WO2008085052A2

WO2008085052A2 - Testing device

Info

Publication number: WO2008085052A2
Application number: PCT/NL2008/050022
Authority: WO
Inventors: Arnoldus Huibert Klapwijk
Original assignee: Arnoldus Huibert Klapwijk
Priority date: 2007-01-11
Filing date: 2008-01-11
Publication date: 2008-07-17
Also published as: WO2008085052A3

Abstract

The invention relates to a testing device comprising a housing comprising a piercing unit provided with a removable cylindrical cartridge, provided along the circumference with several needles in the axial direction, the tips of which are moveable out of the cylindrical cartridge in the axial direction in order to pierce a patient so as to produce a drop of blood, and an analysis unit provided with a removable analysis disk, provided along the circumference with several analysis parts on the disk at the edge for analyzing the drop of blood.

Description

Testing device

Background of the invention

The invention relates to a testing device provided with a piercing device.

WO-A-2006/027101 discloses a piercing device for producing a piercing wound. Such a piercing device, also referred to as a piercing pen, is used, for example by diabetic patients, to produce a piercing wound in order to draw a small amount of blood which can be transferred to a test strip in order to determine the glucose level. This so-called piercing pen has a cylindrical cartridge containing needles.

EP-Al-1.459.683 also discloses such a piercing device which is provided with a cylindrical cartridge containing needles.

In addition to this piercing device, diabetics, but also other people who have to determine the condition of their body by means of a blood analysis, have to have a test strip onto which the drop of blood obtained with the piercing device has to be transferred for analysis.

Furthermore, US-A-2006/0008389 discloses a piercing device which is provided with a cylindrical cartridge containing needles. In this case, the needles are provided with a capillary tube. After the piercing, the needles containing the blood are passed to a test space inside the cartridge where the blood is analyzed in order to determine, for example, the glucose level.

WO-A1-02/00101 discloses a device for checking body fluids. In particular, the latter comprises an annular housing containing needles which are arranged axially with respect to the ring. The housing is intended to be incorporated into a robotic system. Furthermore, the device is intended for the optical analysis of blood samples. The safety and prevention of contamination with blood leave something to be desired. In addition, the housing does not appear to be suitable for mobile use in a so-called portable "personal care" analysis set.

WO-03/071940 discloses a blood analysis device consisting of a housing containing needles for piercing in order to obtain blood, and test elements. The needles are arranged radially on a disk, and can be shot in the radial direction by means of a hammer mechanism. The needles are not optimally arranged. The safety could be improved upon. Also, the contamination with blood could be prevented more effectively.

DE-B3-103 12 357 discloses a piercing aid which is provided with a container with needles. For analysis, a separate analysis set would be required. The container for the needles, in this case a revolving cartridge containing needles in the axial direction, already offers a significant improvement with respect to known systems. Furthermore, however, it relates to hollow needles. In addition, the safety and prevention of contamination with blood could be improved upon. The construction is complicated as well.

Summary of the invention

It is an object of the invention to simplify the analysis of blood samples, in particular to simplify self-analysis.

Furthermore, it is an object of the invention to increase the accuracy of testing devices, in particular for self-testing.

To this end, the invention provides a testing device comprising a housing comprising a piercing unit provided with a removable cylindrical cartridge, provided along the circumference with several needles in the axial direction, the tips of which are movable out of the cylindrical cartridge in the axial direction in order to pierce a patient so as to produce a drop of blood, and an analysis unit provided with a removable analysis disk, provided along the circumference with several analysis parts on the disk at the edge for analyzing the drop of blood. Incorporating the piercing unit and the analysis unit into one housing in this way makes simple self-analysis of blood possible, for example by a diabetic for glucose. Incorporating both units in this way also makes it possible to create a compact apparatus which makes it virtually impossible to make mistakes, and which has no loose components which may get lost. Thus, it becomes easier even for relatively young children to determine their glucose level, for example.

In particular, the integration allows the determinations to be more accurate.

Furthermore, a more accurate determination is made possible as a result of improved hygiene.

In addition, due to the fact that the operation is easier and the apparatus is more hygienic, the threshold for accurate self-assessment is lowered, in particular by young people. Moreover, the data which are produced are more suitable for carrying out scientific research due to the increased reliability.

