Assembly for medical use for administering a product to a patient

Abstract

The present invention relates to an assembly for medical use for administering a product to a patient, the assembly comprising a tube and a connector designed to be attached to an end of the tube, characterized in that the connector comprises an appendage designed to be inserted into the tube, the dimensions of the appendage being adapted to the dimensions of the tube in such a way as to exert a set of forces tending to dilate the tube, and a skirt surrounding the appendage in order to define a groove for receiving the tube between the appendage and the skirt, the dimensions of the skirt being provided in such a way as to exert a set of forces tending to compress the tube.

Claims

1. An assembly for medical use for administering a product to a patient, the assembly comprising a tube and a connector designed to be attached to an end of the tube, the tube having an internal diameter and an external diameter, the connector having a body and an interface zone designed to be attached to an end of the tube at one of the ends of the body, wherein the interface zone comprises: an appendage having an external diameter and designed to be inserted into the tube, dimensions of the appendage being adapted to dimensions of the tube, the external diameter of the appendage-being greater than the internal diameter of the tube at its end nearest the body, in such a way as to exert a set of forces tending to dilate the tube, and a skirt having an internal diameter and surrounding the appendage in order to define a groove for receiving the tube between the appendage and the skirt, the skirt having an inner face opposite the appendage, said inner face frustoconical, the internal diameter of the skirt being less than the external diameter of the tube at an end of the skirt nearest the body, in such a way as to exert a set of forces tending to compress the tube, and the internal diameter of the skirt increasing from the end of the skirt nearest the body in a direction of a free end of the skirt.

2. The assembly as claimed in claim 1, wherein the connector additionally comprises a head for attaching said connector to another connector, and a substantially cylindrical axial channel between the appendage and the head.

3. The assembly as claimed in claim 1, wherein the appendage comprises a frustoconical outer face opposite the skirt, the diameter of the outer face of the appendage decreasing in the direction of its free end.

4. The assembly as claimed in claim 1, wherein the connector is molded in one piece.

5. The assembly as claimed in claim 1, wherein the appendage comprises a breakable portion extending along a longitudinal axis at the free end of the appendage, said breakable portion having at least one wing extending outwardly perpendicular to the longitudinal axis, said wing having the shape of a portion of a sphere.

6. The assembly as claimed in claim 5, wherein the breakable portion comprises four wings extending outwardly perpendicular to the longitudinal axis of the breakable portion, said wings having the shape of a portion of a sphere.

7. The assembly as claimed in claim 1, wherein the connector is made of polycarbonate.

8. The assembly as claimed in claim 1, wherein the skirt is made of a transparent or translucent material.

9. The assembly as claimed in claim 1, wherein the skirt-additionally comprises ribs on its outer face.

10. The assembly as claimed in claim 1, wherein the outer face of the appendage comprises at least one bead extending toward the outside.

11. The assembly as claimed in claim 1, wherein the connector additionally comprises another appendage designed to be inserted into another tube, and another skirt surrounding the other appendage, the dimensions of the other appendage being provided to exert a set of forces tending to dilate the other tube, and the dimensions of the other skirt being provided to exert a set of forces tending to compress the other tube.

12. The assembly as claimed in claim 1, which assembly additionally comprises a flexible bag containing the product to be administered, said bag being connected to another end of the tube.

13. The assembly as claimed in claim 1, wherein the groove has a V-shaped cross section such that, once inserted into the groove, the interface zone subjects the tube to sets of radial forces in opposite directions tending to crush the tube in thickness.

Description

PRESENTATION OF THE FIGURES

(1) Other features and advantages of the invention will become clear from the following description which is purely illustrative and non-limiting and which must be read with reference to the accompanying drawings, in which:

(2) FIG. 1 shows an example of an assembly for medical use according to the invention,

(3) FIGS. 2 and 3 are a perspective view and a sectional view, respectively, showing an example of a connector of the assembly for medical use.

DESCRIPTION OF EMBODIMENTS OF THE INVENTION

(4) The invention will now be described in more detail with reference to the figures. In these figures, elements that are equivalent are designated by the same reference numbers.

