Kit for applying an adhesive composition onto a substrate

Abstract

An applicator (1) comprising: a body (2) defining a chamber (14) for storing an adhesive composition and an outlet (16) for delivering the adhesive composition stored in the chamber (14); a piston (4) translatable relative to the body (2); and a drive element (6) rotatable relative to the body (2), the drive element (6) being configured to detachably engage with a guide (100, 200, 300) on the exterior of the applicator (1), wherein the piston (4) translates relative to the body (2) so that rotating the drive element (6) relative to the body (2) reduces the volume of the chamber (14) and pushes the adhesive composition out of the applicator (1) through the outlet (16).

Description

[Technical Field]

[0001] The present disclosure relates to a kit for applying an adhesive composition to a support such as any substrate having a surface, more particularly to a tissue repair support such as a surgical patch, e.g., a hernia mesh. To handle. [Background technology]

[0002] A hernia occurs when an organ, intestine, or fatty tissue pushes through a hole or weakness in the surrounding muscle or connective tissue. Hernias often occur in the abdominal wall. They may appear as a bulge, especially when strained or compressed.

[0003] Hernia mesh is a surgical patch that provides support for the surrounding damaged tissue as the hernia heals. The handling of hernia mesh and the poor visibility during mesh implantation and fixation, combined with the poor usability and ergonomic limitations of laparoscopic instruments, make it a challenging task for surgeons. Once the mesh is placed at the hernia site, it is secured in place using appropriate attachment means, such as sutures, tacks, staples, or tissue adhesives, to prevent bending or migration.

[0004] Fixation using sutures or staples has been reported to lead to nerve damage and acute and chronic postoperative pain. These complications have led surgeons to evaluate non-invasive fixation methods, such as the use of human fibrin glues (e.g., Tissucol / Tisseel fibrin glue (Baxter Healthcare, Deerfield, IL, USA)).

[0005] If the adhesive is not applied correctly to the mesh, the mesh may not be properly positioned and secured in the target area. In particular, the surgeon may apply too much adhesive in some areas and not enough adhesive in others, which is undesirable.

[0006] Another solution is Adhesix, a mesh coated with a layer of polyvinylpyrrolidone (PVP) and PEG. TM Self-fixating meshes such as

[0007] Also, WO 2017 / 195198 describes a mesh coated with a cross-linkable protein or polypeptide, such as gelatin, using an enzymatic cross-linking agent such as transglutaminase, and U.S. Pat. No. 9,427,298 describes a textile implant having a surface at least partially coated with a bioadhesive composition that is activatable in a moist or humid medium.

[0008] In surgery, meshes, including meshes coated with a fixative (such as an adhesive), are preferably inserted using a trocar having a diameter of about 10 mm to 12 mm, with the rolled mesh placed inside. This may require applying the fixative onto the mesh using a specific pattern, with specific spacing and design. Therefore, it would be desirable to have an instrument capable of producing this type of coated support. Summary of the Invention

[0009] An object of the present disclosure is to reliably apply an adhesive composition to a support such as any substrate having a surface, more particularly to a tissue repair support such as a surgical patch, surgical mesh, surgical film, etc., in a reproducible, standardized, uniform and easy manner.

[0010] The purpose of this is to a body defining a chamber for storing an adhesive composition and an outlet for dispensing the adhesive composition stored in the chamber; a piston translatable relative to the body; This is achieved by an applicator comprising a drive element rotatable relative to the body, the drive element configured to releasably engage with a guide on the exterior of the applicator, and a piston that translates relative to the body so that rotating the drive element relative to the body reduces the volume of the chamber and forces the adhesive composition out of the applicator through the outlet.

[0011] The applicator may, insofar as technically possible, include any of the features defined below, either alone or in any combination.

[0012] The applicator may be configured to expel the adhesive composition out of the applicator through the outlet at a rate proportional to the rotational speed of the drive element relative to the body.

[0013] The outlet may be arranged to deliver the adhesive composition in a direction parallel to an axis of rotation of the drive element relative to the body.

[0014] The piston may be translatable relative to the body in a direction parallel to an axis of rotation of the drive element relative to the body.

[0015] The body may define a passageway connecting the chamber and the outlet, and the drive element may extend around the passageway.

[0016] The drive element may include a pinion meshable with a rack on the exterior of the applicator.

[0017] The applicator may include a grip that allows a user to hold the applicator, and the drive element may be located between the outlet and the grip.

[0018] The applicator may further include a first threaded portion, and the drive element may have a second threaded portion that engages with the first threaded portion, and by rotating the second threaded portion relative to the first threaded portion, the piston may translate relative to the body.

[0019] The applicator may include a grip portion that allows a user to hold the applicator, and a pusher having a first threaded portion, the pusher being slidably attached to the grip portion.

[0020] The applicator may comprise a prevention means for preventing rotation of the body relative to the pusher about the translational axis of the piston relative to the body.

[0021] The body and piston may form a syringe that is a replaceable part of the applicator.

[0022] The applicator may further include an adhesive composition.

[0023] The adhesive composition may be a photocurable compound.

[0024] A kit for applying an adhesive composition onto a substrate may include a guide and the applicator described above, wherein the applicator and guide are configurable into an engagement configuration in which the drive element engages with the guide and the outlet faces the substrate, and while the guide and applicator are in the engagement configuration, moving the drive element along the guide causes the drive element to rotate relative to the body.

[0025] The guide may include a rack mateable with the drive element while the guide and applicator are in the engaged configuration.

[0026] The guide may define a slot that exposes an elongated region of the support when the guide is over the support.

[0027] The applicator may include a mouthpiece defining the outlet and capable of extending into the slot while the applicator and guide are in the engaged configuration.

[0028] The guide may include a guide wall extending along the slot and may be configured such that the outlet is aligned with the slot when the drive element is moved along the guide wall while the guide and applicator are in the engaged configuration.

[0029] The guide wall may include a rack mateable with the drive element while the guide and applicator are in the engaged configuration.

