WO2009022280A2

WO2009022280A2 - Transport module of a single-cartridge diagnostic device

Info

Publication number: WO2009022280A2
Application number: PCT/IB2008/053205
Authority: WO
Inventors: Jozef Christiaan Mathieu Versleegers; Arnold Aalders
Original assignee: Koninklijke Philips Electronics N.V.
Priority date: 2007-08-14
Filing date: 2008-08-11
Publication date: 2009-02-19
Also published as: WO2009022280A3

Abstract

A single -cartridge diagnostic device comprises a transport module for receiving a cartridge on a first plane. The cartridge is configured to hold a sample to be diagnosed. The device also comprises a diagnosing platform disposed on a second plane which is configured for receiving the cartridge from the first plane. The cartrdige is transported along a single axis from the first plane to the second plane. The single axis movement of the transport module males the diagnostic device compact.

Description

Transport module of a single-cartridge diagnostic device

FIELD OF THE INVENTION

The invention relates to a diagnostic device, more particularly a diagnostic device including a single cartridge, and still more particularly a transport module of the single-cartridge diagnostic device.

BACKGROUND OF THE INVENTION For the detection of specific bacteria in a sample, a detection method is known based on a DNA/RNA amplification process. In this method, the detection is done by performing a number of process steps using different instruments , for example a Biorobot for lysis, washing, mixing and elusion, a PCR Cycler for DNA/RNA amplification, and an appropriate optical or electro-magnetic system for detection and identification of the specific amplified DNA/RNA. The samples are handled manually from machine to machine and the detection results are obtained after about 6 hours. An integrated diagnostic device is one in which at least some and preferably all of the above process steps are performed inside a single cartridge without manual interference. This device gives the results sooner and is user- friendly. This device avoids the risk of cross-contamination because all processes are done in a closed disposable cartridge. The execution of the analyses is performed fully automatically , leading to a drastic reduction of processing time to about 2 hours, eliminating all intermediate manual steps and also avoiding operator handling errors.

US-20060002820-A1 describes a new apparatus which is useful for high throughput of samples without the necessity of interrupting any analysis carried out with said apparatus for reloading of disposables. The apparatus comprises a transfer module, a first plane to store the disposables and a second plane to process samples within said disposables. The transfer module is an elevator for transporting said disposables from said plane for storage to said plane for processing. This apparatus uses one actuator for moving the disposables from the output position of the first plane to the input position of the second plane and at least three actuators for positioning the disposables from the input position of the first plane to the output position of the first plane. This makes the apparatus bulky and complex. It would therefore be advantageous to have a diagnostic device which does not have the disadvantages described above and more in particular to have a compact diagnostic device that minimizes handling errors.

Particular and preferred aspects of the invention are set out in the accompanying independent and dependent claims. Features from the dependent claims may be combined with features from the independent claims and with features from other dependent claims, as appropriate and not merely as explicitly set out in the claims.

BRIEF SUMMARY OF THE INVENTION

According to a first aspect of the invention, a single-cartridge diagnostic device comprises a transport module for receiving a cartridge on a first plane, wherein the cartridge is configured to hold a sample to be diagnosed; a diagnosing platform disposed on a second plane, wherein the diagnosing platform is configured for receiving the cartridge from the first plane, and wherein the cartridge is transported along a single axis from the first plane to the second plane. The single axis transportation makes the diagnostic device compact as it needs a less complex mechanism. Compact devices occupy less space in a laboratory.

According to an embodiment of the invention, the axis is a vertical axis. The cartridge is tansported vertically from the first plane to the second plane.

According to another embodiment of the invention, the second plane is parallel to the first plane. The alignment of the cartridge with the diagnosing platform is crucial to ensure a correct diagnosis. When the first and second planes are parallel, accurate alignment can be achieved

According to yet another embodiment of the invention, the cartridge is preloaded with the sample. The current invention involves the miniaturization and full integration of various and different process steps so as to form a single disposable cartridge. Containers with various processing fluids are an integral part of the cartridge. The execution of the analyses is performed fully automatically , leading to a drastic reduction of processing times, elimination of intermediate manual steps and avoidance of operator handling errors. The cartridge is designed so as to be disposable. This avoids the risk of cross- contamination. The fully closed cartridge preferably contains all elements for executing the process steps on the fluids: e.g channels to transport the fluids, specific chambers for mixing, lysing, washing, temperature cycling. The preferably pre-loaded cartridge is inserted into the diagnostic device on the first plane. According to a further embodiment of the invention, the transport module comprises a single actuator for actuating the transport module; and a receiver for receiving the cartridge on the first plane. The single actuator makes the diagnostic device compact. Space in laboratories is expensive and there is always a drive to keep the diagnostic device as compact as possible. The forces required to interface the cartridge with the diagnosing platform during the diagnosing process are relatively high (± 400N). The transport module ensures that this interfacing force is provided.

