CN104825200B

CN104825200B - Surgical incision and closure apparatus

Info

Publication number: CN104825200B
Application number: CN201510230891.4A
Authority: CN
Inventors: 埃米尔·贝尔森; 埃里克·斯托内; 艾伦·斯卡赫尔; 潘卡杰·瑞斯; 柳庆郎; 一柳庆一郎; 彼得·达奎尼; 卢克·克劳森
Original assignee: Qi Pulin Pharmaceuticals
Current assignee: Qi Pulin Pharmaceuticals
Priority date: 2012-10-31
Filing date: 2013-10-30
Publication date: 2017-03-22
Anticipated expiration: 2033-10-30
Also published as: CN104825200A

Abstract

An apparatus for closing a surgical incision comprises left and right base panels, a plurality of closure components, and a plurality of left and right axial supports coupled to the respective base panels. The closure components couple the left and right base panels to each other laterally and have left and right ends coupled to the respective base panels. The closure components are positioned laterally across the left and right panels, the left axial supports are disposed between pairs of left closure component ends, the right axial supports are disposed between pairs of right closure component ends, and the left and right axial supports are offset from one another such that a serpentine arrangement of consecutive closure components and axial supports is formed. The apparatus can be made of antimicrobial materials or materials impregnated with antimicrobial agents. A flexible adhesive cover can be provided over the apparatus when in use.

Description

Surgical incision and closure equipment

The application is submission on 04 13rd, 2015, entitled " surgical incision and closure equipment ", Application No. (international application no is PCT/US2013/067563 to 201380053449.8 Chinese patent application, and international filing date is 2013 October 30) divisional application.

Cross-Reference to Related Applications

This application claims 13/665,160 (the attorney of U.S. Patent Application No. submitted on October 31st, 2012 Priority 35383-709.501), which is 13/286, the 757 (agency of U.S. Patent Application No. submitted on November 1st, 2011 People file number 35383-709.201), and the U.S. Provisional Patent Application No. 61/958,259 submitted on July 24th, 2013 (attorney 35383-710.101), and the U.S. Provisional Patent Application No. 61/ submitted on October 11st, 2013 The continuation-in-part application of 889,569 (attorneys 35383-712.101), the complete disclosure of above-mentioned application pass through It is incorporated by this.

Background of invention

1. invention field.Present invention relates in general to armarium and method.More particularly the invention relate to shape Into the apparatus and method with closure surgical incision.

It is known including the surgical closure device of the binding agent based paster with right panel and left plate.Institute of the invention is special Such device not interested is described in co-pending, jointly owned PCT application US 2010/000430, this application it is complete Portion's disclosure is incorporated by reference in this.As described in the PCT application, surgical incision is desirably formed on patient skin Place bioadhesive patch in position.After paster is placed, otch is formed along the axis extended through in the middle part of paster.Cut in formation After mouthful, otch can be opened to carry out desired operation technique, and after operation technique is completed, can by with clip, The inward flange of the plate is pulled together and close incisions by slide fastener or other enclosed members.

The main target of such surgical closure device is to improve healing and reduce the cicatrization caused because of otch.However, This target is but subject to hindering for some characteristics of currently available device.For example, organization edge is not always equal along a line Gather together evenly, this may increase final cicatrization.Many such closing devices do not have in regulation organization edge Closing force or closing distance ability, thus limit and have been observed that to reduce and synulotic make tissue somewhat " wrinkle " Ability.The other shortcomings of available otch and Wound closure devices include being difficult with, and the nothing during follow-up operation plan Method is adapted to tissue manipulation, i.e. for tissue is securely closed, sufficiently rigid device often cannot be in surgical operation for those It is adapted to tissue movement in operating process.

Self-adhering type wound closure paster occurs particular problem when which is used for and adhering to below surgical incision drop cloth.It is such Drop cloth is for assisting in keeping the aseptic of tissue surface in surgical procedure, and can place previously drop cloth On the tissue closure paster of positioning.As surgical incision drop cloth has the adhesion lower surface for adhering to tissue, therefore drop cloth will Adhere to the upper surface that tissue below closes paster.Surgical incision drop cloth is removed thus often removes previously placed group Knit closure paster or at least shift which.If any pith of tissue closure paster be removed or shift, paster for Closure surgical wound just there is no longer to be used.

For these reasons, expect to provide improved surgical incision closing device and its using method.It is particularly desired in providing Such Tncision closing device：Which can adhere to tissue, allows otch to be formed, adapts in subsequent surgical operation operating process In the deformation of tissue, and the controlled closure at adjacent tissue edge is provided after operation technique.Specifically, expect that otch is closed Attach together while put least commitment that tissue is caused in surgical procedure or stretching, using the teaching of the invention it is possible to provide in organization edge Closing force control and be uniformly distributed.It is also expected to improved surgical incision closing device and its using method as providing： Wherein will resist when lower section use of the device in surgical incision drop cloth and remove and dislocate.Invention hereinafter described will be real At least some target in existing these targets.

2. background technology description.In U.S. Patent number 2,012,755；3,516,409；3,863,640；3,933,158；4, 114,624；3,926,193；4,535,772；4,676,245；4,881,546；4,905,694；5,377,695 and 7,455, 681；And surgical closure device is described in U.S. Patent Publication No. 2005/0020956 and 2008/0114396.Gathering around jointly Some U.S. Patent numbers 8,313,508,8,323,313 and 8,439,945；U.S. Patent Publication No. 2013/0066365；And Describe in PCT Publication WO 2011/139912, WO 2011/159623, WO 2011/043786 and WO 2013/067024 Further surgical closure device, the full content of above-mentioned document are incorporated by reference in this.Commercial Tncision closing device can be from The Ethicon departments of Johnson＆Johnson buy, its trade name Ethizip^TMInterim abdominal wound closing device.

The content of the invention

The invention provides improved apparatus and method are used to close wound, especially by entering in surgical procedure Wound caused by capable incision.Otch generally will be formed on the skin of the patient, such as through abdominal part, but in some feelings In condition, it is also possible on internal organs, in oral cavity, in the body cavity, etc..

The minimum upset of the surgical procedures that apparatus and method of the present invention is carried out after will existing to making otch Or interference.Particularly, described device and method will allow to cut with the least commitment caused by the presence by closing device Tissue opposite edges open, stretching and Free Transform.However, once operation technique is completed, apparatus and method of the present invention Will provide for being uniformly distributed closing force, so as to so that organization edge is pulled together by the mode that cicatrization is minimized. Particularly, the closing device can be formed than otch when the spacing that is slightly moved closer to of the spacing that initially there are by organization edge It is pulled together, synulotic " corrugation " can be reduced to make organization edge turn up upwards and to cause.

Apparatus and method of the present invention will also be able to avoid or reduce be used for surgical incision drop cloth when cut closure apparatus Upset during lower section, the surgical incision drop cloth must be removed from closure apparatus.At at least one of the upper surface of closure apparatus Divide upper offer sacrifice layer, wherein when surgical incision drop cloth is placed on cut closure apparatus, sacrificing covering and being just kept Position.After otch and surgical procedures are completed, it will leave behind surgical incision drop cloth from the skin of patient.Surgical drape is adhered to To sacrifice covering, rather than adhere to tissue closure apparatus and make which dislocate, and covering is only sacrificed with drop cloth from trouble Leave behind with person, and the remainder for leaving cut closure apparatus keeps in situ.

In a first aspect of the present invention, cut closure apparatus includes base portion, and the base portion includes left plate and right panel.Each plate has Lower surface, upper surface, inward flange and outward flange are adhered in a organized way.Undertissue's adhesive surface generally will be applied at least in part It is covered with conventional tissue adhension binding agent, those binding agents such as used in surgical bandage and paster.

(that is, each plate will have coupled thereto the power distributed architecture that cut closure apparatus also includes coupled to each plate At least one power distributed architecture), wherein each power distributed architecture is adapted to allow for plate the axially expanding along inward flange, together When limit lateral magnification over the entire length and axially expand along outer peripheral.By allowing the plate along inward flange Axially expand, organization edge deforms when being subject to minimum constraint to allow to be organized in and be stretched in surgical procedure.Phase Instead, by limiting lateral magnification and axially expanding along outer peripheral, the plate will complete it in surgical procedures Apply the closing force of controlled and distribution when the plate is pulled together afterwards, as described in more detail below.

Cut closure apparatus also includes that closing assembly or assembly, the closing assembly or assembly are attached to power distributed architecture By the plate after being completed with tissue and surgical procedures that the opposite sides of cutting part has been adhered in the plate Inward flange be pulled together.Each plate of base portion will generally include resilient matrix at least in part, generally with it is each to Same sex elasticity (that is, plate is evenly stretched in all directions), but alternatively there is anisotropic elasticity (wherein described matrix It is preferential in one direction or stretch on one part).The elastic matrix includes elastomer film or piece (for example, polyurethane Piece or thermoplastic elastomer (TPE) (TPE)), Woven fabric is (typically at least in part by elastomer filament, elastomer silk thread or elastomer Fiber weaving is formed), short fibre fabric (spun fabric) etc..In some embodiments, elastic matrix is may include by elastic unit Part (usually silk thread, filament, fiber etc.) is woven, and with along outward flange placement and across the nothing for extending laterally therebetween The fabric of flexible member, to provide expansion feature mentioned above relative to power distributed architecture.That is, in some cases, Power distributed architecture can include the inelastic component for being woven in or being otherwise incorporated in fabric membrane or by such without bullet Property element is constituted.

Generally, power distributed architecture will include the single component of cut closure apparatus, for example, include the outward flange with plate The spine of axially adjacent placement, and it is laterally positioned and from the spine towards the inward flange of plate extend it is multiple axially spaced Horizontal support piece.Such " pectination " structure generally will be formed by flexibility but nondistensible material, so as to element Can with the deformation of tissue flexing together, but will not stretch along its length so that they can in a lateral direction with And along the outward flange offer dimensional stability of plate.The example of such material includes nylon, polypropylene, polyethylene and Merlon Or other thermoplastic polymers.It should be noted that power distributed architecture will not restriction plate inward flange axial tension, so as to outside Desired expansivity and adaptability are provided to tissue in section's operative process.Such single power distributed architecture is attached To the upper surface of plate, or can alternatively be embedded in or be stacked in plate.Generally, power distributed architecture will not be extended into or be crossed The lower surface of plate so which will not intervene the adhesion of plate to skin or its hetero-organization.

