Wound closure system with microcannula access

Abstract

An apparatus includes a cannula that can establish fluid communication with a suction source; and a wound closure path sized to cover a wound in the skin. The wound closure patch may receive a topical adhesive to adhere to the skin and form a microbial barrier over the wound. The wound closure patch defines a channel. The wound closure patch includes a top surface, a bottom surface defining at least one channel interposed between the top surface and the bottom surface, and a fluid coupling section in fluid communication with the channel. The fluid coupling section may be coupled with the cannula to establish fluid communication between the cannula, the channel, and at least one opening defined by the bottom surface.

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 automatically separate 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 showing an example of a wound closure system 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 of, showing a mesh layer, a pressure-sensitive adhesive layer, and a removable backing layer;

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

[0007] Figure 3B Shows Figure 1 The wound closure device of, applied over a patient's skin wound to approximate the edges of the wound;

[0008] Figure 3C Shows the Figure 1 Wound closure device of 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 is fully adhered 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 using an adhesive applicator 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 an alternative wound closure system including a suction distribution member and a wound closure patch is shown;

[0013] Figure 5A A perspective view of a suction distribution member longitudinally aligned with a wound in a patient's skin is shown; Figure 4

[0014] Figure 5B A perspective view of a suction distribution member is shown that is applied over a skin wound of a patient to bring the edges of the wound closer together; Figure 4

[0015] Figure 5C A perspective view of a wound closure patch applied over the top of a suction distribution member is shown, wherein longitudinal channels and a corresponding array of openings on the underside of the wound closure patch are aligned with a wound in a patient's skin; Figure 4 Figure 4

[0016] Figure 5D A perspective view of a wound closure patch and a suction distribution member is shown that depicts the application of a liquid topical skin adhesive to the wound closure patch using an adhesive applicator device; Figure 4

[0017] Figure 5E A perspective view of a wound closure patch and a suction distribution member is shown that depicts spreading a topical skin adhesive over and within the wound closure patch and the suction distribution member; Figure 4

[0018] Figure 6A A sectional view taken along line 6 - 6 of Figure 5E is shown of Figure 4 ​​​​​​​​​Cross-sectional views of a wound closure patch and a suction distribution member, the wound closure patch and the suction distribution member having a topical skin adhesive layer covering the wound closure patch and the suction distribution member;

[0019] Figure 6B Shows a cross-section taken along Figure 5E line 6-6 of Figure 4 a wound closure patch and a suction distribution member, the wound closure patch and the suction distribution member having a topical skin adhesive layer as shown in Figure 6A which exudate accumulates within the wound;

[0020] Figure 6C Shows a cross-section taken along Figure 5E line 6-6 of Figure 4 a wound closure patch and a suction distribution member, the wound closure patch and the suction distribution member having a topical skin adhesive layer as shown in Figure 6A which accumulated exudate is suctioned out of the wound via the wound closure patch;

[0021] Figure 7 Shows a top plan view of an alternative wound closure system including a suction distribution member and a wound closure patch;

[0022] Figure 8A Shows a cross-section taken along Figure 7 line 8-8 of Figure 7 a wound closure patch and a suction distribution member, the wound closure patch and the suction distribution member having a topical skin adhesive layer covering the wound closure patch and the suction distribution member;

[0023] Figure 8B Shows a cross-section taken along Figure 7 line 8-8 of Figure 7 a wound closure patch and a suction distribution member, the wound closure patch and the suction distribution member having a topical skin adhesive layer as shown in Figure 8A which a blister containing liquid ruptures to release the liquid into the wound;

[0024] Figure 8C Shows a cross-section taken along Figure 7 line 8-8 of Figure 7 a wound closure patch and a suction distribution member, the wound closure patch and the suction distribution member having a topical skin adhesive layer as shown in Figure 8A which accumulated fluid and / or exudate is suctioned out of the wound via the wound closure patch;

[0025] Figure 9 Shows a central cross-sectional view of another alternative wound closure system;

[0026] Figure 10 A central cross-sectional view of another alternative wound closure system is shown;

[0027] Figure 11 A central cross-sectional view of another alternative wound closure system is shown; and

[0028] Figure 12 A central cross-sectional view of another alternative wound closure system is shown.

[0029] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in many other ways, including those not necessarily shown in the drawings. The drawings incorporated in and forming a part of this specification illustrate several aspects of the invention and, together with the description, serve to explain the principles of the invention; however, it is to be understood that the invention is not limited to the specific arrangements shown. Detailed Description

[0030] The description of certain examples of the present technology 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, which 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.

[0031] 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 position and orientation. For clarity, such terms are used hereinafter with reference to the views and are not intended to limit the invention described herein.

[0032] In addition, as used herein, the terms "about" and "approximately" in connection with any numerical value or range are intended to cover the exact value cited, as well as a suitable tolerance that enables the cited feature or combination of features to be used for the intended purpose described herein.

