Device for applying topical skin adhesive

Abstract

The device comprises a proximal body portion configured to be gripped by a user, a distal body portion terminating in an application tip configured to apply the topical skin adhesive along an application surface, and a bending body portion interconnecting the proximal and distal body portions to define a monolithic body. In response to an input force applied to the proximal body portion by a user when the application tip is positioned against the application surface, the bending body portion is configured to buckle non-uniformly along the lateral width of the device. Additionally or alternatively, the bending body portion is configured to elastically deform such that the distal body portion flexes at an angle relative to the proximal body portion, thereby limiting the resultant normal force exerted by the application tip on the topical skin adhesive along the application surface to a predetermined range.

Description

[Technical Field]

[0001] (Priority) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 427132, filed November 22, 2022, entitled "Device for Spreading Topical Skin Adhesive," the disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0002] Wound closure systems (also referred to as skin closure systems) can be used at the end of a surgical procedure on a patient to close a wound (e.g., a surgical incision) formed in the patient's skin to access a target anatomical structure. By way of example, a wound closure system can include components such as sutures, a substrate, and / or a liquid topical skin adhesive, which are applied by the surgeon to approximate the wound edges and, in some cases, form a stable, protective layer over the wound that promotes efficient 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 may naturally separate from the skin so that they can be discarded by the patient.

[0003] While various wound closure systems and related components and methods have been made and used, it is believed that no one prior to the inventors has made or used the invention as set forth in the appended claims. [Brief explanation of the drawings]

[0004] The accompanying drawings, which are incorporated in and constitute 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. [Figure 1]1 depicts a perspective view of an example wound closure system including a wound closure device, an adhesive applicator, and an adhesive spreader. [Figure 2] 2 depicts an exploded perspective view of the wound closure device of FIG. 1, depicting a mesh layer, a pressure-sensitive adhesive layer, and a removable backing layer. [Figure 3A] 2 depicts a perspective view of the wound closure device of FIG. 1 aligned longitudinally with a wound in a patient's skin and depicts a central section of the backing layer removed; [Figure 3B] 2 depicts a perspective view of the wound closure device of FIG. 1 applied to a patient's skin over a wound to approximate the edges of the wound. [Figure 3C] 2 depicts a perspective view of the wound closure device of FIG. 1 applied to a patient's skin on a wound, with the remaining section of the backing layer removed so that the wound closure device is fully adhered to the skin. [Figure 3D] 2 depicts a perspective view of the wound closure device of FIG. 1 applied to a patient's skin on a wound, showing application of a liquid topical skin adhesive onto the mesh layer using an adhesive applicator. [Figure 3E] 2 depicts a perspective view of the wound closure device of FIG. 1 applied to a patient's skin on a wound, and depicts an adhesive spreader positioned relative to the patient at the beginning of an adhesive application stroke to spread applied topical skin adhesive over and through the wound closure device. [Figure 3F] 2 depicts a perspective view of the wound closure device of FIG. 1 applied to a patient's skin on a wound, depicting the adhesive spreader during a subsequent portion of the adhesive application stroke; [Figure 4] 2 depicts a perspective view of the adhesive spreader of FIG. 1; [Figure 5] 2 depicts a top view of the adhesive spreader of FIG. 1; [Figure 6] 2 depicts a side view of the adhesive spreader of FIG. 1; [Figure 7A] 7 depicts a cross-sectional side view of the adhesive spreader of FIG. 1 taken along line 7-7 of FIG. 4, showing the distal body portion of the adhesive spreader deflected in a first direction. [Figure 7B]7 depicts a cross-sectional side view of the adhesive spreader of FIG. 1 taken along line 7-7, showing the distal body portion deflected in a second direction. [Figure 8] 8 depicts a cross-sectional end view of the adhesive spreader of FIG. 1 taken along line 8-8 of FIG. 4; [Figure 9] 9 depicts a cross-sectional end view of the adhesive spreader of FIG. 1 taken along line 9-9 of FIG. 4; [Figure 10] 2 depicts a plan view of the distal body portion of the adhesive spreader of FIG. 1 showing the application tip of the adhesive spreader conforming to a convexly curved skin surface. [Figure 11] 2 depicts a plan view of the distal body portion of the adhesive spreader of FIG. 1 showing an application tip that conforms to convex and concave curved skin surfaces; [Figure 12] 10 depicts a cross-sectional end view of another exemplary adhesive spreader configured for use with the wound closure system of FIG. 1; [Figure 13] 10 depicts a cross-sectional end view of another exemplary adhesive spreader configured for use with the wound closure system of FIG. 1; [Figure 14] 10 depicts a cross-sectional end view of another exemplary adhesive spreader configured for use with the wound closure system of FIG. 1; [Figure 15] 10 depicts a perspective view of another exemplary adhesive spreader configured for use with the wound closure system of FIG. 1; [Figure 16] 10 depicts a perspective view of another exemplary adhesive spreader configured for use with the wound closure system of FIG. 1;

[0005] The drawings are not intended to be limiting in any manner, and it is contemplated that various embodiments of the invention may be embodied in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings, which are incorporated in and form a part of this specification, illustrate several aspects of the invention and, together with the specification, serve to explain the principles of the invention, it being understood, however, that the invention is not limited to the precise arrangements shown. DETAILED DESCRIPTION OF THE INVENTION

[0006] The following description of specific examples of the present technology should not be used for the purpose of limiting its scope. Other examples, features, aspects, embodiments, and advantages of the present technology will become apparent to those skilled in the art from the following description, which is, by way of example, one of the best modes contemplated for carrying out the present technology. As will be understood, the technology described herein is capable of other different and obvious aspects, all without departing from the technology. Therefore, the drawings and descriptions should be regarded as illustrative in nature, and not as restrictive.

[0007] For clarity of this disclosure, the terms "proximal" and "distal" are defined herein relative to a human or robotic surgical instrument operator. The term "proximal" refers to the location of an element closer to a human or robotic surgical instrument operator and further from a surgical end effector of the surgical instrument. The term "distal" refers to the location of an element closer to a surgical end effector of the surgical instrument and further from a human or robotic surgical instrument operator. It will also be recognized that for convenience and clarity of exposition, spatial terms such as "side," "upwardly," and "downwardly" are used herein to refer to relative positions and directions. Such terms are used hereinafter with reference to the figures as illustrated for clarity and are not intended to limit the invention described herein.

[0008] Furthermore, the terms "about," "approximately," and the like, as used herein in connection with any numerical value or range of values, are intended to encompass the exact value referenced, as well as a suitable tolerance that enables the referenced feature or combination of features to function for the intended purpose described herein.

[0009] I. Wound Closure System Figure 1 shows an example of a wound closure system (10) that includes a wound closure device (20) (also referred to as a patch) configured to be applied to a wound (W) on a patient, an adhesive applicator (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) over and through the wound closure device (20). Each of these components is described in further detail below.

