WO2019123487A1

WO2019123487A1 - Syringe assembly

Info

Publication number: WO2019123487A1
Application number: PCT/IT2017/000282
Authority: WO
Inventors: Nicola Zerbinati
Original assignee: Matex Lab S.P.A.
Priority date: 2017-12-19
Filing date: 2017-12-19
Publication date: 2019-06-27

Abstract

A syringe assembly comprises a pusher unit (1 1) and a containing unit (12) able to be coupled with each other to form a syringe (10), wherein the pusher unit (1 1) comprises a main body (13) and a plunger (18) provided with a shaft (40) slidable in the main body (13) along a longitudinal axis (X), and the containing unit (12) comprises a tubular container (14) defining a chamber (15) for containing a fluid.

Description

“SYRINGE ASSEMBLY”

FIELD OF THE INVENTION

The present invention concerns an assembly suitable to form a syringe, comprising at least one pusher unit and a fluid container unit which can be assembled together to obtain a syringe. The fluid can be a liquid with the most varied viscosity, or a gel. For example, the fluid can be a filling substance, in the aesthetic and medical field called“filler”, which has to be injected under the skin of a patient.

The present invention concerns both the pusher unit and also the container unit of the fluid to be dispensed.

BACKGROUND OF THE INVENTION

Many different types of syringes used in various sectors are known in the state of the art. In particular, in the pharmaceutical and cosmetic field, the use of these syringes is very widespread to inject drugs or similar products for esthetic or medical treatments under the skin of patients.

It is known that an increasing number of users undergo esthetic treatments aimed at reducing wrinkles and/or signs of age from the face, or other zones of their body, generally due to a limited elasticity of the skin, in order to take on a more youthful appearance.

These treatments generally provide to inject a filling substance, known in the field as“filler”, in the zones affected by wrinkles, in such a way as to suitably fill the zone underneath the skin so as to obtain a substantially smooth and taut portion of skin.

The injections are generally carried out by doctors or specialized operators who locally dispense the filling substance in suitable quantities.

Typically, the syringes known in the state of the art are disposable and are thrown away after injection.

The syringes of the conventional type generally comprise a cylindrical tubular body, at one end of which a needle is attached, and in which the fluid to be injected can be introduced, and a piston, sliding inside the cylindrical body and manually operated by the operator to facilitate the delivery of fluid through the needle. Generally the body of the syringe and the needle are supplied separately and are associated with each other by the operator at the time of injection.

In some types of syringes known in the art, after the needle has been screwed to the body of the syringe, the operator penetrates with the needle inside the vial or bottle in which the fluid to be injected is stored, and subsequently the fluid enters the cylinder through the needle. To fill the cylinder, the operator extracts the piston from the cylinder so as to create a depression inside it able to suck in the fluid.

In other types of syringes known in the art, the syringe is supplied already full. In this case, the cylinder is filled with the fluid to be injected during the production of the syringe. When the operator associates the needle with the body of the syringe, it is already ready for injection.

One disadvantage of known syringes is that, after use, they do not comprise any reusable part or component. This has the disadvantage of having to manage the disposal of used syringes, which is particularly costly since they are so-called “special waste” in which different components, such as the needle and the body of the syringe, normally have differentiated and expensive disposal cycles.

Another disadvantage of syringes known in the art is that, during the injection, they do not allow the operator to know in a precise way the quantity of fluid which he is dispensing in an easy and immediate manner.

Given the increasingly widespread trend toward these types of treatments, the need is increasingly felt to find solutions that allow to dose the substances to be injected quickly and easily and at the same time to comply with hygiene standards, preserving the health of patients.

One disadvantage of the syringes known in the art is that they are not convenient and practical to use, in particular in certain conditions of use.

Another disadvantage of the syringes known in the art is that they have a structure which is not suitable to withstand considerable thrust forces, especially in the case of fluids with high viscosity.

One purpose of the present invention is to provide an assembly suitable to form an improved syringe with respect to the syringes known in the art.

Another purpose of the present invention is to provide an assembly to form a syringe which can be assembled by the operator easily and quickly. Another purpose of the present invention is to provide an assembly that allows to obtain a syringe that is easy to use, and has a safe and reliable operation.

