HK1209407B - System for piercing a sealing membrane - Google Patents

Description

Sealing membrane puncture system

Technical Field

The present invention relates to the field of instruments for performing medical analyses.

Background

Traditionally, such instruments, which may also be referred to as "automatic analyzers", make it possible to automatically perform certain medical protocols (protocols), such as puncturing the sealing membrane of a container and moving a liquid (in particular a blood sample, or other type of human sample) into said container, which initially contains one or more reagents.

The apparatus and method of the present invention are particularly useful for piercing the sealing membrane of a gel card (gel card).

In a known manner, a gel card is a container provided with one or more reaction wells, initially closed by a sealing membrane and each containing a reagent, which allows the reagents of different wells in any one gel card to be different.

To prime such gel cards, certain criteria must be met, specifically, an air gap must be formed between the metered or "dose" of liquid dispensed and the reagent previously present downhole in the gel card. The presence of the air gap temporarily prevents any physical contact between the dose of dispensed liquid and the reagent. One advantage of such an air gap is to control the moment at which the chemical reaction starts.

Another criterion to be met by the priming operation is: there should be no splashing on the inner wall of the well to avoid that a small part of the liquid dose sticks to the walls of the well and is thus separated from the reaction mixture to be incubated (incubate) and centrifuged. Such splashes tend to come from the liquid dose dispensed into the well and are separated to varying degrees (but often randomly).

It is now known that the formation of splashes on the inner wall of a well can be avoided by eliminating the electrostatic charge from the container. When a dose of liquid leaves the filling device, the electrostatic charge carried by the container tends to break up the dose of liquid. In this way, a small portion of the dose (liquid) sticks to the well inner wall due to the attraction created by the electrostatic charge. The absence of such electrostatic forces, which tend to divert the dose dropped by the priming device, also contributes to the formation of an air gap between the dispensed liquid dose and the reagent previously present at the bottom of the container. Patent application publication WO 2010/116069 describes a method and apparatus for priming a gel card that is initially closed by a sealing film. The device described (in this document) comprises means for piercing the membrane, as well as other means designed to eliminate the electrostatic charges that may be carried by the wells of the gel card before the dispensing operation.

Disclosure of Invention

It is an object of the invention to provide an improved system compared to prior art devices.

In particular, it is an object of the present invention to provide a system which allows the container to be conditioned more quickly and efficiently than prior art devices, before the container of the gel card type (which is initially closed by a membrane) is filled.

This object is achieved by means of a piercing system for piercing at least one sealing membrane which closes at least one chamber of a container, said system comprising a piercing member configured to pierce the sealing membrane and an ionization device for eliminating electrostatic charges possibly carried by said chamber, said ionization device comprising the piercing member adapted to exhibit (be provided with) ionization properties.

According to the system of the invention, both the operation of piercing the sealing membrane closing the container and the operation of ionizing said container are performed by a single common member, referred to in the present description as "ionizing device".

Firstly, the ionization device is adapted to generate an ion flow of alternating positive and negative charges, which ion flow is conveyed by the ambient air to the container. This alternation (change) of the (positive and negative) sign of the charge makes it possible to eliminate the electrostatic charges carried on the walls of the container.

In addition, the ionization device is shaped so that it can pierce the sealing membrane of the container to be filled.

In this way, the two operations can be performed simultaneously or at least in one common step.

In addition to these arrangements, the ionising means also come into contact with the sealing membrane, so as to be very close to the chamber of the container, or indeed penetrate into said chamber. Additionally, the axis of the ionization device may be aligned with the axis of the container. In this way, the implementation of the ionization can be more efficient and quicker than the devices of the prior art, in which the strip (strip) of the ionization cusps is necessarily far from the wells of the gel card and inclined with respect to these wells.

In certain embodiments, the piercing member comprises a piercing spike designed to penetrate the container chamber through the sealing membrane.

In certain embodiments, the ionization apparatus further comprises a plurality of non-piercing ionization spikes disposed around the piercing spike.

In some embodiments, the container is a gel card comprising a plurality of wells enclosed by a sealing membrane, each well containing one or more reagents, and the chambers are wells in the gel card.

In one embodiment, the piercing spike is connected to a voltage generator. Preferably, the piercing member is adapted to be applied with an electrical potential capable of generating a corona effect (corona effect).