[0010] As best shown in Figure 2, the wound closure device (20) of this variation has an elongated, generally rectangular shape and a three-layer construction. More specifically, the wound closure device (20) includes a substrate layer in the form of a fibrous mesh (22), a layer of pressure-sensitive adhesive (24) formed as a continuous or discontinuous coating along the skin-facing underside of the mesh (22), and a layer of backing (26) removably applied to the underside of the pressure-sensitive adhesive (24). It will be understood that the term "wound closure device" as used herein encompasses both wound closure devices (20) with and without a backing (26), which may be removed and discarded during application of the wound closure device (20) to a patient, as described in more detail below.

[0011] The mesh (22) is configured to retain a liquid topical skin adhesive and may be formed of polyethylene (PET) or any other suitable surgical fabric material. The pressure-sensitive adhesive (24) is configured to allow the wound closure device (20) to self-adhere to the patient's skin in response to pressure applied to the upper side of the mesh (22) during application by a surgeon. The backing (26) serves to protect the pressure-sensitive adhesive (24) prior to application of the wound closure device (20) to the patient. In this variation, the backing (26) includes an array of elongated perforations extending longitudinally therethrough that define an elongated central backing section (28) and a pair of elongated side backing sections (30). While each backing section (28, 30) is shown as generally rectangular in this variation, the backing sections (28, 30) may be of various alternative shapes, sizes, and quantities in other variations.

[0012] As shown in FIG. 1 , the adhesive applicator (40) includes an applicator body (42), a plunger unit (44) slidably received within the open proximal end of the applicator body (42), and a static mixer (46) secured to the distal end of the applicator body (42). The applicator body (42) includes a pair of barrels (48) arranged side by side, each barrel (48) housing a respective component of a two-component liquid topical skin adhesive. The plunger unit (44) includes a pair of plungers (50) arranged side by side and interconnected at their proximal ends by a bridge (52). Each plunger (50) is actuable distally through a respective barrel (48) of the applicator body (42) to force a corresponding liquid adhesive component distally into the static mixer (46). The static mixer (46) is configured to receive the first and second adhesive components and direct them around and through a series of static baffles and passageways (not shown) that mix the two adhesive components into a homogenous liquid adhesive (54) that is then dispensed through the open distal end of the static mixer (46), as shown in FIG. 3D, described below.

[0013] In this variation, the liquid topical skin adhesive (54) is in the form of a silicone-based topical skin adhesive configured to cure on the skin in less than two minutes at body temperature. Once cured, the topical skin adhesive (54) remains elastomeric such that a given section of the cured adhesive (54) is configured to stretch up to 160% of its cured length and then fully recover to its cured length. Thus, the wound closure system (10) may be particularly effective for use on a patient's mobile body parts, such as, for example, a knee, wrist, elbow, or other joint.

[0014] 1, the adhesive spreader (60) of this variation has a monolithic body including a proximal body portion (62) configured to be grasped by a user, a distal body portion (64) terminating in a tip configured to spread an applied topical skin adhesive (54), and an intermediate bending body portion (66) interconnecting the proximal body portion (62) and the distal body portion (64). The bending body portion (66) is configured to elastically deform such that the distal body portion (64) flexes at an angle relative to the proximal body portion (62) to facilitate effective application of the topical skin adhesive (54) along the wound closure device (20) within a predetermined range of suitable normal forces, as described in more detail below.

[0015] 3A-3D show an example of a wound closure system (10) being used to close a wound (W) formed in a patient's skin (S). In some procedures, the wound (W) may be at least partially closed with one or more sutures, for example, in deeper portions of the wound (W), prior to use of the wound closure system (10). Additionally, the wound closure device (20) may be trimmed by a surgeon to any desired suitable shape before application to the patient.

[0016] As shown in FIG. 3A , the central backing section (28) is removed from the wound closure device (20), exposing the central window in the mesh (22) and pressure-sensitive adhesive (24), with the imaginary centerline of the wound closure device (20) 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), adhering the pressure-sensitive adhesive (24) to the skin (S), thus securing the edges of the wound (W) relative to one another. Prior to this step, the edges of the wound (W) may be held in approximation by the surgeon. Alternatively, during this step, the central portion of the wound closure device (20) may be applied laterally, alternating, to approximate the edges of the wound (W) during application. In either approach, the wound closure device (20) is configured to hold the edges of the wound (W) together 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 then remove the remaining two side backing sections (30) and adhere the remainder of the wound closure device (20) to the skin (S).

[0017] As shown in Figure 3D, the adhesive applicator (40) is then used to apply a pattern of topical skin adhesive (54) to the top side of the mesh (22) of the applied wound closure device (20). While the adhesive applicator (40) is shown in this variation applying a linear bead of topical skin adhesive (54), it will be understood that various other patterns of topical skin adhesive (54) may be applied in other variations, such as a T-shaped pattern or a wave pattern as disclosed in U.S. Patent Application No. 17 / 991,992, entitled "Application of Topical Skin Adhesive to Surgical Mesh," filed November 22, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0018] As shown in Figures 3E-3F, an adhesive spreader (60) is then used to evenly distribute the applied topical skin adhesive (54) onto the wound closure device (20) and press the topical skin adhesive (54) directly onto the wound (W) and surrounding skin (S) through the mesh (22) and pressure-sensitive adhesive (24) layers. In this regard, the mesh (22) and pressure-sensitive adhesive (24) layers may be at least partially permeable to allow the topical skin adhesive (54) to be pushed through. As shown in Figure 3E, the curved body portion (66) of the adhesive spreader (60) may be in an undeformed state when the adhesive spreader (60) is initially positioned against the wound closure device (20) at the start of the adhesive application stroke. As the adhesive spreader (60) is dragged longitudinally along the wound closure device (20), an input force exerted by the user may elastically deform the bending body portion (66) such that the distal body portion (64) deflects at an angle relative to the proximal body portion (62), as shown in FIG. 3F. The degree of deformation of the bending body portion (66) may be directly related to the viscosity of the topical skin adhesive (54). In particular, a higher viscosity may require the user to exert a greater input force through the proximal body portion (62) such that the bending body portion (66) deforms relatively more to effectively apply the topical skin adhesive (54) onto and through the wound closure device (20). Conversely, a lower viscosity may require a smaller input force such that the bending body portion (66) deforms less, or not at all.