Another purpose of the present invention is to provide a pusher unit and a container for the fluid which can be connected to one another simply, quickly and at the same time reliably.

Another purpose of the present invention is to provide a pusher unit which is able to withstand considerable thrust forces and to dispense fluids, even of high viscosity.

Another purpose is to provide a pusher unit and a container which can be disconnected from one another in a simple and immediate manner.

Yet another purpose of the present invention is to provide an assembly which allows to obtain a syringe in which the fluid to be injected does not undergo contamination due to contact with non-sterilized external components.

Another purpose of the present invention is to provide a rechargeable system in which it is possible to associate, for each use, a“cartridge” containing the fluid to be dispensed to a perfected pusher unit which is reusable an indefinite number of times. The cartridge defines a container unit for the liquid to be injected, which is sealed and disposable.

The Applicant has devised, tested and embodied the present invention to overcome the shortcomings of the state of the art and to obtain these and other purposes and advantages.

SUMMARY OF THE INVENTION

The present invention is set forth and characterized in the independent claims, while the dependent claims describe other characteristics of the invention or variants to the main inventive idea.

In accordance with the above purposes, embodiments described here concern a syringe assembly comprising a pusher unit and a single-use containing unit of the fluid. The latter unit, once the fluid has been delivered, can be separated from the pusher unit in order to be thrown away, while the pusher unit can be connected to another fluid containing unit for a subsequent delivery.

In some embodiments, the fluid that has to be delivered can be a liquid, which can have the most diverse viscosity or also a gel.

According to some embodiments, the pusher unit comprises a main body and a plunger, which is provided with a shaft, slidable in the main body.

The containing unit comprises a tubular container defining a chamber for containing a fluid.

According to an advantageous embodiment, the fluid containing unit can be removably connected to the pusher unit by a mechanical connection or by same- shape coupling.

According to some embodiments, the mechanical coupling can be of the bayonet type.

According to an advantageous embodiment of the invention, the fluid containing unit and the pusher unit are provided with mating connection means.

According to some embodiments, the coupling means comprise a seating made in the main body and a protruding edge provided at one end of the container and suitable to be inserted in said seating.

According to some embodiments, the seating comprises a housing compartment communicating with an insertion aperture, in which the protruding edge can be made axially along a longitudinal axis, oriented in a position of insertion.

After being inserted, the protruding edge can be rotated in the housing compartment at a desired angle around the longitudinal axis, until it reaches a clamping position, in which the orientation of the protruding edge is rotated with respect to its insertion position by a certain angle of rotation. In the clamping position the pusher unit and the containing unit are constrained in a firm and stable manner to each other, with axial movements of the container with respect to the main body being impeded.

According to other embodiments, the main body comprises a guide element configured to guide the movement of the plunger with respect to the main body, impeding undesired movements in a transverse direction.

According to some embodiments, the guide element is provided internally with a guide canal of a shape mating with the shaft. In this way it is possible to provide a thin shaft, reducing the costs connected to the use of material, but at the same time conferring on the pusher unit increased robustness, making it possible to use it to inject highly viscous fluids or gel, without the risk of breakages or deformations of the shaft. According to other embodiments, the main body comprises a positioning element in which the seating is made, and a gripping element configured to facilitate the handling of the pusher unit by a user.

Advantageously the positioning element and the gripping element are rotatable with respect to each other around the longitudinal axis, in order to allow an operator to grip the syringe in the most suitable position as a function of the orientation of the needle, or of the zone in which the fluid is to be injected.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other characteristics of the present invention will become apparent from the following description of some embodiments, given as a non-restrictive example with reference to the attached drawings wherein:

- fig. 1 is a three-dimensional view of a syringe assembled starting from an assembly according to embodiments described here,

- fig. 2 is a partly exploded three-dimensional view of the assembled syringe in fig. 1 in which the pusher unit and the fluid containing unit are separated from each other;

- fig. 3 is an exploded three-dimensional view of an enlarged detail of the assembly according to embodiments described here;

- fig. 4 is a plan view from below of the pusher unit of fig. 2;

- fig. 5 is a longitudinal section view passing through a median plane of a syringe according to embodiments described here in an insertion position of the containing unit into the pusher unit;

- fig. 6 is a section view of the syringe in a working clamped position.

