CN101629948A - Cryptographic module, biosensor and operating system thereof - Google Patents

Abstract

The invention provides a correction device and a management method of a biosensor, which comprise a receiving device, a code module receiving device comprising a switch array, a database and a code module. The calibration device uses a simple graphic unit to change the on/off state of the switch array to represent a password, thereby calibrating the measurement value of the biosensor.

Description

Cryptographic module, biosensor and its operating system

technical field

The invention relates to a biosensor for detecting sample content in a biological sample, in particular to a cryptographic module, a method for manufacturing a cryptographic module, a biosensing system, a biosensing test set and a method for operating a biosensor.

Background technique

Typical biometers use test strips to measure the levels of substances in the blood, such as sugar or cholesterol. The test strip itself has a reaction zone that allows blood to be deposited thereon. The detection operation is controlled by the microprocessor, and the measurement results are obtained through the execution of different methods.

For sample measurement and routine analysis, biodetectors need to determine parameter values to determine measurement thresholds, time intervals, control numbers, and classification of grade curves. Often these actions require a graded sensing device to compensate for variations in the mass production of test pieces. Different technologies use different codes for test piece information.

As disclosed in U.S. Patent No. 5,053,199 and its reference data, the information code can be an electronically encoded information on the carrier, wherein the coded representation may be a magnetized film, an executive plate, an optical grid code, A fluorescent or a metal foil electronic conductor medium.

Each of the above-mentioned known test strips must be equipped with an information encryption device, which will increase the production process steps and these information encryption devices are quite expensive. Other existing sensors use an add-on cryptographic module or cryptographic key design that plugs into a socket similar to the test strip interface.

When taking measurements, the coded key must be inserted into the sensor before using a new batch of test strips. It is best to keep the combination key in the sensor for the duration of the measurement with the same test strips. Then based on the data provided by the password key or the operation method, parameter or operation represented by the password, a corrected measurement result can be obtained.

The biosensor disclosed in US Pat. No. 5,366,609 and its cited data uses a removable read-only memory (ROM) cryptographic module, which can reconfigure the testing methods and parameters required by the sensor. The voltage threshold, test time, delay time and other related test methods and contents can be input or selected to be input to the ROM password module. The main purpose of this cryptographic module is to provide the type information of the test piece, so each new relevant information of the sensory test strip with a new batch number needs a cryptographic module.

In the same period of application provides another cryptographic module and biosensor. It uses the parameters of an electronic component to represent a code, with a deterministic characteristic, such as resistance or capacitance. Compared with the use of integrated circuits, the use of electronic components can reduce the complexity of use and the cost of design, and some disadvantages of the prior art are thus overcome. However, due to the relationship between components and devices, its cost is still relatively high. At the same time, the use of electronic components also has the risk that their accuracy will be affected by the contamination of biological detection samples. And these combination keys are not easy to clean.

Contents of the invention

The technical problem to be solved by the present invention is to provide a cryptographic module, a biosensor and its operating system, which can realize the correction function with a simple structure.

In order to solve the above problems, the present invention provides a calibration device for biosensors, comprising:

A receiving device for receiving a test piece:

A cryptographic module receiving device, comprising:

A switch array with multiple switches defining multiple passwords;

A database, which is electrically connected to the receiving device of the cryptographic module, for storing a plurality of calibration parameters; and

A password module, which has a specific structure and corresponds to at least one of the plurality of switches, is used to identify a password from the plurality of passwords, wherein the plurality of calibration parameters correspond to the plurality of passwords.

Further, the above-mentioned device may also have the following features:

The device activates one of the plurality of calibration parameters for calibrating the biosensor through the password.

Further, the above-mentioned device may also have the following features:

The specific structure is any one of bumps, sawtooth, rows of teeth, stitches, slits, nicks, grooves or through holes.

Further, the above-mentioned device may also have the following features:

The switch array has at least one arrangement and quantity.

