TW201340941A - A cartridge - Google Patents

Abstract

A cartridge is configured to be inserted into a meter, the cartridge comprises a housing having an aperture, and end face and a side wall; at least one testing member disposed within the housing; a removable seal; and a knob attached in a fixed positional relationship with the seal, wherein when the seal is in a sealed condition a part of the seal covers the aperture and is secured to the housing around the aperture so as to provide a moisture impermeable barrier and the knob is located adjacent the side wall of the housing.

Description

匣 box

The present invention relates to a cassette that is configured to be embedded in a meter.

Diabetic patients can provide insulin quantities, for example, by injection, sometimes requiring multiple injections a day. The appropriate amount of insulin depends on the patient's blood glucose level, so it is also necessary to perform blood glucose level measurements multiple times a day.

Blood glucose level measurement is typically a multi-stage procedure. The first is cutting, in which a small knife or needle is used to puncture the user's skin, such as at the end or side of a finger. After the appropriate amount of blood has been produced, the same is taken on a test strip. The user may need to squeeze a finger to cause enough blood to flow out. Sometimes the cutting must be performed again. The test strip is then provided to a meter, typically an electronic meter, for example by determining the parameters present in the test strip (eg, the electrochemical potential generated from a chemical reaction between the blood sample and the enzyme or Voltage) Analyze the sample and provide blood glucose measurements. This measurement is then used to determine the amount of insulin the patient should use.

PCT patent application numbers PCT/EP2011/061536, PCT/EP2011/061537, PCT/EP2011/061538, PCT/EP2011/061540 and A novel type of blood glucose measuring device is known from PCT/EP2011/061542, and European Application Nos. EP11182381.1, EP11182383.7 and EP11190679.8. The device contains cutting and measuring features. In use, a user places a body part toward an orifice in the device, the device first cutting the body part and then collecting the blood sample, and then processing the blood sample to measure the blood glucose level.

A first aspect of the present invention provides a cassette configured to be embedded in a meter, the cassette comprising: a shield having an aperture, a distal end surface and a side wall; at least one of which is mounted a test member within the shield; a movable seal; and a button attached to the seal in a fixed position relationship, wherein the seal is non-permanent when the seal is in a sealed condition The adhesive is affixed to the outer side wall of the cassette and a portion of the seal covers the aperture to provide a moisture impermeable barrier and the button is placed adjacent to the side wall of the shield.

The cassette has a projection formed on the side wall that coincides with the button when the seal is in the sealed position. The projection can have a longitudinal axis that extends substantially parallel to the longitudinal axis of the cassette. This may provide a configuration that is particularly intuitive to the user, i.e., the movement of the button that is required to move the seal is directed in the direction the user desires to move the button. Furthermore, this can be achieved and at the same time allows the protrusion to act as a guiding member for embedding the cassette in a meter.

The protrusion may extend to a position where the joint between the side wall and the box shroud coincides. This provides a particularly convenient form of use.

The button can be attached to the protrusion by a temporary holder. This helps keep the button in the desired position.

The button may have a groove formed in one side that faces the side wall of the cassette when the seal is in the sealed state.

The slot can have a longitudinal axis that extends substantially parallel to the longitudinal axis of the cassette. This can help ensure that the button and thus the seal remain in the position of the sealing position before the user intends to remove the seal. In addition, it can allow the protrusions to have a corresponding orientation, thus allowing them to act as a guide when the cassette is embedded in the meter.

The protrusions and grooves may have complementary cross sections. For example, the protrusions and grooves may have a generally triangular cross section, and/or the protrusions and grooves may have a generally circular cross section.

When the seal is in the sealed position, an end portion of the button is placed to coincide with the point of engagement between the side wall and the end face of the cassette guard, such as the button portion that is furthest from the aperture. This provides a convenient way to use the cassette. In addition, providing a button on the corner of the cassette guard allows the user to grasp the button relatively easily, potentially assisting in removing the seal when it is desired that the seal is accidentally removed. .

The cassette may have a maximum radial height of the button in an axial direction parallel to the longitudinal axis of the cassette, a downwardly inclined surface toward the position of the aperture. This provides a convenient side for the user to remove the seal from the cassette. Here, when the distance from the maximum radial height of the button toward the aperture increases, the surface It is steeper in the radial direction. This provides a more user-friendly side when removing the seal from the cassette.

The seal has a longitudinal axis that extends substantially parallel to the longitudinal axis of the cassette.

The present invention also provides a system comprising a meter having a shield and a cassette as previously described, wherein the gauge cover is configured such that the cassette is allowed to be embedded in the shield only after the button is removed.

100‧‧‧glucometer

101‧‧‧First input device/button

102‧‧‧Second input device/button

103‧‧‧ Third input device/button

104‧‧‧ display

105‧‧‧孔口

106‧‧‧匣 box

107‧‧‧First shroud parts

108‧‧‧Fixed cover parts

109‧‧‧Active cover parts

110‧‧‧Elongated orifice

200‧‧‧ subsystem

201‧‧‧ drive wheel

202‧‧‧Drive belt

203‧‧‧ hollow cylindrical shield parts

204‧‧‧Elongation shaft/shaft

205‧‧‧First guiding member

206‧‧‧Second guiding member

207‧‧‧ Third guiding member

208‧‧‧Test disc member

209‧‧‧Test disc member

210‧‧‧Test disc member

211‧‧‧ busbar

212‧‧‧Microprocessor

213‧‧‧ Random access memory

214‧‧‧Reading memory

215‧‧‧ button interface

216‧‧‧Display Driver

217‧‧‧Motor interface

218‧‧‧Battery

219‧‧‧Analysis interface circuit

301‧‧‧ notch

302‧‧‧ gap

303‧‧‧Top surface/upper surface

304‧‧‧Lower surface/lower surface

305‧‧‧ disc edge

306‧‧‧through hole

307‧‧‧ drive notch

308‧‧‧Isolated components

309‧‧‧Knife

311‧‧‧Circumference

312‧‧‧ first position

313‧‧‧ second position

314‧‧‧ third position

315‧‧‧ blood collection parts

316‧‧‧Analytical measurement components

317‧‧‧ Conductor orbit

318‧‧‧Contact plate/conducting plate/conducting contact

320‧‧‧Drive hook head

400‧‧‧Slit slit

401‧‧‧Swing arm

402‧‧‧ mandrel

403‧‧‧Connecting arm

404‧‧‧Upright connector

405‧‧‧Electrical contact terminals

405a‧‧‧ horizontal arm

405b‧‧‧Overhanging contact head

500‧‧‧Plunger configuration

501‧‧‧Plunger arm

502‧‧‧Pump head

505‧‧‧Test disc member

506‧‧‧Knife

506A‧‧‧Remote

507‧‧‧ fourth position

508‧‧‧ ring center position

509‧‧‧Second test disc member

600‧‧‧Test disc member

601‧‧‧Bending knife

602‧‧‧ position

701‧‧‧ button

702‧‧‧Seal

703‧‧‧protrusion

704‧‧‧ slots

705‧‧‧ sloped surface

707‧‧‧ end face

708‧‧‧ slot

The specific examples of the present invention will now be described by way of example only, with reference to the accompanying drawings in which: FIG. 1 is a perspective view of a blood glucose meter (BGM) according to the present invention; FIG. 2 is a BGM of FIG. A perspective view in which a portion is displayed in a transparent manner so that the inside of the shield is allowed to be seen; FIG. 3 is the same as FIG. 2, wherein an outer cover portion is shown as being removed; FIG. 4 is the same as FIG. 5 is a structural view of a BGM embodiment of FIG. 1; FIG. 6 is a perspective view of the BGM member of FIG. 5, wherein a hollow cylindrical shield member is transparently displayed; FIG. 7 is formed as FIG. a perspective view of the test disc member of the BGM with part 5; FIG. 8 is a perspective view of the lower side of the test disc member of FIG. 7; 9 to 12 show BGMs of Figs. 5 to 7 at different stages in the process of collecting blood samples; Fig. 13 is a perspective view of the members of BGM of Fig. 1; Fig. 14 is the same as Fig. 13 in which hollow cylinders are not shown Fig. 15 is the same as Fig. 14 in which a swing arm is placed at different positions; Fig. 16 is a perspective view showing a member of a second specific example of BGM of Fig. 1; and Fig. 17 is a view showing a test of a specific example of Fig. 16 forming a portion FIG. 18 to FIG. 21 show a specific example of BGM of FIG. 16 in different job configurations; FIG. 22 is an alternative specific example of a test chart member; FIG. 23 is a flow chart showing the BGM of FIG. Figure 24 is a flow chart showing the operation of the second embodiment of the BGM of Figure 1; and Figure 25 is a side view of the cassette contained in the BGM of Figure 1; Figure 26a is a cassette a perspective view in which a seal is partially removed and indicates the position of the seal when in a sealed position; Figure 26b is the same as Figure 26a, wherein the seal has been completely removed; Figure 26c is an end view of the cassette , the seal is in the position; and Figure 27 is a perspective, cross-sectional view of the interior surface of a BGM shroud housing the cassettes of Figures 25 and 27.

