WO2004028597A2 - Flexible bag and associated injection device - Google Patents

Abstract

The invention relates to a flexible bag which is intended to be used in a medical liquid injection device. The invention comprises a bag (2) which is made from a flexible material and which is joined to a connector (3) by means of a drain tube (4). The invention is characterised in that the flexible bag also comprises specific hooking means (10) which can co-operate with support means which are solidly connected to the injection device.

Description

 FLEXIBLE POCKET AND INJECTION DEVICE THEREOF

The present invention relates to a flexible bag intended to contain a liquid to be injected. The invention also relates to an injection device capable of using such a flexible bag.

The invention finds a particularly advantageous, but not exclusive, application in the field of liquid injection for medical use.

In medicine, liquid injection is commonly used, in particular during transfusion operations, infusion, artificial nutrition by venous or arterial route, injection of contrast liquid, etc. Among all the known techniques, the high pressure injection of liquid conditioned in a flexible bag constitutes one of the most suitable for the medical environment because of the satisfactory hygiene which it provides.

In known manner, a flexible pocket is composed of two sheets of flexible material which are joined by gluing or welding at their respective edges, so as to constitute an internal volume capable of receiving a liquid to be injected. A flow orifice is obviously provided at the periphery.

During its use, such a flexible pocket is intended to be connected to various removable elements. We are thinking here in particular of a filling infuser, an intermediate pipe, an injection pipe such as a catheter or a hypodermic needle, etc. This is why the opening of the flexible bag is generally connected to a connection fitting via a more or less long flow conduit; this connection fitting being capable of being reversibly connected to any of the above-mentioned removable elements.

There are already known traditional medical liquid injectors which are not entirely satisfactory. Also, the applicant has invented a new generation of injectors which have been disclosed in particular by French patent application No. 97 00235. In the device thus imagined, there is provided an enclosure containing an inert liquid capable of being pressurized in order to deform any flexible pocket placed within it. When this is the case, the pressure exerted by the inert liquid gradually compresses a flexible bag which contains the medical liquid, then deforms it until the liquid to be injected is forced to flow through the flow conduit. The enclosure of the injection device is generally closed by a movable closure element, forming a cover, which can be composed of several complementary parts.

Usually, the closure element also serves as a fixing means for the flexible bag. Indeed, the maintenance of the flexible bag in the enclosure is generally achieved by wedging the flow conduit in a bore or a slot, of slightly smaller section, formed in the closure element.

However, this type of injection device has the disadvantage of not offering satisfactory maintenance of the flexible bag in the enclosure, because of the risks of the flow duct sliding in the bore or the associated slot. In addition, wedging fixing naturally tends to systematically injure the flow duct which can then deteriorate rapidly. Also, the technical problem to be solved by the object of the present invention is to propose a flexible bag intended to be used in an injection device in particular such as that disclosed by patent application No. FR 9700235 and comprising a pocket made of flexible material which is connected to a connection fitting by a flow conduit, a flexible bag which would make it possible to avoid the problems of the state of the art by allowing in particular a substantially improved fixing in the injection device, while guaranteeing his physical integrity.

The solution to the technical problem posed consists, according to the present invention, in that the flexible bag further comprises specific attachment means capable of cooperating with support means integral with the injection device.

Maintaining the flexible bag in the injection device is no longer carried out directly on the flow conduit. It is in fact carried out by means of specific attachment means which, as will emerge expressly from the description which follows, allow a substantially more effective fixing and without harmful consequences for the flow conduit.

The invention also relates to an injection device capable of being associated with such a flexible bag, that is to say an injection device comprising an enclosure whose opening is capable of being closed by at least one element. movable closure forming a cover, said enclosure containing an inert liquid capable of being pressurized in order to deform any flexible pocket placed inside said enclosure. Such an injection device is remarkable in that it further comprises support means able to cooperate with the attachment means of a flexible bag as defined above. The present invention also relates to the characteristics which will emerge during the description which follows, and which should be considered in isolation or according to all their possible technical combinations.

Other characteristics and advantages of the invention will emerge from the description which follows with reference to the appended drawings which are given only by way of nonlimiting examples.

Figure 1 shows a flexible bag according to the object of the present invention.

