Hand triggered tissue sealant spray apparatus and system

[0001] The invention relates to a system for applying a tissue adhesive, such as tissue adhesive, to a working surface such as biological tissue.

[0002] Mixing and / or applying the adhesive to working surfaces applies to various anastomoses. In the field of medicine, a binder in the form of tissue swabs was applied to human and animal tissue, for example with the intention of sealing or repairing tissue at the site of surgery or injury, to stop bleeding, seal wounds, treat burns and skin grafts, as well as various other reasons.

[0003] In the medical field, tissue adhesive is typically applied by an applicator like a syringe that injects tissue adhesive directly onto the tissue. Examples of such applicators are set forth in US Patent Nos. 4,846,405, 5,582,596, 5,665,067, 6,461,361 and 6,585,696, in PCT Application Publication Nos. WO 96/39212, WO 95/31138 and WO 97 / 20585 and in European publication EP-A-0 634 140. Further examples of such applicators are also sold under the trademarks Tissomat and Duploject, which are marketed by Baxter AG.

[0004] The tissue adhesive used to treat biological tissue is typically made of one or more components, such as biocompatible substances, which can be absorbed by the body and do not require subsequent removal from the patient's body. One of the known tissue adhesives is made of fibrinogen and thrombin. The tissue adhesive can be placed in more than one container and can be mixed to obtain an adhesive combination after injection from the tissue adhesive applicator. For example, the ingredients may come out of two separate outlet openings positioned side by side in such a way that these ingredients are mixed to form a tissue adhesive adhesive when ejected from the apiikator.

[0005] Tissue adhesive applicators can also provide a tissue adhesive that is atomized with compressed sterile gas, such as, for example, air to form a dispersed mist that is a combination of tissue adhesive and sterile gas or air. The applicator is connected to an air or gas source through a tubing that feeds gas or air to the distal end of the applicator adjacent the outlet openings of one or more tissue adhesive components. For example, the gas may come into contact with one or more tissue adhesive components within the mixing area defined by the applicator. Alternatively, the gas may mix with the tissue adhesive components after being ejected from the applicator. In the latter case, the gas or air outlet is preferably located in close proximity to the outlet of one or more tissue adhesive components and may be, for example, in the form of an annularly shaped outlet opening which surrounds at least one of the outlet holes of the tissue adhesive. The effect is that the tissue glue comes out in the form of an aerosol or a spray mist.

[0006] The gas or air supply is preferably coordinated in such a way that, for example, the gas is fed to the apiikator substantially simultaneously with the ejection of tissue adhesive. However, time synchronization of this supply with the ejection of the tissue adhesive or its components has proved to be laborious and difficult, especially when using many tissue adhesive components.

EP 1 871 237 tkan1 [0007] Conventional tissue adhesive applicators depended on the fact that a user, such as a surgeon or hospital staff member, simultaneously activates the gas supply as the tissue adhesive is ejected as part of separate movements. For example, the user should manually unscrew and turn off the gas supply, such as by foot actuation in addition to the separate operation required to manually eject tissue glue or components, such as, for example, by pushing the syringe plunger or the like. It has proved difficult for the user to coordinate the time synchronization of these two separate maneuvers. Therefore, it is desirable to develop a tissue adhesive applicator that simplifies the actuation of the dispersed tissue adhesive mist and which further provides reliable and continuous discharge of the dispersed tissue adhesive stream. Summary of the invention [0008] The present invention relates to a binder applicator assembly according to claim 1.

[0009] The present invention generally relates to an application system and apparatus or apparatus for use in applying a binder, such as tissue adhesive, to a working surface such as biological tissue, in which the gas supply can be reliably activated while ejecting the binder.

[0010] According to the present invention, the adhesive applicator assembly has been shown to be intended for use in an apparatus of the type having an elongated body defining an internal opening for housing inside the adhesive, for example tissue adhesive, and having a proximal and distal end. This apparatus further includes a piston movably arranged in this opening and a pushing member operatively connected to the piston and extending through the proximal end of the opening. This binder applicator assembly includes a scattering connector that is adapted to remain in communication with the opening in the body and defines a distal outlet. This binder applicator assembly further includes a first gas passageway that is cooperatively connected to the distal outlet and is configured to guide gas to cause dispersed binder to be discharged. The actuating member is adapted to cooperate with the pushing member to move the piston towards the distal end of the body to eject the binder through the distal outlet opening and acts to simultaneously activate the gas supply to the first gas corridor to cause the dispersed stream of the binder to be discharged.

[0011] In one embodiment of the present invention, a control unit has been developed. This control unit can operate after receiving a control signal from the apparatus to activate the gas flow necessary to communicate with the first gas corridor to cause a dispersed binder stream to be output.

