EP2282805A1

EP2282805A1 - Improved connector for medical use

Info

Publication number: EP2282805A1
Application number: EP09724069A
Authority: EP
Inventors: Jean-Luc Carrez; Laurent Barre; Jean-Louis Coussegal; Pierrick Guyomarc'h
Original assignee: Vygon SA
Current assignee: Vygon SA
Priority date: 2008-03-27
Filing date: 2009-03-27
Publication date: 2011-02-16
Also published as: FR2929123B1; FR2929123A1; WO2009118417A1

Abstract

The invention relates to a connector (1) for a liquid circuit, intended in particular for medical use, comprising: means (2, 3) forming a substantially tubular chamber (10) between a downstream coupler (73, 74) and an upstream coupler (21, 22), said downstream coupler defining a passage (7); a stationary hollow tube (4) inside the chamber, intended to provide a communication between the upstream and downstream couplers; a septum (6) including a slot (8) which extends through part of the thickness thereof and is intended to receive the hollow tube, said septum being mounted in the passage such that it can slide between a stable downstream position sealing the passage, in which the hollow tube does not extend through the slot, and an upstream operating position in which the hollow tube extends through the slot; and means (9) for the resilient contraction of at least part of the thickness of the septum around the slot.

Description

CONNECTOR FOR IMPROVED MEDICAL USE

The invention relates to a connector for a fluid circuit, in particular for medical use. In the document EP 0 544 581, such a connector is described as comprising a body delimiting a tubular chamber, the body being formed of a base comprising a locking upstream connection consisting of a male "Luer-lock" connection, as well as a a housing, assembled on this base, having a locking downstream connection constituted by a female "Luer-lock" connection. A stainless steel tube is fitted and / or welded in the lock and an elastomeric membrane, called a septum, is pushed into a passage formed by the female Luer-lock fitting of the housing by a spring. This membrane is slotted in order to allow the tube to pass through said membrane. In the rest position of the device (stable downstream position of closure), the seal of the assembly is ensured at the level of the lock and the tube by the clamping between these during the fitting and / or the welding used for connect them, at the level of the tube and the septum by the clamping between the tube and the septum and at the level of the septum and the casing at the passage formed in the female Luer-lock fitting by the clamping between said septum and the casing, which ensures in addition the closure of the slit made in the septum.

In operation, a male luer connector, present on an element to be connected, is connected to the connection device and pushes the septum into the tubular chamber. The tube then passes through the slit made in the septum and enters a hole of the connected male luer fitting. The seal is ensured by the contact at the end of the cone of the male Luer connector connected against the septum, by the clamping between the tube and the septum, as well as by the clamping and / or the welding performed (s) between the tube and lock.

In practice, the connector of EP 0 544 581 is often brought to be connected to a syringe having a male Luer type connection for injections. These syringes are often equipped with a single male Luer type fitting. It is therefore necessary that these syringes stand alone by tightening the cone of the male Luer connector of the syringe in the female Luer cone of the downstream connection of the connecting device housing, this female Luer cone being truncated therefore shorter. This is incompatible with the use of a stiff spring pushing the septum in the passage of the female Luer-lock fitting of the housing, that is to say having a strong thrust connection, and therefore disconnection. In practice, the connection effort is limited to around 30-35 newtons. As a result, the spring can not exert a strong push at the disconnection on the septum to bring it back into the passage of the downstream connection of the housing. Despite lubrication of the septum, the casing and the tube (by siliconization for example), it is not possible to conceive a large frictional clamping of the septum in the passage of the downstream coupling Luer-lock female crankcase, and therefore it n It is not possible to conceive of a major crushing of the septum cleft at rest.

For these reasons, the connector of EP 0 544 581 has a limited resistance against back pressure, typically of the order of 10 ⁵ Pa, which means that the connector, used as a plug, has difficulty not open at the septum gap if the pressure in the closed circuit by the connecting device becomes greater than 1 bar. It should be noted that this pressure is easily reached with syringes, syringe pumps and pumps, commonly used in the medical and hospital environment.

An object of the invention is to provide a connector that can withstand higher counterpressures when used as a plug, while having a limited connection effort. For this purpose, there is provided according to the invention a connector for a liquid circuit, in particular for medical use, comprising means forming a substantially tubular chamber between a downstream connection and an upstream connection, the downstream connection delimiting a passage, a tube fixed hollow in the chamber and intended to communicate between them upstream and downstream connections, a septum comprising a slot in a thickness to be traversed by the hollow tube, and mounted in the passage so as to slide between a stable down position closing of the passage without being traversed by the hollow tube, and an upstream position of operating by being traversed by the hollow tube through the slot, the connector further comprising elastic necking means of at least a portion of the thickness of the septum around the slot.

