WO2019123488A1

WO2019123488A1 - Cartridge for a syringe, and corresponding syringe

Info

Publication number: WO2019123488A1
Application number: PCT/IT2017/000283
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 to deliver a fluid comprises pusher means (11) and a disposable cartridge (12) configured to contain a fluid to be delivered, wherein the disposable cartridge (12) comprises a container (14) that defines a chamber (15) for the fluid and which is provided with a threaded collar (64) to which fluid delivery means can be removably screwed.

Description

“CARTRIDGE FOR A SYRINGE, AND CORRESPONDING SYRINGE”

* ijc £ 5fe

FIELD OF THE INVENTION

Embodiments described here concern a disposable cartridge containing a fluid configured to be assembled in a pusher unit to obtain a syringe. In particular, the fluid can be a liquid having the most varied viscosity, or a gel.

The present invention also concerns a syringe comprising said cartridge and configured to deliver the fluid by means of a delivery system associable with the cartridge.

BACKGROUND OF THE INVENTION

Many different types of syringes used to deliver a fluid 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, in particular hyaluronic acid, under the skin of patients, for esthetic or medical treatments.

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

The syringes known in the art comprise a body formed by a cylinder and a piston, sliding inside the cylinder, and manually driven by the operator.

At one end, the cylinder has a threaded ridge to which a needle can be screwed. The threaded ridge, and consequently the needle to be screwed on it, has a standard connection thread, which is also called“Luer-lock”.

Generally speaking, the syringe body and 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, the threaded ridge is generally shaped like an annular element associated with the bottom of the cylinder according to methods known in the art.

In this way, the connection thread which allows the needle to be connected to the syringe is made on an element distinct from the cylinder, but connected to it.

In these syringes known in the art, the cylinder is typically made of glass, which makes it more expensive and fragile.

It should be noted that if the cylinder is made of glass it is not possible to make a thread directly on it, since the mechanical working necessary to obtain the thread could break or seriously damage the cylinder. 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 liquid to be injected is stored, and subsequently the liquid 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 liquid.

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.

After positioning the needle in the area where the injection is to be performed, the operator presses on the piston that advances inside the cylinder so as to exert a thrust force on the fluid, which escapes from the cylinder to be injected through the needle.

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 delivering in an easy and immediate manner.

Another 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.

One purpose of the present invention is to provide a disposable cartridge containing the fluid to be delivered which can be associated with a pusher unit so as to form a syringe.

It is also a purpose of the present invention to define a rechargeable system in which it is possible to associate, for example with every use, a different single-use cartridge with the same pusher unit, which is instead reusable an indefinite number of times.

Another 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 robust syringe able to withstand very high thrust forces.

Another purpose of the present invention is to provide a syringe in which any possible tampering with the cartridge before use is clearly evident.

Another purpose of the present invention is to provide an assembly which allows to obtain a syringe provided with means for controlling the flow delivered, thanks to which the operator can know immediately and easily the quantity of fluid that has been delivered.

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

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 disposable cartridge configured to contain a fluid to be delivered, comprising a container that defines a chamber for the fluid.

According to some embodiments described here, the cartridge comprises a threaded collar made in a single body with the container in correspondence with one lower end of the container. Said threaded collar is configured to allow fluid delivery means to be removably screwed to the container.

In some embodiments, the container is made of plastic material.

In some embodiments, the container is not made of glass.

In some embodiments, the fluid to be delivered can be a liquid, which can have the most varied viscosity, or a gel.

According to some embodiments, the cartridge comprises means for closing the chamber for the fluid comprising a closing unit which is positioned in said end to close the latter.

According to some embodiments, the closing unit comprises anti-tampering elements, which, breaking at the first opening, are able to detect quite clearly if the cartridge has already been opened before.

In one embodiment, the anti-tampering means are defined by one or more breakable elements that connect a fixed element and a removable element that must be separated from the fixed element before delivery.

In one embodiment, the fixed element is connected to the container in correspondence with the lower end.

In a preferred embodiment, the fixed element is constrained to the threaded collar and surrounds the latter externally.

According to some embodiments, the connection between the closing unit and the container is obtained by a reciprocal engagement between a groove made on the fixed element and a connection pin made on the container in correspondence with the threaded collar.

In some embodiments, the container comprises a central tang in which an exit pipe of the fluid to be delivered is defined, which allows the fluid to exit from the chamber.