[0012] In one embodiment, the actuating member is operatively connected to a gas supply source to at least selectively activate the gas flow through the first gas corridor to cause the adhesive stream to be discharged to be applied to the work surface.

In one embodiment, the applicator assembly is mated to a gas supply device adapted to feed a compressed gas source in a controlled manner through a first gas outlet, as well as having an input to receive a power signal and control the gas source, in at least partial dependence on signal. In one embodiment, the applicator assembly further includes a tubing in fluid communication with the first gas corridor and adapted to be in fluid communication with the first ga2

EP 1 871 237 z1 with outlet outlet. In one embodiment, the actuating member is configured to generate a power signal as the pusher moves in such a way that gas is fed from the first gas outlet opening in at least partial signal dependence. [0013] In one embodiment, the applicator assembly includes a first apparatus comprising an elongated body defining an inner opening to contain the adhesive, and also having a proximal and distal end. The piston is movably located inside this opening, and the pushing member is operatively connected to the piston extending through the proximal end of the opening. Such an applicator assembly also includes a gas supply device having a first gas outlet, a power input for receiving the power signal, a switch for activating the gas flow to the first gas outlet, and a control mechanism for cooperating switch connection and the signal fed to the power input.

[0014] In one embodiment of the invention, the applicator assembly includes an apparatus comprising an elongated body defining an inner opening for housing the binder, and having a proximal and distal end, a piston movably arranged inside this opening, and a pusher operatively connected to the piston running through the proximal end of the hole, wherein the pushing member is adapted to cooperate with the actuating member of the applicator assembly. Additional aspects or features of the present invention will be given in the description which follows.

[0015] Although further described with reference to specific structures, it should be understood that the system and apparatuses of the present invention are not limited to the identical structures depicted herein.

Brief Description of the Drawing [0016] Fig. 1 is a top perspective view of the apparatus, where parts of the apparatus are shown transparent for ease of illustration, and also includes a binder applicator assembly, control unit, and gas supply source, schematically shown.

[0017] Fig. 2 is a rear perspective view of the control unit shown in Fig. 1.

[0018] Fig. 3 is an enlarged perspective view from above of the apparatus shown in Fig. 1. [0019] Fig. 4 is a partial perspective view from above of an enlarged view of the proximal end of the apparatus shown in Fig. 1.

[0020] Fig. 5 is a bottom perspective view of the apparatus shown in Fig. 1.

[0021] Fig. 6 is a front perspective view of the actuating member in the apparatus.

[0022] Fig. 7 is a rear perspective view of the actuating member.

[0023] Fig. 8 is a top view of the apparatus of Fig. 1.

[0024] Fig. 9 is a side view of the apparatus shown in Fig. 1.

[0025] Fig. 10 is a partial bottom view enlarged of the proximal end of the apparatus shown in Fig. 1.

[0026] Fig. 11 is a front view of the pushing member shown in Fig. 1.

[0027] Fig. 12 is a cross-sectional view taken along the lines 12-12 in Fig. 11.

[0028] Fig. 13 is a rear view of the pushing member.

[0029] Fig. 14 is a pneumatic diagram of the control unit shown in Fig. 1.

[0030] Fig. 15 is an operational diagram of the electrical circuit used in the control unit.

EP 1 871 237 Β1 [0031] Fig. 16 is a schematic diagram of the electrical circuit used in the control unit.

[0032] Fig. 17 shows a modified scatter connector in which gas is mixed with one of the components of the binder.

[0033] Fig. 18 shows another modified scatter connector in which the gas is mixed separately with each component of the binder.

[0034] Fig. 19 shows yet another modified scatter connector in which gas is mixed with both components of the binder after these components have been mixed together.

[0035] Fig. 20 is a perspective view from above of an alternative actuating member, with parts of the apparatus shown as being removed, to simplify the illustration.

[0036] Fig. 21 is a right perspective view of the actuating member of Fig. 20.

[0037] Fig. 22 is a left perspective view of the actuating member shown in Fig. 20.

[0038] Fig. 23 is a top view of the actuating member shown in Fig. 20.

[0039] Fig. 23A is a cross-sectional view taken along the plane 23A shown in Fig. 23. [0040] Fig. 24 is a rear view of the actuating member shown in Fig. 20.

[0041] Fig. 25 is a right side view of the actuating member shown in Fig. 20.

[0042] Fig. 26 is a left side view of the actuating member shown in Fig. 20.

[0043] Fig. 27 is a bottom view of the actuating member shown in Fig. 20.

[0044] Fig. 28 is a view similar to Fig. 26, further comprising a plunger member connected to the actuating member.

