CONTAINER FOR THE EX-VIVO TREATMENT OF BIOLOGICAL FLUIDS

Abstract

The invention relates to a recipient (1) for ex-vivo treatment of biological liquids, which includes: a rigid body (2); a reservoir (3) provided inside the body (2), which is formed by a side wall (4), a rigid upper wall (5) and a rigid lower wall (6) and has an internal thickness defined by the separation between the upper wall (5) and the lower wall (6), at least one of the upper wall (5) or the lower wall (6) having a window area (7) configured to allow the passage of electromagnetic radiation from outside of the body (2) to the reservoir (3); two ports (8, 9) for liquids to gain access to the reservoir (3) from outside of the body (2); and closure means (10, 11) for the ports (8, 9), the closure means (10, 11) being configured to provide, jointly, the reservoir (3) with hermetic sealing against gases and liquids.

Claims

1. A container for the ex vivo treatment of biological fluids, in particular blood, wherein it comprises: a rigid body; a reservoir provided inside said body; formed by a side wall, a rigid upper wall, and a rigid lower wall; said reservoir having an inner thickness defined by the separation between said upper wall and said lower wall; at least one of said upper wall or said lower wall having a window region configured to allow the passage of electromagnetic radiation from the outside of said body to said reservoir; a first access port for fluids to said reservoir from the outside of said body; first closure means for said first port; a second access port for fluids to said reservoir from the outside of said body; second closure means for said second port; said first closure means and said second closure means being configured to jointly provide a gas and liquid tight seal for said reservoir.

2. The container according to claim 1, wherein said inner thickness of said reservoir is equal to or less than 5 mm.

3. The container according to claim 1, wherein said inner thickness of said reservoir is equal to or greater than 1 mm.

4. The container according to claim 1, wherein said inner thickness of said reservoir is comprised in the range of 1 to 4 mm, preferably being 2.5 mm.

5. The container according to claim 1, wherein said reservoir has an inner volume between 2 and 30 ml, preferably, 10 ml.

6. The container according to claim 1, wherein said window region extends throughout the entire said upper wall or said lower wall having said window region.

7. The container according to claim 1, wherein both said upper wall and said lower wall each has a window region configured to allow the passage of electromagnetic radiation from the outside of said body to said reservoir.

8. The container according to claim 1, wherein said electromagnetic radiation is comprised between infrared and ultraviolet radiation, preferably, between near infrared and the visible light spectrum.

9. The container according to claim 1, wherein said body is made of a polymeric material.

10. The container according to claim 1, wherein said side wall, said upper wall, and said lower wall are formed in said body.

11. The container according to claim 10, wherein said body comprises an upper part in which said upper wall is formed, and a lower part in which said lower wall is formed; said upper part and said lower part being attached in ribs forming said side wall of said reservoir, preferably by means of ultrasonic welding.

12. The container according to claim 1, wherein said body is flat, and said upper wall and said lower wall are flat and parallel to one another.

13. The container according to claim 12, wherein said body is rectangular.

14. The container according to claim 12, wherein said reservoir is rectangular.

15. The container according to claim 1, wherein it further comprises a casing made of elastomer, preferably medical grade silicone.

16. The container according to claim 15, wherein said first closure means and said second closure means are formed in said casing, preferably in the form of removable plugs.

17. The container according to claim 1, wherein said body further comprises an identification region configured for receiving a label, said identification region not overlapping said window region.

18. The container according to claim 17, wherein said identification region is provided in the upper portion of said body, preferably close to one of the ends of said body.

19. The container according to claim 1, wherein said first access port and said second access port each comprises a tube extending from said body and forming an access opening communicating the outside of said body with said reservoir.

20. The container according to claim 19, wherein the end of each of said tubes is provided with engagement means configured for taking in and fixing a syringe.

21. The container according to claim 19, wherein said tubes are provided in the upper portion of said body, preferably close to one of the ends.