[0019] Optionally, the topical skin adhesive (54) may also be applied over adjacent portions of the skin (S) not covered by the wound closure device (20) to ensure that the topical skin adhesive (54) is embedded throughout the mesh (22). For example, by way of example only, the topical skin adhesive (54) may be applied onto the skin (S) for at least 1 cm around the entire perimeter of the applied wound closure device (20). Once the topical skin adhesive (54) has been completely applied onto the wound closure device (20), any topical skin adhesive (54) on the skin (S) beyond the perimeter of the device (20) may be wiped away, for example, with sterile gauze. Additionally, in some cases, a quantity of the topical skin adhesive (54) may be applied between the edges of the wound (W) before the wound closure device (20) is applied to the skin (S). The applied topical skin adhesive (54) then hardens within and on the wound closure device (20) to form a complex microbial barrier on the wound (W) that maintains a protective environment that promotes efficient healing. After the wound (W) has healed, the wound closure device (20) may be manually removed from the skin (S) (e.g., by a surgeon) or may naturally separate from the skin (S) so that it can be discarded by the patient.

[0020] The wound closure system (10) may be based on U.S. Patent No. 1,712,229, entitled "Systems, Devices and Methods for Dispensing and Curing Silicone Based Topical Skin Adhesives," issued August 1, 2023, the entire disclosure of which is incorporated herein by reference; U.S. Patent No. 1,518,604, entitled "Systems, Methods and Devices for Aerosol Spraying of Silicone Based Topical Skin Adhesives for Sealing Wounds," issued December 6, 2022, the entire disclosure of which is incorporated herein by reference; U.S. Patent No. 1,1479,669, entitled "Novel Topical Skin Closure Compositions and Systems," issued October 25, 2022, the entire disclosure of which is incorporated herein by reference; and U.S. Patent No. 1,1479,669, entitled "Novel Antimicrobial Topical Skin Closure Compositions and Systems," issued December 2, 2021, the entire disclosure of which is incorporated herein by reference. No. 11,589,867, entitled "Anisotropic Wound Closure Systems," published February 28, 2023, the entire disclosure of which is incorporated herein by reference; and / or U.S. Patent Application 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 December 15, 2022, the entire disclosure of which is incorporated herein by reference.

[0021] II. Adhesive Spreader As described above, the adhesive spreader (60) of this variation has a monolithic body defined by the combination of a proximal body portion (62), a distal body portion (64), and a curved body portion (66). As described in more detail below, this monolithic body has a variable buckling strength along its lateral width and is configured to elastically deform at the curved body portion (66) and its distal end to ensure consistent application of a predetermined appropriate range of normal forces to the topical skin adhesive (54) and wound closure device (20) during use. In that regard, the adhesive spreader (60) is configured to ensure that a topical skin adhesive, such as the topical skin adhesive (54), is sufficiently forced through the wound closure device (20) to contact and bond with the skin (S) without transmitting excessive normal forces that could detach the wound closure device (20) from the skin (S).

[0022] As shown in FIG. 4 , the monolithic body of the adhesive spreader (60) extends longitudinally between a rounded proximal end where the proximal body portion (62) terminates proximally and a square distal end defined by an applicator tip (68) where the distal body portion (64) terminates distally. The adhesive spreader (60) has a lateral width measured between opposing lateral sides (70) and a thickness measured between opposing working sides (72). The adhesive spreader (60) is symmetrical about a first midplane (P1) that bisects the monolithic body along its lateral width and about a second midplane (P2) that bisects the monolithic body along its thickness, the first and second midplanes (P1, P2) intersecting along the longitudinal axis (A) of the adhesive spreader (60). Thus, the adhesive spreader (60) can be used interchangeably in a variety of orientations. Each of the proximal body portion (62) and the distal body portion (64) has a generally elongated oval cross-section, having a generally constant thickness throughout the proximal body portion (62) and tapering in thickness distally through the distal body portion (64) toward the applicator tip (68), which defines the minimum thickness of the adhesive spreader (60) and thus has a lower stiffness than the proximal remainder of the adhesive spreader (60). Thus, the applicator tip (68) may be configured to elastically deflect before and at a faster rate than the bending body portion (66) when pressed against an application surface. The cross-sectional shapes and elastic deflection characteristics of the applicator tip (68) and the bending body portion (66) are described in more detail below.

[0023] As shown in Figures 4-6, the proximal body portion (62) on each working side (72) of the adhesive spreader (60) includes a finger well (74) located proximally near the bent body portion (66) and recessed inward with a concave curvature. Each finger well (74) is sized and shaped to receive one or more fingers, such as a user's thumb, to facilitate effective gripping of the proximal body portion (62). A plurality of surface gripping features in the form of raised protrusions (76) are located within the finger wells (74) and on at least the proximal half of the proximal body portion (62) on each working side (72) of the proximal body portion (62). The raised protrusions (76) are configured to further facilitate effective gripping of the proximal body portion (62) in the presence of fluids, such as bodily fluids or saline, which may otherwise cause the proximal body portion (62) to be slippery during a surgical procedure or when a user grasps the proximal body portion (62) with a gloved finger. The proximal body portion (62) on each working side (72) also includes a recessed region (78) proximal to the finger wells (74) that may include visual indicia (not shown), such as product branding, although it will be understood that the recessed region (78) is merely optional.

[0024] As shown in Figures 4-6, the distal body portion (64) tapers distally to the applicator tip (68) and includes an alignment indicator (80) on each working side (72) that is positioned along the longitudinal axis (A) of the adhesive spreader (60). In this variation, each alignment indicator (80) is shown in the form of a triangular recess, although the alignment indicators (80) may have a variety of other configurations and may be used in other variations. During use, the adhesive spreader (60) is oriented relative to the wound (W) and 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 wound closure device (20), and this alignment is maintained as the adhesive spreader (60) is pulled in longitudinal strokes across the wound closure device (20). As best shown in Figure 5, the applicator 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 applicator tip (68) is slightly wider than the wound closure device (20) so that, during use, the applicator tip (68) spans the entire width of the wound closure device (20) and can spread partially onto the skin (S) on each side of the wound closure device (20). By way of example only, the wound closure device (20) may be approximately 4 cm wide, and the adhesive spreader (60), including the applicator tip (68), may be approximately 4.5 cm wide.

[0025] Still referring to Figures 4-6, the curved 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" refers to the absence of material. Each wedge-shaped channel (84) is centered about the longitudinal axis (A) of the adhesive spreader (60) and has a length equal to approximately 80% of the lateral width of the adhesive spreader (60). As best shown in Figure 6, each wedge-shaped channel (84) has a proximal surface (86) that is generally perpendicular to the first midplane (P1) and a distal surface (88) that is angled obliquely relative to the first midplane (P1). The proximal and distal surfaces (86, 88) of each wedge-shaped channel (84) define an outward flared angle (θ) of approximately 20°.