These necking means make it possible to keep said septal septum closed in the presence of high pressures (typically greater than 10 ^5).

Pa) while maintaining a spring that allows a low connection force and exerting a sufficient thrust on the septum to bring it, during a disconnection, in the passage of the downstream connection sufficiently to have a good cleanability of a face septum intended to be in contact with a connection means introduced into the downstream connection.

Advantageously but optionally, the connector according to the invention has at least one of the following characteristics: the passage comprising at a downstream end of the chamber a rim surrounding the passage, the septum having a shoulder on an outer periphery, the connector comprises stiff reinforcement means mounted on the shoulder and intended to bear on the flange when the septum is in the stable downstream position of closure; rigid reinforcing means comprise a rigid cup whose flank extends around the septum upstream of the shoulder; o the rigid cup comprises at an upstream end of the flank a shoulder extending radially outwardly and intended to abut with a second shoulder located in the chamber when the septum is in steady down position of closure; the rigid cup comprises means for retaining the septum; the retaining means comprise a series of pins penetrating into the shoulder of the septum; o the reinforcement means further comprise a septum encapsulation washer in the reinforcing means; the elastic necking means comprise an elastically deformable ring; o the septum is forced into the ring; the ring comprises a bead on a radially internal periphery; and, o the passage having a portion of frustoconical shape, the ring bears on this portion when the septum comes in stable downstream position shutter.

Other features, objects and advantages of the invention will emerge from the following description of a preferred embodiment of the invention.

In the accompanying drawings: FIG. 1 is a view in longitudinal section of a connector according to the invention, in the stable downstream position of closure; FIG. 2 is a sectional and three-dimensional view of the septum of the connector of FIG. 1 equipped with a necking ring and a reinforcing cup; FIG. 3 is a sectional and three-dimensional view of the cup and the necking ring before mounting on the septum of FIG. 2; FIG. 4 is a view in longitudinal section of the connector according to FIG. 1 in the upstream operating position; and,

FIG. 5 is a sectional and three-dimensional view of an alternative embodiment of the septum of the connector of FIG. 1 equipped with a necking ring, a reinforcing cup and an encapsulation washer.

With reference to FIG. 1, a connector 1 according to the invention comprises a base 2 and a casing 3 mounted on the base 2. The assembly of the casing 3 on the base 2 makes it possible to delimit a substantially tubular chamber 10. The base 2 comprises an upstream connection 21, 22, here, male luer-lock type. Embroidered in this base 2, the connector

1 comprises a hollow tube 4 extending into the substantially tubular chamber 10. The casing 3 comprises a downstream connection 73, 74, here female luer lock type. The downstream connection defines a passage 7 opening on the outside and having a conical wall 74, here to the female Luer standard. In addition, the connector 1 comprises a membrane or septum 6 which comprises a slot 8 in its thickness. The slot 8 is substantially perpendicular to a longitudinal axis of the connector 1. The connection device or connector 1, finally comprises a spring 5, here in the form a compression coil spring, but which can also take any other form known to those skilled in the art. The spring 5 is intended to bear on the base 2 and to push the septum 6 so that the latter comes into a stable downstream position of closing the passage 7, as shown in Figure 1. A more detailed description of the connector 1 is provided EP 0 544 581 to which it is possible to refer for this purpose.

Referring also to FIG. 4, the casing comprises, at the passage 7, a first rim 71 extending in the substantially tubular chamber 10 and surrounding said passage 7. The rim 71 is surmounted in the downstream direction by a frustoconical portion 72 connecting the flange 71 with the conical wall 74 of the passage 7. In addition, the casing 3 comprises a second flange 31 projecting in the substantially tubular chamber 10 and located upstream of the first flange 71.

With reference to FIGS. 2 and 3, the septum 6 will be described in greater detail. The septum 6 is, here, an elastomeric membrane of cylindrical general shape of revolution having a slit 8 substantially flat and perpendicular to a longitudinal axis of the septum 6. This slot 8 extends from a downstream surface 60 into an upstream opening 61 of substantially cylindrical shape of revolution for receiving a free end of the hollow tube 4 sealingly. The septum 6 further comprises a shoulder 62 extending circumferentially on an outer periphery of the septum 6.

