US20050096588A1 - Laparoscopic spray device and method of use - Google Patents

Abstract

A laparoscopic spray device for selectively applying a multiple component material dispensed from a multiple component material applicator to a surgical site in vivo is disclosed. The device comprises an interface member capable of engaging a multiple component applicator, a body having at least two lumens therein, and a detachable spray tip in fluid communication with the body. The detachable spray tip includes a mixing chamber having at least one flexible mixing member positioned therein which is capable of creating a turbulent flow within a mixing chamber. In addition, the at least one mixing member prevents a back flow of material from the mixing chamber to the at least two lumens. The present invention is particularly useful in remotely applying multiple component tissue adhesives to an internal incision.

Description

BACKGROUND
• In recent years, minimally invasive surgical techniques have emerged as an alternative to conventional surgical techniques to perform a plurality of surgical procedures. Minimally invasive procedures differ from conventional surgical procedures in that a plurality of devices may be introduced into the body through a small incision. As a result, trauma to the body is greatly reduced, thereby decreasing the recovery time of the patient.
• One example of a common minimally invasive surgery involves laparoscopic surgical procedures. Laparoscopic procedures may be used to treat hernias, colon dysfunctions, gastroesophageal reflux disease, and gallbladder disorders. Typically, the patient undergoing the procedures will return home hours after undergoing surgery.
• Generally, laparoscopic procedures require making at least one small incision in the patient's abdomen near the area of interest. A cannula or trocar may be inserted into to the incision to limit blood loss and reduce the likelihood of infection. Thereafter, various surgical instruments are introduced into the patient's body through the incision. Generally, these instruments enable the surgeon to visualize the inside of the patient's body and access the internal organs of the patient. Current laparoscopic surgical instruments include cameras, scissors, dissectors, graspers and retractors. Generally, these instruments include a handle attached to an elongated body having a distal tip used to execute the particular procedure. The handle, which remains outside the patient's body, is used by the surgeon to control the operation of the instrument during the procedure.
• One challenge presented when performing minimally invasive surgical procedures relates to closing an incision made within the patient's body by a cutting laparoscopic instrument. As opposed to conventional surgical procedures, the surgeon's access to the site of the incision is greatly reduced during minimally invasive procedures. As a result, several knot pushing devices capable of advancing suture knots formed outside the patient's body to an area of interest in vivo have been developed. Typically, a suturing laparoscopy device is inserted into the patient's body and advanced to the incised area.
• A needle is advanced through the various tissue portions proximate the incision, thereby securing the suture material to the tissue. Thereafter, the suturing device is removed from the patient's abdomen leaving the suture material attached to the tissue. A knot is formed in the suture material and advanced along the suture material by the knot pusher to the incision, thereby applying the suture knot. The extraneous suture material is trimmed with laparoscopic scissors once the incision is adequately sutured. Occasionally, the suture knot becomes entangled in the suture material during the advancement process. The surgeon is then required to remove the entangled suture material from the incision area and reattach new suture material, thereby increasing the likelihood of infection and the patient's exposure to anesthesia.
• Recently, the use of tissue sealants and other biological adhesive materials has emerged as an alternate technique of closing incisions. Preferred tissue sealants include fibrin, which is comprised of thrombin and a fibrinogen material, although other multiple component materials are available. Typically, the individual components of the adhesive material are stored in isolated reservoirs. When mixed, these components may coagulate very quickly, yielding an adhesive gel within perhaps 10 or 20 seconds. When applied to the exterior of the body, or when considerable access to the application site is possible, the rapid coagulative properties of the tissue sealant are welcomed. Though desirable for use during minimally invasive procedures, such fast-acting properties of conventional tissue sealants and adhesive have presented potential problems of fouling or clogging during the application of tissue sealants through laparoscopic devices, which typically results in the destruction of the device.
• Thus, there is a need for a device capable of effectively delivering a multiple component tissue sealant to a location in vivo through from a remote location.
SUMMARY
• Embodiments of the present invention enable a user to apply a multiple component material to an incision site within the patient's body from a remote location without the fouling or clogging problems associated with prior art devices. In one aspect, the present invention provides a laparoscopic spray device comprising an interface member or manifold capable of detachably coupling to a multiple component material applicator, an elongated body or delivery shaft having at least two lumens formed therein in fluid communication with the interface member, and a detachable spray tip having a mixing chamber therein coupled to the elongated body useful in generating a spray to apply the material in vivo. The spray tip assembly may also include a flexible mixing member adjacent the mixing chamber. The flexible mixing member may generate a turbulent flow within the mixing chamber, thereby resulting in impingement mixing of the components of the multiple component material. In addition, the at least one flexible mixing member may be used to prevent a back flow of material from the mixing chamber to the at least two lumens within the elongated body. Those skilled in the art will appreciate that a material applicator may be coupled to the present invention in a plurality of ways, including, without limitation, in slip-fit relation, in Luer-lock relation, and in screw-like relation.
