KR20160122190A - Flexible medical bag - Google Patents

Abstract

The present invention relates to a storage pouch (3) for a medical aqueous solution which can be used in an infusion device (2), said pouch comprising: two pieces of flexible material Superposed sheets (31, 32); An access member (33) comprising a proximal end sealed between the overlapping sheets, for transferring the aqueous solution between the inside and the outside of the pouch; And a connector coupled to the distal end of the access member, the pouch further comprising a plurality of pouches to prevent the superimposed sheets from fully adhering together when the pouch is flattened to maintain an open state of the channel such that aqueous solution flows through the access member And that the spacer member extends into the storage volume between the overlapping sheets and is fixed to the pipe 331 of the access member 33. In this way,

Description

{FLEXIBLE MEDICAL BAG}

The present invention relates to a general technical field of administering a product to a patient, for example, by injection.

More particularly, the present invention relates to an aqueous solution for administration to a patient, in particular a flexible container (hereinafter referred to as a "pouch ") containing a contrast agent product.

BACKGROUND OF THE INVENTION [0002] Flexible pouches containing an aqueous solution, such as a contrast agent product, for administration to a patient are known, for example, during imaging by X-ray or medical imaging such as magnetic resonance imaging (MRI).

This type of pouch 1 typically includes the following:

Two superposed sheets defining a volume (11) for the periphery to be welded to contain the aqueous solution,

An outlet pipe (12) sealed between the overlapping sheets to define a channel for the flow of aqueous solution between the inside and the outside of the pouch, and

A connector (not shown) secured to the free end of the pipe 12 to enable connection of the pouch 1 to the fluid delivery set connected to the patient.

In most cases, administration of the aqueous solution requires transfer of the aqueous solution between the pouch and the patient. Such transfer can be accomplished using an injection device or by gravity, as described in documents FR 2 991 881, EP 0 648 513, and EP 0 852 152. Figure 1 shows the injection device 2 described in document FR 2 991 881, which means that the relative movement between the open position for putting the pouch in place and the closed position for injecting the liquid product contained in the pouch Shells 21, 22, which are described as being possible.

More generally, all the injection devices described in documents FR 2 991 881, EP 0 648 513, and EP 0 852 152 include a housing for receiving the pouch. These are based on the use of a driving fluid 23 which is surrounded and pressed against the pouch 1 to serve to push out the liquid out of the pouch.

In order to facilitate the discharge of unwanted bubbles which may be contained in the flexible pouch, the housing is oriented such that the pipe 12 of the pouch 1 is opened towards the top of the housing, as shown in Fig. 1, Lt; RTI ID = 0.0 > of sheets < / RTI >

The disadvantages of conventional pouches are related to the loss of some of the aqueous solution contained in the pouches. The loss of some of the aqueous solution is associated with the injection process using an injection device, which will be described in more detail below with reference to FIG.

The driving fluid 23 contained in the housing of the injector device 2 during the injection of the aqueous solution into the patient is subjected to forces such that the forces acting on the walls of the pouch 1 which tend to press against each other to push the liquid out of the pouch 1. [ . Pressing of the pouch 1 in the housing is liable to cause adhesion 14 of the overlapping sheets of the pouch.

As shown in Fig. 1B, such an attachment 14 confines a non-negligible portion of the aqueous solution contained in the pouch (up to 20% of the contents, i. E. Corresponding to the dose for the patient).

The adhesion phenomenon occurs when the aqueous solution to be injected is at the bottom of the pouch 1, preferably at the end of the injection, and the pressure applied in the transverse direction by the drive fluid 23 is at the center and upper part of the pouch 1 Blocking the passage of the liquid to form a sealed barrier.

This phenomenon does not occur systematically. This is due to the introduction of a high flow rate by the injection device (i.e. a flow rate greater than 4 ml / s) when the volume of the aqueous solution remains approximately equal to 1/4 to 1/3 of the approximate total volume of the pouch, Lt; / RTI >

Therefore, the adhesion phenomenon leads to a loss of a part of the aqueous solution contained in the pouch 1. If the cost of the aqueous solution is high (often the case of contrast agent products), it is desirable to limit this loss. Moreover, if adhesion occurs during injection of the contrast agent, the patient may not receive a sufficient amount of the contrast agent product and may need to restart the injection procedure.