According to yet another embodiment of the invention, the transport module further comprises a positioning device for accurately positioning the cartridge onto the transport module.The positioning device preferably comprises pins for accurately positioning the cartridge onto the transport module. When the cartridge is loaded onto the receiver on the first plane, it has some play in all directions. This play can result in (relatively) large positioning errors (in X, Y and R _z direction). These errors need to be smaller for the diagnostic device to work efficiently. When the transport module reaches the receiver, two positioning pins on the transport module enter two holes that are in the cartridge. The positioning pins and the holes in the cartridge have very little play. This way the cartridge positions itself with regard to the transport module in X, Y and R _z directions. The cartridge is accurately and automatically positioned when the transport module trans ports the cartridge from the first plane to the second plane, and requires no additional steps and actuators. According to a further embodiment of the invention, the diagnosing platform is provided with an optical detector for diagnosing the sample. In the case of optical detection, the cartridge is provided with radiation transport ports for allowing access of an excitation beam from the optical detector and emision of fluorescence light from the detection spots. According to a second aspect of the invention, a method of diagnosing a sample comprises providing a cartridge onto a first plane; transporting the cartridge from the first plane to a second plane along a single axis; and diagnosing the sample upon receiving the cartridge on the second plane. The method involves very few steps and thus simplifies the diagnosing process. According to a preferred embodiment of the invention, the cartridge is preloaded with the sample.

According to yet another embodiment of the invention, transporting the cartridge to the second plane is performed by a transport module.

According to a further embodiment of the invention, the axis is a vertical axis. According to a still further embodiment of the invention, the transporting of the cartridge comprises positioning the cartridge onto the transport module using positioning pins provided on the transport module; and transporting the cartridge to interface with a diagnostic platform on the second plane. According to a still further embodiment of the invention, transporting the cartridge to the second plane is performed by a single actuator.

According to a third aspect of the invention, a diagnostic system comprises the diagnostic device as described above.The diagnostic system may be able to diagnose multiple samples.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other characteristics, features and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of exa mple, the principles of the invention. This description is given for the sake of example only, without limiting the scope of the invention. The reference figures quoted below refer to the attached drawings. Fig. 1 shows an overall view of a diagnostic device; Fig. 2 shows a positioning pin; Fig. 3 shows an internal view of a transport module;

Fig. 4 shows an embodiment wherein the transport module is in its lower state; Fig. 5 shows an embodiment wherein a cartridge is positioned by positioning pins provided on the transport module;

Fig. 6 shows an embodiment wherein the cartridge is aligned with Z-references on a diagnosing platform; and

Fig. 7 shows an embodiment of the invention wherein the cartridge is finally positioned.

DETAILED DESCRIPTION OFTHE INVENTION

The present invention will be described with respect to particular embodiments and with reference to certain drawings . Any reference signs in the claims shall not be construe d as limiting the scope. The drawings described are only schematic and are non- limiting. In the drawings, the size of some of the elements may be exaggerated and not drawn to scale for illustrative purposes. Where the term "comprising" is used in the present description and claims, it does not exclude other elements or steps. Where an indefinite or definite article is used when referring to a singular noun e.g. "a" or "an", "the", this includes a plural of that noun unless something else is specifically stated.

Furthermore, the terms first, second, third and the like in the description and in the claims, are used for distinguishing between similar elements and not necessarily for describing a sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other sequences than described or illustrated herein.

Moreover, the terms top, bottom, over, under and the like in the description and the claims are used for descriptive purposes and not necessarily for describing relative positions. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other orientations than described or illustrated herein.

As shown in Figures 1-4, the diagnostic device 100 comprises a single actuator 1, gear wheels 2, side plates 3, crank bars 4, central guiding shafts 5, guiding wheels 6, guiding cranks 7, a diagnosing platform 8, a transport module 9, a receiver 10 to receive a cartridge 11, X-Y positioning pin 12 and R_z positioning pin 13. The diagnosing platform 8 includes Z -references 14 and aligns with a surface 15 provided in the cartridge 11. As shown in Figure 2, the surface 15 is a hole , when viewed from the bottom, and a surface when viewed from the top. The first plane is denoted by 200 whereas the second plane is denoted by 300.

