WO2015121355A1 - Flexible medical bag - Google Patents

Abstract

The present invention concerns a storage bag (3) for an aqueous medical solution that can be used in an injection device (2), said bag comprising: - two superposed sheets (31, 32) of flexible material linked along the peripheral edges of same so as to define a storage volume for the aqueous solution, - an access member (33) for conveying the aqueous solution between the inside and the outside of the bag, the access member comprising a proximal end sealed between the superposed sheets, - a connector coupled to a distal end of the access member, remarkable in that the bag further comprises a spacer member (34) for preventing the superposed sheets from sticking completely together when the bag is flattened, in order to keep a channel open for the flow of the aqueous solution to the access member, the spacer member extending into the storage volume between the superposed sheets, and in that the spacer member is secured in a pipe (331) of the access member (33).

Description

 FLEXIBLE MEDICAL POCKET

TECHNICAL AREA

The present invention relates to the general technical field of product delivery to a patient, for example parenterally.

More specifically, it relates to a flexible container - hereinafter referred to as a "bag" - containing an aqueous solution - in particular a contrast product - intended to be administered to a patient.

GENERAL PRESENTATION OF THE PRIOR ART

Soft pouches containing an aqueous solution, such as a contrast medium for administration to a patient, for example in a medical imaging examination, such as X-ray imaging or Resonance Imaging, are known. Magnetic (MRI).

Such a pocket 1 conventionally comprises:

 two superposed sheets welded at their periphery to define a volume 1 1 intended to contain the aqueous solution,

 an outlet pipe 12 sealed between the superimposed sheets to define a circulation channel for the aqueous solution between the inside and the outside of the pocket, and

 - A connector (not shown) attached to the free end of the tubing 12 to allow the connection of the bag 1 to a set of fluid flow connected to the patient.

In the majority of cases, the administration of the aqueous solution requires its transfer between the bag and the patient. This transfer can be implemented by gravity or with the aid of an injection device as described in documents FR 2 991 881, EP 0 648 513 or EP 0 852 152. FIG. injection device 2 described in the document FR 2 991 881, this device comprising a composite housing two half-shells 21 and 22 hinged to allow their relative movement between an open position for the introduction of the pocket and a closed position for the injection of the liquid product contained in the pocket. More generally, all the injection devices described in documents FR 2 991 881, EP 0 648 513 or EP 0 852 152 comprise a housing intended to receive the bag. They are based on the use of a motor fluid 23 enveloping the pocket 1 and which, under pressure, will have the mission of propelling the liquid out of the pocket. In order to facilitate the evacuation of unwanted air bubbles that could be contained in the flexible bag, the casing is oriented so that the tubing 12 of the bag 1 opens towards the top of the casing, as illustrated in FIG. it is found that the portion of the sheets sealed to the tubulure extends at an altitude higher than the other portions of the leaves.

A disadvantage of existing bags is the loss of part of the aqueous solution they contain. The loss of a portion of the aqueous solution is related to the injection process using the injection device, as will be described in more detail below with reference to Figure 1.

When the aqueous solution is injected into a patient, the driving fluid 23 contained in the casing of the injection device 2 exerts forces on the walls of the bag 1 tending to press them against each other to propel the liquid out of the pocket 1. The pressurization of the pocket 1 in the housing is capable of generating collabage 14 of the superposed sheets of the pocket.

As illustrated in Figure 1 B, this collab 14 traps a significant part of the aqueous solution contained in the bag (up to 20% of the content, the equivalent of a dose for a patient).

The collabage phenomenon appears preferentially at the end of the injection, when the aqueous solution to be injected extends to the bottom of the bag 1: the pressure applied laterally by the driving fluid 23 closes the passage of the liquid on the middle and high portions of the the pocket 1 forming a watertight barrier. This phenomenon does not appear in a systematic way. It is encouraged when it remains in the pocket a volume of aqueous solution corresponding to approximately 1/4 to 1/3 of the total volume of the bag as well as by the induction of a high flow (ie a flow greater than 4 ml / s) by the injection device.

The collabage phenomenon thus induces the loss of part of the aqueous solution contained in the bag 1. However, when the price of the aqueous solution is high (which is often the case with contrast media), it is preferable to limit this loss. Moreover, when the phenomenon of collabage appears during an injection of contrast medium, it may be necessary to repeat the injection procedure, the patient has not received a sufficient amount of contrast medium. To overcome these drawbacks, various solutions have been proposed to promote the flow of the aqueous solution to the outside of the bag 1, such as:

 thermoforming the superposed sheets or else

 - The formation of grains on the walls opposite the superimposed sheets, as described in US 4,810,451.