[0033] I. Wound Closure System

[0034] Figure 1Shows 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 the applied topical skin adhesive (54) onto and through the wound closure device (20). Each of these components is described in more detail below.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] 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. Accordingly, the wound closure system (10) can be particularly effective for actuatable body parts of a patient, such as, for example, the knee, wrist, elbow, or other joints.

[0039] 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.

[0040] Figures 3A to 3DShows an example of a wound closure system (10) for closing a wound (W) formed in a patient's skin (S). In some surgeries, the wound (W) may be at least partially closed with one or more sutures prior to using the wound closure system (10), 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 being applied to the patient.

[0041] 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 proximity. 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) closer during application. For either method, the wound closure device (20) is configured to be able to hold the edges of the wound (W) in proximity 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 two side backing portions (30) to adhere the remaining portion of the wound closure device (20) to the skin (S).

[0042] As Figure 3D shown, a pattern of topical skin adhesive (54) is then applied to the upper side of the mesh (22) of the applied wound closure device (20) using an adhesive application device (40). While in this version the adhesive application device (40) is shown applying a linear bead of topical skin adhesive (54), it should be understood that in other versions various other patterns of topical skin adhesive (54) may be applied, such as the T-shaped pattern or the waveform pattern disclosed in the following U.S. patent application: U.S. Patent Application [Attorney Docket No.: ETH6163USNP1] filed on the same date as this application, entitled "Application of Topical Skin Adhesive to Surgical Mesh", the disclosure of which is incorporated herein by reference in its entirety.

[0043] As Figures 3E to 3FAs shown, a topical skin adhesive applicator (60) is then used to spread the applied topical skin adhesive (54) evenly over the wound closure device (20) 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 therethrough. As Figure 3E shown, at the beginning of the adhesive spreading stroke, when the adhesive applicator (60) is first positioned against the wound closure device (20), the flexible body portion (66) of the adhesive applicator (60) may be in an undeformed state. When the adhesive applicator (60) is longitudinally dragged along the wound closure device (20), the input force applied by the user may cause the flexible body portion (66) to elastically deform such that the distal body portion (64) deflects angularly relative to the proximal body portion (62), as Figure 3F shown. The degree of deformation of the flexible body portion (66) may be directly related to the viscosity of the topical skin adhesive (54). Specifically, a greater viscosity may require the user to apply a greater input force through the proximal body portion (62) to effectively spread the topical skin adhesive (54) over and through the wound closure device (20), such that the flexible body portion (66) deforms a relatively greater amount. Conversely, a lower viscosity may require a lower input force, such that the flexible body portion (66) deforms less or not at all.

[0044] Optionally, the topical skin adhesive (54) may 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) may 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) may be wiped away, for example, with a sterile gauze. Additionally, in some cases, a quantity of the topical skin adhesive (54) may be applied between the edges of the wound (W) prior to applying the wound closure device (20) 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. After the wound (W) has healed, the wound closure device (20) may be manually removed (e.g., by a surgeon) from the skin (S), or it may automatically separate from the skin (S) such that it can be discarded by the patient.

[0045] The wound closure system (10) can also be constructed and operated according to at least some of the teachings of the following patents: U.S. Patent Publication No. 2021 / 0369258, entitled "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, entitled "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, entitled "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, entitled "Novel Antimicrobial Topical Skin Closure Compositions and Systems," published on December 2, 2021, the entire disclosure of which is incorporated herein by reference; U.S. Patent Publication No. 2021 / 0369276, entitled "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, 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," filed on February 9, 2022, the entire disclosure of which is incorporated herein by reference.

[0046] II. Exemplary Wound Closure System with Microcatheter Access

[0047] As mentioned above, after the wound closure device (20) is applied to the wound (W) as described above, the topical adhesive (54) is appropriately applied within and over the wound closure device (20) to form a composite microbial barrier over the wound (W), thereby maintaining a protective environment that promotes effective healing. This microbial barrier can effectively seal the wound (W) from the external environment.

[0048] In some cases, after the wound closure device (20) and the topical adhesive (54) are appropriately applied over the wound (W), exudate and / or other substances may accumulate within the wound (W). In the case of effectively sealing the wound (W) from the external environment, the accumulation of exudate and / or other substances within the wound (W) may lead to undesirable consequences such as infection, preventing wound closure, and / or other undesirable consequences, which will be apparent to those skilled in the art in light of the teachings herein. Accordingly, it may be desirable to have a wound closure system that can remove the accumulated exudate and / or other substances after the wound closure device and the topical adhesive (54) are appropriately applied.

[0049] Figure 4 An exemplary wound closure system (100) that can be used to replace the above-described wound closure system (10) is shown. Thus, the wound closure system (100) is configured to be able to close a wound (W) formed in a patient's skin (S), while forming a microbial barrier in combination with a topical skin adhesive (54). Additionally, as will be described in more detail below, the wound closure system (100) is also configured to be able to provide a suitable amount of suction within the wound (W) to remove the accumulated exudate and / or other substances after the microbial barrier is formed.