• In another embodiment, the laparoscopic spray device comprises an interface member capable of detachably coupling to a material applicator, an elongated body having at least two lumens therein in fluid communication with the at least two transport lumens within the interface member, and a spray tip having a mixing chamber containing at least one mixing member therein detachably coupled to and in fluid communication with the elongated body. The interface member further comprises at least two coupling members having at least two receiving apertures formed therein. The receiving apertures are capable of coupling to the material applicator and are in fluid communication with at least two transport lumen positioned within the interface member.
• The elongated body comprises a stationary inner body member positioned within a longitudinally slide-able outer body member. The stationary inner body includes a spray tip receiver adapted to receive a detachable spray tip. The slide-able outer body is capable of being advanced and retracted to cover and expose, respectively, the spray tip receiver. The at least one flexible mixing member of the present invention is capable of generating turbulent flow within the mixing chamber, thereby resulting in impingement mixing of the components of the multiple component material. In addition, the at least one flexible mixing member may be used to prevent a back flow of material from the mixing chamber to the at least two lumens within the elongated body.
• Embodiments of the present invention also provide a method of mixing a multiple component material with at least one flexible mixing member. To practice the present invention the user positions at least one flexible mixing member proximate to the entrance of a material mixing chamber. The mixing chamber is attached to at least two component lumens which are in fluid communication with a multiple component source. The individual components are advanced through the separate lumens towards the mixing chamber. Thereafter, the at least one flexible mixing member engages the individual components and forces the components together, thereby generating turbulent flow within the mixing chamber. The generation of turbulent flow within the mixing chamber results in impingement mixing of the components which yields a mixed material. In addition to enhancing the impingement mixing effects, the at least one flexible mixing member prevents the back flow of material from the mixing chamber to the at least two component lumens. Thereafter, the mixed material is advanced through an aperture formed in the mixing chamber and applied to a work surface.
• Another embodiment includes a laparoscopic spray device for mixing and applying a multiple component agent to a target site having a first fluid reservoir containing a first component and a second fluid reservoir containing a second component. An elongated delivery shaft has a proximal end, a distal end, and at least two fluid delivery channels in fluid communication with the first and second fluid reservoirs. A spray tip assembly is detachably coupled to the distal end of the elongated delivery shaft and has a sealing member disposed at a proximal end of the spray tip assembly that seals distal ports of the fluid delivery channels of the elongated delivery shaft when the sealing member is in a relaxed state. The sealing member is configured to allow fluid flow from the distal ports when pressure is applied to the sealing member. An elongated mixing chamber is in fluid communication with the fluid delivery channels when pressure is applied to the first and second components in the fluid delivery channels.
• Other objects, features, and advantages of the present invention will become apparent from a consideration of the following detailed description.
BRIEF DESCRIPTION OF THE DRAWINGS
• The apparatus of the present invention will be explained in more detail by way of the accompanying drawings, wherein:
• FIG. 1 shows a perspective view of the laparoscopic spray device of the present invention;
• FIG. 2 shows a perspective view of the interface member the present invention;
• FIG. 3 shows a cross-sectional view of the interface member the present invention;
• FIG. 4 shows a cross-sectional view of the interface member attached to the elongated body the present invention;
• FIG. 5 shows a cross-sectional view of a multiple syringe material applicator useful in applying a multiple component material to a work surface;
• FIG. 6 shows a cross-sectional view of a multiple syringe material applicator coupled to the interface member of the present invention;
• FIG. 7 shows a expanded cross-sectional view of an embodiment of the interface member of the present invention engaging a dispensing tip of a multiple syringe material applicator;
• FIG. 8 shows a perspective of another embodiment of the interface member of the present invention engaging a dispensing tip of a multiple syringe material applicator;
• FIG. 9 shows a cross-sectional view of the embodiment ofFIG. 8 wherein the interface member of the present invention is engaging a dispensing tip of a multiple syringe material applicator;
• FIG. 10 shows a perspective of yet another embodiment of the interface member of the present invention engaging a dispensing tip of a multiple syringe material applicator;