However, these solutions are not satisfactory for the following reasons:

 - As regards the thermoforming of the bag, it has the disadvantage of not having sufficient durability over time, especially in the case of superimposed sheets made of a material having a flexibility of the order of 75shA - such as superimposed sheets of PVC type. Indeed, firstly the thermoforming is likely to relax over time, and secondly stacked storage pockets can induce a crushing thermoforming;

 - In addition, the thermoforming of the pocket loses strongly (see fully) its effectiveness in case of injection at high pressure;

- As regards the formation of grains on the walls facing the superimposed sheets, if it is effective during the low pressure injection of an aqueous solution (for example gravity injection), it is totally ineffective in the part of a high-pressure injection using a injection device. Indeed, the size of the grains formed in the walls opposite the superimposed sheets is too small to avoid the phenomenon of collabage. The document WO 85/04383 proposes to arrange an insert in a flexible pouch in order to make it possible to maintain a circulation channel for the fluid of the pouch towards the outside when the pouch empties and when its walls meet. However, the pocket provided with the proposed insert is not entirely satisfactory. Indeed, the attachment of the insert in the pocket is complicated and requires to be implemented before sealing the bag, which requires a specific manufacturing process. Furthermore, the insert does not prevent collabage close to the exit port of the pocket. On the other hand, this bag is designed for the low pressure injection of an aqueous solution (for example gravity injection) and is not suitable for injection at high pressure using an injection device. Finally, the proposed insert has small grooves on its faces, increasing the risk that the pocket fits into these grooves and is stuck.

An object of the present invention is therefore to provide a flexible container for storing an aqueous solution intended to be injected into a patient, said container being designed so as to limit the phenomenon of collabage when it is used in a device. injection, which is simple in its design and is easy to manufacture.

PRESENTATION OF THE INVENTION

For this purpose, the invention proposes a storage bag for aqueous medical solution - more precisely for contrast medium - usable in an injection device - in particular a high-pressure injection device (that is to say at a pressure preferably greater than one bar, more preferably greater than four bars, and even more preferably greater than fourteen bars) - said pocket comprising:

two superposed sheets of flexible material connected along their peripheral edges to define a storage volume of the aqueous solution, each superimposed sheet comprising upper and lower edges between a pair of longitudinal edges,

 an access member for conveying the aqueous solution between the inside and the outside of the bag, the access member having a proximal end sealed between the upper edges of the superposed sheets,

 a connector coupled to a distal end of the access member,

 a spacer member for preventing the total plating of the superposed sheets when the pouch is flattened so as to maintain a flow channel from the aqueous solution to the access member, the spacer member extending into the storage volume between the superimposed sheets between the lower and upper edges of the pocket,

 wherein the spacer member is wedged in a tubing of the access member.

The wedging of the spacer member in the tubing makes it possible to keep the spacer member in the pocket without the latter having specific fixing means: the pocket itself ensures that the spacer is held in position. spacer. The spacer member can then be of very simple design, thus making it possible to manufacture it by an inexpensive method such as extrusion. In addition, the fact that the spacer member passes through the tubing ensures the evacuation of the fluid by the access member via this tubing, by means of maintaining a flow channel passing through the tubing, along of the spacer. In addition, the spacer member may be inserted via the tubing into the pocket after manufacture thereof. This makes it possible to implement the invention within the framework of existing manufacturing processes. Furthermore, the spacer member being wedged in a position extending in the storage space between the superimposed sheets between the lower and upper edges of the pocket makes it possible to stiffen the pocket and to limit the folding thereof.

In the context of the present invention, the term "total plating" means superimposed sheets, a plating thereof over the entire lateral section of the bag. Preferred but non-limiting aspects of the pouch according to the invention are the following:

 - The spacer member may be made of a more rigid material than the material constituting the superimposed sheets; the reader will appreciate that the smaller the section of the superposed sheets, the greater the rigidity of the material constituting the spacer member is greater than the rigidity of the material constituting the superimposed sheets;

 each superimposed sheet may comprise upper and lower edges between a pair of longitudinal edges, the proximal end of the access member being sealed between the upper edges of the superimposed sheets, the spacer member extending between the longitudinal edges superimposed sheets, from the upper edges to the lower edges;

 the spacer member may comprise at least one rod extending through the storage volume between the upper and lower edges of the superposed sheets;

