KR101826450B1 - Surgical incision and closure apparatus - Google Patents

Abstract

An apparatus for sealing a surgical incision includes first and second base panels, a plurality of suture components, and a plurality of first axial support and a second axial support coupled to the respective base panel. The suture component includes first and second ends coupled to the first and second base panels in a transverse direction relative to each other and coupled to the first and second base panels, respectively. The suture component is positioned transversely across the first and second panels, the first axial support is disposed between the pair of first suture component ends and the second axial support is positioned between the second suture component end And the first and second axial support portions are offset from each other to form a serpentine arrangement of successive sealing elements and axial support portions. The device may be made of an antimicrobial material or a material impregnated with an antimicrobial agent. In use, a stretchable adhesive cover may be provided over the device.

Description

[0001] SURGICAL INCISION AND CLOSURE APPARATUS [0002]

Cross reference of related application

This PCT application is a continuation-in-part of PCT Application No. 61 / 889,569 filed on October 11, 2013 (Attorney Docket No. 35383-712.101), filed July 24, 2013, No. 958,259 (Attorney Docket No. 35383-710.101), and U.S. Provisional Patent Application No. 61 / 958,254 (Attorney Docket No. 35383-711.101) filed on July 24, 2013, The entire contents of which are incorporated herein by reference.

This application is a continuation-in-part of U.S. Patent Application No. 13 / 286,757, filed November 1, 2011 (Attorney Docket No. 35383-709.201), filed on October 31, 2012, No. 13 / 665,160 (Attorney Docket No. 35383-709.501), the entire contents of which are incorporated herein by reference.

This application is a continuation-in-part of co-pending U.S. Patent Application No. __________ filed on Feb. 25, 2014 and Feb. 25, 2014 (Attorney Docket No. 35383-712.201) (Attorney Docket No. 35383-709.502), the entire contents of which are incorporated herein by reference.

Technical field

The present invention relates generally to medical devices and methods. More particularly, the present invention relates to an apparatus and method for forming and sealing a surgical incision.

Surgical suturing devices comprising an adhesive-based patch with left and right panels are known. Such an apparatus of particular interest in the present invention is described in co-pending, co-pending PCT application US2010 / 000430, the entire contents of which are incorporated herein by reference. As described in the PCT application, the adhesive patch is placed on the patient ' s skin in a preferred position to form a surgical incision. After the patch is placed, a cut is formed along the axial line extending through the middle of the patch. After the incision is formed, the incision is opened to perform the desired procedure, and after the procedure is completed, the incision can be sutured by pulling together the inner edge of the panel with a clip, zipper or other sealing member.

The primary purpose of these surgical sutures is to improve healing and reduce scarring from the incision. However, this object is limited by certain features of currently available instruments. For example, the edges of tissue are not always uniformly aligned along a given line, which can eventually increase scarring. Many such suturing devices do not have the ability to adjust the seam strength or distance to the edges of the tissue, thereby limiting the ability of the tissue to "pucker" somewhat, which is found to reduce scarring. Other disadvantages of the available incision and wound suture instruments include the difficulty of use and the inability to meet the handling of tissue during subsequent surgical procedures. That is, a device that is sufficiently rigid enough to suture the tissue may sometimes not be able to match the movement of the tissue during the surgical procedure.

A particular problem with self-adhesive wound suture patches arises when these patches are used under an adhesive surgical incision drape. This drape is used to help maintain the sterility of the tissue surface during the surgical procedure, and the drape may be placed on a previously placed tissue sealing patch. Since the surgical incision drape has an adhesive lower surface attached to the tissue, the drape will attach to the upper surface of the underlying tissue stitching patch. Thus, removal of the surgical incision drape will sometimes remove or at least push out the previously deployed tissue stitch patch. If any significant portion of the tissue stitching patch is removed or pushed, the patch will no longer be useful for suturing the surgical wound.

For this reason, it would be desirable to provide an improved surgical incision suturing instrument and method of use thereof. It is particularly advantageous to provide an incision suturing instrument which can be attached to the tissue and permits the formation of incisions, conforms to the deformation of the tissue during subsequent surgical procedures, and is capable of adjustably sealing adjacent tissue edges subsequent to the procedure Do. Particularly, it would be desirable if the incisional suture instrument could control the suture force on the tissue edges while uniformly distributing the tissue while restraining or pulling the tissue to a minimum during the surgical procedure. It may also be desirable to provide an improved surgical incision suture instrument and method of use wherein the suture instrument is prevented from being removed and pushed in use under the surgical incision drape. At least some of these objects will be satisfied by the invention described below.

Surgical sutures are described in U.S. Patent Nos. 2,012,755; 3,516,409; 3,863,640; 3,933,158; 4,114,624; 3,926,193; 4,535,772; 4,676, 245; 4,881, 546; 4,905,694; 5,377,695; 7,455,681; U.S. Patent Publication Nos. 2005/0020956 and 2008/0114396. Additional surgical suture instruments are disclosed in commonly owned U. S. Patent Nos. 8,313, 508; incorporated herein by reference in its entirety; 8,323,313; 8,439,945; U.S. Patent Publication No. 2013/0066365; PCT Publication Nos. WO2011 / 139912, WO2011 / 159623, WO2011 / 043786, WO2013 / 067024. A commercial incision suture instrument is available from Ethicon, a division of Johnson & Johnson, under the trade name Ethizip ^TM , a temporary abdominal wound suture instrument.

The present invention improves apparatus and methods for sealing a wound, in particular a wound resulting from an incision performed during a surgical procedure. The incision is usually made in the skin of the patient, for example through the abdomen, but in some cases it may be formed on the internal organs, in the mouth, in the body cavity or in similar parts.

The apparatus and method of the present invention minimally disturb or interfere with the surgical procedure performed after the incision. In particular, the apparatus and method will allow the opposite edges of the incised tissue to be opened, stretched and freely deformed to a state of least constraint due to the presence of the sealing device. However, once the surgical procedure is complete, the device and method of the present invention will uniformly distribute the suture force so as to attract the edges of the tissue together in a manner that minimizes scarring. In particular, the suturing device can pull the tissue edges together at a somewhat closer spacing than initially present at the time of formation of the incision to cause a "pucker" that can flip the tissue edge upside down to reduce scarring.

The apparatus and method of the present invention may avoid or reduce interference when using the incisional suturing instrument under a surgical incision drape that must be removed from the suture instrument. A sacrificial layer is provided over at least a portion of the upper surface of the suturing instrument, wherein the sacrificial cover is held in place while the surgical incision drape is placed over the incision suturing instrument. After the incision and suturing procedure is completed, the surgical incision drape is peeled from the patient ' s skin. Instead of attaching to the tissue suturing instrument and removing the tissue suturing instrument, the surgical drape is attached to the sacrificial cover and only the sacrificial cover is removed from the patient with the graphene leaving the rest of the incisional suturing instrument in place.

In a first aspect of the invention, the incision closure mechanism comprises a base having a first panel and a second panel. Each panel includes a tissue attach lower surface, an upper surface, an inner edge, and an outer edge. The tissue attach lower surface will typically be coated at least partially with conventional tissue-adhesive adhesives such as those used in surgical dressings and patches.

The incision suture mechanism further includes a load distribution structure coupled to each panel (i.e., each panel has at least one load distribution structure coupled to the panel), each load distribution structure having an overall length To permit axial extension of the panel along the inner edge while limiting axial extension along the transverse extension and outer edge. By allowing the axial extension of the panel along the inner edge, the edges of the tissue are allowed to be minimally degenerate as far as possible to allow tissue deformation when stretched during the surgical procedure. Conversely, by limiting both lateral extension and axial extension along the outer edge, the panel can be adjusted when the panels are pulled together after the surgical procedure is completed, as described in more detail below, .

The incision suture instrument further includes a suture component or assembly attached to the load distribution structure for pulling the inner edges of the panel together after the panel is attached to the tissue at both sides of the incision and the surgical procedure is completed. Each panel of the base is generally at least partially resilient (e.g., the matrix is preferentially stretched in one direction or a portion thereof) having anisotropic elasticity, typically having isotropic elasticity (i.e., the panel is uniformly stretched in all directions) Lt; / RTI > matrix. The elastic matrix may be formed from an elastomeric film or sheet (e.g., a polyurethane sheet or thermoplastic elastomer (TPE)), a fabric (typically at least partially an elastomeric filament, a fabric woven from yarn or fibers), a spun fabric ), And the like. In some embodiments, the elastomeric matrix is woven with elastic elements (typically threads, filaments, fibers, etc.) and disposed along the outer edges to provide the elastic elements with a transverse And may include a fabric having inelastic elements that extend transversely. 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 comprises, for example, a plurality of transverse supports spaced axially from the main skeleton and extending axially to the inner edge of the panel, And an individual component of the incision-suturing mechanism, Such a "comb-like" structure is usually formed of a stretchy but non-inflating material so that the elements can flex together by tissue deformation, but they do not stretch along their length, Stability can be provided. Examples of such materials include nylon, polypropylene, polyethylene and polycarbonate or other thermoplastic polymers. In particular, the load-sharing structure will not limit axial elongation of the inner edge of the panel to provide the desired scalability and consistency for tissue during the surgical procedure. These discrete load distribution structures may be attached to the upper surface of the panel or alternatively may be embedded in or embedded in the panel. Typically, the load distribution structure will not extend into the lower surface of the panel or beyond the lower surface of the panel, so as not to interfere with the attachment of the panel to the skin or other tissue.

Assembly of the base panel and the load distribution structure will typically be performed on a removable backing that covers and protects the mounting surface of the panel prior to use. The backing may be removed to attach the base to the skin or other tissue at the site of the surgical procedure. Additionally, the first and second panels typically have removable tabs, axial strips, or other removable covers to maintain the inner edges at a pre-determined distance or spacing when attaching the inner edges of the panel to the tissue. Or < / RTI > For example, the removable tab may be disposed at each of the axial ends of the base to temporarily secure the two base panels together. Alternatively, a removable strip or tape may be placed over the axial spacing between the first panel and the second panel such that the panels are held in position relative to each other when the base is attached to the tissue surface. Such tabs or strips are typically self-adhesive and can be secured to the panel and then removed by simply pulling after the panel is properly positioned on the tissue. The cover, tab or strip may be removed to leave the panel in place and leave the panel in a disconnected state before forming the surgical incision.

An exemplary first configuration of a seal component or assembly includes a first mating member, a second mating member, and a plurality of transverse braces that maintain these mating members spaced apart by a predetermined distance in the transverse direction. The first engaging member is adapted to releasably engage the support of the first panel along the inner edge of the first panel and the second engaging member is configured to releasably engage the support of the second panel along the inner edge of the second panel . In certain embodiments, at least a portion of the support portion of the load distribution component has a cleat near its inner edge, and the engagement member has a slot to receive the cleat. After the surgical procedure is completed, the suture component can be placed on the load distribution structure such that the cleat on one side is first engaged by the mating member and the opposing mating member is pulled onto the cleat on the opposite side.

Alternatively, the sealing component or assembly may include a plurality of independent transverse ties attached to at least a portion of the transverse supports. This transverse tie is generally fixed to one panel by being fixed between the transverse supports and is adjustably attachable to the other panel. In an exemplary embodiment, the adjustably attachable end includes a ratchet tightening mechanism or the like to allow each lateral tie to be independently adjusted at different intervals between the first panel and the second panel . In this manner, the first and second panels can be tensed differently along the inner edge to control and optimize the force applied to the neighboring tissue edges being pulled together.