[0026] 7A-7B, the wedge-shaped channels (84) cooperate to provide a central web portion of the bending body portion (66) with a lower stiffness than the proximal body portion (62), such that the bending body portion (66) is configured to elastically deform, such that when the applicator tip (68) is pressed against an application surface by a user, the distal body portion (64) deflects at an angle relative to the proximal body portion (62). More specifically, in response to a user input force, the distal body portion (64) is configured to pivotally hinge relative to the proximal body portion (62) about a transverse hinge axis defined by the bending body portion (66) that extends along a first midplane (P1) and intersects a second midplane (P2) orthogonally. The distal body portion (64) may deflect in a first direction by a maximum deflection angle (θ), as shown in FIG. 7A, and in an opposite second direction by a maximum deflection angle (θ), as shown in FIG. 7B. When the distal body portion (64) assumes the maximum deflection angle (θ) in either direction, the proximal and distal surfaces (86, 88) of the wedge-shaped channel (84) in the direction of deflection contact each other, thus acting as a mechanical stop to prevent 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) may resiliently spring back to its relaxed state, shown in FIG. 6, in which the proximal body portion (62) and the distal body portion (64) extend coaxially along the longitudinal axis (A) about the first midplane (P1).

[0027] During use of the adhesive spreader (60), a user grasps the proximal body portion (62) and positions the application 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) so that the longitudinal axis (A) of the adhesive spreader (60), defined by the proximal body portion (62), defines an inclination angle of about 45° to about 60° relative to the application surface, as shown in Figures 3E-3F. 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, with the proximal body portion (62) leading the distal body portion (64). Due to the tilt angle, the applied force generates a moment about the applicator tip (68) that may be sufficient to elastically deform the bending body portion (66) due to its reduced thickness, such that the distal body portion (64) flexes at an angle like a hinge relative to the proximal body portion (62). This elastic deformation of the bending body portion (66) may result in the applicator tip (68) exerting a normal force of about 1.5 lbf to about 5 lbf against the application surface and the topical skin adhesive when the proximal body portion (62) is oriented within the above tilt angle range.

[0028] When the proximal body portion (62) is oriented at an oblique angle greater than 60°, the moment generated at the applicator tip (68) gradually decreases, resulting in less deformation of the bent body portion (66) and more direct transfer of user-applied forces to the application surface via the applicator tip (68). For example, when the proximal body portion (62) is oriented at a 90° oblique angle so that the proximal body portion (62) is perpendicular to the application surface, the applicator tip (68) may exert a normal force of up to approximately 10 lbf. It will be appreciated that when applying a higher viscosity topical skin adhesive, such as a silicone-based adhesive like the topical skin adhesive (54), 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). Conversely, a lesser normal force may be required when applying a lower viscosity topical skin adhesive, which may pass more easily through the wound closure device (20). Thus, when the adhesive spreader (60) is oriented at the exemplary tilt angle ranges described above, applying a higher viscosity adhesive results in greater deflection of the bending body portion (66), for example, to the point where the channel surfaces (86, 88) contact one another. Conversely, applying a lower viscosity adhesive results in less or no deflection of the bending body portion (66).

[0029] The flexibility of the bending body portion 66 allows the user to have increased control and precession when applying the topical skin adhesive 54 onto the wound closure device 20. In that regard, the adhesive spreader 60 is configured to effectively apply the topical skin adhesive 54 onto and through the wound closure device 20 with a suitable normal force that may fall within the predetermined range described above, depending on the viscosity of the topical skin adhesive 54 and how the adhesive spreader 60 is manipulated by the user. Thus, the bending body portion 66 can operate to limit the normal force when applying a relatively low-viscosity topical skin adhesive and can operate to ensure a predetermined minimum normal force when applying a relatively high-viscosity topical skin adhesive. Furthermore, the structure of the adhesive spreader 60 allows for a consistent normal force to be applied onto the wound closure device 20 to create a film of the topical skin adhesive 54 having a uniform film thickness, such as about 0.5 mm. The adhesive spreader (60) may also facilitate the creation of a membrane edge with a tapered thickness that helps minimize the risk of catching hardened adhesive on the patient's clothing or other items that rest against the patient's skin (S).

[0030] As shown in Figures 8 and 9, each of the bending body portion (66) and applicator tip (68) has a non-uniform thickness, and therefore a non-uniform stiffness and buckling strength, along the lateral width of the adhesive spreader (60). More specifically, the thickness and buckling strength of the bending body portion (66) increase perpendicularly from the second central plane (P2) toward the lateral sides (70), with the maximum thickness and buckling strength of the bending body portion (66) defined at each longitudinal end of the wedge-shaped channel (84) adjacent to the lateral sides (70). Thus, the bending body portion (66) has minimum stiffness and buckling strength along the second central plane (P2) and maximum stiffness and buckling strength along the lateral sides (70). These regions of maximum buckling strength along the lateral sides (70) therefore function as structural beam-like features.

[0031] As shown in FIG. 9 , the applicator tip (68) has an inverse configuration with respect to thickness and buckling strength to the curved body portion (66). More specifically, the thickness and buckling strength of the applicator tip (68) decrease perpendicularly from the second central plane (P2) toward the lateral sides (70), with the maximum thickness of the curved body portion (66) defined at the second central plane (P2). Thus, the applicator tip (68) has maximum stiffness and buckling strength along the second central plane (P2) and minimum stiffness and buckling strength along the lateral sides (70). The inverse configurations of thickness and buckling strength of the curved body portion (66) and applicator tip (68) allow the adhesive spreader (60) to elastically deform axially along the longitudinal axis (A), thereby enabling the applicator tip (68) to conform to application surfaces having various types of contours. For example, Figure 10 shows an application tip 68 that conforms to a convex application surface 90, and Figure 11 shows an application tip 68 that conforms to a contoured application surface 92 having both convex and concave portions. Such application surfaces 90, 92 may represent, for example, a patient's body joints, such as a knee, wrist, or elbow.

[0032] To exhibit the various functional properties described above, the adhesive spreader (60) may be formed of an elastomeric material having a hardness of about 50 Shore A to about 70 Shore A, such as about 60 Shore A, which is non-reactive with the topical skin adhesive (54), the wound closure device (20), and the skin (S). By way of example only, the adhesive spreader (60) may comprise silicone rubber and may be formed by injection molding. In other variations, two or more portions of the adhesive spreader (60) may be formed of different materials, with at least the bending body portion (66) and the applicator tip (68) being formed of an elastomeric material. Additionally, all or at least a distal portion of the adhesive spreader (60) may be at least partially transparent to allow visualization through the adhesive spreader (60) while applying the topical adhesive and to facilitate alignment of the alignment indicator (80) with the wound (W).

[0033] III. Alternative adhesive spreader In some cases, it may be desirable to provide an adhesive spreader that includes a curved body portion having void features other than wedge-shaped channels (84), which provide the curved body portion with varying buckling strength along the lateral width of the adhesive spreader, and which facilitate elastic deformation of the curved body portion, allowing the distal body portion of the spreader to flex at an angle relative to the proximal body portion to adjust the normal force applied by the spreader to the application surface. Figures 12-16 show exemplary alternative adhesive spreaders (100, 120) constructed in such a manner, which are similar to adhesive spreader (60) except as otherwise described below.

