EP2825246A1

EP2825246A1 - Secure assembly for transferring liquid for medical use

Info

Publication number: EP2825246A1
Application number: EP13709920.6A
Authority: EP
Inventors: François CAPITAINE; Frédéric Bonnet
Original assignee: Technoflex SA
Current assignee: Technoflex SA
Priority date: 2012-03-16
Filing date: 2013-03-18
Publication date: 2015-01-21
Also published as: US20130245611A1; FR2988006A1; US9149622B2; WO2013135905A1; FR2988006B1; US20150320992A1

Abstract

The invention concerns an assembly for transferring liquid for medical use comprising a male Luer connector (10) and a female Luer connector (11), said female Luer connector (11) comprising a main body comprising an inner channel (15) for liquid to pass through and a collar (12) surrounding the end of said body, the male connector comprising a main body comprising an interior longitudinal opening (19, 21). According to the invention, the main body of the female connector comprises, on the outer surface thereof, a first thread (16) placed at least partly facing an inner surface of the collar (12), - one of the ends of the main body of the male Luer connector (10) comprises, on part of the inner surface thereof, delimiting said interior longitudinal opening (19, 21), a second thread (20) intended to engage with said first thread (16) to ensure the coupling of the male and female Luer connectors, - at least the outer surface of the male Luer connector (10) comprising said second thread (20) forms a male conical portion (24) and the inner surface of the collar (12) forms a female conical mating surface (13) such that said outer surface rests against the female conical mating surface (13) of said collar (12) to ensure a sealed assembly when the male and female Luer connectors are coupled.

Description

Secure set of liquid transfer for medical use

BACKGROUND OF THE INVENTION

Field of the invention

The present invention relates to the field of luer fittings and in particular a secure set of transfer solutions for medical use. Technological background

It is known to use luer connectors for connecting medical devices to each other for the purpose of transferring a medical solution, for example, from a first container to a human body conduit.

Figures 1 and 2 show male and female Luer connectors of the state of the art. A male luer connector 1 thus comprises a collar 2 surrounding at least a portion of a male conical portion 3 whose outer surface abuts against the female conical connecting surface of the female luer connector 4 during the assembly of these connectors. Male luer 1 and female 4.

The collar 2 of the male luer connector 3 has an internal thread 5 while the female luer connector 4 has at its end the widest of the lugs 6 intended to cooperate with the internal thread 5 of the collar 2 of the male luer connector 1 in view of their assembly.

The assembly of the two Luer connectors 1, 4 is obtained simply by application by the operator of a tightening torque. The application of this tightening torque, or twisting movement, thus causes for example a rotational movement of the female luer connector 4 around the internal thread 5 of the collar 2 of the male connector.

The luer connectors 1, 4 thus engaged and engaged are secured to each other, which prevents any inadvertent separation and contamination. of these Luer fittings, as defined by ISO 594-2 (International Organization for Standardization).

This latter standard also defines precise dimensions for each of these luer fittings.

Although these luer fittings 1, 4 are easy to use, there have been cases of operator manipulation error when coupling a large number of luer fittings.

In particular, during the necessary manipulations in apheresis, there is a risk of inversion of two lines, for example of anticoagulant and physiological saline, when they are equipped with identical Luer connectors.

There is therefore an urgent need to find other connectors separate connectors of the state of the art so as to avoid handling errors that could lead to risks to the health of patients.

Furthermore, the liquid transfer systems to avoid bad connections, known from the state of the art, are generally complex structures resulting from the assembly of a large number of initially separate parts. The assembly of these systems is therefore long and these transfer systems are expensive.

The present invention aims to overcome this drawback by proposing a liquid transfer system for medical use particularly simple in its design and in its operating mode, aseptic and economic, allowing a fully secure connection of male and female Luer connectors.

BRIEF DESCRIPTION OF THE INVENTION

To this end, the invention relates to a medical liquid transfer assembly comprising a male luer connector and a female luer connector, said female luer connector comprising a main body having an inner channel for the passage of said liquid and a surrounding collar to at least one end of said main body, said male connector comprising a main body having an inner longitudinal opening.