Alternatively, the sealing device of the present invention may further comprise a fixation layer wherein the assembly of the base and the sealing component is secured onto the incision on the skin of the patient and then placed on the assembly after the surgical procedure is terminated. The fixation layer typically has a self-adhesive lower surface, which can be disposed on the base and on the assembly of the seal components to secure relief by fixing the fixation layer in place. The fixation layer may optionally have apertures that allow access to the wound for observation, disinfectant delivery, and the like.

In a further aspect of the present invention, a method of forming an incision in tissue includes providing an incision suturing mechanism as described above. The first and second panels of the device are attached to the skin of the patient, and the inner edges of the panel are typically spaced by preselected distances from 0.5 mm to 15 mm. An incision (usually straight) is formed in the tissue or skin surface between the inner edges of the panel, and the edges of the incised tissue are then spread out to perform the desired surgical procedure. The inner edges of the panel can coincide with the movement and deformation of the tissue edges while the outer edges and transverse lengths of each panel remain dimensionally stable. After the surgical procedure is completed, the suture component is secured to the load distribution structure to pull the inner edge of the panel back together. Optionally, the suture component has a dimension (or adjustable inter-panel spacing) which pulls the tissue edges together closer than immediately pulled after the formation of the cut. This pulling of the tissue together can reduce the scar by causing the edge to turn upside down and "bite" the tissue.

In a further aspect of the present invention, an incision suture suturing mechanism is provided. The incision suturing mechanism comprises a first and a second base panel, a plurality of sealing components for laterally joining the first and second base panels to each other, and a plurality of first sealing members connected to the first and second base panels, And a second axial support. Each suture component includes first and second suture component ends coupled to the first and second base panels, respectively. (I) at least one of the first axial support portions is disposed between at least a portion of the axially adjacent first suture component ends, and (ii) at least one of the second axial support portions And may be disposed transversely across the first and second panels to form a serpentine arrangement disposed between at least some axially adjacent second suture component ends.

In order to form the sandwich arrangement, the first axial support may couple one axially adjacent pair of first suture component ends together one on top of the first panel, and / or the second axial support may have one And one axially adjacent pair of second suture component ends together on the second panel. The first and / or second panel may comprise one or more apertures disposed between each axially adjacent first and / or second sealing component end, without an 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 extension of the base panel.

One or more of the first or second base panels may comprise a plurality of separate base panel segments. At least two first stitching component ends or at least two second stitching component ends may be coupled to each base panel segment. The first base panel may comprise a plurality of first base panel segments and the second base panel may comprise a plurality of second base panel segments. The first base panel segment and the second base panel segment may be axially offset from each other when applied to the incision and surrounding tissue. The plurality of sealing elements can laterally couple the first and second base panel segments to each other to form a crimp arrangement.

At least one of the first or second base panels may include a tissue attachment lower surface attached to tissue adjacent the incision. At least one of the first or second base panels may comprise a bottom attachment layer having a tissue attach lower surface and an upper layer having a top surface. The upper layer may be harder than the lower adhesive layer. The lower adhesive layer may be sufficiently resilient to minimize swelling and adhesion loss due to movement of the transversely adjacent tissue to the incision closure when covering the incision and surrounding tissue. The lower adhesive layer may comprise a hydrophilic adhesive material. The hydrophilic adhesive material may comprise at least one of a hydrocolloid, a hydrogel, an acrylic polymer or a poly (ethylene glycol). The top layer may comprise one or more of rubber, latex, urethane, polyurethane, silicone, thermoplastic elastomer (TPE), woven or spun fabric. At least one of the first suture component end, the second suture component end, the first axial support, or the second axial support may be embedded in or stacked within the upper surface of the first and second base panels .

At least one of the first suture component end, the second suture component end, the first axial support, or the second axial support may be formed of a stretchable non-intumescent material.

The plurality of suture components, the first axial support and the second axial support, when covered with the incision and the surrounding tissue, are configured to provide the incision suturing apparatus with a cut- It can be made sufficiently hard so as not to expand to Thus, movement of the first tissue region transversely adjacent to the periphery of the incision closure device is substantially translated to the same movement of the second tissue region, which is laterally adjacent to the circumference and opposite to the first tissue region .

The at least one suture component of the plurality of suture components may include a tie that is rigidly coupled to the first or second suture component end and is adjustably attached to the opposite suture component end. The opposite seal component end may include a ratchet tightening mechanism.

The plurality of suture components can be configured to pull together the inner edges of the first and second base panels to compress the incision covered by the incision suture mechanism.

At least one of the plurality of first axial supporting portions or the plurality of second axial supporting portions may be formed in C-shape. Each of the C-shaped first and / or second axial supports may include an axial portion that limits axial expansion of the individual base panel and a lateral portion that limits lateral extension of each base panel.

This aspect of the invention may also provide a system for closing an incision in tissue. The system may include an incision suturing instrument, a corresponding incision suturing instrument, a covered incision, and a resilient cover overlying the surrounding tissue.

The elastic cover may be configured to extend over the lateral and axial edges of the first and second base panels. The cover may have one or more apertures that allow the cover to extend at least partially axially in response to axial extension of the incision and surrounding tissue covered by the incision suturing mechanism. One or more apertures may be disposed along the central axis of the cover. The cover may include at least one reinforcing member 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 hydrocolloid, hydrogel, acrylic polymer or poly (ethylene glycol).

In another aspect of the present invention, an incision suturing mechanism is provided. The incision suture instrument includes a stretchable adhesive bottom layer, an intermediate layer and an upper layer. The stretchable adhesive bottom layer may have a first elasticity. The intermediate layer may be bonded to at least a part of the stretchable adhesive layer to cover the portion and have a second elasticity lower than the first elasticity. The upper layer may be bonded 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 stretchable adhesive bottom layer and the upper layer is such that the movement of the tissue transversely adjacent to the incision suturing mechanism resulting from covering the incision and surrounding tissue does not substantially expand the covered incision and surrounding tissue, Sufficient stiffness can be provided for the suturing mechanism.

The elastic gradient can provide sufficient resilience to the incision suture instrument to minimize swelling and attachment loss due to movement of tissue adjacent to the incision suture apparatus when covering the incision and surrounding tissue.

The incisional suture mechanism may be elongated in the axial direction in response to axial extension of the incision and surrounding tissue covered by the incision suture mechanism. The movement of the first tissue region adjacent to the periphery of the elastic adhesive bottom layer is substantially shifted to the same movement of the second tissue region adjacent to the periphery of the elastic adhesive bottom layer and opposite to the first tissue region.

The stretchable adhesive bottom layer may comprise a hydrophilic adhesive material. The hydrophilic adhesive material may comprise at least one of a hydrocolloid, a hydrogel, an acrylic polymer or a 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 comprise first and second adhesive bottom layers. The intermediate layer may comprise a first upper layer bonded to the first adhesive bottom layer and a second upper layer bonded to the second adhesive bottom layer. The upper layer includes a plurality of axial support structures and a plurality of lateral suture component arrangements coupled to the axial support structure for fastening the first adhesive bottom layer and the first upper layer to the second adhesive bottom layer and the second upper layer . The plurality of axial support structures and the plurality of suture components are configured such that at least one of the lower adhesive layer or the intermediate layer is at least partially in the axial direction of the suturing mechanism in response to axial extension of the cutout and surrounding tissue covered by the incision suturing mechanism So that they can be combined with each other to form a meandering pattern. The plurality of axial support structures and the plurality of transverse sealing elements can be coupled together to form a ladder pattern. At least one of the plurality of axial support structures or the plurality of transverse seal elements may be formed of a stretchable non-intumescent material. The plurality of transverse sealing elements are configured to pull together the inner edges of the at least one of the first or second adhesive bottom layer and the first or second top layer after the elastic adhesive bottom layer is attached to the tissue on either side of the incision . One or more of the transverse sealing components can include a first end, a second end, and a tie that is rigidly coupled to the first or second end and is adjustably attached to the opposite end thereof. One or more of the plurality of axial support structures or the plurality of transverse sealing elements may be embedded in the first and second top layers or laminated to the first and second top layers.

This aspect of the invention may also provide a system for sealing an incision in tissue. The system includes an incision suturing instrument and a resilient cover overlying the incision suturing instrument and the incision and surrounding tissue.

The elastic cover can be configured to extend over the transverse and axial edges of the elastic adhesive bottom layer. The cover may include an incision covered by the incision suturing mechanism and one or more apertures that allow the cover to be at least partially elongated in the axial direction of the cover in response to axial extension of the surrounding tissue. One or more apertures may be disposed along the central axis of the cover. The cover may include at least one reinforcing member 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 at least one of a hydrocolloid, a hydrogel, an acrylic polymer or a poly (ethylene glycol).

In another aspect of the present invention, an incision suturing mechanism is provided. The incision suturing mechanism 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. The elastic gradient is a measure of the stiffness of the incision suture mechanism to ensure that the movement of the transversely adjacent tissue to the incision suture mechanism when covering the incision and surrounding tissue does not substantially extend the covered incision and surrounding tissue, Can be provided. The elastic gradient can provide sufficient resilience to the incision suture instrument to minimize swelling and attachment loss due to the movement of tissue laterally adjacent to the incision suture mechanism when covering the incision and surrounding tissue.

In another aspect of the present invention, an incision suturing mechanism is provided. The incision suturing mechanism may include a base having a first panel and a second panel, first and second load distribution structures, and a plurality of sealing elements. Each panel may include a tissue adhesive lower surface, a top surface, a first transverse edge, and a second transverse edge. The first and second load distribution structures may be coupled to the first and second panels, respectively. Each load distribution structure is configured to permit axial expansion of the panel along one of the first or second transverse edges and to limit lateral expansion along the panel and axial extension along the other transverse edge Can be. The plurality of sealing elements may be secured to the first and second panels so that the first and second panels are attached to the tissue and the incision formed therebetween, and then pull the panels together.

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

The second transverse edge of each panel may comprise the outer edges of each panel. The outer edges of each panel may face each other.

At least one of the first and second panels of the base may comprise an elastic matrix. The elastic matrix may comprise an elastomeric membrane, fabric, or spun fabric. The elastic matrix may comprise a fabric that is woven with elastic elements and has inelastic elements along the first or second transverse edges and extends transversely across the non-elastic elements.

Each load distribution structure having a main skeleton disposed axially adjacent to a first transverse edge of the panel and a plurality of axially spaced apart first and second transverse edges extending from the main skeleton to a first transverse edge side of the panel, And may include a transverse support. The main skeleton and the transverse support may be formed of a stretchable non-intumescent material. The load distribution structure may be embedded in or stacked over the top surface of each panel.

The suture component may include a first engagement member, a second engagement member, and a plurality of transverse straps that maintain the engagement members laterally spaced apart by a predetermined distance. The first engagement member may be adapted to releasably engage the support of the first panel and the second engagement member may be adapted to releasably engage the support of the second panel. At least a portion of the support may have a cleat near one or more of the edges of the first or second transverse edge, and the engagement member may have a slot to receive the cleat. The transverse straps can be adjustably connected to at least one of the engagement members to allow adjustment of a predetermined distance. The suture component may include a plurality of independent lateral ties attached to at least a portion of the transverse supports. The transverse tie may be configured to be fixed between the transverse supports. Independent lateral ties may have one end fixed to the panel and a second end adjustably attached to the other panel. The second end may have a ratchet tightening mechanism.

