CA2627186A1 - Lock mechanism for locking an analysis device in production - Google Patents
Lock mechanism for locking an analysis device in production Download PDFInfo
- Publication number
- CA2627186A1 CA2627186A1 CA002627186A CA2627186A CA2627186A1 CA 2627186 A1 CA2627186 A1 CA 2627186A1 CA 002627186 A CA002627186 A CA 002627186A CA 2627186 A CA2627186 A CA 2627186A CA 2627186 A1 CA2627186 A1 CA 2627186A1
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- Canada
- Prior art keywords
- analysis device
- housing
- lock element
- analysis
- way
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
- A61B2560/04—Constructional details of apparatus
- A61B2560/0406—Constructional details of apparatus specially shaped apparatus housings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/02—Details of sensors specially adapted for in-vivo measurements
- A61B2562/0295—Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49002—Electrical device making
- Y10T29/49004—Electrical device making including measuring or testing of device or component part
Abstract
When performing a final function check of analysis devices (1), such as a blood sugar measuring device, which are completely assembled for delivery, the problem exists that they may not be opened without destruction in case of a require repair. To solve this problem, a lock element (11) is suggested, which is functionally used exclusively for locking the analysis device (1) and is only fitted after the final check of the analysis device. The lock element (11) is preferably incorporated into the design of the housing (2), so that its lock function is not recognizable as such.
Description
Applicant:
F. Hoffmann-La Roche AG
Lock mechanism for locking an analysis device in production The present invention relates to an analysis device for analyzing a medically significant component of a bodily fluid, such as blood or interstitial liquid. A qualitative or quantitative analysis is performed, i.e., for example, the presence, the absence, or the concentration of a specific analyte in a sample is determined. The present invention relates in particular to a portable analysis device, operable by a patient, for patient self-testing, the so-called field of home monitoring, in particular a blood glucose measuring device, a cholesterol measuring device, or a blood coagulation parameter measuring device.
Analysis devices of this type comprise a device housing, a measuring unit, situated in the device housing, for performing the analysis by a sample, and a processor having software for processing the measured values ascertained by the measuring unit and for preparing the analysis measurement data from the measured values, typically taking into account calibration values. For example, the sample may be inserted on a test element through a housing opening into the analysis device and into the measuring unit. In other embodiments, analysis devices are also used, in which the sample or the test elements wetted by a sample on a belt, for example, are moved past a measuring sensor, which is located on the surface of the analysis device or projects therefrom. The use of magazines for test elements is also known in this context.
F. Hoffmann-La Roche AG
Lock mechanism for locking an analysis device in production The present invention relates to an analysis device for analyzing a medically significant component of a bodily fluid, such as blood or interstitial liquid. A qualitative or quantitative analysis is performed, i.e., for example, the presence, the absence, or the concentration of a specific analyte in a sample is determined. The present invention relates in particular to a portable analysis device, operable by a patient, for patient self-testing, the so-called field of home monitoring, in particular a blood glucose measuring device, a cholesterol measuring device, or a blood coagulation parameter measuring device.
Analysis devices of this type comprise a device housing, a measuring unit, situated in the device housing, for performing the analysis by a sample, and a processor having software for processing the measured values ascertained by the measuring unit and for preparing the analysis measurement data from the measured values, typically taking into account calibration values. For example, the sample may be inserted on a test element through a housing opening into the analysis device and into the measuring unit. In other embodiments, analysis devices are also used, in which the sample or the test elements wetted by a sample on a belt, for example, are moved past a measuring sensor, which is located on the surface of the analysis device or projects therefrom. The use of magazines for test elements is also known in this context.
Test methods which work with test elements are used to a large extent for qualitative and quantitative analysis of components of a liquid sample, in particular a bodily fluid of humans or animals. The test elements contain reagents. To perform a reaction, the test element is brought into contact with the sample. The reaction of sample and reagents results in a change of the test element characteristic for the analysis, which is analyzed with the aid of a suitable analysis device. The analysis device is typically capable of analyzing a very specific type of test element of a specific manufacturer. The test elements and the analysis device form 1o components mutually tailored to one another and are referred to as a whole as an analysis system.
Numerous different test element types are known, which differ in the measurement principle and the reagents used and in their construction.
Colorimetric analysis systems are especially widely distributed in regard to the measurement principle. The reaction of the sample with the reagents contained in the test element results in a color change therein, which may be measured visually or using a photometric measuring unit.
In addition, electrochemical analysis systems have achieved great significance, in which the reaction of the sample with the reagents of the test element results in an electrically measurable change (of an electrical voltage or an electrical current), which is measured using corresponding measurement electronics. Analysis systems of this type are also referred to as amperometric systems.
Regular monitoring of specific analytical values of the blood is frequently necessary. This is true in particular for diabetics, who are to check their blood sugar level frequently using blood sugar self-testing, to keep their 3o blood sugar level continuously within specific setpoint limits as much as possible by adapting insulin injections to the greatly varying demand.
Checking blood coagulation parameters through a patient blood coagulation self test is also correspondingly common.
Numerous different test element types are known, which differ in the measurement principle and the reagents used and in their construction.
Colorimetric analysis systems are especially widely distributed in regard to the measurement principle. The reaction of the sample with the reagents contained in the test element results in a color change therein, which may be measured visually or using a photometric measuring unit.
