Dielectric spectrum sensor and method of use

Abstract

The present application relates to a DS sensor, comprising a body and electrodes disposed on the body. The body defines a test cavity between a first surface and an opposite second surface, the second surface being separated from the first surface by a distance that allows a fluid to enter the test cavity from a fluid inlet communicating with the test cavity by capillary action. The electrodes include a first sensing electrode on the first surface configured to receive an input radio frequency signal; a second sensing electrode on the first surface separated from the first sensing electrode and configured to transmit an output radio frequency signal; and a floating electrode on the second surface.

Description

Technical Field

[0001] The present application relates to the field of power electronics technology, and in particular to a dielectric spectrum sensor and a method of using the same. Background Art

[0002] Dielectric spectroscopy (DS) has been described as a useful analytical tool in the biomedical field. It is a label-free, non-destructive, real-time method for studying the interaction between radio frequency (RF) / microwave fields and biological / biochemical samples, which requires minimal sample preparation. Currently, the molecular properties of biological materials (such as human blood, cerebrospinal fluid, breast tissue, and skin) have been studied using DS for disease detection and clinical diagnosis. However, typical DS systems tend to be bulky and expensive, making them cost-prohibitive in some cases.

[0003] US Patent No. 9,995,701 B2 describes a DS system including a sensor having an input configured to receive an input radio frequency signal and an output for providing an output radio frequency signal to an analysis device. The sensor also includes a substantially coplanar first sensing electrode and a second sensing electrode and a floating electrode. The first sensing electrode is coupled to the input and the second sensing electrode is coupled to the output. The floating electrode is separated from the sensing electrodes by a space defining a fluid channel that is flowable to receive a fluid material via a fluid port.

[0004] As such, the aforementioned DS system may be improved upon to make the system more intuitive and user-friendly. Summary of the invention

[0005] In view of the foregoing, the DS sensor of the embodiment of the present application includes a body, the body defining a test cavity between a first surface and an opposite second surface, the first surface being separated from the second surface by a certain distance, the distance allowing a fluid to enter the test cavity from a fluid inlet by capillary action, the fluid inlet being in communication with the test cavity. The electrodes disposed on the body include a first sensing electrode on the first surface and configured to receive an input radio frequency signal, a second sensing electrode on the first surface and separated from the first sensing electrode and configured to transmit an output radio frequency signal, and a floating electrode on the second surface. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Figure 1 is a perspective view of the DS sensor and analysis equipment.

[0007] Figure 2 yes Figure 1 A perspective view of a DS sensor is shown.

[0008] Figure 3yes Figure 1 A plan view of the DS sensor is shown.

[0009] Figure 4 yes Figure 1 Side view of the DS sensor shown.

[0010] Figure 5 yes Figure 1 An exploded perspective view of a DS sensor is shown.

[0011] Figure 6 yes Figure 1 Another exploded perspective view of the DS sensor is shown.

[0012] Figure 7 yes Figure 1 An exploded plan view of the DS sensor is shown.

[0013] Figure 8 yes Figure 1 Another exploded plan view of the DS sensor is shown.

[0014] Fig. 9 is a plan view of a DS sensor and analysis device according to another embodiment.

[0015] Fig.10 is an exploded perspective view of a DS sensor according to another embodiment.

[0016] Fig.11 yes Fig.10 Another exploded perspective view of the DS sensor is shown.

[0017] Fig.12 yes Fig.10 A cross-sectional side view of a DS sensor is shown.

[0018] Fig.13 yes Fig.12 A partial enlarged view of the DS sensor is shown.

[0019] Fig.14 is a schematic diagram of a flexible circuit integrated into a DS sensor according to another embodiment.

[0020] Fig.15 is a schematic diagram of a flexible circuit integrated into a DS sensor according to another embodiment.

[0021] Fig.16 is a schematic diagram of a flexible circuit integrated into a DS sensor according to another embodiment.

[0022] Fig.17 is a schematic diagram of a flexible circuit integrated into a DS sensor according to another embodiment.

[0023] Fig.18 is a schematic diagram of a flexible circuit integrated into a DS sensor according to another embodiment.

[0024] Fig.19 is a partial cross-sectional view of a DS sensor according to another embodiment.

[0025] Fig. 20 is a partial cross-sectional view of a DS sensor according to another embodiment.

[0026] Fig.21 is a partial cross-sectional view of a DS sensor according to another embodiment.

[0027] Fig. 22 is a partial cross-sectional view of a DS sensor according to another embodiment.

[0028] Fig.23 is a schematic cross-sectional view of a main body of a DS sensor according to another embodiment.

[0029] Fig.24 is a schematic cross-sectional view of a main body of a DS sensor according to another embodiment.

[0030] Fig.25 is a schematic cross-sectional view of a DS sensor according to another embodiment.

[0031] Fig.26 is a schematic cross-sectional view of a DS sensor according to another embodiment.

[0032] Fig. 27 is a schematic cross-sectional view of a DS sensor according to another embodiment.

[0033] Fig.28 is a perspective view of a main body of a DS sensor according to another embodiment.

[0034] Fig.29 is a perspective view of a main body of a DS sensor according to another embodiment.

[0035] Fig.30 is a plan view of a DS sensor according to another embodiment, with the cover in an open position.

[0036] Fig.31 yes Fig.30 A perspective view of a DS sensor is shown with the cover in the open locked position.

[0037] Fig.32 yes Fig.30 A plan view of the DS sensor is shown with the cover in the closed position.

[0038] Fig.33 yes Fig.30 A partial perspective view of a DS sensor is shown with the cover in the open locked position.

[0039] Fig.34 yes Fig.30 A perspective view of a DS sensor is shown with the cover in the closed position.

[0040] Fig.35 yes Fig.30 An exploded perspective view of a DS sensor is shown.

[0041] Fig.36 yes Fig.30 A perspective view of a DS sensor is shown with the cover in the open locked position. DETAILED DESCRIPTION

[0042] It should be understood that the description and drawings herein are exemplary only, and various modifications and changes may be made to the disclosed structures without departing from the present disclosure. The following description is made with reference to the accompanying drawings, wherein the same reference numerals represent the same parts in all views.

[0043] Figure 1 An analysis device 90 is shown including a housing 92 having pogo pins 94 and mating features 96 corresponding to the DS sensor 100. The analysis device 90 is configured to receive the DS sensor 100 in the housing 92 and to be connected to the DS sensor 100 in circuit via the pogo pins 94. Figures 2 to 8 The DS sensor 100 is shown, which includes a body 102 having a first body end 104 and a second body end 110. The DS sensor 100 includes a cover 112 cooperating with the first body end 104 and the second body end 110. The body 102 is made of an upper body 114 and a lower body 120, and a partition 122 is disposed between the upper body 114 and the lower body 120 and connects the upper body 114 with the lower body 120.

[0044] like Figure 2 and Figures 4 to 6 As shown, the upper body 114 includes a cutout 124 disposed between the first body end 104 and the second body end 110, and the cutout 124 is aligned with the mating feature 96 of the analysis device 90. As such, the cutout 124 and the mating feature 96 are configured to ensure proper alignment between the DS sensor 100 and the analysis device 90 when the DS sensor 100 is inserted into the analysis device 90. In addition, each of the cutouts 124 provides a grip portion for easy user operation.

[0045] The spacer 122 is located between a first surface 130 defined by the lower body 120 and a second surface 132 defined by the upper body 114 and spaced apart from the first surface 130. The thickness of the spacer 122 is defined as the spacing between the first surface 130 and the second surface 132. The thickness of the spacer 122 is 200-300 microns, and according to at least one embodiment, the thickness of the spacer 122 is 250 microns. The thickness tolerance of the 250 micron spacer 122 can be 10% (i.e., plus or minus 25 microns). The spacer 122 includes a planar first spacer surface 134 and a planar second spacer surface 140. When the DS sensor 100 is assembled, the first spacer surface 134 contacts the first surface 130 and the second spacer surface 140 contacts the second surface 132. According to at least one embodiment, the spacer 122 is a double-sided adhesive tape.