FIG. 2 shows attachment means according to a first embodiment of the invention.

FIG. 3 is a bottom view of the attachment means illustrated in FIG. 2.

FIG. 4 illustrates attachment means according to a second embodiment of the invention.

FIG. 5 is a side view of the attachment means illustrated in FIG. 4.,

FIG. 6 constitutes a bottom view of the attachment means illustrated in FIG. 4.

Figure 7 shows an injection device according to the object of the present invention. FIG. 8 is a cross-sectional view of the injection device of FIG. 1.

FIG. 9 constitutes a top view of the part forming a cover, represented in FIG. 7.

FIG. 10 is a view in longitudinal section of the part forming a cover, represented in FIG. 9.

FIG. 11 illustrates, in longitudinal section, the installation of a flexible bag in the injection device of FIG. 7.

FIG. 12 shows the injection device in longitudinal section, once the flexible bag has been positioned.

Figures 13 and 14 illustrate an alternative embodiment according to which, the flow conduit (4) is independent and is connected to the pocket (2) in a removable manner so that it can be connected and disconnected at will from said pocket.

Figure 13 shows the bag with its disconnected flow conduit.

Figure 14 shows the bag connected to its flow conduit.

FIG. 1 illustrates a flexible bag (1) intended to be used in an injection device (100) which will be described later. This flexible pocket (1) conventionally comprises a pocket (2) of flexible material which is connected to a connection fitting (3) via a flow conduit (4) shown in dotted lines.

In this exemplary embodiment, the pocket (2) consists of two sheets of flexible material, which are joined by bonding or welding at their respective edges, so as to constitute an internal volume capable of receiving a liquid to be injected (5 ). An orifice (6) is obviously provided to allow the liquid (5) to flow, either out of the pocket (2) during an injection phase, or inside said pocket (2 ) during a filling operation. This orifice (6) is connected in a perfectly sealed manner, always by gluing, welding, or any other means, to the flow conduit (4), the free end of which is integral with the connection fitting (3). It will be recalled that the connection connector (3) is intended to allow the flexible bag (1) to be connected to any removable element provided with a complementary connection connector, such as, for example, a filling infuser, an intermediate pipe, an injection pipe, etc.

In accordance with the object of the present invention, the flexible bag (1) further comprises specific hooking means (10) which are able to cooperate with support means (110) integral with the injection device (100) .

According to a feature of the invention, the attachment means (10) are integral with the flow conduit (4). It should be noted that the term integral does not mean that the hooking means (10) are necessarily secured to the flow conduit (4), but that they simply depend on one another, that they are linked together by a link which can be partially mobile. Anyway, the hooking means (10) are thus advantageously positioned in a suitable location so as not to hinder, on the one hand, the deformation of the pocket (2) when the latter is compressed in a device of injection (100), and on the other hand, the implementation of the connection fitting (3). The flexible bag (2) is therefore held at the level of the flow conduit (4), but not directly on it, since the attachment means (10) act as an interface in a way. The flow conduit (4) is thus protected.

It will be added that the attachment means (10) fixed to the bag flow duct (2) constitute, in cooperation with the support means (110, 111) of the injector, a so-called polarizing system imposing on the operator the use of a specific medical bag (2). What secures its use.

According to another feature of the invention, the hooking means (10) are mounted movable along the flow conduit (4), between the orifice (6) of the pocket (2) and the connection fitting ( 3). The degrees of freedom from which the fastening means (10) benefit are however limited to axial sliding and axial rotation relative to the flow conduit (4). Such an arrangement makes it possible to protect the flow conduit (4) even more, by limiting to the minimum the interactions, and therefore the stresses, between the fastening means (10) and said flow conduit (4).

In accordance with the embodiment illustrated in FIG. 1, the part of the hooking means (10), which is integral with the flow conduit (4), has dimensions substantially equal to the length of said flow conduit (4). This characteristic thus allows a limitation of the axial sliding, so that the mobility of the hooking means (10) lies essentially in the axial rotation.

Particularly advantageously, the attachment means

(10) may have an external appearance corresponding to the nature of the liquid (5) which is contained in the pocket (2), the external appearance being specific for a given liquid (5). It should be noted that the external appearance of the attachment means (10) can be defined in particular by a precise shape and / or a specific color and / or a specific surface condition.