 - The rod can be straight;

 - the rod can be curved;

 the sectional shape of the rod may be chosen from an X shape, a U shape, a Y shape and an O shape;

- The cross-sectional area of the rod may be between 0.1 mm ² and 50 mm ² , preferably between 0.2 and 10 mm ² , more preferably between 0.2 and 5 mm ² ;

 the angles of the portions of the rod extending inside the storage volume may be non-projecting; is meant in the context of the present "non-salient angle", an angle having no tear capacity of the pocket;

 the access member may include:

 a base at its proximal end sealed between the superimposed sheets, and

 a tubing extending through the base,

the thickness of the base in a direction perpendicular to the planes of the superimposed sheets being greater than or equal to the diameter of the tubing, so that the upper edges of the superposed sheets are spaced apart by a non-zero distance equal to the thickness of the base; the spacer member can be fixed in the base of the access member;

 - The pocket may also comprise a base sealed between the lower edges of the superimposed sheets the base having a non-zero thickness so that the lower edges of the superimposed sheets are spaced a distance equal to the thickness of the base;

 - The spacer can be fixed in the base;

 - The spacer member is wedged further into a boss formed in the lower edge of the pocket. The invention also relates to a method of manufacturing a storage bag according to the invention, wherein the spacer member is positioned between the superimposed sheets subsequent to the connection of the peripheral edges by inserting said spacer member through a tubing in the storage volume defined by the superimposed sheets.

PRESENTATION OF FIGURES

Other features and advantages of the invention will become apparent from the description which follows, which is purely illustrative and nonlimiting and should be read with reference to the accompanying drawings, in which:

 FIGS. 1A and 1B are diagrammatic representations of an injection device described in the document FR 2 991 881,

 FIGS. 2 to 9 illustrate various embodiments of a storage bag for aqueous medical solution according to the invention,

 FIGS. 10 and 11 are diagrammatic representations in perspective of a spacer member,

- Figure 12 is a cross-sectional view of different examples of spacer member. DESCRIPTION OF EMBODIMENTS OF THE INVENTION

Different embodiments of the flexible container according to the invention will now be described. In the different figures, the equivalent elements bear the same numerical references.

With reference to FIGS. 2 to 9, various examples of flexible containers 3 according to the invention have been illustrated. The container 3 comprises two superposed sheets 31, 32, an access member 33 and one (or more) connector (s) (not shown). It further comprises a spacer 34, and may comprise a base 35.

leaves

The superposed sheets 31, 32 make it possible to define a volume intended to contain an aqueous solution such as a contrast product.

Each sheet 31, 32 may be composed of several layers of thin films laminated with flexible or flexible materials, possibly transparent or translucent such as polymeric materials including polyethylene, polypropylene, polyvinyl chloride, ethylene-vinyl acetate and preferably thermoplastic materials.

The sheets 31, 32 are of length "L1" and width "11" appropriate and are interconnected at their peripheries, for example, by welding, gluing or by any other technique known to those skilled in the art.

More precisely in the embodiments illustrated in FIGS. 2 to 9, each sheet 31, 32 comprises an upper edge 41, a lower edge 42 and two longitudinal edges 43 between the upper 41 and lower 42 edges, the upper 41, lower 42 edges. and longitudinal 43 being respectively interconnected.

The reader will appreciate that the connection between the peripheral edges 41, 42, 43 of the superposed sheets 31, 32 may be direct - that is, the peripheral edges of the sheets 31, 32 are in direct contact with each other. other - or indirect - that is to say that an intermediate piece extends between the peripheral edges of the sheets 31, 32.

Of course the connection between the sheets 31, 32 may be direct on some edges 43 and indirect on others 41.

For example, in some embodiments (as illustrated in Figures 2-3 and 5-9):

 the longitudinal edges 43 and lower 42 of the sheets 31, 32 are connected directly to each other, while

 the upper edges 41 are connected indirectly to each other, a base 332 of the access member 33 extending between the upper edges 41 of the superposed sheets 31, 32. In other embodiments (as illustrated in FIG. 4):

 the longitudinal edges 43 of the sheets 31, 32 are connected directly to each other, while

 the upper edges 41 and lower 42 of the sheets 31, 32 are connected indirectly to each other, a part forming a base 35 extending between the lower edges 42 of the sheets 31, 32 and a base 332 of the access member 33; extending between the upper edges 41 of the sheets 31, 32.

Access member The access member 33 defines a circulation channel of the aqueous solution between the inside and the outside of the pocket.

