THIRD-PARTY ANALYSIS CENTRES

DESCRIPTION

The object of this patent application concerns the transportation of organic materials and liquids in the healthcare and veterinary field. In particular, the device under this patent application and the related method of use allow for the traceability of the transfer process of the tubes coming from the local collection points and the hospital wards that shall be shipped to the analysis labs, the microbiology labs, the molecular biology labs, the transfusion centres, anatomical pathologies and any other analysis centre.

As mentioned, Law provisions, in particular in the Italian territory, provide that diagnostic samples shall be transferred by using a two- or three-case system depending on the situations while there are no specifications concerning the content traceability. This aspect is not regulated and is freely developed by the companies of the sector. As a consequence, the laboratory, following the diagnostic requests that it often already is in possession of at the time of prescription and that are made available thanks to broadly diffused IT systems, usually expects a set quantity of samples that does not often match what it receives by number and type.

Any failures and/or swaps of samples could determine heavy inconveniences such as, for example, waste of time for the operators, late response to the diagnostic question, repetition of collection for the hospitalised patient, recall for day-hospital patient, cost increase, concern and distress for the patient.

At the state of the art, there are devices, mainly upgrades of carriage containers, that try to fix these limits, but that do not fully solve the problems linked to the full traceability of the entire transport process from collection to delivery of the sample to the analysis lab. The limits may consist in the potential tampering of the tube racks, the failed mapping of the sample distribution in the tube racks and the failed directing of the tubes to their exact position/analysis destination.

In particular, at the state of the art, devices subject to patent application such as US2004126283, US8808650, EP2403644 and DE102013210286 already existed. The devices described in the quoted documents describe devices and systems for the sole introduction and identification of the organic material to be transferred. They are made up of a general carriage container normally provided with a lid with a series of holes and a tub rack placed within the container to identify the samples (fig. 10US2004126283).

Consequently, in such systems the transfer of the device implies the transfer of the identification systems as they are associated to the tube rack within the container.

The devices described in the documents US2004 26283, US8808650, EP2403644 and DE 02013210286 do not carry out any pre-sorting of the organic material to be introduced but they allow the recognition of the same only when placed in the tube rack.

In addition, according to the description in US2004126283, US8808650, EP2403644 and DE1020 32 0286, the samples can be transferred or tampered with because the samples are open until the container is closed.

Purpose of the object under this patent application is to solve the described disadvantages of the state of the art, in particular providing for a device and related method of use that is able to be uniquely matched to a carriage container previously identified and classified by place of destination, allow for the introduction of tubes in conditioned mode on the basis of the information associated to the tube and allow for the recognition, without limitation, by bar code reading, of all the tube diagnostic material that is placed in the carriage containers preventing any voluntary or involuntary tampering. Additional purpose of the object and related method of use under this patent application is to allow to select, sort out and direct the tubes to the related labs uniquely and without the need for steps of search, division and sorting of the samples.

The device and related method of use under this patent application is portrayed in the attached Figures

Table 1/3

Fig.1— representation of the head associated to the carriage container

A - Head

S— Housing system

G— Hole for introduction of tubes

B— Carriage container

Fig. 2 - representation of the head not associated to the carriage container

C— Head-container matching system

D— Container lid

E - Container opening grid

G— Hole for the passage of tubes

F - Handle for container carriage

Table 2/3

Fig.3— cross-section of head and container

H— LED light device

I— housing of electronic component

L - Slats or opening grids

M- Tube rack N— USB slot

P-Tube

Table 3/3

Fig.4 -exemplification of the method of use

With reference to the attached Figures 1, 2, 3, the system under this patent application is made up of a multi-functional head (A) matched with a carriage container (B).

The head (A) has a housing system (S) m a d e u p o f a s e ri e s o f h o l e s (G) for the introduction of tubes (P) s a i d housing system (S) corresponds to the tube rack ( ) positioned inside the carriage container (B).

