Surgical incision and closure device

Abstract

This invention discloses an incision closure device, comprising a first substrate for adhesion to a first side of an incision or wound, the first substrate including an upper surface and a tissue adhesion lower surface; a second substrate for adhesion to a second side of the incision or wound opposite to the first side, the second substrate including an upper surface and a tissue adhesion lower surface; a first plurality of longitudinally spaced supports coupled to the upper surface of the first substrate; a second plurality of longitudinally spaced supports coupled to the upper surface of the second substrate; and a plurality of transverse links coupling the first substrate and the second substrate to each other. Each transverse link has a first end and a second end, the first end being permanently fixed relative to a support of the first substrate, and the second end being reversibly and adjustably connected to a transversely opposing support of the second substrate, thereby allowing the transverse links to pull the first substrate and the second substrate laterally together to compress the incision or wound covered by the incision closure device.

Description

[0001] This application is a divisional application of Chinese Patent Application No. 201811248784.4, filed on February 14, 2014, entitled "Surgical Incision and Closure Device". Patent Application No. 201811248784.4 is itself a divisional application of Chinese Patent Application No. 201480050158.8, filed on February 14, 2014, entitled "Surgical Incision and Closure Device". This Chinese Patent Application No. PCT / US2014 / 016587 is a Chinese national phase application. Cross-references to related applications

[0002] This PCT application claims the benefit of U.S. Provisional Application No. 61 / 889,569 (Agent File No. 35383-712.101), filed October 11, 2013; U.S. Provisional Application No. 61 / 958,259 (Agent File No. 35383-710.101), filed July 24, 2013; and U.S. Provisional Application No. 61 / 958,254 (Agent File No. 35383-711.101), filed July 24, 2013, the entire disclosure of which is incorporated herein by reference.

[0003] This application relates to U.S. Patent Application No. 13 / 665,160 (Attorney’s File No. 35383-709.501), filed October 31, 2012, which is a continuation-in-part of U.S. Patent Application No. 13 / 286,757 (Attorney’s File No. 35383-709.201), filed November 1, 2011, the entire disclosure of which is incorporated herein by reference.

[0004] This application relates to co-pending U.S. Patent Application No. 14 / 180,524 (Attorney’s File No. 35383-712.201), filed February 14, 2014, and co-pending U.S. Patent Application No. 14 / 180,564 (Attorney’s File No. 35383-709.502), filed February 14, 2014, the entire disclosure of which is incorporated herein by reference. Technical Field

[0005] This invention generally relates to medical devices and methods. More specifically, this invention relates to devices and methods for forming and closing surgical incisions. Background Technology

[0006] Surgical closure devices comprising adhesive-based patches having a right plate and a left plate are known. Such devices of particular interest to this invention are described in co-pending, co-owned PCT application US 2010 / 000430, the entire disclosure of which is incorporated herein by reference. As described in that PCT application, an adhesive patch is placed on the patient's skin at the site where a surgical incision is desired. After the patch is placed, an incision is formed along an axis extending through the center of the patch. After the incision is formed, it can be opened to perform the desired surgical procedure, and after the surgical procedure is completed, the incision can be closed by pulling the inner edges of the plates together using clips, zippers, or other closure members.

[0007] The primary goal of such surgical closure devices is to improve healing and reduce scarring from incisions. However, this goal is hampered by certain characteristics of currently available devices. For example, tissue edges do not always converge uniformly along a single line, which can increase the eventual scarring. Many such closure devices lack the ability to adjust the closing force or distance at the tissue edges, thus limiting their ability to slightly “wrinkle” the tissue, which has been found to reduce scarring. Other drawbacks of available incision and wound closure devices include difficulty in use and inability to adapt to tissue manipulation during subsequent surgical procedures; that is, devices that are rigid enough for firmly closing tissue often fail to adapt to tissue movement during surgical manipulation.

[0008] Self-adhesive wound closure patches present specific problems when used to adhere under surgical incision drapes. These drapes are used to help maintain the sterility of tissue surfaces during surgical procedures and are placed over a previously positioned tissue closure patch. Because the surgical incision drape has an adhesive underside that adheres to the tissue, the drape will adhere to the upper surface of the underlying tissue closure patch. Removal of the surgical incision drape thus often removes or at least displaces the previously placed tissue closure patch. If any significant portion of the tissue closure patch is removed or displaced, the patch is no longer effective for closing the surgical wound.

[0009] For these reasons, it is desirable to provide an improved surgical incision closure device and its method of use. In particular, it is desirable to provide an incision closure device that adheres to tissue, allows incision formation, adapts to tissue deformation during subsequent surgical procedures, and provides controlled closure of adjacent tissue edges after the surgical procedure. Specifically, it is desirable for the incision closure device to provide control and uniform distribution of closure force on tissue edges while causing minimal constraint or stretching to tissue during surgical procedures. It is also desirable to provide an improved surgical incision closure device and its method of use, wherein when the device is used under a surgical incision drape, it resists removal and dislocation. The invention described below will achieve at least some of these objectives.

[0010] Surgical closure devices are described in U.S. Patent Nos. 2,012,755; 3,516,409; 3,863,640; 3,933,158; 4,114,624; 3,926,193; 4,535,772; 4,676,245; 4,881,546; 4,905,694; 5,377,695 and 7,455,681; and U.S. Patent Publications 2005 / 0020956 and 2008 / 0114396. Further surgical closure devices are described in jointly owned U.S. Patent Nos. 8,313,508, 8,323,313, and 8,439,945; U.S. Patent Publication No. 2013 / 0066365; and PCT Publications Nos. WO 2011 / 139912, WO 2011 / 159623, WO 2011 / 043786, and WO 2013 / 067024, the entire contents of which are incorporated herein by reference. Commercially available incision closure devices are available from Johnson & Johnson's Ethicon division under the trade name Ethizip™ Temporary Abdominal Wound Closure Device. Summary of the Invention

[0011] This invention provides improved devices and methods for closing wounds, particularly those caused by incisions made during surgical procedures. Incisions typically form on the patient's skin, such as across the abdomen, but in some cases, they may also be made on internal organs, inside the mouth, within body cavities, etc.

[0012] The apparatus and method of the present invention will minimize disruption or interference to surgical procedures performed after the incision is made. In particular, the apparatus and method will allow the relative edges of the incised tissue to open, stretch, and deform freely with minimal constraint caused by the presence of the closure device. However, once the surgical procedure is complete, the apparatus and method of the present invention will provide a uniform distribution of the closure force, thereby pulling the tissue edges together in a manner that minimizes scar formation. Specifically, the closure device is capable of pulling the tissue edges together at a distance slightly closer than the initial spacing present when the incision was made, so that the tissue edges are everted upwards and result in a “wrinkling” that reduces scar formation.

[0013] The apparatus and method of the present invention will also be able to avoid or reduce disturbance when an incision closure instrument is used under a surgical incision drape, which must be removed from the closure instrument. A sacrificial layer is provided on at least a portion of the upper surface of the closure instrument, wherein the sacrificial covering is held in place when the surgical incision closure instrument is placed on the incision closure instrument. After the incision and surgical procedure are completed, the surgical incision drape is pulled off the patient's skin. The surgical drape adheres to the sacrificial covering, rather than to the tissue closure instrument and dislocates it, and only the sacrificial covering is pulled off the drape from the patient, leaving the rest of the incision closure instrument in place.

[0014] In a first aspect of the invention, an incision closure device includes a base comprising a left plate and a right plate. Each plate has a tissue adhesion lower surface, a upper surface, an inner edge, and an outer edge. The tissue adhesion lower surface will typically be at least partially coated with a commonly used tissue adhesion adhesive, such as those used in surgical bandages and patches.

[0015] The incision closure instrument also includes a force distribution structure coupled to each plate (i.e., each plate will have at least one force distribution structure coupled thereto), wherein each force distribution structure is adapted to allow the plate to expand axially along its inner edge while restricting lateral expansion over its entire length and axial expansion along its outer edge. By allowing the plate to expand axially along its inner edge, the tissue edge is minimally constrained to allow the tissue to deform when stretched during the surgical procedure. Conversely, by restricting both lateral expansion and axial expansion along the outer edge, the plate will be able to apply a controlled and distributed closure force when the plates are pulled together after the surgical procedure is completed, as described in more detail below.

[0016] The incision closure device also includes a closure assembly or component attached to a force distribution structure to pull the inner edges of the plates together after the plates have adhered to tissues on opposite sides of the incision site and the surgical procedure has been completed. Each plate in the base will typically include at least partially elastic matrix, generally isotropic (i.e., the plates stretch uniformly in all directions), but optionally anisotropic (wherein the matrix is ​​preferably stretched in one direction or on a portion thereof). The elastic matrix includes elastomeric films or sheets (e.g., polyurethane sheets or thermoplastic elastomers (TPEs)), woven fabrics (typically at least partially woven from elastomeric filaments, elastomeric yarns, or elastomeric fibers), short-fiber fabrics, etc. In some embodiments, the elastic matrix may comprise a fabric woven from elastic elements (typically yarns, filaments, fibers, etc.) and having non-elastic elements disposed along the outer edges and extending laterally across them to provide the expansion properties described above relative to the force distribution structure. That is, in some cases, the force distribution structure may include or be composed of inelastic elements woven into or otherwise incorporated into the fabric membrane.

[0017] Typically, the force distribution structure will comprise individual components of the incision closure instrument, such as a ridge positioned axially adjacent to the outer edge of the plate, and a plurality of axially spaced transverse supports positioned laterally and extending from the ridge toward the inner edge of the plate. Such a "comb-like" structure is typically formed of a flexible but non-expandable material so that the elements can buckle with tissue deformation but will not stretch along their length, thus providing dimensional stability in the transverse direction and along the outer edge of the plate. Examples of such materials include nylon, polypropylene, polyethylene, and polycarbonate or other thermoplastic polymers. It should be noted that the force distribution structure will not restrict axial stretching of the inner edge of the plate to provide the desired expandability and adaptability to tissue during surgical manipulation. Such individual force distribution structures may be attached to the upper surface of the plate, or alternatively embedded or stacked within the plate. Typically, the force distribution structure will not extend into or beyond the lower surface of the plate so that it will not interfere with the adhesion of the plate to the skin or other tissues.

[0018] The substrate and force distribution structure assembly is typically supported on a removable backing that covers and protects the adhesion surface of the plate before use. The backing can be removed to allow the base to be applied to the skin or other tissue at the surgical intervention site. Furthermore, the right and left plates are typically held together by removable ear flaps, axial strips, or other removable coverings or structures to maintain the inner surfaces of the plates at a predetermined distance or spacing when the plates are adhered to the tissue. For example, removable ear flaps can be placed at each axial end of the base to temporarily secure the two substrates together. Alternatively, removable strips or tapes can be placed in the axial gap between the left and right plates to hold the plates in place relative to each other when the base is adhered to the tissue surface. Such ear flaps or strips are typically self-adhesive, allowing them to be secured to the plates and then removed by simply peeling them off after the plates have been properly placed on the tissue. The coverings, ear flaps, or strips can then be removed to leave the plates in place but not connected until a surgical incision is made between them.

[0019] A first exemplary configuration of the closure assembly or assembly includes a right engaging member, a left engaging member, and a plurality of lateral struts that maintain the engaging members laterally spaced apart by a predetermined distance. The right engaging member is adapted to releasably engage its support along the inner edge of the right plate, while the left engaging member is adapted to releasably engage its support along the inner edge of the left plate. In a specific embodiment, at least some of the supports of the force distribution assembly will have wedges located near their inner edges, and the engaging members will have grooves receiving the wedges. After the surgical intervention is completed, the closure assembly can then be placed on the force distribution structure, wherein the wedge on one side is first engaged by an engaging member, and the opposing engaging member is then pulled onto the wedge on the opposite side.

[0020] Alternatively, the closure assembly or assembly may include multiple independent lateral tie rods attached to at least some of the lateral supports. Such lateral tie rods are configured for fastening between the lateral supports, typically fixed to one plate and adjustablely attached to another. For an exemplary embodiment, the adjustablely attached ends may include a rack-and-pinion tensioning mechanism or similar structure that allows each lateral tie rod to be independently adjusted at different intervals between the right and left plates. In this way, the right and left plates can be tensioned differentially along their inner edges to control and optimize the force applied to the edges of adjacent tissues that are pulled together.

[0021] Optionally, the closure device of the present invention may further include a fastening layer adapted to be placed on the assembly after the base and closure component have been secured to an incision in the patient's skin and the surgical procedure has been completed. The fastening layer will typically have a self-adhesive lower surface that can be placed on the assembly of the base and closure component to help secure it in place and keep it clean. The fastening layer may optionally have openings to allow access to the wound for observation, delivery of disinfectants, etc.