A blood glucose meter (BGM) 100 is shown in Figure 1. The BGM100 is shown in a perspective view. The BGM100 is a flat base as a whole, and this base cannot be seen in the figure. The height of the BGM 100 is approximately equal to its length and its width is approximately one third of its height.

First, second, and third input devices 101, 102, and 103 are provided on one side of the BGM 100. These input devices may take the form of, for example, push button switches or touch sensitive tranceducers. A display 104 is also provided on the side of the BGM 100 next to the input devices 101 to 103. Such a display 104 can take any suitable form, such as a liquid crystal display (LCD), e-ink, and the like. In use, the user controls the BGM 100 using the input devices 101-103 and can provide information via the display 104 via the BGM.

The front side of the BGM 100 is provided with an aperture 105. The orifice 105 is located at approximately half the height of the BGM 100. The orifice 105 is configured to receive a portion of the body of the user through which the blood sample is drawn. For example, the aperture 105 can be sized to receive the end of one side of the finger or thumb, or it can be sized to receive a side of the user's hand or a small amount of skin on the user's arm. The aperture can be rectangular in shape. The edges can be beveled to guide the user's fingers into a particular position.

The orifice 105 is provided in the side of a cassette 106 having a generally cylindrical shape and arranged upright in the BGM 100.

In particular, the BGM includes a first shroud component 107. First guard The cover member 107 forms the base of the BGM 100, the left and right side faces, and the rear side. On the front side of the BGM 100, the first shroud member 107 also includes the lowermost portion of the side. A fixed outer cover member 108 is attached to the first shroud member 107. The fixed outer cover member 108 includes most of the top surface of the BGM 100. A movable cover member 109 includes the remainder of the top surface of the BGM 100. The movable cover member is mounted above the cassette 106 at the front side of the BGM 100.

The first shroud component 107 is configured such that an elongated aperture 110 is provided at the front side of the BGM 100. The elongated aperture 110 can extend through most of the height of the front side of the BGM 100. The uppermost portion of the elongated aperture 110 is defined by the movable outer cover member 109, and the left, right and bottom portions thereof are defined by the first shield member 107. The BGM 100 is arranged such that the cassette 106 occupies the entire elongated aperture 110 area. The slidable or pivotable door in the BGM 100 shroud component 107 can cover all or a portion of the elongated aperture 110 when the BGM is not in use. The door can cover at least the aperture 105 to prevent dust or other potential contaminants from entering the aperture 105.

The cassette 106 is more clearly shown in FIG. 2 shows a perspective view similar to that of FIG. 1, but the movable outer cover member 109 and the first shroud member 107 are both shown in a line frame. As can be seen from Figure 2, the cassette 106 has a cylindrical form as a whole and is configured upright. The cassette 106 may have a diameter greater than between 5 and 50% of the width of the aperture 110. The cassette 106 has a length between 3 or 4 times its diameter.

In Figure 3, the movable cover member 109 has been removed from the BGM 100. When the movable cover member is in the positioning on the BGM, the first shroud member 107, the fixed outer cover member 108 and the movable outer cover member 109 are both configured such that the mechanical interaction between the three members is maintained The cassette 106 is removable but can be removed by the user. The exact way to remove the active cover member 109 from the BGM 100 is not Difficulties, and will not be described in detail here.

The movable cover member 109 is configured such that when removed from the BGM 100, the cassette 106 can be removed from the BGM by moving upright along its axis. In Figure 4, the cassette 106 has been shown to have been partially removed from the BGM 100. The elongated aperture 110 shows a void in the BGM 100 when completely removed. The replacement cassette can then be introduced into the BGM 100 in a manner opposite to the removal of the old cassette 106. After the bottom of the cavity in the BGM, the new cassette 106 is partially surrounded by the first shroud member 107. When the movable cover member 109 is repositioned in the position shown in Fig. 1, the cassette 106 is held in position by the action of the first cover member 107 and the movable cover member 109. In the same manner as shown in Fig. 1, the orifice 105 in the cassette 106 is displayed at the front side of the BGM 100. The cassette 106 and the cavities that receive the cassette may have keying features such as a protrusion and groove, a non-circular diameter, and the like. Thus, when the cassette 106 is fully embedded, the aperture 105 is in a fixed position in the elongated aperture 110, such as in a central position as shown in FIG.

FIG. 5 shows a subsystem 200 of the blood glucose meter 100. The subsystem 200 includes a cassette 106, a drive wheel 201 and a drive belt 202.

In Fig. 5, the cassette is shown to have a hollow cylindrical shield member 203 which forms part of the shield. The orifice 105 is formed in the hollow cylindrical shroud member 203. An elongated shaft 204 is coaxial with the hollow cylindrical shroud member 203 and only the top portion thereof is shown in FIG. The length of the elongated shaft 204 is such that the uppermost end portion thereof is slightly lower than the uppermost end of the hollow cylindrical shroud member 203. The shaft 204 is mechanically coupled to the drive belt 202 for rotation by the rotation of the drive wheel 201, which will be described below.

The first and second guiding members 205, 206 are formed together with the inner surface of the hollow cylindrical shroud member 203. In Figure 5, it can be seen that the first and second guiding members 205, 206 have a generally triangular cross section. One side of the triangular cross section of the first and second guiding members 205, 206 is integrally formed with the inner surface of the hollow cylindrical shroud member 203, and the tip end of the triangular cross section extends toward the center of the cassette 106. A portion of the length of the first guiding member 205 can be seen in FIG. 5, but only the uppermost surface of the second guiding member 206 can be seen in the drawing.

Figure 5 also shows some of the electronic components that form the components of the blood glucose meter 100. These components are all provided within the shroud 107, but are not part of the cassette 106.

A bus 211 is arranged to connect a plurality of components, including a microprocessor 212, a random access memory (RAM) 213, a read only memory (ROM) 214, a button interface 215, a display driver 216, an analysis interface circuit 219, And motor interface 217. All of the components are powered by battery 218, which may take any suitable form.

The software and firmware stored in the ROM 214 can control the operation of the blood glucose meter 100. The software/tough system is executed by the microprocessor 212 using the RAM 213. The software/tough system stored in ROM 214 is operable to operate blood glucose meter 100, such as to allow a user to control via a button or input device 101-103, the button or input device signal being detected by button interface 215. Blood glucose measurements and other information are provided on display 104 by the appropriate number of times by the software/firmware and microprocessor 212 operations via display driver 216.

Motor interface 217 allows microprocessor 212 to control the motor coupled to drive wheel 201 in accordance with software/firmware stored in ROM 214 Other motors that are included in the blood glucose meter 100 (described in more detail below).

The analysis interface circuit 219 is operable to provide an electrical signal having a voltage to the electrical contact terminal 401 and then to the contact plate 318 and the analytical measurement component 316 to measure parameters of the electrical signal to allow the microprocessor 212 to measure blood glucose of the blood sample Level.

Figure 6 is the same as Figure 5 except that the hollow cylindrical shroud component 203 is shown in wireframe to present the components inside the component 203 and to omit the display electronics. In Figure 6, the third guiding member 207 can be seen. As can be seen in this view, both the first and second guiding members 205, 206 are located only in the uppermost half of the length of the cassette 106, and the third guiding member 207 is only located in the lowermost half of the cassette 106. . The first, second, and third guiding members 205 to 207 are each distributed around the circumference of the hollow cylindrical shroud member 203. In particular, the first and second guiding members 205, 206 are each placed at approximately 100 to 160 degrees to each other. The third guiding member 207 is placed at approximately 60 to 130 degrees from each of the first and second guiding members 205, 206.

Most of the components are assembled on the shaft 204, three of which are shown in Figure 6 individually at 208, 209, 210. Members 208 through 210 will hereinafter be referred to as test disc members. Each test disc member 208 to 210 is substantially identical.

A test disc member 208 shows some details in Figure 7. The test disc member 208 has a generally circular shape, although a notch 301 is formed on one side and a notch portion 302 is provided on the other side. The notched portion constitutes an extruded portion and will be described in more detail below.

The test disc member 208 includes an uppermost surface 303, a lowermost Portion surface 304 (shown in Figure 8) and a disc edge 305. The diameter of the test disc member 208 is between 15 and 25 mm, for example 20 mm. The disc having a height equal to the height of the disc edge 305 is between 0.5 and 1 mm thick. Figure 8 shows the test disc member 208 as viewed from the bottom side. As such, the lower surface 304 can be seen, but the upper surface 303 is not visible. Test disc member 208 will now be described with reference to Figures 7 and 8.

