimize the contact area between the biochemical sensor 18 and the needle body 12.

In another embodiment, when the biochemical sensor 18 is cylindrical in shape, there is only one contact point between the inner shell 16 and the biochemical sensor 18, which can also minimize the contact area between the biochemical sensor 18 and the needle body 12.

In addition, the shape of the biochemical sensor 18 is designed to be different from the shape of the internal shell 16 of the needle body 12. After the biochemical sensor 18 and the internal structure come into contact, some space will be reserved and a specific area will be kept from contacting each other, thereby reducing the contact area between the biochemical sensor 18 and the needle body 12 structure. Ultimately, the wear of the biochemical sensor 18 is reduced and the measurement accuracy of physiological characteristics (such as blood sugar) is improved at the same time.

In one embodiment, the material of the needle body 12 can be selected from one of the groups consisting of steel (e.g., stainless steel), ceramics, titanium, tantalum, nickel, nickel-titanium, iridium, silver, palladium, platinum-iridium, iridium, composites, alloys of the above combinations, and the like.

In another embodiment, the material of the needle body 12 is composed of a polymer. The polymer can be selected from one of the groups consisting of polycarbonate, polymethacrylic acid, ethylene vinyl acetate, polyesters, fluoropolymers, polyethylene, polypropylene, high-density polyethylene, nylons, polyethylene terephthalate, acrylonitrile-butadiene-styrene (ABS) plastic, SUS301 medical stainless steel, SUS316, metal, hard plastic, thermoplastic material, liquid crystal polymer (LCP), polyetheretherketone material and a combination thereof, wherein the fluoropolymer can be polytetrafluoroethylene (TEFLON®). The materials of the needle body 12 listed above are only exemplary, and the material of the needle body 12 is not limited to the above materials.

In various embodiments, the distance from the highest point to the lowest point of the inner shell 16 of the needle body 12 in the x-direction needs to be greater than or equal to the length W of the biochemical sensor 18 in the x-direction. The cross-sectional shape of the needle body 12 can include square and rectangular variants; the cross-sectional shape of the biochemical sensor 18 can include square, rectangular, cylindrical and elliptical cylindrical variants; the cross-sectional shape of the outer shell 14 can include square, rectangular, irregular, arc and semi-elliptical variants; the cross-sectional shape of the inner shell 16 can include arc, square and semi-circular variants. In other words, the cross-sectional shapes of the first surface 26 and the second surface 28 shown in FIG. 1 can be changed to be curved, curved, inner curved, rectangular, etc. The shapes listed above are for illustrative purposes only and are not limited to the above shapes.

As shown in FIG. 2 , the cross-sectional shapes of the outer shell 14, the inner shell 16, the first surface 26 and the second surface 28 of the needle body 12 are further described in a bottom-up manner. The cross-sectional shape of the outer shell 14 is, for example, a semi-ellipse (2a, 2h), an arc (2d), a square (2b, 2c, 2e), and an irregular shape (2f, 2g, 2i). The cross-sectional shape of the inner shell 16 is, for example, a semi-circle (2a, 2c, 2d, 2e, 2f, 2g, 2h), a square (2b), and an arc (2i). The cross-sectional shape of the biochemical sensor 18 is, for example, a rectangle (2a, 2c, 2d, 2e, 2f, 2g, 2h, 2) and a cylinder (2b). The first surface 26 and the second surface 28 may be, for example, straight surfaces (2a, 2b, 2c, 2d, 2e), curved surfaces (2f), inner curved surfaces (2g), curved surfaces (2h) and partial curved surfaces (2i). The above-listed shapes are only for illustrative purposes and are not limited to the above-listed shapes. However, in all variants, the distance from the highest point to the lowest point of the inner shell 16 of the needle body 12 in the x-direction is greater than or equal to the length of the biochemical sensor 18 in the x-direction.

