MXPA99008777A - Laparoscopic sealant applicator - Google Patents

Abstract

A laparoscopic applicator device (10) for the selective directional application of one or more liquids to a surgical site is disclosed. The device (10) comprises a handle (12) with liquid inlets (16, 18, 20) at one end, discrete channels within one or more tubes (21) connecting with said inlets (16, 18, 20) extending through said handle (12) to a nozzle (22), and a dual injection shaft (14) at the nozzle end for inserting the shaft (14) and nozzle (22) through a surgical trocar. The dual shaft (14) comprises a rigid portion immediately adjacent the handle (12) and a flexible portion near the nozzle tip. Means are provided preferably within the handle (12), for the controlled articulation of the flexible shaft (14)/nozzle (22) 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.

Description

LAPAROSCOPIC SEALER APPLICATOR CA PO AND BACKGROUND 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 insert laparoscopically and articulate in a desired direction towards a desired site. PCT / ÜS 96/19505, entitled "A method to apply a mixture of two liquid components," as well as a "Di sposi tive for the purpose of the method", presented on December 6, 1996, describes an applicator device for applying a surgical sealant, for example, a fibrin sealant, to a desired site. The applicator consists of a relatively thin multi-lumen tubing that is in fluid communication with sources of sealing components at one end and shape, or is connected to, a spray tip at the other end. In a preferred embodiment, the pipe runs through a handle at or near the end of ?F. 31370 the tip of the sprayer. The handle is the part of the instrument held by the surgeon to apply the sealant and may include an activation means to operate the sprayer from the sources of the components. Sealants will also be useful in laparoscopic procedures.

BRIEF DESCRIPTION OF THE FIGURES Figure 1 shows a cross-sectional, partial, lateral view of the laparoscopic applicator device of the present invention.

Figures 2a and 2b illustrate the inarticulate and fully articulated arrangement of wedges incorporated in the shaft.

BRIEF DESCRIPTION OF THE INVENTION In accordance with the present invention, a laparoscopic applicator device is described for the directional, selective application of one or more liquids to a surgical site. The device comprises a handle with liquid inlets at one end, discrete channels within one or more tubes which are connected to the inlets and extending through the handle to a nozzle, and a dual insertion shaft at the end of the tube. nozzle to insert the tree and the mouthpiece through a surgical trocar. The dual shaft comprises a stiff portion immediately adjacent to the handle and a flexible portion near the tip of the mouthpiece. Means are provided, preferably inside the handle, for the controlled articulation of the flexible shaft / nozzle assembly, thereby providing the application of the liquids in a desired direction. The present invention is particularly useful in the application of surgical sealants, for example, fibrin sealants. Methods for applying these components are also a part of the invention.

DETAILED DESCRIPTION OF THE PREFERRED MODALITY • 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, for example, a fibrin sealant and the present invention will be further described with respect to fibrin sealants. The device is designed to be used through a surgical trocar and facilitates the directional, selective application of fibrin sealants via the controlled articulation of a flexible portion of an insertion shaft, including a dispensing tip or spray nozzle. Figure 1 shows a device 10 of the present invention that 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 the inlets 16, 18, 20 for one or more sealant or liquid components and the gas component, optional where spraying is desired. Any number of entries can be provided. The inputs 16, 18, 20 are adapted to receive the liquid / gas components, and the sources (not shown) of the components can be directly adjacent to the inputs or they can be far from the inputs, but in fluid communication with the inputs via the supply pipe. A pipe means 21 extends from the inlets through the handle 12 and the insert shaft 14 to an applicator tip or nozzle 22. This provides that the liquid / gaseous components are distributed from the sources to and from the source. nozzle 22 preferably activated by a separate means that controls the actual flow of the liquid and gas. Preferably, the insertion shaft 14 is closed with a coating (not shown) suitable for endoscopic and laparoscopic use. Figure 1 further illustrates that the shaft 14 of the invention is a two-part assembly comprising a rigid tree 24 integral with a second end of the handle 12 of a flexible shaft 26 integral with the rigid shaft 24 and preferably co-extending and is continuous with the pipe means 21 and the nozzle 22. The flexible shaft 26 includes a series of hinges 28 which interconnect to allow bending of the flexible shaft 26 in one direction and the straightening of the flexible shaft 26 to its original position. Preferably, the hinges or hinges 28 are shims interlocked on a pivot in their upper parts and positioned laterally along one or both sides of the portion of the pipe means that is included within the flexible shaft 26. The present device additionally comprises means for articulating the hinges 28 and a flexible shaft through its curved and straightened positions preferably including a control or push / pull wire 30 connected to a first end in or to the nozzle 22 of the pipe means 21 and running at through or along the pipe means to a control means 32 within the handle 12 to control the nozzle joint 22. If the wire 20 runs through the pipe means 21, then the wire 30 and the pipe means are they cross in a manifold 31. This provides a junction in which the wire 30 leaves the pipe means 21 to couple the control means 32. In this way, the pipe means to 21a will comprise a wireless portion and a portion containing wire 21b in fluid communication with each other via the manifold 31. Optionally, the control means can be operated manually or operated by far a pedal system. The control means 32 preferably comprises a rack and pinion assembly comprising a rack 34 (or tooth-containing element) coupled with a rotatable pinion or button 36, such that the rotation of the button 36 extends or retracts the wire 30 at its it articulates or straightens the flexible shaft 26. This articulation is illustrated in Figure 2a and 2b. Figure 2a illustrates the relative position of the hinges 28 when the wire 30 is retracted or removed by the control button or knob (not shown). Figure 2b illustrates the relative position of the hinges or shims 28 when the wire (not shown) is extended by the control button and the shims and tubing (not shown) are allowed to bend downwardly by themselves. The degree of extension / retraction dictates the degree of articulation. Figure 3 shows a terminal view of the nozzle 22 of the device of the present invention. The nozzle 22 includes outlets 38 which correspond by communication for fluids via discrete channels in the pipe means to the inlets 16, 18 and 20. The outlets 38 for liquid and optionally a gas for the spray are shown arranged within the terminal block or , end 28 comprising preferential shims 28a and 28b on either side of the outlets 38 arranged in this manner and further includes a bridge portion 28c. Preferably, the outlets 38 and the joined end 40 of the wire 30 are interconnected within the individual, preferred pipe means 21b, although individual pipes may be employed. As can be seen, the preferred pipe means 21 comprises the pipe means and has integral channels therein that terminate at the outlets 38 in the nozzle 22. The pipe can be of any flexible material, for example, plastic material, suitable for these medical purposes. The nozzle 22 can be a separate component or it can be only the open end of the tube 21b. A liner 42 can be placed around the complete nozzle / pipe assembly as shown and preferably extends the length of the section tree 14, i.e., the rigid shaft 24 and the flexible shaft 26. The liner can be of any suitable material used in endoscopic and laparoscopic devices. Preferably, this is a disposable device, for use for an individual patient. It is intended that the flexible tree and the rigid tree (typically, a total of approximately 12 cm in length) are the parts of the device that will be passed to and through the trocar. It is proposed that the maximum cross-sectional measurement of any part of the flexible or rigid shaft should be governed, so that the device can be used with commercially available trocals. Although any liquid component can be used, the present invention is particularly well suited for surgical sealant, for example, application of fibrin sealant. A preferred sealant is described by Edwarson et al. In EP 592242 which employs a fibrin monomer composition of, under pH 4, co-applied with an acetate buffer of pH 10.

