Laparoscopic sealant applicator

A laparoscopic applicator device for the selective directional application of one or more liquids to a surgical site is disclosed. The device comprises a handle with liquid inlets at one end, discrete channels within one or more tubes connecting with said inlet and exteding through said handle to a nozzle, and a dual injection shaft at the nozzle end for inserting the shaft and nozzle through a surgical trocar. The dual shaft comprises s rigid portion immediately adjacent the handle and a flexible portion near the nozzle tip. Means are provided, preferably within the handle, for the controlled articulation of the flexible shaft/nozzle assembly, thereby providing application of the liquids in a desired direction. The present invention is particularly useful in the application of surgical sealants, e.g., fibrin sealants. Methods of applying such components are also a part of the invention.

FIELD OF THE INVENTION
 This invention relates to a laparoscopic sealant applicator wherein a
 multi-lumen tubing, in fluid communication with a source of sealant,
 extends a suitable distance beyond a handle so that the tubing can be
 laparoscopically inserted and articulated in a desired direction to a
 desired site.
 PCT/US96/19505, entitled A Method of Applying a Mixture of Two Liquid
 Components as well as a Device for Carrying Out the Method, filed Dec. 6,
 1996, discloses an applicator device for applying a surgical sealant,
 e.g., a fibrin sealant, to a desired site. The applicator consists of a
 relatively thin multi-lumen tubing which is in fluid communication with
 sources of sealant components at one end and forms, or is connected to, a
 spray tip at the other end. In a preferred embodiment, the tubing runs
 through a handle at or near the spray tip end. The handle is the part of
 the instrument held by the surgeon to apply the sealant and it may include
 activating means for actuating the spray from the component sources.
 Sealants would also be useful in laparoscopic procedures.