It is to be noted that the author of the present invention has found that when the physiological sensing device is actually operated, the needle assists the biochemical sensor to enter the subcutaneous tissue. The resistance between the needle and the subject's muscle and the tolerance of the needle and the biochemical sensor during the manufacturing process cause the needle and the biochemical sensor to shift during the process of entering the subcutaneous tissue, which in turn causes frictional contact between the biochemical sensor and the needle. However, the shape of the inner shell of the needle is different from that of the biochemical sensor, and there is still a specific distance gap between the two, that is, there is still a specific area between them that does not touch each other, so the problem of deformation or damage caused by frictional contact between the biochemical sensor and the needle can be reduced.

As shown in FIG3 , an embodiment further illustrates the structure of the biochemical sensor 18 and the needle body 12. The biochemical sensor 18 is in the shape of a rectangular parallelepiped, and there are at most two contact points A and B between the biochemical sensor 18 and the inner shell of the needle body 12, which can reduce the contact area between the biochemical sensor 18 and the needle body 12 to reduce the possibility of direct contact between the electrode surface and the needle body 12. In addition, the biochemical sensor 18 includes an electrode surface (not shown in FIG3 ), and the inner shell of the needle body 12 is in the shape of a semicircle. The semicircular inner shell can protect the electrode surface of the biochemical sensor 18 and reduce the damage caused by contact, thereby improving the accuracy of physiological measurement.

The y-x plane cross-sectional view of FIG4 further shows an embodiment of the tip portion structure of the needle body 12 as shown in FIG1 to FIG3. Starting from the tip, the needle body 12 includes an insertion portion 30 and a propping portion 40, and the insertion portion 30 is connected to the propping portion 40. The insertion portion 30 and the propping portion 40 are preferably formed in one piece. In detail, the insertion portion 30 includes a first insertion portion 32 and a second insertion portion 34, and the second insertion portion 34 extends from the end point of the first insertion portion 32, and the first insertion portion 32 is connected to the second insertion portion 34. The propping portion 40 includes a buffer portion 42 and an expansion portion 44. The buffer portion 42 extends from the end point of the second insertion portion 34, and the expansion portion 44 extends from the end point of the buffer portion 42. The buffer portion 42 is connected to the second insertion portion 34 and the expansion portion 44.

It should be noted that during processing, the needle body 12 is a pre-cut thin plate that is bent inward along the symmetry axis (i.e., the y direction) to form a three-dimensional shape similar to a U-shape or a V-shape, so the line L connecting the bottom (or the midpoint of the bottom) of the inner shell of the needle body 12 is parallel to the symmetry axis of the bend (i.e., the y direction). For the sake of easy explanation, the x-y plane cross-sectional view of FIG. 5 shows the needle body 12 as a flat thin plate before bending, and because the needle body 12 is symmetrical relative to the symmetry axis of the bend (i.e., the y direction), FIG. 5 only shows the half side.

As shown in FIG5 , starting from the tip of the needle body 12, from top to bottom, there are the first insertion portion 32, the second insertion portion 34, the buffer portion 42, and the expansion portion 44. In particular, the edges of each of the first insertion portion 32, the second insertion portion 34, the buffer portion 42, and the expansion portion 44 are straight lines, and each extends at a different angle relative to the symmetry axis (i.e., the y direction) of the inward bending of the needle body 12. In particular, as shown in FIG5 , a first angle θ1 is formed between a line connecting the starting point and the end point of the edge of the first insertion portion 32 and the symmetry axis (i.e., the y direction) of the inward bending of the needle body 12, and a second angle θ2 is formed between a line connecting the starting point and the end point of the edge of the second insertion portion 34 and the symmetry axis (i.e., the y direction) of the inward bending of the needle body 12. A third angle θ3 is formed between the line connecting the starting point and the end point of the edge of the buffer portion 42 and the symmetric axis (i.e., the y direction) of the inward bending of the needle body 12, and a fourth angle θ4 is formed between the line connecting the starting point and the end point of the edge of the expansion portion 44 and the symmetric axis (i.e., the y direction) of the inward bending of the needle body 12. It is particularly noted that in this embodiment, the line L connecting the bottom (or the midpoint of the bottom) of the inner shell of the needle body 12 is parallel to the symmetric axis of the bending (i.e., the y direction), so the first angle θ1, the second angle θ2, the third angle θ3, and the fourth angle θ4 can also be referenced by the line L.

