MXPA99002241A - Applicator device for applying a multiple component fluid - Google Patents

Abstract

The applicator device comprises a plurality of supply containers (112), each of which is mechanically connected via fluid control device (148) to a common connecting headpiece (160). Each fluid control device (148) is provided with a first port (152) connected to said common connecting headpiece (160). A second port (150) of each fluid control device (148) is connected to a syringe body (114). Further, each fluid control device (148) comprises a third port adapted to have a medicinal vessel connected therethrough. Said third port is provided with an adaptor (154) for receiving said medicinal vessel and is further provided with a fluid conduit member which, when the vessel is received in the adaptor (154), extends into the interior of the vessel. Each flow control member is selectively movable from a first flow control position enabling a flow path between a first pair of two ports of the fluid control device and a second flow control position enabling a flow path between a second pair of two ports of the fluid control device, each flow control member being coupled to one of those ports for manipulation between said flow control positions.

Description

APPLICATOR DEVICE FOR APPLYING A FLUID OF MULTIPLE COMPONENTS, IN PARTICULAR A MULTIPLE COMPONENT TISSUE GLUE Description of the invention: The present invention relates to an applicator device for applying a multi-component fluid, especially a multi-component tissue glue. Particularly, the invention relates to the direct and sterile loading of such an applicator device with the individual fluid components. Applicator devices for medical multi-component fluids are known, for example, from US-PS 4,874,368, US-PS 4,978,336, EP 0 037 393 Bl and WO 95/31137. All of these applicator devices comprise a plurality of substantially cylindrical supply containers for a fluid component to be applied respectively. These supply reservoirs are usually provided as syringe bodies. Such syringe bodies include a cylindrical receiving chamber for the fluid component, having a piston with a piston rod guided displaceably therein. The outlet ends of the syringe bodies are formed as conically tapered connecting pieces. The tapered ends of the syringe bodies are inserted into the connecting recesses of a front connecting piece, the front connecting piece is formed REF. 29613 with individual channels extending therethrough from the connection recesses to an outlet end of the front connecting piece. When the filled condition is in the syringe bodies, the piston rods are actuated, the fluid components will be discharged via the discharge ends of the syringe bodies and through the channels of the front connecting piece to supply from the outlet ends of the front connecting piece, and therefore allow the fluid components to be applied for the gluing of fabric. To facilitate handling of the applicator device, the applicator device is usually provided with a mounting bracket for the individual supply containers which are placed to be coupled below two fingers of one hand. The piston rods of the supply vessels are connected to each other by a releasable connecting element so that, when pressure is exerted on the connecting element, a plurality of piston rods are simultaneously driven. The known tissue glue applicator devices indicated above are prepared for use in the following manner. First, the individual syringe bodies are filled with the fluid components. After all the syringe bodies have been filled (usually there will be two syringe bodies) with the different components, the syringe bodies are attached to the front connection piece and connected together by means of a mounting bracket. Finally, the connecting element is mounted on the operating ends of the piston rods. In view of the need to perform all these processes under sterile conditions, the management is rather uncomfortable and therefore involves the risk of contamination. An object of the invention is to provide an applicator device for applying a multi-component fluid, especially a multi-component tissue glue, in which the loading of the applicator device with the individual fluid components and the preparation of the device for applying a fluid are simplified. multiple component fluid. To solve the above objective, the invention provides an applicator device for applying a multi-component fluid, especially a multi-component tissue glue, comprising: a plurality of substantially cylindrical supply reservoirs for respectively applying a fluid component, Each of the supply tanks has a front end with an opening to supply the fluid component of the supply tanks, a rear end oriented away from the forward end, and a slidably displaceable piston having a piston rod extending out of the rear end to operate the piston, and a front connection piece provided with the connectors for fluid connection to the ends Forward of the supply reservoirs, the front connection piece has channels for the individual components of the fluid to be applied extending therethrough from the connectors to the outlet end. Furthermore, in an applicator device of the above type, at least one fluid connection is provided with a fluid control device placed between the supply tanks and the front connecting piece, the fluid control device comprises two orifices connected to the tank supply and the front connection piece. The fluid control device is additionally provided with an additional connection hole. This third connection hole is provided with an adapter that helps to receive a medical container and that comprises a fluid conduit member. When the medicinal container is attached to the adapter, the fluid conduit member extends into the interior of the medicinal container. The fluid control device is additionally connected to a flow control member which can be selectively moved within one of the two