In order to help the aqueous solution flow out of the pouch 1, various solutions have been proposed which alleviate these disadvantages as follows:

Thermoforming of the superposed sheets, or

Embossing of the opposed walls of the overlapping sheets, as described in document US 4,810,451.

However, these solutions are unsatisfactory for the following reasons:

When the thermoforming of the pouch is involved, it is disadvantageous in that it does not have sufficient durability over time, such as overlapping sheets of the PVC type, especially when the overlapped sheets are composed of materials having a flexural strength of about 75 shA . In fact, on the one hand, thermoforming is easy to relax over time, and on the other hand the stacking of the pouches can cause the thermoforming to collapse;

Furthermore, thermoforming of the pouch significantly (or even totally) loses its effect when injected at high pressure;

- When embossing of the opposed walls of the overlapping sheets is involved, it is effective during low pressure injection of aqueous solution (for example by gravity injection), whereas it is completely ineffective in relation to high pressure injection using an injection device. In practice, the dimensions of the protrusions formed on the opposed walls of the overlapping sheets are too small to prevent adhesion.

In document WO 85/04383, it is proposed to arrange the insert in the pouch to enable the fluid to retain the channel for circulation from the flexible pouch outward when the pouch is emptied and its walls meet. However, the pouch with the proposed insert is not entirely satisfactory. In fact, securing the insert to the pouch is complex and must be performed prior to sealing the pouch, which requires a dedicated manufacturing process. Moreover, the insert does not prevent adhesion near the exit orifice of the pouch. On the other hand, these pouches are designed for low pressure injection of aqueous solution (e.g., by gravity injection) and are not suitable for high pressure injection using an injection device. Finally, the proposed insert has small grooves on its surface, increasing the risk that the pouch will get caught in these grooves.

It is therefore an object of the present invention to propose a flexible container for storing an aqueous solution to be injected into a patient, said container being designed to limit adhesion phenomena when used in an injection device, Do.

To this end, the invention relates to an injection device, in particular a medical aqueous solution usable in an injection device operating at high pressure (i. E., Preferably above 1 bar, more preferably above 4 bar, even more preferably above 14 bar) , More specifically a storage pouch for a contrast agent product, said pouch comprising:

Two overlapping sheets of flexible material, each of which is connected along a peripheral edge to define a storage volume of the aqueous solution, each having an upper and a lower edge between a pair of longitudinal edges,

An access member for transferring the aqueous solution between the inside and the outside of the pouch, the access member comprising a proximal end sealed between the upper edges of the overlapping sheets,

A connector coupled to the distal end of the access member, and

- to extend into the storage volume between the overlapping sheets between the upper and lower edges of the pouch and to allow the overlap sheets to fully adhere together when the pouch is flattened to maintain the channel open so that aqueous solution flows through the access member And a spacer member for preventing the spacer member from coming off,

The spacer member is fixed to the pipe of the access member.

By fixing the spacer member to the pipe, it is possible to keep the spacer member in the pouch without including a dedicated fastening means in the pouch, and the pouch itself fixes the spacer member in place. The spacer member can then be made in a very simple design, making it possible to manufacture with relatively low cost processes such as extrusion. Moreover, the fact that the spacer member passes through the pipe ensures that fluid is discharged by the access member through this pipe along the spacer member, by keeping the flow channel through the pipe.

Moreover, the spacer member can be inserted into the pouch through the pipe after manufacturing the pouch. This enables the present invention to be used in conjunction with existing manufacturing methods. Moreover, a spacer member that is fixed in a position extending into the storage volume between the overlapping sheets between the upper and lower edges of the pouch makes it stiff and restricts the folding of the pouch.

In the context of the present invention, "complete attachment" of the overlapping sheets means that it is bonded over the entire lateral portion of the pouch.