The assembly of substrate and power distributed architecture will be generally carried on removable backing, and the backing is using it Front covering and the adhesive surface of protection board.Backing can be removed so as to base portion is applied to surgical intervention position skin or its Hetero-organization.Additionally, right panel and left plate generally will by removable auricle, axial bars band or other removable coverings or Structure keeps together, so that the inner surface of plate is maintained at preset distance or spacing when plate is adhered to tissue.For example, may be used So that removable auricle is placed at each axial end of base portion, two substrates to be tightened together temporarily.Or, can So that removable band or adhesive tape are placed in the axial gap between left plate and right panel, to be adhered to tissue table in base portion Plate is relative to each other held in place during face.Such auricle or band generally would is that self-adhering type so that they can be tight Gu to plate, and and in plate, correct placement is removed by simply shutting down after tissue then.Then can remove and cover Cover material, auricle or band, so as to be left in place before plate forms surgical incision therebetween but be not attached to.

First representative configuration of closing assembly or assembly includes right engagement member, left bonded block and multiple horizontal Post, the plurality of lateral struts keep the spaced preset distance of the engagement member.Right engagement member is suitable to releasedly Inward flange along right panel engages its support member, and left engagement member is suitable to the inward flange releasedly along left plate and engages which Support member.In a specific embodiment, at least some support member in the support member of power distribution component will have positioned at its inner edge Chock (cleat) near edge, and engagement member will have the groove for receiving the chock.After surgical intervention is completed, Then closing assembly can be placed on power distributed architecture, wherein the chock positioned at side is connect by an engagement member first Close, and relative engagement member is pulled on the chock of opposite side then.

Or, closing assembly or assembly can include multiple independent sway braces, and the tie-rod is attached at least one A little horizontal support pieces.Such sway brace is arranged to be fastened between horizontal support piece, is normally fixed to one On plate and another plate can be adjustably attached to.For illustrative embodiments, can be attached with adjustable ground End can include that ratch tensioning mechanism or similar structure, the ratch tensioning mechanism or similar structure are allowed on right panel and a left side Each sway brace is independently adjusted with different spacing between plate.In this way it is possible to along right panel and the inward flange of left plate Differentially tensioning right panel and left plate, to control and optimize to the adjacent tissue edge being pulled together the power for applying.

Optionally, closure apparatus of the invention may also include fastened layer, and the fastened layer is suitable in base portion and closing assembly The assembling is placed on after assembly has been fastened onto on the otch on patient skin and surgical procedures have been completed On part.Fastened layer will generally have self-adhering type lower surface, and the self-adhering type lower surface can be placed on base portion and closing assembly Fastened in place with help on assembly and kept cleaning.Fastened layer optionally have opening, with allow for observation and It is close to wound, delivering disinfectant etc..

In still another aspect of the invention, the method for forming otch in the tissue includes providing otch as described above Closure apparatus.The right panel and left plate of the apparatus adhere to the skin of patient, wherein distance interval of the inward flange of plate to preselect Open, the distance is generally from 0.5mm to 15mm.Otch is formed on tissue or skin surface between the inward flange of plate (generally For straight line), and separate then incision tissue edge to carry out desired surgical procedures.The inward flange of plate can be with The movement and deformation of organization edge and stretch and comply with, and the outward flange of each plate and lateral extent dimensionally keep steady It is fixed.After operation technique is completed, closing assembly is fastened to power distributed architecture to retract together the inward flange of plate.Optionally Ground, closing assembly with by organization edge than size which is more closely pulled together after otch is just formed (or scalable Spacing between plates).So tissue is pulled together causing edge to turn up and makes tissue " corrugation ", can so reduce cicatrix shape Into.

In still another aspect of the invention, there is provided cut closure apparatus.The cut closure apparatus may include left substrate and Right substrate, the multiple closing assemblies for left substrate and right substrate are laterally coupled, and correspondingly it is coupled to left substrate With the multiple left axial support and right axial support of right substrate.Each closing assembly include correspondingly coupled to left substrate and The left closing assembly end and right closing assembly end of right substrate.The plurality of closing assembly can be laterally fixed across left plate and right panel Position, wherein (i) one or more described left axial supports be placed at least some axially adjacent left closing assembly end it Between, and (ii) one or more described right axial supports be placed at least some axially adjacent right closing assembly end it Between, to form snakelike arrangement.

In order to form snakelike arrangement, left axial support by every a pair axially adjacent left closing assembly ends in left plate On be coupled, and/or right axial support by every a pair axially adjacent right closing assembly ends on right panel It is coupled.The left plate and/or right panel can be arranged there between with one or more perforation, one or more of perforation Not between the axially adjacent corresponding left/right closing assembly end with axial support.One or more of perforation can Including multiple such perforation：Which contributes to the substrate in the axial tension of substrate and is separated into substrate sections.

One or more in left substrate or right substrate can include multiple single substrate sections.At least two left closures Element end or at least two right closing assembly ends can be coupled to each substrate sections.Left substrate can include multiple left substrates Sections, and right substrate can include multiple right substrate sections.The left substrate sections and the right substrate sections can be in applications It is axially offset to one another when otch and surrounding tissue.The plurality of closing assembly can by left substrate sections and right substrate sections that This lateral gets up to form snakelike arrangement.

One or more in left substrate or right substrate can include tissue adhension lower surface, for adhering to adjacent to cutting The tissue of mouth.One or more in left substrate or right substrate can include lower adhesion layer and upper strata, and the lower adhesion layer includes The tissue adhension lower surface, and the upper strata includes upper surface.Upper strata can be harder than lower adhesion layer.Lower adhesion layer can have There is enough elasticity, so that when covering otch and during surrounding tissue due to being laterally adjacent to the tissue of the Tncision closing device The foaming moved and cause and adhesion loss minimize.The adhesion lower floor can include hydrophilic adhesion material.It is described Hydrophilic adhesion material may include one or more in hydrocolloid, hydrogel, acrylate copolymer or PEG.It is described Upper strata can be comprising in rubber, latex, urethane, polyurethane, silicone, thermoplastic elastomer (TPE) (TPE), Woven fabric or short fibre fabric One or more.One in left closing assembly end, right closing assembly end, left axial support or right axial support Or it is multiple can be embedded in the upper surface of left substrate and right substrate in or be laminated to the upper surface of left substrate and right substrate.

One or many in left closing assembly end, right closing assembly end, left axial support or right axial support It is individual to be formed by flexible not expandable material.

The plurality of closing assembly, left axial support and right axial support can be hard enough, so that when covering The movement that the tissue of the Tncision closing device is laterally adjacent to when otch and surrounding tissue does not substantially make capped otch Expand with surrounding tissue.Therefore, the movement in the peripheral laterally adjacent the first tissue region with the Tncision closing device can be with It is essentially converted to the identical in laterally adjacent with the periphery and relative with the first tissue region minor microstructure region It is mobile.

One or more closing assemblies in the plurality of closing assembly can include tie-rod, and the tie-rod is coupled to securely Left closing assembly end or right closing assembly end, and it is adjustably attached to relative closing assembly end.It is described relative Closing assembly end can include ratch tensioning mechanism.

The plurality of closing assembly can be arranged to be pulled together the inward flange of left substrate and right substrate, with compress by The otch covered by the cut closure apparatus.

One or more in the plurality of left axial support or the plurality of right axial support can be C-shaped.Institute Stating C-shaped left and/or right axial support can each include axial component and lateral part, and the axial component is used to limit phase Axially expanding for substrate is answered, and the lateral part is used to limit the lateral magnification of corresponding substrate.

This aspect of the present invention may also provide the system for closing the otch in tissue.The system may include described Tncision closing device and flexible covers, the flexible covers are used to cover the Tncision closing device and capped otch And surrounding tissue.

Flexible covers can be configured to extend on the transverse edge and axial edge of left substrate and right substrate.It is described to cover Cover material can be with one or more perforation, to allow the covering in response to cutting for being covered by the Tncision closing device Mouthful and surrounding tissue axial tension and axial tension at least in part.One or more of perforation can be along covering Central axis is disposed.Covering can include one or more strenthening members, and one or more of strenthening members are coupled to institute State at least a portion of the adhesion layer of covering.Strenthening member can include rubber, latex, urethane, polyurethane, silicone, thermoplastic One or more in property elastomer (TPE), Woven fabric or short fibre fabric.Covering can include hydrophilic adhesion layer, should Hydrophilic adhesion layer can include one or more in hydrocolloid, hydrogel, acrylate copolymer or PEG.

In still another aspect of the invention, there is provided a kind of cut closure apparatus.The cut closure apparatus includes flexible adhesive Bottom, intermediate layer and top layer.The flexible adhesive bottom can be elastic with first.The intermediate layer can be coupled to and cover described At least a portion of flexible adhesive layer, and with elastic less than the second of first elasticity.The top layer can be coupled to simultaneously At least a portion in the intermediate layer is covered, and with elastic less than the 3rd of second elasticity the.The flexible adhesive bottom Tension gradient between layer and the top layer can provide enough rigidity for the cut closure apparatus, so that when covering is cut The movement of the tissue for being laterally adjacent to the apparatus when mouth and surrounding tissue does not substantially make capped otch and surrounding tissue Expansion.

The tension gradient can provide enough elasticity for cut closure apparatus, so that when covering otch and surrounding group The foaming caused due to the movement of the tissue adjacent to the apparatus when knitting and adhesion loss are minimized.

Cut closure apparatus can be in response to the otch that covered by the cut closure apparatus and the axial direction of surrounding tissue Stretching and be flexible in the axial direction.Movement with the peripheral adjacent the first tissue region of flexible adhesive bottom can be substantially It is converted into the identical in peripheral adjacent with flexible adhesive bottom and relative with the first tissue region minor microstructure region It is mobile.

Flexible adhesive bottom can include hydrophilic adhesion material.The hydrophilic adhesion material can include hydrocolloid, One or more in hydrogel, acrylate copolymer or PEG.

The upper strata can include rubber, latex, urethane, polyurethane, silicone, thermoplastic elastomer (TPE) (TPE), Woven fabric Or one or more in short fibre fabric.