[0046] like Figures 5 to 8 As shown, a first assembly pin 142 and a first assembly hole 144 are provided on the first surface 130, and are provided on the lower body 102 of the main body 102. When the upper body 114 and the lower body 120 are assembled together, the first assembly opening 150 defined by the isolation portion 122 is configured to receive the first assembly pin 142 therethrough. A second assembly pin 152 and a second assembly hole 154 corresponding to the first assembly pin 142 and the first assembly hole 144 are provided on the second surface 132, and are arranged on the upper body 114 of the main body 102. When the upper body 114 and the lower body 120 are assembled together, the second assembly opening 160 defined by the isolation portion 122 is configured to receive the second assembly pin 152 therethrough. When the upper body 114 and the lower body 120 are assembled together, the assembly pins 142, 152 and the assembly holes 144, 154 are respectively configured to snap together. Once the assembly pins 142, 152 and the assembly holes 144, 154 snap together, the user can remove the lower body 120 and the upper body 114 without damaging a portion of the DS sensor 100. In one embodiment, the upper body 114 and the lower body 120 are each secured to the isolation portion 122 using at least one solvent weld. In an alternative embodiment, the upper body 114 and the lower body 120 are directly secured to each other using at least one solvent weld. It should be understood that the same locking relationship between the assembly pins 142, 152 and the corresponding assembly holes 144, 154 can be achieved by switching or otherwise repositioning the assembly pins 142, 152 and the corresponding assembly holes with respect to the first and second surfaces 130, 132.

[0047] like Figures 2 to 5, the buckle 162 disposed at the first body end 104 of the lower body 120 includes a first lower finger 164, a second lower finger 170, and a lower support 172. The buckle 162 also includes a first upper finger 174, a second upper finger 180, and an upper support 182 extending from the upper body 114. The first lower finger 164 and the second lower finger 170 are respectively spaced apart from the lower support 172 and disposed on opposite sides of the lower support 172. The first lower finger 164 and the second lower finger 170 are configured to deflect toward the lower support 172 when pushed toward the lower support 172. The first upper finger 174 and the second upper finger 180 are respectively spaced apart and disposed on opposite sides of the upper support 182. The first upper finger 174 and the second upper finger 180 are configured to deflect toward the upper support 182 when pushed toward the lower support 172.

[0048] The first protrusion 184, the second protrusion 190, the third protrusion 192 and the fourth protrusion 194 are respectively disposed on the first lower finger 164, the second lower finger 170, the first upper finger 174 and the second upper finger 180. The protrusions 184 and 190 are disposed on the first lower finger 164 while the second lower finger 170 extends in a direction opposite to the lower support 172, and the protrusions 184 and 190 are disposed on the first upper finger 174 while the second upper finger 180 extends in a direction opposite to the upper support 182.

[0049] The cover 112 includes a first cover sidewall 200 defining a first cover opening 202 and a second cover sidewall 204 defining a second cover opening 210. Each of the first cover opening 202 and the second cover opening 210 is configured to receive two of the first, second, third, and fourth protrusions 184, 190, 192, 194 when the cover 112 is connected to the first body end 104, thereby locking the cover 112 in a fixed position relative to the subject 102. It should be understood that the cover 112 is reversible relative to the first body end 104, so that each of the first cover opening 202 and the second cover opening 210 is configured to receive the first and third protrusions 184, 192 or the second and fourth protrusions 190, 194. In this way, the cover 112 can be engaged with the first body end 104 in two directions, the difference between the two directions is that the cover 112 is rotated 180 degrees relative to the first body end 104. To remove the cover 112 in a fixed position relative to the first body end 104, the protrusions 184, 190, 192, 194 are pushed inwardly to disengage the cover openings 202, 210 for receiving, thereby unlocking the cover 112 from the fixed position. When the protrusions 184, 190, 192, 194 are pushed out of the cover openings 202, 210, the fingers 164, 170, 174, 180 are deflected toward the supports 172, 182, and when not pushed inwardly, the fingers 164, 170, 174, 180 are configured to retract to an undeflected position away from the supports 172, 182. In this way, once connected, the cover 112 and the first body end 104 are configured to be removed without damaging any portion of the DS sensor 100.

[0050] like Figures 2 to 8 As shown, the second body end 110 is disposed at the other end of the body 102 in the opposite direction to the first body end 104. The second body end 110 includes a fluid inlet 212 defined by a cantilever portion. The cantilever portion includes a first fin 214 and a second fin 220 extending from the body 102 as a part of the second body end 110. More specifically, the cantilever portion extends from a base surface 222 offset relative to a ledge surface 224. The first fin 214 is integrally formed by the upper body 114 and extends from a second surface 132 defined by the upper body 114, and the second fin 220 is integrally formed by the lower body 120 and extends from a first surface 130 defined by the lower body 120. The base surface 222 and the ledge surface 224 are both located in respective planes perpendicular to the direction in which the fins 214, 220 extend from the base surface 222.

[0051] The base surface 222 and the fins 214, 220 define a neck portion 230. More specifically, each of the first fin 214 and the second fin 220 includes a first side edge 232, 234 and a second side edge 240, 242, respectively, disposed inboard of an outer edge 244 of the ledge surface 224. Figure 2 As shown, the first fin 214 and the second fin 220 define a fluid inlet 212 that has a thinner front profile than the front profiles of the base surface 222 and the ledge surface 224 .

[0052] The first surface 130 and the second surface 132 are spaced apart from each other so that the fins 214, 220 define a test chamber 250 into which fluid enters from the fluid inlet 212 by capillary action. The fluid inlet 212 is in communication with the test chamber 250. The test chamber 250 is less than 18 microliters, and according to at least one embodiment of the DS sensor 100, the test chamber is approximately 9 microliters. The fluid inlet 212 and the test chamber 250 are configured such that fluid entering the fluid inlet 212 and the test chamber 250 via capillary action is aspirated without a capillary element. In contrast, the spacing between the upper body 114 and the lower body 120 promotes the flow of fluid driven by capillary action.

[0053] like Figure 2 , Figure 4 and Figure 5 As shown, first fin 214 includes a first peripheral edge 252 angled from first outer surface 254 toward second surface 132 and fluid inlet 212. Second fin 220 similarly includes a second peripheral edge 260 angled from second outer surface 262 toward first surface 130 and fluid inlet 212.

[0054] The fluid inlet 212 in the illustrated embodiment is configured to receive fluid along the peripheral edges 252, 260 of the fins 214, 220. Figure 4 In the embodiment, the peripheral edges 252, 260 form the shape of a "less than" symbol (shaped as "<") taken from a side view of the body 102. This allows a user of the DS sensor 100 to pierce his / her skin, such as with a finger, to deposit a drop of blood between the first peripheral edge 252 and the second peripheral edge 260, and then draw it into the test cavity 250, thereby eliminating the need to use a pipette or dropper to load the fluid to be tested into the test cavity 250. Figure 3 As shown, the test cavity 250 is generally rectangular when viewed from the front. Figure 3 and Figure 4 As shown, the peripheral edges 252 , 260 and the side edges 232 , 234 , 240 , 242 of the fins 214 , 220 provide a rectangular test cavity 250 that is open to ambient air when the cover 112 is not placed on the body 102 .

[0055] When the fins 214, 220 are configured other than rectangular, the peripheral edges 252, 260 may also be configured other than linear. Also, the profile of each peripheral edge 252, 260 may be one of the following: (1) chamfered, such as Figure 2 , Figure 4 and Figure 5 (2) a radius; or (3) a combination of a chamfer and a radius. In addition, the markings 264 ( Figure 3 The dotted area in the figure may provide an opaque or semi-transparent portion that outlines the test cavity 250 and points the user to the location of the blood drop. Figure 3 As shown, the test chamber 250 is outlined by a substantially transparent portion 270 configured to provide a visual indication to a user when fluid resides in the test chamber 250 .

