LIQUID APPLICATOR

Abstract

A liquid applicator (1) for holding and discharging a curable liquid composition, comprises a receiver body (2) for holding a curable liquid composition, a discharge tip (20;30;40) having a longitudinal axis and further having a distal end remote from the receiver body (2) from which the liquid composition is discharged, and a discharge mechanism (5) for transferring liquid composition held by the applicator (1) to the tip (20;30;40) for discharge of the composition. The tip (20;30;40) comprises an outlet section (21d;31d;44d) having at least one groove formation (26;38;48) extending along the tip (20;30;40) to the distal end thereof. The applicator may be a surgical adhesive applicator.

Claims

1-25. (canceled)

26. A liquid applicator for holding and discharging a curable liquid composition, the applicator comprising: a receiver body for holding a curable liquid composition, a discharge tip having a longitudinal axis and further having a distal end remote from the receiver body from which the liquid composition is discharged, and a discharge mechanism for transferring liquid composition held by the applicator to the tip for discharge of the composition, wherein the tip comprises an outlet section having at least one groove formation extending along the tip to the distal end thereof.

27. The applicator as claimed in claim 26 wherein said at least one groove formation has a longitudinal axis parallel to the longitudinal axis of the tip.

28. The applicator as claimed in claim 27 wherein a plurality of said groove formations are provided.

29. The applicator as claimed in claim 28 wherein said groove formations have their longitudinal axis equiangularly spaced around the longitudinal axis of the tip.

30. The applicator as claimed in claim 29 wherein the tip has a bore extending through the tip to the distal end thereof and the groove formations are formed in the interior wall of the bore.

31. The applicator as claimed in claim 30 wherein the bore has an upstream section of constant cross-section and a downstream section in which said groove formations are provided.

32. The applicator as claimed in claim 31 wherein the groove formations are arcuate in transverse cross-section.

33. The applicator as claimed in claim 31 wherein the upstream ends of groove formations are defined by shoulders lying in a plane at right angles to the direction of flow of the liquid composition through the tip.

34. The applicator as claimed in claim 27 wherein said tip has an upstream section provided with a bore and a downstream section providing the outlet section and in the exterior of which the groove formations are provided, said groove formations each being associated with an aperture providing communication between a groove and the bore.

35. The applicator as claimed in claim 34 wherein an aperture is provided at least partly in the base of each of the groove formations.

36. The applicator as claimed in claim 35 wherein the groove formations are arcuate as seen in cross-section transverse to the direction of flow of liquid adhesive composition and each aperture provided extends partly up the arcuate side walls of the groove formations.

37. The applicator as claimed in claim 26 wherein the tip comprises a low surface energy material.

38. The applicator as claimed in claim 37 wherein the low surface energy material is a fluorinated polymer or an acetal plastics material.

39. The applicator as claimed in claim 26 adapted to deliver successive droplets of curable liquid composition.

40. The applicator as claimed in claim 39 comprising a trigger mechanism configured to effect said successive discharge of droplets.

41. The applicator as claimed in claim 26 having an elongate cannula through which the adhesive composition is discharged and at the end of which the tip is mounted.

42. The applicator as claimed in claim 26 for use in laparoscopic surgery.

43. The applicator as claimed in claim 26 charged with curable adhesive composition.

44. The applicator as claimed in claim 43 wherein the curable adhesive composition is a cyanoacrylate adhesive composition.

45. The applicator as claimed in claim 43 wherein the curable adhesive composition comprises n-butyl cyanoacrylate.

Description

[0052] The invention will be further described, by way of example only, with reference to the accompanying drawings, in which:

[0053] FIG. 1 shows a commercially available surgical adhesive applicator;

[0054] FIG. 2 shows views of a conventional applicator tip as supplied with the applicator shown in FIG. 1;

[0055] FIG. 3 shows views of a first embodiment of applicator tip for use in accordance with the invention.

[0056] FIG. 4 shows views of a second embodiment of applicator tip for use in accordance with the invention; and

[0057] FIG. 5 shows views of a third embodiment of applicator tip for use in accordance with the invention.

