KR102008155B1 - Surgical incision and closure apparatus - Google Patents

Abstract

The device for suturing a surgical incision includes a left and right base panel, a plurality of closure components and a plurality of left and right axial supports coupled to each base panel. The closure component couples the left and right base panels laterally relative to each other and includes left and right ends coupled to the left and right base panels, respectively. The suture component is positioned transversely across the left and right panels, the left axial support is disposed between the pair of left suture component ends, and the right axial support is disposed between the pair of the right suture component ends. The left and right axial supports are offset from each other to form a meander arrangement of the continuous closure component and the axial support. The device may be made of an antimicrobial material or a material impregnated with an antimicrobial agent. In use a flexible adhesive cover may be provided over the device.

Description

Surgical Incision and Suture Apparatus {SURGICAL INCISION AND CLOSURE APPARATUS}

Cross Reference of Related Application

This PCT application is directed to US Provisional Patent Application No. 61 / 889,569, filed Oct. 11, 2013, Patent Attorney No. 35383-712.101, and US Provisional Patent Application No. 61 /, filed July 24, 2013. 958,259 (patent attorney no. 35383-710.101) and US provisional patent application 61 / 958,254 (patent attorney no. 33383-711.101) filed Jul. 24, 2013, and claims The entire contents of the provisional patent application are incorporated herein by reference.

The application of this application is a partial continuing application of US patent application Ser. No. 13 / 286,757, filed on Nov. 1, 2011, Patent Attorney No. 35383-709.201, filed Oct. 31, 2012. Application 13 / 665,160 (Patent Attorney No. 35383-709.501), the entire contents of which are incorporated herein by reference.

The content of this application is co-pending U.S. Patent Application Nos. __________ (patent attorney no. (Patent Attorney No. 35383-709.502), the entire contents of the above patent application are incorporated herein by reference.

Field of technology

The present invention relates generally to medical devices and methods. More specifically, the present invention relates to apparatus and methods for forming and suturing surgical incisions.

Surgical suture instruments including adhesive based patches with left and right panels are known. Such an apparatus of particular interest in the present invention is described in co-pending and shared PCT application US2010 / 000430, which is hereby incorporated by reference in its entirety. As described in the PCT application, the adhesive patch is placed in a desired location to form a surgical incision on the patient's skin. After the patch is placed, an incision is made along the axial line extending through the middle of the patch. After the incision is made, the incision is opened to perform the desired treatment, and after the treatment is completed, the incision can be closed by pulling together the inner edge of the panel with a clip, zipper or other closure member.

The main purpose of these surgical closure instruments is to improve healing and reduce scarring from the incision. However, this object is limited by certain features of the mechanisms currently available. For example, the edges of tissue do not always merge evenly along a given line, which may eventually increase scarring. Many such closure devices do not have the ability to adjust the suture force or distance to the edge of the tissue, thus limiting the ability to "pucker" the tissue somewhat, which has been found to reduce scarring. Other disadvantages of the usable incision and wound closure instruments include the difficulty of use and incompatibility with the handling of tissue during subsequent surgical treatment procedures. That is, instruments that are rigid enough to firmly suture the tissue sometimes cannot match the movement of the tissue during the surgical procedure.

A particular problem with self-adhesive wound closure patches arises when these patches are used under an adhesive surgical incision drape. Such drape is used to help maintain sterility of the tissue surface during surgical procedures, and the drape can be placed over previously placed tissue suture patches. Since the surgical incision drape has an adhesive bottom surface attached to the tissue, the drape will attach to the top surface of the underlying tissue suture patch. Thus, removal of surgical incision drape will sometimes remove or at least push out previously placed tissue suture patches. Once any significant portion of the tissue closure patch is removed or pushed away, the patch is no longer useful for closure of the surgical wound.

For this reason, it would be desirable to provide an improved surgical incision closure appliance and method of use. It is particularly desirable to provide an incision closure appliance that can be attached to tissue and allows formation of an incision and that can conform to deformation of the tissue during subsequent surgical procedures and controllably close neighboring tissue edges following the procedure. Do. In particular, it would be desirable if the incision closure appliance could be uniformly distributed with control of the suture force to the tissue edges with minimal restraint or pull of the tissue during the surgical procedure. It would also be desirable to provide an improved surgical incision closure appliance and method of use, wherein the closure appliance is inhibited from being removed and pushed away when used under the surgical incision drape. At least some of these objects will be met by the present invention described below.

Surgical suture instruments are described in US Pat. No. 2,012,755; 3,516,409; 3,863,640; 3,863,640; 3,933,158; 3,933,158; No. 4,114,624; 3,926,193; No. 4,535,772; No. 4,676,245; No. 4,881,546; 4,905,694; 5,377,695; No. 7,455,681; US Patent Publication Nos. 2005/0020956 and 2008/0114396. Additional surgical closure instruments are disclosed in shared US Pat. No. 8,313,508, the entire contents of which are incorporated herein by reference; 8,323,313; 8,323,313; 8,439,945; 8,439,945; US Patent Publication No. 2013/0066365; PCT publications WO2011 / 139912, WO2011 / 159623, WO2011 / 043786, WO2013 / 067024. Commercial incision closure devices may be purchased from Ethicon, a division of Johnson & Johnson, under the trademark Ethizip ^™ temporary abdominal wound closure device.

The present invention improves the devices and methods for closing wounds, particularly those resulting from incisions performed during surgical procedures. An incision is usually made in the patient's skin, such as through the abdomen, but in some cases may be made on the internal organs, in the oral cavity, in the body cavity or in a similar part.

The devices and methods of the present invention present minimal disruption or interference to the surgical procedure performed after the incision. In particular, the apparatus and method will allow the opposite edge of the incised tissue to open, stretch and freely deform with minimal constraint due to the presence of the closure device. However, once the surgical procedure is completed, the apparatus and method of the present invention will evenly distribute the suture force to pull the edges of the tissue together in a manner that minimizes scarring. In particular, the closure device may pull the tissue edges together at slightly closer intervals than initially present in the formation of the incision to cause a “pucker” that may turn the tissue edge up and reduce scarring.

The apparatus and method of the present invention may avoid or reduce obstruction when using an incision closure appliance under a surgical incision drape that must be removed from above the closure appliance. A sacrificial layer is provided over at least a portion of the top surface of the closure appliance, which sacrificial cover is held in place while the surgical incision drape is placed over the incision closure appliance. After the incision and closure procedure is completed, the surgical incision drape is peeled off the patient's skin. Instead of attaching to the tissue closure appliance and removing the tissue closure appliance, the surgical drape is attached to the sacrificial cover and only the sacrificial cover is removed from the patient with the grapes, leaving the remainder of the incision closure appliance in place.

In a first aspect of the invention, the incision closure appliance comprises a base having a left panel and a right panel. Each panel includes a tissue attaching bottom surface, an upper surface, an inner edge, and an outer edge. The tissue attaching bottom surface will typically be coated at least partially with common tissue-adhesive adhesives such as those used for surgical bandages and patches.

The incision closure appliance further includes a load distribution structure coupled to each panel (ie, each panel will have at least one load distribution structure coupled to the panel), and each load distribution structure will have a total length. It is intended to allow axial expansion of the panel along the inner edge while limiting lateral expansion across and axial expansion along the outer edge. By allowing the axial expansion of the panel along the inner edge, the edges of the tissue are only allowed to the minimum that the deformation of the tissue is possible when stretched during the surgical procedure. Conversely, by limiting both the transverse and axial expansion along the outer edge, the panel can apply adjusted and distributed suture force when the panels are pulled together after the surgical procedure is completed, as described in more detail below. It becomes possible.

The incision closure appliance further includes a closure component or assembly attached to the load distribution structure to pull together the inner edges of the panel after the panel is attached to the tissue on both sides of the incision and the surgical procedure is completed. Each panel of the base is at least partially elastic, typically having isotropic elasticity (ie, the panels are uniformly stretched in all directions) but optionally having anisotropic elasticity, in which case the matrix preferentially stretches in one direction or over a portion thereof. Usually contains a matrix. Elastomeric matrices include elastomeric membranes or sheets (e.g., polyurethane sheets or thermoplastic elastomers (TPEs)), fabrics (typically fabrics at least partially woven from elastomeric filaments, yarns or fibers), spun fabrics ) May be included. In certain embodiments, the elastomeric matrix is woven into elastic elements (typically yarns, filaments, fibers, etc.) and disposed along the outer edges to traverse the elastic elements, to provide the aforementioned expansion characteristics with respect to the load distribution structure. It may comprise a fabric having an inelastic element extending laterally across. That is, in some cases, the load distribution structure may comprise or consist of an inelastic element that is woven or otherwise incorporated into the fabric membrane.

Typically, the load distribution structure is for example a plurality of axially spaced lateral supports extending transversely from the main skeleton to the inner edge side of the panel, disposed axially adjacent to the outer edge of the panel. It will include the individual components of the incision-sealing instrument, including. Such "comb" structures are usually formed of a stretchable but non-expandable material so that the elements can be bent together by tissue deformation but do not stretch along their length to dimension along the outer edge of the panel as well as transversely Stability can be provided. Examples of such materials include nylon, polypropylene, polyethylene and polycarbonate or other thermoplastic polymers. In particular, the load distribution structure will not limit the axial elongation of the inner edge of the panel to provide the desired expandability and harmony for the tissue during the surgical procedure. Such individual load distribution structures may be attached to the top surface of the panel or alternatively embedded in or laminated to the panel. Typically, the load distribution structure will not extend into or beneath the bottom of the panel so as not to interfere with the panel's attachment to skin or other tissue.

Assembly of the base panel and the load distribution structure will typically be carried out on a removable backing that covers and protects the attachment surface of the panel before use. The backing can be removed to attach the base to the skin or other tissue at the location of the surgical procedure. In addition, the right and left panels typically have removable tabs, axial strips, or other removable covers or structures to maintain the inner edge at a predetermined distance or interval when the inner edge of the panel is attached to the tissue. Will be kept together by For example, removable tabs may be disposed at each of the axial ends of the base to temporarily secure the two base panels together. Alternatively, removable strips or tapes may be disposed above the axial gap between the right and left panels to hold the panels in place relative to each other when the base is attached to the tissue surface. Such tabs or strips are typically self-adhesive, which can be secured to the panel and then removed by simply pulling out after the panel is properly placed on the tissue. The cover, tab or strip may be removed to leave the panel in place but remain unconnected before forming a surgical incision between the panels.

An exemplary first configuration of the closure component or assembly includes a right engagement member, a left engagement member and a plurality of transverse braces that hold these engagement members laterally spaced apart by a predetermined distance. The right coupling member is configured to releasably engage the support of the right panel along the inner edge of the right panel, and the left coupling member is releasably engages the support of the left panel along the inner edge of the left panel. In certain embodiments, at least a portion of the support of the load distribution component has a cleat near its inner edge and the engagement member has a slot for receiving the cleat. After the surgical procedure is completed, the suture component may be placed over the load distribution structure such that one side cleat is first engaged by the engagement member and then the opposite engagement member is pulled over the opposite cleat.

Alternatively, the closure component or assembly may include a plurality of independent lateral ties attached to at least some of the lateral supports. Such transverse ties are configured to be fixed to one panel and thus adjustablely attachable to the other panel by being fixed between the transverse supports. For an exemplary embodiment, the adjustablely attachable end may include a ratchet tightening mechanism or similar structure that allows each lateral tie to be adjusted independently at different intervals between the right and left panels. . In this way, the right and left panels can be otherwise tensioned along the inner edge to control and optimize the force applied to neighboring tissue edges being pulled together.

Optionally, the closure device of the present invention may further comprise a fixation layer such that the assembly of the base and the closure component is secured over the incision on the patient's skin and then placed over the assembly after the surgical procedure is completed. The pinning layer typically has a self-adhesive bottom surface that can be placed over the assembly of base and closure components to help secure the pinning layer in place and maintain cleanliness. The pinning layer may optionally have holes to allow access to the wound for observation, delivery of disinfectant, and the like.

