Hand triggered tissue sealant spray apparatus and system

DESCRIPTION

Hand operated tissue sealant spraying system and apparatus

BACKGROUND

This invention relates to a system for applying fabric sealant such as fabric sealant to a work surface such as biological fabric.

Mixing and / or applying sealant to work surfaces has application in a variety of scenarios. In the medical field, tissue sealant has been applied to human and animal tissue, for example to seal or repair tissue at the surgical site or a wound, to stop bleeding, seal wounds, treat burns or graft. skin and a variety of other purposes.

In the medical field, the tissue sealant has typically been applied by a syringe-type applicator that ejects tissue sealant directly onto the tissue. Examples of such applicators are shown in U.S. Patent Nos. 4,846,405, 5,582,596, 5,665,067, 6,461,361 and 6,585,696, PCT Publication Nos. WO 96/39212 WO 95/31138 and WO 97/20585 and European Publication No. EP- A-0.634.140. Other examples of such applicators are also sold under the trademarks Tissomat and Duploject, which are marketed by Baxter AG.

The tissue sealant employed in treating biological tissue is typically made by one or more components, such as biocompatible compounds that can be absorbed into the body and do not require further patient removal. An example of a known tissue sealant is made of fibrinogen and thrombin. The fabric sealant may be contained in more than one container that may be mixed in an adhesive combination upon ejection from the fabric sealer applicator. For example, the components may exit two separate outlets positioned next to each other so that these components are blended to create an adhesive fabric sealant upon ejection from the applicator.

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Fabric sealer applicators may also provide fabric sealer that is atomized by pressurized sterile gas, such as, for example, air, to form a spray which is a combination of fabric sealant and a sterile air or gas. The applicator is connected to a piped gas or air source that supplies the gas or air to the distal end of the applicator in the vicinity of the freckles of one or more fabric sealant components. For example, the gas may communicate with one or more of the fabric sealant components within a mixing area defined by the applicator. Alternatively, the gas may be mixed with the fabric sealant components upon ejection from the applicator. In the latter scheme, the air or gas outlet preferably is very close to the outlets of one or more of the fabric sealant components and may, for example, be in the form of an annular outlet surrounding at least one of the outlet seals. fabric sealant component. The result is that the fabric sealant is discharged as an aerosol or spray.

Gas or air supply is preferably coordinated such that, for example, gas is essentially supplied at the same time to the applicator upon ejection of the fabric sealant. However, synchronizing the timing of this supply with the ejection of fabric sealant or its strange and difficult, particularly various component components proved to be when fabric sealant is used.

Conventional tissue sealant applicators have relied on the user, such as a surgeon or hospital staff member, to simultaneously activate gas delivery with separate motion tissue sealant ejection. For example, it is necessary for the user to manually turn the gas supply on and off, such as by standing up, in addition to the separate movement required to manually eject the fabric sealant or components, such as, for example, by pressing a pressure plunger. syringe or something similar. It has been difficult for the user to coordinate the timing of these two separate movements. Therefore, it is desirable to provide a tissue sealer applicator that simplifies activation of

1 871 237 / ΡΤ a fabric sealant spray discharge and further providing a continuous and reliable fabric sealant spray discharge.

Summary of the Invention The present invention provides a sealant applicator assembly according to claim 1.

The present invention is generally directed to a system and apparatus for applying or, an apparatus for use in applying sealant, such as fabric sealant, to a work surface, such as biological fabric, in which a gas supply is provided. it can be reliably driven at essentially the same time with sealant ejection.

According to the present invention, there is provided a sealer applicator assembly for use with an apparatus of the type having an elongate body defining an inner bore for containing sealant, for example fabric sealant and having proximal and distal ends. . The apparatus further includes a piston movably positioned in the bore and a pusher member operably associated with the piston and extending through the proximal end of the bore. The sealant applicator assembly comprises a spray adapter that is adapted to communicate with the body bore and defines a distal outlet. The sealant applicator assembly further comprises a first gas passage that is cooperatively associated with the distal outlet and is configured for directional gas to create a sealant spray discharge. A drive member is adapted to be cooperatively associated with the pusher member to move the plunger to the distal end of the body to eject sealant through the distal outlet and operational to simultaneously drive a gas supply to the first gas passage to create a discharge. spray sealant.