• FIG. 11 shows a cross-sectional view of the embodiment ofFIG. 10 wherein the interface member of the present invention is engaging a dispensing tip of a multiple syringe material applicator;
• FIG. 12 is a cross-section view of the elongated body of the present invention wherein the slidable outer sleeve is positioned over the spray tip receivers;
• FIG. 13 is a cross-section view of the elongated body of the present invention wherein the slidable outer sleeve is positioned over the attachment channel;
• FIG. 14 is a cross-section view of the at least two lumens located within the elongated body of the present invention;
• FIG. 15 is a cross-section view of an alternate embodiment of the at least two lumens located within the elongated body of the present invention;
• FIG. 16 is a cross-section view of another embodiment of the at least two lumens located within the elongated body of the present invention;
• FIG. 17 is a side view of the detachable spray tip of the present invention; and
• FIG. 18 is a cross-section view of the detachable spray tip of the present invention;
• FIG. 19 is a perspective view of another embodiment of a laproscopic spray device;
• FIG. 20 is an elevational view in partial section of a spray tip assembly of the laproscopic spray device ofFIG. 19;
• FIG. 21 depicts the spray tip assembly ofFIG. 20 in use;
• FIG. 22 is an enlarged view in section of a distal portion of the spray tip assembly ofFIG. 19.
DETAILED DESCRIPTION
• Embodiments of a laparoscopic spray device having features of the present invention are used in conjunction with a multiple component applicator to dispense a multiple component fluid to a work surface located within the body of a patient. Embodiments may be used to dispense a multiple component tissue sealant, such as Fibrin, which is capable of effecting hemostasis or achieving other therapeutic results. Embodiments are designed to permit the remote application of a multiple component fluid and may be adapted to functionally couple to a plurality of applicators, including, for example, multiple reservoir syringe-type applicators such as the DUPLOJECT™ syringe-type applicator manufactured by the Baxter Healthcare Corporation. Embodiments may also include a laparoscopic spray device capable of functionally coupling with a plurality of applicators in a plurality of sizes. Some of the exemplary embodiments disclsosed herein may be similar to or the same as embodiments disclosed in co-pending U.S. application Ser. No. 09/972,495, titled “Laproscopic Spray Device and Method of Use”, filed Oct. 5, 2001, by Spero et al., which is incorporated by reference herein in its entirety.
• FIG. 1 shows a perspective view of an embodiment of the present invention. As shown, thelaparoscopic spray device10 comprises aninterface member12 in fluid communication with anelongated body14 having aspray head15 attached thereto. Those skilled in the art will appreciate that the present invention may be manufactured from a plurality of materials, including, without limitation, polyethylene, polypropylene, polystyrene, or a like material. A plurality of materials having different physical properties may be used to manufacture various portions of the present invention. For example, theinterface member12 andelongated body14 may be made rigid, while thespray tip15 is resilient. In an alternate embodiment, theinterface member12 may be manufactured from a rigid material while theelongated body14 andspray tip15 is resilient.
• FIG. 2 shows a perspective view of theinterface member12 of the present invention. Theinterface member12 comprises amember body16 in communication with at least twocoupling members18A,18B. Afirst receiving aperture20A is formed within thefirst coupling member18A. Similarly, asecond receiving aperture20B is formed within thesecond coupling member18B. The receivingapertures20A,20B are sized to receive a material applicator (not shown). Those skilled in the art will appreciate that theinterface member12 may be manufactured in a plurality of sizes to receiving a plurality of material applicators. Theinterface member12 further includes anelongated body receiver22 which is in communication with anattachment device aperture24 sized to receive anattachment device26 therein. Theattachment device26 removably couples theinterface member12 to theelongated body14. Theexemplary attachment devices26 may include, without limitation, screws and buttons.
• FIGS. 3-4 show several cross sectional views of theinterface member12. The receivingapertures20A,20B located within thecoupling members18A,18B are in fluid -communication with at least twotransport lumens28A,28B located within themember body16. As shown, thetransport lumens28A,28B have a uniform diameter. In an alternate embodiment thetransport lumens28A,28B may have different diameters. Thetransport lumens28A,28B terminate within theelongated body receiver22. As shown inFIGS. 3 and 4, theelongated body receiver22 includes at least one aligningmember30 therein. The aligningmember30 ensures that the at least twolumens32A,32B formed in theelongated body14 are aligned with and are in fluid communication with thetransport lumens28A,28B within theinterface member12. In addition, the aligningmember30 may apply a constrictive force to theelongated body14, thereby assisting in the retention thereof.
• FIG. 5 shows a cross-sectional view of anexemplary material applicator34 capable of coupling to the present invention. As shown, thematerial applicator34 comprises at least afirst syringe device36 and asecond syringe device38 coupled by asyringe coupler40. It should be understood that thematerial applicator34 of the present invention may comprise a plurality of material reservoirs, and the present embodiment should not be construed as limiting.
• Thefirst syringe device36 comprises afirst syringe reservoir42 storing afirst component44 and afirst syringe piston46, positionable within thefirst syringe reservoir42. Thefirst syringe device36 has a firstsyringe dispensing tip48 connected to thefirst syringe reservoir42 extending beyond thesyringe coupler40 and afirst syringe pusher50, which is attached to thefirst piston rod52.
