WO2013150154A1

WO2013150154A1 - Collecting device for analysis of biological material

Info

Publication number: WO2013150154A1
Application number: PCT/EP2013/057256
Authority: WO
Inventors: Piergiorgio MESSA; Laura SPINARDI; Stefano PROVASI
Original assignee: Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico; Tecnoline S.R.L
Priority date: 2012-04-06
Filing date: 2013-04-05
Publication date: 2013-10-10
Also published as: EP2833796A1; ITBO20120186A1

Abstract

A collecting device for analysis of biological material comprises a container (2) provided with a hard edge (26) delimiting at least an upper opening (27) hermetically sealable with at least a cap (3) in a biological material analysis condition or container (2) storage or transport (T) condition, a collecting portion (25) fixed under the edge (26), valve means (21, 22) fixed to the container (2) for a flow communication between the container (2) inside and outside, the collecting portion (25) is deformable and the edge (26) is provided with at least one projection which can be coupled to a support means (6), in a biological material collecting condition (R) within the container (2).

Description

Collecting device for analysis of biological material

Technical Field

The present invention relates to the field concerning collecting devices of biological material and subsequent analysis of the collected material and in particular relates to a collecting device for analysis of biological material.

Background Art

There are known collecting containers for biological material, e.g. blood, urine or faecal material, shaped as glass or tube generally made of transparent plastic material.

Said known devices are generally provided with a cap, consisting of a pressure cap or a screw cap, removably fixable to the container to allow an easy transportation and/or storage of the same and the material collected therein.

Said known devices are typically limited in size since the biological tests in most cases require limited amounts, few grams or few centilitres, of material to be tested.

The material collected test is performed taking a material fraction from the container using pipettes or other appropriate tools and treating it in accordance with the required diagnostic procedure.

The main disadvantage of said known devices relates to the difficulty to perform the biological material collection due to the limited size of the container, especially in the case of faecal material collection.

Further disadvantage of said devices relates to the high number of manipulations to be performed on the container and on the biological material to prepare it for subsequent biological test.

Another disadvantage of said devices relates both to the high contamination hazard of the biological material during the collecting or subsequent manipulating phases both the possibility of accidental loss of biological material or its liquid or aeriform with consequent possibility of environmental contamination.

Other known devices are described in the following documents.

U.S. 6,235,010 B1, Bradley M. Wilkinson and others describes a closed container for samples collection. Said container allows the collection and transportation of biological fluids in combination with a collection pipe, it has a cylindrical body to which a lid is fixable. A first collected sample outlet valve is placed on the bottom of the container and a second air inlet valve is placed on the lid. Said device allows taking a sample to be tested and allow transporting the same to a laboratory where it will be taken through the lid or aspirated through the first valve outlet.

The device disclosed in U.S. 6,235,010 B1 is rigid, and therefore requires a lot of space for its storage, even prior to be used, and does not allow to be directly used to perform experimental tests directly therein introducing appropriate chemical reagents without opening the lid. Furthermore, this device is essentially designed to collect liquid samples and not allow an easy collecting and handling of samples of solid or semi solid materials.

U.S. 3,635,091 A, Frederick D. Linzer and others describes an intermediate container for urine samples and liquid fractions collection. Such a collecting container is constituted of a rigid outer casing provided with a first inlet opening and a flexible bag placed inside the casing and also equipped with at least a second opening connected to the first one.

Disclosure of Invention

The main purpose of the present invention is to propose a collecting device of biological material for metabolic analysis that considerably simplifies the material collecting phase even directly by the patient without any help of third persons, even for those persons who have limited motion skills.

Further object of the invention is to propose a device which allows preparing the biological material collected for subsequent tests limiting both the contaminations hazard of the material due to external agents, either the possibility of accidental leakage of the collected material or its liquid or aeriform fractions towards external environment with consequent contamination hazard.

Another object of the invention is to propose a device which allows easily evaluating the weight of the collected biological material and easily performing visual evaluations of the collected material quality.

Brief Description of Drawings

The characteristics of the invention are highlighted in the following with particular reference to the accompanying drawings wherein:

Figure 1 shows a partially exploded perspective view of the device object of the invention;
Figure 2 shows a partially exploded perspective view of the device object of the invention in a first condition;
Figures 3 and 4 show perspective views of the device of Figure 2 in the first condition of use;
Figures 5 and 6 show perspective views of the device of Figure 1 in which some elements have been removed for better underlining other in a second condition;
Figure 7 shows a perspective view of the device of Figure 1 in which some elements have been removed for better underlining others in a third condition;
Figure 8 shows a perspective view of some accessory elements of the device of figure 1.

