Application of topical skin adhesive to surgical meshes

Abstract

A system includes a surgical mesh having an upper side and an underside, where the upper side includes a visual indicia pattern extending longitudinally along the upper side, and the underside is configured to adhere to a portion of a patient's skin surrounding a wound. The system also includes a topical skin adhesive configured to be applied to an upper side of the surgical mesh based on the visual indicia pattern. The topical skin adhesive is configured to cure within the surgical mesh to form a protective layer over the wound.

Description

BACKGROUND OF THE INVENTION

[0001] 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, the wound closure system can include components such as sutures, substrates, and / or liquid topical skin adhesives, which are applied by a surgeon to approximate the edges of the wound 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 detach automatically from the skin such that they can be discarded by the patient.

[0002] Although a variety of wound closure systems and associated components and methods have been made and used, it is believed that the invention described in the appended claims has not been made or used by anyone prior to the present inventors. BRIEF DESCRIPTION OF THE DRAWINGS

[0003] 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.

[0004] 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;

[0005] Figure 2 Shows Figure 1 An exploded perspective view of the wound closure device, showing the mesh layer, the pressure-sensitive adhesive layer, and the removable backing layer;

[0006] Figure 3A Shows the Figure 1 Wound closure device longitudinally aligned with a wound in a patient's skin, showing the central portion of the backing layer that has been removed;

[0007] Figure 3B Shows Figure 1 A perspective view of the wound closure device that is applied over a patient's skin wound to approximate the edges of the wound;

[0008] Figure 3C Shows the Figure 1 Wound closure device applied over a patient's skin wound, showing the remaining portion of the backing layer that has been removed such that the wound closure device adheres fully to the skin;

[0009] Figure 3D A perspective view of a wound closure device applied over a skin wound of a patient is shown, depicting the application of a liquid topical skin adhesive to a mesh layer with an adhesive application device; Figure 1

[0010] Figure 3E A perspective view of a wound closure device applied over a skin wound of a patient is shown, depicting an adhesive spreader positioned against the patient at the start of an adhesive spreading stroke for spreading the applied topical skin adhesive over and through the wound closure device; Figure 1

[0011] Figure 3F A perspective view of a wound closure device applied over a skin wound of a patient is shown, depicting the adhesive spreader during a subsequent portion of the adhesive spreading stroke; Figure 1

[0012] Figure 4 A top plan view of a mesh layer having visual markings in the form of waves is shown;

[0013] Figure 5 A top plan view of another mesh layer having visual markings in the form of a "T" is shown;

[0014] Figure 6 A top plan view of another mesh layer having visual markings in the form of a vertical line is shown;

[0015] Figure 7 A top plan view of another mesh layer having visual markings in the form of a horizontal line is shown;

[0016] Figure 8 A top plan view of another mesh layer having visual markings in the form of a triangular wave is shown;

[0017] Figure 9A A perspective view of a wound closure device is shown Figure 1 having a mesh layer applied over a skin wound of a patient, depicting adhesive beads of a topical skin adhesive being laid over the visual markings of the mesh layer; Figure 4

[0018] Figure 9B A perspective view of a wound closure device having a mesh layer applied over a skin wound of a patient is shown, depicting beads of a topical skin adhesive over the visual markings, and wherein Figure 4 Figure 1 an adhesive spreader spreads the topical skin adhesive;

[0019] Figure 9C ​​​​​Shows a perspective view of a wound closure device applied over a skin wound of a patient, showing a topical skin adhesive spread over a mesh layer; and Figure 9A Shows a cross-sectional view of a patient's skin layer, showing a topical skin adhesive spread into the stratum corneum of the skin.

[0020] Figure 10 The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the present 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.

[0021] DETAILED DESCRIPTION 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 the position of an element 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 the position of an element 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 the views and are not intended to limit the invention described herein.

[0022] The description of certain examples of the present technology below should not be used to limit the scope of the present technology. From the following description, other examples, features, aspects, embodiments, and advantages of the present technology will become apparent to those skilled in the art. The following description is given by way of example and is one of the best ways contemplated for carrying out the present technology. As will be appreciated, the technology described herein can have other different and distinct aspects, all of which do not depart from the present technology. Accordingly, the drawings and description are to be regarded as illustrative in nature and not restrictive.

[0023] In addition, as used herein, the terms "about" and "approximately" in relation to any numerical value or range are intended to cover the exact value cited, as well as a suitable tolerance that enables the cited feature or combination of features to be used for the intended purpose described herein.

[0024]

[0025] I. Wound Closure System

[0026] 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 patient's wound (W), 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 and pass through the applied topical skin adhesive (54) onto the wound closure device (20). Each of these components is described in more detail below.