[0050] The wound closure system (100) includes a wound closure patch (102) and a suction distribution member (120). As Figures 5A to 5B shown, the suction distribution member (120) is configured to be placed on top of the skin (S) so as to cover the wound (W). In this example, the suction distribution member (120) includes an open-cell porous sponge that is configured to distribute suction from an opening (110) defined on the lower side (106) (see Figure 5C ) of the wound closure patch (102) into the wound (W); while also allowing exudate and / or other substances to be suctioned out of the wound (W) and into a channel (108) defined by the wound closure patch (102). The suction distribution member (120) can be formed from any suitable material or combination of materials, which will be apparent to those skilled in the art in light of the teachings herein.

[0051] In some cases, the aspiration distribution member (120) may include a layer of pressure-sensitive adhesive and a backing, which may be substantially similar to the pressure-sensitive adhesive (24) and backing (26) described above. Thus, a surgeon may utilize the pressure-sensitive adhesive to temporarily attach the aspiration distribution member (120) to the skin (S) and wound (W) in substantially the same manner as the wound closure device (20) described above. In some cases, the aspiration distribution member (120) may be completely omitted such that the wound closure patch (102) is placed on top of the skin (S) so as to cover the wound (W).

[0052] In the present aspect of the disclosure, the wound closure patch (102) has a generally rectangular shape and extends longitudinally from a proximal end (116) towards a distal end (118). As Figures 5C to 5D and Figures 6A to 6C best seen, the wound closure patch (102) has a top surface (104) and a bottom surface (106) which together define the thickness of the wound closure patch (102).

[0053] The wound closure patch (102) is sized to define a longitudinally extending channel (108); however, the bottom surface (106) defines a plurality of openings (110) that are in fluid communication with the channel (108). The openings (110) are disposed along the length of the longitudinally extending channel (108). Additionally, the wound closure patch (102) is sized to be placed over the length of the wound (W) such that the channel (108) and openings (110) are adjacent to the wound (W). In some cases, the wound closure patch (102) may be placed over a selected portion of the wound (W). Thus, it should be understood that the wound closure patch (102) may have any suitable size, which will be apparent to those skilled in the art in light of the teachings herein.

[0054] The patch (102) may be formed from a material configured to be capable of suitably conforming to the contour of the skin (S) such that the patch (102) can accommodate patient movement while remaining operatively engaged with the skin (S) and wound (W). Additionally, the patch (102) defines a plurality of local adhesive receiving holes (112). In the present aspect of the disclosure, the holes (112) extend from the top surface (104) to the bottom surface (106). As Figures 6A to 6C best shown, the holes (112) are sized to receive a local adhesive (54) when applied and spread onto the patch (102) as described herein. Thus, when the local adhesive (54) cures, the holes (112) may facilitate the local adhesive (54) to further secure the patch (102) to the patient's skin (S) while forming a microbial barrier. In some cases, the bottom surface (106) may include a pressure-sensitive adhesive to help facilitate initial direct attachment of the patch (102) to the aspiration distribution member (120) or the patient's skin (S).

[0055] As Figures 6A to 6C Best shown, the proximal end (116) of the wound closure patch (102) includes at least one sealed cannula coupling section (114) that is in fluid communication with a suction source (140) via a cannula (142). The cannula coupling section (114) is also in fluid communication with a channel (108) of the patch (102). Thus, when the cannula (142) is coupled to both the suction source (140) and the cannula coupling section (114) of the patch (102), the opening (110) and the channel (108) are in fluid communication with the suction source (140).

[0056] The suction source (140) is configured to selectively apply suction when activated such that the opening (110) applies a suitable suction to the wound (W) during exemplary use as described herein. Thus, the channel (108) is capable of transmitting the suction transmitted from the cannula (142) to the opening (110). Additionally, the channel (108) is sized to accommodate exudate and / or other substances aspirated from the wound (W) through the opening (110) and into the channel (108) such that the aspirated substances can be transferred from the channel (108) into the cannula (142) and further towards the suction source (140). The cannula (142) and the suction source (140) may include suitable components and dimensions which will be apparent to those skilled in the art in light of the teachings herein.

[0057] In the case where the patch (102) defines the channel (108) and the opening (110), it should be understood that the patch (102) is formed of a suitable material that is configured to maintain a suitable communication between the suction source (140) and the wound (W) when deployed as described herein. Thus, the patch (102) is sufficiently rigid to prevent the channel (108) from collapsing in response to the suction transmitted from the suction source (140) to the opening (110). Additionally, as described herein, the patch (102) is configured to suitably maintain its structural integrity for at least a predetermined amount of time after being deployed to promote wound healing while also providing suction between the suction source (140) and the wound (W).