In one embodiment of the present invention, a control unit is provided. The control unit may operate upon receipt of a control signal from the apparatus to activate a gas flow suitable for

1 871 237 / ΡΤ communicating with the first gas passage to create a sealant spray discharge.

In one embodiment, the drive member is operatively connected to the gas supply source to at least selectively drive the gas flow through the first gas passage to create a sealant spray discharge to apply to the work surface. In one embodiment, the applicator assembly is cooperatively associated with a gas supply device adapted to controllably supply a pressurized gas source through a first gas outlet and also having an input for receiving a supply signal and controlling the supply of the gas. at least partially dependent on the signal source. In one embodiment, the applicator assembly further comprises tubing in fluid communication with the first gas passage and adapted to be placed in fluid communication with the first gas outlet. In one embodiment, the drive member is configured to generate the supply signal during movement of the impeller such that gas is supplied from the first gas outlet at least in partial dependence on the signal.

In one embodiment, the applicator assembly comprises a first apparatus comprising an elongate body defining an inner bore for sealant and having proximal and distal ends. A plunger is movably positioned in the bore and a pusher member operatively associated with the plunger extending through the proximal end of the bore. Such applicator assembly further comprises a gas supply device having a first gas outlet, a supply signal input for receiving a supply signal, a switch for driving a gas flow to the first gas outlet and a mechanism. for cooperatively associating the switch and a signal provided for the supply signal input.

In one embodiment of the invention, the applicator assembly comprises an apparatus comprising an elongate body defining an inner bore for containing sealant and having

Proximal and distal ends, a piston movably positioned in the bore and a pusher member operatively associated with the plunger extending through the proximal end of the bore, wherein the pusher member is adapted to be cooperatively associated with the bore. a drive member of the applicator assembly. Additional features or aspects of the present invention will be set forth in the following description.

Although described below in terms of certain structures, it is to be understood that the system and apparatus of the present invention are not limited to the identical structures shown.

Brief Description of Drawings

Fig. 1 is a perspective top view of an apparatus with portions of the apparatus shown as transparent to aid the illustration and also includes a sealant applicator assembly, a control unit and a gas supply source shown. schematically.

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

Fig. 3 is an enlarged perspective view from above of the apparatus shown in Fig. 1.

Fig. 4 is an enlarged partial perspective top view of the proximal end of the apparatus shown in Fig.

1.

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

Fig. 6 is a perspective front view of a drive member of the apparatus.

Fig. 7 is a perspective rear view of the drive member.

Fig. 8 is a top view of the apparatus in Fig. 1.

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

Fig. 10 is an enlarged partial bottom view of the proximal end of the apparatus shown in Fig. 1.

Fig. 11 is a front view of a pusher component shown in Fig. 1.

Fig. 12 is a sectional view taken along line 12-12 of Fig. 11.

Fig. 13 is a rear view of the pusher component.

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

Fig. 15 is a flow chart of an electrical circuit employed in the control unit.

Fig. 16 is a schematic of an electrical circuit employed in the control unit.

Fig. 17 shows a modified spray adapter in which the gas mixes with one of the sealant components.

Fig. 18 shows another modified spray adapter in which the gas mixes separately with each of the sealant components.

Fig. 19 shows yet another modified spray adapter in which gas mixes with both sealant components after the components are mixed together.

Fig. 20 is a perspective top view of an alternate drive member, with portions of the apparatus removed to aid the illustration.

Fig. 21 is a right side perspective view of the drive member shown in Fig. 20.

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Fig. 22 is a left side perspective view of the drive member shown in Fig. 20.

Fig. 23 is a top view of the drive member shown in Fig. 20.

Fig. 23A is a cross-sectional view along plane 23A shown in Fig. 23.

<td>Fig. drive</td><td>24 is a view of shown in Fig. 20.</td><td colspan="2">behind the</td><td>component</td><td>in</td>

<td>Fig. drive</td><td>25 is a side view shown in Fig. 20.</td><td>right</td><td>of</td><td>component</td><td>in</td>

<td>Fig. drive</td><td>26 is a side view shown in Fig. 20.</td><td>left</td><td>of</td><td>component</td><td>in</td>

<td>Fig. drive</td><td>27 is a view as shown in Fig. 20.</td><td>under</td><td>of</td><td>component</td><td>in</td>

Fig. 28 is a view similar to Fig. 26 further including a plunger member associated with the drive member.