In some embodiments, the closing unit comprises a protection cap that is configured to close the exit pipe and that can provide connection means that render it integral with the removable element so that the cap is removed together with the latter when the removable element is separated from the fixed element.

In one embodiment, the closing unit comprises a protection cap that is integrated in a single body with the removable element of the closing unit.

In one embodiment, the protection cap comprises a threaded wall in which a threading is made configured to engage with the threaded collar constrained to the cartridge.

According to another aspect of the present invention, the closing means comprise a sealing element which is mobile inside the chamber to define therein a portion with a variable volume where the fluid is contained.

According to some embodiments, the sealing element contacts the walls of the chamber to insulate said portion in a sealed manner in cooperation with the walls of the chamber. In one embodiment, the sealing element is positioned in correspondence with or in proximity to an upper end of the cartridge so as to close this end in a sealed manner.

In one embodiment, the closing means comprise a protective film that seals an upper end of the cartridge.

According to another aspect of the invention a syringe is provided comprising a disposable cartridge and reusable pusher means both provided with respective coupling means configured to allow a temporary connection between the disposable cartridge and the pusher means. This allows to separate the pusher means from the disposable cartridge once the fluid has been delivered, so that the cartridge can be thrown away, while the pusher means can be connected to another disposable cartridge for subsequent delivery.

According to an advantageous embodiment, the disposable cartridge can be connected to the pusher means temporarily by a mechanical connection, for example by a snap-in connection.

According to another aspect of the present invention, the pusher means comprise a plunger provided with delivery indicator means so that the operator can know, in real time, clearly and immediately, the amount of fluid that is being delivered.

According to another aspect of the present invention, the pusher means comprise abutment means able to automatically separate the sealing element from the plunger. In particular, the separation of the sealing element from the plunger can occur during the return movement of the plunger, after the delivery of the fluid has finished.

These and other aspects, characteristics and advantages of the present disclosure will be better understood with reference to the following description, drawings and attached claims. The drawings, which are integrated and form part of the present description, show some forms of embodiment of the present invention, and together with the description, are intended to describe the principles of the disclosure.

The various aspects and characteristics described in the present description can be applied individually where possible. These individual aspects, for example aspects and characteristics described in the attached dependent claims, can be the object of divisional applications.

It is understood that any aspect or characteristic that is discovered, during the patenting process, to be already known, shall not be claimed and shall be the object of a disclaimer. 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, partly exploded, of an assembled syringe starting from an assembly according to the present description;

- fig. 2 is a lateral elevation view of the syringe of fig. 1 ;

- fig. 3 is a section view of the syringe of fig. 1, taken according to the section plane III- III of fig. 2;

- fig. 4 is an enlarged detail of fig. 3;

- fig. 5 is a section view like that of fig. 4, taken according to the section plane V-V of fig. 3;

- figs. 6 and 7 are respectively a perspective view and a plan view from the bottom of a main body comprised in the assembly suitable to form the syringe of fig. 1 ;

- figs. 8 and 9 are respectively a perspective view and a plan view from the bottom of a guide element comprised in the assembly suitable to form the syringe of fig. 1 ;

- figs. 10 and 1 1 are respectively a perspective view and a lateral elevation view of a cartridge comprised in the assembly suitable to form the syringe of fig. 1 ;

- fig. lOa is a perspective view of a variant made of the cartridge of figs. 10 and 11;

- figs. 12 and 13 are respectively a perspective view and a plan view from above of a closing unit comprised in the assembly suitable to form the syringe of fig. 1 ;

- fig. 12a is a perspective view of a variant made of the closing unit of figs. 12 and 13;

- fig. 14 is another enlarged detail of fig. 3;

- fig. 15 is a section view like that of fig. 14, according to a section plane orthogonal with respect to the plane of the section visible in fig. 14;

- figs. l6a and 16b are respectively a perspective view and a three-dimensional view, partly exploded, of a plunger comprised in the assembly suitable to form the syringe of fig. 1;

- fig. 17 is a cross section of the plunger of fig. l6a, taken according to the section XVII-XVII of fig. 2;

- figs. 18 and 19 are respectively a perspective view and a front elevation view of a tip comprised in the cartridge of figs. 10 and 1 1;

- fig. 20 is a section view like that of fig. 15, in which a variant of a syringe according to the invention is visible, comprising the cartridge of fig. lOa and the closing unit of fig. l2a.

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 include all such modifications and variants.