Flexible adhesive bottom can include the first adhesion sublayer and the second adhesion sublayer.Intermediate layer can be included coupled to institute State first upper strata and the second upper strata coupled to second adhesion sublayer of the first adhesion sublayer.Top layer can include multiple axles To supporting construction and the arrangement of the multiple horizontal closing assembly coupled to the axial support structure, for described first is adhered to Bottom and first upper strata are fastened to second adhesion sublayer and second upper strata.The plurality of axial support structure and The plurality of closing assembly can be with coupled to each other to form serpentine pattern, for allowing in the lower adhesion layer or the intermediate layer One or more in response to the otch that covered by the Tncision closing device and surrounding tissue axial tension and described Stretched on the axial direction of closing device at least in part.The plurality of axial support structure and the plurality of horizontal closing assembly Can be with coupled to each other forming scalariform pattern.One in the plurality of axial support structure or the plurality of horizontal closing assembly Or multiple can be formed by flexible not expandable material.The plurality of horizontal closing assembly can be arranged in flexible adhesive bottom After the tissue of the opposite sides for adhering to otch, by first adhesion sublayer or the second adhesion sublayer and described first The inward flange of one or more in layer or the second upper strata is pulled together.One or more in the horizontal closing assembly can be with Including left-end point, right end and tie-rod, the tie-rod is coupled to the left-end point or right end and adjustable ground securely It is attached to relative end.One or more in the plurality of axial support structure or the plurality of horizontal closing assembly can be with In being embedded in first upper strata and the second upper strata or it is laminated to first upper strata and the second upper strata.

This aspect of the present invention may also provide the system for closing the otch in tissue.The system includes described cutting Mouthful closure apparatus and flexible covers, the flexible covers be used to covering the cut closure apparatus and capped otch and Surrounding tissue.

Flexible covers can be configured to extend on the transverse edge and axial edge of the flexible adhesive bottom.It is described Covering can be with one or more perforation, to allow the covering in response to being covered by the cut closure apparatus The axial tension of otch and surrounding tissue and at least in part on the axial direction of the covering stretch.It is one or many Individual perforation can be disposed along the central axis of covering.Covering can include one or more strenthening members, one Or multiple strenthening members are coupled at least a portion of the adhesion layer of the covering.The strenthening member can comprising rubber, One or more in latex, urethane, polyurethane, silicone, thermoplastic elastomer (TPE) (TPE), Woven fabric or short fibre fabric.Cover Thing can include hydrophilic adhesion layer.The hydrophilic adhesion layer can be comprising hydrocolloid, hydrogel, acrylate copolymer or poly- One or more in (ethylene glycol).

In still another aspect of the invention, there is provided a kind of cut closure apparatus.The cut closure apparatus is may include with The lower part of one elasticity, with less than first elasticity the second elasticity upper part, and the lower part with it is described on Tension gradient between part.The tension gradient can provide enough rigidity for the cut closure apparatus, so that working as The movement for covering the tissue for being laterally adjacent to the apparatus when otch and surrounding tissue does not substantially make capped otch and week Enclose tissue bulking.The tension gradient can provide enough elasticity for the cut closure apparatus, so that when covering otch Minimize with the foaming and adhesion loss caused due to the movement for being laterally adjacent to the tissue of the apparatus during surrounding tissue.

In still another aspect of the invention, there is provided a kind of cut closure apparatus.The cut closure apparatus is may include comprising a left side The base portion of plate and right panel, left power distributed architecture and right power distributed architecture, and multiple closing assemblies.Each plate can have tissue Adhesion lower surface, upper surface, the first transverse edge, the second transverse edge.The left power distributed architecture and right power distributed architecture can To be correspondingly coupled to the left plate and right panel.Each power distributed architecture may be adapted to allow the plate horizontal along described first One of edge or the second transverse edge are axially expanded, and are suitable to limit across the lateral magnification of the plate and along relative Transverse edge is axially expanded.The plurality of closing assembly can be fastened to the left plate and right panel, to adhere in the plate The plate is pulled together after tissue and the otch for being formed therebetween.

First transverse edge of each plate can include the inward flange of each plate.The inward flange of each plate can be towards that This.

Second transverse edge of each plate can include the outward flange of each plate.The outward flange of each plate can dorsad that This.

One or more in the left plate and right panel of base portion can include elastic matrix.The elastic matrix can include bullet Gonosome film, Woven fabric or short fibre fabric.The elastic matrix can include it is woven by flexible member, and with along institute State the first transverse edge or the second transverse edge the fabric across the inelastic component for extending laterally therebetween.

Each power distributed architecture can include the spine of the first transverse edge placement for being located axially adjacent to the plate, with And laterally positioned and extend towards first transverse edge of the plate from the spine multiple axially spaced horizontal Support member.The spine and horizontal support piece can be formed by flexible not expandable material.The power distributed architecture can be embedded in often In the upper surface of individual plate or it is laminated to the upper surface of each plate.

Closing assembly can include right engagement member, left engagement member and multiple lateral struts, the plurality of horizontal Post keeps the spaced preset distance of the engagement member.The right engagement member may be adapted to be releasably engaged right panel Support member, and the left engagement member may be adapted to be releasably engaged the support member of left plate.In the support member at least one A little support members can have the chock of one or more in first transverse edge or the second transverse edge, and institute State engagement member and there can be the groove for receiving the chock.The lateral struts can be adjustably coupled to the engagement member At least one of, to allow the regulation of the preset distance.The closing assembly can include multiple independent sway braces, The plurality of independent sway brace is attached at least some horizontal support piece in the horizontal support piece.The sway brace Can be arranged to be fastened between horizontal support piece.The independent sway brace can each have and be fixed to one of plate End, and it is adjustably attached to the second end of another plate.The second end can include ratch tensioning mechanism.

The cut closure apparatus can also include fastened layer, and the fastened layer is suitable in the base portion and the closing assembly Assembly be anchored on the otch on patient skin after, be placed on the assembly.The fastened layer can have There is self-adhering type inner surface.

Description of the drawings

Fig. 1 is the exploded view of the cut closure apparatus built according to the principle of the invention.

Fig. 2 is the top view of the assembly of the base portion and power distributed architecture of the part as cut closure apparatus.

Fig. 3 is the profile of the line 3-3 interceptings along Fig. 2.

Fig. 4-Fig. 7 illustrates using the cut closure apparatus of the present invention to form and close the otch in patient skin.

Fig. 8 illustrates the constructive alternative of the closing assembly of the closure apparatus of the present invention.

Fig. 9 is the exploded view of the further embodiment of the cut closure apparatus built according to the principle of the invention.

Figure 10 is the amplification isometric view of the base portion of the system of Fig. 9 and power distributed architecture.

Figure 11 A and Figure 11 B illustrate alternative sway brace construction that can be used in the apparatus of Fig. 1 or Fig. 9.

Figure 12 illustrates the sacrifice covering being positioned on cut closure apparatus in accordance with the principles of the present invention.

Figure 13 A to Figure 13 E illustrate sacrifice covering shown in Figure 12 with surgical incision drop cloth of the invention Operating principle and execution method when being used together.

Figure 14 A1- Figure 14 A3 are the perspectives of the further embodiment of the cut closure apparatus built according to the principle of the invention Figure.

Figure 14 B are of the invention similar to the cut closure apparatus of Figure 14 A- Figure 14 A3 and are positioned over experimenter's knee On cut closure apparatus top view.

Figure 15 A are shown according to the principle of the invention, cutting with the pulley system to two adjacent substrates of lateral The schematic diagram of mouth closure apparatus.

Figure 15 B show the profile of the cut closure apparatus of Figure 15 A.

Figure 15 C show the cut closure apparatus according to the present invention, Figure 15 A being positioned on model knee.

Figure 15 D show the schematic diagram of the cut closure apparatus similar to the cut closure apparatus of Figure 15 A.

Figure 15 E and Figure 15 F respectively illustrate various for what is be used together with the cut closure apparatus of Figure 15 A and Figure 15 D Sway brace assembly structure.

Figure 16 A- Figure 16 D show various retaining mechanisms in accordance with the principles of the present invention.

Figure 17 is shown according to the principle of the invention, for the linkwork of cut closure apparatus.

Figure 18 is similar to the cut closure apparatus of Figure 14 A according to the principle of the invention and is positioned on experimenter's knee The top view of cut closure apparatus.

Figure 19 show it is of the invention, including the cut closure apparatus of single substrate sections pair.

Figure 20 A are shown according to the principle of the invention cut closure apparatus similar to the cut closure apparatus of Fig. 9 and Figure 10 Perspective view.

Figure 20 B show the zoomed-in view of the sway brace assembly of the cut closure apparatus of Figure 20 A.

Figure 21 shows the exploded view of a part for the cut closure apparatus of Figure 21.

Figure 22 A show it is in accordance with the principles of the present invention, for cut closure apparatus disclosed herein covering perspective Figure.

Figure 22 B show the exploded view of the covering of Figure 22 A.

Figure 23 A show that covering in accordance with the principles of the present invention, including the cut closure apparatus and Figure 22 A of Figure 21 is cut The exploded view of mouth closure apparatus assembly.

Figure 23 B show the perspective view of the cut closure apparatus assembly of Figure 23 A adhered on patient skin.

Figure 23 C show the top view of the elastomer back-up coat of the covering of Figure 22 A.

Figure 24 A show the cut closure apparatus assembling of in accordance with the principles of the present invention, Figure 23 A adhered on patient skin The perspective view of part.

Figure 24 B show cuing open for the cut closure apparatus of in accordance with the principles of the present invention, Figure 23 A adhered on patient skin Face schematic diagram.

Figure 25 A- Figure 25 C illustrate cut closure apparatus in accordance with the principles of the present invention, the application drawing 23A on patient skin The method of assembly.

Figure 26 A- Figure 26 E illustrate it is in accordance with the principles of the present invention, for wound dressing and the covering of cut closure apparatus Embodiment.

Figure 27 A- Figure 27 E illustrate the in accordance with the principles of the present invention, wound closure with the pharmaceutical preparation for merging thereon The embodiment of apparatus.

Figure 28 A- Figure 28 E illustrate the in accordance with the principles of the present invention, wound closure with the pharmaceutical preparation for merging thereon The embodiment of device coverings.

Figure 29 is illustrated according to the principle of the invention, another sacrifice covering being positioned on cut closure apparatus.