[0027] Preferably as Figure 2 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 the patient, as described in more detail below.

[0028] The mesh (22) is configured to hold the 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 the 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.

[0029] As Figure 1As shown, the adhesive application device (40) includes an application device body (42), a plunger unit (44) slidably received within the proximal end of 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 barrels (48) arranged side by side, with each barrel (48) containing a respective portion of a two-part 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 actuatable distally through a respective barrel (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 open distal end of the static mixer (46), as described below Figure 3D As shown.

[0030] In this form, 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 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. Thus, the wound closure system (10) can be particularly effective for actuation body parts of a patient, such as, for example, the knee, wrist, elbow or other joints.

[0031] 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.

[0032] Figures 3A through 3DAn example of a wound closure system (10) for closing a wound (W) formed in a patient's skin (S) is shown. In some procedures, the wound (W) may be at least partially closed with one or more sutures prior to using the wound closure system (10), for example, at the deeper portions of the wound (W). Additionally, the wound closure device (20) may be trimmed by the surgeon into any suitable shape desired prior to applying it to the patient.

[0033] As Figure 3A 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 bring the edges of the wound (W) into approximation during application. For either method, the wound closure device (20) is configured to be able 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).

[0034] As Figure 3D shown, a pattern of the 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 application device (40). Although in this version the adhesive application device (40) is shown applying a linear bead of the topical skin adhesive (54), it should be understood that in other versions various other patterns of the topical skin adhesive (54) may be applied, such as a T-shaped pattern or a waveform pattern, as described in more detail below.

[0035] As Figures 3E through 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 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 an undeformed 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 lesser viscosity may require a lesser input force, such that the flexible body portion (66) deforms less or not at all.

[0036] Optionally, the topical skin adhesive (54) can also be spread over adjacent portions 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 over the wound closure device (20), any topical skin adhesive (54) on the skin (S) outside the perimeter of the device (20) can be wiped away, 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 over the wound closure device (20) to form a composite microbial barrier above the wound (W) that maintains a protective environment that promotes effective healing. 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.

[0037] The wound closure system (10) may also be constructed and operated according to at least some of the teachings of U.S. Patent Publication No. 2021 / 0369258, titled "Systems, Devices and Methods for Dispensing and Curing Silicone Based Topical Skin Adhesives", published on December 2, 2021, the entire disclosure of which is incorporated herein by reference; U.S. Patent Publication No. 2021 / 0371190, titled "Systems, Methods and Devices for Aerosol Spraying of Silicone Based Topical Skin Adhesives for Sealing Wounds", published on December 2, 2021, the entire disclosure of which is incorporated herein by reference; U.S. Patent Publication No. 2021 / 0371658, titled "Novel Topical Skin Closure Compositions and Systems", published on December 2, 2021, the entire disclosure of which is incorporated herein by reference; U.S. Patent Publication No. 20210369639, titled "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 Publication No. 2021 / 0369276, titled "Anisotropic Wound Closure Systems", published on December 2, 2021, the entire disclosure of which is incorporated herein by reference; and / or U.S. Patent Application No. 17 / 667,950, titled "Gas Sterilizable Syringes Having Apertures Covered By Gas Permeable Barriers For Enabling Ingress and Egress of Sterilization Gases While Preventing Leakage of Flowable Materials", filed on February 9, 2022, the entire disclosure of which is incorporated herein by reference.

[0038] II. Examples of Meshes with Visual Markers Indicating the Path of Adhesive Beads

[0039] Once mixed, the topical adhesive (54) can have a high viscosity (e.g., greater than 10,000 centipoise) relative to conventional cyanate ester acylating adhesives. This higher viscosity prevents the topical adhesive (54) from self-leveling on the mesh (22) during a relatively short time period after the topical adhesive (54) is applied and before it begins to cure. The cure time can range from between 1 minute and 2 minutes from the start of application, but can be shorter or longer. Given that the topical adhesive (54) does not self-level and the short time period for spreading the topical adhesive before the topical adhesive (54) begins to cure, a system and method may be needed to allow the topical adhesive (54) to spread quickly and evenly over the mesh (22) and over the skin (S).

[0040] As described in more detail below, Figures 4 through 8 Examples of alternative mesh layers (122, 222, 322, 422, 522) that can be incorporated into the wound closure device (20) in place of the mesh (22) are shown. Each layer of mesh (122, 222, 322, 422, 522) includes a corresponding pattern of visual markings (170, 270, 370, 470, 570) that are configured to serve as traceable guides for applying the topical skin adhesive (54) to the wound closure device (20) using an adhesive applicator device (40). The visual markings (170, 270, 370, 470, 570) can be printed, embossed, and / or recessed on the mesh (122, 222, 322, 422, 522), for example. Additionally, in other examples not shown in the figures, various combinations of different features of the visual markings (170, 270, 370, 470, 570) can be employed.