Before describing these embodiments, we must also clarify that the present description is not limited in its application to details of the construction and disposition of the components as described in the following description using the attached drawings. The present description can provide other embodiments and can be obtained or executed in various other ways. We must also clarify that the phraseology and terminology used here is for the purposes of description only, and cannot be considered as limitative.

With reference to figs. 1-3, embodiments of an assembly suitable to form a syringe are described, 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 do-it-yourself or small home repairs for delivering adhesive compositions in order to repair or maintain the most diverse objects.

The syringe assembly according to the present invention comprises a pusher unit 11 and a container unit 12 for the fluid to be delivered, hereafter also called cartridge.

In one embodiment, the cartridge 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.

According to one aspect of the present invention, the pusher unit 11 and the cartridge 12 can be temporarily connected to each other.

In some embodiments, the pusher unit 11 and the cartridge 12 extend mainly along the same longitudinal axis X (figs. 2 and 3).

According to some embodiments, the pusher unit 1 1 comprises a main body 13, shown in the detailed views of figs. 6 and 7.

According to some embodiments, the pusher unit 11 comprises a guide element 25, shown in the detailed views of figs. 8 and 9.

According to some embodiments, the pusher unit 1 1 comprises a plunger 40, shown in the detailed views of figs. 16a, l6b and 17.

According to some embodiments, the cartridge 12 is of the disposable type and comprises a container 14, better visible in figs. 10 and 1 1.

The container 14 defines a chamber 15 for the fluid, visible in the section view of fig. 3.

In some embodiments, the container 14, also called the drum, is an elongated container of a substantially cylindrical shape.

The container 14 comprises a lower end l4a and an upper end l4b, on opposite sides with respect to each other.

According to some embodiments, the container 14 can be made of plastic material.

According to some embodiments, the cartridge 12 comprises a closing assembly 60, better seen in figs. 12-15, which will be described in greater detail hereafter.

In one embodiment, the closing assembly 60 is positioned in correspondence with the lower end 14a to close the latter.

According to some embodiments, in addition to the closing assembly 60, the cartridge 12 comprises a sealing element 37 conformed as a tip, which will be described in greater detail below with reference to figs. 18 and 19.

According to one aspect of the invention, the sealing element or tip 37 is mobile inside the chamber 15 so as to define a portion l5a with a variable volume, included in the chamber 15, and containing the fluid.

In some embodiments, the tip 37 contacts the walls of the chamber 15 to insulate the portion 15a in a sealed manner in cooperation with the walls of the chamber.

In one embodiment, the tip 37 is positioned in correspondence with or near the upper end l4b to close the latter.

According to preferred embodiments, the main body 13 and the container 14 comprise respective coupling means 16, 17 which allow the cartridge 12 to be connected in a firm and stable manner to the pusher unit 11.

In some embodiments, the cartridge 12 and the pusher unit 11 are connected to each other by means of a connection with play. This means that the cartridge 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.

In a preferred embodiment, the cartridge 12 can rotate with respect to the pusher unit 1 1 according to a rotary motion around the longitudinal axis X. This can be convenient for the operator because he can also modify the angular position of the pusher unit 11 even when the needle has already penetrated the patient’s skin.

The coupling means made on the main body 13 are configured as a seating 16, while the mating coupling means made on the container 14 are configured as a protruding edge 17.

In one embodiment, the seating 16 opens on one of the sides of the main body 13 and is configured to allow a lateral insertion of the container 14, according to the insertion direction indicated by the arrow Fl in fig. 1.

It should be noted that in order to correctly insert the container 14 into the main body 13, it is not necessary for the protruding edge 17 of the container 14 to take on a particular orientation because, on the contrary, it can be in any angular position whatsoever.

This makes the assembly of the cartridge 12 to the pusher unit 11 particularly simple and easy.

In one embodiment, the seating 16 is made in a lower portion of the main body 13. In this embodiment, the seating 16 is delimited at the lower part by an attachment element 18 which projects downward from the main body 13.

In a preferred embodiment, the attachment element 18 is integrated in a single body with the main body 13.

The attachment element 18 is shaped substantially in the shape of a U (fig. 7) and is joined to the main body 13 along a perimeter which extends for an angle a, measured with respect to the longitudinal axis X, comprised between 180° and 270°. In this way, the attachment element 18 defines a mouth 19 of the seating 16 in correspondence with the area in which it is not joined to the main body 13.