• Likewise,second syringe device38 comprises asecond syringe reservoir54 storing asecond component56 and asecond syringe piston58, positionable within thesecond syringe reservoir54. Thesecond syringe device38 has a secondsyringe dispensing tip60 connected to thesecond syringe reservoir54 extending beyond thesyringe coupler40, and asecond syringe pusher62, which is attached to thesecond piston rod64.
• Thecoupling members18A,18B of the present invention may couple to thematerial applicator34 in a plurality of ways, including, in screw-able relation or snap-fit relation.FIG. 6 shows one embodiment of theinterface member12 of the present invention coupled to amaterial applicator34. As shown, thesyringe dispensing tips48,60 are slidably positioned within thecoupling members18A,18B, in a luer-lock relation. In one embodiment thecoupling members18A,18B are manufactured from a resilient material such as a biologically compatible elastomer, thereby permitting thecoupling members18A,18B to resiliently receive the dispensingtips48,60. Those skilled in the art will appreciate that the receivingapertures20A,20B formed in thecoupling members18A,18B may be tapered to ensure that a sealable interface between theinterface member16 and theapplicator34 is obtained. In an alternate embodiment, the receivingapertures20A,20B is not tapered.
• An alternate embodiment of thecoupling members18A,18B is shown inFIG. 7. Acoupling member18A is shown, which comprises a rotate-able threadedsleeve65 and includes alock member66 positioned within the receivingaperture20A. Thelock member66 engages atip thread68 located on the dispensingtip48 in a screw-like relation.
• FIGS. 8 and 9 show an alternate embodiment of the coupling members of the present invention. As shown, thecoupling members18A,18B may comprise engagingchannels70A,70B formed in themember body16. The receivingchannels70A,70B include at least onelock ridge72A,72B positioned within each receivingchannel70A,70B. Thelock ridge72A,72B slide-ably engages at least one engagingchannel74A,74B formed on the dispensingtips48,60 of thematerial applicator34.
• FIGS. 10 and 11 show yet another embodiment of thecoupling members18A and18B. As shown, thecoupling members18A,18B each include acompressible collet76A,76B therein. Eachcollet76A,76B, which defines a receivingaperture20A,20B sized to be a slightly larger diameter than the inside diameter of the threadedouter sleeve80A,80B, includes a threadedbase78A,78B. As shown, eachcollet76A,76B is tapered and includes a plurality of compression slits82 positioned radially around the collet. During use each dispensingtip48,60 is inserted into the receivingaperture20A,20B defined by theindividual collet76A,76B. Thereafter, the threadedouter sleeve80A,80B is positioned to engage the threadedbase78A,78B and rotated. As a result, the threadedouter sleeve80A,80B forcibly compresses thecollet76A,76B thereby decreasing the diameter of the receivingaperture20A,20B and applying a retentive force to the dispensingtips48,60 of thematerial applicator34 positioned therein. Those skilled in the art will appreciate the dispensingtips48,60 of thematerial applicator34 may, but need not, include a retaining channel (not shown) thereon.
• FIG. 12 shows a cross-sectional view of theelongate body14. As shown, theelongated body14 includes a longitudinally slide-ableouter sleeve84 positioned around a stationaryinner body86. At least twoelongated body lumens32A,32B are positioned within theinner body86. The at least twoelongated body lumens32A,32B are capable of engaging thetransport lumens28A,28B positioned within theinterface member12. Anattachment channel88 is formed on theelongated body14 thereby enabling the elongated body to engageattachment device26 positioned on theinterface member12. The distal portion of theelongated body14 includes aspray tip receiver90 capable of receiving a detachable spray tip (not shown) thereon. As shown inFIG. 13, theouter sleeve84 may be slidably retracted towards theattachment channel88 thereby exposing thespray tip receiver90.
• Theelongated body lumens32A,32B positioned within theelongated body14 may be formed in a plurality of shapes, including, without limitation, circular lumens and D-shaped lumens.FIG. 14 shows one embodiment wherein theelongated body lumens32A,32B are D-shaped. Those skilled in the art will appreciate that the D-shapedelongated body lumens32A,32B of the present embodiment allow a larger cross sectional area for the lumen in a smaller overall diameter shaft. As a result, less force is required to advance the individual components through the device with a flow rate sufficient to permit the sprayed application of the multiple component material.
• As shown inFIG. 14, theelongated body lumens32A,32B positioned within theelongated body14 may have uniform diameters. Commonly, the individual components comprising the multiple component materials may have different viscosities and flow rates, or may require a disproportionate amount of one component in relation to another component. As such, in an alternate embodiment of the present invention theelongated lumens32A,32B may be different diameters to accommodate the different viscosities and flow rates of the component materials, or to account for the uneven distribution of one component in relation to another component.FIGS. 15 and 16 show cross-sectional views of alternate embodiments of the present invention wherein theelongated lumens32A,32B have different diameters to account for different viscosities and flow rate of individual components, or to dispense a disproportionate amount of one component in relation to another component. Similarly, thetransport lumens28A,28B may also have different diameters or shapes as well. As shown inFIG. 15, the firstelongated body lumen32A has a diameter considerably smaller then the diameter of the secondelongated body lumen32B. Therefore, thedevice10 will transport a greater volume of component material through the secondelongated body lumen32B with respect to the firstelongated body lumen32A. Similarly,FIG. 16 shows another embodiment of the present invention wherein the secondelongated body lumen32B is capable of transporting a larger volume of material therethrough with respect to the firstelongated body lumen32A.