[0058] Figures 5A to 5E An example of a wound closure system (100) for closing a wound (W) formed in a patient's skin (S) is shown; simultaneously Figures 6A to 6C A wound closure system (100) for removing exudate (E) from a patient's wound (W) is shown. First, as Figure 5A shown, the suction distribution member (120) is longitudinally aligned with the edge of the wound (W). Next, as Figure 5BAs shown, the suction distribution member (120) is then applied to the patient's skin (S) above the wound (W). As mentioned above, the suction distribution member (120) may include a pressure-sensitive adhesive such that a surgeon can apply pressure to the suction distribution member (120) to adhere to the skin (S).

[0059] Next, as Figure 5C shown, the wound closure patch (102) can be applied to the top surface of the suction distribution member (120) such that the communication channel (108) and the opening (110) extend adjacent to the wound (W). As mentioned above, in some cases, the suction distribution member (120) is not used. Thus, in some cases, the wound closure patch (102) can be applied directly to the skin (S) to cover the wound (W). Once the wound closure patch (102) is positioned such that the channel (108) and the opening (110) are appropriately adjacent to the wound (W), as Figure 5D shown, the adhesive application device (40) is then used to apply a pattern of the liquid topical skin adhesive (54) on the top surface (104) of the patch (102).

[0060] As Figure 5E shown, the adhesive spreader (60) is then used to spread the applied topical adhesive (54) onto the patch (102), a portion of the suction distribution member (120), the skin (S), and the cannula (142). It should be understood that the patch can be formed of a material that resists absorption of the topical adhesive (54). Thus, in accordance with the description herein, the adhesive spreader (60) can push some of the topical adhesive (54) into the holes (112) of the patch (102) to further facilitate fixing of the patch (102) to the patient's skin (S). Then, the applied topical adhesive (54) cures above the patch (102), a portion of the suction distribution member (120), the skin (S), and the cannula (142) to form a composite microbial barrier above the wound (W) that maintains a protective environment that promotes effective healing.

[0061] As Figures 6A to 6B shown, after the microbial barrier is formed above the wound (W), exudate (E) and / or other substances may tend to accumulate within the wound (W) such that the exudate (E) may not be able to flow out of the wound (W). In such a case, as Figure 6CAs shown, the suction source (140) can be selectively activated to create a suitable negative pressure within the wound (W). The suitable negative pressure can create a suction force within the wound (W) such that exudate (E) is drawn away from the wound (W), enters the channel (108) via the opening (110), and enters the cannula (142) towards the suction source (140). Allowing removal of the exudate (E) can promote faster healing of the wound (W) or other benefits, which will be apparent to those skilled in the art in light of the teachings herein. Negative pressure can be induced within the wound (W) for any other suitable purpose, which will be apparent to those skilled in the art in light of the teachings herein.

[0062] In some cases, it may be desirable to apply a suitable fluid within the wound (W) after forming a microbial barrier over the wound (W). For example, in some cases, it may be desirable to insert a therapeutic agent into the wound (W) to further aid in effective healing. Figures 8A to 8C Another exemplary wound closure system (200) is shown that can be readily incorporated to replace the above-described wound closure system (100). As will be described in more detail below, the wound closure system (200) is configured to be able to provide suction within the wound (W) and also selectively deliver a suitable medicament into the wound (W) after forming a microbial barrier over the wound (W).

[0063] The wound closure system (200) is substantially similar to the above-described wound closure system (100), with the differences being detailed below. Thus, the wound closure system (200) includes a suction distribution member (220); a wound closure patch (202) having an upper surface (204), a bottom surface (206), a longitudinal channel (208), an array of openings (210), local adhesive receiving holes (212), a sealed fluid coupling section (214), a proximal end (216), and a distal end (218); which can be substantially similar to the above-described section distribution member (120), wound closure patch (102), upper surface (104), bottom surface (106), longitudinal channel (108), array of openings (110), local adhesive receiving holes (112), sealed fluid coupling section (114), proximal end (116), and distal end (118), respectively, with the differences being detailed below.

[0064] Additionally, the patch (202) includes at least one blister package (230) extending upwardly from the upper surface (204). As Figures 8A to 8C shown, each blister package (230) is located near the channel (208). The blister package (230) is configured to be able to hold a medicament (232). As Figure 8BAs best shown, if desired, the operator can compress the blister package (230) with a suitable force to release the medicament (232) into the channel (208). The medicament (232) can then be dispersed through the opening (210) into the wound (W). Thus, after forming the microbial barrier, the user can compress the cured topical adhesive (54) to cover the desired portion of the blister package (230) to release the medicament (232) into the wound (W). Any suitable medicament (232) can be utilized, which will be apparent to those skilled in the art in light of the teachings herein. For example, the medicament (232) can include a therapeutic liquid configured to treat an infection of the wound (W). The medicament (232) can include steroids to promote faster healing of the wound (W). The medicament (232) can include a saline solution. Additionally, the blister package (230) can contain different medicaments (232) in each package (230), which can be used for different scenarios or combined with each other to achieve different desired results.