[0056] like Figure 3 and Figures 5 to 8 As shown, the electrode or at least a portion thereof is located in the test cavity 250 to allow a DS test to be performed on the fluid in the test cavity 250. After the fluid is loaded into the test cavity 250 and the cover 112 is closed, the DS sensor 100 is configured to be inserted into the analysis device 90 so that a DS test can be performed on the fluid in the test cavity 250.

[0057] The first sensing electrode 272 and the second sensing electrode 274 are disposed on the first surface 130 of the lower body 120, and extend from the first terminal ends 280, 282 located on the first surface 130 to the corresponding second terminal ends 284, 290 located on the opposite side of the base surface 222 in the test cavity 250. The adhesive is deposited between the isolation portion 122 and the first surface 130, and between the isolation portion 122 and the second surface 132, so that when a fluid is provided in the test cavity 250, the fluid is prevented from flowing between the isolation portion 122 and the first surface 130, and between the isolation portion 122 and the second surface 132. With this configuration, the sensing electrodes 272, 274 are disposed, for example, printed on the first surface 130, so that when covered by the isolation portion 122 on which the adhesive is deposited, the fluid in the test cavity 250 is prevented from flowing from the base surface 222 to the second terminal ends 284, 290 of the corresponding sensing electrodes 272, 274. The floating electrode 292 is disposed on the second surface 132 of the upper body 114 and is spaced apart from the sensing electrodes 272, 274 across the test cavity 250. Each of the sensing electrodes 272, 274 and the floating electrode 292 may be a conductive material (e.g., gold, copper, or aluminum) deposited on a suitable surface by, for example, sputtering deposition using a shadow mask and a lift-off process. In such an embodiment, each of the sensing electrodes 272, 274 and the floating electrode 292 may be formed to a thickness of 25 microns or less.

[0058] like Figure 5 and Figure 6 As shown, the isolation part 122 includes pin holes 294, 300 corresponding to the second terminal ends 284, 290 of the sensing electrodes 272, 274 and the pin openings 302, 304 of the upper body 114. When the isolation part 122 is assembled with the upper body 114, the second terminal ends 284, 290 are exposed to the outside of the DS sensor 100 accessible to the analysis device 90. Figure 2 , Figure 3 and Figure 5 As shown, the second body end 110 of the upper body 114 defines pin openings 302, 304 disposed between the base surface 222 and the ledge surface 224. When the spacer 122 is positioned on the upper body 114, the pin openings 302, 304 are aligned with the pin through holes 294, 300 in the spacer 122, respectively.

[0059] The connector or spring pin 94 of the analysis device 90 can extend through the pin openings 302, 304 and the pin through holes 294, 300 to provide electrical connection with the second terminal ends 284, 290 of the corresponding sensing electrodes 272, 274, and provide appropriate input and output RF signals to the sensing electrodes 272, 274, as described in U.S. Patent No. 9,995,701 B2. Specifically, the first sensing electrode 272 on the first surface 130 is configured to receive the input RF signal, and the second sensing electrode 274 on the first surface 130, which is spaced apart from the first sensing electrode 272, is configured to provide an output RF signal. When analyzing a sample, the input RF signal bridges the test cavity 250 and passes through the sample, connecting the floating electrode 292 on the first surface 130 to the first sensing electrode 272 and the second sensing electrode 274 in the circuit.

[0060] like Figures 2 to 6 As shown, the second body end 110 includes a first locking mechanism 310, which is integrally formed by the second outer surface 262 between the base surface 222 and the ledge surface 224 of the lower body 120. The second body end 110 includes a second locking mechanism 312, which is integrally formed by the first outer surface 254 between the base surface 222 and the ledge surface 224, and is also located between the pin openings 302, 304. According to one embodiment, the first locking mechanism 310 and the second locking mechanism 312 are integrally formed by the upper body 114 and the lower body 120, respectively.

[0061] Each of the first locking mechanism 310 and the second locking mechanism 312 is shaped as a wedge, having an inclined surface 314, 320 adjacent to the second body end 110, each wedge pointing toward the test cavity 250. The first and second locking mechanisms 310, 312 include a substantially vertical surface 322, 324 adjacent to the respective inclined surface 314, 320. The inclined surfaces 314, 320 and the substantially vertical surfaces 322, 324 merge to form outwardly directed edges 330, 332, respectively. The first locking mechanism 310 and the second locking mechanism 312 include two side surfaces 334, 340, 342, 344, respectively, disposed between the inclined surfaces 314, 320 and the substantially vertical surfaces 322, 324. The angled surfaces 314 , 320 , the substantially vertical surfaces 322 , 324 , and the side surfaces 334 , 340 , 342 , 344 together form a wedge shape that defines the first locking mechanism 310 and the second locking mechanism 312 , respectively.

[0062] like Figure 2 , Figure 3 , Figure 5 and Figure 6 As shown, the cover 112 defines a first notch 350 in the upper cover wall 352 and a second notch 354 in the lower cover wall 360. As the cover 112 is connected to the second body end, the inner surfaces 362, 364 of the upper cover wall 352 and the lower cover wall 360 slide on the inclined surfaces 314, 320 of the first locking mechanism 310 and the second locking mechanism 312, respectively. Each notch 350, 354 can receive the first locking mechanism 310 or the second locking mechanism 312 when the cover 112 is connected to the second body end 110. Once the locking mechanisms 310, 312 are engaged with the notches 350, 354, the inner surfaces 362, 364 of the upper cover wall 352 and the lower cover wall 360 cannot pass over the edges 330, 332 to disconnect the cover 112 from the second body end 110. As such, the first locking mechanism 310 and the second locking mechanism 312 are each configured to engage the first notch 350 or the second notch 354 in the locked position. Once the first notch 350 or the second notch 354 is in the locked position, neither the first locking mechanism 310 nor the second locking mechanism 312 can be removed from the receiving notch 350, 354 without damaging a portion of the DS sensor 100. Thus, once the cover 112 is connected to the second body end 110, the cover 112 cannot be removed from the second body end 110 without damaging the DS sensor 100. It should be appreciated that the same locking relationship between the cover 112 and the second body end 110 can be achieved by switching the positions of the first locking mechanism 310 and the second locking mechanism 312 with the positions of the first notch 350 and the second notch 354, respectively.

[0063] The cover 112 has pin holes 370, 372 defined in the upper cover wall 352 and pin holes 374, 380 defined in the lower cover wall 360. The pin holes 370, 372, 374, 380 are configured to receive the spring pins 94 of the analytical device 90 when the cover 112 is assembled with the second body end 110, thereby allowing the analytical device 90 to enter the pin openings 302, 304. The pin holes 374, 380 on the upper cover wall 352 and the lower cover wall 360 are coaxial. In this way, the cover 112 is reversible around the second body end 110, that is, the cover 112 can engage the second body end 110 in two directions, the two directions being distinguished by rotating the cover 112 180 degrees relative to the second body end 110, and the spring pins 94 can access the pin openings 302, 304 in each position.

[0064] like Figures 2 to 6 As shown, the second body end 110 includes a gasket 382 arranged around the periphery of the second body end 110, and the gasket 382 is located between the pin openings 302, 304 and the test cavity 250. Specifically, the gasket 382 is located between the pin openings 302, 304 and the base surface 222. When the cover 112 is assembled with the second body end 110, the cover 112 is arranged on the test cavity 250, and the gasket 382 and the cover 112 form a liquid-tight seal so that the fluid deposited at the fluid inlet 212 cannot pass through the gasket 382 to reach the pin openings 302, 304. In this way, the liquid-tight seal prevents the pin openings 302, 304 from being contaminated by contaminants in the fluid when the cover 112 is connected to the second body end 110. In addition, the cover 112 and the liquid-tight seal are configured to isolate the second body end 110 from the surrounding air when the cover 112 is connected to the second body end 110, thereby preventing air from entering the test cavity when the cover 112 and the second body end 110 are connected. The liquid-tight seal can also be achieved by, for example, plastic contact between the cover 112 and the second body end 110.

