FR2718017A1 - Disposable ampoule - Google Patents

Abstract

The disposable ampoule has a neck (4) with a rotary locking screw (11) at least at the outer surface (9) which forms a retainer (10) for the screw. A stretch (12) at the neck (4), between the retainer (10) and detachable end (6), has a taper matching the safety lock and can be cut and removed by the rotating screw (11) and by a taper (13) at a matching stretch (15). A tubular fitting, such as a needle or catheter, connecting tube or push button, has locking tabs (16) to be secured to the screw (11).

Description

SINGLE USE BULB COMPRISING A TIP
CONNECTION WITH SAFETY LOCK
The invention relates to a single-use bulb mainly consisting of a wall of synthetic, thermoplastic material extruded and / or molded and / or blown, and which is sealed in a leaktight manner to delimit an internal closed enclosure.

 Single-use ampoules are already known which are made from a sheath of flexible thermoplastic synthetic material (for example polyethylene or flexible PVC) sealed after forming and filling, and which comprise a neck, the end of which is normally closed to the sealing of the container. bulb with a detachable end portion generally in the form of a tongue. This tab is formed integrally with the neck, but can be separated from the neck to create a dispensing orifice for the contents of the bulb. The body of the ampoule has sufficient flexibility so that by compressing it, the content can be ejected through the orifice.

 These ampoules are generally used as primary packaging for liquid or pasty products, in particular for topical use, such as physiological serum, eye drops, distilled water, oils, silicone oils, ointments, creams, cosmetic samples, etc.

 These ampoules have the advantage of ensuring perfect asepsis since they can be sterilized after sealing with their contents and require immediate use of the entire contents after they have been opened. The detachable portion for opening thus constitutes in itself a guarantee seal for the user. In addition, these bulbs are very inexpensive to manufacture.

Thus, the patents US-A-3,669,602,
US-RE-27155 or FR-A-2 234 197 describe manufacturing processes applicable for manufacturing and filling these ampoules.

 However, these known ampoules do not make it possible to accurately dose the quantities of product dispensed. Also, such a known ampoule cannot be used when the product it contains must be applied to a very localized area with great precision. In particular, the bulb should generally be approached in the immediate vicinity of the area to which the product is to be applied, which may be difficult or impossible given its size.

Also, these known ampoules cannot be connected to a tubular dispensing or application element such as a needle, a cannula, a connecting pipe, a dosing cap or the like. For example, these ampoules could not be integrated into a circuit of tubes or pipes for medical or surgical use (perfusion or dialysis lines) nor be connected to a tubular line for dispensing a product on a surgical operating field.

 The invention therefore aims to overcome these drawbacks by proposing a single-use bulb mainly consisting of a wall of extruded and / or molded and / or blown thermoplastic synthetic material, which is sealed in a sealed manner to delimit a closed enclosure, and which comprises at least one neck, the end of which is normally closed by a detachable portion which is formed by! in one piece with the neck, but which can be separated from the neck to create an orifice, and with which it can be used: take advantage of the aforementioned advantages of such a single-use bulb (asepsis, guarantee seal, low price ... ) while using the bulb connected to a tubular element for greater accuracy in the application and / or dosage of the product, while ensuring the reliability and safety of the connection to this tubular element.

 The invention aims more particularly to provide such a bulb which can be connected to a tubular element such as a cannula, a needle or a connecting pipe for dispensing and / or applying the product contained in the bulb with a high precision on a localized area, for example on the area affected by surgery (internal or external) and in particular during microsurgery.

 The invention also aims to provide such a bulb which can be connected to a tubular element such as a cannula, a needle, a connecting pipe, a stopper, a metering member, a dropper, etc., allowing to precisely measure the quantity of product flowing through the neck, from the internal enclosure to the tubular element.

 The invention also aims to propose such an ampoule constituting a safe and sterilizable primary packaging of a product for surgical, medical, cosmetic, or veterinary use, and the cost price of which is low, in particular of the same order as that of known ampoules. for single use mentioned above.

 The invention also aims to propose such an ampoule intended for the packaging of a product for surgical, medical, cosmetic, or veterinary use intended for topical or parenteral administration.

 The invention aims in particular to propose such an ampoule making it possible to instill an ophthalmological solution on or in the eye, in particular during a surgical operation.

