Device for spreading topical skin adhesive

Abstract

In one embodiment, an apparatus includes: a proximal body portion configured to be graspable by a user; a distal body portion terminating in a spreading tip configured to spread a topical skin adhesive along an application surface; and a flexible body portion interconnecting the proximal body portion and the distal body portion to define a unitary body. The flexible body portion is configured to non-uniformly flex along a lateral width of the device in response to an input force applied to the proximal body portion by a user when the spreading tip is positioned against the application surface. Additionally or alternatively, the flexible body portion is configured to be elastically deformable such that the distal body portion is angularly deflected relative to the proximal body portion to limit a normal resultant force applied by the spreading tip on the topical skin adhesive along the application surface to a predetermined range.

Description

[0001] Priority

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 427,132, filed on Nov. 22, 2022, entitled "Device for Spreading Topical Skin Adhesive", the disclosure of which is incorporated herein by reference in its entirety. BACKGROUND OF THE INVENTION

[0003] A wound closure system (also referred to as a skin closure system) can be used at the end of a patient's surgical procedure to close a wound (e.g., a surgical incision) formed in the patient's skin for access to a target anatomical structure. By way of example, a wound closure system can include components such as sutures, substrates, and / or liquid topical skin adhesives, which are applied by a surgeon to bring the edges of the wound closer together and, in some cases, form a stable and protective layer over the wound that promotes effective healing. In some cases, one or more components of the applied wound closure system can be absorbed by the patient during the healing process. After the wound has healed, the remaining components of the wound closure system can be removed from the skin by the surgeon and / or they can automatically separate from the skin such that they can be discarded by the patient.

[0004] Although a variety of wound closure systems and associated components and methods have been made and used, it is believed that no one prior to the present inventors has made or used the invention described in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0005] The drawings incorporated in and forming a part of this specification illustrate embodiments of the invention and, together with the description given below, serve to explain the principles of the invention.

[0006] Figure 1 A perspective view of an example of a wound closure system is shown that includes a wound closure device, an adhesive application device, and an adhesive spreader;

[0007] Figure 2 Shows Figure 1 An exploded perspective view of the wound closure device of, showing a mesh layer, a pressure-sensitive adhesive layer, and a removable backing layer;

[0008] Figure 3A Shows the Figure 1 wound closure device of longitudinally aligned with a wound in a patient's skin, showing the central portion of the backing layer that has been removed;

[0009] Figure 3B Shows Figure 1A perspective view of a wound closure device applied to a patient's skin over a wound to approximate the edges of the wound;

[0010] Figure 3C Shown is a drug applied to a patient's skin above a wound. Figure 1 A perspective view of a wound closure device showing the remaining portion of the backing layer that has been removed so that the wound closure device is fully adhered to the skin;

[0011] Figure 3D Shown is a drug applied to a patient's skin above a wound. Figure 1 A perspective view of a wound closure device showing application of a liquid topical skin adhesive to a mesh layer using an adhesive applicator;

[0012] Figure 3E Shown is a drug applied to a patient's skin above a wound. Figure 1 a perspective view of a wound closure device of , showing an adhesive spreader positioned against a patient at the beginning of an adhesive spreading stroke for spreading an applied topical skin adhesive over and through the wound closure device;

[0013] Figure 3F Shown is a drug applied to a patient's skin above a wound. Figure 1 A perspective view of a wound closure device showing an adhesive spreader during a subsequent portion of an adhesive spreading stroke;

[0014] Figure 4 Shows Figure 1 A perspective view of an adhesive spreader;

[0015] Figure 5 Shows Figure 1 A top plan view of an adhesive spreader;

[0016] Figure 6 Shows Figure 1 A side elevation view of an adhesive spreader;

[0017] Figure 7A Shown along Figure 4 The line 7-7 is intercepted Figure 1 A side cross-sectional view of an adhesive spreader showing a distal body portion of the adhesive spreader deflected in a first direction;

[0018] Figure 7B A cross-sectional view taken along line 7-7 is shown. Figure 1 a side cross-sectional view of an adhesive spreader showing a distal body portion deflected in a second direction;

[0019] Figure 8 Shown along Figure 4 The line 8-8 is intercepted Figure 1End cross-sectional view of an adhesive spreader;

[0020] Figure 9 Shows an end cross-sectional view of an adhesive spreader taken along Figure 4 line 9-9 of Figure 1 the adhesive spreader;

[0021] Figure 10 Shows a plan view of the distal body portion of an adhesive spreader, showing the spreading tip of the adhesive spreader conforming to a convexly curved skin surface; Figure 1

[0022] Figure 11 Shows a plan view of the distal body portion of an adhesive spreader, showing the spreading tip conforming to convexly and concavely curved skin surfaces; Figure 1

[0023] Figure 12 Shows an end cross-sectional view of another exemplary adhesive spreader configured to be used with a Figure 1 wound closure system;

[0024] Figure 13 Shows an end cross-sectional view of another exemplary adhesive spreader configured to be used with a Figure 1 wound closure system;

[0025] Figure 14 Shows an end cross-sectional view of another exemplary adhesive spreader configured to be used with a Figure 1 wound closure system;

[0026] Figure 15 Shows a perspective view of another exemplary adhesive spreader configured to be used with a Figure 1 wound closure system; and

[0027] Figure 16 Shows a perspective view of another exemplary adhesive spreader configured to be used with a Figure 1 wound closure system.

[0028] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in many other ways, including those not necessarily shown in the drawings. The drawings incorporated in and forming a part of this specification illustrate several aspects of the invention and, together with the description, serve to explain the principles of the invention; however, it is to be understood that the invention is not limited to the specific arrangements shown. Detailed Description

[0029] ​​The following description of certain examples of the technology should not be used to limit the scope of the technology. From the following description, other examples, features, aspects, embodiments, and advantages of the technology will become apparent to those skilled in the art. The following description is given by way of example, which is one of the best ways contemplated for implementing the technology. As will be appreciated, the technology described herein can have other different and distinct aspects, all of which do not depart from the technology. Therefore, the drawings and description should be regarded as illustrative in nature and not restrictive.

[0030] For the sake of clarity of the disclosure, the terms "proximal" and "distal" are defined herein relative to the human or robotic operator of the surgical instrument. The term "proximal" refers to an element position that is closer to the human or robotic operator of the surgical instrument and farther from the surgical end effector of the surgical instrument. The term "distal" refers to an element position that is closer to the surgical end effector of the surgical instrument and farther from the human or robotic operator of the surgical instrument. It should also be understood that, for convenience and clarity, spatial terms such as "side", "upward", and "downward" are also used herein with reference to relative positions and orientations. For clarity, such terms are used hereinafter with reference to views and are not intended to limit the invention described herein.