[0065] Although three blister packages (230) are shown in the current example, any suitable number of blister packages (230) can be utilized, which will be apparent to those skilled in the art in light of the teachings herein. The blister package (230) can include any suitable structure and be formed of any suitable material, which will be apparent to those skilled in the art in light of the teachings herein.

[0066] Figure 9 Another exemplary wound closure system (300) is shown that can be readily incorporated to replace the above-described wound closure system (100). As will be described in more detail below, the wound closure system (300) is configured to selectively deliver a suitable fluid to the wound (W) and also provide suitable suction after forming a microbial barrier over the wound (W).

[0067] The wound closure system (300) is substantially similar to the above-described wound closure system (100), with the differences being detailed below. Thus, the wound closure system (300) includes a suction distribution member (320); a wound closure patch (302) having an upper surface (304), a bottom surface (306), a longitudinal channel (308), an array of openings (310), local adhesive receiving holes (312), a sealed fluid coupling section (314), a proximal end (316), and a distal end (318); which are respectively substantially similar to the above-described section distribution member (120), wound closure patch (102), upper surface (104), bottom surface (106), longitudinal channel (108), array of openings (110), local adhesive receiving holes (112), sealed fluid coupling section (114), proximal end (116), and distal end (118), with the differences being detailed below.

[0068] The wound closure system (300) includes a fluid reservoir (146) in communication with a suction / pumping device (148), rather than using a blister package (230) to disperse a desired medicament into the wound (W). The fluid reservoir (146) is in fluid communication with the channel (308) via a cannula (144). The suction / pumping device (148) is capable of providing suction within the wound (W) or pumping fluid from the fluid reservoir (146) into the channel (308) and through the openings (310). Thus, the suction / pumping device (148) can be used to remove exudate from the wound (W) and / or pump a suitable fluid from the fluid reservoir (146) into the wound (W) via the channel (308) and the openings (310). Although in this example, a single fluid reservoir (146) is used, any suitable number of fluid reservoirs (146) can be used, which will be apparent to those skilled in the art in light of the teachings herein. The fluid reservoir (146) can contain any suitable fluid, which will be apparent to those skilled in the art in light of the teachings herein. For example, therapeutic agents, steroids, saline, etc. can be contained within the fluid reservoir (146).

[0069] The suction / pumping device (148) can include any suitable components, which will be apparent to those skilled in the art in light of the teachings herein.

[0070] In some cases, it may be desirable to more accurately control the direction in which suction is applied to the wound (W). Additionally, it may be desirable to more accurately control the direction in which fluid is introduced into the wound (W). Figure 10Shown is another exemplary wound closure system (400) that can be readily incorporated to replace the above-described wound closure system (100). As will be described in more detail below, the wound closure system (400) is configured to be able to apply suction within the wound (W) in a predetermined direction after forming a microbial barrier over the wound (W).

[0071] The wound closure system (400) is substantially similar to the above-described wound closure system (100), with the differences being detailed below. Accordingly, the wound closure system (400) includes a wound closure patch (402) having an upper surface (404), a bottom surface (406), a longitudinal channel (408), local adhesive receiving holes (412), a sealed fluid coupling section (414), a proximal end (416), and a distal end (418); which can be substantially similar to the above-described wound closure patch (102), upper surface (104), bottom surface (106), longitudinal channel (108), local adhesive receiving holes (112), sealed fluid coupling section (114), proximal end (116), and distal end (118) respectively, with the differences being detailed below.

[0072] The wound closure patch (402) includes a plurality of atraumatic nozzles (410) extending downward from the bottom surface (406) into the wound (W), rather than having a plurality of openings (110) providing fluid communication between the channel (408) and the wound (W). The atraumatic nozzles (410) are positioned along the channel (408) such that when the patch (402) is applied to the skin (S) to cover the wound (W), the atraumatic nozzles (410) can extend within the wound (W). The atraumatic nozzles (410) can allow for deeper suction to be provided within the wound (W). Additionally, the atraumatic nozzles (410) can extend from the bottom surface (406) at a desired angle, thereby providing control over the direction of the applied suction.

[0073] The atraumatic nozzles (410) are small enough to prevent inadvertently inhibiting the wound (W) from healing properly. Additionally, the atraumatic nozzles (410) are formed of a suitable material such that if the nozzles (410) abut against the skin (S) rather than properly extending within the wound (W) after the patch (402) is secured to the patient in accordance with the teachings herein, the nozzles (410) can deform properly without damaging the patient's skin (S). Additionally, the atraumatic nozzles (410) can have appropriate elasticity such that the nozzles (410) return to their intended shape after the deforming force (e.g., contact with the skin (S)) no longer exists. Thus, the atraumatic nozzles (410) can provide a greater degree of access within the wound (W) without inadvertently causing damage to the skin (S) or irreversibly inhibiting the effective healing of the wound (W).

[0074] In the present example, a patch (402) is shown that does not use a suction distribution member.