[0034] Figure 12 shows an alternative adhesive spreader (100) including 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 bending body portion (106), a pair of lateral sides (108), and a pair of working sides (110). The bending body portion (106) includes void features in the form of a pair of wedge-shaped channels (112) that face each other relative to a first central plane (P1) (see Figures 4 and 6). Each channel (112) has a root (114) that extends concavely relative to the first central plane (P1). Thus, similar to the bending body portion (66), the thickness and buckling strength of the bending body portion (106) increase orthogonally from the second central plane (P2) toward the lateral sides (108). Specifically, the bent body portion (106) has a minimum thickness and buckling strength along the second central plane (P2) and a maximum thickness and buckling strength at the lateral edges of the wedge-shaped channel (112) adjacent to the lateral sides (108).

[0035] Figure 13 shows another alternative adhesive spreader (120) including a proximal body portion (122) similar to proximal body portion (62), a distal body portion (not shown) similar to distal body portion (64), a unique bending body portion (126), a pair of lateral sides (128), and a pair of working sides (130). The bending body portion (126) includes a void feature in the form of a pair of wedge-shaped openings (132) opposed to each other relative to a first midplane (P1) (see Figures 4 and 6). The wedge-shaped openings (132) are similar to the wedge-shaped channels (84, 112), but communicate with each other to define a central opening (134) (also referred to as a window) that penetrates a central portion of the bending body portion (126), extends longitudinally along the first central plane (P1), and opens to each working side (130). Similar to the bending body portions (66, 106), the thickness and buckling strength of the bending body portion (106) increase toward the lateral sides (128) away from the second central plane (P2). Specifically, the bending body portion (126) has a minimum buckling strength at the second central plane (P2) and along the length of the central opening (124), and a maximum buckling strength at the lateral ends of the wedge-shaped openings (132).

[0036] 14 illustrates another alternative adhesive spreader (140) including a proximal body portion (142) similar to the proximal body portion (62), a distal body portion (not shown) similar to the distal body portion (64), a unique bending body portion (146), a pair of lateral sides (148), and a pair of working sides (150). The bending body portion (146) includes void features in the form of a plurality of recesses (152, 154, 156, 158) formed in the working side (150), the recesses (152, 154, 156, 158) being symmetrically arranged about a second central plane (P2) and separated from one another by respective webs of material. In particular, the central recess (152) is located on the laterally central second central plane (P2) and is open through the second working side (150) and closed along the first working side (150). The first intermediate recesses (154) are disposed laterally on either side of the central recess (152) and open through the first working side (150) and are closed along the second working side (150). The second intermediate recesses (156) are disposed laterally outward of each first intermediate recess (154) and similarly open through the second working side (150) and are closed along the first working side (150). Finally, outer recesses (158) are disposed laterally outward of each second intermediate recess (156) adjacent each lateral side (148), and each outer recess (158), like the central recess (152), is open through the second working side (150) and is closed along the first working side (150).

[0037] In this variation, the interior volumes of the recesses (152, 154, 156, 158) decrease in a direction away from the second central plane (P2), with the central recess (152) having the largest interior volume of the recesses (152, 154, 156, 158) and each outer recess (158) having the smallest interior volume of the recesses (152, 154, 156, 158). In addition, 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 and second intermediate recesses (154, 156). Thus, the buckling strength of the bending body portion (146) increases in a direction away from the second central plane (P2), with a minimum buckling strength at the second central plane (P2) and a maximum buckling strength at the lateral sides (148).

[0038] 15 shows another alternative adhesive spreader (160) including 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 bending body portion (166), a pair of lateral sides (168), and a pair of working sides (170). The bending body portion (166) in 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 through the thickness of the adhesive spreader (160) and are arranged in pairs, each pair defining an arrow or chevron-like shape with an apex oriented toward a respective lateral side (168). Additionally, the angled slits (174) have opening sizes that gradually increase in size in the direction from the lateral side (168) toward the second midplane (P2) that bisects the adhesive spreader (160) along its thickness. Thus, the buckling strength of the bending body portion (166) decreases in the direction from the lateral side (168) toward the second midplane (P2).

[0039] 16 illustrates another alternative adhesive spreader (180) including 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 curved body portion (186), a pair of lateral sides (188), and a pair of working sides (190). The curved body portion (186) in this example includes void features in the form of an array of holes (192) extending through the thickness of the adhesive spreader (180) along linear paths extending transversely to the longitudinal axis of the adhesive spreader (180) and parallel to the second midplane (P2). In this variation, the holes (192) are formed symmetrically with respect to the second midplane (P2), with the average diameter and density of the holes (192) increasing in a direction toward the second midplane (P2). Thus, the buckling strength of the bending body portion (186) decreases in the direction toward the second mid-plane (P2).

[0040] IV. Example Combinations 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 presented at any time in this application or any subsequent application related to this application. No disclaimer is intended. The following examples are provided merely for illustrative purposes. It is contemplated that the various teachings herein may be configured and applied in many other ways. It is also contemplated that certain features referred to in the following examples may be omitted in some variations. Accordingly, none of the aspects or features referred to below should be considered critical unless later expressly indicated otherwise by the inventors or their successors. If a claim presented in this application or a subsequent application related to this application includes additional features other than those referred to below, those additional features should not be considered added for any reasons of patentability. [Example]

[0041] A device comprising: (a) a proximal body portion configured to be gripped by a user; (b) a distal body portion terminating distally in an application tip configured to apply a topical skin adhesive along an application surface; and (c) a bending body portion interconnecting the proximal and distal body portions to define a monolithic body, wherein in response to an input force applied to the proximal body portion by the user when the application tip is positioned against the application surface, the bending body portion is configured to do at least one of: (i) buckle non-uniformly along the lateral width of the device; or (ii) elastically deform such that the distal body portion flexes at an angle relative to the proximal body portion, thereby limiting the resultant normal force exerted by the application tip on the topical skin adhesive along the application surface to a predetermined range. [Example]

[0042] 10. The device of example 1, wherein the monolithic body comprises an elastomeric material having a hardness of about 50 Shore A to about 70 Shore A. [Example]

[0043] 10. The device of any one of the preceding examples, wherein the elastomeric material comprises silicone rubber. [Example]

[0044] The device of any one of the preceding examples, wherein the proximal body portion extends along a longitudinal axis and the applicator tip is configured to exert a normal force of about 1.5 lbf to about 5 lbf on the topical skin adhesive when the bending body portion is in an elastically deformed state such that the distal body portion is deflected at an angle relative to the proximal body portion. [Example]