In addition, electrochemical analysis systems have achieved great significance, in which the reaction of the sample with the reagents of the test element results in an electrically measurable change (of an electrical voltage or an electrical current), which is measured using corresponding measurement electronics. Analysis systems of this type are also referred to as amperometric systems.
Regular monitoring of specific analytical values of the blood is frequently necessary. This is true in particular for diabetics, who are to check their blood sugar level frequently using blood sugar self-testing, to keep their 3o blood sugar level continuously within specific setpoint limits as much as possible by adapting insulin injections to the greatly varying demand.
Checking blood coagulation parameters through a patient blood coagulation self test is also correspondingly common.
A blood glucose measuring device is a measuring device, with the aid of which the blood sugar content may be determined qualitatively or quantitatively. For this purpose, a piercing wound is typically generated in a body, a blood droplet is taken, the blood droplet is applied to the test element, and the blood glucose content in the drop is determined with the aid of the test element and the blood glucose measuring device. However, measuring the blood glucose by a permanent measurement, for example, using sensors inserted into the body or through the skin, is also conceivable.
Above all in the field of so-called "home monitoring", i.e., in which medical laypersons perform simple analyses of the blood themselves, and particularly therein for the regular blood acquisition to be performed multiple times daily by diabetics for checking the blood glucose concentration, it is important that simple and reliable operation of the blood glucose measuring device is possible and informative and reliable determination and display of the measurement results are provided.
The typical analysis devices are so-called standalone measuring devices.
2o These devices operate autonomously, self-contained, and independently.
They thus have a display screen, a measuring unit, a power supply, and a complete user interface, which may comprise a keypad, a display, a signal generator, or a user guide, for example. The intended purpose and the properties of devices of this type are fixed, except for occasional adaptations of the firmware.
The present invention relates. in particular to the manufacturing of analysis devices of this type in the factory, such as the assembly of housing parts, as are used for blood sugar measuring devices, for example. For this purpose, the housing comprises two parts, for example, namely a housing upper shell and a housing lower shell, the housing - comprising operating elements in the housing surface, e.g., a keypad, for the blood sugar measuring device. A function check of the measuring device is performed, after the two housing halves have been joined, to terminate the assembly of the analysis device. Snap connections are frequently used according to the prior art to make the assembly as favorable as possible. Further disassembly of the housing halves which have been joined together is not possible, because the assembly must meet the requirement of ensuring a housing not to be opened by the end-user. Therefore, if flaws are established during the final check of -the housing functions, e.g., in the operating elements, to repair the device, the housing halves must be destroyed upon opening.
Up to this point, analysis measuring devices have either been connected to one another by a screw connection or the housing parts are snapped together in the final assembly step. Because it is important that one may recognize whether a device which was returned to the manufacturer for repair because of a malfunction has already been opened, the snap connection is designed so that it is destroyed upon reopening of the device. Screws are normally covered by a seal, a label, or protective lacquer. In this case, the label must be pulled off (which results in damage to the label) or the protective lacquer on the screw is damaged to open the device.
Seals of containers or devices which prevent opening or allow only a single use of the device are known, for example, from the following publications: US 3,753,586, US 4,834,706, US 4,875,486, US 1,487,885, DE 4240327 C2, GB 984,593, GB 850,385, GB 2 040 267 A, US 6,685,085 B2, WO 98/19723, US 2005/0227370 Al, US 4,663,970, DE 27 53 285 Al, US 2,772,109, US 4,416,478, US 2,142,048, FR 970,463, US 2,081,627, US 1,995,878, GB 1 475 543.
After the assembly of an analysis device, for example, during production or after performing repair or maintenance, a final function test is performed. For this purpose, the device must be completely assembled according to the prior art. If a flaw arises at this point, the device must be disassembled again and repaired. The disadvantage of the screw connection and/or the nonremovable snap connection here is that after the disassembly, components may not be used again and increased costs thus occur. With a snap connection, _the components having the catch hooks are affected above all in this case. With parts which are screwed together, the reuse of the components having the screw bosses is critical.
In addition, the use of screw connections increases the assembly effort and thus the costs.
Above all in the field of so-called "home monitoring", i.e., in which medical laypersons perform simple analyses of the blood themselves, and particularly therein for the regular blood acquisition to be performed multiple times daily by diabetics for checking the blood glucose concentration, it is important that simple and reliable operation of the blood glucose measuring device is possible and informative and reliable determination and display of the measurement results are provided.
The typical analysis devices are so-called standalone measuring devices.
2o These devices operate autonomously, self-contained, and independently.
They thus have a display screen, a measuring unit, a power supply, and a complete user interface, which may comprise a keypad, a display, a signal generator, or a user guide, for example. The intended purpose and the properties of devices of this type are fixed, except for occasional adaptations of the firmware.
The present invention relates. in particular to the manufacturing of analysis devices of this type in the factory, such as the assembly of housing parts, as are used for blood sugar measuring devices, for example. For this purpose, the housing comprises two parts, for example, namely a housing upper shell and a housing lower shell, the housing - comprising operating elements in the housing surface, e.g., a keypad, for the blood sugar measuring device. A function check of the measuring device is performed, after the two housing halves have been joined, to terminate the assembly of the analysis device. Snap connections are frequently used according to the prior art to make the assembly as favorable as possible. Further disassembly of the housing halves which have been joined together is not possible, because the assembly must meet the requirement of ensuring a housing not to be opened by the end-user. Therefore, if flaws are established during the final check of -the housing functions, e.g., in the operating elements, to repair the device, the housing halves must be destroyed upon opening.