The access member may be sealed (preferentially by thermal welding or by high frequency welding or by gluing) between the superposed sheets 31, 32, on the upper edges thereof.

The access member 33 may consist of one (or more) tubing (s) 331. In this case, the proximal end of (each) tubing 331 is sealed to the upper edges of the superposed sheets 31, 32. Alternatively, the access member 33 may comprise a base 332 through which extends one (or more) tubing (s) 331. In this case, the base 332 is sealed at the upper edges of the superimposed sheets. The base has lengths "L2", width "12" and thickness "e" nonzero.

The base can be of different shapes. For example, in the embodiments shown in Figures 2 to 9, the base has a hexagonal shape in section. In the context of the present invention, the term "length" and "width" of the base 332 is understood to mean the dimensions of the base 332 in orthogonal directions contained in a plane parallel to the superimposed sheets 31, 32.

In the context of the present invention, the term "thickness" of the base 332 is understood to mean a dimension of the base 332 in a direction perpendicular to the planes of the sheets 31, 32, this thickness e defining the spacing between the superposed sheets 31 , 32 at base 332.

The use of an access member 33 comprising a base 332 keeps the superposed sheets 31, 32 spaced by a non-zero distance at their upper edges 41 even when the pocket is flattened. This avoids the collabage of superimposed sheets 31, 32 near the tubing 331.

The use of an access member 33 comprising a base 332 also provides a surface for anchoring the spacer 34 which will be described in more detail below.

The distal end of the (each) tubing 331 is connected to (at one) connector (s).

connector

The (Each) connector allows the coupling of the bag to a fluid transfer set connected to the patient. The (each) connector comprises a substantially cylindrical body, a locking zone at one end of the body and a tube interface zone at the other end of the body.

An axial passage is provided in the body and the zones to allow the delivery of the liquid to be administered through the connector.

Basement

As illustrated in FIG. 4, the pocket 3 may optionally comprise a base 35 sealed between the lower edges 42 of the superposed sheets 31, 32. Like the base 332, the base 35 may be hexagonal in section. The base 35 advantageously has a thickness e non-zero so as to keep the superposed sheets 31, 32 spaced apart at their lower edges 42.

Spreader

The spacer 34 is intended to prevent the total sealing of the flow path of the aqueous solution between the lower edges 42 and upper 41 of the bag 3 when it flattens. More precisely, the spacer member 34 makes it possible to prevent the superimposed sheets 31, 32 from sticking together while keeping open a conduit for conveying the aqueous solution between the lower and upper edges 42 of the bag 3.

The spacer member 34 extends inside the volume defined by the superposed sheets 31, 32. More specifically, the spacer member 34 extends between the lower edges 42 and upper 41 of the pocket 3 .

Preferably, the spacer member extends between the superposed sheets 31, 32 over a length substantially equal to the distance between the upper edges 41 and lower 42 of the bag 3. This prevents the collabage of superimposed sheets 31, 32 over the entire length L1 of the bag 3 to limit losses in aqueous solution. Advantageously, the spacer member 34 is made of a material that is more rigid than the material constituting the superimposed sheets 31, 32. This allows the spacer member 34 to prevent crushing of the spacer member when the flattening of the pocket, so as to keep open a liquid delivery pipe, even when the pressure exerted on the pocket to flatten it is important (ie typically greater than one bar).

The spacer 34 may have different shapes. It may for example consist of:

 - a single rectilinear rod (see Figures 3 and 4) or a single curved rod (see Figure 2),

 a plurality of rods connected together (see FIGS. 5, 6 and 11) to facilitate their placement, or

 a plurality of separate rods (see FIGS. 7 to 9) to facilitate the flow of the aqueous solution out of the pocket when the latter flattens.

The use of a curved rod makes it possible in particular to maximize the surface covered by the spacer member so as to facilitate the flow of the aqueous solution out of the pocket when the latter flattens. Each rod 34 may have variable shapes in section. For example, and as illustrated in FIG. 12, the sectional shape of the rod may be an X shape 34a, 34h, a U shape 34b, a Y shape, or an O shape 34c, 34d. Preferably, the cross-sectional shape of the rod 34 is chosen from an X-shape, a U-shape or a Y-shape. These different shapes in a stick section have the advantage of giving the best results. In particular, these shapes of sections make it possible to ensure the flow of the fluid without the risk that the pocket gets stuck there, as it would be the case with grooves on a plane face. In the context of the present invention, the term "O-shape" of a rod means a circular or elliptical shape of the rod, this rod being hollow or solid. In a variant, each strip 34 may have a triangular, square or rectangular shape in section.