A preferred but non-limiting aspect of the pouch according to the present invention is as follows:

The spacer element can be made of a material which is harder than the material constituting the superposed sheet; It will be appreciated that the smaller the portion of the overlapping sheets, the greater the stiffness of the material constituting the spacer member than the stiffness of the material constituting the overlapping sheet;

Each of the overlapping sheets may have 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 overlapping sheets, and the spacer member being overlapped from the upper edge toward the lower edge Extends between the longitudinal edges of the sheets;

The spacer element may comprise at least one rod extending over the storage volume between the upper and lower edges of the overlapping sheets;

- the rod can be straight;

- the rod can be curved;

- the cross-sectional shape of the rod can be selected from X-shaped, U-shaped, Y-shaped and O-shaped;

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

The edges of the parts of the rod inside the storage volume may not protrude; In the context of the present invention, "non-protruding edge" means an edge that does not cause the pouch to tear;

The access member may include a base portion with a proximal end sealed between the overlapping sheets and a pipe extending through the base portion so that the upper edge of the overlapping sheets is spaced apart by a nonzero distance equal to the thickness of the base portion, The thickness of the base portion in a direction perpendicular to the plane of the sheets is greater than or equal to the diameter of the pipe;

The spacer member can be fixed within the base of the access member;

The base has a non-zero thickness such that the pouch comprises a base sealed between the lower edges of the overlapping sheets, the lower edge of the overlapping sheets being spaced by a distance equal to the thickness of the base;

The spacer element can be fixed to the base;

The spacer member is also fixed to the protrusion formed on the lower edge of the pouch.

The present invention also relates to a method of manufacturing a storage pouch in accordance with the present invention, wherein after inserting the spacer member through a pipe into a storage volume defined by the overlap sheets, connecting the peripheral edges, The spacer member is located.

Other features and advantages of the present invention will become more apparent from the following description, which is illustrative and not restrictive, and should be read with reference to the accompanying drawings.
Figures 1a and 1b are schematic diagrams of the injection device described in document FR 2 991 881.
Figures 2-9 illustrate various embodiments of a storage pouch according to the present invention for a medical aqueous solution.
10 and 11 are schematic perspective views of the space member.
12 is a cross-sectional view of various examples of spacer members.

Various embodiments of flexible containers according to the present invention will now be described. In the various drawings, equivalent elements are given the same reference numerals.

2 to 9, there are shown various examples of the flexible container 3 according to the present invention. The container 3 comprises two superposed sheets 31, 32, an access member 33 and one or more connectors (not shown). The container further includes a spacer member (34) and may include a base (35).

Sheet

The superposed sheets 31, 32 may define a volume for containing an aqueous solution such as a contrast agent product.

Each sheet 31,32 is made of a flexible or flexible material, possibly transparent or translucent, such as a polymeric material, preferably a thermoplastic material, including polyethylene, polypropylene, polyvinyl chloride, vinyl ethylene acetate And may be composed of a plurality of stacked thin films.

The sheets 31,32 consist of an approximate length "L1" and an approximate width "11 ", and are connected together by welding, by adhesion, or by any other technique known to those skilled in the art .

2 to 9, each of the sheets 31,32 includes an upper edge 41, a lower edge 42, and a lower edge 42 between the upper edge 41 and the lower edge 42. In this embodiment, And each of the lower edges 42 and each of the longitudinal edges 43 are connected to one another.

The connection between the peripheral edges 41, 42 and 43 of the overlapping sheets 31 and 32 may be direct (that is, the peripheral edges of the sheets 31 and 32 are in direct contact with each other) or indirectly (The middle portion extends between the peripheral edges of the first and second portions 31, 32).

Of course, the connection between the sheets 31, 32 may be direct at some edge 43 and indirect at the other edge 41. [

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

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

The upper edge 41 is connected indirectly to one another and the base 332 of the access member 33 extends between the upper edges 41 of the overlapping sheets 31,

In another embodiment (as shown in Figure 4);

The longitudinal edges 43 of the sheets 31, 32 are connected directly to one another,

The upper edge 41 and the lower edge 42 of the sheets 31 and 32 are connected indirectly to each other and the portion forming the base 35 extends between the lower edges 42 of the sheets 31 and 32 And the base portion 332 of the access member 33 extends between the upper edges 41 of the sheets 31,32.

Access member

The access member 33 allows to define a channel for the flow of aqueous solution between the inside and the outside of the pouch.

The access member can be sealed between the overlapping sheets 31, 32 at its upper edge (preferably by heat welding, by high frequency welding or by adhesion).