[0045] Fig. 29 is a view similar to Fig. 28, except that it comprises a different plunger member having a larger diameter dimension than the plunger shown in Fig. 28.

[0046] Fig. 30 is a view similar to Fig. 29, except that it comprises an alternative plunger member having a larger diameter dimension than the plunger shown in Fig. 29.

[0047] Fig. 31 is a top perspective view of an alternative embodiment of the apparatus according to the present invention, with portions of the apparatus shown as being removed, to simplify the illustration.

[0048] Fig. 32 is a top perspective view of yet another embodiment of the apparatus of the present invention.

Description of Preferred Embodiments [0049] In accordance with one aspect of the present invention, Fig. 1 generally illustrates a system for applying a binder, such as tissue adhesive, to a working surface such as biological tissue. This system preferably includes a tissue adhesive apparatus generally indicated by reference number 2, a control unit generally indicated by reference number 4, and a source of compressed sterile gas or air supply, generally indicated by reference number 6. Each of these structures will be described in more detail below, in accordance with various aspects of this invention.

[0050] In Fig. 1, the tissue adhesive apparatus 2 comprises a distal end, generally indicated by reference number 12, and a proximal end, generally indicated by reference number 14. This apparatus 2 is preferably connected to the control unit 4 via the first and a second gas corridor 8 and 10, which can be formed, at least in part, as a pipe that preferably connects the rudder unit 4

EP 1 871 237 aparat1 and apparatus 2. Generally, the first gas corridor 8 is connected or in fluid communication with the distal end 12 of the apparatus, while the second corridor 10 is connected or in fluid communication with the proximal end 14. The ends of the piping may have ends of various shapes, such as connectors of the plug or socket type, which are connected to the control unit 4 in such a way as to enable the creation of a detachable connection of the piping with the control unit and to prevent incorrect loading the tubing on the control unit. The apparatus 2 is preferably constructed in such a way that it can be easily disposed of after use.

[0051] The control unit 4 is preferably connected to the gas supply source 6 by means of a supply corridor 16 which extends from the control unit 4. It is also possible that the gas supply source 6 can be used integrally with the control unit 4. The control unit 4 preferably feeds gas to one or both of the gas corridors 8 and 10, and will be described in more detail below. The gas supply may have a pressure range of approximately 350 to 700 kPa (3.5 to 7 bar), although other ranges are also possible. The control unit 4 may further comprise a pressure control knob 18 for manually controlling the pressure of the gas supplied to the apparatus through at least one of the first and second gas corridors 8 and 10, and preferably through the first gas corridor 8. The pressure gauge 20 may allow visual monitoring of the gas pressure in the first gas corridor 8 to facilitate setting the appropriate pressure. In a preferred embodiment, the desired pressure is in the range of 10 to 300 kPa (0.1 to 3 bar), while the pressure gauge can indicate pressures from 0 to 400 kPa (0.0 to 4.0 bar).

[0052] As shown in Fig. 2, the rear surface of the control unit 4 may include a horizontally arranged clamping member 22 and / or a vertically arranged clamping member 24 having a biasing member 26 to assist in attaching the control unit to a table, rod, post or other horizontally or vertically arranged clamping surfaces during use.

[0053] In a further aspect of the present invention, the apparatus 2 according to Fig. 1 essentially comprises an elongated body 28 having a proximal end, generally indicated by reference number 27, and also a distal end, generally indicated by reference number 29. By way of example and without being applied by these restrictions, Fig. 1 and 3 show an elongated body 28 defining two inner holes 30 and 32, for example, an apparatus of the type having two syringe applicator sleeves, each sleeve containing a tissue adhesive component. Each opening 30 and 32 is adapted to include a tissue adhesive component. For example, each hole may contain one of fibrinogen or thrombin or the like for tissue adhesive components. The structure illustrated here is exemplary and not limiting, and it should be noted that other structures are also possible. For example, alternative structures such as single or multi-chamber internal openings may be used in the apparatus, such structure may depend on the type of binder used.

[0054] As shown in Fig. 3, the frame 34 preferably supports the inner holes 30 and 32 inside the respective recess 36 and 38 in such a way that the inner holes run along axes parallel to each other. The frame 34 may also define the slots 40 and 42, shown in Fig. 3, at the proximal end of the frame in which the crown end 44 and 46 of the respective opening is received.

EP 1 871 237 ru1 ru 30 and 32. Pistons 48 and 50 are arranged movably in each respective inner hole 30 and 32.