According to the invention,

the main body of said female connector comprises on at least a portion of the outer surface of its part surrounded by said collar, a first threading at least partially facing an inner surface of said collar,

one of the ends of the main body of said male Luer connector has on at least a portion of its inner surface delimiting said inner longitudinal opening, a second thread intended to engage and cooperate with said first thread to assemble the male Luer connectors. and female,

at least the outer surface of said end of said male luer connector including said second thread forms a conical portion of male revolution and said inside surface of the collar of said female connector forms a conical connecting surface of female revolution so that the outer surface of said male conical portion abuts against the female conical connecting surface of the collar of said female luer connector to provide a tight assembly when assembling said male and female luer connectors.

The disengagement of the male and female Luer connectors is thus obtained by applying a loosening torque.

The locking system formed by the first and second helical threads of the male and female Luer connectors is therefore placed between the liquid passage zone and the sealing zone of the liquid transfer assembly, formed by the contact of the male conical portion and female conical connecting surface. This locking system plays a role of stress dissipator so as to reduce the pressure exerted on the sealing zone during the transfer of liquid so as to preserve the latter and thus prevent any contamination or leakage.

In order to reinforce the tight assembly of the male and female Luer connectors, the collar of the female Luer connector may be lengthened to have a larger female conical connecting surface while the outer surface of the male cone portion is also increased by an elongation of this male conical portion.

In various particular embodiments of this system, each having its particular advantages and capable of many possible technical combinations:

at least one of the male and female Luer connectors is made in one piece of plastic material, the male luer connector comprises a collar, or skirt, surrounding at least in part the conical portion of male revolution so as to protect said male conical portion.

Advantageously, thus prevents the risk of scratching on this conical male portion and external contamination during storage of this luer connector.

Of course, the internal diameter of this collar is such that the collar of the female Luer connector can be received in this collar surrounding the male conical portion when assembling male and female Luer connectors.

the diameter of the inner longitudinal opening of said male luer connector taken at the base of said second thread is equal to + 0.2 mm near the diameter of the main body of said female luer connector considered between its external thread,

Advantageously, it will provide a game in the first part of the assembly of male and female Luer connectors so that the screwing is facilitated for the operator but this game will be reduced at the end of screwing to avoid possible translation. On part of the threads corresponding to the end of the assembly of male and female Luer connectors, there may be a force assembly of these connectors.

said male luer connector, and / or female luer connector, has an inner wall placed in its inner longitudinal opening, respectively and / or its inner channel, said inner wall comprising an orifice for the passage of the liquid.

Preferably, said male luer connector having an inner wall comprising an orifice in its inner longitudinal opening, said orifice comprises a frustoconical portion placed on the end side of the inner longitudinal opening comprising said second thread so as to provide guiding of the liquid flowing in the inner channel of the end of the main body of said female luer connector when this end is placed near the orifice of said inner wall.

the collar of the female luer connector is movable in rotation or not around said female conical connection,

at least one of said male and female Luer connectors has an end guaranteeing the seal connected breakably or not to said main body. This end is purely illustrative, a shutter member breakable to ensure its asepsis.

The invention also relates to a male luer connector for use in the liquid transfer assembly for medical use as described above.

According to the invention, this connector comprises

a main body having an inner longitudinal opening,

one of the ends of said main body having on at least a portion of its inner surface delimiting said longitudinal inner opening a thread intended to engage and cooperate with said thread of a female Luer connector to ensure the assembly of the male and female luer connectors; female,

at least the outer surface of said end of said male luer connector comprising said thread forming a tapered portion of male revolution intended to abut against the female revolution conical connection surface of the female Luer connector collar during assembly of said Male and female luer connectors.

The opposite end of the male connector to that forming a tapered portion of male revolution, may include gripping elements on its outer surface to facilitate its handling.

The invention also relates to a female luer connector for use in the liquid transfer assembly for medical use as described above.

According to the invention, this female luer connector comprises:

a main body comprising an internal channel for the passage of said liquid and a collar surrounding at least one end of said main body,

the main body of said female luer connector has on at least a portion of the outer surface of its portion surrounded by said collar, a first thread placed at least partly facing an inner surface of said collar,

said inner surface of the collar of said female connector forming a female revolution conical connecting surface so that the outer surface of said conical portion of male revolution of a male Luer connector abuts against said female conical connecting surface when assembling said male and female luer connectors. Advantageously, the portion of the main body of said female luer connector surrounded by the collar comprises at least one opening opening laterally by providing a fluid communication between the inner channel and the space between the inner surface of said collar and the outer surface of said portion. in order to limit any loss of liquid during its transfer.