Preferably, the fourth angle θ4 is greater than the third angle θ3, the third angle θ3 is greater than the second angle θ2, and the second angle θ2 is greater than the first angle θ1. Preferably, the first angle θ1, the second angle θ2, the third angle θ3 and the fourth angle θ4 are all sharp angles. Preferably, the sum of the first angle θ1 and the second angle θ2 is between 0° and 90°, the sum of the second angle θ2 and the third angle θ3 is between 0° and 90°, and the sum of the third angle θ3 and the fourth angle θ4 is between 0° and 90°.

For example, when the first angle θ1 of the first insertion portion 32 shown in FIG5 is sharp, when the needle body 12 is formed after bending, it can reduce the force required to puncture the skin and reduce the size of the wound caused by the needle body to the skin, thereby reducing the discomfort of the subject during the test. The function of the second insertion portion 34 is to roughly maintain the sharp angle of the first insertion portion 32, that is, to continue the function of the first insertion portion 32, wherein the sum of the first angle θ1 and the second angle θ2 is between 0° and 90°, but the second angle θ2 needs to be greater than the first angle θ1. In one embodiment, the first angle θ1 is less than 5°, preferably 4°, and more preferably 3°; the second angle θ2 is less than 15°, however, the first angle θ1 and the second angle θ2 are not limited to the above angles, as long as the sum of the first angle θ1 and the second angle θ2 is between 0° and 90°, for example, the sum of the first angle θ1 and the second angle θ2 is less than 20°, the discomfort of the subject can be reduced when the needle 12 is inserted into the skin.

As shown in FIG5 , the buffer portion 42 further enlarges the second angle θ2 of the second insertion portion 34. The third angle θ3 of the buffer portion 42 enables the needle body 12 to reduce the discomfort of the subject while expanding the injection opening. The expansion portion 44 then extends from the end point of the buffer portion. The expansion portion 44 has a fourth angle θ4, which functions to extend the sharp angle of the buffer portion 42 to expand the injection opening, and to allow the needle body 12 to fully enter the subcutaneous tissue through the expanded injection opening, and to completely cover the biochemical sensor by increasing the space inside the needle body 12. Furthermore, the sum of the third angle θ3 and the fourth angle θ4 is between 0° and 90°. Preferably, the sum of the third angle θ3 and the fourth angle θ4 is less than 32°.

In addition, the length L1 of the straight edge of the first insertion portion 32 in the y direction is between 0.7 mm and 1.7 mm; the length L2 of the straight edge of the second insertion portion 34 in the y direction is between 0.3 mm and 0.7 mm; the length L3 of the straight edge of the buffer portion 42 in the y direction is between 0.18 mm and 0.42 mm; and the length L4 of the straight edge of the expansion portion 44 in the y direction is between 0.3 mm and 0.7 mm.

In one embodiment, at least one of the edge of the first inserting portion 32, the edge of the second inserting portion 34, the edge of the buffer portion 42, and the edge of the expansion portion 44 is a straight edge, and it is not necessary that all of them are straight edges as shown in FIG. 5 .

The x-y plane cross-sectional view of FIG6 shows another embodiment in which the needle body 12 is still a flat thin plate before being bent. Compared with the straight edges of the first insertion portion 32, the second insertion portion 34, the buffer portion 42 and the expansion portion 44 in FIG. 5, in order to reduce the sharpness of the needle body 12 during the insertion of the skin and to enhance the mechanical strength of the needle body 12, the edges of the first insertion portion 32, the second insertion portion 34, the buffer portion 42 and the expansion portion 44 in FIG. 6 can be changed from straight lines to arc lines, and can have different arc radii, without changing the angle between the line connecting the starting point and the end point (which is a straight line) and the symmetry axis (i.e., the y direction) of the inward bending of the needle body 12. For example, the arc radius R1 of the edge of the first insertion portion 32 is between 5.5 mm and 6 mm; the arc radius R2 of the edge of the second insertion portion 34 is between 10 mm and 10.8 mm; the arc radius R3 of the edge of the buffer portion 42 is between 19.35 mm and 20 mm; the arc radius R4 of the edge of the expansion portion 44 is between 0.2 mm and 2.4 mm. When the needle body 12 is composed of the same material, the stress of the arc edge will be greater than the stress of the straight edge. Therefore, the needle body 12 structure with an arc edge of the present invention can increase the structural stress and at the same time improve the mechanical strength of the inserted user's skin, thereby achieving the effect of protecting the internal biochemical sensor.

