WO2012056152A2

WO2012056152A2 - Mixing syringe

Info

Publication number: WO2012056152A2
Application number: PCT/FR2011/052462
Authority: WO
Inventors: Olivier Cuilleron; Bernard Pain
Original assignee: Microval
Priority date: 2010-10-29
Filing date: 2011-10-21
Publication date: 2012-05-03
Also published as: WO2012056152A3; JP2013544569A; JP5889908B2; FR2966738A1; FR2966738B1; EP2632343A2; BR112013010530A2

Abstract

According to the invention, the syringe for mixing a surgical adhesive and a hardener comprises two separate chambers (2 and 3), each receiving a product of different composition (PI, P2), which chambers (2 and 3) do not communicate with each other and are arranged coaxially with respect to each other in such a way as to provide a first, outer chamber (2) and a second, inner chamber (3), each of the chambers (2 and 3) being equipped with two coaxially arranged pistons (4 and 5), of which the faces in contact with the product are both located at any given time in the same plane transverse to the syringe, and of which their movement within their respective chamber (2 and 3) takes place simultaneously, so as to allow total delivery of the products (PI and P2), to a common outlet, in combination with an outlet arrangement of the syringe, in order to provide a mixing of said products (PI and P2), the mixture obtained being in the form of an inner product, composed of the hardener, and of a coating product, composed of the surgical adhesive.

Description

MIXING SYRINGE

The present invention relates to a mixing syringe, particularly for mixing a surgical glue and a hardener for the repair of large vessels.

According to the prior art, during the repair of large vessels, surgeons use a specific surgical glue including the biological glue type, such as that known under the trademark "G F". This surgical glue consists of an aqueous mixture of gelatin and resorcinol. The polymerization is obtained by adding a hardener based on formaldehyde. The hardener must be injected into the thickness of the mixture and must not be in direct contact with living tissue. The adhesive properties of gelatin are enhanced by the combination of resorcinol. This composition makes the glue insoluble in water.

For the repair of large vessels, surgeons generally use a surgical glue tube on one side and a conventional syringe filled with hardener on the other. The surgeon then deposits the surgical glue on the part of the vessels to be repaired and then has to inject, almost simultaneously in the thickness of the glue, the hardener. This operation encumbered both hands of the surgeon and the optimal dosage of the delivered products depends on the experience of the surgeon. This step also requires great precision to inject the hardener into the thickness of the surgical glue without it coming into direct contact with the living tissue of a patient. This operation also requires the assistance of a third person to hold, by means of a suitable tool, the big ship to repair. Nowadays there is no device allowing surgeons to perform this operation in any other way. Thus, the present invention aims to remedy these major drawbacks by proposing a new and inventive solution by means of a mixing syringe specially adapted for mixing a surgical glue and a hardener for the repair of large vessels.

In an attempt to overcome the drawbacks mentioned above, it would be possible to use mixing syringes known in other fields. However, as indicated below, these known syringes are not adapted to the technical field of the invention given the problem to solve and the difficulty of obtaining a homogeneous mixture between two products of different viscosities. For example, mixing syringe devices are known from US Pat. No. 6,398,761 and US Pat. No. 2002/0035351. This first US Patent No. US 6,398,761 relates to a mixing syringe device comprising two separate chambers for delivering two materials to be mixed. This syringe comprises a piston unit consisting of two pistons engaging two reservoirs of a double syringe. The two tanks are arranged side by side so that when mixing the two products, it may not be homogeneous, in the case of a mixture of products of different viscosities. In this way, if a product A is mixed with a product B which does not have to come into contact with living tissues for example, the mixture A + B at the outlet of such a syringe may have a composite outer part. that of B with risks for the patient. The same disadvantages are found in the solution disclosed by US Patent Application No. US 2002/0035351. This application describes a syringe comprising two chambers receiving two products intended to be mixed and delivered. The two rooms communicate with each other. It is necessary to actuate a piston for pushing a product, contained in a first chamber, to a second chamber already filled with another product. This causes the two products to mix in said second chamber. In the technical field of the invention, and therefore in the case of gelatinous products, the mixture may, as previously, show an external part of the mixture composed of a product that is dangerous for living tissues, but also a risk of crosslinking. inhomogeneous in the second chamber causing difficulties ejection products.