[0075] Figure 11 Shown is another exemplary wound closure system (500) that can be readily incorporated to replace the above-described wound closure system (200). The wound closure system (500) is substantially similar to the above-described wound closure system (200), with the differences being detailed below. Thus, the wound closure system (500) includes a wound closure patch (502) having an upper surface (504), a bottom surface (506), a longitudinal channel (508), local adhesive receiving holes (512), a sealed fluid coupling section (514), a proximal end (516), a distal end (518), and a blister package (530) filled with a medicament (532); which can be substantially similar to the wound closure patch (202), upper surface (204), bottom surface (206), longitudinal channel (208), local adhesive receiving holes (212), sealed fluid coupling section (214), proximal end (216), distal end (218), and blister package (230) filled with a medicament (232) described above, with the differences being detailed below.

[0076] Specifically, the wound closure system (500) includes a plurality of atraumatic nozzles (510) that are substantially similar to the above-described atraumatic nozzle (410), rather than defining an opening (210). Thus, when the blister package (530) ruptures as described herein, the medicament (532) can travel through the atraumatic nozzles (410) into the channel (408) and into the wound (W). Additionally, suction can be applied via the nozzles (510) in a manner similar to the above-described nozzle (410). Similar to the above-described patch (402), a patch (502) that does not use a suction dispensing member is also shown.

[0077] Figure 12Shown is another exemplary wound closure system (600) that can be readily incorporated to replace the above-described wound closure system (300). The wound closure system (600) is substantially similar to the above-described wound closure system (300), with differences detailed below. Thus, the wound closure system (600) includes a wound closure patch (602) having an upper surface (604), a bottom surface (606), a longitudinal channel (608), local adhesive receiving apertures (612), a sealed fluid coupling section (614), a proximal end (616), and a distal end (618); which can be substantially similar to the above-described wound closure patch (302), upper surface (304), bottom surface (306), longitudinal channel (308), local adhesive receiving apertures (312), sealed fluid coupling section (314), proximal end (316), and distal end (318), respectively, with differences detailed below. Thus, the patch (602) is operable to work in a manner similar to the above-described patch (302) in combination with a fluid reservoir (146) and a suction / pumping device (148).

[0078] The wound closure system (600) includes a plurality of atraumatic nozzles (610) that are substantially similar to the above-described atraumatic nozzle (410), rather than defining an opening (310). Thus, when the suction / pumping device (148) is activated in accordance with the description herein, fluid pumped from the fluid reservoir (146) can travel through the atraumatic nozzles (610) into the channel (408) and into the wound (W). Additionally, the suction / pumping device (148) can provide suction to the wound (W) via the nozzles (610) to effect controlled suction in accordance with the description herein. Similar to the above-described patch (402), a patch (602) is also shown that does not use a suction distribution member.

[0079] III. Combined Examples

[0080] The following embodiments relate to various non-exhaustive ways in which the teachings herein can be combined or applied. It should be understood that the following embodiments are not intended to limit the scope of any claims that may be provided at any time in this patent application or in subsequent filings of this patent application. No disclaimer is intended. The following embodiments are provided merely for illustrative purposes. It is contemplated that the various teachings herein can be arranged and applied in many other ways. It is also contemplated that some variations may omit certain features mentioned in the following embodiments. Thus, none of the aspects or features mentioned below should be considered decisive, unless expressly so indicated by the inventors or successors in interest to the inventors at a later date. If any claims presented in this patent application or in subsequent filings related to this patent application include additional features beyond those mentioned below, such additional features should not be assumed to have been added for any reason related to patentability.

[0081] Example 1

[0082] An apparatus comprising: (a) an intubation tube configured to establish fluid communication with a suction source; and (b) a wound closure patch sized to cover a wound in the skin, wherein the wound closure patch is configured to receive a topical adhesive to adhere to the skin and form a microbial barrier over the wound, wherein the wound closure patch defines a channel, wherein the wound closure patch comprises: (i) a top surface, (ii) a bottom surface defining at least one opening in fluid communication with the channel, wherein the channel is disposed between the top surface and the bottom surface, and (iii) a fluid coupling section in fluid communication with the channel, wherein the fluid coupling section is configured to couple with the intubation tube to establish fluid communication between the intubation tube, the channel, and the at least one opening defined by the bottom surface.

[0083] Example 2

[0084] The apparatus according to any one or more of the preceding embodiments, wherein the fluid coupling section further comprises a sealed fluid coupling section.

[0085] Example 3

[0086] The apparatus according to any one or more of the preceding embodiments, wherein the wound closure patch further defines at least one topical adhesive receiving hole.

[0087] Example 4

[0088] The apparatus according to any one or more of the preceding embodiments, wherein the at least one topical adhesive receiving hole extends from the top surface to the bottom surface.

[0089] Example 5

[0090] The apparatus according to any one or more of the preceding embodiments, wherein the wound closure patch extends from a proximal end towards a distal end.