[0055] The pushing member, generally indicated by reference number 52, is operatively connected to pistons 48 and 50, and also includes plunger members 53 and 54, which extend through the proximal end of each opening 30 and 32 corresponding to each piston 48 and 50. Movement of the member pushing 52 towards the distal end 12 of the apparatus 2 simultaneously moves the pistons 48 and 50 to eject the tissue adhesive contained within. As shown in Fig. 8 and 9, a retractable arm 56 can be used that extends adjacent from the frame 34, parallel to the plunger members 52 and 53, to the proximal platform 58 of the pushing member 52, and is slidably attached to the frame to allow the pushing member 52 to move relative to body 2. In Fig. 3 - 4, the coronary end 60 and 62 of each of the plunger members 53 and 54, respectively, can be received in the respective slot 64 and 66 (also shown in Figs. 12-13) defined in the distal surface 68 of the closer platform 58 so as to synchronize the movement of the members plunger 53 and 54 by pressing on the pushing member 52. In an alternative embodiment, the push member 52 may be composed of plunger members 53 and 54, integrally attached to the proximal platform 58.

[0056] As shown in Figs. 10-12, the pushing member 52 is provided with a proximal surface 70, which includes two ridges 72 spaced apart from each other, extending from the lower edge 76 to the upper edge 78 of the pushing member 52. As has been as shown in Figs. 11 and 12, the threshold 74 is preferably located on each ridge 72 and is spaced between the upper and lower edges 76 and 78. In Fig. 12, the threshold 74 forms an inclined surface that extends from the recessed edge 79 defined near the lower edge 76 to the notch 80 defined near the upper edge 78. Preferably, each threshold 74 is inclined at an angle of 2 ° from the recessed edge 79 to the notch 80. As shown in Figs. 10 and 11, two channels, grooves or the like 82 and 84 are preferably formed in a proximal surface 70, in a furrow defined between ridges 72. These channels 82 and 84 extend to the proximal surface 70 in a distal direction at an oblique angle, as best shown in Fig. 10.

Returning to Figs. 4-5, the actuating member, generally indicated by reference number 86, is connected to allowing interaction with the pistons 48 and 50 to eject the binder. By "combined with interoperability" is meant that the actuating member may be part of the structure that initiates ejection of the binder or the actuating member may be operatively attached or supported by such a structure, or may be separate from the structure but cooperating directly or indirectly with this structure. In Figs. 4-5, the actuating member is preferably supported in a detachable manner or mounted to the pushing member 52. It is also possible for the actuating member to be integrally formed with the pushing members (as shown in Figs. 22-31) and / or with other elements of the apparatus (as shown in Fig. 32). In Figs. 4-5, the actuating member is connected to the proximal end of the pushing member 52, although other locations are also possible.

[0058] The actuating member also operates in such a way that it activates the gas supply to cause the dispersed stream to be discharged, simultaneously with the ejection of tissue adhesive.

It is contemplated that the actuating member may operate in such a way that it triggers dispersion ejection6

EP 1 871 237 strumienia1 stream in various ways. Actuation by the actuating member can be accomplished by air, pressure, electricity or other mechanisms. By way of example and without imposing any restrictions thereon, it is possible for the actuating member to be operated for actuation, via an electric switch or the like. Startup can also be triggered by changes in control gas pressure, either by increasing or decreasing. This description is not exhaustive with respect to the techniques that may be used to cause the dispersed stream to be output, and it is understood that other changes than those discussed in this document are also possible.

[0059] The actuating member comprises a second gas passage that includes an opening for allowing gas to flow. This second gas corridor can be placed in fluid communication with the power signal input in the gas supply device. After the user actuates the actuating member to move the plunger, the opening is restricted, generating a supply signal to the gas supply device. In Fig. 6, the actuating member 86 preferably includes a proximal portion 88 that defines a surface contacting the user, as well as a distal portion 90 that is attached to the pushing member 52. Although the surface contacting the user will be described by the specific structures below, they are shown by way of example and without imposing restrictions. It is contemplated that the contacting surface of the user may be connected to a manually or electrically operated switch that causes gas or pressure changes or generates an electrical signal in such a way as to activate the gas supply to the first gas corridor 8. It is also possible for the contacting surface the user could be connected to various parts of the actuating member 86, other than the proximal part 88.

[0060] In Figs. 6-7, the proximal portion 88 preferably includes a recess 92 having a concave shape or configuration that is adapted to receive a user's finger, such as a thumb. This recess 92 may include a tubular projection 94 located in the recess 92 in such a way that the user's finger substantially contacts this projection 94 during the ejection of tissue adhesive. In Fig. 6, the projection 94 is preferably defined around the opening 96. As shown in Fig. 5, the actuating member 86 preferably forms part of the second flow corridor 10, while the opening 96 allows gas to flow into or from the second flow corridor 10. After the actuating member is actuated to move the piston, the orifice is restricted, generating a supply signal to the gas supply device. In Fig. 5, the tubing that preferably defines another portion of the second flow passage 10 is in fluid communication with the actuating member 86 by connecting to the flow port 102 designated in the actuating member on one side thereof, as shown in Fig. 6. opening 96 and flow port 102 are shown in Fig. 5-7 on the proximal part 88 and respectively on the side part of the actuating member 86, other variants are also possible.