Further, the above-mentioned device may also have the following features:

The calibration device also includes a test piece, which is integrally formed with the password module.

The present invention also provides a calibration method for biosensors, comprising the following steps:

Provide a cryptographic module receiving device;

receiving a cryptographic module to identify a cryptogram; and

A calibration parameter is activated according to the password.

Further, the above correction method may also have the following features:

The password module receiving device is provided with a switch array with multiple switches and multiple passwords are defined.

Further, the above correction method may also have the following features:

The switch array has at least one arrangement and quantity.

Further, the above correction method may also have the following features:

The password module has a specific structure corresponding to at least one of the plurality of switches.

Further, the above correction method may also have the following features:

The specific structure is any one of bumps, sawtooth, rows of teeth, stitches, slits, nicks, grooves or through holes.

Further, the above correction method may also have the following features:

The password module is set on a test piece.

The present invention also provides a password identification device, comprising:

A cryptographic module receiving device, comprising:

a switch array, having a plurality of switches, defining a plurality of passwords; and

A password module has a specific structure corresponding to at least one of the plurality of switches in the switch array, and is used for identifying a password from the plurality of passwords.

Further, the above password identification device may also have the following features:

The switch array has at least one arrangement and quantity.

Further, the above password identification device may also have the following features:

The specific structure is any one of bumps, sawtooth, rows of teeth, stitches, slits, nicks, grooves or through holes.

The present invention also provides a password identification method, comprising:

providing a cryptographic module receiving device; and

A password module is received to identify a password.

Further, the above method can also have the following features:

The password module receiving device is provided with a switch array with multiple switches and multiple passwords are defined.

Further, the above method can also have the following features:

The switch array has at least one arrangement and quantity.

Further, the above method can also have the following features:

The password module has a specific structure corresponding to at least one of the plurality of switches.

Further, the above method can also have the following features:

The specific structure is any one of bumps, sawtooth, rows of teeth, stitches, slits, nicks, grooves or through holes.

The present invention also provides a password module that can be connected to a bio-sensing device for receiving a test piece. The password module has a password that can be translated into parameters for the operation of the biosensor, wherein:

The password is composed of a graphic component.

Further, the above-mentioned cryptographic module can also have the following characteristics:

The graphic element is used to activate and/or engage a switch on the biosensing device.

Further, the above-mentioned cryptographic module can also have the following characteristics:

The graphic component is any one of bumps, sawtooth, rows of teeth, pins, slits, nicks, grooves or through holes.

Further, the above-mentioned cryptographic module can also have the following characteristics:

The password is formed by any one of the arrangement and quantity of the graphic components.

The present invention also provides a cryptographic module, comprising:

At least two cryptographic modules as claimed in claim 8, wherein the two cryptographic modules are composed of two graphic components with different numbers, shapes and arrangements.

The present invention also provides a method for making the above-mentioned cryptographic module, comprising the following steps:

(1) making a cryptographic module representing a first password on a model to form a graphic component;

(2) adjusting the model to form at least one graphical component representing other passwords except the first password;

(3) making at least one cryptographic module representing said other cryptograms on said model; and

(4) Re-execute the above step (2).

The present invention also provides a method for making the above-mentioned cryptographic module, comprising:

(1) manufacture a prototype of a basic cryptographic module;

(2) Adjusting the graphical component in any way of adding, removing or changing to provide a way of expressing the password.

The present invention also provides a bio-sensing device for receiving a test strip, which can receive a password module, wherein the bio-sensing device includes a device for receiving information from a password defined by the password module, in:

The biometric sensing means includes a means for sensing a code represented by a graphical component on the code module.

The above bio-sensing device may further include: any device selected from mechanical, electromagnetic or optical devices, which is used to sense the graphic component.

The bio-sensing device above may further include: a switch activated by the graphic component.