[0041] A. Mesh with Visual Markers in a Wave Form

[0042] As Figure 4As shown, the upper side of the mesh (122) may include a visual marker (170) configured to serve as a visual guide when applying a bead of the topical adhesive (54) to the mesh (122). The visual marker (170) of the present example is patterned to include a wave, which may be in the form of a sine curve, and / or may include various other similarly shaped arcuate paths between the longitudinal ends of the mesh (122). The wave portion of the visual marker (170) may include any number of wavelengths (λ), each wavelength defined by a pair of adjacent peaks or valleys, and may extend up to the outer perimeter of the mesh (122) or may be inset from the outer perimeter of the mesh (122). The wavelength (λ) may be consistent along the length of the mesh (122) as shown, or it may vary across the length of the mesh (122). The amplitude (A) of the wave may be approximately equal to or slightly less than the width of the mesh (122) such that the visual marker (170) extends up to the outer perimeter of the mesh (122) or is slightly inset from the outer perimeter of the mesh (122). The amplitude (A) may be consistent along the length of the mesh (122) or it may vary across the length of the mesh (122). By way of example only, the amplitude (A) may be in the range of 1.5 centimeters to 3 centimeters.

[0043] The visual marker (170) may include one or more straight portions (132) located at a first longitudinal end of the mesh (122) as shown, where each straight portion (132) extends substantially the entire width or a portion of the width of the mesh (122). The straight portions (132) may be configured to ensure a larger initial amount of the topical adhesive (54) is applied at the first longitudinal end of the mesh (122). Once spreading of the topical adhesive (54) has begun, the larger initial amount of the topical adhesive (54) at the longitudinal end of the mesh (122) corresponding to the starting position of the spreading stroke of the adhesive spreader (60) may assist in loading the adhesive spreader (60) with the topical adhesive (54). The mesh (122) may include at least one direction indicator (172) that may indicate a preferred direction of travel when applying the topical adhesive (54) to the mesh (122). The direction indicator (172) may be incorporated into the visual marker (170) and may include one or more arrows, numbers, words, scale marks, other symbols, or any other indicator that reasonably indicates a direction of travel.

[0044] B. Mesh with Visual Markers in a "T" Form

[0045] As Figure 5As shown, the upper side of the mesh (222) may include a visual marker (270) configured to serve as a visual guide when applying a bead of the topical adhesive (54) to the mesh (222). The visual marker (270) of the present example is patterned in the form of a "T". The linear top portion (273) of the "T" may extend along a portion of the width of the mesh (222) and be positioned towards or at the longitudinal end of the mesh (222), such as at the first longitudinal end of the mesh (222), as shown. The linear axis portion (275) of the "T" may extend directly above or adjacent and parallel to the longitudinal centerline of the mesh (222). In doing so, the visual marker (270) may extend from the first longitudinal end of the mesh (222) to the second longitudinal end of the mesh (222) and may extend directly above and along the longitudinal centerline. In other forms, the linear axis portion (275) may be angled relative to the longitudinal centerline and intersect the longitudinal centerline.

[0046] The mesh (222) may further include a series of time-based indicators (T0, T1, T2) spaced along the visual marker (270) to visually indicate a timeline for applying the topical adhesive (54) to the visual marker (270). The time-based indicators (T0, T1, T2) may allow a user to measure the rate of application of the topical adhesive (54) in an effort to prevent premature curing of the topical adhesive (54) or applying the topical adhesive (54) too fast or too slow such that the desired thickness of the topical adhesive (54) is not achieved. In some forms, the timeline of the time-based indicators (T0, T1, T2) may be linearly defined such that the amount of time to transition from each time-based indicator (T0, T1, T2) to the next is the same, such as for example one second. In other forms, the timeline may be non-linear such that the amount of time to transition from the time-based indicator (T0) to the time-based indicator (T1) is a first duration, such as for example three seconds, whereas the amount of time to transition from the time-based indicator (T1) to the time-based indicator (T2) is a second duration, such as for example six seconds.

