WO2013186300A2

WO2013186300A2 - Assembly for injecting a viscous liquid product

Info

Publication number: WO2013186300A2
Application number: PCT/EP2013/062238
Authority: WO
Inventors: Samuel TERRASSE; Damien MATRAY; Nathalie MANEUF; Anne-Marie Milcent
Original assignee: Medex
Priority date: 2012-06-13
Filing date: 2013-06-13
Publication date: 2013-12-19
Also published as: FR3005581B1; FR3005581A1; WO2013186300A3

Abstract

The present invention concerns an assembly for medical use comprising: - an injection line for transferring the product to be injected between a container and the patient, said injection line comprising an upstream tubular portion and a downstream tubular portion and a check valve with a threshold on the downstream tubular portion, said check valve with a threshold allowing the passage of the fluid product from the container to the patient, - a filling line for transferring the product to be injected between a supply source and the container via the upstream tubular portion, said filling line being connected to the injection line between the upstream and downstream tubular portions and comprising a check valve allowing the passage of the fluid product from the supply source to the container, - a coupling interface on the filling line intended to be coupled to a pumping unit allowing the movement of the liquid between the supply source and the container.

Description

INJECTION ASSEMBLY OF LIQUID OR VISCOUS PRODUCT

TECHNICAL FIELD The present invention relates to the general technical field of the administration of a product, in particular liquid or viscous, to a patient, for example parenterally, possibly from a flexible bag.

More specifically, the present invention relates to an assembly for medical use for injecting liquid or viscous product into the human body.

GENERAL PRESENTATION OF THE PRIOR ART

The developments in medicine have led to the development of different methods of analyzing and monitoring the condition of patients.

Among these methods, there are the analyzes made after injection of a contrast medium, for example for medical imaging which includes both X-ray imaging and Magnetic Resonance Imaging (MRI) or nuclear medicine.

In most cases, the contrast injection operation requires the transfer of the contrast product between a container containing this contrast medium and the patient. This transfer is implemented using a medical use assembly comprising an injection line - such as a tube connected to the container on the one hand and the patient on the other hand - for the transfer of the contrast medium between the container and the patient.

It is often necessary to fill the container of contrast medium prior to transfer thereof to the patient. In this case, the injection operation comprises:

a step of filling the container with the contrast product from the power source, and

a step of transferring the contrast product between the container and the patient.

For filling the container, for example an autonomous device is used to fill the container from a power source.

However, such a solution has the disadvantage of requiring a large number of manipulations for: the connection / disconnection of the container to the autonomous device on the one hand, and

- the connection / disconnection of the container to the injection line on the other hand.

These manipulations can reduce the quality of asepsis.

To remedy this drawback, EP 0 648 513 proposes a set for medical use comprising:

an injection line for transferring the product to be injected between the container and the patient, and

- A filling line for the transfer of the product to be injected between a power source and the container.

This set has the advantage of limiting the number of connections / disconnections required for the implementation of the step of filling the container.

Using the assembly for medical use described in EP 0 648 513, the filling step can be implemented according to three different techniques: i) a gravity filling of the power source:

A disadvantage of this technique is that the filling time of the container is very long, which induces a long duration of the injection operation. The following two filling techniques are intended to reduce the filling time: ii) suction filling of the product contained in the feed source:

A disadvantage of this technique is that it can degrade the quality of the contrast product. Indeed, during suction filling, particularly with the aid of a syringe, a significant depression is created in the filling line and the water component of the contrast product can pass into the gas phase. This phenomenon is amplified in the case where the contrast product is heated.

Another disadvantage of this technique is the loss of charge in the filling line. Indeed, the displacement of the contrast product being induced by the depression created by the syringe, the speed of displacement of the contrast product is limited by the pressure difference generated between the atmospheric pressure and the pressure in the syringe, a physical limit of one bar; iii) filling by pressurization of the supply source:

A disadvantage of this technique is that it can be implemented only with a rigid power source. Moreover, this technique can be implemented at a very low pressure (less than one bar) to limit the risk of leakage. Finally, this technique does not make it possible to determine the quantity of product transferred between the primary source and the container.