In one embodiment, the housing comprises a first receiving space for the removable cylindrical cartridge. In a further embodiment, the housing comprises a second receiving space for the removable analysis disk.

In one embodiment, the housing comprises a lid for closing off the first and second receiving spaces, which gives access to both receiving spaces when it is removed.

In one embodiment, the number of needles in the cylindrical cartridge and the number of analysis parts of the analysis disk are a multiple of each other, preferably the number of needles in the cylindrical cartridge corresponds to the number of analysis parts of the analysis disk.

In one embodiment, the housing comprises a removable housing part for closing off an analysis aperture which gives access to one analysis part. In one embodiment, the testing device according to the invention furthermore comprises an pierce operating button for activating the piercing unit, in which activation of the pierce operating button causes a part of a needle of the cylindrical cartridge to shoot out of the housing and return inside the cylindrical cartridge, and causes the cylindrical cartridge to rotate about its longitudinal axis until a new needle has been brought into an operating position.

In one embodiment, the testing device according to the invention furthermore comprises an analysis operating button for activating the analysis unit, in which activation of the analysis operating button causes a subsequent analysis part to be brought into an operating position.

In one embodiment, the analysis disk comprises a lower disk, an upper disk, provided with a working opening, and a measuring disk between the lower disk and the upper disk, and which is provided on its circumference with the analysis parts, in which the size of the working opening is adapted to the size of an analysis part. In one embodiment thereof, the upper disk comprises a removable disk part which provides the working opening when it is removed. In a fiirther embodiment thereof, the working opening corresponds to the analysis aperture. The lower disk and the upper disk in this case form a housing, which housing may be made of plastic. If desired, the lower disk and the upper disk can be detached from one another and the measuring disk can be replaced.

In a further or alternative embodiment, the analysis disk can be used on both sides. In that case, the lower disk and the upper disk both have a working opening. In addition, the measuring disk may be provided with analysis parts on both sides. Alternatively, only the measuring disk is provided with analysis parts on both sides and can be turned over in the analysis disk.

In one embodiment, the analysis disk comprises an engagement part which engages with an analysis drive mechanism which can make the analysis disk and/or the measuring disk rotate about its rotation axis through an angle. In order to be able to use the analysis disk on both sides, the analysis disk can be provided with engagement parts on both sides.

In one embodiment, the cylindrical cartridge comprises an engagement part which engages with a piercing drive mechanism which can make the cylindrical cartridge rotate about its rotation axis through an angle.

In one embodiment, the cylindrical cartridge comprises a number of chambers for the needles along its circumference.

In one embodiment, the needles comprise an engagement part provided with a locking projection and an entrainment projection.

In one embodiment, the engagement part is held in a chamber of the cartridge in a sliding manner.

In one embodiment, the chambers comprise an engagement part which cooperates with a locking projection in order to keep a needle in a locking position.

In one embodiment, the chamber is provided with an access aperture to provide access to the entrainment projection, and the testing device furthermore comprises a drive unit for moving the needle up and down, in the axial direction in the cartridge, in which the driving device comprises a driving projection for engaging the entrainment projection.

In one embodiment, the testing device according to the invention is furthermore provided with a memory for storing test results, in which the memory is preferably designed for storing a number of test results which corresponds to at least the number of needles in the cylindrical cartridge or at least the number of analysis parts on the analysis disk. The memory may be removable, for example in the form of a memory card, for example an SD, MMC, compact flash or similar memory card. As a result, measurement or test results can be exchanged in a simple manner or the testing device can be provided with new or additional data or modified software. Furthermore, the testing device may be provided with a data-processing unit, and may in particular be provided with software for carrying out calculations on the basis of the test results. In addition, the testing device may be provided with a display device or display for displaying test results, a drugs dose to be administered, the status of the testing device, or a static overview of previous test results or a trend therein.

In one embodiment, the testing device according to the invention is furthermore provided with a connection provided with contact members for producing an electrical contact with an external positioning unit or docking station, for example for providing electrical power or exchanging data. The contact members can also be connected to a computer, for example by means of a well-known USB connection or the like.

It is also conceivable to make wireless data transfer possible with an external apparatus or computer by means of, for example Bluetooth, Wifi, UMTS, IRdA (infrared), RFID technology or another wireless data transfer. From the testing device to an external apparatus, but also from the external apparatus to the testing device, for example data on drugs to be administered or the dosage thereof.