22. The container according to claim 1, wherein it further comprises a sealed packaging containing said body and, in which said container is sterilized.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0048] The advantages and features of the invention will become apparent from the following description in which preferred embodiments of the invention are described in a non-limiting manner with respect to the scope of the main claim, referring to the drawings.

[0049] FIG. 1 corresponds to a top view of an embodiment of the container of the invention. The window region 7 has been shaded to distinguish it from the upper wall. For the sake of clarity, this shading is not included in the rest of the drawings.

[0050] FIGS. 2A and 2B are perspective views of another embodiment of the container.

[0051] In FIG. 2A, the closure means are closed, whereas in FIG. 2B they are open.

[0052] FIG. 3 is a perspective view of the rigid body of the container according to the preceding embodiment.

[0053] FIGS. 4A and 4B are perspective views of the upper part of the body according to an embodiment of the invention. FIG. 4A shows the top perspective view, whereas FIG. 4B shows the same part from below.

[0054] FIG. 5 is a perspective view of the lower part of the body according to the same embodiment as in FIGS. 4A and 4B.

[0055] FIG. 6 is a perspective view of the casing for an embodiment of the container of the invention.

[0056] FIG. 7 is a horizontal section of the body according to the embodiment of FIGS. 4A, 4B, and 5 in top view.

[0057] FIG. 8 is a side view vertical section of the body according to the same embodiment of FIG. 7.

DETAILED DESCRIPTION

[0058] FIG. 1 shows an embodiment of a container 1 for the ex vivo treatment of biological fluids, in particular blood. Said container 1 comprises a rigid body 2 which, in the example, is flat, rectangular, and made of a polymeric material. In particular, in the embodiment said polymeric material is an injection grade polymer based on methylmethacrylate acrylonitrile butadiene styrene (MABS) marketed by Terlux® HD 2812.

[0059] A reservoir 3 is provided inside said body 2. Said reservoir is 3 formed by a side wall 4, a rigid upper wall 5, and a rigid lower wall 6. For the embodiments of the drawings, said upper wall 5 and said lower wall 6 are flat and parallel to one another. Said reservoir 3 has an inner thickness defined by the separation between said upper wall 5 and said lower wall 6. For the embodiments in which the container is intended for the ex vivo treatment of blood, said inner thickness is 2.5 mm.

[0060] At least one of said upper wall 5 or said lower wall 6 has a window region 7 configured to allow the passage of electromagnetic radiation from the outside of said body 2 to said reservoir 3. In the example of FIG. 1, said window region 7 is present in said upper wall 5 and, for the sake of clarity, it has been shaded with cross hatching so that it stands out from of the rest of container. This shading does not appear in the rest of drawings.

[0061] For the embodiments herein described, said electromagnetic radiation is comprised between near infrared and the visible light spectrum. Other embodiments contemplate other ranges of the electromagnetic spectrum, such as ultraviolet radiation or even higher frequencies such as X-rays or lower frequencies in the range of the microwaves. Sample irradiation uniformity is affected by the penetration capacity of the radiation in said sample, and this in turn may depend on the band of the electromagnetic spectrum. For this reason, the skilled person will understand that the reservoir thickness limit of 5 mm mentioned above in this document many vary for some embodiments.

[0062] As can be seen in the examples of the drawings of the embodiments, said reservoir 3 has a rectangular shape. In particular, for the examples herein described in which the fluid to be treated is blood, reservoir 3 measures 74.4×54.4 mm. Given that the inner thickness is 2.5 mm, these dimensions correspond to a total volume of about 10 ml.

[0063] Said container 1 also comprises a first access port 8 for fluids to said reservoir 3 from the outside of said body 2, and a second access port 9 for fluids to said reservoir 3 from the outside of said body 2. For the examples of the drawings, said first access port 8 and said second access port 9 each comprises a tube 17 extending from said body 2 and forming an access opening 18 communicating the outside of said body 2 with said reservoir 3. Said tubes 17 are provided in the upper portion of said body 2 at one of the ends thereof. Additionally, in the examples of the drawings the end of each of said tubes 17 is provided with engagement means 19 configured for taking in and fixing a syringe.