fluid control positions. In the first fluid control position, there is a flow path between a first pair comprising two of the three orifices of the fluid control device while, in the second fluid control position, there is a flow path between a second pair comprising a different combination of two of the three fluid control device orifices. The flow control member engages one of the orifices so that it is operable from the outside to be moved between the two flow control positions. According to the invention, the loading of the applicator device and a preparation of the device for applying a multi-component fluid is extremely simple. To load the supply tanks, the applicator device may remain in its assembled state necessary to apply the fluid. An intermediate removal of the supply devices of the front connecting piece is not necessary. Instead, each fluid control device is pre-adjusted to a first flow control position; in this first flow control position, there is a flow path between the second orifice, connected to the supply container, and the third orifice. When a medical container is connected in the first flow control position of the flow control member, to the adapter of the third orifice, the contents of the medicinal container can be sucked from the container into the supply reservoir connected to the fluid control device . In this way, all of the supply tanks (normally there will be two supply tanks because their use is mainly made of two component tissue glues) are loaded with a fluid component. After the individual supply reservoirs have been charged, the flow control members of the fluid control devices connected to the supply reservoirs are moved to the second flow control position in which the second orifices connected to them Supply tanks are in fluid connection with the first orifices of the fluid control devices which are connected to the front connection piece connectors. Therefore, the applicator device is ready for use because, when the piston rods are driven, the content of the supply tanks will move directly through the fluid control devices and the front connecting piece towards the outlet end of the front connecting piece. At this outlet end, the two components will mix together and jointly provide the desired effect of the fabric glue. Therefore, the decisive advantage provided by the applicator device of the invention is based on an extremely simple handling of the applicator device during the process of loading the individual supply tanks. The stages of handling necessary for this purpose are reduced to a minimum so that under this aspect, the danger of contamination is considerably reduced (what is called the aseptically closed system). It is particularly advantageous that, when the supply tanks are loaded, the applicator device is already ready in the assembled condition necessary for the subsequent application process. Therefore, at this point in time, the supply tanks are already connected (via the fluid control devices) to the front connection piece. Furthermore, at this point, also the elements necessary to handle the applicator device while applying the tissue glue are already in their assembled condition. These elements include, for example, a mounting bracket that receives the supply tanks, and a connecting element for connecting the operating ends of the piston rods. In addition, other elements or components, respectively different, necessary for the operation of the applicator device can already be assembled in advance. In accordance with the teachings of the present invention, a family of fluid control devices is provided for use in tissue glue applicator devices which are adapted for the aseptic application of tissue glue either directly or indirectly to a application site. In particular, the selection of the most suitable fluid control device depends on the type of fluid to be applied and / or the manner in which it is packaged. Some of the devices are designed to allow the reconstitution of a fluid component provided in powder form or as a liquid concentrate. Some of the devices are suitable for bottles or ampoules containing a single dose of a fluid, "while others are suitable for IV bottles or bags containing multiple doses.In a preferred embodiment of a fluid control device, the The flow control is rotatably mounted on a body member so that it is selectively rotatable between its first flow control position and its second flow control position.The adapter can be formed integrally with the flow control member and can be design so that it is detached by easy rupture thereof after rotation of the flow control member from its first flow control position to its second flow control position., the adapter can be detachably coupled to the flow control member by means of an intercoupling means that allows the axial detachment of the adapter from the body member at a tive rotation therebetween to a position which drives the flow control member from its first flow control position to its second flow control position. In a preferred embodiment of a fluid control device suitable for use with fluid components which require reconstitution, the fluid control device includes a fourth hole in the form of an adapter to allow attachment of a second medicinal container to the body member . In a preferred embodiment of a fluid control device, the first orifice is also provided with an adapter adapted for attachment thereto of a medical container and, in this case, the orifice is adapted to receive the syringe is rotatably coupled to the syringe member. flow control. In each case, the adapter can be adapted for attachment thereto of a vial, a vial or an IV bag, the former requiring that the fluid conduit member be formed as a piercing tool to pierce the rubber stopper of the vial in its union to it. In the case of joining an ampoule, because the ampoule can not be inverted, it is required that the fluid conduit member be provided