[0091] Example 6

[0092] The apparatus according to any one or more of the preceding embodiments, wherein the fluid coupling section is located at the proximal end of the wound closure patch.

[0093] Example 7

[0094] The device according to any one or more of the foregoing embodiments, wherein the channel extends longitudinally from the proximal end towards the distal end.

[0095] Example 8

[0096] The device according to any one or more of the foregoing embodiments, wherein the top surface comprises a blister package filled with a medicament.

[0097] Example 9

[0098] The device according to any one or more of the foregoing embodiments, wherein the blister package is configured to be ruptured to thereby dispense the medicament into the channel.

[0099] Example 10

[0100] The device according to any one or more of the foregoing embodiments, wherein the medicament comprises a therapeutic fluid.

[0101] Example 11

[0102] The device according to any one or more of the foregoing embodiments, wherein the wound closure patch further comprises at least one non-invasive nozzle in fluid communication with a respective opening of the at least one opening.

[0103] Example 12

[0104] The device according to any one or more of the foregoing embodiments, wherein the at least one non-invasive nozzle extends downwardly from the bottom surface of the wound closure patch.

[0105] Example 13

[0106] The device according to any one or more of the foregoing embodiments, further comprising a second cannula, wherein the wound closure patch comprises a second fluid coupling section in fluid communication with the channel and the second cannula.

[0107] Example 14

[0108] The device according to any one or more of the foregoing embodiments, wherein the second cannula is configured to establish fluid communication with a fluid reservoir.

[0109] Example 15

[0110] The device according to any one or more of the foregoing embodiments, further comprising a suction dispensing member configured to abut against the bottom surface of the wound closure patch such that the suction dispensing member is interposed between the skin and the wound closure patch.

[0111] Example 16

[0112] An apparatus, comprising: (a) an intubation tube configured to establish fluid communication with a suction source; and (b) a wound closure patch sized to cover a wound in the skin, wherein the wound closure patch is configured to receive a topical adhesive to adhere to the skin and form a microbial barrier over the wound, wherein the wound closure patch includes a bottom surface defining a plurality of openings, and wherein the wound closure patch defines a longitudinally extending channel in fluid communication with the intubation tube such that the intubation tube is configured to cause suction through the plurality of openings via the longitudinally extending channel.

[0113] Example 17

[0114] The apparatus according to any one or more of the preceding embodiments, wherein the apparatus further comprises a suction distribution member configured to be attached to the bottom surface of the wound closure patch.

[0115] Example 18

[0116] The apparatus according to any one or more of the preceding embodiments, wherein the wound closure patch further comprises a plurality of atraumatic nozzles in fluid communication with respective ones of the plurality of openings.

[0117] Example 19

[0118] An apparatus, comprising: (a) a wound closure patch sized to cover a wound in the skin, wherein the wound closure patch is configured to receive a topical adhesive to adhere to the skin and form a microbial barrier over the wound, wherein the wound closure patch includes a bottom surface defining a plurality of openings, and wherein the wound closure patch defines a longitudinally extending channel in fluid communication with the plurality of openings; and (b) a suction distribution member configured to be attached to the bottom surface of the wound closure patch.

[0119] Example 20

[0120] The apparatus according to any one or more of the preceding embodiments, wherein the suction distribution member comprises an open-cell sponge material.

[0121] IV. Miscellaneous

[0122] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Accordingly, the foregoing teachings, expressions, embodiments, examples, etc. should not be regarded as mutually exclusive. Various suitable ways in which the teachings herein 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.

[0123] In addition, any one or more of the teachings in the teachings herein may be combined with any one or more of the teachings disclosed in the following patent applications: U.S. Patent Application [Attorney Docket No.: ETH6161USPSP1] filed on the same day as this application, entitled "Spreader Device for Applying Topical Skin Adhesive", the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent Application [Attorney Docket No.: ETH6163USNP1] filed on the same day as this application, entitled "Application of Topical Skin Adhesive to Surgical Mesh", the disclosure of which is incorporated herein by reference in its entirety; and / or U.S. Patent Application [Attorney Docket No.: ETH6164USNP1] filed on the same day as this application, entitled "Surgical Mesh Securing Device for Wound Closure System", the disclosure of which is incorporated herein by reference in its entirety.

[0124] 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.

[0125] The above-described types of devices can be applied to traditional medical treatments and surgeries performed by medical professionals, as well as robot-assisted medical treatments and surgeries. By way of example only, the various teachings herein can be readily incorporated into robotic surgical systems, such as the DAVINCI of Intuitive Surgical, Inc. (Sunnyvale, California)TM system

[0126] Devices of the type described above can be designed to be discarded after a single use, or they can be designed for multiple uses. In either case or both cases, these types can be repaired for reuse 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 portions of the device can be selectively replaced or removed in any combination. When cleaning and / or replacing specific components, some types of the device can be reassembled at a repair facility or by the user immediately prior to surgery for subsequent use. Those skilled in the art will appreciate that the repair of the device can be carried out for disassembly, cleaning / replacement, and reassembly using a variety of techniques. The use of such techniques and the resulting repaired device are all within the scope of this application.