[0047] A preferred timeline of time-based indicators (T0, T1, T2) can be indicated in a support device document (such as, an instruction manual or a packaging insert). Additionally, the time-based indicators (T0, T1, T2) themselves can visually indicate the preferred timeline. For example, it may be preferred that it takes one second to transition from the time-based indicator (T0) to the time-based indicator (T1), and an additional one second to transition from the time-based indicator (T1) to the time-based indicator (T2). In the illustrated example, this would result in a thicker bead of the local adhesive (54) along the shorter segment (273) of the visual marker (270) between the time-based indicators (T0, T1), and a thinner bead of the local adhesive (54) along the longer segment (275) of the visual marker (270) between the time-based indicators (T1, T2). In another example, the time-based indicator (T2) can be replaced with a higher value time-based indicator (such as, for example, T6), which indicates that the recommended duration for transitioning from the time-based indicator (T1) to the time-based indicator (T6) is 5 seconds. In such an example, the thickness of the beads of the local adhesive (54) applied along the shorter marker segment (273) between the indicators (T0, T1) and along the longer marker segment (275) between the indicators (T1, T6) can be approximately equal. In yet another example, the mesh (222) can include a series of consecutive time-based indicators (T0, T1, T2, T3, T4, T5, T6, etc.) spaced equidistantly along the visual marker segments (273, 275).

[0048] It should be understood that, in addition to those shown and described, various alternative numbers and arrangements of time-based indicators can be applied to the mesh (222). Additionally, in some configurations, the time-based indicators can be constructed to be capable of indicating discontinuous beads of the local adhesive (54) such that a constant bead of the adhesive (54) is not laid between all of the time-based indicators. It should also be understood that time-based indicators (such as Figure 5 those shown and described above) can be applied to any of the other exemplary meshes and visual markers disclosed herein to facilitate the proper application of the local adhesive (54).

[0049] C. Mesh with Visual Markers in a Vertical Line Form

[0050] As Figure 6As shown, the upper side of the mesh (322) may include a visual marker (370) configured to serve as a visual guide when applying the topical adhesive (54) to the mesh (322). The visual marker (370) of the present example is patterned in the form of a plurality of discrete vertical lines, each discrete vertical line spanning along the width of the mesh (322) and transverse to the length of the mesh (322) such that they may be positioned perpendicular to the longitudinal centerline of the mesh (322). In other configurations, one or more of these lines may be angled relative to the longitudinal centerline. The vertical lines may extend along at least a portion of the width of the mesh (322) and may be parallel to each other along the length of the mesh (322). The vertical lines may be discrete pattern segments of the visual marker (370) that are spaced apart from each other and disconnected along the entire length of the mesh (322). Alternatively, the vertical lines may include non-uniform spacing or may include a combination of uniform and non-uniform spacing. An example of a combination of uniform and non-uniform spacing may exhibit vertical lines that are positioned closer together at a starting portion at a first longitudinal end of the mesh (322), followed by vertical lines that are spaced farther apart from each other in a direction advancing toward the opposite second longitudinal end of the mesh (322). This spacing may facilitate initially loading the adhesive spreader (60) with the topical adhesive (54) and then providing only enough topical adhesive (54) to evenly coat the remaining portion of the mesh (322) once the adhesive spreader (60) is loaded.

[0051] D. Mesh with Visual Markers in a Horizontal Line Form

[0052] As Figure 7As shown, the upper side of the mesh (422) may include a visual marker (470) configured to serve as a visual guide when applying the topical adhesive (54) to the mesh (422). The visual marker (470) of this example is patterned in the form of a plurality of discrete horizontal lines, each discrete horizontal line spanning the longitudinal length of the mesh (422) and parallel to the longitudinal centerline of the mesh (422). In other forms, all or a portion of one or more of these lines may be angled relative to the longitudinal centerline. Each horizontal line may span the entire length of the mesh (422), or one or more of these lines may have a different length than the other lines. The horizontal lines may be evenly spaced or may be unevenly spaced. The visual marker (470) may also include a direction indicator (472) to indicate the direction in which each bead of the topical adhesive (54) should be dispensed onto the mesh (422). The mesh (422) may also include application information (474) configured to indicate the order in which each bead should be dispensed onto the mesh (422). For example, the application information (474) may be in the form of a numerical value that indicates that any intermediate horizontal line should be applied to the mesh (422) before any outer horizontal line. Applying the intermediate horizontal line to the mesh (422) before the outer horizontal line may reduce the chance of the adhesive application device (40) contacting the beads of the already laid topical adhesive (54).