The invention furthermore relates to a testing device comprising a cylindrical cartridge, provided along its circumference with needles whose longitudinal axis runs in the axial direction of the cylindrical cartridge, in which the cylindrical cartridge is provided along its circumference with chambers extending in the axial direction which are each provided with a needle, with each of the needles having an engagement part, the engagement parts being slidable, or displaceable, in the axial direction of the cylindrical cartridge in the chambers, and being provided with locking projections for engaging with locking projections in the chambers to retain a needle in a locking position in a locking position in its chamber, and driving projections for engaging with a driving device to make a tip of a needle shoot out of the cylindrical cartridge from an inoperative position to a piercing position, in which the needle extends outside the cylindrical cartridge, and return beyond the inoperative position to the locking position. The locking device prevents re-use of a needle, as a result of which infections can be prevented. In addition, it makes a simple and safe construction possible. It makes it possible to prevent contamination with blood.

The chambers extending in the axial direction may be designed to retain a needle in a locking position in a locked position in a far end of the chamber.

This testing device may be combined with further aspects mentioned in this application, as well as with further details regarding the analysis disk.

The invention furthermore relates to a testing device comprising an analysis disk comprising a lower disk, a upper disk, and a measuring disk which is rotatably accommodated between the lower disk and the upper disk and which is provided along its circumference at the edge with analysis parts.

This testing device can be combined with further aspects mentioned in this application, as well as with further details regarding the analysis disk.

The invention furthermore relates to a cylindrical cartridge for a testing device as described in this application.

The invention furthermore relates to an analysis disk for a testing device as described in this application.

The invention furthermore relates to a measuring disk for a testing device or analysis disk as described in this application.

The invention furthermore relates to an assembly of a testing device as described and when provided with a connection, and to a positioning unit, the positioning unit preferably being provided with a data connection for enabling data exchange between the testing device and a data-processing device. According to another aspect, the invention furthermore relates to a testing or piercing device comprising a cartridge provided with needles which can be displaced axially from an inoperative position to a piercing position outside the cartridge in which a needle extends outside the cartridge through a passage opening and can subsequently be displaced further in the axial direction past the unused position to a used position, in which the cartridge is provided with closure parts which rest against the needles under prestress in the unused position, and which close off the passage opening when the needles are in the used position.

The closure parts improve the prevention of contamination and further improve re-use.

In one embodiment of said testing or piercing device, the cartridge is a cylindrical cartridge, provided along its circumference with needles whose longitudinal axis runs in the axial direction of the cylindrical cartridge, in which the cylindrical cartridge is provided along its circumference with chambers extending in the axial direction which are each provided with a needle, with each of the needles having an engagement part, the engagement parts being slidable in the chambers in the axial direction of the cylindrical cartridge, and being provided with locking projections for engaging with locking projections in the chambers to retain a needle in the used position in a locking position in its chamber, and driving projections for engaging with a driving device to make a tip of a needle shoot out of the cylindrical cartridge from an inoperative position to the piercing position, and return beyond the inoperative position to the locking position.

In a further embodiment in which the cartridge is substantially made of plastic, the closure parts each comprise a plastic closure cover which is formed integrally with the cartridge, and the plastic closure covers are made of flexible resilient plastic, each closure cover being formed so as to rest against a needle in the inoperative position under prestress and to close off the passage opening when the needle is in the locking position.

This testing device and/or the cartridge may be combined with any of the above- described. It will be clear that the various aspects which are mentioned in the present patent application can be combined and may each separately be considered for a divisional patent application. This applies in particular to the cartridge for the needles, and to the cartridge, in this case the disk, for analysis parts.

Short description of the figures

The attached figures illustrate various embodiments of a testing device according to the invention, in which:

fig. 1 shows a testing device according to the invention; fig. 2 shows the testing device from fig. 1 in exploded view; fig. 3 shows an analysis disk for a testing device according to fig. 1; fig.4 shows a cylindrical cartridge for a testing device according to fig. 1 ; fig. 5 shows a cross section through a cartridge from fig.4; fig. 6 shows an assembly of a testing device, a readout station and data-processing device.