[0022] In another aspect of the invention, a method for forming an incision in tissue includes providing an incision closure device as described above. The right and left plates of the device are adhered to the patient's skin, wherein the inner edges of the plates are spaced apart at a preselected distance, typically from 0.5 mm to 15 mm. An incision (typically a straight line) is formed on the tissue or skin surface between the inner edges of the plates, and the edges of the incised tissue are subsequently separated to perform the desired surgical procedure. The inner edges of the plates can stretch and conform to movement and deformation of the tissue edges, while the outer edges and lateral extent of each plate remain dimensionally stable. After the surgical procedure is completed, the closure assembly is tightened to a force distribution structure to pull the inner edges of the plates back together. Optionally, the closure assembly has a dimension (or an adjustable interplate spacing) that pulls the tissue edges closer together than they would have been immediately after the incision was formed. This pulling of the tissue together causes the edges to evert and "wrinkle" the tissue, thus reducing scar formation.

[0023] In another aspect of the invention, a cut closure device is provided. The cut closure device may include a left substrate and a right substrate, a plurality of closure components for laterally coupling the left and right substrates to each other, and a plurality of left-axial supports and right-axial supports correspondingly coupled to the left and right substrates. Each closure component includes a left closure component end and a right closure component end correspondingly coupled to the left and right substrates. The plurality of closure components may be laterally positioned across the left and right substrates, wherein (i) one or more of the left-axial supports are disposed between at least some axially adjacent left closure component ends, and (ii) one or more of the right-axial supports are disposed between at least some axially adjacent right closure component ends to form a serpentine arrangement.

[0024] To form a serpentine arrangement, a left axial support couples every other pair of axially adjacent left closure assembly ends together on the left plate, and / or a right axial support couples every other pair of axially adjacent right closure assembly ends together on the right plate. The left and / or right plates may have one or more perforations disposed between corresponding axially adjacent left and / or right closure assembly ends that do not have axial supports. The one or more perforations may include a plurality of perforations that facilitate separation of the substrate into substrate segments during axial stretching of the substrate.

[0025] One or more of the left or right substrates may include multiple individual substrate segments. At least two left closure assembly ends or at least two right closure assembly ends may be coupled to each substrate segment. The left substrate may include multiple left substrate segments, and the right substrate may include multiple right substrate segments. The left and right substrate segments may be axially offset from each other when applied to the incision and surrounding tissue. The multiple closure assemblies may laterally couple the left and right substrate segments to each other to form a serpentine arrangement.

[0026] One or more of the left or right substrates may include a tissue adhesion lower surface for adhesion to tissue adjacent to the incision. One or more of the left or right substrates may include a lower adhesion layer and an upper layer, the lower adhesion layer including the tissue adhesion lower surface, and the upper layer including the upper surface. The upper layer may be harder than the lower adhesion layer. The lower adhesion layer may be sufficiently elastic to minimize bubbling and adhesion loss due to movement of tissue laterally adjacent to the incision closure device when covering the incision and surrounding tissue. The lower adhesion layer may contain a hydrophilic adhesive material. The hydrophilic adhesive material may include one or more of hydrocolloids, hydrogels, acrylic polymers, or poly(ethylene glycol). The upper layer may contain one or more of rubber, latex, urethane, polyurethane, silicone, thermoplastic elastomers (TPE), woven fabrics, or short-fiber fabrics. One or more of the left closure component end, right closure component end, left axial support, or right axial support may be embedded in or laminated to the upper surfaces of the left and right substrates.

[0027] One or more of the left closure component end, the right closure component end, the left axial support, or the right axial support may be formed of a flexible, non-expandable material.

[0028] The plurality of closure components, the left axial support, and the right axial support are all sufficiently rigid that movement of tissue laterally adjacent to the incision closure device when covering the incision and surrounding tissue does not substantially cause expansion of the covered incision and surrounding tissue. Therefore, movement of a first tissue region laterally adjacent to the periphery of the incision closure device can be substantially translated into the same movement of a second tissue region laterally adjacent to the periphery and opposite to the first tissue region.

[0029] One or more of the plurality of closure components may include a tie rod that is securely coupled to the end of the left or right closure component and adjustably attached to the end of the opposing closure component. The opposing closure component ends may include a toothed tensioning mechanism.

[0030] The plurality of closure components may be configured to pull the inner edges of the left and right substrates together to compress the cut covered by the cut closure device.

[0031] One or more of the plurality of left-hand axial supports or the plurality of right-hand axial supports may be C-shaped. Each of the C-shaped left and / or right-hand axial supports may each include an axial portion and a lateral portion, the axial portion being used to limit the axial expansion of the corresponding substrate, and the lateral portion being used to limit the lateral expansion of the corresponding substrate.

[0032] This aspect of the invention can also provide a system for closing incisions in tissue. The system may include the incision closure device and a flexible covering for concealing the incision closure device, the covered incision, and surrounding tissue.

[0033] The flexible cover may be configured to extend along the lateral and axial edges of the left and right substrates. The cover may have one or more perforations to allow it to at least partially stretch axially in response to axial stretching of the incision and surrounding tissue covered by the incision closure device. The one or more perforations may be positioned along the central axis of the cover. The cover may include one or more reinforcing members coupled to at least a portion of the adhesive layer of the cover. The reinforcing members may comprise one or more of rubber, latex, urethane, polyurethane, silicone, thermoplastic elastomer (TPE), woven fabric, or short-fiber fabric. The cover may include a hydrophilic adhesive layer comprising one or more of hydrocolloids, hydrogels, acrylic polymers, or poly(ethylene glycol).

[0034] In another aspect of the invention, an incision closure device is provided. The incision closure device includes a flexible adhesive underlayer, an intermediate layer, and a top layer. The flexible adhesive underlayer may have a first elasticity. The intermediate layer may be coupled to and cover at least a portion of the flexible adhesive layer and has a second elasticity less than the first elasticity. The top layer may be coupled to and cover at least a portion of the intermediate layer and has a third elasticity less than the second elasticity. The elastic gradient between the flexible adhesive underlayer and the top layer can provide sufficient stiffness for the incision closure device such that lateral movement of tissue adjacent to the device when covering the incision and surrounding tissue does not substantially cause expansion of the covered incision and surrounding tissue.

[0035] The elastic gradient can provide sufficient elasticity to the incision closure instrument to minimize blistering and adhesion loss caused by movement of tissue adjacent to the instrument when covering the incision and surrounding tissue.

[0036] The incision closure instrument can be axially flexible in response to axial stretching of the incision and surrounding tissue covered by the incision closure instrument. Movement of a first tissue region adjacent to the periphery of the flexible adhesive substrate can be substantially translated into the same movement of a second tissue region adjacent to the periphery of the flexible adhesive substrate and opposite to the first tissue region.

[0037] The flexible adhesive substrate may contain a hydrophilic adhesive material. The hydrophilic adhesive material may include one or more of hydrocolloids, hydrogels, acrylic polymers, or poly(ethylene glycol).

[0038] The upper layer may include one or more of the following: rubber, latex, urethane, polyurethane, silicone, thermoplastic elastomer (TPE), woven fabric, or short-fiber fabric.

[0039] The flexible adhesive underlayer may include a first adhesive underlayer and a second adhesive underlayer. The intermediate layer may include a first upper layer coupled to the first adhesive underlayer and a second upper layer coupled to the second adhesive underlayer. The top layer may include an arrangement of multiple axial support structures and multiple lateral closure components coupled to the axial support structures for securing the first adhesive underlayer and the first upper layer to the second adhesive underlayer and the second upper layer. The multiple axial support structures and the multiple closure components may be coupled to each other to form a serpentine pattern, allowing one or more of the lower adhesive layer or the intermediate layer to at least partially stretch in the axial direction of the closure device in response to axial stretching of the incision and surrounding tissue covered by the incision closure device. The multiple axial support structures and the multiple lateral closure components may be coupled to each other to form a ladder-like pattern. One or more of the multiple axial support structures or the multiple lateral closure components may be formed of a flexible, non-expandable material. The multiple lateral closure components may be configured to pull the inner edges of one or more of the first adhesive underlayer or the second adhesive underlayer and the first upper layer or the second upper layer together after the flexible adhesive underlayer has adhered to tissue on opposite sides of the incision. One or more of the lateral closure components may include a left end, a right end, and a tie rod, the tie rod being securely coupled to the left or right end and adjustablely attached to the opposite end. One or more of the plurality of axial support structures or the plurality of lateral closure components may be embedded in or stacked on the first and second upper layers.

[0040] This aspect of the invention also provides a system for closing incisions in tissue. The system includes the incision closure instrument and a flexible covering for concealing the incision closure instrument, the covered incision, and surrounding tissue.

[0041] A flexible cover may be configured to extend along the lateral and axial edges of the flexible adhesive underlayer. The cover may have one or more perforations to allow it to stretch at least partially in the axial direction in response to axial stretching of the incision and surrounding tissue covered by the incision closure device. The one or more perforations may be positioned along the central axis of the cover. The cover may include one or more reinforcing members coupled to at least a portion of the adhesive layer of the cover. The reinforcing members may comprise one or more of rubber, latex, urethane, polyurethane, silicone, thermoplastic elastomer (TPE), woven fabric, or short-fiber fabric. The cover may include a hydrophilic adhesive layer. The hydrophilic adhesive layer may comprise one or more of hydrocolloids, hydrogels, acrylic polymers, or poly(ethylene glycol).

[0042] In another aspect of the invention, an incision closure device is provided. The incision closure device may include a lower portion having a first elasticity, an upper portion having a second elasticity less than the first elasticity, and an elastic gradient between the lower portion and the upper portion. The elastic gradient can provide sufficient stiffness for the incision closure device such that lateral movement of tissue adjacent to the device when covering the incision and surrounding tissue does not substantially cause swelling of the covered incision and surrounding tissue. The elastic gradient can provide sufficient elasticity for the incision closure device such that blistering and adhesion loss due to lateral movement of tissue adjacent to the device when covering the incision and surrounding tissue are minimized.

[0043] In another aspect of the invention, an incision closure device is provided. The incision closure device may include a base comprising a left plate and a right plate, a left force distribution structure and a right force distribution structure, and a plurality of closure components. Each plate may have a tissue adhesion lower surface, an upper surface, a first lateral edge, and a second lateral edge. The left force distribution structure and the right force distribution structure may be correspondingly coupled to the left and right plates. Each force distribution structure may be adapted to allow the plate to expand axially along one of the first or second lateral edge, and to limit lateral expansion across the plate and axial expansion along opposing lateral edges. The plurality of closure components may be fastened to the left and right plates to pull the plates together after the plates have adhered to tissue and an incision formed therebetween.

[0044] The first lateral edge of each board may include the inner edge of each board. The inner edges of each board may face each other.

[0045] The second lateral edge of each board may include the outer edge of each board. The outer edges of each board may face away from each other.

[0046] One or more of the left and right plates of the base may include an elastic matrix. The elastic matrix may include an elastomeric membrane, a woven fabric, or a short-fiber fabric. The elastic matrix may also include a fabric woven from elastic elements and having non-elastic elements extending laterally along the first or second lateral edge and across it.

[0047] Each force distribution structure may include a ridge axially adjacent to the first lateral edge of the plate, and a plurality of axially spaced lateral supports laterally disposed and extending from the ridge toward the first lateral edge of the plate. The ridge and lateral supports may be formed of a flexible, non-expandable material. The force distribution structure may be embedded in or stacked onto the upper surface of each plate.

[0048] The closure assembly may include a right engaging member, a left engaging member, and a plurality of lateral struts that maintain the engaging members laterally spaced apart by a predetermined distance. The right engaging member may be adapted to releasably engage a support member of a right plate, and the left engaging member may be adapted to releasably engage a support member of a left plate. At least some of the supports may have wedges near one or more of a first or second lateral edge, and the engaging member may have grooves receiving the wedges. The lateral struts may be adjustablely connected to at least one of the engaging members to allow adjustment of the predetermined distance. The closure assembly may include a plurality of independent lateral tie rods attached to at least some of the lateral supports. The lateral tie rods may be configured for fastening between the lateral supports. Each independent lateral tie rod may have an end fixed to a plate and a second end adjustablely attached to another plate. The second end may include a toothed tensioning mechanism.

[0049] The incision closure device may further include a fastening layer adapted to be placed on the assembly after the base and the assembly of the closure component have been secured to the incision in the patient's skin. The fastening layer may have a self-adhesive inner surface. Attached Figure Description

[0050] Figure 1 This is an exploded view of an incision closure device constructed according to the principles of this invention.

[0051] Figure 2 This is a top view of the assembly of the base and force distribution structure, which is part of the incision closure device.

[0052] Figure 3 It is along Figure 2 The cross-sectional view taken from line 3-3.

[0053] Figures 4-7The illustration shows the use of the incision closure device of the present invention to form and close an incision in a patient's skin.

[0054] Figure 8 The illustration shows an alternative configuration of the closure component of the closure device of the present invention.

[0055] Figure 9 This is an exploded view of a further embodiment of the incision closure device constructed according to the principles of the present invention.

[0056] Figure 10 yes Figure 9 An enlarged isometric view of the system's base and force distribution structure.

[0057] Figure 11A and Figure 11B The diagram shows that it can be used Figure 1 or Figure 9 The alternative transverse tie rod configuration used in the instrument.

[0058] Figure 12 The illustration shows a sacrificial covering positioned on an incision closure device according to the principles of the present invention.

