WO2008114164A1

WO2008114164A1 - An integrated safe sampling system for external body fluids

Info

Publication number: WO2008114164A1
Application number: PCT/IB2008/050881
Authority: WO
Inventors: Pietro Giuseppe Argento
Original assignee: Pietro Giuseppe Argento
Priority date: 2007-03-19
Filing date: 2008-03-11
Publication date: 2008-09-25
Also published as: ITBO20070191A1

Abstract

An integrated safe sampling system for body fluids comprises at least one main bag (30) which is capable, when in use, of receiving a predetermined quantity of collected blood, and one or more secondary bags (40, 50, 60) hydraulically connected to the said main bag by means of a plurality of tubes. The secondary bags (40, 50, 60) are particularly suitable, when in use, for receiving some of the said blood and/or one or more of its components. The system also comprises sampling means (100) associated in a selectively detachable way with at least one of the said bags (30, 40, 50, 60).

Description

AN INTEGRATED SAFE SAMPLING SYSTEM FOR EXTERNAL BODY FLUIDS

The present invention relates to the field of the treatment of body fluids extracted from the human body, and specifically to the field of the treatment of blood collected for the purposes of transfusion and/or donation and infusion. The handling of blood or its components such as platelets, plasma and red corpuscles plays a essential part in all transfusion situations, particularly in emergencies. One of the best known and most widely used methods of collecting blood for transfusion is known as the "manual" collection method, in which the blood is taken from a donor, using a needle and without the use of external pumps or similar devices, and is passed through one or more tubes to be received in at least one container, preferably a bag or sachet of plastics material. The collection system composed of the needle, the tubes and the bag is normally of the pre- sterilized disposable closed-circuit type, in order to minimize any possible risk of contamination of the collected blood by external agents. Clearly, it is naturally essential to consider the possible contamination of the blood by external agents, such as bacteria dispersed in the environment and/or in the system before use. When the body fluid has been received in a main container, a sample of this fluid is taken and analysed, for example in order to determine the presence of any pathogens such as viruses, bacteria or other external substances, but also, and primarily in the case of blood, to check the blood group and other properties in order to establish its compatibility when it is administered to a specified patient.

One of the main problems of the known systems is that of successfully taking a sample of collected blood from the system without compromising the aseptic and sterile properties of the collecting system, even in unfavourable environmental conditions and in a very limited interval of time .

Another problem of the known systems is that of establishing an absolutely certain and secure association between the sample which is taken for analysis and the bag of body fluid which contained this sample, in order to avoid giving the patient a body fluid from the bag when the fluid has different characteristics from those of the analysed sample, as this could give rise to problems of compatibility and/or pathogenesis .

The object of the present invention is to overcome the problems of the known systems by providing a system which can associate, in an unambiguous and secure way, a sample of body fluid taken from a specific bag with the bag itself, for example within a collecting system for the purposes of transfusion and/or donation and infusion.

Another object of the present invention is to provide an integrated safe sampling system which is simple to construct, easy to use and economical to manufacture.

In order to achieve the aforesaid objects, the present invention proposes an integrated safe sampling system for body fluids as defined in the claims below.

Other features and advantages of the invention will become clear from the following detailed description of a preferred embodiment, which is described purely by way of a non- limiting explanatory example, with reference to the appended drawings, in which:

- Figure 1 is a front view of an integrated safe sampling system according to the present invention;

Figure 2 is an enlarged view of a sampling test tube connected to a body fluid receiving bag; - Figure 3 is an enlarged view of a sampling test tube connected to a tube for the passage of body fluid;

- Figure 4 is a schematic view of a system for collecting blood for transfusion, comprising one of the embodiments of the safe sampling system of the present invention; and

Figure 5 is a schematic view of a system for collecting blood for transfusion, comprising another of the embodiments of the safe sampling system of the present invention.

With reference to Figures 1 and 2, a safe sampling system for a collected body fluid, for example blood, comprises a body fluid receiving means 30, which is, for example, but not exclusively, a bag or sachet of plastics material in which the collected blood is received. The bag 30, of a known type, comprises one or more fluid connection means to enable the collected blood to pass into and out of it. In particular, the bag 30 comprises an inlet 32 connected by a tube 20 to blood collection means, such as a collecting needle of a known type (not shown), and an outlet 31.