Description of embodiments

Fig. 1 shows a testing device 1 provided with a detachable lid 2. The detachable Ud 2 is provided with an opening 3 in order to allow a needle to pass through. The testing device furthermore comprises an analysis aperture 4. In this case, the analysis aperture consists of a removed part of the detachable Hd 2, which may optionally be provided with a removable, folding or sliding lid. Furthermore, the testing device 1 is provided with a display device or display 5, an operating button 6 for operating a piercing device and an operating button 7 for operating an analysis device, or for switching on the testing device 1 and preparing it for use. The piercing device and the analysis device are both arranged in the testing device 1 , in one housing.

Fig. 2 shows the testing device 1 from fig. 1 in an exploded view. Inside the housing of the testing device 1 , below the removable protective lid or protective cover 2, there are shown a cylindrical cartridge 8 which is provided with needles, and an analysis disk 9, which is provided with a testing disk or measuring disk 100 provided with analysis parts 32 for analyzing body fluids such as for example blood. The cylindrical cartridge 8 forms part of a piercing device and the analysis disk 9 forms part of an analysis device, both of which are accommodated in the housing of the testing device 1. The receiving space 21 for the cylindrical cartridge 8 and receiving space 11 for the analysis disk 9 can be seen inside the housing. Furthermore, a transmission 12 is shown in the receiving space 11, by means of which a driving device, which is not shown in any more detail, can operate the analysis disk 9, that is to say is able to produce a rotary movement as a result of which a subsequent analysis strip becomes available.

Furthermore, a transmission 31 is shown in receiving space 21 for the cylindrical cartridge, by means of which a (further) driving device can cause the cylindrical cartridge to rotate about its longitudinal axis in order to bring a subsequent needle into an operative position.

Fig. 3 shows an example of an analysis disk 9 in exploded view. The analysis disk 9 is provided with a working opening 10 via which the analysis parts 32 can be accessed. The analysis disk 9 is furthermore provided with engagement parts 30, in this case a gear part, which can cooperate with engagement part 12 of a driving device in the testing device 1. The analysis disk 9 furthermore has a lower disk 13, which in this case is provided with a raised circumferential edge 18 and the gear part 30, which engages with a first subdisk 14, an intermediate disk 15 and a second subdisk 16 which together form a testing disk or measuring disk 100 provided with test strips comprising analysis parts 32. The testing disk is illustrated diagrammatically in this case. The analysis parts 32 may each be constructed in the same way as for example the well-known test strips which are commercially available from, for example, ACCU-CHEK^®, for example under the name Accu-Chek Aviva, for determining the blood glucose level, but then arranged on a measuring disk 100. Other examples of glucose-determining systems whose determination principle can also be used are the Bayer Glucometer DEX2, Glucometer Elite and Glucometer Elite XL, the H.D.I. Prestige Smart System IQ, the LifeScan Gluco Touch/Road Runner, One Touch Ultra, and One Touch InDuo, the ABBOTT/MediSense Soft Sense and the Precision Xtra, the Menarini GlucoCard Memory 2 and the Memory PC, and the Accutrend Sensor and Accu Chek Compact by Roche. The analysis parts can also be based on another measuring principle such as osmotic measurement of the blood glucose level. Alternatively, it is also possible to use analysis parts which are suitable for determining the cholesterol level of blood, or for determining another parameter. These analysis parts are known per se to those skilled in the art. The known test strips or other determining methods for determining blood parameters can be accommodated in or on the measuring disk. Also, on both sides of the measuring disk The blood is in each case preferably applied at the edge of the measuring disk. In this case, the position where the blood is to be applied may be indicated on the measuring disk.

The analysis disk 9 is furthermore covered by means of a upper disk 17, which is provided with the working opening 10 which has already been discussed. The upper disk 17, in conjunction with the lower disk 13 and the circumferential edge 18, inside which the testing disk provided with test strips or analysis parts fall, together protect the test strips or analysis parts 32 against access from above. After the analysis disk 9 has been placed in the receiving space 11 of the testing device 1, the working opening 10 will coincide with the analysis aperture 4, as a result of which, for example, blood can be applied to a test strip. The working opening may be provided with a removable covering, such as a tear-off film or foil, or a snap-off part. As a result of the accommodation of the measuring disk illustrated here, it can be stored and used in a simple manner without external influences adversely affecting the measuring disk.