Specific embodiment

The apparatus and method of the present invention will be used in be made to patient skin or its hetero-organization during outer section's operation technique Surgical incision formation and closing course in.As mentioned below, the direction of otch will limit " axial direction " used herein " horizontal " direction.Most of otch will be made along substantially straight line, and the line will limit axial direction.Horizontal direction Will be substantially across axial direction, generally but not necessarily perpendicular or normal to axial direction.Most of otch will be substantially Straight line, but otch is probably bending or has other geometries in some cases.Term " axial direction " then will Direction suitable for being in the otch of any specific location, so as to produce also transformable horizontal direction.

With reference to Fig. 1-Fig. 3, cut closure apparatus 10 includes base portion assembly 12, and the base portion assembly 12 includes 14 He of right panel Left plate 16.Right power distributed architecture 18 is fastened to right panel 14, tight typically by the upper surface that power distributed architecture is laminated to plate Gu；And left power distributed architecture 20 is similarly attached to the upper surface of left plate 16.Cut closure apparatus also includes closing assembly 22, The closing assembly 22 can be removably attachable to right power distributed architecture 18 and left power distribution knot as described in more detail below Structure 20 is so as to close incisions, and the apparatus also includes optional fastened layer 24, and the fastened layer 24 can be in the base portion of combination Assembly 12 and closing assembly 22 have been secured to patient and have been pulled together the plate by using closing assembly and make It is placed on after cut closure on the base portion assembly 12 and closing assembly 22 of combination.

Closing assembly 22 is intended to and is suitable to pull power distributed architecture 18 and power distributed architecture 22 inwardly toward each other, to close The surgical incision that conjunction is formed therebetween.In the embodiment shown, in the ridge by power distributed architecture 18 and power distributed architecture 20 Multiple chocks 26 are formed on the horizontal support piece 36 that portion 37 axially retains.Chock 26 is accepted in groove 38, the groove 38 along The inward flange of the relative engagement member 40 of closing assembly 22 is formed.The relative engagement member 40 is kept by lateral struts 42 Together, to make, engagement member keeps fixed, (in other embodiments, spacing distance can for spaced distance Being adjustable).Groove 38 can be preferably formed in flexible ear laminated structure 44, and this is allowed on corresponding chock upwards The groove is pulled, so that closing assembly 22 is anchored on power distributed architecture 18 and power distributed architecture 20.

The lower surface 32 of each plate 18 and 20 generally will be coated with pressure-responsive binding agent, wherein described adhesive most Matcoveredn 48 is covered just, the protective layer 48 just can be peeled off before the use.It is furthermore possible to also provide be pulled away from auricle 50 or other Similar structure, so as to after the removed layer 48 and before plate to be adhered to patient skin or other tissue surfaces Right panel 14 and left plate 16 are kept together by distance at a predetermined interval.Importantly, as far as possible with original object spacing closely Keep the distance between inward flange 28 of each plate 14 and 16 so that organization edge will be smart when being closed by closing assembly 22 Really gather together, generally slightly turn up.

With reference to Fig. 4 to Fig. 7, it will description is in accordance with the principles of the present invention, for forming otch and in subsequent close incisions Scheme.First, as shown in Figure 4, right panel 14 and left plate 16 are placed on the patient skin by reference letter S labellings.Pass through Protective layer 18 is pulled away from first and plate is placed into into tissue and plate 14 and plate 16 is applied, can remove auricle 50 after this, from And leave the kerf path 52 being defined between inward flange 28.It is fixed pre- to provide that the spacing of inward flange 28 will be selected Set a distance d₁。

Right panel 14 and left plate 16 in place after, as shown in Figure 5, it is possible to use scalpel or other electrosurgical cutting devices Otch I is formed in CD spaces between the plates.

After otch I is made, as shown in Figure 6, surgical procedures can be carried out by beating scalloping inward flange, This transfers to deform right panel 14 and the inward flange 28 of left plate 16.As the most inside end of support member 36 is not connected, therefore it Can be freely separating and allow the elastic matrix expansion of right panel 14 and left plate 16, be clearly shown that in such as Fig. 6.However, plate The dimensional stability of remainder will be kept by horizontal support piece 36 and axial ridges 37, the horizontal support piece 36 and axle Extend under the influence of the power applied by otch by will not stretched open to spine 37.

As shown in Figure 7, after surgical procedures are completed, closing assembly 22 will be fastened onto power distributed architecture 18 On power distributed architecture 20.Specifically, the groove 38 in ear laminated structure 44 is engaged on relative chock 26, so as to by plate Opposite edges and tissue cut be pulled together.By the depth for being appropriately spaced the groove 38, closed group can be adjusted Part 22, so as to by plate 14 and plate 16 with preselected distance d₂Gather together.Generally, apart from d₂Initial gap d will be less than₁, so as to The inward flange of tissue is gathered together to cause organization edge somewhat to be turned up (wrinkle upwards) along otch, can so be improved Healing and reduction cicatrization.

Optionally, as shown in Figure 8, closing assembly 22' can include engagement member 40', wherein by adjustable buckle Hook or other mechanisms 54 link an end of each lateral struts 42', so as to adjust the interior of relative engagement member 40' The distance between edge, with increase or reduce therebetween apart from d₂。

The alternate embodiment 100 of the cut closure apparatus of the present invention is illustrated in figure 9 and in figure 10.Apparatus 100 includes Base portion assembly 102, the base portion assembly 102 have right panel 104 and left plate 106.As being best shown in Figure 10, positioning or right Floating screed is provided for the inward flange of each plate tightens together with 108, and the positioning or aligned stripes 108 include end Auricle 109, the end auricle 109 allow user after plate 104 and plate 106 are in place on tissue surface from institute State plate and pull out the band.

Cut closure apparatus 100 also includes backing 110, and the backing 110 has the end that partly can be turned back, will be following Adhesion backing be exposed on the plate, and allow the end of base portion assembly 102 is adhered to into tissue, while making base portion group The remainder of piece installing is still covered by the backing.Offer includes the fastened layer 112 of reinforcing frame 113, in base portion group Piece installing 102 is placed on right panel 104 and left plate 106 after closing on otch, and this is generally related to prior embodiments Ground description.Generally, it will provide and keep pallet 114, for aseptically the component of apparatus keeps together, wherein holding in the palm Disk 114 will be covered by conventional medical package covering.

As shown in figs. 9 and 10, right power distributed architecture is correspondingly provided on the upper surface of right panel 104 and left plate 106 116 and left power distributed architecture 118.Right power distributed architecture 116 includes right axial ridges 120 and multiple horizontal support pieces 122.It is logical Often, right axial ridges 120 include snakelike or serrated member, and the snakelike or serrated member is embedded or is laminated to base portion band 121.Snakelike axial ridges 120 generally will be formed by flexible elastoplast (usually duroplastss), and base portion band 121 Polyurethane or similar plastic layer will be included.The lower surface of layer of polyurethane will be coated with hydrocolloid layer, for tissue adhension. The structure of left power distributed architecture 118 would is that identical, including left axial ridges 124, left horizontal support piece 126 and left base portion bar Band 127.

As shown in Figure 9, cut closure apparatus 100 will include close mechanism, and the close mechanism includes multiple transverse ties Bar assembly 128.Best seen from each sway brace assembly 128 will include bar and ratch mechanism in such as Figure 10 (ratchet mechanism) 132, the bar are anchored on an end of left horizontal support piece 126, and the ratch mechanism 132 are fastened to right horizontal support piece 122.Each bar 130 generally will be aligned with the axis of 106 part of left plate so that right panel 104 Will keep unlimited with the gap 129 between left plate 106, so as to make otch therebetween.After otch is made, it will Each bar 130 is moved to the ratch 132 associated on right panel 104.A series of ratch rings on each bar will be drawn in association In ratch mechanism 132, and the bar is laterally pulled then, until expectation being applied with the point along base portion assembly 102 Closure tension force.It is particularly advantageous in that, can individually adjusts each sway brace assembly 128, so as to along is closed The length of the otch of conjunction, there is provided inter-organization desired closure tension force.Once desired closing is provided along whole otch Close tension force, you can fastened layer 112 is placed on base portion assembly 102, the apparatus and tissue are kept in place.

With reference to Figure 11 A and Figure 11 B, the alternative design of the sway brace assembly 140 of the present invention in figure, is shown.These are horizontal Can be used together with any one in previously described cut closure apparatus 10 or 100 to tie-rod assembly 140.Each transverse tie Bar assembly 140 includes right power distributed architecture 142 and left power distributed architecture 144.Right power distributed architecture includes right spine 146 and many Individual horizontal support piece 148.Though it is shown that three horizontal support pieces, it is to be understood that, 4,5,6 or more can also be included Multiple horizontal support pieces.Left power distributed architecture 144 is similarly included left spine 150 and multiple left horizontal support pieces 152.In order to carry For closure, right power distributed architecture 142 includes from center horizontal support piece 148 bar 154 for extending.Generally, bar 154 is by active or quilt Dynamic connecting piece 158 is linked to the support member.Draw ring 156 is provided in the free terminal of bar 154, and along the stage casing of bar 154 Part provides multiple ratchets 162.

Left power distributed architecture 144 includes ratch mechanism 160, and the ratch mechanism 160 is suitable to the bar for receiving right power distributed architecture Tooth 162 on 154.By this way, bar 154 can be made to fall into soldered tooth 162 in ratch 160, so as to allow to promote forward institute Bar is stated, so that right power distributed architecture 142 and left power distributed architecture 144 are pulled together, to apply tension force to right panel and left plate.

As shown in Figure 12, another aspect of the present invention is shown in figure.Schematically illustrate cut closure apparatus 100, wherein illustrate only right panel 104 and left plate 106 and right power distributed architecture 116 and left power distributed architecture 118.Remaining is System component is not shown for the ease of diagram.

Right panel 104 is covered by right sacrifice covering (sacrificial cover) 170, and left plate 106 is by left sacrifice Covering 172 is covered.Right panel 104 and left plate 106 can be right wherein to sacrifice covering 170 and left sacrifice with limited area 175 Right panel 104 and left plate 106 are separated by covering 172.Covering 170 is respective with 172 removably along the substrate for associating Each edge is fastened so that normal process of the covering in cut closure apparatus 100 on tissue surface to be cut and put Keep during putting in situ.Use and the purposes that these sacrifice covering 170 and 172 is described with reference to Figure 13 A and Figure 13 E.