The carriage container (B) has a lid (D) made up of an opening grid (E) in turn made up of a series of holes (G') corresponding to holes (G) of the housing system (S) so as to allow for the housing of the tubes once they are introduced in the holes (G, G').

When the carriage container (B) is not matched to the head (A) the holes (G') of the opening grid (E)are completely closed.

The carriage container (B) has a tube rack inside (M) while the lid (D) has a mechanical or magnetic closing that only opens at the destination centre. The resulting system (Fig. 3) allows for the creation of a series of holes perfectly aligned head (A) - container(B)— rack (M) inside which the tubes are introduced (P).

The housing system (S) made up of the holes (G, Figure 3) may be diversified by number and arrangement depending on the type of underlying opening grid (E) in turn associated to the type of tube rack ( ); additionally, the housing system (S) m a d e u p o f individual slots (G) is equipped with selective opening/closing device for each passage.

With reference to Figure 3, in the bottom part of the head (A) and exactly matching each hole G there's an additional passage system made up of an opening and closing grid preferably but not exclusively consisting of slats (L).

The head (A) also has a housing of the electronic component (I) inducing an identification system, preferably but not exclusively barcode reader or chip detector, a tube introduction detection system, preferably but not exclusively light barrier, power supply and circuit board for the management of individual functions.

The head (A) also has LEDs (H) indicating t e exact position ing of the tube . The head (A) also has a USB slot (N) for the powering of the entire system and two-way transmission of the IT component.

With reference to the attached Figures and the above-listed specifications, the system under this patent application appears like a head (A) associated to the carriage container (8) preferably but not exclusively through a mechanical or magnetic coupling system (C) a n d s u c h a s to allows for the passage of tubes (P) only and exclusively when head (A) and carriage container (B) are physically coupled.

Purpose of the object is to allow for the selective introduction in the system and in set positions by analysis area of the previously identified samples making a perfect match between sample, carriage system and analysis destination.

Operationally, the use of the device under the patent application provides for the following steps

First step: Definition of the management logics of the material to be shipped to the labs and definition of the match of the individual heads (A) with the individual carriage containers (B). Without limitation, the match could be made by giving a specific colour to the individual beneficiary labs (for example BLUE carriage container corresponding to target lab X and matching the head (A) only if previously associated to the target lab X - if previously associated to the target lab X— GREEN carriage container corresponding to the target lab Y and matching to the head (A) only if previously associated to the target lab Y.

Second step: Match of the head (A) with the corresponding carriage container (B) and activation of the coupling device (C) that in turn triggers the opening of the hols (G') of the opening grid (E) of the container (8).

Third step: According to the management logics the match of the head (A) with the carriage container (B) triggers the switch-on of the signalling devices (H) associated with the hole (G), preferably but not exclusively LEDs, indicating the correct positioning of the first tube (P) on the basis of the set destination indications. The signalling devices (H) are triggered separately and the activation of the second device does not happen until the entire introduction process of the previous tube (P) is completed.

Once introduced in the hole (G) the tube (P) gets stuck in the slats (L).

Fourth step: In the indicated position, the information associated to the tube (P) is read, preferably but not exclusively through barcode reader; the information entered in addition to containing the patient data, also reports the destination of the lab where the sample shall be examined so if the information is consistent with the first step, the slat (L) opens letting the tube slide inside the carriage container (B). At the passage of the tube (P) inside the container, a detecting device will check and record the correct passage and positioning of the tube.

If, on the contrary, the information is not consistent with the first step, the slat (L) stays closed and the failed coupling sample / container / destination is immediate.

Fifth step: Once the introduction sequence is completed, the container (B) will be decoupled from the head (A) causing the closing of the holes (G'); the lid (O) of the container (B) may only be opened at the time of receiving the tube in the lab to avoid any tampering as a guarantee of total traceability. In addition to samples, traceabiiity is also ensured for container since they have a recognition system, barcode or chip.

The information conceming the container content (B) and the positioning of the individual tubes (P) will allow for the traceabiiity and recognition of the samples throughout all the steps of collection and carriage.