Gear 30, which is illustrated here, may be provided on the bottom side (not shown) with an internal toothing which engages with the gear 12 when it is placed in the testing device 1. However, this form of transmission and drive mechanism are given by way of example. Many other forms of drive mechanism are possible and conceivable.

Fig. 4 shows a cylindrical cartridge 8 according to the invention, illustrated in perspective view, in which the top side of the cylindrical cartridge 8 can be seen. The top side of the cylindrical cartridge 8 is provided with internal toothing 50, on which gear 31 of a driving device, which is situated in the housing of the testing device 1 , can engage for rotating the cylindrical cartridge 8 about its longitudinal axis. Again, this embodiment of transmission and drive mechanism are only given by way of example. Many alternatives are conceivable.

On the side or in the side walls, recesses or passages 19 are arranged, which give access to the needles 22 provided with engagement parts 23. These will be discussed in detail in figures 5a-5d.

Fig. 2 shows the bottom side of a cylindrical cartridge 8. In said view, the passage openings 27 can be seen, which are provided on the edge around the circumference, for allowing the tips of the needles 22 through.

Figs. 5a-5d show a longitudinal section through a part of the cylindrical cartridge 8. These sections show the passage 19, which gives access to the needle 22 and the engagement part 23 thereof. The dimensions of the chamber 25 in the cylindrical cartridge 8 are adapted to the dimensions of the engagement part 23 of the needle 22 so as to enable the needle 22 with engagement part 23 to move up and down. The engagement part 23 of the needle 22 is provided with locking projections 24, which can cooperate with locking projections 26 in chamber 25. Furthermore, the engagement part 23 is provided with an entrainment projection 29, which can engage with a driving projection 20 of a driving device, which can bring about a reciprocating movement of the needle 22 with engagement part 23, that is to say reciprocating in the axial direction with respect to the cylindrical cartridge 8.

Fig. 5a shows the driving projection 20 in an inoperative position and in engagement with the entrainment projection 29 of engagement part 23 of the needle 22. The needle 22 extends in the axial direction through a through-passage of the chamber 25 and to a through-passage 27 in the cylindrical cartridge 8. The through-passage is in this case provided with a protective film or foil 28, which prevents the needle 22, held in the cylindrical cartridge 8, from coming into contact with the environment before use. In this case, this protective film or foil 28 is disposed on the outside of the cylindrical cartridge 8 which makes it easy to visually observe whether or not a needle has been used. If desired, the protective film or foil 28 can also be disposed on the inside over the through-passage 27. Furthermore, the cylindrical cartridge 8 is provided with a protective cover 35 which is designed to close off the through-passage after the needle 22 has been used, hi this embodiment, a protective cover 35 of a flexible plastic is integrally formed on the cylindrical cartridge. The protective cover 35 rests against the needle 22 under prestress. The length is chosen in such a manner that, in the position where the needle 22 has not yet been used, it rests on the needle and that it no longer rests on the needle 22 in the position where the needle is locked, as illustrated in fig. 5d, in which the needle 22 is situated in a higher position. As a result of the prestress, or as a result of the flexibility of the material or by means of a spring, the protective cover covers the access to the needle. This additionally prevents re-use of the needle. Moreover, it can be seen in a different manner that the needle 22 has already been used. Furthermore, contamination with blood, or contamination of the inside of the cylindrical cartridge 8, can be prevented. Protective cover 35 may be hinges. Resting on the needle 22, as illustrated, has the advantage that it is "failsafe". Such a protective cover 35 in the form of an integrally formed part can be produced in a simple manner. A prestressed closure part 35 which rests on the needle in the unused position thus has clear advantages. The closure part can be formed as a closure cover 35.

Fig. 5b shows the driving projection 20 in its limit, bottommost position, in which the needle 22 extends outside the cylindrical cartridge 8. When the cylindrical cartridge 8 is accommodated in the testing device, the needle 22 in this case extends outside the testing device 1. In this case, the needle 22 pierces the protective film or foil 28 when it passes through the through-passage 27. The device may be provided with an adjustment means by means of which the limit bottommost position of the driving projection can be adjusted in such a way that the depth to which the needle penetrates into the skin can be adjusted thereby.