An object of the present invention is to provide a set for medical use to overcome at least one of the aforementioned drawbacks.

PRESENTATION OF THE INVENTION

For this purpose, the invention proposes an assembly for medical use for injecting a patient with a liquid or viscous product, such as a contrast product, characterized in that the assembly comprises:

an injection line for transferring the product to be injected between a container and the patient, said injection line comprising an upstream tubular part, a downstream tubular part and a threshold non-return valve on the downstream tubular part, said threshold check valve allowing the liquid product to pass from the container to the patient,

a filling line for transferring the product to be injected between a supply source and the container via the upstream tubular part, said filling line being connected to the injection line between the upstream and downstream tubular parts and comprising a non-return valve allowing the passage of the liquid product from the supply source to the container,

- A coupling interface on the filling line to be coupled to a pumping unit for moving the liquid between the power source and the container. Preferred but non-limiting aspects of the assembly for medical use according to the invention are the following:

the filling line comprises a pipe upstream of the coupling interface and a pipe downstream of the coupling interface, the hardness of the pipe upstream of the coupling interface being greater than the hardness of the pipe in downstream of the coupling interface;

the hardness of the tubing upstream of the coupling interface is equal to or greater than 70 ShA (the Shore hardness, expressed in Shore A or ShA, corresponds to a unit of measurement of the hardness of elastomers or of certain plastics very well known to those skilled in the art and recognized by the international standards ISO 868 and 7619, ASTM D 2240 and DIN 53505);

the filling line comprises a pipe upstream of the coupling interface and a pipe downstream of the coupling interface, the inside diameter of the pipe upstream of the coupling interface being greater than the inside diameter the tubular part downstream of the injection line;

the inside diameter of the tubing upstream of the coupling interface is between 3 and 6 millimeters;

the filling line comprises a pipe upstream of the coupling interface and a pipe downstream of the coupling interface, the hardness of the pipe downstream of the pumping unit being less than the hardness of the tubular part downstream of the injection line;

the shore hardness of the pipe downstream of the pumping unit is between 60 and 80 ShA;

- The filling line comprises a pipe upstream of the coupling interface and a pipe downstream of the coupling interface, the diameter of the pipe downstream of the coupling interface being greater than the diameter of the downstream tubular part. the injection line;

the assembly for medical use further comprises the container, said container being connected to the injection line prior to its use;

- The container is a pocket composed of two sheets of material superimposed and welded at their periphery to define a space for containing the liquid or viscous product;

the assembly for medical use further comprises an irremovable connection between the container and the injection line. The reader will appreciate that the assembly for medical use can be used in an injector of the type described in the French patent application No. FR 1255530 filed in the name of the company MEDEX. In this case, the container of the assembly for medical use is a pocket with superimposed sheets and welded at their periphery and a pipe for the passage of the liquid or viscous product. This pocket is intended to be positioned in the injector so that the pipe of the pocket is the element of the pocket farthest from the ground, so that a possible volume of air contained in the pocket is in contact with the when the bag is filled with liquid or viscous product.

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 FIG. 1 which illustrates an embodiment of a set for medical use for the injection of a liquid or viscous product to a patient.

DESCRIPTION OF EMBODIMENTS OF THE INVENTION As indicated above, an injection operation generally comprises two phases:

a phase of filling a container with a product to be injected, and

a phase of administering the product to the patient from the container.

Indeed, the container used during an injection operation is generally empty to allow the user to use it with different types and / or concentrations of products to be injected.

The injection assembly for medical use described below allows the implementation of these two phases (i.e. filling / administration) during an injection operation.

Overview With reference to FIG. 1, there is illustrated an embodiment of the assembly for medical use for injecting a patient with a liquid or viscous product, such as a contrast product.