with a long tube to allow all or almost all of its contents to be aspirated from the same The adapter may also include a conduit for venting the container when attached thereto. The conduit may include a filter to filter the air that passes through it. The filter can be used within a lateral cavity provided within the adapter or, alternatively, the filter can be provided as a separate element external to the fluid control device. For a better understanding of the present invention and to show how it can be carried out in practice, and only by way of non-limiting examples, reference will now be made to the accompanying drawings, in which: Figure 1 is a top view of an applicator device for applying a two-component tissue glue, according to the invention, Figure 2 is a perspective view of an assembled fluid control device including a base member and an adapter formed integrally with a flow control member for use with the applicator device according to Figure 1, Figure 3 is a perspective view of the fluid control device of Figure 2, prior to assembly, - li Figure 4 is a vertical cross-sectional view of the fluid control device of Figure 2 along the line AA after insertion of a syringe of the applicator device of Figure 1 and the attachment of a vial, and prior to the rotation of the adapter relative to the base member, Figure 5 in a horizontal cross-sectional view of the fluid control device of Figure 2 along the line BB after the insertion of a syringe of the application device of figure 1 and the joining of a bottle, and before the rotation of the adapter in relation to the base member, Figure 6 is a horizontal cross-sectional view of the control device of fluid of Figure 2 along the line CC before the rotation of the adapter relative to the base member, Figure 7 is a vertical cross-sectional view of the fluid control device of Figure 2, throughout of the AA line after the rotation of the adapter relative to the base member, Figure 8 is a horizontal cross-sectional view of the fluid control device of Figure 2 along the line BB after rotation of the adapter in relation to the base member, Figure 9 is a horizontal cross-sectional view of the fluid control device of Figure 2 along the line CC before the rotation of the In relation to the base member, FIG. 10 is a perspective view of an adapter integrally formed, modified, with a flow control member adapted so that the adapter is separated by rupture of the flow control member before rotation of the adapter in relation to the base member exceeding a predetermined position, Figure 11 is a perspective view of a fluid control device including the modified adapter with the flow control member of Figure 10 after the adapter broken apart, Figure 12 is a perspective view of an assembled fluid control device including a base member and an adapter designed for releasable coupling with the base member, Figure 13 is a perspective view of the device of fluid control of figure 12 after the adapter has been rotated a quarter of a turn, ready for its detachment from the base member, Figure 14 is a vertical, cross-sectional view of the base member of the fluid control device of Figure 12, Figure 15 is a vertical cross-sectional view of the adapter of the control device of FIG. fluid of Figure 12, Figure 16 is a perspective view of the flow control member of the fluid control device of Figure 12, Figures 17A and 17B are vertical cross-sectional views of a fluid control device in which the flow control member is required to rotate 180 ° to allow switching between its flow control positions, the Figure 18 is a vertical cross-sectional view of a fluid control device - Im provided with an arrangement for venting a bottle attached to its adapter, Figures 19A and 19B are two views showing a fluid control device having a filter to filter ventilation air to a bottle attached to its adapter, the filter is provided as a separate element external to the device, Figure 20 is a vertical cross-sectional view of a fluid control device having a adapter provided with a lateral cavity to receive a filter to filter ventilation air to a bottle attached to it, Figure 21 is a cross sectional view salt, vertical, of a fluid control device in a first operative position that allows flow communication between a medicinal container containing a powder component and a medicinal container containing a physiological solution to allow reconstitution of the powder component, Figure 22 is a vertical cross-sectional view of the fluid control device of Figure 21 in a second operative position that allows flow communication between the bottle containing the reconstituted component and a syringe of the applicator device of the figure Figure 23 is a vertical cross-sectional view of the fluid control device of Figure 21, and a third operative position allowing flow communication between the syringe and manifold of the applicator device of Figure 1, Figure 24 is a cross-sectional, longitudinal view of a fluid control device For use with a syringe and a pair of medical containers of the applicator device of Figure 1, Figure 25 is a horizontal, cross-sectional view of the flow control member of the fluid control device of Figure 24, as shown in FIG. along the line DD, Figure 26 shows a series of steps (Figures 24A-24F) showing the operation of the fluid control device of Figure 24, Figure 27 is a longitudinal cross-sectional view of the device - fluid control of Figure 24, with a modified flow control member, Figure 2i is a horizontal cross-sectional view of the flow control member of Figure 27, along the line EE in the Figure 27, Figure 29 is a longitudinal cross-sectional view of a modified fluid control device of Figure 24, with an in-line filter, and Figure 30 is a longitudinal cross-sectional view of a device of fluid control with a modified adapter that allows the ventilation of a medicinal container attached to it, placed with a hydrophobic filter.