[0061] As shown in Fig. 7, the actuating member 86 preferably defines two parallel ribs 98 and 99 extending from the distal portion 90, the ribs 98 and 99 can extend between side edges 97 and are preferably substantially symmetrical around side line A. The actuating member 86 also preferably includes two angled projections 100 and 101, which are located between the ridges 98 and 99 and extend further at an oblique angle. Projections 100 and 101 are generally symmetrical about vertical axis B. As shown in Fig. 10, each of projections 100

EP 1 871 237 Β1 and 101 is preferably shaped and angled so as to be received by the respective channels 82 and 84 in such a way that the actuating member 86 is removably attached to the pushing member 52. To connect the actuating member can be other fastening structures used than those shown and described herein. In addition, an attachment in the form of a protrusion formed in the pushing member 52 that is received by the actuating member 86 can be used. As shown in Fig. 10, the actuating member can be detachably attached by slidingly inserting the projections 100 and 101 into the respective channels 82 and 84. Also referring to Fig. 11, during insertion, ribs 98 and 99 slide over ridges 72 and frets 74 until the front rib 98 is received by the notches 80 and the next rib 99 engages with the recessed edge 79. Protrusions 100 and 101 engage channels 82 and 84 . The inclined shoulder surfaces 74 preferably contact the front rib 98, causing the actuating member to bend slightly in a manner such as a leaf spring and provide increased resistance to movement as the slope increases. In this way, when the rib 98 slides past the thresholds 74 and engages with the notches 80, while the rib 99 slides over the ridge 72 and engages with the recessed edge 79, the user feels less resistance and more preferably receives a tactile sensation and possibly an acoustic indication. The actuating member 86 can be slidably removed by the user by pushing the ribs 98 out of the notch 80 and along the thresholds 74, and also by moving the ribs 99 out from the recessed edge 79. The ribs 98 and 99 preferably have sufficient flexibility to allow sliding insertion and removal. It is also possible to attach the actuating member to the pushing member 52 in an orientation rotated 180 degrees relative to the orientation shown in the drawings, for example when it is desired that the tubing may extend from the other side of the actuating member.

[0063] Returning to Figs. 8 and 9, a jet diffuser connector 104 is used here that is supported or connected to the distal end 29 of the body. In Fig. 8, further outlet openings 106 and 108 may be connected to respective internal openings 30 and 32 of body 28 to allow adhesive components to be splattered and to maintain communication with the jet diffuser connector 104. Corresponding adhesive corridors 110 and 112 may be made in the jet diffuser connector 104 to allow the adhesive to communicate with the respective inner holes 30 and 32. The jet diffuser connector 104 may define separate outlet holes 114 and 116 for each component of the adhesive, as shown in Fig. 8, or alternatively, it may allow the mixed stream of ingredients to be ejected, as shown in Fig. 19, wherein the mixture of ingredients is within the stream diffuser 104. It is contemplated that the stream spreading connector 104 in Figs. 8 and 9 is shown as an example and without imposing any restrictions, and other configurations are possible.

[0064] In Fig. 9, the scatter connector 104 also preferably forms part of the first gas corridor 8 and preferably connects to the tubing forming another part of the first gas corridor 8. In Figs. 8 and 9, the scatter connector 104 defines the gas flow path 118, which is in communication with the gas outlet 120. In Fig. 8 and 9, part of the gas flow path 118 preferably has an annular or circular shape, although other shapes are also possible, such as, for example, oval, oblong or the like. Figures 8 and 9 also show the gas outlet 120, located around the outlet openings 114 and 116 of the adhesive, although other variants are also possible.

ΕΡ 1 871 237 Β1 you, including a situation in which a separate gas outlet is located around each binder outlet. It is possible for the gas to mix with at least one of the components of the binder before or after the components are mixed together. In Figs. 17-18, the gas mixes with one of the binders, as in Fig. 17, and / or two binders, as in Fig. 18, before the components of the binder are mixed together, and in Fig. 19, the gas is mixed with the already mixed binder in front of the distal outlet of the combined gas and the binder. Operation of the actuating member 86 ensures gas is supplied to the distraction connector 104 through the first gas passageway 8, simultaneously with the ejection of the binder.

