JP2016527958A - Surgical incision and closure device - Google Patents

Abstract

An apparatus for closing a surgical incision includes left and right base panels, a plurality of closure components, and a plurality of left and right axial supports coupled to individual base panels. The closure component has left and right ends that join the left and right base panels laterally to each other and are joined to separate base panels. The closure component is positioned laterally across the left and right panels, the left axial support is disposed between the pair of left closure component ends, and the right axial support is the pair of right closures Located between the component ends, the left and right axial supports are offset from each other such that a serpentine arrangement of continuous closure components and axial supports is formed. The device can be made from an antimicrobial material or a material impregnated with an antimicrobial agent. A flexible adhesive cover can be provided to cover the device in use.

Description

(Cross-reference to related applications)
This PCT application was filed on October 11, 2013, US provisional application number 61 / 889,569 (attorney document number 35383-712.101), filed July 24, 2013. 61 / 958,259 (attorney document number 35383-710.101) and 61 / 958,254 (attorney document number 35383-711.101) filed on July 24, 2013 The entire disclosure of these US provisional applications is incorporated herein by reference.

  The contents of this application are related to U.S. Patent Application No. 13 / 665,160 (Attorney Docket No. 35383-709.501) filed on Oct. 31, 2012. Is a continuation-in-part of U.S. Patent Application No. 13 / 286,757 filed on November 1, 2011 (Attorney Docket No. 35383-709.201). Is hereby incorporated by reference.

  The contents of this application are filed on Feb. 2014, pending US patent application no./, (No. 35383-712.201) filed on Feb. 2014. The entire disclosures of these US patent applications are hereby incorporated by reference.

(Background of the Invention)
The present invention generally relates to medical devices and methods. More specifically, the present invention relates to an apparatus and method for forming and closing a surgical incision.

1. FIELD OF THE INVENTION Surgical closure devices are known that include adhesive-based patches with right and left panels. Of particular note to the present invention, such a device is described in co-pending co-owned PCT application US 2010/000430, the entire disclosure of which is incorporated herein by reference. It is. As described in this PCT application, the adhesive patch is placed over the patient's skin at the site where it is desired to form a surgical incision. After the patch is deployed, an incision is made along an axial line that extends through the center of the patch. After it is formed, the incision can be opened to perform the desired procedure, and after the procedure is complete, the incision pulls the inner edge of the panel together by clips, zippers, or other closure members. May be closed.

  The main purpose of such a surgical closure device is to improve healing and reduce scarring resulting from the incision. However, this objective is hampered by certain characteristics of currently available devices. For example, tissue edges are not always joined along a uniform line, which can increase final scarring. Many such closure devices do not have the ability to adjust the closure force or distance on the tissue edge, but have the ability to “swell” tissue (which has been shown to reduce scarring) slightly. Restrict. Another disadvantage of available incision and wound closure devices is that they are difficult to use and not adaptable to tissue manipulation during subsequent surgical protocols, i.e., rigid enough to secure and close the tissue These devices are often cited as being unable to adapt to tissue movement during the surgical procedure.

  Certain problems arise with self-adhesive wound closure patches when used directly under an adhesive surgical incision drape. Such a drape is used to help maintain the sterility of the tissue surface during the surgical procedure, and the drape may be placed over a previously positioned tissue closure patch. Because the surgical incise drape has an adhesive lower surface that adheres to the tissue, the drape adheres to the upper surface of the underlying tissue closure patch. Removal of the surgical incise drape therefore 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 will no longer be useful for closing the surgical wound.

  For these reasons, it would be desirable to provide an improved surgical incision closure device and method for its use. In particular, it can adhere to tissue, allow for the formation of incisions, adapt to tissue deformation during subsequent surgical procedures, and provide a controlled closure of adjacent tissue edges following the procedure It would be desirable to provide an incision closure device. In particular, it may be desirable if the incision closure device is capable of providing a controlled and uniform distribution of closure force over the tissue edge while producing minimal restraint or extension of the tissue during the surgical procedure. . Furthermore, it would be desirable to provide an improved surgical incision closure device and method of use thereof that when used directly under a surgical incise drape, the device resists removal and translocation. At least some of these objectives will be met by the present invention described below.

For surgical closure devices, see U.S. Pat. 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 US Patent Publication Nos. 2005/0020956 and 2008/0114396. Additional surgical closure devices include co-owned US Pat. Nos. 8,313,508, 8,323,313, and 8,439,945, US 2013/0066365, and PCT Publication No. WO 2011/139912, WO 2011/159623, WO 2011/043786, and WO 2013/067024, the entire disclosures of which are incorporated herein by reference. Also included is a temporary abdominal wound closure device, which is a commercially available incision closure device available under the Ethizip ^™ trademark name from Ethicon, a small company of Johnson & Johnson.

US Patent No. 2,012,755 US Pat. No. 3,516,409 US Pat. No. 3,863,640 U.S. Pat. No. 3,933,158 U.S. Pat. No. 4,114,624 US Pat. No. 3,926,193 US Pat. No. 4,535,772 US Pat. No. 4,676,245 U.S. Pat. No. 4,881,546 US Pat. No. 4,905,694 US Pat. No. 5,377,695 US Pat. No. 7,455,681 US Patent Application Publication No. 2005/0020956 US Patent Application Publication No. 2008/0114396

(Summary of the Invention)
The present invention provides an improved apparatus and method for closing wounds, particularly wounds resulting from incisions made during a surgical procedure. An incision will typically be made in the patient's skin, such as through the abdomen, but in some cases it may also be made on an internal organ, in the oral cavity, in a body cavity, or the like.

  The devices and methods of the present invention present minimal obstacles or interference to the surgical procedure performed after the incision is created. In particular, the devices and methods allow the opposed edges of the dissected tissue to be opened, stretched, and freely deformed with minimal constraints resulting from the presence of the closure device. However, once the procedure is complete, the devices and methods of the present invention provide a uniform distribution of the closing force and pull the tissue edges together in a manner that minimizes scarring. In particular, the closure device can ablate the tissue edge upwards, create “shrinkage” and reduce scarring, so that the tissue edge is slightly closer than what was originally present at the time of the incision. Can be pulled together.

  The devices and methods of the present invention can also avoid or reduce crushing when the incision closure device is used directly under a surgical incision drape, which must be removed from the closure device. A sacrificial layer is provided over at least a portion of the upper surface of the closure device and the sacrificial cover is held in place while a surgical incision drape is placed over the incision closure device. After the incision and surgical procedure is complete, the surgical incise drape is withdrawn from the patient's skin. Instead of adhering to and removing the tissue closure instrument, the surgical drape adheres to the sacrificial cover and only the sacrificial cover, with the drape, is pulled down from the patient, leaving the rest of the incision closure instrument in place.

  In a first aspect of the present invention, an incision closure device comprises a base including a left panel and a right panel. Each panel has a tissue adhesive lower surface, an upper surface, an inner edge, and an outer edge. The lower tissue adhesive surface is typically coated, at least in part, with common tissue adhesive adhesives such as those used in surgical dressings and patches.

  The incision closure device further includes a force distribution structure coupled to each panel (ie, each panel has at least one force distribution structure coupled thereto), each force distribution structure along the inner edge. It is adapted to allow axial expansion of the panel while limiting lateral expansion over the entire length and axial expansion along the outer edge. By providing an axial expansion of the panel along the inner edge, the tissue edge is constrained to a minimum to allow the tissue to deform as it is extended during the surgical procedure. Conversely, by limiting both lateral and axial expansion along the outer edge, the panel is pulled together after the surgical procedure is completed, as will be described in more detail below. Then, it is possible to apply a controlled and distributed closing force.

  The incision closure device further includes a closure component or assembly that is adhered to the tissue on both sides of the incision site and attached to the force distribution structure after the surgical procedure is completed and pulls the inner edge of the panel together. Each panel of the base typically includes, at least in part, an elastic matrix and typically has isotropic elasticity (ie, the panels extend equally in all directions), but optionally Have anisotropic elasticity (the matrix preferentially extends in one direction or part thereof). The elastic matrix can be an elastomeric film or sheet (eg, polyurethane sheet or thermoplastic elastomer (TPE)), woven fabric (typically woven at least partially from elastomeric filaments, yarns, or fibers), spun fabric, Or equivalents may be included. In some embodiments, the elastomeric matrix is along the elastic elements (typically yarns, filaments, fibers, or the like) and outer edges to provide the aforementioned expansion properties to the force distribution structure. It may consist of a fabric woven from both inelastic elements, arranged and extending laterally across it. That is, in some cases, the force distribution structure may comprise or consist of an inelastic element that is woven or otherwise incorporated into the fabric membrane.

  Typically, the force distribution structure comprises separate components of the incision closure device, e.g., an axially disposed back adjacent to the outer edge of the panel and laterally disposed from the back to the panel. A plurality of axially spaced side supports extending toward the inner edge. Such “comb” structures allow the elements to flex together as the tissue deforms, but do not extend along their length, they are laterally as well as the panel Along the outer edge, it will typically be flexible but will be formed from a non-stretchable material so as to provide dimensional stability. Examples of such materials include nylon, polypropylene, polyethylene, and polycarbonate, or other thermoplastic polymers. It should be noted that the force distribution structure does not limit the axial extension of the inner edge of the panel to provide the desired expandability and ability to conform to tissue during the surgical procedure. Such a separate force distribution structure may be attached to the upper surface of the panel, or alternatively may be embedded or laminated within the panel. Typically, the force distribution structure does not extend in or beyond the lower surface of the panel so as not to interfere with the adhesion between the panel and skin or other tissue.

  The assembly of the base panel and force distribution structure will typically be carried on a removable backing that covers and protects the adhesive surface of the panel prior to use. The backing may be removed to apply the base to the skin or other tissue at the site of the surgical intervention. In addition, as the right and left panels are typically adhered to tissue, removable tabs, axial strips, or other removals to keep the inner edges of the panels at a predetermined distance or spacing. They are held together by a possible cover or structure. For example, a removable tab may be placed at each axial end of the base to temporarily secure the two base panels together. Alternatively, a removable strip or tape may be placed over the axial gap between the right and left panels to hold the panels in place relative to each other as the base is adhered to the tissue surface. Good. Such tabs or strips are typically self-adhering so that they can be secured to the panel and then removed by simply pulling after the panel is properly placed on the tissue. obtain. The cover, tab, or strip is then removed, leaving the panel in place, but may not be connected prior to forming the surgical incision therebetween.

  A first exemplary structure of the closure component or assembly includes a right engagement member, a left engagement member, and a plurality of side posts that hold the engagement members laterally apart by a predetermined distance. Prepare. The right engagement member is adapted to removably engage the right panel support along its inner edge and the left engagement member is removed from the left panel support along its inner edge Adapted to engage possible. In a specific embodiment, at least some of the force distribution component supports have a non-slip device near its inner edge and the engagement member has a slot that receives the anti-slip device. After the surgical intervention is complete, the closure component may then be placed over the force distribution structure, with one anti-slip device first engaged by the engagement member and then the opposing engagement. The mating member is pulled over the opposite anti-slip device.

  Alternatively, the closure component or assembly may comprise a plurality of independent side ties that are attached to at least some of the side supports. Such side ties are configured to be secured between the side supports and are typically fixed to one panel and adjustably attachable to the other panel. For the exemplary embodiment, the adjustably attachable ends allow each lateral tether to be adjusted independently at different intervals between the right and left panels. Alternatively, a similar structure may be provided. Thus, the right and left panels may be tensioned differently along their inner edges to control and optimize the forces applied to adjacent tissue edges that are being pulled together. Good.

  Optionally, the closure device of the present invention is further adapted to be secured over the incision on the patient's skin and placed over the base and closure component assembly after the surgical procedure is completed. The fixing layer may be provided. The anchoring layer typically has a self-adhesive lower surface that is placed over the base and closure component assembly to help secure it in place and maintain cleanliness. . The anchoring layer may optionally have an opening that provides access to the wound for observation, disinfectant delivery, and the like.

  In a further aspect of the invention, a method for making an incision in tissue includes providing an incision closure device as described above. The right and left panels of the instrument are adhered to the patient's skin and the inner edges of the panels are separated by a preselected distance, typically 0.5 mm to 15 mm. An incision (typically linear) is formed in the tissue or skin surface between the inner edges of the panel, and the incised tissue edges are then separated to perform the desired surgical procedure. While the inner edge of the panel stretches and adapts as the tissue edge moves and deforms, the outer edge and lateral extent of each panel can remain dimensionally stable. After the procedure is complete, the closure component is secured to the force distribution structure and pulls the panel's inner edge back together. Optionally, the closure components have dimensions (or adjustable inter-panel spacing) that pull the tissue edge closer than they were immediately after the incision was made. Pulling the tissue together in such a manner can ablate the edge, “sag” the tissue, and reduce scarring.

  In another further aspect of the present invention, an incision closure device is provided. The incision closure device includes a left and right base panel, a plurality of closure components for laterally coupling the left and right base panels to each other, and a plurality of left and right bases coupled to the left and right base panels, respectively. And an axial support. Each closure component includes left and right closure component ends coupled to left and right base panels, respectively. The plurality of closure components includes (i) one or more left axial supports disposed between at least some axially adjacent left closure component ends, and (ii) at least some axial directions. One or more of the right axial supports disposed between the right closure component ends adjacent to each other may be positioned laterally across the left and right panels to form a serpentine array.

  To form a serpentine arrangement, the left axial support couples every other axially adjacent pair of left closure component ends together on the left panel and / or the right axial support. Couples every other axially adjacent pair of right closure component ends together on the right panel. The left and / or right panels have one or more disposed between axially adjacent individual left and / or right closure component ends that do not have an axial support disposed therebetween. Of perforations. The one or more perforations may comprise a plurality of perforations that facilitate separation of the base panel into base panel segments in response to axial extension of the base panel.