[0030] The slot may extend for at least 180 degrees around a point and / or may form part of a loop extending around a point.

[0031] The guide may define a plurality of holes including the first slot, the plurality of holes forming a loop extending about a point.

[0032] The guide may further define a plurality of holes forming a second loop extending about the point, the loop and the second loop being concentric.

[0033] The guide may include a central hole that exposes another area of ​​the support when the guide is over the support, and the point may be the center of the central hole.

[0034] The guide may include a second guide wall extending along the slot, and the drive element may be located between the guide wall and the second guide wall while the guide and applicator are in the engaged configuration.

[0035] The guide may define a second slot that exposes a second elongated region of the support when the guide is over the support, and the guide may include a second guide wall extending along the second slot, and the outlet may be configured to align with the second slot when the drive element is moved along the second guide wall while the applicator and guide are in the engaged configuration.

[0036] The second guide wall may be located between the slot and the second slot.

[0037] The kit may further include a support, which may be a surgical mesh such as a hernia mesh.

[0038] The kit may further include a container that houses the support and guide to be assembled together.

[0039] Also proposed is a method for applying an adhesive composition onto a substrate using the above-described kit, the method comprising the steps of placing the applicator and guide in an engaged configuration, and, while the guide and applicator are in the engaged configuration, moving the drive element along the guide so as to rotate the drive element relative to the body. [Brief explanation of the drawings]

[0040] Further details, features and advantages are explained in more detail below using exemplary embodiments shown in the drawings.

[0041] [Figure 1] 1 is a perspective view of an applicator according to a first embodiment. FIG. [Figure 2] FIG. 2 is a side view of the applicator shown in FIG. 1. [Figure 3] 2 is a perspective view of the body of the applicator shown in FIG. 1. FIG. [Figure 4] 2 is a cross-sectional view of the drive element of the applicator shown in FIG. 1. [Figure 5] 2 is a cross-sectional view of a grip portion of the applicator shown in FIG. 1. FIG. [Figure 6] FIG. 6 is a perspective view of the gripping portion shown in FIG. 5. [Figure 7] 2A-2C illustrate different parts of the applicator shown in FIG. 1; [Figure 8] FIG. 3 is a cross-sectional view taken along line AA shown in FIG. 2. [Figure 9] 2 is a top view of a kit including the applicator shown in FIG. 1 and a guide according to the first embodiment. [Figure 10] FIG. 10 is a perspective view of the kit shown in FIG. 9. [Figure 11] FIG. 10 is a cross-sectional view of the kit shown in FIG. [Figure 12] 2 is a top view of a kit including the applicator shown in FIG. 1 and a guide according to a second embodiment. [Figure 13] FIG. 13 is a perspective view of the kit shown in FIG. 12. [Figure 14]10 is a top view of a kit including an applicator similar to that shown in FIG. 1 and a guide according to a third embodiment. [Figure 15] FIG. 10 is a bottom view of the applicator according to the second embodiment. [Figure 16] FIG. 10 is a perspective view of a kit including an applicator according to a third embodiment and a guide according to a third embodiment. [Figure 17] 17 is another view of the kit of FIG. 16 showing the interior of the applicator according to the third embodiment. [Figure 18] FIG. 10 is a perspective view of a kit including an applicator according to the fourth embodiment and a guide according to the third embodiment. [Figure 19] 17 is another view of the kit of FIG. 16 showing the interior of the applicator according to the fourth embodiment. [Figure 20] FIG. 13 is a perspective view of a particular embodiment of a body without tabs and including two topographical elements that prevent the syringe from rotating when engaged. [Figure 21] FIG. [Figure 22] 4 is another view of the particular embodiment of the locking pin of FIG. 3 in place on the outlet luer lock cap. [Figure 23] FIG. 10 is a side view of a particular embodiment with the pusher in a closed position. DETAILED DESCRIPTION OF THE INVENTION

[0042] 1) The applicator 1 and 2, an applicator 1 according to one embodiment comprises a body 2, a piston 4, a drive element 6, a grip 8, and a pusher 10.

[0043] As shown in more detail in FIG. 3, the body 2 is an elongate body extending along a longitudinal axis X from its distal end to its proximal end.

[0044] The body 2 includes a cylinder 12 that defines a chamber 14 for storing an adhesive composition (which will be described in more detail below). The chamber 14 may have a volume of 0.1 to 500 ml, preferably 1 to 50 ml, for example 3 ml.

[0045] The body 2 further includes an outlet 16 for dispensing the adhesive composition stored in the chamber 14 from the applicator 1 .

[0046] The outlet 16 is axially arranged at the distal end of the body 2. The adhesive composition therefore flows in a direction parallel to the longitudinal axis X when it leaves the applicator through the outlet 16. According to one particular embodiment, the outlet 16 is a luer lock outlet, which may further comprise a cap when the applicator is not in use. In this case, the applicator advantageously further comprises a locking pin that prevents the drive element from rotating while unscrewing the luer lock cap (Figures 21 and 22).

[0047] The body 2 further includes a mouthpiece 18 that defines a passageway 20 connecting the chamber 14 and the outlet 16. The outlet 16 actually forms the distal opening of the passageway 20 (and of the applicator 1).

[0048] The mouthpiece 18 has a smaller diameter than the cylinder 12 .

[0049] The chamber 14, the outlet 16, and the passage 20 extend along the longitudinal axis X. The passage 20 is linear. The passage is located between the chamber 14 and the outlet 16. Thus, the adhesive composition stored in the chamber 14 flows in a direction parallel to the longitudinal axis X to reach the outlet 16 and exit the applicator 1.

[0050] The body 2 further includes an inlet 22 on the opposite side of the chamber 14 from the outlet 16. The inlet 22 is defined by the cylinder 12 at the proximal end of the body 2.