The invention also relates to a medical device comprising at least one container containing a liquid for medical use equipped with a liquid transfer assembly for medical use as described above.

This container may be for illustrative purposes only a flexible pouch or a bottle.

The invention finally relates to a medical device comprising a syringe equipped with a male Luer connector or a female Luer connector as described above.

BRIEF DESCRIPTION OF THE DRAWINGS

Other advantages, aims and particular features of the present invention will emerge from the description which follows, for an explanatory and non-limiting purpose, with reference to the appended drawings, in which:

FIG. 1 is a view of a male Luer connector / female Luer connector assembly according to an embodiment of the prior art;

FIG. 2 is a partial sectional view of the male luer connector of the

Fig. 1,

FIG. 3 is a profile view of a liquid transfer assembly for medical use comprising a male Luer connector and a female Luer connector, according to a first embodiment of the invention,

FIG. 4 is a partial view in longitudinal section of the liquid transfer assembly of FIG. 3;

FIG. 5 shows a profile view of the female luer connector of the liquid transfer assembly of FIG. 3,

FIG. 6 shows a profile view of the male luer connector of the liquid transfer assembly of FIG. 3,

FIG. 7 is a partial sectional view of a liquid transfer assembly for medical use comprising a male Luer connector and a female luer connector, according to a second embodiment of the invention,

FIG. 8 shows a profile view of the female luer connector of the liquid transfer assembly of FIG. 7,

FIG. 9 shows a profile view of the male luer connector of the liquid transfer assembly of FIG. 7,

FIG. 10 shows a partial view of a liquid transfer assembly for medical use comprising a male Luer connector and a female Luer connector, according to a third embodiment of the invention,

FIG. 11 shows a partial view of a liquid transfer assembly for medical use comprising a male Luer connector and a female Luer connector, according to a fourth embodiment of the invention,

FIG. 12 shows partial and sectional views showing unsuccessful assembly attempts between a male or female Luer connector of FIGS. 3 to 6 and a connector of the prior art, in particular:

FIG. 12a) shows a male luer connector of FIG. 6 and a female connector of the state of the art,

FIG. 12b) shows a male luer connector of FIG. 6 and a male connector of the state of the art,

FIG. 12c) shows the female luer connector of FIG. 5 and a male connector of the state of the art,

FIG. 12d) shows the female Luer connector of FIG. 5 and a female connector of the state of the art,

FIG. 12e) shows a male Luer connector of FIG. 6 and an ISO 594-1 Slip-fit fit Luer of the state of the art,

FIG. 12f) shows a female luer connector of FIG. 5 and an ISO 594-1 Slip Fit Luer fitting of the state of the art.

DETAILED DESCRIPTION OF EMBODIMENTS OF

THE INVENTION

It should first be noted that the figures are not to scale. Figures 3 to 6 are schematic representations of a liquid transfer assembly for medical use according to a preferred embodiment of the invention.

This transfer assembly comprises a male Luer connector 10 and a female Luer connector 1 1 intended to be assembled by application of a tightening torque, in order to ensure the transfer of a liquid.

The female luer connector 11 comprises a fixed collar or skirt 12 having an inner surface 13 and an outer surface. While the outer surface of this collar 12 is cylindrical, its inner surface 13 has a conical surface of revolution, which is smooth. This inner surface 13 thus forms a taper cone of conicity equal to 6%, this surface being called female conical connecting surface.

This collar 12 surrounds one end of a main body 14 of the female luer connector 11. This main body 14 has an inner channel 15 for the passage of the liquid.

This inner channel 15 has a diameter greater than or equal to the diameter of the inner channel of the male conical portion of the male Luer connector defined by the ISO 594-2 standard. Thus, the female luer connector 1 1 has a flow of medical solution at least equal to the luer connectors of the prior art. However, the diameter of the inner channel 15 is such that it is not possible to insert a male conical portion of a male luer connector defined by the ISO 594-2 standard.