SUMMARY OF THE INVENTION
 In accordance with the present invention a laparoscopic applicator device
 for the selective directional application of one or more liquids to a
 surgical site is disclosed. The device comprises a handle with liquid
 inlets at one end, discrete channels within one or more tubes connecting
 with said inlets and extending through said handle to a nozzle, and a dual
 insertion shaft at the nozzle end for inserting the shaft and nozzle
 through a surgical trocar. The dual shaft comprises s rigid portion
 immediately adjacent the handle and a flexible portion near the nozzle
 tip. Means are provided, preferably within the handle, for the controlled
 articulation of the flexible shaft/nozzle assembly, thereby providing
 application of the liquids in a desired direction. The present invention
 is particularly useful in the application of surgical sealants, e.g.,
 fibrin sealants. Methods of applying such components are also a part of
 the invention.
 DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
 The present invention provides a useful device for the laparoscopic
 application of one or more liquid components to a surgical site.
 Preferably, the components form a surgical sealant, e.g., a fibrin sealant
 and the present invention will be further disclosed with regard to fibrin
 sealants. The device is designed to be utilized through a surgical trocar
 and facilitates the selective directional application of fibrin sealants
 via the controlled articulation of a flexible portion of an insertion
 shaft, including a dispensing tip or spray nozzle.
 FIG. 1 shows a device 10 of the present invention which includes a handle
 12 and an insertion shaft 14 adapted to be insertable through a surgical
 trocar. At a first end of the handle 12 are inlets 16, 18, 20 for the one
 or more liquid or sealant components and optional gas component where
 spray application is desired. Any number of inlets may be provided. The
 inlets 16, 18, 20 are adapted to receive the liquid/gas components, and
 sources (not shown) of the components may be directly adjacent to inlets
 or may be remote from said inlets but in fluid communication with the
 inlets via supply tubing. A tubing means 21 extends from the inlets
 through the handle 12 and insertion shaft 14 to a nozzle or applicator tip
 22. This provides for the liquid/gas components to be delivered from the
 sources to, and out of, the nozzle 22 preferably activated by a separate
 means controlling the actual flow of liquid and gas. Preferably, the
 insertion shaft 14 is enclosed with a cladding (not shown) suitable for
 endoscopic and laparoscopic use. FIG. 1 further illustrates that the
 invention shaft 14 is a two-part assembly comprising a rigid shaft 24
 integral with a second end of the handle 12 and a flexible shaft 26
 integral with the rigid shaft 24 and preferably coextending and continuous
 with the tubing means 21 and nozzle 22. The flexible shaft 26 includes a
 series of hinges 28 which are interconnected so as to enable the bending
 of the flexible shaft 26 in one direction and straightening of the
 flexible shaft 26 to its original position. Preferably, the hinges 28 are
 wedges pivotally interlocked at their tops and disposed laterally along
 one or both sides of the portion of the tubing means which is included
 within the flexible shaft 26. The present device further comprises a means
 for articulating the hinges 28 and flexible shaft through its bent and
 straightened positions which preferably includes a control or push/pull
 wire 30 connected at a first end at or in the nozzle 22 of the tubing
 means 21 and running through or along the tubing means to a control means
 32 within said handle 12 for controlling the articulation of the nozzle
 22. If the wire 30 runs through the tubing means 21, then the wire 30 and
 tubing means intersect at a manifold 31. This provides a juncture at which
 the wire 30 exits the tubing means 21 to engage the control means 32.
 Thus, the tubing means would comprise a wireless portion 21a and a wire
 containing portion 21b in fluid communication with each other via manifold
 31. Optionally, the control means can be a remote manually operated or
 foot pedal-operated system. The control means 32 preferably comprises a
 rack and pinion assembly comprising a rack 34 (or tooth-containing
 element) engaged with a rotable pinion or knob 36, such that rotation of
 the knob 36 extends or retracts the wire 30 which in turn articulates or
 straightens the flexible shaft 26. This articulation is illustrated in
 FIG. 2a and 2b. FIG. 2a illustrates the relative position of the hinges or
 wedges 28 when the wire 30 is retracted or withdrawn by the control knob
 (not shown). FIG. 2b illustrates the relative position of the hinges or
 wedges 28 when the wire (not shown) is extended by the control knob and
 the wedges and tubing (not shown) are allowed to fold down upon
 themselves. The degree of extension/retraction dictates the degree of
 articulation.
 FIG. 3 shows an end view of the nozzle 22 of the device of the present
 invention. The nozzle 22 includes outlets 38 corresponding by fluid
 communication via discrete channels in the tubing means to inlets 16, 18
 and 20. The outlets 38 for liquids and optionally a gas for spray are
 shown arranged within the end wedge 28 which preferably comprises wedges
 28a and 28b on either side of the so-arranged outlets 38 and further
 includes a bridging portion 28c. Preferably, the outlets 38 and attached
 end 40 of the wire 30 are incorporated within the preferred single tubing
 means 21b, although individual tubes can be employed. As can be seen the
 preferred tubing means 21 comprises the tubing means and having integral
 channels therein which terminate in the outlets 38 on the nozzle 22. The
 tube can be of any flexible material, e.g., plastic material, suitable for
 such medical purposes. The nozzle 22 can be a separate component or can
 just be the open end of the tube 21b. A cladding 42 can be placed around
 the entire nozzle/tubing assembly as shown and preferably extends the
 length of the insertion shaft 14, i.e., the rigid shaft 24 and the
 flexible shaft 26. The cladding can be of any convenient material utilized
 in endoscopic and laparoscopic devices.
 Preferably, this is a single patient use, disposable device. It is intended
 that the flexible shaft and the rigid shaft (typically, a total of about
 12 cm in length) are the parts of the device which are to be passed into
 and through the trocar. It is intended that the maximum cross sectional
 measurement of any part of the rigid or flexible shaft shall be chosen, so
 that the device can be used with commercially available trocars.
 Although any liquid components can be used, the present invention is
 particularly well-suited for surgical sealant, e.g., fibrin sealant
 application. A preferred sealant is disclosed by Edwardson et al. In EP
 592242 which employs a low pH4 fibrin monomer composition co-applied with
 a ph10 acetate buffer.