In particular, as shown in FIG6 , the arc edges adjacent to each other on the edges of the first insertion portion 32, the second insertion portion 34, the buffer portion 42 and the expansion portion 44 may be in opposite directions to enhance the mechanical strength of the needle body 12, for example, the arc edges of the second insertion portion 34 and the expansion portion 44 may protrude outward, while the arc edges of the buffer portion 42 may be concave inward, which is different from the arc directions of the second insertion portion 34 and the expansion portion 44. Preferably, the arc edge of the first insertion portion 32 is concave inward.

In another embodiment, at least one of the edge of the first inserting portion 32, the edge of the second inserting portion 34, the edge of the buffer portion 42, and the edge of the expansion portion 44 is an arc edge.

FIG7 is a schematic diagram of one side of the needle body 12, wherein the needle body 12 is symmetrical to the L axis, and the y-z perspective diagram shown is a finished product after the needle body 12 is bent. In this embodiment, the angle of the outer shell on one side of the needle body 12 is designed to gradually increase. As shown in FIG7, the needle body 12 of the physiological sensing device 10 has an outer shell 14 and an inner shell 16. At a position close to the tip of the needle body 12, the angle of the outer shell on one side may first have a fifth angle θ5, and then change to increase to a sixth angle θ6. The starting position of the sixth angle θ6 preferably corresponds to the position where the needle body 12 can completely accommodate the biochemical sensor (that is, the starting position where the biochemical sensor is set in the inner shell), and the starting position of the fifth angle θ5 preferably corresponds to the position at the tip of the needle body 12 where the biochemical sensor is not yet placed.

Preferably, the fifth angle θ5 and the sixth angle θ6 are sharp angles, wherein the fifth angle θ5 is defined as the sum of angles formed along both sides of the L line with the L line in the Y-axis direction as the center line. In addition, the definition of the sixth angle θ6 is the same as the fifth angle θ5. Preferably, the fifth angle θ5 is between 10° and 12°; the sixth angle θ6 is greater than the fifth angle θ5; and the sum of the fifth angle θ5 and the sixth angle θ6 is between 0° and 90°.

Because the needle of the physiological sensing device of the invention can make the biochemical sensor be located within the protection range of the needle during the injection process, and because the shape of the inner shell of the needle is different from the shape of the biochemical sensor, even if the biochemical sensor and the inner shell of the needle come into contact during the operation, the contact area between the biochemical sensor and the needle can be reduced, thereby reducing the possibility of the electrode surface of the biochemical sensor and the needle coming into contact. Furthermore, the discomfort of the subject during the test can be reduced by the outer shape structure of the insertion part, the expansion part and the gradual angle of the needle.

The present invention has been disclosed in the above with preferred embodiments, but those skilled in the art should understand that the embodiments are only used to describe the present invention and should not be interpreted as limiting the scope of the present invention. It should also be noted that all modifications and replacements equivalent to the embodiments should be included in the scope of the present invention. Therefore, the scope of protection of the present invention shall be subject to the scope defined by the patent application.

10: Physiological sensing device 12: Needle body 14: External housing 16: Internal housing 18: Biochemical sensor 20: Electrode surface 22: First side 24: Second side 26: First side 28: Second side 30: Insertion part 32: First insertion part 34: Second insertion part 40: Spreading part 42: Buffer part 44: Expansion part H1: First length H2: Second length Hc: Longitudinal length W: Height of biochemical sensor θ1: First angle θ2: Second angle θ3: Third angle θ4: Fourth angle θ5: Fifth angle θ6: Sixth angle A: Contact point B: contact point L: bottom (or bottom midpoint) connection line

In order to fully understand the content revealed by this work, the following description should be read in conjunction with the attached pictures.

FIG1 is a three-dimensional cross-sectional view of the physiological sensing device of the present invention.