 The invention therefore also aims to provide such an ampoule for packaging an ophthalmic solution for rinsing or ophthalmic treatment.

There are already known conical fittings with safety locking allowing connection, without risk of inadvertent disconnection later, a tubular element such as a needle, a connecting pipe, or a plug to another tubular element or to a tank such as a syringe or vial. These fittings are standardized to be able to offer satisfactory sealing, asepsis and pressure resistance characteristics. It is generally considered that to meet these requirements, the elements to be connected must be made of rigid or semi-rigid materials, to the exclusion of flexible or elastomeric materials. For example, when connecting flexible tubes in
Flexible PVC, their ends are welded 9 rigid end caps in rigid PVC or polycarbonate forming the connector. These fittings are intended specifically for the assembly of needles on syringes and for the assembly of tubes or pipes for medical or surgical use (dialysis or perfusion lines ...) between them or with the devices or instruments which they connect . Consequently, these fittings, tubes and instruments are a priori considered incompatible with ampoules made of flexible thermoplastic material, the use of which is reserved exclusively for the primary packaging of medical or cosmetic products for topical use intended for the general public.

 In addition, the presence of the detachable portion at the end of the neck is a priori an obstacle to the adaptation of such a conical connector with safety lock on such a bulb.

 The invention therefore aims more particularly to propose such a bulb which can be connected to a tubular element such as a needle, a cannula, a connecting pipe, a plug or the like, etc., by a connector - in particular a conical connector- with safety locking ensuring the tightness and asepsis of the connection thus produced, while eliminating any risk of inadvertent disconnection later, in particular under the effect of the pressure induced when the bulb is compressed in view distribution of the product it contains.

 The invention aims more particularly to propose such a bulb which can be used directly with a tubular element fitted with a connection end piece - in particular a conical connection end piece - with safety lock comprising threads for tightening a rotary nut of locking.

 To do this, the invention relates to a single-use bulb mainly consisting of a wall of extruded and / or molded and / or blown thermoplastic synthetic material, sealed in a sealed manner to delimit a closed enclosure, and comprising at least one neck of which the end is normally closed by a detachable portion which is integrally formed with the neck but which can be separated from the neck to create an orifice, characterized in that at least one neck has its outer surface which forms a shoulder for retaining a rotary locking nut, and in that this neck comprises, between the shoulder and the detachable portion, a bearing end piece of safety locking connector which can be tightened and secured by the rotary nut on a bearing of complementary shape of a conjugate end piece of a tubular element such as a needle, a cannula, a connecting pipe, a plug, etc., which comprises tightening threads on which the rotary nut can be screwed. The neck therefore constitutes a safety locking connector connector which can be associated and locked by the rotary nut which it carries with a conjugate connector of such a connector.

 Advantageously and according to the invention, the range of the neck is a male range formed by the outer surface of the neck, and which is adapted to be engaged in a female range of the conjugate end piece, and the rotary nut is a female nut with internal thread capable of cooperating with external male threads projecting from the conjugate end piece. Thus, the end piece formed by the neck is a male end piece with a rotating female locking nut, and the conjugate end piece is a female end piece with male threads for receiving the female locking nut. In a variant (s), the end-piece formed by the neck of the bulb can be a female end-piece (the range of the neck being made up of an internal surface of the neck) intended to be connected to a male conjugate end-piece and / or the 'rotary nut is a nut with male external thread intended to be engaged in tightening threads of a corresponding thread of the conjugate end piece.

 Advantageously and according to the invention, the scope of the neck is a frustoconical bearing adapted to be clamped on a frustoconical bearing complementary to a conjugate end piece.

 According to the invention, the rotary nut comprises an axial bore of diameter substantially smaller than the external diameter of the retaining shoulder. In addition, the rotary nut is made of a more rigid material than the retaining shoulder. In particular, the rotary nut is made of a material which is not flexible and cannot be compressed. On the contrary, according to the invention, the thermoplastic synthetic material of the wall of the bulb, and therefore of the shoulder, has sufficient flexibility so that the flow and distribution of the product contained in the internal enclosure can be controlled by compressing the wall.