The present invention also provides a biosensor for analyzing samples, comprising:

at least one cryptographic module as described above, which defines at least one cryptogram;

A means for determining at least one password from the cryptographic module, for decoding at least one parameter value from the at least one password, and using the parameter value to control the operation performed by the biosensor algorithm to analyze The sample, wherein the at least one password is represented by at least one graphical component; and

A device for sensing at least one graphic element representing the at least one password.

The present invention also provides a biosensor test set, comprising:

at least one test strip, having a sample test agent; and

An above-mentioned cryptographic module, connected with the at least one test piece and inserted into the biosensor, the cryptographic module is used to define at least one parameter value for controlling the operation performed by the biosensor to analyze the sample;

Wherein, the at least one password is represented by at least one graphic component.

The present invention also provides a method of operating a biosensor comprising the steps of:

inserting a cryptographic module into the biosensor, the cryptographic module defining at least one password;

detecting said at least one password, wherein the detecting operation is implemented by sensing at least one graphic component, said at least one graphic component being arranged on said password module;

determining at least one parameter value based on the at least one password;

A sample is analyzed based on the at least one parameter value.

Compared with the prior art, the present invention can achieve the effect of the prior art by using a simple structure to change the on/off state of the circuit, thereby improving the use efficiency and saving the production cost.

Description of drawings

FIG. 1A is a top view of a biosensor in Embodiment 1 of the present invention;

Figure 1B is a bottom view of the biosensor in Embodiment 1 of the present invention;

2 is a schematic diagram of Embodiment 1 of the present invention;

FIG. 3A is a top view of the cryptographic module 10 and the corresponding switches in the sensing device 155 in Embodiment 1 of the present invention;

FIG. 3B is a top view of the cryptographic module 10 inserted into the sensing device 155 in FIG. 3A;

FIG. 4A is a side view of the switch 156 and the cryptographic module 10 when the cryptographic module 10 has not been inserted;

Fig. 4B is a sectional view of A-A line in Fig. 3B;

Fig. 4C is a sectional view of the B-B line in Fig. 3B;

5A to 5E are schematic diagrams of different implementations of graphic components on the cryptographic module 10 of the present invention;

6A to 6C are schematic diagrams of the synergy between the cryptographic module and the test piece in Embodiment 2 of the present invention;

7A is a top perspective view of the encryption module 11 and the sensing device 155 with the electrical contacts 50 and the encryption area 32;

7B is a bottom perspective view of the cryptographic module 11 with electrical contacts 50;

Fig. 8 is a top perspective view of Embodiment 3 of the present invention;

9A to 9G are schematic diagrams of the integral formation of the graphics component and the test piece in Embodiment 4 of the present invention.

Detailed ways

The technical solution of the present invention will be described in more detail below with reference to the drawings and embodiments.

FIG. 1A is a top view of the biosensor in Embodiment 1 of the present invention. The biosensor 100 has a display 111 , an operation button 112 and a receiver 113 . The receiver 113 is used to receive a disposable test piece 200 . The test piece 200 has a reaction area containing a conductive electrode, a reactant layer (not shown) covering the electrode and a sample inlet 220 are arranged on the reaction area. A liquid containing a sample, such as a drop of blood, can contact the reactant layer through the sample inlet 220 . The biosensor 100 also has a second receiver 114 for receiving a password module 10 . The cryptographic module 10 is provided with graphic components 30a, . . . 30n. FIG. 1B is a bottom view of the biosensor in Embodiment 1 of the present invention. When the cryptographic module 10 is inserted into the second receptacle 114, the sensing device in the biosensor 100 will be in contact with the graphic components 30a, 30b...30n.