  One or more of the left or right base panels may comprise a plurality of separate base panel segments. At least two left closure component ends or at least two right closure component ends may be coupled to each base panel segment. The left base panel may include a plurality of left base panel segments, and the right base panel may include a plurality of right base panel segments. The left and right base panel segments may be axially offset from each other when applied to the incision and surrounding tissue. A plurality of closure components may join the left and right base panel segments laterally to each other to form a serpentine array.

  One or more of the left or right base panels may comprise a tissue adhesive lower surface for adhering to the tissue adjacent to the incision. One or more of the left or right base panels may comprise a lower adhesive layer comprising a tissue adhesive lower surface and an upper layer comprising an upper surface. The upper layer may be more rigid than the lower adhesive layer. The lower adhesive layer is sufficiently elastic when covering the incision and surrounding tissue so that bulges and adhesive losses due to movement of tissue adjacent to the side of the incision closure device are minimized. Also good. The adhesive underlayer may comprise a hydrophilic adhesive material. The hydrophilic adhesive material may include one or more of a hydrocolloid, a hydrogel, an acrylic polymer, or poly (ethylene glycol). The top layer may include one or more of rubber, latex, urethane, polyurethane, silicone, thermoplastic elastomer (TPE), woven fabric, or spun fabric. One or more of the left closure component end, the right closure component end, the left axial support, or the right axial support is embedded in or within the upper surface of the left and right base panels May be laminated.

  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 from a flexible, non-stretchable material.

  When the multiple closure components, the left axial support, and the right axial support together cover the incision and surrounding tissue, the movement of the tissue adjacent to the side of the incision closure device is It may be sufficiently rigid so as not to substantially expand the tissue. Thus, movement of the first tissue region adjacent to the side of the periphery of the incision closure device is substantially identical to movement of the second tissue region adjacent to the side of the periphery and opposite the first tissue region. May be converted to

  One or more of the plurality of closure components may comprise a tether that is securely coupled to the left or right closure component ends and adjustably attached to the opposing closure component ends. Opposing closure component ends may be provided with ratchet clamping mechanisms.

  The plurality of closure components may be configured to pull together the inner edges of the left and right base panels and compress the incision covered by the incision closure device.

  One or more of the plurality of left axial supports or the plurality of right axial supports may be C-shaped. Each of the C-shaped left and / or right axial supports includes an axial portion for limiting the axial extension of the individual base panel, and a side portion for limiting the lateral extension of the individual base panel. May be provided.

  This aspect of the invention may also provide a system for closing an incision in tissue. The system may comprise an incision closure device and a flexible cover for covering the incision closure device and the incision and surrounding tissue covered thereby.

The flexible cover may be configured to extend over the lateral and axial edges of the left and right base panels. The cover has one or more perforations that allow the cover to extend axially at least partially in response to the incision covered by the incision closure device and the axial extension of the surrounding tissue. May be. One or more perforations may be disposed along a central axial line of the cover. The cover may comprise one or more reinforcing members that are coupled to at least a portion of the adhesive layer of the cover. The reinforcing member may include one or more of rubber, latex, urethane, polyurethane, silicone, thermoplastic elastomer (TPE), woven fabric, or spun fabric. The cover may comprise a hydrophilic adhesive layer that may include one or more of hydrocolloids, hydrogels, acrylic polymers, or poly (ethylene glycol).

  In another further aspect of the present invention, an incision closure device is provided. The incision closure device comprises a flexible adhesive bottom layer, an intermediate layer, and a top layer. The flexible adhesive bottom layer may have a first elasticity. The intermediate layer may be bonded to the flexible adhesive layer, cover at least a portion thereof, and have a second elasticity that is less than the first elasticity. The top layer may be coupled to the intermediate layer, covering at least a portion thereof, and having a third elasticity that is less than the second elasticity. The elastic gradient between the flexible adhesive bottom layer and the top layer is such that when the incision and surrounding tissue are coated, the movement of the tissue adjacent to the side of the instrument will substantially cause the coated incision and surrounding tissue to move. Sufficient rigidity may be provided to the incision closure device so that it does not spread.

  The elastic gradient may provide sufficient resilience to the incision closure instrument such that when covering the incision and surrounding tissue, blisters and adhesion loss due to movement of tissue adjacent to the instrument is minimized.

  The incision closure device may be axially flexible in response to the incision covered by the incision closure device and the axial extension of the surrounding tissue. The movement of the first tissue region adjacent to the periphery of the flexible adhesive bottom layer is the same movement of the second tissue region adjacent to the periphery of the flexible adhesive bottom layer and facing the first tissue region. May be substantially converted to

  The flexible adhesive bottom layer may include a hydrophilic adhesive material. The hydrophilic adhesive material may comprise one or more of a hydrocolloid, a hydrogel, an acrylic polymer, or poly (ethylene glycol).

  The top layer may comprise one of rubber, latex, urethane, polyurethane, silicone, thermoplastic elastomer (TPE), woven fabric, or spun fabric.

  The flexible adhesive bottom layer may comprise first and second adhesive bottom layers. The intermediate layer may comprise a first upper layer bonded to the first adhesive bottom layer and a second upper layer bonded to the second adhesive bottom layer. The top layer includes a plurality of axial support structures and an axial support structure for fastening the first adhesive bottom layer and the first top layer to the second adhesive bottom layer and the second top layer. An arrangement with a plurality of side closure components coupled may be provided. The plurality of axial support structures and the plurality of closure components are responsive to an incision and an axial extension of surrounding tissue in which one or more of the lower adhesive layers or intermediate layers are covered by the incision closure device. In part, they may be coupled together to form a serpentine pattern in order to be able to extend in the axial direction of the closure device. The plurality of axial support structures and the plurality of side closure components may be coupled together to form a ladder pattern. One or more of the plurality of axial support structures or the plurality of side closure components may be formed from a flexible inextensible material. The plurality of lateral closure components may include one of the first or second adhesive bottom layer and the first or second top layer after the flexible adhesive bottom layer is adhered to the tissue on both sides of the incision. You may comprise so that the above inner edge may be pulled together. One or more of the side closure components may comprise a left end, a right end, and a tether that is securely coupled to the left or right end and adjustably attached to the opposite end. One or more of the plurality of axial support structures or the plurality of side closure components may be embedded in or laminated to the first and second upper layers.

  This aspect of the invention may also provide a system for closing an incision in tissue. The system includes an incision closure device and a flexible cover for covering the incision closure device and the covered incision and surrounding tissue.

  The flexible cover may be configured to extend over the side and axial edges of the flexible adhesive bottom layer. The cover has one or more perforations that allow the cover to extend at least partially in the axial direction of the cover in response to the incision covered by the incision closure device and the axial extension of the surrounding tissue. You may have. One or more perforations may be disposed along a central axial line of the cover. The cover may comprise one or more reinforcing members that are coupled to at least a portion of the adhesive layer of the cover. The reinforcing member may include one or more of rubber, latex, urethane, polyurethane, silicone, thermoplastic elastomer (TPE), woven fabric, or spun fabric. The cover may include a hydrophilic adhesive layer. The hydrophilic adhesive layer may comprise one or more of a hydrocolloid, hydrogel, acrylic polymer, or poly (ethylene glycol).

  In another further aspect of the invention, an incision closure device is provided. The incision closure device may comprise a lower part having a first elasticity, an upper part having a second elasticity less than the first elasticity, and an elastic gradient between the lower part and the upper part. . The elastic gradient provides sufficient rigidity to the incision closure device so that movement of the tissue adjacent to the side of the instrument does not substantially spread the covered incision and surrounding tissue when covering the incision and surrounding tissue. May be provided. The elastic gradient provides sufficient resilience to the incision closure instrument so that, when covering the incision and surrounding tissue, bulging and adhesive loss due to movement of tissue adjacent to the side of the instrument is minimized. Also good.

  In another further aspect of the invention, an incision closure device is provided. The incision closure device may include a base including a left panel and a right panel, a left and right force distribution structure, and a plurality of closure components. Each panel may have a tissue adhesive lower surface, an upper surface, a first side edge, and a second side edge. The left and right force distribution structures may be coupled to the left and right panels, respectively. Each force distribution structure is such that the axial extension of the panel along one of the first or second side edges limits the side extension across the panel and the axial extension along the opposite side edge. May be adapted to enable. The plurality of closure components may be secured to the left and right panels and pull the panels together after the panels are adhered to the tissue and incision created therebetween.

  The first side edge of each panel may comprise the inner edge of each panel. The inner edges of each panel may face each other.

  The second side edge of each panel may comprise the outer edge of each panel. The outer edges of each panel may face away from each other.

  One or more of the left and right panels of the base may include an elastic matrix. The elastic matrix may comprise an elastomeric membrane, woven fabric, or spun fabric. The elastic matrix may comprise a fabric woven from elastic elements and having inelastic elements extending laterally along and across the first or second lateral edge.

  Each force distribution structure is disposed axially adjacent to the first side edge of the panel, and is disposed laterally and extends from the back toward the first side edge of the panel. A plurality of axially spaced side supports may be provided. The back and side supports may be formed from a flexible, non-stretchable material. The force distribution structure may be embedded in or laminated to the upper surface of each panel.

  The closure component may comprise a right engagement member, a left engagement member, and a plurality of side struts that hold the engagement member laterally apart by a predetermined distance. The right engagement member may be removably adapted to the right panel support and the left engagement member may be removably adapted to the left panel support. At least some of the supports may have anti-slip devices near one or more of the first or second side edges, and the engagement member has a slot that receives the anti-slip device May be. The side struts may be adjustably connected to at least one of the engagement members to provide a predetermined distance adjustment. The closure component may comprise a plurality of independent side ties attached to at least some of the side supports. The side tie material may be configured to be secured between the side supports. Each independent side tie may have one end fixed to the panel and a second end adjustably attached to the other panel. The second end may comprise a ratchet tightening mechanism.

  The incision closure device may further comprise an anchoring layer adapted to be placed over the assembly after the base and closure component assembly is anchored over the incision on the patient's skin. . The anchoring layer may have an inner self-adhesive surface.

FIG. 1 is an exploded view of an incision closure device constructed in accordance with the principles of the present invention. FIG. 2 is a top view of the base and force distribution structure assembly that is part of the incision closure device. FIG. 3 is a cross-sectional view taken along line 3-3 of FIG. 4-7 illustrate the use of the incision closure device of the present invention to make and close an incision in the patient's skin. 4-7 illustrate the use of the incision closure device of the present invention to make and close an incision in the patient's skin. 4-7 illustrate the use of the incision closure device of the present invention to make and close an incision in the patient's skin. 4-7 illustrate the use of the incision closure device of the present invention to make and close an incision in the patient's skin. FIG. 8 illustrates an alternative construction of the closure component for the closure device of the present invention. FIG. 9 is an exploded view of a further embodiment of an incision closure device constructed in accordance with the principles of the present invention. FIG. 10 is an enlarged isometric view of the base and force distribution structure of the system of FIG. 11A and 11B illustrate an alternative lateral tie structure that can be used in the device of either FIG. 1 or FIG. FIG. 12 illustrates a sacrificial cover positioned over an incision closure device in accordance with the principles of the present invention. 13A-13E illustrate the principle of operation of the sacrificial cover illustrated in FIG. 12 when performing a method according to the present invention in conjunction with a surgical incision drape. 14A1-14A3 are perspective views of a further embodiment of an incision closure device constructed in accordance with the principles of the present invention. 14A1-14A3 are perspective views of a further embodiment of an incision closure device constructed in accordance with the principles of the present invention. 14A1-14A3 are perspective views of a further embodiment of an incision closure device constructed in accordance with the principles of the present invention. FIG. 14B is a top view of an incision closure device, similar to that of FIGS. 14A-14A3, placed on a subject's knee, in accordance with the present invention. FIG. 15A shows a schematic view of an incision closure device having a pulley system for laterally joining two adjacent base panels in accordance with the principles of the present invention. FIG. 15B shows a cross-sectional view of the incision closure device of FIG. 15A. FIG. 15C shows the incision closure device of FIG. 15A placed on a model knee in accordance with the present invention. FIG. 15D shows a schematic view of an incision closure device similar to that of FIG. 15A. 15E and 15F show various side tie assembly structures for use with the incision closure instrument of FIGS. 15A and 15D, respectively. 15E and 15F show various side tie assembly structures for use with the incision closure instrument of FIGS. 15A and 15D, respectively. Figures 16A-16D illustrate various locking mechanisms in accordance with the principles of the present invention. FIG. 17 illustrates a hinge mechanism for an incision closure device in accordance with the principles of the present invention. 18 is a top view of an incision closure device, similar to that of FIG. 14A, placed on a subject's knee, according to the present invention. FIG. 19 shows an incision closure device comprising individual pairs of base panel segments according to the present invention. FIG. 20A shows a perspective view of an incision closure device, similar to that of FIGS. 9 and 10, in accordance with the principles of the present invention. FIG. 20B shows an enlarged view of the side tie assembly of the incision closure device of FIG. 20A. FIG. 21 shows an exploded view of a portion of the incision closure device of FIG. FIG. 22A shows a perspective view of a cover for an incision closure device disclosed herein in accordance with the principles of the present invention. FIG. 22B shows an exploded view of the cover of FIG. 22A. FIG. 23A shows an exploded view of an incision closure instrument assembly comprising the incision closure instrument of FIG. 21 and the cover of FIG. 22A in accordance with the principles of the present invention. FIG. 23B shows a perspective view of the incision closure device assembly of FIG. 23A adhered onto the subject's skin. FIG. 23C shows a top view of the elastomer reinforcing layer of the cover of FIG. 22A. FIG. 24A shows a perspective view of the incision closure device assembly of FIG. 23A adhered onto the subject's skin in accordance with the principles of the present invention. FIG. 24B shows a cross-sectional schematic diagram of the incision closure device of FIG. FIGS. 25A-25C illustrate a method of applying the incision closure device assembly of FIG. 23A on a subject's skin in accordance with the principles of the present invention. FIGS. 26A-26E illustrate an embodiment of a cover for a wound dressing and incision closure device in accordance with the principles of the present invention. FIGS. 26A-26E illustrate an embodiment of a cover for a wound dressing and incision closure device in accordance with the principles of the present invention. FIGS. 26A-26E illustrate an embodiment of a cover for a wound dressing and incision closure device in accordance with the principles of the present invention. FIGS. 26A-26E illustrate an embodiment of a cover for a wound dressing and incision closure device in accordance with the principles of the present invention. FIGS. 26A-26E illustrate an embodiment of a cover for a wound dressing and incision closure device in accordance with the principles of the present invention. FIGS. 27A-27E illustrate an embodiment of a wound closure device having a pharmaceutical agent incorporated thereon in accordance with the principles of the present invention. FIGS. 27A-27E illustrate an embodiment of a wound closure device having a pharmaceutical agent incorporated thereon in accordance with the principles of the present invention. FIGS. 27A-27E illustrate an embodiment of a wound closure device having a pharmaceutical agent incorporated thereon in accordance with the principles of the present invention. FIGS. 27A-27E illustrate an embodiment of a wound closure device having a pharmaceutical agent incorporated thereon in accordance with the principles of the present invention. FIGS. 27A-27E illustrate an embodiment of a wound closure device having a pharmaceutical agent incorporated thereon in accordance with the principles of the present invention. 28A-28E illustrate an embodiment of a wound closure device cover having a pharmaceutical agent incorporated thereon in accordance with the principles of the present invention. 28A-28E illustrate an embodiment of a wound closure device cover having a pharmaceutical agent incorporated thereon in accordance with the principles of the present invention. 28A-28E illustrate an embodiment of a wound closure device cover having a pharmaceutical agent incorporated thereon in accordance with the principles of the present invention. 28A-28E illustrate an embodiment of a wound closure device cover having a pharmaceutical agent incorporated thereon in accordance with the principles of the present invention. 28A-28E illustrate an embodiment of a wound closure device cover having a pharmaceutical agent incorporated thereon in accordance with the principles of the present invention. FIG. 29 illustrates another sacrificial cover positioned over the incision closure device in accordance with the principles of the present invention.