In a further aspect of the invention, a method of making an incision in tissue comprises providing an incision closure appliance as described above. The right and left panels of the instrument are attached to the patient's skin and the inner edge of the panel is spaced apart by a preselected distance, typically 0.5 mm to 15 mm. An incision (usually straight) is made in the tissue or skin surface between the inner edges of the panel, and the edges of the incised tissue are then opened to perform the desired surgical procedure. The inner edges of the panels can be stretched to match the movement and deformation of the tissue edges while the transverse length of each panel and the lateral length remain dimensionally stable. After the surgical procedure is completed, the suture component is secured to the load distribution structure to pull together the inner edge of the panel again. Optionally, the closure component has a dimension (or adjustable interpanel spacing) that pulls the tissue edges together closer together than immediately pulled after formation of the incision. This pulling the tissue together can reduce the scarring by causing the edges to turn over and "clogging" the tissue.

In a further aspect of the invention, an incision closure appliance is provided. The incision closure appliance includes a left and right base panel, a plurality of closure components for transversely coupling the left and right base panels to each other, and a plurality of left and right axial supports coupled to the left and right base panels, respectively. can do. Each closure component includes left and right closure component ends coupled to left and right base panels, respectively. The plurality of closure components include (i) one or more of the left axial supports are disposed between at least some axially neighboring left closure component ends, and (ii) one or more of the right axial supports are at least partially It can be disposed transversely across the left and right panels to be disposed between the axially adjacent right closure component ends to form a serpentine arrangement.

In order to form a sandal arrangement, every other left axial support joins the axial neighboring pair of left suture component ends together on the left panel and / or every other right axial support is axially one by one Adjacent pairs of right closure component ends are joined together on the right panel. The left and / or right panel may include one or more holes disposed between each axially neighboring left and / or right suture component end with no axial support disposed therebetween. The one or more holes may include a plurality of holes that facilitate separating the base panel into base panel segments upon axial stretching 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 base panel segment and the right base panel segment may be axially offset from each other when applied to the incision and the surrounding tissue. The plurality of closure components may laterally join the left and right base panel segments with each other to form a sandboard arrangement.

One or more of the left or right base panels may include a tissue attachment bottom surface that is attached to tissue adjacent to the incision. One or more of the left or right base panels may comprise a lower attachment layer having a tissue attachment bottom surface and an upper layer having a top surface. The top layer can be harder than the bottom adhesive layer. The lower adhesive layer may be sufficiently elastic to cover swelling and surrounding tissue such that swelling and adhesion loss due to movement of tissue laterally adjacent to the incision closure device are minimized. The lower adhesive layer may comprise a hydrophilic adhesive material. The hydrophilic adhesive material may comprise one or more of hydrocolloids, hydrogels, acrylic polymers or poly (ethylene glycol). The top layer may comprise one or more of rubber, latex, urethane, polyurethane, silicone, thermoplastic elastomer (TPE), woven 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 may be embedded in or laminated to the top surfaces of the left and right base panels.

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

The plurality of suture components, the left axial support and the right axial support substantially extend the incision and the surrounding tissue covered with movement of the tissue laterally adjacent to the incision closure device when covering the incision and the surrounding tissue. They can all be hard enough to prevent them from doing so. Thus, movement of the first tissue region transversely adjacent to the outer periphery of the incision closure device may substantially translate into the same movement of the second tissue region transversely adjacent to the outer periphery and opposite the first tissue region. Can be.

One or more closure components of the plurality of closure components may include a tie securely coupled to the left or right closure component end and adjustablely attached to the opposite closure component end. The opposite closure component end may comprise a ratchet tightening mechanism.

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

One or more of the plurality of left axial supports or the plurality of right axial supports may be formed C-shaped. Each of the C-shaped left and / or right axial supports may comprise an axial portion that limits the axial expansion of the individual base panel and a transverse portion that limits the lateral expansion of each base panel.

This aspect of the invention can also provide a system for closing an incision in a tissue. The system may include an incision closure appliance and an elastic cover overlying the incision closure appliance and the covered incision and surrounding tissue.

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

In another aspect of the invention, an incision closure appliance is provided. The incision closure appliance includes a stretch adhesive bottom layer, an intermediate layer and a top layer. The stretchable adhesive bottom layer may have a first degree of elasticity. The intermediate layer may be bonded to at least a portion of the stretchable adhesive layer to cover the portion and may have a second elasticity lower than the first elasticity. The upper layer may be coupled to at least a portion of the intermediate layer to cover the portion and have a third elasticity lower than the second elasticity. The elasticity gradient between the elastic adhesive bottom layer and the top layer is such that the movement of the tissue transversely adjacent to the incision closure appliance, which occurs when covering the incision and the surrounding tissue, does not substantially expand the covered incision and the surrounding tissue. Sufficient rigidity can be provided for the closure appliance.

The elasticity gradient may provide sufficient elasticity to the incision closure appliance so that swelling and loss of adhesion due to movement of adjacent tissue in the incision closure device is minimized when covering the incision and the surrounding tissue.

The incision closure appliance may extend axially in response to the axial extension of the incision and surrounding tissue covered by the incision closure appliance. Movement of the first tissue region adjacent to the outer periphery of the stretchable adhesive bottom layer results in substantially the same movement of the second tissue region neighboring the outer periphery of the stretchable adhesive bottom layer and opposite the first tissue region.

The stretchable adhesive bottom layer may comprise a hydrophilic adhesive material. The hydrophilic adhesive material may comprise one or more of hydrocolloids, hydrogels, acrylic polymers or poly (ethylene glycol).

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

The stretchable adhesive bottom layer may include first and second adhesive bottom layers. The intermediate layer may include a first top layer coupled to the first adhesive bottom layer and a second top layer coupled to the second adhesive bottom layer. The top layer may include a plurality of axial support structures and a plurality of lateral closure components coupled to the 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. Can be. The plurality of axial support structures and the plurality of suture components extend at least partially in the axial direction of the suture device in response to the axial stretching of the incision and surrounding tissue covered by the incision closure device. Can be combined with one another to form a meandering pattern. The plurality of axial support structures and the plurality of lateral closure components can be joined together to form a ladder pattern. At least one of the plurality of axial support structures or the plurality of lateral closure components may be formed of a flexible non-expandable material. The plurality of lateral closure components may be configured to pull together the inner edges of one or more of the first or first adhesive bottom layer and the first or second top layer after the elastic adhesive bottom layer is attached to the tissue on both sides of the incision. Can be. One or more of the transverse closure components can include a tie securely coupled to the left end, the right end, and the left or right end and adjustablely attached to the opposite end thereof. One or more of the plurality of axial support structures or the plurality of lateral closure components may be embedded in or laminated to the first and second top layers.

This aspect of the invention can also provide a system for closing an incision in a tissue. The system includes an incision closure appliance and an elastic cover overlying the incision closure appliance and the covered incision and surrounding tissue.

The stretchable cover can be configured to extend over the lateral and axial edges of the stretchable adhesive bottom layer. The cover may include one or more holes that allow the cover to at least partially extend in the axial direction of the cover in response to the axial extension of the incision and surrounding tissue covered by the incision closure appliance. One or more holes may be disposed along the central axis of the cover. The cover may include one or more reinforcing members coupled to at least a portion of the adhesive layer of the cover. The reinforcing member may comprise one or more of rubber, latex, urethane, polyurethane, silicone, thermoplastic elastomer (TPE), fabric, or spun fabric. The cover may comprise a hydrophilic adhesive layer. The hydrophilic adhesive layer may comprise one or more of hydrocolloids, hydrogels, acrylic polymers or poly (ethylene glycol).

In another aspect of the invention, an incision closure appliance is provided. The incision closure appliance may include a lower portion having a first elasticity and an upper portion having a second elasticity lower than the first elasticity, and an elasticity gradient exists between the lower portion and the upper portion. Elasticity gradient is sufficient rigidity to the incision closure appliance such that movement of tissue laterally adjacent to the incision closure appliance, which occurs when covering the incision and surrounding tissue, does not substantially expand the covered incision and surrounding tissue. Can be provided. The elasticity gradient can provide sufficient elasticity to the incision closure appliance so that swelling and loss of adhesion due to the movement of the tissue laterally adjacent to the incision closure appliance is minimized when covering the incision and the surrounding tissue.

In another aspect of the invention, an incision closure appliance is provided. The incision closure appliance may include a base having a left panel and a right panel, left and right load distribution structures, and a plurality of closure components. Each panel may include a tissue adherent bottom surface, an upper surface, a first side edge and a second side edge. The left and right load distribution structures can be coupled to the left and right panels, respectively. Each load distribution structure may be adapted to allow axial expansion of the panel along one of the first or second side edges and to limit lateral expansion across the panel and axial expansion along the other side edge. have. The plurality of suture components may be secured to the left and right panels such that the left and right panels are attached to the tissue and the incision formed therebetween and then pull the panels together.

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

The second side edge of each panel may include the outer edges of each panel. The outer edges of each panel may face each other.

One or more of the left and right panels of the base may comprise an elastic matrix. The elastic matrix can comprise an elastomeric membrane, a fabric, or a spun fabric. The elastic matrix may comprise a fabric woven into an elastic element and having an inelastic element along the first or second side edges and extending transversely across the inelastic element.

Each load distribution structure has a main skeleton disposed axially adjacent to the first side edge of the panel, and a plurality of axially spaced laterally disposed transversely and extending from the main skeleton to the first side edge side of the panel. It may include a support. The main skeleton and the transverse support may be formed of a flexible non-expandable material. The load distribution structure can be embedded in or laminated to the top surface of each panel.

The closure component may comprise a right engaging member, a left engaging member and a plurality of transverse braces that hold these engaging members laterally spaced apart by a predetermined distance. The right engagement member may be adapted to releasably engage the support of the right panel, and the left engagement member may be adapted to releasably engage the support of the left panel. At least a portion of the support may have a cleat near one or more edges of the first or second side edges, and the engagement member may have a slot for receiving the cleat. The transverse brace can be adjustablely connected to at least one of the engagement members to allow adjustment of a predetermined distance. The closure component can include a plurality of independent lateral ties attached to at least some of the lateral supports. The transverse tie can be configured to be secured between the transverse supports. The independent lateral ties may each have one end fixed to the panel and a second end that is adjustablely attached to the other panel. The second end may have a ratchet tightening mechanism.

The incision closure appliance may further include a fixation layer adapted to be placed over the assembly after the assembly of the base and the closure component is secured over the incision on the skin of the patient. The pinned layer may have an inner surface with self adhesiveness.

1 is an exploded view of an incision closure appliance constructed in accordance with the principles of the present invention.
2 is a top view of the assembly of the base and load distribution structure that is part of the incision closure appliance.
3 is a cross-sectional view taken along line 3-3 of FIG.
4-7 show the use of the incision closure appliance of the present invention to form and close the incision in the patient's skin.
8 shows an alternative configuration of a closure component for the closure appliance of the present invention.
9 is an exploded view of a further embodiment of an incision closure appliance constructed in accordance with the principles of the present invention.
10 is an enlarged isometric perspective view of the base and load distribution structure of the system of FIG. 9.
11A and 11B illustrate alternative transverse tie configurations that may be used in the instrument of FIG. 1 or 9.
12 illustrates a sacrificial cover positioned over an incision closure appliance in accordance with the principles of the present invention.
13A-13E illustrate the principle of operation of the sacrificial cover shown in FIG. 12 when used with a surgical incision drape to carry out the method according to the invention.
14A-14C are perspective views of additional embodiments of an incision closure appliance constructed in accordance with the principles of the present invention.
FIG. 14D is a top view of the incision closure appliance similar to that of FIGS. 14A-14C and disposed on a subject's knee in accordance with the present invention.
15A is a schematic diagram of an incision closure appliance having a pulley system for laterally joining two neighboring base panels in accordance with the principles of the present invention.
15B is a cross-sectional view of the incision closure appliance of FIG. 15A.
15C shows the incision closure appliance of FIG. 15A disposed on the knee of the model according to the present invention.
FIG. 15D is a schematic diagram of an incision closure appliance similar to the incision closure appliance of FIG. 15A.
15E and 15F show various transverse tie assembly structures for use with the incision closure appliance of FIGS. 15A and 15D, respectively.
16A-16D show various fastening mechanisms in accordance with the principles of the present invention.
17 shows a hinge mechanism for an incision closure appliance in accordance with the principles of the present invention.
FIG. 18 is a top view of the incision closure appliance similar to that of FIG. 14A and disposed on the subject's knee in accordance with the present invention. FIG.
19 shows an incision closure appliance comprising individual pairs of base panel segments in accordance with the present invention.
20A is a perspective view of an incision closure appliance similar to that of FIGS. 9 and 10 and in accordance with the principles of the present invention.
20B is an enlarged view of the transverse tie assembly of the incision closure appliance of FIG. 20A.
21 is an exploded view of a portion of the incision closure appliance of FIG. 20.
22A is a perspective view of a cover for an incision closure appliance disclosed herein in accordance with the principles of the present invention.
22B is an exploded view of the cover of FIG. 22A.
FIG. 23A is an exploded view of an incision closure appliance assembly comprising the incision closure appliance of FIG. 21 and the cover of FIG. 22A in accordance with the principles of the present invention.
FIG. 23B is a perspective view of the incision closure appliance assembly of FIG. 23A attached to the skin of a patient.
FIG. 23C is a top view of the elastomeric reinforcement layer of the cover of FIG. 22A. FIG.
24A is a perspective view of the incision closure appliance assembly of FIG. 23A attached to the skin of a patient in accordance with the principles of the present invention.
24B is a schematic cross-sectional view of the incision closure appliance assembly of FIG. 23A attached to the skin of a patient in accordance with the principles of the present invention.
25A-25C illustrate a method of attaching the incision closure appliance assembly of FIG. 23A on a patient's skin in accordance with the principles of the present invention.
26A-26E illustrate embodiments of a cover for a wound dressing and an incision closure appliance in accordance with the principles of the present invention.
27A-27E illustrate an embodiment of a wound closure appliance comprising a medicament in accordance with the principles of the present invention.
28A-28E illustrate an embodiment of a wound closure appliance cover comprising a medicament in accordance with the principles of the present invention.
29 illustrates another sacrificial cover positioned over an incision closure appliance in accordance with the principles of the present invention.