Figure 13 A illustrate right panel 104 in place on tissue surface T before otch is made and left plate 106.Right panel 104 Covered by right sacrifice covering 170, and left plate 106 is covered by left sacrifice covering 172.Many surgery handss are common in such as In art like that, place on tissue surface T and adhere to surgical incision drop cloth 180.Any conventional drop cloth can be used, such as can be from bright The Ioban that the 3M of Ni Su Dazhou City St.Paul is buied^TMAntimicrobial otch drop cloth.

After otch drop cloth 180 is in place on cut closure apparatus, it is desired for carrying out to make surgical incision I Surgical intervention.As seen in FIG., correspondingly otch can be cut out right panel 104 and left plate 106 through surgical drape 180 I.After surgical procedures are completed, it will remove surgical drape 180 from tissue surface T.As surgical drape has lower gluing Subordinate list face, therefore before making the present invention, removing for drop cloth may make any or all both shifting in right panel 104 and left plate 106 Position.However, the presence of sacrifice layer 170 and sacrifice layer 172 prevents such displacement.Removing for surgical drape 180 will be removed Sacrifice layer 170 and sacrifice layer 172, but as each layer in these layers is arranged to break with relatively low separating force From, therefore removing for sacrifice layer will not result in following plate 104 or plate 106 is shifted.Therefore, plate 104 and plate 106 will be as Stay put shown in Figure 13 D, and as shown in Figure 13 E, power distributed architecture 116 and power can be used as previously described Distributed architecture 118 is by plate closing together so as to close incisions.

With reference to Figure 29, right sacrifice blanket layer 170 and it is left sacrifice blanket layer 172 can each free urethane film (for example, 0.001 " it is thick) it is built-up.The middle part of urethane piece can adhere to the top of right panel 104 and left plate 106, and by power distributed architecture 116th, power distributed architecture 118 and any band 130 and lock 132 are assembled on urethane piece.Then urethane piece can be wound Around power distributed architecture 116, power distributed architecture 118 (and as shown in Figure 29 band 130 can curve inwardly so that They are comprised on plate 106), and the free terminal of urethane piece is stacked on one another along its length.Therefore, it can twine urethane piece Be wound on power distributed architecture 116, power distributed architecture 118 and closure member 130, on closure member 132, it is outer to protect them from Section's drop cloth 180 affects.Urethane piece preferably includes multiple perforation, and the plurality of perforation is disposed along its length, and with it is every Individual plate 104, the inward flange 104e of plate 106 and outward flange 106e alignment.The perforation can allow removing surgical drape (example Such as, surgical drape as herein described 180) when, tear urethane piece with surgical drape 180 in a controlled manner.Perforation preferably by The otch and 1mm tie-rods of 3mm is built-up, but can also change definite size to control desired tear edge.Perforation can be along Single ordinate or multiple lines and formed.Multiple longitudinal perforation lines can allow reliable separation, regardless of whether surgical drape with it is sacrificial Change in domestic animal layer 170, the adhesion of sacrifice layer 172.Can will perforation be made for easily near plate 104,106 edge it Place unclamps, and to help improve the detached probability at plate 104, edge 104e, 106e of plate 106, and makes what is left Unnecessary urethane is minimized.In order to help sacrifice layer 170, sacrifice layer 172 to lift, auricle 170t, auricle 172t can be glued It is attached to each end of the urethane bag comprising sacrifice layer 170, sacrifice layer 172.Auricle 170t, auricle 172t preferably can be adhered to To the inside of the upper surface of urethane bag.Auricle 170t, auricle 172t can be shaped to prevent urethane to the adhesion of its own or To any from each plate 104, the adhesion of the binding agent of the ends exposed of plate 106.Each plate 104, the perforation of the end of plate 106 Pre- fracture can help to auricle 170t, auricle 172t initially lift and user to tear initiation.

With reference to Figure 14 A1- Figure 14 A3, the further embodiment of cut closure apparatus in figure, is shown.Base portion assembly 1400a (Figure 14 A1), base portion assembly 1400b (Figure 14 A2) and base portion assembly 1400c (Figure 14 A3) can each include right base Plate 1402 and left substrate 1404.Right substrate 1402 may include upper strata 1406 and lower floor 1408.Similarly, left substrate 1404 may include Upper strata 1410 and lower floor 1412.Upper strata 1406,1410 generally would is that flexibility, but hard enough, to securely close tissue And minimize the upset to otch and surrounding tissue.Upper strata 1406,1410 may include plastic layer, and the plastic layer is by rubber, breast Glue, polyurethane, silicone, thermoplastic elastomer (TPE), Woven fabric, short fibre fabric or similar material are made.Adhesion sublayer 1408, 1412 generally would is that flexibility, and more flexible than upper strata 1406,1410, any with tissue to follow following skin It is mobile, so as to keeping adhering to, minimizing foaming and in addition reduce to stimulate.Adhesion sublayer 1408,1412 may include parent Aqueouss adhesion material, hydrocolloid, hydrogel, acrylate copolymer, PEG etc..

Right substrate 1402 and left substrate 1404 may include to promote and limit base portion assembly 1400 axially and transversely The structure of stretching.These structures can also be evenly distributed the closing force put on otch, and can assemble along base portion The axial length of part 1400a, base portion assembly 1400b and base portion assembly 1400c is placed on them.Right substrate 1402 can Including one or more right power distributed architectures or axial support 1414.Each right axial support 1414 may include axial support Part or spine 1414a and two cross-brace part 1414b, the cross-brace part 1414b are coupled to spine 1414a Axial end.Spine 1414a and described two cross-brace part 1414b form C-shaped together, and the C-shaped is in some embodiment party Axially can open in formula to a certain degree, to promote right substrate 1402 in two laterally adjacent horizontal strokes of adjacent supporting piece 1414 Axial tension between support section 1414b, while being limited in two cross-brace part 1414b of single support member 1414 Between axial tension.In many embodiments, C-shaped axial support 1414 only has and be enough to allow the soft of vertical deflection Property, but be hard to minimize axial tension and cross directional stretch.As shown in Figure 14 A1, right axial support 1414 Can be inward-facing.As shown in Figure 14 A2 and Figure 14 A3, right axial support 1414 can be faced out, and this can help Help and any mechanical load for tissue closure is distributed to into the otch I between right substrate 1402 and left substrate 1404.Similar, Left substrate 1404 may include one or more left power distributed architectures or axial support 1416.Each left axial support 1416 can Including axial support portion or spine 1416a and two cross-brace part 1416b, the cross-brace part 1416b couplings It is bonded to the axial end of spine 1416a.Spine 1416a and described two cross-brace part 1416b form C-shaped together, the C-shaped Axially can be opened to a certain degree, to promote left substrate 1402 at two of adjacent supporting piece 1416 in some embodiments Axial tension between laterally adjacent cross-brace part 1416b, while being limited in two of single support member 1416 laterally Axial tension between support section 1416b.In many embodiments, C-shaped axial support 1416 only has and be enough to allow The flexibility of vertical deflection, but be hard to minimize axial tension and cross directional stretch.As shown in Figure 14 A1, left axle Can be inward-facing to support member 1416.As shown in Figure 14 A2 and Figure 14 A3, left axial support 1416 can be towards Outer, this can help any mechanical load for tissue closure is distributed between right substrate 1402 and left substrate 1404 Otch I.

As shown in Figure 14 A3, substrate in batch piece installing 1400c may also include skirt section 1424 and skirt section 1426.Skirt section 1424, 1426 can be similar to thin base portion assembly covering hereinafter described.For example, each skirt section 1424,1426 may include 0.001 English Very little thick urethane film, acryloid cement of the urethane film coupled to 0.002 inch.Binding agent can put on skirt section 1424th, 1426 whole lower surface, or can be applied only to skirt section 1424,1426 beyond substrate 1402 or substrate 1404 Region.In the building process of substrate in batch piece installing 1400c, skirt section 1424,1426 can correspondingly directly apply to whole adhesions On layer 1408,1412 or one part.Correspondingly can come alternately or additionally in thin film upper strata using skirt section 1424,1426 1406、1410.Cable release as described herein can be further provided for and carry out the adhesion lower surface line to skirt section 1424,1426. Skirt section 1424,1426 can each extend over external boundary beyond substrate 1402,1404 up in the range of such as 8mm or 1 to 20mm, but The not transverse area between substrate 1402,1404, to improve the ability for being visualized to cutting part and/or being cleaned. Therefore, skirt section 1424,1426 can help to provide additional adhesion support to the adhesion layer 1408,1412 of substrate 1402,1404 And/or creep reduces, and without the need for single covering or covering piece are directed at and placed in substrate in batch piece installing 1400.In manufacture Afterwards, skirt section 1424,1426 is generally accurately aligned with relative to substrate 1402,1404.Still can use described herein Single covering or covering piece preventing the play of the component of cutting part and substrate in batch piece installing 1400c.Due to skirt section 1424th, 1426 extend laterally on substrate 1402,1404 respectively, therefore such single covering or covering piece can With need not relative to the accurate placement of substrate in batch piece installing 1400c, and with other coverings as herein described or covering piece Comparing can be with narrower.

One or more perforation 1418 can be provided between the axially adjacent right axial support 1414 of right panel 1402, To promote the axially and/or laterally stretching of right panel 1402.Perforation 1418 can run through upper strata 1406 and lower floor 1408 with to following Tissue ventilation is provided, or can be only present on upper strata 1406.It is likewise possible on an axially adjacent left side for left plate 1404 One or more perforation 1420 are provided between axial support 1416, to promote the axially and/or laterally stretching of substrate 1402.Wear Hole 1420 can be run through upper strata 1410 and lower floor 1412 to provide ventilation to tissue below, or can be only present in upper strata On 1410.As shown in Figure 14 A1, can only have single perforation 1418 or 1420 between axial support 1414 or 1418. As shown in Figure 14 A2 and 14A3, there can be the multiple perforation 1418 for lining up x wire between axial support 1414 or 1418 Or 1420.Perforation 1418,1420 can also reduce and radially outward be stretched from otch I (such as, in joint motions or swollen due to skin Swollen period) and the stress that causes.