The invention also provides a piercing method for piercing at least one sealing membrane which closes at least one chamber of a container, said method comprising piercing the sealing membrane in order to open said chamber and eliminate the electrostatic charge that said chamber may carry, wherein the piercing of the sealing membrane and the elimination of the electrostatic charge are performed by means of a single common member, i.e. a piercing member adapted to exhibit ionising properties.

According to the invention, the operation of eliminating electrostatic charges (i.e. ionization) from the container chamber is performed during and/or after the piercing.

In general, the piercing of the sealing film and the elimination of the electrostatic charge are performed together.

In one embodiment, the piercing member and the chamber of the container are arranged facing each other, the piercing member being inserted into the chamber and subsequently withdrawn therefrom, thereby piercing a sealing membrane closing said chamber, the piercing member exhibiting an ionizing property at least at one moment (instant) between the two points of time at which the operations of inserting the piercing member into the chamber and withdrawing the piercing member from the chamber are completed.

The piercing member typically comprises an electrically conductive element having an ionizing property when subjected to an electrical potential, in particular an electrical potential capable of generating a corona effect. During the performance of the method, the potential applied to the piercing member can be controlled and adjusted as desired. Thus, the piercing member may exhibit an ionizing property instantaneously or continuously at some point in time.

In an advantageous embodiment, the penetrating member exhibits ionizing properties continuously or substantially continuously from the start of the insertion of the penetrating member into the chamber to the end of the withdrawal of the penetrating member from the chamber.

In certain embodiments, the method comprises at least the following steps in sequence:

placing the piercing member and the container in an access position;

inserting a piercing member into the chamber to a depressed position in which the sealing membrane is pierced; and

withdrawing the piercing member from the chamber and placing the piercing member and the container in the withdrawn position.

The entry position is the position in which the piercing member is located in the vicinity of the inlet of the chamber, in particular facing the chamber, more particularly aligned with the axis of the chamber.

Likewise, the exit position is the position in which the piercing member located near the chamber outlet (in particular facing the chamber, more in particular aligned with the axis of the chamber) is located.

According to certain embodiments, the method comprises:

placing the piercing member in an entry position over the sealing membrane;

lowering the piercing member into the chamber to a press-in position in which the sealing membrane is pierced; and

the piercing member is raised back from its depressed position to a withdrawn position above the chamber.

According to certain embodiments, the method comprises:

placing the container in an entry position facing the piercing member;

moving the container toward the piercing member, thereby causing the piercing member to penetrate the chamber to a depressed position in which the sealing membrane is pierced; and

the container is moved away from the piercing member by bringing the container to an exit position located facing said piercing member.

In any case, the container may be removed from the piercing member (or vice versa) in the following step.

In certain embodiments, the piercing member and container remain in the depressed position for a predetermined period of time.

In certain embodiments, inserting and withdrawing the piercing member into and from the chamber (i.e., lowering and raising the piercing member, or raising and lowering the container) is performed in a continuous back and forth movement. In other words, the piercing member or the container is moved in a continuous back and forth movement, during which the push-in position of the piercing member in the chamber of the container does not remain stationary.

In certain embodiments, the piercing member and the container remain stationary in the withdrawn position for a predetermined period of time after the sealing membrane has been pierced.

In certain embodiments, insertion of the piercing member (i.e., lowering the piercing member from its entry position to its depressed position, or raising the container from its entry position to its depressed position) is performed at a first predetermined speed, and then withdrawal of the piercing member (i.e., raising the piercing member from its depressed position to its exit position, or lowering the container from its depressed position to its exit position) is performed at a second predetermined speed, which may be equal to, less than, or greater than the first predetermined speed.

A number of different examples and embodiments are described in this specification. However, features described with reference to any one embodiment or implementation may be applied to any other embodiment or implementation unless otherwise indicated.