Fig. 29 is a view similar to Fig. 28 except for including a different plunger component having a larger diameter size than shown in Fig. 28.

Fig. 30 is a view similar to Fig. 29 except that it includes an alternate plunger component having a larger diameter size than shown in Fig. 29.

Fig. 31 is a perspective top view of an alternative embodiment of an apparatus of the present invention, with portions of the apparatus removed to aid the illustration.

Fig. 32 is a perspective top view of still another embodiment of an apparatus of the present invention.

EP 1 871 237 / EN

Description of Preferred Embodiments

In accordance with one aspect of the present invention, Fig. 1 generally illustrates a system for applying sealant, such as fabric sealant, to a work surface such as biological fabric. The system preferably includes a tissue seal apparatus generally indicated by 2, a control unit generally indicated by 4 and a pressurized sterile air or gas supply source generally indicated by 6. Each of these structures will be described below in more detail in accordance with various aspects of the invention.

In Fig. 1, the tissue seal apparatus 2 includes a distal end generally indicated by 12 and a proximal end generally indicated by 14. Apparatus 2 is preferably connected to control unit 4 by first and second gas passages 8 and 10, respectively, which may be formed at least in part by tubing preferably connecting control unit 4 and apparatus 2. Generally, the first gas passage 8 is fluidly associated or communicates with the distal end 12 of the apparatus and the second gas passage 10 is fluidly associated or communicates with the proximal end 14. The ends 15 of the tubing may have different shaped ends, such as male or female connectors, where they are connected to the control unit 4 to allow removable connection of the tubing to the control unit and to prevent improper connection of the tubing to the control unit. control unit. The apparatus 2 is preferably constructed so that it can be easily disposed of after use.

The control unit 4 is preferably connected to the gas supply source 6 using a supply passage 16 extending from the control unit 4. It is also possible that the gas supply source 6 may be incorporated as an integral part. of control unit 4. Control unit 4 preferably supplies gas to one or both gas passages 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 they are also possible.

Other ranges. Control unit 4 may further include a pressure control knob 18 for manually controlling the gas pressure supplied to the apparatus through at least one of the first and second gas passages 8 and 10 and preferably of the first gas passage 8. A pressure gauge 20 may allow visible monitoring of the gas pressure in the first gas passage 8 to facilitate adjustment of the desired pressure. In a preferred embodiment, the desired pressure is from 10 to 300 kPa (0.1 to 3 bar) and the pressure gauge may indicate pressures from 0 to 400 kPa (0.0 to 4.0 bar).

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 which has a criss-cross member 26 to assist in securing the control unit. to a table, rod, pole or other mounting surfaces arranged vertically or horizontally during use.

In a further aspect of the present invention, apparatus 2 of Fig. 1 generally includes an elongate body 28 having a proximal end, generally indicated by 27, and a distal end, generally indicated by 29. By way of example and not limitation, the Figs. 1 and 3 show the elongate body 28 defining two inner holes 30 and 32, for example, an apparatus of the type having a double-barreled syringe applicator where each barrel contains a fabric sealant component. Each hole 30 and 32 is adapted to contain a fabric sealant component. For example, each hole may contain fibrinogen or thrombin or other similar tissue sealant components. The illustrated structure is shown by way of example and not limitation and it is understood that other structures are also possible. For example, the apparatus may employ alternative structures such as single or multiple inner bore and such structure may depend on the type of sealant employed.

As shown in Fig. 3, a frame 34 preferably supports the inner holes 30 and 32 within a corresponding cavity 36 and 38 so that the inner holes extend along an axis parallel to one another.

Another. Frame 34 may also define slots 40 and 42 shown in Fig. 3 at a proximal end of the frame into which a flanged end 44 and 46 of corresponding hole 30 and 32 is received. A plunger 48 and 50 is movably positioned in each respective inner bore 30 and 32.

A pusher member, generally indicated at 52, is operatively associated with pistons 48 and 50 and includes plunger members 53 and 54 extending through the proximal end of each bore 30 and 32 corresponding to each piston 48 and 50. Movement of the pusher member 52 toward the distal end 12 of apparatus 2 simultaneously moves the plungers 48 and 50 to eject the fabric sealer contained therein. As shown in Figs. 8th and 9, an extension arm 56 extending proximally from the frame 34 parallel to the plunger members 52 and 53 may be provided to a proximal platform 58 of the pusher member 52 and is slidably fixed to the frame for permit movement of the pusher member 52 relative to body 2. In Figs. 3 4, a flanged end 60 and 62 of each respective plunger member 53 and 54 may be received in a corresponding slot 64 and 66 (also shown in Figs. 12 to 13) defined on a distal surface 68 of proximal platform 58 so synchronizing the movement of the plunger components 53 and 54 by pressing the impeller component 52. In an alternative embodiment, the pusher member 52 may be comprised of plunger components 53 and 54 attached as integral part of the proximal platform 58.