Fig. 5c shows the needle 22 in its uppermost locking position. In this uppermost locking position, the engagement part 23 of the needle 22 is situated at the top of the chamber 25 and the locking projection 24 is in engagement with the locking projection 26 of the chamber 25. In this case, the needle 22 has been brought into this uppermost position by being driven by driving projection 20. If desired, it is also possible to provide a prestressed spring means between the engagement part 23 and the bottom wall of chamber 25, in which a passage for the needle 22 is provided. This spring means may be neutral when engagement part 23 is in the inoperative position, be prestressed to its maximum extent when the engagement part 23 is in its bottommost position, and cause the engagement part 23 to shoot up, in which case the locking projections 24, 26 engage with one another.

Fig. 5d shows the needle 22 with engagement part 23 in its locked position, and in which the driving projection 20 has returned to its inoperative position, the position which is also illustrated in fig. 5a. The driving projection 20 is disconnected from the entrainment projection 29.

The operation is as follows. In fig. 5a, the driving projection 20 engages with the entrainment projection 29 of engagement part 23 of the needle by means of the driving device, which is not shown in any more detail. When the operating button of the piercing device is activated, driving projection 20 will be driven down by the driving device by a striking motion. As a result thereof, the needle 22 with engagement part 23 will be moved down quickly. There, the needle 22 will carry out its piercing action by the needle 22 extending beyond the cylindrical container or cylindrical cartridge and extending outside the testing device 1 through the passage opening 3 in the housing. The driving projection 20 will then shoot back into its uppermost position, which is illustrated in fig. 5c. When the driving projection 20 shoots back, it will carry the engagement part 23 with needle 22 along upward and as a result of the speed, the engagement projections 24 will end up past the projections 26 and snap into position behind the latter. As the engagement part 23 is now locked by means of the projections 26 of the chamber or guiding space 25 of the cylindrical cartridge 8, said driving projection 20 will come off engagement projection 29 when the driving projection 20 carries out its return movement, in which case the driving projection 20 returns to its starting position without carrying engagement part 23 of the needle 22 along. A needle can then only be used once which benefits hygiene and accuracy of the determination. When the needle 22 is in the uppermost locked position, it will not extend through the passage opening 27 of the cylindrical cartridge. The needle is now locked inside the cylindrical cartridge 8 after use.

A user of the testing device has now produced a drop of blood by activating the piercing device. Subsequently, the user will have made an analysis part of the analysis disk freely accessible and transferred the drop of blood to an analysis part 32 of the analysis disk 9. There, said drop of blood will then be analyzed and the result of the analysis will be shown on the display device or display 5. By activating operating button 7, either before or after the transfer of the drop of blood, the analysis disk 9, which is situated inside the latter, will be rotated by a small angle so that the next test strip or analysis part 32 is made available. It is also conceivable to provide the testing device with a single firing button, by means of which a needle is first shot, following which (or prior to which) a new analysis part 32 will be made available in the analysis disk 9. After a needle has been shot, the cylindrical cartridge will also be rotated about its longitudinal axis by the driving device mentioned earlier, as a result of which a subsequent needle is made available.

Preferably, the number of needles in the cylindrical cartridge 8 and the number of test strips in the analysis disk 9 will either be a multiple of each other, but preferably the number is equal, so that both have to be replaced at the same time and the testing device only has to be opened once. In one embodiment, for example, a multiple of 7 needles will be provided in a cylindrical cartridge, and a multiple of 7 test strips in the analysis disk. Once all needles have been used once, they will all be in the locked position. In one embodiment, the drive mechanism which makes the cylindrical cartridge rotate about its longitudinal axis will then be locked, and the user will be shown a warning message on the display to replace the cylindrical cartridge. In addition, the analysis disk will then preferably also have to be replaced.

Furthermore, in one embodiment, the drive mechanism for the cylindrical cartridge and the drive mechanism for the analysis disk may be coupled so that a new analysis part or test strip is also made available when a new needle is used. In one embodiment, the two are mechanically coupled. Furthermore, in one embodiment, the testing device is provided with a memory for storing at least as many measurement values as there are test strips on an analysis disk.

In fig. 6, the testing device illustrated is placed in a readout station or so-called "docking station" 60. To this end, the testing device 1 is provided with contact members, which come into contact with the contact members in readout station 60 when the testing device 1 is placed into a positioning opening in the readout station 60. The measurement results can subsequently be transmitted from the testing device 1 to the computer 61 for further processing, for example passing on to a hospital, by means of wired or wireless connection to a computer 61. The readout device 60 may furthermore be provided with a power connection for recharging the batteries of the testing device 1.