Figure 1 shows a plan view of an applicator device 110 for multi-component tissue glues. The applicator device 110 comprises two supply reservoirs provided as commercially available syringes 112 for solutions of proteins, such as fibrinogen and of fibrinolytic substances, such as thrombin, of a two-component tissue glue. Each syringe 112 comprises a hollow cylindrical, syringe body 114, having a forward end 116 with an outlet opening 118 and connection pieces 120, and an open rear end 122. Placed in each syringe body 114 is a piston 124 in sealing engagement on the inner surface of the syringe body 114. The piston 124 is held by a piston rod 126 guided out of the syringe body 114 through the rear end 122. The piston rods 126 extend respectively in the longitudinal direction of the syringe bodies 114 (see the longitudinal axes 128 of the syringe bodies 114, indicated in the drawings). The free ends 130 of the piston rods 126 are oriented away from the piston 124 and have annular flanges 132 formed therein. These angular flanges 132 are mechanically connected to each other by a connecting element 134. The connecting element 134 is formed with two receiving recesses 136 which open laterally and are positioned for insertion of the annular flanges 132 therein. As shown in the figures, the two syringe bodies 114 are connected to each other by a clasp-retaining means 138 (hereinafter referred to as a retention element). The retaining element 138 comprises two C-shaped retaining clips 140 of which the openings 142 are oriented away from each other and which are connected to each other by their middle portions ("back portions"). The openings 142 are oriented in the direction of the extension of that plane (here coinciding with the plane of Figure 1) in which the longitudinal axes 128 of the syringe bodies 114 are arranged. Such staples 140 are provided with two lower clamping projections 144. (In the view of figure 1, only a projection 144 is visible). These projections 144 extend in mutually opposite directions, and are placed at a rotational displacement of 90 ° relative to the two staples 140 or their openings 142, respectively. Therefore, the two projections 144 project respectively at right angles from the plane (of Figure 1) in which the longitudinal axes 128 of the "syringe bodies 114 are placed, when the syringe bodies 114 are retained by the retaining element 138 or respectively in which the longitudinal axes of the staples 140 extend coincident with the longitudinal axes 128 of the syringe bodies 114. This means that the projections 144 protrude in opposite directions along the axes of the syringe. symmetry of the twin staple arrangement The syringe bodies 114 are supported for sliding movement on the retaining element 138, because the resilient elastic retaining clips 140 extend more than 180 °, and preferably up to 200 ° around the bodies 114 of the syringe, and therefore enclose or enclose the syringe bodies 114 with a clamping force that allows relative displacement. The retaining element 138 is positioned to abut the edges 146 projecting laterally on the rear ends 122 of the syringe bodies 114, thereby providing a mutual abutment of the retaining element 138 and the syringe body 114. The axial dimension of the retaining element 138, and especially of the retaining clips 140, is such that the scale marks placed externally on the syringe bodies 114 are left unobstructed and are not covered by the retaining element 138. As is evident from Figure 1, the slightly conical connecting pieces 120 on the forward ends 116 of the syringe bodies 114 are respectively connected to a fluid control device 148. Each fluid control device 148 is provided with a connector 150, which receives the conical connection piece 120 from a syringe body 114. Each fluid control device 148 is provided with an output connection piece 152 opposite the connector 150. In addition, each fluid control device 148 is provided with a receiver adapter 154 comprising a fluid conduit member 156. The receiver adapter 154 is configured for insertion of a medical container therein, with the fluid conduit member, formed as a piercing needle penetrating the rubber saw cap of the container and extending into the interior of the container. Each fluid control device 148 has a flow control member (not shown in Figure 1) rotatably supported therein. This flow control member can be rotated from the outside, which is done in particular by rotating the adapter 154. By rotating the flow control member, the flow control member can be moved from a first flow control position. fluid, in which there is a fluid path between the syringe body 114 and the medical container, to a second fluid control position in which the syringe body 114 is in fluid connection with the output connection piece 152 if the fluid control device 148. The structure and function of each fluid control device 148 will be explained in more detail below in the following, in relation to the preferred embodiments according to figures 2 to 30. The parts 152 of output connection of the fluid control device 148 have the connectors 158 of a front connecting piece 160 mounted thereon.The front connecting piece 160 is f orma with channels 162 extending therethrough to connect the connectors 158 to the output end 164 of the front connection piece 160. In addition, the front connecting piece 160 is formed with an additional channel 166 extending therethrough and having a hose 168 for a medicinal gas, for example 02, connected thereto. In addition, the channel 166 extends toward the output end 164 of the connection front piece 160. On the outlet end 164, the connecting front piece 160 is joined by a three-lumen, three-lumen catheter 170, its three lumens being in the same plane as the inner channels 162 and 166 of the connecting front piece 160. at the output end 164 of the front piece 160. Preferred embodiments of the fluid control device of the applicator device 110 according to FIG. 1 will be explained in greater detail in the following. Figures 2 to 9 show an embodiment of a fluid control device, designated generally with the number 10, to allow control of flow of a fluid between a syringe, a medical container and the manifold of the applicator device 110 of Figure 1 The fluid control device 10 includes an elongate base member 11 having a hole 12 adapted to receive a syringe from the applicator device 110 and a dispenser orifice 13 adapted as a plastic cannula for insertion into the manifold of the applicator device 110. The hole 12 is typically adapted as a female Luer connector. As shown in Figure 4, the hole 2 includes a lumen 14 having an interior opening 14 'and the spout hole 13 includes a lumen 16 having an interior opening 16'. The lumens 14 and 16 are coaxial and in flow communication via an orifice 17 positioned transversely in relation to the elongated base member 11. The hole 17 includes an upper peripheral flange 18 and a smaller peripheral wall stop portion 19, lower, projecting radially inward relative to its main peripheral wall portion 19"(see Figure 6). As shown, the stop wall portion 19 'typically extends through an arc angle of approximately 90. The fluid control device 10 further includes an adapter integrally formed with a flow control member, generally designated 20, for insertion into the orifice 17, where it is restrained by means of a peripherally formed groove 22. to receive the flange 18 therein The flow control member 20 'is formed with two flow ducts as follows: a first flow duct 23 (see Figure 4) in the form of an L-shaped channel has a radial opening 23 'for alignment with the interior opening 14' and an axial opening 23 'of a member 24 of fluid conduit integrally formed as part of the adapter 20"in the arrangement of the flow control member 20 'in a first flow control position allowing flow communication between a syringe inserted in the port 12 and a container attached to adapter 20"; a second flow duct 25 (see Figure 5) in the form of a groove larger, slightly peripheral semicircular, having a first end portion 25 'for alignment with one of the inner openings 14' and 16 'and a second end portion 25"for alignment with the other of the openings 14' and 16 'inside' when the flow control member 20 'is placed in a second flow control position to allow flow communication between a syringe inserted in the hole 12 and the supply orifice 13. In addition, the control member 20' flow is provided with a minor peripheral wall portion 26 'projecting radially outwardly relative to its main peripheral wall portion 26"(see Figure 6). As shown, the stop wall portion 26 'typically extends through an arc angle of about 90 ° The smaller peripheral wall stop portions 19', 26 'are placed in this manner so that assume substantially diagonally opposite positions one in relation to the other (see Figure 6) in the first flow control position of the flow control member 20 'The adapter 20"is shown to be adapted for attachment thereto of a bottle 28 (not drawn to scale) provided with a rubber plug 29. As such, the fluid conduit member 24 is adapted as a piercing tool 30 to penetrate the rubber plug 29 for attachment of a bottle 28 to its adapter 20. "Alternatively, the adapter 20" can be adapted for attachment to the same. of a bottle 31 (not drawn to scale), the difference is such that the adapter will preferably have relatively large flexible fasteners.