Up to this point, analysis measuring devices have either been connected to one another by a screw connection or the housing parts are snapped together in the final assembly step. Because it is important that one may recognize whether a device which was returned to the manufacturer for repair because of a malfunction has already been opened, the snap connection is designed so that it is destroyed upon reopening of the device. Screws are normally covered by a seal, a label, or protective lacquer. In this case, the label must be pulled off (which results in damage to the label) or the protective lacquer on the screw is damaged to open the device.
Seals of containers or devices which prevent opening or allow only a single use of the device are known, for example, from the following publications: US 3,753,586, US 4,834,706, US 4,875,486, US 1,487,885, DE 4240327 C2, GB 984,593, GB 850,385, GB 2 040 267 A, US 6,685,085 B2, WO 98/19723, US 2005/0227370 Al, US 4,663,970, DE 27 53 285 Al, US 2,772,109, US 4,416,478, US 2,142,048, FR 970,463, US 2,081,627, US 1,995,878, GB 1 475 543.
After the assembly of an analysis device, for example, during production or after performing repair or maintenance, a final function test is performed. For this purpose, the device must be completely assembled according to the prior art. If a flaw arises at this point, the device must be disassembled again and repaired. The disadvantage of the screw connection and/or the nonremovable snap connection here is that after the disassembly, components may not be used again and increased costs thus occur. With a snap connection, _the components having the catch hooks are affected above all in this case. With parts which are screwed together, the reuse of the components having the screw bosses is critical.
In addition, the use of screw connections increases the assembly effort and thus the costs.
The present invention is based on the object of providing an analysis device, whose housing may be locked during the assembly only after performing the function check in such a way that it is secured against undesired opening and/or such opening is recognizable on the device, for 1o the lock element used in this case, the lock function preferably not being recognizable by the user of the device. Furthermore, the present invention is directed to a corresponding method for manufacturing an analysis device having an improved capability of the function check in the manufacturing.
This object is achieved according to the present invention by an analysis device and a method having the features of the attached independent claims. Preferred embodiments and developments of the present invention result from the dependent claims and the following description with associated drawing.
An analysis device according to the present invention for analyzing a medically significant component of a sample, in particular a blood glucose measuring device, comprising a device housing having at least two housing parts, a measuring unit situated in the device housing for performing the analysis by a sample, and a processor having software for processing the measured values ascertained by the measuring unit and for preparing analysis measurement data from the measured values, thus has the special feature that the analysis device comprises a lock element, which is functionally used for locking the analysis device by producing a fixed mechanical connection between the at least two housing parts, the analysis device and the lock element being implemented in such a way that the analysis device is functional even without the lock element, is designed in such a way that during the assembly of the analysis device to perform a final function check of the analysis device, which is completely assembled except for the lock element, the function of the analysis device may be tested and if necessary the housing may be opened without destruction for repair, and is designed in such a way that during the assembly of the lock element- on the housing, in particular after performing a final function check of the analysis device, the housing is locked, so that afterwards reopening of the housing is no longer possible, without this reopening being recognizable on the housing or the lock element.
1o The lock element preferably has no function for the operation and for operating elements of the analysis device and/or no function for the functioning or complete functioning of the analysis device. It may be exclusively functionally used for locking the analysis device by producing a fixed mechanical connection between the at least two housing parts or possibly may be implemented having a different functional purpose, in particular in regard to the shaping and/or handling of the functional device. The lock element is preferably implemented in such a way that it does not exert any function which is required for the complete functioning of the analysis device; this feature is to be understood to mean that the analysis device is functional or completely functional even without the lock element, which does not preclude auxiliary functions originating from the lock element, for example, in regard to the design, the manual handling, for example, the provision of grip elements for grasping the analysis device, or other auxiliary functions integrated in the lock element or provided for the analysis device by the lock element alone or in interaction with the analysis device.
According to the present invention, such a lock element may be used during the assembly of the analysis device, so that the two or more 3o housing halves may be opened again without destruction. Reopening the housing is no longer possible only after fitting the lock element. In the solution according to the present invention, an additional housing part is thus employed, which is (exclusively) functionally used for locking the analysis device. In contrast to sealing, for example, this part may be a component of the overall housing and be included into the design, so that the "lock" used for locking the housing is not recognizable as such by the user of the analysis device.
Because the lock element does not exert any function which is_ required for the (complete) functioning of the analysis device, during assembly, the device may be constructed and tested completely except for the lock.
If a flaw arises, disassembly and repair may be performed without damage. The lock is fitted and the device thus locked only after successful testing. The locking is preferably designed in such a way that damage of lo the lock part and/or the housing occurs upon opening and the recognizability of opening by the user is thus ensured.