(Detailed description of the invention)
The devices and methods of the present invention are used during both surgical procedure incisions and closures created in the patient's skin or other tissues during surgical procedures. As described later in this specification, the direction of incision defines both the “axial” and “lateral” directions, as those terms are used herein. Most incisions are made along a substantially straight line that defines the axial direction. The lateral direction is generally typically transverse to the axial direction, but is not necessarily perpendicular or perpendicular to the axial direction. Most incisions are generally linear, but in some cases the incision may be curved or have other geometric shapes. The term “axial” is then applied in the direction of the incision at any particular location, resulting in a lateral direction that may vary as well.

  1-3, the incision closure device 10 includes a base assembly 12 that includes a right panel 14 and a left panel 16. The right force distribution structure 18 is typically secured to the right panel 14 by laminating the force distribution structure on the upper surface of the panel, and the left force distribution structure 20 is also on the upper surface of the left panel 16. It is attached. The incision closure device further comprises a closure component 22 that is removably attachable to the right and left force distribution structures 18 and 20 to close the incision, as will be described in more detail below, With an optional anchoring layer 24 that is secured to the patient and can be placed over the combined base assembly 12 and closure component 22 after the incision is closed by pulling the panel together using the closure component. Completed.

  The closure component 22 is intended and adapted to pull the inner portions of the force distribution structures 18 and 20 inwardly toward each other and close the surgical incision formed therebetween. In the illustrated embodiment, a plurality of antiskid devices 26 are formed on the side supports 36 that are held axially by the backs 37 of the force distribution structures 18 and 20. The anti-slip device 26 is received in a slot 38 formed along the inner edge of the opposing engagement member 40 of the closure component 22. The counter-engagement member 40 is a lateral strut so that the engagement member is held at a fixed laterally spaced distance (in other embodiments, the spaced distance may be adjustable). 42 are held together. The slot 38 allows the slot to be pulled upward to the corresponding anti-slip device, preferably in the form of a flexible tab, to secure the closure component 22 over the force distribution structures 18 and 20. Formed on structure 44.

  The lower surface 32 of each panel 18 and 20 is typically coated with a pressure sensitive adhesive, which is initially coated with a protective layer 48 that can be peeled off just prior to use. In addition, a pull-off tab 50 or other similar structure may be used to remove the right and left panels 14 and 16 after the layer 48 has been removed, but prior to panel adhesion to the patient's skin or other tissue surface. It may be provided to hold together at a predetermined separation distance. The distance between the inner edge 28 of each panel 14 and 16 is such that when the tissue edge is closed by the closure component 22, it is typically joined precisely with some abduction. It is important that it be kept as close as possible to the target spacing.

  4-7, a protocol for both making an incision and subsequently closing the incision according to the principles of the present invention will now be described. Initially, the right and left panels 14 and 16 are placed on the patient's skin with the reference letter S, as shown in FIG. Panels 14 and 16 are first applied by tearing off protective layer 18 and placing the panel on tissue, after which tab 50 is removed, leaving an incision path 52 defined between inner edges 28. . The spacing of the inner edges 28 is selected to provide a fixed predetermined distance d1.

  Once the right and left panels 14 and 16 are in place, an incision I is formed in the space between the panels using a scalpel or other surgical ablation device CD as shown in FIG. Can be done.

  After the incision I is created, the surgical procedure is performed by opening the inner edge of the incision and, in turn, deforming the inner edges 28 of the right and left panels 14 and 16, as shown in FIG. May be. Since the innermost ends of the supports 36 are not connected, they are free to separate and allow the elastic matrices of the right and left panels 14 and 16 to expand, as is apparent in FIG. However, the remaining dimensional stability of the panel is retained by the side support 36 as well as the axial back 37 that does not stretch under the influence of the force applied by the extension that opens the incision.

  After the surgical procedure is complete, the closure component 22 is secured over the force distribution structures 18 and 20, as illustrated in FIG. In particular, the slot 38 in the tab-like structure 44 is engaged over the opposing anti-slip 26 to pull together the panel and the opposing edge of the tissue incision. By appropriately spacing the depth of the slot 38, the closure component 22 can be adjusted so that the panels 14 and 16 are joined together by a preselected distance d2. Typically, the distance d2 is such that the inner edges of the tissue can be joined and the tissue edges along the incision can be slightly abducted (bumped upward) to improve healing and reduce scarring. , Smaller than the initial separation d1.

  Optionally, as shown in FIG. 8, the closure component 22 ′ may include an engagement member 40 ′, one end of each side post 42 ′ being the distance between the inner edges of the opposing engagement member 40 ′. Are joined by an adjustable clasp or other mechanism 54 so that they can be adjusted to increase or decrease the distance d2 between them.

  An alternative embodiment 100 of the incision closure device of the present invention is illustrated in FIGS. The instrument 100 includes a base assembly 102 having a right panel 104 and a left panel 106. A positioning or alignment strip 108 is provided to secure the inner edges of each panel together, as best shown in FIG. 10, and after the panels are in place on the tissue surface, the user can remove the strip. An end tab 109 is included that allows the panels 104 and 106 to be pulled.

  The incision closure device 100 is further partially folded back to expose the underlying adhesive backing on the panel, allowing the end of the base assembly 102 to be adhered to tissue, while the base assembly's The remainder still includes a backing 110 that has an edge that can be covered by the backing. The anchoring layer 112, including the reinforcing frame 113, generally covers the right panel 104 and the left panel 106 after the base assembly 102 is closed over the incision, as described in connection with the previous embodiments. Provided for detention. Typically, a holding tray 114 is provided to maintain the instrument components together in a sterile condition where the tray 114 is covered by a conventional medical packaging cover.

  As illustrated in FIGS. 9 and 10, right force distribution structure 116 and left force distribution structure 118 are provided on the upper surface of right panel 104 and left panel 106, respectively. The right force distribution structure 116 includes a right axial back 120 and a plurality of side supports 122. Typically, the right axial back 120 is embedded in or laminated to the base strip 121, or comprises a meander or zigzag number. The serpentine axial back 120 may typically be formed from a flexible elastic plastic, typically a hard plastic, while the base strip 121 may include a polyurethane or similar plastic layer. The lower surface of the polyurethane layer can be coated with a hydrocolloid layer for tissue adhesion. The structure of the left force distribution structure 118 is identical and includes a left axial back portion 124, a left side support 126, and a left base strip 127.

  The incision closure device 100 includes a closure mechanism comprising a plurality of side tie assemblies 128, as shown in FIG. As best seen in FIG. 10, each side tie assembly 128 includes, at one end, a rod secured to the left support 126 and a ratchet mechanism 132 secured to the right support 122. Including. Each rod 130 is typically aligned with the axis associated with the left panel 106 so that the gap 129 between the right panel 104 and the left panel 106 remains open and an incision can be created therebetween. It will be. After the incision is created, each rod 130 is pulled over the associated ratchet 132 on the right panel 104. The series of ratchet rings on each rod is retracted into the associated ratchet mechanism 132 and the rod is then pulled laterally until the desired closure tension is applied to that point along the base assembly 102. . It is particularly advantageous that each of the side tie assemblies 128 can be individually adjusted to provide the desired closure tension along the length of the incision to be closed, across the tissue. Once the desired closure tension is provided along the entire incision, the anchoring layer 112 may be placed over the base assembly 102 to hold the instrument and tissue in place.

  11A and 11B, an alternative design for the side tie assembly 140 of the present invention is illustrated. These side tie assemblies 140 may be used in conjunction with either the incision closure device 10 or 100 described above. Each side tie assembly 140 includes a right force distribution structure 142 and a left force distribution structure 144. The right force distribution structure includes a right back 146 and a plurality of side supports 148. Although three are shown, it is understood that four, five, six, or more side supports may be included. The left force distribution structure 144 similarly includes a left back 150 and a plurality of left side supports 152. To provide closure, the right force distribution structure 142 includes a rod 154 that extends from the central side support 148. Typically, the rod 154 is joined to the support by a live or passive joint 158. A pull loop 156 is provided at the free end of the rod 154 and a plurality of ratchet teeth 162 are provided along the central section of the rod 154.

  The left force distribution structure 144 includes a ratchet mechanism 160 adapted to receive the teeth 162 on the rod 154 of the right force distribution structure. In this way, the rod 154 is lowered into the ratchet 160 and engages the teeth 162 so that the rod pulls the right and left force distribution structures 142 and 144 together to apply tension to the right and left panels. Can be pushed forward.

  As illustrated in FIG. 12, a further aspect of the present invention is illustrated. The incision closure device 100 is schematically illustrated, but only the right and left panels 104 and 106 and the right and left force distribution structures 116 and 118 are illustrated. The remaining system components are not shown for ease of illustration.

  The right panel 104 is covered with a right sacrificial cover 170, and the left panel 106 is covered with a left sacrificial cover 172. The right and left panels 104 and 106 may define a region 175 where the right and left sacrificial covers 170 and 172 are separate from the right and left panels 104 and 106. Each cover 170 and 172 extends along each edge of the associated base panel so that the cover remains in place while normal handling of the incision closure instrument 100 and it is placed over the tissue surface to be incised. And is detachably fixed. The use and purpose of these sacrificial covers 170 and 172 will be described with reference to FIGS. 13A and 13E.

FIG. 13A illustrates the right and left panels 104 and 106 in place on the tissue surface T prior to incision generation. The right panel 104 is covered with a right sacrificial cover 170, and the left panel 106 is covered with a left sacrificial cover 172. An adhesive surgical incision drape 180 is placed over the tissue surface T as is common in many surgical procedures. Any conventional drape may be used, such as the Ioban ^™ antimicrobial incise drape available from 3M (St. Paul, Minnesota).

  Once the incision drape 180 is in place over the incision closure instrument, a surgical incision I may be created to perform the desired surgical intervention. As can be seen, incision I cuts through surgical drape 180 between right and left panels 104 and 106, respectively. After the surgical procedure is completed, the surgical drape 180 is removed from the tissue surface T. Since surgical drapes had a lower adhesive surface prior to the present invention, removal of the drape could displace either or both of the right panel 104 and the left panel 106. However, the presence of sacrificial layers 170 and 172 prevents such displacement. Removal of the surgical drape 180 removes the sacrificial layers 170 and 172, but each of these layers is configured to break with relatively low separation forces, so removal of the sacrificial layer can be accomplished with an underlying panel. 104 or 106 is not displaced. Thus, the panels 104 and 106 are left in place, as shown in FIG. 13D, and the force distribution structures 116 and 118 are used to close the panels together and close the incision, as shown in FIG. 13E. Can be used as described above.

