WO2008035240A2

WO2008035240A2 - Platelet freezing system

Info

Publication number: WO2008035240A2
Application number: PCT/IB2007/052856
Authority: WO
Inventors: Pietro Giuseppe Argento
Original assignee: MEDICAL MEDITERRANEA Srl
Current assignee: MEDICAL MEDITERRANEA Srl
Priority date: 2006-07-19
Filing date: 2007-07-18
Publication date: 2008-03-27
Anticipated expiration: 2009-01-19
Also published as: WO2008035240A3; ITBO20060539A1

Abstract

Platelet freezing system comprising containing means (1) of platelet preparation, and connecting means (2, 5) that can be sterile connected, in use, to a container device and/or dispenser of a platelet concentrate. The system also comprises feeding means (8) of a freezing solution connected to said connection means (2, 5). The containing means (1), the connection means (2, 5) and the feeding means (8) are connected each other so as to create a closed circuit.

Description

PLATELET FREEZING SYSTEM

The present invention is referred to a Platelet freezing system, and to a feasible platelet freezing method with such system. The field of application of the invention pertains to the area of the treatment of extra-bodily biological fluid and the preservation of its components. The system according to the invention was developed with special care to the cryo- preservation of a platelet concentrate, or of a therapeutic unit of platelet, to a temperature, preferably, of about - 8O⁰C. The platelet of the concentrate are usually obtained by an apheresis procedure and/or from a platelet aggregate, a so-called platelet "pool", that usually includes a platelet concentrate obtained from a so-called "buffy coat".

The procedure of freezing platelet concentrates or therapeutic units of platelets today is carried out employing systems including a circuit for the accommodation of platelets of the "open" type, that is to say in contact with the neighboring environment. These types of known systems are however subject to pathogen pollution and present numerous disadvantages. In order to guarantee the necessary sterility of the final product, the known types of systems employ cumbersome and expensive equipment, for example sterile hood, that however does not succeed in guaranteeing the full sterility of the final product.

Purpose of the present invention is that of resolving the problems of the known technique, supplying a platelet freezing system of simple and economical accomplishment, that guarantees the sterility of the final product. It is also purpose of the present invention to supply a flexible system, that allows a simple and swift freezing and thawing of the therapeutic platelet units in it contained. Another purpose is that of allowing a simple separation of the platelet concentrate from the freezing solutions used for its freezing. A further purpose is that of realizing a system that allows a simple division in containers of the platelet contents of the therapeutic unit, realizing at the same time a sampling of the portions distributed.

In order to reach the above indicated purposes, the invention has for object a platelet freezing system and a method of platelet freezing as reported in the claims that follow.

One of the advantages of the present invention is that of allowing the cryo-preservation of a platelet concentrate, realizing a sterile connection and preserving therefore the concentrate from the risk of pathogen pollution. The system according to the present invention allows besides the defrosting and the centrifugation of the platelet concentrate, the procedures necessary to separate the freezing solution and the added physiological solution to the platelet contents.

Advantageously, the system according to the invention allows an operator to add a freezing solution in a percentage, between those more in use, variable, permitting so to add precisely the quantity wanted.

An operator is then in a position of deciding the freezing of the platelet at any time during the short period of preservation of the same, according to the laws in force. Consequently it can satisfy the necessity of every individual transfusion center, without the need to supply itself of all of the components singularly, and without the need of adding other like known products to the state of the art.

Further features and advantages will result from the following detailed description of an example of representation of the invention, given as a simple example and not limited to it, with reference to the annexed figure 1, that represents a schematic view of a platelet freezing system according to the present invention.

With reference now to the figure, a platelet freezing system according to the present invention comprises containing means for the accommodation and the sterile containment of a platelet preparation. The containing means are of the type suitable for freezing a extra-bodily biological fluid and in particular a platelet preparation. In particular, the containing means comprise at least a container for the platelet concentrate collection prepared to be frozen, preferably a couple of main bags 1 in plastic material, for example, but not limited to PVC, sterile, non-pyrogenic and dry. Each main bag 1 includes at least an access opening 16 for the withdrawal of the relevant content.