[0031] Furthermore, as used herein, the terms "about" and "approximately" in connection with any numerical value or range are intended to cover the exact value cited, as well as a suitable tolerance that enables the recited feature or combination of features to be used for the intended purpose described herein.

[0032] I. Wound Closure System

[0033] Figure 1 An example of a wound closure system (10) is shown, which includes a wound closure device (20) (also referred to as a patch) configured to be applied to a wound (W) of a patient, an adhesive application device (40) configured to apply a topical skin adhesive (54) (see Figure 3D ) to the applied wound closure device (20), and an adhesive spreader (60) configured to spread the applied topical skin adhesive (54) onto and through the wound closure device (20). Each of these components is described in more detail hereinafter.

[0034] Best as Figure 2As shown, the wound closure device (20) of this type has an elongated generally rectangular shape and a three-layer structure. More specifically, the wound closure device (20) includes a base layer in the form of a fabric mesh (22), a pressure-sensitive adhesive layer (24) formed as a continuous or discontinuous coating along the skin-facing lower side of the mesh (22), and a backing layer (26) removably applied to the lower side of the pressure-sensitive adhesive (24). It should be understood that as used herein, the term "wound closure device" encompasses wound closure devices (20) with and without a backing (26), which can be removed and discarded during the application of the wound closure device (20) to a patient, as described in more detail below.

[0035] The mesh (22) is configured to be able to hold a liquid topical skin adhesive and can be formed of polyethylene (PET) or any other suitable surgical textile material. The pressure-sensitive adhesive (24) is configured to enable the wound closure device (20) to self-adhere to the patient's skin in response to pressure applied by a surgeon to the upper side of the mesh (22) during its application. The backing (26) is used to protect the pressure-sensitive adhesive (24) before the wound closure device (20) is applied to a patient. In this type, the backing (26) includes an elongated perforated array that extends longitudinally and defines an elongated central backing portion (28) and a pair of elongated side backing portions (30). Although each backing portion (28, 30) is shown as generally rectangular in this type, in other types, the backing portions (28, 30) can be of various alternative shapes, sizes, and numbers.

[0036] As Figure 1 shown, the adhesive application device (40) includes an application device body (42), a plunger unit (44) slidably received within the proximal end of the opening in the application device body (42), and a static mixer (46) fixed to the distal end of the application device body (42). The application device body (42) includes a pair of cylinders (48) arranged side by side, where each cylinder (48) houses a respective portion of a two-part liquid topical skin adhesive. The plunger unit (44) includes a pair of plungers (50) that are arranged side by side and interconnected at their proximal ends by a bridge (52). Each plunger (50) can be actuated distally through the respective cylinder (48) of the application device body (42) to force the corresponding liquid adhesive portion distally into the static mixer (46). The static mixer (46) is configured to receive a first adhesive portion and a second adhesive portion and direct them around and through a series of static baffles and channels (not shown) that mix the two adhesive portions together into a homogeneous liquid adhesive (54), which is then dispensed through the distal open end of the static mixer (46), as described below Figure 3D shown.

[0037] In this form, the liquid topical skin adhesive (54) is in the form of a silicone-based topical skin adhesive that is configured to cure on the skin in less than two minutes at body temperature. Once cured, the topical skin adhesive (54) remains an elastomer such that a given portion of the cured adhesive (54) is configured to stretch up to 160% of its cured length and then fully recover to its cured length. Accordingly, the wound closure system (10) can be particularly effectively used for actuatable body parts of a patient, such as, for example, the knee, wrist, elbow, or other joints.

[0038] Also as Figure 1 shown, the adhesive spreader (60) of this form has an integral body that includes a proximal body portion (62) configured to be grasped by a user, a distal body portion (64) terminating at an end configured to spread the applied topical skin adhesive (54), and an intermediate flexible body portion (66) interconnecting the proximal body portion (62) and the distal body portion (64). The flexible body portion (66) is configured to elastically deform such that the distal body portion (64) angularly deflects relative to the proximal body portion (62) to facilitate effective spreading of the topical skin adhesive (54) along the wound closure device (20) with a suitable normal force within a predetermined range.

[0039] Figures 3A to 3D An example of a wound closure system (10) for closing a wound (W) formed in a patient's skin (S) is shown. In some surgeries, the wound (W) may be at least partially closed with one or more sutures prior to using the wound closure system (10), such as at a deeper portion of the wound (W). Additionally, the wound closure device (20) may be trimmed by a surgeon into any suitable shape desired prior to being applied to the patient.

[0040] As Figure 3AAs shown, the central backing portion (28) is removed from the wound closure device (20) to expose the central window of the mesh (22) and the pressure-sensitive adhesive (24), and the imaginary centerline of the wound closure device (20) is longitudinally aligned with the edges of the wound (W). The wound closure device (20) is then applied to the patient's skin (S) over the wound (W), and the surgeon applies pressure to the central portion of the mesh (22) to force the pressure-sensitive adhesive (24) to adhere to the skin (S), thereby fixing the edges of the wound (W) relative to each other. Prior to this step, the surgeon may hold the edges of the wound (W) in approximation. Alternatively, during this step, the central portion of the wound closure device (20) may be applied in a lateral alternating manner to approximate the edges of the wound (W) during application. For either method, the wound closure device (20) is configured to hold the edges of the wound (W) in approximation after this initial application step. Once the surgeon is satisfied with the position of the wound closure device (20) relative to the wound (W), the surgeon may remove the remaining side backing portions (30) to adhere the remaining portion of the wound closure device (20) to the skin (S).

[0041] As Figure 3D shown, a pattern of topical skin adhesive (54) is then applied to the upper side of the mesh (22) of the applied wound closure device (20) using an adhesive applicator (40). Although in this version the adhesive applicator (40) is shown applying a linear bead of topical skin adhesive (54), it should be understood that in other versions various other patterns of topical skin adhesive (54) may be applied, such as the T-shaped pattern or the waveform pattern disclosed in the following U.S. patent application: U.S. Patent Application No. 17 / 991,992, entitled "Application of Topical Skin Adhesive to Surgical Mesh", filed November 22, 2022, the entire disclosure of which is incorporated herein by reference.