 According to the invention, the retaining shoulder extends radially outwardly relative to the portion of the neck extending between this retaining shoulder and the end of the neck. In addition, the detachable portion has overall width dimensions less than the diameter of the retaining shoulder. In particular, the detachable portion has overall width dimensions less than the diameter of the axial bore of the rotary nut. In this way, the rotary nut can be engaged, after the manufacture and filling of the bulb, around the detachable portion, around the neck and forcefully passed beyond the retaining shoulder.

 Advantageously and according to the invention, the ampoule is filled with a liquid or a paste before or during the sealing of the wall, this liquid or this paste being able to flow and be distributed through the neck after separation of the detachable portion. Alternatively, the bulb according to the invention can be filled with a gas such as air or the like. This gas can be used for cleaning or as a gas reserve in a closed circuit.

 Advantageously and according to the invention, the ampoule is filled with a product for medical, surgical, cosmetic, or veterinary use. The ampoule according to the invention is then a ampoule for medical, surgical, cosmetic, or veterinary use.

 The invention also relates to a bulb comprising in combination all or part of the characteristics described above or below.

Other characteristics and advantages of the invention will appear on reading the following description which refers to the attached figures in which
- Figure 1 is a view consisting of a left half-view in axial section and a right half-view in elevation of an end portion of a bulb according to the invention shown after assembly and connection to a tubular delivery cannula,
- Figure 2 is a partial exploded view consisting of a left half-view in axial section and a right elevation view of a bulb according to the invention illustrating the assembly and connection of a conjugate end piece a tubular delivery cannula,
FIG. 3 is an elevation view of a bulb according to the invention after manufacture and filling and before mounting of a rotary locking nut,
FIG. 4 is a view from the left of FIG. 3,
FIG. 5 is a top view of FIG. 3,
FIG. 6 is an axial view of a rotary nut for locking the bulb according to the invention shown in FIG. 1,
FIG. 7 is an axial view of the conjugate end piece of the tubular dispensing cannula intended to be connected to the bulb according to the invention shown in FIG. 1,
- Figure 8 is a left view of Figure 7.

FIG. 1 represents an ampoule 1 for single surgical, medical or cosmetic use, which mainly consists of a wall 2 of extruded and / or molded and / or blown thermoplastic synthetic material, and which is sealed in sealed manner to delimit an enclosure internal close 3. The bulb 1 can be manufactured and filled with a liquid, a paste or another product capable of flowing, in particular under pressure, and this by a process in a single operation as described for example in patents US-A-3,669,602, US-RE-27155 or
FR-A-2 264 197. The thermoplastic synthetic material may consist of polyethylene, polypropylene or flexible polyvinyl chloride. This thermoplastic synthetic material has sufficient flexibility so that the flow and distribution of the product contained in the internal enclosure 3 can be controlled by compressing the wall 2.

 The bulb 1 comprises a neck 4 whose end 5 is normally closed by a detachable portion 6 which is formed integrally with the neck 4, but which can be separated from this neck 4 to create an orifice 7 d end of the neck 4. The neck 4 has an internal duct 8 connecting the internal enclosure 3 to the orifice 7 at the end through which the product contained in this enclosure 3 can flow. The detachable portion 6 closes the orifice 7 (Figure 2), and is in the form of a frangible tab. This tongue can be folded relative to the neck 4, which cuts its connection at the end 5 of the neck 4 and allows it to be detached by opening the orifice 7 for distribution.

 The bulb 1 shown in the figures has a single neck 4. However, it could, in a variant not shown, include several necks 4, and in particular a distribution neck and a venting neck.

 According to the invention, the neck 4 has its outer surface 9 which forms a retaining shoulder 10 for a rotary locking nut 11. The neck 4 also includes a male frustoconical bearing surface 12 extending between the shoulder 10 and the detachable portion 6, so that this neck 4 constitutes a male end piece of conical connector with safety locking which can be tightened and secured by the rotary nut 11 on a female end piece 13 of a tubular element 14 such as a needle, a cannula , a connecting pipe, a plug, etc ...

 The conjugate female endpiece 13 has a bearing 15 conjugate in a shape complementary to the bearing 12 of the neck 4 on which it comes into contact. Thus, the range 15 of the conjugate end piece 13 is tapered female.

 In a variant not shown, the bearing 12 of the neck 4 could be a female bearing in which a male bearing of the conjugate end piece 13 is engaged.

Also, the coupling bearing surfaces 12, 15 could have complementary non-frustoconical shapes, for example cylindrical or pyramidal.