[0058] Illustrated in FIG. 1 is an adhesive applicator 1 sold by Advanced Medical Solutions (Plymouth) Ltd under the trade mark LIQUIBAND? FIX8? for use in fixing a support mesh (usually of polypropylene) in place during a hernia repair operation, particularly such an operation effected laparoscopically. The LIQUIBAND? FIX8? device is intended for use in a single hernia repair operation during which a plurality of drops of curable cyanoacrylate adhesive composition are selectively and successively discharged to fix the mesh in position. The illustrated applicator 1 is of the type disclosed in WO 2014/072688 and WO 2014/072689 the disclosure of which is hereby incorporated by reference and to which reference may be made for full details as to the manner in which the applicator 1 is constructed and operated. However, in brief, applicator 1 comprises a body unit 2, an elongate cannula 3 extending from the body unit 2 and provided at its free distal end with an applicator tip 4, and further provided with a trigger mechanism 5. Although not illustrated in FIG. 1, cannula 3 has a liner tube of a fluorinated polymer which extends along cannula 3 from its proximal end within body unit 2 into the bore of the applicator tip 4 to a position level with the free distal end of tip 4. As supplied, the FIX8? device includes in the body unit 2 thereof a frangible ampoule (not shown) containing a liquid adhesive composition incorporating a curable cyanoacrylate adhesive composition which is curable on contact with patient tissue to which the aforementioned support mesh is to be adhered. Provided on and within the body unit 2 are mechanisms which allow the ampoule to be fractured to release the adhesive and then to allow the cannula 3 (or more specifically the fluorinated liner tube) to be primed more-or-less along its full length with adhesive so that operation of the trigger mechanism 5 allows (for each such operation) discharge from the tip 4 of a droplet of liquid adhesive of a fixed volume (about 10-15 ?l). The amount of adhesive supplied with the FIX8? applicator is sufficient for discharge of about 33 droplets of adhesive.

[0059] During a hernia repair operation, the aforementioned mesh is located in position against the patient's internal tissue to be repaired and droplets of adhesive (discharged as briefly described above by operation of trigger mechanism 5) are applied to the junctions of the mesh (on the side remote from patient tissue) so that adhesive can flow over the junction and into contact with the tissue (to form an adhesive anchor) and cure, whereby the mesh becomes bonded to the tissue.

[0060] The tip 4 currently supplied with the FIX8? device is shown in FIG. 2 and will be seen to comprise a tubular body 11 with an inwardly converging inlet 12 and an outlet 13 connected by a bore 14 which is of uniform, circular cross-section along its length from the downstream end of converging inlet 12 to the outlet 13. The provision of the inwardly converging inlet 12 facilitates insertion of the aforementioned fluorinated liner tube into the tip 4.

[0061] Body 11 is provided approximately mid-way along its length with an external annular shoulder 15 which sub-divides body 11 into upstream and downstream sections 11u and 11d respectively. Upstream section 11u is for location within the distal end of cannula 3 such that annular shoulder 15 abuts against the distal end of cannula 3 with the downstream end 11d projecting beyond the end of cannula 3.

[0062] Tip 4 as supplied with the FIX8? device has the dimensions shown in Table 1 below.

TABLE-US-00001 TABLE 1 Length of body 11 20 mm Length of upstream section 11u 10 mm Length of downstream section 11d 10 mm Outside diameter of upstream section 11u 5 mm Height of shoulder 15 0.9 mm Diameter of bore 14 1.85 mm

[0063] As indicated in Table 1, bore 14 has an internal diameter of about 1.85 mm. This allows small quantities of adhesive to be applied (about 13 ?l with each activation of the trigger mechanism 5), which is advantageous since cyanoacrylate is known to interfere with natural healing at the immediate point of contact with patient tissue. Therefore, for internal applications, it has been found that controlling and minimising the amount of adhesive applied is critical. However, due to the high moisture content of internal tissues, coupled with the narrow diameter of bore 14, issues arise with the interior of the tip becoming blocked with polymerised cyanoacrylate material (and also polymerised cyanoacrylate around the exterior of the distal end of the tip 4). If the blockage cannot be cleared then the applicator cannot be used for further application of adhesive.