The incisional suture mechanism may further comprise a fixation layer wherein the assembly of the base and the suture component is adapted to be placed over the incision on the patient's skin and then placed on the assembly. The fixed layer may have an inner surface with self-adhesive properties.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is an exploded view of an incision suturing instrument constructed in accordance with the principles of the present invention.
Figure 2 is a top view of an assembly of a base and load distribution structure that is part of an incision suturing mechanism.
3 is a cross-sectional view taken along line 3-3 of FIG.
Figures 4-7 illustrate the use of the incision suture instrument of the present invention to create and seal incisions in the skin of a patient.
8 shows an alternative configuration of the sealing component for the suture mechanism of the present invention.
9 is an exploded view of a further embodiment of an incision suture mechanism configured in accordance with the principles of the present invention.
Figure 10 is an enlarged isometric perspective view of the base and load distribution structure of the system of Figure 9;
Figs. 11A and 11B illustrate alternative lateral tie configurations that may be used in the Fig. 1 or Fig. 9 instrument.
Figure 12 illustrates a sacrificial cover positioned over an incision suturing instrument in accordance with the principles of the present invention.
Figures 13A-13E illustrate the working principle of the sacrificial cover shown in Figure 12 when used in conjunction with a surgical incision drape to perform the method according to the present invention.
14A-14C are perspective views of a further embodiment of an incision suture mechanism constructed in accordance with the principles of the present invention.
Figure 14d is a top view of the incision suture instrument similar to the instrument of Figures 14a-14c and disposed on the knee of the subject according to the present invention.
15A is a schematic view of an incision suture mechanism having a pulley system for laterally coupling two adjacent base panels in accordance with the principles of the present invention.
15B is a sectional view of the incisional suture mechanism of Fig. 15A.
15C shows the incision suture mechanism of Fig. 15A disposed on the knee of the model according to the present invention.
15D is a schematic view of an incision suture mechanism similar to the incision suture mechanism of FIG. 15A.
Figs. 15E and 15F show various lateral tie assembly structures used in the incision sewing mechanisms of Figs. 15A and 15D, respectively.
16A-16D show various securing mechanisms in accordance with the principles of the present invention.
Figure 17 shows a hinge mechanism for an incision suture instrument in accordance with the principles of the present invention.
Figure 18 is a top view of an incision suturing instrument similar to that of Figure 14a and disposed on the knee of an object according to the present invention;
Figure 19 shows an incision suturing instrument comprising a separate pair of base panel segments in accordance with the present invention.
20A is a perspective view of an incision suturing instrument similar to that of Figs. 9 and 10 and in accordance with the principles of the present invention.
Figure 20B is an enlarged view of the lateral tie assembly of the incision suturing mechanism of Figure 20A.
21 is an exploded view of a part of the incisional suture mechanism of Fig.
Figure 22A is a perspective view of a cover for an incision suture instrument as disclosed herein in accordance with the principles of the present invention.
22B is an exploded view of the cover of FIG. 22A.
Figure 23A is an exploded view of an incision suture instrument assembly including the incision suture mechanism of Figure 21 and the cover of Figure 22A in accordance with the principles of the present invention.
23B is a perspective view of the incision suture instrument assembly of Fig. 23A attached to a patient ' s skin.
Fig. 23C is a top view of the elastomeric reinforcing layer of the cover of Fig. 22A. Fig.
24A is a perspective view of the incision suture instrument 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 suture instrument assembly of Fig. 23A attached to the skin of a patient in accordance with the principles of the present invention.
Figures 25A-25C illustrate a method of attaching the incision suture instrument assembly of Figure 23A onto the skin of a patient in accordance with the principles of the present invention.
Figures 26A-26E illustrate embodiments of a cover for a wound dressing and an incision suturing instrument in accordance with the principles of the present invention.
Figures 27A-27E illustrate an embodiment of a wound suture device comprising a medicament in accordance with the principles of the present invention.
28A-28E illustrate an embodiment of a wound closure mechanism cover that includes a medicament in accordance with the principles of the present invention.
Figure 29 illustrates another sacrificial cover positioned over an incision suturing instrument in accordance with the principles of the present invention.

The apparatus and method of the present invention is used for both the formation and closure of surgical incisions that are formed in a patient's skin or other tissue during a surgical procedure. As will be described later, the direction of the incision defines both "axial" and "transverse" when the term is used in this specification. Most incisions will be formed along a generally straight line that defines the axial direction. The transverse direction generally transverses 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 have curved or other geometric shapes. Thus, the term "axial direction " is applied in the direction of the incision at any particular location, so that the lateral direction may also vary accordingly.

Referring now to Figures 1-3, the incision closure mechanism 10 includes a base assembly 12 having a first panel 16 and a second panel 14. A second load distribution structure 18 is fixed to the second panel 14 by stacking a load distribution structure on the upper surface of the panel. The first panel 16 has a first load distribution The structure 20 is similarly attached. The incision suture instrument further comprises a seam component (22) detachably attachable to the first and second load distribution structures (20, 18) for sealing the incision, as described in more detail below, Is completed with an optional fixation layer 24 that is secured to the patient with the base assembly 12 and suture component 22 being joined and the sutures pulling the panels together using the suture component And may be disposed upon the combined base assembly 12 and the sealing component 22 after completion.

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

The lower surface 32 of each panel 18, 20 is usually covered with a pressure-sensitive adhesive, which is covered with a protective layer 48 that can be stripped off immediately prior to use. In addition, pulls may be used to hold the first and second panels 16, 14 together at a predetermined, spaced distance after the protective layer 48 has been removed prior to attaching the panels to the patient's skin or other tissue surface -away tab 50 or other similar structure may be provided. The distance between the inner edges 28 of each panel 14,16 is maintained as close as possible to the original target distance so that the edges of the tissue are normally correctly joined by some eversion during suture by the suture component 22 .

Referring now to Figures 4-7, a planning procedure for forming an incision in accordance with the principles of the present invention and subsequently sealing the incision will be described. First, the first and second panels 16 and 14 are disposed on the skin of the patient to which the reference character S is affixed, as shown in Fig. The panels 14 and 16 are attached by first removing the protective layer 18 and placing the panel in tissue and then removing the tab 50 to create a cut path 52 between the inner edges 28 . The spacing of the inner edges 28 will be selected to provide a fixed predetermined distance d1.

After the first and second panels 16,14 are in place, a cut or cut I is formed in the space between the panels using a scalpel or other surgical cutting mechanism CD, as shown in Fig. can do.

After the incision I is formed, a surgical procedure is performed to open the internal edge of the incision as shown in Fig. 6 thereby deforming the internal edge 28 of the first and second panels 16,14 accordingly . Since the innermost ends of the supports 36 are not connected, these ends are free to separate and allow the elastic matrix of the first and second panels 16, 14 to expand, as is clearly shown in Fig. However, the dimensional stability of the remainder 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 aperture of the incision.

After the surgical planning procedure is completed, the suture component 22 is secured over the load distribution structure 18, 20 as shown in Fig. In particular, the slots 38 in the tab-like structure 44 are coupled onto opposing cleats 26 to pull together the tissue cuts as well as the opposite ends of the panel. By properly spacing the depth of the slot 38, the sealing component 22 can be adjusted such that the panels 14 and 16 are combined by a preselected distance d ₂ . Typically, the distance d ₂ is greater than the initial separation distance d ₁ to allow the internal edges of the tissue to coalesce so that the tissue edges along the incision are somewhat abduction (upward and downward) so as to improve treatment and reduce scarring. It will be small.

Alternatively, as shown in FIG. 8, the sealing component 22 may include a mating member 40 ', wherein one end of each of the transverse braces 42' 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 the inner surface 40 '.

An alternative embodiment 100 of the incision suture mechanism of the present invention is illustrated in Figs. 9 and 10. Fig. The apparatus 100 includes a base assembly 102 having a first panel 106 and a second panel 104. The first panel 106 and the second panel 104 are shown in Fig. A positioning strip or alignment strip 108 is provided to secure the inner edges of each panel together, as best seen in FIG. 10, where the strip is positioned such that after the panel is in place on the tissue surface, 104, and 106, respectively.

The incision suturing instrument 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 be attached to the tissue while the remainder of the base assembly is still covered by the backing And a backing 110 having an end. As described in greater detail above with respect to the previous embodiments, the base assembly 102 may be secured to the fixation layer, including the reinforcement frame 113, for placement over the first and second panels 106, (112) is provided. Typically, a holding tray 114 may be provided to keep the components of the device together in a sterile condition, in which the tray 114 is covered with a conventional medical wrapper.

9 and 10, a first load distribution structure 118 and a second load distribution structure 116 are provided on the upper surfaces of the first panel 106 and the second panel 104, respectively. The second load distribution structure 116 includes a second axial main skeleton 120 and a plurality of lateral supports 122. Typically, the second axial main skeleton 120 includes a serpentine or zigzag-shaped member that is embedded within the base strip 121 or laminated to the base strip. The truncated axial main skeleton 120 may typically be formed of an elastic, resilient plastic (typically rigid plastic) while the base strip 121 may be comprised of a polyurethane or similar plastic layer. The lower surface of the polyurethane layer will be covered with a hydrocolloid layer for tissue attachment. The structure of the first load distribution structure 118 will be identical, including the first axial main skeleton 124, the first lateral support 126, and the first base strip 127.

The incision suturing instrument 100 will include a suturing mechanism including a plurality of transverse tie assemblies 128 as shown in FIG. 10, each transverse tie assembly 128 includes a rod having one end secured to the first transverse support 126 and a ratchet mechanism (not shown) secured to the second transverse support 122 132). Each of the rods 130 is generally arranged so that the gap 129 between the first panel 106 and the second panel 104 is opened so that a cut portion can be formed therebetween. ≪ / RTI > After the incision is formed, each rod 130 is pulled by an associated ratchet 132 on the second panel 104. A series of ratchet rings on each rod is pulled into the associated ratchet mechanism 132 and then the rod is pulled laterally until the desired suture tension is applied to that 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, the fixation layer 112 may be disposed on the base assembly 102 to maintain 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 can be used in the previously described incision suturing apparatus 10 or 100. [ Each lateral tie assembly 140 includes a second load distribution structure 142 and a first load distribution structure 144. The second load distribution structure 142 includes a second main framework 146 and a plurality of lateral supports 148. Although three are shown, it will be appreciated that four, five, six or more transverse supports may be included. The first load distribution structure 144 similarly includes a first main framework 150 and a plurality of first lateral supports 152. To achieve the seal, the second load distribution structure 142 includes a rod 154 extending from a central transverse support 148. Typically, the 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 are provided.

The first load distribution structure 144 includes a ratchet mechanism 160 adapted to receive a tooth 162 on the rod 154 of the second load distribution structure. In this manner, the rod 154 is pushed forward by being lowered into the ratchet 160 to which the teeth 162 are coupled, pulling the first and second load distribution structures 144, 142 together, Tension can be applied to the second panel.

As shown in FIG. 12, further embodiments of the present invention are illustrated. The incision suturing instrument 100 is schematically illustrated as having only first and second panels 106, 104 and first and second load distribution structures 118, 116 as shown. The remaining system components are not shown for convenience of illustration.

The first panel 106 is covered by a first sacrificial cover 172 and the second panel 104 is covered by a second sacrificial cover 170. The first and second panels 106 and 104 may form a region 175 in which the first and second sacrificial covers 172 and 170 are separated from the first and second panels 106 and 104. As each cover 170, 172 is releasably secured along the respective edges of the associated base panel, the cover is held in place during placement and normal handling of the incisional suturing instrument 100 on the tissue surface to be incised. The use and purpose of the sacrificial covers 170 and 172 are described with reference to Figures 13A and 13E.

13A illustrates the first and second panels 106, 104 in place on the tissue surface T before the incision is formed. The first panel 106 is covered by a first sacrificial cover 172 and the second panel 104 is covered by a second sacrificial cover 170. An adhesive surgical incision drape 180 is placed over the tissue surface T, as is common in many surgeries. Any conventional drapes such as Ioban ^TM antimicrobial incision drape to be purchased from 3M located in St. Paul, Minnesota, may be used.