To facilitate comprehension, the same reference numbers have been used, where possible, to identify identical common elements in the drawings. It is understood that elements and characteristics of one embodiment can conveniently be incorporated into other embodiments without further clarifications.

DETAILED DESCRIPTION OF SOME EMBODIMENTS

We shall now refer in detail to the various embodiments of the present invention, of which one or more examples are shown in the attached drawings. Each example is supplied by way of illustration of the invention and shall not be understood as a limitation thereof. For example, the characteristics shown or described insomuch as they are part of one embodiment can be adopted on, or in association with, other embodiments to produce another embodiment. It is understood that the present invention shall comprise all such modifications and variants.

With reference to figs. 1-6, we will now describe embodiments of an assembly suitable to form a syringe, which is indicated in its entirety by the reference number 10.

The syringe 10 can be obtained by assembling the various elements comprised in the assembly according to the present invention, as will be explained in more detail hereafter in the present description.

The syringe 10 is able to inject a fluid composition, for example a liquid or a gel, in particular of a pharmaceutical or cosmetic nature.

By way of non-restrictive example, the syringe 10 can be used to inject under the skin of a patient compositions based on hyaluronic acid to treat wrinkles or other imperfections of the skin.

It is obvious, however, that the syringe 10 according to the present invention can advantageously be used in various technical fields according to different methods of use. In addition to the pharmaceutical and cosmetic field, the syringe 10 according to the invention can also be used, for example, in the veterinary sector, or in the building trade for dispensing adhesive compositions in order to repair or maintain the most diverse objects.

The syringe assembly according to the present invention comprises a pusher unit 1 1 and a container unit 12 for the fluid to be injected.

The fluid container unit 12 is configured to be associated with a needle suitable to perform subcutaneous injections, which is not shown, and of a type known in the state of the art.

In some embodiments, when assembled, the pusher unit 1 1 and the fluid container unit 12 extend mainly along the same longitudinal axis X (figs. 5 and 6).

According to some embodiments, the pusher unit 11 comprises a main body 13, and a plunger 18 provided with a shaft 40 sliding along the longitudinal axis X with respect to the main body 13.

According to some embodiments, the fluid container unit 12 comprises a container 14, which defines a chamber 15 for the fluid, visible for example in figs. 5 and 6. According to some embodiments, the main body 13 and the container 14 comprise respective coupling means 16, 17 which allow the fluid container unit

12 to be connected in a firm and stable manner to the pusher unit 11.

In some embodiments, the fluid container unit 12 and the pusher unit 11 are connected to each other by means of a connection with play. This means that the fluid container unit 12, and therefore the container 14, maintains at least one degree of freedom of movement with respect to the pusher unit 11 , that is, with respect to the main body 13.

According to some embodiments, the coupling means 16, 17 can be of the bayonet type.

In this way the pusher unit 11 and the fluid container unit 12 can be inserted one into the other in an axial direction along the longitudinal axis X, and then rotated with respect to each other until a reciprocal clamping position is reached, in which an axial movement of the fluid container unit 12 with respect to the pusher unit 1 1 is prevented.

According to some embodiments, the coupling means made on the main body

13 are configured as a seating 16, while the coupling means made on the container 14 are configured as a protruding edge 17 having a shape mating with the seating 16.

According to some embodiments, the protruding edge 17 has two opposite linear portions 22 and two opposite curvilinear portions 23, so that each linear/curvilinear portion 22, 23 is interposed between the other two curvilinear/linear portions 23, 22.

In some embodiments, the container 14, also called cartridge or drum, is an elongated container with a tubular shape, in which the chamber 15 is substantially cylindrical.

According to some embodiments, the container 14 is provided, at a first end 14a, with the protruding edge 17, and with an opening hole 19.

The opening hole 19 allows to introduce the fluid into the container 14 during production, and can be passed through by the plunger 18 to enter the chamber 15 during use.