Drawings

Further characteristics and advantages of the invention will appear from reading the description of several embodiments of the invention, given below by way of non-limiting example. This description is given with reference to the accompanying drawings, in which:

FIG. 1 is a schematic view of an automated medical analyzer adapted to process a sample obtained from a human body, the automated medical analyzer further comprising a multi-articulated robot provided with a first embodiment of a piercing system of the present invention;

FIG. 2 is a front view of a gel card type container designed for use with the automated analyzer of FIG. 1;

FIG. 3 is a detail view of a first embodiment of the lancing system of the present invention;

FIG. 4A is a cross-sectional view of the first embodiment of the piercing system of the present invention, showing the piercing member in a fully retracted position;

FIG. 4B is a cross-sectional view of the beginning of puncturing the sealing membrane of a gel card using the first embodiment of the puncturing system of the invention;

FIG. 4C is a cross-sectional view of the first embodiment of the piercing system of the present invention with the piercing member in a depressed position;

FIG. 5 is a partial view of a variation of the first embodiment of the ionization apparatus of the present invention;

FIG. 6 is a detail view of a second embodiment of the lancing system of the present invention;

FIG. 7A is a cross-sectional view of a second embodiment of the piercing system of the present invention, showing a gel card type container in an access position below the piercing member;

FIG. 7B is a cross-sectional view of the beginning of puncturing the gel card sealing membrane in accordance with the second embodiment of the puncturing system; and

fig. 7C is a cross-sectional view of a second embodiment of the piercing system of the present invention with the container in the depressed position.

Detailed Description

Fig. 1 is a schematic diagram of an example of an automated medical analyzer 10.

The automated medical analyzer 10 manipulates the gel card. As shown in fig. 2, the gel card 12 is provided with a plurality of wells or chambers 14 (specifically 6 wells) that open onto the top wall 12a of the gel card. These wells 14 have openings 16 formed in the top wall 12a of the gel card 12, the openings 16 being initially closed by a sealing membrane 18 extending in the length direction L of the gel card 12. In this example, the sealing film 18 is an elongated thin strip sealed to the top wall of the gel card 12.

Each well 14 of the gel card 12 is filled with a reagent R, which may vary from well to well in the gel card 12. In addition, each well 14 has a generally cylindrical upper chamber 14a, which upper chamber 14a is connected to a lower chamber 14b, also generally cylindrical, by a frustoconical intermediate chamber. The upper chamber 14a has a diameter much larger than the diameter of the lower chamber 14b, the lower and upper chambers being aligned with each other along a common axis a. The level of the reagent is at a level slightly lower than the top of the lower chamber 14b, while the upper chamber 14a (initially empty) opens onto the top wall 12a of the gel card 12.

Referring again to fig. 1, it can be seen that the automated analyzer 10 includes: a first embodiment of a piercing system 100 of the present invention, the piercing system 100 mounted on a distal end (or "end member") 106 of an arm of an articulated robot 102; an injection device 200 for injecting the gel card; a monitoring station 300 for verifying the location of the liquid poured into the well 14 by the injection apparatus 200; a centrifuge 400; and means 500 for analysing chemical reactions that can take place in the wells 14 of the gel card 12, such means being constituted in particular by a viewing station.

The gel cards 12 are made of plastic, which often carry an electrostatic charge C⁺And C^—(see FIG. 2).

Before inserting the sample to be analyzed into the well 14 selected for performing the analysis, it is necessary, for the reasons mentioned above, to pierce the portion of the membrane 18 located above the well 14 and to ionize the well 14 in order to eliminate the electrostatic charge.

According to a first embodiment of the puncture system 100 according to the invention, which will be described in more detail with reference to fig. 3, 4A, 4B and 4C, the puncture and ionization operations are performed using a single common member, which operations are performed together as a whole. However, this embodiment is not limiting, and alternatively or additionally, the ionization operation may also be performed after the puncturing operation.

As shown in fig. 3, the puncture system 100 comprises an ionization device 108, which ionization device 108 is provided with a spike 110 forming a puncture member, which spike 110 is detachably fixed to a cylindrical sleeve 112, which enables said spike 110 to be cleaned periodically.

According to the invention, the piercing spike 110 performs both the operation of piercing the portion of the membrane 18 located above the well 14 and the operation of ionizing said well 14.

In order to ionize said well 14, the piercing spike 110 is adapted to be applied with an electric potential capable of generating a corona effect which can eliminate the electrostatic charges carried by the gel card. In this example, the piercing spike 110 creates an electric field E at the well of the gel card. For this purpose, a power source outputting an approximate sine wave having a frequency of 250 hertz (Hz), a minimum potential difference of 4.2 kilovolts (kV), and capable of outputting a current of less than 3.5 milliamps (mA) may be selected, for example, for the piercing spike 110.