After the incision drape 180 is in place on the incision suturing instrument, a surgical incision I may be made to perform the desired surgical procedure. As can be appreciated, the incision I is cut through the surgical drape 180 between the first panel 106 and the second panel 104. After the surgical procedure is completed, the surgical drape 180 will be removed from the tissue surface T. [ Prior to the present invention, removal of the drape would displace either or both of the first panel 106 and the second panel 104 because the surgical drape had an adhesive lower surface. However, this displacement is prevented by the presence of the sacrificial layers 170 and 172. [ Removal of the surgical drape 180 will remove the sacrificial layer 170, 172, but since each of these layers is configured to be separated by a relatively low separation force, the displacement of the lower panel 104, 106 due to removal of the sacrificial layer Is not caused. Thus, the panels 104, 106 are held in place as shown in Fig. 13d, and the load distribution structures 116,116, as described above, to suture the panels together to seal the incisions, 118) may be used.

29, the first and second sacrificial cover layers 172 and 170 may each be constructed of a sheet of urethane (e.g., 0.001 inch thick). The middle portion of the urethane sheet can be attached to the top of the first and second panels 106 and 104 and the load distribution structure as well as any straps 130 and the fixing portion 132 are assembled on top of the urethane sheet. The urethane sheet may then be wrapped around the load distribution structure 116, 118 (and the strap 130 may bend inward as shown in Figure 29 to be rolled over the panel 106) The ends are laminated together along their length. Thus, the urethane sheet can surround the load distribution structures 116, 118 and the sealing elements 130, 132 to protect them from the surgical drape 180. The urethane sheet may preferably include a plurality of apertures 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 tear away with the surgical drape 180 in a controlled manner when the surgical drape, such as the surgical drape 180 described herein, is removed. The holes may preferably consist of 3 mm cuts and 1 mm connections, although the exact dimensions vary to control the desired bursting force. The holes may be formed along a single longitudinal line or along a plurality of lines. A plurality of longitudinal bore lines may enable reliable separation despite variations in which the surgical drape is attached to the sacrificial layer 170, 172. The holes may be more easily pulleyed near the edges of the panels 104 and 106 to help improve the possibility of separation near the edges 104e and 106e of the panels 104 and 106 and to minimize leaving behind excess urethane. . To assist in lifting the sacrificial layer 170, 172, a tab 170t may be attached to each end of the urethane package, including the sacrificial layer 170, 172. The tabs 170t, 172t may preferably be attached to the interior of the upper surface of the urethane package. The tabs 170t and 172t may have a shape that prevents the urethane from being attached to the tab itself or to any adhesive exposed from the end of each panel 104 and 106. [ The pre-rupture of the holes at the end of each panel 104, 106 may initially lift the tabs 170t, 172t and help the rupture to be initiated by the user.

Referring now to Figures 14A-14C, further embodiments of the incision closure mechanism are illustrated. The base structure 1400a (FIG. 14a), 1400b (FIG. 14b), and 1400c (FIG. 14c) may include a first base panel 1404 and a second base panel 1402, respectively. The second base panel 1402 may include an upper layer 1406 and a lower layer 1408. Similarly, the first base panel 1404 may include an upper layer 1410 and a lower layer 1412. The upper layers 1406 and 1410 are typically stretchable, but are strong enough to firmly suture the tissue and minimize disruption of the incision and surrounding tissue. The top layers 1406 and 1410 may comprise a plastic layer formed from rubber, latex, polyurethane, silicone, thermoplastic elastomer, fabric, spun fabric or similar material. Adhesive lower layers 1408 and 1412 are typically stretchable to follow any movement of underlying skin and tissue to maintain adhesion and minimize swelling and otherwise reduce irritation and are more resilient than upper layers 1406 and 1410 to be. Adhesive lower layers 1408 and 1412 may include hydrophilic adhesive materials such as hydrocolloids, hydrogels, acrylic polymers, poly (ethylene glycol), and the like.

The first and second base panels 1404 and 1402 may include structures that permit and restrict axial and lateral extension of the base assembly 1400. These structures can also distribute the sealing forces exerted on the incisions uniformly and can be placed on the base assemblies 1400a, 1400b, 1400c along their axial lengths. The second base panel 1402 may include one or more second load distribution structures or axial supports 1414. Each second axial support 1414 may include an axial support or main skeleton 1414a and two lateral supports 1414b coupled to the axial ends of the main skeleton 1414a. Together, the main skeleton 1414a and the two lateral supports 1414b form a C-shaped configuration, which in some embodiments is adjacent to two laterally adjacent sides of the adjacent support 1414 The axial extension of the second base panel 1402 between the transverse supports 1414b while the axial extension between the two transverse supports 1414b of one of the supports 1414 is limited to an axial extent Lt; / RTI > In many embodiments, the C-shaped axial support 1414 is stretchable only to such an extent that it can flex vertically and is sufficiently rigid to minimize axial and lateral stretch. As shown in Fig. 14A, the second axial supporting portion 1414 can be directed inward. 14B and 14C, the second axial support 1414 can be directed outward, which allows any mechanical load resisting tissue seam to pass between the first and second base panels 1404 and 1402 Lt; RTI ID = 0.0 > I < / RTI > Similarly, the first base panel 1404 can include one or more first load distribution structures or axial supports 1416. Each first axial support 1416 may include an axial support or main skeleton 1416a and two lateral supports 1416b coupled to the axial ends of the main skeleton 1416a. Together, the main skeleton 1416a and the two lateral supports 1416b form a C-shaped configuration, which in some embodiments is adjacent to two laterally adjacent portions of the neighboring support 1416 The axial extension between the two transverse supports 1416b of one support 1416 while allowing axial extension of the first base panel 1402 between the transverse supports 1414b is limited to a certain degree in the axial direction Lt; / RTI > In many embodiments, the C-shaped axial support 1416 is stretchable only to such an extent that it can flex vertically and is sufficiently rigid to minimize axial and lateral stretching. As shown in Fig. 14A, the first axial supporting portion 1416 can be directed inward. 14B and 14C, the first axial support 1416 can be directed outward, which allows any mechanical load resisting tissue seam to pass between the first and second base panels 1404 and 1402 Lt; RTI ID = 0.0 > I < / RTI >

As shown in Fig. 14C, the base panel assembly 1400c may further include skirt portions 1424 and 1426. Fig. The skirt portions 1424 and 1426 may be similar to the thin base 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 surface of the skirt portions 1424 and 1426 or may be applied only to the skirt portions 1424 and 1426 beyond the base panel 1402 or 1404. [ The skirt portions 1424 and 1426 may be attached directly over all or a portion of the adhesive layers 1408 and 1412, respectively, during construction of the base panel assembly 1400c. The skirt portions 1424 and 1426 may be attached in place of or in addition to the thin film upper layers 1406 and 1410, respectively. The release liner described herein may be additionally provided to cover the adhesive bottom of the skirt portions 1424, The skirt portions 1424 and 1426 may extend beyond the boundaries of the base panels 1402 and 1404 by, for example, 8 mm or 1 to 20 mm, but may also extend beyond the base panels 1402 and 1404 to enhance the ability to visualize and / 1402, 1404, respectively. The skirt portions 1424 and 1426 may provide additional adhesive support and / or adhesive to the adhesive layers 1408 and 1412 of the base panels 1402 and 1404 without having to align and position the individual covers or cover sheets on the base panel assembly 1400. [ Or to provide a reduction in progressive creep. After manufacture, the skirt portions 1424, 1426 are typically already precisely aligned with respect to the base panels 1402, 1404. A separate cover or cover sheet as described herein may still be used to prevent tampering of the incision site and components of the base panel 1402, 1404. Since the skirt portions 1424 and 1426 each extend laterally above the base panels 1402 and 1404, such individual covers or cover sheets may not require accurate placement with respect to the base panel assembly 1400c, The width may be narrower in comparison with other covers or cover sheets that are made of the same material.

One or more apertures 1418 are provided between the axially adjacent second axial support portions 1414 on the second panel 1402 to facilitate axial and / or lateral extension of the second base panel 1402 Can be provided. The holes 1418 may be present over the top and bottom layers 1406 and 1408 or may be present only in the top layer 1406 to allow air to pass through to the underlying tissue. Similarly, one or more apertures 1420 may be provided between the axially adjacent first axial support portions 1416 on the first panel 1404 to facilitate axial and / or lateral extension of the base panel 1402 Can be provided. The holes 1420 may be present over the top and bottom layers 1410 and 1412 or may exist only in the top layer 1410 to allow air to pass through to the underlying tissue. As shown in FIG. 14A, there can be only one hole 1418 or 1420 between the axial support 1414 or 1418. As shown in FIGS. 14B and 14C, there may be a plurality of holes 1418 or 1420 in a transverse line between the axial supports 1414 or 1418. Holes 1418 and 1420 may also reduce stresses that occur during the time that the skin extends radially outwardly from the incision I, such as during joint motion and during swelling.

The plurality of holes 1418 and 1420 may be formed between the axial ends of the first and / or second axial support portions 1416 and 1414 along the first and second lines 1426 and 1424, Can be provided. Each of the line segments 1424 and 1426 can be separated into individual segments when at least the top and bottom layers 1410 and 1412 of the base panels 1402 and 1404 are each axially elongated as described further below. A plurality of axially aligned holes may be provided. In some cases, holes 1418 and 1420 may be formed in layers 1410 and 1412 of first panel 1404 and layers 1406 and 1408 of second panel 1402 during the wearing of instrument 1400, It may be allowed to fall completely apart, as shown in Figures 14b and 14c. The ability to completely separate and detach further allows the skin to be axially elongated as needed, which is permitted by the connection of the axial support portions 1414, 1416 and the sealing component 1422, discussed below And limited). As discussed herein, after the incision I is sealed, an elastic, flexible cover can be attached over the base panels 1402 and 1404. [ The cover may additionally have the function of providing (and restricting) axial and lateral movement of the base structure 1400b. Alternatively, or in combination, one or more of the first or second base panels 1404, 1402 may be used to facilitate axial and / or lateral extension of the first and / or second base panel 1404, 1402 Can be cut and separated laterally between the load distribution structure or the axial support 1414, 1416.

In order to couple the first and second base panels 1404 and 1402 laterally together and optionally to fasten the first and second base panels 1404 and 1402 relative to each other, the base assembly 1400 includes a plurality of And may further include a transverse sealing component or tie assembly 1422. The transverse sealing component or tie assembly 1422 may include a ratchet mechanism similar to the ratchet mechanism of the transverse tie assembly 128, 140 described above. The transverse tie assembly 1422 can couple transversely adjacent first and second axial supports 1416 and 1414, typically at their axial ends. 14A-14C, the arrangement of the first and second axial support portions 1416, 1414 on the first and second panels 1404, 1402 can be offset or axially offset, respectively, The first and second axial support portions 1416 and 1414 are C-shaped having transverse ends 1414b and 1416b that are laterally opposite and aligned with each other (and are connected to each other by a transverse tie assembly 1422) Type structure. For example, the distal side end 1414b of one second axial support 1414 may be laterally aligned with the proximal side end 1416b of one first axial support 1416, The distal side end 1416b of the first axial support portion 1416 of the second axial support portion 1414 may be laterally aligned with the proximal side end portion 1414b of the other second axial support portion 1414, Thus, the transverse tie assembly 1422 and the first and second axial supports 1416 and 1414 are connected to each other to form a continuous transverse tie assembly 1422 and first and second axial supports 1416 and 1414, Which can be used to cross the first and second base panels 1404 and 1402 in a transverse direction as shown in Figs. 14A to 14C (i.e., the first and second base panels 1404, 1402), which are spaced apart from one another. The meandering arrangement of the transverse tie assembly 1422 and the first and second axial supports 1416 and 1414 may be achieved by uniformly distributing the sealing force provided by the base assembly 1400 on the incision, 1400c to provide sufficient rigidity or rigidity to the base assembly 1400a, 1400b, 1400c to sufficiently seal the incision, and to allow the incision to be healed with minimized collapse and expansion (I. E., Provide lateral and axial stability). ≪ / RTI > In many embodiments, the lateral supports 1414 and 1416 are rigid enough to extend the area of the base panels 1402 and 1404 not covered by the lateral supports 1414 and 1416. [ Since these uncovered areas are offset from each other from the first base panel 1404 to the second base panel 1402, the tie assembly 1422 is configured such that when the incision I extends axially, And can be pivoted axially. This axial pivoting of the tie assembly 1422 may cause the first and second panels 1404 and 1402 to close together to maintain the sealing of the incision I.