[0059] Figures 13A to 13E The diagram shows... Figure 12 The operating principle and method of the sacrificial covering shown are as follows when used with a surgical incision drape according to the invention.

[0060] Figures 14A1-14A3 This is a perspective view of a further embodiment of an incision closure device constructed according to the principles of the present invention.

[0061] Figure 14B It is based on the invention and Figures 14A1-14A3 A top view of an incision closure device similar to the one placed on the subject's knee.

[0062] Figure 15A A schematic diagram of a cut-closing device having a pulley system for laterally coupling two adjacent substrates, according to the principles of the present invention, is shown.

[0063] Figure 15B It shows Figure 15A A cross-sectional view of the incision closure device.

[0064] Figure 15C This illustrates a device, according to the invention, placed on the model's knee. Figure 15A Incision closure instruments.

[0065] Figure 15D It shows the relationship with Figure 15A A schematic diagram of an incision closure device similar to the one used in this incision closure device.

[0066] Figure 15E and Figure 15F The following are examples of methods for using... Figure 15A and Figure 15D Various transverse tie rod assembly structures used in incision closure devices.

[0067] Figures 16A-16D Various locking mechanisms according to the principles of the present invention are shown.

[0068] Figure 17 A hinge mechanism for an incision closure device according to the principles of the present invention is shown.

[0069] Figure 18 This is a top view of an incision closure device based on the principle of the present invention, similar to the incision closure device in Figure 14A, and placed on the subject's knee.

[0070] Figure 19 A cut closure device comprising a single substrate segment pair according to the present invention is shown.

[0071] Figure 20A This illustrates the principles of the present invention, and Figure 9 and Figure 10 A perspective view of an incision closure device similar to the one described above.

[0072] Figure 20B It shows Figure 20A An enlarged view of the transverse tie rod assembly of the incision closure device.

[0073] Figure 21 An exploded view of a portion of the incision closure device shown in Figure 20 is displayed.

[0074] Figure 22A A perspective view of a cover for an incision closure device disclosed herein, according to the principles of the present invention, is shown.

[0075] Figure 22B It shows Figure 22A An exploded view of the covering.

[0076] Figure 23A The invention illustrates a method comprising... Figure 21 incision closure instruments and Figure 22A Exploded view of the incision closure device assembly with covering.

[0077] Figure 23B It shows the adhesion to the patient's skin Figure 23A A perspective view of the incision closure device assembly.

[0078] Figure 23C It shows Figure 22A A top view of the elastomeric reinforcement layer of the covering.

[0079] Figure 24A This illustrates an adhesive method for adhering to a patient's skin according to the principles of the present invention. Figure 23A A perspective view of the incision closure device assembly.

[0080] Figure 24B This illustrates an adhesive method for adhering to a patient's skin according to the principles of the present invention. Figure 23A A cross-sectional schematic diagram of an incision closure device.

[0081] Figures 25A-25C The illustration shows the application of the invention, based on the principles of the invention, to a patient's skin. Figure 23A Methods for assembling incision closure instruments.

[0082] Figures 26A-26E The illustration shows an embodiment of a covering for wound dressings and incision closure instruments according to the principles of the present invention.

[0083] Figures 27A-27E The illustration shows an embodiment of a wound closure device having a pharmaceutical preparation incorporated thereon, according to the principles of the present invention.

[0084] Figures 28A-28E The illustration shows an embodiment of a wound closure device cover having a pharmaceutical preparation incorporated thereon, according to the principles of the present invention.

[0085] Figure 29 The illustration shows another sacrificial covering positioned on an incision closure device according to the principles of the present invention. Detailed Implementation

[0086] The apparatus and method of the present invention will be used in the formation and closure of surgical incisions made in a patient's skin or other tissues during surgical procedures. As described below, the orientation of the incision will define the "axial" and "lateral" directions as used herein. Most incisions will be made along a generally straight line that defines the axial direction. The lateral direction will generally cross the axial direction, and is usually, but not necessarily, perpendicular to or orthogonal to the axial direction. Most incisions will be generally straight, but in some cases the incision may be curved or have other geometries. The term "axial" will then be applied to the orientation of the incision at any given location, resulting in a lateral direction that may also vary.

[0087] refer to Figures 1-3The incision closure device 10 includes a base assembly 12 comprising a right plate 14 and a left plate 16. A right force distribution structure 18 is fastened to the right plate 14, typically by laminating the force distribution structure onto the upper surface of the plate; and a left force distribution structure 20 is similarly attached to the upper surface of the left plate 16. The incision closure device also includes a closure assembly 22, which can be removably attached to the right force distribution structure 18 and the left force distribution structure 20 for incision closure, as described in more detail below. The device also includes an optional fastening layer 24, which can be placed on the combined base assembly 12 and closure assembly 22 after the combined base assembly 12 and closure assembly 22 have been fastened to the patient and the incision has been closed by pulling the plates together using the closure assembly.

[0088] The closure assembly 22 is designed and adapted to pull the inner portions of the force distribution structures 18 and 20 inward toward each other to close a surgical incision formed therebetween. In the illustrated embodiment, a plurality of wedges 26 are formed on a transverse support 36 held axially by the ridges 37 of the force distribution structures 18 and 20. The wedges 26 are received in grooves 38 formed along the inner edges of the opposing engagement members 40 of the closure assembly 22. The opposing engagement members 40 are held together by transverse struts 42 to maintain a fixed, laterally spaced distance between the engagement members (in other embodiments, the spacing may be adjustable). The grooves 38 may preferably be formed on a flexible ear-like structure 44, which allows the grooves to be pulled upward on the corresponding wedges to secure the closure assembly 22 to the force distribution structures 18 and 20.

[0089] The lower surface 32 of each plate 18 and 20 will typically be covered with a pressure-responsive adhesive, which initially covers a protective layer 48 that can be peeled off just before use. Additionally, a pull-away earpiece 50 or other similar structure may be provided to hold the right plate 14 and left plate 16 together at predetermined intervals after layer 48 has been removed and before the plates are adhered to the patient's skin or other tissue surface. It is important to maintain the distance between the inner edges 28 of each plate 14 and 16 as close as possible to the original target spacing so that the tissue edges are precisely brought together, typically slightly everted, when closed by the closure assembly 22.

[0090] Now for reference Figures 4 to 7 This will describe a scheme for forming and subsequently closing an incision according to the principles of the present invention. First, as Figure 4As shown, the right plate 14 and left plate 16 are placed on the patient's skin, marked with the reference letter S. Plates 14 and 16 are applied by first pulling away the protective layer 18 and placing the plates onto the tissue, after which the ear flap 50 can be removed, leaving an incision path 52 defined between the inner edges 28. The spacing of the inner edges 28 will be selected to provide a fixed predetermined distance d1.

[0091] After the right panel 14 and the left panel 16 are in place, as Figure 5 As shown, an incision I can be formed in the space between the plates using a scalpel or other surgical cutting device CD.

[0092] After making incision I, as follows Figure 6 As shown, surgical procedures can be performed by opening the inner edge of the incision, which in turn deforms the inner edges 28 of the right plate 14 and the left plate 16. Since the innermost ends of the supports 36 are not connected, they can be freely separated, allowing the elastic matrix of the right plate 14 and the left plate 16 to expand, as... Figure 6 This is clearly shown in the diagram. However, the dimensional stability of the rest of the plate will be maintained by the lateral support 36 and the axial ridge 37, which will not elongate under the influence of the force applied by the stretching open cut.

[0093] like Figure 7 As shown, after the surgical procedure is completed, the closure assembly 22 is secured to the force distribution structures 18 and 20. Specifically, the groove 38 in the ear-shaped structure 44 engages with the opposing wedges 26 to pull the opposing edges of the plates and the opposing edges of the tissue incision together. By appropriately spacing the depth of the grooves 38, the closure assembly 22 can be adjusted to bring the plates 14 and 16 together at a preselected distance d2. Typically, the distance d2 will be smaller than the initial interval d1 to bring the inner edges of the tissue together so that the tissue edges are slightly everted (wrinkled upwards) along the incision, which improves healing and reduces scar formation.

[0094] Optional, such as Figure 8 As shown, the closure assembly 22' may include engagement members 40', wherein one end of each transverse support 42' is connected by an adjustable hook or other mechanism 54 so that the distance between the inner edges of the opposing engagement members 40' can be adjusted to increase or decrease the distance d2 therebetween.

[0095] exist Figure 9 and Figure 10 The figure illustrates an alternative embodiment 100 of the incision closure device of the present invention. Device 100 includes a base assembly 102 having a right plate 104 and a left plate 106. (As shown...) Figure 10As best shown, a positioning or alignment strip 108 is provided for securing the inner edges of each plate together, and the positioning or alignment strip 108 includes an end tab 109 that allows a user to pull the strip from the plate after the plates 104 and 106 have been placed in place on the tissue surface.

[0096] The incision closure device 100 also includes a backing 110 having a partially foldable end to expose an underlying adhesive backing on the plate and allow adhesion of the end of the base assembly 102 to the tissue while the remainder of the base assembly remains covered by the backing. A fastening layer 112, including a reinforcing frame 113, is provided for placement on the right plate 104 and left plate 106 after the base assembly 102 has been closed over the incision, generally in connection with the description of the previous embodiments. Typically, a retaining tray 114 will be provided for holding the components of the device together under aseptic conditions, wherein the tray 114 will be covered by conventional medical packaging coverings.

[0097] like Figure 9 and Figure 10 As shown, a right force distribution structure 116 and a left force distribution structure 118 are correspondingly provided on the upper surfaces of the right plate 104 and the left plate 106. The right force distribution structure 116 includes a right axial ridge 120 and a plurality of lateral supports 122. Typically, the right axial ridge 120 includes a serrated or sawtooth member embedded in or stacked onto a base strip 121. The serrated axial ridge 120 will typically be formed of a flexible, elastic plastic (typically a rigid plastic), while the base strip 121 will contain a polyurethane or similar plastic layer. The lower surface of the polyurethane layer will be covered with a hydrocolloid layer for tissue adhesion. The left force distribution structure 118 will have the same structure, including a left axial ridge 124, left lateral supports 126, and a left base strip 127.

[0098] like Figure 9 As shown, the incision closure device 100 will include a closure mechanism comprising a plurality of transverse tie rod assemblies 128. Figure 10As best illustrated, each transverse tie rod assembly 128 will include a rod and a rack mechanism 132, the rod being fastened at one end to a left transverse support 126, and the rack mechanism 132 being fastened to a right transverse support 122. Each rod 130 will generally be aligned with the axis of the left plate 106 portion such that the gap 129 between the right plate 104 and the left plate 106 will remain open to allow for a cut therein. After the cut is made, each rod 130 will be pulled to the associated rack 132 on the right plate 104. A series of rack rings on each rod will be pulled into the associated rack mechanism 132, and the rod will then be pulled laterally until the desired closing tension is applied at that point along the base assembly 102. It is particularly advantageous that each transverse tie rod assembly 128 can be individually adjusted to supply the desired closing tension across the tissue along the length of the closed cut. Once the desired closure tension has been provided along the entire incision, the fastening layer 112 can be placed on the base assembly 102 to hold the instrument and tissue in place.

[0099] Now for reference Figure 11A and Figure 11B The figure illustrates an alternative design for the lateral tie rod assembly 140 of the present invention. These lateral tie rod assemblies 140 can be used with any of the previously described incision closure devices 10 or 100. Each lateral tie rod assembly 140 includes a right force distribution structure 142 and a left force distribution structure 144. The right force distribution structure includes a right spine 146 and a plurality of lateral supports 148. Although three lateral supports are shown, it should be understood that four, five, six, or more lateral supports may also be included. The left force distribution structure 144 similarly includes a left spine 150 and a plurality of left lateral supports 152. To provide closure, the right force distribution structure 142 includes a rod 154 extending from the central lateral support 148. Typically, the rod 154 is connected to the support by an active or passive connector 158. A pull ring 156 is provided at the free end of the rod 154, and a plurality of ratchet teeth 162 are provided along the middle portion of the rod 154.

[0100] The left force distribution structure 144 includes a rack mechanism 160 adapted to receive teeth 162 on the rod 154 of the right force distribution structure. In this way, the rod 154 can be lowered into the rack 160 to engage the teeth 162, thereby allowing the rod to be pushed forward to pull the right force distribution structure 142 and the left force distribution structure 144 together to apply tension to the right and left plates.

[0101] like Figure 12As shown in the figure, another aspect of the invention is illustrated. An incision closure device 100 is schematically illustrated, with only the right plate 104 and left plate 106, as well as the right force distribution structure 116 and left force distribution structure 118, shown. The remaining system components are not shown for illustration purposes.

[0102] The right plate 104 is covered by a right sacrificial covering 170, and the left plate 106 is covered by a left sacrificial covering 172. The right plate 104 and left plate 106 may define a region 175 in which the right sacrificial covering 170 and the left sacrificial covering 172 separate the right plate 104 and the left plate 106. The coverings 170 and 172 are each removably secured along each edge of the associated base plate, such that the coverings remain in place during the normal handling and placement of the incision closure instrument 100 on the tissue surface to be incised. Reference Figure 13A and Figure 13E Describe the use and purpose of these sacrificial coverings 170 and 172.