The main bags 1 are sterile connected to connecting means comprising, for example, connecting tubes and one or more "Y" type connection elements. Two first connecting tubes 2 connect the main bags 1 to a second connection tube 5 through a "Y" connection element 4. Flow controlling means, for example clamps and/or so-called "break-away" devices 3, are disposed on the pair of the connecting tubes 2. As it will appear clearer, the flow controlling means 3 permit to divide or to direct, in the use, the prepared platelet concentrate coming from the connecting tube 5 in one or in both the main bags 1, at discretion of the operator carrying out the control .

The connecting tube 5, in its turn, is connected on one side to the "Y"connection 4 and on the other one, by a second "Y" connection 6, to a container device and/or dispenser of the platelet concentrate to freeze, not illustrated for simplicity, and to feeding means of a freezing solution. The container device and/or dispenser of the platelet concentrate includes for example a bag containing the platelet concentrate sterile connected to the connection tube 5. The feeding means include for example, but not limited to, a syringe 8, or a bag, containing a certain quantity of freezing solution, and can naturally be connected, according to the various requirements, also to an other connection tube, for example but do not limited to, to the tube 2, without for this go out from the scope of the present invention. The feeding means also include flow controlling means, for example clamps 7, to moderate, in the use, the influx of the freezing solution in the inside of the connection tube 5. Preferably, the syringe 8 is of known type and capable of containing at least a quantitative of about 30 ml of freezing solution, sufficient for the cryopreservation of a therapeutic unit of platelets.

The system of the present invention includes futher containing means, for example mini-bags 9 of smaller dimensions in respect to the main bags. Each of these mini- bags comprise sterile connecting means for the connection to the main bags 1 and, preferably, but not limited to, a vacuum-packed sampling system 15, and further flow controlling means, for example, but do not limited to, clamps and/or "break-away" devices 10, for controlling the platelet preparation flowing between the main bag 1 and the mini-bag 9. Such disposition of elements is able to realize closed circuit bacteriological controls on the platelet preparation present in every main bag 1.

The system of the present invention includes a further mini- bag 11, of smaller dimensions with respect to the main bags. This mini-bag 11 is connected to one of the two main bags 1, in particular to the bag on the left according to the system represented in figure 1, by means of a sterile connection, and includes, preferably, but not limited to, a vacuum-packed sampling system 15, and further flow controlling means, for example, but not limited to, clamps and/or "break-away" devices 12. Such disposition of elements is able to carry out the operation of platelet count.

The mini-bag 11 for platelet count is connected, by means of another "Y" connection also to a third connection tube, including a "luer-lock" type terminal 13 and further flow controlling means, for example a clamp 14 for controlling the flow, preferably but not limited to, of a solution towards the bag 1.

The platelet freezing system according to the present invention can naturally be connected to an independent refrigeration system for freezing or defrosting of prepared platelets. The refrigeration system, not illustrated for simplicity of illustration, can be of known type without for this change the advantages and the results obtained from the present invention.

In use, a platelet concentrate freezing procedure comprises a first phase of providing the above listed closed circuit means for the accommodation and the sterile containment of a platelet concentrate, a second phase of sterile connection of the connection tube 5 to the container device and/or dispenser of the platelet concentrate to freeze, and a third phase of dispensing of the platelet content to the inside of the connection tube 5. Therefore, in the following phases a certain quantity of freezing solution is added to the inside of the connection tube 5 through the syringe 8, for example about 30 ml for a therapeutic unit of platelets. The platelet preparation so made is directed to the main bags 1, where it it is collected after that the first flow controlling means have determined the division and the direction of the preparation in the precise quantity requested by the operator. At this point, if the operator wants to, a vacuum- packed sampling of the prepared platelets present in each of the main bags 1 can be activated. Furthermore, the operation of platelet count may be activated by the disposition of elements connected to the main bag 1 on the left. Finally, it will be possible to proceed to the freezing of the system above described to cryopreserve the platelet preparation, typically at a temperature of -8O⁰C.