[0065] According to another example of the present invention, a binder applicator assembly 122 has been developed, as best shown in Fig. 1, which includes a scatter connector 104, a first gas corridor 8 and an actuation member 86 as shown and described above. These binder apiikator assembly structures are preferably attached to each other in the configuration shown in Fig. 1, and may also be sold as a disposable kit for use with the plunger structure of a twin-tube tissue adhesive injection syringe similar to the structure of the syringe plunger shown and described above, or other similar structures. The spreading connector and actuating member of the binder applicator assembly are preferably attached to the respective locations on the syringe plunger structure, as in the above description. By way of example and without imposing any restrictions on it, the syringe plunger structure may be utilized and adapted for use with other disposable binder applicator assembly kits containing other connectors, such as a catheter or cannula, or other connectors that provide distracting or non-dispersive distracting ejection of tissue glue. It is also possible for the syringe plunger structure to be included in the binder applicator assembly as a combined disposable set.

[0066] According to yet another aspect of the present invention, the control unit 4 can be used with any of the systems and apparatus described. As shown in Fig.

1, the control unit 4 is connected to the apparatus in a manner enabling their cooperation to simultaneously activate the gas supply and the ejection of tissue glue. By way of example and without imposing thereby restrictions, Figs. 14-16 show an example of a control unit 4 that can be used to supply and control gas to the first and second gas corridors 8 and 10. It is understood that this description is not exhaustive, and that modifications to the control unit 4 are possible, which depend on the structures used to apply the tissue adhesive and on how they are actuated, such as, for example, by pneumatic, electric, and also other types of startup techniques.

[0067] As shown in Fig. 14, the control unit 4 can be supplied with gas from the gas supply source 6 through the supply passage 16. The incoming gas can be filtered through the IF1 filter. The supplied gas may flow to the first flow leg 126 and the second flow leg 128. Each flow leg 126 and 128 preferably includes a corresponding pressure regulator PR1 and PR2. Each pressure regulator is preferably configured to monitor the pressure along the corresponding flow branch, and can also be adjusted to accommodate differences in tubing such as the inside diameter and length of such tubing.

EP 1 871 237 Β1 [0068] In the first flow leg 126, the gas pressure is preferably adjusted to manual control and / or adjustment by the user by means of the strait adjusting knob 18 as shown in Fig. 1. In Fig. 14, the pressure gauge PG1, as well as represented by reference number 20 in Fig. 1 and also the flow controller FC2 can also be used to monitor pressure, which can preferably be in the range of approximately 0 to 300 kPa (0 to 3 bar), and preferably can be in the range of approximately 200 to 300 kPa (2 to 3 bar). In Fig. 14, the first flow leg 126 preferably includes an outlet 127 that is adapted to communicate with the first flow passage 8 to control the desired jet pressure of the dispersed jet, and further includes an emergency safety switch PS1 and an inlet valve V1. The supply valve V1 can normally be deflected to a closed position in such a way that no gas is supplied to the first gas corridor 8 and thus no dissipative discharge is caused. The emergency pressure switch PS1 and the supply valve V1 will be described in more detail below.

[0069] In Fig. 14, the second fluid branch 128 may include a suitable flow controller FC1 and preferably maintains control gas pressure. This control gas pressure is preferably some predetermined pressure or pressure range that can be set during the manufacturing process. This control gas strait is preferably in the range of approximately 1 to 20 kPa (0.01-0.20 bar), and more preferably in the range of approximately 5 to 15 kPa (0.05-0.15 bar). Referring to Figs. 4-5, the control gas strait is preferably provided through outlet 129 (Fig. 14) to the second gas passage 10, and exits from the opening 96 defined in the actuating member 86. This control gas strait is preferably sufficient. to provide a tactile feel for the user's finger to indicate to the user that such a finger has been placed over the opening 96. Alternatively, it is also possible for the control gas pressure to be maintained under conditions such that gas does not escape through the opening 96.

As shown in Fig. 14, the control unit 4 additionally preferably comprises a pressure switch PS2, which remains in communication with the flow leg 128. This pressure switch PS2 is preferably operatively connected to the supply valve V1, which remains in communication with the second flow branch 126. This pressure switch PS2 can operate such that it opens the supply valve V1 in such a way that the gas is fed to the first gas corridor 8, and thus a discharge of tissue adhesive is provided. This pressure switch PS2 is preferably activated to open the valve in response to receiving control signal from the apparatus. This control signal is generated when the force with which the user acts is applied to cause the tissue adhesive to eject out.