[0051] The body 2 further comprises two tabs 24, 25 that project radially from the outer surface of the cylinder 12. The tabs 24, 25 face each other relative to the cylinder 12. According to an alternative embodiment, these two tabs are absent and are replaced by round tab collars (see Figure 20).

[0052] The piston 4 is translatable relative to the body 2 in a direction coaxial with the longitudinal axis X. When the piston 4 is inserted into the cylinder 12 through the inlet 22, it actually defines a chamber 14. As the piston 4 translates relative to the body 2 towards the outlet 16, the volume of the chamber 14 decreases. This causes the adhesive composition stored in the chamber 14 to flow out of the chamber 14, through the passage 20, and then out of the applicator 1 through the outlet 16. As the piston 4 moves away from the outlet 16, the volume of the chamber 14 increases.

[0053] The body 2 and piston 4 form a medical device such as a syringe, which is a replaceable part of the applicator 1 independent of the drive part 6, grip part 8, and pusher 10. It can therefore be replaced with another syringe.

[0054] Referring now to FIG. 4, the drive element 6 includes a tube 26 extending about a longitudinal axis X.

[0055] Tube 26 has an inner surface 28 and an outer surface 30 opposite inner surface 28. Inner surface 28 defines a cylindrical cavity 32.

[0056] The tube 26 has two opposing openings, a distal opening 34 and a proximal opening 36, that communicate with the cavity 32. The cylinder 12 can be positioned so that it is inserted into the cavity 32 of the tube 26 through the proximal opening 36, with the mouthpiece 18 protruding from the drive element 6 through the distal opening 34.

[0057] The drive element 6 further includes a threaded portion 38. The threaded portion 38 is formed on the outer surface 30 of the tube 26. The threaded portion 38 extends from the proximal opening 36.

[0058] The drive element 6 further comprises a wheel 40 fixed to the tube 26. The wheel 40 and the tube 26 are coaxial (about the longitudinal axis X). The wheel 40 forms a collar around the distal opening 34 and around the tube 26. The wheel 40 therefore has a diameter greater than the diameter of the outer surface 30.

[0059] The distal opening 34 is provided in the wheel 40 .

[0060] The distal opening 34 has a smaller diameter than the cylinder 12. Thus, when the body 2 is inserted into the tube 26, the cylinder 12 abuts against the wheel 40.

[0061] In the embodiment shown in Figure 4, the wheel 40 is actually a pinion. The pinion 40 has teeth on its outer periphery.

[0062] The drive element 6 further includes a rib 42 projecting from the outer surface 30. The rib 42 is located between the threaded portion 38 and the pinion 40. The rib may form a collar that extends around the tube 26.

[0063] 5 and 6, the handle portion 8 of the applicator 1 includes a tube 44 extending about a longitudinal axis X.

[0064] The tube 44 has an inner surface 46 and an outer surface 48 opposite the inner surface 46. The inner surface 46 defines an interior cavity 50. The outer surface 48 is the free surface of the applicator 1. The outer surface can be grasped by a user's hand.

[0065] The tube 44 has two opposing openings, a distal opening 52 and a proximal opening 54 , which communicate with the cavity 50 .

[0066] The tube 26 of the drive element 6 can be inserted into the second tube 44 through the distal opening 52 so that both tubes are coaxial and freely rotatable relative to each other about a common axis. As a result, the drive element 6 is rotatably mounted to the grip portion 8.

[0067] The inner surface 46 defines a recess 56 that can accommodate the rib 42 when the tube 26 of the drive element 6 is inserted into the tube 44 of the gripping portion 8. The recess 56 may form a groove that extends around the periphery of the cavity 50. The recess 56 and the rib 42 form a locking means that prevents the drive element 6 from moving relative to the gripping portion 8.

[0068] The diameter of the inner surface 46 is greater than the diameter of the outer diameter 30 of the tube 26 so as to provide an annular gap in the cavity 50 between the tubes 26, 44. In particular, the threads 38 widen this annular gap.

[0069] The gripping portion 8 may further include two tabs 58, 59 that project radially from the inner surface 46. These two tabs 58, 59 actually define the proximal opening 54 therebetween. These two tabs may be replaced by collar tabs that project radially from the inner surface 46.

[0070] The proximal opening 54 has a central portion and two peripheral portions that face each other across the central portion. The central portion is circular and has a diameter that is substantially equal to the outer diameter of the cylinder 12 and substantially equal to the diameter of the inner surface 28.

[0071] The gripping portion 8 further has a plurality of protrusions 60 protruding from the tabs 58, 59 in a direction parallel to the axis of the tubular body 44. The plurality of protrusions 60 includes two first protrusions protruding from the tab 58 and two second protrusions protruding from the tab 59. The two first protrusions and the tab 58 form a first recess capable of receiving the tab 24, and the two second protrusions and the tab 59 form a second recess capable of receiving the tab 25 (or vice versa). The design and number of the protrusions can be adapted to the design of the tabs 24 and 25 or the round tab collar (FIG. 20). For example, they may include a topographical element that prevents the syringe from rotating when engaged.

[0072] The drive element 6 is locked to the grip portion 8 by the recess 56 and the rib 42. The central portion of the proximal opening 54 is aligned with the proximal opening 36 of the drive element 6. Furthermore, the wheel 40 is located outside the grip portion 8. Therefore, the wheel can engage with a guide on the outside of the applicator 1 (this guide will be described in more detail later). Furthermore, the drive element 6 can rotate freely relative to the grip portion 8.

[0073] The body 2 can be inserted through the proximal opening into the grip part 8 and further into the drive element 6 locked therein. During this insertion, the body 2 reaches a position in two recesses defined by a plurality of protrusions 60, where the tabs 24, 25 of the body 2 abut against the tabs 58, 59 of the grip part 8. As a result, the tabs 24, 25, 58, 59 and the protrusions 60 form a prevention means for preventing the body 2 from rotating relative to the grip part 8. However, other prevention means for performing this function can also be used.