In some embodiments, the attachment element 18 defines a support area 20 configured to receive resting on it a portion of the protruding edge 17 of the container 14, as better visible in the sections of figs. 4 and 5. In a preferred embodiment, the support area 20 extends substantially along the entire perimeter along which the attachment element 18 is joined to the main body 13, that is, along the angular extension a. The attachment element 18 defines a guide for inserting and extracting the container 14 with respect to the main body 13. In one embodiment, the attachment element 18 is configured in such a way as to define a substantially linear guide for inserting and extracting the container laterally, in particular in a direction parallel to the arrow Fl.

In one embodiment, the attachment element 18 comprises a tapered portion 21 (fig. 7) which defines a narrowing which delimits the seating 16 on the side facing the mouth 19.

Thanks to the tapered portion 21, a snap-in connection can be made between the pusher unit 1 1 and the cartridge 12, that is, between the main body 13 and the container 14.

Moreover, the tapered portion 21 advantageously prevents the container 14 from disengaging from the main body 13, that is, it prevents the protruding edge 17 from accidentally exiting from its seating 16.

It should be noted that the shape of the seating 16 and of the protruding edge 17 are mating, so that the protruding edge 17 can be received in the seating 16. For example, the thickness of the seating 16 and the conformation of the attachment element 18 are correlated to the thickness and shape of the protruding edge 17.

As seen in figs. 1 and 10, according to a preferred embodiment, 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.

This conformation of the shaped edge 17 is advantageous. In fact, it ensures, on the one hand, a firm anchorage on the support area 20 since it increases the contact surface between the shaped edge 17 and the seating 16. On the other hand, this conformation ensures that in any angular position in which the container 14 finds itself with respect to the main body 13, the shaped edge 17 does not escape from the seating 16.

According to some embodiments described here, the main body 13 comprises a through hole 24 which extends along the longitudinal axis X and communicates with the seating 16.

In some embodiments, the main body 13 comprises two gripping flaps 33 which depart from the through hole 24 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.

In a preferred embodiment, the two gripping flaps 33 each comprise a concave portion 34 which gives the main body an ergonomic shape so that it is convenient to grasp.

The through hole 24 is configured to house the guide element 25.

The guide element 25, during use, is suitable to guide the movement of the pusher unit 11.

The guide element 25 comprises an engagement element 26 which is configured to engage with a respective engagement element 27 made on the main body 13 to hold the guide element 25 in position inside the through hole 24 (fig. 4).

In one embodiment, the engagement element of the guide element 25 is configured as an elastic fin 26 provided with a shaped step 28 which projects toward the outside, that is, - during use - toward the walls of the through hole 24.

In one embodiment, the respective engagement element of the main body 13 is configured as a cavity 27 (figs. 4 and 6) configured to receive the shaped step 28. For this purpose, the cavity 27 and the shaped step 28 are shaped so as to have their shape and sizes mating with each other.

In a preferred embodiment, the guide element 25 comprises two elastic fins 26, disposed at about 180° with respect to each other, and on the walls of the through hole 24 two cavities 27 are made, also disposed at about 180° from each other and intended to receive a corresponding shaped step 28.

During use, it is provided to insert the guide element 25 into the through hole 24 from above. During the descent of the guide element 25, the elastic fins 26 retract slightly to allow the movement of the guide element 25 without interference with the walls of the through hole 24. When the shaped steps 28 reach the cavities 27, they enter into the latter allowing to retain the guide element 25 inside the through hole 24.

In some embodiments, the guide element 25 comprises a head portion 29 and a jacket 30, which develops starting from the head portion 29 around the longitudinal axis X.

In one embodiment, the jacket 30 comprises two semi-circular walls 31 between which the two elastic fins 26 mentioned above are interposed.

According to some embodiments described here, the head portion 29 comprises an opening 32 configured to allow the plunger 40 to slide.

Consequently, the opening 32 and the plunger 40 substantially have the same profile so as to reciprocally engage according to a same-shape coupling.

In one embodiment, the same-shape coupling of the opening 32 and the plunger 40 is a coupling with play.

In a preferred embodiment, the opening 32, and therefore the cross-section of the plunger 40, substantially have the shape of a cross.

In some embodiments, the main body 13 and the guide element 25 can be made of suitable plastic materials, known in the state of the art.

In a preferred embodiment, the main body 13 can be made of a plastic material having characteristics such as to give it a high degree of transparency so as to make the inside visible.