This main body 14 also has on the outer surface of its end surrounded by the collar 12, a first thread 16 placed vis-à-vis the inner surface 13 of the collar 12.

Alternatively, the end of the main body 14 could be placed projecting from the collar 12, a portion of the first thread 16 being placed facing the inner surface 13 of the collar 12 while another portion of this threading would be placed in a projection of necklace 12.

This first thread 16 is a helix of constant pitch which is defined by the ISO 594-2 standard having a trapezoidal profile which offers good resistance to tearing.

The diameter of the main body 14 of said female Luer connector 1 1 considered between its external thread is advantageously too large to can be inserted by mistake into the inner channel of a female Luer connector defined by ISO 594-2.

The main body 14 of the female Luer connector 1 1 has at its end opposite to that surrounded by the collar 1 2, a conical profile so as to be inserted into a conduit for example in a tubing (not shown). This tapered end of the main body 14 of the female luer connector 11 may alternatively be connected in a breakable manner to the collar 12.

The end of the inner channel 1 5 placed at the frustoconical end of the main body 14 of the female Luer connector 1 1 is here advantageously closed by a shutter member 1 7 breakable.

The male Luer connector 1 0 comprises a main body January 8 having an inner longitudinal opening. This inner longitudinal opening defines a first connection zone January 9 having a second threading 20 intended to engage and cooperate with the first threading 1 6 of the female Luer connector 1 1 to ensure the assembly of male and female Luer connectors, and a second connection zone 21 intended to receive a tube. The latter may for example be assembled to the wall of the main body 1 8 of the male Luer connector 1 0 defining the second zone 21 of connection by bonding by means of a solvent.

These two zones 19, 21 of connection are separated by a wall having an orifice 22 ensuring fluid communication therebetween. This wall also constitutes a stop for the insertion of the tube into the second zone 21 of connection.

Advantageously, the orifice 22 of this wall has a flared portion 23 on the side of the connecting zone 1 9 so that the male and female Luer connectors are assembled and one end of the inner channel of the main body 14 of the female Luer connector 1 1 being placed near this orifice 22, the liquid leaving the internal channel 1 5 is guided towards the second zone 21 of connection of the male Luer connector 1 0 without seeing the second threading 20.

It should be noted that the internal diameter of the connection zone January 9 considered between the vertices of two threads placed opposite is such that it does not allow the position of the conical male portion of a connector to be maintained in position. male Luer defined by the ISO 594-2 standard which would have been inserted in the connection zone 19 inadvertently during the assembly of male and female Luer connectors.

The end of the main body 18 of the male luer connector 10 having the connecting zone 19 has an outer surface 24 having a conical profile of 6% conicity.

This conical portion 24 of male revolution comes to bear against the conical connecting surface 13 of female revolution of the collar 12 of the female Luer connector 1 1 during the assembly of said male and female luer connectors 10, 1 1 to ensure the sealing of this assembly.

Furthermore, the main body of the male luer connector 10 has gripping elements 25 on its outer surface to facilitate its handling and a flange 36 placed at the non-free end of the male conical portion 24. This flange 36 which delimits the end of the male conical portion 24 allows the prevention of contamination of this conical portion with the plug.

The male 10 and female 1 1 Luer connectors are here in one piece and obtained by injection molding a medically inert thermoplastic material. They may, for illustrative purposes, be made of polycarbonate, polystyrene, acrylonitrile butadiene styrene (ABS) or in PC-ABS copolymers, polyolefin (such as polyethylene, polypropylene, a polypropylene homopolymer or copolymer) ) or polyolefin comprising a thermoplastic elastomer (TPE) such as SEB (block copolymer Styrene, Ethylene, Butylene), SEBS

(Styrene block copolymer, ethylene, butylene, styrene) or cyclopolyolefin ...

The liquid transfer assembly of the present invention is therefore particularly economical to produce and does not result from an assembly of several elements that would make its structure complex.

Advantageously, an operator having to connect several pairs of connectors can not mistakenly connect a female Luer connector, respectively male, of the state of the art with the male or female Luer connector of the invention.

