Patent Application
20050096588
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.
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.
The apparatus of the present invention will be explained in more detail by way of the accompanying drawings, wherein:
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.
The first syringe device 36 comprises a first syringe reservoir 42 storing a first component 44 and a first syringe piston 46, positionable within the first syringe reservoir 42. The first syringe device 36 has a first syringe dispensing tip 48 connected to the first syringe reservoir 42 extending beyond the syringe coupler 40 and a first syringe pusher 50, which is attached to the first piston rod 52.
Likewise, second syringe device 38 comprises a second syringe reservoir 54 storing a second component 56 and a second syringe piston 58, positionable within the second syringe reservoir 54. The second syringe device 38 has a second syringe dispensing tip 60 connected to the second syringe reservoir 54 extending beyond the syringe coupler 40, and a second syringe pusher 62, which is attached to the second piston rod 64.
The coupling members 18A, 18B of the present invention may couple to the material applicator 34 in a plurality of ways, including, in screw-able relation or snap-fit relation.
An alternate embodiment of the coupling members 18A, 18B is shown in
The elongated body lumens 32A, 32B positioned within the elongated body 14 may be formed in a plurality of shapes, including, without limitation, circular lumens and D-shaped lumens.
As shown in
The spray tip 15 further includes a mixing chamber 100 which is in communication with the at least two lumen receivers 98A, 98B. At least one flexible mixing member 102 is positioned within the mixing chamber 100, proximate to the at least two lumen receivers 98A, 98B. The at least one flexible mixing member 102 assists in causing impingement mixing of the at least two material components by forming a turbulent flow within the mixing chamber 100. During use, the individual components are advanced through the elongated body lumens 32A, 32B and individually engage the at least one mixing member 102 positioned within the mixing chamber 100. The force applied by the advancement of the individual components forces the at least one flexible mixing member 102 to flex in response thereto. The at least flexible mixing member 102 provides sufficient resistance to the applied force so as to form a narrowing element within the mixing chamber 100 and thereby force the individual components together within the mixing chamber 100. The resistance applied by the at least one flexible mixing member 102 in addition to the forward advancement of the material results in generation of turbulent flow within the mixing chamber 100. In addition to forming turbulent flow within the mixing chamber 100, the resilient nature of the at least one flexible mixing member 102 prevents a backflow of material from the mixing chamber 100 into the elongated body lumens 32A, 32B thereby acting as a directional flow valve. As shown in
A spray regulator 104 is positioned within the mixing chamber 100 proximate to the spray aperture 94. The spray regulator 104 further ensures that the material located within the mixing chamber 100 are adequately mixed and provides an impedance within the mixing chamber 100 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 the spray aperture 94, effects the emitted spray volume.
In use, a multiple component fluid may be applied by the laproscopic spray device 10 to a work surface located within the body of a patient The illustrated embodiment shows a syringe-type material applicator 34, although other applicators may be used.
Initially, the user attaches the spray tip 15 to the elongated body 14 by sliding the outer sleeve 84 of the elongated body 14 towards the interface member 12, thereby exposing the spray tip receiver 90. Thereafter, the user attaches the spray tip 15 to the elongated body 14, wherein the at least one mounting member 96 of the spray tip 15 engages the exposed spray tip receiver 90 on the elongated body 14. The outer sleeve 84 is then slid towards the spray tip 15, thereby locking the spray tip 15 in place. The user may then insert the dispensing tips 48, 60 of the syringe-type material applicator 34 into the receiving apertures 20A, 20B formed on the coupling members 18A, 18B of the interface member 12. Thereafter, the coupling members 18A, 18B are actuated to engage and retain the dispensing tips 48, 60. Syringe-type material applicators 34 may be single-use disposable devices constructed of inexpensive plastics and polymers. The application of force to the first piston rod 52 and second piston rod 64 of the syringe-type material applicator 34 will result in the application of the fluid components.
The spray tip 15 may then be inserted into the patient's body and advanced to the area of interest. Once suitably positioned the user applies force to the first piston rod 52 and second piston rod 64 of the syringe-type material applicator 34. Material stored within the syringe reservoirs 42, 54 is advanced through the dispensing tips 48, 60 and into the transport lumens 28A, 28B. The continued application of force advances the material into the elongated body lumens 32A, 32B, which are in communication with the spray tip 15. Thereafter, the material encounters the flexible mixing member 102 positioned within the mixing chamber 100 of the spray tip 15. The mixing member 102 forces the individual materials together and forms a turbulent flow within the mixing chamber 100. The continued application of force expels the mixed material as a spray mixture through the spray aperture 94. The disclosed configuration permits the user to easily detach and apply the spray tip 15 to the elongated body 14, thereby permitting the user to easily replace the spray tip 15 should the device foul or clog.
Another embodiment of a laproscopic spray device 110 is depicted in
The spray tip assembly 122 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.
The spray tip assembly 122 also includes an elongated chamber body 134 disposed within an internal cavity 136 of an outer spray tip body member 138. The elongated chamber body 134 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. The elongated chamber body 134 has an outer surface 140 that mates with an inner surface 142 of the internal cavity 136 of the spray tip body member 138. The flexible disc 128 is disposed within a recess of the proximal end 144 of the elongated chamber body 134, and has a central passage 146 to allow a flow of components therethrough. The diameter or transverse dimension of the central passage 146 can be about 0.01 inches to about 0.04 inches.
The central passage 146 is in fluid communication with an elongated mixing chamber 148 of the spray tip assembly 122. The elongated mixing chamber 148 is in fluid communication with lateral ports 150 and 152 which in turn communicate with longitudinal channels 154 formed into the inside surface 142 of the outer spray tip body member 138. The lateral ports 150 and 152 are disposed proximally of a distal end 149 of the elongated mixing chamber. The longitudinal channels 154 terminate distally in spiral mixing channels 156 on an inside surface 158 of the distal face 160 of the outer spray tip body member 138. The spiral mixing channels 156 converge axially inward to an aperture 162 which is configured to spray an atomized mixture of the components delivered from the dual syringe assembly 115 as depicted in
During use, as shown in
Turbulent flow of the components through the elongated mixing chamber 148 serves to mix the components 112 and 114 substantially before the components are then expelled radially outwardly through the lateral ports 150 and 152 of the elongated chamber 148. The components 112 and 114 then flow into a gap 166 between an outer surface 140 of the elongated chamber body 134 and an inside surface 142 of the outer spray tip body member 138, and then into the longitudinal channels 154 of the outer spray tip body member 138. The flow of components 112 and 114 then continues into the spiral mixing channels 156 on the inside surface 158 of the distal face 160 of the outer spray tip body member 138. Thereafter, the mixed components 112 and 114 are expelled from the apterture 162 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.