The assembly for medical use comprises an injection line 1 and a filling line 2. The injection line 1 allows the transfer of the product to be injected between a container 3 and the patient. The filling line 2 allows the transfer of the product to be injected between a primary supply source 4 and the container 3.

The presence of a filling line 2 improves the asepsis of the injection operation, the number of connections / disconnections necessary to allow the filling of the container 3 being limited.

The assembly for medical use also comprises a coupling interface 26 on the filling line 2. This coupling interface 26 is used to couple a pumping unit 22 to the filling line of the assembly for medical use.

The presence of a coupling interface 26 when associated with a pumping unit 22 makes it possible to accelerate the filling speed while limiting the risks of degradation of the quality of the liquid product displaced between the primary supply source 4 and the container 3.

The pumping unit 22 may be a peristaltic pump - composed of rollers and a motor - and the coupling interface 26 may be a flexible hose intended to come into contact with the rollers of the peristaltic pump. The diameter, the thickness and the elasticity of the flexible pipe are adapted to make it possible to improve the coupling of the filling line 2 with the pumping unit 22. In particular, the pumping interface may be a pipe:

- Of inner diameter between 2 and 8 millimeters, preferably between 3 and 6 millimeters and more preferably equal to 4.8 millimeters,

- Of thickness between 1 and 3 millimeters, preferably between 1 and 2 millimeters and more preferably equal to 1, 6 millimeters, and

of Shore A hardness between 55 and 75 ShA, preferably between 55 and 65 ShA and more preferably equal to 60 ShA.

The presence of a coupling interface 26 integrated with the filling line 2 makes it possible to prevent direct contact of the pumping unit 22 with the injectable solution. Thus, it is no longer necessary to clean the pumping unit 22 with each replacement of the power source, and especially when the power sources successively used contain products of different natures.

The asepsis of the filling operation is also improved, since the pumping unit 22 is not directly connected to the assembly for medical use, but is coupled thereto via the interface of FIG. coupling 26.

Injection line

The injection line 1 comprises an upstream tubular part 12, a downstream tubular part 1 1 and a connector 14 with three inputs - in particular of Y or T type connector - between the upstream and downstream tubular parts 1 1, 12. The connector 14 with three inputs makes it possible to connect the filling line 2 to the injection line 1.

One of the ends of the injection line 1 comprises a connecting element - such as a "luer lock" - intended to be connected to an injection conduit 15. This injection conduit 15 is, for example, a catheter, a hypodermic or intravenous needle or any other type of injection conduit known to those skilled in the art.

The other end of the injection line 1 is connected to the container 3 for containing the product to be injected into the patient.

Advantageously, the container 3 can be integrated into the assembly for medical use. In other words, the assembly for medical use comprises the container 3. In this case, the container 3 is pre-connected to the injection line 1 during the manufacture of the assembly for medical use.

Thus, the user does not need to connect the container 3 to the injection line 1 when using the assembly for medical use.

This limits the number of manipulations required for the installation of the assembly for medical use. This also makes it possible to increase the asepsis of the assembly for medical use. Finally, this limits the risk of error - for example related to the connection of a container that is not suitable for the assembly for medical use - during the installation of the assembly for medical use. Preferably, the assembly for medical use further comprises an irremovable connection 31 between the container 3 and the injection line 1. This limits the risk of disconnection between the container 3 and the injection line 1.

In the context of the present invention, the term "irremovable connection" means an element (for example a weld, a glue, or any other element known to those skilled in the art) permitting a permanent assembly of two parts so that these two pieces can no longer be separated from one another, the assembly of the two parts by this element being performed prior to the use of the assembly, especially during the manufacture of the assembly.