As can be seen in all of Figures 1 to 6, the hooking means (10, 20) consist of a rigid element (11, 21) comprising, on the one hand, at least one through bore (12, 22a, 22b) intended for the passage of the flow conduit (4), and on the other hand, a projecting part (13, 23) extending substantially perpendicular to each through bore (12, 22a, 22b ).

Of course, if the pocket had a double compartment, the rigid element would then have more than one bore, to receive the conduits.

In these exemplary embodiments, the rigid element (11, 21) consists of a cylindrical sheath in which each through bore (12, 22a, 22b) is formed axially. The projecting part (13, 23) is, in turn, constituted by a portion of the cylindrical sheath, forming a stop, which has a larger diameter. The rigid element (11, 21) acts as a sheath in the sense that it envelops the flow duct (4) in order to protect it. The protruding part (13, 23) plays the role of stop when it cooperates with support means (110) integral with the injection device (100). In a particularly advantageous manner, the projecting part (13, 23) is positioned on the rigid element (11, 21), at its so-called distal end (14, 24), that is to say that which is oriented towards the connection fitting (3).

According to an advantageous characteristic of the invention, the so-called proximal end (15, 25) of the rigid element (11, 21), that is to say that which is oriented towards the pocket (2), comprises at least one external chamfer (16, 26a, 26b). As will be understood when describing the injection device (100), this characteristic makes it easier to engage the attachment means (10, 20) in the support means (110) integral with said injection device (100).

Figures 2 and 3 illustrate hooking means (10) similar to those shown in Figure 1 and which correspond to a first embodiment of the invention. There is therefore a rigid element (11) in the form of a cylindrical sheath provided with a central through bore (12), that is to say formed axially in the body of said rigid element (11). The projecting part (13) also has a cylindrical shape, which is concentric with the rest of the body of the rigid element (11) but of greater diameter, in order to constitute a stop in the axial direction. Regardless of the external shape of the rigid element (11), the through bore (12) is formed axially and continuously over the entire height of said rigid element (11).

It can clearly be seen in FIG. 2 that the projecting part (13) is made entirely at the distal end (14) of the rigid element (11). The proximal end (15) of the rigid element (11) comprises, for its part, an external chamfer (16) of frustoconical shape which extends around the entire periphery of said proximal end (15).

As can be seen in FIG. 3, the cylindrical sleeve, the projecting part (13), the through bore (12) and the external chamfer (16) are all perfectly concentric with respect to the axis of the rigid element ( 11).

FIGS. 4 to 6 show hooking means (20) according to a second embodiment of the invention, which differs from the first essentially by the fact that said hooking means (20) have two through bores (22a , 22b). The cylindrical sheath and the projecting part (23) have, in fact, the same characteristics as in the first embodiment of the invention. However, as can be clearly seen in FIGS. 4 and 6, the rigid element 21 is here provided with two through bores (22a, 22b) formed parallel and symmetrically with respect to the axis of said rigid element (21) .

The proximal end (25) of the rigid element (21) here comprises two external chamfers (26a, 26b), being in the form of two bevels arranged symmetrically with respect to a plane passing through the axes of the through bores (22a , 22b).

In accordance with the object of the present invention, FIG. 7 illustrates an injection device (100) intended to receive the flexible bag of the invention. The reader can refer to the patent application of the applicant FR No. 97 00235. It will therefore only be briefly described. Note however that it comprises an enclosure (101) whose opening (102) is capable of being closed by at least one movable closing element (103a, 103b) forming a cover. The enclosure (101) contains an inert liquid (104) capable of being pressurized in order to deform any flexible pocket (1) placed inside said enclosure (101). The injection device (100) further comprises support means (110), not visible in this FIG. 7, which are able to cooperate with the hooking means (10, 20) of a flexible pocket (1) as previously described.

In this exemplary embodiment, and as can be clearly seen in FIG. 8, the injection device (100) is, moreover, provided with a deformable envelope (105) which takes place inside the enclosure (101) and which is hermetically secured to said enclosure (101), substantially near the edge (106) delimiting the opening (102). Thus positioned, the deformable envelope (105) defines, in combination with the internal surface of the enclosure (101), a variable volume in which the inert liquid (104) is contained. The internal volume of the deformable envelope (105) is, for its part, intended to receive the flexible pocket (1).