The system also comprises means for receiving a sample, fixed to the means for receiving body fluid. In the example shown in figures 1 and 2, the system comprises a sachet or a test tube 100 fixed to the bag 30 by a portion of tube 34 connected to the outlet 31. The test tube 100, which is made from plastics and/or glass material and has a predetermined capacity, can preferably, but not necessarily, contain substances and/or solutions of various types, for example substances for helping to preserve a sample of body fluid, such as anticoagulants where the body fluid consists of blood. The test tube 100 can also comprise closing means which are, for example but not exclusively, a threaded or break-away plug. Tube interruption means are placed on the portion of tube 34 to selectively interrupt the fluid connection between the bag 30 and the test tube 100. The interruption means can comprise, for example, an element of the "breakaway" type which keeps the tube interrupted until it is activated, or an element known as a "clamper" 36 for pressing the walls of the tube together to interrupt the passage of fluid.

In use, when the sample has to be analysed in order to determine the chemical and physical characteristics of the fluid contained in the bag, the interruption means 36 are opened and a sample of fluid is introduced into the test tube through the portion of tube 34. The fluid can be made to pass by gravity, if the bag is inverted with respect to the position shown in Figure 1, or by the application of pressure to the walls of the bag, or by any other method for effectively transferring a fluid from one container to another. When the fluid sample has been taken, the portion of tube 34 is re-closed by interrupting the fluid connection between the bag 30 and the test tube 100. The fluid connection can be interrupted by using the clamper 36 while keeping the bag 30 and the test tube 100 physically connected to each other until the tube 34 is cut, or alternatively by welding a portion of the tube 34, using a heat welder or ultrasonic welder for example, and simultaneously causing the physical detachment of the test tube 100 from the bag 30. When it is detached from the bag 30, the test tube 100 remains connected to a residual portion of tube. In order to make the contents of the test tube accessible and allow the test tube to be directly inserted into a known analysis device, the residual portion of tube must be additionally cut and/or broken away.

In a particularly advantageous embodiment of the present invention, the system comprises selectively openable connecting means which connect the sachet or test tube 100 directly to the bag 30 or to the portion of tube 34, and which enable the test tube 100 to be separated selectively from the bag 30 or from the tube 34 after its separation from the bag 30. For example, the connecting means can comprise a pair of complementary threads formed on the inner walls of the test tube 100 and on the inner walls of the portion of tube 34, or a snap-in lock system, or any other means for selectively detaching the test tube 100 from the portion of tube 34 without the need for cutting and/or breaking away.

The sample can be taken at any time, either in the "pre- storage" stage, as soon as the bag has been filled after collection from the patient, or in the "post-storage" stage, after a predetermined time interval during which the bag is kept in a storage area and/or transported to another place for administration. Preferably, after sampling has taken place, the test tube 100 is detached from the bag and its content is analysed.

One of the principal advantages of the present invention is that the sampling means 100 remain physically associated with the main receiving bag 30 until the moment of sampling and analysis of their contents, which can take place even if a considerable period has elapsed after the collection stage, thus minimizing the risk of confusion and/or incorrect association of the fluid sample with the fluid contained in this bag.

Alternatively, the test tube 100 can be connected to one of the fluid tubes connected either to the inlet or to the outlet of the bag 30, as shown in figure 3, using a T- connector 15 or other similar connecting element which enables the results and objects of the present invention to be achieved. This configuration may be particularly advantageous for the examination of a sample before, or after, the body fluid has entered the receiving bag 30, and it is used, for example, in cases in which substances required for the treatment of the body fluid, for example anticoagulants, are already present in the bag, or in cases in which the body fluid has been kept in the bag 30 for a long time and its integrity has to be checked before administration .

Additionally, the system according to the present invention comprises unambiguous elements for mutually identifying the bag 30 and the test tube 100. The identifying elements are applied simultaneously to both the bag and the test tube before the latter is detached from the bag. Preferably, the unambiguous mutual identification elements are applied before the use of the safe sampling system, for example during the manufacturing stage. The unambiguous identification elements can comprise a bar code, a tag, a label carrying textual and/or graphic information, or any other known element which facilitates identification.

As shown in Figure 4, an integrated safe sampling system according to the present invention can also be incorporated into a body fluid collection system, particularly in a system for collecting blood for transfusion. The sampling system comprises blood collection means, for example a collecting needle 10 of a known type, connected by means of a tube, usually a plastics tube 20 of predetermined diameter, to a main blood receiving means, for example but not exclusively a receiving bag 30. The main blood receiving means is connected to one or more further receiving elements, for example but not exclusively two or three or more bags of the standard or "top and bottom" type, possibly in a configuration with a line filter, using further plastics tubes. In the embodiment shown in Figure 4, the main bag 30 is connected by means of a series of tubes and a Y-connector 32 to a bag 40 for containing platelet concentrate and to a bag 50 for containing plasma. In particular, the series of tubes comprises a first tube 34 connected at one end to the bag 30 and at the other end to the connector 32, a second tube 35 connected at one end to the connector 32 and at the other end to the platelet bag 40, and a third tube 38 connected at one end to the Y-connector 32 and at the other end to the plasma bag 50. The main bag 30 is also connected to a further bag 60 for containing leucodepleted red cell concentrate if a line filter is present, by means of a tube 62. Alternatively, the bag 60 can be connected by means of a tube 64 to a further container. This configuration enables the blood collected and contained in the main bag 30 to be divided into its principal components, namely plasma, platelets and red cell concentrates, and enables these to be kept in separate containers 40, 50 and 60, ready for subsequent use.