[0065] like Figure 2 , Figure 3 and Figures 5 to 8 As shown, the DS sensor 100 may include a heating system configured to heat the test chamber 250 including the sensing electrodes 272, 274 and the test sample a (not shown) to a predetermined temperature. The heating system of the DS sensor 100 may be configured to heat the test chamber 250 to 37 degrees Celsius plus or minus 0.5 degrees Celsius within 30 seconds. In another embodiment, the test chamber 250 may be heated to 37 degrees Celsius plus or minus 0.5 degrees Celsius within 60 seconds. Figures 5 to 8As shown, the DS sensor 100 heating system includes a support 384 as a circuit support, which is a printed circuit board (PCB) in the illustrated embodiment, and is disposed between the upper body 114 and the lower body 120. More specifically, the support 384 is disposed between the upper body 114 and the isolation portion 122. The first support surface 390 is flat and contacts the first isolation portion surface 134. The support 384 is disposed within the body 102 and includes a first support end 392, which is arranged toward the first body end 104, and a second support end 394, which extends in the opposite direction and toward the second body end 110. The second support end 394 extends into the second body end 110 and terminates before reaching the gasket 382. In another embodiment, as shown in FIG. Figures 19 to 22 , Fig.28 and Fig.29 As shown, the second support member end 394 does not terminate before reaching the washer 382 and extends further into the second body end 110 .

[0066] like Figures 5 to 7 As shown, the heating system of the DS sensor 100 has at least one heater 400, a first thermistor 402, a conductive insert 404, and a heating system circuit connected to contacts 410, 412, 414, 420. The first thermistor 402, the heater 400, and the electrode contacts 410, 412, 414, 420 are arranged on a second support surface 422. The second support surface 422 is planar. The heater 400 and the first thermistor 402 are disposed on the second support end 394. The heater 400 is located on the opposite side of the liquid-tight seal compared to the test cavity 250 to prevent fluid from contacting the heater 400.

[0067] like Figure 6 As shown, the upper body 114 contains a heating system including a support 384, a heater 400, and a first thermistor 402 in an upper body cavity 424. As such, when mounted on the support 384, the heater 400 and the first thermistor 402 are spaced apart from the second surface 132 of the upper body 114. In one embodiment, the heating system components include the support 384, the heater 400, and the first thermistor 402 are spaced apart from the second surface 132 in the upper body cavity 424 by approximately 5 millimeters. In one embodiment, the heater 400 can perform a periodic heat load within a temperature range of 60 degrees Celsius to 80 degrees Celsius to bring the test cavity 250 to a predetermined temperature. It should be appreciated that placing the heater 400 in close proximity to the test cavity 250 can provide a higher level of control and efficiency in heating the test cavity 250, and this advantage can be further improved by isolating the heater 400 and the test cavity 250 from ambient temperature.

[0068] like Figures 5 to 7 As shown, the electrode contacts 410, 412, 414, 420 of the heating system are disposed on the first support end 392. The contacts 410, 412, 414, 420 are aligned laterally in a row on the body 102. With respect to the body 102, the inner electrode contacts 412, 414 correspond to the first thermistor 402, while the outer electrode contacts 410, 420 correspond to the heater 400. The contacts can be contacted by a spring pin in the analysis device 90 from the outside of the DS sensor 100 through the upper body hole 430 defined by the upper body 114. It should be understood that although the four electrode contacts are in Figures 5 to 7 As shown in FIG. 3 , electrodes and corresponding contacts may be added or rearranged to support 384 as desired to change the performance of the heating system.

[0069] Fig. 9 One embodiment of a DS sensor 100 is shown with a barcode 432 disposed thereon. The barcode 432 is a QR code that can be used to identify a particular DS sensor 100. The housing 92 of the analysis device 90 includes a door 434 for securing the DS sensor 100 in the analysis device 90. When the door 434 is closed on the DS sensor 100 in the housing 92, the door 434 secures the DS sensor 100 in the housing 92. The analysis device 90 is configured to scan the barcode 432 when the DS sensor 100 is placed in the housing 92.

[0070] Figures 10 to 13 Shows Figures 1 to 8 An alternative embodiment of the DS sensor 100 is shown. Figures 10 to 13 In the embodiment of Figures 1 to 10 Like components of the illustrated DS sensor 100 are identified by like reference numerals but followed by a prime suffix symbol '. Fig.10 An embodiment of a DS sensor 100 is shown, which includes a flexible circuit 440 having a support 442, which is a circuit as a circuit support, wherein contacts 410', 412', 414', 420' are arranged on the support 442, in particular, a first support end 444. The support 442 is configured to be inserted into the body 102' so that the support 442 is located between the upper body 114' and the lower body 120'. To this end, the lower body 120' has a lower body support cavity 450 defined in the first surface 130', configured to receive the support 442, and the second surface 132' has a raised portion 452 corresponding to the lower body support cavity 450, configured to press the support 442 into the lower body support cavity 450 when the DS sensor 100 is assembled.

[0071] When the support member 442 is assembled with the body 102', the first support member end 444 is disposed toward the first body end 104' and terminates before the lower support member 172' and the upper support member 182'. The second support member end 454 of the support member 442 extends in a direction opposite to the first support member end 444, so that when the support member 442 is assembled with the body 102', the second support member end 454 is disposed toward the second body end 110'. A tab 460 integrally formed by the second support member end 454 extends, and a first tab surface 462 is disposed along the downwardly inclined surface 464 of the raised portion 452 and an offset surface 470 of the upper body 114', which is offset from the raised portion 452. The distal end 472 of the tab 460 extends along the offset surface 470 toward the first face 474 of the first injection molded ladder 480 and terminates on the side of the first injection molded ladder 480 opposite the test cavity 250'. The first thermistor 402' is disposed at the distal end 472 of the tab 460, on a second tab surface 482 opposite the first tab surface 462. As shown, the second support end 454 extends through the second body end 110' to the fins 214', 220', between the first insert 484 and the lower body 120', such that the second support end 454 is separated from the fluid inlet 212' by the first insert 484 and is received in the lower body support cavity 450 of the second body end 110'.

[0072] like Fig.10 As shown, the first sensing electrode 272' and the second sensing electrode 274' are disposed on the first insert 484. The first insert 484, as shown in FIG. Fig.12 and 13 As shown, at least a portion of the second fin 220' is formed and includes an edge 260'. The first insert 484 is configured to be assembled with the lower body 120' at the second body end 110', so that the first insert 484 is arranged on the first surface 130' defined by the lower body 120' at the second body end 110'. To this end, the lower body 120' has a lower body insert cavity 490 configured to receive the first insert 484, and the first insert 484 includes at least one ridge 492 configured to engage the flexible circuit 440 in the lower body insert cavity 490. As shown in FIG. Fig.11 As shown, the upper body 114 ′ includes an upper body insert cavity 494 configured to receive the first insert 484 such that the first insert 484 is disposed within the lower body insert cavity 490 and the upper body insert cavity 494 when the DS sensor 100 is assembled.

[0073] like Fig.11As shown, the floating electrode 292' is disposed on the second insert 500, and the second insert 500 is configured to be assembled with the upper body 114' at the second body end 110'. Fig.12 and Fig.13 As shown, when the second insert 500 is assembled with the upper body 114', the second insert 500 forms at least a portion of the first fin 214' including the peripheral edge 252', and the second surface 132 defines the test cavity 250' at the second body end 110'. With this configuration, the second peripheral edge 260' defined by the first insert 484 and the first peripheral edge 252' defined by the second insert 500 together form the fluid inlet 212', while the inner surface 276' of the first insert 484 and the inner surface 278' of the second insert 500 define the test cavity 250'. The offset surface 470 of the upper body 114' is offset from the raised portion 452 by a distance that aligns the second tab surface 482 with the inner surface 276' of the first insert 484 to position the first thermistor 402' at the same height on the side of the injection molded ladder 480 opposite the test cavity 250'.