[0053] E. Mesh with Visual Markers in a Triangular Wave Form

[0054] As Figure 8As shown, the upper side of the mesh (522) may include a visual marker (570) configured to serve as a visual guide when applying the topical adhesive (54) to the mesh (522). The visual marker (570) of the present example is patterned in the form of a triangular wave along the length of the mesh (522). The triangular wave may include any number of wavelengths and may extend to the outer perimeter of the mesh (522) or may be inset from the perimeter of the mesh (522). The wavelength may vary along the length of the mesh (522). The amplitude of the triangular wave may be approximately equal to or slightly less than the width of the mesh (522) such that the visual marker (570) extends to the outer perimeter of the mesh (522) or is slightly inset from the outer perimeter of the mesh (522). The amplitude may be consistent along the length of the mesh (522) or it may vary along the length of the mesh (522). The visual marker (570) may include one or more straight portions (532) located at a first longitudinal end of the mesh (522), where each straight portion (532) extends substantially the entire width or a portion of the width of the mesh (522). The straight portion (532) may be configured to ensure a larger initial amount of the topical adhesive (54) is applied at the first longitudinal end of the mesh (522). As similarly described above with respect to the mesh (122), once the spreading of the topical adhesive (54) has begun, the larger initial amount of the topical adhesive (54) at the longitudinal end of the mesh (522) corresponding to the starting position of the spreading stroke of the adhesive spreader (60) may help to initially load the adhesive spreader (60) with the topical adhesive (54). The mesh (522) may include a direction indicator (572) that may indicate a preferred direction of travel when applying the topical adhesive (54) to the mesh (522). The direction indicator (572) may be incorporated into the visual marker (570) and may include one or more arrows, numbers, words, scale marks, other symbols, or any other indicator that reasonably indicates the direction of travel.

[0055] III. Method of Using a Mesh with Visual Markers

[0056] Figures 9A through 9C An example of a wound closure system (10) for closing a wound (W) formed in a patient's skin (S) is shown, having a mesh (122) with a visual marker (170). It should be understood that the visual markers (170, 270, 370, 470, 570) of any of the meshes (122, 222, 322, 422, 522) can be used in the following method. Figure 4 of the mesh (122). It should be understood that Figures 4 through 8 of any mesh (122, 222, 322, 422, 522) can be used in the following method.

[0057] As Figure 9AAs shown, a wound closure device (20) having a mesh (122) with a visual marker (170) is secured to the skin (S) and the wound (W), and the backing (26) has been removed. An adhesive application device (40) can be used to apply a topical adhesive (54) to the mesh (122). When applying the topical adhesive (54), the adhesive application device (40) can follow (i.e., trace) the visual marker (170) such that beads of the topical adhesive (54) are applied onto the visual marker (170). The adhesive application device (40) can follow the visual marker (170) in the direction indicated by the previously mentioned direction indicator (172). As discussed above in connection with Figure 4 the visual marker (170), beads of the topical adhesive (54) can first be applied to a straight portion (132) that extends along at least a portion of the width of the mesh (122) at its first longitudinal end (e.g., on the left hand end as shown). Also as described above, at the start of the adhesive spreading stroke, the adhesive spreader (60) first engages the portion of the topical adhesive (54) applied to the straight portion (132) of the visual marker (170) in order to initially load the adhesive spreader (60) with the topical adhesive (54). Thus, the topical adhesive (54) is applied to the visual marker (170) and is also spread by the adhesive spreader (60) along the length of the mesh (122) in the same forward direction (e.g., from left to right in the illustrated example). This method can minimize the risk that any portion of the topical adhesive (54) applied to the visual marker (170) starts to cure before it has been spread by the adhesive spreader (60). The adhesive application device (40) can apply the topical adhesive (54) along the visual marker (170) in the direction indicated by the direction indicator (172).

[0058] In a form of the mesh (322, 422) having visual markers (370, 470) arranged in discrete portions, the adhesive application device (40) can start and stop applying a plurality of beads of the topical adhesive (54) so as to individually cover each discrete portion. The adhesive application device (40) can apply the topical adhesive (54) along each discrete portion of the visual markers (370, 470) in the direction indicated by the direction indicator (472). The adhesive application device (40) can also apply the topical adhesive (54) to each discrete portion of the visual markers (370, 470) in an order indicated by application information (474), where a particular discrete portion is applied before a separate discrete portion. For example, the adhesive application device (40) can apply the topical adhesive (54) to the discrete portions of the mesh (322, 422) from the most inward discrete portion to the most outward discrete portion, or can be applied from one end of the mesh (322, 422) to the other end of the mesh (322, 422), such as from one longitudinal end to the opposite longitudinal end.

[0059] As Figure 9B shown, an adhesive spreader (60) is then used to evenly spread the applied topical adhesive (54) over the wound closure device (20) to force the topical adhesive (54) through the mesh (122) and against the wound (W). As Figure 3E and Figure 9B shown, the adhesive spreader (60) can be pulled by a user through one or more longitudinal strokes parallel to its centerline along the length of the mesh (122). In other cases, the adhesive spreader (60) can be guided along all or a portion of a path defined by visual markings (170). Additionally, in some cases, the topical adhesive (54) can also be spread over adjacent portions of the skin (S) not covered by the wound closure device (20) to ensure an effective seal around the outer perimeter of the wound closure device (20).