Best Mode for Carrying Out the Invention

With reference to Figures 1 - 8, numeral 1 indicates the collecting device of biological material for metabolic analysis object of the invention.

In the preferred embodiment, shown in Figure 1, the device 1 comprises a roughly cylindrical or tapered shaped container 2 that is equipped with at least one opening 27 placed in the upper part of the container 2 itself. The latter 2 is provided of a rigid edge 26 protruding towards the outside, delimiting the opening 27 and supporting a bottom collection portion 25.

The collection portion 25 is deformable and is made of a flexible transparent membrane which is heat sealed to the upper edge 26 and it is closed at the bottom, always by heat sealing, so as to form a sort of bag. Moreover, the deformable portion 25 has two valve means 21 and 22, an upper valve means 21 is placed closer to the edge 26 with respect to a lower valve means 22.

The lower valve means 22 has an inner diameter bigger than the one of the upper valve means 21 to facilitate the collected material taking from the container 2, while the upper valve means 21, being arranged above the lower one 22 allows a safe and easy insertion of substances, such as distilled water or saline solution, limiting the risk of leakage of the collected material.

A cap 3 is coupled to the edge 26 at the opening 27 and has sealing elements, such as o-ring, along its circumference, and locking means 31 which, coupling to the edge 26 and collaborating therewith, achieve an irreversible junction, in a condition of collected material analysis or storage or transport T of the device 1.

To facilitate the closure of the device 1 and ensure that the irreversible junction is strong enough, the edge 26 of the container 2 and the cap 3 are made of rigid material. The cap 3 is also provided with a handle 32 or a fastening element which allows hanging up the device 1 to a stand, known and not illustrated.

In a biological material collecting condition R, shown in Figures 2, 3 and 4, the container 2 is fixed to a support means 6, such as a water closet or a commode chair or any other means suitable for the purpose, supporting the edge 26 to one or more upper edges of the support mean 6.

In the case the support means 6 is a water closet, the container 2 is partially inserted inside the water and the edge 26 is further bound to the support means lowering a tablet 61, usually connected to the water.

To prevent the container 2, and particularly the portion of the collection 25, gets dirty due to the contact with substances that may be present into the water closet, a protection means 54, constituted of a bag or a waterproof membrane, is interposed between the container 2 and the support means 6.

In the analysis or storage or transport T conditions, illustrated in Figures 1, 5 and 6, the container 2 is placed inside a transportation means 4, substantially consisting of a box-shaped element open at the top and internally provided with a supporting element 41. Such support element 41 is constituted of a surface that is parallel to and spaced from a base of the box element and which has a central hole 42 having diameter nearly equal to the transverse dimension of the outer edge 26 of the container 2, to accommodate the latter 2.

Furthermore, the transportation means 4 comprises covering flaps 44 provided on the free edge of wings 45 to lock the flaps 44 in a closure condition of the transportation means 4. In the closure condition of the transportation means 4, shown in Figure 6, there are both a handle 46 to facilitate the transport of the device 1, both a label 47 placed on the transportation means 4 and bearing the data about the collected biological material.

The transportation means 4 comprises furthermore flaps 43 to stiffen the support means and to fix better the container 2 inside the transportation means 4 in the analysis or storage or transport T condition.

The device 1 also includes accessories useful for diagnostic phases subsequent to the biological material collecting phase R. In particular there are a syringe 51 and a catheter.

The syringe 51 is connectable to the valve means 21 and 22 to insert into or take from the container 2 the collected biological material, eventually pre-treated, while the catheter 53 is also connectable with one of the valve means 21 or 22 to insert into the container 2 some liquids, such as saline or bi-distilled water, taken from a vial or a water bag 52.

In a variant of the preferred embodiment of the device 1 one or both the valve means 21 and 22 are placed on the cap 3 rather than on the collection portion 25.

The operation of the preferred embodiment of the device 1 provides:

putting the protection means 54, for example consisting of a sheet, on the support means 6, for example a water closet or a commode chair, and partially inside the same;
putting the container 2, with the collection portion 25 within the support means 6, laying the edge 26 on the upper edges of the support means 6;
lowering the tablet 61, if present, of the support means 6 on the edge 26 of the container 2 to better lock the device 1 at the support means 6;
removing the cap 3, if present, from the container 2;
collecting the biological material evacuated from the patient seat over the device 1;
removing the container 2 from the support means 6 and putting it inside the transportation means 4, laying the edge 26 of the container 2 to the supporting means 41 and deforming the collection portion 25 of the container 2 inside the transportation means 4;
putting the cap 3 near the opening 27 and seal the container 2 letting going out the air therein contained ;
closing the flaps 44 of the transportation means 4 in the analysis or storage or transport T condition.