  Referring to FIG. 29, the right and left sacrificial cover layers 170 and 172 may each be constructed from a thin sheet of urethane (eg, 0.001 inch thick). The center of the urethane sheet may be glued to the top of the right and left panels 104 and 106, along with the force distribution structures 116, 118 and optional straps 130 and locks 132 assembled to the top of the urethane sheet. The urethane sheet may then be wrapped around the force distribution structures 116, 118 with the free end of the urethane laminated together along its length (and the strap 130 is contained over the panel 106). As may be bent inward as shown in FIG. 29). Accordingly, the urethane sheet may wrap around the force distribution structures 116, 118 and the closure elements 130, 132 to protect them from the surgical drape 180. The urethane sheet may preferably comprise a plurality of perforations arranged along its length and aligned adjacent to the inner and outer edges 104e, 106e of each panel 104,106. The perforations may allow the urethane sheet to rupture with the surgical drape 180 in a controlled manner once the surgical drape, eg, the surgical drape 180 described herein, is removed. . The perforations may preferably be constructed from 3 mm cuts and 1 mm tethers, but the exact dimensions may be varied to control the desired tear force. The perforations may be formed along a single longitudinal line or multiple lines. The plurality of longitudinal perforations can allow reliable separation despite variations in the surgical drape adhering to the sacrificial layers 170, 172. The perforations are made to peel more easily near the edges of the panels 104, 106, improving the likelihood of separation near the edges 104e, 106e of the panels 104, 106 and minimizing excess urethane remaining Can help to. To assist in lifting the sacrificial layers 170, 172, tabs 170t, 172t may be bonded to each end of the urethane wrap including the sacrificial layers 170, 172. The tabs 170t and 172t may preferably be bonded to the inside of the upper surface of the urethane winding portion. The tabs 170t, 172t may be shaped to prevent adhesion of the urethane to any exposed adhesive itself or from the end of each panel 104,106. Pre-breaking of the perforations at the end of each panel 104, 106 can assist in the initial lifting of the tabs 170t, 172t and initiation of tearing by the user.

  Referring now to FIGS. 14A1-14A3, a further embodiment of an incision closure device is illustrated. Base assemblies 1400a (FIG. 14A1), 1400b (FIG. 14A2), and 1400c (FIG. 14A3) may each include a right base panel 1402 and a left base panel 1404. The right base panel 1402 may include an upper layer 1406 and a lower layer 1408. Similarly, the left base panel 1404 may include an upper layer 1410 and a lower layer 1412. The top layers 1406, 1410 are typically flexible but sufficiently rigid to tightly close the tissue and minimize incision and division of surrounding tissue. The upper layers 1406, 1410 may comprise a plastic layer made from rubber, latex, polyurethane, silicone, thermoplastic elastomer, woven fabric, spun fabric, or similar materials. The adhesive bottom layer 1408, 1412 is typically flexible and more elastic than the top layer 1406, 1410 to follow any movement of the underlying skin and tissue and maintain adhesion, It will minimize blistering and otherwise reduce inflammation. Adhesive bottom layer 1408, 1412 may include hydrophilic adhesive materials such as hydrocolloids, hydrogels, acrylic polymers, poly (ethylene glycol), and the like.

  The right and left base panels 1402, 1404 may comprise structures to promote and limit the axial and lateral extension of the base assembly 1400. These structures may also distribute the closing force applied to the incision uniformly and may be disposed on the base assemblies 1400a, 1400b, and 1400c along their axial length. The right base panel 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 back 1414a and two side support portions 1414b coupled to the axial end of the back 1414a. Together, the back 1414a and the two side support portions 1414b are adjacent supports in some embodiments while limiting the axial extension between the two side support portions 1414b of the single support 1414. 14- 14 forms a C-shape that can be opened axially to the extent that it promotes axial extension of the right base panel 1402 between the lateral support portions 1414b adjacent to the two sides. In many embodiments, the C-shaped axial support 1414 is sufficiently flexible to only allow vertical flexing but is rigid to minimize axial and lateral extension. . As shown in FIG. 14A1, the right axial support 1414 may face inward. As shown in FIGS. 14A2 and 14A3, the right axial support 1414 may face outward, which is optional for tissue closure to the incision I between the right and left base panels 1402, 1404. Can help to distribute the mechanical load of Similarly, the left base panel 1404 may include one or more left force distribution structures or axial supports 1416. Each left axial support 1416 may comprise an axial support portion or back 1416a and two side support portions 1416b coupled to the axial ends of the back 1416a. Together, the back 1416a and the two side support portions 1416b, in some embodiments, are adjacent supports while limiting the axial extension between the two side support portions 1416b of the single support 1416. 1416 forms a C-shape that can be opened axially to the extent that it promotes axial extension of the left base panel 1402 between the lateral support portions 1416b adjacent to the two sides. In many embodiments, the C-shaped axial support 1416 is sufficiently flexible to allow vertical flexing but is rigid to minimize axial and lateral extension. . As shown in FIG. 14A1, the left axial support 1416 may face inward. As shown in FIGS. 14A2 and 14A3, the left axial support 1416 may face outward, which is an optional machine for tissue closure to the incision I between the right and left base panels 1402, 1404. Can help to distribute the dynamic load.

  As shown in FIG. 14A3, the base panel assembly 1400c may further comprise skirts 1424 and 1426. Skirts 1424, 1426 may be similar to the thin base assembly cover described below. For example, each skirt 1424, 1426 may comprise a 0.001 inch thick urethane film bonded to a 0.002 inch thick acrylic adhesive. The adhesive may be applied to the entire lower surface of the skirt 1424, 1426, or may be applied only to the area of the skirt 1424, 1426 beyond the base panel 1402 or 1404. During construction of the base panel assembly 1400c, the skirts 1424, 1426 may be applied directly over all or part of the adhesive layers 1408, 1412, respectively. Skirts 1424, 1426 may be applied instead of or in addition to the thin film upper layers 1406, 1410, respectively. A release liner as described herein may further be provided to line the adhesive lower surface of the skirts 1424, 1426. The skirts 1424, 1426 may extend beyond the outer boundary of the base panels 1402, 1404, respectively, for example, by 8 mm or in the range of 1-20 mm, respectively, but visualize and / or clean the incision site In order to improve the ability to do so, it does not spread across the lateral area between the base panels 1402, 1404. Accordingly, the skirts 1424, 1426 provide additional adhesive support and adhesive layers to the adhesive layers 1408, 1412 of the base panels 1402, 1404 without the need for a separate cover or cover sheet to be aligned and placed so as to cover the base panel assembly 1400. It may help to provide creep reduction. After manufacture, the skirts 1424, 1426 are typically already precisely aligned with the base panels 1402, 1404. A separate cover or cover sheet as described herein may still be used to prevent tampering of the incision site and components of the base panel assembly 1400c. Since the skirts 1424, 1426 already extend laterally over the base panels 1402, 1404, such separate covers or cover sheets may not require precise placement with respect to the base panel assembly 1400c. Well, it can be narrower compared to other covers or cover sheets described herein.

  One or more perforations 1418 may be provided between axially adjacent right axial supports 1414 on the right panel 1402 to facilitate axial and / or lateral extension of the right base panel 1402. All perforations 1418 may penetrate the upper and lower layers 1406, 1408 to provide ventilation to the underlying tissue, or may be present only on the upper layer 1406. Similarly, one or more perforations 1420 may be provided between axially adjacent left axial supports 1416 on the left panel 1404 to facilitate axial and / or lateral extension of the base panel 1402. . All perforations 1420 may penetrate the upper and lower layers 1410, 1412 to provide ventilation to the underlying tissue or may be present only on the upper layer 1410. As shown in FIG. 14A1, there may be only a single perforation 1418 or 1420 between the axial supports 1414 or 1418. As shown in FIGS. 14A2 and 14A3, there may be a plurality of perforations 1418 or 1420 in the lateral line between the axial supports 1414 or 1418. The perforations 1418, 1420 may also reduce stress experienced as the skin extends radially outward from the incision I, such as during articulation and bulging.

  A plurality of perforations 1418, 1420 may be provided between the axial ends of the right and / or left axial supports 1414, 1416, eg, along the right and left lines 1424, 1426 shown in FIG. 14B. . The plurality of axially aligned perforations divide into separate segments, at least when the upper and lower layers 1410, 1412, respectively, of the base panels 1402, 1404 are extended axially as further described below. As may be provided on each line segment 1424 or 1426. In some cases, during the wearing duration of device 1400, perforations 1418, 1420 are perforated lines where layers 1406 and 1408 of right panel 1402 and layers 1410 and 1412 of left panel 1404 are shown in FIGS. 14A2 and 14A3. It may be possible to completely divide and separate. The ability to fully divide and separate further, as the skin is enabled (and limited) by the coupling of axial supports 1414 and 1416 and closure component 1422 discussed below, If necessary, it can be extended in the axial direction. As discussed herein, a flexible extensible cover may be applied over the base panels 1402, 1404 after the incision I is closed. The cover may further serve to provide (and limit) axial and lateral movement of the base structure 1400b. Alternatively or in combination, one or more of the right or left base panels 1402, 1404 can be laterally cut and separated between force distribution structures or axial supports 1414, 1416 to provide right and / or left base panels. The axial and / or lateral extension of 1402, 1404 may be facilitated.

  In order to join the right and left base panels 1402, 1404 together laterally and optionally tighten the right and left base panels 1402, 1404, the base assembly 1400 further includes a plurality of side closure components. Alternatively, a tether assembly 1422 may be provided. The side closure component or tie assembly 1422 may include a ratchet mechanism similar to that of the side tie assemblies 128 and 140 described above. The side tie assembly 1422 may typically join together laterally adjacent right and left axial supports 1414, 1416 at its axial ends. As shown in FIGS. 14A1-14A3, the placement of the right and left axial supports 1414, 1416 on the right and left panels 1402, 1404, respectively, may be offset or offset axially, And left axial supports 1414, 1416 are laterally facing and aligned with each other (and connected to each other by lateral tie assemblies 1422), with side end portions 1414b, 1416b, C It may be a shape structure. For example, the far end side portion 1414b of the first right axial support 1414 may be laterally aligned with the near end side portion 1416b of the first left axial support 1416, and the first left The far end side portion 1416b of the axial support 1416 may be laterally aligned with the near end side portion 1414b of the second right axial support 1414, and so on. Accordingly, the side tie assembly 1422 and the right and left axial supports 1414, 1416 are connected together to form a line of the continuous side tie assembly 1422 and the right and left axial supports 1414, 1416. The main line extends to the sides of the right and left base panels 1402, 1404 (ie, traverses the distance between the right and left base panels 1402, 1404), as shown in FIGS. 14A1-14A3. You may have. The serpentine arrangement of the side tie assembly 1422 and the right and left axial supports 1414, 1416 distributes the closure force provided by the base assembly 1400 evenly over the incision, the axial flexibility of the base assembly 1400. (And provide lateral and axial stability) that allow (and restrict) and close the incision sufficiently to heal with minimal disruption and expansion One or more of providing rigidity or rigidity to the base assemblies 1400a, 1400b, and 1400c may be performed. In many embodiments, the side supports 1414, 1416 are rigid so that the area of the base panel 1402, 1404 that is not covered by the side supports 1414, 1416 extends. These uncovered areas are offset from each other from the right base panel 1402 to the left base panel 1404 so that the tether assembly 1422 is axially removed from its anchor point as the incision I is extended axially. You may pivot. Such axial pivoting of the tether assembly 1422 may bring the left and right panels 1402, 1404 closer together and maintain the incision I closed.

  The material of the side tie assembly 1422 and the right and left axial supports 1414, 1416 can be, for example, flexible elastic plastics, typically nylon, polypropylene, polyethylene, polycarbonate, and other thermoplastic polymers. The hard plastic may be included. In many cases, the side tie assembly 1422 and the right and left axial supports 1414, 1416 may comprise materials that are not as elastic as those of the right and left base panels 1402, 1404. Thus, as with many other base assemblies of the incision closure devices disclosed herein, greater stiffness (and lower elasticity) is directed toward the top of the base assemblies 1400a, 1400b, and 1400c. May be provided. In other words, there may be an elastic gradient between the top and bottom of the base assemblies 1400a, 1400b, and 1400c. The top of the base assemblies 1400a, 1400b, and 1400c allows the movement of tissue adjacent to the side of the instrument to be substantially covered by the incision and surroundings when the incision closure instrument is applied to the incision and surrounding tissue. It may be sufficiently rigid or rigid to prevent the tissue from expanding. That is, movement of at least a portion of the applied incision closure device (eg, the lower portion of the stiffer layer) is collective and does not disrupt the underlying incision. Also, the bottom of the base assemblies 1400a, 1400b, and 1400c may be sufficiently elastic so that bulging and adhesive loss due to movement of tissue adjacent to the applied incision closure device is minimized. . Although the primary function of the side tie assembly 1422 may be to apply tension to each base panel 1402, 1404 and hold the incision I closed, in many embodiments the side tie assembly 1422 is Also, column strength to isolate the incision I by minimizing the impact of compression (or flexion / creep along it) on the incision I from the opening force that can disrupt the incision edge alignment and juxtaposition. It may play a role to provide. The axial spacing, material properties, and dimensions of the side tie 1422 may be optimized for sufficient axial bending flexibility and lateral compression and bending support. In a preferred embodiment, the spacing between the tethers 1422 is 10 mm and the tether 1422 is made of nylon and has a circular cross section of 0.030 inches in size.

  Referring now to FIG. 14B, the base assembly 1400b may be placed over an incision in a patient's skin, such as a knee, or a subject's joint. With articulating joints, especially incisions placed close to the knee, the closure device or closure instrument integrity is often difficult due to several factors. These factors include longitudinal stretching, circumferential bulging, wound opening as articulation occurs, skin damage such as swelling, loss of adhesion, and passage of wound exudate. Joints such as knees, elbows, ankles, and shoulders can sometimes undergo movement that results in articulations that encompass movements of more than 135 ° and can lead to the aforementioned challenges.