[0042] As Figures 3E to 3F shown, the applied topical skin adhesive (54) is then evenly spread over the wound closure device (20) using an adhesive spreader (60) to force the topical skin adhesive (54) through the layers of the mesh (22) and the pressure-sensitive adhesive (24) and directly against the wound (W) and the surrounding skin (S). In this regard, the layers of the mesh (22) and the pressure-sensitive adhesive (24) may be at least partially permeable to allow the topical skin adhesive (54) to be forced through its channels. As Figure 3EAs shown, at the beginning stage of the adhesive spreading stroke, when the adhesive spreader (60) is first positioned against the wound closure device (20), the flexible body portion (66) of the adhesive spreader (60) can be in a non-deformed state. When the adhesive spreader (60) is longitudinally dragged along the wound closure device (20), the input force applied by the user can cause the flexible body portion (66) to elastically deform, such that the distal body portion (64) angularly deflects relative to the proximal body portion (62), as Figure 3F shown. The degree of deformation of the flexible body portion (66) can be directly related to the viscosity of the topical skin adhesive (54). Specifically, a greater viscosity may require the user to apply a greater input force through the proximal body portion (62) to effectively spread the topical skin adhesive (54) over and through the wound closure device (20), such that the flexible body portion (66) deforms a relatively greater amount. Conversely, a lower viscosity may require a smaller input force, such that the flexible body portion (66) deforms less or not at all.

[0043] Optionally, the topical skin adhesive (54) can also be spread on the adjacent portion of the skin (S) not covered by the wound closure device (20) to ensure that the entire mesh (22) is encapsulated by the topical skin adhesive (54). For example and by way of illustration only, the topical skin adhesive (54) can be spread around the entire outer periphery of the applied wound closure device (20) onto the skin (S) for at least 1 cm. Once the topical skin adhesive (54) has been fully spread on the wound closure device (20), any topical skin adhesive (54) on the skin (S) outside the periphery of the device (20) can be wiped off, for example, with a sterile gauze. Additionally, in some cases, a quantity of the topical skin adhesive (54) can be applied between the edges of the wound (W) before the wound closure device (20) is applied to the skin (S). Then, the applied topical skin adhesive (54) cures within and above the wound closure device (20) to form a composite microbial barrier that maintains a protective environment promoting effective healing above the wound (W). After the wound (W) has healed, the wound closure device (20) can be manually removed (e.g., by a surgeon) from the skin (S), or it can automatically separate from the skin (S) such that it can be discarded by the patient.

[0044] The wound closure system (10) can also be constructed and operated according to at least some of the teachings of U.S. Patent No. 11,712,229, entitled "Systems, Devices and Methods for Dispensing and Curing Silicone Based Topical Skin Adhesives", published on August 1, 2023, the entire disclosure of which is incorporated herein by reference; U.S. Patent No. 11,518,604, entitled "Systems, Methods and Devices for Aerosol Spraying of Silicone Based Topical Skin Adhesives for Sealing Wounds", published on December 6, 2022, the entire disclosure of which is incorporated herein by reference; U.S. Patent No. 11,479,669, entitled "Novel Topical Skin Closure Compositions and Systems", published on October 25, 2022, the entire disclosure of which is incorporated herein by reference; U.S. Patent Publication No. 2021 / 0369639, entitled "Novel Antimicrobial Topical Skin Closure Compositions and Systems", published on December 2, 2021, the entire disclosure of which is incorporated herein by reference; U.S. Patent No. 11,589,867, entitled "Anisotropic Wound Closure Systems", published on February 28, 2023, the entire disclosure of which is incorporated herein by reference; and / or U.S. Patent Publication No. 2022 / 0395643, entitled "Gas Sterilizable Syringes Having Apertures Covered by Gas Permeable Barriers for Enabling Ingress and Egress of Sterilization Gases While Preventing Leakage of Flowable Materials", published on December 15, 2022, the entire disclosure of which is incorporated herein by reference.

[0045] II. Adhesive Spreader

[0046] As noted above, the adhesive spreader (60) of this type has an integral body defined by the combination of a proximal body portion (62), a distal body portion (64), and a flexible body portion (66). As described in more detail below, the integral body has a variable buckling strength along its transverse width and is configured to be elastically deformable at the flexible body portion (66) and at its distal end to ensure that a predetermined appropriate range of normal forces is continuously applied to the topical skin adhesive (54) and the wound closure device (20) during use. In this regard, the adhesive spreader (60) is configured to ensure that a topical skin adhesive, such as the topical skin adhesive (54), is sufficiently driven through the wound closure device (20) to contact and bond to the skin (S), but does not transmit excessive normal forces that could cause the wound closure device (20) to separate from the skin (S).

[0047] As Figure 4 shown, the integral body of the adhesive spreader (60) extends longitudinally between a rounded proximal end and a squared distal end defined by a spreading tip (68), with the proximal body portion (62) terminating proximally at the rounded proximal end and the distal body portion (64) terminating distally at the squared distal end. The adhesive spreader (60) has a transverse width measured between opposite transverse sides (70) and a thickness measured between opposite working sides (72). The adhesive spreader (60) is symmetric about a first intermediate plane (P1) that bisects the integral body along its transverse width and is also symmetric about a second intermediate plane (P2) that bisects the integral body along its thickness, where the first intermediate plane and the second intermediate plane (P1, P2) intersect along the longitudinal axis (A) of the adhesive spreader (60). Thus, the adhesive spreader (60) can be used interchangeably in various orientations. Each of the proximal body portion (62) and the distal body portion (64) has a generally elongated oval cross-section that has a generally constant thickness through the proximal body portion (62) and the thickness tapers distally through the distal body portion (64) toward the spreading tip (68), which defines the minimum thickness of the adhesive spreader (60) and thus has a lower stiffness than the remainder of the proximal portion of the adhesive spreader (60). Thus, the spreading tip (68) can be configured to elastically deflect before and at a faster rate than the flexible body portion when pressed against an application surface. The cross-sectional shapes and elastic flexure characteristics of the spreading tip (68) and the flexible body portion (66) are described in more detail below.

[0048] As Figures 4 to 6As shown, the proximal body portion (62) on each working side (72) of the adhesive spreader (60) includes a finger recess (74) that is located just proximal to the flexible body portion (66) and is recessed inwardly with a certain concave curvature. The size and shape of each finger recess (74) are configured to receive one or more fingers of the user, such as the thumb, to facilitate effective grasping of the proximal body portion (62). A plurality of surface gripping features in the form of raised bumps (76) are disposed on each working side (72) of the proximal body portion (62), within the finger recesses (74), and on at least the proximal half of the proximal body portion (62). The raised bumps (76) are configured to further facilitate effective grasping of the proximal body portion (62) in the presence of a fluid, such as body fluid or saline, that might cause the proximal body portion (62) to slip during a surgical procedure or when the user grasps the proximal body portion (62) with gloved fingers. The proximal body portion (62) on each working side (72) further includes a recessed area (78) located proximal to the finger recesses (74), which may include a visual marking (not shown), such as a product brand, but it should be understood that the recessed area (78) is merely optional.