FIG. 2 is a schematic diagram of Embodiment 1 of the present invention, showing the working mode of the biosensor 100 , the cryptographic module 10 and the test piece 200 . The biosensor 100 is equipped with a microprocessor including a central processing unit, a read-only memory and a random-access memory, a display, a current sensing device, an electrode working voltage supplier, and a temperature sensor as standard equipment. These components also belong to the standard equipment in the prior art. In addition, the biosensor also has a sensing device 155, which on the one hand is operatively connected to the microprocessor, and on the other hand is also connected to the switches 156a, 156b, . . . Graphical components 30a, . . . 30n. However, the arranged arrangement of graphic components 30a,...30n can be used to decipher the ciphers to be described next. Sensing of the graphics components 30a, . . . 30n is a method known to those skilled in the art, especially using current to determine whether the switches 156a, 156b, . . . 156n are on or off. An analog/digital converter (A/D) is used to convert the current value to the microprocessor.

3A is a top view of the encryption module 10 and the sensing device 155 in Embodiment 1 of the present invention, wherein the sensing device 155 includes five switches 156a, 156b, ... 156e, and these five switches have the same voltage and It is in electrical contact with a conductor arrangement 157 . Before the cryptographic module 10 is inserted, the five switches 156a, 156b, ... 156e are all in contact with a second conductor 158, so all the switches 156a, 156b, ... 156e are in the open state and allow a predetermined current passes through. The cryptographic module 10 forms cutouts 31 on its graphic components 30a, . . . The number and arrangement of the cutouts 31 are used to represent a set of ²⁵ passwords. When the cryptographic module 10 is inserted into the biosensor 100 , the graphic components 30 a , . . . 30 d are in contact with the sensing device 155 . As shown in Fig. 3B, each predetermined position 33a, ... 33d of a graphic component 30a, ... 30d corresponds to a switch 156a, ... 156d. At this time, due to the insertion of the cryptographic module 10, except for the switches 156a and 156d, all the switches 156a, 156b, ... 156e form open circuits, that is, the contact between the conductors 157 and 158 is cut off, and the switches 156a and 156d are just The cutouts 31 correspond to the positions 33 a and 33 d provided on the password module 10 . The current through switches 156a and 156d is sensed by measuring the difference in voltage across a resistor (not shown explicitly) in series with switches 156a, 156b, . . . 156e.

FIG. 4A is a side view of the switch 156 and the cryptographic module 10 when the cryptographic module 10 is not inserted. At this time, the switch 156 is in the ON state and conducts a current, and the current flows through the resistor 159 connected in series with the switch 156 to cause a difference in potential.

FIG. 4B is a cross-sectional view of line A-A in FIG. 3B , in which the switch 156b engages with the graphic component 30b on the cryptographic module 10, causing the switch 156b to be in an open circuit state and the current is thus interrupted.

FIG. 4C is a cross-sectional view of the B-B line in FIG. 3B , where the switch 156d is just located at the cutout 31 at the position 33d on the cryptographic module 10 . Therefore, when the cryptographic module 10 is inserted, the switch 156d is still in the ON state.

Based on the description of the above-mentioned embodiments, that is, the current flowing through the switches 156a, 156b, ... 156e on the biosensor 100 is closely related to the number and arrangement of the cutouts 31 on the encryption module 10, and the The codes represented by the graphical elements 30a, 30b, ... 30e can thus be detected through changes in current and voltage.

5A to 5E are different implementations of graphic components on the cryptographic module 10, such as the slit 34 in FIG. 5A, the raised bar 35 in FIG. 5B, the through hole 36 in FIG. Bump 38 in Figure 5E. In addition, the front edge area 40 on the encryption module 10 is a kind of cone, the purpose is to make the insertion of the encryption module 10 and the disconnection of the switch easier.

FIGS. 6A-6C show the second embodiment of the present invention, in which the biosensor 101 has a receiver 115 for receiving the test piece 200 and the password module 11 . When the password module 11 is inserted into the biosensor 101, the test piece 200 can also be inserted into a gap 116 of the same receptor 115 in the biosensor 101 at the same time, and the electrical contacts 50 on the password module 11 will be in contact with the electrodes of the test piece 200. The contact causes the biosensor 101 to make an electrical connection with the test strip 200 .