  In the flexed position, the skin around the knee can stretch up to 50% axially (ie, parallel to the incision) and laterally (ie, across or perpendicular to the incision). An incision closure device that adheres to the skin within this area preferably closes the incision but may be capable of providing sufficient tension to accommodate extension with minimal local stress. Minimizing local stress may prevent local skin adhesion loss or damage to the skin if no adhesion loss occurs. An important property for many incision closure devices disclosed herein is the ability of the device's closure element tensile load to be distributed across an area larger than that of the tension element attachment point itself. In addition, the adhesive-containing structure to which the tensile element is attached often crosses the area of skin extension so that the instrument holds the incision in place while the skin moves around it. It may have the ability to disperse the extensibility of the structure. Embodiments described herein may include a composite design of non-extension tension elements (commonly referred to as “straps”) that are coupled to “locks” that hold the straps in place. . For example, such elements may include the aforementioned side tie assemblies 128, 140, and 1422. These elements may be mounted across the skin adhesive with an elastic polymeric material that helps to distribute the tensile load. Such elastomeric polymers often can have high extensibility before buckling or permanently deforming and may include thermoplastic elastomers such as polyurethane as well as various grades of silicone. Such materials can also be easily formed into thin films necessary to maintain a low profile and sufficient extensibility.

  The skin adhesive used in the device may also need to be able to withstand skin stretch and be retractable / recoiled when the skin returns to a non-stretched state (eg, a fully extended knee position). . Hydrocolloid adhesives can provide such properties and are preferably suitable for this application. Other adhesives such as acrylic may also be used to provide this property. In general, such an adhesive may need to be attached to an elastic membrane such as those described above in order to retain its structure during expansion and recoil. In the absence of such a support, the adhesive can tear and separate with repeated stretching.

  An incision closure device constructed as a series of short segments can accommodate higher overall extensibility if there is no loss of adhesion or skin damage. Each individual segment can undergo a local extension of the underlying skin. The space between two adjacent segments may act as a stress relaxation space and allow the skin to stretch within that space. Segmentation (1) lays individual segments along the incision line, or (2) allows the device to break into short segments as applied to the skin or after application to the skin May be achieved in several ways.

  A preferred means of achieving segmentation after application to the skin, as described above, is the perforation (eg, the side line of the perforation to promote tearing) with a polyurethane layer (ie, the top layer 1406 of the base panels 1402, 1404). 1410) and leaving the underlying adhesive intact as shown in FIG. 14B. The perforations, when subjected to extension as the knee flexes (ie, articulates), at least along the perforation lines (eg, lines 1424, 1426), at least the upper layer (eg, upper layers 1406, 1410) of the base panel. Can result in tears. In a preferred embodiment, the adhesive panels on each side of the incision may be 12 mm wide, and the perforations in a given panel are about 12-20 mm apart. Experiments have been performed and it has been shown that perforations with a 3 mm cut and 1 mm tether distance are effective in achieving segmentation in a 0.001 inch thick urethane base panel when the knee flexes. As the knee flexes, the skin may stretch up to 50% axially (along the incision) and laterally in some places. Polyurethane separation can therefore relieve stress in the device as it undergoes extension.

  As an example, a surgically repaired knee can be inflamed, which can result in approximately 30% radial bulging of the joint after closure for several days. A resilient material such as polyurethane may allow the incision closure device (eg, including base assembly 1400b bonded to the resulting incision I in FIG. 14B) to expand with this circumferential bulge. Minimizing the instrument width (eg, 12 mm or less for each base panel segment 1402, 1404) can minimize the amount that the instrument undergoes expansion in a direction perpendicular to the incision I, and thus Adhesion can be preserved while minimizing the potential for skin damage. FIG. 14B shows a perforation in the adhesive segment that extends laterally with respect to the incision along lines 1424, 1426, allowing easier axial extension. Perforations or other fenestrations are also located near the outer edge of the adhesive segment parallel to the incision to reduce the stress experienced as the skin extends radially outward from the incision, such as during articulation and bulging. Can be made.

  Referring now to FIGS. 15A-15D, the incision can often experience forces that tend to open the incision due to flexion of the knee or other joint. In many embodiments, the incision closure device includes a locking mechanism that counteracts the opening force by closing tightly during flexing and helping to keep the incision closed. FIGS. 15A and 15B show an incision closure instrument base assembly 1500 that utilizes a pulley effect, i.e., a mechanism that reduces the distance between the locking points on both sides of the incision as the skin extends along the incision. In a preferred embodiment, the adhesive panels 1510a, 1510b on either side of the incision between the base panel 1510a, 1510b pair are 12 mm wide, and the linear perforations 1530 in a given panel 1510 are about 18 mm apart. Typically, all members of the locking mechanism do not extend. The triangle formed by anchor 1540, pulley 1520, locking portion 1550, and flexible locking element 1580 (eg, tether or strap) is a base B that is axially along the incision, as shown in FIG. 15C. And its height H across the incision laterally. As the knee flexes, the triangle base length increases. Typically, all triangular members do not extend, which requires that the height must be reduced to maintain the length of the individual elements that connect between any two points. And provides additional closing force across the incision. 15A and 15B further illustrate that the lower surface of the base panels 1510a, 1510b may include a hydrocolloid adhesive 1560, with one of the panels 1510a or 1510b being a locking arm for locking the strap 1580 in place. 1570 may be provided. Although the triangular base is shown in FIG. 15A on the left base panel 1510b, it is also contemplated that the triangular base may instead be on the right base panel 1510a.

  A triangle is formed by anchor 1540, pulley 1520, locking portion 1550, and flexible locking element 1580, but other shapes are also contemplated. For example, the pulley 1520 may be wound around two anchors 1540 to form a square or rectangular shape, or the pulley 1520 may be wound around three or more anchors 1540 to form a trapezoidal shape. May be formed. Referring to FIG. 15D, a base assembly 1500a of an incision closure instrument similar to the base assembly 1500 is shown. In the base panel 1500a, the anchor 1540, the two pulleys 1520, the locking portion 1550, and the flexible locking element 1580 form a rectangle and provide additional closure to the incision I when the underlying skin is extended. . In the rectangular configuration shown in FIG. 15D, the spacing between the two fixation points on either side of the incision I is typically the same. On the other hand, in the triangular configuration shown in FIGS. 15A and 15C, the fixed point on the pulley 1520 side may be further spaced from the other side of the incision I. Although the rectangle is shown as being “open” on the left base panel 1510b, it is also contemplated that the rectangle may instead be “open” on the right base panel 1510a.

  In the incision closure instrument base assemblies 1400a, 1400b, and 1400c shown in FIGS. 14A1-14A3 and others described herein, the individual straps 1422 engage individual locks on the opposite side of the incision I. May be used as well. 15A-15D, each flexible locking element or strap 1580 is typically anchored on one side of incision I and wrapped around the other side, and then the location of anchor 1540 and incision I's Engages with the locking portion 1550 on the same side. In the embodiment illustrated by FIG. 15D, the flexible locking element or strap 1580 is moved to the two locking spools (bobbin / pulley 1520 on the other side of the incision I before engaging the locking portion 1550 on the same side. ) A spool 1520 around which a flexible strap 1580 is wound is preferably coupled with a rigid member so that the distance between them does not increase when the closure device base panel assembly 1500 extends axially. May be. In an alternative embodiment, it may be desirable to allow expansion between pulleys or spools 1520. It is noted that the flexible locking element 1580 may be anchored in one base panel segment while remaining locked in adjacent segments separated by perforations 1530 in the base panel 1510a or 1510b. I want. Such anchoring and locking can create a connection between the three segments of the base strip (two on the same side and one on the other side). When assembled together across the length of the incision closure device or base assembly 1500 or 1500a, the attachment mechanism forms a continuous “S” shaped (ie, serpentine) connection across the incision I.

  A tensioned flexible connector 1580 that wraps around a spindle, spool, or pulley 1520 allows the release force to attempt to open the incision and cause excess compression of the incision I when the underlying skin undergoes extension. May be configured to provide. The flexible strap 1580, in some cases, potentially slides away from the spindle 1520 and the two base panels 1510a are further squeezed by external forces that are mated together without any extension of the underlying skin. Can relax. To prevent such slippage from occurring, a flexible wrapping member 1580 may be slidably included or anchored within an element 1590 anchored on the base strip 1510a. it can. FIGS. 15E and 15F show a flexible element 1580 that is threaded through tube 1590 and in turn attached or anchored to base panel 1510a. When the base panels 1510a, 1510b are closer together, the flexible strap element 1580 is still captured and continues to provide the necessary closure function. In other embodiments, the spool feature 1590 shown in FIGS. 15E and 15F may have a hole through the center through which the trap 1590 slides. Flexible strap 1580 and element 1590 that slides therethrough may preferably be designed to minimize friction between elements 1580 and 1590.

  Experiments were performed and the base B was 12 mm and the height H was determined by the distance between the strap connection points on the two base panels 1510a, 1510b after the incision was closed (typically About 16 mm), bending of the device 1500 on the human knee was shown to result in a 5% reduction in height H within the area where the elongation of the skin S was maximal. Note that the reduction in height may depend on several factors, such as the triangular base, the level of underlying skin stretch, and the distance between the two bases on either side of the incision. The “strap” connecting between anchor 1540 and locking portion 1550 may need to be at least partially flexible to allow looping around the pulley. In a preferred embodiment, the monofilament plastic thread is integrated with a feature that engages in a locking mechanism. Such a feature may be a rounded “tooth” that engages in a ratchet-like mechanism in the lock. Such plastics can be used to achieve the desired flexibility, longitudinal stiffness, low bacterial habitability and allow extrusion and / or injection molding processes. Braided sutures (preferably coated to limit bacterial residence) can also be used to create flexible but non-extensible connectors. Rounded wires or tubing made from a flexible material such as silicone can also be used to achieve flexibility. The pulley strap can be a composite of materials such as molded plastic and braided suture. In other embodiments, the pulley strap can be formed by necking the molded strap. Pulling the molded strap beyond its buckling point can permanently reduce the cross-section of the strap and make it more flexible when stretched. Heat can be used in the necking process to help reduce elongation and cross-sectional area. The alternative mechanism shown in FIGS. 16A-16B can be used to lock strap materials such as sutures and softer plastics once the desired closure is achieved. FIG. 16A shows a locking mechanism comprising a slot 1610 for sliding and an anchoring frame 1620. FIG. 16B shows a locking mechanism with locking teeth 1630. FIG. 16C shows a locking mechanism comprising a slot 1640 for sliding and an anchoring frame 1650. FIG. 16D shows a locking mechanism comprising a cylindrical tube 1660 and locking teeth 1670.

  When the knee flexes, additional closing force across the incision may be achieved by using a hinge mechanism 1700, as shown in FIG. As shown in FIG. 17, four points on either side of the incision (two anchor points 1720 on either side of the incision closure instrument or on the base panel 1710) are used in the shape of X using the hinge provided at the intersection 1740. The non-extending arm 1730 may be connected. As the knee flexes and the distance between two points on the same side of the incision increases, the distance between the segments on both sides of the incision can decrease, resulting in additional closing force. As shown in FIG. 17, the base panel 1710 may also include a plurality of perforations 1750 to facilitate axial extension relative to the base panel 1710 or its separation into discrete segments in response to axial extension.

  As shown in FIG. 18, according to many embodiments, the strap and locking portion of the incision closure instrument 1800 form an S-shape or serpentine connection or array across the entire length of the incision I on the knee skin S. Can be configured to. The incision closure device 1800 may be similar in many respects to the incision closure device 1400 described above. Segments 1810a, 1810b of device 1800 are connected to each other by connecting each segment 1810a on one side of incision I and two adjacent segments 1810b on the opposite side of the incision. This may be accomplished by mounting a pair of straps 1820 in each segment 1810a and a pair of locking portions 1830 on the corresponding segment 1810b on the other side. Each pair of locking portions 1830 and straps 1820 may be connected to each other. During closure of the wound or incision I, one of the straps 1820 (eg, strap 1820a) of the base panel segment 1810a (eg, 1810a1) is engaged with a locking portion on the other segment 1810b (eg, segment 1810b1) of the incision I. 1830 (eg, 1830a) and the second strap 1820 (eg, strap 1820b) is connected to the segment 1810b (eg, 1810b1) to which the previous pair of straps 1820 (eg, strap 1820a) is connected. It may be connected to a locking portion 1830 (eg, 1830b) in the segment 1810 (eg, segment 1810b2) opposite the adjacent incision I. The foregoing connection forms a single loop of S-shaped or serpentine arrangement of base panel segment 1810, strap 1820, and locking portion 1830. Perforation line 1850 may separate axially adjacent base panel segments 1810a and 1810b. Perforation lines 1850 on one side (eg, with base panel segment 1810a) may alternate with perforation lines 1850 on the other side (eg, with base panel segment 1810b). Similar to FIG. 15A, in a preferred embodiment, the adhesive panels on both sides of the incision may be 12 mm wide and the perforations in a given panel may be spaced approximately 18 mm apart.

  An incision closure instrument or device as described herein may be applied in a number of ways. FIG. 19 illustrates an exemplary incision closure device 190, according to some embodiments. Here, individual base pair segments 1910 arranged in pairs may be provided on individual carrier / release liners. Each base panel segment 1910 pair comprises a strap 1920 and a lock 1930 that can be independently aligned with the incision and adhered to the skin adjacent to each other. Individual segments 1910 may be held together with the release liner and outer carrier tape 1950 together. The release liner 1950 may be removed to expose the adhesive, but the entire device 1900 or a grouped portion of the device 1900 may be coupled with an outer carrier tape. Depending on the application to the skin, the carrier tape 1950 may be removed and left with an adhesive segment 1910 that is aligned with each other but can move independently.

