Sealed sterile device for the aseptic separation and concentration of biological components

Abstract

A sealed sterile device for the aseptic separation and concentration of biological components, which includes: a tube sealed at first end and which has a mouth at second end; a plunger of flexible material, without an actuation rod, installed inside the tube with the possibility of longitudinal movement, and which has a hole for charging with a fluid to be separated and concentrated and discharging the separated fractions, the hole being provide with a valved female Luer lock connection, the plunger also having a purging duct provided with a self-sealing filter for the automatic purging of the air/gas contained in the tube during the filling of the tube with the fluid to be separated and concentrated; and a cap for protecting the connection-plunger assembly, couplable to the mouth of the tube.

Claims

1. A sealed and sterile device for aseptic separation and concentration of biological components, comprising: a tube sealed by a first end and having a mouth at a second end; a plunger of flexible material, without a drive shaft, mounted inside the tube with the possibility of and configured for longitudinal movement therein, the plunger having a hole for loading a fluid to be separated and concentrated, and for discharging the separated fractions, the hole is provided with a female luer-lock valved connection, and a purge duct, provided with a self-sealing filter, through which automatic purge of air/gas contained in the tube during the filling of the tube is carried out, with the fluid to be separated and concentrated; and a cap for protecting the plunger, which can be coupled to the mouth of the tube.

2. The device according to claim 1, wherein the plunger has a concave front end provided with radial fins, which prevent turbulence and stabilize passage of one of the separated liquid fractions from inside the cylinder to an extraction syringe coupled to the female luer-lock connection of the plunger.

3. The device according to claim 1, wherein the plunger has a side surface with a perimeter recess defined between some adjustment rings and the inside of the tube.

4. The device according to claim 1, wherein the self-sealing filter of the plunger, arranged in the duct for the automatic purging of the air/gas, comprises a gelling filler which, when in contact with the fluid to be separated, is moistened and it gels and seals immediately, thus losing its permeability to air/gas and liquids.

5. The device according to claim 1, wherein the cap features an absorbent filler inside, which protects and dries the female luer-lock connection from possible drops of the fluid to be separated and concentrated.

6. The device according to claim 1, further comprising within the tube, a cylindrical buoy of a predetermined density, of a diameter suitable for the diameter of the inside of the tube and provided with a central hole with a unidirectional valve for passage of denser fractions towards a zone located below the buoy; said buoy forming a physical barrier between liquid fractions of different density.

7. The device according to claim 6, wherein the buoy has a concave upper face that abuts the central hole of fluid passage through the buoy.

8. The device according to claim 6, wherein the buoy has a perimeter chamfer on its upper face facing a perimeter lip defined at a lower end of the plunger, the perimeter chamfer causes a lateral expansion of said perimeter lip and the stopping of the progress of the plunger when said plunger contacts the buoy during the extraction of one of the separated fractions of liquid.

Description

DESCRIPTION OF THE FIGURES

(1) In order to complement the description that is being made and in order to facilitate the understanding of the features of the invention, a set of drawings in which, the following has been represented with an illustrative and non-limiting character, is attached to the present specification:

(2) FIG. 1 shows an elevation view of an embodiment of the sealed and sterile device for separation of aseptic concentration of biological components, with the cap in the open position.

(3) FIG. 2 shows an exploded elevation view in of the device of the previous figure, sectioned by a vertical plane.

(4) FIG. 3 shows an elevation view of the device of the previous figures during the loading of the fluid to be separated inside the tube by means of a loading syringe provided with a male “luer-lock” connection, complementary to the female “luer-lock” valved connection of the plunger, and coupled with it.

(5) FIG. 4 shows a view of the device in the sealed position once centrifuged, featuring the buoy located between the two fractions of liquid of different density, separated and concentrated.

(6) FIG. 5 shows a view of the device of the previous figures during the extraction of one of the fractions of liquid by means of an extraction syringe coupled to the luer-lock connection of the plunger, and said plunger contacting, by means of its perimeter lip, with the perimeter corner of the buoy.

PREFERRED EMBODIMENT OF THE INVENTION

(7) As seen in FIG. 1, the sealed and sterile device for aseptic separation and concentration of biological components comprises a tube (1) with a first sealed end (11) and having a mouth (12) at a second end.

(8) Inside the tube (1) a plunger (2) of flexible material, without a drive shaft, is mounted with the possibility of longitudinal movement.

(9) Said plunger (2) has a hole (21) for loading a fluid to be separated and concentrated in various fractions, and for discharging the fractions of said fluid, of different density, separated by centrifugation.

(10) The hole (21) has at the end facing the mouth (12) of the tube (1) a valved female luer-lock connection (22), whose valve is usually kept in a sealed position and opens when it is coupled with a male luer-lock connection (CM).

(11) The plunger (2) also has a duct (23) for the automatic purging of the air/gas contained in the tube (1) during the filling of the tube (1) with the fluid to be separated and concentrated, this filling operation being carried out by means of a loading syringe (JC) provided with a male “luer-lock” connection (CM) complementary to that of the plunger (2), as shown in FIG. 3.

(12) Said purge duct (23) is provided with a self-sealing filter (24) comprising a gelling filler which, when it comes into contact with the fluid to be separated due to the complete filling of the tube (1) and moistened with said fluid, gels and seals immediately, thus losing its permeability to air/gas and liquids.

(13) The plunger (2) has a concave front end (25), oriented towards the first end (11) of the tube (1) and provided with radial fins (25), which prevent turbulence and favour a precise fractioning, stabilizing the passage of the liquid fraction separated from inside the tube (1) to an extraction syringe (JE) coupled to the female “luer-lock” valved connection (22) from the plunger (2) by means of a male “luer-lock” connection (CM) complementary, as shown in FIG. 5. This extraction syringe (JE) has a smaller diameter than the tube (1) acting in the coupling position as shaft of the plunger (2). The plunger has a perimeter recess (27) on its side surface defined between some adjustment rings (28) and the inside of the tube (1).

(14) The device comprises a cap (3) for protecting the connection/plunger assembly, which can be coupled to the mouth (12) of the tube (1).

(15) This protective cap (3) features an absorbent pad (31) inside it that protects and dries the female luer-lock connection (22) of the plunger (2) from possible drops of the fluids to be separated and concentrated, thus avoiding risks of contamination.

(16) The device of the invention comprises a cylindrical plastic buoy (4) inside the tube (1), of a predetermined density and provided with a central hole (41) with a unidirectional valve (42) for the passage of the denser fractions towards the area below the buoy; said buoy forming a physical barrier between fractions of different density, once separated by centrifugation, as shown in FIG. 4.

(17) Said buoy (4) has a concave upper face (43) that internally abuts the central hole (41) of fluid passage through the buoy (2) and, externally, in a perimeter chamfer (44).

(18) The mission of this perimeter chamfer (44) is to cause a lateral expansion of the perimeter lip (29) of the plunger (2) and the braking of the advancement of the plunger (2) through the inside of the tube (1) when said plunger (2) contacts the buoy (4) during the extraction of one of the separated fractions of liquid, as shown in FIG. 5.

(19) In order to perform the extraction of the fraction of liquid located above the buoy (4) the plunger (2) is moved to the lower area, pushing it with the extraction syringe (JE) and keeping the stem of said extraction syringe free so that said shaft can move freely upward as the liquid fraction enters said syringe.

(20) Once the nature of the invention has been sufficiently described, as well as a preferred embodiment, it is stated for the appropriate purposes that the materials, shape, size and arrangement of the described elements may be modified, provided that this does not entail an alteration of the essential features of the invention that are claimed below.