• FIGS. 17 and 18 show various views of thedetachable spray tip15. As shown inFIG. 17, the exterior of thespray tip15 includes a tip body having aspray aperture94 formed therein. Thespray tip15 further includes at least one low-profile mounting member96 attached thereto, thereby enabling thespray tip15 to detachably mount to theelongated body14. The spray tip may be manufactured from a plurality of materials, including, for example, biologically-compatible elastomers, plastics, and metals.
• FIG. 18 shows a cross sectional view of thedetachable spray tip15 coupled to theelongated body14. As shown, the at least one mountingmember96 is located between theouter body84 and the stationaryinner body86 of theelongated body14, and is engaging thespray tip receiver90. Thedetachable spray tip15 of the present invention may detachably couple to theelongated body14 in a plurality of ways, including, in snap-fit relation. At least twolumen receivers98A,98B receive theelongated body lumens32A,32B.
• Thespray tip15 further includes a mixingchamber100 which is in communication with the at least twolumen receivers98A,98B. At least oneflexible mixing member102 is positioned within the mixingchamber100, proximate to the at least twolumen receivers98A,98B. The at least oneflexible mixing member102 assists in causing impingement mixing of the at least two material components by forming a turbulent flow within the mixingchamber100. During use, the individual components are advanced through theelongated body lumens32A,32B and individually engage the at least one mixingmember102 positioned within the mixingchamber100. The force applied by the advancement of the individual components forces the at least oneflexible mixing member102 to flex in response thereto. The at leastflexible mixing member102 provides sufficient resistance to the applied force so as to form a narrowing element within the mixingchamber100 and thereby force the individual components together within the mixingchamber100. The resistance applied by the at least oneflexible mixing member102 in addition to the forward advancement of the material results in generation of turbulent flow within the mixingchamber100. In addition to forming turbulent flow within the mixingchamber100, the resilient nature of the at least oneflexible mixing member102 prevents a backflow of material from the mixingchamber100 into theelongated body lumens32A,32B thereby acting as a directional flow valve. As shown inFIG. 18, the at least one mixingmember102 is capable of engaging the elongatedbody support member103, thereby restricting access of the material to theelongated body lumens31A,32B from the mixingchamber100 and preventing a backflow of material. The at least oneflexible mixing member102 may be manufactured in a plurality of shapes, including, for example, washer-like shapes.
• Aspray regulator104 is positioned within the mixingchamber100 proximate to thespray aperture94. Thespray regulator104 further ensures that the material located within the mixingchamber100 are adequately mixed and provides an impedance within the mixingchamber100 to aid in forming a material spray. Those skilled in the art will appreciate that the position and size of the spray regulator, in cooperation with the size of thespray aperture94, effects the emitted spray volume.
• In use, a multiple component fluid may be applied by thelaproscopic spray device10 to a work surface located within the body of a patient The illustrated embodiment shows a syringe-type material applicator34, although other applicators may be used.
• Initially, the user attaches thespray tip15 to theelongated body14 by sliding theouter sleeve84 of theelongated body14 towards theinterface member12, thereby exposing thespray tip receiver90. Thereafter, the user attaches thespray tip15 to theelongated body14, wherein the at least one mountingmember96 of thespray tip15 engages the exposedspray tip receiver90 on theelongated body14. Theouter sleeve84 is then slid towards thespray tip15, thereby locking thespray tip15 in place. The user may then insert the dispensingtips48,60 of the syringe-type material applicator34 into the receivingapertures20A,20B formed on thecoupling members18A,18B of theinterface member12. Thereafter, thecoupling members18A,18B are actuated to engage and retain the dispensingtips48,60. Syringe-type material applicators34 may be single-use disposable devices constructed of inexpensive plastics and polymers. The application of force to thefirst piston rod52 andsecond piston rod64 of the syringe-type material applicator34 will result in the application of the fluid components.
• Thespray tip15 may then be inserted into the patient's body and advanced to the area of interest. Once suitably positioned the user applies force to thefirst piston rod52 andsecond piston rod64 of the syringe-type material applicator34. Material stored within thesyringe reservoirs42,54 is advanced through the dispensingtips48,60 and into thetransport lumens28A,28B. The continued application of force advances the material into theelongated body lumens32A,32B, which are in communication with thespray tip15. Thereafter, the material encounters theflexible mixing member102 positioned within the mixingchamber100 of thespray tip15. The mixingmember102 forces the individual materials together and forms a turbulent flow within the mixingchamber100. The continued application of force expels the mixed material as a spray mixture through thespray aperture94. The disclosed configuration permits the user to easily detach and apply thespray tip15 to theelongated body14, thereby permitting the user to easily replace thespray tip15 should the device foul or clog.