Each step of the two-step operation of the fluid control device 10 for filling the bodies of the syringe with tissue glue components provided in powder form for dilution with a physiological solution provided in a pre-filled syringe is described below with reference to figures 4 to 6 and figures 7 to 9, respectively. As shown in Figs. 4 to 6, the fluid control device 10 is best provided in an installation position in which the fluid control member 20 is in its first fluid control position and the two portions of the fluid control member are in their first position. 'and 26' of wall with smaller stops are diagonally opposite each other As shown, it should be noted, as best seen in Figure 5, that the semicircular groove 25 is aligned with the interior opening 16 ', but does not provide In this arrangement, a pre-filled syringe 32 is inserted into the hole 12 and the bottle 28 is attached to the adapter 20"by means of which action, the piercing tool 30 pierces the rubber stopper 29 of the container, so that it allows flow communication with its interior via the fluid conduit member 24 '. Typically, the syringe 32 requires the drive for the delivery of its contents into the bottle 28 while, in some cases, if the contents of the bottle 28 are under vacuum, then the physiological solution of the syringe 32 can be sucked into the bottle without user intervention. Subsequently, the components of the bottle 28 are agitated so that the powdered tissue glue component is formed. The fluid control device 10 together with the bottle 28 is then preferably inverted, and the syringe 22 is aspirated so as to extract the reconstituted liquid tissue glue component therein. Returning now to Figures 7 to 9, the bottle 28 together with the adapter 20"is rotated either clockwise or counterclockwise relative to the base member 11 to the moment in which the stop wall portion 26 'makes contact with the stop wall portion 19' (see Figure 9)., the flow control member 20 'is rotated to its second flow control position which activates the flow path between the syringe 32 and the supply orifice 13 by means of the end portions 25' and 25" the semicircular groove 25 which is aligned with the inner openings 14 'and 16. The tissue glue component can then be supplied by actuating the syringe 32. As is readily appreciated now, the fluid control device 10 ensures that the filling of the syringe body of the tissue glue applicator device 110 of Figure 1 with the tissue glue component is performed under aseptic conditions Figs 10 and 11 show a second embodiment of a fluid control device, generally designated with the number 34, constructed and operative according to the teachings of the present invention to activate the fluid flow control between a syringe, a medicinal container and an orifice cio supplier The fluid control device 34 is of construction or operation similar to the fluid control device 10 and therefore the same reference numerals will be used, where appropriate. The main difference between the two fluid control devices 34 and 10 resides in the fact that the first includes an adapter formed integrally with a flow control member 35 provided with a weakened portion, generally denoted by the number 36, between its wall-to-wall portion 26 'of its flow control member 35, and its adapter 35. As shown, this weakened portion 36 is obtained by leaving spans 36' extending radially, formed by cut-outs 36". The advantage of this design is that after the rotation of the bottle 28 (not shown) and the adapter 35"90 °, so as to rotate the flow control member 35 'from its first flow control position to its second flow control position, any additional torque applied will tend to interrupt the adapter 35"which can be discarded together with the bottle, thereby providing a less problematic and lighter remnant assembly of the tissue glue applicator device 110 Figure 1, so as to facilitate the application of a tissue glue. An additional difference between the fluid control devices 34 and 10 resides in the fact that the first includes "a dispenser orifice 38 adapted as a male Luer connector." Figures 14 to 16 show a third embodiment of a fluid control device. , designated generally with the number 40, constructed and operative in accordance with the teachings of the present invention for activating a fluid flow control between a syringe, a medical container and a dispensing orifice The fluid control device 40 is of construction and operation similar to the fluid control device 10 and therefore the same reference numbers are used here, where appropriate.The main difference between the two fluid control devices 40 and 10 resides in the fact that the first includes an adapter 41 designed for a detachable, non-destructive coupling, with a flow control member 42. As such, the base member 11 is intended to be it is provided with a rectangular shaped skirt 43 that hangs down, provided with outwardly extending shoulders 43 'and 43"for engagement with a rectangular shaped holder 44 extending upwardly of the adapter 41 provided with the slots 44' 44"directed inwards to receive flanges 43 'and 43". In addition, the adapter 41 is provided with an upwardly extending rod 46 provided with a rectangular shaped key 46 'for insertion into a similarly sized and shaped slot 42' formed on the underside of the control member 42 flow. In the fluid control device 40, the flow control member 42 is placed in its first flow control position which activates a flow path between the orifice 12 and a medical container that is to be attached to the adapter 21 when the adapter 21 is mounted on base member 11. Inversely, by rotating the adapter 41 in relation to the base member 11 to a position allowing axial detachment thereof, the adapter 41 urges the flow control member 42 from its flow control position to its second control position. flow which activates a flow path between the orifice 12 and the supply orifice 13. Preferably, there is a screw threaded coupling between the base member 11 and the adapter 41 designed such that there is an axial displacement of the adapter 41 away from the base member 11 when it is rotated from its engaged position to its uncoupled position. It can be readily appreciated that the advantage of this design over the design of the fluid control device 34, while retaining all the advantages of the latter, resides in the fact that the former is reusable after sterilization, while the latter can only be reused. to be used once due to the destruction of the adapter with the flow control member 35. An additional difference between devices 40 and fluid control resides in the fact that the first includes a spout hole 13 provided with a needle 47. Figures 17A and 17B show a fourth embodiment of a fluid control device, generally designated with the number 48, constructed and operative according to the teachings of the present invention for activating a fluid flow control between a syringe, a medical container and a delivery orifice. The fluid control device 48 is similar in operation construction to the fluid control device 41, and therefore the same reference numbers are used where appropriate. The main difference between the two fluid control devices 48 and 41 resides in the fact that the first includes a flow control member 49 which is required to rotate a 180 ° turn between its first flow control position. (see Fig. 17A) and its second flow