A method according to the present invention for producing an analysis device for analyzing a medically significant component of a sample, in particular a blood glucose measuring device, the analysis device comprising a device housing having at least two housing parts, a measuring unit situated in the device housing for performing the analysis by a sample, and a processor having software for processing the measured vaiues ascertained by the measuring unit and for preparing analysis measurement data from the measured values, and the analysis device being subjected to a function check and closed using a lock element during its production, accordingly has the special feature that the analysis device is closed using a lock element, which is functionally used for locking the analysis device by producing a fixed mechanical connection between the at least two housing parts, the analysis device and the lock element being implemented in such a way that the analysis device is functional even without the lock element, is designed in such a way that during the assembly of the analysis device to perform a final function check of the analysis device, which is completely assembled except for the lock element, the function of the analysis device may be tested and if necessary the housing may be opened for repair without destruction, and is designed in such a way that upon the fitting of the lock element on the housing, in particular after performing a final function check of the analysis device, the housing is locked, so that thereafter reopening of the housing is no longer possible, without this reopening being recognizable on the housing or the lock element, and during the assembly of the analysis device to perform a final function check of the analysis device, which is completely assembled except for the lock element, the function of the analysis device is checked and thereafter, upon the fitting of the lock element on the housing, after performing a final function check of the analysis device, the housing is locked.
In an advantageous embodiment, during the assembly of the analysis device, after performing a final function check of the analysis device, io which is completely assembled except for the lock element, the function of the analysis device is tested, in case of an established functional error, the housing is opened without destruction for correcting the error or repair and the error is corrected, subsequently, to perform a final function check of the analysis device, which is completely assembled except for the lock element, the function of the analysis device is tested again and then upon the fitting of the lock element on the housing, after performing the further final function check of the analysis device, the housing is locked.
2o Further details and advantages of the present invention are explained in greater detail on the basis of an exemplary embodiment with reference to the attached drawing. The features described may be used individually or in combination to provide preferred embodiments of the present invention.
Figure 1 shows an analysis device according to the present invention, which is completely assembled to perform a function final check, but still without a lock element according to the present invention;
Figure 2 shows the attachment of a lock element according to the present invention to the readily tested analysis device from Figure 1;
Figure 3 shows another view of Figure 2; and Figure 4 shows the completely assembled analysis device from Figures 1 through 3 having an engaged lock element according to the present invention.
Figure 1 shows an analysis device according to the present invention.
Such an analysis device 1 is, for example, an analysis device for analyzing a bodily fluid, in particular for patient self-testing, for example, a blood glucose meter, a cholesterol measuring device, or a blood coagulation parameter measuring device. The analysis device 1 shown in Figure 1 is a 1o portable analysis device, which may . be manually handled, manually actuated, and manually operated by a patient, in the form of a blood glucose measuring device for patient'self-testing of blood glucose values.
It comprises a housing 2 having a display 3, operating elements 4, and an opening 5 for inserting a test element having a sample, which is analyzed using the analysis device 1.
A measuring unit for performing a blood glucose determination is situated in the housing 2 of the blood glucose measuring device. The blood glucose values are performed using a blood droplet obtained from the patient, which is applied to a test panel of a test element. The test element may be inserted through the opening 5 in the housing 2 into the blood glucose measuring device and into the measuring unit located therein. Such a measuring unit may be a colorimetric or electrochemical measuring unit, for example. In other embodiments, the test elements are located in the housing 2, for example, in the form of magazines, and are wetted by the blood droplet through an opening in the housing 2.
The blood glucose measuring device may alternatively also be an integrated device having a strip magazine. This is to be understood to mean a device in which so-called integrated disposables are used.
Integrated disposables are consumption elements which are characteristic in that they comprise both a needle element for performing the piercing procedure for obtaining a bodily fluid sample, such as a blood sample, and also a test chemical for performing the analysis of a medically significant component of the sample. Such disposables are frequently used in suitable magazines which have the form of a strip, for example.
The blood glucose measuring device performs the blood glucose 5 determination using a processor, possibly taking into account calibration values, and transmits the ascertained analysis measurement data to the integrated display 3 and/or via an interface 6 to an external display or a computer.
This object is achieved according to the present invention by an analysis device and a method having the features of the attached independent claims. Preferred embodiments and developments of the present invention result from the dependent claims and the following description with associated drawing.
An analysis device according to the present invention for analyzing a medically significant component of a sample, in particular a blood glucose measuring device, comprising a device housing having at least two housing parts, a measuring unit situated in the device housing for performing the analysis by a sample, and a processor having software for processing the measured values ascertained by the measuring unit and for preparing analysis measurement data from the measured values, thus has the special feature that the analysis device comprises a lock element, which is functionally used for locking the analysis device by producing a fixed mechanical connection between the at least two housing parts, the analysis device and the lock element being implemented in such a way that the analysis device is functional even without the lock element, is designed in such a way that during the assembly of the analysis device to perform a final function check of the analysis device, which is completely assembled except for the lock element, the function of the analysis device may be tested and if necessary the housing may be opened without destruction for repair, and is designed in such a way that during the assembly of the lock element- on the housing, in particular after performing a final function check of the analysis device, the housing is locked, so that afterwards reopening of the housing is no longer possible, without this reopening being recognizable on the housing or the lock element.
1o The lock element preferably has no function for the operation and for operating elements of the analysis device and/or no function for the functioning or complete functioning of the analysis device. It may be exclusively functionally used for locking the analysis device by producing a fixed mechanical connection between the at least two housing parts or possibly may be implemented having a different functional purpose, in particular in regard to the shaping and/or handling of the functional device. The lock element is preferably implemented in such a way that it does not exert any function which is required for the complete functioning of the analysis device; this feature is to be understood to mean that the analysis device is functional or completely functional even without the lock element, which does not preclude auxiliary functions originating from the lock element, for example, in regard to the design, the manual handling, for example, the provision of grip elements for grasping the analysis device, or other auxiliary functions integrated in the lock element or provided for the analysis device by the lock element alone or in interaction with the analysis device.