[0064] On the other hand, the container 1 of FIG. 1 also comprises first closure means 10 for said first port 8 and second closure means 11 for said second port 9. Both closure means 10 and 11 comprise removable plugs configured for being inserted into their corresponding openings 18 of the ports 8 and 9, and jointly providing a gas and liquid tight seal for said reservoir 3.

[0065] Other embodiments of the container 1 according to the invention sharing a large part of the features described in the preceding paragraphs are shown below. Accordingly, only the differentiating elements will be described hereinafter, whereas reference is made to the description of the first embodiment for common elements.

[0066] FIGS. 2 to 8 show another embodiment of the container 1 in which said side wall 4, said upper wall 5, and said lower wall 6 are formed in said body 2. In particular, in FIGS. 3, 4, and 5 it can be observed that said body 2 comprises an upper part 12 in which said upper wall 5 is formed, and a lower part 13 in which said lower wall 6 is formed. Said upper part 12 and said lower part 13 are attached in ribs 14 forming said side wall 4 of said reservoir 3. The upper part 12 is depicted separately in FIGS. 4A and 4B, whereas the lower part 13 is depicted separately in FIG. 5. The body 2 resulting from the attachment of both parts 12 and 13 is shown in a perspective view in FIG. 3, and by means of section views in FIGS. 7 and 8. To manufacture the container 1 of the example, the attachment between said ribs 14 is done by means of ultrasonic welding.

[0067] It can be observed in FIGS. 4A and 4B how the access ports 8 and 9 each comprises a tube 17 with an opening 18 going through the upper wall 5 and communicating with channels 20 that in turn connect with the inside of said reservoir 3. Said channels 20 can also be clearly observed in FIG. 5 and FIG. 7.

[0068] For the embodiment, both the upper wall 5 and the lower wall 6 each has a window region 7. In turn, these window regions 7 extend almost entirely throughout each respective wall 5 and 6. For manufacturing reasons, a small margin may actually exist between the side wall 4 and the window region 7. This can be seen in the cross-section view shown in FIG. 7. Therefore, when “almost entirely” is used herein, it will be understood that there will be no more than 10% difference between the surface of the window region 7 and the surface of its corresponding wall 8 or 9.

[0069] On the other hand, the container 1 of this embodiment further comprises an identification region 16 configured for receiving a label, said identification region 16 not overlapping said window regions 7. During the manufacturing of the body 2, a textured region is created on the entire surface of said body 2, except in the window regions 7, and optionally also except in the identification region 16. Said textured region improves gripping and allows differentiating and providing different characteristics to the different regions of the body 2, even if the latter is manufactured in a single material, like in the case of the example.

[0070] As can be observed in the drawings, said identification region 16 is provided in the upper portion of said body 2, close to one of the ends of said body 2, in particular at the end opposite where the access ports 8 and 9 to the reservoir 3 are located.

[0071] In the example shown in FIGS. 2A, 2B, and 6, it can be seen how the container 1 further comprises a casing 15 made of elastomer which, for this example, is a medical grade silicone. The skilled person will understand that the definition of medical grade silicone depends on the particular regulations of each territory, and that these regulations may also change over time. In this example, both closure means 10 and 11 are formed in said casing 15 in the form of removable plugs.

[0072] In other embodiments, the container is intended for other biological fluids with a higher viscosity than blood, so the inner thickness of said reservoir 3 is greater than 2.5 mm, but less than 5 mm, in the case of using the same regions of the electromagnetic spectrum.

[0073] Still in other embodiments, the container is intended for other biological fluids with a lower viscosity than blood, so the inner thickness of said reservoir is less than 2.5 mm, where it can even be less than 1 mm for fluids of very low viscosity.

[0074] For some embodiments, said container 1 further comprises a sealed packaging containing said body 2 and in which said container 1 is sterilized.

[0075] The embodiments described up until now represent non-limiting examples, such that one skilled in the art will understand that, beyond the shown examples, multiple combinations between the claimed features are possible within the scope of the invention.