[0074] 7, the pusher 10 includes a base 62 and two legs 64, 66 protruding from the base 62. The legs 64, 66 have two opposing inner surfaces separated by a space. A piston is housed in this space.

[0075] The pusher 10 has a threaded portion 68. The threaded portion 68 is formed on the inner surfaces of the two legs 64, 66.

[0076] When the body 2 is locked to the gripper 8 and the piston 4 is inserted into the cylinder 12, the two legs 64, 66 are inserted from the two peripheries of the proximal opening 54 into the annular gap remaining between the gripper 8 and the drive element 6, and the threads 68 engage the threads 38. The tabs 58, 59 form a means for preventing the pusher from rotating relative to the gripper 8 (although other means may alternatively be used for this function). As a result, the pusher 10 is slidably mounted to the gripper 8. Rotation of the threads 38 relative to the threads 68 causes the pusher 10 to translate relative to the gripper 8 in a direction parallel to the longitudinal axis X.

[0077] 1, the gripper 8 and the pusher 10 together form a housing that contains the piston 4 and the body 2. The pusher 10 prevents the piston 4 from moving out of the body 2 because the base 62 abuts the piston 4.

[0078] According to a particular embodiment, the pusher 10 is closed all around and does not have legs 64 and 66 (FIG. 23). A thread 68 is formed on the inner surface of the closed pusher, which provides the main advantages of blocking light and preventing deformation of the pusher and piston.

[0079] When the body 2, piston 4, drive element 6, grip 8, and pusher 10 are assembled as described above, the applicator 1 is formed, as shown in FIG.

[0080] 2) Adhesive composition The chamber 14 is filled with an adhesive composition.

[0081] Preferably, the adhesive composition is a photocurable compound. "Photocurable compound" refers to a compound that is configured to polymerize or otherwise harden upon exposure to radiant energy, particularly radiant energy that is light from a light source.

[0082] The photocurable compound may include a prepolymer and a photoinitiator, which is capable of inducing polymerization of the prepolymer when irradiated with light of a particular wavelength.

[0083] According to certain embodiments, the photoinitiator is sensitive to ultraviolet (UV) radiation.

[0084] Examples of suitable prepolymers include, but are not limited to, the prepolymers described in U.S. Pat. No. 10,179,195 or WO 2016 / 202984 or WO 2016 / 202985.

[0085] Preferably, the polymer backbone of the prepolymer is composed of polymer units of the general formula (-AB-)n, where A is a derivative of a substituted or unsubstituted polyol or mixture thereof, B is a derivative of a substituted or unsubstituted polyacid or mixture thereof, and n is an integer greater than 1. The polymer backbone is composed of repeating monomer units of the general formula -AB-. The term "substituted" has its usual meaning in chemical nomenclature and is used to describe compounds in which hydrogens on the primary carbon chain are replaced with substituents such as alkyl, aryl, carboxylic acid, ester, amide, amine, urethane, ether, carbonyl, etc. Component A of the prepolymer can be derived from a diol, triol, tetraol, higher polyol, or mixtures thereof. Suitable polyols include diols such as alkanediols, preferably octanediol, triols such as glycerol, trimethylolpropane, trimethylolpropane ethoxylate, triethanolamine, etc., tetraols such as erythritol, pentaerythritol, etc., and higher polyols such as sorbitol. Component A can also be derived from other polyols, including unsaturated diols such as tetradeca-2,12-diene-1,14-diol, polybutadiene diol, macromonomer polyols such as polyethylene oxide, polycaprolactone triol, and N-methyldiethanolamine (MDEA). 5 Preferably, the polyol is substituted or unsubstituted glycerol. Component B of the prepolymer is derived from a polyacid or mixture thereof, preferably a diacid or triacid. Exemplary acids include, but are not limited to, glutaric acid (5 carbon atoms), adipic acid (6 carbon atoms), pimelic acid (7 carbon atoms), sebacic acid (8 carbon atoms), azelaic acid (9 carbon atoms), and citric acid. Exemplary long-chain diacids include diacids having 10 or more, 15 or more, 20 or more, or 25 or more carbon atoms. Non-aliphatic diacids can also be used. For example, the above-mentioned diacids having one or more double bonds can be used to prepare polyol-diacid copolymers. Preferably, the polyacid is substituted or unsubstituted sebacic acid.

[0086] According to a preferred embodiment, suitable prepolymers are selected from the group consisting of poly(glycerol sebacate acrylate) or derivatives thereof, such as aminated PGSA (WO 2021 / 078962).

[0087] Examples of suitable photoinitiators sensitive to ultraviolet light include 2-dimethoxy-2-phenyl-acetophenone, 2-hydroxy-1-[4-(hydroxyethoxy)phenyl]-2-methyl-1-propanone (Irgacure 2959), 1-hydroxycyclohexyl-1-phenyl ketone (Irgacure 184), 2-hydroxy-2-methyl-1-phenyl-1-propanone (Darocur 1173), 2-benzyl-2-(dimethylamino)-1-[4-morpholinyl)phenyl]-1-butanone (Irgacure 369), and methyl benzoyl formate. (DarocurMBF), oxy-phenyl-acetic acid-2-[2-oxo-2-phenyl-acetoxy-ethoxy]-ethyl ester (Irgacure754), 2-methyl-1-[4-(methylthio)phenyl]-2-(4-morpholinyl)-1-propanone (Irgacure907), diphenyl(2,4,6-trimethylbenzoyl)-phosphine oxide (DarocurTPO), phosphine oxide, phenylbis(2,4,6-trimethylbenzoyl) (Irgacure819), and combinations thereof.

[0088] According to another embodiment, the photoinitiator is sensitive to visible light (typically blue or green light).

[0089] Examples of photoinitiators sensitive to visible light include, but are not limited to, diphenyl(2,4,6-trimethylbenzoyl)-phosphine oxide, eosin Y disodium salt, N-vinyl-2-pyrrolidone (NVP), triethanolamine, camphorquinone, and the like.