The ionization apparatus 108 is also enabled to contact the gel card 12 due to the absence of arcing.

In the example shown, the outer diameter of the piercing spike 110 is substantially equal to the inner diameter of the upper chamber 14a of the well in the gel card 12. However, this example is not limiting, and the outer diameter of the piercing spike 110 may also be much smaller than the inner diameter of the upper chamber 14a of the well 14 in the gel card 12.

In addition, the piercing spike 110 may be provided with a plurality of inclined facets (inclined facets) 110 a. The number of inclined facets 110a of the piercing spike 110 and the inclination of said inclined facets 110a with respect to the main axis of the piercing spike 110 can be adjusted according to the nature of the material from which the sealing film 18 is made.

In one variation of the present invention, a plurality of non-piercing ionization spikes 114 may be disposed around piercing spikes 110 in an annular configuration, as shown in FIG. 5, which may enhance the ionization effect of wells 14 in gel card 12.

The method of piercing the sealing membrane 18 of the gel card 12 of the present invention is described below with reference to fig. 4A-4C.

During the first step, the piercing spike 110 is first aligned with the axis a of the well 14 in the gel card 12, as shown in fig. 4A. At this point, the piercing spike 110 is placed in an "in" position over the sealing membrane 18.

In a second step of the method, as shown in fig. 4B and 4C, the piercing spike 110 is lowered into the upper chamber 14a of the well 14 in a vertically translating motion until it is in a "press-in" position in which the membrane 18 is fully pierced. It can be noted that the sleeve 112 will be positioned on the top wall 12a in an abutting manner on either side of the well 14.

As described above, the outer diameter of the piercing spike 110 is substantially equal to the inner diameter of the upper chamber 14a of the well in the gel card 12. Thus, as shown in fig. 4B and 4C, when the sealing membrane of the well 14 is pierced, the piercing spike 110 slides along the wall of the upper chamber 14a of the well, pushing the pierced portion 18a of the membrane back along the wall of said upper chamber 14 a. In this case, since the piercing spike 110 is in contact with the sealing film 18, the closed environment around the piercing spike 110 benefits from a residual effect of ionization.

The piercing spike 110 both pierces the portion of the membrane 18 of the gel card 12 that is above the well 14 and ionizes the well 14.

In a third step, the piercing spike 110 is then raised back from its depressed position to its withdrawn position above the well 14.

Preferably, throughout the puncturing operation (i.e., during the second and third steps), the puncturing tip 110 is applied with a potential capable of generating corona, so that the electrostatic charge carried by the gel card can be continuously eliminated.

Finally, in a fourth step, the piercing spike 110 is removed from the gel card 12, so that the above-described steps are optionally repeated on another well 14 of the gel card 12.

Thus, the puncturing method of the present invention allows both puncturing 18 of the sealing membrane of the well 14 in the gel card 12 and ionization of said well 14. This is particularly advantageous for gel cards 12 that are partially used during analysis. In some cases, some wells are used for a first analysis, while other wells are used for a second analysis. However, for each analysis, it is necessary to ensure the quality of the reagent R present in the wells 14 of the gel card 12. It is therefore recommended to open the well 14 again at the last moment before filling the well 14.

In one embodiment of the puncturing method of the present invention, the puncturing tip 110 may remain stationary in its depressed position for a predetermined period of time (e.g., one second).

In another embodiment of the puncturing method, the puncturing tip 110 can also be lowered and raised in a continuous back and forth movement. The cusps do not remain stationary in the depressed position.

In an advantageous manner, after a portion of the membrane located above a selected well 14 is punctured, the puncturing spike 110 may remain stationary in its exit position for a predetermined period of time (e.g., such as one second). This embodiment provides good results in terms of creating an air gap between the dispensed liquid dose and the reagent.

The formation of an air gap is further promoted when the piercing tip 110 is lowered from its entry position to its pressed-in position at a first predetermined speed, and when the piercing tip 110 is raised back to its exit position at a second predetermined speed (less than said first predetermined speed). For example, the piercing spike 110 may thus be raised from its depressed position to the withdrawn position within one second, with the piercing operation being performed in less than one second.