According to the present invention, such a lock element may be used during the assembly of the analysis device, so that the two or more 3o housing halves may be opened again without destruction. Reopening the housing is no longer possible only after fitting the lock element. In the solution according to the present invention, an additional housing part is thus employed, which is (exclusively) functionally used for locking the analysis device. In contrast to sealing, for example, this part may be a component of the overall housing and be included into the design, so that the "lock" used for locking the housing is not recognizable as such by the user of the analysis device.
Because the lock element does not exert any function which is_ required for the (complete) functioning of the analysis device, during assembly, the device may be constructed and tested completely except for the lock.
If a flaw arises, disassembly and repair may be performed without damage. The lock is fitted and the device thus locked only after successful testing. The locking is preferably designed in such a way that damage of lo the lock part and/or the housing occurs upon opening and the recognizability of opening by the user is thus ensured.
A method according to the present invention for producing an analysis device for analyzing a medically significant component of a sample, in particular a blood glucose measuring device, the analysis device comprising a device housing having at least two housing parts, a measuring unit situated in the device housing for performing the analysis by a sample, and a processor having software for processing the measured vaiues ascertained by the measuring unit and for preparing analysis measurement data from the measured values, and the analysis device being subjected to a function check and closed using a lock element during its production, accordingly has the special feature that the analysis device is closed using a lock element, which is functionally used for locking the analysis device by producing a fixed mechanical connection between the at least two housing parts, the analysis device and the lock element being implemented in such a way that the analysis device is functional even without the lock element, is designed in such a way that during the assembly of the analysis device to perform a final function check of the analysis device, which is completely assembled except for the lock element, the function of the analysis device may be tested and if necessary the housing may be opened for repair without destruction, and is designed in such a way that upon the fitting of the lock element on the housing, in particular after performing a final function check of the analysis device, the housing is locked, so that thereafter reopening of the housing is no longer possible, without this reopening being recognizable on the housing or the lock element, and during the assembly of the analysis device to perform a final function check of the analysis device, which is completely assembled except for the lock element, the function of the analysis device is checked and thereafter, upon the fitting of the lock element on the housing, after performing a final function check of the analysis device, the housing is locked.
In an advantageous embodiment, during the assembly of the analysis device, after performing a final function check of the analysis device, io which is completely assembled except for the lock element, the function of the analysis device is tested, in case of an established functional error, the housing is opened without destruction for correcting the error or repair and the error is corrected, subsequently, to perform a final function check of the analysis device, which is completely assembled except for the lock element, the function of the analysis device is tested again and then upon the fitting of the lock element on the housing, after performing the further final function check of the analysis device, the housing is locked.
2o Further details and advantages of the present invention are explained in greater detail on the basis of an exemplary embodiment with reference to the attached drawing. The features described may be used individually or in combination to provide preferred embodiments of the present invention.
Figure 1 shows an analysis device according to the present invention, which is completely assembled to perform a function final check, but still without a lock element according to the present invention;
Figure 2 shows the attachment of a lock element according to the present invention to the readily tested analysis device from Figure 1;
Figure 3 shows another view of Figure 2; and Figure 4 shows the completely assembled analysis device from Figures 1 through 3 having an engaged lock element according to the present invention.
Figure 1 shows an analysis device according to the present invention.
Such an analysis device 1 is, for example, an analysis device for analyzing a bodily fluid, in particular for patient self-testing, for example, a blood glucose meter, a cholesterol measuring device, or a blood coagulation parameter measuring device. The analysis device 1 shown in Figure 1 is a 1o portable analysis device, which may . be manually handled, manually actuated, and manually operated by a patient, in the form of a blood glucose measuring device for patient'self-testing of blood glucose values.
It comprises a housing 2 having a display 3, operating elements 4, and an opening 5 for inserting a test element having a sample, which is analyzed using the analysis device 1.
A measuring unit for performing a blood glucose determination is situated in the housing 2 of the blood glucose measuring device. The blood glucose values are performed using a blood droplet obtained from the patient, which is applied to a test panel of a test element. The test element may be inserted through the opening 5 in the housing 2 into the blood glucose measuring device and into the measuring unit located therein. Such a measuring unit may be a colorimetric or electrochemical measuring unit, for example. In other embodiments, the test elements are located in the housing 2, for example, in the form of magazines, and are wetted by the blood droplet through an opening in the housing 2.
The blood glucose measuring device may alternatively also be an integrated device having a strip magazine. This is to be understood to mean a device in which so-called integrated disposables are used.
Integrated disposables are consumption elements which are characteristic in that they comprise both a needle element for performing the piercing procedure for obtaining a bodily fluid sample, such as a blood sample, and also a test chemical for performing the analysis of a medically significant component of the sample. Such disposables are frequently used in suitable magazines which have the form of a strip, for example.
The blood glucose measuring device performs the blood glucose 5 determination using a processor, possibly taking into account calibration values, and transmits the ascertained analysis measurement data to the integrated display 3 and/or via an interface 6 to an external display or a computer.