FIG. 2 is a bottom view of a physiological sensing device according to different embodiments of the present invention.

FIG. 3 is a bottom view showing the biochemical sensor in the physiological sensing device of the present invention in contact with the inner shell of the needle body.

FIG. 4 is a partial schematic diagram of the needle structure of this invention.

FIG5 is a partial schematic diagram of the needle structure of one embodiment of the present invention.

FIG6 is a partial schematic diagram of a needle structure of another embodiment of the present invention.

FIG. 7 is a schematic diagram of one side of the needle body of the physiological sensing device of the present invention.

10: Physiological sensing device

12: Needle body

14: External shell

16: Inner shell

18: Biochemical sensor

22: First side

24: Second side

26: First page

28: Second side

H1: First length

H2: Second length

Hc: longitudinal length

Claims (13)

A physiological sensing device comprises: a biochemical sensor; and a needle body, wherein the needle body comprises an insertion portion and a spreading portion connected to each other from the needle tip, the insertion portion further comprises a first insertion portion and a second insertion portion connected to each other, the spreading portion further comprises a buffer portion connected to the second insertion portion and an expansion portion connected to the buffer portion; wherein the needle body is formed by bending a plate inwardly based on a symmetry axis and forming a groove, The biochemical sensor is arranged in the groove; wherein the line connecting the starting point and the end point of the edge of the first insertion part and the symmetry axis have a first angle, the line connecting the starting point and the end point of the edge of the second insertion part and the symmetry axis have a second angle, the line connecting the starting point and the end point of the edge of the buffer part and the symmetry axis have a third angle, and the line connecting the starting point and the end point of the edge of the expansion part and the symmetry axis have a fourth angle. A physiological sensing device as described in claim 1, wherein the needle body further comprises an inner shell forming the groove, and the inner shell accommodates the biochemical sensor. A physiological sensing device as described in claim 2, wherein the inner housing comprises a first surface and a second surface that are opposite and parallel to each other; wherein in a first direction perpendicular to the axis of symmetry, the distance between the first surface and the second surface is greater than the width of the biochemical sensor. A physiological sensing device as described in claim 1, wherein the fourth angle is greater than the third angle, the third angle is greater than the second angle, and the second angle is greater than the first angle. A physiological sensing device as described in claim 2, wherein the shape of the biochemical sensor is different from the shape of the inner housing. A physiological sensing device as described in claim 3, wherein the first surface has a first length in a second direction perpendicular to the first direction and the symmetry axis, and the second surface has a second length in the second direction; the sum of the length from the lowest point of the bottom of the inner housing along the second direction to the bottom edge of the first surface and the first length is greater than or equal to the height of the biochemical sensor along the second direction; the sum of the length from the lowest point of the bottom of the inner housing along the second direction to the bottom edge of the second surface and the second length is greater than or equal to the height of the biochemical sensor along the second direction. A physiological sensing device as described in claim 6, wherein the first length is equal to the second length. The physiological sensing device as described in claim 1, wherein the first angle, the second angle, the third angle and the fourth angle are all sharp angles. The physiological sensing device as described in claim 1, wherein the sum of the first angle and the second angle is between 0° and 90°, the sum of the second angle and the third angle is between 0° and 90°, and the sum of the third angle and the fourth angle is between 0° and 90°. A physiological sensing device as described in claim 1, wherein at least one of the edge of the first insertion portion, the edge of the second insertion portion, the edge of the buffer portion, and the edge of the expansion portion is an arc edge. The physiological sensing device as described in claim 1, wherein the edge of the first insertion portion, the edge of the second insertion portion, the edge of the buffer portion, and the edge of the expansion portion are all arc edges. The physiological sensing device as described in claim 11, wherein the arc radius of the edge of the first insertion portion is between 5.5 mm and 6 mm; the arc radius of the edge of the second insertion portion is between 10 mm and 10.8 mm. In the physiological sensing device as described in claim 11, the arc radius of the edge of the buffer portion is between 19.35 mm and 20 mm; and the arc radius of the edge of the expansion portion is between 0.2 mm and 2.4 mm.