The septum 6 is mounted in a rigid cup 11 forming part of reinforcement means. The rigid cup 11 comprises a flange 113 which, when the septum is mounted in the rigid cup 11, bears on the shoulder 62 of the septum 6. A radially inner edge of the flange 113 comprises a series of pins 114 extending in protruding from the edge of the flange substantially parallel to the longitudinal axis of the septum and towards the downstream. The series of pins 114 is preferably uniformly distributed over the edge of the flange 113 of the rigid cup 11. Thus, during the mounting of the rigid cup 11 on the septum 6, as shown in Figure 2, the series of pins enters the elastomeric material forming the septum 6 at the shoulder 62. This ensures optimum retention and positioning of the rigid cup 11 on the septum 6. The rigid cup 11 has a side wall 112 extending from the flange 113 to a shoulder 111 preferably substantially parallel to the longitudinal axis of the septum 6 and in the downstream direction of the septum 6. The side wall 112 forms a flank extending around a downstream portion of the septum 6 upstream of the shoulder 62 of said septum 6. The shoulder 111 extends here preferably circumferentially and radially outwardly from the side wall 112. The rigid cup 11 is solid or honeycombed. As an alternative embodiment, it can be integrated into the septum by overmolding the latter around. On the flange 113 of the rigid cup 11 is mounted a ring 9 elastically deformable. The ring 9 has a base 92 resting on the top of the flange 113 of the rigid cup 11. As illustrated in FIG. 3, the ring 9 is overmoulded on the rigid cup 11 which has, for this purpose, on the top flange 113, cavities 93 defined by protrusions 115 issuing from the material of the flange 113 and protruding from said flange 113, and uniformly distributed over a circumference of the flange 113 in which, during an overmolding of the ring on the rigid cup, the material of the ring fills the cavities 93. Overlying the base 92 of the ring 9, the latter comprises a circumferential bead 91 which, in a state of rest, as illustrated in FIG. 3, reduces the central passage of the ring 9. The bead 91 is elastically deformable. When mounting the septum 6 on the cup 11, the septum 6 is force-fitted into the ring 9, which has the effect of elastically deforming the bead 91 of the ring 9 in a radially outward manner. the effect of the force generated by the elastic return of the bead 91 of the ring 9 towards its rest form, a necking is performed in part of the thickness of the septum 6 all around of the slot 8. This has the effect and role of ensuring the sealing of said slot 8. Thus, the assembly has a greater resistance against back pressure when the connector according to the invention is used as a plug. The ring 9 thus forms means of elastic strictions. In an alternative embodiment, the constriction means comprise, instead of the ring 9, a series of fingers or excrescences uniformly distributed or not on a circumference of the flange 113 of the cup and projecting from that of -this. The series of fingers or excrescences are elastically deformable. At rest, the series of fingers or excrescences form a cone, the free ends of the fingers or protrusions extend into the central passage. During a mounting of the septum 6 on the cup 11, the septum 6 is force-fitted between the series of fingers or protrusions which has the effect of elastically deforming radially outwardly said fingers or excrescences. Thus, under the effect of the force generated by the elastic return of the series of fingers or excrescences to its resting form, a necking is performed in part of the thickness of the septum 6 around the slot 8 Other similar structures of constriction means can be envisaged without departing from the scope of the invention.

As an alternative embodiment of the invention, the constriction means can be used alone, without being mounted on the cup 11.

Referring again to FIG. 1, we will describe the interactions of the various elements that have just been described. Figure 1 shows the connection device or connector 1 according to the invention in a stable downstream position of closure. In this position, the septum 6 sealingly closes the passage 7 so that the downstream surface 60 of the septum 6 touches the downstream end of said passage 7. For information, in this position, a manipulator of the connection device according to the invention 1 can easily clean the downstream surface 60 of the septum 6, to minimize the risk of nosocomial infections that could result from improper cleaning or cleaning of this surface. On the other hand, in this steady downstream position of shutter, the flange 113 of the rigid cup 11 abuts on the first flange 71 of the casing 3, on the one hand, and, on the other hand, the shoulder 111 of the rigid cup 11 bears on the second flange 31 of the casing 3. In an alternative embodiment, the base 92 of the ring 9 mounted on the flange 113 of the rigid cup 11 is interposed between said flange 113 and the first flange 71 of the housing 3 when the assembly is in a down position Stable shutter. The role of the rigid cup 11 is to prevent that, under a counterpressure, the septum 6 is expelled through the passage 7. In addition, in this stable downstream position of closure, the bead 91 of the ring 9 comes resting on the frustoconical portion 72 of the passage 7. When the entire ring 9 rigid cup 11 septum 6 arrives in the stable downstream position of closure, the support of the frustoconical portion 72 on the bead 91 reinforces the effect of necking exerted by the elastic return towards its rest position of said bead 91 on a part of the thickness of the septum 6 around the slot 8.