Figures 7 to 9 are diagrammatic representations of a liquid transfer assembly for medical use according to another embodiment of embodiment of the invention. The elements of FIGS. 7 to 9 bearing the same references as the elements of FIGS. 3 to 6 represent the same objects, which will not be described again below.

The liquid transfer assembly of FIG. 7 differs from that described above in that the end of the main body 26 of the female luer connector 11 surrounded by the collar 12 is formed of two semi-cylindrical parts 27, 28 spaced apart and parallel to each other.

Each of these portions 27, 28 has on its rounded outer surface a helical thread portion 29, the threads on the outer surface of one of the parts continuing on the outer surface of the other half-cylindrical portion so as to form a semi-continuous thread adapted to cooperate with the thread 20 placed on the inner surface of the main body 18 of the male luer connector 1 0 for the purpose of assembling these male and female luer connectors.

In addition, following the assembly of the male and female Luer connectors, the cylindrical inner surface of the connection zone 1 9 of the male Luer connector, comprising the second threading 20, surrounds the two half-cylindrical portions 27, 28 on the least part of their longitudinal extension.

The assembly formed on the one hand by the parts of the inner surface of the connection zone 1 9 between the two half-cylindrical parts 27, 28 spaced apart from each other, and on the other hand, the surfaces planes 30, 31 opposite the two half-cylindrical parts, thus defines a channel for the circulation of the liquid. This liquid is then guided to the second zone 21 for connecting the longitudinal inner opening of the male luer connector 1 0.

The channel thus formed by the assembly of the male and female Luer connectors is in fluid communication with a chamber 32 formed at the base of these two half-cylindrical parts 27, 28, this chamber 32 itself being in fluid communication. on the one hand, with an internal channel 1 5 of the female Luer connector 1 1 for the passage of the liquid, this inner channel 15 being placed at the other end of the female Luer connector 1 1 and on the other hand, with the base 33 of the collar 1 2 connected to the main body 14 of the female luer connector 1 1. Thus, it ensures the recovery of flows that can occur along the threads between the inner cylindrical surfaces of the connection area of the male Luer connector and rounded outer of the two half-cylindrical parts. It is therefore ensured of the minimization of any loss of liquid to be transferred and possible stagnation of liquid.

Figure 10 shows a partial view of a liquid transfer assembly for medical use according to a third embodiment of the invention. The liquid transfer assembly of FIG. 10 differs from that described in FIGS. 3 to 6 in that the male luer connector 10 having an internal wall comprising an orifice 22 in its inner longitudinal opening, said orifice 22 comprises a frustoconical portion 23. placed on the side of the end of the inner longitudinal opening comprising said second thread 20, and the end of the main body of the female luer connector 1 1 is conical 34 so that said end being placed near the orifice 22, 23 of said inner wall, the fluid is guided through the orifice. Advantageously, no fluid retention is observed with this fluid guide assembly.

However, these tapered portions 23, 34 are not in contact with each other to avoid double centering.

FIG. 11 shows a partial view of a liquid transfer assembly for medical use according to a fourth embodiment of the invention. The liquid transfer assembly of FIG. 11 differs from that described in FIGS. 3 to 6 in that the male luer connector 10 having an internal wall comprising an orifice 22 in its inner longitudinal opening, said orifice comprises a protruding portion. 35 of said wall being placed on the side of the end of the inner longitudinal opening having said second thread 20. This projection portion 35 which is here by way of example a tube portion, has an outside diameter less than the diameter. the inner channel 15 of the main body of said female luer connector 1 1 so as to be received in this inner channel 15 during assembly of said male and female luer connectors 1 1 to guide the fluid through said orifice 22. This projecting portion 35 and the wall of the main body of the female luer connector delimiting the inner channel 15 are not in contact with each other to avoid double centering.