[0049] As Figures 4 to 6 shown, the distal body portion (64) tapers distally towards the spreading tip (68) and includes an alignment indicator (80) located along the longitudinal axis (A) of the adhesive spreader (60) on each working side (72). In this form, each alignment indicator (80) is shown in the form of a triangular recess, but various other configurations of alignment indicators (80) may be employed in other forms. During use, the adhesive spreader (60) is oriented relative to the wound (W) and the wound closure device (20) such that the distal tip of the alignment indicator (80) is aligned with the longitudinal centerline of the wound (W) and the wound closure device (20), and this alignment is maintained as the adhesive spreader (60) is pulled longitudinally across the wound closure device (20). As Figure 5 best shown, the spreading tip (68) extends transversely to the longitudinal axis (A) of the adhesive spreader (60) and includes a central flat surface (82) on each working side (72). Additionally, the adhesive spreader (60) may be sized such that the spreading tip (68) is slightly wider than the wound closure device (20), such that the spreading tip (68) can span the entire width of the wound closure device (20) and partially extend onto the skin (S) on each side of the wound closure device (20) during use. By way of example only, the wound closure device (20) may be approximately 4 cm wide, and the adhesive spreader (60) may be approximately 4.5 cm wide, including at the spreading tip (68).

[0050] Still referring toFigures 4 to 6 , the flexible body portion (66) on each working side (72) of the adhesive spreader (60) includes a void feature shown in the form of a wedge-shaped channel (84). As used herein, "void" means the absence of material. Each wedge-shaped channel (84) is centered on the longitudinal axis (A) of the adhesive spreader (60) and has a length equal to approximately 80% of the transverse width of the adhesive spreader (60). As Figure 6 best shown, each wedge-shaped channel (84) has a proximal surface (86) that is substantially perpendicular to the first intermediate plane (P1) and a distal surface (88) that is angled with respect to the first intermediate plane (P1). The proximal and distal surfaces (86, 88) of each wedge-shaped channel (84) define an outwardly opening angle (θ) of approximately 20°.

[0051] As Figures 7A to 7B shown, the wedge-shaped channels (84) cooperate to provide the central web portion of the flexible body portion (66) with a lower stiffness than the proximal body portion (62), such that the flexible body portion (66) is configured to be elastically deformable such that when the spreading tip (68) is pressed by a user against an application surface, the distal body portion (64) angularly deflects relative to the proximal body portion (62). More specifically, in response to a user input force, the distal body portion (64) is configured to be pivotally articulated relative to the proximal body portion (62) about a transverse hinge axis defined by the flexible body portion (66), the transverse hinge axis extending along the first intermediate plane (P1) and intersecting orthogonally with the second intermediate plane (P2). The distal body portion (64) can deflect a maximum deflection angle (θ) in a first direction, as Figure 7A shown, and can also deflect a maximum deflection angle (θ) in an opposite second direction, as Figure 7B shown. When the distal body portion (64) exhibits the maximum deflection angle (θ) in either direction, the proximal and distal surfaces (86, 88) of the wedge-shaped channel (84) in the deflection direction contact each other and thus act as mechanical stops to inhibit further deflection of the distal body portion (64) in that direction. When the user input force is released, for example when the adhesive spreader (60) is lifted from the application surface, the distal body portion (64) can elastically and rapidly retract to Figure 6 the relaxed state shown, where the proximal and distal body portions (62, 64) extend coaxially along the longitudinal axis (A) and are centered about the first intermediate plane (P1).

[0052] During use of the adhesive spreader (60), the user grasps the proximal body portion (62) and positions the spreading tip (68) in contact with an application surface, such as the mesh (22) of the wound closure device (20) and / or the skin (S). The user then tilts the adhesive spreader (60) such that its longitudinal axis (A), defined by the proximal body portion (62), defines an angle of inclination of about 45° to about 60° relative to the application surface, as Figures 3E to 3F shown. The user then applies a downward force through the proximal body portion (62) in a direction perpendicular to the application surface while dragging the adhesive spreader (60) across the application surface such that the proximal body portion (62) guides the distal body portion (64). Due to the angle of inclination, the applied force creates a moment about the spreading tip (68) that may be sufficient to elastically deform the flexible body portion (66) due to its reduced thickness such that the distal body portion (64) angularly deflects relative to the proximal body portion (62) in a hinge-like manner. This elastic deformation of the flexible body portion (66) can result in the spreading tip (68) applying a normal force of about 1.5 lbf to about 5 lbf to the application surface and the topical skin adhesive when the proximal body portion (62) is oriented within the above-described angle of inclination range.

[0053] When the proximal body portion (62) is oriented at an angle of inclination greater than 60°, the moment generated at the spreading tip (68) gradually decreases, resulting in less deformation of the flexible body portion (66) such that the force applied by the user is transmitted more directly through the spreading tip (68) to the application surface. For example, if the proximal body portion (62) is oriented at an angle of inclination of 90° such that the proximal body portion (62) is perpendicular to the application surface, the spreading tip (68) can apply a normal force of up to about 10 lbf. It should be understood that a greater normal force may be required to force the topical skin adhesive (54) through the wound closure device (20) and into contact with the underlying wound (W) and skin (S) when spreading a topical skin adhesive having a greater viscosity, such as a silicone-based adhesive like the topical skin adhesive (54). Conversely, a smaller normal force may be required when spreading a topical skin adhesive having a lower viscosity that can more readily pass through the wound closure device (20). Thus, when the adhesive spreader (60) is oriented within the above-described exemplary angle of inclination range, spreading of a higher viscosity adhesive will result in greater deflection of the flexible body portion (66), e.g., to the extent that the channel surfaces (86, 88) contact each other. Conversely, spreading of a lower viscosity adhesive will result in less or no deflection of the flexible body portion (66).

[0054] When applying the topical skin adhesive (54) over the wound closure device (20), the flexibility of the flexible body portion (66) enables the user to employ enhanced control and precession. In this regard, the applicator (60) is configured to effectively apply the topical skin adhesive (54) over and through the wound closure device (20) with a suitable normal force that can fall within the aforementioned predetermined range, depending on the viscosity of the topical skin adhesive (54) and how the applicator (60) is manipulated by the user. Thus, the flexible body portion (66) is operable to limit the normal force when applying a relatively low-viscosity topical adhesive and is operable to ensure a predetermined minimum normal force when applying a relatively high-viscosity topical skin adhesive. Additionally, the applicator (60) is constructed to apply a consistent normal force over the wound closure device (20) to produce a film of the topical skin adhesive (54) having a uniform film thickness (such as approximately 0.5 mm). The applicator (60) may also facilitate the production of a film edge having a tapered thickness, which helps to minimize the risk of the cured adhesive snagging on the patient's clothing or other articles positioned against the patient's skin (S).