[0060] By applying the topical adhesive (54) to the visual markings (170) of the mesh (122), the topical adhesive (54) can be evenly spread over the wound closure device (20) in a rapid manner such that a uniform layer is applied to the wound closure device (20) and the surrounding skin (S) before the topical adhesive (54) cures. For example, the topical adhesive (54) can be applied to the mesh (122) and evenly spread in about 30 seconds or less. As described above, in some cases, a quantity of 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). The applied topical skin adhesive (54) then cures within and over the wound closure device (20) to form a composite microbial barrier above the wound (W) that maintains a protective environment that promotes effective healing. As Figure 9C shown, the topical adhesive (54) can remain at least partially transparent after curing such that the visual markings (170) and / or the wound (W) can be observed through the topical adhesive (54) once cured.

[0061] As Figure 10 shown, the adhesive spreader (60) can be capable of spreading and / or pushing the topical adhesive (54) into the stratum corneum (SC) of the skin (S). This can increase the adhesion and liquid resistance of the topical adhesive (54) and the wound closure device (20) on the skin (S) and the wound (W). The adhesive spreader (60) can be capable of applying the topical adhesive (54) directly along the perimeter of the wound closure device (20) or through the wound closure device (20) (not shown) into the stratum corneum (SC) of the skin (S).

[0062] In addition to or in place of having visual markings (170, 270, 370, 470, 570) on any of the meshes (122, 222, 322, 422, 522), the pattern may be depicted in the product instructions, packaging inserts, or other accompanying materials available to the operator.

[0063] IV. Examples of Combinations

[0064] 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. There is no intention to disclaim. 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. Therefore, none of the aspects or features mentioned below should be considered decisive, unless expressly so indicated by the inventor or successors in interest to the inventor 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, these additional features should not be assumed to have been added for any reason related to patentability.

[0065] Example 1

[0066] A system includes a surgical mesh that includes an upper side and a lower side. The upper side includes a visual marking pattern that extends longitudinally along the upper side. The lower side is configured to be able to adhere to a portion of the patient's skin surrounding a wound. And a topical skin adhesive that is configured to be applied to the upper side of the surgical mesh based on the visual marking pattern. The topical skin adhesive is configured to be able to cure within the surgical mesh to form a protective layer over the wound.

[0067] Example 2

[0068] The system according to embodiment 1, wherein the surgical mesh is configured to be able to adhere to opposite sides of the patient's wound, thereby bringing the opposite sides closer together.

[0069] Example 3

[0070] The system according to any of the preceding embodiments further includes a spreader that is configured to be able to spread the topical skin adhesive across the upper side.

[0071] Example 4

[0072] The system according to any one of the preceding embodiments, wherein the surgical mesh includes a first longitudinal end, a second longitudinal end, and a longitudinal centerline extending therebetween, and wherein a portion of the visual marking pattern intersects the longitudinal centerline or is directly above and extends along the longitudinal centerline.

[0073] Example 5

[0074] The system according to embodiment 4, wherein the visual marking pattern extends from the first longitudinal end to the second longitudinal end.

[0075] Example 6

[0076] The system according to any one of the preceding embodiments, wherein the visual marking pattern includes a plurality of discrete pattern segments that are disconnected from each other.

[0077] Example 7

[0078] The system according to any one of the preceding embodiments, wherein at least a portion of the visual marking pattern extends along an arcuate path.

[0079] Example 8

[0080] The system according to any one of the preceding embodiments, wherein the visual marking pattern includes a sine wave.

[0081] Example 9

[0082] The system according to any one of the preceding embodiments, wherein the visual marking pattern includes a "T" shape.

[0083] Example 10

[0084] The system according to any one of embodiments 4 to 9, wherein the visual marking pattern includes a first line segment that intersects the longitudinal centerline transversely at the first longitudinal end, and a second line segment that is directly above the longitudinal centerline and extends along the longitudinal centerline from the first longitudinal end to the second longitudinal end.

[0085] Example 11

[0086] The system according to any one of the preceding embodiments, wherein the visual marking pattern includes a series of parallel lines.

[0087] Example 12

[0088] The system according to embodiment 11, wherein at least some of the parallel lines extend parallel to the longitudinal centerline.

[0089] Example 13

[0090] The system according to embodiment 11, wherein at least some of the parallel lines extend transversely to the longitudinal centerline.