In any case, the container 3 intended to contain the product to be injected may be:

a syringe composed of a cylindrical body in which is housed a piston covered with an elastomer seal on its front face, said piston being able to move in translation between a retracted position (where the syringe is empty) and an extended position (where the syringe is filled with the product to be injected),

a flexible pouch composed for example of two superimposed sheets and welded at their periphery to define a space intended to contain the liquid or viscous product,

- or any other type of container known to those skilled in the art.

However, in certain embodiments, a container 3 of the pocket type will be preferred, in particular to improve the asepsis of the assembly for medical use. Indeed, in the case of a container 3 of the syringe type, the internal portion of cylindrical body located at the rear of the elastomeric seal is in contact with the ambient air, which, when the piston moves between the deployed positions and retracted, can decrease asepsis.

The injection line 1 may also comprise a non-return valve 13 on the downstream tubular part 1 1. This non-return valve 13 allows the passage of liquid in a single direction, namely from the container 3 to the patient.

Advantageously, the nonreturn valve 13 may have a high opening threshold (i.e. greater than 500 mbar). This avoids the risk of transfer of liquid product directly to the patient (without passing through the container) during the filling phase.

The non-return valve 13 may also have a higher opening threshold, in particular greater than 1.5 bar (ideally greater than or equal to 2 bar) for allow the use of the assembly for medical use in an injector of the type described in French Patent Application No. FR 1255530 in the name of the company MEDEX.

Such an injector comprises a housing consisting of two articulated half-shells in order to allow the relative displacement of the half-shells relative to one another between:

an open position for the placement of the container 3 of the assembly for medical use, and

- a closed position for the implementation of the filling and administration phases.

One of the half-shells comprises a bladder - called "active bladder" - deformable variable volume under the action of a hydraulic power source supplying said bladder with hydraulic fluid. The other of the half-shells includes a deformable cushion at constant volume - called "passive cushion".

The fact that the opening threshold of the threshold valve is greater than 1.5 bar (and preferably greater than or equal to 2 bar) makes it possible to ensure good veneering of the container against the bladder and the cushion. This plating is necessary to allow such an injector to control:

the quantity of contrast medium injected into the patient during an administration phase,

the amount of contrast medium introduced into the container during a filling phase.

Indeed, during an administration phase, the operating principle of such an injector is as follows: the bladder is filled with hydraulic fluid so that the walls of the container are pressed against the walls of the cushion and the bladder . When the walls of the bladder and cushion are pressed against the container, the introduction of a given amount of hydraulic fluid into the bladder induces the expulsion of the same amount of contrast medium out of the container. For example, one milliliter of incompressible fluid introduced into the bladder mechanically "flushes" one milliliter of contrast material out of the container 3. Thus, once the walls of the container are pressed against the bladder and cushion, it is possible to accurately control the amount of product injected into the patient by measuring the amount of hydraulic fluid introduced into the bladder.

During a filling phase, the operating principle of such an injector is as follows: the bladder is filled with hydraulic fluid so that the container walls are pressed against the cushion and bladder. The introduction of contrast material into the container induces an increase in its volume which tends to apply a pushing force on the cushion and the bladder. This force induces the expulsion of hydraulic fluid from the bladder. More specifically, when the walls of the container are pressed against the bladder and the cushion, the introduction of a given amount of contrast medium into the container induces the expulsion of the same amount of hydraulic fluid out of the bladder. . Thus, once the walls of the container are pressed against the bladder and cushion, it is possible to accurately control the amount of contrast medium introduced into the container by measuring the amount of hydraulic fluid expelled from the bladder.

The fact that the opening threshold of the threshold valve is greater than 1.5 bar (and preferably greater than or equal to 2 bar) makes it possible to guarantee a good plating of the container 3 on the bladder and the cushion even before the slightest flow of contrast product out of the container, the flow of contrast product out of the container requiring a minimum pressure of 1.5 bar in the container.

Filling line

The filling line 2 comprises a pipe 21 upstream of the coupling interface 26 and a pipe 23 downstream of the coupling interface 26.