[0055] As Figure 8 and Figure 9 shown, each of the flexible body portion (66) and the spreading tip (68) has a non-uniform thickness along the lateral width of the applicator (60) and thus has non-uniform stiffness and buckling strength. More specifically, the thickness and buckling strength of the flexible body portion (66) increase in an orthogonal direction from the second intermediate plane (P2) toward the lateral sides (70), where the maximum thickness and buckling strength of the flexible body portion (66) are defined at each longitudinal end adjacent to the lateral sides (70) of the wedge-shaped channel (84). Thus, the flexible body portion (66) has a minimum stiffness and buckling strength along the second intermediate plane (P2) and a maximum stiffness and buckling strength along the lateral sides (70). Accordingly, these regions of maximum buckling strength along the lateral sides (70) serve as structural beam-like features.

[0056] As Figure 9As shown, in terms of thickness and buckling strength, the spreading tip (68) exhibits a configuration opposite to that of the flexible body portion (66). More specifically, the thickness and buckling strength of the spreading tip (68) decrease in an orthogonal direction from the second intermediate plane (P2) towards the lateral side (70), where the maximum thickness of the flexible body portion (66) is defined at the second intermediate plane (P2). Thus, the spreading tip (68) has the maximum stiffness and buckling strength along the second intermediate plane (P2) and the minimum stiffness and buckling strength along the lateral side (70). The opposite configurations of thickness and buckling strength of the flexible body portion (66) and the spreading tip (68) enable the adhesive spreader (60) to elastically deform axially along the longitudinal axis (A) such that the spreading tip (68) can conform to various types of contoured application surfaces. For example, Figure 10 shows a spreading tip (68) conforming to a convex application surface (90), and Figure 11 shows a spreading tip (68) conforming to a contoured application surface (92) having a convex portion and a concave portion. Such application surfaces (90, 92) can represent patient body joints such as the knee, wrist, or elbow.

[0057] To exhibit the various functional characteristics described above, the adhesive spreader (60) can be formed of an elastomeric material having a hardness of from about 50 Shore A to about 70 Shore A, such as about 60 Shore A, where the elastomeric material does not react with the topical skin adhesive (54), the wound closure device (20), and the skin (S). By way of example only, the adhesive spreader (60) can comprise silicone rubber and can be formed by injection molding. In other configurations, two or more portions of the adhesive spreader (60) can be formed of different materials, where at least the flexible body portion (66) and the spreading tip (68) are formed of an elastomeric material. Additionally, all or at least the distal portion of the adhesive spreader (60) can be at least partially transparent to enable visualization through the adhesive spreader (60) when spreading the topical adhesive and to facilitate alignment of the alignment indicator (80) with the wound (W).

[0058] III. Alternative Adhesive Spreader

[0059] In some cases, it may be desirable to provide an adhesive spreader that includes a flexible body portion having void features other than the wedge channels (84), where the void features provide the flexible body portion with a buckling strength that varies along the lateral width of the adhesive spreader, and where the void features facilitate elastic deformation of the flexible body portion to enable the distal body portion of the spreader to deflect angularly relative to the proximal body portion to adjust the normal force applied by the spreader to the application surface. Figures 12 to 16An exemplary alternative adhesive spreader (100, 120) constructed in such a manner is shown, where the adhesive spreader (100, 120) is similar to the adhesive spreader (60), except as otherwise described below.

[0060] Figure 12 An alternative adhesive spreader (100) is shown, which includes a proximal body portion (102) similar to the proximal body portion (62), a distal body portion (not shown) similar to the distal body portion (64), a unique flexible body portion (106), a pair of lateral sides (108), and a pair of working sides (110). The flexible body portion (106) includes void features in the form of a pair of wedge-shaped channels (112) that are opposite each other about a first intermediate plane (P1) (see Figure 4 and Figure 6 ). Each channel (112) has a root (114) that extends concavely with respect to the first intermediate plane (P1). Thus, similar to the flexible body portion (66), the thickness and buckling strength of the flexible body portion (106) increase in the orthogonal direction from the second intermediate plane (P2) toward the lateral sides (108). Specifically, the flexible body portion (106) has a minimum thickness and buckling strength along the second intermediate plane (P2) and a maximum thickness and buckling strength at the lateral ends of the wedge-shaped channels (112) adjacent to the lateral sides (108).

[0061] Figure 13 Another alternative adhesive spreader (120) is shown, which includes a proximal body portion (122) similar to the proximal body portion (62), a distal body portion (not shown) similar to the distal body portion (64), a unique flexible body portion (126), a pair of lateral sides (128), and a pair of working sides (130). The flexible body portion (126) includes void features in the form of a pair of wedge-shaped openings (132) that are opposite each other about a first intermediate plane (P1) (see Figure 4 and Figure 6)。The wedge-shaped opening (132) is similar to the wedge-shaped channels (84, 112), but is connected to each other to define a central opening (134) (also referred to as a window), which completely extends through the central portion of the flexible body part (126) and longitudinally extends along the first intermediate plane (P1), such that the central opening (134) opens towards each working side (130). Similar to the flexible body parts (66, 106), the thickness and buckling strength of the flexible body part (106) increase towards the lateral sides (128) in a direction away from the second intermediate plane (P2). Specifically, the flexible body part (126) has a minimum buckling strength at the second intermediate plane (P2) and along the length of the central opening (124), and has a maximum buckling strength at the lateral ends of the wedge-shaped opening (132).

[0062] Figure 14 Another alternative adhesive spreader (140) is shown, which includes a proximal body part (142) similar to the proximal body part (62), a distal body part (not shown) similar to the distal body part (64), a unique flexible body part (146), a pair of lateral sides (148) and a pair of working sides (150). The flexible body part (146) includes void features in the form of a plurality of recesses (152, 154, 156, 158) formed in the working sides (150), wherein the recesses (152, 154, 156, 158) are symmetrically arranged around the second intermediate plane (P2) and are separated from each other by corresponding material webs. Specifically, the intermediate recess (152) is laterally centered on the second intermediate plane (P2), and opens through the second working side (150) and closes along the first working side (150). The first intermediate recess (154) is provided on each lateral side of the intermediate recess (152), and opens through the first working side (150) and closes along the second working side (150). The second intermediate recess (156) is provided on the lateral outside of each first intermediate recess (154), and also opens through the second working side (150) and closes along the first working side (150). Finally, the outer recesses (158) are provided on the lateral outside of each second intermediate recess (156) adjacent to each lateral side (148), wherein each outer recess (158) opens through the second working side (150) and closes along the first working side (150), similar to the intermediate recess (152).