The access member 33 may comprise one or more pipes 331. In this case, the proximal end of the (each) pipe 331 is sealed to the upper edge of the overlapping sheets 31, 32.

Alternatively, the access member 33 may include a base portion 332 through which one or more pipes 331 extend. In this case, the base portion 332 is sealed at the upper edge of the overlapped sheet. The base has non-zero length "L2 ", width" 12 ", and thickness "e ".

The base can have various shapes. For example, in the embodiment shown in Figures 2-9, the base has a hexagonal cross-sectional shape.

In the context of the present invention, the "length" and "width" of the base portion 332 refer to the dimensions of the base portion 332 in the orthogonal direction included in the plane parallel to the overlapping sheets 31,

The thickness of base 332 means the dimension of base 332 in a direction perpendicular to the plane of sheets 31 and 32 and such thickness e is at the level of base 332 And defines the interval between the superposed sheets 31,

The use of the access member 33 including the base portion 332 makes it possible to maintain the overlapping sheets 31 and 32 at a distance other than 0 at the level of the upper edge 41 even when the pouch is flattened Do. This prevents the overlapping sheets 31 and 32 from adhering together in the vicinity of the pipe 331.

Using an access member 33 that includes a base portion 332, it is also possible to provide a surface for securing the spacer member 34, which will be described in greater detail below.

The distal end of the (each) pipe 331 is connected to one of the connectors or connectors.

connector

(Each) connector allows the pouch to be coupled to the fluid delivery set connected to the patient.

(Each) connector includes a substantially cylindrical body, a locking region of one of the ends of the body, and a tube connecting region at the other end of the body.

An axial passageway is provided in the body, and the above-described zones enable the delivery of liquid to be dispensed through the connector.

Base

4, the pouch 3 may optionally include a base 35 sealed between the lower edges 42 of the overlapped sheets 31, 32. As shown in Fig. Like the base portion 332, the base portion 35 may have a hexagonal cross-section.

The base 35 advantageously has a non-zero thickness e so as to keep the overlapped sheets 31, 32 apart from the level of the lower edge 42.

Spacer  absence

The spacer member 34 is for preventing the flow path of the aqueous solution from being completely sealed between the upper edge 41 and the lower edge 42 of the pouch 3 when the pouch is flattened.

More specifically, the spacer member 34 is formed by overlapping the superposed sheets 31 and 32 by keeping the ducts for the flow of the aqueous solution between the upper edge 41 and the lower edge 42 of the pouch 3 open. Can be prevented from adhering together.

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

The length of the spacer member between the overlap sheets 31 and 32 is preferably substantially the same as the distance between the upper edge 41 and the lower edge 42 of the pouch 3. This can prevent the overlapped sheets 31 and 32 from adhering to the entire length L1 of the pouch 3 in order to limit the loss of the aqueous solution.

The spacer member 34 is advantageously made of a material that is harder than the material of the overlapping sheets 31, 32. This allows the spacer member 34 to prevent the spacer member from collapsing when the pouch is flattened so that even when the pressure that is applied to the pouches to flatten them is high (i.e., typically greater than 1 bar) Keep the duct open.

The spacer member 34 may have various shapes. This may for example consist of:

- a single straight rod (see FIGS. 3 and 4) or a single curved rod (see FIG. 2)

- a plurality of rods (Figures 5, 6 and 11) interconnected to facilitate mounting, or

A plurality of individual rods (see Figures 7 to 9) that facilitate the flow of aqueous solution out of the pouch when the pouch is flattened.

The use of the curved rod maximizes the area covered by the spacer member in particular and facilitates the flow of aqueous solution out of the pouch when the pouch is flattened.

Each rod 34 may have various cross-sectional shapes. For example, as shown 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. The cross-sectional shape of the rod 34 is preferably selected from an X-shape, a U-shape or a Y-shape. These various rod cross-sectional shapes have the advantage of providing the best results. In particular, these cross-sectional shapes make it possible to ensure fluid flow, without the risk of being trapped, such as when grooves are provided on planar surfaces.

In the context of the present invention, the "O-shape" of the rod means a circular or elliptical shape of the rod, which rod is hollow or solid.

Alternatively, each rod 34 may have a triangular, square, or rectangular cross-sectional shape.