The devices and methods of the present invention are used for both the formation and closure of surgical incisions formed in the skin or other tissues of a patient during surgical procedures. As will be explained later, the direction of the incision defines both "axial" and "lateral" when the term is used herein. Most incisions will be made along an approximately straight line that defines the axial direction. The transverse direction is generally transverse to the axial direction but is not necessarily perpendicular or perpendicular to the axial direction. Most incisions are generally straight but in some cases the incisions may be curved or have other geometric shapes. The term "axial" therefore applies in the direction of the incision at any particular position, so the transverse direction may also change accordingly.

Referring now to FIGS. 1-3, the incision closure appliance 10 includes a base assembly 12 having a right panel 14 and a left panel 16. The right load distribution structure 18 is fixed to the right panel 14 by laminating a load distribution structure on the upper surface of the panel, and the left load distribution structure 20 on the upper surface of the left panel 16. Are similarly attached. The incision closure appliance further includes a closure component 22 detachably attachable to the right and left load distribution structures 18, 20 for closing the incision as described in more detail below, the instrument being optional. The fixed layer 24 is completed after the combined base assembly 12 and the suture component 22 are secured to the patient and the incision pulls the panels together using the suture component to complete the suture. And may be disposed over the combined base assembly 12 and the closure component 22.

The suture component 22 is intended and is intended to pull the inner portions of the load distribution structures 18, 20 inward toward each other to close the surgical incision that has been formed therebetween. In the illustrated embodiment, a plurality of cleats 26 are formed on the transverse support 36 axially held by the main skeleton 37 of the load distribution structures 18, 20. The cleat 26 is received in a slot 38 formed along the inner edge of the opposing engagement member 40 of the closure component 22. The opposing engaging members 40 are held together by the transverse braces 42 such that the engaging members are fixed and held at laterally spaced distances (in other embodiments, the distances are adjustable). The slot 38 is formed on a flexible tabbed structure 44 that allows the slot to be pulled upwards over the corresponding cleats to secure the sealing component 22 over the load distribution structures 18, 20. desirable.

The lower surface 32 of each panel 18, 20 is usually covered with a pressure sensitive adhesive, which is initially covered with a protective layer 48 that can be peeled off immediately before use. In addition, after the protective layer 48 has been removed prior to attaching the panels to the patient's skin or other tissue surface, pull-away to keep the right and left panels 14, 16 together at a predetermined spaced distance. Tab 50 or other similar structure may be provided. The distance between the inner edges 28 of each panel 14, 16 is kept as close as possible to the original target distance so that the tissue edges are correctly merged by a slight eversion when closed by the suture component 22. It is important to be.

Referring now to FIGS. 4-7, a planning procedure for making an incision and subsequently closing the incision in accordance with the principles of the present invention will be described. First, the right and left panels 14, 16 are arranged on the skin of the patient to which the reference letter S is attached as shown in FIG. The panels 14, 16 are attached by first removing the protective layer 18 and placing the panel in the tissue, followed by the formation of an incision path 52 between the inner edges 28 by removing the tab 50. It can be done. The spacing of the inner edges 28 will be selected to provide a fixed predetermined distance d1.

After the right and left panels 14, 16 are in place, a cutout I can be made in the space between the panels using a scalpel or other surgical cutting instrument (CD) as shown in FIG. have.

After the incision I is formed, a surgical procedure can be performed to open the inner edge of the incision as shown in FIG. 6, thereby deforming the inner edge 28 of the right and left panels 14, 16 accordingly. . Since the innermost ends of the supports 36 are not connected, as shown clearly in FIG. 6, these ends are free to separate and allow the elastic matrices of the right and left panels 14, 16 to expand. However, the dimensional stability of the rest of the panel will be preserved by the transverse support 36 as well as the axial main skeleton 37 which does not stretch under the influence of the applied load by increasing the hole in the incision.

After the surgical planning procedure is completed, the suture component 22 is secured over the load distribution structures 18, 20 as shown in FIG. 7. In particular, the slots 38 in the tabular structure 44 are engaged over the opposing cleats 26 to pull together the tissue incision as well as the opposite ends of the panel. By properly spacing the depth of the slot 38, the closure component 22 can be tailored such that the panels 14, 16 are joined by a preselected distance d ₂ . Typically, the distance d ₂ is greater than the initial separation distance d ₁ so that the inner edges of the tissues merge so that the tissue edges along the incision are somewhat abduction (upward recession) to improve treatment and reduce scarring. Will be small.

Optionally, as shown in FIG. 8, the closure component 22 can include a coupling member 40 ', wherein one end of each transverse brace 42' in the coupling member is opposed to the coupling member. It is coupled by an adjustable clasp or other mechanism 54 such that the distance can be adjusted to increase or decrease the distance d ₂ between the inner edges of 40 '.

An alternative embodiment 100 of the incision closure appliance of the present invention is illustrated in FIGS. 9 and 10. The instrument 100 includes a base assembly 102 having a right panel 104 and a left panel 106. As best shown in FIG. 10, a positioning strip or alignment strip 108 is provided to secure together the inner edges of each panel, which is applied to the user after the panel is placed in place on the tissue surface. And end tabs 109 to allow the strip to be pulled from 10, 106.

The incision closure appliance 100 can be partially folded back to expose the lower adhesive backing on the panel and allow the end of the base assembly 102 to attach to the tissue while the remainder of the base assembly is still covered by the backing. It further comprises a backing 110 having an end. Fixed layer 112 comprising reinforcement frame 113 for placement over right and left panels 104, 106 after base assembly 102 is closed over the incision as outlined in connection with the above-described embodiment. ) Is provided. Typically, a holding tray 114 may be provided to hold the components of the instrument together in a sterile state, where the tray 114 is covered with a conventional medical packaging cover.

As shown in FIGS. 9 and 10, a right load distribution structure 116 and a left load distribution structure 118 are provided on the top surfaces of each of the right panel 104 and the left panel 106. The right load distribution structure 116 includes a right axial main skeleton 120 and a plurality of lateral supports 122. Typically, the right axial main skeleton 120 includes a sand member or a zigzag member embedded in or laminated to the base strip 121. The sand axial main skeleton 120 may typically be formed of stretchable elastic plastic (typically, rigid plastic), while the base strip 121 will consist of a polyurethane or similar plastic layer. The bottom side of the polyurethane layer will be covered with a hydrocolloid layer for tissue attachment. The structure of the left load distribution structure 118 includes and will be identical to the left axial main skeleton 124, the left transverse support 126 and the left base strip 127.

The incision closure appliance 100 will include a closure mechanism that includes a plurality of lateral tie assemblies 128 as shown in FIG. 9. As best shown in FIG. 10, each transverse tie assembly 128 has a rod fixed at one end to a left transverse support 126 and a ratchet mechanism 132 secured to a right transverse support 122. It includes. Each rod 130 will typically be aligned with the axis of the left panel 106 group so that the gap 129 between the right panel 104 and the left panel 106 is left open so that an incision can be formed therebetween. will be. After the incision is made, each rod 130 is pulled into the associated ratchet 132 on the right panel 104. A series of ratchet rings on each rod is pulled into the associated ratchet mechanism 132, and then the rods are pulled laterally until the desired sealing tension is applied to the point along the base assembly 102. It is a particular advantage that each of the transverse tie assemblies 128 can be individually adjusted to provide the desired suture tension across the tissue along the length of the incision to be sutured. Once the desired suture tension is provided along the entire incision, a pinning layer 112 can be placed over the base assembly 102 to hold the instrument and tissue in place.

Referring now to FIGS. 11A and 11B, an alternative configuration of the transverse tie assembly 140 of the present invention is illustrated. These transverse tie assemblies 140 may be used in the incision closure appliance 10 or 100 previously described. Each lateral tie assembly 140 includes a right load distribution structure 142 and a left load distribution structure 144. The right load distribution structure 142 includes a right main skeleton 146 and a plurality of lateral supports 148. While three are shown, it will be appreciated that four, five, six or more lateral supports may be included. The left load distribution structure 144 similarly includes a left main skeleton 150 and a plurality of left transverse supports 152. To achieve closure, the right load distribution structure 142 includes a rod 154 extending from the central transverse support 148. Typically, rod 154 is coupled to the support by a live joint or passive joint 158. The free end of the rod 154 is provided with a pull loop 156 and a plurality of ratchet teeth 162 along the middle portion of the rod 154.

The left load distribution structure 144 includes a ratchet mechanism 160 adapted to receive the teeth 162 on the rod 154 of the right load distribution structure. In this way, the rod 154 is pushed forward by being lowered into the ratchet 160 to which the teeth 162 are coupled to pull the right and left load distribution structures 142 and 144 together to the right and left panels. Tension can be applied.

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

The right panel 104 is covered by the right sacrificial cover 170, and the left panel 106 is covered by the left sacrificial cover 172. The right and left panels 104, 106 may form an area 175 in which the right and left sacrificial covers 170, 172 are separated from the right and left panels 104, 106. Each cover 170, 72 is removably secured along each edge of the associated base panel such that the cover is held in place during placement and normal handling of the incision closure appliance 100 over the tissue surface to be cut. The use and purpose of the sacrificial covers 170, 172 are described with reference to FIGS. 13A and 13E.

13A illustrates the right and left panels 104, 106 in place on tissue surface T before an incision is made. The right panel 104 is covered by the right sacrificial cover 170, and the left panel 106 is covered by the left sacrificial cover 172. As is common in many surgeries, an adhesive surgical incision drape 180 is placed over the tissue surface T. Any conventional drape may be used, such as the Ioban ^™ antimicrobial incision drape, available from 3M, Minnesota St. Paul.

After the incision drape 180 is in place over the incision closure appliance, a surgical incision I can be formed to perform the desired surgical procedure. As can be appreciated, the incision I is cut through the surgical drape 180 between the right panel 104 and the left panel 106. After the surgical procedure is completed, surgical drape 180 will be removed from the tissue surface T. Since the surgical drape has an adhesive bottom surface, prior to the present invention, removal of the drape would displace either or both of the right panel 104 and the left panel 106. However, such displacement is prevented by the presence of sacrificial layers 170 and 172. Removal of surgical drape 180 will remove sacrificial layers 170, 172, but because each of these layers is configured to separate with relatively low separation forces, displacement of lower panels 104, 106 due to removal of sacrificial layers Is not caused. Thus, the panels 104 and 106 are held in place as shown in FIG. 13D and the load distribution structure 116 as described above to seal the panels together to seal the incision as shown in FIG. 13E. 118) can be used.