The container 14 is also provided, at a second end 14b, opposite the first end 14a, with an exit pipe 20 for the fluid to be injected. According to some embodiments, the container 14 can be made of plastic or glass.

In some embodiments, the opening hole 19 can be covered by a protective film (not shown), which closes the container 14 at the upper part, isolating the fluid contained therein from the surrounding environment, guaranteeing its hygiene and cleanliness.

According to other embodiments, not shown, a sealing element 21 can be provided in the container 14, positioned above the fluid to be dispensed, suitable to couple with the plunger 18 and prevent it from coming into contact with the fluid itself.

According to some embodiments, the sealing element 21 can comprise a plurality of annular sealing portions 21a which contact the walls of the chamber.

In this way, the pusher unit 1 1 can be reused many times with different container units 12, since none of the parts of which it consists comes into contact with the fluid contained in the containers 14, so that the danger of the pusher unit 1 1 being contaminated by a previously injected fluid or contaminating the fluids to be injected later is avoided.

According to other embodiments, the main body 13 comprises a positioning element 25 (fig. 3), in which the seating 16 is provided.

According to some embodiments, the positioning element 25 has an annular shape.

According to some embodiments, the seating 16 comprises a housing compartment 26 (fig. 5), suitable to allow the protruding edge 17 to rotate around the longitudinal axis X.

In one embodiment, the housing compartment 26 has a substantially circular development around the longitudinal axis X.

According to some embodiments, the seating 16 comprises an insertion aperture 27 of a shape mating with the shape of the protruding edge 17 of the container 14, through which the latter can be inserted along the longitudinal axis X and positioned in the housing compartment 26.

The insertion aperture 27 can be defined by two rectilinear portions 28, connected on one side and on the other by two curved portions 29, correlated in shape and size to the respective linear portions 22 and curvilinear portions 23 of the protruding edge 17.

According to other embodiments, protruding portions 30 are provided in the seating 16, protruding from the internal lateral walls of the positioning element 25 toward the longitudinal axis X, which define the rectilinear portions 28 of the insertion aperture 27.

According to some embodiments, after inserting the protruding edge 17 through the insertion aperture 27 (fig. 5, 1), this can be made to rotate around the longitudinal axis X by an angle a so as to position it in a stable manner in the housing compartment 26 in an operative clamping position (Fig. 6, L).

This rotation is shown in fig. 4, in which the shape of the protruding edge 17 is shown with a solid line when it is in the insertion position I, while it is shown with a line of dashes when it is in the clamping position L, after having rotated by the angle a.

When the container 14 is rotated around the longitudinal axis X with respect to the insertion position I, part of the protruding edge 17 is positioned above the protruding portions 30, which prevent it from moving in a longitudinal direction.

According to some embodiments, the angle a can be greater than 0° and less than 180°, preferably around 90°.

The greater the contact that occurs between the protruding edge 17 and the protruding portions 30, the greater the overall stability of the syringe 10 in the clamping position L.

In this regard, the protruding portions 30 can be positioned at a height suitable to define a thickness of the housing compartment 26 sufficient to allow the positioning and rotation of the protruding edge 17 therein, but at the same time such as to prevent movements of the latter along the longitudinal axis X.

According to some embodiments, the main body 13 also comprises a gripping element 31 which allows a user to grip the syringe 10 once assembled.

The gripping element 31 is provided with a through hole 32 which extends along the longitudinal axis X.

In some embodiments, the gripping element 31 comprises two gripping flaps 33 which depart from the through hole 32 opposite each other, approximately 180° from each another. The two gripping flaps 33 are configured to provide the operator with a comfortable support for two fingers of the hand with which the injection is being performed, at the same time ensuring a firm grip.

According to other embodiments, the main body 13 also comprises a guide element 35 configured to guide the movement of the plunger 18 with respect to the main body 13.

According to possible solutions, the guide element 35 has internally a guide channel 36 of a shape mating with the shape and size of the shaft 40 of the plunger 18, so as to constrain it to move only in an axial direction, preventing unwanted movements in the transverse direction.