It is noted that in relation to this date, the best method known by the applicant to carry out the present invention, is the conventional one for the manufacture of the objects to which it refers.

Having described the invention as above, the content of the following is claimed as property:

Claims (10)

1. An applicator device for the laparoscopic, directional distribution of one or more liquid components to a surgical site, characterized in that it comprises: a handle having, at a first end, entries for fluid communication with sources of one or more liquid components; discrete channels corresponding to each of the inlets for each of the liquid components, the channels incorporated in a pipe means extending from the first end and through a handle to a second end of the handle where the channels form, or they are integral with, a • nozzle to distribute one or more liquid components to the surgical site; a two-part insertion shaft at the second end of the handle adapted to be insertable into a trocar, the insertion shaft comprising a rigid shaft integral with the handle and a flexible shaft integral with the rigid shaft, the flexible shaft being co-extensive and co-terminating with the nozzle and the pipe means, a means within the shaft for the controlled articulation of the flexible shaft, and thereby the nozzle, to provide distribution of one or more liquids in a desired direction in a surgical site.

2. The laparoscopic applicator device according to claim 1, characterized in that the means for the hinge comprises: (a) a series of interconnected hinge means, positioned laterally along the length of the pipe and nozzle means within the flexible shaft; (b) a push / pull wire connected to and extending from the nozzle end of the pipe means, through or along the pipe means or towards the handle, and (c) a control means within the handle connected to a second part of the push / pull wire such that the actuation of the control means provides the desired degree of articulation in the flexible shaft to apply one or more liquids in a desired direction.

3. The laparoscopic applicator according to claim 2, characterized in that the hinge means comprises shims of a rigid material placed along the length of the pipe means comprising the flexible shaft.

4. The laparoscopic applicator according to claim 2, characterized in that the control means comprises an integral rack and pinion assembly with the second end of the push / pull wire and a control button or actuator.

5. The laparoscopic applicator according to claim 1, characterized in that the sources of one or more liquids can be located directly adjacent to the inlets or can be removed from the inlets and in fluid communication with the inlets via a supply line.

6. The laparoscopic applicator according to claim 1, characterized in that one or more liquids are components to form a liquid sealant.

7. The laparoscopic applicator according to claim 6, characterized in that the sealant is a fibrin sealant.

8. The laparoscopic applicator according to claim 7, characterized in that the components comprise a fibrinogen component and a component capable of catalyzing the cleavage of fibrinopeptides A and / or B of fibrinogen.

9. The laparoscopic applicator according to claim 7, characterized in that the components comprise a fibrin component and a component capable of polymerizing the fibrin monomer.

10. The laparoscopic applicator according to claim 6, characterized in that a gas is incorporated to spray the sealant.