 The conjugate endpiece 13 also includes threads 16 for tightening onto which the rotary nut 11 can be screwed. In particular, in the embodiments shown and according to the invention, the rotary nut 11 is a female nut with internal thread intended to cooperate with external male threads 16 projecting from the conjugate end piece 13. In a variant not shown, the rotary nut 11 could be a male nut with external threads intended to cooperate with internal threads of a thread of the conjugate end piece 13.

 In the embodiment shown, the threads 16 for tightening the conjugate end piece (FIG. 7) consist of two diametrically opposite fins 16a, 16b, extending radially projecting from the outer surface of the conjugate end piece 13 , and forming helical bearing surfaces intended to be engaged in the helical threads of the thread of the nut 11. In a variant not shown, the tightening threads 16 can also consist of two fins defining non-helical bearing surfaces, in particular frustoconical, which can s '' engage in the threads of the female nut 11.

 The rotary nut 11 also comprises an axial bore 17 whose diameter is substantially less than the external diameter of the retaining shoulder 10.

 The retaining shoulder 10 extends radially outwardly relative to the portion of the neck 4 which extends between this retaining shoulder 10 and the end 5 of the neck 4. Thus, the shoulder 10 is radially projecting from the frustoconical bearing 12 male. In addition, the detachable portion 6 has overall dimensions in width (that is to say perpendicular to the axis of the neck 4) less than the overall external diameter of the retaining shoulder 10. More precisely, the portion detachable 6 has overall dimensions smaller than the internal diameter of the axial bore 17 of the rotary nut 11, so that this rotary nut 11 can be passed around this detachable portion 6, around the frustoconical bearing 12, and engaged by force beyond the retaining shoulder 10. To facilitate the forced engagement of the nut 11 beyond the retaining shoulder 10, the internal surface 18 of the axial bore 17 of this nut 11 can be chamfered in frustoconical shape. As a variant or in combination, the external surface 19 of the retaining shoulder 10 oriented towards the end 5 of the neck 4 can also be chamfered or rounded. The rotary nut 11 is made of a more rigid material than the retaining shoulder 10. For example, the rotary nut 11 is made of polycarbonate, or polypropylene, or of polyethylene or rigid polyvinyl chloride. Thus, to carry out the assembly shown in FIG. 1, a rotary nut 11 is first mounted on the bulb according to the invention by engaging it around the detachable portion 6, around the frustoconical surface 12 and around and beyond the retaining shoulder 10. In doing so, the retaining shoulder 10 is deformed radially elastically. The rotary nut 11 has a bearing 20 in the form of a crown extending in a radial plane oriented towards the end 5 of the neck 4, and which abuts against the shoulder 10, so that the rotary nut 11 does not can no longer be disengaged from the bulb beyond the shoulder 10. When it is desired to use the bulb according to the invention, the detachable portion 6 is torn off, then the conjugate end piece 13 is connected. To do this , the male frustoconical bearing 12 is introduced into the female bearing 15 of this conjugate end piece 13, then the rotary nut 11 is turned to screw it onto the tightening threads 16. To facilitate tightening, the rotary nut 11 has external ribs 21 extending parallel to the axis of the nut 11.

 Furthermore, the neck 4 comprises, between the retaining shoulder 10 and the neck 22 of the bulb, a cylindrical seat 23 whose length is sufficient to allow the engagement of the frustoconical bearing 12 of the neck 4 in the bearing 15 of 11 conjugate end piece 13 before the threads of the thread of the nut 11 are engaged around the tightening threads 16 of the conjugate end piece 13, and to allow subsequent dissociation of the conjugate end piece 13, that is to say say the subsequent disassembly of the tubular element 14, after unscrewing the rotary nut 11. The external diameter of the cylindrical seat 23 is slightly less than the internal diameter of the axial bore 17 of the nut 11 so as to allow free rotation of this nut 11 around this cylindrical seat 23.

 In 'Figure 2, there is shown on the same axis the neck 4 of the bulb 1, the rotary nut 11 before its engagement around the shoulder 10, and the conjugate nozzle 13 intended to be mounted on the neck 4 after tearing off the detachable portion 6.