control position (see Fig. 17B). In particular, the flow control member 49 includes an inclined channel 50 having a radial opening 50 'for alignment with the inner opening 14', and an axial opening 50"for alignment with the fluid conduit member 24, so which activates the flow path between a syringe and the interior of a medical container In addition, the flow control member 49 includes a second inclined channel 52 having a radial opening 52 'for alignment with the interior opening 14' and an opening 52"radial for alignment with the interior opening 16 ', so as to activate the flow path between the syringe to the spout 13. As shown, in this case, lumens 14 and 16 are not coaxial. Figures 17 to 20 show other modified fluid control devices, designated generally with numerals 53, 54 and 55 constructed and operative in accordance with the teachings of the present invention, to activate the control of fluid flow between a syringe, a medicinal container and a dispensing orifice. The fluid control devices 53, 54 and 55 are of construction and operation similar to the fluid control device 41 and therefore the same reference numerals will be used, where appropriate. The main difference between the fluid control devices 53, 54 and 55 and the fluid control device 41 is that they provide arrangements for venting a flask and, if necessary, for filtering the incoming air. Returning now to FIG. 18, the fluid control device 53 includes an adapter 56 that is provided with a vent duct 58 for venting a flask 28 to the atmosphere, in addition to the fluid conduit member 24. Ventilation duct 58 is preferably provided with a filter 59 to filter incoming air. Returning now to FIGS. 19a and 19b, the fluid control device 54 is similar to the fluid control device 53, except that it includes a filter 60 exterior to the adapter 56. Returning now to FIG. 20, the control device 55 fluid is similar to fluid control device 53, except that its adapter 61 includes a laterally positioned filter 62, which is formed integrally. Figures 21 to 23 show a fluid control device, generally designated with the number 64, to activate the reconstitution of a powdered tissue glue component, with a physiological solution contained in a medicinal container, instead of being contained within a pre-filled syringe, as required with the fluid control device 10. The fluid control device 64 is of construction and operation - similar to the fluid control device 41, and therefore the same reference numerals are used, where appropriate. The main difference between the two fluid control devices 64 and 41 resides in the fact that the first is adapted to be placed with two medicinal containers and as such, its base member 11 is provided with a hole 12, a supply hole 13 and two perforations 17A and 17B which are interconnected by a channel 65. As shown, the medicinal containers are bottles 28A and 28B where the bottle 28A it contains a powdered tissue glue component and the bottle 28B contains the physiological solution for diluting the glue component of powdered tissue. As explained in greater detail in the following for the case in which the bottle 28A has its content under high vacuum, the sequence and the order of joining of the bottles 28A and 28B to the adapters 41A and 41B is not arbitrary. In this case, the flow control member 42A has a first flow control position in which its L-shaped flow duct 23A is aligned in flow communication with the channel 65 and a medicinal container attached to its adapter 41A (see Figures 21 and 22), and a second flow control position in which its peripheral slot flow duct -25A is aligned in flow communication with channel 65 and spout hole 13 (see Figure 23) . In contrast, the flow control member 42B has a first flow control position in which the L-shaped flow duct 23B is in flow communication with the channel 65 and a medicinal container attached to its adapter 41B (see Fig. 21) and a second flow control position in which its peripheral slot flow duct 25B is aligned in flow communication with the channel 65 and the orifice 12 (see Figs. 22 and 23). The operation of the fluid control device 64 for filling the syringe body of the applicator device 110 of FIG. 1 is described below with a tissue and powder glue component that is provided in the pressurized bottle 28A after reconstitution with a physiological solution provided in the bottle 28B. First, as shown in Figure 21, the fluid control device 64 is provided in its first operative position, specifically, which activates the flow path between the bottles 28A and 28B when they are attached to the base member 11. It should be noted that the bottle 28B is attached to the adapter 41b and subsequently the pressurized bottle 28A is attached to the adapter 41A so that the physiological solution contained in the bottle 41B is sucked into the bottle 28A. Reconstitution typically requires shaking the fluid control device 64. As shown in Figure 22, the adapter 4IB together with the bottle 28B is then rotated so as to activate its detachment from the base member 11 while, at the same time, carrying out the rotation of the flow control member 42B so as to activate the flow path between the hole 12 and the remaining bottle 28A. The syringe 66 is inserted into the hole 12 and, after inversion of the fluid control device 64 so that the bottle 28 containing the reconstituted tissue glue component assumes an upward position, the syringe 66 is aspirated to extract the contents of the bottle 28A therein. Subsequently, as shown in Figure 23, the adapter 41A together with the bottle 28A are rotated so as to activate their detachment from the base member 11 while, at the same time, carrying out the rotation of the control member 42A. flow so as to activate a flow path between the syringe 66 and the supply orifice 13. Finally, in this position, the syringe 66 is operated so as to eject the respective tissue glue component for application together with another component to an application site via the supply orifice 13. Figures 24 to 26 show a fluid control device 67 allowing the preparation of the tissue adhesive component by mixing between a first substance contained in a first additional container, in a second substance contained in a second medicinal container, and subsequently the transfer of the tissue glue component to a dispensing tool, specifically a syringe. The syringe control device 67 includes a base member 68 having a generally tubular intermediate portion 70 defining a lumen 71 in which the flow control member 72 is rotatably inserted. The flow control member 72 has a hole 73 for receiving a dispensing tool, typically a syringe 74 (see Fig. 26). The hole 73 is preferably adapted as a 'female Luer connector. The flow control member 72 also has handles 76 integrally formed to allow manual rotation thereof. As shown, a filter 77 can also be placed within the hole 73 to filter a tissue glue component onto its suction in a syringe 74. The base member 68 includes two adapters 78 and 69 which are suitable for attachment to the tissue. same of the medicinal containers. In this case, the adapters 78 and 79 are suitable for joining thereto of jars and, as such, include respective coaxial fluid conductor members 78 'and 79' adapted as drilling tools for drilling the rubber stoppers of. the jars. The fluid conduit members 78 'and 79' have the respective internal openings 78"and 79".