A through hole 306 is formed in the center of the test disc member 208. The through hole 306 contains two main components. A circular member is centered on the test disc member 208 and has a diameter equal to or slightly larger than the outer diameter of the shaft 204. A drive recess 307 abuts the circular member of the bore 306 and includes an edge that can be joined by a drive hook.

A drive hook 320 (a portion visible in FIG. 9 and more fully visible in FIG. 10) is formed on the shaft 204. The drive hook 320 can be coupled to a drive recess 307 in the through hole 306 of the test disc member 208. This combination allows rotation of the shaft 204 to cause rotation of the test disc member 208.

A spacer member 308 is provided on the underside of the test disc member 208. The spacer member 308 includes a sheet of a hollow cylinder. The cylinder is centered at the center of the test disc member 208. The inner diameter of the isolation member 308 is selected such that the through holes 306 do not overlap the isolation member 308. The outer diameter of the spacer member 308 is only slightly larger than the inner diameter, and thus the spacer member 308 has a minute thickness. The height of the spacer member 308 is between 0.5 and 1 mm. When a plurality of test disc members are stacked together, the spacer member 308 provides a separation between the upper surface 303 of the test disc member and the lower surface 304 of the test disc member directly above it. The separation is determined by the height of the isolation member 308.

Referring again to Figure 7, a knife 309 projecting from the edge 305 of the disc is shown. A knife 309 is provided in the notch portion 302. The first end of the knife 309 is embedded within the material of the test disc member 208, and the second end is provided with a sharp corner and extends outward. At the end of the knife 309 is embedded at the position of the test disc member, the knife 309 extends from the radius line of the test disc member 208 at an angle between 30 and 60 degrees. The second end of the knife 309 is located or just outside the perimeter 311 of the test disc member 208. The perimeter 311 is shown in phantom in Figure 7 because it is virtual rather than tangible. The knife 309 extends from the disc edge 305 at a first location on the edge of the disc. The first position 312 is proximate to the second position 313 at which the notch portion 302 begins. The first position 312 is proximate to the second position 313 at which the notch portion 302 begins. The notch portion 302 terminates at a third location 314. Between the second and third positions 313, 314 of the notch portion 302, the disk edge 305 generally takes a circular form, although the notch 301 interrupts the circle.

A blood collection component 315 is adjacent to the third location 314. This component 315 can take any suitable form. For example, it may comprise a laminate material. The blood collection member 315 has a blood drawing function that draws blood contacting the disc edge 305 at the third position into the test disc member 208 and into the blood analysis measuring member 316 in combination with the blood collection member 315, which member 316 For example, it is a component containing an enzyme for blood glucose measurement or the like. Blood can be drawn through capillary action. Analytical measurement component 316 contains an enzyme that chemically reacts with blood, and blood glucose levels can be measured in this manner. The analysis measuring part 316 is connected to the first to third contact plates 318 by the first to third conductive tracks 317. Contact plate 318 and conductive track 317 are both formed on upper surface 303 of test disc member 208. Analytical measurement component 316 is also formed on upper surface 303 of test disc member 208. Some or all of the guide rails Lane 317, contact plate 318 and analytical measurement component 316 can be printed on upper surface 303 of test disc member 208.

As will be explained in more detail below, in use, a portion of the user is first punctured by the knife 309, which is then squeezed at the notch portion 302 by the disc edge 305, and the blood is then provided to the analytical measurement via the blood collection member 315. Component 316. A measurement circuit is coupled to the analytical measurement component 316 via a conductive track 317, and the contact plate 318 can then determine the blood glucose level of the user. This level is then displayed on display 104.

The operation will now be described with reference to the drawings.

As shown in Figure 6, test disc members 208-210 begin in the same orientation. Here, the first test disc member 208 is at the top. The third guiding member 207 is placed in the recess 301 of the lowermost test disc member 209, 210. The notch 301 of the first disc test member 208 is aligned with the third guiding member 207, but is not thereby limited. The upper surface 303 of the uppermost test disc member 208 is in contact with the lowermost surface of the first guiding member 205. The lowermost surface of the second guiding member 206 is at the same level as the lowermost end of the first guiding member 205. However, in the orientation of the test disc member 208 shown in FIG. 6, the second guide member 206 coincides with the notch portion 302 of the first test disc member 208. As such, when the first test disc member is in this position, there is no contact between the second guide member 206 and the first test disc member 208. The test disc members 208 to 210 are each biased in an upward direction by a biasing mechanism (not shown) which can be a spring. However, due to the contact of the upper surface 303 of the first test disc member 208 with the lowermost end of the first guiding member 205, the test disc members 208 to 210 can be prevented from moving upward within the cassette 106.

At the position shown in Fig. 6, the distal end of the knife 309 does not cooperate with the aperture 105. As such, the knife 309 in this position fails to operate. Stated another way, the knife 309 in this position is shielded by a hollow cylindrical member 203 that forms part of the shield.

At the position shown in Fig. 6, the action of the drive wheel 201 and the drive belt 202 causes the shaft 204 to rotate in a clockwise direction. The drive hook 320 is coupled to the drive recess 307 in the through bore 306 of the test disc member 308 and thus allows rotation of the shaft 204 and results in rotation of the test disc member 308. Rotation can carry the knife 309 to the front of the orifice 105. Thus, the user's skin covering portion (which will be referred to hereinafter as the user's finger for ease of explanation) is punctured by the knife 309. Thus, a small hole is created in the user's finger from which blood can flow out. Figure 9 shows the first test disc member 208 being rotated to a position where the knife 309 can pierce the user's finger. The shaft 204 causes rotation only in a predetermined total amount, and the maximum degree of travel of the knife 309 is controlled. The puncture of the knives 309 on the user's fingers is based on a number of factors, as will be appreciated by those skilled in the art. The total amount of rotation and thus the depth of penetration can be determined by the user. The rotation of the shaft 204 is controlled via the soft body or the firmware to achieve a user-specified penetration depth. The user can define the penetration depth, for example, using one or more of the first, second, and third input devices 101-103. For example, the first and second input devices 101, 102 can be individually increased and decreased, and the third input device 103 can be a selection or confirmation input device. The value defining the depth can be stored in the memory. Thereafter, the shaft 204 is controlled to rotate in the counterclockwise direction. This may cause the knife 309 to be removed from the user's finger, and the disc edge 305 at the notch portion 302 may be used to rub the user's finger as the test disc member 208 is rotated. At a point at which the test disc member 208 is rotated, the second guiding member 206 The lowermost portion stops to coincide with the notch portion 302, and thus a reaction force can be applied to the upper surface 303 of the test disc member 208. After a short period of time, the first guiding member 205 becomes a coincident notch portion and stops contacting the upper surface 303 of the test disc member 208. At this point, the first test disc member 208 is prevented from moving upward within the cassette by the second guiding member 206.

The test disc member 208 continues to rotate until the blood collection site 315 is aligned with the aperture 105. Here, the rotation is stopped. At this position, blood from the user's finger caused by the action of the knife 309 on the user's finger on the edge 305 of the disc is drawn to the analytical measuring member 316 by capillary action. The blood then reacts with the enzyme.

At a suitable time, the shaft 204 is caused to rotate further in the counterclockwise direction. Here, the test disc member 208 is caused to rotate to the position shown in Fig. 11 from the position where the blood collection portion 315 shown in Fig. 10 coincides with the orifice 105. Here, the notch 301 is aligned with the second guiding member 206. Because the first guiding member 205 coincides with the notch portion 302 of the test disc member 208 at this location, neither of the first or second guiding members 205, 206 fails to prevent upward movement of the first test disc member 208. Thus, the first to third disc members 208 to 210 are each moved upward by the bias of a biasing mechanism (not shown).

When the first test disc member 208 is moved upward, between FIGS. 11 and 12, the drive hook 320 stops cooperating with the drive recess 307 of the through hole 306 of the first test disc member 208. The lower surface of the drive hook 320 contacts the upper surface 303 of the second test disc member 209 before the first test disc member 208 reaches the position shown in FIG. This further prevents further upward movement of the second test disc member 209 and thus prevents the test disc member 210 from moving further upwards mobile. At this position, the shaft 204 is caused to rotate by the drive wheel 201 and the drive belt 202 such that the drive hook 320 overlaps the drive recess 307 of the second test disc member 209. At this location, the second disc member 209 is movable upwardly on the shaft 204, thereby engaging the drive recess 320 and the drive recess 307 of the second test disc member 209. After the second test disc member 208 is moved upward at a distance equal to the height of the spacer member 308, the second is prevented by contact between the first guiding member 205 and the upper surface 303 of the second test disc member 209 The test disc member 209 is further moved upward. At this point, which is shown in FIG. 12, the second guiding member 206 is placed within the recess 301 of the first test disc member 208. This further prevents the first test disc member 208 from rotating further within the cassette 106.