As shown in Figs. 10 to 12, the pusher member 52 is provided with a proximal surface 70 including two spaced apart Christian 72 extending from a lower edge 76 to an upper edge 78 of the pusher member 52. As shown in Figs. 11 and 12, preferably a ramp 74 is positioned on each Christian 72 and is spaced between the upper and lower edges 76 and 78. In Fig. 12, the ramp 74 forms an inclined surface extending from a lowered edge 79 defined near the lower edge 76 to a notch 80 defined near the upper edge 78. Preferably each

Ramp 74 is inclined at an angle of 2 ° from the lowered edge 79 to notch 80. As shown in Figs. 10 and 11 are preferably formed two channels, grooves or the like 82 and 84 on the proximal surface 70 in the Christian 72. Channels 82 and 84 the proximal surface 70 in one direction is best shown in the valley defined between extending distally with a oblique angle, such as Fig. 10.

Turning to Figs. 4 to 5, a drive member, generally indicated by

86, is cooperatively associated with pistons 48 and 50 for ejecting sealant. By cooperatively associated is meant that the drive member may be part of the structure driving the sealant or the drive member may be operatively fixed or supported by such a frame or may be separate from the frame but interact directly or indirectly with such a frame. . In Figs. 4 5, the drive member is preferably removably mounted or supported on the push member 52. The drive member may also be formed as an integral part of the push members (as shown in Figs. 22-31). ) and / or other components of the apparatus (as shown in Fig. 32). In Figs. 4 5, the drive member is connected to the proximal end of the pusher member 52 although other locations are also possible.

The drive member is also operative to drive a gas supply to create a spray discharge at the same time as the fabric sealant ejection. It is contemplated that the drive member may be operable to drive a spray discharge in a variety of ways. Actuation via the actuating member may be provided by air, pressure, mechanisms. By way of example it is possible that the drive member may be operated to operate by means of an electric switch or the like. The actuation may also be triggered by a change in a control gas pressure, either by an increase or decrease. This description is not exhaustive of electricity and other and not of limitation, it is

Techniques that may be employed to create the triggering of a spray discharge and it is understood that variations other than those discussed herein are possible.

drive member comprises a second gas passageway including an opening allowing gas flow. The second gas passage may be placed in fluid communication with the supply signal input of the gas supply device. When the user drives the drive member to move the plunger, the opening is restricted, generating the supply signal to the gas supply device. In fig. 6, the drive member 86 preferably includes a proximal portion 88 defining a user contact surface and a distal portion 90 securing to the pusher member 52. Although the user contact surface is described by specific structures below. , these are shown by way of example and not limitation. It is contemplated that the user contact surface may be associated with an electrically or manually operated switch that causes a variation in gas or pressure or generates an electrical signal to drive the gas supply to the first gas passage 8. It is also possible that the user contact surface may be associated with different portions of the drive member 86 different from the proximal portion 88.

In Figs. 6 to 7, the proximal portion 88 preferably includes a depression 92 having a concave shape or shape that is adapted to receive a finger from the wearer, such as a thumb. The depression 92 may include a tubular protrusion 94 positioned in the depression 92 such that the user's finger generally contacts this protrusion 94 during ejection of the tissue sealant. In Fig. 6, the protrusion 94 is preferably defined around an opening 96. As shown in Fig. 5, the drive member 86 preferably forms a portion of the second flow passage 10 and the opening 96 allows gas to flow to or from the second gas flow passage 10. After the user driving the drive member to move the plunger, the opening is restricted, generating the supply signal to the

8 1 871 237 / ΡΤ gas supply. In fig. 5 tubing preferably defining another portion of the second flow passage 10 fluidly communicates with the drive member 86 by connecting to a flow hole 102 defined in the drive member on one side thereof, as shown in Fig. 6. While the positioning of opening 96 and flow hole 102 are shown in Figs. 5th 7 at the proximal portion 88 and at a lateral portion respectively of the drive member 86, other variations are also possible.