Claims

1. A medical liquid transfer assembly having a male luer connector (10) and a female luer connector (1 1), said female luer connector (1 1) comprising a main body (14) having an inner channel (15) for the passage of said liquid and a collar (12) at least partially surrounding one end of said main body, said male luer connector (10) comprising a main body (18) having an inner longitudinal opening (19, 21), characterized in that

- the main body (14) of said female connector comprises on at least a portion of the outer surface of its portion surrounded by said collar (12), a first thread (16) placed at least partly facing an inner surface of said collar (12),

one end of the main body (18) of said male luer connector

(10) comprises on at least a portion of its inner surface delimiting said inner longitudinal opening (19, 21), a second thread (20) intended to engage and cooperate with said first thread (16) to ensure the assembly of male and female luer connectors,

at least the outer surface of said end of said male luer connector (10) having said second thread (20) forms a conical portion (24) of male revolution and said inner surface of the collar (12) of said female connector forms a connecting surface (13) female revolution cone so that the outer surface of said male conical portion (24) abuts against the female conical connecting surface of the collar (12) of said female luer connector (1 1) to provide a sealed assembly when assembling said male and female luer connectors.

2. An assembly according to claim 1, characterized in that at least one of said male Luer connectors (10) and female (1 1) is made of a single piece of plastic.

3. An assembly according to claim 1 or 2, characterized in that said male Luer connector (10), and / or female Luer connector (1 1), has an inner wall placed in its inner longitudinal opening (19, 21), respectively and / or its inner channel (15), said inner wall comprising an orifice for the passage of the liquid.

4. The assembly of claim 3, characterized in that said male luer connector (10) having an inner wall comprising an orifice in its inner longitudinal opening (19, 21), said orifice comprises a frustoconical portion placed on the end side. the inner longitudinal opening (19, 21) having said second thread (20) and that the end of the main body of said female luer connector (1 1) is conical so that said end is placed close to the orifice of said inner wall, the fluid is guided through the orifice.

5. The assembly of claim 3, characterized in that said male luer connector (10) having an inner wall comprising an orifice in its inner longitudinal opening (19, 21), said orifice comprises a portion projecting from said wall being placed on the side of the end of the inner longitudinal opening (19, 21) having said second thread (20), said protruding portion having an outer diameter smaller than the diameter of the inner channel (15) of the main body of said female luer connector ( 1 1) so as to be received in this inner channel (15) during the assembly of said male and female Luer connectors to guide the fluid through said orifice.

6. An assembly according to any one of claims 1 to 5, characterized in that the inner channel (15) of said female luer connector (1 1) has a diameter at least equal to the diameter of the inner channel (15) of the portion ( 24) male conical male luer connector (10) defined by ISO 594-2.

7. Male luer connector (10) for use in the medical fluid transfer assembly of any one of claims 1 to 6, characterized in that it comprises

a main body having an inner longitudinal opening (19, 21),

one of the ends of said main body having on at least a portion of its inner surface delimiting said inner longitudinal opening (19, 21) a thread intended to engage and cooperate with said thread of a female luer connector (1 1) for assemble the male and female Luer connectors,

at least the outer surface of said end of said male luer connector (10) comprising said thread forming a conical portion (24) of male revolution intended to abut against the conical connecting surface (13) of female revolution of the collar (12) of the female Luer connector (1 1) during assembly of said male and female Luer connectors.

8. The connector of claim 7, characterized in that the opposite end of the male connector to that forming a portion (24) conical male revolution, has gripping elements on its outer surface.

9. Connector according to claim 7 or 8, characterized in that it comprises a collar forming a stop for the collar (12) of said connector.

Female luer (1 1).

10. Female luer connector (1 1) for use in the medical fluid transfer assembly according to any one of claims 1 to 6, characterized in that said female Luer connector (1 1) comprises:

a main body comprising an internal channel (15) for the passage of said liquid and a collar (12) surrounding at least one end of said main body,

the main body of said female connector comprises on at least a portion of the outer surface of its portion surrounded by said collar (12), a first thread (16) placed at least partly facing an inner surface of said collar (12); )

said inner surface of the collar (12) of said female connector forming a conical connecting surface (13) of female revolution so that the outer surface of said conical portion (24) of male revolution of a male luer connector (10) abut against said female conical connecting surface (13) during assembly of said male and female Luer connectors.

1 1. Connector according to claim 10, characterized in that said portion surrounded by said collar (12) comprises at least one opening opening laterally ensuring a fluid communication between the inner channel (15) and the space between the inner surface of said collar (12) and the outer surface of said portion to limit any loss of liquid during its transfer.

Medical device comprising at least one container containing a liquid for medical use equipped with a medical liquid transfer assembly according to any one of claims 1 to 6.