The materials of the lateral tie assembly 1422 and the first and second axial supports 1416 and 1414 include elastic elastic plastics which are typically hard plastics such as nylon, polypropylene, polyethylene, polycarbonate and other thermoplastic polymers can do. The lateral tie assembly 1422 and the first and second axial supports 1416 and 1414 may include less resilient material than the materials of the first and second base panels 1404 and 1402. [ Thus, the upper side of the base assemblies 1400a, 140bb, 1400c, including many of the other base assemblies of the incision suture mechanisms disclosed herein, 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 assembly 1400a, 1400b, 1400c. The upper portions of the base assemblies 1400a, 1400b, and 1400c may be configured such that the incision suturing mechanism is configured to receive tissue adjacent to the tissue adjacent to the incision and surrounding tissues, It may be hard or hard enough to prevent movement. In other words, movement of at least a portion of the attached incision suture mechanism (i. E., The lower portion of the harder layer) is collective and does not interfere with the underlying incision. And the bottom of the base assemblies 1400a, 1400b, 1400c may be sufficiently resilient to minimize swelling and adhesion losses due to tissue movement adjacent to the attached incision suture mechanism. The main function of the transverse tie assembly 1422 may be to apply tension to each base panel 1402, 1404 to retain the sealed incisions I, but in many embodiments the transverse tie assembly 1422 may be used to minimize the effect of compression (or bending / wrinkling along the incision) from the distraction forces that may interfere with incision edge alignment and attachment apposition, It may also have the function of providing columnar strength to break the part (I). The axial spacing, material properties, and dimensions of the lateral tie 1422 can be optimized for sufficient axial flexural stretchability and lateral compression and flexural support. In a preferred embodiment, the spacing of the ties 1422 is 10 mm, the material of the ties 1422 is nylon, and the dimensions are round cross-section of 0.30 inches.

Referring now to FIG. 14D, a base assembly 1400b may be disposed on a joint of the subject, such as a knee, or an incision in the skin of a patient. Especially in the case of incisions located near joints, such as the knees, the entire suturing instrument or suturing device is often challenged by a number of factors. These factors include longitudinal stretching, peripheral swelling, opening of the wound at the onset of joint motion, skin damage such as swelling, adhesion loss and passage of wound secretions. Joints such as knees, elbows, ankles, and shoulders can sometimes cause the above-described challenges by exhibiting movements that can result in joint movements that include motion above 135 degrees.

In the bent position, the skin around the knee can be stretched up to 50% in the axial direction (i.e., parallel to the incision) and transverse (i.e., transverse to the incision or perpendicular to the incision). An incision suture instrument attached to the skin in this area would preferably provide sufficient tension to allow the incision to be sutured and stretched with minimal local stress. Minimization of local stress can prevent damage to the skin if local skin adhesion loss or adhesion loss does not occur. An important characteristic for the multiple incision suture instruments disclosed herein is the ability to tension the suture element of a device that is distributed across an area larger than the area of the tension element attachment point itself. In addition, the structure including the adhesive to which the tensile element is attached can often have the ability to distribute the compliance of the structure across the skin elongation region so that the suturing mechanism maintains the incision in place while the skin is moving back and forth have. Embodiments described herein may include a composite design of a non-stretch tension element (collectively referred to as a "strap ") connected to a" fixture "that holds the strap in place. For example, these 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 aids in distributing tensile loads. Such elastomers may in many cases have a high elongation before yield or permanent deformation, and may include thermoplastics such as polyurethane as well as various grades of silicone. In addition, such materials can be easily formed into thin films necessary to maintain a low profile and sufficient compliance.

In addition, the skin adhesive used in the suturing device should be able to shrink / restore when the skin resists stretching of the skin and the skin returns to a non-stretched state, e.g., from a fully stretched knee position. Hydrocolloid adhesives can provide such properties and are preferably suitable for such applications. Other adhesives such as acrylic can also be used to provide this property. In general, such an adhesive needs to be attached to an elastic thin film such as the one described above to maintain the structure during expansion and contraction. Without such support, the adhesive can be ruptured and separated by repeated stretching.

An incision suture mechanism constructed as a series of short segments may allow higher overall elongation without loss of attachment or skin damage. Each individual segment may experience localized elongation of the skin in its lower part. The space between the two neighboring segments can act as a stress relief space allowing the skin to stretch within the space. Segmentation can be accomplished in a variety of ways by (1) placing individual segments along the incision line or (2) attaching the device to the skin, or after the device is attached to the skin, so that the device is split into segment segments.

The preferred means of achieving post-attachment segmentation to the skin is to provide holes in the polyurethane layer (i. E., Upper layers 1406 and 1410 of base panels 1402 and 1404) And leaving the underlying adhesive intact as shown in Figure 14D. The holes may cause at least the top layer (e.g., top layer 1406, 1410) of the base panel to tear along the perforation line (e.g., 1424, 1426) when experiencing an elongation when the knee is flexed . In a preferred embodiment, the adhesive panels on each side of the cut may be 12 mm wide and the holes in a given panel are spaced apart by about 12 to 20 mm. Experiments were carried out and it was found that 3 mm cutting and 1 mm connection distance holes were effective in achieving segmentation of a 0.001 inch thick urethane base panel when the knee was flexed. When the knee is flexed, the skin may be stretched axially (along the incision) and transversely to 50% at some locations. Therefore, the separation of polyurethane can alleviate stress in the device when undergoing elongation.

As an example, a surgically treated knee may develop inflammation for several days, which may result in radial swelling of the joint by about 30% after suturing. Elastic material, such as polyurethane, may cause the incisional suture mechanism (e.g., including the base assembly 1400b attached to the resulting incision I of FIG. 14D) to be inflated by this peripheral annoyance. Minimizing the width of the instrument (e.g., 12 mm or less per each base panel segment 1402, 1404) can reduce the amount of expansion of the instrument in a direction perpendicular to the incision I, The adhesion can be maintained while minimizing the adhesion. Figure 14d shows holes in the adhesive segment that extend laterally along the lines 1424 and 1426 to the incision to allow easier axial extension. Holes or other perforations can be formed near the outer edge of the adhesive segment parallel to the incision to reduce the stresses that occur when the skin extends radially outwardly from the incision, for example during and during joint motion.

Referring now to Figures 15A-15D, the incision can often be subjected to a force to open the incision due to bending of the knee or other joint. In many embodiments, the incisional suture mechanism includes a securing mechanism that resists the opening force by closely sealing the suture during bending to help keep the incision in the sutured condition. 15A and 15B illustrate a base assembly 1500 of an incision suturing instrument that includes a mechanism utilizing a pulley effect, i.e., a mechanism by which the distance between the anchor points on each side of the incision becomes shorter as the skin extends along the incision, Lt; / RTI > In a preferred embodiment, the adhesive panels 1510a, 1510b on each side of the cut between the pair of base panels 1510a, 1510b have a width of 12 mm and the lineated holes 1530 in a given panel 1510 About 18 mm apart. Normally, all members of the securing mechanism do not stretch. The triangle formed by the anchor 1540, the pulley 1520, the securing portion 1550 and the retractable securing element 1580 (e.g., a sling or a strap) B and the height H of the transverse direction across the incision. When the knee bends, the base length of the triangle increases. Normally, all the members of the triangle do not stretch, which requires that the height be reduced to cause additional sealing forces across the incision by maintaining the length of the individual elements between any two points. 15A and 15B further illustrate that the bottom surface of the base panel 1510a and 1510b may include a hydrocolloid adhesive 1560 and one of the panels 1510a and 1510b may be secured to the strap 1580 in place Arm 1570 as shown in FIG. Although the base of the triangle is shown as being on the first base panel 1510b in Figure 15a, it is contemplated that the base of the triangle may instead be on the second base panel 1510a.

The triangle can be formed by the anchor 1540, the pulley 1520, the fixing portion 1550 and the elastic fixing element 1580, but other forms are also contemplated. For example, the pulley 1520 may be wrapped 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. 15D, a base assembly 1500a of an incision suturing apparatus similar to the base assembly 1500 is illustrated. In the base panel 1500a, the anchor 1540, the two pulleys 1520, the fixing portion 1550 and the elastic fixation element 1580 are arranged to provide additional sealing to the incision I when the underlying skin is stretched Thereby forming a rectangle. In the rectangular configuration shown in Fig. 15D, the spacing between the two fixed points on each side of the incision I will generally be the same. On the other hand, in the triangular configuration shown in Figs. 15A and 15C, the fixed point on the pulley 1520 side can be farther away from the other side of the incision I. The rectangle is illustrated as being "open" on the first base panel 1510b, but the rectangle may instead be "open" on the second base panel 1510a.

14A, 1400b, 1400c of the incision suture apparatus shown in Figs. 14A-14C and other assemblies described herein, a separate strap 1422 is provided for joining the individual fasteners on the opposite side of the incision I, Can be used. 15A-15D, each of the elastic constrictions or straps 1580 is fixed to one side of the incision I and is wound on the other side and is then wound on the same side of the incision I as the anchor 1540 And engages with the fixing portion 1550 on the side. In the embodiment illustrated by Fig. 15d, the retractable anchorage element or strap 1580 includes two fixed spools (the bobbins / pulleys 1520, 1520) on the other side of the incision I before being engaged with the fixed portion 1550 on the same side )]. The spools 1520 with the stretchable straps 1580 wrapped may be preferably connected to the rigid member such that the distance between the suture mechanism base panel assemblies 1500 when they are extended in the axial direction is not increased. In an alternate embodiment, it may be desirable to allow for expansion between the pulleys or spools 1520. It should be noted that the retractable securing element 1580 can 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. Such anchoring and fastening can form a connection between the three segments of the base strip on one side and two on the same side. The attachment mechanism, when taken together across the length of the incision suturing instrument or base assembly 1500, 1500a, forms a continuous 'S' type (ie, meandering) connection across the incision I.

A flexible connection 1580 that is wrapped around the spindle, spool, or pulley 1520 and is tensioned may be configured to provide extra pressure to the incision I as the disruptive force tries to open the incision and the underlying skin is stretched have. The stretchable straps 1580 may in some cases be loosened by potentially slipping off the spindle if the two base panels 1510a are further compressed by the combined external force without stretching the underlying skin. To prevent the occurrence of such slippage, the retractable winding member 1580 may be slidably contained or fixed within the element 1590 fixed to the base strip 1510a. Figs. 15E and 15F illustrate a stretchable element 1580 threaded in turn through a tube 1590 attached or secured to the base panel 1510a. When the base panels 1510a, 1510b are close together, the retractable strap element 1580 will still provide the necessary sealing function in the restrained condition. In another embodiment, the spool feature 1590 shown in Figs. 15E and 15F may have a center hole through which the strap 1580 slides. The elements 1590 through which the stretchable straps 1580 and the straps slide may be desirably designed to minimize friction between these elements 1580, 1590.