It follows from this analysis of the state of the art that the known mixing syringes are unsatisfactory in the claimed technical field by involving risks to the living tissue of a patient for example.

An object of the present invention is thus to provide a new mixing syringe including mixing a surgical glue composed of gelatin and a liquid hardener for the repair of large vessels that overcomes the disadvantages mentioned above.

This object is achieved according to the invention by means of a syringe for mixing a surgical glue and a hardener characterized in that it comprises two separate chambers, each receiving a product of different composition, said chambers not communicating with each other and are arranged coaxially one relative to each other so as to have a first external chamber and a second internal chamber, each of the chambers being provided with two pistons, arranged coaxially, whose faces in contact with the product are both and at all times included in the same plane transverse to the syringe and whose movement in their respective chamber is done simultaneously so as to allow the total delivery of products to a common outlet, in combination with an arrangement at the outlet of the syringe, to achieve a mixing said products, the resulting mixture being in the form of an internal product, consisting of the hardener, and a coating product, consisting of the surgical glue.

In this way, the mixture of the two products is controlled. In fact, in the case of an operation consisting in repairing large vessels, use is made, as mentioned above, of a surgical glue and a hardener that is dangerous for the living tissues of a patient. In the solution provided by the present invention, the hardener, which is to be delivered in smaller amounts, is in the second inner chamber while the surgical glue is in the first outer chamber. Thus, during the delivery of the products, there is obtained a mixture consisting of hardener, as an internal product, and surgical glue, as a coating product. In this way, the living tissues are protected from contact with the hardener by means of the surgical glue forming a coating. To solve the problem of the quantity of product to be delivered and the sufficient quantity of coating product to be delivered so that the internal product is well coated, in the mixing syringe according to the invention, the chambers comprise a predefined volume so as to the mixture of products is produced in the appropriate proportions. To solve the problem of filling the mixing syringe, its packaging and also its delivery, the mixing syringe according to the invention is preferably pre filled with said products to be delivered.

This feature promotes the simplicity and speed of surgery performed by surgeons. The delivery of a pre-filled syringe with the correct proportions of products eliminates the preparation time of said mixing syringe and the surgeons thus receive a single syringe instead of a kit generally comprising a tube of glue, a bottle of hardener, a instructions, a syringe, a spatula and a needle. According to a particular embodiment and to solve the problem of reusing said syringe or preparing it before the operation, the mixing syringe according to the invention may advantageously comprise orifices allowing the pre-filling of said chambers with said products. to deliver.

It goes without saying that the invention is not limited to the embodiment described above by way of example but that it extends to all embodiments covered by the appended claims. The invention will be better understood, and other features and advantages thereof will appear, with reference to the accompanying drawings, showing, by way of non-limiting example, a preferred embodiment it relates. Figure 1 is a perspective view showing an embodiment of the mixing syringe according to the invention.

Figure 2 is a view similar to Figure 1, showing the exploded perspective mixing syringe and a closure cap thereof.

Fig. 3 is an exploded perspective view showing a first outer chamber and a second inner chamber of the mixing syringe according to the present invention.

Figure 4 is a view similar to Figure 3 seen from another angle, and more particularly showing the interior of the first outer chamber and the second inner chamber of the mixing syringe according to the present invention.

Fig. 5 is an exploded perspective view showing the respective pistons of the first outer chamber and the second inner chamber.

Figure 6 is a view similar to Figure 5, showing the assembly of the pistons of the first outer chamber and the second inner chamber.

Figures 7 and 8 are sectional views of the mixing syringe according to the invention representing the principle of mixing products.

For simplicity, the parts or elements of an embodiment that are identical or similar in another form of realization will be identified by the same numerical references and will not be described again.