10 The analysis device 1 of Figure 1 also comprises a holder 7 having a removable piercing apparatus 8 for obtaining the blood droplet for performing the analysis.
The housing 2.of the analysis device 1 comprises an upper housing part 9 and a lower housing part 10, which, like the remainder of the analysis device 1, with the exception of the lock element still to be attached on the left housing side, are assembled for performing a final function check.
Because the analysis device 1 is completely assembled, with the exception of the lock element, a complete function check may be performed thereon and, if a repair is necessary, it may be opened without problems and without destroying parts.
Figure 2 shows the attachment of a lock element 11 according to the present invention to the housing 1 of the completely checked analysis device 1 from Figure 1. After successfully passed checking, the lock element 11 may be applied, the lock element engaging in housing parts of the housing 1 in such a way that it is no longer possible to disassemble the lock element 11 without destruction. For this purpose, the lock element 11 has catch hooks 12, which are implemented for insertion into corresponding receptacle openings 13 of the housing. Figure 3 shows another view of Figure 2. It may be seen that in this exemplary embodiment, the lock element 11 has a total of four catch hooks 12, specifically two on each end of the lock element 11, these two catch hooks being situated adjacent to one another and one of these two catch hooks engaging in the upper housing part 9 and the other, adjacent catch hook 12 engaging in the lower housing part 12. These catch hooks 12 represent predetermined breaking points, which break upon opening of the analysis device 1 and/or upon removal of the lock element 11 from the housing 2. Subsequent or unauthorized opening of the analysis device 1 may be recognized in this way.
In other embodiments, it is also possible that the lock element 11 does not have a predetermined breaking point, and is connected to the housing 2 in such a way, for example, by catch hooks 12, that it is destroyed upon 1o opening of the analysis device 1 and/or upon removal of the lock element 11. In general it is advantageous if the locking of the housing 2 by the lock element 11 is implemented in such a way that damage to the lock element 11 occurs upon opening of the housing 1, by which the recognizability of the opening of the housing 2 is ensured.
Figure 4 shows the completely assembled analysis device 1 from Figures 1 through 3 having an engaged lock element 11 according to the present invention. It may be seen that the lock element 11 is implemented as an additional housing part, which connects at least two housing parts, 2o namely the upper housing part 9 and the lower housing part 10, and is included into the design of the housing 2 in such a way that its function as a lock is not recognizable as such to the user of the analysis device 1. The lock element 11 is a component of the overall housing, and may be implemented as a housing part or integrated in a housing part.
In a preferred implementation, the lock element 11 is a load-bearing component of the housing construction, so that it contributes to keeping the housing parts mechanically together. In the exemplary embodiment shown, the lock element 11 is a hard plastic part, which is placed on the left side of the analysis device 1, forms the lateral end of the housing 2 at this point, and is implemented for more secure grasping of the analysis device 1 by the user through its shaping as a grip part.
The housing 2.of the analysis device 1 comprises an upper housing part 9 and a lower housing part 10, which, like the remainder of the analysis device 1, with the exception of the lock element still to be attached on the left housing side, are assembled for performing a final function check.
Because the analysis device 1 is completely assembled, with the exception of the lock element, a complete function check may be performed thereon and, if a repair is necessary, it may be opened without problems and without destroying parts.
Figure 2 shows the attachment of a lock element 11 according to the present invention to the housing 1 of the completely checked analysis device 1 from Figure 1. After successfully passed checking, the lock element 11 may be applied, the lock element engaging in housing parts of the housing 1 in such a way that it is no longer possible to disassemble the lock element 11 without destruction. For this purpose, the lock element 11 has catch hooks 12, which are implemented for insertion into corresponding receptacle openings 13 of the housing. Figure 3 shows another view of Figure 2. It may be seen that in this exemplary embodiment, the lock element 11 has a total of four catch hooks 12, specifically two on each end of the lock element 11, these two catch hooks being situated adjacent to one another and one of these two catch hooks engaging in the upper housing part 9 and the other, adjacent catch hook 12 engaging in the lower housing part 12. These catch hooks 12 represent predetermined breaking points, which break upon opening of the analysis device 1 and/or upon removal of the lock element 11 from the housing 2. Subsequent or unauthorized opening of the analysis device 1 may be recognized in this way.
In other embodiments, it is also possible that the lock element 11 does not have a predetermined breaking point, and is connected to the housing 2 in such a way, for example, by catch hooks 12, that it is destroyed upon 1o opening of the analysis device 1 and/or upon removal of the lock element 11. In general it is advantageous if the locking of the housing 2 by the lock element 11 is implemented in such a way that damage to the lock element 11 occurs upon opening of the housing 1, by which the recognizability of the opening of the housing 2 is ensured.
Figure 4 shows the completely assembled analysis device 1 from Figures 1 through 3 having an engaged lock element 11 according to the present invention. It may be seen that the lock element 11 is implemented as an additional housing part, which connects at least two housing parts, 2o namely the upper housing part 9 and the lower housing part 10, and is included into the design of the housing 2 in such a way that its function as a lock is not recognizable as such to the user of the analysis device 1. The lock element 11 is a component of the overall housing, and may be implemented as a housing part or integrated in a housing part.