The flow control member 72 is rotatably mounted for activation either, in a first flow control position, of a flow path between the bottles attached to the adapters 78 and 79, or, in a second control position of flow, a flow path between the syringe and one of the bottles. As such, in a manner similar to the flow control member 20 '(see FIGS. 3 and 5), the flow control member 72 includes two flow conduits as follows: a first flow conduit 80 in the form of a peripheral groove slightly larger than the portions 80 'and 80"of end having semicircular for alignment with the interior openings 78" and 79", so as to activate a flow path between the interiors of the bottles when they are attached to the adapters 78 and 79. And a second flow duct in the form of an L-shaped channel having a radial opening 82 'for alignment with the inner opening 72' and an axial outlet hole 82"so as to activate a path of flow between the bottle attached to one of the adapters 78 and 79, and a syringe inserted in the hole 77. Now the operation of the fluid control device 67 will be described with reference to the steps shown in Figure 26 for the case in that the jar 83 contains a component of dry tissue glue, for example a powder, a crystalline material, a lyophilisate, etc., stored at high vacuum, and a bottle 84 containing a physiological solution. As explained in more detail in the following, for the case in which the bottle 83 has its content under high vacuum, the sequence of joining of the bottles 83 and 84 to the adapters 78 and 79 is not arbitrary. The fluid control device 67 is typically provided in a hermetically sealed package with its flow control member 72 positioned so as to activate the flow path between the flow conduit members 78 'and 79' by the ends 80 'and 80"of the semicircular groove 80 aligned with its interior openings 78" and 79" (figure 26A). The bottle 84 containing the diluent solution is attached to the adapter 78 (Figure 26B), the joining action is by piercing its rubber stopper and subsequently the bottle 83 containing the dry tissue glue component is attached to the adapter 79. (Figure 26C) so it sucks the diluent solution into it, once its rubber plug is punctured (Figure 26D). The contents of the bottle 83 are then stirred so that the diluting solution is mixed with the dry tissue glue component. The syringe 74 is inserted into the hole 73 (Figure 26D) and the flow control member 72 is rotated a quarter turn in relation to the base member 11 so as to activate the flow path between the syringe 74 and the bottle 83 (Figure 26A). The fluid control device 67 is then inverted (FIG. 26F) and the syringe 74 is aspirated so as to extract the glue component from reconstituted tissue into the interior thereof, and the medicinal preparation passes through the filter 77 deployed, in FIG. if it finds it, so that a particle-free system is obtained for application in an application site. Figures 27 and 28 show the fluid control device 67 with a modified flow control member 85 having just the L-shaped flow duct 82, so it requires that a 180 ° turn be rotated to switch between its two flow control positions, the first flow control position is between a syringe inserted in the hole 73 and a first medicinal container, while the second flow control position is between a syringe inserted in the hole 73 and a second medicinal container. The difference between the flow control members 85 and 72 is such that the fluid control device 67 with the first can be used with medicinal containers in which their contents are subject to low or no vacuum, so it requires the intervention of the user to perform the mixing of the glue component of powdered tissue, with the physiological solution. In particular, the flow control member 85 is suitable for use with the fluid control device 67 having an adapter suitable for connection to an IV bag, so that by adjusting the flow control member 85 in its first position operative, the syringe 74 is aspirated so as to introduce a predetermined volume of diluent solution thereto. Subsequently, by placing the flow control member 85 in its second operative position, the syringe 74 is operated so as to introduce the diluent solution into the second medicinal container containing the tissue glue component to be reconstituted. After mixing the tissue glue component with the diluting solution, the syringe 74 is sucked a second time, so that it introduces the medicinal liquid into it, at which time the syringe 74 is removed for application of the glue tissue to an application site. In this way, this fluid control device can be used many times with one or more medicinal containers. Fig. 29 shows the fluid control device 86 with an orifice 87 provided with an in-line, integral filter 88, whereby the need for a filter 77 is eliminated. Fig. 30 shows a fluid control device 89 with a modified adapter 90 having a vent duct 91 for venting the bottle attached thereto that is provided with a hydrophobic filter 92 so as to avoid wasting glue component from mixed tissue when the fluid control device 89 is manipulated to the position shown in Figure 26F. The use of the different embodiments of the fluid control device 148 of the applicator device 110 described above with reference to FIGS. 20 to 30 provides the advantage that the applicator device can be filled by the glue components in a simple and uncomplicated manner. . For this filling process, the applicator device 110 is used in the configuration shown in FIG. 1, that is, in the condition suitable for applying the tissue glue. The two medicinal containers containing the components only need to be mounted to the adapters 154. Subsequently, the two piston rods 126 are actuated by pulling the connecting element 134 so that the contents of the medicinal container are sucked into the interior of the bodies 114. of syringes. At this point in time, the flow control members of both fluid control devices 148 are placed in the fluid control position in which the piercing needles 156 are connected to the syringe bodies 114. After the syringe bodies 114 have been filled, the adapters 154 are rotated and thus the flow control members are also rotated at the same time, so that the syringe bodies 114 are now connected to the manifold. After having rotated, the adapters 154 are extracted from the fluid control devices 148. In this way, the adapters 154 of relatively large size do not alter the application of the tissue glue. Now the tissue glue can be applied without further manipulation of the applicator device. It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is the conventional one for the manufacture of the objects or products to which it refers.