• Another embodiment of alaproscopic spray device110 is depicted inFIGS. 19-22. In this embodiment, at least twoadhesive components112 and114 can be delivered simultaneously from adual syringe assembly115 through an interface member in the form of amanifold assembly113 in a manner that is similar to or the same as the delivery of components discussed above with regard to theapplicators34 andinterface member12. The adhesive components may include any suitable biological materials for delivery to a desired target site. Two such suitable components include fibrinogen and thrombin, which when appropriately combined, form a useful biological adhesive. The manifold assembly is in fluid communication with isolatedfluid channels116 and118 extending the length of anelongated delivery shaft120. The manifold assembly may have features that are similar to or the same as theinterface member12 discussed above. Aspray tip assembly122 is detachably snapped onto a distal end of the elongateddelivery shaft120 by means of alocking ring124 which is radially constrained by a rigidouter sleeve126 of the elongateddelivery shaft120. Thespray tip assembly122 may have features, dimensions and materials which are similar to or the same as those of thespray tip15 discussed above, and vice versa. A sealing member in the form of aflexible disc128 is disposed overdistal ports130 and132 of thefluid channels116 and118, respectively. Theflexible disc128 in a relaxed state covers and seals thedistal ports130 and132. This sealed configuration prevents backflow ofcomponents112 and114 into thefluid channels130 and132 when positive pressure urging the components in a distal flow is not present.
• Thespray tip assembly122 can have an outer diameter of about 2 mm to about 10 mm, more specifically, about 4 mm to about 8 mm. The spray tip assembly can have an axial length of about 10 mm to about 25 mm.
• Thespray tip assembly122 also includes anelongated chamber body134 disposed within aninternal cavity136 of an outer spraytip body member138. Theelongated chamber body134 may be made from a high strength resilient material, such as stainless steel and the outer spray tip body member can be formed of an injection molded polymer. Theelongated chamber body134 has anouter surface140 that mates with aninner surface142 of theinternal cavity136 of the spraytip body member138. Theflexible disc128 is disposed within a recess of theproximal end144 of theelongated chamber body134, and has acentral passage146 to allow a flow of components therethrough. The diameter or transverse dimension of thecentral passage146 can be about 0.01 inches to about 0.04 inches.
• Thecentral passage146 is in fluid communication with anelongated mixing chamber148 of thespray tip assembly122. Theelongated mixing chamber148 is in fluid communication withlateral ports150 and152 which in turn communicate withlongitudinal channels154 formed into theinside surface142 of the outer spraytip body member138. Thelateral ports150 and152 are disposed proximally of adistal end149 of the elongated mixing chamber. Thelongitudinal channels154 terminate distally inspiral mixing channels156 on aninside surface158 of thedistal face160 of the outer spraytip body member138. Thespiral mixing channels156 converge axially inward to anaperture162 which is configured to spray an atomized mixture of the components delivered from thedual syringe assembly115 as depicted inFIG. 21. The mixingchamber148 can have an axial length of about 5 mm to about 25 mm, more specifically about 10 mm to about 20 mm. The mixingchamber148 can have an inner diameter or transverse dimension of about 1 mm to about 3 mm. The inner diameter of the mixingchamber148 may taper distally to a smaller transverse dimension relative to a transverse dimension of the proximal end of the mixing chamber.
• During use, as shown inFIG. 21, theindividual components112 and114 are advanced by pressure from thedual syringe assembly115 through thefluid channels116 and118 to a distal end of the elongateddelivery shaft120 where thecomponents112 and114 then contact aproximal surface164 of theflexible disc128. Force from the pressurized component flow then pushes theproximal surface164 of theflexible disc128 from thedistal ports130 and132 of thefluid delivery channels116 and118 and breaks the seal between the distal end of the fluid delivery channels and theflexible disc128. Thecomponents112 and114 then flow radially inward and converge and begin to mix together as they pass through thecentral passage146 of theflexible disc128 and thereafter, into theelongated mixing chamber148 disposed within theelongated chamber body134.
• Turbulent flow of the components through theelongated mixing chamber148 serves to mix thecomponents112 and114 substantially before the components are then expelled radially outwardly through thelateral ports150 and152 of theelongated chamber148. Thecomponents112 and114 then flow into agap166 between anouter surface140 of theelongated chamber body134 and aninside surface142 of the outer spraytip body member138, and then into thelongitudinal channels154 of the outer spraytip body member138. The flow ofcomponents112 and114 then continues into thespiral mixing channels156 on theinside surface158 of thedistal face160 of the outer spraytip body member138. Thereafter, themixed components112 and114 are expelled from theapterture162 in atomized form onto a target site.
• Embodiments disclosed herein are illustrative of the principles of the invention. Other modifications may be employed which are within the scope of the invention; thus, by way of example but not of limitation, alternative coupling devices, alternative spray tips, and alternative material applicator devices. Accordingly, the present invention is not limited to that precisely as shown and described in the present invention.