Referring to FIG. 29, the right and left sacrificial cover layers 170 and 172 may each be made of a urethane thin sheet (eg, 0.001 inch thick). The middle portion of the urethane sheet may be attached to the top of the right and left panels 104 and 106, and any strap 130 and fixture 132 as well as a load distribution structure are assembled on top of the urethane sheet. The urethane sheet can then be wrapped around the load distribution structure 116, 118 (and bent inward as shown in FIG. 29 so that the strap 130 is wound over the panel 106), free of urethane The ends are stacked on each other along their length. Thus, the urethane sheets may surround over the load distribution structures 116, 118 and the suture elements 130, 132 to protect them from the surgical drape 180. The urethane sheet may preferably include a plurality of holes disposed along its length and disposed adjacent to the inner and outer edges 104e, 106e of each panel 104, 106. The hole may allow the urethane sheet to be torn away with the surgical drape 180 in a controlled manner when the surgical drape, such as the surgical drape 180 described herein, is removed. Although the exact dimensions change to control the desired bursting force, the holes may preferably consist of a 3 mm cut and a 1 mm connection. The holes may be formed along a single longitudinal line or along a plurality of lines. The plurality of longitudinal hole lines may allow for reliable separation despite the change in which the surgical drape is attached to the sacrificial layers 170 and 172. The holes are more easily pulled off near the edges of the panels 104 and 106 to improve the likelihood of separation near the edges 104e and 106e of the panels 104 and 106 and to minimize the excess urethane left behind. It can be formed to be. To help lift the sacrificial layers 170 and 172, a tab 170t may be attached to each end of the urethane package including the sacrificial layers 170 and 172. The tabs 170t, 172t may preferably be attached to the interior of the upper surface of the urethane package. Tabs 170t and 172t may have a shape that prevents urethane from adhering to the tab itself or to any adhesive exposed from the ends of each panel 104, 106. Preliminary rupture of the holes at the ends of each panel 104, 106 may initially lift the tabs 170t, 172t and initiate the rupture by the user.

Referring now to FIGS. 14A-14C, a further embodiment of an incision closure appliance is illustrated. The base structures 1400a (FIG. 14A), 1400b (FIG. 14B), and 1400c (FIG. 14C) may include a right base panel 1402 and a left base panel 1404, respectively. The right base panel 1402 may include an upper layer 1406 and a lower layer 1408. Similarly, left base panel 1404 may include top layer 1410 and bottom layer 1412. Top layers 1406 and 1410 are typically stretchable but strong enough to firmly seal tissue and minimize disruption of the incision and surrounding tissue. Top layers 1406 and 1410 may include plastic layers formed from rubber, latex, polyurethane, silicone, thermoplastic elastomers, fabrics, spun fabrics, or similar materials. The adhesive lower layers 1408 and 1412 are typically stretchable and more elastic than the upper layers 1406 and 1410 to follow any movement of the underlying skin and tissue to maintain adhesion, minimize swelling and otherwise reduce irritation. to be. The adhesive underlayers 1408 and 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 can include structures that enable and limit axial and transverse stretching of the base assembly 1400. These structures can also distribute the sealing force applied to the incision uniformly and can be disposed on the base assemblies 1400a, 1400b, 1400c along their axial lengths. The right base panel 1402 can include one or more right load distribution structures or axial supports 1414. Each right axial support 1414 may include an axial support or mainframe 1414a and two transverse supports 1414b coupled to the axial end of the mainframe 1414a. In addition, the mainframe 1414a and the two transverse supports 1414b form a C-shaped shape, which in some embodiments is the two transversely neighboring sides of the adjacent support 1414. The axial extension between the two lateral supports 1414b of one support 1414 is axially stretched to allow axial extension of the right base panel 1402 between the lateral supports 1414b. Can be opened. In many embodiments, the C-shaped axial support 1414 is stretchable only to the extent that it can be bent vertically and rigid enough to minimize axial and transverse stretching. As shown in FIG. 14A, the right axial support 1414 may face inward. As shown in FIGS. 14B and 14C, the right axial support 1414 may be facing outwards, which cuts any mechanical loads between the right and left base panels 1402, 1404 that resist tissue closure. It may help to dispense with (I). Similarly, left base panel 1404 may include one or more left load distribution structures or axial supports 1416. Each left axial support 1416 may include an axial support or mainframe 1416a and two transverse supports 1416b coupled to the axial end of the mainframe 1416a. In addition, the mainframe 1416a and the two transverse supports 1416b form a C-shaped shape, which in some embodiments is the two transversely neighboring sides of the adjacent support 1416. The axial extension between the two lateral supports 1416b of one support 1416 is axially limited to allow axial extension of the left base panel 1402 between the lateral supports 1414b. Can be opened. In many embodiments, the C-shaped axial support 1416 is stretchable only to the extent that it can be bent vertically and rigid enough to minimize axial and transverse stretching. As shown in FIG. 14A, the left axial support 1416 may face inward. As shown in FIGS. 14B and 14C, the left axial support 1416 may be facing outwards, which is an incision between the right and left base panels 1402, 1404 that resists any mechanical load that resists tissue closure. It may help to dispense with (I).

As shown in FIG. 14C, the base panel assembly 1400c may further include skirt portions 1424, 1426. The skirt portions 1424, 1426 may be similar to the thin base assembly cover described below. For example, each skirt portion 1424, 1426 may comprise a 0.001 inch thick urethane film bonded to a 0.02 inch thick acrylic adhesive. The adhesive may be applied to the entire bottom of the skirt portions 1424, 1426 or only to the skirt portions 1424, 1426 beyond the base panel 1402 or 1404. During the construction of the base panel assembly 1400c, the skirt portions 1424 and 1426 may be attached directly to all or a portion of the adhesive layers 1408 and 1412, respectively. The skirt portions 1424, 1426 may be attached instead of or in addition to the thin film top layers 1406, 1410, respectively. The release liner described herein may further be provided to cover the adhesive bottom of the skirt portions 1424, 1426. The skirt portions 1424, 1426 can extend beyond the boundaries of the base panels 1402, 1404 by, for example, 8 mm or 1 to 20 mm, but the base panel (to improve the ability to visualize and / or clean the incision site). It does not run across the transverse region between 1402, 1404. Thus, the skirt portions 1424, 1426 may provide additional adhesive support to the adhesive layers 1408, 1412 of the base panels 1402, 1404 without the need to align and place individual covers or cover sheets over the base panel assembly 1400. Or help to provide a reduction in gradual creep. After manufacture, the skirt portions 1424, 1426 are typically already correctly aligned with respect to the base panels 1402, 1404. Individual covers or cover sheets as described herein may still be used to prevent tampering of the incision and the components of the base panels 1402, 1404. The skirt portions 1424 and 1426 already extend laterally over the base panels 1402 and 1404, respectively, so that such individual covers or cover sheets may not require precise placement of the base panel assembly 1400c and are described herein. The width may be narrower in comparison to other covers or cover sheets that may be used.

One or more holes 1418 may be provided between the axially neighboring right axial supports 1414 on the right panel 1402 to facilitate axial and / or transverse stretching of the right base panel 1402. have. The holes 1418 may exist over the top and bottom layers 1406 and 1408 or only in the top layer 1406 to allow air to flow into the underlying tissue. Similarly, one or more holes 1420 may be provided between the axially neighboring left axial supports 1416 on the left panel 1404 to facilitate axial and / or transverse stretching of the base panel 1402. Can be. The apertures 1420 may exist over the top and bottom layers 1410, 1412 or only in the top layer 1410 to allow air to flow into the underlying tissue. As shown in FIG. 14A, only one hole 1418 or 1420 may be present between the axial supports 1414 or 1418. As shown in FIGS. 14B and 14C, there may be a plurality of holes 1418 or 1420 in the transverse line between the axial supports 1414 or 1418. The holes 1418 and 1420 may reduce the stress that occurs while the skin extends radially outward from the incision I, such as during joint motion and during swelling.

A plurality of holes 1418, 1420 may be provided between the axial ends of the right and / or left axial supports 1414, 1416, for example, along the right and left lines 1424, 1426 shown in FIG. 14D. . Each line segment 1424, 1426 such that at least each of the upper and lower layers 1410, 1412 of the base panel 1402, 1404 can be separated into individual segments as they are axially stretched as described further below. A plurality of holes axially aligned on the top may be provided. In some cases, the holes 1418 and 1420 during wear of the instrument 1400 are such that the layers 1406 and 1408 of the right panel 1402 and the layers 1410 and 1412 of the left panel 1404 are completely separated from the hole lines. Can be allowed to fall off, which is illustrated in FIGS. 14B and 14C. The ability to completely separate and fall further allows the skin to stretch axially as needed, which is allowed by the connection of the axial supports 1414 and 1416 and the closure component 1422 as discussed below. And limited). As discussed herein, after the incision I is closed, an elastic flexible cover may be attached over the base panels 1402 and 1404. The cover may further have the ability to provide (and limit) axial and transverse movement of the base structure 1400b. Alternatively or in combination, one or more of the right or left base panels 1402, 1404 may have a load distribution structure or to facilitate axial and / or transverse stretching of the right and / or left base panels 1402, 1404. It can be cut and separated transversely between the axial supports 1414, 1416.

In order to join the right and left base panels 1402 and 1404 together laterally and optionally tighten the right and left base panels 1402 and 1404 relative to each other, the base assembly 1400 is configured with a plurality of transverse sutures. Element or tie assembly 1422 may further be included. The lateral closure component or tie assembly 1422 may include a ratchet mechanism similar to the ratchet mechanism of the lateral tie assemblies 128 and 140 described above. The transverse tie assembly 1422 can engage the laterally adjacent right and left axial supports 1414, 1416 together at their axial ends. As shown in FIGS. 14A-14C, the placement of the right and left axial supports 1414, 1416 on the right and left panels 1402, 1404 can be staggered or axially offset, respectively, and the right and left axes The directional supports 1414, 1416 may be C-shaped structures having transverse ends 1414b, 1416b that are laterally opposite and aligned with each other (and connected to each other by a lateral tie assembly 1422). For example, the far side end 1414b of the first right axial support 1414 may be laterally aligned with the near side end 1416b of the first left axial support 1416 and the first left side. The far side end 1416b of the axial support 1416 may have a configuration such as to be laterally aligned with the near side end 1414b of the second right axial support 1414. Thus, the lateral tie assembly 1422 and the right and left axial supports 1414, 1416 are connected to each other to form a line of continuous lateral tie assemblies 1422 and the right and left axial supports 1414, 1416. This line may indicate the distance between the right and left base panels 1402 and 1404 transversely (i.e., the right and left base panels 1402 and 1404), as shown in FIGS. 14A-14C. May have a serpentine arrangement. The meandering arrangement of the lateral tie assembly 1422 and the right and left axial supports 1414, 1416 distributes the sealing force provided on the incision by the base assembly 1400, the base assembly 1400. Providing (limiting) the axial stretch of the substrate, providing rigidity or rigidity to the base assembly 1400a, 1400b, 1400c to fully seal the incision, and allowing the incision to heal with minimal collapse and expansion (i.e., , Lateral stability and axial stability). In many embodiments, the transverse supports 1414, 1416 are rigid enough to allow an area of the base panels 1402, 1404 not covered with the transverse supports 1414, 1416. Because these uncovered areas are offset from each other from the right base panel 1402 to the left base panel 1404, the tie assembly 1422 is axially from its anchor point when the incision I extends in the axial direction. Can be pivoted. This axial pivot of the tie assembly 1422 may bring the left and right panels 1402 and 1404 closer together to maintain the suture of the incision I. FIG.