According to some embodiments, the guiding element 35 can have a truncated cone shape.

This is particularly advantageous when the fluid to be dispensed has a high viscosity, such as for example a gel, or substances based on hyaluronic acid. In this case, in fact, to deliver the fluid through the needle, it is necessary to exert great force on the plunger 18. Since the transverse size of the plunger 18 is much less than its longitudinal extension, it could deform due to the high stresses in the longitudinal direction if it is not adequately supported.

According to some embodiments, the positioning element 25 and the guide element 35 can be positioned on one side and on the other side of the gripping element 31 (for example, one above and one below, as visible in fig. 3) and be attached to each other with play. In this way, the gripping element 31 can rotate with respect to both around the longitudinal axis X.

In other words, the gripping element 31 has a degree of freedom in the main body 13, allowing an operator to position the respective gripping flaps 33 in the most appropriate manner according to the orientation of the needle and/or of the zone in which the fluid has to be injected.

According to some embodiments, the gripping element 31 is provided with an internal annular portion 37 protruding in the through hole 32, suitable to act as an abutment portion of respective external annular portions 38, 39 provided on the external surfaces of the positioning element 25 and of the guide element 35.

According to other embodiments, moreover, the guide element 35 and the positioning element 25 can be provided with respective recesses 44 and protrusions 45 suitable to define a stable mechanical coupling with each other.

Thanks to the annular abutment portion 37 and the respective external annular portions 38, 39, together with the respective recesses 44 and protrusions 45, the positioning element 25 and the guide element 35 are reciprocally connected to each other and to the gripping element 31 through a jointed connection.

According to possible variants, the positioning element 25 and the guide element 35 can be joined to each other by glues or adhesives.

According to other variants, the positioning element 25 and the guide element 35 can be joined together by means of attachment members, such as for example screws, pins, etc.

According to other embodiments, the plunger 18 can comprise a shaft 40 provided with a distal terminal part 41 able to slide inside the chamber 15, and a proximal terminal part 42, opposite the previous one.

The distal terminal part 41 advantageously has a slightly larger diameter than the shaft 40 and the section size of the guide channel 36, such as to ensure that the plunger 18 cannot escape from the main body 13, while still allowing it to slide inside the chamber 15.

According to some embodiments, also the proximal terminal part 42 has a larger diameter than the shaft 40, so as to keep the plunger 18 constrained to the main body 13.

In this way, once the pusher unit 11 has been formed, constraining the main body 13 and the plunger 18 together, it constitutes an indivisible unit, ready to be coupled with a container unit 12.

According to other embodiments, the proximal terminal part 42 can comprise an upper face 43 configured to receive a finger of the operator resting on it, in order to allow him to exert a thrust action on it and bring it closer to the gripping flaps 33.

It is clear that modifications and/or additions of parts can be made to the syringe 10, the pusher unit 11 and the containing unit 12 as described heretofore, without departing from the field and scope of the present invention.

It is also clear that, although the present invention has been described with reference to some specific examples, a person of skill in the art shall certainly be able to achieve many other equivalent forms of syringe 10, the pusher unit 1 1 and the containing unit 12, having the characteristics as set forth in the claims and hence all coming within the field of protection defined thereby.

Claims

1. Syringe assembly comprising a pusher unit (11) and a containing unit (12) able to be coupled with each other to form a syringe (10), characterized in that said pusher unit (1 1) comprises a main body (13) and a plunger (18) provided with a shaft (40) slidable in said main body (13) along a longitudinal axis (X), and said containing unit (12) comprises a tubular container (14) defining a chamber (15) for containing a fluid, wherein said main body (13) and said container (14) comprise respective coupling means (16, 17) configured to obtain a bayonet connection between said containing unit (12) for the fluid and said pusher unit (11), said coupling means comprising a seating (16) made in said main body (13) and a protruding edge (17) provided at one end of said container (14), said seating (16) being configured to receive said protruding edge (17); wherein an insertion position (I) is defined in which said protruding edge (17) is inserted into said seating (16) and a clamping position (L) in which the protruding edge (17) has rotated its orientation with respect to said insertion position (I) by an angle (a) around said longitudinal axis (X) and in which said containing unit (12) is constrained to said pusher unit (11).