As shown in Fig. 7, the drive member 86 preferably defines two parallel ribs 98 and 99 extending from the distal portion 90. The ribs 98 and 99 may extend between the side edges 97 and preferably they are usually symmetrical around a lateral line A. The drive member 86 preferably also includes two inclined projections 100 and 101 which are positioned between the Christian 98 and 99 and extend in a distal direction at an oblique angle. Projections 100 and 101 are generally symmetrical about a vertical line B. As shown in Fig. 10, each projection 100 and 101 is preferably molded and inclined to be received by the corresponding channels 82 and 84 such that the drive member 86 is removably attached to the pusher member 52. Other fastening structures may be employed. different from the structures shown and described for connecting the drive member. Further, the attachment may be provided by a projection formed on the pusher member 52 which is received by the drive member 86.

As shown in Fig. 10, the drive member can be removably fixed by slidingly inserting projections 100 and 101 into corresponding channels 82 and 84. Also with reference to Fig. 11, during insertion, ribs 98 and 99 traverse Christian 72 and ramps 74 until leading rib 98 is received by notches 80 and next rib 99 engages the lowered edge 79. Projections 100 and 101 engage channels 82 and 84. The inclined surfaces of the ramps 74 preferably contact the leading rib 98 causing the bending

1 871 237 / ΡΤ lightly of the drive member similar to a leaf spring and provide greater resistance to movement as the inclination increases. As such, when rib 98 slides past ramps 74 and engages notches 80 and rib 99 slides over Christian 72 and engages the lowered edge 79, the user feels less resistance and more preferably feels a tactile sensation and possibly an indication. sound The drive member 86 may be slidably removed by the user by forcing rib 98 out of the notch 80 and along ramps 74 and moving rib 99 out of the lowered edge 79. Ribs 98 and 99 preferably have sufficient flexibility. to allow sliding insertion and removal. It is also possible to secure the drive member to the pusher member 52 in an orientation rotated 180 degrees with respect to the orientation shown in the drawings, for example when it is desired that the tubing may extend from the other side of the drive member.

Turning to Figs. 8 and 9 there is provided a spray adapter 104 which is preferably supported or attached to the distal end 29 of the body. In Fig. 8, distal outlets 106 and 108 may be associated with respective inner holes 30 and 32 of body 28 to allow ejection of sealant components and for communication with spray adapter 104. Respective sealant passages 110 and 112 may be formed in the spray adapter 104 for sealant communication from the respective inner holes 30 and 32. The spray adapter 104 may define separate outlets 114 and 116 for each of the sealant components as as shown in Fig. 8, or alternatively may allow ejection of a stream of mixed components as shown in Fig. 19, wherein mixing of the components is provided within the spray adapter 104. Spray adapter 104 is contemplated in Figs. 8 and 9 shown by way of example and not limitation, have other possible configurations.

In Fig. 9, the spray adapter 104 preferably also forms a portion of the first gas passage 8 and preferably connects to the tubing that forms another portion of the

8 1 871 237 / ΡΤ first gas passage 8. In Figs. 8 and 9, spray adapter 104 defines a gas flow path 118 that communicates with a gas outlet 120. In Figs. 8 and 9, a portion of the gas flow path 118 preferably has an annular or circular shape, although other shapes such as, for example, oval, oblong, or the like are also possible. Figs. 8th and 9 also show the gas outlet 120 disposed around the sealant outlets 114 and 116 although other variations are also possible including one where a separate gas outlet is arranged around each sealant outlet. It is possible for the gas to mix with at least one of the sealant components either before or after the components are mixed together. In Figs. 17 to 18, the gas mixes with one of the sealants as in Fig. 17 and or two sealants as in Fig. 18, before the sealant components are mixed together and in Fig. 19, the gas is mixed with an already mixed upstream sealant stream from a combined distal sealant and gas outlet. Operation of the drive member 86 provides a gas supply to the spray adapter 104 through the first gas passage 8 simultaneously with sealant ejection.