[0063] In this form, the internal volume of the recesses (152, 154, 156, 158) decreases in a direction away from the second intermediate plane (P2), wherein the intermediate recess (152) has the largest internal volume of the recesses (152, 154, 156, 158), and each outer recess (158) has the smallest internal volume of the recesses (152, 154, 156, 158). Additionally, the web of material separating the outer recess (158) from the second intermediate recess (156) is thicker than the web of material separating the first intermediate recess from the second intermediate recess (154 156). Accordingly, the buckling strength of the flexible body portion (146) increases in a direction away from the second intermediate plane (P2), wherein the minimum buckling strength is at the second intermediate plane (P2) and the maximum buckling strength is at the lateral side (148).

[0064] Figure 15 Another alternative adhesive spreader (160) is shown and includes a proximal body portion (162) similar to the proximal body portion (62), a distal body portion (164) similar to the distal body portion (64), a unique flexible body portion (166), a pair of lateral sides (168), and a pair of working sides (170). The flexible body portion (166) of this example includes a first void feature in the form of a pair of wedge-shaped channels (172), and a second void feature in the form of an array of angled slits (174) formed between the lateral ends of the wedge-shaped channels (172) and the lateral sides (168) of the adhesive spreader (160). The angled slits (174) extend completely through the thickness of the adhesive spreader (160) and are arranged in pairs, wherein each pair defines an arrow or chevron shape having a vertex oriented towards the respective lateral side (168). Additionally, the angled slits (174) have an opening size that gradually increases in a direction advancing from the lateral side (168) towards the second intermediate plane (P2) that bisects the adhesive spreader along its thickness. Accordingly, the buckling strength of the flexible body portion (166) decreases in a direction from the lateral side (168) towards the second intermediate plane (P2).

[0065] Figure 16Another alternative adhesive spreader (180) is shown, which includes a proximal body portion (182) similar to the proximal body portion (62), a distal body portion (184) similar to the distal body portion (64), a unique flexible body portion (186), a pair of lateral sides (188), and a pair of working sides (190). The flexible body portion (186) of this example includes void features in the form of an array of holes (192) that extend completely through the thickness of the adhesive spreader (180) along a linear path that is transverse to the longitudinal axis of the adhesive spreader (180) and parallel to the second intermediate plane (P2). In this configuration, the holes (192) are symmetrically formed about the second intermediate plane (P2), and the average diameter and density of the holes (192) increase in a direction toward the second intermediate plane (P2). Accordingly, the buckling strength of the flexible body portion (186) decreases in a direction toward the second intermediate plane (P2).

[0066] IV. Combined Examples

[0067] The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claims that may be provided at any time in this patent application or in subsequent filings of this patent application. No disclaimer is intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be arranged and applied in many other ways. It is also contemplated that some variations may omit certain features mentioned in the following examples. Accordingly, none of the aspects or features mentioned below should be considered decisive, unless expressly so indicated by the inventors or successors in interest to the inventors at a later date. If any claims presented in this patent application or in subsequent filings related to this patent application include additional features beyond those mentioned below, such additional features should not be assumed to have been added for any reason related to patentability.

[0068] Example 1

[0069] A device, the device comprising: (a) a proximal body portion configured to be grasped by a user; (b) a distal body portion terminating distally in a spreading tip configured to spread a topical skin adhesive along an application surface; and (c) a flexible body portion interconnecting the proximal body portion and the distal body portion to define an integral body, wherein in response to an input force applied by the user to the proximal body portion when the spreading tip is positioned against the application surface, the flexible body portion is configured to be capable of at least one of the following: (i) buckling non-uniformly along a transverse width of the device, or (ii) elastically deforming such that the distal body portion is angularly deflected relative to the proximal body portion, thereby limiting a normal resultant force applied by the spreading tip to the topical skin adhesive along the application surface to a predetermined range.

[0070] Example 2

[0071] The device according to embodiment 1, wherein the integral body comprises an elastomeric material having a hardness of from about 50 Shore A to about 70 Shore A.

[0072] Example 3

[0073] The device according to any of the foregoing embodiments, wherein the elastomeric material comprises silicone rubber.

[0074] Example 4

[0075] The device according to any of the foregoing embodiments, wherein the proximal body portion extends along a longitudinal axis, wherein the spreading tip is configured to apply a normal force of from about 1.5 lbf to about 5 lbf to the topical skin adhesive when the flexible body portion is in an elastically deformed state, such that the distal body portion is angularly deflected relative to the proximal body portion.

[0076] Example 5

[0077] The device according to any of the foregoing embodiments, wherein the flexible body portion comprises void features.

[0078] Example 6

[0079] The device according to embodiment 5, wherein the void features comprise a pair of wedge-shaped channels disposed on opposite sides of the integral body, wherein each of the wedge-shaped channels extends transversely to the longitudinal axis of the device.

[0080] Example 7

[0081] The device according to embodiment 6, wherein each of the wedge-shaped channels has opposing first and second surfaces defining an angle of approximately 20°.

[0082] Example 8

[0083] The device according to any one of the foregoing embodiments, wherein the distal body portion tapers distally and the spreading tip defines the minimum thickness of the integral body.

[0084] Example 9

[0085] The device according to any one of the foregoing embodiments, wherein each of the flexible body portion and the spreading tip has a non-uniform thickness along the transverse width of the integral body, such that the buckling strength of the flexible body portion varies along the transverse width.

[0086] Example 10

[0087] The device according to any one of the foregoing embodiments, wherein the integral body is symmetric about a median plane that bisects the integral body between opposite transverse sides thereof.

[0088] Example 11

[0089] The device according to embodiment 10, wherein the buckling strength of the flexible body portion increases orthogonally from the median plane towards the transverse side, and wherein the buckling strength of the spreading tip decreases orthogonally from the median plane towards the transverse side.

[0090] Example 12

[0091] The device according to any one of the foregoing embodiments, wherein the thickness of the flexible body portion increases orthogonally from the median plane towards the transverse side, and wherein the thickness of the spreading tip decreases orthogonally from the median plane towards the transverse side.

[0092] Example 13

[0093] The device according to any one of the foregoing embodiments, wherein the distal body portion is at least partially transparent and includes alignment indicators configured to align with the longitudinal axis of the wound when spreading a topical adhesive over the wound.

[0094] Example 14

[0095] A system, the system comprising: (a) a wound closure device having a mesh layer and a pressure-sensitive adhesive layer on the underside of the mesh layer, wherein the wound closure device is configured to be applied to a wound in a patient's skin; (b) an adhesive application device containing a topical skin adhesive, wherein the adhesive application device is operable to dispense the topical skin adhesive onto the mesh layer of the applied wound closure device; and (c) a device according to Embodiment 1, wherein the device is configured to spread the topical skin adhesive applied by the adhesive application device onto the mesh layer of the wound closure device.

[0096] Example 15

[0097] The system according to Embodiment 14, wherein the topical skin adhesive comprises silicone.