Claims (17)

1. A laparoscopic spray device for mixing and applying a multiple component agent to a target site, comprising:

a first fluid reservoir containing a first component and a second fluid reservoir containing a second component;

an elongated delivery shaft having a proximal end, a distal end, and at least two fluid delivery channels in fluid communication with the first and second fluid reservoirs, the fluid delivery channels having distal ports;

a spray tip assembly having a proximal end, a distal end, and a discharge aperture disposed at the distal end, the spray tip assembly detachably coupled to the distal end of the elongated delivery shaft and having a sealing member disposed at the proximal end of the spray tip assembly that seals the distal ports of the fluid delivery channels of the elongated delivery shaft when the sealing member is in a relaxed state and which allows fluid flow from the distal ports when pressure is applied to the sealing member;

an elongated mixing chamber having a proximal end and a distal end, the elongated mixing chamber in fluid communication with the fluid delivery channels when pressure is applied to the first and second components in the fluid delivery channels;

at least one lateral port disposed proximally of the distal end of the elongated mixing chamber and in fluid communication with the elongate mixing chamber; and

at least one spiral mixing channel proximal to the discharge aperture of the spray tip assembly, the at least one spiral mixing chamber in fluid communication with the elongated mixing chamber via the at least one lateral port and in fluid communication with the discharge aperture of the spray tip assembly.