(5) Assembly for Medical Use

(6) Referring to FIG. 1, this shows an example of an assembly for medical use comprising a bag 1, a tube 2 and a connector 3.

(7) The medical bag 1 has two superposed leaves of suitable length and width which are composed of several stratified thin film layers made of flexible or pliable materials, optionally transparent or translucent, for example the polymer materials comprising polyethylene and polypropylene, and preferably thermoplastic materials.

(8) The proximal end 21 of the tube 2 is connected to the upper part of the bag 1. This tube 2 is sealed between the superposed films. The distal end 22 of the tube 2 is attached to the connector 3 for coupling the bag 1 to a fluid transfer kit connected to the patient.

(9) Connector

(10) The connector 3 is shown in FIGS. 2 and 3.

(11) It comprises a substantially cylindrical body 31, a locking zone 32 at one of the ends of the body 31, and a tube interface zone 33 at the other end of the body 31.

(12) An axial passage is formed in the body 31 and the zones 32, 33 such that the liquid to be administered is able to flow through the connector 3.

(13) The connector 3 is preferably made of polycarbonate. The inner (or internal) part of the tube is preferably a layer of ethylene-vinyl acetate (or EVA). The use of such materials makes it possible to increase the adherence between the connector 3 and the tube 2 after their sterilization, once they have been joined together to form the assembly for medical use.

(14) Locking Zone

(15) The locking zone 32 of the connector 3 has a head for coupling the assembly for medical use to a transfer kit connected to the patient.

(16) This head includes, for example, an endpiece 321 designed to engage in a head of another connector and/or a collar (not shown) designed to retain the head of another connector.

(17) The endpiece 321 and/or the collar can comprise radially extending teeth 322 or a thread for snap-fitting them or screwing them onto the head of the other connector.

(18) A cap can be provided in order to cover the head of the connector before the latter is coupled to another connector. In this way, it is possible to avoid the risks of bacterial contamination of the assembly for medical use.

(19) The material from which the cap is made is preferably chosen in such a way as to limit the adherence between the cap and the head, even after their sterilization.

(20) Interface Zone

(21) The interface zone is composed of: an appendage 331 designed to be inserted into the end of the tube 2 of the assembly for medical use, and a skirt 332 which surrounds the appendage 331 and into which the end of the tube is designed to be inserted.
Appendage

(22) The appendage 331 is of frustoconical shape so as to permit its engagement by friction in the tube 2. The external diameter of the appendage 331 is adapted to the internal diameter of the tube 2.

(23) More precisely: at its end farthest from the body, the external diameter of the appendage 331 is slightly smaller than or equal to the internal diameter of the tube 2, which makes it easier to insert the appendage 331 into the tube 2, at its end nearest the body, the external diameter of the appendage 331 is slightly greater than the internal diameter of the tube 2; thus, when the appendage 331 is engaged in the tube 2, it subjects the tube 2 to a set of forces tending to dilate the tube 2.

(24) The connector 3 can comprise a breakable portion 333 at the end of the appendage 331 opposite the body 31 of the connector 3. The breakable portion 333 comprises at least one wing 334 shaped as a portion of a sphere and extending radially outward.

(25) The breakable portion 333 preferably comprises four wings 334: extending radially outward, shaped as a portion of a sphere, and offset by 90 with respect to one another in order to form a ball.

(26) This ball shape of the wings 334 makes it possible to avoid the risks of injury to a user when the assembly for medical use is being manipulated in order to separate the breakable portion from the connector. Moreover, the ball shape makes it possible to avoid the retention of microbubbles. Finally, the ball shape makes it possible to avoid the risk of perforation of the tube 2 when the assembly for medical use is being manipulated in order to separate the breakable portion 333 from the connector 3.

(27) Skirt

(28) The skirt 332 extends at the periphery of the appendage 331 in such a way as to surround the latter, the inner face of the skirt 332 facing the outer face of the appendage 331.