According to one aspect of the present invention, the pusher unit 1 1 comprises engagement means 35 configured to allow a correct interaction between the guide element 25 and the plunger 40, as will be explained in greater detail hereafter in the present description.

In one embodiment, the engagement means 35 comprise an abutment element 36 (figs. 5 and 9) intended to abut with the tip 37.

Thanks to the abutment element 36, it is possible to separate the tip 37 from the plunger 40, to which the tip 37 is associated during delivery.

In one embodiment, the engagement means 35 comprise an end-of-travel element 38 (figs. 5 and 9) configured to prevent the plunger 40 from completely coming out of the guide element 25.

Thanks to the end-of-travel element 38, the plunger 40 therefore remains constrained to the guide element 25, and therefore to the main body 13 to which the guide element 25 is connected, in any condition of use of the pusher unit 11.

In one embodiment, the engagement means 35 comprise at least one presser element 39 (figs. 4 and 9) configured to engage with one or more notches 41 made on the plunger 40.

In one embodiment, the presser element can be configured as a tooth 39 that projects from the head portion 29 inside the jacket 30.

In some embodiments, the tooth 39 can be made of a polymer material. In this way, the tooth 39 is provided with a certain elasticity which allows it to return to assume the intended position, when it is moved from the latter.

In a preferred embodiment, the engagement means comprise two teeth 39, disposed at about 180° from one another so as to contact the plunger 40 from opposite sides.

In one embodiment, each tooth 39 comprises a protruding end 42 facing toward the plunger 40. During the sliding of the plunger 40, the protruding end 42 contacts the latter, and as the notches 41 gradually appear in front of it, the protruding end 42 penetrates inside a notch 41.

Thanks to the tooth 39 and to the protruding end 42, the operator also has an acoustic and tactile feedback every time a notch 41 is engaged/disengaged by/from the tooth 39, so that this configuration can advantageously also provide an acoustic and tactile indication, as well as visual, of the amount of fluid that is being delivered.

According to another aspect of the present invention, the plunger 40 comprises an internal core 43 and an external body 44 (fig. l6b).

In some embodiments, the external body 44 comprises a cavity 45 intended to receive the internal core 43.

In some embodiments, the cavity 45 develops along the longitudinal axis X.

As shown in fig. 17, the cavity 45 has the same profile as the internal core 43 so that the external body 44 and the internal core 43 are connected to one another according to a mechanical connection with interference. In other words, once connected, the external body 44 and the internal core 43 are not mobile with respect to each other, but can only move together. The assembly formed by the external body 44 and the internal core 43 has an external profile mating with the profile of the opening 32.

In some embodiments, the internal core 43 comprises, on one of its walls that extend longitudinally, a plurality of said notches 41. In particular, the notches 41 are made on an external wall 46 which remains exposed to the operator's view, that is, on the only wall of the internal core 43 which is not received in the cavity 45.

In a preferred embodiment, the internal core 43 comprises ten notches 41 which are equidistant from each other so as to define a graduated scale that can provide the operator with an indication of the amount of fluid being delivered.

In a preferred embodiment, the external body 44 is made of a metal material, preferably aluminum, and the internal core 43 is made of plastic material.

The fact that the external body 44 is made of a metal material, preferably aluminum, is advantageous because in this way it significantly increases the structural resistance of the plunger 40.

It should be noted that this is particularly appreciated when it is necessary to deliver fluids with high viscosity, such as for example hyaluronic acid. In these cases the operator must exert a very high pressure on the pusher unit 11 to make the fluid exit from the needle.

Another advantage of the fact that the internal core 43 is made of plastic is connected to the method of making the notches 41 on the core itself. In fact, with the technological processes known in the state of the art it is much easier to make the notches 41 on a plastic element rather than on an element made of metal material because the latter can be subject to breakages and weakening when the notches 41 are made.

In some embodiments, the plunger 40 also comprises a base 47 which is configured to cooperate with the end-of-travel element 38 so that the plunger 40 is always kept constrained to the guide element 25.

In one embodiment, the base 47 is connected to the internal core 43 and, once the external body 44 has been connected to the internal core 43, also defines a support base for the external body 44.

It should be noted that this configuration is advantageous because, thanks to the base 47, it is possible to prevent the relative movement between the external body 44 and internal core 43 in a direction parallel to the longitudinal axis X.

The plunger 40 also comprises a distal end 48 (fig. 16b) configured to cooperate with the tip 37.