[0071] The force provided by the user simultaneously causes a change in pressure. Such a force provided by the user preferably limits or blocks the gas outlet from the orifice 96 to prevent gas from escaping from the orifice and cause a pressure increase sufficient to receive the control signal through the pressure switch. Alternatively, in an alternative embodiment, it is possible for the user-provided force to be able to trigger a pressure drop if that user-provided force allows gas to be released from the opening that would otherwise exit from the opening 96. The pressure switch PS2 preferably monitors such pressure changes in second gas corridor 10, and is activated to open or close the valve in response to such a pressure change. Obtained in the 10

EP 1 871 237 Β1 the method of discharging with dissipation ensures obtaining a dispersed stream of gas and tissue glue coming out from the distal end of the apparatus 2. When the action of the force provided by the user stops, then the ejection of tissue glue may stop immediately, or alternatively, the gas supply may be stopped after the pre-defined delay period has elapsed.

[0072] As shown in Fig. 14, the time delay control member PFC1 can be operatively connected to the control unit 4 in the same way as the pressure switch PS2. The time delay controlling member PFC1 preferably prevents the pressure switch PS2 from closing the valve for a predetermined period of time after the operation of the force provided by the user has ceased. In Fig. 14, the time delay control member PFC1 preferably remains in communication with the flow passage 118 (shown in Figs. 8-9) and can use additional tubing 130. Preferably, the time delay is in the range of approximately 0.1 seconds to 0.9 seconds and more preferably approximately 0.5 seconds. The time delay ensures gas evacuation after the user has stopped ejecting the tissue adhesive. Additional gas evacuation can be helpful when removing any residual tissue adhesive from the distal end of the apparatus in such a way as to prevent blockage or jamming of the distal end.

[0073] As further illustrated in Fig. 14, the emergency pressure switch PS1 may be in communication with the flow passageway 126 and is used for overpressure protection. This emergency pressure switch prevents the pressure supplied to the apparatus from exceeding a predetermined threshold level. When such a threshold level is reached, the gas supply to the distal end of the apparatus can be automatically cut off.

[0074] Figs. 15 and 16 illustrate a block diagram and electrical circuit diagram that can be used in connection with the operation of the pressure switch PS2 and the supply valve V1 as described above. As shown in Fig. 16, the pressure switch PS2 is connected to a power source, such as a battery. The battery LED indicator can be used to indicate the status when the battery is running low, losing the necessary charge. As shown in Figs. 15 and 16, actuation of the pressure switch PS2 causes the electrical circuit to close in such a way as to supply voltage to valve V1, thereby opening valve V1. In Fig. 16, the voltage supplied to valve V1 is compared with some predetermined threshold voltage VpRoe- If the voltage exceeds the threshold voltage V_PR0G, then the PS1 emergency pressure switch overloads the PS2 pressure switch and closes the V1 valve.

[0075] The pushing member may be integral with the actuating member. Alternatively, the pushing member may be separate and adapted to be connected to the actuating member in a manner enabling their interaction. An alternative embodiment of the actuating member, generally indicated by reference numeral 140, is shown in Figs. 20-30, for use with an apparatus similar to the apparatus described in Figs. 1-16. Such an embodiment is similar to the embodiment described in Figs. 6-7, except that the embodiment in Figs. 20-30 includes an actuating member 140, which is formed as an integral part of the pushing member or members that are connected to a conventional one. syringe plunger design. Therefore, discussions of those parts of the apparatus that are identical to those in Figs. 1-16 will not be repeated.

[0076] In Figs. 20-30, the actuation member 140 includes a proximal or upper portion 142 that defines a surface contacting the user, as well as a distal portion or bottom 144 that is attached to

EP 1 871 237 Β1 plunger members 146 and 148 syringes / ek. In Fig. 23A, the actuating member 140 may define a gas passage 150 that extends between the first and second ends 152 and 154. The first end 152 may be defined on the surface contacting the user 142 (as shown in Fig. 20-24), while the other end 154 of the corridor 150 may be defined along the side edge of the actuating member, extending between the proximal and distal parts 142 and 144 (or top and bottom, respectively) (see Figs. 21, 23A and 25 and everywhere therein, where it's convenient). Making reference to Fig. 20, the second end 154 of the corridor 150 is preferably in communication with the tubing 156, the control unit and the gas or pressure source (as indicated by reference numbers 4 and 6 in Fig. 1).

[0077] In Figs. 20-24, the proximal part of the contacting surface 142 has a profiled surface different from that shown in Figs. 1-13. Although other profiles are also possible and the present application is not limited to the profiled surfaces shown in this document, the closer part 142 in Fig. twenty - 24 preferably includes a raised central portion 158 in which the first end 152 of the corridor 150 can be defined, as well as concave portions 160 that extend to each side of the raised portion 158. As shown in Fig. 24, the first end 152 of the corridor 150 may end slightly above the raised portion 158 in such a way that the user can determine the location of the first end 152 based on tactile sensation. Alternatively, for example, the first end 152 may be recessed or surface leveled with the raised portion 158.