As shown in FIG. 1, after the puncturing and ionizing operations, the gel card 12 is typically sent to a priming device 200. These injection devices 200 comprise at least one pipette 202, which pipette 202 is inserted into the upper chamber 14a of the well 14 through a hole made in the sealing film 18 in order to pour a dose of liquid into the pipette. Preferably, provision is made for forming an air gap between the reagent and the pre-dose as described above.

Then, after the priming step, the gel card 12 is sent to a monitoring station 300 in order to verify the presence of an air gap. Thereafter, the gel card 12 is incubated and centrifuged using a centrifuge 400. Finally, the result of the chemical reaction is analyzed using the apparatus for analyzing a chemical reaction 500.

A second embodiment of the puncture system of the present invention is described (below) with reference to fig. 6 to 7C. The second embodiment of the present invention differs from the first embodiment mainly in that: in the automated medical analyzer 10, the piercing system 600 is stationary, while the gel card 60 (manipulated by the automated medical analyzer 10) is mounted for movement relative to the piercing system 600.

The gel card 60 shown in fig. 6 is substantially the same as that of the first embodiment, and therefore will not be described in detail below. All of the above features of the gel card are applicable to the second embodiment unless otherwise stated.

As in the first embodiment according to the puncturing system 100, in this example, the puncturing and ionizing operations of the wells 62 of the gel card 60 are performed by one common member.

Fig. 6 shows that lancing system 600 includes an ionization device 602, which ionization device 602 is provided with a spike 604 forming a lancing member. In the example shown, piercing spike 604 is secured to a mount 608, which mount 608 is removably secured to a support 606, which support 606 is a triangular plate (setsquare) secured to a stand of automated analyzer 10 in this example. The installation of the piercing system 600 is thus simplified and can be easily incorporated into an automated medical analyzer 10. The removable mounting of the piercing spike 604 also enables it to be periodically cleaned.

As in the first embodiment, piercing spike 604 is adapted to be applied with an electrical potential that continuously produces a corona effect.

The gel card 60 is movable relative to the lancing system by means of an articulated robot 610 of the automated analyzer 10. As shown in fig. 6, the gel card 60 is clamped at both ends by jaws 614a, 614b, which jaws 614a, 614b are generally L-shaped and partially form an end member 612 of the articulated robot 610.

The method of puncturing the sealing membrane 64 of the gel card 60 using the puncturing system mentioned above differs from the puncturing method described with reference to fig. 4A to 4C only in that the container is mounted to be movable, while the puncturing member is stationary.

Thus, in a first step shown in fig. 7A, the gel card 60 is moved by the articulated robot 610 to an entry position in which the gel card 60 is positioned under the piercing spike 604, the axis a of the well 62 in the card being aligned with the piercing spike 604.

In a second step of the method, as shown in fig. 7B and 7C, the gel card 60 is moved in a translational movement (in this example, a vertical translation) towards the puncture tip 604 until the gel card 60 is in a depressed position in which the membrane 64 is punctured.

It should be noted that in this example, the piercing spike 604 has a diameter that is much smaller than the diameter of the upper cavity 62a of the gel card 60. In other examples, the diameter of the piercing spike 604 may be more or substantially equal to the diameter of the upper cavity 62a of the gel card 60.

The gel card 60 is eventually lowered from its depressed position to an exit position below the piercing point 604.

Generally, the penetration of the well 62 is performed in conjunction with the ionization operation, and more specifically, the ionization operation is performed throughout the penetration operation. This embodiment is not limiting and, for example, ionization may be performed during and after the lancing operation, or only after the lancing operation.

The various sequentially arranged configurations of the lancing operations described with reference to the first embodiment may also be applied to this second embodiment.

Thus, the gel card 60 may be configured to remain stationary in its depressed position and/or in its withdrawn position for a predetermined period of time, or conversely, the gel card 60 may be moved in a continuous back and forth movement within the upper chamber 62a, or the piercing spike 604 may be pushed at a greater rate than the piercing spike 604 is withdrawn.

Although the invention has been described with reference to specific examples and embodiments, it will be appreciated that various modifications and changes may be made to these examples without departing from the general scope of the invention as defined in the claims. In particular, individual features of the various different examples and embodiments shown/mentioned may be combined in other examples and embodiments. The specification and drawings are, accordingly, to be regarded in an illustrative rather than a restrictive sense.