  Typically, the perforated segment of the base panel top layer, comprising polyurethane, is held with a continuous layer of adhesive bottom layer, typically containing a hydrocolloid adhesive, and onto the skin in one continuous motion. May be possible. The incision closure devices 1400, 1500, and 1800 of FIGS. 14A-14B, 15A-15C, and 18, respectively, may comprise such a continuous adhesive bottom layer.

  The base assembly or base panel of the incision closure device described herein may be coated with a flexible adhesive membrane material, preferably at the end of the wound or incision closure. This membrane area may preferably be larger than the base incision closure panel element so that the element rests on the skin. The membrane can help prevent movement of the base and can prevent any accidental movement of the anchor and locking mechanism. The cover membrane may be made from a stretchable material such as rubber, latex, polyurethane, silicone, or thermoplastic elastomer. In a preferred embodiment, a thin cover (eg, a laminate of 0.001 inch urethane and 0.002 inch thick acrylic adhesive) will have more flexibility than the composite structure of the base panel element. As a result, the cover can provide some strain relief between the exposed skin and the base segment. The cover may also be transparent to allow visual inspection of the incision. The cover may be completely sealed across the incision (eg, as a barrier to infection), or an opening in the cover that is aligned with the incision line and allows any exudate to pass from the wound May be present. The cover may also serve to improve the juxtaposition of the incision edges by bridging the base panel and adhering to the skin edges between the base strips. The cover may also be constructed with additional reinforcing elements that improve the tensile strength between the base panel elements but allow extensibility along the incision length. Preferred embodiments may comprise a series of polyethylene adhesive tape strips applied to the cover.

  The user may apply the cover after the base assembly and panel have been placed on the skin, but the cover material may also be supplied as a “skirt” that extends around the outer periphery of the base segment. Good is contemplated. Thus, the alignment of the cover material to the base may not depend on user placement. These identical cover materials limit the exposure of the hydrocolloid adhesive to the patient's garment, limit the migration of the hydrocolloid or other adhesive underlayer, and provide strain relief for tension on the base segment Etc. can be provided.

  In many embodiments, the hydrocolloid adhesive is used to pull the skin for incision closure. Hydrocolloids can either (1) use a laminate on the surface to limit creep, or (2) apply an adhesive cover across the skin and hydrocolloid adhesive to prevent creep and Creep may be prevented by one or more of providing strain relief and preventing skin damage.

  In many embodiments, a cover, such as used in conjunction with a base assembly, includes one or more perforations or openings and wound exudate (as well as any applied) without removal of the bonded base assembly. Removal of the bandage / absorbent material) may be possible.

  In many embodiments, the cover comprises a composite of flexible urethane and reinforced strip. The composite structure may provide strength across the incision and provide extensibility along the incision length.

  In many embodiments, the cover, in combination with the base assembly, aligns the skin incision edge or significantly prevents subsequent misalignment of the skin edge in both the axial and lateral directions.

  In many embodiments, a cover liner configuration is provided so that a portion of the cover can be first applied to the skin and then assists in the removal of other liners, thus with minimal wrinkle generation It can help to control the thin material so that it is evenly distributed.

  In many embodiments, removal of the first liner may allow visualization during placement and may prevent the rest of the device from sticking to the user.

  Referring back to FIGS. 9 and 10, two adhesive panels 104, 106 are applied to both sides of the surgical incision (either before or after the incision is made) in many preferred embodiments. A closure mechanism may be mounted on top of the adhesive panels 104, 106 and is preferably attached to the component 120 and may help distribute the closure force between the attachment points of the closure mechanism. As shown in FIGS. 9 and 10 and FIGS. 20A and 20B, the closure mechanism may include a strap 130 and a locking portion 132. The strap 130 may comprise an elongate component with engaging teeth. The locking part 132 may be provided with a feature for capturing the engaging teeth of the strap 130. The strap 130 can be clamped within the lock 132 and pull the adhesive panels 104, 106 (and thus the incision edge) together. The user may disengage the strap 130 and re-engage it in the lock 132 as needed to adjust the amount of skin closure appropriately. Together, the incision closure device illustrated in FIG. 20A may be described as a base or base assembly 102.

  The skin adhesive used for each panel 104, 106 may preferably include a hydrocolloid adhesive. Alternatively or in combination, the skin adhesive may comprise one of many acrylic formulations known in the art. Hydrocolloid adhesives can have the advantage of being very viscous and capable of adsorbing moisture and shed skin cells. Accordingly, hydrocolloid adhesives may be particularly suitable for long-term wear applications (eg, up to 14 days). In at least some cases, the hydrocolloid structure may be soft, however, the hydrocolloid adhesive layer is coated with a stiffer base panel 102, 104 or other coating structure disclosed herein. By doing so, it may tend to creep under tension unless it is reinforced in some manner.

  Thus, further aspects of the present invention also provide various means to reinforce and protect the adhesive layer within the base assembly of the incision closure device described herein, and hold the skin edges together, particularly in the axial direction. Provide additional means to: In at least some cases, the hydrocolloid adhesive alone has a very low tensile strength and may require means of reinforcement so as not to tear or cause creep during use. As illustrated in FIG. 21, the adhesive layer 211 used in the base panels 104, 106 has a potential range of up to 0.010 inch thick, preferably 0.001 inch thick urethane or the like. It may be laminated with a thin layer of extensible plastic or polymer 212, which can help maintain its structure during clinical use. The adhesive layer itself may nominally be 0.010 inches thick, but may range from 0.005 inches to 0.020 inches thick. The possibility that the material may creep over time because a tensioning element comprising a strap 130 or a lock 132 attached to the load distribution component 118 can be mounted on top of the adhesive structure 211. Exists. The laminate 212 and any other adhesive laminate 215a, 215b between the adhesive layer 211 and the load distribution component 118 can help provide a structure for preventing creep of the adhesive layer.

  In order to further prevent movement of the adhesive panel 211, a cover 220 may also be applied over the panels 104, 106, as shown in FIG. 22A. As shown in FIG. 22B, the cover 220 may comprise a stretchable elastomer 221 coated with a thin adhesive. In many embodiments, the cover 220 is further a thin urethane coated with a skin adhesive (preferably 0.002 inches thick) such as an acrylic adhesive that may be provided on one or more release liners 223a, 223b. With a layer (preferably 0.001 inches thick). The cover may further comprise a reinforcing feature 225.

  As shown in FIGS. 23A and 23B, the cover 220 is constructed to extend beyond the base panels 104, 106 and thereby span the distance d3 between the skin S and the panels 104, 106. May be. A typical minimum required distance d3 may be 8 mm, but may also be in the range of 2-15 mm. In addition to helping prevent creep of the adhesive layer of the base panels 104, 106, the urethane skin adhesive of the cover 220 also distorts the tension applied to the base panels 104, 106 from movement of the surrounding skin S. Can help to. This may serve to prevent skin damage (eg, from erosion or blistering) at the edges of the base panels 104,106. It should be noted, however, that the stretch properties of hydrocolloids provide local protection from blistering by themselves that can move with the skin S and thus resist damage to the skin S. In many embodiments, even when using a more rigid structure mounted on the outer surface of the adhesive layer, extensibility within the nominal 0.010 inch thickness of the adhesive layer to the skin surface is Can provide resistance.

  In addition to stabilizing the base panel structure and strain relief, the cover 220 may serve other purposes. By covering where the strap 130 will engage the lock 132, the cover 220 will allow the patient to tamper with the lock 132 until the strap 130 can be disengaged. Can be prevented. As shown in FIGS. 23A-23C, the cover 220 has openings 224, 224 ′ along the length of the area overlying the incision so that the gauze applied externally can absorb wound exudate. You may equip it. In other embodiments, the cover 220 may not have an opening to protect the wound from an infection source. The cover 220 itself may have reinforcing features 225, 225 'and may provide the base 102 with additional resistance to the incision opening, particularly in the region between the straps 130. FIG. 23C shows a particular embodiment where the reinforcing feature 225 'can be a rectangular strip of adhesive tape. Tape 225 ′ may preferably be more rigid perpendicular to the skin incision than the surrounding extensible urethane layer 221. Tape 225 'may be constructed from any combination of 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 a "body", i.e., rigidity, to the cover 220 to assist in its placement. Urethane layer 210 may be constructed from such materials and provide bi-directional extension.

  The spacing between the reinforcing features 225, 225 'can be important to ensure the longitudinal direction (parallel to the incision line) of the cover 220 for extensibility (eg, with extensible thin urethane). This may serve to improve patient comfort and resistance to skin damage by allowing the cover 220 and the underlying base assembly 102 to move with body movement. This effect may be from the cover 220 alone or as a combined effect with features on the base assembly 102 that may allow longitudinal extensibility. The stiffeners 225, 225 'are also of a uniform structure, but are perforated, slitted, or otherwise mechanically interrupted to allow stretch and / or controlled tearing as the body moves. Also good. The thin urethane layer (s) of cover 220 may also be mechanically interrupted to the same result. In at least some cases, the reinforcing features 225, 225 'of the cover 220 may not extend the entire width of the cover 220 (perpendicular to the incision). This limited covering width can help ensure strain relief from body movement from the base assembly 102 perpendicular to the incision I. In the preferred embodiment, the area of the cover 220 reinforced by the reinforcing members 225, 225 'extends 10 mm in each direction from the incision edge, but this may range from 2-50 mm.

  Another feature of the cover 220 may be that, in particular, it may be possible to add control to the incision edge between the tensile elements 130, 132 of the base assembly. As illustrated in FIG. 24A, the tension elements 130, 132 in combination with the base panels 104, 106 may serve to bring the incision edges 205 together. Once the skin S is in close proximity, it may be important that the skin edges are aligned vertically (perpendicular to the skin surface). Vertical misalignment can lead to slower healing at the incision and visible “steps”, ie bulges, which can lead to poor scar appearance. By adhering portions of the cover 220 to the edges of the base panels 104, 106 along the incision, each edge can be held in vertical alignment under tension, as indicated by arrows 201a, 201b. The adhesive on the portion of the cover 220 that intersects the incision I can also adhere directly to the skin S at the incision edges, further reducing the distance between the incision edges to be adhered, and further improving vertical skin alignment. In the preferred embodiment, the portion of cover 220 that intersects incision I is a rectangular strip 225 'of adhesive tape, as shown in FIG. 23C. The width of each strip 225 'and the axial gap between strips 225' may be optimized for incision edge control, incision visibility, and wound exudate escape. A preferred embodiment may comprise strips 12 mm wide, 6 mm apart, and a strap located between each strip. Other widths and spacings are also contemplated. By not bridging / spanning tents over each strap 130, the strip 225 can lie flat against the skin S for better adhesion and edge control.

  In some embodiments, the reinforcing features 225, 225 'may be constructed to limit the amount of bending at the incision site. The reinforcing features 225, 225 'in these embodiments may be more rigid than the skin S, preferably more rigid than the surrounding elements of the base panels 104,106. In this way, bending or compression of skin S through normal patient movement will be isolated or limited in propagation around the incision site. This sequestration or restriction of movement will help to strengthen the incision site under tension, but the superior advantage is that the incision edge is adducted significantly or non-uniformly perpendicular to the skin surface, It may be to prevent abduction or deviation. The aforementioned reinforcing materials may be used with a thickness adjusted to provide the desired stiffness. Preferably, the composite of base assembly 102 and cover 220 may be constructed to provide a rigid and extensible smooth transition to an incision site isolated from the surrounding skin.

  In a particular method of use, using the base assembly 102 to bring the skin edges close together, after initial closure of the incision, the base panels 104, 106 are pushed further together, with the closed incision I facing upwards. "Rounding", slightly abducting the edge and / or pressing the skin S around the incision edge to relieve tension. Figures 25A-25C illustrate an embodiment of the present method in an in vivo tissue model. FIG. 25A shows step 250A where the base panels 104, 106 are glued to the skin S adjacent to the incision I and are pushed together to “roll” the closed incision I upward. The base panels 104, 106 may then be pushed together further to hold the tissue in this orientation. These methods can be improved by positioning the base panels 104, 106 at a distance of 5-10 mm from the incision edge. In step 250B illustrated by FIG. 25B, the base panels 104, 106 may be locked in place relative to each other using the strap 130 and the locking portion 132. In step 250C illustrated by FIG. 25C, the cover 220 may then be applied to the lock at the relative location of the base panels 104, 106 and the “rolled” incision I. The incision I can be further reinforced using the aforementioned reinforcing elements 225, 225 '.

  A given cover 220, in many embodiments, may be equipped with a release liner to assist the user in handling the cover 220 before and during patient application. As shown in FIGS. 22A and 22B, the cover 220 may have release liners 223a, 223b applied in a three-part configuration. The user may first remove the longitudinal centerliner 223b and apply a center exposed adhesive to the base assembly 102 and the skin incision area. First removing the liner 223b in combination with a clear plastic in the center of the base 220 and / or visualization through an opening, the cover 220 properly aligns with the base assembly 102 as the cover 220 is applied. As may be done, the user may be able to see the underlying base assembly 102. This may also help provide an area of the cover 220 that does not stick to the user until the cover 220 is first secured to the base assembly 102 and / or the skin S. Next, the side release liner 223a may be removed in a direction perpendicular to the incision I. As the liner 223a is applied to the skin S, it holds and tensions the ultra-thin urethane so that it does not substantially wrinkle. Also, by first sticking the center of the cover 220 to the base assembly 102 and / or the skin S, the cover 220 has sufficient tension and control so that the remainder of the cover 220 coated with a thin adhesive to the patient. For smooth application, it can be held in place so that it can be applied to the side release liner 223a. Alternatively or in combination, the liner is removed from the first assembly, exposing the strips across the entire width of the cover 220 (perpendicular to the incision I) and onto the base assembly 102 and / or skin S It may be constructed to allow for initial placement, followed by removal of one or two additional liners in a direction parallel to incision I. The first liner may be in the middle of the length, at either end, or somewhere in between. If not on the edge, two additional liners may be required and each may be removed in an outward direction from the location of the first liner along the length of the device. If the first liner is at one end, the second single liner may be removed from the location of the first liner toward the end of the device.