[0074] In preparation for assembling the first insert 484 and the second insert 500 into the DS sensor 100, the first sensing electrode 272', the second sensing electrode 274' and the floating electrode 292 are arranged on a plurality of such inserts in a mass production manner. In this way, arranging the first sensing electrode 272' and the second sensing electrode 274' on the first insert 484 and arranging the floating electrode 292' on the second insert 500 can improve the manufacturability of the DS sensor 100. As described above, each of the sensing electrodes 272', 274' and the floating electrode 292' can be a conductive material (e.g., gold, copper, or aluminum) deposited on a suitable surface by, for example, sputtering deposition, such as using a shadow mask and lift-off process. Figures 2 to 8 In the embodiment shown, the entire upper body 114 or the lower body 120 must be covered. Figures 10 to 13 The embodiment only needs to cover the corresponding inserts 484, 500. In this way, since the size of the inserts 484, 500 is relatively small compared with the upper body 114 or the lower body 120, more parts can be processed in the same manufacturing stage. This can greatly reduce the manufacturing cost.

[0075] like Fig.10 As shown, a third assembly hole 502 and a fourth assembly hole 504 are defined in the first surface 130' defined by the lower body 120'. The third assembly hole 502 and the fourth assembly hole 504 are laterally centered on the first surface 130' and are as shown in FIG. Fig.11As shown, the third assembly pin 510 and the fourth assembly pin 512 correspond to extending from the second surface 132' defined by the upper body 114' toward the lower body 120' when the DS sensor 100 is assembled. The third assembly pin 510 and the fourth assembly pin 512 are laterally centered on the second surface 132', and the flexible circuit 440 defines a corresponding first flexible circuit assembly opening 514 and a second flexible circuit assembly opening 520. It can be seen that the DS sensor 100 has a plurality of flexible circuit assembly openings, such as the first flexible circuit assembly opening 514 and the second flexible circuit assembly opening 520, to prevent the flexible circuit 440 from rotating relative to the upper body 114' and the lower body 120' when the DS sensor 100 is assembled.

[0076] When the upper body 114' and the lower body 120' are assembled together, the third assembly pin 510 and the fourth assembly pin 512 are respectively engaged with the third assembly hole 502 and the fourth assembly hole 504. Once the third assembly pin 510 forms an engaging connection with the third assembly hole 502, and the fourth assembly pin 512 forms an engaging connection with the fourth assembly hole 504, the user cannot disassemble the lower body 120' and the upper body 114' without damaging a portion of the DS sensor 100. In one embodiment, the upper body 114' and the lower body 120' are respectively fixed to the support member 442 by at least one solvent weld. It should be understood that the same locking relationship between the third assembly pin 510, the fourth assembly pin 512, the third assembly hole 502 and the fourth assembly hole 504 can be achieved by switching or repositioning the assembly pins 510, 512 and the corresponding assembly holes 502, 504 with respect to the first surface 130' and the second surface 132'.

[0077] like Fig.12 and Fig.13As shown, when the DS sensor 100 is assembled, the second insert 500 is positioned on the first ledge surface 522 of the upper body 114' and abuts the second surface 524 of the first injection molded ladder 480, the second surface 524 of the first injection molded ladder 480 defining a side of the first injection molded ladder 480 opposite the first surface 474 of the first injection molded ladder 480. The second ledge surface 530 is offset from the first ledge surface 522 by the first injection molded ladder 480, and the second ledge surface 530 is formed as part of the upper body insert cavity 494. The first insert 484 is disposed between the upper body 114' and the lower body 120', and in the lower body insert cavity 490 and the upper body insert cavity 494, the first insert 484 is located on the second ledge surface 530 and abuts the second injection molded ladder 532 formed by the raised portion 452 of the upper body 114'. The positional relationship of the first insert 484 and the second ledge surface 530 provides a seal therebetween that is impermeable to fluid from the test cavity 250', thereby restricting the flow of the test sample in the test cavity 250' between the first insert 484 and the second ledge surface 530 of the upper body 114'. The height of the second injection molded ladder 532 matches the height of the first insert 484 on the second ledge surface 530, so that the first insert 484 is flush with the raised portion 452 of the upper body 114'. With this configuration, the height of the test cavity 250' is the offset distance between the first insert 484 and the second insert 500, which is defined by the height of the first injection molded ladder 480 on the second insert 500. The first insert 484 is arranged in the upper body insert cavity 494 and overlaps with the flexible circuit 440 arranged in the lower body support cavity 450, so that the flexible circuit 440 is between the first insert 484 and the lower body 120', so that the second support end 454 is separated from the fluid inlet 212' by the first insert 484 and accommodated in the lower body support cavity 450 at the second body end 110.

[0078] When the DS sensor 100 is assembled, at least one ridge 492 separates the first insert 484 from the flexible circuit 440. In this manner, the first insert 484 and the flexible circuit 440 are configured to accommodate the heater 400' on the second support end 454 on a side of the first insert 484 opposite the test cavity 250', and accommodate the first thermistor 402' on the second tab surface 482 and at a height consistent with the test cavity 250', located on a side of the first injection molded ladder 480 opposite the test cavity 250'. Notably, positioning the first thermistor 402' at the same height as the test cavity 250' is advantageous for tracking the temperature of the test cavity 250'.

[0079] The first insert 484 includes at least one heating system cavity defined by at least one ridge 492. Fig.11 As shown, the first insert 484 includes a first heating system cavity 534 and a second heating system cavity 540 defined by at least one ridge 492. The at least one ridge 492 includes a first side ridge 542 disposed on a side of the first insert 484 along the length direction of the first insert 484, a second side ridge 544 disposed on the other side of the first insert 484 along the length direction of the first insert 484, and a middle ridge 550 disposed between the first side ridge 542 and the second side ridge 544 and transversely spanning the first insert 484, thereby connecting the first side ridge 542 and the second side ridge 544. The first heating system cavity 534 is further defined by a first insert protrusion 552, which connects the first side ridge 542 and the second side ridge 544.

[0080] Each of the first heating system cavity 534 and the second heating system cavity 540 is configured to receive components of a heating system including at least one heater 400' and a first thermistor 402'. The at least one heater 400' and the first thermistor 402' may be received in the first heating system cavity 534 and the second heating system cavity 540 in various combinations and positions relative to the test cavity 250'. For example, the at least one heater 400' may be disposed in the first heating system cavity 534, while the first thermistor 402' is disposed in the second heating system cavity 540. Alternatively, the first thermistor 402' may be disposed in the first heating system cavity 534, while the at least one heater 400' is disposed in the second heater system cavity 540. With this configuration, the at least one heater 400' is separated from the first thermistor 402' by the intermediate ridge 550. Moreover, the at least one heater 400' and the first thermistor 402' may be disposed together in the first heating system cavity 534 or the second heating system cavity 540.

[0081] like Fig.10 As shown, the flexible circuit 440 includes a heater 400' and a first thermistor 402' disposed on a support 442. In the illustrated embodiment, the heater 400' is located in front of the first thermistor 402' relative to the test cavity 250'. Multiple heaters 400' can be assembled with the first thermistor 402 in different configurations. For example, Fig.14 An alternative embodiment of a flexible circuit 440 having two heaters 400 is shown, wherein the first thermistor 402 is closer to the test cavity 250 ′ and further from the first support end 444 than the first thermistor 402 is to the test cavity 250 ′. Fig.15An alternative embodiment of the flex circuit 440 is shown in which the two heaters 400 are further away from the test cavity 250 ′ and closer to the first support end 444 than the first thermistor 402 . Fig.16 An alternative embodiment of the flex circuit 440 is shown in which one heater is closer to the test cavity 250 ′ and further from the first support end 444 than the first thermistor 402 is to the test cavity 250 . Fig.17 An alternative embodiment of the flex circuit 440 is shown in which one heater 400 is located farther from the test cavity 250 ′ and closer to the first support end 444 than the first thermistor 402 . Fig.18 An alternative embodiment of a flexible circuit 440 is shown in which two heaters 400 are respectively disposed closer to and further away from the test cavity 250 ′ than the first thermistor 402 .

[0082] In one embodiment, a second thermistor (not shown) is disposed within the DS sensor 100 and is configured to measure the ambient temperature. The second thermistor is disposed within the DS sensor 100 such that the second thermistor is not accessible or visible from the outside of the DS sensor 100. In one embodiment, the ambient temperature that the DS sensor 100 may be designed to operate at ranges from 15 degrees Celsius to 35 degrees Celsius.