[0045] 10. The device of any one of the preceding examples, wherein the bending body portion includes a void feature. [Example]

[0046] The device of Example 5, wherein the void feature comprises a pair of wedge-shaped channels disposed on opposite sides of the monolithic body, each of the wedge-shaped channels extending transversely to the longitudinal axis of the device. [Example]

[0047] 7. The apparatus of example 6, wherein each of the wedge-shaped channels has opposing first and second surfaces that define an angle of about 20°. [Example]

[0048] 10. The device of any one of the preceding embodiments, wherein the distal body portion is distally tapered and the application tip defines a minimum thickness of the monolithic body. [Example]

[0049] The device of any one of the preceding embodiments, wherein the bending body portion and the application tip each have a non-uniform thickness along the lateral width of the monolithic body, such that the buckling strength of the bending body portion varies along the lateral width. [Example]

[0050] 10. The apparatus of any one of the preceding embodiments, wherein the monolithic body is symmetrical about a midplane that bisects the monolithic body between opposing lateral sides of the monolithic body. [Example]

[0051] The device of example 10, wherein the buckling strength of the bending body portion increases from the central plane toward the lateral sides in a direction perpendicular to the plane, and the buckling strength of the application tip decreases from the central plane toward the lateral sides in a direction perpendicular to the plane. [Example]

[0052] 10. The device of any one of the preceding embodiments, wherein the thickness of the curved body portion increases from the central plane toward the lateral sides in a direction perpendicular to the central plane, and the thickness of the application tip decreases from the central plane toward the lateral sides in a direction perpendicular to the central plane. [Example]

[0053] 10. The device of any one of the preceding examples, wherein the distal body portion is at least partially transparent and includes an alignment indicator configured to be aligned with a longitudinal axis of the wound when applying the topical adhesive onto the wound. [Example]

[0054] A system comprising: (a) a wound closure device having a mesh layer and a pressure-sensitive adhesive layer on a lower surface of the mesh layer, the wound closure device configured to be applied onto a wound in a patient's skin; (b) an adhesive applicator containing a topical skin adhesive, the adhesive applicator operable to dispense the topical skin adhesive onto the mesh layer of the applied wound closure device; and (c) the apparatus described in Example 1, the apparatus configured to spread the topical skin adhesive applied by the adhesive applicator to the mesh layer of the wound closure device. [Example]

[0055] The system of example 14, wherein the topical skin adhesive comprises a silicone. [Example]

[0056] 1. A device comprising: (a) a proximal body portion; (b) a distal body portion extending coaxially with the proximal body portion and terminating distally in an application tip configured to apply a topical skin adhesive along an application surface; and (c) a bent body portion interconnecting the proximal and distal body portions to define a monolithic body, the bent body portion including void features configured to facilitate elastic deformation of the monolithic body at the bent body portion, such that the distal body portion deflects at an angle relative to the proximal body portion in response to an input force applied to the proximal body portion by a user, thereby limiting a resultant normal force exerted by the application tip on the topical skin adhesive along the application surface. [Example]

[0057] 17. The device of example 16, wherein the void feature comprises a pair of wedge-shaped channels disposed on opposite sides of the monolithic body. [Example]

[0058] 18. The apparatus of claim 16 or 17, wherein the bending body portion has a buckling strength that varies along the lateral width of the monolithic body, the bending body portion having a minimum buckling strength at its lateral midpoint. [Example]

[0059] 1. A device comprising: (a) a proximal body portion configured to be gripped by a user; (b) a distal body portion terminating distally in an applicator tip configured to apply a topical skin adhesive along an application surface; and (c) a bent body portion interconnecting the proximal and distal body portions to define a monolithic body, wherein the bent body portion is configured to elastically deform in response to an input force applied to the proximal body portion by a user such that the distal body portion flexes at an angle relative to the proximal body portion, thereby limiting a resultant normal force exerted by the applicator tip on the topical skin adhesive along the application surface; wherein the monolithic body is symmetrical about a midplane that bisects the monolithic body along its thickness between opposing lateral sides of the monolithic body; wherein the thickness of the bent body increases or decreases from the midplane toward the lateral sides in a direction perpendicular to the midplane; and wherein the thickness of the applicator tip increases or decreases from the midplane toward the lateral sides in a direction perpendicular to the midplane. [Example]

[0060] The device of example 19, wherein the thickness of the curved body portion increases in a direction from the central plane toward the lateral sides, and the thickness of the application tip decreases in a direction perpendicular to the central plane toward the lateral sides. [Example]

[0061] 1. A wound closure device comprising: (a) a wound closure device having a mesh layer and a pressure-sensitive adhesive layer on a lower surface of the mesh layer, the wound closure device configured to be applied onto a wound in a patient's skin; (b) an adhesive applicator containing a topical skin adhesive, the adhesive applicator 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, the adhesive spreader being (i) configured to be grasped by a user. (ii) a proximal body portion distally terminating in an applicator tip configured to apply a topical skin adhesive along an upper surface of the wound closure device; and (iii) a bending body portion interconnecting the proximal and distal body portions to define a monolithic body, wherein in response to an input force applied to the proximal body portion by a user when the applicator tip is positioned against an application surface, the bending body portion is configured to elastically deform such that the distal body portion flexes at an angle relative to the proximal body portion, thereby limiting a resultant normal force exerted by the applicator tip on the topical skin adhesive along the upper surface to a predetermined range. [Example]

[0062] The device of Example 21, wherein the topical skin adhesive is curable and configured to remain elastomeric after curing. [Example]

[0063] The device of Example 22, wherein the topical skin adhesive comprises silicone. [Example]

[0064] 1. A method for applying a topical skin adhesive onto a wound closure device positioned over a wound in a patient's skin using an adhesive spreader including a proximal body portion, a distal body portion terminating distally in an applicator tip, and a curved body portion interconnecting the proximal and distal body portions, the method comprising: (a) positioning the applicator tip in contact with the topical skin adhesive on an upper surface of the wound closure device; (b) tilting the adhesive spreader so that a longitudinal axis of the adhesive spreader defines an angle of about 45° to about 60° with respect to the upper surface; (c) applying a force to the proximal body portion, whereby the curved body portion elastically deforms and the distal body portion deflects at an angle relative to the proximal body portion, whereby the applicator tip exerts a normal force in the range of about 1.5 lbf to about 5 lbf on the topical skin adhesive and the upper surface; and (d) dragging the applicator tip along the upper surface to push the topical skin adhesive through the wound closure device. [Example]

[0065] The device of Example 24, wherein the topical skin adhesive comprises silicone.

[0066] V. Other It is understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein can be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Accordingly, the above teachings, expressions, embodiments, examples, etc. should not be considered in isolation from one another. Various suitable ways in which the teachings herein can be combined will be readily apparent to those skilled in the art in light of the teachings herein. Such modifications and variations are intended to be within the scope of the claims.