The materials of the lateral tie assembly 1422 and the right and left axial supports 1414, 1416 may comprise stretchable elastic plastic, which is typically a hard plastic such as, for example, nylon, polypropylene, polyethylene, polycarbonate, and other thermoplastic polymers. have. Sometimes the lateral tie assembly 1422 and the right and left axial supports 1414, 1416 may comprise a material that is less elastic than the materials of the right and left base panels 1402, 1404. Thus, including many other base assemblies of the incision closure appliance disclosed herein, the upper side of the base assemblies 1400a, 140bb, 1400c can be provided more rigidly (and less elastically). In other words, there may be an elasticity gradient between the top and bottom of the base assemblies 1400a, 1400b, 1400c. The upper portions of the base assemblies 1400a, 1400b, 1400c are provided with the transverse neighboring tissue of the instrument so that the incision closure appliance substantially expands the covered and surrounding tissue when attached to the incision and surrounding tissue. It can be hard or hard enough to prevent migration. In other words, the movement of at least a portion of the attached incision closure appliance (ie, the lower portion of the harder layer) is collective and does not interfere with the incision below. And, the bottom of the base assembly 1400a, 1400b, 1400c may be sufficiently elastic to minimize bloat and adhesion loss due to movement of tissue adjacent to the attached incision closure appliance. The primary function of the transverse tie assembly 1422 may be to apply tension to each of the base panels 1402 and 1404 to maintain the closed incision I, but in many embodiments the transverse tie assembly ( 1422 is incised by minimizing the effect of compression (or bending / wrinkling along the incision) on the incision I from a distraction force that may interfere with incision edge alignment and attachment apposition. It may also have the function of providing column strength to break the portion (I). The axial spacing, material properties and dimensions of the transverse tie 1422 can be optimized for sufficient axial flexural flexibility and lateral compression and flexural support. In a preferred embodiment, the spacing of the tie 1422 is 10 mm, the material of the tie 1422 is nylon, and the dimension is a round cross section of 0.30 inches.

Referring now to FIG. 14D, the base assembly 1400b may be placed over an incision in a subject's joint, such as a knee, or the patient's skin. Especially for incisions located close to articulated joints, such as knees, the suture device or the suture device as a whole is often challenged by a number of factors. These factors include longitudinal stretching, peripheral swelling, opening of the wound when joint motion occurs, skin damage such as swelling, loss of adhesion and passage of wound secretions. Joints such as knees, elbows, ankles, shoulders, and the like, can cause the aforementioned challenges by exhibiting movements that can sometimes result in joint motions involving movements of 135 degrees or more.

In a bent position, the skin around the knee may stretch by 50% in the axial direction (ie, parallel to the incision) and in the transverse direction (ie, across or perpendicular to the incision). The incision closure appliance attached to the skin in this area will preferably provide sufficient tension to close the incision and allow elongation with minimal local stress. Minimization of local stress can prevent damage to the skin if no local skin loss or adhesion loss has occurred. An important property for many of the incision closure devices disclosed herein is the ability of the tensioning of the closure elements of the device to be distributed across an area greater than the area of the tension element attachment point itself. In addition, the structure comprising the adhesive to which the tensioning element is attached may in many cases have the ability to distribute the compliance of the structure across the skin elongation region so that the suture device holds the incision in place while the skin moves around. have. Embodiments described herein may include a complex design of non-extension tension elements (collectively referred to as "straps") connected to "fixes" that hold the strap in place. For example, such elements may include the lateral tie assemblies 128, 140, 1422 described above. These elements can be mounted on the skin adhesive with an elastomeric material that helps distribute the tensile load. Such elastomers can in many cases have high elongation prior to yielding or permanent deformation, and can include various grades of silicone as well as thermoplastic elastomers such as polyurethanes. In addition, these materials can be easily formed into thin films required to maintain a low profile and sufficient compliance.

In addition, the skin adhesive used in the closure device must be able to resist stretching of the skin and to shrink / recover when the skin returns to an unextended state, such as in a fully extended knee position. Hydrocolloid adhesives can provide these properties and are preferably suitable for this application. Other adhesives such as acrylics can also be used to provide this property. In general, such adhesives need to be attached to an elastic thin film as described above to maintain the structure during expansion and contraction. Without this support, the adhesive can rupture and separate by repeated stretching.

An incision closure appliance configured as a series of short segments can allow a higher value of total stretching without loss of adhesion or skin damage. Each individual segment may experience local elongation of the skin beneath it. The space between two neighboring segments can act as a stress relief space that allows the skin to stretch within that space. Segmentation can be accomplished in a variety of ways by (1) laying down individual segments along the incision line, or (2) allowing the instrument to be divided into fragment segments when attaching to the skin or after attaching to the skin.

Preferred means of achieving segmentation after attachment to the skin are holes (i.e., holes that facilitate rupture) in the polyurethane layer (i.e., top layers 1406, 1410 of base panels 1402, 1404), as described above. Lateral lines) and leave the underlying adhesive intact as shown in FIG. 14D. The holes can cause at least the top layer of the base panel (eg, top layer 1406, 1410) to tear along the hole line (eg, 1424, 1426) if the knee experiences stretching when the knee is bent (ie, during joint movement). . In a preferred embodiment, the adhesive panel on each side of the incision can be 12 mm wide and the holes in a given panel are separated by about 12-20 mm. Experiments were performed and the results showed that holes of 3 mm cutting and 1 mm connection distance were effective in achieving segmentation of 0.001 inch thick urethane base panels when the knees were bent. When the knee is bent, the skin can be stretched axially (in the direction along the incision) and in the transverse direction by 50% in some locations. Thus, the separation of the polyurethane can relieve stress in the apparatus when undergoing stretching.

For example, a surgically treated knee may become inflamed for several days, which can result in radial swelling of the joints about 30% after closure. An elastic material, such as polyurethane, may cause the surrounding swelling to inflate the incision closure appliance (eg, including the base assembly 1400b attached to the resulting incision I of FIG. 14D). Minimizing the width of the instrument (eg, 12 mm or less for each base panel segment 1402, 1404) can reduce the amount of inflation of the instrument in a direction perpendicular to the incision I and thereby reduce the likelihood of skin damage. The attachment can be maintained while minimizing. 14D shows the holes in the adhesive segment running laterally to the incision along lines 1424 and 1426 to allow for easier axial stretching. Holes or other perforations can be formed near the outer edge of the adhesive segment parallel to the incision to reduce the stress that occurs when the skin stretches radially outward from the incision, for example, during joint movement and during swollenness.

Referring now to FIGS. 15A-15D, the incision may be forced to open the incision, often due to bending of the knee or other joint. In many embodiments, the incision closure appliance includes a locking mechanism that resists opening forces by tight closure during bending to help maintain the incision closed. 15A and 15B illustrate a base assembly 1500 of an incision closure appliance that includes a mechanism that utilizes the pulley effect, i.e., the use of the shortening of the distance between the fixation points on each side of the incision as the skin stretches along the incision. Shows. In a preferred embodiment, the adhesive panels 1510a, 1510b on each side of the cutout between the pair of base panels 1510a, 1510b have a width of 12 mm and the lined holes 1530 in a given panel 1510 Separated by about 18 mm. Typically, all members of the fastening mechanism do not stretch. The triangle formed by the anchor 1540, pulley 1520, fastening 1550 and stretchable fastening element 1580 (eg, rope or strap) is an axial base along the incision as shown in FIG. 15C. B) and transverse height H across the incision. When the knee is bent, the base length of the triangle increases. Normally, all the members of the triangle do not stretch, which requires the height to be reduced to cause further closure force across the incision by maintaining the length of the individual elements between any two points. 15A and 15B further show that the bottom surface of the base panels 1510a and 1510b may include a hydrocolloid adhesive 1560 and one of the panels 1510a and 1510b is secured to hold the strap 1580 in place. It is shown that it may include an arm 1570. While the bottom side of the triangle is shown as being on the left base panel 1510b in FIG. 15A, it is contemplated that the bottom side of the triangle may instead be on the right base panel 1510a.

The triangle may be formed by anchor 1540, pulley 1520, anchor 1550 and stretchable anchor element 1580, although other forms are also contemplated. For example, the pulley 1520 may be wound around two anchors 1540 to form a square or rectangular shape, or may be wound around three or more anchors 1540 to form a trapezoidal shape. Referring to FIG. 15D, a base assembly 1500a of an incision closure appliance similar to the base assembly 1500 is illustrated. In the base panel 1500a, the anchor 1540, two pulleys 1520, the anchor 1550 and the elastic anchor element 1580 provide additional closure to the incision I when the underlying skin is stretched. Form a rectangle. In the rectangular configuration shown in FIG. 15D, the spacing between two fixed points on each side of the incision I will usually be the same. In contrast, in the triangular configuration shown in FIGS. 15A and 15C, the fixed point on the pulley 1520 side may be spaced farther than the other side of the cutout I. FIG. The rectangle is illustrated as "open" on the left base panel 1510b, but the rectangle may instead be "open" on the right base panel 1510a.

In the base assemblies 1400a, 1400b, 1400c of the incision closure appliance shown in FIGS. 14A-14C and the other assemblies described herein, individual straps 1422 for engaging individual fixtures on the opposite side of the incision I This can be used. In FIGS. 15A-15D, each stretchable securing element or strap 1580 is typically secured to one side of the incision I and wound around the other side of the incision I at the same position as the anchor 1540. Coupling with the fixture 1550 on the side. In the embodiment illustrated by FIG. 15D, the stretchable fastening element or strap 1580 is fitted with two fastening spools (bobbin / pulley 1520) on the other side of the incision I before engaging the fastening 1550 on the same side. )] Is wound around. It may be desirable for the spools 1520 to which the elastic straps 1580 are wound to connect with a rigid member so that the distance therebetween does not increase when the suture base panel assembly 1500 is axially stretched. In alternative embodiments, it may be desirable to allow expansion between pulleys or spools 1520. It should be noted that the elastic anchoring element 1580 may be secured to one base panel segment while being fastened to a neighboring segment separated by holes 1530 in the base panel 1510a or 1510b. This fastening and fastening can form a connection between three segments of the base strip, two on the same side and one on the other side. When taken together across the length of the incision closure appliance or base assembly 1500, 1500a, the attachment mechanism forms a continuous 'S' shaped (ie meandering) connection across the incision (I).

The elastic connection 1580 wound and tensioned around the spindle, spool or pulley 1520 may be configured to provide extra pressure to the incision I when the interference forces open the incision and the underlying skin is stretched. have. Elastic strap 1580 can in some cases become loose by potentially slipping off the spindle if the two base panels 1510a are further compressed by a combined external force without stretching the underlying skin. To prevent the occurrence of such slippage, the stretchable winding member 1580 can be slidably included or secured in the element 1590 secured to the base strip 1510a. 15E and 15F show stretchable element 1580 stitched in turn through a tube 1590 that is attached or secured to base panel 1510a. When the base panels 1510a and 1510b are brought together close together, the elastic strap element 1580 will continue to provide the necessary closure function while still being constrained. In another embodiment, the spool feature 1590 shown in FIGS. 15E and 15F may have a center hole through which the strap 1580 slides. Elastic strap 1580 and elements 1590 through which the strap slides may be preferably designed to minimize friction between these elements 1580, 1590.

The experiment was carried out when 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 (typically about 16 mm) after closure of the incision. The bending of the suture device on the knee resulted in a 5% decrease in height H in the region where the stretching of skin S was at its maximum. It should be noted that the height reduction may depend on a number of factors, such as the base of the triangle, the stretch level of the underlying skin and the distance between the two bases on the side of the incision. The connection "strap" between the anchor 1540 and the anchor 1550 may need to be able to be at least partially curved to allow the formation of a loop around the pulley. In a preferred embodiment, monofilament plastic yarns are incorporated with the features that are incorporated into the fixing mechanism. This feature may be a round “teeth” that engages in a ratchet mechanism in the fixture. Such plastics can be used to achieve the desired stretch, longitudinal stiffness, low bacterial propagation and tolerance of extrusion and / or injection molding processes. Braided sutures (preferably coated to inhibit bacterial propagation) may be used to form stretchable but unstretched connections. Round wires or tubes made of a stretchable material such as silicone may be used to achieve stretch. The strap of the pulley may be a composite of materials such as molded plastic and braided sutures. In another embodiment, the strap of the pulley may be formed by necking the molded strap. Pulling the forming strap beyond the yield point can permanently reduce the cross section of the strap and make it more stretchable when stretched. Heat may be used in the necking process to facilitate stretching and cross-sectional area reduction. Once the desired closure is achieved, an alternative mechanism shown in FIGS. 16A and 16B can be used to secure the strap material such as suture and soft plastic. 16A shows a locking mechanism that includes a slot 1610 and a locking frame 1620 for sliding. 16B shows a fixation mechanism that includes fixation teeth 1630. 16C shows a locking mechanism that includes a slot 1640 and a locking frame 1650 for sliding. 16D shows a fixation mechanism that includes a cylindrical tube 1660 and a fixation tooth 1670.