Due to the upward movement of the first to third test disc members 208 to 210 in the cassette 106, the third guiding member 207 stops being placed in the recess 301 of the second test disc member 209. At this stage, the third guiding member 207 cannot prevent the rotational movement of the second disc member 209.

In the position shown in Figure 12, the position of the second test disc member 209 is identical to the position of the first test disc member 208 shown in Figure 6. Further, the shaft 204 and thus the drive hook 320 all have the same orientation. As such, the second test disc member 209 can be used to draw a blood sample from the user and test its blood glucose level in the same manner as the first test disc member 208.

The cassette 106 can be used for multiple testing by providing a stack of test disc members 208 to 210 within the cassette 106 and arranged by a suitable physical configuration. When the cassette 106 is new, the test disc members 208 to 210 are both located in the bottom half of the cassette 106, and the uppermost test disc member is aligned with the aperture 105. After the test disc member is used, the stack of test disc members moves upward in the crucible. After the last test disc member is used, the cassette can be said to have been exhausted. At this stage, all of the test disc members are located in the uppermost portion of the cassette 106.

It is to be understood that the number of test disc members 208 to 210 that can be housed in the cassette 106, and thus the number of tests that the cassette 106 can provide, is determined by the height of the cassette 106, and adjacent test disc members 208. It depends on factors such as the separation distance between the corresponding components of 210 (for example, the upper surface). A higher cassette and/or a reduced separation distance of the test disc member can increase the number of times the test is performed using a single cassette 106.

Reference will now be made to Figures 13 through 15 which show the connection of the analytical measuring component 316 to the measuring circuit (not shown).

Referring first to Figure 13, it is shown that the hollow cylindrical shroud member 203 provided with the apertures 105 and the shaft 204 are placed as previously described. A slotted opening 400 is provided in the hollow cylindrical shield member 203. The slotted aperture 400 is placed at a level substantially the same as the aperture 105. However, the slotted opening 400 is placed on one side of the hollow cylindrical shroud member 203 substantially opposite the aperture 105.

The slotted aperture 400 does not coincide with the elongated aperture 110 formed at the front side of the BGM 100. As such, the slotted aperture 400 is not visible when the cassette 106 is positioned within the BGM 100.

Fig. 14 is the same as the one shown in Fig. 13, but the hollow cylindrical shield member 203 is omitted.

A swing arm 401 is placed adjacent to the slit aperture 400. As shown in Figure 15, the swing arm 401 is rotatable about a mandrel 402. The axis of the mandrel 402 Parallel to the axis of the shaft 204. The axis of the mandrel 402 is placed over the drive belt 202. A connecting arm 403 connects the mandrel 402 to the swing arm 401. In this example, the connecting arm 403 is coupled to the swing arm 401 by an upright connector 404. The upright connector 404 allows the mandrel 402 to which the connecting arm 403 is fitted to be placed at different upright positions relative to the swing arm 401. The mandrel 402, the link arm 403, and the upright connector 404 are each arranged such that when the link arm 403 is rotated on the axis of the mandrel 402, the swing arm 401 is moved toward the axis. The movement of the swing arm 401 with respect to the shaft 204 is substantially radial.

First to third electrical contact terminals 405 are mounted on the swing arm 401. Each of the terminals includes a horizontal arm 405a and a depending contact head 405b. The electrical contact terminals 405 are each fabricated from an elastic conductive material such as metal. The overhanging contact head 405b forms an oblique angle at the farthest end of its swing arm 401.

In the positions shown in Figures 13 and 14, the electrical contact terminals 405 are each supported by the swing arm 401 such that the depending contact heads 405b are all located within the slotted apertures 400, or alternatively may be located within the hollow cylindrical shield member 203. Outside. As shown in FIG. 14, when the test disc member 208 is rotated such that the blood collection member 315 coincides with the aperture 105, the contact plates 318 are coincident/aligned with the slotted aperture 400. When the test disc member 208 is held in this position, the connecting arm 403 is caused to rotate about the axis of the mandrel 402 such that the swing arm 401 moves toward the shaft 204. This configuration is such that when the electrical contact terminal 405 is moved into the space above the upper surface 303 of the test disc member 208, the overhanging contact head 405b of the electrical contact terminal 405 is in contact with the contact plate 318, and the horizontal arm 405a is not associated with the plate. 318 contact. The resilient nature of the electrical contact terminals 405 causes the electrical contact terminals to be pressed against the contact plate 318. Thus, at the horizontal arm 405a of the electrical contact terminal 405 and the analysis measuring component 316 An electrical connection is provided. An electronic measuring mechanism (not shown) connected to the electrical contact terminal 405 operates to transmit a voltage through the electrical contact terminal 405 and the analytical measuring component 316 and to take measurements of electrical parameters, thereby determining, for example, blood glucose The measured value of the concentration level is measured.

The connecting arm 403 is controlled to remain in the position shown in Figure 15 for a predetermined time, or alternatively until it detects that the blood glucose level measurement has been completed, and then the connecting arm 403 is caused to rotate about the mandrel 402, The electrical contact terminal 405 is removed from the position above the upper surface of the test disc member 208. At this stage, the configuration is as shown in FIG. After the electrical contact terminals 405 have been withdrawn, the test disc member 208 is rotated in a counterclockwise direction to allow the test disc members 208-210 to move up on the shaft 204.

Alternatively or additionally, at least a portion of each of the conductive contact plates 318 is substantially concentric with the shaft 204. As such, a plurality of terminals 405 are allowed to remain in contact with their individual conductive contact plates 318 as the member rotates. Thus, for example, the test disc member 208 can be rotated away from the position at which the blood analysis component is exposed to collect the blood sample while still allowing the majority of the terminals 405 to maintain electrical contact with the blood analysis member.

It must be understood that the maximum allowable height dimension of the electrical contact terminals 405 is determined by the height of the isolation member 308. A thicker isolation member allows the use of larger electrical contact terminals 405. However, this increases the separation distance between adjacent test disc members 208 to 210 and thus reduces the capacity of the cassette 106. The use of an electrical contact terminal 405 comprising a horizontal arm 405a and a depending contact head 405b allows for minimizing the height dimension of the electrical contact terminals while still allowing excellent electrical contact between the electrical contact terminals and the contact plate 318, and also allows for a sufficient number of times After recycling The electrical contact terminal 405 can still be operated correctly.

Referring now to Figures 16 through 21, an alternative configuration incorporating a novel piercing technique is shown.

As shown in Fig. 16, the hollow cylindrical shroud member 203 is provided with an orifice 105 and a slit orifice 400. The shaft 204 is centrally supported within the hollow cylindrical shroud member 203 of the cassette 106. However, the diameter of the shaft is smaller than the specific examples described above.

The plunger arrangement 500 includes a plunger arm 501 and a plunger head 502 that is provided adjacent a plunger orifice (not shown) in the hollow cylindrical shroud component 203. A plunger orifice (not shown) is placed against the slit orifice 400. A plunger orifice (not shown) is placed directly opposite the orifice 105. The plunger aperture and slotted aperture 400 can be combined to form a single aperture. The plunger orifice is configured to allow the plunger head 502 to be pressed into a position inside the hollow cylindrical shroud component 203 by the plunger arm 501.

A plurality of test disc members are provided in the cassette 106, one of which is shown as 505 in FIG. Here, similar originals retain the reference numbers in the foregoing figures.

A knife 506 is provided extending from the disc edge 305 in the indentation site 302. In particular, the lance 506 extends in a radial direction with respect to the center of the test disc member 505. The knife 506 extends from a fourth position near the second position. The fourth position 507 is further from the second position 313 than the corresponding first position 312 in the previous specific example. However, because the lance 506 is radially related to the test disc member 505, the distal end 506A of the lance 506, i.e., the distal end that is furthest from the center of the test disc member 505, is approximately the same end as the lancet 309. position.

The main portion of the test disc member 505 is substantially rigid. However, an annular central portion 508 is constructed of an elastically deformable material. special, The annular central portion 508 is deformable when an external force is applied. This represents that the test disc member 505 can be displaced relative to the shaft 204 as will be described in more detail below. The material used to form the annular central portion 508 can take any suitable form and can be, for example, a rubberized plastic.