[0127] By way of example only, the types described herein can be sterilized before and / or after surgery. In one sterilization technique, the device is placed in a closed and sealed container such as a plastic bag or a TYVEK bag. The container and the device can then be placed in a radiation field that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation can kill bacteria on the device and in the container. The sterilized device can then be stored in a sterile container for later use. Any other techniques known in the art can also be used to sterilize the device, which includes but is not limited to beta radiation or gamma radiation, ethylene oxide, or steam.

[0128] Various embodiments of the invention have been shown and described. Further improvements to the methods and systems described herein can be achieved by appropriate modification by those of ordinary skill in the art without departing from the scope of the invention. Several such possible modifications have been mentioned, and other modifications will be obvious to those skilled in the art. For example, the embodiments, implementations, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not essential. Therefore, the scope of the invention should be considered in light of the following claims and should be understood to be not limited to the details of the structures and operations shown and described in the specification and drawings.

Claims

1. An apparatus, comprising: (a) an intubation tube configured to establish fluid communication with a suction source; and (b) a wound closure patch sized to cover a wound in the skin, wherein the wound closure patch is configured to receive a topical adhesive to adhere to the skin and form a microbial barrier over the wound, wherein the wound closure patch defines a channel, and wherein the wound closure patch comprises: (i) a top surface, (ii) a bottom surface defining at least one opening in fluid communication with the channel, wherein the channel is disposed between the top surface and the bottom surface, and (iii) a fluid coupling section in fluid communication with the channel, wherein the fluid coupling section is configured to be coupled to the intubation tube to establish fluid communication between the intubation tube, the channel, and the at least one opening defined by the bottom surface.

2. The device according to claim 1, wherein, The fluid coupling section further comprises a sealed fluid coupling section.

3. The device according to claim 1 or 2, wherein, The wound closure patch further defines at least one topical adhesive receiving hole.

4. The device according to claim 3, wherein, The at least one topical adhesive receiving hole extends from the top surface to the bottom surface.

5. The apparatus according to any one of the preceding claims, wherein, The wound closure patch extends from a proximal end towards a distal end.

6. The device according to claim 5, wherein The fluid coupling section is located at the proximal end of the wound closure patch.

7. The device according to claim 5 or 6, wherein The channel extends longitudinally from the proximal end towards the distal end.

8. The apparatus according to any one of the preceding claims, wherein, The top surface comprises a blister package filled with a medicament.

9. The device according to claim 8, wherein The blister package is configured to rupture to thereby dispense the medicament into the channel.

10. The device according to claim 9, wherein, The medicament comprises a therapeutic fluid.

11. The apparatus according to any one of the preceding claims, wherein, The wound closure patch further comprises at least one atraumatic nozzle in fluid communication with a respective one of the at least one opening.

12. The device according to claim 11, wherein, The at least one atraumatic nozzle extends downwardly from the bottom surface of the wound closure patch.

13. The device according to any one of the preceding claims, further comprising a second cannula, wherein, The wound closure patch comprises a second fluid coupling section in fluid communication with the channel and a second intubation tube.

14. The apparatus according to claim 13, wherein, The second intubation tube is configured to establish fluid communication with a fluid reservoir.

15. The apparatus according to any one of the preceding claims, further comprising a suction distribution member configured to abut against the bottom surface of the wound closure patch such that the suction distribution member is disposed between the skin and the wound closure patch.

16. An apparatus, comprising: (a) an intubation tube configured to establish fluid communication with a suction source; and (b) a wound closure patch sized to cover a wound in the skin, wherein the wound closure patch is configured to receive a topical adhesive to adhere to the skin and form a microbial barrier over the wound, wherein the wound closure patch comprises a bottom surface defining a plurality of openings, and wherein the wound closure patch defines a longitudinally extending channel in fluid communication with the intubation tube such that the intubation tube is configured to cause suction through the plurality of openings via the longitudinally extending channel.

17. The device according to claim 16, wherein, The apparatus further comprises a suction distribution member configured to be attached to the bottom surface of the wound closure patch.

18. The apparatus according to claim 16 or 17, wherein, The wound closure patch further includes a plurality of atraumatic nozzles in fluid communication with respective ones of the plurality of openings.

19. An apparatus comprising: (a) A wound closure patch sized to cover a wound in skin, wherein the wound closure patch is configured to receive a topical adhesive to adhere to the skin and form a microbial barrier over the wound, wherein the wound closure patch includes a bottom surface defining a plurality of openings, and wherein the wound closure patch defines a longitudinally extending channel in fluid communication with the plurality of openings; and (b) A suction distribution member configured to attach to the bottom surface of the wound closure patch.

20. The apparatus according to claim 19, wherein, The suction distribution member includes an open cell sponge material.

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