Furthermore, in one embodiment the device according to the invention is furthermore provided with a temperature sensor. The temperature measured can be stored in a data file together with the test result or measurement result. In addition, the temperature may be displayed on the display during piercing. In a further embodiment, the temperature is stored in the memory at the point in time when it is being measured.

In a further and/or alternative embodiment, which is only illustrated diagrammatically and not in any more detail, the device according to the invention may be provided with a data connection for transferring data to a metering device for administering substances to a body, such as for example an insulin pump, such as for example commercially available from ACCU-CHEK®, for example the Accu-Chek D- TRONplus or the Accu-Chek Spirit. The measurement data from the device according to the invention can then (wirelessly or by means of a wire connection) be transmitted to the insulin pump. In a further embodiment thereof, the device can also receive data from the insulin pump relating to, for example, the amount of insulin administered. Transfer of the data may, for example, be effected by means of the readout device 60.

The device itself and/or the readout device may be provided with a data-transmission device and/or a data-receiving device, so that data can be exchanged directly, that is without the use of the readout station described above, with a computer, for example by means of a wired connection, but also or instead of the latter by means of a wireless connection, such as Wifi, Bluetooth, or a similar connection.

It will be clear that the above description is given in order to illustrate the operation of preferred embodiments of the invention and not in order to limit the scope of the invention. Based on the above explanation, many variants will be evident for a person skilled in the art which are within the spirit and scope of the present invention.

Claims

1. A testing device comprising a housing comprising a piercing unit provided with a removable cylindrical cartridge, provided along the circumference with several needles in the axial direction, the tips of which are moveable out of the cylindrical cartridge in the axial direction in order to pierce a patient so as to produce a drop of blood, and an analysis unit provided with a removable analysis disk, provided along the circumference with several analysis parts on the disk at the edge for analyzing the drop of blood.

2. The testing device according to claim 1 , in which the housing comprises a first receiving space for the removable cylindrical cartridge.

3. The testing device according to claim I or 2, in which the housing comprises a second receiving space for the removable analysis disk.

4. The testing device according to one of the preceding claims, in which the housing comprises a lid for closing off the first and second receiving spaces, which gives access to both receiving spaces when it is removed.

5. The testing device according to one of the preceding claims, in which the number of needles in the cylindrical cartridge and the number of analysis parts of the analysis disk are a multiple of each other, preferably the number of needles in the cylindrical cartridge corresponds to the number of analysis parts of the analysis disk.

6. The testing device according to one of the preceding claims, in which the housing comprises a removable or fold-away housing part for closing off an analysis aperture which gives access to one analysis part.

7. The testing device according to one of the preceding claims, furthermore comprising an pierce operating button for activating the piercing unit, in which activation of the pierce operating button causes a part of a needle of the cylindrical cartridge to shoot out of the housing and return inside the cylindrical cartridge, and causes the cylindrical cartridge to rotate about its longitudinal axis until a new needle has been brought into an operating position.

8. The testing device according to one of the preceding claims, furthermore comprising an analyze operating button for activating the analysis unit, in which activation of the analyze operating button causes a subsequent analysis part to be brought into an operating position.

9. The testing device according to one of the preceding claims, in which the analysis disk comprises a lower disk, a upper disk provided with a working opening, and a measuring disk between the lower disk and the upper disk, and which is provided on its circumference with the analysis parts, in which the size of the working opening is adapted to the size of an analysis part.

10. The testing device according to one of the preceding claims, in which the upper disk comprises a removable disk part which provides the working opening when it is removed.

11. The testing device according to one of the preceding claims 9-10, in which the working opening corresponds to the analysis aperture.

12. The testing device according to one of the preceding claims, in which the analysis disk comprises an engagement part which engages with an analysis drive mechanism which can make the analysis disk and/or the measuring disk rotate about its rotation axis through an angle.

13. The testing device according to one of the preceding claims, in which the cylindrical cartridge comprises an engagement part which engages with a piercing drive mechanism which can make the cylindrical cartridge rotate about its rotation axis through an angle.

14. The testing device according to one of the preceding claims, in which the cylindrical cartridge comprises a number of chambers for the needles along its circumference.