It should be noted that the inert liquid (104) is pressurized by means of compression means not shown in the different figures, but which are conventionally coupled to the enclosure (101) by a connection orifice (107) located in the lower part.

As shown in Figure 9, the cover portion is composed of two movable closing elements (103a, 103b) whose formal complementarity is able to guarantee complete closure of the opening (102) of the enclosure (101) . These two closing elements (103a, 103b) are movable relative to the enclosure (101), but also one relative to the other (arrows f1 and f2). These relative mobilities can be assisted by specific articulation means, such as, for example, hinges, or be directly carried out manually by the user, as in the embodiment shown here. FIG. 9 also shows the orifice (108) of a through bore (109) which is intended for the passage of a portion of the flow conduit (4), a portion which is located between the fastening means (10 , 20) and the connection fitting (3).

As can be seen in FIG. 10, and according to a characteristic of the invention, the support means (110) are able to cooperate by at least partial interlocking with the hooking means (10, 20) of the flexible bag (1). To this end, the support means (110) are advantageously of forms substantially complementary to the attachment means (10, 20) which are associated with them.

It should be noted that the concept of partial nesting means that the interpenetration of the support means (110) and the attachment means (10, 20) is not necessarily total but that it can vary in variable proportions. , provided that the hold function is performed. In an extreme case, the nesting can even be reduced to its simplest expression. The support means (110) are then likely to constitute substantially only a simple bearing surface against which a part, forming a stopper, would come to cooperate, hooking means (10, 20).

According to another characteristic of the invention, perfectly visible in Figure 10, the support means are integral with at least one movable closure element (103a, 103b) forming a cover.

In this particular embodiment, the injection device 100 comprises two movable closing elements (103a, 103b). Also, the support means (110) consist of two recesses (111a, 111b) complementary, which are provided respectively in each of the two movable closure elements (103a, 103b). The combination of these two recesses (111a, 111b) forms a housing of shape substantially complementary to the attachment means (10, 20) used, when said movable closing elements (103a, 103b) close the opening (102) of the 'enclosure (101).

In accordance with FIG. 11, the installation of a flexible bag (1) in the injection device (100) therefore consists, first of all, of inserting the bag (2) into the enclosure (101), and more precisely in the deformable envelope (105) in the embodiment chosen. Then, in a second step, it is necessary to fit the movable closure elements (103a, 103b) around the rigid element (11) which is carried by the flexible pocket (1). Once the rigid element (11) is completely integrated into the complementary recesses (111a, 111b), the assembly is able to be positioned at the level of the opening (102) of the enclosure (101), in the closed position.

FIG. 12 illustrates the cooperation between the hooking means (10) of the flexible bag (1) and the support means (110) of the injection device (100).

It goes without saying that the hooking means (10) could be produced by a simple projecting ring, like the rigid element (11) but without the tubular lower part (130), that is to say with only the projecting part (13).

Figures 13 and 14 illustrate an alternative embodiment according to which, the flow conduit (4) is independent of the bag and is removably connected so that it can be connected and disconnected at will.

Thus, the pocket comprises an upstream flow conduit (40) which comprises a connecting link (30) intended to cooperate with a complementary connection element (31) disposed at the upstream end of the flow conduit (4) which further includes a threshold valve (40).

According to this alternative embodiment, the attachment means (10 ′) are produced by a rigid element (11 ′), the latter being constituted by a ring, integral with the upstream end of the flow pipe (4). According to this variant, the ring (11 ') constituting the attachment means is integral with the complementary fitting (31) which is intended to cooperate with the connecting fitting (30) fixed to the pocket (2).

Of course, the injector cover comprises a hollow profile (111) corresponding in its shape and in its dimensions to the shape and to the dimension of the ring (11 '). Once in place in the injector, the bag is suspended from the cover to be retained there up and down, as well as laterally, thanks to its retaining means constituted by the ring (11 ').