For example, can be along the right line 1424 and left line 1426 shown in Figure 14 B on right axial support 1414 and/or a left side Multiple perforation 1418,1420 are provided between the axial end of axial support 1416.Can be on each line segment 1424 or 1426 Multiple axially aligned perforation are provided, so that at least the upper strata 1410 of substrate 1402,1404 and lower floor 1412 can be entered with following article The description of one step is broken into single sections like that when by axial tension respectively.In some cases, wearing in device 1400 Period, perforation 1418,1420 can allow the layer 1410 and 1412 of the layer 1406 and 1408 and left plate 1404 of right panel 1402 to exist Fully separate at perforation line and separate, this is illustrated in Figure 14 A2 and Figure 14 A3.Completely separable and detached ability is further Axial tension skin as desired is allowed, wherein by axial support 1414 and 1416 discussed below and closing assembly 1422 connection (and restriction) elongation allowing.As described herein, after otch I closures, can be in substrate 1402,1404 Upper application flexibility, compliance covering.The covering can be further used for the axle for providing (and restriction) base structure 1400b To mobile and transverse shifting.Alternatively or in combination, can be between power distributed architecture or axial support 1414,1416 laterally Cutting and one or more in separating right substrate 1402 or left substrate 1404, to promote right substrate 1402 and/or left substrate 1404 axially and/or laterally stretching.

In order to by right substrate 1402 together with 1404 lateral of left substrate and optionally in order to by right substrate 1402 Tensed with left substrate 1404 against each other, base portion assembly 1400 may also include multiple horizontal closing assemblies or tie-rod assembly 1422.Laterally closing assembly or tie-rod assembly 1422 may include the tooth with sway brace assembly mentioned above 128 and 140 The similar ratch mechanism of linkage.Sway brace assembly 1422 can be by laterally adjacent right axial support 1414 and left axle It is coupled to support member 1416, typically axially end coupling.As shown in Figure 14 A1- Figure 14 A3, right axle to The corresponding placement of support member 1414 and left axial support 1416 on right panel 1402 and left plate 1404 can be staggeredly or axially Skew, and right axial support 1414 and left axial support 1416 can be C-shaped configurations, and the C-shaped configuration is with each other Laterally face and be aligned lateral end portions 1414b, 1416b of (and being connected with each other by sway brace assembly 1422). For example, the remote end lateral part 1414b of the first right axial support 1414 can be with the nearly end of the first left axial support 1416 End lateral part 1416b is laterally aligned to, and the remote end lateral part 1416b of the first left axial support 1416 can be with the second right axle It is laterally aligned to the proximal end lateral part 1414b of support member 1414, and so on.Therefore, sway brace assembly 1422 And right axial support 1414 and left axial support 1416 can be joined to one another, to form continuous sway brace group Piece installing 1422 and the line of right axial support 1414 and left axial support 1416, and the line can have snakelike arrangement, should Snakelike arrangement (that is, passes through right substrate 1402 laterally across right substrate 1402 and left substrate 1404 as shown in Figure 14 A1- Figure 14 A3 The distance between with left substrate 1404).Sway brace assembly 1422 and right axial support 1414 and left axial support 1416 snakelike arrangement can realize following one or more：The closing force provided by base portion assembly 1400 is uniformly distributed in On otch；The axial elasticity of (and restriction) base portion assembly 1400 is provided；And be base portion assembly 1400a, 1400b and 1400c provides hardness or rigidity with fully close incisions and allows which to heal and (that is, carry with the upset and expansion that minimize For lateral stability and axial stability).In many embodiments, horizontal support piece 1414,1416 is hard so that not It is coated with the region stretching of the substrate 1402,1404 of horizontal support piece 1414,1416.As these uncovered regions are from the right side Substrate 1402 is offset from one another to left substrate 1404, thus tie-rod assembly 1422 can with otch I by axial tension from which Anchor point is axially pivoting.Right substrate 1402 and left substrate 1404 more can be leaned on by the such axially pivoting of tie-rod assembly 1422 Near-earth gathers together, to keep the closure of otch I.

The material of sway brace assembly 1422 and right axial support 1414 and left axial support 1416 can be with example Such as include flexible elastoplast, usually duroplastss, such as nylon, polypropylene, polyethylene, Merlon or other thermoplasticity Polymer.Generally, sway brace assembly 1422 and right axial support 1414 and left axial support 1416 can include bullet Property be less than the material of right substrate 1402 and left substrate 1404.Therefore, it is many other with cut closure apparatus disclosed herein Base portion assembly is the same, can provide bigger rigidity (and more towards the top of base portion assembly 1400a, 1400b and 1400c Little elasticity).That is, there may be elasticity between the top and bottom of base portion assembly 1400a, 1400b and 1400c Gradient.The top of base portion assembly 1400a, 1400b and 1400c can be hard enough or firm so that cut closure apparatus exists The movement of tissue for preventing from being laterally adjacent to the apparatus when otch and surrounding tissue is applied to, it is capped substantially not make Otch and surrounding tissue expansion.That is, at least a portion of the cut closure apparatus of application is (for example, under harder layer Part) movement be overall, and do not upset following otch.Also, base portion assembly 1400a, 1400b and 1400c Bottom can be flexible enough so that the foaming caused because of the movement of the tissue adjacent to the cut closure apparatus applied Minimize with adhesion loss (adhesion loss).Although the major function of sway brace assembly 1422 can be to every Individual substrate 1402,1404 applies tension force to keep otch I to close, but in many embodiments, sway brace assembly 1422 Can be also used for providing column intensity, made from the right of the distraction force that may upset notching edge alignment and pairing with will pass through The compression (or along bending or fold of otch I) of otch I is minimized and isolates otch I.Enough axial directions can be directed to curved Bent flexible and transverse compression and bent support and optimize axial spacing, material character and the size of sway brace 1422.Excellent In selecting embodiment, the spacing between tie-rod 1422 is 10mm, and the material of tie-rod 1422 is nylon, and size is 0.030 English Very little circular section.

With reference to Figure 14 B, base portion assembly 1400b can be placed on the skin in the joint (such as knee) of patient or experimenter In otch on.Near motion joint in place of, especially proximate to knee place otch in, closing device or closure apparatus Integrity suffers from the challenge of many factors.These factors include：The longitudinal direction elongation of wound, circumference when there are joint motions Swelling, opening；The skin injurys such as foaming；Adhesion loss；And the discharge of wound fluid.Such as knee, ancon, foot The joint such as ankle and shoulder may experience movement, and this there may come a time when to cause to cover the joint motions mobile more than 135 °, so as to cause Above-mentioned challenge.

Skin around the bending position, knee may axially (that is, parallel to otch) and laterally (that is, transverse to or it is vertical Directly in otch) stretching up to 50%.The cut closure apparatus for adhering to the skin in the region can be preferably able to provide foot Enough tension force carrys out close incisions, but stretching is adapted to minimum local stress.Minimize local stress is allow to prevent office Portion's skin adhesion loss or the damage in the case where adhesion loss does not occur to skin.Many otch disclosed herein The critical nature of closure apparatus is to be distributed in than tension element attachment point itself more the tension load of the closure member of apparatus Ability on big area.Additionally, including the binding agent attached by 2 element of tensioning structure in many cases can with The ability of the compliance of the structure is distributed on the region of skin stretch so that otch is protected by apparatus when skin is moved around which Hold original position.Embodiments described herein can include the composite design of non-stretching tension element (commonly referred to " band "), The non-stretching tension element links to " lock " for being held in place band.For example, this class component can include mentioned above Sway brace assembly 128,140 and 1422.These elements may be mounted at the surgical appliance adhesive with elastic polymer material On, the elastic polymer material contributes to being distributed tension load.In many cases, such elastomeric polymer can be in surrender Or there is before permanent deformation high elongation rate, and can including polyurethane etc. thermoplastic elastomer (TPE) and various grades Silicone.Such material can also be easily formed thin film necessary to the compliance for keeping slim and enough.

Surgical appliance adhesive used in apparatus may also need to the elongation for bearing skin, and can skin recover to Retract/rebound during unstretched state (for example, in the knee position of full extension).Hydrocolloid adhesives can provide such property Matter, and preferably it is suitable for such application.This property can also be provided using other binding agents such as acrylic acid Matter.In general, such binding agent may need to be attached to all elastic films as above, so as in expansion and Its structure is kept in rebound process.If not having such support, binding agent is torn and is separated such as cyclic extension.

A series of cut closure apparatus for being built as short segments can be in the situation without adhesion loss or skin injury It is lower to adapt to higher percentage of total elongation.Each single sections can suffer from the local elongation of skin under it.Two phases Stress relieving space can be served as in space between adjacent sections, so as to allow skin to stretch within this space.Segmentation can be with more Kind of mode is realizing：(1) by laying single sections along cut line, or (2) allow device when which is applied to skin Or it is divided into short segment after being applied to skin.

Realize that the optimal way being segmented is included as described above in layer of polyurethane (that is, substrate after skin is applied to 1402nd, 1404 upper strata 1406,1410) middle creation perforation (for example, the horizontal line of perforation, to promote tear), and keep following Binding agent is perfect, as shown in Figure 14 B.Perforation can undergo to draw with knee flexion (that is, carrying out joint motions) at which Cause when stretching substrate at least upper strata (for example, upper strata 1406,1410) along perforation line (for example, line 1424, tear 1426). In a preferred embodiment, adhesion sheet of the otch per side can be 12mm width, and the punched interval in given plate Open about 12-20mm.Carry out testing and proving, the perforation of the otch and 1mm tie-rods of 3mm is for the realization in knee flexion Segmentation in the urethane substrate of 0.001 inch is effective.With the flexing of knee, skin may be in some positions along axle To (along otch) and horizontal direction elongation up to 50%.Therefore, the separation of polyurethane can mitigate when device undergoes stretching Stress in device.

As an example, the knee of Jing surgical repair may be in inflammation in a couple of days, and this may cause joint big after closure About 30% radial direction swelling.Elastomeric material such as polyurethane etc can allow cut closure apparatus (for example, including adhering to figure The base portion assembly 1400b of the otch I formed in 14B) expand with such circumferential swelling.Minimize the width of apparatus (for example, each substrate sections 1402,1404 is 12mm or less) can be such that apparatus is being subjected on the direction of otch I Amount of expansion is minimized, and therefore can keep adhesion while the probability for making skin injury is minimized.Figure 14 B show Perforation in adhesion sections, the perforation extends to otch along line 1424,1426 in a lateral direction, easier to allow Axial tension.Can be perforation or other windowings be made parallel to otch in the outer edge near adhesion sections, to reduce The stress caused as skin radially outward stretches (such as during joint motions and swelling) from otch.