FIG. 7A is a top perspective view of the cryptographic module 11 and the sensing device 155 with the electrical contacts 50 and the cryptographic field 32 . When the cryptographic module 11 is inserted into the biosensor, the cryptographic area 32 with the graphic elements 30a, 30b, . . . 30n will be in contact with the switches 156a, .

FIG. 7B is a bottom perspective view of cryptographic module 11 with electrical contacts 50 . When both the code module 11 and the test strip 200 are inserted into the biosensor 101 , the electrical contacts 50 on the code module 11 will be in contact with the electrodes of the test strip 200 . Therefore, based on the above combination conditions, the electrode strip 160 of the biosensor 101 will contact the electrical contact 50 of the encryption module 11 and further be electrically connected to the electrode of the test piece 200 .

The point of this embodiment is that the biosensor 101 cannot operate without the correct insertion of the cryptographic module 11 .

The electrical connection between the electrodes of the test strip and the electrodes 161 of the biosensor 102 can be replaced by other methods. As shown in FIG. 8 , in the third embodiment of the present invention, a groove 60 is designed on the password module 12 so that the electrodes of the test piece and the electrodes 161 of the biosensor 102 can be directly electrically connected when the password module 12 is inserted.

In addition, if the graphic components 91-97 of the cryptographic module are directly arranged on the test piece, as shown in FIGS. 9A-9G , then when the test piece is inserted each time, the on/off state of the switch on the sensing device will correspond to the test state. Graphic components 91-97 on the chip are changed, so the password represented by the graphic components 91-97 on the test chip can be detected, so that the representation of the password and the test of the sample can be completed on the test chip.

To sum up, the present invention can use a simple structure to change the on/off state of the circuit to achieve the effect of the prior art, which can improve the use efficiency and save the production cost.

Certainly, the present invention also can have other multiple embodiments, without departing from the spirit and essence of the present invention, those skilled in the art can make various corresponding changes and deformations according to the present invention, but these corresponding Changes and deformations should belong to the scope of protection of the appended claims of the present invention.

Claims (18)

1, a kind of means for correcting that is used for biology sensor is characterized in that, comprising:

One receiving trap is used to receive a test pieces:

One crypto module receiving trap comprises:

One switch arrays have a plurality of switches on it, define a plurality of passwords;

One database, it is electrically connected with described crypto module receiving trap, is used to store a plurality of correction parameters; And

One crypto module, its have an ad hoc structure and at least with described a plurality of switches in one corresponding, be used for picking out a password from described a plurality of passwords, wherein said a plurality of correction parameters are corresponding to a plurality of passwords.

2, means for correcting as claimed in claim 1 is characterized in that,

One of starting in described a plurality of correction parameter by described password of described means for correcting is used to proofread and correct this biology sensor;

And/or

Described ad hoc structure is projection, sawtooth, toothrow, stitch, joint-cutting, incise, in groove or the through hole any one.

3, means for correcting as claimed in claim 1 is characterized in that,

Described switch arrays have at least a arrangement mode and quantity; And/or

Described means for correcting also comprises a test pieces, and itself and described crypto module are one-body molded.

4, a kind of bearing calibration that is used for biology sensor is characterized in that, may further comprise the steps:

One crypto module receiving trap is provided;

Receive a crypto module with identification one password; And

Start a correction parameter according to this password.

5, bearing calibration as claimed in claim 4 is characterized in that,

Be provided with switch arrays in this crypto module receiving trap and define a plurality of passwords, and described crypto module has an ad hoc structure with corresponding with in described a plurality of switches at least one with a plurality of switches; And/or

Described crypto module is arranged on the test pieces.

6, a kind of password device for identifying is characterized in that, comprising:

One crypto module receiving trap comprises:

One switch arrays have a plurality of switches, define a plurality of passwords; And

One crypto module has an ad hoc structure corresponding in a plurality of switches in the described switch arrays at least one, is used for picking out a password from described a plurality of passwords.