[0103] Figure 13A The illustration shows the right plate 104 and left plate 106 positioned on the tissue surface T before the incision is made. The right plate 104 is covered by a right sacrificial covering 170, and the left plate 106 is covered by a left sacrificial covering 172. As is common in many surgical procedures, an adhesive surgical incision drape 180 is placed on the tissue surface T. Any conventional drape can be used, such as the Ioban™ antimicrobial incision drape available from 3M in St. Paul, Minnesota.

[0104] After the incision drape 180 is in place on the incision closure instrument, a surgical incision I can be made for the desired surgical intervention. As shown in the figure, incision I can be cut through the surgical drape 180 between the right plate 104 and the left plate 106. After the surgical procedure is completed, the surgical drape 180 will be removed from the tissue surface T. Because the surgical drape has an underlying adhesive surface, prior to this invention, removal of the drape could have displaced either or both of the right plate 104 and the left plate 106. However, the presence of sacrificial layers 170 and 172 prevents such displacement. Removal of the surgical drape 180 will remove sacrificial layers 170 and 172, but because each of these layers is configured to break off with a relatively low separation force, removal of the sacrificial layers will not cause displacement of the underlying plate 104 or plate 106. Therefore, plates 104 and 106 will remain as Figure 13D As shown, it remains in place, and as Figure 13E As shown, force distribution structure 116 and force distribution structure 118 can be used as described above to close the plates together in order to close the cut.

[0105] refer to Figure 29The right sacrificial covering layer 170 and the left sacrificial covering layer 172 can each be constructed from urethane sheets (e.g., 0.001” thick). The middle portion of the urethane sheet can be adhered to the top of the right plate 104 and the left plate 106, and force distribution structures 116 and 118, as well as any cable ties 130 and locks 132, can be assembled onto the urethane sheet. The urethane sheet can then be wrapped around the force distribution structures 116 and 118 (and can be as follows). Figure 29 The ties 130 shown are bent inward so that they are contained on the plate 106, with the free ends of the urethane sheets overlapping each other along their length. Thus, the urethane sheets can be wrapped around the force distribution structures 116 and 118, and the closure elements 130 and 132 to protect them from the surgical drape 180. The urethane sheets may preferably include a plurality of perforations arranged along their length and aligned with the inner edge 104e and outer edge 106e of each plate 104 and plate 106. The perforations allow the urethane sheets to be torn off in a controlled manner along with the surgical drape 180 when it is removed (e.g., the surgical drape 180 described herein). The perforations may preferably be constructed with a 3 mm incision and a 1 mm tie, but the exact dimensions can be varied to control the desired tearing force. The perforations may be formed along a single longitudinal line or multiple lines. Multiple longitudinal perforations allow for reliable separation regardless of variations in the adhesion of the surgical drape to sacrificial layers 170 and 172. The perforations can be designed to facilitate release near the edges of plates 104 and 106, helping to increase the likelihood of separation near the edges 104e and 106e of plates 104 and 106, and minimizing residual excess urethane. To aid in the lifting of sacrificial layers 170 and 172, ear flaps 170t and 172t can be adhered to each end of the urethane package containing sacrificial layers 170 and 172. Ear flaps 170t and 172t can preferably be adhered to the interior of the upper surface of the urethane package. Ear flaps 170t and 172t can be shaped to prevent adhesion of urethane to themselves or to any adhesive exposed at the ends of each plate 104 and 106. The pre-fracture of the perforations at the ends of each plate 104 and plate 106 can help with the initial lifting of the ear pieces 170t and 172t and the user's initiation of tearing.

[0106] Now for reference Figures 14A1-14A3 The figure illustrates a further embodiment of the incision closure device. Base assembly 1400a ( Figure 14A1 ), base assembly 1400b ( Figure 14A2 ) and base assembly 1400c ( Figure 14A3Each of the following substrates may include a right substrate 1402 and a left substrate 1404. The right substrate 1402 may include an upper layer 1406 and a lower layer 1408. Similarly, the left substrate 1404 may include an upper layer 1410 and a lower layer 1412. The upper layers 1406 and 1410 will generally be flexible but rigid enough to securely close the tissue and minimize disturbance to the incision and surrounding tissue. The upper layers 1406 and 1410 may include a plastic layer made of rubber, latex, polyurethane, silicone, thermoplastic elastomer, woven fabric, short-fiber fabric, or similar materials. The adhesive underlayers 1408 and 1412 will generally be flexible and more elastic than the upper layers 1406 and 1410 to follow any movement of the underlying skin and tissue, thereby maintaining adhesion, minimizing blistering, and otherwise reducing irritation. The adhesive substrates 1408 and 1412 may include hydrophilic adhesive materials, such as hydrocolloids, hydrogels, acrylic polymers, poly(ethylene glycol), etc.

[0107] The right substrate 1402 and left substrate 1404 may include structures for facilitating and limiting axial and lateral stretching of the base assembly 1400. These structures may also uniformly distribute the closing force applied to the cut and may be disposed on the base assemblies 1400a, 1400b, and 1400c along their axial length. The right substrate 1402 may include one or more right force distribution structures or axial supports 1414. Each right axial support 1414 may include an axial support portion or ridge 1414a and two lateral support portions 1414b coupled to the axial ends of the ridge 1414a. The ridge 1414a and the two lateral support portions 1414b together form a C-shape, which in some embodiments can be axially opened to a certain extent to facilitate axial stretching of the right substrate 1402 between the two laterally adjacent lateral support portions 1414b of the adjacent support 1414, while limiting axial stretching between the two lateral support portions 1414b of a single support 1414. In many embodiments, the C-shaped axial support 1414 has only enough flexibility to allow vertical deflection, but is also rigid to minimize axial and lateral stretching. Figure 14A1 As shown, the right axial support 1414 can be inward-facing. Figure 14A2 and Figure 14A3As shown, the right axial support 1414 may be outward-facing, which helps distribute any mechanical loads for tissue closure to the cut I between the right substrate 1402 and the left substrate 1404. Similarly, the left substrate 1404 may include one or more left force distribution structures or axial supports 1416. Each left axial support 1416 may include an axial support portion or ridge 1416a and two lateral support portions 1416b coupled to the axial ends of the ridge 1416a. The ridge 1416a and the two lateral support portions 1416b together form a C-shape, which in some embodiments may be axially opened to a certain extent to facilitate axial stretching of the left substrate 1402 between two laterally adjacent lateral support portions 1416b of an adjacent support 1416, while limiting axial stretching between the two lateral support portions 1416b of a single support 1416. In many embodiments, the C-shaped axial support 1416 is only flexible enough to allow vertical deflection, but rigid enough to minimize axial and lateral tension. For example... Figure 14A1 As shown, the left axial support 1416 can be inward-facing. Figure 14A2 and Figure 14A3 As shown, the left axial support 1416 can be outward-facing, which can help distribute any mechanical loads for tissue closure to the cut I between the right substrate 1402 and the left substrate 1404.

[0108] like Figure 14A3As shown, the substrate assembly 1400c may further include skirts 1424 and 1426. Skirts 1424 and 1426 may resemble the thin base assembly cover described below. For example, each skirt 1424 and 1426 may include a 0.001-inch thick urethane film coupled to a 0.002-inch thick acrylic adhesive. The adhesive may be applied to the entire lower surface of the skirts 1424 and 1426, or it may be applied only to the areas of the skirts 1424 and 1426 beyond the substrate 1402 or substrate 1404. During the construction of the substrate assembly 1400c, skirts 1424 and 1426 may be applied directly to all or a portion of the adhesive layers 1408 and 1412. Skirts 1424 and 1426 may be applied accordingly to replace or be attached to the upper film layers 1406 and 1410. Release lines, as described herein, can be further provided to scribble the adhesive underside of skirts 1424 and 1426. Skirts 1424 and 1426 may extend beyond the outer boundaries of substrates 1402 and 1404 by, for example, 8 mm or 1 to 20 mm, but not across the lateral region between substrates 1402 and 1404, to improve visibility and / or cleaning of the cut-out areas. Thus, skirts 1424 and 1426 can help provide additional adhesive support and / or creep reduction to the adhesive layers 1408 and 1412 of substrates 1402 and 1404 without aligning and placing separate covers or cover sheets on substrate assembly 1400. After manufacturing, skirts 1424 and 1426 are typically already precisely aligned relative to substrates 1402 and 1404. Separate covers or cover sheets, as described herein, can still be used to prevent misalignment of the cut-out areas and components of substrate assembly 1400c. Since the skirts 1424 and 1426 have already extended laterally on the substrates 1402 and 1404 respectively, such individual covers or cover sheets do not require precise placement relative to the substrate assembly 1400c and can be narrower than other covers or cover sheets described herein.

[0109] One or more perforations 1418 may be provided between axially adjacent right axial supports 1414 on the right plate 1402 to facilitate axial and / or lateral stretching of the right substrate 1402. The perforations 1418 may extend through the upper layer 1406 and the lower layer 1408 to provide ventilation to the underlying tissue, or may exist only in the upper layer 1406. Similarly, one or more perforations 1420 may be provided between axially adjacent left axial supports 1416 on the left plate 1404 to facilitate axial and / or lateral stretching of the substrate 1402. The perforations 1420 may extend through the upper layer 1410 and the lower layer 1412 to provide ventilation to the underlying tissue, or may exist only in the upper layer 1410. Figure 14A1As shown, there may be only a single through hole 1418 or 1420 between the axial support members 1414 or 1418. Figure 14A2 and 14A3 As shown, there may be a plurality of perforations 1418 or 1420 arranged in a transverse line between the axial supports 1414 or 1418. The perforations 1418, 1420 can also reduce stress caused by the skin being stretched radially outward from the incision I (e.g., during joint movement or swelling).

[0110] For example, it can be along Figure 14B The right line 1424 and left line 1426 shown provide a plurality of perforations 1418, 1420 between the axial ends of the right axial support 1414 and / or the left axial support 1416. A plurality of axially aligned perforations may be provided on each line segment 1424 or 1426 so that at least the upper layer 1410 and lower layer 1412 of the substrates 1402, 1404 can break into individual segments when axially stretched, as further described below. In some cases, during wear of the device 1400, the perforations 1418, 1420 may allow layers 1406 and 1408 of the right plate 1402 and layers 1410 and 1412 of the left plate 1404 to completely separate and separate at the perforation lines, which in Figure 14A2 and Figure 14A3 As shown in the diagram. The ability to fully separate and dissociate further allows for axial stretching of the skin as needed, wherein elongation is permitted (and restricted) by the connection of the axial supports 1414 and 1416 discussed below and the closure assembly 1422. As described herein, after the cut I is closed, a flexible, compliant covering can be applied to the substrates 1402, 1404. This covering can further be used to provide (and restrict) axial and lateral movement of the base structure 1400b. Alternatively or in combination, one or more of the right substrate 1402 or left substrate 1404 can be laterally cut and separated between the force distribution structure or the axial supports 1414, 1416 to facilitate axial and / or lateral stretching of the right substrate 1402 and / or left substrate 1404.

[0111] To laterally couple the right substrate 1402 and the left substrate 1404 together, and optionally to abut and tighten the right substrate 1402 and the left substrate 1404 against each other, the base assembly 1400 may also include a plurality of lateral closing components or tie rod assemblies 1422. The lateral closing components or tie rod assemblies 1422 may include rack mechanisms similar to the rack mechanisms of the lateral tie rod assemblies 128 and 140 described above. The lateral tie rod assemblies 1422 may couple laterally adjacent right axial support 1414 and left axial support 1416 together, typically at their axial ends. Figures 14A1-14A3As shown, the corresponding placement of the right axial support 1414 and the left axial support 1416 on the right plate 1402 and the left plate 1404 can be staggered or axially offset, and the right axial support 1414 and the left axial support 1416 can be C-shaped structures having lateral end portions 1414b, 1416b that face and align with each other laterally (and are connected to each other by lateral tie rod assembly 1422). For example, the distal lateral portion 1414b of the first right axial support 1414 can be laterally aligned with the proximal lateral portion 1416b of the first left axial support 1416, the distal lateral portion 1416b of the first left axial support 1416 can be laterally aligned with the proximal lateral portion 1414b of the second right axial support 1414, and so on. Therefore, the lateral tie rod assembly 1422, the right axial support 1414, and the left axial support 1416 can be connected to each other to form a continuous line of lateral tie rod assemblies 1422, right axial support 1414, and left axial support 1416, and this line can have a serpentine arrangement, such as... Figures 14A1-14A3 The lateral arrangement shown crosses the right substrate 1402 and the left substrate 1404 (i.e., across the distance between the right substrate 1402 and the left substrate 1404). The serpentine arrangement of the lateral tie assembly 1422 and the right axial support 1414 and the left axial support 1416 can achieve one or more of the following: uniformly distributing the closing force provided by the base assembly 1400 across the cut; providing (and limiting) axial flexibility of the base assembly 1400; and providing stiffness or rigidity to the base assemblies 1400a, 1400b, and 1400c to adequately close the cut and allow it to heal with minimal disturbance and expansion (i.e., providing lateral and axial stability). In many embodiments, the lateral supports 1414, 1416 are rigid, causing stretching of the areas of the substrates 1402, 1404 not covered by the lateral supports 1414, 1416. Because these uncovered areas are offset from each other from the right substrate 1402 to the left substrate 1404, the tie rod assembly 1422 can pivot axially from its anchor point as the cut I is axially stretched. This axial pivoting of the tie rod assembly 1422 brings the right substrate 1402 and the left substrate 1404 closer together to keep the cut I closed.