In a preferred embodiment, the distal end 48 comprises at least one portion having a truncated cone shape.

In one embodiment, the plunger 40 also comprises a top element 49, to which the external body 44 and the internal core 43 are joined.

The top element 49 comprises a shaped recess 50 having the same external profile formed by the assembly of the external body 44 and internal core 43, as well as the opening 32.

During use, the shaped recess 50 is intended to receive a proximal end 51 of the plunger 40 (fig. 16b). For example, the proximal end 51 of the plunger 40 can be inserted under pressure into the shaped recess 50.

In some embodiments, the top element 49 can comprise an upper face 52 configured to receive a finger of the operator resting on it. It should be noted that the upper face 52, exposed to view, can also optionally bear prints or engravings, for example of logos, writings, or advertising or promotional messages.

In a preferred embodiment, the upper face 52 can have a concave profile, which makes the upper face 52 more ergonomic for a more comfortable grip. During use, the operator for example rests his thumb on the upper face 52, and two other fingers, for example the ring and middle fingers, respectively on each concave portion 34 so that the operator can exert an effective pushing action with only one hand.

The container 14 has an opening hole 53. In some embodiments, the plunger 40 can pass through the opening hole 53 to enter the chamber 15.

In some embodiments, the opening hole 53 can be covered by a protective film (not shown), which closes the container 14 at the top, guaranteeing the hygiene and cleanliness thereof.

The tip 37 is integrated into the container 14, is received inside the opening hole 53 and projects toward the chamber 15.

The tip 37 comprises an upper edge 54 which, before the container 14 is used, is disposed substantially flush with the shaped edge 17.

In one embodiment, the tip 37 comprises a plurality of annular sealing portions 55 which contact the walls of the chamber 15.

Thanks to the annular sealing portions 55, the plunger 40 never comes into contact with the fluid contained inside the cartridge 12, although it does penetrate into the chamber 15.

In this way, the pusher unit 11 can be re-used many times without any part of it being contaminated by the fluid to be injected, so as to prevent fluids previously injected from contaminating the fluids to be subsequently injected.

In some embodiments, the tip 37 is made of a suitable polymer material which has a low coefficient of sliding friction so as to facilitate the sliding of the tip 37, in particular of its annular sealing portions 55, against the walls of the chamber 15.

In one embodiment, the tip 37 comprises a recess 56 which can be delimited peripherally by the upper edge 54.

In a preferred embodiment, a blind hole 57 is made in the recess 56, and is configured to receive the distal end 48 of the plunger 40. Thanks to the recess 56, and possibly to the blind hole 57, it is possible to join temporarily and in a stable manner the tip 37 to the pusher unit 11.

In some embodiments, the closing assembly 60 comprises a fixed element 61 and a removable element 62 which are connected by one or more breakable elements 63 (figs. 15 and 20).

In one embodiment, the closing assembly 60 comprises four breakable elements 63.

When the operator acts with a rotary movement on the removable element 62, the breakable elements 63 break, making visible the opening that has been made (fig. 14). The breakable elements 63 thus act as anti-tampering elements since their breakage makes it clear to the operator and patients that the cartridge 12 to be used has already been opened previously and, therefore, is no longer sterile.

According to one embodiment, the container 14 comprises a threaded collar 64 (figs 14, 15 and 20), thanks to which it is possible to screw the delivery means, for example the needle, to the cartridge 12.

In one embodiment, the threaded collar 64 projects from the lower end l4a of the container 14 and has an internal thread.

In one embodiment, the threaded collar 64 is made in a single body with the container 14.

The fixed element 61 is constrained to the threaded collar 64 and surrounds it externally.

In some embodiments, the container 14 comprises a central tang 65 in which an outlet pipe 66 of the fluid to be delivered is defined. The central tang 65 projects from the bottom of the container 14 and is configured to be inserted inside a needle support structure, when it is associated with the cartridge 12, so as to allow the fluid to pass from the chamber 15 to the needle.

In some embodiments, the closing assembly 60 comprises a protection cap 67 configured to close the outlet pipe 66.

In some embodiments, the protection cap 67 is configured to fit on the central tang 65.

Thanks to the protection cap 67, it is possible to effectively close the chamber 15 so as to prevent both unwanted leakages of fluid and also unwanted contamination of the fluid with polluting elements, such as dust and dirt.

In a preferred embodiment, the protection cap 67 is made of plastic material.