The integrated safe sampling system according to the present invention also comprises a plurality of sampling test tubes 100, placed at various points of the system, and each connected to a corresponding bag. In particular, if the group of bags and tubes described above is considered as a closed circuit whose inlet is formed by the collecting needle 10 and the tube 20, the sampling test tubes 100 are all placed downstream of the main bag 30. A first sampling test tube 100 is connected to the tube 62 downstream of the main bag 30 and upstream of the bag 60 for containing red cell concentrates. Another sampling test tube 100 can be connected to the tube 34 downstream of the main bag 30 but upstream of the Y- connector 32. Another sampling test tube 100 can be connected to the tube 35 upstream of the platelet bag 40. Another sampling test tube 100 can be connected to the tube 38 upstream of the bag 50.

Clearly, in this configuration each sampling test tube 100 is connected to and associated with a corresponding bag, and can receive only the blood leaving the corresponding bag or the blood entering the corresponding bag. In other words, the blood sample in the test tube cannot differ in any way from the blood contained in the corresponding bag. In another embodiment of the present invention, shown in Figure 5, the test tubes 100 of the safe sampling system are connected directly to the bags 30, 40, 50 and 60 through inlets formed on these bags.

Clearly, the positioning of the test tubes 100 and their points of connection to the system, which may be on the tubes or on the bags, have been described and illustrated solely by way of example, and without affecting in any way the objects and results achieved with the present invention. It is possible to provide either a sampling system comprising test tubes which are all connected to the bags, or a sampling system comprising test tubes which are all connected to the tubes, or a sampling system comprising some test tubes connected to the bags and some connected to the tubes. The number of test tubes and the points of connection of the test tubes to the tubes or to the bags can also be varied considerably according to the requirements of sampling and/or construction and/or the conditions of use of the system, provided that the condition of unambiguous association between the content of a test tube connected to a bag and the content of the said bag is met.

As mentioned above, each bag 30, 40, 50 and 60 and each corresponding test tube 100 is distinguished by means of identical identifying elements. The identifying elements are applied to the bag and the test tube before the latter is detached from the bag. Preferably, the unambiguous mutual identifying elements are applied before the use of the safe sampling system, for example during the manufacture of the sampling system. The identifying means can comprise a bar code, a tag, a label carrying textual and/or graphic information, or any other known element which facilitates identification . As described above, the bag or test tube 100 is fixed to the bag or to the tube circuit by means of a portion of tube 34. The test tube 100, which is made from plastics and/or glass material and has a predetermined capacity, can preferably, but not necessarily, contain substances for helping to preserve a sample of body fluid, such as anticoagulants where the body fluid consists of blood. Tube interruption means are placed on the portion of tube 34 to selectively seal the fluid connection between the bag 30 and the test tube 100. The interruption means can comprise, for example, an element of the "breakaway" type which keeps the tube sealed until it is activated, or an element known as a "clamper" 36 for pressing the walls of the tube together to interrupt the passage of fluid.

In a particularly advantageous embodiment of the present invention, the system comprises connecting means which connect the sachet or test tube 100 to the portion of tube 34, and which enable the test tube 100 to be separated from the tube 34 after its separation from the bag 30. For example, the connecting means can comprise a pair of complementary threads formed on the inner walls of the test tube 100 and on the inner walls of the portion of tube 34, or a snap-in lock system, or any other means for selectively detaching the test tube 100 from the portion of tube 34 without the need for cutting and/or breaking away.

The operating principle of the sampling system according to the present invention is identical for both of the embodiments shown in Figures 4 and 5, and is identical to that described above for the embodiment using a single bag. In particular, the safe sampling system provides a test tube which is always connected to a corresponding bag, maintaining a "closed circuit" configuration and preventing any risk of contamination by external agents. Thus it is possible at any time to take a sample of the material contained in the bags, introduce it into the test tube, detach the test tube from the bag, and analyse the sample. Even if a bag is separated from the sampling system, for example but not exclusively in order to administrate the contents to a patient, the corresponding test tube remains connected to it until it is detached for the purpose of analysing the sample contained in the test tube.