[0112] The materials of the lateral tie rod assembly 1422, the right axial support 1414, and the left axial support 1416 can include, for example, flexible elastic plastics, typically rigid plastics such as nylon, polypropylene, polyethylene, polycarbonate, or other thermoplastic polymers. Typically, the lateral tie rod assembly 1422, the right axial support 1414, and the left axial support 1416 may contain materials with less elasticity than the right substrate 1402 and the left substrate 1404. Therefore, as with many other base assemblies of the incision closure device disclosed herein, greater stiffness (and less elasticity) can be provided towards the top of the base assemblies 1400a, 1400b, and 1400c. That is, an elastic gradient can exist between the top and bottom of the base assemblies 1400a, 1400b, and 1400c. The tops of the base assemblies 1400a, 1400b, and 1400c can be sufficiently rigid or stiff to prevent transverse movement of tissue adjacent to the instrument when the incision closure device is applied to the incision and surrounding tissue, so as to substantially prevent swelling of the covered incision and surrounding tissue. That is, the movement of at least a portion of the applied incision closure device (e.g., the portion beneath a stiffer layer) is collective and does not disturb the underlying incision. Furthermore, the bottoms of the base assemblies 1400a, 1400b, and 1400c can be sufficiently resilient to minimize blistering and adhesion loss caused by movement of tissue adjacent to the applied incision closure device. While the primary function of the lateral tie rod assembly 1422 may be to apply tension to each substrate 1402, 1404 to keep cutout I closed, in many embodiments, the lateral tie rod assembly 1422 may also be used to provide column strength to isolate cutout I by minimizing compression (or bending or wrinkling along cutout I) from tension that could disrupt the alignment and engagement of cutout edges. The axial spacing, material properties, and dimensions of the lateral tie rods 1422 can be optimized for sufficient axial bending flexibility as well as lateral compression and bending support. In a preferred embodiment, the tie rods 1422 are spaced 10 mm apart, are made of nylon, and have a circular cross-section of 0.030 inches.

[0113] Now for reference Figure 14B The base assembly 1400b can be placed over an incision in the skin of a patient's or subject's joint, such as the knee. In incisions near moving joints, particularly near the knee, the integrity of the closure device or instrument is often challenged by a number of factors. These factors include: longitudinal elongation, circumferential swelling, and opening of the wound during joint movement; skin damage such as blistering; loss of adhesion; and drainage of wound exudate. Joints such as the knee, elbow, ankle, and shoulder may undergo movement, sometimes resulting in joint movements covering more than 135° of motion, thus leading to the aforementioned challenges.

[0114] In a bent position, the skin around the knee may stretch by up to 50% axially (i.e., parallel to the incision) and laterally (i.e., laterally or perpendicular to the incision). An incision closure device that adheres to the skin in this area can preferably provide sufficient tension to close the incision while accommodating the stretch with minimal local stress. Minimizing local stress prevents local skin adhesion loss or damage to the skin without causing adhesion loss. An important property of many incision closure devices disclosed herein is the ability to distribute the tension load of the device's closure element over an area larger than the tension element attachment point itself. Furthermore, the structure including the adhesive to which the tension element is attached can, in many cases, have the ability to distribute the structure compliantly over the area of ​​skin stretching, allowing the device to hold the incision in place as the skin moves around it. Embodiments described herein may include composite designs of non-tension tension elements (commonly referred to as "cableties") coupled to a "lock" that holds the cablety in place. For example, such elements may include the lateral tie assembly 128, 140, and 1422 described above. These components can be mounted on skin adhesives containing elastic polymer materials that help distribute tensile loads. In many cases, such elastic polymers can have high elongation before yielding or permanent deformation and can include thermoplastic elastomers such as polyurethane as well as various grades of silicone. Such materials can also be readily formed into films necessary to maintain thinness and sufficient compliance.

[0115] Skin adhesives used in devices may also need to withstand skin stretching and be able to retract / spring back when the skin returns to an unstretched state (e.g., in a fully extended knee position). Hydrocolloid adhesives can provide this property and are preferably suitable for such applications. Other adhesives, such as acrylics, can also provide this property. Generally, such adhesives may need to be attached to an elastic film, such as those described above, to maintain their structure during expansion and rebound. Without such support, the adhesive may tear and separate with repeated stretching.

[0116] Incision closure devices constructed as a series of short segments can accommodate high total elongation without adhesion loss or skin damage. Each individual segment may be subject to localized stretching of the skin beneath it. The space between two adjacent segments can act as a stress-relief space, allowing the skin to stretch within that space. Segmentation can be achieved in several ways: (1) by laying individual segments along the incision line, or (2) by allowing the device to be segmented into short segments during or after its application to the skin.

[0117] Preferred methods for achieving segmentation after application to the skin include creating perforations (e.g., transverse lines of perforations to facilitate tearing) in the polyurethane layer (i.e., the upper layers 1406 and 1410 of substrates 1402 and 1404) as described above, while keeping the underlying adhesive intact. Figure 14B As shown in the diagram, the perforations can cause at least the upper layer of the substrate (e.g., upper layers 1406, 1410) to tear along the perforation lines (e.g., lines 1424, 1426) when it is stretched as the knee flexes (i.e., during joint movement). In a preferred embodiment, the adhesive plate on each side of the incision can be 12 mm wide, and the perforations within a given plate are spaced approximately 12-20 mm apart. Experiments have been conducted and it has been demonstrated that perforations with 3 mm incisions and 1 mm tie rods are effective for achieving segmentation in a 0.001-inch thick urethane plate during knee flexion. As the knee flexes, the skin may stretch by up to 50% in some locations both axially (along the incision) and laterally. Therefore, the separation of the polyurethane can alleviate stress in the device when it is subjected to stretching.

[0118] As an example, a surgically repaired knee may become inflamed within days, which can cause approximately 30% radial swelling of the joint after closure. Elastic materials such as polyurethane can allow incision closure devices (e.g., those that adhere to...) Figure 14B The base assembly 1400b of the incision I formed expands with such circumferential swelling. Minimizing the width of the instrument (e.g., 12 mm or less for each base segment 1402, 1404) minimizes the amount of expansion the instrument suffers in the direction perpendicular to the incision I, and thus maintains adhesion while minimizing the possibility of skin damage. Figure 14B A perforation in the adhesion segment is shown, extending laterally along lines 1424, 1426 to the incision to allow for easier axial stretching. Perforations or other openings may also be made parallel to the incision near the outer edge of the adhesion segment to reduce stress caused by radially outward stretching of the skin from the incision, such as during joint movement and swelling.

[0119] Now for reference Figures 15A-15D Incisions may frequently be subjected to forces that tend to open due to flexion of the knee or other joints. In many embodiments, incision closure devices have a locking mechanism that counteracts opening forces by tightening during flexion, thereby helping to keep the incision closed. Figure 15A and Figure 15BA base assembly 1500 of an incision closure device is shown, which includes a mechanism utilizing the pulley effect, i.e., the distance between locking points on either side of the incision shortens as the skin is stretched along the incision. In a preferred embodiment, the adhesive plates 1510a, 1510b on each side of the incision between the base plates 1510a, 1510b are 12 mm wide, and the linear perforations 1530 within a given plate 1510 are spaced approximately 18 mm apart. Typically, all components of the locking mechanism are non-stretchable. Figure 15C As shown, the triangle formed by anchor 1540, pulley 1520, lock 1550, and flexible locking element 1580 (e.g., chain or cable tie) has an axial length along the base B of the cut and a lateral height H across the cut. The length of the base of the triangle increases as the knee flexes. Typically, all members of the triangle are non-stretchable, requiring the height to be reduced to maintain the length of the individual element connecting any two points, thus generating an additional closing force across the cut. Figure 15A and Figure 15B It is also shown that the lower surfaces of substrates 1510a and 1510b may contain a hydrocolloid adhesive 1560, and one of the boards 1510a or 1510b may include a locking arm 1570 for locking the cable tie 1580 into place. Although Figure 15A The triangle is shown with its base on the left substrate 1510b, but it is conceivable that the base of the triangle could instead be on the right substrate 1510a.

[0120] Although the anchor 1540, pulley 1520, lock 1550, and flexible locking element 1580 form a triangle, other shapes are conceivable. For example, pulley 1520 can be wrapped around two anchors 1540 to form a square or rectangular shape, or pulley 1520 can be wrapped around three or more anchors 1540 to form a trapezoidal shape. (Reference) Figure 15D The figure shows a base assembly 1500a of an incision closure device, which is similar to base assembly 1500. In base 1500a, anchors 1540, two pulleys 1520, a lock 1550, and a flexible locking element 1580 form a rectangle to provide additional closure at incision I when the underlying skin is stretched. Figure 15D In the rectangular configuration shown, the spacing between the two fixed points on either side of cut I will typically be the same. And... Figure 15A and Figure 15C In the triangular configuration shown, the fixing point on the pulley 1520 side can be spaced further apart than on the other side of cutout I. Although the rectangle is shown as "open" on the left substrate 1510b, it is conceivable that the rectangle could alternatively be "open" on the right substrate 1510a.

[0121] exist Figures 14A1-14A3In the incision closure device base assemblies 1400a, 1400b, and 1400c shown herein, and in other incision closure device base assemblies described herein, a single cable tie 1422 can be used to engage a single lock located on opposite sides of the incision I. Figures 15A-15D In this configuration, each flexible locking element or cable tie 1580 is typically anchored to one side of the cut I, wrapped around the other side, and then engages the lock 1550 located on the same side of the cut I as the anchor 1540. Figure 15D In the illustrated embodiment, the flexible locking element or cable tie 1580 is wound around two fixed reels (spools / pulleys 1520) on the other side of the cut I before engaging the lock 1550 located on the same side. The reels 1520 to which the flexible cable tie 1580 is wound can preferably be connected to rigid members such that the distance between them does not increase as the closure device base assembly 1500 elongates in the axial direction. In alternative embodiments, it may be desirable to allow expansion between the pulleys or reels 1520. It should be noted that the flexible locking element 1580 can be anchored in one base segment while locking in adjacent segments separated by perforations 1530 in base segments 1510a or 1510b. Such anchoring and locking can create a connection between the three segments of the base strip (two segments on the same side and one segment on the opposite side). When the length of the cross-cut closure device or the base assembly 1500 or 1500a is taken into account, the attachment mechanism forms a continuous “S”-shaped (i.e., serpentine) connection across cut I.

[0122] A tensioned flexible connector 1580 wound around a mandrel, reel, or pulley 1520 can be configured to provide additional compression to the incision I when tension attempts to open the incision and the underlying skin is stretched. In some cases, if the two substrates 1510a are further compressed by a combined external force, the flexible cable tie 1580 may potentially slip off the mandrel 1520 and loosen without causing any stretching of the underlying skin. To prevent such slippage, the flexible winding member 1580 can be slidably accommodated within or anchored to an element 1590 anchored to the base strip 1510a. Figure 15E and Figure 15F A flexible element 1580 is shown passing through a tube 1590, which then attaches to or anchors to a substrate 1510a. The flexible cable tie element 1580 remains secured even when the substrates 1510a and 1510b are brought closer together, and continues to provide the necessary closure function. In other embodiments, Figure 15E and Figure 15FThe spool feature 1590 shown may have a hole through the center through which the cable tie 1590 slides. The flexible cable tie 1580 and the element 1590 through which it slides may preferably be designed to minimize the friction between the element 1580 and the element 1590.

[0123] Experiments have been conducted and demonstrated that, with a base B of 12 mm and a height H (typically about 16 mm) determined by the distance between the cable tie connection points on the two substrates 1510a and 1510b after the incision is closed, flexion of the device 1500 located on the human knee results in a 5% reduction in height H in the area where the skin S elongates most. It should be noted that the reduction in height may depend on several factors, such as the base of the triangle, the degree of skin elongation beneath, and the distance between the two bases on either side of the incision. The connection “cable tie” between the anchor 1540 and the lock 1550 may need to be at least partially flexible to allow circulation around the pulley. In a preferred embodiment, a monofilament plastic filament is integrated with features engaged in the locking mechanism. Such features may be circular “teeth” engaged in a toothed mechanism within the lock. Such plastic can be used to obtain the desired flexibility, longitudinal stiffness, low bacterial load tendency, and allow for extrusion and / or injection molding processes. Braided stitches (preferably coated to limit bacterial load) can also be used to create flexible yet non-stretchable connectors. Flexibility can also be achieved using round filaments or tubes made of flexible materials such as silicone. The cable ties of the pulley can be a composite of materials such as molded plastic and braided thread. In other embodiments, the cable ties of the pulley can be formed by necking a molded cable tie. Pulling the molded cable tie beyond its yield point permanently reduces the cross-sectional area of ​​the cable tie and makes it more flexible when elongated. Heat can be used in the necking process to promote elongation and reduction of cross-sectional area. Figures 16A-16B The alternative mechanism shown is used to lock the cable tie material, such as stitching and softer plastic, once the desired closure is achieved. Figure 16A The locking mechanism is shown, which includes a groove 1610 for sliding and an anchor frame 1620. Figure 16B A locking mechanism is shown, which includes locking teeth 1630. Figure 16C The locking mechanism is shown, which includes a groove 1640 for sliding and an anchor frame 1650. Figure 16D The locking mechanism is shown, which includes a cylindrical tube 1660 and locking teeth 1670.