[0083] Heating the test chamber 250' can be accomplished by a variety of heater configurations. As another example, Fig.19 As shown, an embodiment of the DS sensor 100 includes an end insert including an upper insert 806 overmolded into the first fin 214 and a lower insert 808 overmolded into the second fin 220. Each of the upper insert 806 and the lower insert 808 can be made of steel or another material suitable for providing an induced current and generating heat. When the DS sensor 100 is inserted into the analysis device 812, the induction coil 816 disposed in the analysis device 812 and aligned with each insert 806, 808 is configured to induce a current in each insert 806, 808, thereby causing heating of the test cavity 250.

[0084] Fig. 20An embodiment of the DS sensor 100 is shown in which a cover insert 904 made of copper and overmolded is disposed within the upper cover wall 352, the lower cover wall 360, and the top cover 906 of the cover 112. When the cover 112 is connected to the second body end 110, the cover insert 904 faces the test cavity 250 from at least three sides. When the DS sensor 100 is inserted into the analytical device 812, the analytical device heater 910 disposed in the analytical device 812 is configured to generate thermal energy and conduct the thermal energy to the cover insert 904 through the thermal vias 912. When the thermal energy is conducted from the analytical device heater 910 to the cover insert 904 disposed around the test cavity 250, the cover insert 904 dissipates the thermal energy within the interior of the cover 112 surrounding the test cavity 250, thereby heating the test cavity 250. In one embodiment, the cover 112 can be preheated for a sufficiently long period of time to prevent any portion of the cover 112 from exceeding a user contact temperature of 41 degrees Celsius.

[0085] Fig.21 An embodiment of the DS sensor 100 is shown, which includes an improved upper insert 1004 and an improved lower insert 1006, each including a portion exposed to the outside of the DS sensor 100. Each of the upper insert 1004 and the lower insert 1006 is made of copper and is partially exposed to the outside of the DS sensor 100. The exposed portions of the upper insert 1004 and the lower insert 1006 are configured to be connected to the cover insert 904 when the cover 112 is connected to the second body end 110. In this way, when the analysis device heater 910 dissipates heat energy to the cover insert 904, in addition to dissipating the heat energy through the interior of the cover 112, the cover insert 904 conducts the heat energy to the upper insert 1004 and the lower insert 1006. In this way, the heat energy is conducted within the first fin 214 and the second fin 220, relative to the heat energy of the upper fin 214 and the lower fin 220. Fig. 20 In the illustrated embodiment, the test cavity 250 is heated more directly.

[0086] Fig. 22An embodiment of the DS sensor 100 is shown in which an improved upper insert 1104 is arranged in the first fin 214, and a portion of the upper insert 1104 extends through the gasket 382, ​​terminating in the second body end 110. An improved lower insert 1106 is arranged in the second fin 220, and a portion of the lower insert 1106 extends through the gasket 382, ​​terminating in the second body end 110. Each of the upper insert 1104 and the lower insert 1106 is connected to a heater 1110 disposed in the support member 384, and is configured to conduct heat energy from the heater 1110 to the test cavity 250, thereby heating the test cavity 250. The heater 1110 is powered by an energy storage unit (not shown), which may be a capacitor. As a capacitor, the energy storage unit may also be a supercapacitor. The energy storage unit is connected to the heater and charged from an external power source (e.g., the analysis device 812). Additionally, contacts similar to contacts 410 , 412 , 414 , 420 may be provided on support 384 to receive electrical power from analysis device 812 prior to loading test cavity 250 with blood from a patient.

[0087] Independent of the heating system embodiment of the DS sensor 100, it should be understood that alternatives to the separator 122, such as double-sided adhesive tape, may be provided to separate the upper body 114 and the lower body 120 in other ways. For example, Fig.23 The improved spacer 1280 is shown as a solid acrylic sheet having a thickness of 250 microns and fixed between the upper body 114 and the lower body 120. The improved spacer 1280 can include a tolerance of 10% (i.e., plus or minus 25 microns). Fig.24 In the illustrated alternative embodiment, the DS sensor 100 has an injection molded step 1282 formed on the second surface 132 of the upper body 114, separating the lower body 120 from a portion of the upper body 114 according to the height of the injection molded step 1282. The injection molded step 1282 is 250 microns and may include a tolerance of 10% (i.e., plus or minus 25 microns). It should be understood that the injection molded step 1282 may be formed by the upper body 114 or the lower body 120.

[0088] Fig.25 An embodiment of the DS sensor 100 is shown in which at least one heater 400 is embedded in the first fin 214. The first fin 214 has a recess 1404 configured to accommodate the at least one heater 400 so that an outer surface 1410 of the at least one heater 400 is flush with the first outer surface 254 of the first fin 214. The support 384 extends from the body 102 to the at least one heater 400. The first thermistor 402 is disposed in the support 384, in the body 102.

[0089] Fig.26An embodiment of the DS sensor 100 is shown in which at least one heater 400 and a first thermistor 402 are adjacent to each other and disposed between the upper body 114 and the isolation portion 122. The at least one heater 400 is disposed in the body 102, and the first thermistor 402 is disposed in the first fin 214. The at least one heater 400 and the first thermistor 402 are connected to a support 384 disposed on an opposite side of the body 102 from the fluid-tight seal (e.g., provided by the gasket 382) with respect to the test cavity 250. Each of the first thermistor 402, the at least one heater 400, and the support 384 is received in an upper body recess 1504 defined in the upper body 114.

[0090] Fig. 27 An embodiment of the DS sensor 100 is shown in which at least one heater 400 and a first thermistor 402 are disposed between the lower body 120 and the upper body 114 and within a gap of depth defined by the isolation portion 122. The at least one heater 400 and the first thermistor 402 are connected to a support 384 disposed on an opposite side of a fluid-tight seal (e.g., provided by a gasket 382) within the body 102 from the test cavity 250. The upper body 114 has an upper body heater cavity 1610 configured to receive the at least one heater 400, while the lower body 120 has a lower body heater cavity 1604 configured to receive the at least one heater 400.

[0091] Fig.28 1 shows an embodiment of a DS sensor 100 having at least one heater 400 between the test cavity 250 and the first thermistor 402, and Fig.29 An embodiment of the DS sensor 100 is shown in which the first thermistor 402 is disposed between the at least one heater 400 and the test cavity 250. In this manner, the first thermistor 402 may be disposed in front of or behind the at least one heater 400 relative to the test cavity 250. Fig.28 and Fig.29An embodiment of the DS sensor 100 is shown in which the heating system electrodes 1704, 1706, 1710, 1714 have corresponding contacts 1716, 1720, 1722 aligned in a row across the body 102. The inner contacts 1720 correspond to both the at least one heater 400 and the first thermistor 402, while the lateral contacts correspond to the at least one heater 400. The conductive insert 404 can be an overmolded copper insert connected to the at least one heater 400 and configured to introduce thermal energy into the test cavity 250. Notably, the integration of the first thermistor 402 into the DS sensor 100 heating system allows the DS sensor 100 to receive temperature data input for adjusting the at least one heater 400, thereby improving the accuracy of maintaining the sample temperature in the test cavity 250 within a desired range.

[0092] Figures 30 to 36 DS sensor 1920 is shown, which includes a body 1922 and a cover 1924 cooperating with the body 1922. The body 1922 defines a test cavity 1926, into which fluid enters via capillary action from a fluid inlet 1928. The electrode or at least a portion thereof resides in the test cavity 1926 (see Fig.30 ) to allow DS testing of the fluid in the test chamber 1926. After the fluid is loaded into the test chamber 1926 and the lid 1924 is closed (see Fig.32 ), the DS sensor 1920 is configured to be inserted into an analysis device (not shown) so that a DS test can be performed on the fluid in the test cavity 1926.