 In Figures 3 to 5, there is shown a bulb 1 according to the invention comprising a single neck 4 at an axial end. The bulb 1 essentially consists of the wall 2 formed hot. Such a bulb 1 conventionally has a height of between 3 and 30 cm and a width of between 1 and 20 cm. It can have a capacity of between 0.3 ml and several liters.

The ampoule 1 according to the invention can be filled with a liquid or a paste; before or during the sealing of the wall 2, in particular physiological saline, an ophthalmological solution (eye drops), distilled water, an oily and / or silicone solution, an ointment, a cream, a sample of cosmetic or pharmaceutical product, a rinsing and / or antiseptic solution. This liquid or this paste can flow and be distributed through the neck 4 through the internal conduit 8 and the orifice 7 after separation of the detachable portion 6. Also, the bulb 1 can be filled with a gas, in particular with a neutral gas, such as air, l 'nitrogen, or whatever.

 The bulb 1 according to the invention may comprise more than two necks 4, and in particular a plurality of necks 4 intended respectively to be connected to a plurality of pipes of a distribution circuit.

 The bulb 1 can be connected to a tubular element such as the cannula 14 shown, to any other element comprising a conjugate end piece 13 capable of being tightened on the end of the neck 4, in particular a needle, a connecting pipe (d '' a dialysis, infusion or distribution line), a stopper, a dropper device ...

Claims (12)

 1 / - Single-use ampoule mainly consisting of a wall (2) of extruded and / or molded and / or blown thermoplastic synthetic material, sealed in a sealed manner to delimit a closed enclosure (3), and comprising at least one neck ( 4) whose end (5) is normally closed by a detachable portion (6) which is integrally formed with the neck (4) but which can be separated from the neck (4) to create an orifice (7) , characterized in that at least one neck (4) has its outer surface (9) which forms a retaining shoulder (10) of a rotary locking nut (11), and in that this neck (4) has , between the shoulder (10) and the detachable portion (6), a bearing surface (12) of a safety locking connector end piece which can be tightened and secured by the rotary nut (11) on a bearing surface (15) of complementary shape of a conjugate end piece (13) of a tubular element (14) such as a needle, a cannula, a connecting pipe, a plug, etc ..., which comprises threads (16) for tightening onto which the rotary nut (11) can be screwed.  2 / - Bulb according to claim 1, characterized in that the bearing surface (12) of the neck (4) is a frustoconical bearing adapted to be clamped on a complementary frustoconical bearing (15) of a conjugate nozzle.  3 / - Bulb according to one of claims 1 and 2, characterized in that the bearing surface (12) of the neck (4) is a male bearing formed by the external surface (9) of the neck (4) and which is adapted for be engaged in a female seat (15) of the conjugate end piece (13).  4 / - Bulb according to one of claims 1 to 3, characterized in that the rotary nut (11) is a female nut (11) capable of cooperating with male threads projecting from the conjugate end piece (13).  5 / - Bulb according to one of claims 1 to 4, characterized in that the rotary nut (11) has an axial bore (17) of diameter substantially smaller than the external diameter of the retaining shoulder (10).  6 / - Bulb according to one of claims 1 to 5, characterized in that the rotary nut (11) consists of a more rigid material than the retaining shoulder (10).  7 / - Bulb according to one of claims 1 to 6, characterized in that the retaining shoulder (10) extends radially outwardly relative to the portion of the neck (4) extending between this retaining shoulder (10) and the end (5) of the neck (4).  8 / - Bulb according to one of claims 1 to 7, characterized in that the detachable portion (6) has overall dimensions in width less than the diameter of the shoulder (10) retaining.  9 / - Bulb according to one of claims 5 to 8, characterized in that the detachable portion (6) has overall dimensions in width less than the diameter of the axial bore (17) of the rotary nut (11).  10 / - Ampoule according to one of claims 1 to 9, characterized in that it is filled with a liquid or a paste before or during the sealing of the wall (2), this liquid or this paste can s '' flow and be distributed through the neck (4) after separation of the detachable portion (6).  11 / - Bulb according to one of claims 1 to 10, characterized in that the thermoplastic synthetic material of the wall (2) has sufficient flexibility so that the flow and distribution of the product contained in the enclosure (3) can be checked by compressing the wall (2).  12 / - Ampoule according to one of claims 1 to 11, characterized in that it contains a product for surgical, medical, cosmetic, or veterinary use.