[0124] By using, for example Figure 17 The articulation mechanism 1700 shown can provide additional closing force across the incision when the knee is flexed. Figure 17As shown, four points on either side of the incision (each side of the incision closure device or two anchor points 1720 on the base plate 1710) can be connected using an X-shaped non-stretching arm 1730, providing a hinge at the intersection 1740. As the distance between the two points on the same side of the incision increases with knee flexion, the distance between the segments on either side of the incision can decrease, thereby generating additional closing force. Figure 17 As shown, the substrate 1710 may also have a plurality of through holes 1750 to facilitate axial stretching of the substrate 1710, or to facilitate its separation into discrete segments during axial stretching.

[0125] like Figure 18 As shown, according to many embodiments, the straps and locks of the incision closure device 1800 can be configured to form an S-shaped or serpentine connection or arrangement along the entire length of the incision I across the skin S on the knee. The incision closure device 1800 can be similar in many respects to the incision closure device 1400 described above. The segments 1810a, 1810b of the device 1800 are connected to each other by connecting each segment 1810a on one side of the incision I to two adjacent segments 1810b on the opposite side of the incision. This can be achieved by installing a pair of straps 1820 in each segment 1810a and a pair of locks 1830 on the corresponding segment 1810b on the other side. Each pair of locks 1830 and straps 1820 can be connected to each other. During the closure of the wound or incision I, one of the straps 1820 of the base plate segment 1810a (e.g., strap 1820a) can be connected to a lock 1830 (e.g., 1830a) on a segment 1810b (e.g., 1810b1) on the other side of the incision I, and a second strap 1820 (e.g., strap 1820b) can be connected to a lock 1830 (e.g., 1830b) on the opposite side of the incision I, adjacent to the segment 1810b (e.g., segment 1810b2) in which the previously paired straps 1820 (e.g., strap 1820a) are connected. The above connections form a single loop of S-shaped or serpentine arrangement of the base plate segments 1810, straps 1820, and locks 1830. The perforation line 1850 can separate axially adjacent substrate segments 1810a and 1810b. A perforation line 1850 on one side (e.g., accompanying substrate segment 1810a) can intersect with a perforation line 1850 on the other side (e.g., accompanying substrate segment 1810b). Similar to... Figure 15A In a preferred embodiment, the adhesive plate located on each side of the cut may be 12 mm wide, and the perforations within a given plate may be spaced approximately 18 mm apart.

[0126] The incision closure instruments or devices described herein can be used in many ways. Figure 19An example incision closure device 190 according to some embodiments is shown. Here, individual base segments 1910 arranged in pairs can be provided on a single carrier / release pad. Each pair of base segments 1910 includes a cable tie 1920 and a lock 1930, which can be independently aligned with the incision and adhered to the skin adjacent to each other. The individual segments 1910 can be held together relative to each other using the release pad and an outer carrier band 1950. The release pad 1950 can be removed to expose the adhesive, but the entire device 1900 or grouped portions of the device 1900 can be coupled to the outer carrier band. When applied to the skin, the carrier band 1950 can be removed, leaving the adhesive segments 1910 aligned with each other but movable independently.

[0127] The perforated segments on the upper layer of the substrate (typically containing polyurethane) can be held together by a continuous adhesive underlayer (typically containing a hydrocolloid adhesive) to allow for application to the skin in a continuous motion. Figure 14A- Figure 14B , Figures 15A-15C as well as Figure 18 The incision closure devices 1400, 1500 and 1800 can each have such a continuous adhesive underlayer.

[0128] The base assembly or substrate of the incision closure device described herein may be covered by a flexible adhesive membrane material at the end of the wound or incision closure. This membrane area is preferably larger than the base incision closure plate element so that it overlaps the element on the skin. The membrane helps prevent migration of the base and prevents any accidental movement of the anchors and locking mechanisms. The covering membrane may be made of stretchable materials such as rubber, latex, polyurethane, silicone, or thermoplastic elastomers. In a preferred embodiment, a thin covering (e.g., a laminate of 0.001” urethane and 0.002” thick acrylic adhesive) will have greater compliance than the composite structure of the substrate element. Therefore, the covering can provide some strain relief between the exposed skin and the base segment. The covering may also be transparent to allow visual inspection of the incision. The covering may be completely sealed across the incision (e.g., as a barrier against infection), or it may have openings aligned with the incision line to allow drainage of any exudate from the wound. The cover can also be used to improve the alignment of the cut edges by bridging the substrate and adhering to the skin edges between the base strips. The cover can also be constructed with additional reinforcing elements that improve tensile strength between substrate elements but allow for compliance along the length of the cut. A preferred embodiment may include a series of polyethylene tape strips applied to the cover.

[0129] While the user can apply the covering after the basal assembly and plate have been placed on the skin, it is also envisioned that the covering material could be supplied as a “skirt” extending around the outer perimeter of the basal segment. Therefore, the alignment of the covering material relative to the base can be independent of the user's placement. These same covering materials could provide the following effects: prevent hydrocolloid adhesives from being exposed to the patient's clothing, limit the migration of hydrocolloids or other adhesive sublayers, and provide strain relief from tension on the basal segment.

[0130] In many embodiments, hydrocolloid adhesives are used to stretch the skin for incision closure. Creep of the hydrocolloid can be prevented by one or more of the following methods: (1) using a laminate on the surface to limit creep, or (2) applying an adhesive covering across the skin and the hydrocolloid adhesive to prevent creep and provide strain release to the skin to prevent skin damage.

[0131] In many implementations, the covering used with the base assembly may include one or more perforations or openings to allow removal of wound exudate (and any applied bandage / absorbent material) without removing the adhered base assembly.

[0132] In many embodiments, the covering comprises a composite of flexible urethane and reinforcing strips. The composite construction can provide strength across the cut, as well as compliance along the length of the cut.

[0133] In many implementations, the covering, combined with the base assembly, aligns the skin incision edges in both the axial and lateral directions, or significantly prevents subsequent skin edge misalignment.

[0134] In many implementations, a covering pad configuration is provided so that a portion of the covering can be applied to the skin first, which in turn helps in the removal of the remaining pads and thus helps in controlling the thin material so that it is laid evenly with minimal wrinkles.

[0135] In many implementations, the removal of the first pad can allow for visualization during placement and can prevent the rest of the device from sticking to the user.

[0136] See again Figure 9 and Figure 10 In many preferred embodiments, two adhesive plates 104, 106 are applied to either side of the surgical incision (before or after making the incision). A closure mechanism may be mounted on the adhesive plates 104, 106 and is preferably attached to component 120, which facilitates the distribution of closing force between the attachment points of the closure mechanism. Figure 9 and Figure 10 as well as Figure 20A and Figure 20BAs shown, the closure mechanism may include a cable tie 130 and a lock 132. The cable tie 130 may include an elongated assembly with engaging teeth. The lock 132 may include features for engaging teeth to capture the cable tie 130. The cable tie 130 can be tightened in the lock 132 to pull the adhesive plates 104, 106 (and thus the cut edges) together. If necessary, the user can untie and re-engage the cable tie 130 in the lock 132 to appropriately adjust the amount of skin closure. Meanwhile, Figure 20A The incision closure device shown in the figure can be described as a base or base assembly 102.

[0137] The skin adhesive used for each plate 104, 106 may preferably comprise a hydrocolloid adhesive. Alternatively or in combination, the skin adhesive may comprise one of many acrylic formulations known in the art. Hydrocolloid adhesives may have the benefits of being very viscous and capable of absorbing moisture and exfoliating skin cells. Therefore, hydrocolloid adhesives may be particularly suitable for long-term wear devices (e.g., up to 14 days). However, in at least some cases, the hydrocolloid structure may be soft and prone to creep under tension unless reinforced in some way, such as by covering the hydrocolloid adhesive layer with a stiffer substrate 120, 104 or other overlay structures disclosed herein.

[0138] Accordingly, another aspect of the invention also provides various means of reinforcing and protecting the adhesive layer in the base assembly of the incision closure device described herein, as well as additional means of holding the skin edges together (particularly in the axial direction). In at least some cases, the hydrocolloid adhesive alone has very low tensile strength and may require reinforcement means to prevent it from tearing or creeping during use. Figure 21 As shown, the adhesive layer 211 used in substrates 104, 106 can be laminated with a thin layer of compliant plastic or polymer 212 (such as urethane), preferably 0.001 inches thick, potentially up to 0.010 inches thick, to help maintain its structure during clinical use. The adhesive layer itself may be nominally 0.010 inches thick, but can range between 0.005 inches and 0.020 inches thick. Since tensioning elements, including cable ties 130 or locks 132 attached to the load distribution assembly 118, may be mounted on top of the adhesive structure 211, there is a possibility that the material may creep over time. The laminate 212, and any other adhesive laminates 215a, 215b located between the adhesive layer 211 and the load distribution assembly 118, can help provide a structure to prevent adhesive layer creep.

[0139] like Figure 22A As shown, to further prevent the migration of the adhesive plate 211, a covering 220 can also be applied to plates 104 and 106. Figure 22BAs shown, the cover 220 may include a thin, adhesive-coated compliant elastomer 221. In many embodiments, the cover 220 also includes a thin urethane layer (preferably 0.001 inch thick) coated with a skin adhesive such as an acrylic adhesive (preferably 0.002 inch thick), which may be provided on one or more release pads 223a, 223b. The cover may also include a reinforcing feature 225.

[0140] like Figure 23A and Figure 23B As shown, the cover 220 can be constructed such that it extends beyond the substrates 104, 106, thereby bridging the distance d3 between the skin S and the substrates 104, 106. A typical minimum required distance d3 can be 8 mm, but can be in the range of 2-15 mm. In addition to helping prevent creep of the adhesive layer on the substrates 104, 106, the urethane skin adhesive of the cover 220 also helps to release strain from the tension applied to the substrates 104, 106 by the movement of the surrounding skin S. This can be used to prevent skin damage (e.g., erosion or blistering) at the edges of the substrates 104, 106. However, it should be noted that the compliant nature of the hydrocolloid provides localized protection against blistering by its ability to move with the skin S and thus resist damage to the skin S. In many embodiments, even with a stiffer structure mounted to the outer surface of the adhesive layer, compliance within 0.010” of the nominal thickness of the adhesive layer down to the skin surface still provides resistance to skin damage.

[0141] In addition to stabilizing the substrate structure and providing strain relief, the cover 220 can be used for other purposes. By covering the position where the cable ties 130 engage the lock 132, the cover 220 prevents the patient from moving the lock 132 to a degree that could cause the cable ties 130 to come undone. Figures 23A-23C As shown, the covering 220 may have openings 224, 224' along the length of the area overlapping the incision, allowing externally applied gauze to absorb wound exudate. In other embodiments, the covering 220 may not have openings to protect the wound from sources of infection. The covering 220 itself may have reinforcing features 225, 225' to provide additional resistance to incision opening to the base 102, particularly in the area between the cable ties 130. Figure 23CA specific embodiment is shown, in which the reinforcing feature 225' may be a rectangular strip of adhesive tape. Preferably, the tape 225' may be more rigid than the surrounding compliant urethane layer 221 perpendicular to the skin incision. The tape 225' may be constructed from any combination of the following: an adhesive-coated woven fabric, polymer fibers, polyethylene, polypropylene, nylon, PET, hydrocolloid, or other materials known in the art. The reinforcing feature 225' may also add "shape" or stiffness to the covering 220 to aid in its placement. The urethane layer 210 may be constructed from such materials to provide it with bidirectional tension.

[0142] The spacing of the reinforcing features 225, 225' may be important for ensuring the longitudinal (parallel to the incision line) compliance of the covering 200 (e.g., due to the urethane layer of compliance). This can be used to improve patient comfort and resistance to skin injury by allowing the covering 220 and the underlying base assembly 102 to move with body movement. This effect may arise solely from the covering 220 or as a combined effect with the features of the base assembly 102 that allow longitudinal compliance. The reinforcing features 225, 225' may also be of a uniform construction but are perforated, slotted, or otherwise mechanically interrupted to allow stretching and / or controlled tearing with body movement. One or more urethane layers(s) of the covering 220 may also be mechanically interrupted to achieve the same effect. In at least some cases, the reinforcing features 225, 225' of the covering 220 may not extend the entire width of the covering 220 (perpendicular to the incision). This limited coverage width helps ensure strain release for body movements perpendicular to the cut I away from the base assembly 102. In a preferred embodiment, the area of ​​the cover 220 reinforced by the reinforcing members 225, 225' extends 10 mm in each direction away from the cut edge, but this can be in the range of 2-50 mm.