In an alternative embodiment, the length of the tubing 21 upstream of the coupling interface 26 is between 400 and 800 millimeters in order to limit the pressure drops between the coupling interface 26 and the power source 4 when suction of the fluid for filling the container 3.

Moreover, the inside diameter of the pipe 21 upstream of the coupling interface 26 may be greater than the inside diameter of the downstream tubular part 1 1 of the injection line 1. In particular, the internal diameter of the tubing 21 upstream of the pumping unit 22 may be between 3 and 6 millimeters.

Maximizing the internal diameter of the pipe 21 upstream of the coupling interface 26 limits the pressure losses between the primary power source 4 and the coupling interface 26 during the suction of the fluid for the filling of the container 3.

In addition, the hardness of the tubing 21 upstream of the coupling interface 26 may be greater than the hardness of the tubing 23 downstream of the coupling interface 26. In particular, the hardness of the tubing 21 upstream of the coupling interface 26 may be equal to or greater than 70 ShA. The fact of having a tubing 21 with a hardness equal to or greater than 70 ShA makes it possible to avoid collapsing thereof during the suction of the fluid for filling the container 3. Preferably, the hardness of the tubing is selected less than 90 ShA to facilitate its winding during packaging and facilitate its handling by the operator during installation on the injector.

Advantageously, the hardness of the pipe 23 downstream of the coupling interface 26 may be chosen to be less than the hardness of the downstream tubular portion 11 of the injection line 1. In particular, the Shore A hardness of the tubing 23 downstream of the coupling interface 26 may be between 60 and 80 ShA.

The fact that the hardness of the tubing 23 is less than or equal to 80 ShA enables the filling line 2 to absorb the pulsations possibly generated by the pumping unit 22 in order to limit the risks of overpressure in the overall use. medical, overpressure may induce product leakage to the patient through the high-threshold check valve 13 of the injection line 1. The fact that the hardness of the tubing 23 is greater than or equal to 60 ShA limits the risk of rupture of this tubing 23 under the effect of pressure.

As a variant, the diameter of the pipe 23 downstream of the coupling interface 26 may be chosen to be greater than the diameter of the downstream tubular portion 11 of the injection line 1. In particular, the diameter of the tubing 23 downstream of the coupling interface 26 may be between 3 and 6 millimeters. Here again, this makes it possible to absorb the pulsations generated by the pumping unit 22.

The filling line 2 may also include a check valve 25 allowing the passage of liquid in a single direction, namely from the primary supply source 4 to the container 3. The presence of a nonreturn valve 25 allows to isolate the filling line 2 after completion of the filling phase, and this without requiring manipulation of the user prior to the implementation of the phase of administration of the product to the patient.

The filling line 2 may comprise a bubble scavenger 24 such as a dropper chamber between the primary supply source 4 and the container 3. This bubble scavenger 24 makes it possible to drive the air between the source of the fuel. primary feed 4 and the container 3. Principle of operation of the whole

The operating principle of the assembly for medical use described above is as follows: during the implementation of a product injection operation to a patient, the user exits the assembly for medical use of its packaging. It connects:

the free end of the filling line 2 to the primary power source 4, and

- The free end of the injection line 1 to the patient after purging it.

When the container 3 is integrated into the assembly, no connection step thereof is necessary, which limits the risk of contamination of the assembly when it is put in place.

The user then implements the filling phase. The pumping unit 22 is actuated to fill the container 3 with the product to be injected. The product to be injected moves between the primary supply source 4 and the container 3. The high-threshold check valve 13 prevents the passage of the product in the downstream tubular part 1 1 of the injection line 1 so that to avoid any risk of inadvertent output of product to be injected to the free end of the injection line 1 during the filling phase.

The container 3 fills with product to be injected. When the quantity of product contained in the container 3 is sufficient, the user interrupts the filling phase to implement the phase of administering the product to the patient having previously purged the air initially contained in the filling lines 2 and injection 1.