According to another aspect of the present invention, there is provided a sealer applicator assembly 122, as best shown in Fig. 1, which includes a spray adapter 104, a first gas passage 8 and a drive member 86, as shown and described above. These sealant applicator assembly structures are preferably connected to each other in the configuration shown in Fig. 1 and may be sold as a disposable assembly for use with a double-barreled syringe plunger for ejecting tissue sealant, similar to the syringe plunger structure shown and described above, or other similar structures. The spray adapter and drive member of the sealant assembly are preferably removably attached to the appropriate locations of the syringe plunger structure, similar to the above description. By way of example and not limitation, the syringe plunger structure may be used and adapted for use with other disposable sealant applicator assembly assemblies containing

Other adapters, such as a catheter or cannula, or other adapters that provide a spray discharge or non-spray fabric sealant discharge. It is also possible that the syringe plunger structure is included with the sealant applicator assembly as a disposable combination assembly.

According to yet another aspect of the present invention, control unit 4 may be provided for use with any of the apparatus and system described. As shown in Fig. 1, control unit 4 is cooperatively associated with the apparatus for simultaneously activating gas supply with tissue sealant ejection. By way of example and not limitation, Figs. 14th Figures 16 and 16 show an example of control unit 4 which may be used to supply and control gas for first and second gas passages 8 and 10. It is contemplated that this description is not exhaustive and that modifications to control unit 4 are possible. and will depend upon the structures employed to apply fabric sealant and how they are operated or driven, such as for example pneumatically, electrically, or other types of drive techniques.

As shown in Fig. 14, the control unit 4 may be supplied with gas from the gas supply source 6 via a supply passage 16. The incoming gas supply may be filtered by an IF1 filter. The gas supply may flow to a first flow extension 126 and a second flow extension 128. Each flow extension 126 and 128 preferably includes a corresponding pressure regulator PR1 and PR2. Each pressure regulator is preferably configured to monitor pressure along its respective flow line and may further be adjustable to accommodate variations in tubing such as the inside diameter and length of such tubing.

At the first flow branch 126, the gas pressure is preferably adapted for manual control and / or regulation by the user via the pressure control knob 18, as shown in Fig. 1. In Fig. 14, a pressure gauge pressure PG1 as also shown at 20 in Fig. 1 and a

FC2 flow regulator may also be provided to monitor the pressure, which preferably may be in the range of approximately 0 to 300 kPa (0 to 3 bar) and more preferably may be in the range of approximately 200. at 300 kPa (2 to 3 bar). In Fig. 14, first flow branch 126 preferably includes an outlet 277 which is adapted for communication with first flow passage 8 to control the desired spray discharge pressure and further includes a safety pressure switch PS1 and a safety valve. supply VI. Supply valve VI may be normally energized to a closed position so that no gas is supplied to the first gas passage 8 and thus no spray discharge is created. PS1 safety pressure switch and delivery valve VI will be described in more detail below.

In Fig. 14, the second flow branch 128 may include a corresponding flow regulator FC1 and preferably maintains a control gas pressure. The control gas pressure is preferably a predetermined pressure or pressure range that may be adjusted during the manufacturing process. The control gas pressure is preferably in the range of approximately 1 to 20 kPa (0.01 to 0.20 bar) and more preferably in the range of approximately 5 to 15 kPa (0.05 to 0.15 bar). With reference to Figs. 4 to 5, the control gas pressure is preferably supplied through an outlet 129 (Fig. 14) to the second gas passage 10 to exit the opening 96 defined in the drive member 86. The control gas pressure is preferably sufficient to provide a tactile feel to the user's finger to indicate to the user when the finger is positioned over opening 96. Alternatively, the control gas pressure can also be maintained under conditions. such that gas does not escape from opening 96.

As shown in Fig. 14, the control unit 4 preferably further comprises a pressure switch PS2 communicating with flow extension 128. The pressure switch PS2 preferably is operatively associated with the supply valve VI communicating with the another extension of

1,871,237 / flow 126. The pressure switch PS2 is operable to open the supply valve VI so that gas is supplied to the first gas passage 8 thereby providing a tissue sealant spray discharge. The pressure switch PS2 preferably activates to open the valve in response to receiving a control signal from the apparatus. The control signal is created when the force applied by the user is supplied to eject tissue sealant.