[0143] Another feature of the cover 220 is its ability to add control over the cut edges, particularly between the tensioning elements 130 and 132 of the base assembly. For example... Figure 24AAs shown, tension elements 130 and 132, combined with substrates 104 and 106, can be used to bring the incision edges 205 together. Once the skin S is brought close, it may be important to align the skin edges vertically (perpendicular to the skin surface). Vertical misalignment can lead to slower healing and visible “steps” or ridges in the incision, which can result in poor scar aesthetics. By attaching portions of the covering 220 along the incision to each edge of substrates 104 and 106, each edge can be kept vertically aligned under tension, as shown by arrows 201a and 201b. Adhesive on portions of the covering 220 that cross the incision I can also adhere directly to the skin S at the incision edges, further reducing the distance between the bonded incision edges and further enhancing vertical skin alignment. Figure 23C As shown, in a preferred embodiment, the portion of the covering 220 spanning the incision I is a rectangular strip of adhesive tape 225'. The width of each strip 225' and the axial gap between the strips 225' can be optimized for incision edge control, incision visibility, and wound exudate drainage. A preferred embodiment may include strips 12 mm wide and spaced 6 mm apart, with cable ties positioned between each strip. Other widths and spacings are also contemplated. By not bridging / covering each cable tie 130, the strips 225 can rest more flat against the skin S for better adhesion and edge control.

[0144] In some embodiments, reinforcing features 225, 225' may be constructed to limit the amount of bending at the incision site. In these embodiments, reinforcing features 225, 225' may be stiffer than the skin S, and preferably stiffer than the surrounding elements of the substrates 104, 106. In this way, bending or compression of the skin S around the incision site by normal patient movement can be isolated, or its propagation can be limited. While such movement isolation or limitation will help reinforce the incision site under tension, a greater benefit may be preventing significant or uneven inward, eversion, or displacement of the incision edges in a direction perpendicular to the skin surface. The reinforcing materials discussed above can be used, and the thickness adjusted to create the desired stiffness. Preferably, a composite of the base assembly 102 and the covering 220 can be constructed to create a smooth transition of stiffness and compliance from the surrounding skin to the isolated incision site.

[0145] In a particular method of use, after the base assembly 102 is used to initially close the incision that brings the skin edges closer together, the base plates 104 and 106 can be further pushed together to "push" the closed incision I upward so that the edges are slightly everted and / or the skin S around the incision edges is compressed to release tension. Figures 25A-25C The illustration shows how this method is implemented in an in vivo tissue model. Figure 25AStep 250A is shown, in which substrates 104 and 106 are adhered to the skin S adjacent to incision I and pushed together to "push" the closed incision I upward. Substrate 104 and 106 can then be further pulled together to hold the tissue in this orientation. These methods can be enhanced by positioning substrates 104 and 106 5-10 mm away from the incision edge. Figure 25B In step 250B shown, the substrates 104 and 106 can be locked in place relative to each other using cable ties 130 and locks 132. Figure 25C In step 250C shown, the cover 220 can then be applied to lock the relative positions of the substrates 104, 106 and the “pushing” cutout I. The cutout I can be further reinforced using the reinforcing elements 225, 225' discussed above.

[0146] In many embodiments, a given cover 220 may be fitted with a release liner to help the user handle the cover 220 before and during application to the patient. For example... Figure 22A and Figure 22BAs shown, the cover 220 may have release pads 223a and 223b applied in a three-part configuration. The user may first remove the longitudinal center pad 223b to apply the centrally exposed adhesive to the base assembly 102 and the skin incision area. This initial removal of the pad 223b, combined with visualization through a transparent plastic or opening within the center of the base 220, allows the user to see the base assembly 102 below, thus enabling proper alignment of the cover 220 with the base assembly 102 when applying it. This also helps to provide an area of ​​the cover 220 that does not stick to the user until the cover 220 is initially secured to the base assembly 102 and / or the skin S. Next, the side release pads 223a may be removed in a direction perpendicular to the incision I. Pads 223a hold and stretch a very thin layer of urethane to keep it substantially wrinkle-free when applied to the skin S. Furthermore, by first attaching the center of the cover 220 to the base assembly 102 and / or the skin S, the cover 220 can be held in place so that sufficient tension and control can be applied to the lateral release pads 223a for smooth application of the remaining portion of the cover 220, coated with a thin adhesive, to the patient. Alternatively or in combination, the pads can be constructed such that the first pad is removed to expose a narrow strip (perpendicular to incision I) across the entire width of the cover 220 to allow initial placement on the base assembly 102 and / or the skin S, followed by removal of one or two additional pads in a direction parallel to incision I. The first pad may be located in the middle of the length, at either end, or in between. If not at an end, two additional pads may be required, each removed outward along the length of the device from the location of the first pad. If the first pad is at an end, a second single pad can be removed outward toward the end of the device from the location of the first pad.

[0147] Another release liner configuration may be a single liner that can be completely removed from the bottom of cover 220 before application. This type of liner may require an outer film or cast sheet that gently adheres to the outer surface of cover 220 to help the thin urethane maintain its shape and provides the user with adhesive-free areas on the sides and / or ends that will not stick to the user's hands during application. The outer film may be on the entire outer surface or only on a specific width around the perimeter of cover 220. The film and / or release liner may also have an area extending beyond the thin urethane in cover 220. Once the cover adhesive is attached to base assembly 102 or skin S, the cast sheet can be easily removed from the outside of cover 220.

[0148] As described herein, flexible wound dressings and wound or incision closure devices or instruments are typically flexible and stretchable to conform to the contours of curved parts of the body (e.g., arms, long, curved incisions, etc.) or areas subjected to stretching (e.g., knees). To assist in covering such devices, a backing material can be used to help maintain the shape of the dressing during application. Such temporary backing materials described herein can have several advantages. The backing material can be transparent to support viewing of the wound. The material can be non-stretchable to prevent the dressing or closure device or instrument from elongating during application. The backing can be easily removed after the application of the wound dressing or closure device or instrument without affecting the adhesion of the actual dressing to the wound site. The backing material can also aid in the handling of the dressing during manufacturing. In many embodiments, the backing material can be coupled to the dressing or closure device with a tear-off release pad on the adhesive side of the dressing to support easy and reliable removal of the backing material.

[0149] Now for reference Figure 26A The wound dressing cover 2600 may include a flexible sheet 2610 made of a flexible material such as rubber, urethane, or silicone. The flexible material 2610 may be laminated on a relatively rigid material in the form of a cast sheet or carrier layer 2620. The cast sheet 2620 prevents the flexible material 2610 from curling up and becoming unusable. The flexible sheet 2610 may have an adhesive on one side (e.g., the bottom side) and a relatively rigid (hard) carrier layer or cast sheet 2620 on the other side. The adhesive side is protected by two pads 2630, 2640, which can be removed sequentially to expose the adhesive in a controlled manner. To apply the dressing 2600 to a wound or incision, a small strip of adhesive is exposed by removing one of the release pads, typically the smaller release pad 2630. This release pad 2630 can be attached to the cast sheet 2620 using tape 2650. The exposed portion of the flexible sheet 2610 can then be adhered to one end of the wound or incision. As the second release pad 2640 is slowly removed to continuously expose the adhesive, the flexible cover 2600 then follows the contours of the wound or incision and the curves of the body.

[0150] The first release pad 2630, which is usually still attached to the cast sheet 2620 with tape 2650, can then be used to lift the cast sheet 2620 from the flexible dressing 2610.

[0151] The manufacturing process of the wound dressing cover 2600 and associated pads 2630, 2640 may use a single mold to cut out the common contour (perimeter) of the laminate of release pad 2630, release pad 2640, flexible dressing 2610 (with adhesive), and cast sheet 2620. After removing pads 2630, 2640 and applying dressing sheet 2610 to the skin, cast sheet 2620 may remain on dressing sheet 2610. Removal of cast sheet 2620 may require initiation by delaminating and peeling the edges of cast sheet 2620 from dressing sheet 2610. Once initiation has been achieved, continued peeling and removal of cast sheet 2620 may be straightforward. Initiation and lifting of the edges of cast sheet 2620 may not always be intuitive and may require attaching to the free edges of cast sheet 2620 to help identify lifting points and begin peeling. Tape 2650 can be used to bridge the cast sheet 2620 to the release liner 2630 and can provide an easily identifiable tab that can be used to initiate peeling.

[0152] like Figures 26B-26E As shown, an alternative configuration of the cast sheet 2620 can be used to initiate the peeling of the cast sheet 2620.

[0153] like Figure 26B As shown, the molded sheet template can be cut so that the molded sheet 2620a extends axially beyond the flexible dressing sheet 2610 (for example, the pads 2630, 2640 of the flexible dressing sheet 2610 and the urethane material can be "kissed" to the surface of the molded sheet 2620a).

[0154] like Figure 26C As shown, the cast sheet 2620 may have an adhesive tape 2650 applied to either or both axial sides to extend beyond the cast sheet. The adhesive tape 2650 may not necessarily be attached to the release liner 2630.

[0155] like Figure 26D As shown, the molded sheet tape 2650 may be attached to or near one or more axial edges of the molded sheet 2620 and also extends within the contour of the molded sheet 2620, with a loose, non-adhesive edge 2652 for the user to grip.

[0156] like Figure 26E As shown, the cast plastic sheet 2620 can be cut from one axial edge to another, either partially or fully, along its length (e.g., by a kissing cut, so that the cast plastic sheet 2620 is not cut into the flexible dressing sheet 2610). The cut cast plastic sheet 2620 can be separated by the user's "pinch" to create an edge for gripping. Figure 26EAs shown, the inner molded edge may also have tape or similar tabs 2654 applied to one or both inner edges for gripping and peeling.

[0157] In many embodiments, the molded sheets 2620, 2620a and / or tapes 2650, 2652, 2654 may be different colors or have markings to distinguish them from the flexible dressing sheet 2610 and the release pads 2630, 2640.

[0158] The incision closure device or incision closure device assembly disclosed herein, including one or more of various base assemblies, base plates, force distribution structures, axial supports, lateral supports, closure components, tie rod assemblies, cable ties, locks, adhesive layers, coverings, covering structures, drapes, etc., may include, be coated with, or otherwise incorporated into one or more of the following: antifungal materials, antibacterial materials, antimicrobial materials, antiseptic materials, or pharmaceutical materials. For example, such materials may be incorporated into a hydrocolloid adhesive layer as another layer or coating between the skin and the adhesive layer (covering at least a portion of the adhesive layer), incorporated into a base assembly cover or at least its adhesive layer, etc. One or more holes, grooves, openings, pores, or similar structures may be provided on the device or equipment assembly to facilitate such incorporation. In many embodiments, such materials may include one or more of silver, iodides, zinc, chlorine, copper, or natural materials such as tea tree oil as active agents.Examples of such antifungal, antibacterial, antimicrobial, preservative, or pharmaceutical materials include, but are not limited to, the Acticoat™ series of materials available from Smith & Nephew plc in the UK, the Acticoat® humidity control series of materials available from Smith & Nephew plc in the UK, the Contreet® foam series of materials available from Coloplast A / S in Denmark, the UrgoCell® silver series of materials available from Urgo Limited (a subsidiary of Laboratoires URGO in France) in the UK, the Contreet® hydrocolloid series of materials available from Smith & Nephew plc in the UK, the Aquacel® Ag series of materials available from ConvaTec Inc. in Skillman, New Jersey, the Silvercel® series of materials available from Kinetic Concepts, Inc. in San Antonio, Texas, the Actisorb® Silver 220 available from Kinetic Concepts, Inc. in San Antonio, Texas, and the Urgo® series of materials available from Smith & Nephew plc in the UK. The following materials are available: Urgotul® SSD series materials (available from Laboratoires URGO Limited, a subsidiary of Laboratoires URGO, France); Inadine® series materials (available from Kinetic Concepts, Inc., San Antonio, Texas); Iodoflex® series materials (available from Smith & Nephew plc, UK); Sorbsan Silver™ series materials (available from Aspen Medical Europe Ltd., UK); Polymem Silver® series materials (available from Ferris Mfg. Corp., Burr Ridge, Illinois); Promogram™ series materials (available from Kinetic Concepts, Inc., San Antonio, Texas); Promogram Prisma™ series materials (available from Kinetic Concepts, Inc., San Antonio, Texas); and Arglaes® series materials (available from Medline Industries, Mundelein, Illinois).The components of the closure device described in the jointly owned U.S. Patent Nos. 8,313,508, 8,323,313 and 8,439,945; U.S. Patent Publication No. 2013 / 0066365; and PCT Applications Nos. US 2010 / 000430, US 2011 / 139912, US 2011 / 40213, US 2011 / 34649 and US 2013 / 067024 may also include, be coated with or otherwise incorporated into one or more of antifungal, antibacterial, antimicrobial, preservative or pharmaceutical materials, including but not limited to one or more of the materials listed above.