In Fig. 18, the hollow cylindrical shield member 203 is omitted from the drawings. In Figure 18, the test disc member 505 has been rotated to the position where the knife 506 coincides with the aperture 105. It can be seen that the plunger head 502 is aligned with the test disc member 505 such that the plunger arrangement 500 moves along the longitudinal axis of the plunger arm 501, leading to the plunger head contacting the test disc member and applying pressure thereto. . Because the longitudinal axis of the plunger arm 501 is radially related to the shaft 204, the force applied by the plunger arrangement is directed to the shaft 204.

In Figure 19, this configuration shows the displacement of a force in a predetermined amount after it has been applied to the plunger arrangement 500. Here, the plunger head 502 has contacted the test disc member 505 on the side relative to the lancet 506. The annular central portion 508 is compressed on the side closest to the plunger arrangement 500 such that the overall test disc member 505 is displaced in the direction in which the plunger arrangement 500 applies pressure. Due to the function of the isolation member 308, the test disc member 505 maintains a level.

The displacement of the test disc member 505 in the direction of the supply pressure of the plunger arrangement 500 has resulted in the displacement of the lance 506 radially away from the shaft 204. In this position, the knife 506 penetrates the skin of the user's finger. The pressure of the plunger arrangement 500 is removed, allowing the annular central portion 508 to return to its original form (via elastic recombination). After the plunger configuration 500 has been fully retracted, the configuration again has the form shown in FIG. Here, the test disc member 505 is in its original position and the knife 506 is retracted from the user's finger. Preferably, When the pressure supplied through the plunger arrangement 500 is removed, the elasticity of the annular central portion 508 of the test disc member 505 allows the test disc member 505 to return to this position.

After the pressure supplied by the plunger arrangement 500 is removed, the test disc member 505 can be rotated by the drive wheel 201 and the drive belt 202 to provide for squeezing the user's finger and then collecting blood at the blood collection site 315, which The location is shown in Figure 20. After performing the measurement of the blood glucose level, the test disc member 505 is further rotated in a counterclockwise direction, so the second guiding member 206 is aligned with the recess 301 and thus allows the test disc member 505 to move upward within the cassette 106. As a result, the test disc member 509 directly below the first test disc member 505 is also moved upward within the cassette 106 and is provided to coincide with the aperture 105, the slotted aperture 400, and the plunger aperture (not shown). In the picture). Thereafter, the plunger arrangement 500 applies pressure, causing the lancet 506 of the second test disc member 509 to be forced out of the orifice 105, as shown in FIG. The execution of other test disc members contained in the cassette 106 can be repeated.

The advantage of the configuration shown in Figures 16 through 21 is that a rotational configuration can be used while allowing the knife 506 to penetrate the user's skin in the longitudinal direction associated with the knife 506. Another advantage is that a puncture can be created at any desired location, such as on the end of a user's finger, instead of a puncture occurring on the sides of the microtips at the end of the finger.

Another advantage is that this configuration may allow for easy prediction of the penetration depth of the knife 506.

In addition, it allows for adjustable penetration or penetration depth. In particular, wear can be achieved by a mechanical arrangement that limits the movement of the plunger arrangement toward the shaft 204. Through depth adjustment. Alternatively, the depth adjustment can be achieved electromechanically by measuring the position or displacement of certain components of the mechanism and stopping applying the energizing voltage to an electromagnetic coil or other transducer that is used to affect the movement of the plunger arrangement 500. Penetration depth control is important to many users because lancet penetration is often painful and because penetration depth control allows the user to control via their experience.

An alternative form of test disc member 600 is shown in FIG. Similar originals retain the reference numbers in the previous specific examples.

The difference between the test disc member 600 and the test disc member 208 shown in Figure 7 is primarily the use of a curved lance 601. The curved lance 601 protrudes from the disc edge 305 at a position 602 that is relatively close to the second position 313 at the beginning of the notch portion 302.

The curved lance 601 is adjacent to a portion of the disc edge 305, and the longitudinal axis of the curved lance 601 is drawn at an angle X relative to the intersection between the curved knive 601 and the disc edge 305 and the center of the shaft 204. Straight line. The curvature of the curved knives 601 is such that the longitudinal axis of the curved lance 601 at the end remote from the edge 305 of the disk is at an angle greater than the angle X relative to the intersection and axis between the curved knives 601 and the edge 305 of the disk. The line drawn between the centers of 204. The purpose is to align the distal end of the curved scalpel 601 with the periphery of the test disc member 600 more than the end of the curved lance 601 in conjunction with the disc edge 305. When the knife punctures the user's finger or other body part due to the rotation of the test disc member 600, such a configuration has a positive effect, and the path of the knife passing through the user's finger is more experienced than the corresponding configuration in which the straight knife is provided. The shape and orientation of the knife can be more closely matched.

This effect of the knife 601 is further enhanced because the cylindrical form of the knife 601 terminates at the distal end by beveling. In particular, the distal end of the curved lance 601 resembles a cylinder that has been cut at an oblique angle that is not perpendicular to the longitudinal axis of the cylinder. Thus, the end face of the curved lance 601 has an elliptical shape. The ellipse has a half major axis and a half short axis, and a tip at the end of the semi-long axis that forms a tip at the furthest from the edge 305 of the disc. The slit is formed by the knife 601 such that the tip is formed to extend in a substantially peripheral direction associated with the test disc member 600.

The configuration of the test disc members 208 to 210, 505, 600 is such that the result of the squeezing operation can be performed in the perforations in the user's fingers caused by the lancet 309. In particular, the aperture 105 is configured such that when the user presses the finger toward the aperture 105, the meat at the end of the user's finger can be exposed within the interior space of the cylindrical member 203. When the user applies pressure into the aperture 105 with a finger, the finger is twisted and the meat of a bulbous portion of the finger is provided within the inner diameter of the hollow cylindrical shield member 203. The size of the bulbous portion, and in particular the height of the bulbous portion, is determined by a number of factors, including the physical characteristics of the user's fingers and the strength of the force applied by the user, as well as the configuration of the orifice 105.

The orifice 105 is sized such that in normal use (i.e., a typical strength is applied to a typical user), the bulbous portion of the user's finger extends into the interior of the hollow cylindrical member 203 to a depth of about 1 mm. . The test disc members 208 to 210, 505, 600 are each configured with a notch portion 302 that is shaped such that when the lancet 309 is at a position where the user's finger can be cut, the disc edge 305 does not contact The finger (ie, the separation between the disc edge 305 and the aperture 105 is greater than 1 mm). Notch portion 302 This portion of the portion can be defined as a first extrusion site. This notch portion 302 can be defined as a first extruded portion. In this position, the pressure exerted by the user causes the fluid pressure in the bulbous portion of the finger to be slightly greater than the normal pressure. The increased pressure is caused by the force applied by the user to their fingers. This pressure can excite the bleeding of the cut-out caused by the knife 309. advantageous. The configuration of the related features is such that the knife 309 penetrates the user's finger to a depth of between 0.4 and 0.7 millimeters.

Since the test disc members 208 to 210, 505, 600 are then rotated in the counterclockwise direction, the knife 309 is removed from the user's finger. In a short time thereafter, the end of the bulbous portion of the user's finger contacts the disc edge 305 at a position along about one-third to two-fifth of the gap portion 203. This part can be defined as the second extrusion site. The test disc members 208 to 210, 505, 600 have a substantially constant radius at the second extruding site, the second extruding portion extending to approximately two-thirds or four-fifths of the gap portion 302. . When the test disc members 208 to 210, 505 rotate, the second squeeze portion overlaps the bulbous portion of the user's finger, and the internal pressure of the bulbous portion of the user's finger is compared with when the user's finger contacts the knife 309. Was added. In addition, as the disc edge 305 moves into contact and passes through the finger bulbous portion, blood under the skin is caused to push the perforations caused by the scalpel.

Between the second extrusion site and the position of the blood collection member 315, the radius of the test disc members 208 to 210, 505, 600 is reduced, or in other words, has a lower value. This portion can be defined as the third extrusion site. Thus, the pressure applied by the disc edge 305 to the bulbous portion of the user's finger and the pressure applied at the second extruding portion are reduced before the user receives the blood collecting member 315 after the second squeezing portion. . Advantageously, the test disc member 208 is The radius of the 210, 505, 600 at the third squeezing position is selected such that the bulbous portion of the user's finger does not contact the disc edge 305 (ie, the separation between the disc edge 305 and the aperture 105 is greater than 1 mm). ). At the same time, the third squeezing portion overlaps the user's finger when the test disc members 208 to 210, 505, 600 rotate, and the blood freely flows out from the perforation caused by the lance 309. As the test disc members 208 to 210, 505, 600 continue to rotate, the disc edge 305 again contacts the bulbous portion of the user's finger at a position prior to the blood collection site 315. In this way, the internal pressure in the bulbous portion of the user's finger is again increased. Thus, the excitation blood moves toward the analysis measuring portion 316. The separation of the disc edge 305 between the location of the blood collection site 315 and the aperture 105 is approximately 0.5 mm.