[0067] Additionally, any one or more of the teachings herein may be incorporated by reference in their entirety, including, but not limited to, U.S. patent application Ser. No. 29 / 860,717, filed Nov. 22, 2022, entitled "Device for Spreading Topical Skin Adhesive," the entire disclosure of which is incorporated by reference herein; U.S. patent application Ser. No. 17 / 991,992, filed Nov. 22, 2022, entitled "Application of Topical Skin Adhesive to Surgical Mesh," the entire disclosure of which is incorporated by reference herein; U.S. patent application Ser. No. 17 / 991,945, filed Nov. 22, 2022, entitled "Surgical Mesh Securing Device for Wound Closure System," the entire disclosure of which is incorporated by reference herein; and / or U.S. patent application Ser. No. 17 / 991,945, filed Nov. 22, 2022, entitled "Wound Closure System Having Microcannulated Endothelial Cells," the entire disclosure of which is incorporated by reference herein. The present invention may be combined with any one or more of the teachings disclosed in US patent application Ser. No. 17 / 991,950, entitled "Primary Pathways."

[0068] It should be understood that all or part of any patent, publication, or other disclosure referred to as being incorporated herein by reference is incorporated herein only to the extent that the incorporated material does not contradict existing definitions, opinions, or other disclosures set forth in this disclosure. As such, and to the extent necessary, the disclosure explicitly set forth herein shall prevail over any conflicting statements incorporated herein by reference. Any material, or portions thereof, that is referred to as being incorporated herein by reference but that contradicts current definitions, opinions, or other disclosures set forth herein shall be incorporated only to the extent that no conflict arises between the incorporated material and the current disclosures.

[0069] Variations of the above devices may be applied not only to traditional medical procedures and surgeries performed by medical professionals, but also to robotic-assisted medical procedures and surgeries. By way of example only, the various teachings herein may be readily incorporated into robotic surgical systems such as the DAVINCI™ system by Intuitive Surgical, Inc. (Sunnyvale, California).

[0070] Variations of the devices described above may be designed to be disposed of after a single use, or they may be designed to be used multiple times. Variations, in either or both cases, may be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular parts, and subsequent reassembly. Specifically, some device variations may be disassembled and any number of particular portions or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and / or replacement of particular parts, some device variations may be reassembled for subsequent use at a reconditioning facility or by a user immediately prior to a procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.

[0071] By way of example only, the variations described herein may be sterilized before and / or after treatment. In one sterilization technique, the device is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and device may then be placed in a radiation field that can penetrate the container, such as gamma radiation, X-rays, or a high-energy electron beam. The radiation may kill bacteria on the device and in the container. The sterilized device may then be stored in the sterile container for later use. The device may also be sterilized using any other technique known in the art, including, but not limited to, beta or gamma radiation, ethylene oxide, or steam.

[0072] While various embodiments of the present invention have been shown and described, further adaptations of the methods and systems described herein may be achieved by appropriate modifications by those skilled in the art without departing from the scope of the present invention. While some of such possible modifications have been mentioned, other modifications will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, proportions, steps, etc. discussed above are illustrative and not required. Accordingly, it will be understood that the scope of the present invention should be considered in terms of the following claims, and is not limited to the details of structure and operation shown and described in this specification and drawings.

[0073] [Embodiment] (1) A device comprising: (a) a proximal body portion configured to be grasped by a user; (b) a distal body portion terminating distally in an application tip configured to apply a topical skin adhesive along an application surface; (c) a bent body portion interconnecting the proximal body portion and the distal body portion to define a monolithic body; In response to an input force applied to the proximal body portion by a user when the applicator tip is positioned against the application surface, the bending body portion: (i) uneven buckling along the width of the device; or (ii) the distal body portion is elastically deformed to deflect at an angle relative to the proximal body portion, thereby limiting the resultant normal force exerted by the applicator tip on the topical skin adhesive along the application surface to a predetermined range. (2) The device of claim 1, wherein the monolithic body comprises an elastomeric material having a hardness of about 50 Shore A to about 70 Shore A. (3) The device of any one of claims 1 to 2, wherein the elastomeric material comprises silicone rubber. (4) The device of any one of claims 1 to 3, wherein the proximal body portion extends along a longitudinal axis and the applicator tip is configured to exert a normal force of about 6.67 N to about 22.24 N (about 1.5 lbf to about 5 lbf) on the topical skin adhesive when the bending body portion is in an elastically deformed state such that the distal body portion is deflected at an angle relative to the proximal body portion. (5) The device of any one of embodiments 1 to 4, wherein the curved body portion includes a void feature.

[0074] (6) The device of claim 5, wherein the void feature comprises a pair of wedge-shaped channels disposed on opposite sides of the monolithic body, each of the wedge-shaped channels extending transversely to a longitudinal axis of the device. (7) The device of embodiment 6, wherein each of the wedge-shaped channels has opposing first and second surfaces that define an angle of approximately 20°. (8) The device of any one of claims 1 to 7, wherein the distal body portion is tapered distally and the application tip defines a minimum thickness of the monolithic body. (9) The device of any one of claims 1 to 8, wherein the curved body portion and the applicator tip each have a non-uniform thickness along a lateral width of the monolithic body, and wherein a buckling strength of the curved body portion varies along the lateral width. (10) The apparatus of any one of claims 1 to 9, wherein the monolithic body is symmetrical about a midplane that bisects the monolithic body between opposing lateral sides of the monolithic body.

[0075] (11) The device of claim 10, wherein the buckling strength of the bending body portion increases from the central plane toward the lateral sides in a direction perpendicular to the plane, and the buckling strength of the applicator tip decreases from the central plane toward the lateral sides in a direction perpendicular to the plane. (12) The device of claim 10 or 11, wherein the thickness of the curved body portion increases from the central plane toward the lateral sides in a direction perpendicular to the central plane, and the thickness of the application tip decreases from the central plane toward the lateral sides in a direction perpendicular to the central plane. (13) The device of any one of embodiments 1 to 12, wherein the distal body portion is at least partially transparent and includes an alignment indicator configured to be aligned with a longitudinal axis of a wound when applying the topical adhesive onto the wound. (14) (a) a wound closure device having a mesh layer and a pressure-sensitive adhesive layer on a lower surface of the mesh layer, the wound closure device being configured to be applied over a wound in a patient's skin; (b) an adhesive applicator containing a topical skin adhesive, the adhesive applicator operable to dispense the topical skin adhesive onto the mesh layer of the applied wound closure device; and (c) The system comprises the device of embodiment 1, wherein the device is configured to apply topical skin adhesive applied to the mesh layer of the wound closure device by the adhesive applicator. 15. The system of claim 14, wherein the topical skin adhesive comprises a silicone.