In procedures in which the main bag 30 is to be subjected to a predetermined treatment for distributing its content among other bags, for example in a centrifuging process for separating platelets and plasma and red cell concentrates and filling the corresponding bags 40, 50 and 60, the test tubes 100 remain connected to the corresponding bags throughout the process and are ready to receive samples of material for analysis, still in aseptic and sterile conditions and without the circuit being opened to the outside at any time.

The connection of the sampling test tubes 100 to one of the bags or to one of the tubes connecting the bags, in the types of system described above with triple or quadruple bags which may be standard or "top and bottom" bags, with or without a line filter, enables the user to obtain at all times a sample which can be securely associated with the blood component contained in the bag to which the system is connected, thus preventing the occurrence of any labelling error between the parent bag and the corresponding sample. The operator is free to choose the bag or bags or tubes, and more generally the positioning, in which this system is to be installed.

The system according to the present invention enables the contents of the test tube to be used for routine examinations, and enables the sample to be alternatively left connected to the parent bag so as to maintain, throughout the period in which the specific blood component may be used, a secure reference to the specific bag which may be used for post-infusion checks or whenever such checks may become necessary. The system reduces the possibility of human error in the labelling of the bags and test tubes, which may occur at present at different points. For example, in a hospital centre using a "Type and Screen" processing system, the integrated sampling system according to the present invention can reduce the number of examinations and the processing time .

Clearly, provided that the principle of the invention is retained, the forms of embodiment and the details of construction can be varied widely from what has been described and illustrated, without departure from the scope of the present invention.

Claims

1. An integrated safe sampling system for external body fluids of the type comprising means (30, 40, 50, 60) for receiving body fluid and/or its components, and means (100) for sampling the said body fluid and/or its components, characterized in that the sampling means (100) are directly connected to the said receiving means (30, 40, 50, 60) and are selectively detachable during use from the said receiving means (30, 40, 50, 60) .

2. A system according to Claim 1, characterized in that it also comprises means for the unambiguous mutual identification of the receiving means (30, 40, 50, 60) and the sampling means (100), positioned on the receiving means and on the sampling means.

3. A system according to Claim 2, characterized in that the identifying means comprise any one of the following elements: bar code, tag, label carrying textual and/or graphic information .

4. A system according to Claim 1, characterized in that the sampling means comprise a test tube (100) .

5. A system according to Claim 1, characterized in that the sampling means (100) and the receiving means (30, 40, 50, 60) are connected by means of a tube (34) .

6. A system according to Claim 5, characterized in that it also comprises means of interruption (36) positioned on the tube (34) to selectively interrupt the passage of fluid from the receiving means (30, 40, 50, 60) to the sampling means

(100) .

7. An integrated safe sampling system for external body fluids, characterized in that it comprises at least one main bag (30) which, when in use, can receive a predetermined quantity of collected blood, and one or more secondary bags

(40, 50, 60) hydraulically connected to the said main bag by means of a plurality of tubes, the secondary bags (40, 50, 60) being capable, when in use, of receiving some of the said blood and/or one or more of its components, the system also comprising a plurality of sampling means (100), each associated with at least one of the said bags (30, 40, 50, 60) .

8. A system according to Claim 7, characterized in that the sampling means are connected in a selectively detachable way to the bags (30, 40, 50, 60) and/or to the plurality of tubes downstream of the main receiving bag (30) .

9. A system according to Claim 8, characterized in that each sampling means (100) is connected to a corresponding bag in such a way that it receives, when in use, only the blood leaving or entering the bag (30, 40, 50, 60) corresponding to it.

10. A system according to Claim 9, characterized in that the sampling means comprise a test tube (100) connected directly to the corresponding bag (30, 40, 50, 60) .

11. A system according to Claim 7, characterized in that the system also comprises means for the unambiguous and mutual identification of each bag (30, 40, 50, 60) with each sampling means (100) .

12. A system according to Claim 7, characterized in that it comprises selectively openable connecting means which connect the sampling means (100) directly to the bag (30) or to a tube (34), and which enable the sampling means (100) to be separated selectively from the bag (30) or from the tube (34) when in use.

13. A method of safe sampling in a system for collecting blood for the purposes of transfusion, comprising the steps of: a) filling a main bag (30) with a predetermined quantity of collected blood, b) filling one or more secondary bags (40, 50, 60) with a portion of the said blood and/or one or more of its components by means of any one of the known methods, characterized in that it comprises the subsequent step of: c) taking a sample of blood from at least one of the said bags, using a test tube (100) connected to the said at least one bag.