After a predetermined interval of time, it is possible to thaw the platelet preparation. It's clear that, by means of the illustrated system, the preparation is immediately ready for the elimination of the freezing solution from the platelet present in the inside of the main bags 1. Such main bags 1, in fact, can be simply withdrawn from the system and put, sterile and sealed, inside means of element separators, for example, but not limited to, centrifugation accelerators, to carry out the separation and to obtain again only the platelet concentrate.

Advantageously, the system just described includes a closed circuit, sterile that has no need to operate in neighboring sterile environment or to use a special device for such purpose. The system also allows an operator to be able to decide if and when to freeze the platelet concentrate, without the need to acquire all the components singularly. In this manner the operator, without the need of further products or of supplementary procedures, acquires an absolute freedom of making in the process of freezing and thawing of the platelet concentrates, succeeding therefore in satisfying the need of the center and/or of the hospital where he/she works .

Naturally numerous variants can be expected of the platelet freezing system based on the invention, without for this going out of the present invention.

Claims

1. Platelet freezing system, of the type comprising containing means (1) of a platelet preparation, and connecting means (2, 5) that can be sterile connected, in use, to a container device and/or dispenser of a platelet concentrate, the system also comprising feeding means (8) of a freezing solution connected to said connecting means (2, 5), characterized in that the containing means (1), the connecting means (2, 5) and the feeding means (8) are connected each other so as to create a closed circuit.

2. System according to claim 1, characterized in that it includes a plurality of flow controlling means (3), associated to the connecting means (2) in order to moderate and to distribute, in use, the platelet preparation to the inside of said containing means (1) .

3. System, according to claim 1 or 2, characterized in that it includes secondary flow controlling means (7) associated to the feeding means (8) to control the influx of the freezing solution in the connecting means (5) .

4. System, according to any one of the previous claims, characterized in that it also comprises a sampling system (15) .

5. System, according to claim 4, characterized in that the sampling system comprises at least a bag (9) associated to at least one of the containing means (1), and flow controlling means (10) for controlling, in use, the platelet concentrate flowing between the bag (9) and the containing means (1) .

6. System, according to claim 3, characterized in that it comprises a disposition of elements (11, 12, 15) connected to the containing means (1) to carry out, in the use, a count operation of the platelets contained in the platelet concentrate .

7. System, according to claim 6, characterized in that the disposition of elements includes a bag (11) to which are associated a sampling system (15) and flow controlling means (12) .

8. System, according to claim 3, characterized in that it comprises a "luer-lock" type terminal (13) and flow controlling means (14) engaged to the connecting means connected to the containing means (1) .

9. Method of platelet freezing, including the phases of:

- providing a closed circuit platelet freezing system as defined in claims 1 to 8;

- sterilely connecting a container device and/or dispenser of platelet concentrate to freeze to the closed circuit platelet freezing system;

- distributing the platelet preparation to the inside of the connecting means (5) ;

- adding a predetermined quantity of a freezing solution to the inside of the connecting means (5), in such manner to mix it to the platelet concentrate to form a platelet preparation suitable to be frozen;

- collecting the platelet preparation in the inside of at least one containing means (1);

- freezing the platelet preparation.

10. Method according to claim 9, characterized in that the freezing temperature is of about -80° C.

11. Method, according to claim 9, characterized in that it also includes the phase of sampling of the platelet preparation present in a containing means (1), particularly the sampling having been done under vacuum.

12. Method, according to claim 9, characterized in that it also includes the phase of platelet counting of the platelet concentrate present in at least one of the containing means (D •