In a preferred implementation, the lock element 11 is a load-bearing component of the housing construction, so that it contributes to keeping the housing parts mechanically together. In the exemplary embodiment shown, the lock element 11 is a hard plastic part, which is placed on the left side of the analysis device 1, forms the lateral end of the housing 2 at this point, and is implemented for more secure grasping of the analysis device 1 by the user through its shaping as a grip part.
List of reference numerals 1 analysis device 2 housing 3 display 4 operating elements opening 6 interface 7 holder 8 piercing apparatus 9 upper housing part lower housing part 11 lock element 12 catch hook 13 receptacle opening
Claims (15)
1. An analysis device (1) for analyzing a medically significant component of a sample, in particular a blood glucose measuring device, comprising a device housing (2) having at least two housing parts (9, 10), a measuring unit, situated in the device housing (2), for performing the analysis by a sample, and a processor having software for processing the measured values ascertained by the measuring unit and for preparing analysis measurement data from the measured values, characterized in that the analysis device (1) comprises a lock element (11), which is functionally used for locking the analysis device (1) by producing a fixed mechanical connection between the at least two housing parts (8, 9), the analysis device (1) and the lock element (11) being implemented in such a way that the analysis device (1) is functional even without the lock element (11), is designed in such a way that upon the assembly of the analysis device (1) to perform a final function check of the analysis device (1), which is completely assembled except for the lock element (11), the function of the analysis device (1) may be tested and if necessary the housing (2) may be opened for repair without destruction, and is designed in such a way that upon the mounting of the lock element (11) on the housing (2), in particular after performing a final function check of the analysis device (1), the housing (2) is locked, so that thereafter reopening of the housing (2) is no longer possible without this reopening being recognizable on the housing (2) or the lock element (11).
2. The analysis device (1)_according to claim 1, characterized in that the locking of the housing (2) by the lock element (11) is implemented in such a way that damage occurs to the lock element (11) upon opening of the housing (2), by which the recognizability of the opening of the housing (2) is ensured.
3. The analysis device (1) according to any one of the preceding claims, characterized in that the lock element (11) engages in housing parts (9, 10) in such a way that is no longer possible to remove the lock element (11) without destruction.
4. The analysis device (1) according to any one of the preceding claims, characterized in that the lock element (11) has catch hooks (12), which are implemented for insertion into corresponding receptacle openings (13) of the housing (2).
5. The analysis device (1) according to any one of the preceding claims, characterized in that the lock element (11) has a predetermined breaking point, which breaks upon opening of the analysis device (1) and/or removal of the lock element (11).
6. The analysis device (1) according to any one of the preceding claims, characterized in that the lock element (11) has no predetermined breaking point, so that it is destroyed upon opening of the analysis device (1) and/or removal of the lock element (11).
7. The analysis device (1) according to any one of the preceding claims, characterized in that the lock element (11) is implemented as an additional housing part which connects at least two housing parts (9, 10).
8. The analysis device (1) according to any one of the preceding claims, characterized in that the lock element (11) is a component of the overall housing.
9. The analysis device (1) according to any one of the preceding claims, characterized in that the lock element (11) is implemented as a housing part or is integrated in a housing part.
10. The analysis device (1) according to any one of the preceding claims, characterized in that the lock element (11) is a load-bearing component of the housing construction, so that it contributes to keeping the housing parts (9, 10) mechanically together.
11. The analysis device (1) according to any one of the preceding claims, characterized in that the lock element (11) is included into the design of the housing (2) in such a way that its function as a lock is not recognizable as such to the user of the analysis device (1).
12. The analysis device (1) according to any one of the preceding claims, characterized in that it is an analysis device (1) for analyzing a bodily fluid, in particular for patient self-testing, such as a blood glucose meter, a cholesterol measuring device, or a blood coagulation parameter measuring device.
13. The analysis device (1) according to any one of the preceding claims, characterized in that it is a portable analysis device (1), which may be manually handled, manually actuated, and manually operated by a patient.
14. A method for producing an analysis device (1) for analyzing a medically significant component of a sample, in particular a blood glucose measuring device, the analysis device (1) comprising a device housing (2) having at least two housing parts (9, 10), a measuring unit, situated in the device housing (2), for performing the analysis by a sample, and a processor having software for processing the measured values ascertained by the measuring unit and for preparing analysis measurement data from the measured values, and the analysis device (1) being subjected to a function check and being closed using a lock element during its production, characterized in that the analysis device (1) is locked using a lock element (11), which is functionally used for locking the analysis device (1) by producing a fixed mechanical connection between the at least two housing parts (8, 9), the analysis device (1) and the lock element (11) being implemented in such a way that the analysis device (1) is functional even without the lock element (11), is designed in such a way that upon the assembly of the analysis device (1) to perform a final function check of the analysis device (1), which is completely assembled except for the lock element (11), the function of the analysis device (1) may be checked and if necessary the housing (2) may be opened for repair without destruction, and is designed in such a way that upon the fitting of the lock element (11) on the housing (2), in particular after performing a final function check of the analysis device (1), the housing (2) is locked, so that thereafter reopening of the housing (2) is no longer possible without this reopening being recognizable on the housing (2) or the lock element (11), and upon the assembly of the analysis device (1) for performing a final function check of the analysis device (1), which is completely assembled except for the lock element (11), the function of the analysis device (1) is tested and thereafter, upon the mounting of the lock element (11) on the housing (2), after performing a final function check of the analysis device (1), the housing (2) is locked.