Additional closure force across the incision that occurs when the knee is bent may be achieved by using a hinge mechanism 1700 as shown in FIG. 17. As shown in FIG. 17, four points on each side of the incision (each side of the incision closure appliance or two fixation points 1720 on the base panel 1710) are connected X-shaped with the unstretched arm but intersect. A hinge connection may be provided to the unit 1740. As the knee is bent so that the distance between two points on the same side of the incision increases, the distance between segments on the side of the incision can decrease so that additional suturing force can be formed. As shown in FIG. 17, the base panel 1710 may also include a plurality of holes 1750 to facilitate axial stretching to the base panel 1710 or separation into individual segments during axial stretching. have.

As shown in FIG. 18, the straps and fixtures of the incision closure appliance 1800 according to various embodiments are S-shaped or meandering across the entire length of the incision I on the skin S of the knee, or It can be configured to form a batch. The incision closure appliance 1800 may be similar in many respects to the incision closure appliance 1400 described above. The segments 1810a and 1810b of the instrument 1800 are connected to each other by connecting each segment 1810a on one side of the incision I with two neighboring segments 1810b on the opposite side of the incision. This can be accomplished by mounting a pair of straps 1820 in each segment 1810a and a pair of fastenings 1830 on corresponding segments 1810b on the other side. Each pair of fixing parts 1830 and the strap 1820 may be connected to each other. One of the straps 1820 of the base panel segment 1810a (eg, segment 1810a1) (eg, strap 1820a) during the closure of the wound or incision I is a segment of the other side of the incision I. 1810b (eg, a strap 1820a) on the (e.g., segment 1810b1), the second strap 1820 (e.g., strap 1820b) may be connected to a previous strap (e.g. 1820 (eg, strap 1820a) a fixture in segment 1810 (eg, segment 1810b2) opposite the cutout I adjacent to segment 1810b (eg, segment 1810b1) to which the pair is connected 1830 (eg, 1830b). The aforementioned connection forms a single loop of S-shaped or meandering arrangement of base panel segment 1810, strap 1820 and fixture 1830. Hole line 1850 may separate adjacent base panel segments 1810a and 1810b in the axial direction. Hole line 1850 on one side (eg, in base panel segment 1810a) may be staggered with hole line 1850 on the other side (eg, in base panel segment 1810b). Similar to FIG. 15A, in a preferred embodiment, the adhesive panel on each side of the incision can be 12 mm wide and the holes in a given panel can be spaced about 18 mm apart.

An incision closure device or instrument as described herein can be applied in a number of ways. 19 shows an exemplary incision closure appliance 190 in accordance with some embodiments. Here, pairs of separate base segments 1910 may be provided on separate carrier / release liners. Each base panel segment 1910 pair includes a strap 1920 and a fixture 1930 that are aligned independently of the incision and can be attached to the skin adjacent to each other. Individual segments 1910 may be held together relative to each other with release liner and outer carrier tape 1950. The release liner 1950 may be removed to expose the adhesive, but the entire instrument 1900 or grouped portions of the instrument 1900 may be connected with an outer carrier tape. When attached to the skin, the carrier tape 1950 can be removed, leaving adhesive segments that are aligned with each other but independently movable.

The perforated segments of the base panel top layer, typically comprising polyurethane, can be maintained with a continuous layer of adhesive underlayer, typically comprising a hydrocolloid adhesive, to allow it to be laid down on the skin in one continuous operation. The incision closure mechanisms 1400, 1500, and 1800 of FIGS. 14A-14D, 15A-15C, and 18 may each comprise such a continuous adhesive underlayer.

The base assembly or base panel of the incision closure appliance described herein may preferably be coated with a stretchable adhesive film material at the ends of the wound or incision closure. This film area may preferably be larger than the base incision closure panel element so as to overlap the base incision closure panel element over the skin. The film can help to prevent movement of the base and can prevent any accidental movement of the anchor and the fixing mechanism. The cover film may be made of stretchable material such as rubber, latex, polyurethane, silicone or thermoplastic elastomer, and the like. In a preferred embodiment, a thin cover (eg, a laminate of 0.001 inch thick urethane and 0.002 inch thick acrylic adhesive) will have greater compliance 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 so that the incision can be visually observed. The cover may be completely sealed across the incision (eg, as a barrier to infection) or there may be an opening in the cover aligned with the incision line to allow passage of any secretion from the wound. The cover may also have the function of improving the attachment growth of the incision edge by bridging the base panel and attaching to the skin edge between the base strips. The cover may be composed of additional reinforcing elements that improve the tensile strength between the base panel elements but allow for compliance along the incision length. Preferred embodiments may include a series of polyethylene adhesive tape strips attached to a cover.

The user may attach the cover after the base assembly and the panel have been placed on the skin, but it is also contemplated that the cover material is supplied as a "skirt" extending around the outer periphery of the base segment. Thus, the alignment of the cover material with respect to the base may not depend on user placement. These same cover materials can provide effects such as preventing the hydrocolloid adhesive from being exposed to the patient's clothing, limiting the movement of the hydrocolloid or other adhesive underlayer, providing strain relief to tension on the base segment, and the like.

In various embodiments, hydrocolloid adhesives are used to tighten the skin for incision closure. Hydrocolloids can cross the skin and hydrocolloid adhesive to (1) use laminates on the surface to limit creep movement or (2) prevent creep movement and provide strain relief to the skin to prevent skin damage. Creep movement can be prevented by one or more of attaching the adhesive cover.

In various embodiments, the cover used with the base assembly may include one or more of holes or openings to remove wound secretions (and any bandages / adsorbent material attached) without removing the attached base assembly. have.

In various embodiments, the cover comprises a composite of stretchable urethane and reinforcing strips. The composite configuration can provide compliance along the incision length as well as providing strength across the incision.

In various embodiments, the cover in combination with the base assembly can significantly prevent aligning the skin incision edges or subsequently misaligning the skin edges in the axial and transverse directions.

In various embodiments, a cover liner configuration is provided so that a portion of the cover can be first attached to the skin, which aids in the removal of the other liner, thereby adjusting the thin material to evenly spread the thin material with minimal wrinkles. Can help.

In various embodiments, removal of the first liner may allow observation during placement to prevent the rest of the closure appliance from sticking to the user.

Referring again to FIGS. 9 and 10, in various preferred embodiments, two adhesive panels 104, 106 may be attached to the side of the surgical incision (prior to or after the incision). Suspension mechanisms may be mounted on top of the adhesive panels 104, 106, and preferably attached to components 20 to help distribute the suture force between the attachment points of the closure mechanisms. As shown in FIGS. 20A and 20B as well as FIGS. 9 and 10, such a closure mechanism may include a strap 130 and a fixture 132. Strap 130 may include an elongate component with mating teeth. Fixing portion 132 may include features that constrain the engaging teeth of strap 130. The strap 130 can be tightened in the fixture 132 to pull the adhesive panels 104, 106 (and thus the incision edges) together. The user may loosen or restrain the strap 130 in the fixing part 132 as necessary to appropriately adjust the degree of skin closure. In addition, the incision closure appliance shown in FIG. 20A can be described as the base or base assembly 102.

The skin adhesive used for each panel 104, 106 may preferably comprise a hydrocolloid adhesive. Alternatively or in combination, the skin adhesive may comprise one of a number of acrylic formulations known in the art. Hydrocolloid adhesives may have the advantage of being highly tacky, absorbing moisture and exfoliating skin cells. Thus, hydrocolloid adhesives may be particularly suitable for long time wear applications (eg, up to 14 days). However, at least in some cases, the hydrocolloid structure is soft, under tension unless it is reinforced in some way, such as by covering the hydrocolloid adhesive layer with a harder base panel 102, 104 or other cover structures disclosed herein. There may be a tendency to creep.

Accordingly, a further aspect of the present invention is also to provide various means for reinforcing and protecting the adhesive layer in the base assembly of the incision closure appliance disclosed herein, as well as additional means for maintaining the skin edge together, particularly in the axial direction. Do too. In at least some cases, the hydrocolloid adhesive alone has a very low tensile strength and may require reinforcement means to prevent tearing or creep movement during use. As illustrated in FIG. 21, the adhesive layer 211 used in the base panels 104 and 106 is preferably a soft plastic or polymer 212 such as urethane having a thickness of 0.001 inches and potentially up to 0.010 inches. A thin layer of) may be stacked, which may help to maintain the structure during clinical use. The adhesive layer itself may normally be 0.010 inches thick but may have a variety of thicknesses between 0.005 inches and 0.020 inches. Since the tensioning element including the strap 130 or the fixture 132 attached to the load distribution component 118 can be mounted on top of the adhesive structure 211, there is a possibility that the material will creep over time. exist. Any other adhesive laminates 215a, 215b as well as the laminate 212 between the adhesive layer 211 and the load distribution component 118 may help the structure to prevent creep movement of the adhesive layer.

To further prevent movement of the adhesive panel 211, a cover 220 may also be attached over the panels 104, 106 as shown in FIG. 22A. As shown in FIG. 22B, the cover 220 may include a thin flexible elastomer 221 coated with an adhesive. In various embodiments, the cover 220 is a thin layer of urethane (preferably 0.001) coated with a skin adhesive such as an acrylic adhesive (preferably 0.002 inches thick) that may be provided on one or more release liners 223a, 223b. Inch thickness). The cover can further include reinforcing features 225.

As shown in FIGS. 23A and 23B, the cover 220 may be configured to extend beyond the base panels 104, 106 to connect the distance d3 between the skin S and the panels 104, 106. Typical minimum required distance d3 can be 8 mm but can range from 2 to 15 mm. In addition to helping to prevent creep movement of the adhesive layers of the base panels 104, 106, the urethane skin adhesive of the cover 220 may also be subject to tension applied to the base panels 104, 106 from the movement of the surrounding skin S. Can help to mitigate strain. This may have the function of preventing skin damage (eg, swelling or swelling) at the edges of the base panels 104, 106. However, it should be noted that the soft properties of the hydrocolloids can provide local protection from its swelling, which is movable with the skin S, thereby resisting damage to the skin S. In various embodiments, even in the case of tighter structures mounted to the outer surface of the adhesive layer, compliance within the normal 0.010 inch thick adhesive layer down to the skin surface may provide resistance to skin damage.

In addition to stabilizing and straining the base panel structure, the cover 220 can accomplish other purposes. By covering the position where the strap 130 can be engaged with the fixing portion 132, the cover 220 can prevent the patient from tampering with the fixing portion 132 to the point where the strap 130 can be released. Can be. As shown in FIGS. 23A-23C, the cover 220 may have openings 224, 224 ′ formed along the length of the region overlapping the incision, so that externally attached gauze may absorb the wound secretion. Can be. In another embodiment, cover 220 may not have an opening to protect the wound from an infectious agent. The cover 220 itself may have reinforcing features 225, 225 ′ to provide additional resistance to the base 102, particularly to the cutout opening in the area between the straps 130. 23C illustrates a particular embodiment where the reinforcing features 225 ′ may be rectangular strips of adhesive tape. The tape 225 'may preferably be harder perpendicular to the skin incision than the surrounding flexible urethane layer 221. The tape 225 'may be constructed from an adhesive coated fabric, polymer fibers, polyethylene, polypropylene, nylon, PET, hydrocolloids, or any combination of other materials known in the art. Reinforcing features 225 ′ may also provide “body” or rigidity to cover 220 to assist with its placement. The urethane layer 210 may be made of a material that provides bidirectional stretching.