With reference to FIGS. 1 and 2, the mixing syringe (1) according to the invention comprises a first external chamber (2), a second internal chamber (3), an outer chamber piston (4), an internal chamber piston ( 5), an applicator tip (6) and a sealing plug (7) of the mixing syringe. The first outer chamber (2) is in the form of a cylinder and forms a cavity (2h) to be filled by a first product (PI) to be mixed with a second product (P2). The mixture itself being intended to be delivered by the mixing syringe (1) of the present invention. This first outer chamber (2) comprises a lower open end (2h) for receiving the outer chamber piston (4) and an upper end. The upper end of the first outer chamber (2) comprises gripping means in the form, for example, of tabs (2a). The lower end includes a protruding portion with a filling port (2b) of the first outer chamber (2). The orifice (2b) can be closed by a plug (2c).

Referring to Figures 2 to 4, the upper end of the first outer chamber (2) further comprises a first outlet (2d) of said first product and a second outlet (2e) of said second product. Said upper end of said first outer chamber (2) further comprises a particular arrangement in the form of a threaded head (2f). This threaded head (2f) is adapted to be capped first of said closure cap (7) when the mixing syringe (1) is not used. When using the mixing syringe (1), the threaded head (2f) is advantageously capped with an applicator tip (6) via a portion (6a) that has said applicator tip (6). This portion (6a) is flared relative to the remainder of said applicator tip (6). In this way, the applicator tip (6) has a flared connection end with said threaded head (2f) and an opposite end adapted to deliver the mixture of the first product and the second product. Thus the flared shape narrowing at the second end, the mixture is delivered with more precision. The tip (6) comprises an applicator tube (6b) of variable length for delivering the mixture further and facilitate said delivery of the mixture.

According to a particular embodiment, the applicator tip (6) comprises a static mixer (8) arranged inside thereof. For example, this static mixer (8) is in the form of a succession of helices (8b) acting as worm to facilitate the mixing of the product leaving the first outer chamber (2) with the liquid product exiting of the second internal chamber (3) via a separator (8a). The separator optimizes the distribution of the liquid product in the gelatinous product for better mixing.

With reference to FIGS. 2 to 4, said second internal chamber (3) is also in the form of a cylinder and forms a cavity (3h) intended to be filled by the second product constituting the mixture. This second internal chamber (3) comprises an upper open end (3h) for receiving the inner chamber piston (5) and a lower end comprising an outlet (3 e). This outlet (3e) is intended to deliver the second product of said second internal chamber (3). The second inner chamber (3) is mounted in the first outer chamber (2), coaxially by means for example of a threaded head (3g) that comprises the upper end of said second inner chamber (3), and suitable to cooperate with a threaded recess (2g) that includes the first outer chamber (2). In this way, the outlet orifice (3e) is arranged, after placement of the second internal chamber (3) in the first outer chamber (2), opposite the second outlet orifice (2e) of said first chamber external (2). The rooms (2, 3) do not communicate with each other.

With reference to FIGS. 2 to 6, the outer chamber piston (4) slides tightly into the bore (2h) of the outer chamber (2). The outer chamber piston (4) comprises a lower open end and an upper end comprising a circular opening (9) of diameter slightly greater than the diameter of the second internal chamber (3). In this way, the inner chamber piston (4) is slidable around said second internal chamber (3). The lower open end of said outer chamber piston (4) is adapted to receive said inner chamber piston (5).

The inner chamber piston (5) comprises two parts. A first portion (5a) of cylindrical shape for slidably fitting into the bore (3h) of the second inner chamber (3) and a second portion (5b) comprising a gripping zone (5c) and an arrangement particular (5d) in the form of a threaded surface intended to cooperate with a threaded zone (not shown) that comprises the lower part of the outer chamber piston (4). A seal member (10) is mounted at the upper end of the cylindrical portion (5a) of the inner chamber plunger (5) to permit sealing in said second inner chamber (3).

In the same way, the upper end of the outer chamber piston (4) comprises a seal member (1 1) for sealingly sliding in said first outer chamber (2). Similarly, a circular opening (9) which comprises the upper end of said outer chamber piston (4), is provided on its periphery with a seal member (not shown) for said piston (4) to slide tightly around of the second internal chamber (3).