Claims (12)

CLAIMS Having described the invention as above, property is claimed as contained in the following:

1. An applicator device for applying a multi-component fluid, especially a multi-component tissue glue, comprising: a plurality of substantially cylindrical supply reservoirs for respectively a component of the fluid to be applied, each of the supply reservoirs has a front end with an opening for supplying the fluid component of the supply reservoir, the trailing end facing away from the leading end, and a slidably displaceable piston having a piston rod extending out of the trailing end to operate the piston, and A front connecting piece provided with connectors for fluid connection with the forward ends of the supply reservoirs, the front connecting piece has channels for the individual components of the fluid to be applied, which extend therethrough from the connectors of the front piece of co nexion- to an outlet end, the device is characterized in that the fluid control device is arranged in at least one of the fluid connections between the front ends of the supply tanks and the connectors of the front connection piece, The fluid control device comprises: a first hole connected to a connector of the front connecting piece, a second hole connected to the front end of a supply tank, a third hole connectable to a medicinal container, the third hole comprises an adapter for receiving the container, the adapter has a fluid conduit member extending from the interior of the container when it is attached to the adapter, and - a flow control member selectively operable in a first portion of activating flow control a flow path between a first pair of holes and a second flow control position that activates a path As the flow path between a second pair of two orifices, the flow control member engages one of the orifices for manipulation between the flow control positions.

2. The applicator device, according to claim 1, characterized in that the flow control member is rotatably mounted within the fluid control device.

3. The applicator device, according to claim 1 or 2, characterized in that the adapter is coupled to the flow control member to urge the flow control member from the first flow control position to the second flow control position before the rotation of the adapter.

4. The applicator device, according to claim 3, characterized in that the adapter is formed integrally with the first flow control member.

5. The applicator device according to claim 4, characterized in that the adapter formed integrally with the flow control member includes a weakened portion that allows the detachment of the adapter from the flow control member after the member has been driven. of flow control from the first flow control position to the second flow control position.

6. The applicator device, according to claim 3, characterized in that the adapter is coupled to the flow control member by means of intercoupling which allows detachment therebetween after the flow control member has been driven. the first flow control position to the second flow control position.

7. The applicator device according to any of claims 1 to 6, characterized in that at least one fluid control device further comprises a fourth orifice connectable to a medicinal container, the fourth orifice comprises an adapter for receiving the container, the adapter has a fluid conduit member extending inside the container when it is attached to the adapter.

8. The applicator device according to any of claims 1 to 7, characterized in that the adapter or adapters are provided for the attachment thereto of a container of the type of a bottle, a glass bottle, a vial or a bag IV. The applicator device according to any of claims 1 to 8, characterized in that the adapter or adapters are provided with a ventilation duct for venting a medicinal container when they are attached thereto. 10. The applicator device according to any of claims 1 to 9, characterized in that the fluid control device is provided in each of the fluid connections between the forward ends of the supply tanks and the connectors of the part front connection. The applicator device according to any of claims 1 to 10, characterized in that the front connecting piece is provided with a gas connector for supplying a medicinal gas, and with a channel extending from the gas connector to the gas connector. exit end. 12. The applicator device according to any of claims 1 to 11, characterized in that the output end of the front connection piece has a multi-lumen catheter connected to it, the lumens of the ultilaminar catheter are in the same plane as the channels ending at the outlet end of the front connecting piece.