The force applied by the user simultaneously causes a pressure variation. Such force applied by the user preferably restricts or occludes the gas outlet from the opening 96 so as to prevent gas from leaving the opening and causing an increase in pressure sufficient for the control signal to be received by the pressure switch. Alternatively, in an alternate embodiment, it is possible that the force applied by the user may trigger a decrease in pressure if the force applied by the user allows gas to be released from the opening that would not otherwise leave the opening 96. Pressure switch PS2 monitors preferably such a change in pressure in the second gas passage 10 is active to open or close the valve in response to such a change in pressure. The resulting spray discharge provides a combined spray of gas and fabric sealant from the distal end of apparatus 2. When the force applied by the user is removed, the fabric sealant ejection may be terminated immediately or alternatively the delivery gas can be stopped after a predetermined delay time.

As shown in Fig. 14, a delay timing control component PFC1 may be operatively connected to control unit 4, such as pressure switch PS2. The delay timing control component PFC1 preferably prevents the pressure switch PS2 from closing the valve for a predetermined period of time after the user applied force is removed. In Fig. 14, the delay timing control component PFC1 preferably communicates with flow passage 118 (shown in Figs. 8 to 9) and may use additional piping 130. Preferably, the delay time is in the range of approximately 0 ° C. , 1 seconds to 0.9 seconds and more

8 1,871,237 / ΡΤ preferably about 0.5 seconds. The delay time provides a gas discharge after the user has stopped the tissue sealant ejection. Additional gas discharge may be useful for dislodging any remaining tissue sealant from the distal end of the apparatus to prevent clogging or obstruction of the distal end.

As further shown in Fig. 14, a safety pressure switch PS1 can communicate with flow passage 126 and provide overpressure protection. The safety pressure switch preferably prevents the gas supply pressure to the apparatus from exceeding a predetermined limit level. When the limit level is reached, the gas supply to the distal end of the appliance may be switched off automatically.

Figs. 15 and 16 illustrate a flowchart and schematic of an electrical circuit which may be used in connection with the operation of pressure switch PS2 and supply valve VI as described above. As shown in Fig. 16, the pressure switch PS2 is connected to a main power supply, such as a battery. A battery LED indicator can be used to indicate when the battery is running out of charge. As shown in Figs. 15 and 16, activation of pressure switch PS2 closes the electronic circuit to supply voltage to valve VI, thereby opening valve VI. In Fig. 16, the voltage that is supplied to valve VI is compared to a predetermined threshold voltage V threshold. · If the voltage exceeds the threshold voltage V threshold / · then the safety pressure switch PS1 overlaps the pressure switch PS2 and closes. the valve VI.

The pusher member may be an integral part of the drive member. Alternatively, the pusher member may be separated and adapted to be cooperatively associated with the drive member. An alternative embodiment of a drive member, indicated generally at 140, is shown in Figs. 20 to 30 for use with an apparatus similar to the apparatus described in Figs. 1 to 16. Such an embodiment is similar to the embodiment described in Figs. 6th to 7 except

That the embodiment in Figs. 20-30 includes a drive member 140 which is formed as an integral part of the pusher member or components that are associated with a conventional syringe plunger construction. Accordingly, those portions of the apparatus that are identical to those portions in Figs. 1 to 16 will not be repeated.

In Figures 20 to 30, drive member 140 includes an upper or proximal portion 142 which defines a user contact surface and a distal or underside 144 that attaches to plunger components 146 and 148 of the syringe ( s). In Fig. 23A, drive member 140 may define a gas passageway 150 extending between first and second ends 152 and 154. The first end 152 may be defined on the user contact surface 142 (as shown in Figs. 20 to 24) and the second end 154 of the passage 150 may be defined along a lateral edge of the drive member which is extends between the proximal and distal portions 142 and 144 (or top and bottom, respectively) (see Figs. 21, 23A and 25 or elsewhere as appropriate). With reference to Fig. 20, the second end 154 of passage 150 preferably communicates via tubing 156 with a control unit and pressure or gas source (as indicated at 4 and 6 in Fig. 1).

In Figs. 20 to 24, the proximal portion or user contact surface 142 has a different contour surface than that shown in Figs. 1 through 13. While other contours are also possible and the present application is not limited to the contour surfaces shown herein, the proximal portion 142 in Figs. 20 24 preferably includes a raised central portion 158 in which the first end 152 of the passage 150 may be defined and concave portions 160 extending to either side of the raised portion 158. As shown in Fig. 24, the first end 152 of passage 150 may terminate slightly above raised portion 158 so that the user can determine the location of first end 152 based on tactile sensation. Alternatively, for example, the first end 152

May be lowered or flush with raised portion 158.