  Another release liner configuration can be to have a single liner that can be completely removed from the bottom of the cover 220 prior to application. This type of liner is lightly adhered to the outer membrane, i.e., the outer surface of the cover 220, and the thin urethane helps to retain its shape and allows the user to remove the adhesive-free side and / or end. A casting sheet may be required that provides a place and therefore will not stick to the user's hand when applied. The outer membrane may only span a specific width that surrounds the entire outer surface or the periphery of the cover 220. The membrane and / or release liner may also have an area that extends beyond the area of the thin urethane in the cover 220. Once the cover adhesive is attached to the base assembly 102 or skin S, the casting sheet can be easily removed from the outside of the cover 220.

  As described herein, flexible wound dressings and wound or incision closure devices or instruments are typically flexible and extensible, and can be curved parts of the body (eg, arms, curves, etc.). Follow the contours of the area (eg, knee) undergoing extension. To assist in the draping of such devices, a backing material may be used to assist in maintaining the bandage shape during application. Such temporary backing materials described herein may have several advantages. The backing material may be transparent and allow visualization of the wound. The material may not be stretchable and may prevent stretching of the bandage or closure device or instrument during application. The backing may be easily removable after application of the wound dressing or closure device or instrument so as not to affect the actual dressing adhesion at the wound site. The backing material may also assist in handling the bandage during the manufacturing process. In many embodiments, the backing material, along with a release release liner on the adhesive side of the bandage, may be coupled to the bandage or closure device to allow easy and reliable removal of the backing material.

  Referring now to FIG. 26A, the wound dressing cover 2600 may comprise a flexible sheet 2610 made from a flexible material such as rubber, urethane, silicone, and the like. The flexible material 2610 may be laminated over a relatively more rigid material in the form of a casting sheet or carrier layer 2620. Casting sheet 2620 prevents flexible material 2610 from curling itself and from becoming unusable. The flexible sheet 2610 may have an adhesive on one side (eg, bottom side) and a relatively rigid (rigid) carrier layer or casting sheet 2620 on the other side. The adhesive side is protected by two liners 2630, 2640 that can be sequentially removed in a controlled manner to expose the adhesive. In order to apply the bandage 2600 over the wound or incision, a strip of adhesive is exposed by removing one of the release liners, usually the smaller release liner 2630. The release liner 2630 may be attached to the casting sheet 2620 using tape 2650. The exposed portion of flexible sheet 2610 may then be adhered to one end of the wound or incision. The flexible cover 2600 then follows the contours of the wound or incision and curvature on the body as the second release liner 2640 is slowly removed and sequentially exposes the adhesive.

  A first release liner 2630, which is typically still attached to the casting sheet 2620 using tape 2650, may then be used to lift the casting sheet 2620 from the flexible bandage 2610.

  The manufacturing process for wound dressing cover 2600 and associated liners 2630, 2640 uses a single die to release liners 2630, 2640, flexible dressings (using adhesive) 2610, and casting sheet 2620. Cutting the common profile (periphery) of the stack. Depending on the removal of liners 2630, 2640 and application of bandage sheet 2610 to the skin, casting sheet 2620 may remain on bandage sheet 2610. The removal of casting sheet 2620 may require initiation by delaminating and peeling the edges of casting sheet 2620 from bandage sheet 2610. Once started, continuous peeling and removal of the casting sheet 2620 can be simplified. The initiation and lifting of the edge of the casting sheet 2620 may not always be intuitive, and may require a free edge connected to the casting sheet 2620 to help identify the lifting point and begin to tear off. . Tape 2650 may be used to bridge casting sheet 2620 to release liner 2630 and may provide an easily identifiable tab that may be used to initiate tearing.

  Alternative configurations of casting sheet 2620 may be used to initiate tearing off of casting sheet 2620, as shown in FIGS. 26B-26E.

  As shown in FIG. 26B, the casting sheet die may be cut such that the casting sheet 2620a extends axially beyond the flexible bandage sheet 2610 (eg, of the flexible bandage sheet 2610). The liners 2630, 2640 and the urethane material may be “kiss cut” to the surface of the casting sheet 2620a).

  As shown in FIG. 26C, the casting sheet 2620 may have a tape 2650 applied to either one or both axial sides so as to extend beyond the casting sheet. Tape 2650 does not necessarily have to be attached to release liner 2630.

  As shown in FIG. 26D, the casting sheet tape 2650 is attached to or near the axial edge of the casting sheet 2620 and extends inside the profile of the casting sheet 2620 for free gripping by the user. It may be accompanied by an adhesive edge 2652.

  As shown in FIG. 26E, the casting sheet die is cut at a partial or full distance from one axial edge of the casting sheet 2620 to another axial edge (eg, the casting sheet 2620 is a flexible bandage). The sheet 2610 may be kiss-cut so as not to be cut. The cut casting sheet 2620 may be separated by “knobs” to create an edge for gripping by the user. The inner die cut edge may also be applied to one or both of the inner edges and have a tape or similar tab 2654 for gripping and tearing, as shown in FIG. 26E.

  In many embodiments, the casting sheets 2620, 2620a and / or tapes 2650, 2652, 2654 are of different colors or have markings to distinguish the flexible bandage sheet 2610 and release liners 2630, 2640 May be.

Various base assemblies, base panels, force distribution structures, axial supports, side supports, closure components, tie assemblies, straps, locks, adhesive layers, adhesive layers, covers, cover structures, drapes One or more of the components of the incision closure device or incision closure device assembly disclosed herein comprising one or more of: an antifungal, antibacterial, antimicrobial, antiseptic, or medicinal material One or more may be included, coated with it, or otherwise incorporated. For example, such a material may be incorporated into the hydrocolloid adhesive layer as a separate layer or coating between the skin and the adhesive layer (covering at least a portion of the adhesive layer), the base assembly cover Alternatively, it may be incorporated into at least the adhesive layer. One or more wells, grooves, openings, pores, or similar structures may be provided on the device or apparatus component to facilitate such incorporation. In many embodiments, such materials may comprise one or more natural materials such as silver, iodide, zinc, chlorine, copper, or tea tree oil as the active material. Examples of such antifungal, antibacterial, antimicrobial, antiseptic, or medicinal materials include, but are not limited to, Acticoat ^™ family of materials commercially available from Smith & Nephew plc (UK), Smith & Nephewplc (UK) Acticoat (registered trademark) Moisture Control series, which are commercially available materials from the United States, Contreet (registered trademark) Foam series, commercially available materials from Coloplast A / S (Denmark), Urgo Limited (UK) (Laboratoires URGO (France)) UrgoCell (registered trademark) Silver series, a commercially available material from a subsidiary), and Contret (registered trademark) Hydro, a commercially available material from Smith & Nephewplc (UK) ocolloids, ConvaTec Inc. (Skillman, NJ) commercially available from Aquacel® Ag series, Kinetic Concepts, Inc. (San Antonio, TX), commercially available materials such as Silvercel® family, Kinetic Concepts, Inc. Actisorb (R) Silver 220 commercially available from San Antonio, TX, Urgotul (R) SSD series, Kinetic Concepts, a commercially available material from Urgo Limited (subsidiary of Laboratoires URGO (France)) . (San Antonio, TX), commercially available Inadine® series, materials available from Smith & Nephewplc (UK), Iodoflex® series, commercially available from Aspen Medical Europe Ltd. Sorbsan Silver ^™ series, Ferris Mfg. Corp. (Burr Ridge, IL), commercially available materials such as Polymer Silver® family, Kinetic Concepts, Inc. (San Antonio, TX), a commercially available material, the Program ^™ family, Kinetic Concepts, Inc. (San Antonio, TX), commercially available materials such as the Program Prism ^™ family, and Medline Industries, Inc. Arglaes®, a commercially available material from (Mundelein, IL). U.S. Patent Nos. 8,313,508, 8,323,313, and 8,439,945, U.S. Patent Publication No. 2013/0066365, and PCT Application No. US2010 / 000430, owned by the same person, The components of the closure device described in US 2011/139912, US 2011/40213, US 2011/34649, and US 2013/0607024 also include, but are not limited to, one or more of the aforementioned materials. May consist of, be coated with or otherwise incorporate one or more of antifungal, antibacterial, antimicrobial, antiseptic, or medicinal materials.

  In many embodiments, the topical pharmaceutical agent is incorporated directly into the wound closure device described herein. Since wound closure devices are often applied in close proximity to wounds or incisions that require medical protection, the direct incorporation of such medication into the closure device can be beneficial. In wounds at risk of infection, for example, the incorporation of antimicrobial agents can be beneficial. Antimicrobial agents can include antibiotic drugs and antiseptic metal ions and related compounds, which can include silver, iodine, copper, and chlorine, or natural materials such as tea tree oil. For wounds that suffer from fungi, for example, pharmaceutical agents such as zinc may be appropriate. Any combination of these agents may also be beneficial and may therefore be incorporated into a wound closure device.

  A topical pharmaceutical agent may be incorporated into the closure device to give the closure device the ability to draw exudate from the wound while keeping the wound fully hydrated for improved healing ( For example, unwanted microorganisms are removed from the wound and / or skin erosion is prevented).

  Referring now to FIG. 27A, a wound or incision closure instrument 2700 includes an upper polymer layer 2720R, 2720L and a lower adhesive layer 2730R, 2730L that are adapted in close proximity to both sides of the surgical incision I. A base is provided with two base panels 2710R, 2710L. Features of panels 2710R, 2710L, such as strap 2740, may allow the skin on both sides of incision I to be pulled together and held in place during the healing cycle. The adhesive may preferably comprise a hydrocolloid formulation, but may comprise acrylic or other adhesives known in the art. Upper polymer layers 2710R, 2710L (eg, 1 mil polyurethane) are preferably applied on top of the adhesive layers 2720R, 2720L to isolate the adhesive layers 2720R, 2720L. Pharmaceutical agents may be incorporated into the structure of the base panels 2710R, 2710L. At a minimum, the drug may inhibit unwanted microbial growth where skin contacts from the base panels 2710R, 2710L. The drug may be released from the base panels 2710R, 2710L and may be moved to an area within or near the wound. The drug may be contained with a carrier structure such as adhesive layers 2730R, 2730L that can absorb fluid and assist in the release of the drug. Such structures may include hydrocolloids, hydrofibers (such as those containing sodium carboxymethylcellulose), hydrogels, collagen, alginic acid, polyurethane or silicone foam, or other related materials known in the art. . The carrier may alternatively or in combination be an ointment, cream, gel, or powder. Pharmaceutical agents (such as silver ions) may alternatively or in combination be applied to metals or polymers (eg, in mesh form) via solvent coating processes or vapor deposition. Such a mesh product may be joined or embedded within the structure of the closure device.

  In an exemplary embodiment, a pharmaceutical agent comprising a silver compound such as silver sulfate may be incorporated into the base panels 2710R, 2710L. As the base panels 2710R, 2710L come into contact with the wound exudate and / or sweat or external fluid, the drug may be delivered toward the wound. As fluid is absorbed into the base panels 2710R, 2710L, the base panels 2710R, 2710L can release silver ions and can interfere with bacterial growth. Examples in which agents such as silver can be incorporated into the base panel are shown in FIGS. 28A-28B, showing various embodiments of the sample segment 2750 of the right base panel 2710R in FIG. These embodiments may also be applied to the left base panel 2710L.

  FIG. 27B shows a pharmaceutical agent 2760R hybridized directly into the adhesive layer 2730R within the sample segment 2750. The adhesive is typically a hydrocolloid that can absorb a significant percentage of its weight in the fluid, thereby assisting in the release of the drug.

  FIG. 27C shows a sample segment of the base panel 2710R in which the pharmaceutical agent is incorporated into a carrier structure 2770R, preferably concentrated on a portion of the base panel 2710R near the incision I, which is incorporated at the top of the base panel 2710R. 2750 shows another embodiment. If additional features are saturated with the exudate or other fluid, and / or if the concentration of the pharmaceutical agent falls below and below the effective level, the carrier structure 2770R is removed (and replaced if necessary) May be incorporated in order to:

  FIG. 27D shows an embodiment similar to that of FIG. 27C in which a carrier structure 2770R containing a pharmaceutical agent is incorporated on the inner edge of the base panel 2710R.

  FIG. 27E illustrates how the carrier 2770R can be incorporated into both the top and inner edges of the base panel 2710R. In these examples, the carrier structure 2770R on one or both inner edges of the base panel 2710R may be compressed over the wound or incision I and assist in its stability across the wound or incision I.

  The pharmaceutical agent and its carrier structure may alternatively or in combination be incorporated into a cover for the incision closure device. As described above, the cover is typically applied over the base panel of the incision closure device to help secure the device to the skin and protect the skin. As shown in FIG. 28A, the cover 2800 may incorporate the pharmaceutical agent 2810 into the entire surface of the cover 2800 with or without a carrier structure, such as an adhesive layer 2810 mixed with the pharmaceutical agent. . Alternatively or in combination, the medicament may be incorporated into a discrete portion of cover 2800, preferably in carrier structure 2820 that lies directly across the wound site, as shown in FIG. 28B.