[0090] Alternatively, the "adhesive composition" can be any composition that has flow properties (e.g., relatively low viscosity) that allow it to be applied to the desired site with a syringe or catheter, while still being viscous enough to remain in place at the application site.

[0091] 3) Guide 3.1) First embodiment Referring to Figures 9, 10 and 11, a kit for applying an adhesive composition onto a support such as any substrate having a surface, more particularly onto a tissue repair support such as a surgical patch, preferably a hernia mesh, comprises an applicator 1 and a guide 100 according to a first embodiment.

[0092] The guide 100 has a lower surface 102 and an upper surface 104 opposite the lower surface 102. The lower surface 102 is configured to contact a support.

[0093] Guide 100 includes stabilizing means that prevent guide 100 from sliding relative to the support. These stabilizing means include, for example, protrusions 106 that protrude from lower surface 102. If the support is a mesh, such as a surgical mesh, these protrusions can engage or attract the loosely woven mesh body, thereby preventing sliding movement.

[0094] The guide 100 defines a first slot 108 that opens to both the lower surface 102 and the upper surface 104 such that when the lower surface 102 of the guide 100 is placed against the support, the first slot 108 exposes a first elongated region of the support.

[0095] The first slot 108 has a first lateral edge 110 and a second lateral edge 111 opposite the first lateral edge 110. The first slot 108 has a width measured as the distance separating the two lateral edges 110, 111.

[0096] The first slot 108 has two opposite ends 112, 113 that connect the two side edges 110, 111. The two opposite ends 112, 113 are curved so that the first slot 108 is horizontally long.

[0097] The first slot 108 forms part of a first ring having a center C. That is, the two side edges 110, 111 are arc-shaped. The first side edge 110 has a larger radius of curvature than the second side edge 111.

[0098] The first slot 108 extends over at least 180 degrees relative to the center C. In a first embodiment, the first slot 108 extends over an angular sector close to 180 degrees relative to the center C, typically less than 190 degrees.

[0099] The guide 100 further defines a second slot 114 that opens to both the lower surface 102 and the upper surface 104. This allows the second slot 114 to expose another elongated region of the support when the lower surface 102 of the guide 100 is placed against one of the two surfaces of the hernia mesh.

[0100] The second slot 114 has a first lateral edge 116 and a second lateral edge 117 opposite the first lateral edge 116. The second slot 114 has a width measured as the distance separating the two lateral edges 116, 117.

[0101] The second slot 114 has two opposite ends 118, 119 that connect the two side edges 116, 117. The two opposite ends 118, 119 are curved so that the second slot 114 is horizontally long.

[0102] The second slot 114 forms part of the second ring, i.e., the two lateral edges 116, 117 are arc-shaped. The first lateral edge 116 has a larger radius of curvature than the second lateral edge 117.

[0103] The second slot 114 extends over at least 180 degrees relative to the center C. In a first embodiment, the second slot 114 extends over an angular sector close to 180 degrees relative to the center C, typically less than 190 degrees.

[0104] The two portions of the ring formed by the first slot 108 and the second slot 114, respectively, are concentric (have the same center C).

[0105] The guide 100 further has a central hole 120. The second slot 114 is located between the central hole 120 and the first slot 108. The first slot 108 surrounds the second slot 114, and the second slot 114 surrounds the central hole 120.

[0106] The center of the central hole 120 is actually the center C of the two rings mentioned above.

[0107] The guide 100 further includes a first guide wall 122 that extends along the first slot 108. The first guide wall 122 protrudes from the top surface 104.

[0108] The first lateral edge 110 is closer to the first guide wall 122 than the second lateral edge 111. The first guide wall 122 is spaced apart from the first slot 108 in the sense that there is a non-zero distance between the first lateral edge 110 of the first slot 108 and the first guide wall 122. This distance is always constant along the first lateral edge 110.

[0109] The first guide wall 122 has a first side surface 124, a second side surface 125 opposite the first side surface 124, and an upper surface connecting the two side surfaces. The second side surface 125 faces the first region located above the first slot 108.

[0110] The first guide wall 122 includes a first rack 126 that is meshable with the pinion 40. The first rack 126 is formed on a second side surface 125 of the first guide wall 122 and is configured such that when the pinion 40 is meshed with the first rack 126, the rotation axis X of the pinion is perpendicular to the lower surface 102 of the guide 100.

[0111] The guide 100 further includes a second guide wall 128 that also extends along the second slot 114. The second guide wall 128 protrudes from the top surface 104.

[0112] The first slot 108 is located between the first guide wall 122 and the second guide wall 128 .

[0113] The first guide wall 122 and the second guide wall 128 define a first groove therebetween, in which the first region described above is located.

[0114] The pinion 40 can fit into the first groove. To this end, the first groove has a width, measured as the distance between the first guide wall 122 and the second guide wall 128, that is equal to or greater than the diameter of the pinion. When the pinion is engaged with the first rack 126, the outlet 16 faces the first slot 108, and the pinion is spaced apart from the second guide wall 128.

[0115] The first slot 108 is closer to the first guide wall 122 than to the second guide wall 128 .

[0116] The second lateral edge 111 of the first slot 108 may be closer to the second guide wall 128 than to the first guide wall 122. The first guide wall 122 is spaced from the second guide wall in the sense that there is a non-zero distance between the second lateral edge 111 of the first slot 108 and the second guide wall 128. This distance is generally constant along the second lateral edge 111.

[0117] The second guide wall 128 has a first side surface 130, a second side surface 131 opposite the first side surface, and a top surface connecting the two side surfaces. The first side surface 130 faces the first region above the first slot 108 and also faces the second side surface 125 of the first guide wall 122.

[0118] The second guide wall 128 is located between the first slot 108 and the second slot 114 .

[0119] A first lateral edge 116 of the second slot 114 is closer to the second guide wall 128 than the second lateral edge 117. The second guide wall 128 is spaced apart from the second slot 114 in the sense that there is a non-zero distance between the first lateral edge of the second slot 114 and the second guide wall 128. This distance is generally constant along the first lateral edge.