With reference to Figure 15 A- Figure 15 D, otch may be often subject to the tendency caused due to the flexing in knee or other joints In beating scalloping power.In many embodiments, cut closure apparatus possesses retaining mechanism, and the retaining mechanism is by flexing During close to resist tensile force, to assist in keeping cut closure.Figure 15 A and Figure 15 B show cut closure apparatus Base portion assembly 1500, which includes the mechanism using pulley effect, i.e. when skin is along lancing-drawing, otch either side The distance between locking point shortens.In a preferred embodiment, substrate is to the viscous of every side of the otch between 1510a, 1510b Attached plate 1510a, 1510b is 12mm width, and the perforation 1530 into line in given plate 1510 is spaced apart about 18mm.It is logical Often, all components of retaining mechanism are non-stretching formula.As shown in Figure 15 C, by anchoring piece 1540, pulley 1520, lock 1550 The triangle formed with flexible locking element 1580 (for example, tethers or band) with the base B axially along otch and Laterally across the height H of otch.With knee flexion, the increase of triangle base length.Generally, all components of triangle are Non-stretching formula, this requires that height must reduce to remain attached to the length of the discrete component between any two points, so as to produce The raw additional closing force across otch.Figure 15 A and Figure 15 B also show the lower surface of substrate 1510a, 1510b and can include glue Body binding agent 1560, and one of plate 1510a or 1510b can include locking arm 1570, for band 1580 is locked onto Position.Although the base of triangle is illustrated in Figure 15 A on left substrate 1510b, it is contemplated that the base of triangle can be with It is alternatively positioned on right substrate 1510a.

Although forming triangle by anchoring piece 1540, pulley 1520, lock 1550 and flexible locking element 1580, it is also possible to It is susceptible to other shapes.For example, pulley 1520 can be wrapped in around two anchoring pieces 1540 to form square or rectangle shape Shape, or pulley 1520 can be wrapped in around three or more anchoring pieces 1540 to form trapezoidal shape.With reference to Figure 15 D, The base portion assembly 1500a of cut closure apparatus is shown in figure, which is similar to base portion assembly 1500.In substrate 1500a, 1540, two pulleys 1520 of anchoring piece, lock 1530 and flexible locking element 1580 form rectangle with following skin stretch When additional closure is provided at the otch I.In rectangular arrangement shown in Figure 15 D, the two fixing points of otch I either sides it Between spacing generally would is that identical.And in the triangular arrangement shown in Figure 15 A and Figure 15 C, pulley 1520 side is consolidated Fixed point can be spaced apart farther than otch I opposite sides.Although rectangle is shown as " opening wide " on left substrate 1510b, can be with It is contemplated that the rectangle alternatively " can be opened wide " on right substrate 1510a.

Cut closure apparatus base portion assembly 1400a, 1400b and 1400c and sheet shown in Figure 14 A1- Figure 14 A3 In other cut closure apparatus base portion assemblies described by text, it is possible to use single band 1422 is engaging positioned at otch I's The single lock of opposite side.In Figure 15 A- Figure 15 D, each flexible locking element or band 1580 are generally anchored in the one of otch I Side, is wrapped in around opposite side, and engages then the lock 1550 positioned at the position identical otch I sides with anchoring piece 1540. In the embodiment shown in Figure 15 D, flexible locking element or band 1580 were twined before the lock 1550 of the same side in engagement Around two fixing spools (spool/pulley 1520) of the opposite side for being wound on otch I.Flexible band 1580 winds volume thereon Axle 1520 preferably can be coupled with rigid member so that the distance between they are in the piece installing 1500 of closing device substrate in batch in axle Do not increase when protruding upward to side.In the alternative, it may be desirable to allow the expansion between pulley or spool 1520. It should be noted that flexible locking element 1580 can be anchored in a substrate sections, at the same be locked in by substrate 1510a or In the adjacent segment separated by perforation 1530 in 1510b.Such anchoring and locking can be in the three of base portion band sections Connection is created between (two sections are located at the same side, and a sections is located at opposite side).When across Tncision closing device or base When the length of portion's assembly 1500 or 1500a considers in the lump, it is (that is, snakelike) even that across the otch I of attachment means forms continuous serpentine Connect.

The flexible connector 1580 of the tensioning being wrapped in around heart axle, spool or pulley 1520 can be arranged in stretching Power attempts to open otch and following skin provides the additional compression to otch I when undergoing to stretch.In some cases, if The external force got together by two substrate 1510a is further compressed, then flexible band 1580 potentially may be slided from heart axle 1520 Take off and fluff, and do not cause any stretching of following skin.In order to prevent such slippage, flexible winding component 1580 Can be slidably received in or be anchored in the element 1590 anchored on base portion band 1510a.Figure 15 E and Figure 15 F are illustrated Through the flexible member 1580 of pipe 1590, the pipe 1590 then be attached to or be anchored to substrate 1510a.When substrate 1510a, When 1510b is gathered together closer to ground, flexible taped components 1580 will still be captured, and offer is provided must The closure function wanted.In other embodiments, the spool feature 1590 shown in Figure 15 E and Figure 15 F can be with through center Hole, the hole is slid through by band 1590.Flexible band 1580 and its element 1590 for being slid through preferably are set Count into the minimum friction forces for making between element 1580 and element 1590.

Carried out testing and proving, on base B be 12mm, and after cut closure by two substrate 1510a, In the case that the distance between band junction point on 1510b determines height H (normally about 16mm), the device on human knee Reduce 5% in the region that the flexing of tool 1500 causes the elongation of height H skin S wherein maximum.It should be noted that the reduction of height It is likely to be dependent on Multiple factors, two bases of the base of such as triangle, the elongation degree of lower surface skin and otch either side The distance between portion.The possible needs of connection " band " at least partly flexibility between anchoring piece 1540 and lock 1550, To allow to circulate around pulley.In a preferred embodiment, by monofilament plastics silk thread and the feature phase engaged in retaining mechanism It is integrated.Such feature can be the circle " tooth " in the ratch shape mechanism being engaged in lock.Such plastics can be used for obtaining Desired flexible, longitudinal hardness, low Carried bacteria tendency are obtained, and allows to extrude and/or injection molding technique.Can also use Braided suture (preferably have coating with restricting bacterial carry) is creating flexible and non-stretchable adapter.Can also use Justify silk or pipe by made by the flexible materials such as silicone to obtain flexibility.The band of pulley can be such as moulded plastic and The complex of the materials such as braided suture.In other embodiments, the band of pulley can by make molding band constriction and shape Into.Molding band is drawn to into the cross section that can for good and all reduce band beyond its yield point, and make its in elongation more Tool is flexible.Can promote to extend the reduction with cross-sectional area in necking process using heat.Figure 16 A- Figure 16 B can be used Shown in alternate mechanism, so as to once band material is locked in the case of realizing desired closure, such as suture and softer Plastics.Figure 16 A show retaining mechanism, and which includes the groove 1610 for sliding and anchoring frame 1620.Figure 16 B show locking Mechanism, which includes locking teeth 1630.Figure 16 C show retaining mechanism, and which includes the groove 1640 for sliding and anchoring frame 1650. Figure 16 D show retaining mechanism, and which includes cylindrical tube 1660 and locking teeth 1670.

Can be obtained by using linkwork 1700 as shown in Figure 17 and be closed across the additional of otch in knee flexion With joint efforts.As shown in Figure 17, can use X-shaped non-stretching arm 1730 by four points of otch either side (cut closure apparatus 1720) two anchor points on per side or substrate 1710 couple together, and provide at cross point 1740 and be hinged.With knee The distance between two points of the same side of flexing and otch increase, and the distance between sections of either side of otch can subtract It is little, so as to produce additional closing force.As shown in Figure 17, substrate 1710 can also possess multiple perforation 1750 to promote to substrate 1710 axial tension, or promote its vertical sections of separated component in axial tension.

As shown in Figure 18, according to many embodiments, the band and lock of cut closure apparatus 1800 can be arranged to The S-shaped or snakelike connection or arrangement of the whole length of the otch I being formed across on the skin S of knee.Cut closure apparatus 1800 Cut closure apparatus 1400 that can be similarly as described above in many aspects.By by each sections 1810a of the side of otch I Couple together with two adjacent segment 1810b of the opposite side of otch and make sections 1810a, 1810b of device 1800 phase each other Even.This can by install in each sections 1810a a pair of bands 1820 and on the corresponding sections 1810b of opposite side install Lock 1830 to realize for a pair.Each pair lock 1830 and band 1820 can be connected with each other.In the closing course of wound or otch I, base One of the band 1820 of plate segment 1810a (for example, 1810a1) (for example, band 1820a) can be with the section of the opposite side of otch I Lock 1830 in section 1810b (for example, 1810b1) is connected, and the second band 1820 (for example, band 1820b) can with adjacent to Connect the sections 1810b (for example, 1810b1) of band 1820 (for example, band 1820a), the otch I being previously paired wherein Opposite side sections 1810 (for example, sections 1810b2) in lock 1830 (for example, 1830b) be connected.It is above-mentioned to constitute Substrate sections 1810, band 1820 and lock 1830 S-shaped or snakelike arrangement it is monocyclic.Perforation line 1850 can separate axially adjacent Substrate sections 1810a and 1810b.The perforation line 1850 (for example, with substrate sections 1810a) of side can be worn with opposite side Hole line 1850 (for example, with substrate sections 1810b) is staggeredly.Similar to Figure 15 A, in a preferred embodiment, positioned at otch Adhesion sheet per side can be 12mm width, and the perforation in given plate can be spaced apart about 18mm.

Cut closure apparatus or device can be applied in many ways as described herein.Figure 19 is shown according to some realities Apply the exemplary cut closure apparatus 190 of mode.Here it is possible to single base portion arranged in pairs is provided in sections 1910 single On carrier/release liner.Each pair substrate sections 1910 includes that band 1920 and lock 1930, the band 1920 and lock 1930 can be with Skin is adhered to cut alignment and adjacent to each other independently.Release liner and outer belt carrier 1950 can be used by single sections 1910 relative to each other keep together.Release liner 1950 can be removed to expose binding agent, but whole device 1900 or dress Put 1900 packet partial to be coupled with outer belt carrier.When skin is applied to, belt carrier 1950 can be removed, it is viscous so as to stay Attached sections 1910, the adhesion sections 1910 is aligned with each other but can independently move.