If the experiment was performed and the base B was 12 mm and the height H was determined by the distance between the strap connection points on the two base panels 1510a and 1510b after sealing the incision (typically about 16 mm) The bending of the suture mechanism on the knee resulted in a 5% decrease in height (H) in the region where the stretching of the skin (S) is maximum. It should be noted that the height reduction may depend on a number of factors, such as the base of the triangle, the level of elongation of the underlying skin, and the distance between the two bases on the side of the incision. It may be necessary that the connection "strap" between the anchor 1540 and the securing portion 1550 can be at least partially curved to allow the formation of a loop around the pulley. In a preferred embodiment, the monofilament plastic yarn is incorporated with the feature to be incorporated into the securing mechanism. These features may be round "teeth" that engage in a ratchet-type mechanism within the fixture. Such plastics may be used to achieve the desired stretchability, longitudinal stiffness, low bacterial propagation and acceptable extrusion and / or injection molding processes. A braided suture (preferably coated to inhibit bacterial growth) may be used to form a flexible but non-stretchable connection. A round wire or tube made of an elastic material such as silicone may be used to achieve stretchability. 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 over the yield point can permanently reduce the cross-section of the strap and make it more elastic when stretched. Heat may be used in the necking process to facilitate stretching and reducing cross-sectional area. Once the desired suture is achieved, the alternative mechanisms shown in Figures 16A and 16B can be used to secure the suture and the strap material, such as soft plastic. 16A shows a securing mechanism including a slot 1610 and a fixed frame 1620 for sliding. 16B shows a securing mechanism including a fixing tooth 1630. Fig. 16C shows a securing mechanism including a slot 1640 for sliding and a fixed frame 1650. Fig. 16D shows a securing mechanism including a cylindrical tube 1660 and a fixing tooth 1670. Fig.

An additional suture force across the incision that occurs when the knee flexes can be achieved by using a hinge mechanism 1700 as shown in Fig. As shown in FIG. 17, four points on the side of the incision (each side of the incision suturing mechanism or two anchor points 1720 on the base panel 1710) are connected in X-shape with arms that do not extend, A hinge connection may be provided to the portion 1740. As the knee flexes to increase the distance between two points on the same side of the incision, the inter-segment distance on the side of the incision can be reduced and additional sealing force can be formed. 17, the base panel 1710 may also include a plurality of holes 1750 to facilitate axial elongation to the base panel 1710 or separation into individual segments during axial elongation. have.

18, the straps and fasteners of the incision suturing instrument 1800 according to various embodiments may be S-shaped or meandering connections across the entire length of the incision I on the skin S of the knee, May be configured to form a disposition. The incision suturing instrument 1800 can be similar in many respects to the incision suturing instrument 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 achieved by mounting a pair of straps 1820 in each segment 1810a and mounting a pair of fixed portions 1830 on the corresponding segment 1810b on the other side. The pair of fixing portions 1830 and the straps 1820 may be connected to each other. One of the straps 1820 of the base panel segment 1810a (e.g., segment 1810a1) (e.g., strap 1820a) during the sealing of the wound or incision I is such that the segment The second strap 1820 (e.g., the strap 1820b) may be connected to the fixing portion 1830 (e.g., the fixing portion 1830a) on the first strap 1810b (e.g., the segment 1810b1) (E.g., segment 1810b2) in the opposite side of the incision I adjacent to the segment 1810b (e.g., segment 1810b1) to which the pair 1820 (e.g., strap 1820a) 1830 < / RTI > (e. G., 1830b). The above-described connection forms a single loop of the S-shaped or meandering arrangement of the base panel segment 1810, the strap 1820 and the fixing portion 1830. Hole line 1850 can separate axially adjacent base panel segments 1810a and 1810b. The hole line 1850 on one side (e.g., at the base panel segment 1810a) may be staggered with the hole line 1850 (e.g., at the base panel segment 1810b) of the other side. Similar to Fig. 15A, in a preferred embodiment, the adhesive panels on each side of the incision can be 12 mm wide and the holes in a given panel can be spaced apart by about 18 mm.

The incision closure device or device as described herein may be applied in various ways. 19 shows an exemplary incision suturing instrument 190 according to some embodiments. Here, pairs of individual base segments 1910 may be provided on separate carrier / release liners. Each pair of base panel segments 1910 includes a strap 1920 and a securement portion 1930 that can be attached to neighboring skin independently and aligned with the incision. The individual segments 1910 can be held together with respect to each other by a release liner and an outer carrier tape 1950. The release liner 1950 may be removed to expose the adhesive, but the entire device 1900, or grouped portions of the device 1900, may be connected to an external carrier tape. Upon adhering to the skin, the carrier tape 1950 can be removed, leaving adhesive segments that are aligned with each other but can be moved independently.

The perforated segments of the base panel upper layer, typically comprising polyurethane, may be held together with a continuous layer of an adhesive underlayer, usually comprising a hydrocolloid adhesive, so as to allow the skin to be laid down on the skin in one continuous operation. The lancing suture mechanisms 1400, 1500, 1800 of Figs. 14A-14D, 15A-15C and 18 may each include such a continuous adhesive bottom layer.

The base assembly or base panel of the incision suture mechanism described herein can preferably be coated with an elastic adhesive film material at the end of the wound or incision suture. The film area may preferably be larger than the base incision seal panel element to overlie the base incision seal panel element over the skin. The film may help prevent movement of the base and may prevent any accidental movement of the anchors and fastening mechanisms. The cover film may be made of an extensible material such as rubber, latex, polyurethane, silicone or thermoplastic elastomer. In a preferred embodiment, a thin cover (e.g., a 0.001 inch thick urethane and a 0.002 inch thick acrylic adhesive laminate) 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 (e.g., as a barrier to infection), or an opening aligned with the incision line may be present in the cover to permit passage of any secretions from the wound. The cover may also have the function of improving the adhesion growth of the cut edges by bridging the base panel and attaching to the skin edges between the base strips. The cover may comprise additional reinforcement elements that enhance the tensile strength between the base panel elements but permit compliance along the length of the incision. A preferred embodiment may comprise a series of polyethylene adhesive tape strips attached to a cover.

It is also contemplated that the user may attach the cover after the base assembly and panel have been placed on the skin, but the cover material may be supplied as a "skirt portion " extending around the 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 inhibiting the exposure of the hydrocolloid adhesive to the patient's clothing and limiting the movement of the hydrocolloid or other adhesive underlayer and providing strain relief to the tension on the base segment.

In various embodiments, a hydrocolloid adhesive is used to tighten the skin for incisional closure. The hydrocolloids are used to (1) use a laminate on the surface to limit creep migration, or (2) to prevent creep migration and to provide skin with strain relief, It is possible to prevent the creep movement by one or more of attaching the glue cover.

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

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

In various embodiments, the cover in combination with the base assembly can significantly align the skin incision edge or subsequent misalignment of the skin edge in the axial and transverse directions.

In various embodiments, a cover liner configuration is provided to allow a portion of the cover to be first attached to the skin, which helps remove the other liner and thus adjusts the thin material so that the thin material spreads evenly with minimal wrinkles Can help.

In various embodiments, removal of the first liner may allow observation during placement, thereby preventing the remainder of the suture mechanism from sticking to the user.

Referring again to Figures 9 and 10, two adhesive panels 104, 106 can be attached to the sides of the surgical incision in various preferred embodiments (before or after the incision is formed). A sealing mechanism may be mounted on the top of the adhesive panels 104 and 106, preferably attached to the component 20 to assist in distributing the sealing force between the attachment points of the sealing mechanism. As shown in FIGS. 9 and 10 as well as FIGS. 20A and 20B, such a sealing mechanism may include a strap 130 and a fixing portion 132. The strap 130 may comprise a long component having an engagement tooth. The fixing portion 132 may include a feature for restricting the engaging teeth of the strap 130. The straps 130 can be tightened within the securement 132 to pull together the adhesive panels 104, 106 (and thus the incision edges). The user can loosen or re-tighten the strap 130 within the fixing portion 132 as needed to appropriately adjust the degree of skin sealing. 20 (a) can be described as a base or base assembly 102. As shown in FIG.

The skin adhesive used in each of the panels 104, 106 may preferably include a hydrocolloid adhesive. Alternatively or in combination, the skin adhesive may comprise one of a plurality of acrylic agents known in the art. Hydrocolloid adhesives are highly sticky and can absorb moisture and have the advantage of stripping skin cells. Thus, the hydrocolloid adhesive may be particularly suitable for long-time (e.g., up to 14 days) wearing applications. However, at least in some cases, the hydrocolloid structure may be softer, so that it can be applied under tension, for example, if it is not reinforced in any manner, such as by covering the hydrocolloid adhesive layer with a harder base panel 102, 104, Creep may tend to move.

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 suture apparatus disclosed herein, as well as additional means for holding the skin edges together, especially in the axial direction Also. In at least some cases, the hydrocolloid adhesive alone may have a very low tensile strength and may require reinforcement means to prevent tearing or creep during use. As illustrated in Figure 21, the adhesive layer 211 used in the base panels 104, 106 is preferably a soft plastic or polymer 212, such as urethane, having a thickness of up to 0.001 inches and potentially up to 0.010 inches ) Can be laminated, which can help maintain the structure during clinical use. The adhesive layer itself may normally be 0.010 inches thick, but may have varying thicknesses between 0.005 inches and 0.020 inches. The tension element comprising the strap 130 or the securing portion 132 attached to the load distribution component 118 may be mounted on top of the adhesive structure 211 so that the likelihood that the material will creep over time exist. Any other adhesive laminate 215a, 215b as well as the laminate 212 between the adhesive layer 211 and the load distribution component 118 can help the structure prevent creep migration of the adhesive layer.

To further prevent movement of the adhesive panel 211, a cover 220 may also be attached over the panels 104 and 106 as shown in Figure 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 may be a thin urethane layer coated with a skin adhesive, such as an acrylic adhesive (preferably 0.002 inches thick) that may be provided on one or more release liner 223a, 223b Inch thickness). The cover may further include a reinforcement feature (225).

23A and 23B, the cover 220 may be configured to extend beyond the base panels 104 and 106 to connect the distance d3 between the skin S and the panels 104 and 106. As shown in Figs. Typical minimum required distance d3 can be 8 mm, but can range from 2 to 15 mm. The urethane skin adhesive of the cover 220 may also be applied to the tension applied to the base panels 104 and 106 from the movement of the surrounding skin S in addition to helping to prevent creep movement of the adhesive layers of the base panels 104 and 106. [ It can help mitigate the strain on. This may have the function of preventing skin damage (e.g., rash or bulge) at the edges of the base panels 104, 106. It should be noted, however, that the ductile nature of the hydrocolloid may provide local protection from self-inflating movements with the skin S to resist damage to the skin S. In some embodiments, even in the case of a harder structure mounted on the outer surface of the adhesive layer, compliance within the normal 0.010 inch thick adhesive layer down to the skin surface can provide resistance to skin damage.

In addition to stabilizing and strain relieving the base panel structure, the cover 220 may achieve other objectives. By covering the position where the strap 130 can be engaged with the fixing portion 132, the cover 220 prevents the patient from tampering with the fixing portion 132 to the point where the strap 130 can be loosened . 23A to 23C, the cover 220 may be formed with openings 224 and 224 'along the length of the area overlapping the incision, so that the externally adhered gauze absorbs the wound secretion . In another embodiment, the cover 220 may not have an opening to protect the wound from the infectious source. The cover 220 itself may have reinforcement features 225, 225 'to provide additional resistance to the base 102, and particularly to the incision openings in the region between the straps 130. 23C shows a particular embodiment in which the reinforcing feature 225 'may be a rectangular strip of adhesive tape. The tape 225 'may preferably be more rigid than the surrounding flexible urethane layer 221, perpendicular to the skin incision. The tape 225 'may be constructed from an adhesive coated fabric, polymer fibers, polyethylene, polypropylene, nylon, PET, hydrocolloid, or any combination of materials known in the art. The reinforcement feature 225 'may also provide a "body" or stiffness to the cover 220 to aid its placement. The urethane layer 210 may be composed of a material that provides bi-directional stretching.