It has been understood that the hooking means (10, 10 ') fixed to the pocket

(2) constitute, in cooperation with the support means (111) of the injector, a so-called polarizing system requiring the operator to use a determined medical pocket (2). What secures its use.

We also understood that once in place in the injector, the bag is suspended from the lid to be held up and down there, as well as laterally, thanks to its retaining means constituted by the ring (11, 11 '), in cooperation with the corresponding hollow (111) produced in the injector and more particularly in its cover. Thus thanks to this cooperation the lower face ( 60) of the ring (11, 1 ') with the corresponding face, therefore upper (61) of the hollow profile (111).

Furthermore, the hooking protrusion (13) could include an annular hooking groove.

Claims

1. flexible bag (1) intended for use in an injection device (100) of medical liquid (5), and comprising a pocket (2) of flexible material which is connected to a connection fitting (3) by a flow conduit (4), characterized in that the flexible bag (1) further comprises specific hooking means (10, 20, 10 ') capable of cooperating with support means (110) integral with the device injection (100). 2. flexible bag (1) according to claim 1, characterized in that the hooking means (10, 20) are integral with the flow conduit (4). 3. flexible bag (1) according to one of claims 1 or 2, characterized in that the attachment means (10, 20) are movably mounted along the flow conduit (4), between the pocket (2 ) and the connection fitting (3). 4. flexible bag (1) according to any one of claims 1 to 3, characterized in that the part of the attachment means (10, 20), which is integral with the conduit, flow (4), has dimensions substantially equal to the length of said flow conduit (4). 5. flexible bag (1) according to any one of claims 1 to 4, characterized in that the hooking means (10, 20) have an external appearance corresponding to the nature of the liquid (5) which is contained in the pocket (2), the external appearance being specific for a given liquid (5). 6. flexible bag (1) according to any one of claims 1 to 5, characterized in that the attachment means (10, 20) are constituted by a rigid element (11, 21) comprising, on the one hand, at least one through bore (12, 22a, 22b) intended for the passage of the flow conduit (4), and on the other hand, a projecting part (13, 23) extending substantially perpendicular to each through bore ( 12, 22a, 22b). 7. flexible pocket (1) according to claim 6, characterized in that the rigid element (11, 21) is constituted by a cylindrical sheath in which each through bore (12, 22a, 22b) is formed axially, the projecting part (13, 23) being constituted by a portion of the cylindrical sheath, forming a stop, which has a larger diameter. 8. flexible bag (1) according to any one of claims 1 to 7, characterized in that the projecting part (13, 23) is positioned on the rigid element (11, 21), at the distal end (14, 24) which is oriented towards the connection fitting (3). 9. flexible bag (1) according to any one of claims 1 to 8, characterized in that the proximal end (15, 25) of the rigid element (11, 21), which is oriented towards the pocket (2), has an external chamfer (16, 26a, 26b). 10. Injection device (100) comprising an enclosure (101), the opening (102) of which is capable of being closed by at least one movable closure element (103a, 103b) forming a cover, said enclosure (101) containing a inert liquid (104) capable of being pressurized in order to deform any flexible pocket (1) placed inside said enclosure (101), characterized in that the injection device (100) further comprises means for support (110) able to cooperate with the means for hanging (10, 20) a flexible pocket (1) according to any one of the preceding claims. 11. Injection device (100) according to claim 10, characterized in that the support means (110) are able to cooperate by at least partial interlocking with the hooking means (10, 20) of the flexible bag ( 1). 12. Injection device (100) according to one of claims 10 or 11, characterized in that the support means (110) are substantially complementary in shape to the attachment means (10, 20) of the flexible bag ( 1). 13. Injection device (100) according to any one of claims 10 to 12, characterized in that the support means (110) are integral with at least one of the movable closure elements (103a, 103b) forming a cover . 14. Injection device according to any one of claims 10 to 13, characterized in that it comprises two movable closing elements (103a, 103b) forming a cover, and in that the support means (110) are constituted by two complementary recesses (111a, 111b) formed respectively in each of the two movable closing elements (103a, 103b), the two recesses (111a, 111b) forming a housing of shape substantially complementary to the hooking means (10, 20) when said movable closure elements (103a, 103b) close the opening (102) of the enclosure (101).