7, a kind of password discrimination method is characterized in that, comprising:

One crypto module receiving trap is provided; And

Receive a crypto module with identification one password.

8, a kind of crypto module that is used to receive the biosensing apparatus of a test pieces that is connected in has a password on this crypto module, can be translated into to be used for the operational parameter of described biology sensor, it is characterized in that:

Described password is made of a graphic assembly.

9, crypto module as claimed in claim 8 is characterized in that,

Described graphic assembly is used to start and/or meshes a switch on described biosensing apparatus;

Described graphic assembly is projection, sawtooth, toothrow, stitch, joint-cutting, incise, in groove or the through hole any one; And/or

Described password is made of the arrangement mode of described graphic assembly and any institute in the quantity.

10, a kind of crypto module is characterized in that, comprising:

At least two crypto modules as claimed in claim 8, wherein said two crypto modules are made of the graphic assembly of two varying numbers, shape and arrangement modes.

11, a kind of making as the sharp method that requires 8 described crypto modules is characterized in that,

The crypto module of one first password is represented in making one on a model, to form a graphic assembly;

Adjust described model, form the graphic assembly of other password of at least one representative except that first password;

On described model, make the crypto module of described other password of at least one representative; And

Re-execute above-mentioned set-up procedure.

12, a kind of method of making crypto module as claimed in claim 8 is characterized in that,

Make the blank of a basic crypto module;

Adjust described graphic assembly with any one mode in increasing, remove or changing, for password provides a kind of expression mode.

13, a kind of biosensing apparatus that is used for the acceptance test sheet, it can receive a crypto module, and wherein said biosensing apparatus comprises that one is used for the device of the information that receives from the defined password of described crypto module, it is characterized in that,

Described biosensing apparatus comprises that one is used for the device of the password of the graphic assembly representative on the described crypto module of sensing.

14, biosensing apparatus as claimed in claim 13 is characterized in that,

Also comprise: one is selected from any one device in machinery, electromagnetism or the optical devices, and it is in order to this graphic assembly of sensing; And/or

One switch, it is started by described graphic assembly.

15, a kind of biology sensor that is used for analyzing samples is characterized in that, comprising:

At least one crypto module as claimed in claim 8, its definition has at least one password;

One is used for from the device of described at least one password of crypto module decision, it is used for deciphering out at least one parameter value from described at least one password, and control operation that described biology sensor computing carries out to analyze described sample with described parameter value, wherein, described at least one password is represented by at least one graphic assembly; And

One is used for sensing, and at least one is used to represent the graphic assembly of described at least one password.

16, a kind of biological response test group is characterized in that, comprising:

At least one test pieces has a sample test agent; And

One crypto module as claimed in claim 8 links with described at least one test pieces and is inserted in the biology sensor, and described crypto module is used to define at least one parameter value, is used to control operation that described biology sensor computing carries out to analyze described sample;

Wherein, described at least one password is represented by at least one graphic assembly.

17, a kind of method of operating biology sensor is characterized in that, may further comprise the steps:

Crypto module is inserted in the described biology sensor, and described crypto module has defined at least one password;

Detect described at least one password, wherein detecting operation is implemented by at least one graphic assembly of sensing, and described at least one graphic assembly is arranged on the described crypto module;

Determine at least one parameter value according to described at least one password;

According to described at least one parameter value analytic sample.

18, a kind of means for correcting that is used for the bioid sensor comprises:

One receiving trap is used to receive a test pieces:

One crypto module receiving trap comprises:

One switch arrays have a plurality of switches on it, define a plurality of passwords;

One database, it is electrically connected with described crypto module receiving trap, is used to store a plurality of correction parameters; And

One crypto module, itself and described test pieces are one-body molded, have an ad hoc structure and at least with described a plurality of switches in one corresponding, be used for picking out a password from described a plurality of passwords, wherein said a plurality of correction parameters are corresponding to a plurality of passwords.

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