The configuration of the test disc members 208 to 210, 505, 600 thus energizes the blood sample from the user's fingers. The sequence is as follows: First, the knife 309 is cut at a relatively low pressure (lower pressure caused by the disc edge 305 not touching the user's finger), and the relatively low amount of pressure and massage motion for the next period of time is second squeezed. The portion is provided to the user's finger, with little or no pressure being provided to the user's finger by the disc edge 305 for a period of time, followed by a relatively high pressure from the disc edge 305 to the user's finger prior to the blood collection member 315. .

The operation of the blood glucose meter 100 will now be described with reference to the flowchart of FIG. The job starts in step S1. In step S2, the user places a finger in the aperture 105. As previously mentioned, the user presses their fingers into the aperture 105 with a pressure or force suitable to allow cutting and blood collection. In step S3, the user initiates a blood glucose measurement. This involves the user pressing one of the input devices 101 to 103. Microprocessor 212 detects this input via button interface 215. Stored in The software/firmware in ROM 214 uses a button input to perform a function or execute a software module. The software/firmware stored in the ROM 214 then causes the microprocessor 212 to issue an instruction via the motor interface 217 to the motor that is attached to the drive wheel 201 to rotate the shaft 204 in a clockwise direction. The software/firmware controls the degree of rotation. In step S4, the total amount of rotation is sufficient to cut the user's finger with the knife 309. In step S5, the software/firmware stored in ROM 214 then causes microprocessor 212 to control the motor to rotate shaft 204 in the opposite direction. In step S6, the extrusion is caused by the test disc member rotating against the clock. First, in step S6A, no pressure is applied to the finger by the test disc member. At step S6B, a moderate amount of pressure is applied to the finger. At step S6C, low or no pressure is applied to the finger by the test disc member. At this point, the finger is placed in front of the blood collection member 315 to coincide with the components of the test disc member.

In step S7, when the shaft 214 causes the blood collection member 315 to coincide with the aperture 105 and thus coincides with the user's finger, the software/firm body causes the microprocessor 212 to control the motor to stop rotating. In step S8, the software/firmware control motor causes the swing arm 401 to be rotated toward the shaft 204. The software/tough system stored in ROM 214 causes microprocessor 212 to cause swing arm 401 to have only the desired total amount of travel. At this point, the analysis interface circuit 219 is directly coupled to the blood analysis measurement component 316, which has been provided with blood from the user's finger by the action of the blood collection component 315. At step S9, an analytical measurement is performed. This involves the analysis interface circuit 219 providing a voltage to the electrical connection contact plate 318, and thus to the blood analysis measurement component 316 and measuring the parameters of the generated signal. The measured parameters, particularly a voltage parameter, are used by the software/firmware stored in the ROM 214, and the microprocessor 212 performs the calculation of the user's blood glucose measurement level. Blood glucose measurement The effect on the display driver 216 via the microprocessor 212 then causes it to be displayed on the display 104. In step S10, under the control of the software stored in the ROM 214, the swing arm is removed by the action of the microprocessor 212, the motor interface 217, and the motor (not shown).

In step S11, the software/firmware causes the microprocessor 212 to control the drive wheel 201 to rotate in the counterclockwise direction. The rotation continues until the recess 301 on the test disc member coincides with the guide 206. At step S12, the test disc member is raised in the cassette 106. The condition in which the test disc member is biased in the cassette 106 is provided by, for example, a spring biasing mechanism, and step S12 does not require any action of the software/firmware and microprocessor 212 components, although it may be required prior to the next step. time out. In a specific example where the test disc member moves along the axis 204 via a drive action, step S12 involves the microprocessor 212 controlling the motor via the motor interface 217 under software/firmware control stored in the ROM 214. Thereafter, in step S13, the microprocessor 212 causes the shaft 204 to rotate again in the clockwise direction under the software/firmware control stored in the ROM 214, and when the drive hook 320 is coupled to the next test in the cassette 106. When the member drives the notch 307, the rotation stops. At this stage, the test disc member rises slightly in the cassette 106.

The job is aborted at step S14

Fig. 24 shows the operation of the blood glucose meter 100 explained with reference to Figs.

The job starts at step T1. At step T2, the user places a finger in the aperture 105. As previously mentioned, the user presses their fingers into the aperture 105 with a pressure or force suitable to allow cutting and blood collection. At step T3, the user initiates a blood glucose measurement. This involves the user pressing the input devices 101 to 103. one. Microprocessor 212 detects this input via button interface 215. The software/firmware stored in the ROM 214 employs a function or executes a software module using key input. The software/firmware stored in the ROM 214 then causes the microprocessor 212 to issue an instruction via the motor interface 217 to the motor attached to the drive wheel 201 to rotate the shaft 204 in a clockwise direction. The software/firmware controls the degree of rotation.

Following the step T3, in step T4A, the microprocessor 212, under software/firmware control stored in the ROM 214, causes the shaft 204 to be rotated by the motor via the motor interface 217, and the apertures 508 are aligned with the apertures 508 and thus aligned with the user. Stop rotating when your finger. At step T4B, the microprocessor 212 causes the plunger arrangement 500 to be actuated via the motor interface 217 under software/firmware control stored in the ROM 214. The control of the plunger actuation causes the degree of movement of the knives 508 to be limited to a predetermined extent. The predetermined degree is set by the user via the operation buttons 102, 103 before the blood glucose measurement. In effect, the user can use the buttons 102, 103 to set the depth of cut, which is stored in the ROM 214 by the microprocessor 212 in a suitable manner and operates under software/firmware control stored in the ROM 214.

When the maximum degree of plunger actuation is reached in step T4B, in step T4C, under software/firmware control stored in ROM 214, microprocessor 212 deactivates the plunger configuration and stops cutting. In this step, the test disc member is returned to its original position by the resilient action of the annular central portion 508 of the test disc member 508.

Although in the drawings, particularly in Figure 7, three conductive tracks 317 and three conductive plates 318 are shown, it must be understood that this is for exemplary purposes only. Conversely, there may be only two conductive tracks 317 and two conductive plates, or alternatively, there may be more than three Conductive track and conductive plate.

At step T5, the software/firmware stored in ROM 214 then causes microprocessor 212 to control the motor to rotate shaft 204 in the opposite direction. At step T6, the extrusion is caused by the rotation of the test disc member in the counterclockwise direction. First, in step T6A, no pressure is applied to the finger by the test disc member. At step T6B, a moderate amount of pressure is applied to the finger. At step T6C, low or no pressure is applied to the finger by the test disc member. At this point, the finger is placed in front of the blood collection member 315 to coincide with the components of the test disc member.

At step T7, when the shaft 214 causes the blood collection member 315 to coincide with the aperture 105 and thus coincides with the user's finger, the software/firm body causes the microprocessor 212 to control the motor to stop rotating. At step T8, the software/firmware control motor causes the swing arm 401 to be rotated toward the shaft 204. The software/tough system stored in ROM 214 causes microprocessor 212 to cause swing arm 401 to have only the desired total amount of travel. At this point, the analysis interface circuit 219 is directly coupled to the blood analysis measurement component 316, which has been provided with blood from the user's finger by the action of the blood collection component 315. At step T9, an analytical measurement is performed. This involves the analysis interface circuit 219 providing a voltage to the electrical connection contact plate 318, and thus to the blood analysis measurement component 316 and measuring the parameters of the generated signal. The measured parameters, particularly the voltage parameters, are used by the software/hardware stored in the ROM 214, and the microprocessor 212 performs the calculation of the user's blood glucose measurement level. The blood glucose measurement is then displayed on the display 104 by software/firmware via the action of the microprocessor 212 on the display driver 216. In step T10, under the control of the software stored in the ROM 214, the swing arm is removed by the action of the microprocessor 212, the motor interface 217, and the motor (not shown).

In step T11, the software/firmware causes the microprocessor 212 to control the drive wheel 201 to rotate in the counterclockwise direction. The rotation continues until the recess 301 on the test disc member coincides with the guide 206. At step T12, the test disc member is raised in the cassette 106. The case where the test disc member is biased in the cassette 106 is provided by, for example, a spring biasing mechanism, and step T12 does not require any action of the software/firmware and microprocessor 212 components, although it may be required prior to the next step. time out. In a specific example where the test disc member moves along the axis 204 via a drive action, step T12 involves the microprocessor 212 controlling the motor via the motor interface 217 under software/firmware control stored in the ROM 214. Thereafter, at step T13, the microprocessor 212 causes the shaft 204 to rotate again in the clockwise direction under software/firmware control stored in the ROM 214, and when the drive hook 320 is coupled to the next test disc in the cassette 106. When the member drives the notch 307, the rotation stops. At this stage, the test disc member rises slightly in the cassette 106.