[0159] In many embodiments, topical pharmaceutical preparations are incorporated directly into the wound closure devices described herein. Since wound closure devices are often applied in close proximity to wounds or incisions requiring pharmacological protection, such direct incorporation of the medication into the closure device can be advantageous. For example, in wounds at risk of infection, the incorporation of antimicrobial agents can be beneficial. Antimicrobial agents may include antimicrobial drugs as well as antiseptic metal ions and associated compounds, which may include silver, iodine, copper, and chlorine, or natural materials such as tea tree oil. For example, in wounds susceptible to fungal infection, pharmaceutical preparations such as zinc may be approved. Any combination of these agents may also be beneficial and therefore can be incorporated into the wound closure device.

[0160] Topical drug formulations can be incorporated into closure devices in such a way that the closure device can improve the healing ability by aspirating exudate from the wound while keeping the wound adequately hydrated (e.g., guiding unwanted organisms away from the wound and / or preventing skin maceration).

[0161] refer to Figure 27AThe wound or incision closure device 2700 includes a base comprising two substrates 2710R, 2710L, each substrate 2710R, 2710L including an upper polymer layer 2720R, 2720L and a lower adhesive layer 2730R, 2730L applied immediately adjacent to each side of the surgical incision I. Features of the substrates 2710R, 2710L, such as a zip tie 2740, allow the skin on either side of the incision I to be pulled together and held in place during healing. The adhesive may preferably comprise a hydrocolloid formulation, but may also comprise acrylic or other adhesives known in the art. The upper polymer layer 2710R, 2710L (e.g., 1 mil polyurethane) may preferably be applied on top of the adhesive layers 2720R, 2720L to isolate the adhesive layers 2720R, 2720L. Pharmaceutical formulations may be incorporated into the structure of the substrates 2710R, 2710L. At a minimum, the agent can inhibit the growth of unwanted organisms at the point of contact between the substrates 2710R and 2710L and the tissue. The agent can be released from the substrates 2710R and 2710L and migrate into or immediately adjacent to the wound. The agent can be contained in a carrier structure such as the adhesive layers 2730R and 2730L, which is capable of absorbing fluids and facilitating the release of the agent. Such structures may include hydrocolloids, hydrophilic fibers (such as those containing sodium carboxymethyl cellulose), hydrogels, collagen, alginate, polyurethane foam, or silicone foam, or other relevant materials known in the art. The carrier may alternatively or in combination be an ointment, cream, gel, or powder. The pharmaceutical formulation (such as silver ions) may alternatively or in combination be applied to a metal or polymer (e.g., a mesh of metal or polymer) via a solvent coating process or vapor deposition. Such a mesh product may be incorporated into or embedded in the structure of a closure device.

[0162] In an exemplary embodiment, a pharmaceutical formulation comprising a silver compound such as silver sulfate can be incorporated into substrates 2710R and 2710L. As substrates 2710R and 2710L come into contact with wound exudate and / or sweat or external fluids, the pharmaceutical agent can be delivered toward the wound. As fluid is absorbed into substrates 2710R and 2710L, substrates 2710R and 2710L may be able to release silver ions that interfere with bacterial growth. Figures 28A-28B Examples of how agents such as silver can be incorporated into a substrate are shown in the figure, illustrating various embodiments of sample segment 2750 of the right substrate 2710R in FIG. 27. These examples are also applicable to the left substrate 2710L.

[0163] Figure 27B A pharmaceutical formulation 2760R is shown, which is directly mixed into an adhesive layer 2730R in a sample segment 2750. The adhesive is typically a hydrocolloid, which may be able to absorb a significant percentage of fluid by its weight, thereby facilitating the release of the pharmaceutical formulation.

[0164] Figure 27C Another embodiment of the sample segment 2750 of the right substrate 2710R is shown, wherein the pharmaceutical formulation is incorporated into a carrier structure 2770R incorporated on the substrate 2710R, preferably concentrated on the portion of the substrate 2710R near the cut I. Further features may be incorporated to allow for the peeling off (and replacement as needed) of the carrier structure 2770R in the event that the carrier structure 2770R is saturated with exudate or other fluid and / or the concentration of the pharmaceutical formulation drops below an effective level.

[0165] Figure 27D It shows the relationship with Figure 27C A similar embodiment is described, wherein a carrier structure 2770R containing a pharmaceutical preparation is incorporated on the inner edge of a substrate 2710R.

[0166] Figure 27E The illustration shows how a carrier 2770R can be incorporated into both the top and inner edges of a substrate 2710R. In these examples, the carrier structure 2770R on either or every inner edge of the substrate 2710R can be pressed against the wound or cut I to aid its stability on the wound or cut I.

[0167] Drug formulations and their carrier structures may be alternatively or in combination incorporated into the cover of an incision closure device. As described above, the cover is typically applied to the base plate of the incision closure device to help secure the device to the skin and protect the skin. Figure 28A As shown, the cover 2800 may have a pharmaceutical preparation 2810 incorporated into the entire surface of the cover 2800, which may or may not have a carrier structure (such as an adhesive layer 2810 mixed with a pharmaceutical preparation). Alternatively or in combination, the pharmaceutical preparation may be incorporated into discrete portions of the cover 2800, preferably in, for example... Figure 28B The carrier structure 2820 shown is located directly on the wound site.

[0168] In at least some cases, the carrier structure 2820 may become saturated and / or lose its pharmacodynamic strength over time, and replacing the drug structure 2820 would be beneficial. Figure 28C As shown, the drug structure 2820 may be removable (e.g., by tearing off the perforation 2830 in the cover 2800) and optionally coupled to Figure 28DThe narrow covering strip 2801 shown replaces another drug structure 2821. In the narrow covering strip 2801, the adhesive portion of the covering 2801 may extend beyond the drug structure 2821 to keep the structure 2821 in contact with the skin. The narrow strip 2801 may alternatively be applied to the wound site prior to the application of the covering 2800. The covering 2800 may be designed to cover the narrow strip 2801, or may have perforations 2830 to allow removal of the underlying strip.

[0169] For any or all of the two substrates 2710R, 2710L and the cover 2800, the carrier structure 2770R or 2820 (with or without a pharmaceutical formulation) or the individual pharmaceutical formulation may have a patterned adhesive layer of its respective structure. The patterned construction may include repeating shapes of the adhesive material (e.g., circles, ellipses, polygons, grooves, etc.) adjacent to similar repeating shapes of the carrier structure (or the remainder of its matrix). This will help ensure adhesion of the substrates 2710R, 2710L or the cover 2800 while integrating the pharmaceutical formulation within the carrier structure 2770R or 2820. Figure 28E A simple example is shown in which the carrier structure 2820 includes repeating shapes 2850. The drug formulation and carrier structure 2820 can also be applied to a basal ligature 2740 across the incision I.

[0170] While preferred embodiments of the invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Many variations, alterations, and substitutions can be made by those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in the practice of the invention. The appended claims are intended to define the scope of the invention and therefore cover the methods and structures within the scope of these claims and their equivalents.

Claims

1. An incision closure device, comprising: A first substrate for adhesion to a first side of an incision or wound, the first substrate including an upper surface, an adhesive underlayer and an outer lateral edge; A second substrate is used to adhere to the second side of the incision or wound opposite to the first side. The second substrate includes an upper surface, an adhesive underlayer, and an outer lateral edge. Left and right force distribution structures are respectively connected to a first substrate and a second substrate, wherein each force distribution structure is adapted to allow the substrate to expand axially along one of the outer lateral edges and to limit one or more of the lateral expansion across the plates and the axial expansion along the opposite outer lateral edges; A first skirt connected to a first substrate adhesion substrate and a second skirt connected to a second substrate adhesion substrate are precisely aligned relative to the first and second substrates after the substrate assembly is manufactured. The first and second skirts have tissue adhesion under surfaces, wherein the first and second skirts extend laterally beyond the outer lateral edges of the respective first and second substrates. Each skirt is configured to provide additional adhesion support and / or creep reduction to the tissue adhesion under surfaces of the first and second substrates, and to provide strain relief to the tension applied to the first and second substrates. as well as Multiple lateral tie rods couple the first and second substrates to each other. Each of the lateral tie rods has a first end and a second end, the first end being permanently fixed relative to a support of the first substrate, and the second end being reversibly and adjustably connected to a laterally opposing support of the second substrate, thereby allowing the lateral tie rods to pull the first and second substrates laterally together to compress the incision or wound covered by the incision closure device. The first end of each of the transverse tie rods is integral with the corresponding support member on the first base plate, and Each of the lateral tie rods is reversibly and adjustablely connected to the second substrate such that the lateral spacing between the first substrate and the second substrate is adjustable.

2. The incision closure device of claim 1, wherein the second end of each of the transverse links is detachable from and re-engaged from the corresponding support on the second base plate.

3. The incision closure device according to claim 1, wherein the lateral tie rod is individually adjustable such that the lateral spacing between the first substrate and the second substrate is variable along the length of the first substrate and the second substrate.

4. The incision closure device of claim 1, wherein the second end of each of the transverse links is releasably connected to a locking member, and wherein the transverse links and the locking member together form a toothed tensioning mechanism.

5. The incision closure device according to claim 1, wherein one or more of the left and right force distribution structures are respectively arranged laterally between the inner and outer edges of the first substrate or the second substrate.

6. The incision closure device according to claim 1, wherein one or more of the left and right force distribution structures comprise a flexible, non-expandable material.

7. The incision closure device of claim 1, wherein one or more of the left and right force distribution structures are embedded in or stacked on the upper surface of each substrate.

8. The incision closure device according to claim 1, wherein one or more of the left and right force distribution structures are C-shaped.

9. The incision closure device according to claim 1, wherein one or more of the first substrate or the second substrate includes an elastic matrix.

10. The incision closure device according to claim 9, wherein the elastic matrix comprises an elastomer membrane, a woven fabric, a short-fiber fabric, rubber, latex, urethane, polyurethane, silicone, or a thermoplastic elastomer.

11. The incision closure device of claim 10, wherein the elastic matrix comprises a fabric woven from elastic elements and having non-elastic elements extending laterally along and across one or more of the first substrate or the second substrate.

12. The incision closure device of claim 1, wherein one or more of the first substrate or the second substrate includes one or more preferential separation regions to facilitate one or more of longitudinal separation or lateral stretching of the first substrate or the second substrate.

13. The incision closure device of claim 12, wherein the one or more preferential separation regions include one or more perforations.

14. The incision closure device of claim 13, wherein the one or more perforations are arranged longitudinally between axially adjacent supports on one or more of the first substrate or the second substrate.

15. The incision closure device of claim 13, wherein the one or more perforations comprise a plurality of perforations arranged along a transverse line of one or more of the first substrate or the second substrate.

16. The incision closure device of claim 13, wherein the one or more perforations are arranged along the lateral edge of one or more of the first substrate or the second substrate.

17. The incision closure device of claim 1, wherein the adhesive underlayer of one or more of the first substrate or the second substrate comprises a hydrophilic adhesive material.

18. The incision closure device of claim 17, wherein the hydrophilic adhesive material comprises one or more of hydrocolloids, hydrogels, acrylic polymers, or polyethylene glycol.

19. The incision closure device of claim 1, further comprising a fastening layer adapted to be placed on the assembly after the assembly of the first substrate, the second substrate and the transverse tie rod has been fastened to the incision or wound.

20. The incision closure device of claim 19, wherein the fastening layer has a self-adhesive inner surface.

21. The incision closure device of claim 19, wherein the fastening layer is configured to extend laterally beyond the outer lateral edge of the first substrate or the second substrate.

22. The incision closure device of claim 19, wherein the fastening layer has one or more preferential separation regions to allow the fastening layer to be at least partially stretched longitudinally in response to lateral stretching of the incision or wound and surrounding tissue on which the incision closure device is placed.

23. The incision closure device of claim 22, wherein the one or more preferential separation regions include one or more perforations.

24. The incision closure device of claim 1, wherein each of the transverse links is longitudinally pivotable relative to its first or second end.

25. The incision closure device of claim 24, wherein each of the transverse links is configured such that each of the transverse links is longitudinally pivotable relative to its first or second end when one or more of the first or second substrates are longitudinally stretched.

26. The incision closure device of claim 24, wherein when the transverse link pivots longitudinally, the transverse link pulls the first substrate and the second substrate closer together in the transverse direction.

27. An incision closure device, comprising: The base includes a left plate and a right plate, each plate having a tissue adhesion lower surface, an upper surface, a first transverse edge, and a second transverse edge; A left force distribution structure and a right force distribution structure, respectively coupled to the left and right plates, wherein each force distribution structure is adapted to allow the plates to expand axially along one of the first or second lateral edges, and to limit one or more of the lateral expansion across the plates or the axial expansion along the opposing lateral edges; and Multiple closure components, which can be fastened to the left and right plates, to pull the plates together after the plates have adhered to the tissue and incisions made therebetween. The tissue adhesion surface comprises a hydrophilic adhesive material, and the hydrophilic adhesive material includes one or more of hydrocolloids, hydrogels, acrylic polymers, or polyethylene glycol.

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