The spacing of the reinforcing features 225, 225 'may be important in ensuring longitudinal compliance (parallel to folding) compliance of the cover 220 (e.g., due to thin flexible urethane). This can serve to improve patient comfort and improve resistance to skin damage by allowing cover 220 and underlying base assembly 102 to move in accordance with the movement of the body. This effect may be derived from the cover 220 alone or as a composite effect combined with the features of the base assembly 102 that may allow for longitudinal compliance. The reinforcement 225, 225 'may also have a uniform configuration, but may be perforated, slit-formed, or otherwise mechanically blocked to permit stretched and / or controlled tearing in accordance with body movement. The thin urethane layer (s) of the cover 220 may also be mechanically blocked for the same purpose. At least in some cases, the reinforcing features 225, 225 'of the cover 220 may not extend over the entire width of the cover 220 (perpendicular to the cutout). This limited coverage width can help to 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, 225 'extends 10 mm in each direction away from the edge of the incision, but it may have a range of 2 to 50 mm.

Another feature of the cover 220 is that it further enables adjustment to the cutting edge, particularly between the tension elements 130, 132 of the base assembly. As illustrated in Figure 24A, the tension elements 130, 132 associated with the base panels 104, 106 can act to bring the cutout edges 205 close together. Once approaching the skin S, it can be important that the skin edges are aligned vertically (perpendicular to the skin surface). Vertical misalignment can delay treatment and result in visible "step-off" or ledge that can lead to poor scar formation in the incision. By allowing different portions of the cover 220 to adhere to each edge of the base panel 104, 106 along the cutout, each edge can be maintained in vertical alignment under tension as indicated by arrows 201a, 201b. The adhesive on the various portions of the cover 220 across the incision I may also be attached directly to the skin S at the incision edge to further reduce the distance between the attached incision edges to further improve vertical alignment of the skin have. In a preferred embodiment, various portions of the cover 220 across the incision I are rectangular strips 225 'of adhesive tape as shown in Figure 23C. The axial gap between the width of each strip 225 'and the strip 225' may be optimized for cutting edge adjustment, observation of the incision, and discharge of wound secretions. The preferred embodiment may include a strip 12 having a width of 12 mm and a spacing of 6 mm, with a strap positioned between each strip. Other widths and spacings are also contemplated. By not bridging / tenting over each strap 130, the strip 225 can be laid flat against the skin S for better attachment and edge adjustment.

In some embodiments, the reinforcing 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 stiffer than the skin S and preferably more rigid than the peripheral elements of the base panels 104, 106. In this way, bending or compression of the skin S through normal patient motion may be blocked around the incision site or its propagation may be limited. While this blocking or restricting motion may help to increase the tensile strength of the incision site, a more useful advantage is that the incision edge is largely or unevenly reversed, abducted or moved vertically to the skin surface It can be to prevent. The above-described reinforcing material can be used in a thickness-adjusted manner so as to form a desired rigidity. Preferably, the composite of the base assembly 102 and the cover 220 can be configured such that stiffness and compliance are transiently transitioned from the surrounding skin to the severed incision site.

In certain applications, after the initial sealing of the incision using the base assembly 102 to approximate the skin edges, the base panels 104, 106 may "swell" the sealed incision I upwards, And / or to compress the skin S around the incision edge to relieve tension. Figures 25A-C illustrate an embodiment of a method of this body tissue model. 25A shows step 250A of "popping up" the gathered and sealed up incision I after the base panels 104, 106 are attached to the skin S adjacent to the incision I. The base panels 104, 106 may then be further joined to maintain the tissue in this orientation. These methods can be improved by placing the base panels 104, 106 at a distance of 5 to 10 mm from the incision edge. In step 250B shown in Figure 25B, the base panels 104 and 106 can be secured in position relative to each other by strap 103 and securing portion 132. [ At step 250C shown by Fig. 25C, a cover 220 is then attached to the fixed and "inflated" incision I at the relative positions of the base panels 104, The incision I may be further reinforced with the above-described reinforcing elements 225 and 225 '.

A given cover 220 may be attached with a release liner to aid user handling of the cover 220 prior to and during attachment to the patient in many embodiments. As shown in FIGS. 22A and 22B, the cover 220 may have release liner 223a, 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. Removal of the liner 223b allows the user to first look under the base assembly 102 with an opening in the center of the base 220 and / or through a transparent plastic so that the cover 220 can cover the cover 220 May 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 the skin S. Next, the side release liner 223a can be removed in a direction perpendicular to the incision I. The liner 223a retains and imparts a very thin urethane to keep it substantially wrinkled when it is attached to the skin (S). Also, by first attaching the central portion of the cover 220 to the base assembly 102 and / or the skin S, the cover 220 can be securely attached to the patient with the remainder of the thin cover 220 coated with the adhesive Sufficient tension and adjustment may be maintained in place to apply to the side release liner 223a. Alternatively or in combination, the liners can be removed from the base assembly 102 and / or skin (not shown) by exposing a narrow strip (perpendicular to the incision I) over the entire width of the cover 220, S, and then remove one or two additional liner in a direction parallel to the incision I. The first liner can be in the middle, at either end, or somewhere in between. If not present on the ends, two additional liners may be required and removed from the position of the first liner respectively in the outward direction along the length of the instrument. If the first liner is on one end, the second single liner can be removed outwardly from the position of the first liner toward the end side of the instrument.

Other release liner configurations may 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 can be used to provide the user with the position of the side and / or end where the thin urethane retains its own shape and has no adhesiveness to the user ' A lightly attached outer film or cast sheet may be required. The outer film may be present over the entire outer surface or only with a certain width surrounding the periphery of the cover 200. The film and / or release liner may also have an area extending beyond the area of the thin urethane of the cover 220. Once the cover adhesive is attached to the base assembly 102 or the skin S, the cast sheet can be easily removed from the outside of the cover 220.

As described herein, a stretch wound dressing and wound or incision suture apparatus or device typically follows the contour of a curved portion of the body (e.g., an arm, a long incision made of a curve, etc.) or an elongated region (e.g., a knee) And can be stretched. To aid drape of such a device, a backing material may be used that helps maintain the dressing shape during attachment. The temporary backing material described herein can have several advantages. The backing material may be transparent to allow the wound to be seen by the eye. The backing material may be non-stretchable to prevent stretching of the dressing or suture mechanism or device during attachment. The backing can be easily removed after attachment of the wound dressing or suturing instrument or device so as not to affect the attachment of the actual dressing on the wound. The backing material may also be helpful in handling the dressing during the manufacturing process. In many embodiments, the backing material may be coupled to a dressing or suturing device or device to have a release release liner on the adhesive side of the dressing to enable the backing material to be easily and reliably peeled off.

Referring now to FIG. 26A, wound dressing cover 2600 may comprise a stretchable sheet 2610 made of an elastic material such as rubber, urethane, silicone, and the like. The stretchable material 2610 can be laminated onto a relatively rigid material in the form of a cast sheet or carrier layer 2620. [ The cast sheet 2620 prevents the stretchable material 2610 from rolling out of the sheet itself and becoming unusable. The elastic sheet 2610 may include a side (e.g., bottom side) adhesive 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. A small strip of adhesive is exposed by removing one of the release liners, typically the small release liner 2630, to attach the dressing 2600 on the wound or incision. The release liner 2630 may be attached to the casting sheet 2620 using a tape 2650. The exposed portion of the flexible sheet 2610 may then be attached to one end of the wound or incision. The elastomeric cover 2600 then follows the contour of the wound or incision and the curvature of the body as the second release liner 2640 is slowly removed to sequentially expose the adhesive.

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 from the stretchable dressing 2600. [

The manufacturing process for the wound dressing cover 2600 and the associated liner 2630 and 2640 is similar to that of the laminate of the release liner 2630 and 2640, the elastic dressing (including the adhesive body) 2610 and the casting sheet 2620 Lt; RTI ID = 0.0 > die) < / RTI > The casting sheet 2620 of the dressing sheet 2610 can be held on the dressing sheet 2610 when the liner 2630 and 2640 are removed and attached to the skin. Removal of the casting sheet 2620 may require initiation by peeling and peeling back the edge of the casting sheet 2620 from the dressing sheet 2610. Once initiated, continuous peeling and removal of the casting sheet 2620 can be straightforward. The opening and lifting of the edge of the casting sheet 2620 is not always intuitive and may require a free edge connected to the casting sheet 2620 to help identify the lifting point and initiate peeling. A tape 2650 can be used to bridge the casting sheet 2620 to the release liner 2630 and the tape can provide an easily identifiable tab that can be used to initiate delamination.

An alternative configuration of the casting sheet 2620 can be used to initiate the peeling of the casting sheet 2620 as shown in Figs. 26B-26E.

The casting sheet die may be cut so that the casting sheet 2620a extends axially beyond the stretchable dressing sheet 2610 (e.g., the liner 2630, 2640 and the elastic dressing sheet 2610) Of the urethane material may be "kiss cut" on the surface of the cast sheet 2620a.

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

26D, a casting sheet tape 2650 can be attached to or near the axial edge of the casting sheet 2620, and also extends into the profile of the casting sheet 2620, 0.0 > 2652 < / RTI >

26E, the casting sheet die may be cut to a partial or full length distance from one axial edge to the other axial edge of the casting sheath 2620 (e.g., casting sheet 2620) Kissed so as not to be cut by the elastic dressing sheet 2610). The cut cast sheet 2620 can be separated into a pinch "by the user to form a catchable edge. &Quot; The inner die cutting edge can also be cut out of the inner edge < A tape or the like tab 2654 attached to one or both of them.

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

The disclosed cutter suture mechanism comprising at least one of a variety of base assemblies, a base panel, a load distribution structure, an axial support, a transverse support, a seal component, a tie assembly, a strap, a fixture, an adhesive layer, a cover, a cover structure, a drape, Or the cutter suture instrument assembly may comprise, or otherwise comprise, or consist of 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, which is incorporated into the base assembly cover or at least to its adhesive layer. To facilitate such incorporation, one or more recesses, grooves, openings, voids, or similar structures may be provided on the instrument or device component. In various embodiments, such materials may include one or more of the natural materials such as silver, iodide, zinc, chlorine, copper, or tea tree oil as active agents. Examples of such antifungal, antibacterial, antimicrobial, bactericidal or drug additive materials include, but are not limited to, the Acticoat ^TM series of materials available from Smith & Nephew PLC of Great Britain, Smith & adjust Acticoat ^® water of commercially available materials from the family of commercially available material from Coloplast a / S of Denmark Contreet ^® foam series of commercially available materials from the UK Urgo Limited (French Laboratories subsidiary of URGO) UrgoCell ^® Silver series, United Kingdom of Smith & Nephew of commercially available materials from the PLC Contreet ^® hydrocolloid series, Aquacel ^® Ag series, a commercially available material from Kinetic Concepts, Inc. of San Antonio, Texas, the material of commercially available materials from ConvaTec Inc. in the United States, New Jersey skill far Silvercal® series, purchased from Kinetic Concepts, Inc., of 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, of commercially available materials from Smith & Nephew PLC of the United Kingdom Iodoflex ^® family of commercially available materials from the United Kingdom Aspen Medical Europe Ltd. Sorbsan Silver ^TM series, Burr Ridge, Illinois Ferris Mfg material. Of commercially available materials from Corp. Polymen Silver ^® series, San Antonio, Texas, the material Kinetic Concepts, Promogram ^TM Inc. of commercially available materials from the series, San Antonio, Texas, the material Kinetic Concepts, Promogram Prisma ^TM series of commercially available materials from Inc. , and an Illinois statement Arglaes ^® family of commercially available materials from Medline Industries, Inc. of Delaware in the material. Co-owned U.S. Patent Nos. 8,313,508, 8,323,313, 8,439,945, U.S. Patent Publication No. 2013/0066365, PCT Application US 2010/000430, US 2011/139912, US 2011/40213, US 2011/34649, US 2013 / 067024 may also include one or more of an antifungal material, an antibacterial material, an antimicrobial material, a bactericidal material, or a drug additive material including, but not limited to, one or more of the above listed materials ≪ / RTI > or otherwise comprise the material.