[0120] The second guide wall 128 includes a second rack 132 that is meshable with the pinion 40. The second rack 132 is formed on a second side surface 131 of the second guide wall 128. Thus, the teeth of the rack face a second region located above the second slot 114.

[0121] Additionally, the second slot 114 is located between the second guide wall 128 and the central hole 120 .

[0122] Guide 100 further includes a gripping portion 134 spaced apart from guide walls 122, 128 and away from holes 108, 114, 120. A user can maintain guide 100 against the support by pressing on gripping portion 134 without covering guide walls 122, 128 or holes 108, 114, 120.

[0123] The guide 100 can be obtained by injection molding or 3D printing.

[0124] The guide preferably has a height dimension of less than 5 cm in a direction perpendicular to the bottom and top surfaces.

[0125] 3.2) Second embodiment A guide 200 according to a second embodiment is shown in FIGS.

[0126] The guide 200 includes features that correspond to the features of the guide 100 described above. As a rule, the reference numbers of two corresponding features in the guides 100, 200 differ by 100. Thus, the guide 200 includes the following features: A lower surface 202 and an upper surface 204. Stabilizing means including protrusions 206. A plurality of first slots 208, a plurality of second slots 214, and a central hole 220 having a common center C. A first guide wall 222 including a first rack 226, and a second guide wall 228 including a second rack 232. Both racks 226, 232 are meshable with the pinion 40. ·Gripper 234.

[0127] Guide 200 differs from guide 100 in the number and shape of the slots and the shape of the guide walls. All other features of guide 200 are similar to the corresponding features of guide 100.

[0128] The first slots 208 are distributed around a center C to form first loops. The loops are interrupted by first bridges 250. Each first bridge 250 extends radially relative to the center C and separates two adjacent first slots 208. Due to the presence of the first bridges, the first slots 208 extend over an angular sector that is not exactly 360 degrees relative to the center C. However, the first bridges 250 have a small width so that this angular sector is close to 360 degrees, and typically greater than 320 degrees. In the embodiment shown in FIG. 12, the number of first bridges 250 is 16, but may be a different number (two or more).

[0129] Similarly, the second slots 214 are distributed around the center C to form second loops within the first loop. The second loops are interrupted by second bridges 252. Each second bridge 252 extends radially relative to the center C and separates two adjacent second slots 214. Due to the presence of the second bridges, the second slots 214 extend over an angular sector that is not exactly 360 degrees relative to the center C. However, the second bridges 252 have a small width so that this angular sector is close to 360 degrees, and typically greater than 320 degrees. In the embodiment shown in FIG. 12, the number of second bridges 252 is eight, but a different number (two or more) may also be used.

[0130] Additionally, the first guide wall 222 and the second guide wall 228 form two separate loops that extend 360 degrees about the center C. The racks 226 and 232 form two closed circumferences that also extend 360 degrees about the center C.

[0131] 12, the loops formed by the slots 208, 214 and the guide walls 222, 228 form two rings (circular loops). However, in other embodiments, the loops may have other closed shapes, such as an oval or polygon, extending around the central hole 220.

[0132] 3.3) Third embodiment A guide 300 according to a third embodiment is shown in FIG.

[0133] Guide 300 differs from guide 100 in that it has a single slot 308 and a single guide wall 322 that extends along slot 308. The guide wall includes a rack 326.

[0134] The slot 308, the guide wall 322, and the rack 326 are linear.

[0135] Guide 300 further includes a gripping portion 334 extending along guide wall 322 .

[0136] 4) Further components of the kit The present disclosure provides a kit including the applicator 1 and any of the guides 100, 200 and 300.

[0137] According to a preferred embodiment, the kit comprises a body 2, the chamber 14 of which is filled with an adhesive composition.

[0138] A kit including the applicator 1 and any of the guides 100, 200, 300 may further include a support onto which the adhesive composition can be applied.

[0139] The support has an upper surface which can be partially covered by any of the guides 100, 200, 300. This can have any shape (circular, rectangular, etc.).

[0140] The support is, for example, any substrate having a surface, more particularly, a tissue repair support such as a surgical patch, a surgical mesh such as a hernia mesh, etc. Mesh is a screen-like material used as a reinforcement for tissue, organs, or bone. It can be made of synthetic polymers or biopolymers. Materials used for surgical meshes include: Non-absorbable synthetic polymer (polypropylene). ·Absorbable synthetic polymers (polyglycolic acid, polycaprolactone). · Biopolymer (acellular collagen of bovine or porcine origin). · Composites (combinations of any of the three materials mentioned above). The mesh itself is known.

[0141] A kit including the applicator 1 and any of the guides 100, 200, 300 may further include a container, such as a blister, that can house the guide 100, 200, or 300 pre-assembled with a support, such as any substrate having a surface, more particularly a tissue repair support, such as a surgical patch, surgical mesh, etc. This container can be used for a variety of purposes, including: Sterilize the guide 100 or 200 or 300 on the support. Perfect alignment of guides and supports. Hydrates support.

[0142] 5) A method of applying an adhesive composition onto a support 5.1) How to use the applicator 1 and guide 100 A first method for applying an adhesive composition onto a support using the applicator 1 and guide 100 includes the following steps: In the following, it is assumed that the support is a hernia mesh, which is a particular type of surgical mesh.

[0143] The user places the guide over the mesh so that the underside of the guide is in contact with the top side of the mesh, with the first slot 108 exposing a first elongated region of the mesh, the second slot 114 exposing a second elongated region of the mesh, the central hole 120 exposing a circular region of the mesh, and the remaining areas of the mesh being covered by the guide.

[0144] The chamber 14 of the applicator is filled with the adhesive composition described above. This step may be a preliminary step performed before assembling the body 2 and other parts of the applicator 1.