The use of an O shape for the rod 34 makes it possible to limit the risk of drilling one of the superposed sheets when the pocket is flattened.

Whatever the shape in section retained for the (or) rod (s), the angles of the rod portions 34 extending within the volume defined by the superimposed sheets are non-salient. Preferably, the cross-sectional area of the rod is between 0.1 mm ² and 50 mm ² . This makes it possible to guarantee the maintenance of a conduit for conveying the open aqueous solution.

Each rod can be anchored in the base 332 or in the base 35 of the pocket. This avoids the risk of displacement of the spacer member 34 within the volume defined by the superposed sheets 31, 32.

Alternatively, each strip 34 of the spacer member may be keyed in one (or more) bosses 36 formed in the edges of the pocket. For example, with reference to FIGS. 3 and 5, embodiments of the flexible bag in which the spacer member is wedged are illustrated:

 on the one hand in a boss 36 formed in the lower edge 42 of the pocket 3, and

 on the other hand in the tubing 331 of the access member 33.

Advantageously, the spacer member may be positioned between the superposed sheets 31, 32 prior to the connection of their peripheral edges 41, 42, 43, or subsequent to the connection of the peripheral edges 41, 42, 43. In this case, the spacer member is inserted through the tubing 331 into the storage volume defined by the superposed sheets 31, 32.

The reader will understand that many changes can be made without materially escaping the new lessons and benefits described here.

Therefore, all such modifications are intended to be incorporated within the scope of the appended claims.

Claims

1. Storage pouch (3) for aqueous medical solution for use in an injection device (2), said pouch comprising:  two superposed sheets (31, 32) of flexible material connected along their peripheral edges (41, 42, 43) to define a storage volume of the aqueous solution, each superposed sheet comprising upper and lower edges (41, 42 ) between a pair of longitudinal edges (43),  an access member (33) for conveying the aqueous solution between the inside and the outside of the bag, the access member having a proximal end sealed between the upper edges of the superposed sheets,  a connector coupled to a distal end of the access member,  a spacer (34) for preventing the total plating of the superposed sheets when the pouch is flattened so as to maintain a flow channel of the aqueous solution towards the access member;  characterized in that the spacer member extends in the storage space between the superimposed sheets between the lower (42) and upper (41) edges of the bag (3), the spacer being wedged in a tubing (331) of the access member (33). 2. Storage bag according to claim 1, wherein the spacer member is made of a material more rigid than the material constituting the superimposed sheets. The storage bag according to any one of claims 1 to 2, wherein the spacer member comprises at least one wand extending through the storage volume between the upper and lower edges of the superposed sheets. 4. Storage bag according to claim 3, wherein the rod is rectilinear. 5. Storage bag according to claim 3, wherein the rod is curved. The storage bag according to any one of claims 3 to 5, wherein the sectional shape of the rod is selected from an X shape, a U shape, a Y shape and an O shape. 7. Storage bag according to any one of claims 3 to 5, wherein the sectional area of the rod is between 0.1 mm ² and 50 mm ² . The storage bag according to any of the preceding claims, wherein the angles of the portions of the wand extending within the storage volume are non-protruding. The storage bag of any one of claims 1 to 8, wherein the access member comprises:  a base (332) at its proximal end sealed between the superposed sheets, and  a tubular (331) extending through the base,  the thickness of the base in a direction perpendicular to the planes of the superimposed sheets being greater than or equal to the diameter of the tubing, so that the upper edges of the superposed sheets are spaced apart by a non-zero distance equal to the thickness of the based. 10. The storage bag according to any one of claims 1 to 9, which further comprises a base (35) sealed between the lower edges (42) of the superimposed sheets the base having a non-zero thickness so that the lower edges of the overlapping sheets are spaced a distance equal to the thickness of the base. 1 1. Storage bag according to claim 10, wherein the spacer is fixed in the base. 12. Storage bag according to one of claims 1 to 10, wherein the spacer member is wedged further into a boss (36) formed in the lower edge (42) of the pocket (3). 13. A method of manufacturing a storage bag according to any one of claims 1 to 12, wherein the spacer member is positioned between the superposed sheets (31, 32) subsequent to the connection of the peripheral edges (41). , 42, 43) by inserting said spacer member through tubing (331) in the storage volume defined by the superposed sheets (31, 32).