In one embodiment, the protection cap 67 has an extension in a direction parallel to the longitudinal axis X which is greater than the extension of the central tang 65 in the same direction.

In one embodiment, the protection cap 67 comprises connection means 68 which make it integral with the removable element 62.

In one embodiment, the removable member 62 comprises a hole 69 which is configured so that the connection means 68 pass through it.

In one embodiment, the hole 69 is made in a recess 70 made on the bottom of the removable element 62.

In some embodiments, the connection means 68 are configured as a shaped end comprising one or more holding elements 71. The holding elements 71 are received in the recess 70.

Thanks to this configuration, the protection cap 67 remains constrained to the removable element 62 of the closing assembly 60. In this way, the operator, when removing the removable element 62, also directly removes the protection cap 67.

In a variant embodiment, a closing assembly 60’ is provided (fig. l2a) which comprises a protection cap 67’ integrated in a single body with the removable element 62, as better visible from the section of fig. 20.

Thanks to this configuration, the closing assembly 60’ advantageously comprises one component fewer than the closing assembly 60 described above, and thus allows to save on the costs of manufacturing the syringe, at the same time simplifying the technological process for producing the closing assembly 60’. In this embodiment, the protection cap 67’ comprises a threaded wall 75.

The threaded wall 75 is intended to engage with the threaded collar thread 64 which, in this case, in addition to defining a“Luer-lock” thread to receive the needle during delivery, before the syringe is used, also defines an attachment system for the removable element 62 of the closing assembly 60’.

Thanks to the threaded wall 75 which engages with the threaded collar 64, the closing assembly 60’ advantageously ensures an improved fluid seal compared to the closing assembly 60, so as to close the outlet pipe 66 very reliably.

Another advantage obtainable thanks to the threaded wall 75 is given by the fact that, after the first opening of the syringe during which the breakable elements 63 are broken, it is possible to re-screw the removable element 62 to the fluid containing unit 12. In this way, the latter becomes re-closable, if the fluid contained inside it is not delivered in a single delivery cycle, but is to be delivered at different times at a distance of time from each other. This variant therefore guarantees the possibility of using the syringe according to the invention in a very flexible manner according to needs, at the same time ensuring good cleanliness and adequate hygiene.

In one embodiment, the removable element 62 also comprises two flat portions 72 (of which only one is visible in figs. 12 and l2a), opposite each other, which are configured to facilitate the grip of the operator when removing the removable item 62.

In some embodiments, the closing assembly 60 comprises a groove 73 (figs. 12 and 13) configured to guide the insertion of the closing assembly onto the container 14. For this purpose, the container 14 comprises a connection pin 74 (figs. 10 and 1 1) configured to be received in the groove 73.

In particular, the groove 73 is made on the internal wall of the fixed element 61, that is, on the wall facing toward the container 14.

Thanks to the connection between the groove 73 and the connection pin 74, the fixed element 61 of the closing assembly 60 remains anchored to the container 14, without any degree of freedom of movement with respect to the latter.

In one embodiment, the groove 73 and the connection pin 74 extend substantially parallel to the longitudinal axis X.

In a variant embodiment, visible in figs. lOa and 12a, the container 14 comprises a connection pin 74’ disposed horizontally, that is, substantially orthogonal to the longitudinal axis X. Consequently, in this variant, a groove 73 is made on the fixed element 61 of the closing assembly 60’, disposed horizontally and configured to receive the connection pin 74’.

In one embodiment, two connection pins 74’ are provided, angularly equidistant by about 180° with respect to each other, and two respective grooves 73’.

In one embodiment, the grooves 73’ are grooves of the through type.

According to this variant, during assembly of the syringe, it is provided to associate the closing assembly 60’ with the fluid containing unit 12 by screwing the closing assembly 60’ so that the threaded wall 75 of the protection cap 67’ engages with the threaded collar 64 associated with the container 14. During this screwing operation, the connection pin 74’, which is preferably made of polymer material with an elastic behavior, slightly deforms to allow screwing until it reaches the respective groove 73’, inside which it is received. At this point the screwing is completed and the closing assembly 60’ is firmly constrained to the fluid containing unit 12.

We will now describe a possible method of using a syringe 10 obtained by assembling a pusher unit 11 and a cartridge 12 according to the invention.

Initially, the operator can remove the thin film (not shown) so as to uncover the opening hole 53 and the tip 37 disposed inside it. Similarly, the operator removes the removable element 62, and with it the protection cap 67, 67’, so as to be able to screw a needle, of a known type, to the threaded collar 64.