[0098] Example 16

[0099] A device, the device comprising: (a) a proximal body portion; (b) a distal body portion that extends coaxially with the proximal body portion and terminates distally in a spreading tip configured to spread a topical skin adhesive along an application surface; and (c) a flexible body portion that interconnects the proximal body portion and the distal body portion to define an integral body, wherein the flexible body portion includes a void feature configured to facilitate elastic deformation of the integral body at the flexible body portion such that the distal body portion angularly deflects relative to the proximal body portion in response to an input force applied by a user to the proximal body portion, thereby limiting the normal resultant force applied by the spreading tip along the application surface to the topical skin adhesive.

[0100] Example 17

[0101] The device according to Embodiment 16, wherein the void feature includes a pair of wedge-shaped channels disposed on opposite sides of the integral body.

[0102] Example 18

[0103] The device according to Embodiment 16 or 17, wherein the flexible body portion has a buckling strength that varies along the transverse width of the integral body, wherein the flexible body portion has a minimum buckling strength at its lateral midpoint.

[0104] Example 19

[0105] An apparatus, the apparatus comprising: (a) a proximal body portion configured to be grasped by a user; (b) a distal body portion terminating distally in a spreading tip configured to spread a topical skin adhesive along an application surface; and (c) a flexible body portion interconnecting the proximal body portion and the distal body portion to define an integral body, wherein the flexible body portion is configured to elastically deform such that the distal body portion angularly deflects relative to the proximal body portion in response to an input force applied by the user to the proximal body portion, thereby limiting the normal resultant force applied by the spreading tip along the application surface to the topical skin adhesive, wherein the integral body is symmetric about a median plane that bisects the integral body along the thickness of the integral body between opposite lateral sides of the integral body, wherein the thickness of the flexible body increases or decreases in an orthogonal direction from the median plane toward the lateral sides, and wherein the thickness of the spreading tip increases or decreases in an orthogonal direction from the median plane toward the lateral sides.

[0106] Example 20

[0107] The apparatus according to embodiment 19, wherein the thickness of the flexible body portion increases in a direction toward the lateral sides from the median plane, and wherein the thickness of the spreading tip decreases in an orthogonal direction from the median plane toward the lateral sides.

[0108] Example 21

[0109] A system, the system comprising: (a) a wound closure device having a mesh layer and a pressure-sensitive adhesive layer on the underside of the mesh layer, wherein the wound closure device is configured to be applied over a wound in a patient's skin; (b) an adhesive application device containing a topical skin adhesive, wherein the adhesive application device is operable to dispense the topical skin adhesive onto the mesh layer of the applied wound closure device; and (c) an adhesive spreader operable to spread the applied topical skin adhesive over and through the wound closure device, wherein the adhesive spreader includes: (i) a proximal body portion configured to be grasped by a user; (ii) a distal body portion terminating distally in a spreading tip configured to spread the topical skin adhesive along the top surface of the wound closure device; and (iii) a flexible body portion interconnecting the proximal body portion and the distal body portion to define a unitary body, wherein the flexible body portion is configured to elastically deform in response to an input force applied by the user to the proximal body portion when the spreading tip is positioned against the application surface, such that the distal body portion deflects angularly relative to the proximal body portion, thereby limiting the normal resultant force applied by the spreading tip along the top surface to the topical skin adhesive to a predetermined range.

[0110] Example 22

[0111] The device according to embodiment 21, wherein the topical skin adhesive is curable and configured to remain elastic after curing.

[0112] Example 23

[0113] The device according to embodiment 22, wherein the topical skin adhesive comprises silicone.

[0114] Example 24

[0115] A method of spreading a topical skin adhesive onto a wound closure device positioned over a skin wound of a patient using an adhesive spreader, the adhesive spreader including a proximal body portion, a distal body portion terminating distally in a spreading tip, and a flexible body portion interconnecting the proximal body portion and the distal body portion, the method comprising: (a) positioning the spreading tip in contact with the topical skin adhesive on a top surface of the wound closure device; (b) angling the adhesive spreader such that its longitudinal axis defines an angle of about 45° to about 60° relative to the top surface; (c) applying a force to the proximal body portion such that the flexible body portion elastically deforms and the distal body portion deflects angularly relative to the proximal body portion such that the spreading tip applies a normal force in the range of about 1.5 lbf to about 5 lbf on the topical skin adhesive and the top surface; and (d) dragging the spreading tip along the top surface to force the topical skin adhesive through the wound closure device.

[0116] Example 25

[0117] The device according to embodiment 24, wherein the topical skin adhesive comprises silicone.

[0118] V. Miscellaneous

[0119] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Accordingly, the foregoing teachings, expressions, embodiments, examples, etc. should not be regarded as mutually exclusive. Various suitable ways in which the teachings herein may be combined will be apparent to those of ordinary skill in the art in light of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0120] In addition, any one or more of the teachings in the teachings of this article can be combined with any one or more of the teachings in the teachings disclosed in the following patent applications: U.S. Patent Application No. 29 / 860,717, entitled "Device for Spreading Topical Skin Adhesive", filed on November 22, 2022, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent Application No. 17 / 991,992, entitled "Application of Topical Skin Adhesive to Surgical Mesh", filed on November 22, 2022, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent Application No. 17 / 991,945, entitled "Surgical Mesh Securing Device for Wound Closure System", filed on November 22, 2022, the disclosure of which is incorporated herein by reference in its entirety; and / or U.S. Patent Application No. 17 / 991,950, entitled "Wound Closure System Having Microcannulaic Pathways", filed on November 22, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0121] It should be understood that any patent, patent publication or other publicly available material purported to be incorporated herein by reference, whether in whole or in part, is incorporated herein only to the extent that such incorporated material does not conflict with the existing definitions, statements or other publicly available material set forth in this disclosure. Accordingly, and to the extent necessary, the disclosure set forth herein expressly supersedes any conflicting material incorporated herein by reference. Any material or portion thereof purported to be incorporated herein by reference that conflicts with the existing definitions, statements or other publicly available material set forth herein will be incorporated only to the extent that the incorporated material does not create a conflict with the existing publicly available material.

[0122] The above-described types of devices can be applied to traditional medical treatments and surgeries performed by medical professionals, as well as robot-assisted medical treatments and surgeries. By way of example only, the various teachings herein can be readily incorporated into robotic surgical systems, such as the DAVINCI TM system.

[0123] Devices of the type described above can be designed to be discarded after a single use, or they can be designed to be reusable multiple times. In either case or both cases, these types can be repaired to be reused after at least one use. The repair can include any combination of the following steps: disassembling the device, then cleaning or replacing specific parts and subsequently reassembling. Specifically, some types of devices can be disassembled, and any number of specific parts or portions of the device can be selectively replaced or removed in any combination. When cleaning and / or replacing specific components, some types of the device can be reassembled at a repair facility or by the user immediately prior to surgery for subsequent use. Those skilled in the art will appreciate that the repair of the device can be carried out for disassembly, cleaning / replacement, and reassembly using a variety of techniques. The use of such techniques and the resulting repaired device are all within the scope of this application.