As shown in Figs. 22, 23A and 26 to 30, the distal or underside portion 144 includes laterally disposed slots 162, 164 and 166 for receiving plunger components 146 and 148 having flanged ends of different dimensions. As best seen in Figs. 28 to 30, flanged ends of small, medium and large diameter dimensions may be received in correspondingly sized slits 162, 164 and 166. Flange size is typically different for different size syringes (volume). This allows an actuator to accommodate different syringe dimensions (volumes) that may be required for different procedures. As shown in Figure 27, each of the slots 162, 164 and 166 may be sized and configured to receive a single plunger component or pair of plunger components oriented in a side-by-side relationship.

According to the invention described above, the embodiment of Figs. 20 to 30, may be associated with control unit 4 (as shown in Fig. 1) to supply and control gas from a gas source. In Figs. 20 to 30 the gas passage 150 is occluded by the user when the user's thumb is placed over the second opening 152 formed on the user contact surface 142. According to previously described embodiments, gas passage 150 may fluidly communicate with the control unit and / or pressure or gas source (e.g., indicated at 4 and 6 in Figure 1) via piping 156 connected to second end 154 of gas passage 150. In Figure 20, such a connection may be obtained by connecting one end of the pipe 156 having a projection or hook 168 that engages behind a shoulder or ramp detent 170 on the user contact surface 142. Other types of connections are also possible. attachment structures and are not limited to those shown and described. According to the invention described above, when the second opening 152 is occluded by the user, preferably a gas supply is provided to the distal end of the applicator.

By appropriate tubing (e.g. as indicated at 8 in Figure 1).

In Fig. 31, an apparatus, generally indicated at 172, includes a drive member 174 which is also combined with the pusher member, similar to the previously described embodiments, and includes an upper side or user contact surface 176 having a contour. 1 to 13 and a distal or underside portion 178. Similar to the embodiment shown in Figs. 1 to 13, the embodiment in Fig. 31 includes a frame 180 having a sliding extension arm 182 and includes a pair of adjacent hollow cavities 184 and 186. Cavities 184 and 186 receive respective cylindrical holes (not shown) containing fabric sealant components. Distal (or underside) portion 178 of drive member 172 preferably includes two slots 190 and 192 which each slidably receive a flanged end of a plunger member extending proximally from each other. fluid-containing bore disposed in respective cavities 184 and 186.

Figure 32 shows an alternative woven sealant apparatus, generally indicated at 200. Such an apparatus is shown to have a conventional gun-type applicator construction, although other constructions are also possible. Apparatus 200 generally defines a body 202 and a handle 204. The body 202 defines respective cavities for receiving fluid filled cylindrical holes 206 having respective plunger components 208 extending therefrom. Each proximal end of the plunger member 208 is received by a pusher member 210. A drive member, generally indicated at 212, is preferably operatively associated with the pusher member 210. The drive member 212 includes a lever 214 which may be distally and pivotally movable relative to the handle 204. Lever 214 may be operably connected to pusher member 210 by a drive mechanism shown and described in US Patent No. 6,585,696, which is assigned to Baxter International Inc., the assignee of the present application.

EP 1 871 237 / EN

In Fig. 32, lever 214 is preferably pivotally connected to handle 204. Lever 214 may be turned towards and / or from handle 204 for actuation. Lever 214 also preferably defines at least a portion of a gas passageway 216. A first end or opening 218 of passageway 216 is preferably defined at a distal portion of lever 214. To enable tissue seal delivery, the user may cover or occlude first end 218 of passageway 216, such as with an index finger. A second end 220 of passage 216 preferably connects to a gas supply via tubing 222 which preferably defines another portion of gas passage 216 to provide gas or pressure for passage 216. A gas supply is also preferably supplied to the distal end of the apparatus 200 by appropriate piping 224.

During operation of the apparatus 200 in Fig. 32, lever 214 pivots to eject fabric sealant from holes 206 through the spray end 226 of the device. Gas or pressure may be simultaneously supplied to the spray end 226 through the tubing 224 when occluding the opening 218 formed on lever 214 in accordance with the invention described above. Gas supply may be interrupted immediately or with a time delay when the user ceases to occlude opening 218 also in accordance with the invention described above.

As can be seen from the above description, the present invention has several different aspects, which are not limited to the specific structures shown in the attached drawings.

Lisbon, 2012-12-07

ΕΡ 1,871,237 / ΡΤ