In various embodiments, a topically effective agent is included directly into the wound suture described herein. Since the wound suture instrument is often attached close to a wound or incision requiring pharmacological protection, it may be advantageous to include such drug directly in the suture instrument. For example, it would be advantageous to include an antimicrobial agent in a wound that is at risk of infection. Antimicrobial agents may include antimicrobial agents, as well as bactericidal metal ions and their associated components, which may include silver, iodide, copper and natural materials such as chlorine or tea oil. Wounds susceptible to fungi can be guaranteed drugs, such as zinc. Combinations of any of these agents may also be advantageous and may therefore be contained within the wound suturing device.

Topically-effective medicaments have the ability to remove secretions from the wound while maintaining the wound sufficiently hydrated for improved treatment (e.g., the ability to remove unwanted organisms from the wound and / or prevent skin maceration) May be included in the suturing mechanism in such a manner as to give the suturing mechanism.

Referring now to Figure 27A, a wound or incision suturing mechanism 2700 includes a top polymeric layer 2720R, 2720L and a second side having a lower adhesive layer 2730R, 2730L attached proximate to each side of the surgical incision I And a base including two base panels 2710R and 2710L. The features of panel 2710R, 2710L, such as strap 2740, can allow skin on either side of incision I to be pulled together and held in place during treatment. The adhesive may be comprised of a hydrocolloid formulation, but may include acrylics or other adhesives known in the art. The upper polymer layers 2710R, 2710L (e.g., 1 mil polyurethane) are preferably attached to the top of the adhesive layers 2720R, 2720L to sever the adhesive layers 2720R, 2720L. Agents may be included in the structure of the base panels 2710R and 2710L. At a minimum, the medicament can inhibit the growth of unwanted organisms that contact the skin from the base panels 2710R, 2710L. The medicament may be ejected from the base panels 2710R, 2710L and moved to the area within the wound or to the area near the wound. The medicament may be contained by a carrier structure such as an adhesive layer 2730R, 2730L capable of absorbing the fluid and helping release of the medicament. Such structures may include hydrocolloids, hydrofibers (such as those containing sodium carbomethylcellulose), hydrogels, collagen, alginates, polyurethane or silicone foams, or other related materials known in the art . The carrier may alternatively or in combination be ointment, cream, gel, or powder. Agents (e.g., silver ions) may alternatively or in combination be attached to the metal or polymer (e.g., in the form of a mesh) via a solvent coating process or vapor deposition. Such a mesh-like product may be bonded or embedded within the structure of the suture mechanism.

In an exemplary embodiment, the base panel 2710R, 2710L may include a medicament comprising a silver component such as silver sulfate. When the base panel 2710R, 2710L is in contact with wound drainage and / or sweat or external fluid, the medicament may be delivered to the wound side. As the fluid is absorbed into the base panels 2710R, 2710L, the base panels 2710R, 2710L can emit silver ions that interfere with the growth of the bacteria. An example of how an agent such as silver can be included in the base panel is shown in Figs. 28a and 28b, which illustrate several embodiments of a sample segment 2750 of the second base panel 2710R of Fig. These examples are also applicable to the first base panel 2710L.

Figure 27B shows the medicament 2760R directly mixed in the adhesive layer 2730R in the sample segment 2750. Fig. The adhesive is usually a hydrocolloid, which is capable of absorbing a significant percentage of the weight of the fluid and can help release the drug.

Figure 27c shows a sample segment of the base panel 2710R (Figure 27C) in which the medicament is contained within a carrier structure 2770R concentrated on a portion of the base panel 2710R at an upper portion of the base panel 2710R, 2750). ≪ / RTI > Additional features may be included to strip carrier structure 2770R (and replace it if necessary) when it is saturated with secretions or other fluids and / or when the concentration of drug drops below an effective level.

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

Figure 27E illustrates how the carrier 1770R can be included in both the top and inner edges of the base panel 2710R. In these examples, either the inner edge of the base panel 2710R or the carrier structure 2770R on each inner edge may be pressed onto 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 included in a cover for the incisional suturing instrument. As described above, the cover is typically affixed on the base panel of the incision suture instrument to help secure the incision suture instrument to the skin and protect the skin. 28A, the cover 2800 may have a medicament 2810 contained within the entire surface of the cover 2800, with or without a carrier structure such as an adhesive layer 2810 mixed with the medicament 2810 I can not. Alternatively, or in combination, the medicament may be contained within a suitable portion of the cover 2800, preferably within the carrier structure 2820 directly above the wound site, as shown in Figure 28B.

In at least some instances, it may be beneficial to replace the drug structure 2820, as the carrier structure 2820 may be saturated over time and / or lose its pharmacological strength. 28C, the medicament structure 2820 is removable (e.g., by tearing the holes 2830 in the cover 2800) and optionally is attached to the narrow cover strip 2801 shown in FIG. 28D It may be replaced with another drug structure 2821. [ The adhesive portion of the cover 2801 in the narrow cover strip 2801 may extend beyond the medicament structure 2821 to hold the medicament structure 2821 against the skin. The narrow strip 2801 may alternatively be attached to the wound site prior to attachment of the 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.

In the case of either or both of the base panels 2710R, 2710L and the cover 2800, only the carrier structure 2770R or 2820 (with or without a medicament) or medicament can be patterned with the adhesive layer of the respective structure have. The patterned configuration may include a repeating shape (e.g., circle, ellipse, polygon, slot, etc.) of adhesive material adjacent to a similar repeating form (or the remainder of the matrix) of the carrier structure. 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 with carrier structure 2820 repeating form 2850 is illustrated in Figure 29e. The medicament and carrier structure 2820 may also be attached to the base strap 2740 across the incision I.

While the preferred embodiments of the present invention have been illustrated and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Many variations, modifications 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 the practice of the invention. It is intended that the following claims define the scope of the invention and that the methods and structures within the claims and their equivalents are thereby intended to be embraced thereby.

10: incision suture instrument
22: Sealing component
1402, 1404: Base panel
1414:

Claims (60)

In an incision closure device,
A first base panel attached to a first side of an incision or wound, the first base panel comprising a top surface and a tissue attaching bottom surface;
A second base panel attached to a second side of the incision or wound opposite the first side, the second base panel comprising an upper surface and a tissue attaching lower surface;
A plurality of longitudinally spaced first transverse supports coupled to an upper surface of the first base panel;
A plurality of longitudinally spaced second transverse supports coupled to an upper surface of the second base panel;
An axially main skeleton connected to the first or second transverse support, the main skeleton being oblong or zigzag; And
A plurality of transverse ties for joining the first and second base panels together,
Lt; / RTI >
Each of the transverse ties comprises a first end permanently secured to the transverse support of the first base panel and a second transverse support that is removably and adjustably attached to the transverse support opposite the transverse support of the second base panel Said lateral ties pulling the first and second base panels laterally together to compress the incision or wound covered by the incision closure device,
Wherein a first end of each transverse tie is associated with an individual transverse support on said first base panel,
Wherein each of the lateral ties is removably and adjustably attached to the second base panel such that the lateral spacing between the first and second base panels can be adjusted. The method according to claim 1,
And the second end of each transverse tie may be disengaged from, or recombined from, the discrete transverse support on the second base panel. The method according to claim 1,
Wherein the transverse tie is adjustable independently so that the transverse spacing between the first and second base panels can vary along the length of the first and second base panels. The method according to claim 1,
Wherein the second end of each of the transverse ties is detachably attached to the securing portion, the transverse tie and the securing portion together forming a ratchet tightening mechanism. delete The method according to claim 1,
Wherein at least one of the plurality of longitudinally spaced first or second transverse supports is laterally disposed between an inner edge and an outer edge of the first or second base panel, respectively, Device. The method according to claim 1,
Wherein at least one of the plurality of longitudinally spaced transverse supports of the first or second transverse supports comprises a stretchable non-intumescent material. The method according to claim 1,
Wherein at least one of the plurality of longitudinally spaced first or second transverse supports is embedded in the top surface of each of the base panels or stacked on the top surface of each of the base panels. delete The method according to claim 1,
Wherein the at least one base panel of the first or second base panel comprises an elastic matrix. 11. The method of claim 10,
Wherein the elastic matrix comprises an elastomeric membrane, fabric, spun fabric, rubber, latex, urethane, polyurethane, silicone, or Thermo Plastic Elastomer (TPE). 12. The method of claim 11,
Wherein the elastic matrix comprises a fabric woven with an elastic element, the fabric having an inelastic element along the transverse edge of at least one of the base panels of the first or second base panel, transversely across the inelastic element An incision suturing device. The method according to claim 1,
Wherein at least one base panel of the first or second base panel includes one or more preferentially separated areas to facilitate at least one of longitudinal separation or lateral extension of one or more base panels of the first or second base panel And an incision suturing device. 14. The method of claim 13,
Wherein the at least one preferentially discrete region comprises one or more apertures. 15. The method of claim 14,
Wherein the at least one aperture is longitudinally disposed between axially adjacent transverse supports on at least one of the base panels of the first or second base panel. 15. The method of claim 14,
Wherein the at least one aperture comprises a plurality of apertures disposed along a transverse line of the at least one base panel of the first or second base panel. 15. The method of claim 14,
Wherein the at least one aperture is disposed along a transverse edge of at least one of the first or second base panels. The method according to claim 1,
Wherein the tissue attaching lower surface of the at least one base panel of the first or second base panel comprises a hydrophilic adhesive material. 19. The method of claim 18,
Wherein the hydrophilic adhesive material comprises at least one of hydrocolloid, hydrogel, acrylic polymer or poly (ethylene glycol). The method according to claim 1,
Further comprising a fixation layer adapted to rest on the assembly after the first and second base panels and the transverse tie assembly are fixed on the incision or wound. 21. The method of claim 20,
Wherein the fixation layer has a self-adhesive inner surface. 21. The method of claim 20,
Wherein the fixation layer is configured to extend transversely beyond an outer transverse edge of the first or second base panel. 21. The method of claim 20,
Wherein the fixation layer has one or more preferentially discrete regions such that the incision suture device causes the incision or wound overlying and the fixation layer to be at least partially elongated in the longitudinal direction in response to longitudinal stretching of the surrounding tissue An incision closure device. 24. The method of claim 23,
Wherein the at least one preferentially discrete region comprises one or more apertures. The method according to claim 1,
Each transverse tie being longitudinally pivotable about at least one of its first or second ends. 26. The method of claim 25,
Each lateral tie configured to pivot longitudinally about at least one of said first or second ends when said at least one base panel of said first or second base panel is elongated in a longitudinal direction, Suture device. 26. The method of claim 25,
Wherein the transverse tie moves the first and second base panels closer together when the transverse ties are pivoted longitudinally. 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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