Claims (14)

1. A piercing system (100, 600) for piercing at least one sealing membrane (18, 64), the sealing membrane (18, 64) closing at least one chamber (14, 62) of a container (12, 60), the system comprising a piercing member (110, 604) configured to pierce the sealing membrane (18, 64) and an ionizing device (108, 602) for eliminating electrostatic charges possibly carried by the chamber (14, 62), characterized in that the ionizing device (108, 602) comprises the piercing member (110, 604) adapted to exhibit ionizing properties.

2. A piercing system as claimed in claim 1, wherein the piercing member (110, 604) comprises a piercing spike designed to penetrate into a cavity (14, 62) of the container (12, 60) by passing through the sealing membrane (18, 64).

3. A piercing system as claimed in claim 1 or claim 2, wherein the container (12, 60) is a gel card comprising a plurality of wells closed by sealing membranes (18, 64), each well containing one or more reagents (R), and wherein the chambers (14, 62) are wells in the gel card.

4. Piercing system according to claim 1 or 2, wherein the piercing member (110, 604) is adapted to be applied with an electrical potential capable of generating a corona effect.

5. A piercing method for piercing at least one sealing membrane (18, 64) closing at least one chamber (14, 62) of a container (12, 60), said method comprising piercing said sealing membrane (18, 64) in order to open said chamber (14, 62) and eliminating the electrostatic charge possibly carried by said chamber (14, 62), wherein the piercing of the sealing membrane (18, 64) and the elimination of the electrostatic charge are carried out by means of a single common member, namely by means of a piercing member (110, 604) adapted to exhibit ionising properties.

6. A piercing method as claimed in claim 5, wherein the piercing of the sealing membrane (18, 64) and the elimination of the electrostatic charge are carried out together.

7. A piercing method as claimed in claim 5 or claim 6, comprising at least the following successive steps:

placing the piercing member (110, 604) and the container (12, 60) in an access position;

inserting the piercing member (110, 604) into the chamber (14, 62) to a depressed position in which the sealing membrane (18, 64) is pierced; and

withdrawing the piercing member (110, 604) from the chamber (14, 62) and placing the piercing member (110, 604) and the container (12, 60) in an exit position.

8. A piercing method as claimed in claim 7, wherein the piercing member (110, 604) exhibits ionizing properties continuously or substantially continuously from the start of insertion of the piercing member (110, 604) into the chamber to the end of withdrawal of the piercing member (110, 604) from the chamber (14, 62).

9. A piercing method as claimed in claim 5 or 6, comprising at least the following successive steps:

-placing the piercing member (110) in an entry position above the sealing membrane (18);

lowering the piercing member (110) into the chamber (14) to a pressed-in position in which the sealing membrane (18) is pierced; and

-raising the piercing member (110) from its depressed position back to an withdrawn position above the chamber (14).

10. A piercing method as claimed in claim 5 or 6, comprising at least the following successive steps:

-placing the container (60) in an entry position facing the piercing member (604);

-moving the container (60) towards the piercing member (604), thereby causing the piercing member (604) to penetrate the chamber (62) to a depressed position in which the sealing membrane (64) is pierced; and

-moving the container (60) away from the piercing member (604) by bringing the container (60) to an exit position located facing the piercing member.

11. A piercing method as claimed in claim 7, wherein the piercing member (110, 604) and the container (12, 60) are held in the depressed position for a predetermined period of time.

12. A piercing method as claimed in claim 7, wherein the operations of inserting the piercing member (110, 604) into the chamber (14, 62) and withdrawing the piercing member from the chamber (14, 62) are performed in a continuous back and forth movement.

13. A piercing method as claimed in claim 7, wherein the piercing member (100, 604) and the container (12, 60) remain stationary in the withdrawn position for a predetermined period of time after the sealing membrane (18, 64) is pierced.

14. A piercing method according to claim 7 wherein insertion of the piercing member (110, 604) is performed at a first predetermined speed and withdrawal of the piercing member (110, 604) is performed at a second predetermined speed, the second predetermined speed being equal to, less than or greater than the first predetermined speed.