[0124] By way of example only, the types described herein can be sterilized before and / or after surgery. In one sterilization technique, the device is placed in a closed and sealed container such as a plastic bag or a TYVEK bag. The container and the device can then be placed in a radiation field that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation can kill bacteria on the device and in the container. The sterilized device can then be stored in a sterile container for later use. Any other technique known in the art can also be used to sterilize the device, which includes but is not limited to beta radiation or gamma radiation, ethylene oxide, or steam.

[0125] Various embodiments of the invention have been shown and described. Further improvements to the methods and systems described herein can be achieved by appropriate modification by those of ordinary skill in the art without departing from the scope of the invention. Several such possible modifications have been mentioned, and other modifications will be obvious to those skilled in the art. For example, the embodiments, implementations, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not essential. Therefore, the scope of the invention should be considered in light of the following claims and should be understood to be not limited to the details of the structures and operations shown and described in the specification and drawings.

Claims

1. An apparatus, comprising: (a) a proximal body portion configured to be grasped by a user; (b) a distal body portion terminating distally in a spreading tip configured to spread a topical skin adhesive along an application surface; and (c) a flexible body portion interconnecting the proximal body portion and the distal body portion to define a unitary body, wherein when the spreading tip is positioned against the application surface, in response to an input force applied by the user to the proximal body portion, the flexible body portion is configured to be capable of at least one of the following: (i) buckle non-uniformly along a transverse width of the apparatus, or (ii) elastically deform such that the distal body portion angularly deflects relative to the proximal body portion, thereby limiting a normal resultant force applied by the spreading tip to the topical skin adhesive along the application surface to a predetermined range.

2. The device according to claim 1, wherein The unitary body comprises an elastomeric material having a hardness of from about 50 Shore A to about 70 Shore A.

3. The device according to claim 1 or 2, wherein The elastomeric material comprises silicone rubber.

4. The device according to any one of the preceding claims, wherein, The proximal body portion extends along a longitudinal axis, wherein the spreading tip is configured to apply a normal force of from about 1.5 lbf to about 5 lbf to the topical skin adhesive when the flexible body portion is in an elastically deformed state such that the distal body portion angularly deflects relative to the proximal body portion.

5. The device according to any one of the preceding claims, wherein, The flexible body portion comprises void features.

6. The device according to claim 5, wherein, The void features comprise a pair of wedge-shaped channels disposed on opposite sides of the unitary body, wherein each of the wedge-shaped channels extends transversely to the longitudinal axis of the apparatus.

7. The apparatus according to claim 6, wherein, Each of the wedge-shaped channels has opposing first and second surfaces defining an angle of about 20°.

8. The apparatus according to any one of the preceding claims, wherein, The distal body portion tapers distally, and the spreading tip defines a minimum thickness of the unitary body.

9. The apparatus according to any one of the preceding claims, wherein, Each of the flexible body portion and the spreading tip has a non-uniform thickness along the transverse width of the unitary body such that a buckling strength of the flexible body portion varies along the transverse width.

10. The device according to any one of the preceding claims, wherein, The unitary body is symmetric about a median plane that bisects the unitary body between opposite lateral sides of the unitary body.

11. The apparatus according to claim 10, wherein, The buckling strength of the flexible body portion increases orthogonally from the median plane toward the lateral sides, wherein the buckling strength of the spreading tip decreases orthogonally from the median plane toward the lateral sides.

12. The device according to claim 10 or 11, wherein, The thickness of the flexible body portion increases orthogonally from the median plane toward the lateral sides, wherein the thickness of the spreading tip decreases orthogonally from the median plane toward the lateral sides.

13. The device according to any one of the preceding claims, wherein, The distal body portion is at least partially transparent and includes an alignment indicator configured to align with a longitudinal axis of a wound when spreading the topical adhesive over the wound.

14. A system, comprising: (a) A wound closure device having a mesh layer and a pressure - sensitive adhesive layer on the underside of the mesh layer, wherein the wound closure device is configured to be applied to a wound in a patient's skin; (b) An adhesive application device comprising a topical skin adhesive, wherein the adhesive application device is operable to dispense the topical skin adhesive onto the mesh layer of the applied wound closure device; and (c) The device according to claim 1, wherein the device is configured to spread the topical skin adhesive applied by the adhesive application device onto the mesh layer of the wound closure device.

15. The system according to claim 14, wherein, The topical skin adhesive comprises silicone.

16. A device comprising: (a) A proximal body portion; (b) A distal body portion that extends coaxially with the proximal body portion and terminates distally in a spreading tip configured to spread a topical skin adhesive along an application surface; and (c) A flexible body portion that interconnects the proximal body portion and the distal body portion to define a monolithic body, wherein the flexible body portion includes a void feature configured to facilitate elastic deformation of the monolithic body at the flexible body portion such that the distal body portion angularly deflects relative to the proximal body portion in response to an input force applied by a user to the proximal body portion, thereby limiting the normal resultant force applied by the spreading tip to the topical skin adhesive along the application surface.

17. The apparatus according to claim 16, wherein, The void feature includes a pair of wedge - shaped channels disposed on opposite sides of the monolithic body.

18. The device according to claim 16 or 17, wherein The flexible body portion has a buckling strength that varies along the transverse width of the monolithic body, wherein the flexible body portion has a minimum buckling strength at its lateral mid - point.

19. A device comprising: (a) A proximal body portion configured to be grasped by a user; (b) A distal body portion that terminates distally in a spreading tip configured to spread a topical skin adhesive along an application surface; and (c) A flexible body portion that interconnects the proximal body portion and the distal body portion to define a monolithic body, wherein the flexible body portion is configured to elastically deform such that the distal body portion angularly deflects relative to the proximal body portion in response to an input force applied by a user to the proximal body portion, thereby limiting the normal resultant force applied by the spreading tip to the topical skin adhesive along the application surface, wherein the monolithic body is symmetric about a middle plane that bisects the monolithic body along its thickness between opposite lateral sides of the monolithic body, wherein the thickness of the flexible body increases or decreases in an orthogonal direction from the middle plane towards the lateral sides, wherein the thickness of the spreading tip increases or decreases in an orthogonal direction from the middle plane towards the lateral sides.

20. The apparatus according to claim 19, wherein The thickness of the flexible body portion increases in a direction toward the lateral side from the intermediate plane, wherein the thickness of the spreading tip decreases in an orthogonal direction toward the lateral side from the intermediate plane.

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