  In at least some instances, the carrier structure 2820 can be saturated over time and / or lose its medical strength, and replacement of the medical structure 2820 can be beneficial. As shown in FIG. 28C, the medical structure 2820 is removable (eg, through tearing of the perforations 2830 in the cover 2800) and is optionally integrated into the narrow cover strip 2801 shown in FIG. 28D. Can be replaced with another medical structure 2821. In the narrow cover strip 2801, the adhesive portion of the cover 2801 may extend beyond the medical structure 2821 and hold the structure 2821 against the skin. The narrow strip 2801 may alternatively be applied to the wound site before the cover 2800 is applied. Cover 2800 may be designed to cover strips 2801 or may have perforations 2830 to allow removal of the underlying strips.

  For one or both of base panels 2710R, 2710L and cover 2800, carrier structure 2770R or 2820 (with or without a pharmaceutical agent) or pharmaceutical agent alone can be patterned with an adhesive layer of a separate structure. The patterned structure may comprise a repeating shape of adhesive material (eg, circular, oval, polygonal, slot, etc.) adjacent to a similar repeating shape of the carrier structure (or the rest of the substrate). This will help ensure adhesion of the base panel 2710R, 2710L or cover 2800 while integrating the pharmaceutical agent within the carrier structure 2770R or 2820. A simple example is shown in FIG. 29E where the carrier structure 2820 comprises a repeating shape 2850. The pharmaceutical agent and carrier structure 2820 can also be applied to a base strap 2740 that intersects the incision I.

  While preferred embodiments of the present invention have been illustrated and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, modifications, and substitutions will now occur to 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 practicing the invention. The following claims define the scope of the invention, and methods and structures within the scope of these claims and their equivalents are intended to be covered thereby.

Claims (60)

An incision closure device,
A flexible adhesive bottom layer having a first elasticity;
An intermediate layer coupled to the flexible adhesive layer, covering at least a portion thereof and having a second elasticity less than the first elasticity;
A top layer coupled to the intermediate layer and covering at least a portion thereof and having a third elasticity less than the second elasticity;
With
When the elastic gradient between the flexible adhesive bottom layer and the top layer covers the incision and surrounding tissue, the movement of tissue adjacent to the side of the instrument may cause the coated incision and surrounding tissue to move. An incision closure device that provides sufficient rigidity to the incision closure device so that it does not substantially spread.   The elastic gradient provides sufficient resilience to the incision closure instrument so that, when covering the incision and surrounding tissue, bulging and adhesive loss due to movement of tissue adjacent to the instrument is minimized. The incision closure device according to claim 1.   The incision closure device of claim 1, wherein the incision closure device is axially flexible in response to an axial extension of the incision and surrounding tissue covered by the incision closure device.   The movement of the first tissue region adjacent to the periphery of the flexible adhesive bottom layer is adjacent to the periphery of the flexible adhesive bottom layer and is opposed to the first tissue region. The incision closure device of claim 3, wherein the incision closure device is substantially converted to   The incision closure instrument according to claim 1, wherein the flexible adhesive bottom layer comprises a hydrophilic adhesive material.   6. The incision closure device of claim 5, wherein the hydrophilic adhesive material comprises one or more of a hydrocolloid, a hydrogel, an acrylic polymer, or poly (ethylene glycol).   The incision closure device according to claim 1, wherein the upper layer comprises one or more of rubber, latex, urethane, polyurethane, silicone, thermoplastic elastomer (TPE), woven fabric, or spun fabric.   The incision closure instrument according to claim 1, wherein the flexible adhesive bottom layer comprises first and second adhesive bottom layers.   The intermediate layer comprises at least one base panel having a first upper layer coupled to the first adhesive bottom layer and a second upper layer coupled to the second adhesive bottom layer. The incision closure device according to claim 8.   The top layer includes a plurality of axial support structures for fastening the first adhesive bottom layer and the first top layer to the second adhesive bottom layer and the second top layer; and The incision closure device of claim 9, comprising an array with a plurality of side closure components coupled to an axial support structure.   The plurality of axial support structures and the plurality of closure components are responsive to an axial extension of the incision and surrounding tissue covered by the incision closure device, the lower adhesive layer and the intermediate layer The incision closure instrument of claim 10, wherein one or more of the are coupled together to form a serpentine pattern to allow at least partially extending in an axial direction of the closure device.   The incision closure device according to claim 10, wherein the plurality of axial support structures and the plurality of side closure components are coupled together to form a ladder pattern.   11. The incision closure device of claim 10, wherein one or more of the plurality of axial support structures and the plurality of side closure components are formed from a flexible, non-stretchable material.   The plurality of side closure components may include the first and second adhesive bottom layers and the first and second adhesive layers after a flexible adhesive bottom layer is adhered to tissue on both sides of the incision. 11. The incision closure device of claim 10, configured to pull together one or more inner edges of the upper layer.   The one or more of the side closure components comprise a left end, a right end, and a tether that is securely coupled to the left or right end and adjustably attached to the opposite end. 10. The incision closure device according to 10.   The incision closure device according to claim 10, wherein one or more of the plurality of axial support structures and the plurality of side closure components are embedded or laminated within the first and second upper layers. A system for closing an incision in tissue,
An incision closure device according to claim 1;
A flexible cover for covering the incision closure device and the coated incision and surrounding tissue;
A system comprising:   The system of claim 17, wherein the flexible cover is configured to extend over lateral and axial edges of the flexible adhesive bottom layer.   The cover allows the cover to extend at least partially in the axial direction of the cover in response to an axial extension of the incision and surrounding tissue covered by the incision closure instrument; The system of claim 17 having one or more perforations.   The system of claim 19, wherein the one or more perforations are disposed along a central axial line of the cover.   The system of claim 17, wherein the cover comprises one or more reinforcing members coupled to at least a portion of the adhesive layer of the cover.   The system of claim 21, wherein the reinforcing member comprises one or more of rubber, latex, urethane, polyurethane, silicone, thermoplastic elastomer (TPE), woven fabric, or spun fabric.   The system of claim 17, wherein the cover comprises a hydrophilic adhesive layer.   24. The system of claim 23, wherein the hydrophilic adhesive layer comprises one or more of a hydrocolloid, hydrogel, acrylic polymer, or poly (ethylene glycol). An incision closure device,
A lower portion having first elasticity;
An upper portion having a second elasticity less than the first elasticity;
An elastic gradient between the lower part and the upper part;
With
The elastic gradient provides sufficient rigidity when the incision and surrounding tissue are covered so that movement of tissue adjacent to the side of the instrument does not substantially spread the covered incision and surrounding tissue. An incision closure device provided to the closure device.   The elastic gradient provides sufficient elasticity to the incision closure device so that, when covering the incision and surrounding tissue, bulging and adhesive loss due to movement of tissue adjacent to the side of the device is minimized. 26. The incision closure device of claim 25, provided. A method for closing an incision in a patient's skin, comprising:
Adhering a lower portion of the incision closure device adjacent to an incision, the lower portion having a first elasticity and coupled to an intermediate portion having a second elasticity less than the first elasticity; Steps,
Pulling together the side edges of the upper part of the incision closure device and compressing the incision between the side edges, wherein the upper part is coupled to the middle part and is smaller than the first and second elasticity. 3 having a step of elasticity;
With
An elastic gradient exists between the upper and lower portions, and when the elastic gradient covers the incision and surrounding tissue, movement of the tissue adjacent to the side of the instrument is Providing sufficient rigidity to the incision closure device so that it does not substantially unfold.   26. The method of claim 25, further comprising placing the anchoring layer over the incision closure device such that an anchoring layer extends over the upper first and second lateral edges. .   26. The method of claim 25, wherein the incision closure device is axially flexible in response to an axial extension of the incision and surrounding tissue covered by the incision closure device.   The movement of the first tissue region adjacent to the lower periphery is substantially translated into the same movement of a second tissue region adjacent to the lower periphery and opposite the first tissue region. Item 30. The method according to Item 29. An incision closure device,
A base including a left panel and a right panel, each panel including a tissue adhesive lower surface, an upper surface, a first side edge, a second side edge;
Left and right force distribution structures respectively coupled to the left and right panels, wherein an axial extension of the panel along one of the first or second lateral edges respectively traverses the panel A force distribution structure adapted to allow limiting one or more of the lateral extensions or axial extension along the opposite lateral edge;
A plurality of closure components that are secured to the left and right panels after the panel has been glued to tissue and an incision has been created between them and can pull the panel together;
An incision closure device comprising:   32. The incision closure device of claim 31, wherein the first side edge of each panel comprises the inner edge of each panel, and the inner edges of each panel face each other.   33. The incision closure device of claim 32, wherein the plurality of closure components are configured to pull together the inner edges of the left and right base panels to compress the incision covered by the incision closure device.   32. The incision closure device of claim 31, wherein the second lateral edge of each panel comprises the outer edge of each panel, the outer edges of each panel facing away from each other.   32. The incision closure device of claim 31, wherein one or more of the left and right panels of the base includes an elastic matrix.   36. The incision closure device according to claim 35, wherein the elastic matrix comprises an elastomeric membrane, woven fabric, spun fabric, rubber, latex, urethane, polyurethane, silicone, thermoplastic elastomer (TPE).   The elastic matrix comprises a woven fabric woven from elastic elements and includes inelastic elements extending laterally along and across the first or second lateral edges. 36. The incision closure device according to 35.   Each force distribution structure is disposed axially adjacent to the first side edge of the panel and laterally from the back to the first side edge of the panel. 36. The incision closure device of claim 35, comprising a plurality of axially spaced side supports extending in the direction.   39. The incision closure device of claim 38, wherein the back and side supports are formed from a flexible, non-stretchable material.   39. The incision closure device of claim 38, wherein the force distribution structure is embedded or laminated within the upper surface of each panel.   The plurality of closure components are separated from each other by a predetermined distance from a plurality of right engagement members and a plurality of left engagement members to hold the right and left engagement members laterally. And the right engagement member is adapted to removably engage the right panel support, and the left engagement member is removably engaged to the left panel support. 39. The incision closure device of claim 38, adapted to:   At least some of the supports have anti-slip devices in the vicinity of one or more of the first and second side edges, and the engagement member has a slot for receiving the anti-slip devices; 42. The incision closure device according to claim 41.   42. The incision closure instrument of claim 41, wherein the side struts are adjustably connected to at least one of the engagement members to allow adjustment of the predetermined distance.   The closure component comprises a plurality of independent side ties attached to at least some of the side supports, the side ties configured to be secured between the side supports. An incision closure device according to claim 38.   45. The incision closure device of claim 44, wherein each of the independent side ties has one end secured to a panel and a second end adjustably attached to the other panel.   46. The incision closure device of claim 45, wherein the second end comprises a ratchet tightening mechanism.   32. The assembly of the base and closure component assembly further comprises an anchoring layer adapted to be placed over an incision on a patient's skin and then placed over the assembly. The incision closure device described in 1.   48. The incision closure device of claim 47, wherein the anchoring layer has an inner self-adhesive surface.   48. The incision closure device of claim 47, wherein the anchoring layer is configured to extend over one or more of the first or second side edges of the left and right base panels.   The anchoring layer has one or more perforations, and the anchoring layer extends at least partially in an axial direction in response to an axial extension of the incision and surrounding tissue in which the incision closure device is deployed. 48. The incision closure device of claim 47, which makes it possible to do so. The plurality of closure components comprises a left closure component end secured to the left panel and a right closure component end secured to the right panel;
The plurality of closure components include one or more of the left force distribution structures disposed between at least some axially adjacent left closure component ends, wherein one or more of the right force distribution structures are Positioned laterally across the left and right panels, positioned between at least some axially adjacent right closure component ends, forming a serpentine array of force distribution structures and closure components The incision closure device according to claim 31.   52. The incision closure device of claim 51, wherein the left force distribution structure couples every other axially adjacent pair of left closure component ends together on the left panel.   52. The incision closure device of claim 51, wherein the right force distribution structure couples every other axially adjacent pair of right closure component ends together on the left panel.   32. The incision closure device of claim 31, wherein the tissue adhesive lower surface comprises a hydrophilic adhesive material.   55. The incision closure device of claim 54, wherein the hydrophilic adhesive material comprises one or more of a hydrocolloid, hydrogel, acrylic polymer, or poly (ethylene glycol).   32. The incision closure device of claim 31, wherein the at least one force distribution structure of the plurality of left and right force distribution structures is C-shaped.   The C-shaped force distribution structure includes an axial portion for restricting an axial extension of the left or right base panel, and a side portion for restricting a lateral extension of the left or right base panel. Item 54. The incision closure device according to Item 54. A method for closing an incision in a patient's skin, comprising:
Gluing the right and left base panels to the right and left of the incision, respectively;
Pulling the inner edges of the right and left base panels together and compressing the incision therebetween,
A lateral extension or first lateral across the right and left base panels, while allowing an axial extension of the right and left base panels along the first lateral edges of the right and left base panels Limiting one or more of the axial extensions along the second lateral edges of the left and right base panels opposite the edges;
Including a method. Towing the inner edges together includes tightening a plurality of closure components coupled to the right and left base panels;
Allowing axial expansion of the right and left base panels includes providing a plurality of left and right force distribution structures coupled to the right and left base panels, respectively;
59. The method of claim 58, wherein the plurality of closure components and the plurality of left and right base panels are joined together to form a serpentine array.   59. The method of claim 58, further comprising placing the anchoring layer across the right and left base panels such that the anchoring layer extends across first and second lateral edges of the right and left base panels. The method described.