The spacing of the reinforcing features 225, 225 ′ may be important in ensuring the longitudinal (parallel to the incision) compliance of the cover 220 (eg, due to thin soft urethane). This may function to enhance the comfort of the patient and to improve skin resistance by allowing the cover 220 and its base assembly 102 to be moved in accordance with the movement of the body. This effect may be derived from the cover 220 alone or as a combined effect in combination with features of the base assembly 102 that may allow for longitudinal compliance. Reinforcements 225 and 225 ′ may also have a uniform configuration, but may be perforated, slits formed, or otherwise mechanically blocked to allow stretching and / or controlled tearing as the body moves. The thin urethane layer (s) of cover 220 may also be mechanically blocked for the same purpose. In at least some cases, the reinforcing features 225, 225 ′ of the cover 220 may not extend over the full width of the cover 220 (perpendicular to the incision). This limited sheath width may help ensure strain relief for body movement away from the base assembly 102 perpendicular to the incision I. In a preferred embodiment, the area of the cover 220 that is reinforced by the reinforcing members 225 and 225 'extends by 10 mm in each direction away from the incision edges, but it can range from 2 to 50 mm.

Another feature of the cover 220 is to further enable adjustment to the incision edge, in particular between the tensioning elements 130, 132 of the base assembly. As illustrated in FIG. 24A, the tensioning elements 130, 132 associated with the base panels 104, 106 may act to bring the incision edges 205 together. Once the skin S is approached, it may be important for the skin edges to be aligned vertically (perpendicular to the skin surface). Vertical misalignment can delay treatment and result in visible "step-off" or ledges that can cause poor scar formation in the incision. By allowing various portions of cover 220 to be attached to each edge of base panels 104 and 106 along the incision, each edge can be maintained in vertical alignment under tension as indicated by arrows 201a and 201b. The adhesive on the various portions of the cover 220 across the incision I can also be attached directly to the skin S at the incision edge, thereby further reducing the distance between the incision edges attached to further improve the vertical alignment of the skin. have. In a preferred embodiment, the various portions of the cover 220 across the incision I are rectangular strips 225 'of adhesive tape as shown in Figure 23C. The width of each strip 225 ′ and the axial gap between the strips 225 ′ can be optimized for incision edge adjustment, incision observation, and ejection of wound secretions. A preferred embodiment may comprise strips 12 of width 12 mm and spaced 6 mm, with a strap located between each strip. Other widths and spacings are also contemplated. By not bridging / tenting over each strap 130, the strip 225 can be laid flatter with respect to the skin S for better adhesion and edge control.

In some embodiments, the reinforcement features 225, 225 ′ may be configured to limit the amount of bending at the incision site. The reinforcing features 225, 225 ′ of these embodiments may be harder than the skin S and may preferably be harder than the peripheral elements of the base panels 104, 106. In this way, bending or compression of the skin S through the normal operation of the patient can be blocked around the incision site or its propagation can be limited. While this blocking or limiting of motion can help to increase the tensile strength of the incision site, a more useful advantage is that the incision edge is largely or non-uniformly inverted, abducted or moved in the direction perpendicular to the skin surface. It may be to prevent. The aforementioned reinforcing material can be used with a thickness adjusted to form the desired rigidity. Preferably, the composite of base assembly 102 and cover 220 may be configured to allow for a smooth transition of stiffness and compliance from the surrounding skin to the cut incision site.

In certain methods of use, after initial closure of the incision using the base assembly 102 to approximate the skin edges, the base panels 104, 106 may “bulk” the closed incision I upwards to slightly abduct the edge. Or / or may be gathered together to relieve tension by compressing the skin S around the incision edge. 25A-25C illustrate embodiments of methods of such body tissue models. FIG. 25A shows a step 250A in which the base panels 104, 106 are attached to the skin S adjacent to the incision I and then gathered to “swell up” the closed incision I. Base panels 104 and 106 may then be further joined to keep the tissue in this orientation. These methods can be improved by positioning the base panels 104, 106 5-10 mm away from the incision edge. In step 250B shown in FIG. 25B, base panels 104 and 106 may be secured in place relative to each other by strap 103 and fixture 132. In step 250C shown by FIG. 25C, the cover 220 is then attached to the fixation and “inflated” incision I at the relative positions of the base panels 104, 106. The cutout I can be further reinforced with the aforementioned reinforcing elements 225, 225 ′.

A given cover 220 may be attached with a release liner in many embodiments to assist user handling of the cover 220 before and during attachment to the patient. As shown in FIGS. 22A and 22B, the cover 220 may have release liners 223a and 223b attached in a three-part configuration. The user may first remove the longitudinal center liner 223b to attach the central exposed adhesive to the base assembly 102 and the skin incision area. The removal of this liner 223b first allows the user to look under the base assembly 102 with observation through the central opening of the base 220 and / or the transparent plastic so that the cover 220 can cover the cover 220. ) Can be properly aligned with the base assembly 102 when attached. This may also help to provide an area of the cover that is not attached to the user until the cover 220 is initially secured to the base assembly 102 and / or skin (S). Next, the side release liner 223a may be removed in a direction perpendicular to the cutout I. FIG. The liner 223a retains and tensions very thin urethane to keep it substantially wrinkle-free when attached to the skin S. In addition, by first attaching the central portion of the cover 220 to the base assembly 102 and / or the skin S, the cover 220 is smoothly attached to the patient with the rest of the thin cover 220 coated with an adhesive. Sufficient tension and adjustment may be maintained in place to apply to the side release liner 223a. Alternatively or in combination, the liners may be configured to expose the base assembly 102 and / or the skin (1) by removing the first liner and exposing a narrow strip over the entire width of the cover 220 (perpendicular to the incision I). It may be configured to allow one or two additional liners in a direction parallel to the incision I after allowing initial adhesion on S). The first liner may be in the middle, either end or between the lengths. If not present on the end, two additional liners may be needed and may be removed from the position of the first liner in the outward direction along the length of the instrument, respectively. Once the first liner is on one end, a second single liner can be removed outwardly from the position of the first liner toward the end of the instrument.

Other release liner configurations can be provided to have a single liner that can be completely removed from the bottom of the cover 220 prior to attachment. This type of liner may be applied to the outer surface of the cover 220 to help the thin urethane maintain its shape and provide the user with the location of non-adhesive side and / or ends so that it is not attached to the user's hand during attachment. It may require a lightly attached outer film or casting sheet. The outer film may be present over the entire outer surface or only at a specific width surrounding the periphery of the cover 200. The film and / or release liner may also have an area that extends beyond the area of thin urethane of the cover 220. Once the cover adhesive is attached to the base assembly 102 or the skin S, the casting sheet can be easily removed from the outside of the cover 220.

As described herein, elastic wound dressings and wound or incision closure devices or devices typically follow the contours of curved portions of the body (eg, arms, long incisions, etc.) or elongated regions (eg, knees). Can be bent and stretched. To aid in draping of such instruments, a backing material can be used that helps maintain the dressing form during attachment. The temporary backing material described herein can have several advantages. The backing material may be transparent to make the wound visible. The backing material may be non-extending to prevent stretching of the dressing or closure device or device during attachment. The backing can be easily removed after attachment of the wound dressing or suture apparatus or device so as not to affect the attachment of the actual dressing on the wound site. The backing material may also assist in the handling of the dressing during the manufacturing process. In many embodiments, the backing material may be coupled to a dressing or closure device or device to have a release release liner on the adhesive side of the dressing to enable the backing material to be peeled off easily and reliably.

Referring now to FIG. 26A, wound dressing cover 2600 may include an elastic sheet 2610 made of an elastic material, such as rubber, urethane, silicone, and the like. Elastic material 2610 may be laminated on a relatively rigid material in the form of a casting sheet or carrier layer 2620. The casting sheet 2620 prevents the stretchable material 2610 from rolling in the sheet itself and making it unusable. Elastic sheet 2610 may include adhesive on one side (eg, bottom side) and a relatively hard (hard) carrier layer or casting sheet 2620 on the other side. The adhesive side is protected by two liners 2630 and 2640 that can be removed in series to expose the adhesive in a controlled manner. To attach the dressing 2600 onto the wound or incision, a small strip of adhesive is exposed by removing one of the release liners, typically a small release liner 2630. Such release liner 2630 may be attached to casting sheet 2620 using tape 2650. The exposed portion of the stretchable sheet 2610 may then be attached to one end of the wound or incision. The stretchable cover 2600 then follows the contour of the wound or incision and curvature on the body as the second release liner 2640 is slowly removed to expose the adhesive sequentially.

The first release liner 2630 still attached to the casting sheet 2620 by the tape 2650 can be used to lift the casting sheet 2620 out of the elastic dressing 2600.

The fabrication process for the wound dressing cover 2600 and associated liners 2630 and 2640 includes a common profile of a stack of release liners 2630 and 2640, stretchable dressings (including adhesive) 2610 and casting sheet 2620 ( It may be to use a single die to cut the outer periphery). Upon removal of the liners 2630 and 2640 and attachment to the skin, the casting sheet 2620 of the dressing sheet 2610 may be retained on the dressing sheet 2610. Removal of casting sheet 2620 may require initiation by peeling off and peeling back the edge of casting sheet 2620 from dressing sheet 2610. Once initiated, continued peeling and removal of casting sheet 2620 may be straightforward. Since the initiation and lifting of the edge of the casting sheet 2620 is not always intuitive, it may require a free edge connected to the casting sheet 2620 to help identify the lifting point and start peeling. Tape 2650 may be used to bridge the casting sheet 2620 to the release liner 2630, which tape may provide an easily identifiable tab that may be used to initiate peeling.

Alternative configurations of the casting sheet 2620 may be used to initiate peeling of the 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 elastic dressing sheet 2610 (eg, the liners 2630 and 2640 and the elastic dressing sheet 2610). Urethane material may be "kiss cut" to the surface of the casting sheet 2620a].

As shown in FIG. 26C, casting sheet 2620 may include a tape 2650 attached to one or both axial sides to extend beyond the casting sheet. The tape 2650 may not necessarily be attached to the release liner 2630.

As shown in FIG. 26D, casting sheet tape 2650 may be attached at or near the axial edge of casting sheet 2620, and also extends into the profile of casting sheet 2620 and may be held by a user. Loose non-adhesive edge 2652 is provided.

As shown in FIG. 26E, the casting sheet die may be cut partially or over a full length of distance from one axial edge to another axial edge of the casting sheath 2620 (eg, the casting sheet 2620 may be Kiss cut to not cut into elastic dressing sheet 2610]. The cut casting sheet 2620 may be separated by a "pinch" by the user to form a catchable edge. The inner die cutting edge may also be cut out of the inner edge to catch and peel off as shown in Figure 26E. It may have a tape or similar tab 2654 attached to one or both.

In various embodiments, the casting sheets 2620, 2620a and / or tapes 2650, 2652. 2654 may have different colors or markings to distinguish them from the elastic dressing sheet 2610 and the release liners 2630, 2640. Can be.

Cut suture closures disclosed herein including one or more in various base assemblies, base panels, load distribution structures, axial supports, lateral supports, closure components, tie assemblies, straps, fixtures, adhesive layers, covers, cover structures, drapes, and the like. Alternatively, one or more of the components of the cut closure appliance assembly may consist of or be coated with or otherwise include one or more of an antifungal material, an antimicrobial material, an antimicrobial material, a bactericidal material, or a drug additive material. For example, such material may be incorporated into the hydrocolloid adhesive layer as another layer or coating (covering at least a portion of the adhesive layer) between the skin and the adhesive layer, such as incorporated into the base assembly cover or at least its adhesive layer. One or more recesses, grooves, openings, voids, or similar structures may be provided on the instrument or device component to facilitate such coalescing. In various embodiments, such materials may include one or more of natural materials such as silver, iodide, zinc, chlorine, copper, or tea tree oil as active agents. Examples of such antifungal, antimicrobial, antimicrobial, bactericidal or drug addition materials include, but are not limited to, the Acticoat ^TM family of materials available from Smith & Nephew PLC in the UK, Smith & Nephew PLC in the UK Acticoat ^® moisture control series of materials available from, Contreet ^® foam series of materials available from Coloplast A / S, Denmark, UrgoCell ^® silver series of materials available from Urgo Limited (subsidiary of Laboratories URGO of France), UK ^® hydrocolloid family of materials available from Smith & Nephew PLC of USA, Aquacel ^® Ag series of materials available from ConvaTec Inc. of Skillman, NJ, Kinky Concepts, Inc. of San Antonio, TX, USA Silvercal® Series from Kinetic Concepts, Inc. in San Antonio, Texas, USA Of possible material Actisorb ^® Silver 220, a commercially available material from the UK Urgo Limited (a subsidiary of the French Laboratories URGO) Urgotul ^® SSD series, the commercially available material from Kinetic Concepts, Inc. of San Antonio, Texas, USA Material Inadine ^® series, Iodoflex ^® series of materials available from Smith & Nephew PLC of the UK, Sorbsan Silver ^TM series of materials available from Aspen Medical Europe Ltd. of the UK, Ferris Mfg. Of Burr Ridge, Illinois. Polymen Silver ^® series of materials available from Corp., Promogram ^TM series of materials available from Kinetic Concepts, Inc., San Antonio, Texas; Promogram Prisma ^TM series of materials available from Kinetic Concepts, Inc., San Antonio, Texas. , And Arglaes ^® family of materials available from Medline Industries, Inc. of Mundelline, Illinois. Co-owned US Pat. Nos. 8,313,508, 8,323,313, 8,439,945, US Patent Publication No. 2013/0066365, PCT Application US 2010/000430, US 2011/139912, US 2011/40213, US 2011/34649, US 2013 Components of the closure device described in / 067024 may also include, but are not limited to, one or more of an antifungal material, an antimicrobial material, an antimicrobial material, a bactericidal material, or a drug additive material comprising one or more of the above listed materials It may be constructed or coated or otherwise include the material.