The job ends in step T14.

Substituting the blood collection member 315 in close proximity to the third position 314, i.e., the boundary frame of only the portion of the fully circumferential disc edge 305, the blood collection member can be placed at the notch portion 302 in combination with the circumferential periphery. At the point of the disc edge 305. In this case, the blood collection member 315 can extend between the gaps 302 along the disc edge 305 by between 0.5 mm and 2 mm. In this case, the blood collecting member 315 may also extend between the disc edges 305 by 0.5 mm and 2 mm at the peripheral portion.

Alternatively or additionally, the analytical measurement component 316 can be clamped between two layers of wicking material that causes blood to be drawn through the analytical measurement component 316.

Although the shaft 204 is driven by the drive wheel 201 coupled to the shaft 204 by the drive belt 202 (ie, the drive mechanism is directly coupled to the shaft 204), or may be by a toothed belt, a V-belt, or directly Gear drive connection. A clockwork drive can be used instead of an electric motor. The clockwork drive mechanism has a number of advantages, particularly in the case of battery or battery charging or limited power supply. In a specific example using a clockwork mechanism, the user can ensure that the BGM 100 does not stop working because the battery power is exhausted. Clockwork agencies may be particularly suitable for developing countries and emerging markets.

In a specific example of driving the shaft 204 using an electric motor, it is preferred to control the motor by software. In this way, the rate of rotation can be easily controlled. In addition, it is easier to control the degree of rotation. The motor can be a stepper motor.

Alternatively, in this case, the mechanical drive configuration can be manually actuated, for example, using a lever or other device. Suitable mechanisms can be similar to those previously used in SLR cameras.

The swing arm 401 can be steered in any suitable manner. For example, it can be driven by a motor or mechanism that is identical to the shaft 204. Alternatively, it can be driven by a separate motor. In either case, the rotation of the swing arm 404 can be affected by a cam mechanism, or a pin and slot (track path) mechanism. In the case of an electric motor, the motor is preferably driven by a soft body. The motor is preferably a stepper motor.

The mechanical arrangement can include a mechanism that is biased and then released by a biasing member, such as a mechanical compression spring, to push the electrical contact terminal 405 into position. The terminal 405 can then be withdrawn by the swing arm 401 using a rotational motion. The overall mechanism can be defined as a latch type trigger mechanism.

Instead of using the swing arm 401 to rotate the electrical contact terminal 405 into the fixed Position, contact plate 318 can be placed over disc edge 305 to allow for the use of fixed electrical contact terminals 405. The electrical contact terminals can include a brush or other deformable feature such that the test disc members 208 to 210, 505, 600 can move and simultaneously contact the electrical contact terminals without any component damage. A similar configuration is used in brushed DC motors. In this case, the electrical contact terminals 405 can be flexible finger contacts that are placed around the test disc members 208 to 210, 505, 600.

Alternatively, in addition to the swing arm 401, a mechanism can be used to affect the longitudinal movement of the electrical contact terminal 405 into contact with the contact plate 318.

The conductive track 317 and the contact plate 318 may be formed by a lead frame. Alternatively, a molding method can be used. Alternatively, printed circuit board (PCB) printing can be used.

Alternatively, each test disc member 209, 210, 505, 600 is separated from adjacent test disc members by a film (not shown). In this case, the film is preferably tightly fitted to the inner surface of the hollow cylindrical shroud member 203. One effect of the film is to reduce the likelihood of disc cross-contamination. The use of a film may allow the test disc members 208 to 210, 505, 600 to have a reduced separation distance than if the film were not used.

The test disc members 208 to 210, 505, 600 in the foregoing are biased upward by a biasing mechanism such as a compression spring. Other selectable mechanisms can be used to move the test disc members 208 to 210, 505, 600 up in the cassette. For example, a threaded raised cam can be provided on the shaft 204 or alternatively on the interior surface of the hollow cylindrical shroud component 203. Alternatively, the test disc members 208 to 210, 505, 600 may remain stationary and the apertures 105 and drive hooks 320 are replaced to move along the axis of the cassette 106. By an elongation The movement of the orifice 105 can be achieved by using a sliding door in the notch. Movement of the door allows different strips to be exposed at the aperture 105.

The blood collecting member 315 is replaced by capillary action to the analytical measuring member 316, and the blood can be connected to the analytical measuring member 316 by gravity.

Additionally, the test disc members 208 to 210, 505, 600 can include a disinfecting or cleaning site that contacts the fingers prior to cutting. This reduces the risk of wound infection and can also increase accuracy by removing any glucose from the skin, which may occur after eating fruit or the like.

Alternatively or additionally, the test disc members 208 to 210, 505, 600 may include a cleaning portion that is arranged to contact the finger after the blood collection member 305. This removes excess blood from the finger and can also act to assist in closing the perforation.

The device referred to herein is also described in PCT/EP2011/061536.

Although not shown in Figures 13 and 16, the cassette 106 is provided with a seal 702 above the orifice 105.

Most preferably shown in Figure 26a, the seal 702 is a rectangular member as a whole, but other shapes are possible. The seal 702 has a longitudinal axis that is substantially aligned parallel to the longitudinal axis of the cassette 106. The seal 702 is planar and the seal 702 can be formed from a sheet of plastic material.

The front side of the seal 702 is in close contact with the outer side surface of one of the side walls of the cassette 106 when the seal 702 is positioned. The best is shown in Figures 26a and 25. In these figures, the seal 702 is shown in two positions. In the first position, shown in phantom in the figure, the seal extends through the aperture 105 (see Figure 26a, Figure 25 is not visible). In the second position, the seal 702 has been oriented toward the cassette 106 The end face 707 is oriented along the longitudinal axis of the seal 702 and parallel to the longitudinal axis of the cassette 106.

When the seal 702 is in the sealed position, i.e., at the location covering the aperture 105, the seal 702 is affixed to the outer sidewall of the cassette 106. Seal 702 can be secured by a non-permanent adhesive. Adhesives can be provided around the entire circumference of the aperture 105, thereby creating a moisture seal that prevents moisture from entering the interior of the cassette 106 via the aperture 105. The seal 702 may not require an adhesive adjacent to the aperture 105. Seal 702 can also be bonded directly to the cassette by only a non-permanent adhesive.

The orifice 105 is covered by one end of the seal 702 when the seal 702 is positioned. A button 701 is attached to the other end of the seal 702. The button 701 is a molded plastic member. Button 701 is secured to seal 702 in any suitable manner. As will be appreciated from the following description, the button 701 is sufficiently secured to the seal 702 to allow the application of the required force to overcome the viscous force of the adhesive when the seal 702 is separated from the outer surface of the cassette 106.

A protrusion 703 is formed on the cassette 106. The projection 703 is located on the side wall of the cassette 106. The projection 703 is located at the end of the cassette 106 and is thus located at the junction between the end face 707 and the side wall of the cassette 106. As can be seen more clearly from Figures 26b and 26c, the protrusion 703 has a substantially circular triangular cross section. The protrusions 703 all have approximately the same cross section in length. This length generally runs parallel to the longitudinal axis of the cassette 106.

The projections 703 have a height that is a few millimeters from the longitudinal axis of the cassette 106, for example between 1 and 5 millimeters. The projection 703 has a length of several millimeters parallel to the longitudinal axis of the cassette 106, for example between 2 and 8 mm. between.

The protrusion 703 functions as a guiding member. The projection 703 cooperates with a groove 708 formed on the inner surface portion of the BGM 100 that receives the cassette in use.

Slot 708 is shown in FIG. The trough 708 shown in Figure 27 is a triangular cross-section, but it may alternatively employ some other cross-section. The aperture system of the BGM 100 portion into which the cassette 106 is embedded is selected to be slightly larger than the outer diameter of the side wall of the cassette 106. As such, the cassette 106 can be embedded within the BGM 100 only when the protrusion 703 is aligned with the slot 708 in the BGM 100. This means that when the cassette 106 is contained within the BGM 100, it is ensured that it is placed in the correct calibration position.

The longitudinal axis of the slot 708 in the inner portion of the BGM 100 is parallel to the longitudinal axis of its aperture and thus has the same axis as the protrusion 703.

The button 701 has a slot 704 formed in one of its faces. A slot 704 is formed in the face of the button 701 that faces the sidewall of the cassette 106 when the seal 702 is in the sealed position. The groove 704 in the button 701 has a cross section corresponding to the cross section of the protrusion 703. When the seal 702 is attached to the side wall of the cassette 106 at the sealing position, the button 701 is positioned such that the protrusion 703 is received in the slot 704 of the button 701. This best is shown in Figure 26C. It is also shown at the rightmost position of button 701 in Figure 25, although protrusions 703 and slots 704 are not visible in this figure.