In this way, and with reference to Figure 2, in use, the mixing syringe (1) is filled with two products to be mixed and then delivered. In this way, for example, if, in the case of a surgical procedure consisting in repairing a large vessel, it is necessary to deliver a mixture of surgical glue and hardener, the surgical glue is introduced into the first outer chamber (2). ) and the hardener is introduced into the second internal chamber (3). Referring to Figures 7 and 8 which show the principle of operation of the syringe. The two internal chambers (3) and external (2) filled with products (PI and P2), said chambers being arranged coaxially. The inner (5) and outer (4) chamber pistons are also arranged coaxially with one another and sliding in the respective chambers. By the translation of said pistons (4 and 5), simultaneously in view of their connection as indicated, the products present in each chamber are pushed towards the upper end of the mixing syringe (1). In this way, the product (PI) in the first outer chamber (2) passes through the first outlet (2d) and the product (P2) present in the second inner chamber (3) passes through the second outlet (2e). A mixture comprising an internal product and a coating product is thus obtained at the outlet of the mixing syringe (1). This mixture then passes into an applicator tip (6) which can comprise in a particular embodiment, the static mixer (8) for optimally mixing the mixture. The applicator tube (6b) makes it possible to deposit the mixture further and more easily on the area of the large vessel to be bonded. As is apparent from the foregoing, the invention provides a novel and inventive mixing syringe (1) with many advantages over prior art solutions. In particular, the invention provides a syringe which is not very complex to the embodiment, making it possible to deliver a controlled quantity of a mixture consisting of two products and, in some cases, such as in large vessel repair for example, in which products are used. dangerous for living tissues, the mixing syringe (1) according to the invention makes it possible to deliver a mixture comprising the dangerous product coated in another product. In this way the delivery of the mixture poses no risk to the living tissue of a patient. This syringe (1) thus performs the function of mixing syringe, in particular for the mixing of a surgical glue and a hardener for the repair of large vessels satisfactorily by providing a safe character to its use. It goes without saying that the invention is not limited to the embodiment described above by way of example but that it extends to all embodiments covered by the appended claims.

Claims

R E V E N D I C A T IO N S

-1- syringe (1) for mixing a surgical glue and a hardener characterized in that it comprises two separate chambers (2 and 3), each receiving a product of different composition (PI, P2), said chambers (2 and 3) not communicating with each other and arranged coaxially relative to each other so as to have a first external chamber (2) and a second internal chamber (3), each of the chambers ( 2 and 3) being equipped with two pistons (4 and 5), arranged in a coaxial manner, whose faces in contact with the product are both and at all times included in the same plane transverse to the syringe and whose movement in their respective chambers (2 and 3) are made simultaneously so as to allow the total delivery of the products (PI and P2) to a common outlet, in combination with an arrangement at the outlet of a syringe, for mixing said products ( PI and P2), the mixture obtained having in the form of an internal product, consisting of hardener, and a coating product, consisting of surgical glue.

-2- syringe (1) according to claim 2 characterized in that said arrangement at the syringe outlet comprises a first opening (2d) cooperating with the first outer chamber (2) and a second opening (2e) cooperating with the second internal chamber (3), said second opening (2e) being arranged in said first opening (2d).

-3- syringe (1) according to claims 1 to 2 characterized in that it comprises an applicator tip (6) arranged on said output arrangement. -4- syringe (1) according to claim 3 characterized in that said applicator tip (6) comprises a mixing member (8).

-5- syringe (1) according to claims 1 to 4 characterized in that the chambers (2 and 3) comprise a predefined volume so that the mixture of products (PI and P2) is made in the appropriate proportions.

-6- syringe (1) according to claims 1 to 5 characterized in that it is pre-filled with said products (PI and P2) to be delivered.

-7- syringe (1) according to claims 1 to 6 characterized in that it comprises orifices (2b) for pre-filling said chambers (2) with said products (PI and P2) to be delivered.