(29) The dimensions of the skirt 332 are adapted to avoid any spreading, in particular inflation, of the tube 2 in the event of an increase of the pressure inside the latter.

(30) The skirt 332 is of frustoconical shape in order to allow the tube 2 to be engaged by friction in the skirt 332. The internal diameter of the skirt 332 is adapted to the external diameter of the tube 2.

(31) More precisely: at its end farthest from the body, and over a very short distance, that is to say less than 10% of the depth of the groove, the internal diameter of the skirt 332 is greater than or equal to the external diameter of the tube 2; at its end nearest the body, the internal diameter of the skirt 332 is slightly less than the external diameter of the tube 2.

(32) Thus, when the tube 2 is engaged in the skirt 332, the skirt 332 subjects the tube 2 to a set of forces tending to compress the tube 2.

(33) The outer face of the skirt 332 can comprise ribs 335 extending radially outward in order to make it easier to grip, especially when screwing/unscrewing a cap mounted on the tube interface zone prior to its being joined to the tube in order to form the assembly for medical use.

(34) The skirt 332 is preferably transparent or translucent so as to make it possible to visually check the quality of the attachment between the connector 3 and the tube 2. In particular, the fact that the skirt 332 is transparent or translucent makes it possible to check that the tube 2 is correctly inserted as far as the bottom of the volume defined by the appendage 331 and the skirt 332.

(35) Combination of Appendage and Skirt

(36) It will thus be appreciated that the appendage 331 and the skirt 332 form a groove for receiving the tube 2.

(37) This groove preferably has a V-shaped cross section such that, once inserted into the receiving groove, the tube interface zone subjects the tube 2 to sets of radial forces in opposite directions tending to crush the tube 2 in its thickness, so as to avoid any risk of the product to be administered leaking at the interface between the tube 2 and the connector 3.

(38) The table below gives examples of values: for the external diameter (D.ext) of the skirt 332, and the internal diameter of the skirt 332 at its end farthest (D.int1) from the body 31 and at its end nearest (D.int2) to the body 31, for the external diameter of the appendage 331 at its end farthest (d.ext1) from the body 31 and at its end nearest (d.ext2) to the body 31, the total length L1 of the connector 3, the length L2-L3 of the tube interface zone of the connector 3, and the length L3 of the locking zone of the connector 3.

(39) TABLE-US-00001 Dimensions Ranges of values (in mm) D.ext 10 to 12, preferably 10.5 to 10.7 (still more preferably 10.6) d.ext1 6.35 to 6.45 (preferably 6.40) d.ext2 6.45 to 6.55 (preferably 6.50) D.int1 8.75 to 8.85 (preferably 8.80) D.int2 8.69 to 8.79 (preferably 8.74) L1 30 to 40 (preferably 36.5) L2 15 to 25 (preferably 20) L3 7 to 10 (preferably 8.5) L2-L3 Greater than 9 mm (preferably 10)

(40) These dimensions allow a person skilled in the art to produce an example of a connector that can be used to solve the technical problem addressed by the invention.

(41) The length L2-L3 defines the zone of adhesion between the tube and the connector. The difference between the diameters D.ext and D.int of the skirt makes it possible to define an example of the skirt thickness sufficient to avoid the inflation of the tube in the event of an increase in the pressure inside the tube. The relations between the other dimensions defined in the table above permit the industrial production of the connector and also the automatic assembling of the assembly for medical use. For example, the dimensions D.int1, D.int2 and d.ext1, d.ext2 make it possible to define frustoconical appendages and skirts. When the connector is produced in a mold, the fact that the skirt and/or the appendage are frustoconical makes it easier to remove the connector from the mold.

(42) Thus, the invention proposes an assembly for medical use which allows a liquid product or viscous product to be administered to a patient without risk of leaking, even when the pressure inside the assembly is considerable.

(43) This assembly can be used to administer different types of product, irrespective of the type of injector used to administer said product.

(44) The reader will appreciate that numerous modifications may be made without departing materially from the novel teaching and the advantages described here.

(45) Therefore, all modifications of this kind are intended to be incorporated within the scope of the accompanying claims.