2. (canceled)

3. The device ofclaim 1 wherein the elongated mixing chamber of the spray tip assembly comprises an elongated cylindrical cavity that tapers distally to a transverse dimension that is less than a transverse dimension of the proximal end of the elongate mixing chamber.

4. (canceled)

5. (canceled)

6. The device ofclaim 1 wherein the first and second fluid reservoirs comprise syringes and wherein the device further comprises a manifold disposed between and in fluid communication with the syringes and the fluid delivery channels of the elongated delivery shaft.

7. The device ofclaim 6 wherein the syringes are detachably coupled to the manifold by a Luer-lock configuration.

8. The device ofclaim 1 wherein the sealing member comprises a flexible disc having an aperture therein for mixing and constraining the flow of components therethrough.

9. The device ofclaim 8 wherein the flexible disc is comprised of a silastic polymer.

10. A laparoscopic spray device for mixing and applying a multiple component agent to a target site, comprising:

an elongated delivery shaft having a proximal end, a distal end, and at least two fluid delivery channels in fluid communication with the first and second fluid reservoirs, the fluid delivery channels having distal ports;

a spray tip assembly detachably coupled to the distal end of the elongated delivery shaft having a sealing member disposed at a proximal end of the spray tip assembly that seals the distal ports of the fluid delivery channels of the elongated delivery shaft when the sealing member is in a relaxed state and which allows fluid flow from the distal ports when pressure is applied to the sealing member, and having a discharge aperture disposed at a distal end of the spray tip assembly;

an elongated mixing chamber having a proximal end and a distal end, the elongated mixing chamber in fluid communication with the fluid delivery channels when pressure is applied to the first and second components in the fluid delivery channels;

at least one lateral port disposed proximally of a distal end of the elongated mixing chamber and in fluid communication with the elongate mixing chamber; and

at least one spiral mixing channel proximal to the discharge aperture of the spray tip assembly, the at least one spiral mixing chamber in fluid communication with the elongated mixing chamber via the at least one lateral port and in fluid communication with the discharge aperture of the spray tip assembly.

11. (canceled)

12. The device ofclaim 10 wherein the elongated mixing chamber of the spray tip assembly comprises an elongated cylindrical cavity that tapers distally to a transverse dimension that is less than a transverse dimension of the proximal end of the elongate mixing chamber.

13. The device ofclaim 10 wherein the sealing member comprises a flexible disc having an aperture therein for mixing and constraining the flow of components therethrough.

14. The device ofclaim 10 wherein the flexible disc is comprised of a silastic polymer.

15. A method of mixing and spraying a multiple component agent, comprising:

providing a laparoscopic spray device having a first fluid reservoir containing a first component and a second fluid reservoir containing a second component, an elongated delivery shaft having a proximal end, a distal end, and at least two fluid delivery channels in fluid communication with the first and second fluid reservoirs, a spray tip assembly detachably coupled to the distal end of the elongated delivery shaft having a sealing member disposed at a proximal end of the spray tip assembly that seals distal ports of the fluid delivery channels of the elongated delivery shaft when the sealing member is in a relaxed state and which allows fluid flow from the distal ports when pressure is applied to the sealing member and an elongated mixing chamber in fluid communication with the fluid delivery channels when pressure is applied to the first and second components in the fluid delivery channels;

advancing the components by pressure from the fluid reservoirs through the fluid delivery channels to a distal end of the elongated delivery shaft where the components then contact a proximal surface of the sealing member;

pushing a proximal surface of the sealing member from distal ports of the fluid delivery channels so as to break the seal between the distal end of the fluid delivery channels and the sealing member;

flowing the components into a mixing chamber of the spray tip assembly where the components are at least partially mixed;

flowing the at least partially mixed components laterally outward from the mixing chamber and into a spiral mixing chamber; and

discharging the mixed components from a discharge aperture of the spray spiral mixing chamber onto a target site.

16. The method ofclaim 15 wherein the mixed components are discharged from the discharge aperture in atomized form.

17. The method ofclaim 15 wherein the sealing member comprises a flexible disc having a central passage disposed in a center portion thereof and the components flow radially inward from discharge ports of the fluid delivery channels and converge and begin to mix together as they pass through the central passage of the flexible disc and thereafter, into the elongated mixing chamber.

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