[0093] The body 1922 and the cover 1924 can be made of polymethyl methacrylate (PMMA), also known as acrylic or acrylic glass. Therefore, the body 1922 and the cover 1924 can be transparent, which can allow the user to visually identify that the fluid resides in the test cavity 1926 and also provide an indication of the position of the sensing electrodes 1932, 1934 and the floating electrode 1936.

[0094] When finally assembled, the body 1922 includes a base 1940 and a cantilevered portion 1942 extending from the base 1940. Fig.31 and Fig.32 As shown, the cantilever portion 1942 includes a first fin 1944 and a second fin 1946 extending from the base 1940, respectively. Fig.33As shown, where electrodes 1932, 1934, 1936 are not shown, the first fin 1944 defines a first inner surface 1948, and the second fin 1946 defines an opposite second inner surface 1952 spaced from the first inner surface 1948. The first inner surface 1948 is spaced from the second inner surface 1952 by a distance that allows fluid to enter the test cavity 1926 from the fluid inlet 1928 by capillary action. In the embodiment shown, the first inner surface 1948 is flat and parallel to the second inner surface 1952, which is also flat. The first inner surface 1948 can be spaced from the second inner surface 1952 by a distance of less than about 500 microns, and preferably about 50 microns. The first sensing electrode 1932 and the second sensing electrode 1934 are disposed on the first inner surface 1948, and the floating electrode 1936 is disposed on the second inner surface 1952 so as to be spaced from the sensing electrodes 1932 and 1934. In the illustrated embodiment, the fins 1944, 1946 are shown as being rectangular in plan view, however the fins 1944, 1946 may take other shapes, for example, may have a curved profile.

[0095] First fin 1944 includes a chamfered peripheral edge 1954 angled from first outer surface 1956 toward base 1940 to first inner surface 1948 and fluid inlet 1928. Second fin 1946 similarly includes a chamfered peripheral edge 1958 angled from second outer surface 1960 toward base 1940 to second inner surface 1952 and fluid inlet 1928.

[0096] The fluid inlet 1928 in the illustrated embodiment is arranged along the edge of the test cavity 1926. Fig.31 As shown, the fluid inlet 1928 is L-shaped in plan view. This configuration allows a user of the DS sensor 1920 to pierce his / her skin, such as with the pad of a finger, deposit a drop of blood on the inclined peripheral edges 1954, 1958, and then draw it into the test cavity, thereby eliminating the need to use a pipette or dropper to load the test fluid into the test cavity 1926. In the illustrated embodiment, the fluid inlet 1928 is along a linear edge of the test cavity 1926 that is most spaced apart from the base 1940 and also includes side edges that extend from the farthest edge of the test cavity 1926 toward the base 1940. In the illustrated embodiment, the test cavity 1926 is generally rectangular in plan view (see Fig.30 ), and the fluid inlet 1928 is located on two adjacent sides of the rectangle. As such, the fluid inlet 1928 is relatively long and is almost equal to the longest dimension of the test chamber 1926. In the illustrated embodiment, both sides of the rectangular test chamber 1926 are closed, that is, not open to the environment when the cover 1924 is not placed on the body 1922. However, at least one side, such as a side parallel to the side extending between the farthest edge and the base 1940, can be open to the surrounding.

[0097] When the fins 1944, 1946 are configured other than rectangular, the chamfered peripheral edges 1954, 1958 may also be configured other than linear. For example, markings such as frosting on the fins 1944, 1946 to provide opaque or translucent portions may outline the test cavity 1926 and mark the location of the blood drop for the user. Furthermore, each chamfered edge may be one of the following, such as Figures 30 to 36 As shown: (1) chamfer, (2) radius, or (3) a combination of chamfer and radius.

[0098] The body 1922 also includes cover buckles 1962 and 1964 that extend from the base 1940 in the same direction as the fins 1944 and 1946 extend from the base 1940. Both the fins 1944, 1946 and cover buckles 1962, 1964 extend from a base surface 1966 that is offset from a ledge surface 1968 that defines an edge of the base 1940 that is closest to the cantilever portion 1942. Both the ledge surface 1966 and the base surface 1968 lie in respective planes that are perpendicular to the direction in which the fins 1944, 1946 extend from the base 1940. The cover buckles 1962, 1964 cooperate with the cover 1924 to prevent removal of the cover 1924 from the body 1922 once the cover 1924 is in the closed position, as shown. Fig.32 Thus, the DS sensor 1920 can be a "single-use" device because the cover 1924 is placed Fig.31 Opening of the cover 1924 after the closed position shown is not permitted unless the cover latches 1962, 1964 and / or the cover 1924 are destroyed. Fig.33 When the cover 1924 is in a closed position relative to the body 1922 , the gasket 1970 can surround the base 1972 (whose upper surface is the substrate surface 1966 ) to cooperate with the cover 1924 to prevent the fluid from covering the DS sensor 1920 .

[0099] like Fig.34 As shown, the body 1922 includes a cover connector groove 1980 provided along a peripheral edge 1982 of the body 1922 and more specifically in the base 1940 of the body 1922. The cover connector groove 1980 is shaped to receive a corresponding protrusion 1984 on the cover 1924 so that when the cover 1924 is in the locked position (as shown in FIG. Fig.311924 is secured relative to the body 1922. When in the locked position, the protrusion 1984, when received in the cover connector recess 1980, frictionally engages with the side surface of the cover connector recess 1980. This secures the position of the cover 1924 relative to the body 1922, which is beneficial for loading the test cavity 1926 because the user does not need to hold the cover 1924 to prevent the cover 1924 from moving relative to the body 1922. By overcoming the friction between the protrusion 1984 and the side of the cover connector recess 1980, the protrusion 1984 can be removed from the cover connector recess 1980, which allows the cover 1924 to be secured relative to the body 1922 (see Fig.30 ) to pivot so that the DS sensor 1920 moves from Fig.31 Move the lock position shown in Fig.30 Open position as shown and then Fig.32 Shown in closed position.

[0100] like Fig.34 As shown, the body 1922 includes a hinge connector groove, hereinafter referred to as the body hinge connector groove 1986. Similarly, the cover 1924 includes a hinge connector groove, hereinafter referred to as the cover hinge connector groove 1988. The hinge link connector 1992 is received in the body hinge connector groove 1986 and the cover hinge connector groove 1988 and is connected to each of the body 1922 and the cover 1924 to allow the cover 1924 to be moved relative to the body 1922 from an open position (such as Fig.31 ) to the closed position (as shown) Fig.32 The hinge link connector 1992 also allows the cover 1924 to have some translational movement relative to the body 1922.

[0101] Fig.35 An exploded schematic diagram of the body 1922 is shown, which may be composed of a first (top) portion 2002, a second (bottom) portion 2004, and a separator 2006 disposed between the top 2002 and the bottom 2004 (see Fig.33 ). The isolation portion 2006 can be a double-sided tape for connecting the top 2002 and the bottom 2004 and providing an appropriate spacing between the first inner surface 1948 and the second inner surface 1952 to provide the test cavity 1926. The isolation portion 2006 can also be made of polymethyl methacrylate (PMMA) and an adhesive can be applied on the opposite surface to allow the connection of the top 2002 to the bottom 2004.

[0102] Each sensing electrode 1932, 1934 is disposed on the top portion 2002 and extends from a corresponding first terminal end 2012, 2014 located on the first inner surface 1948 in the test cavity 1926 located on the first fin 1944 into the base 1940 to a corresponding second terminal end 2016, 2018 located in the base 1940. The sensing electrodes 1932, 1934 are arranged on the first inner surface 1948 along, for example, a printing direction so that when it is covered by the isolation portion 2006 having an adhesive thereon, the bottom portion 2004 is also adhered to the isolation portion 2006, thereby preventing the fluid in the test cavity 1926 from flowing over the base surface 1966 toward the second terminal end 2016, 2018 of the corresponding sensing electrode 1932, 1934. The floating electrode 1936 is disposed on the second inner surface 1952 on the bottom portion 2004. Each of the sensing electrodes 1932, 1934 and the floating electrode 1936 can be a conductive material (e.g., gold, copper, or aluminum) that can be deposited on a suitable surface by, for example, sputtering deposition using a shadow mask and a lift-off process. As an example, each of the sensing electrodes 1932, 1934 and the floating electrode 1936 can be formed to have a thickness of 1000 angstroms or less.