[0091] Example 14

[0092] The system according to any one of the foregoing embodiments, wherein the surgical mesh includes a pressure-sensitive adhesive along the lower side.

[0093] Example 15

[0094] The system according to any one of the foregoing embodiments, wherein the surgical mesh includes a plurality of time-based indicators that are collectively configured to visually indicate a timeline for applying a topical skin adhesive to the upper side of the surgical mesh relative to the visual marking pattern.

[0095] Example 16

[0096] A method comprising: adhering a surgical mesh according to embodiment 1 to a portion of a patient's skin such that the surgical mesh covers a wound in the skin; applying a topical skin adhesive according to embodiment 1 to the upper side of the surgical mesh with an adhesive application device by tracing the visual marking pattern with a dispensing tip of the adhesive application device; and spreading the applied topical skin adhesive across the upper side and onto an adjacent portion of the skin to form a protective layer over the wound.

[0097] Example 17

[0098] A system comprising: a surgical mesh including an upper side and a lower side, the upper side including a visual marking pattern extending longitudinally along the upper side, the lower side including a pressure-sensitive adhesive configured to adhere to a portion of a patient's skin surrounding a wound; a topical skin adhesive configured to be applied to the upper side of the surgical mesh based on the visual marking pattern, the topical skin adhesive configured to cure within the surgical mesh to form a fluid-resistant layer over the wound; and a spreader configured to spread the applied topical skin adhesive across the upper side before curing.

[0099] Example 18

[0100] A method includes: adhering a lower side of a surgical mesh to a portion of a patient's skin such that the surgical mesh covers a wound in the skin, wherein an upper side of the surgical mesh includes a visual marking pattern extending longitudinally along the upper side; applying a topical skin adhesive to the upper side of the surgical mesh with an adhesive application device by tracing the visual marking pattern with a dispensing tip of the adhesive application device; and spreading the applied topical skin adhesive across the upper side with a spreader, wherein the spread topical skin adhesive is configured to cure to form a protective layer over the wound.

[0101] Example 19

[0102] The method according to embodiment 18, wherein the surgical mesh includes a pressure-sensitive adhesive along the lower side, and adhering the surgical mesh to the patient's skin includes applying pressure to the pressure-sensitive adhesive.

[0103] Example 20

[0104] The method according to any one of embodiments 18 to 19, wherein spreading the topical skin adhesive includes pushing the topical skin adhesive into cavities of the stratum corneum of the skin.

[0105] V. Miscellaneous

[0106] It should be 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. Therefore, the above teachings, expressions, embodiments, examples, etc. should not be regarded as isolated from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those of ordinary skill in the art. Such modifications and variations are intended to be included within the scope of the claims.

[0107] In addition, any one or more of the teachings in the teachings of this article may be combined with any one or more of the teachings disclosed in the following patent applications: the U.S. Patent Application [Attorney Docket No.: ETH6161USPSP1] filed on the same day as this application, entitled "Device for Spreading Topical Skin Adhesive", the disclosure of which is incorporated herein by reference in its entirety; the U.S. Patent Application [Attorney Docket No.: ETH6164USNP1] filed on the same day as this application, entitled "Surgical Mesh Securing Device for Wound ClosureSystem", the disclosure of which is incorporated herein by reference in its entirety; and / or the U.S. Patent Application [Attorney Docket No.: ETH6166USNP1] filed on the same day as this application, entitled "Wound Closure System HavingMicrocannulaic Pathways", the disclosure of which is incorporated herein by reference in its entirety.

[0108] It should be understood that any patent, patent publication, or other published 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 published 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 published material set forth herein will be incorporated only to the extent that there is no conflict between the incorporated material and the existing published material.

[0109] 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 DA system.

[0110] The devices of the types described above can be designed to be discarded after a single use, or they can be designed to be reusable. In either case or both, these types can be repaired to be reused after at least one use. 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 parts of the device can be selectively replaced or removed in any combination. When cleaning and / or replacing specific parts, some types of the device can be reassembled at a repair facility or reassembled by the user before surgery is about to be performed for subsequent use. Those skilled in the art will appreciate that the repair of the device can be disassembled, cleaned / replaced, and reassembled using a variety of techniques. The use of such technology and the resulting repair device are all within the scope of the present application.

[0111] By way of example only, the devices described herein may 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 The container and device may then be placed in a field of radiation 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 may then be stored in a 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.

[0112] Various embodiments of the present invention have been shown and described, and further improvements of the methods and systems described herein may be achieved by appropriate modifications by those of ordinary skill in the art without departing from the scope of the present invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those of skill in the art. For example, the embodiments, embodiments, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not required. Therefore, the scope of the present invention should be considered in light of the following claims, and should be understood not to be limited to the details of the structure and operation shown and described in the specification and drawings.