2. Syringe assembly as in claim 1, characterized in that said seating (16) comprises a housing seating (26) communicating with an insertion aperture (27) able to be passed through by said protruding edge (17) in an axial direction substantially parallel to said longitudinal axis (X) in said insertion position (I), and in that said housing seating (26) is able to prevent an axial movement of said protruding edge (17) parallel to said longitudinal axis (X) in said clamping position (L).

3. Syringe assembly as in claim 1 or 2, characterized in that said main body (13) comprises a guide element (35) configured to guide the movement of said plunger (18) with respect to said main body (13) and provided internally with a guide channel (36) with a shape mating to said shaft (40).

4. Syringe assembly as in claim 2 or 3, when dependent on claim 2, characterized in that said protruding edge (17) has two opposite linear portions (22) and two opposite curvilinear portions (23), each linear/curvilinear portion (22, 23) being interposed between the other two curvilinear/linear portions (23, 22) and in that said insertion aperture (27) is defined by two rectilinear portions (28) connected on one side and the other by two curved portions (29), having shape and sizes correlated respectively to said linear portions (22) and said curvilinear portions (23).

5. Syringe assembly as in any claim hereinbefore, characterized in that said main body (13) comprises a positioning element (25) in which said seating (16) is made, and a gripping element (31 ) configured to facilitate the gripping of said pusher unit (11) by a user, said positioning element (25) and said gripping element (31) being rotatable with respect to each other around said longitudinal axis (X).

6. Syringe assembly as in claims 3 and 5, characterized in that said positioning element (25) and said guide element (35) are positioned on one side and the other of said gripping element (31) and attached to each other so as to allow said gripping element (31) to rotate with respect to them around said longitudinal axis (X).

7. Syringe assembly as in claims 3 and 5, or 6, characterized in that said gripping element (31) is provided with a through hole (32) and an internal annular portion (37) protruding into said through hole (32), suitable to function as an abutment portion for respective external annular portions (38, 39) provided on the external surfaces of said positioning element (25) and said guide element (35), wherein said positioning element (25) and said guide element (35) are at least partly positioned in said through hole (32).

8. Syringe assembly as in any claim hereinbefore, characterized in that said shaft (40) is provided with a distal terminal part (41) able to be inserted into said chamber (15), and with a proximal terminal part (42), said distal terminal part (41) and said proximal terminal part (42) having bigger transverse sizes than the transverse sizes of said shaft (40) and being suitable to constrain said plunger (18) to said main body (13).

9. Pusher unit suitable to be coupled with a container (14) of a unit for containing fluid (12) to obtain a syringe (10), characterized in that it comprises a main body (13) and a plunger (18) provided with a shaft (40) slidable in said main body (13) along a longitudinal axis (X), wherein said main body (13) comprises coupling means (16) configured to obtain a bayonet connection with said container (14), said coupling means comprising a seating (16) made in said main body (13) and configured to receive a protruding edge (17) provided at one end of said container (14); wherein an insertion position (I) is defined in which said protruding edge (17) is inserted into said seating (16) and a clamping position (L) in which the protruding edge (17) has rotated its orientation with respect to said insertion position (I) by an angle (a) around said longitudinal axis (X) and in which said containing unit (12) is constrained to said pusher unit (1 1).

10. Unit for containing a fluid suitable to be coupled with a main body (13) of a pusher unit (11) to obtain a syringe (10), characterized in that said containing unit (12) comprises a tubular container (14) defining a chamber (15) for containing a fluid, provided with coupling means (17) to obtain a bayonet connection with said main body (13), said coupling means comprising a protruding edge (17) provided at one end of said container (14) and configured to be received in a seating (16) of said main body (13), wherein an insertion position (I) is defined in which said protruding edge (17) is inserted into said seating (16) and a clamping position (L) in which the protruding edge (17) has rotated its orientation with respect to said insertion position (I) by an angle (a) around said longitudinal axis (X) and in which said containing unit (12) is constrained to said pusher unit (11).