[0145] Next, the user grasps the grip portion 8 of the applicator 1 filled with the adhesive composition.

[0146] The user places the guide and applicator in a first engagement configuration, for example, as shown in FIG.

[0147] In the first engagement configuration, the drive element 6 is engaged with the guide 100. More precisely, the pinion 40 is located in a first groove between the first guide wall 122 and the second guide wall 128 and is engaged with the first rack 126.

[0148] In the first engagement configuration, the outlet 16 faces a first elongated area of ​​the mesh exposed by the first slot 108. The mouthpiece 18 extends into the first slot 108.

[0149] While the applicator 1 and guide 100 are in the first engagement configuration, the user translates the applicator 1 relative to the guide 100 along the first guide wall 122. During this translation, the outlet 16 moves through the first elongated region and the pinion 40 rotates relative to the rack 126. The coupling between the first rack 126 and the pinion 40 causes the drive element 6 to rotate relative to the gripper 8, the pusher 10, and the body 2. The rotation of the drive element 6 relative to the pusher 10 causes the pusher 10 to translate relative to the body 2 in a direction parallel to the longitudinal axis X. During this translation, the pusher 10 pushes against the piston 4, thereby reducing the volume of the chamber 14. The adhesive composition stored in the chamber 14 flows through the passage 20 and is then forced out of the applicator 1 through the outlet 16. At the same time, the outlet 16 moves through the first elongated region, causing the adhesive composition to be evenly applied to the first elongated region.

[0150] The design of the applicator 1 forces the adhesive composition out of the applicator through the outlet 16 at a rate proportional to the rotational speed of the drive element relative to the body. This characteristic is highly advantageous because it allows the user to apply the adhesive composition evenly onto the mesh without having to move the applicator 1 at a constant speed relative to the guide 100. This makes it easy to deposit the adhesive composition evenly onto the mesh.

[0151] The ratio of flow rate to rotational speed depends on various parameters, including the diameter of the pinion 40 and the width of the chamber 14. Preferably, the flow rate is between 0.04 g / cm and 0.08 g / cm.

[0152] The user moves the applicator 1 so that the outlet 16 moves from one end of the first slot 108 to the other opposite end of the first slot 108. As a result, the entire first elongated area of ​​the mesh is coated with the adhesive composition.

[0153] During this process, the guide 100 acts as a stencil: the adhesive composition is applied only to the first elongated areas with a predetermined pattern that can be very easily reproduced.

[0154] During the above steps, the user can use the central hole 120 as a visor. The user may use a tool, such as a pen, to draw a mark on the mesh at the center C of the central hole 120. Movement of the mark in the hole alerts the user that the guide 100 has moved relative to the mesh.

[0155] Next, the user repeats the above steps to coat a second elongated region of the mesh with the adhesive composition. To this end, the user sets the guide 100 and the applicator in a second engagement configuration in which the pinion 40 engages the second rack and the outlet faces the second slot 114 and the second elongated region of the mesh exposed by the second slot 114. While the applicator 1 and guide 100 are in the second engagement configuration, the user translates the applicator 1 relative to the guide 100 along the second guide wall 128. The user moves the applicator 1 so that the outlet moves from one end of the second slot 114 to the other end opposite the second slot 114. As a result, the entire second elongated region of the mesh is coated with the adhesive composition.

[0156] The user then removes the guide 100 from the mesh, revealing the adhesive composition selectively applied to the first elongated region and the second elongated region.

[0157] The first elongated region and the second elongated region extend across the front half of the mesh.

[0158] The user folds the rear half of the mesh over the front half, about a fold line that intersects the mark the user made at center C while guide 100 was covering the mesh. This transfers the adhesive composition to the rear half of the mesh, and when the mesh is opened, two concentric loops of adhesive are formed on the substrate.

[0159] However, the mesh does not immediately unfold to reveal two concentric loops.

[0160] The folded mesh is rolled into a "taco" shape, grasped with a grasper, and inserted (e.g., via a laparoscopic trocar) into the patient's body, e.g., the abdominal cavity. The mesh is then unfolded, unfolded, and placed against the abdominal wall to cover the hernia.

[0161] If the adhesive composition is a photocurable compound, the adhesive composition is irradiated with light so that the adhesive composition polymerizes, thereby adhering the adhesive composition to the abdominal wall together with the mesh.

[0162] 5.2) Second Method of Using Applicator 1 and Guide 200 A second method of applying adhesive composition onto a substrate uses applicator 1 and guide 200 instead of guide 100. The second method involves similar steps to the first method, the only difference being that the user can move applicator 1 360 degrees about center C along guide walls 222, 228 to form two loops of adhesive composition on the substrate instead of two portions of a loop.

[0163] The advantage of the second method over the first method is that it eliminates the need to fold the support over to form loops of adhesive on the support, thus eliminating the need to provide a uniform, symmetrical coating on the mesh surface.

[0164] 5.3) Third Method of Using Applicator 1 and Guide 300 A third method of applying adhesive composition onto a substrate uses applicator 1 and guide 300 instead of guide 100 or 200. The third method includes similar steps to the first method, the only difference being that the user can move the applicator along guide wall 322 to form a line of adhesive composition on the substrate.

[0165] 6) Other embodiments The present disclosure is not limited to the embodiments described above in connection with the figures.

[0166] While these features are advantageous, the drive element wheel 40 need not necessarily be a pinion, and the guide wall need not necessarily include a rack. The wheel may have a smooth circumference that adheres to and rolls on a smooth surface.

[0167] The axis of rotation of the wheel 40 may be different. For example, it may be perpendicular to the longitudinal axis X so that the wheel 40 can roll on the top surface of one of the guides 100, 200, or 300, or so that it can roll directly on the surface of the support to which the adhesive composition is to be applied. In the latter case, the support can be used directly as a guide, eliminating the need for an external guide such as the guide 100 or 200. Figure 15 shows an applicator 1' that can replace the applicator 1 in any of the methods described above. The applicator 1' comprises a wheel 70 that can roll on the surface of the support to push the adhesive composition stored therein out of the applicator 1' through an outlet 74. A valve 72 made of a flexible material such as rubber may be arranged at the outlet 74 to close it. When the applicator 1' rolls on the surface, the valve opens the outlet 74 due to the influence of the adhesive composition.