In various embodiments, topically effective agents are included directly into the wound closure device described herein. Wound closure devices are often attached in close proximity to wounds or incisions requiring pharmacological protection, so it may be advantageous to contain such drugs directly within the closure device. For example, it would be advantageous to contain an antimicrobial agent in a wound at risk of infection. Antibacterial agents may include antibiotics as well as sterile metal ions and their related components, which may include natural substances such as silver, iodide, copper and chlorine or tea tree oil. Wounds susceptible to fungi can be warranted, for example, drugs such as zinc. Combinations of any of these agents may also be advantageous and thus contained within the wound closure appliance.

Topically effective agents can be used to remove secretions from a wound (eg, to remove unwanted organics from a wound and / or to prevent skin maceration) while keeping the wound sufficiently hydrated to improve treatment. ] May be included in the closure device in a manner that imparts the closure device.

Referring now to FIG. 27A, wound or incision closure appliance 2700 includes two upper polymer layers 2720R and 2720L and a lower adhesive layer 2730R and 2730L attached proximate to each side of surgical incision I. FIG. A base comprising two base panels 2710R, 2710L. Features of panels 2710R, 2710L, such as strap 2740, may allow the skin on either side of the incision I to be drawn together and held in place during the treatment period. The adhesive may preferably consist of a hydrocolloid formulation but may include acrylic or other adhesives known in the art. Upper polymer layers 2710R, 2710L (eg, 1 mil polyurethane) are preferably attached on top of the adhesive layers 2720R, 2720L to break the adhesive layers 2720R, 2720L. Agents may be included in the structure of the base panels 2710R and 2710L. At a minimum, the agent may inhibit the growth of unwanted organics in contact with the skin from the base panels 2710R, 2710L. The medicament may be released from the base panel 2710R, 2710L and moved to an area within the wound or to an area near the wound. The medicament may be contained by a carrier structure, such as adhesive layers 2730R, 2730L, which may absorb the fluid and aid in the release of the medicament. Such structures may include hydrocolloids, hydrofibers (such as those containing sodium carbomethyl cellulose), hydrogels, collagen, alginates, foams of polyurethane or silicone, or other related materials known in the art. It may include. The carrier may alternatively or in combination be an ointment, cream, gel, or powder. A medicament (eg, silver ions) may alternatively or in combination be attached to the metal or polymer (eg, in the form of a mesh) via a solvent coating process or vapor deposition. Such meshed products may be bonded or embedded within the structure of the closure appliance.

In an exemplary embodiment, the base panels 2710R, 2710L may include a medicament comprising a silver component, such as silver sulfate. When the base panels 2710R, 2710L are in contact with the wound secretion and / or sweat or external fluid, medication may be delivered to the wound side. As the fluid is absorbed into the base panels 2710R and 2710L, the base panels 2710R and 2710L can release silver ions that interfere with the growth of bacteria. An example of how a medicament such as silver can be included in the base panel is shown in FIGS. 28A and 28B, which show various embodiments of sample segment 2750 of the right base panel 2710R of FIG. 27. These examples may also apply to the left base panel 2710L.

27B shows the drug 2760R mixed directly into the adhesive layer 2730R in the sample segment 2750. The adhesive is usually a hydrocolloid, which can absorb significant weight percent fluids, which may aid in the release of the medicament.

FIG. 27C shows a sample segment of a base panel 2710R, wherein a medicament is contained within the carrier structure 2770R concentrated on a portion of the base panel 2710R at the top of the base panel 2710R, preferably near the incision (I). Another example of 2750 is shown. Additional features may be included to saturate (and replace as necessary) the carrier structure 2770R when saturated with secretions or other fluids and / or the concentration of the medicament falls below an effective level.

FIG. 27D illustrates an embodiment similar to the embodiment of FIG. 27C in which a carrier structure 2770R comprising a medicament is included on the inner edge of the base panel 2710R.

27E illustrates how the carrier 1770R can be included at both the top and inner edges of the base panel 2710R. In these examples, the carrier structure 2770R on either the inner edge or each inner edge of the base panel 2710R may be pressed over the wound or incision I to aid in stability on the wound or incision I. .

The medicament and its carrier structure may alternatively or in combination be incorporated into a cover for the incision closure appliance. As mentioned above, the cover is typically attached over the base panel of the incision closure appliance to help protect the skin by securing the incision closure appliance to the skin. As shown in FIG. 28A, cover 2800 may have a medicament 2810 contained within the entire surface of the cover 2800, with or with a carrier structure such as adhesive layer 2810 mixed with the medicament. You can't. Alternatively or in combination, the medicament may be included in an appropriate portion of cover 2800, preferably in carrier structure 2820 placed just above the wound site as shown in FIG. 28B.

In at least some cases, the carrier structure 2820 may saturate over time and / or lose pharmacological strength, so that it is beneficial to replace the drug structure 2820. As shown in FIG. 28C, the drug structure 2820 is removable (eg, by tearing the holes 2830 in the cover 2800) and optionally coupled to the narrow cover strip 2801 shown in FIG. 28D. It may be replaced with another drug structure (2821). In the narrow cover strip 2801, the adhesive portion of the cover 2801 may extend beyond the drug structure 2821 to hold the drug structure 2821 against the skin. Narrow strip 2801 may alternatively be attached to the wound site prior to attachment of cover 2800. The cover 2800 may be designed to cover the narrow strip 2801 or may include holes 2830 to allow removal of the lower strip.

For either or both of the base panel 2710R, 2710L and the cover 2800, only the carrier structure 2770R or 2820 (with or without drugs) or drugs can be patterned with the adhesive layer of each structure. have. The patterned configuration can include repeating forms of adhesive material (eg, circles, ellipses, polygons, slots, etc.) adjacent to similar repeating forms of the carrier structure (or the rest of the matrix). This may help to ensure adhesion of the base panel 2710R, 2710L or cover 2800 while containing the agent in the carrier structure 2770R or 2820. A simple example in which the carrier structure 2820 has a repeating form 2850 is illustrated in FIG. 29E. The medicament and carrier structure 2820 may also be attached to base strap 2740 across incision I.

While preferred embodiments of the invention have been illustrated and described herein, it will be apparent to those skilled in the art that these embodiments are provided by way of example only. Many modifications, variations, and alternatives will 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 the methods and structures and equivalents within these claims are intended to be encompassed accordingly.

10: incision closure appliance
22: suture component
1402, 1404: Base Panel
1414: axial support

Claims (60)

In the incision closure appliance,
A first base panel and a second base panel attached to the first and second sides of the incision or wound, respectively, each base panel having an upper surface, a tissue attachment bottom surface, an outer edge, and an incision or wound; A first base panel and a second base panel, including an inner edge located adjacently;
A plurality of lateral ties coupling the first and second base panels to each other; And
At least one skirt portion coupled to at least one top surface of the top surface of the first base panel or the top surface of the second base panel, wherein the at least one skirt portion is the top surface of the first base panel or the second surface At least one skirt portion extending transversely beyond an outer edge of at least one of the top surfaces of the base panel, the at least one skirt portion having a tissue attachment bottom surface
Including,
The at least one skirt portion is between one or more panels of the first base panel or the second base panel and the exposed skin next to the at least one skirt portion, and the tissue attaching lower portion of the first and second base panels. Greater compliance than the composite structure of the first and second base panels and the plurality of transverse ties to provide strain relief between the faces and the skin covered by the first and second base panels. Incision closure appliance to have. 2. The apparatus of claim 1, wherein the at least one skirt portion comprises a first skirt portion and a second skirt portion, wherein the first skirt portion is coupled to an upper surface of the first base panel to cross from an outer edge of the first base panel. Extending in a direction, wherein the second skirt portion is coupled to an upper surface of the second base panel and extends laterally from an outer edge of the second base panel. The inner edges of the first and second base panels, respectively, wherein the first and second skirt portions are left uncovered by the first and second skirt portions. An incision closure appliance extending laterally outwardly from the incision. The incision closure appliance of claim 2, wherein the first and second skirt portions extend laterally inwardly to cover the incision or wound. The incision closure appliance of claim 1, wherein the at least one skirt portion is at least partially transparent. The incision closure appliance of claim 1, wherein the at least one skirt portion comprises an extensible material. The incision closure appliance of claim 6, wherein the stretchable material comprises at least one of rubber, latex, urethane, polyurethane, silicone, or a thermoplastic plastic elastomer (TPE). The at least one skirt portion of claim 1, wherein the at least one skirt portion is at or near the outer edge of the at least one skirt portion to provide at least one of increased compliance or reduced adhesion loss at least at the outer edge of the at least one skirt portion. An incision closure appliance, wherein the thickness is thinner than the thickness of the first or second base panel at or near the medial edge of the at least one skirt portion. The apparatus of claim 1, wherein the incision closure appliance further comprises a plurality of first supports and a plurality of second supports respectively spaced in the longitudinal direction and coupled to the top surfaces of the first and second base panels, respectively. A transverse tie of the first end coupled to a first support of the plurality of first supports spaced longitudinally on the first base panel and the plurality of firstly spaced longitudinally spaced on the second base panel An incision closure appliance having a second end coupled to a second support of two supports. 10. The incision closure appliance of claim 9, wherein at least one of the plurality of first or second supports spaced longitudinally comprises a force distribution structure. 10. The incision closure appliance of claim 9, wherein the at least one skirt portion has greater compliance than a structure consisting of the plurality of first and second support portions spaced in the longitudinal direction and the composite structure. 10. The incision closure of claim 9, wherein the plurality of longitudinally spaced first and second supports and lateral ties are less resilient than the first and second base panels and the at least one skirt. Instrument. 10. The incision closure appliance of claim 9, wherein the supports comprise a flexible non-expandable material. 10. The incision closure appliance of claim 9, wherein the supports are embedded in or laminated to the top surface of each panel. The incision closure appliance of claim 9, wherein at least one of the supports is C-shaped. 16. The apparatus of claim 15, wherein at least one C-shaped support includes a longitudinal portion for limiting longitudinal expansion of the first or second base panel at the support, and transverse of the first or second base panel at the support. An incision closure appliance comprising a transverse portion for limiting directional expansion. The incision closure appliance of claim 1, wherein at least one of the first or second base panels comprises an elastic matrix. 18. The incision closure appliance of claim 17, wherein the elastic matrix comprises an elastomeric membrane, a fabric, a spun fabric, rubber, latex, urethane, polyurethane, silicone, or a thermoplastic elastomer. 19. The inelastic element of claim 18, wherein the elastic matrix comprises a fabric woven from elastic elements, the fabric extending transversely along the side edges of at least one of the first or second base panels. An incision closure appliance which has The incision closure appliance of claim 1, wherein the tissue attaching bottom surface of at least one of the first or second base panels comprises a hydrophilic adhesive material. 21. The incision closure appliance of claim 20, wherein the hydrophilic adhesive material comprises one or more of hydrocolloids, hydrogels, acrylic polymers or poly (ethylene glycol). delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete

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