After this, the operator can connect the cartridge 12 to the pusher unit 11, according to the methods explained previously. It should be noted that, in this step, the plunger 40 must be completely raised.

At this point, the operator can deliver the desired amount of fluid contained in the chamber 15. As soon as the delivery begins, the distal end 48 of the plunger 40 enters the blind hole 57 so that the tip 37 contained in the container 14 becomes the tip of the plunger 40. As the plunger 40, together with the tip 37, gradually advance into the chamber 15, the volume of the portion l5a containing the fluid decreases.

Once delivery is complete, the operator removes the needle and retracts the plunger 40. During this return movement of the plunger 40, the tip 37 meets the abutment element 36, which allows the tip 37 to be detached from the plunger 40. By further continuing the return movement of the plunger 40, the base 47 meets the end-of-travel element 38 and the return movement of the plunger 40 is stopped.

When the plunger 40 is in this fully retracted position, it is possible to separate the disposable cartridge 12 from the pusher unit 11, extracting it in the direction indicated by the arrow F2 in fig. 1.

When it is necessary to perform another injection, it is sufficient to repeat what is described above, always using the same pusher unit 11, and another cartridge 12.

It is clear that modifications and/or additions of parts can be made to the syringe 10, the pusher unit 1 1 and the elements comprised therein that have been 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 and/or elements to assemble it, having the characteristics as set forth in the claims and hence all coming within the field of protection defined thereby.

In the following claims, the sole purpose of the references in brackets is to facilitate reading: they must not be considered as restrictive factors with regard to the field of protection claimed in the specific claims.

Claims

1. Disposable cartridge configured to contain a fluid to be delivered, comprising a container (14) that defines a chamber (15) intended to contain the fluid, characterized in that it comprises a threaded collar (64) made in a single body with said container (14) and positioned in correspondence with one end (l4a) of said container (14); said threaded collar (64) being configured at least to allow fluid delivery means to be removably screwed to said container (14).

2. Cartridge as in claim 1, characterized in that said container (14) is made of plastic material.

3. Cartridge as in claim 1 or 2, characterized in that said container (14) is not made of glass.

4. Cartridge as in any claim hereinbefore, characterized in that it comprises means for closing said chamber (15) comprising a closing unit (60; 60’) which is positioned in said end (l4a) to close said end (l4a) and comprises a fixed element (61) and a removable element (62) which are connected to each other by one or more breakable elements (63) which function as anti-tampering elements; wherein said fixed element (61) is connected to said container (14) in correspondence with said end (14a) so as to be constrained to said threaded collar (64) and to surround the latter externally.

5. Cartridge as in claim 4, characterized in that said fixed element (61) comprises a groove (73; 73’) which is intended to receive a connection pin (74; 74’) made in said container (14); said groove (73; 73’) and said connection pin (74; 74’) reciprocally engaging in a same-shape coupling.

6. Cartridge as in claim 4 or 5, characterized in that said container (14) comprises a central tang (65) in which an exit pipe (66) of the fluid to be delivered is defined, which allows the fluid to exit from said chamber (15), and in that said closing unit (60; 60’) comprises a protection cap (67; 67’) configured to close said exit pipe (66).

7. Cartridge as in claim 6, characterized in that said protection cap (67’) comprises a threaded wall (75) configured to engage with said threaded collar (64).

8. Cartridge as in any claim from 4 to 7, characterized in that said closing means comprise a sealing element (37) which is mobile inside said chamber (15) so as to define a portion (l5a) with a variable volume of said chamber (15) where the fluid is contained, and in that said sealing element (37) contacts the walls of said chamber (15) to insulate said portion (15a) in a sealed manner in cooperation with the walls of said chamber (15).

9. Cartridge as in claim 8, characterized in that said sealing element (37) comprises a plurality of annular sealing portions (55) which contact the walls of said chamber (15), and in that said sealing element (37) comprises joining means (56, 57) configured to allow to join said sealing element (37) temporarily and stably to pusher means (11) associable with said cartridge.

10. Syringe to deliver a fluid, characterized in that it comprises pusher means (1 1) and a disposable cartridge (12) as in any of the claims hereinbefore, wherein said pusher means (11) and said disposable cartridge (12) comprise respective coupling means (16, 17) configured to allow a temporary connection between said disposable cartridge (12) and said pusher means (11).