15. The method according to the preceding claim, characterized in that, upon the assembly of the analysis device (1) after performing a final function check of the analysis device (1), which is completely assembled except for the lock element (11), the function of the analysis device (1) is tested, in case of an established functional error, the housing (2) is opened without destruction for correcting the error or repair and the error is corrected, subsequently, to perform a final function check of the analysis device (1), which is completely assembled except for the lock element (11), the function of the analysis device (1) is tested again and thereafter, upon the mounting of the lock element (11) on the housing (2), after performing the final function check of the analysis device (1) again, the housing (2) is locked.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP07006359.9 | 2007-03-28 | ||
| EP07006359A EP1974658B1 (en) | 2007-03-28 | 2007-03-28 | Locking mechanism for locking an analysis device in the production area |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2627186A1 true CA2627186A1 (en) | 2008-09-28 |
Family
ID=38542044
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002627186A Abandoned CA2627186A1 (en) | 2007-03-28 | 2008-03-25 | Lock mechanism for locking an analysis device in production |
Country Status (10)
| Country | Link |
|---|---|
| US (1) | US7946171B2 (en) |
| EP (1) | EP1974658B1 (en) |
| JP (1) | JP4954128B2 (en) |
| CN (1) | CN101275952B (en) |
| AT (1) | ATE449563T1 (en) |
| CA (1) | CA2627186A1 (en) |
| DE (1) | DE502007002104D1 (en) |
| ES (1) | ES2334166T3 (en) |
| HK (1) | HK1122357A1 (en) |
| PL (1) | PL1974658T3 (en) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009075066A1 (en) * | 2007-12-10 | 2009-06-18 | Arkray, Inc. | Medical device |
| EP2325718A1 (en) * | 2009-11-24 | 2011-05-25 | F. Hoffmann-La Roche AG | Exchangeable Transparent Cover |
| TWD176176S (en) * | 2015-03-20 | 2016-06-01 | 五鼎生物技術股份有限公司 | Part of a measuring instrument |
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| US1995878A (en) * | 1933-10-13 | 1935-03-26 | Gen Electric | Meter casing |
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| US2081627A (en) * | 1936-04-09 | 1937-05-25 | Kearney James R Corp | Meter box |
| US2772109A (en) * | 1954-03-31 | 1956-11-27 | Gen Electric | Seal for a meter housing |
| GB850385A (en) | 1956-02-17 | 1960-10-05 | Shantilal Pranshanker Joshi | Improvements in or relating to seals and to methods of sealing containers and the like against illicit opening |
| DE1225540B (en) | 1962-04-17 | 1966-09-22 | Charles Nicolle Ets | Locking device for container |
| US3668476A (en) * | 1970-09-11 | 1972-06-06 | Seeburg Corp | Self-locking enclosure for electronic circuitry and method of assembling the same |
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| US4068288A (en) * | 1976-05-12 | 1978-01-10 | Westinghouse Electric Corporation | Tamper proof watthour meter enclosure having a permanent locking arrangement |
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| US4416478A (en) * | 1980-11-10 | 1983-11-22 | General Electric Co. | Tamper deterent seal providing indication of tampering for watthour meters |
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| EP0223905B1 (en) * | 1985-11-21 | 1991-10-16 | E.J. Brooks Company | Security seal of the padlock type |
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-
2007
- 2007-03-28 AT AT07006359T patent/ATE449563T1/en active
- 2007-03-28 EP EP07006359A patent/EP1974658B1/en active Active
- 2007-03-28 ES ES07006359T patent/ES2334166T3/en active Active
- 2007-03-28 PL PL07006359T patent/PL1974658T3/en unknown
- 2007-03-28 DE DE502007002104T patent/DE502007002104D1/en active Active
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2008
- 2008-03-13 US US12/047,877 patent/US7946171B2/en active Active
- 2008-03-17 JP JP2008067778A patent/JP4954128B2/en not_active Expired - Fee Related
- 2008-03-25 CA CA002627186A patent/CA2627186A1/en not_active Abandoned
- 2008-03-26 CN CN2008100870269A patent/CN101275952B/en not_active Expired - Fee Related
- 2008-12-12 HK HK08113533.9A patent/HK1122357A1/en not_active IP Right Cessation
Also Published As
| Publication number | Publication date |
|---|---|
| CN101275952A (en) | 2008-10-01 |
| ATE449563T1 (en) | 2009-12-15 |
| HK1122357A1 (en) | 2009-05-15 |
| US20080257040A1 (en) | 2008-10-23 |
| CN101275952B (en) | 2012-12-19 |
| US7946171B2 (en) | 2011-05-24 |
| DE502007002104D1 (en) | 2010-01-07 |
| ES2334166T3 (en) | 2010-03-05 |
| EP1974658B1 (en) | 2009-11-25 |
| JP2008241710A (en) | 2008-10-09 |
| PL1974658T3 (en) | 2010-05-31 |
| EP1974658A1 (en) | 2008-10-01 |
| JP4954128B2 (en) | 2012-06-13 |
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Legal Events
| Date | Code | Title | Description |
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| EEER | Examination request |
Effective date: 20130320 |
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| FZDE | Discontinued |
Effective date: 20150325 |