The transition from the stable downstream shutter position as illustrated in FIG. 1 to an upstream operating position as illustrated in FIG. 4 is described in document EP 0 544 581, to which it is possible to refer for further details. Moreover, during the transition from the stable downstream shutter position to the upstream operating position, the free end of the hollow tube 4 enters the slot 8 of the septum 6 by spacing said slot. When the free end of the hollow tube 4 is at the bead 91 of the ring 9, the free end of the hollow tube 4 further deforms the bead 91 more elastically in the direction of a larger opening. The bead 91 is no longer supported on the frustoconical wall 72, it is then free to move more elastically to the passage of the hollow tube 4. In addition, during the transition from a stable downstream position shutter to an upstream position of operation, the spring 5 is found compressed and is ready to bring back, by pushing it, the septum 6 to the stable downstream position of closure when disconnecting the connector.

With the connector 1 according to the invention, the tightness of the assembly against pressure is greatly increased, without destroying the performance in terms of connections / disconnections repeated. Moreover, the use a rigid cup 11 prevents any expulsion of the septum 6 outside the connection device or connector 1 according to the invention under the effect of high pressures.

Referring to Figure 5, we will briefly describe an alternative embodiment of the septum and its reinforcing cup. This septum assembly 6 and reinforcement cup of FIG. 5 differs from that of FIG. 2 by the addition of an encapsulation washer 12. The encapsulation washer 12 comprises an annular body 121 whose radially external diameter is substantially equivalent to a radially inner diameter of the wall 112 of the reinforcing cup 111. The encapsulation washer further comprises a shoulder 123 extending radially outwardly projecting from the annular body 121. This particular form of the encapsulation washer allows him, during an assembly, to be fitted in the lower part of the reinforcing cup 11 at the shoulder 111 of the latter. The complementarity of shapes between the encapsulation washer 12 and the reinforcing cup 11 allows the annular body 121 of the encapsulation washer 12 to penetrate into the reinforcing cup 11 until an upper edge of the shoulder 123 of the encapsulation washer 12 comes to bear on a lower edge of the shoulder 111 of the reinforcing cup 11. Thus the septum 6 is completely encapsulated in the reinforcing cup 11 as shown in FIG. this prevents the septum 6 from being driven out of the reinforcing cup 11 during repeated connections of the connector according to the invention.

In addition, the annular body 121 has a lower bearing face 122, located here, recessed axially relative to a lower flange of the shoulder 123. Once the connector mounted, the spring 5 bears on this face 122. The encapsulation washer is force-fitted into the reinforcement cup or else fitted into the latter. Of course, it is possible to bring to the present invention many modifications without departing from the scope thereof. In particular, those skilled in the art will be able to provide the constructions with elements and arrangements as described above any variation in shape as long as it does not alter its function and the result it provides.

Claims

Connector (1) for a liquid circuit, in particular for medical use, comprising: means (2, 3) forming a substantially tubular chamber (10) between a downstream connection (73, 74) and an upstream connection (21) , 22), the downstream coupling defining a passage (7), • a hollow tube (4) fixed in the chamber and intended to communicate with each other the upstream and downstream connections, "a septum (6) having a slot (8) in a thickness, intended to be traversed by the hollow tube and mounted in the passage so as to be slidable between a stable downstream position of closing the passage without being traversed by the hollow tube, and an upstream position of operation being traversed by the hollow tube through the slot, connector characterized in that it further comprises stripping means (9) elastic at least a portion of the thickness of the septum around the slot.

2. Connector according to claim 1, characterized in that the passage (7) comprises at a downstream end of the chamber a rim (71) surrounding the passage, the septum comprises a shoulder (62) on an outer periphery, and the connector comprises rigid reinforcement means (11) mounted on the shoulder and intended to bear on the flange when the septum comes to stable downstream position of closure.

3. The connector of claim 2, characterized in that the reinforcing means comprise a rigid cup (11), a flank (112) extends around the septum upstream of the shoulder (62).

4. Connector according to claim 3, characterized in that the rigid cup comprises at an upstream end of the side a shoulder (111) extending radially outwardly and intended to bear with a second flange (31) located in the chamber when the septum comes in stable downstream shutter position.

5. Connector according to one of claims 3 to 4, characterized in that the rigid cup comprises retaining means (114) of the septum.

6. Connector according to claim 5, characterized in that the retaining means comprise a series of pins (114) penetrating into the shoulder of the septum.

7. Connector according to one of claims 2 to 6, characterized in that the reinforcing means further comprises an encapsulation washer (12) of the septum (6) in the reinforcing means.

8. Connector according to one of claims 1 to 7, characterized in that the elastic necking means comprise a ring (9) elastically deformable.

9. The connector of claim 8, characterized in that the septum is forced into the ring.

10. Connector according to one of claims 8 to 9, characterized in that the ring comprises a bead (91) on a radially inner periphery.

11. Connector according to one of claims 8 to 10, characterized in that the passage (7) comprises a portion of frustoconical shape (72), the ring bearing on this portion when the septum comes in stable downstream positon d shutter.