Using an O-shape for the rod 34, it is possible to limit the risk of penetrating one of the overlapping sheets when the pouch is flattened.

No matter what the cross-sectional shape is for the rod or rods, the edge of the portion of the rod 34 extending within the volume defined by the overlapping sheets does not protrude.

The cross-sectional area of the rod is preferably from 0.1 mm 2 to 50 mm 2. This can ensure that the flow duct of the aqueous solution remains open.

Each rod may be secured within the base 332 or within the base 35 of the pouch. This makes it possible to avoid the risk of the spacer member 34 moving within the volume defined by the overlapping sheets 31,

Alternatively, each rod 34 of the spacer member may be secured to one or more protrusions 36 provided at the edge of the pouch. For example, referring to Figures 3 and 5,

On the one hand, to the projection 36 provided on the lower edge 42 of the pouch 3, and

On the other hand, to the pipe 331 of the access member 33

Embodiments of a fixed flexible pouch are shown.

The spacer member may advantageously be positioned between the overlapping sheets 31, 32 before connecting the peripheral edges 41, 42, 43 or after connecting the peripheral edges 41, 42, 43. In this case, the spacer member is inserted through the pipe 331 into the storage volume defined by the overlap sheets 31, 32.

It will be understood that numerous modifications may be made without departing substantially from the novel teachings and advantages herein.

As a result, all modifications of this type are deemed to fall within the scope of the appended claims.

Claims (13)

In a storage pouch (3) for a medical aqueous solution usable in the injection device (2)
And defining a storage volume of the aqueous solution to be connected along peripheral edges 41,42 and 43 and each having upper and lower edges 41,42 between a pair of longitudinal edges 43, Two overlapping sheets (31, 32) made up of;
An access member (33) comprising a proximal end sealed between said upper edges of said overlapping sheets, for transferring said aqueous solution between the inside and outside of said pouch;
A connector coupled to a distal end of the access member; And
And a spacer member (34) for preventing the superposed sheets from fully adhering together when the pouch is flattened to maintain an open state of the channel so that the aqueous solution flows through the access member,
The spacer member extends into the storage volume between the overlapping sheets between the upper edge 41 and the lower edge 42 of the pouch 3 and is fixed to the pipe 331 of the access member 33 Storage pouch to make. The method according to claim 1,
Wherein the spacer member is made of a material that is harder than the material making up the overlap sheets. 3. The method according to claim 1 or 2,
Wherein the spacer member comprises at least one rod extending across the storage volume between the upper and lower edges of the overlap sheets. The method of claim 3,
Wherein said rod is straight. The method of claim 3,
Said rod being curved. 6. The method according to any one of claims 3 to 5,
Wherein the cross-sectional shape of the rod is selected from an X-shape, a U-shape, a Y-shape and an O-shape. 6. The method according to any one of claims 3 to 5,
Sectional area of the rod is 0.1 mm < 2 > to 50 mm < 2 >. 8. The method according to any one of claims 1 to 7,
Wherein edges of portions of the rod extending within the storage volume do not protrude. 9. The method according to any one of claims 1 to 8,
The access member comprising:
A base portion (332) having a proximal end sealed between the overlapping sheets; And
And a pipe (331) extending through the base,
The thickness of the base portion being greater than or equal to the diameter of the pipe in a direction perpendicular to the plane of the overlapping sheets such that the upper edge of the overlapping sheets is spaced apart by a non-zero distance equal to the thickness of the base portion. 10. The method according to any one of claims 1 to 9,
Further comprising a base portion (35) sealed between the lower edges (42) of the overlapping sheets, wherein the base portion has a non-zero thickness such that the lower edge of the overlapping sheets is spaced by a distance equal to the thickness of the base portion , Storage pouch. 11. The method of claim 10,
Wherein the spacer member is secured to the base. 11. The method according to any one of claims 1 to 10,
Wherein the spacer member is also secured to a projection (36) formed in a lower edge (42) of the pouch (3). The spacer member is formed by connecting the peripheral edges 41, 42 and 43 by inserting the spacer member through the pipe 331 into the storage volume defined by the overlap sheets 31 and 32, Is located between the first and second openings (31,32). ≪ RTI ID = 0.0 > 11. < / RTI >

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