[0076] (16) (a) a proximal body portion; (b) a distal body portion extending coaxially with said proximal body portion and terminating distally in an application tip configured to apply a topical skin adhesive along an application surface; (c) a bending body portion interconnecting the proximal body portion and the distal body portion to define a monolithic body, the bending body portion including void features configured to facilitate elastic deformation of the monolithic body at the bending body portion, such that the distal body portion deflects at an angle relative to the proximal body portion in response to an input force applied to the proximal body portion by a user, thereby limiting a resultant normal force exerted by the applicator tip on the topical skin adhesive along the application surface. (17) The device of claim 16, wherein the void feature comprises a pair of wedge-shaped channels disposed on opposite sides of the monolithic body. (18) The device of claim 16 or 17, wherein the curved body portion has a buckling strength that varies along a lateral width of the monolithic body, and the curved body portion has a minimum buckling strength at its lateral midpoint. (19) (a) a proximal body portion configured to be grasped by a user; (b) a distal body portion terminating distally in an application tip configured to apply a topical skin adhesive along an application surface; (c) a bent body portion interconnecting the proximal body portion and the distal body portion to define a monolithic body; the bending body portion is configured to elastically deform such that the distal body portion deflects at an angle relative to the proximal body portion in response to an input force applied to the proximal body portion by a user, thereby limiting a resultant normal force exerted by the applicator tip on the topical skin adhesive along the application surface; the monolithic body is symmetrical about a midplane that bisects the monolithic body along its thickness between opposing lateral sides of the monolithic body; the thickness of the bending body increases or decreases orthogonally from the midplane toward the lateral sides; The thickness of the coating tip increases or decreases perpendicularly from the central plane toward the lateral sides. (20) The device of claim 19, wherein the thickness of the curved body portion increases in a direction from the central plane toward the lateral sides, and the thickness of the application tip decreases perpendicularly from the central plane toward the lateral sides.

Claims

1. 1. An apparatus comprising: (a) a proximal body portion configured to be grasped by a user; (b) a distal body portion terminating distally in an application tip configured to apply a topical skin adhesive along an application surface; (c) a bent body portion interconnecting the proximal body portion and the distal body portion to define a monolithic body; In response to an input force applied to the proximal body portion by a user when the applicator tip is positioned against the application surface, the bending body portion: (i) uneven buckling along the width of the device; or (ii) the distal body portion elastically deforms to flex at an angle relative to the proximal body portion, thereby limiting the resultant normal force exerted by the applicator tip on the topical skin adhesive along the application surface to a predetermined range.

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

3. The device of claim 1 or 2, wherein the elastomeric material comprises silicone rubber.

4. 10. The device of claim 1, wherein the proximal body portion extends along a longitudinal axis and the applicator tip is configured to exert a normal force of about 1.5 lbf to about 5 lbf on the topical skin adhesive when the bending body portion is in an elastically deformed state such that the distal body portion is deflected at an angle relative to the proximal body portion.

5. The device of claim 1 , wherein the curved body portion includes a void feature.

6. 6. The device of claim 5, wherein the void feature comprises a pair of wedge-shaped channels disposed on opposite sides of the monolithic body, each of the wedge-shaped channels extending transversely to a longitudinal axis of the device.

7. 7. The apparatus of claim 6, wherein each of the wedge-shaped channels has opposing first and second surfaces that define an angle of approximately 20 degrees.

8. The device of claim 1 , wherein the distal body portion is distally tapered and the application tip defines a minimum thickness of the monolithic body.

9. 10. The device of claim 1, wherein the bending body portion and the application tip each have a non-uniform thickness along a lateral width of the monolithic body, and the buckling strength of the bending body portion varies along the lateral width.

10. The apparatus of claim 1 , wherein the monolithic body is symmetrical about a midplane that bisects the monolithic body between opposing lateral sides of the monolithic body.

11. 11. The device of claim 10, wherein the buckling strength of the bending body portion increases perpendicularly from the central plane toward the lateral sides, and the buckling strength of the applicator tip decreases perpendicularly from the central plane toward the lateral sides.

12. 12. The device of claim 10 or 11, wherein the thickness of the curved body portion increases from the central plane toward the lateral sides in a direction perpendicular to the plane, and the thickness of the application tip decreases from the central plane toward the lateral sides in a direction perpendicular to the plane.

13. 10. The device of claim 1, wherein the distal body portion is at least partially transparent and includes an alignment indicator configured to be aligned with a longitudinal axis of a wound when applying the topical adhesive onto the wound.

14. (a) a wound closure device having a mesh layer and a pressure-sensitive adhesive layer on a lower surface of the mesh layer, the wound closure device being configured to be applied over a wound in a patient's skin; (b) an adhesive applicator containing a topical skin adhesive, the adhesive applicator operable to dispense the topical skin adhesive onto the mesh layer of the applied wound closure device; (c) the device of claim 1, wherein the device is configured to apply a topical skin adhesive applied to the mesh layer of the wound closure device by the adhesive applicator.

15. 15. The system of claim 14, wherein the topical skin adhesive comprises silicone.

16. (a) a proximal body portion; (b) a distal body portion extending coaxially with said proximal body portion and terminating distally in an application tip configured to apply a topical skin adhesive along an application surface; (c) a bending body portion interconnecting the proximal body portion and the distal body portion to define a monolithic body, the bending body portion including void features configured to facilitate elastic deformation of the monolithic body at the bending body portion, such that the distal body portion deflects at an angle relative to the proximal body portion in response to an input force applied to the proximal body portion by a user, thereby limiting a resultant normal force exerted by the applicator tip on the topical skin adhesive along the application surface.

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

18. 18. The apparatus of claim 16 or 17, wherein the bending body portion has a buckling strength that varies along the lateral width of the monolithic body, the bending body portion having a minimum buckling strength at its lateral midpoint.

19. (a) a proximal body portion configured to be grasped by a user; (b) a distal body portion terminating distally in an application tip configured to apply a topical skin adhesive along an application surface; (c) a bent body portion interconnecting the proximal body portion and the distal body portion to define a monolithic body; the bending body portion is configured to elastically deform such that the distal body portion deflects at an angle relative to the proximal body portion in response to an input force applied to the proximal body portion by a user, thereby limiting a resultant normal force exerted by the applicator tip on the topical skin adhesive along the application surface; the monolithic body is symmetrical about a midplane that bisects the monolithic body along its thickness between opposing lateral sides of the monolithic body; the thickness of the bending body increases or decreases orthogonally from the midplane toward the lateral sides; The thickness of the coating tip increases or decreases perpendicularly from the central plane toward the lateral sides.

20. 20. The device of claim 19, wherein the thickness of the curved body portion increases in a direction from the central plane toward the lateral sides, and the thickness of the application tip decreases perpendicularly from the central plane toward the lateral sides.

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