[0168] In applicator 1, the transmission means for converting the rotational motion of wheel 40 into the translational motion of piston 4 includes threads 38, 68, making applicator 1 highly efficient and robust. However, other transmission means, including, for example, pulleys, screws, and / or belts, can be used instead. For example, FIGS. 16 and 17 show applicator 1″ that can replace applicator 1 in any of the ways described above. Applicator 1″ includes body 2, piston 4, gripping portion 80 that performs the same function as gripping portion 8, wheel 82 that performs the same function as wheel 40, gear 84, and thread 86. Gear 84 includes a drum. Thread 86 has a first end attached to gear 84 and a second end opposite the first end that is attached to gripping portion 80. Rotation of wheel 82 relative to gripping portion 80 causes thread 86 to wrap around the drum, sliding piston 4 within body 2.

[0169] It is assumed that the applicator 1 is perpendicular to the substrate while applying the adhesive composition thereto. This is due to the fact that the chamber, the passage, and the outlet are aligned along the longitudinal axis X. The passage may be bent, for example, by 90 degrees, so that the chamber extends horizontally when the applicator is in the engaged configuration. Figures 18 and 19 show an alternative applicator 1'" that achieves this and can replace the applicator 1 in any of the above-described ways. More specifically, the applicator 1'" comprises the body 2 and piston 4 described above. The applicator 1'" further comprises a wheel 90 that performs the same function as the wheel 40 of the applicator 1. The wheel 90 has an axis of rotation perpendicular to the translation axis of the piston 4 relative to the body 2. Furthermore, the applicator further comprises a passage 92 that is bent by 90 degrees and arranged to extend the passage 20 defined by the body 2.

[0170] Guides 100, 200 may have different numbers of slots. Guide 100 may have a single slot in the shape of an arc. Guide 200 may be designed to apply one loop of adhesive instead of two. A central hole is advantageous as it can serve as a visor, but is not required.

[0171] Of course, any of the applicators described above can be used to apply any type of adhesive composition to any substrate (patch, film, biological tissue, etc.).

Claims

1. 1. A kit for applying an adhesive composition onto a substrate, comprising: The kit comprises: an applicator (1); Guides (100, 200, 300) and Equipped with The applicator (1) comprises: a body (2) defining a chamber (14) for storing an adhesive composition, such as a photocurable compound, and an outlet (16) for delivering the adhesive composition stored in the chamber (14); a piston (4) translatable relative to said body (2); a drive element (6) rotatable relative to the body (2) and configured to releasably engage with a guide (100, 200, 300) external to the applicator (1); Equipped with Rotating the drive element (6) relative to the body (2) reduces the volume of the chamber (14) and causes the piston (4) to translate relative to the body (2) so as to force the adhesive composition out of the applicator (1) through the outlet (16); the guide (100, 200, 300) defines a slot (108, 208, 308) that exposes an elongated region of the support when the guide is over the support; the applicator (1) and the guide (100, 200, 300) are configurable into an engagement configuration in which the drive element (6) engages with the guide and the outlet (16) faces the support; The kit, wherein the drive element (6) is rotated relative to the body (2) by moving the drive element (6) along the guide (100, 200, 300) while the guide and the applicator (1) are in an engaged configuration.

2. 2. The kit of claim 1, wherein the applicator (1) is configured to extrude the adhesive composition out of the applicator (1) through the outlet (16) at a flow rate proportional to the rotational speed of the drive element (6) relative to the body (2).

3. 3. A kit according to claim 1 or 2, wherein the piston (4) is translatable relative to the body (2) in a direction parallel to the axis of rotation of the drive element (6) relative to the body (2).

4. The kit according to any one of claims 1 to 3, wherein the drive element (6) comprises a pinion (40) meshable with a rack (126, 226, 326) of the guide (100, 200, 300).

5. The applicator (1) comprises a grip (8) that allows a user to hold the applicator (1); Kit according to any one of claims 1 to 4, wherein the drive element (6) is arranged between the outlet (16) and the gripping part (8).

6. The applicator (1) further comprises a first threaded portion (68); The drive element (6) has a second threaded portion (38) that engages with the first threaded portion; The kit according to any one of claims 1 to 4, wherein the piston (4) translates relative to the body (2) by rotating the second threaded portion relative to the first threaded portion (68).

7. The applicator (1) comprises: a grip (8) that allows a user to hold the applicator (1); a pusher (10) having the first threaded portion (68) and slidably attached to the grip portion (8); The kit of claim 6 comprising:

8. 8. A kit according to claim 7, wherein the applicator (1) comprises means for preventing the body (2) from rotating relative to the pusher about the axis of translation of the piston (4) relative to the body (2).

9. Kit according to any one of the preceding claims, wherein the body (2) and the piston (4) form a syringe, the syringe being a replaceable part of the applicator (1).

10. The kit according to any one of claims 1 to 9, wherein the guide (100, 200, 300) comprises a rack (125, 225, 325) engageable with the drive element (6) while the guide and the applicator (1) are in an engaged configuration.

11. 11. The kit of claim 1, wherein the guide (100, 200, 300) includes a guide wall (122, 222, 322) extending along the slot (108, 208, 308), and wherein the outlet (16) is configured to align with the slot (108, 208, 308) when the drive element (6) is moved along the guide wall (122, 222, 322) while the guide and the applicator (1) are in an engaged configuration.

12. The kit of claim 11, wherein the guide wall (122, 222, 322) includes a rack (125, 225, 325).

13. The kit of any one of claims 1 to 12, wherein the guide (200) defines a plurality of holes including a first slot, the plurality of holes forming a loop extending about a point (C).

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