[0103] The isolation portion 2006 includes key notches 2022, 2024 that align with the respective second terminal ends 2016, 2018 of the sensing electrodes 1932, 1934 when the isolation portion 2006 is properly positioned on the first inner surface 1948 of the base 1940 of the top portion 2722. Similarly, the bottom portion 2004 includes key notches 2026, 2028 that align with the key notches 2022, 2024 in the isolation portion 2006, respectively, when the isolation portion 2006 is properly positioned on the top portion 2022 and the bottom portion 2004 is properly positioned on the isolation portion 2006. Connectors or spring pins may extend through openings 2022, 2026 and openings 2024, 2028 to provide electrical connection to second terminal ends 2016, 2018 of respective sensing electrodes 1932, 1934 to provide appropriate input and output RF signals to sensing electrodes 1932, 1934 as described in US 9,995,701 B2.

[0104] The spacer 2006, which has been described above as a tape, has edges that match the peripheral edges of the top 2002 and bottom 2004 in the base 1940. Portions of the spacer 2006 extend into the cantilevered portion 1942 of the body 1922. The spacer 2006 may include a finger-like extension 2032 that extends into the cantilevered portion along the edge of each fin 1944, 1946. As described above, due to the location of the finger-like extension 2032, the fluid inlet 1928 can be only on two edges of each rectangular fin 1944, 1946. As shown in FIG. Fig.33As shown, except for the finger-like extension 2032, the edge of the isolation portion 2006 terminates to be coplanar with the base surface 1966 and the ledge surface 1968, so that one edge of the isolation portion 2006 is coplanar with the base surface 1966, which defines one edge of the test cavity 1926.

[0105] The cover 1924 is hingedly connected to the body 1922 via a hinge connector link 1992. The hinge connector link 1992 can connect the cover 1924 and the body 1922 in a manner that allows the cover 1924 to perform pivotal and translational movement relative to the body 1922. The cover 1924 includes a receiver 2040 that is configured to engage the cover 1924 when the cover 1924 is in the closed position (see FIG. Fig.32 ), in which the cantilevered portion 1942 of the body 1922 is received. The cover 1924 may also include a groove-shaped shelf 2042, which is similar to the base 1972 and is configured to cooperate with the gasket 1970. When the cover 1924 is in the closed position, the fluid in the test cavity 1926 is sealed from the surrounding environment to prevent the fluid therein from evaporating for at least 30 minutes, so that the DS test can be performed. Fig.36 As shown, an angled protrusion 2044 disposed in the cover 1924 can cooperate with the fins 1944, 1946, and more specifically with the chamfered peripheral edges 1954, 1958 of the fins 1944, 1946, to maintain a desired spacing between the first inner surface 1948 and the second inner surface 1952 when a DS test is performed on the fluid within the test cavity 1926. The inclined surface of the inclined protrusion 2044 can match the inclined surface of the chamfered peripheral edges 1954, 1958.

[0106] In use, the DS sensor 1920 can be packaged with the cover 1924 in a Fig.31 and 33 The lid 1924 is then closed (eg, closed by the user) and the test chamber 1926 is opened. A drop of fluid, such as blood, may be deposited directly from the user's finger onto the chamfered peripheral edges 1954, 1958. The drop of fluid is then drawn into the test chamber 1926 through the fluid inlet 1928 by capillary action without the need for a capillary element. Fig.32 ), and the DS sensor 1920 can be loaded into an analysis device (not shown), where, for example, a spring pin contacts the corresponding second terminal end 2016, 2018.

[0107] The above is the implementation method of the embodiment of the present application. It should be noted that the steps in the method described in the specific embodiment of the present application can be adjusted in order, merged and deleted according to actual needs. In the above embodiments, the description of each embodiment has its own emphasis. For the part that is not described in detail in a certain embodiment, refer to the relevant description of other embodiments. It is understandable that the structure shown in the embodiment of the present application and the accompanying drawings does not constitute a specific limitation on the relevant device or system. In other embodiments of the present application, the relevant device or system may include more or fewer components than the specific embodiments and the accompanying drawings, or combine certain components, or split certain components, or have different component arrangements. Those skilled in the art will understand that, without departing from the spirit and scope of the specific embodiments of the present application, various modifications or changes can be made to the arrangement, operation and details of the methods and equipment recorded in the specific embodiments; without departing from the principles of the embodiments of the present application, several improvements and modifications can also be made, and these improvements and modifications are also regarded as the scope of protection of the present application.

Claims

1. A method for assembling a DS sensor, characterized in that: The method comprises: fixing a first insert to the lower body, wherein the first insert includes a first terminal end of the first sensing electrode and a first terminal end of the second sensing electrode; securing a second insert to the upper body, wherein the second insert includes a floating electrode disposed on the second insert, the second insert being located on a ledge surface of the upper body and proximate to the first injection molded ladder; and The lower body and the upper body are connected to form a body, the body is formed by the upper body and the lower body, the body defines a test cavity between a first surface and an opposite second surface, the test cavity is defined by the first insert fixed to the lower body and the second insert fixed to the upper body, the second surface is spaced apart from the first surface by a distance allowing fluid to enter the test cavity from a fluid inlet, and the fluid inlet communicates with the test cavity by capillary action.

2. The method according to claim 1, characterized in that The method further comprises: A circuit support is disposed in a cavity formed in one of the lower body and the upper body.

3. The method according to claim 1, characterized in that Connecting the lower body and the upper body to form the body includes: At least one assembly hole and a corresponding at least one assembly pin are engaged, wherein the at least one assembly hole is defined in one of the upper body and the lower body, and the at least one assembly pin extends from the other of the upper body and the lower body.

4. The method according to claim 1, characterized in that: The method further comprises: A circuit support is disposed between the upper body and the lower body such that at least one assembly hole defined in the circuit support receives at least one assembly pin extending from one of the upper body and the lower body.

5. The method according to claim 1, characterized in that The method further comprises: A circuit support is arranged between the upper body and the lower body such that two assembly holes defined in the circuit support respectively receive corresponding assembly pins extending from one of the upper body and the lower body.

6. The method according to claim 1, characterized in that The method further comprises: A circuit support is disposed between the upper body and the lower body and is disposed on a protruding portion of at least one of the upper body and the lower body to be accommodated in a cavity formed in one of the lower body and the upper body.

7. The method according to claim 1, characterized in that The method further comprises: A circuit support is disposed between the first insert and the lower body.

8. The method according to claim 1, characterized in that The method further comprises: A heater is disposed in the cavity defined by the first insert.

9. The method according to claim 8, characterized in that The method further comprises: A thermistor is disposed in a cavity defined by the first insert.

10. The method according to claim 9, characterized in that The method further comprises: The heater is closer to the test cavity than the thermistor.

11. The method according to claim 9, characterized in that The method further comprises: The thermistor is closer to the test cavity than the heater.

12. The method according to claim 1, characterized in that Fixing the first insert to the lower body comprises: The first insert is placed in the cavity of one of the upper body and the lower body, and the first insert is placed on the circuit support so that the circuit support is separated from the test cavity by the first insert.

13. The method according to claim 1, characterized in that Connecting the lower body and the upper body to form the body includes: A fluid-tight seal is formed between the first insert and the upper body.

14. The method according to claim 13, characterized in that Forming the fluid-tight seal between the first insert and the upper body comprises: The fluid-tight seal is formed across the first sensing electrode between at least one of the first terminal end of the first sensing electrode and the first terminal end of the second sensing electrode and the corresponding second terminal end.

15. The method according to claim 1, characterized in that Fixing the first insert to the lower body comprises: The first insert is placed in the cavity of the upper body and the cavity of the lower body, and the first insert is overlapped with a circuit support, the circuit support is in one of the cavity of the upper body and the cavity of the lower body, so that the circuit support is separated from the test cavity by the first insert, and the circuit support is between the first insert and one of the upper body and the lower body.

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