15. The testing device according to one of the preceding claims, in which the needles comprise an engagement part provided with a locking projection and an entrainment projection.

16. The testing device according to one of the preceding claims, in which the engagement part is held in a chamber of the cartridge in a sliding manner.

17. The testing device according to one of the preceding claims, in which the chambers comprise an engagement part which cooperates with a locking projection in order to keep a needle in a locking position.

18. The testing device according to one of the preceding claims, in which the chamber is provided with an access aperture to provide access to the entrainment projection, and the testing device furthermore comprises a drive unit for moving the needle up and down, in the axial direction in the cartridge, in which the driving device comprises a driving projection for engaging the entrainment projection.

19. The testing device according to one of the preceding claims, furthermore provided with a memory for storing test results, in which the memory is preferably designed for storing a number of test results which corresponds to at least the number of needles in the cylindrical cartridge or at least the number of analysis parts on the analysis disk.

20. The testing device according to one of the preceding claims, furthermore provided with a connection provided with contact members for producing an electrical contact with an external positioning unit.

21. A testing device comprising a cylindrical cartridge, provided along its circumference with needles whose longitudinal axis runs in the axial direction of the cylindrical cartridge, in which the cylindrical cartridge is provided along its circumference with chambers extending in the axial direction which are each provided with a needle, with each of the needles having an engagement part, the engagement parts being slidable in the axial direction of the cylindrical cartridge in the chambers, and being provided with locking projections for engaging with locking projections in the chambers to retain a needle in a locking position in a locking position in its chamber, and driving projections for engaging with a driving device to make a tip of a needle shoot out of the cylindrical cartridge from an inoperative position to a piercing position, in which the needle extends outside the cylindrical cartridge, and return beyond the inoperative position to the locking position.

22. A testing device comprising an analysis disk comprising a lower disk, a upper disk, and a measuring disk which is rotatably accommodated between the lower disk and the upper disk and which is provided along its circumference at the edge with analysis parts.

23. The testing device according to one of the preceding claims, furthermore provided with a memory for storing digital measurement or test data, and optionally further data, a data-processing unit, for example for carrying out arithmetical operations on the measurement or test results, and a data-transfer apparatus, for example for wired or wireless transfer of test or measurement data to an external device.

24. A cylindrical cartridge, clearly intended and suitable for a testing device according to one of the preceding claims.

25. An analysis disk, clearly intended and suitable for a testing device according to one of the preceding claims.

26. A measuring disk, clearly intended and suitable for an analysis disk according to one of the preceding claims.

27. An assembly comprising: a testing device according to one of the preceding claims when provided with a connection, and a positioning unit, in which the positioning unit is preferably provided with a data connection for enabling data exchange between the testing device and a data-processing device.

28. A testing or piercing device comprising a cartridge provided with needles which can be displaced axially from an inoperative position to a piercing position outside the cartridge in which a needle extends outside the cartridge through a passage opening and can subsequently be displaced further in the axial direction past the unused position to a used position, in which the cartridge is provided with closure parts which rest against the needles under prestress in the unused position, and which close off the passage opening when the needles are in the used position.

29. The testing or piercing device according to claim 28, in which the cartridge is a cylindrical cartridge, provided along its circumference with needles whose longitudinal axis runs in the axial direction of the cylindrical cartridge, in which the cylindrical cartridge is provided along its circumference with chambers extending in the axial direction which are each provided with a needle, with each of the needles having an engagement part, the engagement parts being slidable in the chambers in the axial direction of the cylindrical cartridge, and being provided with locking projections for engaging with locking projections in the chambers to retain a needle in the used position in a locking position in its chamber, and driving projections for engaging with a driving device to make a tip of a needle shoot out of the cylindrical cartridge from an inoperative position to the piercing position, and return beyond the inoperative position to the locking position.

30. The testing or piercing device according to claim 28 or 29, in which the cartridge is substantially made of plastic, and the closure parts each comprise a plastic closure cover which is formed integrally with the cartridge, and the plastic closure covers are made of flexible resilient plastic, each closure cover being formed so as to rest against a needle in the inoperative position under prestress and to close off the passage opening when the needle is in the locking position.

31. A device provided with one or more of the characterizing measures described in the attached description and/or shown in the attached drawings.

32. A method comprising one or more of the characterizing steps described in the accompanying description and/or in the accompanying drawings.

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