The container 3 is then pressurized - for example by using a bag injector or a syringe pusher device - to induce the movement of the product between the container 3 and the patient.

The non-return valve 25 of the filling line 2 prevents the passage of the product between the container 3 and the primary supply source 4. The product passes through the injection conduit 15 and enters the patient. When a sufficient quantity of product has been administered to the patient, the administration phase is interrupted either automatically or by user actuation.

Thus, the assembly described above makes it possible to carry out rapid transfers of liquid or viscous product between:

a primary power source 4 and a receptacle 3 on the one hand, and the container 3 and a patient on the other hand,

while limiting the risk of contamination by the user.

The reader will have understood that many modifications can be made to the assembly for medical use without physically going out of the new teachings and advantages described here.

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

Claims

Assembly for medical use for injecting a patient with a liquid or viscous product, such as a contrast product, characterized in that the assembly comprises:

- an injection line (1) for transferring the product to be injected between a container (3) and the patient, said injection line (1) comprising an upstream tubular part (12), a downstream tubular part (1 1 ) and a threshold non-return valve on the downstream tubular part, said threshold non-return valve (13) allowing the passage of the liquid product from the container (3) towards the patient,

- a filling line (2) for transferring the product to be injected between a power source (4) and the container (3) via the upstream tubular part (12), said filling line

(2) being connected to the injection line (1) between the upstream and downstream tubular parts (1 1, 12) and comprising a non-return valve (25) allowing the passage of the liquid product from the supply source ( 4) towards the container

(3),

- a coupling interface (26) on the filling line (2) intended to be coupled to a pumping unit (22) allowing the movement of the liquid between the power source

(4) and the container (3).

Assembly for medical use according to the preceding claim, in which the filling line (2) comprises a tube (21) upstream of the coupling interface (26) and a tube (23) downstream of the coupling interface ( 26), the hardness of the tubing (21) upstream of the coupling interface (26) being greater than the hardness of the tubing (23) downstream of the coupling interface (26).

Assembly for medical use according to the preceding claim, in which the hardness of the tubing (21) upstream of the coupling interface (26) is equal to or greater than 70 ShA.

Assembly for medical use according to one of the preceding claims, in which the filling line (2) comprises a tube (21) upstream of the coupling interface (26) and a tube (23) downstream of the interface coupling (26), the internal diameter of the upstream tubing (21) of the coupling interface (26) being greater than the internal diameter of the downstream tubular part (1 1) of the injection line (1).

5. Assembly for medical use according to the preceding claim, wherein the internal diameter of the tubing (21) upstream of the coupling interface (26) is between 3 and 6 millimeters.

6. Assembly for medical use according to one of the preceding claims, in which the filling line (2) comprises a tube (21) upstream of the coupling interface (26) and a tube (23) downstream of the coupling interface (26), the hardness of the tubing (23) downstream of the pumping unit (22) being less than the hardness of the downstream tubular part (1 1) of the injection line (1) .

7. Assembly for medical use according to the preceding claim, in which the shore hardness of the tubing (23) downstream of the pumping unit (22) is between 60 and 80 ShA.

8. Assembly for medical use according to one of the preceding claims, in which the filling line (2) comprises a tube (21) upstream of the coupling interface (26) and a tube (23) downstream of the coupling interface (26), the diameter of the tubing (23) downstream of the coupling interface (26) being greater than the diameter of the downstream tubular part (1 1) of the injection line (1).

9. Assembly for medical use according to one of the preceding claims, which further comprises the container (3), said container (3) being connected to the injection line (1) prior to its use.

10. Assembly for medical use according to the preceding claim, in which the container (3) is a pocket composed of two sheets of material superimposed and welded at their periphery to define a space intended to contain the liquid or viscous product. Assembly for medical use according to one of the preceding claims, which further comprises an irremovable connection (31) between the container (3) and the injection line (1).