[0064] Reference is now made to FIG. 3 which illustrates an embodiment of tip 20 which is for use in an applicator in accordance with the invention and which has been found significantly to reduce problems associated with blockage from polymerised cyanoacrylate. Thus, for example, tip 20 may be used in the FIX8? device in place of the tip 4 described with reference to FIG. 2. The illustrated tip 20 has some general similarity with tip 4 and as such comprises a generally tubular body 21 having an inwardly converging inlet 22 and an outlet 23 connected by a bore 24 that extends from the downstream end of inwardly converging inlet 22 to the outlet 23. Body 21 is provided with an external annular shoulder 25 which, in effect, sub-divides body 21 into upstream and downstream sections 21u and 21d whereof the former is of lower external diameter than the latter. Upstream body section 21u locates in the distal end of cannula 3 with the shoulder 25 locating against the distal end of cannula 3.

[0065] Formed in the wall of the bore 24 are four axially parallel, equiangularly spaced grooves 26 that extend from a location about halfway along downstream body section 21d to the outlet 23. More specifically, the groves 26 extend in the downstream direction (to the outlet 23) from respective upstream end faces 27 formed as a result of the grooves 26 being moulded in the walls of block 24. Grooves 26 are generally semi-circular as seen in transverse cross-section (i.e. in a plane at right angles to the longitudinal axis of tip 20) and their configuration is best seen in the cut-away sectional view (which is to a much enlarged scale) in the lowermost drawing of FIG. 3.

[0066] Tip 20 may have the dimensions shown in Table 2 below.

TABLE-US-00002 TABLE 2 Length of body 21 20 mm Length of upstream section 21u 10 mm Length of downstream section 21d 10 mm Outside diameter of upstream section 21u 5 mm Height of shoulder 25 0.9 mm Diameter of bore 24 1.85 mm Lengths of grooves 26 5 mm Radius of grooves 26 0.5 mm with centre positioned 0.8 mm from centre of distal tip

[0067] FIG. 4 illustrates a further embodiment of tip 30 that may be used in an applicator in accordance with the invention to alleviate the above described blockage problems. Tip 30 has some similarity in overall construction with tip 20 and therefore, for convenience parts in tip 30 that have a counterpart in tip 20 are designated by a reference with the same final numeral and ten more than the corresponding numeral in FIG. 3. Thus, for example, the body of tip 30 is referenced as 31 (cf body 21 of tip 20). Also, for convenience, description of the like parts is not repeated.

[0068] In contrast with the embodiment of applicator tip 20 illustrated in FIG. 3, the applicator tip 30 is provided with external grooves 38 extending parallel to the longitudinal axis of tip 30 and being open along their length at the outer surface of tip 30. Each groove 38 is generally arcuate in transverse cross-section and extends between the distal end 33 of tip 30 and a respective wall 39 at the upstream end of groove 38. Over their lengths, the upper edges of grooves 38 rise slightly in going from distal end 33 to wall 39 whereby the grooves 38 increase in depth in going in this direction. Formed in the base of each groove 38 at the upstream end thereof (and extending part way up the lateral surfaces of the grooves) are respective apertures 39 that provide communication with the bore 34, which in this embodiment extends from the downstream end of inwardly converging inlet section 34 to the downstream ends of apertures 38. Thus, when tip 30 is located in the end of cannula 3 of applicator 1 and the applicator is primed with adhesive, operation of trigger mechanism 5 causes adhesive to pass into bore 34 of tip 30 and then via apertures 39 into the grooves 38 for discharge from tip 30.

[0069] Tip 30 may have the dimensions shown in Table 3 below.