The length of the groove 704 can be greater than the length of the protrusion 703, or it can have the same length as the protrusion 703. The slot 704 can be tapered from the end of the seal end that is furthest from the cover aperture 105 such that there is less depth (lighter) at the location closest to the aperture 105. If there is a taper, the taper is initially parallel to the side of the cassette and is first tapered at a gentle angle. Start the tangential taper to help achieve smoothing industry.

When the seal 702 is sealed to the side wall of the cassette 106, the face of the button 701 furthest from the aperture 105 is substantially horizontal to the end face plane of the cassette 106. This side can be in the same plane as the end face 707. This provides a convenient profile for the cassette 106 and allows for ease of operation, as will be described in more detail below.

Button 701 is highly visible. For example, button 701 can be formed from a bright colored material, such as a plastic.

When the seal 702 is in the sealed position above the aperture 105, the button 701 is coupled to the protrusion 703.

The button 701 and the cassette 106 can be pressed together by a temporary holder. The temporary holder can be formed by plastic molding. For example, button 701 and cassette 106 can be molded simultaneously to provide a breakable rib between the two members. The temporary fixture has the effect of maintaining the position of the button 701 on top of the protrusion 703 when the seal 702 is in the sealed position, allowing the user to separate the button row 701 from the protrusion 703 when needed, and thus separate from the aperture 105 Seal 702.

When the button 701 is positioned on the protrusion 703, the material of the button 701 substantially increases the diameter of the cassette 106. The increase in diameter is relatively small at the tip of the projection 703 and is large at either side of the tip of the projection 703. Such a utility is such that when the button 701 is positioned on the protrusion 703, the presence of the button 701 prevents the cassette 106 from being embedded within the BGM 100. In particular, the presence of the button 701 prevents the protrusion 703 from being incorporated into the slot 708 in the interior surface of the BGM 100. As such, the cassette 106 cannot be embedded within the BGM 100 until the button 701 and thus the seal 702 are removed. Because during the BGM100 operation, the presence of the seal 702 above the orifice 105 causes one or more of its components to be damaged. Bad, so the possibility of damage occurring can be reduced by removing the seal before use.

Button 701 includes an angled surface 705 that is opposite the end of seal 702 that is furthest from cover aperture 105. The inclined surface 705 of the button 701 is inclined downward from the highest portion of the button 701, that is, it is the highest in the radial direction of the longitudinal axis of the cassette 106, and is inclined downward toward the direction of the aperture 105. Further, the inclined surface 705 of the button 701 is curved such that the slope of the surface is steeper over a greater radial distance and less steep in a smaller radial distance from the longitudinal axis of the cassette 106. This provides a convenient surface for the user to apply pressure in a direction parallel to the longitudinal axis of the cassette 106, such as using the thumb thereof.

The user's removal of the seal will now be described, primarily with reference to Figures 25 and 26a.

The initial position is the positioning of the seal 702 in the aperture 105 and the button 701 is placed on the projection 703. This is indicated by a broken line indicating the position of the rightmost button 701 in FIG.

The user then has two main options to manipulate the button 701 to remove the seal 702.

The first option involves the user grabbing the cassette 106 with his palm, such as the hand shown on the right side of FIG. The user is ready to remove the seal 702 by grasping the cassette 106 with his palm and fingers and placing his thumb on the inclined surface 705 of the button 701. To remove the seal, the user elongates his thumb in the direction of the arrow shown in FIG. The button 701 is free to move when the force applied by the user is sufficient to break the temporary holder.

The direction in which the button 701 moves is set by the mutual operation of the protrusion 703 and the groove 704 in the button. The continued presence of the protrusions 703 in the slots 704 is ensured by the nature of the configuration, as the user must apply pressure toward the longitudinal axis of the cassette 106 (downward direction of Figure 25) and in a direction parallel to the longitudinal axis of the cassette 106. On the button 701. The taper of the slot 704 allows the button 701 to move through the protrusion 703. The control buttons are moved parallel to the longitudinal axis of the cassette 106 to provide the user with a positive experience, in particular the user can confirm that they have performed the correct movement.

When the button 701 has been sufficiently moved such that the temporary adhesive seal of the outer side wall of the seal 702 and the cassette 106 has been broken, the seal 702 and the button 701 are no longer bonded to the cassette 106. In this position, button 701 and seal 702 can be removed, with the result being a cassette 106 as shown in Figure 26b. When the button 701 and the seal are removed, the cassette 106 can be embedded within the BGM 100 with the protrusion 703 aligned with the slot 708.

An alternative manner in which the user can manipulate the button 701 will now be described. Initially, the seal 702 is in the sealed position on the aperture 105 and the button 701 is positioned above the protrusion 703, and the user can grasp the button 701 differently than the other hand holding the hand of the cassette 106. Here, the user grasps the button 701 between its finger and the thumb, one of the fingers is placed toward the inclined face, and the other finger at least partially contacts the face farthest from the aperture 105. Alternatively, by providing a force to leverage the end face 707 of the cassette 106, the user can pull the button 701 away from the aperture 105. The remainder of the job is as previously described in relation to the manner in which the user can manipulate the button 701.

A seal 702 is present on the aperture 105 to protect the cassette 106 The inner test member is contaminated with moisture, dust, reactive gases (such as sulfur dioxide), and bacteria during storage prior to use.

The configuration of the foregoing specific example prevents the cassette 106 from being embedded within the BGM 100 prior to removal of the seal 702. In other words, the cassette 106 can be embedded within the BGM 100 only after the user has removed the seal 701 and the button 701.

When the seal 702 is removed, cooperation between the protrusion 703 and the slot 704 of the button 701 can assist the user. Moreover, after the seal 702 and button 701 have been removed, the protrusions 703 are present on the sidewalls of the cassette 106, allowing for proper orientation of the cassette 106 within the BGM 100 due to cooperation between the protrusions 703 and the slots 708.

After all of the test components within the cassette 106 have been used, the cassette 106 can be removed from the BGM 100 and discarded or reused. At this stage, the seal 702 can be removed from the cassette 106 and the cassette 106 is then embedded within the BGM 100.

106‧‧‧匣 box

701‧‧‧ button

702‧‧‧Seal

707‧‧‧ end face

Claims (14)

A cassette configured to be embedded in a meter, the cassette comprising: a shield having an aperture, a distal end and a side wall; at least one test mounted within the shield a member; a removable seal; and a button attached to the seal in a fixed position relationship, wherein the seal is non-permanently bonded when the seal is in a sealed state The agent is affixed to the outer side wall of the cassette and a portion of the seal covers the aperture to provide a moisture impermeable barrier and the button is placed adjacent to the side wall of the shield. A cassette according to claim 1, wherein the cassette has a projection formed on the side wall, the protrusion being coincident with the button when the sealing member is in the sealing position. A cassette according to claim 2, wherein the projection has a longitudinal axis extending substantially parallel to a longitudinal axis of the cassette. A cassette of claim 2 or 3, wherein the protrusion extends to a position where the junction between the side wall and the end face of the cassette guard coincides. The cassette of any one of claims 2 to 4, wherein the button is coupled to the protrusion by a temporary holder. A cassette according to any one of claims 2 to 5, wherein the button has a groove formed in one side, the face facing the side wall of the cassette when the seal is in the sealed state Wherein the protrusion has a complementary cross section with the groove. A cassette of claim 6 wherein the slot has a longitudinal axis extending substantially parallel to a longitudinal axis of the cassette. The cassette of any one of clauses 6 to 7, wherein the protrusion has a triangular cross section with the groove as a whole. A cassette according to any one of claims 6 to 8, wherein the protrusion and the groove have a circular cross section as a whole. The cartridge of any one of claims 1 to 9 wherein when the seal is in a sealed position, a last portion of the button is placed with the side wall and the end face of the cassette shield The points of convergence coincide. The cassette of any one of claims 1 to 10, wherein the button has a side facing a maximum radial height of the button in an axial direction parallel to the longitudinal axis of the cassette, toward the The position of the orifice is inclined downward. The cartridge of claim 12, wherein the face is inclined downward from a maximum radial height of the button toward the position of the orifice such that when the distance from the orifice increases, it is radial The direction is steeper. The cassette of any one of claims 1 to 12 wherein the seal has a longitudinal axis extending substantially parallel to a longitudinal axis of the cassette. A system comprising a gauge having a shield and a cassette according to any one of claims 1 to 13 wherein the gauge of the gauge is configured to be removed only after the button is removed The cassette is allowed to be embedded in the shield.