Claims

1. A system, comprising: (i) A surgical mesh, the surgical mesh including an upper side and a lower side, the upper side including a visual marking pattern extending longitudinally along the upper side, the lower side being configured to adhere to a portion of the patient's skin surrounding a wound; And (ii) A topical skin adhesive, the topical skin adhesive being configured to be applied to the upper side of the surgical mesh based on the visual marking pattern, the topical skin adhesive being configured to cure within the surgical mesh to form a protective layer over the wound.

2. The system according to claim 1, wherein The surgical mesh is configured to adhere to opposite sides of the patient's wound, bringing the opposite sides closer together.

3. The system according to claim 1 or 2, further comprising a spreader configured to spread the topical skin adhesive across the upper side.

4. The system according to any one of the preceding claims, wherein, The surgical mesh includes a first longitudinal end, a second longitudinal end, and a longitudinal centerline extending between the first longitudinal end and the second longitudinal end, wherein a portion of the visual marking pattern intersects the longitudinal centerline or is directly above and extends along the longitudinal centerline.

5. The system according to claim 4, wherein, The visual marking pattern extends from the first longitudinal end to the second longitudinal end.

6. The system according to any one of the preceding claims, wherein, The visual marking pattern includes a plurality of discrete pattern segments that are disconnected from each other.

7. The system according to any one of the preceding claims, wherein, At least a portion of the visual marking pattern extends along an arcuate path.

8. The system according to claim 7, wherein, The visual marking pattern includes a sine wave.

9. The system according to any one of the preceding claims, wherein, The visual marking pattern includes a "T" shape.

10. The system according to any one of claims 4 to 9, wherein, The visual marking pattern includes a first line segment that intersects the longitudinal centerline transversely at the first longitudinal end, and a second line segment that is directly above the longitudinal centerline and extends along the longitudinal centerline from the first longitudinal end to the second longitudinal end.

11. The system according to any one of the preceding claims, wherein, The visual marking pattern includes a series of parallel lines.

12. The system according to claim 11, wherein, At least some of the parallel lines extend parallel to the longitudinal centerline.

13. The system according to claim 11, wherein, At least some of the parallel lines extend transversely to the longitudinal centerline.

14. The system according to any one of the preceding claims, wherein, The surgical mesh includes a pressure-sensitive adhesive along the lower side.

15. The system according to any one of the preceding claims, wherein, The surgical mesh includes a plurality of time-based indicators collectively configured to visually indicate a timeline for applying the topical skin adhesive to the upper side of the surgical mesh relative to the visual marking pattern.

16. A method, comprising: (i) Adhering the surgical mesh according to claim 1 to a portion of the patient's skin, such that the surgical mesh covers a wound in the skin; (ii) Applying the topical skin adhesive according to claim 1 to the upper side of the surgical mesh by tracing the visual marking pattern with a dispensing tip of an adhesive application device; And (iii) Spreading the applied topical skin adhesive across the upper side and onto adjacent portions of the skin to form a protective layer over the wound.

17. A system, comprising: (i) A surgical mesh, the surgical mesh including an upper side and a lower side, the upper side including a visual marking pattern extending longitudinally along the upper side, the lower side including a pressure-sensitive adhesive configured to adhere to a portion of the patient's skin surrounding a wound; (ii) A topical skin adhesive, the topical skin adhesive configured to be applied to the upper side of the surgical mesh based on the visual marking pattern, the topical skin adhesive configured to cure within the surgical mesh to form a liquid-resistant layer over the wound; and (iii) A spreader, the spreader configured to spread the applied topical skin adhesive across the upper side before curing.

18. A method, comprising: (i) Adhering a lower side of a surgical mesh to a portion of the patient's skin such that the surgical mesh covers a wound in the skin, wherein an upper side of the surgical mesh includes a visual marking pattern extending longitudinally along the upper side; (ii) Applying a topical skin adhesive to the upper side of the surgical mesh with an adhesive application device by tracing the visual marking pattern with a dispensing tip of the adhesive application device; and (iii) Spreading the applied topical skin adhesive across the upper side with a spreader, wherein the spread topical skin adhesive is configured to cure to form a protective layer over the wound.

19. The method according to claim 18, wherein the surgical mesh includes a pressure-sensitive adhesive along the lower side, where Adhering the surgical mesh to the patient's skin includes applying pressure to the pressure-sensitive adhesive.

20. The method according to claim 18 or 19, wherein Spreading the topical skin adhesive includes pushing the topical skin adhesive into cavities of the stratum corneum of the skin.

Images