TABLE-US-00003 TABLE 3 Length of body 31 20 mm Length of upstream section 31u 10 mm Length of downstream section 31d 10 mm Outside diameter of upstream section 31u 5 mm Height of shoulder 35 0.9 mm Diameter of bore 34 1.85 mm Lengths of grooves 38 5 mm Radius of grooves 38 0.75 mm radius with the centre positioned 1.3 mm from the centre of the distal tip

[0070] A further embodiment of tip 40 is illustrated in FIG. 5 and, like tip 30 shown in FIG. 4, is provided with external grooves referred as 48, although in this case the grooves 48 are of constant depth along their length is going from distal end 43 of tip 40 to end face 49. Tip 40 includes a stepped bore shown as having an upstream section 44u and narrower downstream section 44d which extends a short distance beyond the upstream ends of grooves 48. Provided on the base of each groove 48 of the upstream end is a respective aperture 39 providing communication between a groove 38 and the downstream section 44d of the bore.

[0071] Tip 4 may have the dimensions shown in Table 4 below.

TABLE-US-00004 TABLE 4 Length of body 41 23 mm Diameter of upstream bore section 44u 3.2 mm Diameter of downstream bore section 44d 4.53 mm Lengths of grooves 48 7.68 mm Radius of grooves 48 0.6 mm with the centre positioned 1.35 mm from the centre of the distal tip

[0072] To demonstrate the effectiveness of the invention, samples of tips as shown in FIGS. 2-5 and having the dimensions indicated in the respective Tables above were manufactured from PTFE and further samples were manufacture from a Class VI acetal plastics material (Delrin?). The various tips were tested for their blockage characteristics using a test rig reliably simulating the delivery characteristics of the FIX8 device (repeated delivery of ca 13 ?l droplets of a curable cyanoacrylate adhesive composition as supplied with the device). In all tests, the adhesive composition was delivered to the tips through a fluorinated polymer tube of the type used in the FIX8 device. The tube was inserted into the upstream end of the tip and extended to a position 5 mm from the discharge end of the tip.

[0073] The tests involved bonding a polypropylene mesh (of the type used in a hernia fixation operation) to chicken tissue using the various tips at angles of 90? to the horizontal (i.e. tip pointing vertically downwards), 60? to the horizontal (tip inclined downwardly), and 75? to the vertical (tip inclined upwards).

[0074] For each tip at each angle, the test was conducted using the following procedure.

[0075] (A) An adhesive anchor (provided by a droplet of adhesive) was expressed on to the mesh/chicken tissue surface.

[0076] (B) After each anchor application, the mesh was pushed and held in place using the tip for 10 seconds.

[0077] (C) After a wait of 20 seconds, the next adhesive anchor was deployed.

[0078] (D) The rate of adhesive delivery was such that at least 5 anchors were delivered within 2 minutes.

[0079] (E) The tip was observed for blockage due to debris accumulation after each adhesive anchor delivery.

[0080] (F) After deployment of every 3 adhesive anchors, the tip was subjected to the moist surface on the chicken tissue for 10 seconds.

[0081] (G) Steps (A)-(F) were repeated until at least 33 anchors had been expressed onto the mesh/chicken sample or until tip blockage (whichever occurred earlier).

[0082] As a result of the tests, it was found that tips of the type shown in FIG. 2 and made from either PTFE or acetal plastics material were prone to blockage that could not be cleared before 33 anchors had been expressed.

[0083] The tip shown in FIG. 3 and made of acetal plastics material provided the best results of all tips tested and was able to deliver adhesive composition for the required minimum of 33 anchors even though debris had accumulated around the tip. In the case of the tip of FIG. 3 made from PTFE, accumulated debris blocked the tip but the block was clearly visible and could easily be removed to restore the flow of adhesive to allow expression of the minimum 33 anchors.

[0084] In the case of the tips shown in FIGS. 4 and 5 (for both PTFE and acetal plastics) it was found that the adhesive bleed holes did not block completely but debris did accumulate on the four external grooves. The debris could easily be removed to allow continued flow of adhesive but it was observed there was some difficulty in detecting whether or not adhesive reached the target site due to the accumulation of debris at the tip.