The device 1 also allows to prepare the collected biological material in the container 2 for subsequent diagnostic tests through the following phases:

inserting into the container 2 a predetermined amount of liquid, for example saline or bi-distilled water, through the upper valve means 21;
weighing the device 1 including collected material and inserted fluid;
shaking the device 1 to homogenize the biological material;
taking one or more fractions of collected biological material through the lower valve means 22;
analyzing the taken biological material.

Advantageously, the device 1 allows simplifying the collection of biological material, especially faecal material, even by patients with reduced mobility, as it easily adapts to the usual hygienic devices, such as water closet, commode chair or the like, and thanks to its rigid structure it can be easily handled without the risk of leakage of the contents.

To ensure the highest and the best conditions of use, in the development of the device 1 it has been paid special attention to the possibility to interface with all or at least most of the known hygienic devices.

Furthermore, the possibility offered by the device 1 to be hermetically and irreversibly seal the opening 27 at the end of the collecting phase R of the biological material allows to persons working with the device 1 to operate without running the risk of accidental loss of material, generally smelly, greatly improving their working conditions. In fact, it is possible to prepare the biological material collected for subsequent operations, such as adding liquid, homogenizing the compound, and taking samples of material for metabolic analysis, directly into the container 2 through the upper 21 and lower 22 valve means, avoiding or greatly limiting the possibility that the operator may get in touch with the biological material itself.

The main advantage of the present invention is to provide a collecting device of biological material for metabolic analysis that considerably simplifies the material collecting phase even directly by the patient without any help of third persons, even for those persons who have limited motion skills.

Further advantage of the invention is to provide a device which allows preparing the biological material collected for subsequent tests limiting both the contaminations hazard of the material due to external agents, either the possibility of accidental leakage of the collected material or its liquid or aeriform fractions towards external environment with consequent contamination hazard.

Another advantage of the invention is to provide a device which allows easily evaluating the weight of the collected biological material and easily performing visual evaluations of the collected material quality.

Claims

Collecting device of biological material for analysis comprising: - a container (2) having a hard edge (26) delimiting at least an upper opening (27) hermetically sealed with at least one plug (3) in a conditions of analysis of the biological material or of storage or transport (T) of the container (2); - a collection portion (25) fixed underneath the edge (26); - valve means (21, 22) fixed to the container (2) to achieve the flow communication between the inside and the outside of container (2); said device (1) being characterized in that: the collection portion (25) is deformable; - the edge (26) is provided with at least one projection coupled to a support means (6), in a collecting condition (R) of the biological material within the container (2).
Device according to claim 1 characterized in that the support means (6) is a water closet or a commode chair.
Device according to claim 1 characterized in that the cap (3) has locking means (31) to the edge (26) to realize an irreversible joint, in analysis or storage or transport (T) conditions.
Device according to any of the previous claims characterized in that the valve means (21, 22) are connected to the collection portion (25).
Device according to any of the previous claims characterized in that the valve means (21, 22) comprise an upper valve means (21) for the insertion of a solution in the container (2) and a lower valve means (22) for biological material taking from the container (2).
Device according to claim 5 characterized in that the lower valve means (22) has an inner diameter bigger than the upper valve means (21) to facilitate the biological material taking from the container (2).
Device according to any of the previous claims characterized in comprising a transportation means (4) for the container (2), in analysis or storage or transport (T) conditions, consisting of: - a support element (41) having a hole (42) for accommodating the edge (26); - at least one covering flap (44) having some wings (45) on the free edge to lock the flap (44) in a closing condition (C) of the transportation means (4).
Device according to claim 7 ch aracterized in that the edge of the hole (42) has a plurality of flaps (43) to stiffen the support element (41) and to better fix the container (2) inside the transportation means (4) in the analysis or storage or transport (T) conditions.
Device according to any of the previous claims characterized in comprising a graduated syringe (51) connectable to the valve means (21, 22) to insert substances into the container (2) or take substances from the same.
Device according to any of the previous claims characterized in comprising a protection means (54) disposed between the container (2) and the support means (6) in a collecting condition (R) to avoid any possible contamination of the container (2).