The cartridge 11 is received by the receiver 10 on the first plane 200 as shown in Figure 1. The transport module 9 is positioned by two central shafts 5, and four crank bars 4 as illustrated in Figure 2 The crank bars are actuated using the gear wheels 2 and the actuator 1. The receiver 10 is positioned by the same two central shafts 5, four guiding wheels 6 and guiding cranks 7 and the shape of the side plates 3. Using a number of extension springs , the receiver 10 is pulled towards the transport module 9. The bottom position in Z direction of the receiver 10 is derived from the shape of the side plates 3. The diagnostic device 100 after receiving the cartridge is shown in Figure 3 and is ready to interface the cartridge 11 with the diagnosing platform 8 with the help of the transport module 9. The diagnosing platform 8 may have a PCR head and a heater for lysis of the sample besides the optics module .

The interfacing sequence is done in three steps. All three steps are performed by the actuator 1. The actuator 1 operates continuously. As soon as the actuator 1 starts turning the gear wheels 4, the transport module starts to move vertically up. When the transport module 9 reaches the receiver 10, two positioning pins 12 and 13 on the transport module position the cartrdige in the X, Y and R_z direction. When the cartridge 11 is loaded onto the receiver 10 on the first plane 200, it has some play in all directions. This play can result in large positioning errors (in the X, Y andR_z direction). These errors need to be smaller for the diagnostic device 100 to work efficiently. When the transport module 9 reaches the receiver 10, two positioning pins 12 and 13 on the transport module 9 enter two holes 15 that are in the cartridge 11. These holes 15 are holes, when viewed from the bottom, so that the positioning pins can align with them. The holes 15 are surfaces, when viewed from the top, so they can align smoothly with the diagnosing platform 8. The positioning pins 12 and 13 and the holes 15 in the cartridge 11 have very little play. In this way the cartridge 11 positions itself with regard to the transport module 9 in X, Y and R _z directions. No force other then the positioning force is applied on the cartridge . This ends step one and is shown in Figure 5.

Next , the receiver 10 containing the cartridge 11 is pushed further upwards . The diagnostic platform 8 consists of the z-references 14. As soon as the transport module 9 along with the cartridge 11 reach the diagnostic platform 8, the cartridge 11 is fully constrained and positioned. This is shown in Figure 6.

In the final step, as shown in Figure 7, the transport module 9 is moved to its final psition. Since the cartridge 11 is already positioned, the (minimal) forces applied by the last interfacing features on the cartridge 11 do not influence the positioning of the cartridge 11. All three steps are carried out during gradual motion of the transport module 9.

It is to be understood that although preferred embodiments, specific constructions and configurations have been discus sed herein for devices according to the present invention, various changes or modifications in form and detail may be made without departing from the scope and spirit of this invention.

Claims

CLAIMS:

1. A single -cartridge diagnostic device (100) comprising: a transport module (9) for receiving a cartridge (11) on a first plane (200), wherein the cartridge (11) is configured to hold a sample to be diagnosed; a diagnosing platform (8) disposed on a second plane (300), wherein the diagnosing platform (8) is configured for receiving the cartridge (11) from the first plane

(200), and wherein the cartrdige (11) is transported along a single axis from the first plane

(200) to the second plane (300).

2 The diagnostic device (100) of claim 1, wherein the axis is a vertical axis.

3. The diagnostic device (100) of claim 1, wherein the second plane (300) is parallel to the first plane (200).

4. The diagnostic device (100) of claim 1, wherein the cartridge (11) is pre- loaded with a sample.

5. The diagnostic device (100) of claim 1, wherein the transport module (9) comprises a single actuator (1) for actuating the transport module (9); and a receiver (10) for receiving the cartridge (11) on the first plane (200).

6. The diagnostic device (100) of claim 5, wherein the transport module (9) further comprises a positioning device for accurately positioning the cartridge (11) onto the transport module (9).

7. The diagnostic device (100) of claim 5, wherein the positioning device comprises pins (12,13) for accurately positioning the cartridge onto the transport module.

8. The diagnostic device (100) of claim 1, wherein the diagnosing platform (8) is provided with an optical detector for diagnosing the sample.

9. A method of diagnosing a sample comprising: providing a cartridge (11) onto a first plane (200); transporting the cartridge (11) from the first plane (200) to a second plane (300) along a single axis; and diagnosing the sample upon receiving the cartridge (11) on the second plane

(300).

10. The method of claim 9, wherein the cartridge (11) is pre-loaded with a sample.

11. The method of claim 9, wherein transporting the cartridge (11) to the second plane (300) is performed by a transport module (9).

12. The method of claim 9, wherein the axis is a -serα^'cal axis.

13. The method of claim 9, wherein the transporting of the cartridge (11) comprises: positioning the cartridge (11) onto the transport module (9) using positioning pins (12,13) provided on the transport module (9); and transporting the cartridge (11) to interface with a diagnostic platform (8) on the second plane (300).

14. The method of claim 9, wherein transporting the cartridge (11) to the second plane (300) is performed by a single actuator (1).

15. A diagnostic system comprising the diagnostic device (100) of claim 1.