[0078] As shown in Figs. 22, 23A and 26-30, the distal portion or bottom 144 includes laterally spaced slits 162, 164 and 166 for receiving plunger members 146 and 148 having differently dimensioned crown ends. As best seen in Figs. 28-30, the small, medium and large diameter sizes of the coronary ends can be received in appropriately sized slits 162, 164 and 166. The size of the rim is typically different for different syringe sizes (volumes). This enables one actuator to handle different syringe sizes (volumes) that are needed for different procedures. As shown in Fig. 27, each of the slits 162, 164 and 166 can be dimensioned and configured to receive a single plunger member or a pair of plunger members oriented in a side-by-side relationship.

[0079] According to the above-described invention, the embodiment according to Figs. 20-30 can be combined with a control unit 4 (as shown in Fig. 1) to supply and control gas from a gas source. In Figs. 20-30, the gas passage 150 is blocked by the user when the user's thumb is placed on the second opening 152 formed in the surface contacting the user 142. According to the previously described embodiments, the gas passage 150 may be in fluid communication with the control unit and / or the gas or pressure source (e.g. indicated by reference numbers 4 and 6 in Fig. 1) via a pipe 156 connected to the other end 154 of the gas corridor 150. In Fig. 20, such a connection can be achieved by attaching the end of a tubing 156 having a protrusion or hook 168 that is engaged at the back behind the threshold having a hook or eye 170 on the surface contacting the user 142. Other types of fastening structures are also possible and they are not limited to the structures shown and described above. According to the invention described above, when the second opening 152 is plugged by the user, the supplied gas is preferably fed to the distal end 12

EP 1 871 237 Β1 applicator via a suitable tubing (e.g. as indicated by reference number 8 in Fig. 1).

[0080] In Fig. 31, the apparatus, generally indicated by reference numeral 172, includes an actuating member 174, which is also connected to a pushing member, similar to the previously described embodiments, and also includes a top side or user-contact surface 176, having an outline similar to that of Figs. 1-13 and a distal or bottom portion 178. As with the embodiment shown in Figs. 1-13, the embodiment in Fig. 31 includes a frame 180 having a retractable slide arm 182 and includes a pair of adjacent hollow recesses 184 and 186. These recesses 184 and 186 receive respective cylindrical holes (not illustrated) containing tissue adhesive components. The distal portion (or bottom) 178 of the actuating member 172 preferably includes two slots 190 and 192, each slidably receiving the ring end of the plunger member extending close to each fluid-containing opening located in respective recesses 184 and 186. [0081] Fig. 32 shows an alternative tissue adhesive apparatus, generally indicated by the designation 200. Such an apparatus has been depicted as having a conventional pistol type applicator design, although other designs are also possible. This apparatus 200 generally defines a body 202 and a handle 204. The body 202 defines respective recesses for receiving fluid-filled cylindrical openings 206 having respective plunger members 208 extending therefrom. Each proximal end of plunger member 208 is received by push member 210. The actuating member, indicated generally by reference numeral 212, is preferably operatively connected to the pushing member 210. The actuating member 212 comprises a lever 214 which can be positioned further and can be rotatable relative to the handle 204. Lever 214 may be operatively connected to a pushing member 210 via a drive mechanism as illustrated and described in US Patent No. 6,585,696, to which rights have been transferred to Baxter Internationai Inc., the owner of the present application. [0082] In Fig. 32, the lever 214 is preferably pivotally connected to the handle 204. The lever 214 can be rotated towards and / or away from the handle 204 for actuation. The lever 214 also preferably defines at least a portion of the gas corridor 216. The first end or opening 218 of the corridor 216 is preferably defined downstream of the lever 214. To activate tissue adhesive delivery, the user can cover or block the first end 218 of corridor 216, such as with the index finger . The other end 220 of the corridor 216 preferably connects to the gas supply via a conduit 222, which preferably defines another portion of the gas corridor 216, to supply gas or pressure to the corridor 216. The gas supply is also preferably fed to the distal end of the apparatus 200 via a suitable conduit tubular 224.

[0083] During operation of the apparatus 200 in Fig. 32, the lever 214 rotates to eject tissue adhesive from the openings 206 through the scattering end 226 of the device. Gas or pressure can be simultaneously supplied to the diffusion end 226 through the tubing 224 after blocking the opening 218 formed in the lever 214, in accordance with the invention described above. The gas supply may be stopped, immediately or with a certain time delay, when the user stops blocking the opening 218, also in accordance with the invention described above.

[0084] As can be seen from the above description, the present invention has a number of different aspects that are not limited to the specific structures shown in the accompanying drawings.

EP 1 871 237 Β1