The perforation sections (generally comprising polyurethane) on substrate upper strata (can generally comprise water by one layer of continuous adhesion sublayer Colloidal adhesive) keep together, to allow to be laid on skin in a continuous motion.Figure 14 A- Figure 14 B, Figure 15 A- The cut closure apparatus 1400,1500 and 1800 of Figure 15 C and Figure 18 can possess such continuous adhesion sublayer respectively.

The base portion assembly or substrate of cut closure apparatus as herein described can be in the end of wound or cut closure by soft Property adhesion membrane material covered.The diaphragm area preferably may be larger than base portion cut closure panel element, so which makes the element It is overlapped on skin.The film can help to the migration for preventing base portion, and can prevent any of anchoring piece and retaining mechanism Accidental movement.The coverlay can be made up of Stretch materials such as rubber, latex, polyurethane, silicone or thermoplastic elastomer (TPE)s. In a preferred embodiment, thin covering (for example, 0.001 " urethane and 0.002 " thick acryloid cement duplexer) will Can be with the bigger compliance of the composite construction than base component.Therefore, covering can be in exposed skin and base segment Between some strain relief are provided.Covering can also be transparent, to allow the visual inspection to otch.Covering can be across Otch fully seals (for example, as the barrier to infecting), or can have the opening being aligned with cut line on covering, with Allow passing through for any transudate from wound.Covering is can be additionally used in by bridging substrate and adhering between base portion band Skin edge improving the pairing of notching edge.Covering can be also built into additional fastening element, described additional Fastening element improve tensile strength between base component, but allow the compliance along incision length.Preferred implementation A series of polyethylene glue tapes of covering can be included being applied to.

Although user can apply covering after base portion assembly and plate are placed on skin, it is contemplated that arrive can To supply covering material as " skirt section " extended around the outer perimeter of base segment.Therefore, covering material is relative to base portion Alignment can not rely on the placement of user.These identical covering materials can provide following effect：Prevent hydrocolloid Binding agent is exposed to patient garments, the migration of restriction hydrocolloid or other adhesion lower floors, provides to the tension force on base segment Strain relief etc..

In many embodiments, hydrocolloid adhesives are for the tensioning skin for cut closure.Can pass through following In one or more modes preventing the creep of hydrocolloid：(1) on the surface using duplexer limiting creep, or (2) Covering is adhered to across skin and hydrocolloid adhesives application to prevent creep and provide strain relief to prevent skin from damaging to skin Wound.

In many embodiments, the covering being used together with base portion assembly may include to bore a hole or be open in one Or it is multiple, to allow to remove wound fluid (and any application in the case where the base portion assembly of adhesion need not be removed Binder/absorbing material).

In many embodiments, the covering includes the complex of flexible urethane and reinforcing strip band.Compound structure can To provide the intensity across otch, and provide the compliance along incision length.

In many embodiments, on axial direction and horizontal direction, the covering combined with base portion assembly is made Skin incision edge is aligned or significantly prevents subsequent skin edge from misplacing.

In many embodiments, there is provided cover gasket is configured, so as to first to the one of dermal application covering Part, this helps removing for other liners then, and therefore can help control thin material so which is equal with minimum fold Lay evenly.

In many embodiments, the first liner removes the visualization that can be allowed in placement process, and can be with The remainder of anti-locking apparatus clings user.

Referring again to Fig. 9 and Figure 10, in many preferred implementations, two adhesion sheets 104,106 are applied to into surgery The either side (before or after otch is made) of otch.Close mechanism is may be mounted on adhesion sheet 104,106, and can Component 120 is preferably attached to, and the component 120 contributes to closing force being distributed between the attachment point of close mechanism.Such as Fig. 9 and Tu Shown in 10 and Figure 20 A and Figure 20 B, the close mechanism may include band 130 and lock 132.Band 130 is may include with engagement The elongated member of tooth.Lock 132 is may include for catching the feature of the soldered tooth of band 130.Band 130 can be tensed in lock 132 In, so that adhesion sheet 104,106 (and so as to by notching edge) is pulled together.When necessary, user can disengage and The band 130 being re-engaged in lock 132, suitably to adjust the amount of skin closure.Meanwhile, the cut closure illustrated in Figure 20 A Apparatus can be described as base portion or base portion assembly 102.

Surgical appliance adhesive for each plate 104,106 preferably includes hydrocolloid adhesives.Alternatively or in combination, Surgical appliance adhesive may include one of many propylene acid supplements known in the art.Hydrocolloid adhesives can have very glue and The benefit of moisture and exuviae skin cell can be absorbed.Therefore, hydrocolloid adhesives can be particularly suitable for long periods of wear apparatus (for example, up to 14 days).However, at least some cases, hydrocolloid structure is probably softness, and easily under tension Generation creep, unless reinforce in some manner, such as by other coverings of the harder substrate 120,104 or disclosed herein of use Structure is covering hydrocolloid adhesion layer.

Correspondingly, another aspect of the present invention additionally provides the base portion reinforced and protect cut closure apparatus as herein described The various means of the adhesion layer in assembly, and skin edge is kept together the additional of (particularly in the axial direction) Means.In at least some cases, single hydrocolloid adhesives have low-down tensile strength, and may need reinforcement Means are torn or creep in use with preventing which.As shown in Figure 21, the adhesion layer used in substrate 104,106 211 can be mutually laminated with compliance plastics or polymer 212 (such as urethane) thin layer, and the compliance plastics or polymer 212 are thin Layer is preferably 0.001 inch, and potential scope is up to 0.010 " it is thick, keep which to tie during may assist in Clinical practice Structure.Adhesion layer itself can be nominally 0.010 inch, but can be between 0.005 inch and the scope of 0.020 inch.By Adhesion arrangement 211 may be attached in the tensioning element including the band 130 or lock 132 for being attached to power load distributing component 118 Top, therefore there is a possibility that material can creep over time.Duplexer 212 and it is located at adhesion layer 211 and negative Any other adhesion duplexer 215a, 215b between lotus distribution component 118 can help provide to prevent adhesion layer creep Structure.

As shown in FIG. 22 A, in order to further prevent the migration of adhesion sheet 211, can be covered with applying on plate 104,106 Cover material 220.As shown in Figure 22 B, covering 220 can include compliance elastomer 221 that is thin, scribbling binding agent.Permitted In many embodiments, covering 220 also includes scribbling the surgical appliance adhesives such as acryloid cement (preferably 0.002 English Very little thickness) thin urethane layer (preferably 0.001 inch), which is may be provided on one or more release liners 223a, 223b. Covering may also include reinforcing feature 225.

As shown in Figure 23 A and Figure 23 B, can by covering 220 be constructed so that its it is extensible beyond substrate 104, 106, so as to bridge the distance between skin S and plate 104,106 d3.Typical minimum can must be 8mm apart from d3, but can be with In the range of 2-15mm.In addition to helping prevent the adhesion layer creep of substrate 104,106, the urethane skin of covering 220 Binding agent is also assisted in carries out strain relief to the tension force that substrate 104,106 is applied to by the movement of surrounding skin S.This can use In the skin injury (for example, rotten to the corn or foaming) for preventing substrate 104,106 edges.It should be noted, however, that due to hydrocolloid certainly Body can move and thereby resist the damage to skin S with skin S, and the compliance property of hydrocolloid provides the local for foaming Protection.In many embodiments, even if there is the harder structure of the outer surface for being attached to adhesion layer, down to skin surface Compliance in the nominal thickness of the 0.010 of adhesion layer " stills provide the opposing to skin injury.

Except board structure is stabilized and strain relief in addition to, covering 220 can be used for other purposes.By covering Band 130 will engage the position of lock 132, and covering 220 can prevent patient from will lock 132 plays may disengagement to band 130 Degree.As shown in Figure 23 A- Figure 23 C, covering 220 can be equipped with opening along the length in the region overlap with otch 224th, 224 ' so that the outside gauze for applying can be with absorbing wound exudate.In other embodiments, covering 220 can be with There is no opening, to protect the wound from the evil of the source of infection.Covering 220 itself can have reinforce feature 225,225 ' with to Base portion 102 provides the additional resistance power opened for otch, particularly in the region between band 130.Figure 23 C show spy Determine embodiment, wherein it can be rectangle article tape to reinforce feature 225 '.Preferably, perpendicular to skin incision, adhesive tape 225 ' can It is harder with the compliance urethane layer 221 than surrounding.Adhesive tape 225 ' can be built-up by the combination in any of the following：Scribble bonding The Woven fabric of agent, polymer fiber, polyethylene, polypropylene, nylon, PET, hydrocolloid or other materials known in the art. Reinforce feature 225 ' and can also increase " body " or rigidity to covering 220, to help which to place.Urethane layer 210 can be by this class material Material is built-up, to give its biaxial tension.

The spacing of feature 225,225 ' is reinforced for longitudinal direction (parallel to the cut line) compliance (example for guaranteeing covering 200 Such as, due to the thin urethane of compliance) it is probably important.This can be used for by allowing covering 220 and following base portion group Piece installing 102 is moved with the motion of body, improves the comfort level and the resistance for skin injury of patient.The effect can Can individually from covering 220, or as the compound effect with the feature for allowing longitudinal compliance of base portion assembly 102 Really.Reinforcing member 225,225 ' can also be uniform construction, but be perforated, slot or otherwise mechanically interrupt, to permit Perhaps with the stretching and/or controlled tear of body kinematicses.One or more thin urethanes of covering 220 can also mechanically be interrupted Layer is realizing identical effect.In at least some cases, the reinforcing feature 225,225 ' of covering 220 can not be extended over The whole width (perpendicular to otch) of thing 220.This limited cover width is can help to ensure that for perpendicular to the remote of otch I From the strain relief of the body kinematicses of base portion assembly 102.In a preferred embodiment, reinforced by strenthening member 225,225 ' The region of covering 220 upwardly extends 10mm away from the side of notching edge at each, but this can be in the range of 2-50mm.

Another feature of covering 220 can increase the control for notching edge, particularly assemble in base portion Between the tensioning element 130,132 of part.As shown in fig. 24 a, the tensioning element 130,132 for combining with substrate 104,106 can For making notching edge 205 be close to together.Once skin S is approached, and skin edge is vertical (perpendicular to skin surface) Alignment is probably important.Vertical dislocation may cause healing relatively slow, and visible " sublevel " or rib ridge in otch, and this may Cause bad cicatrix aesthetic property.By some parts of covering 220 are attached to along otch substrate 104,106 each Edge, can make each edge keep perpendicular alignmnet as shown in arrow 201a, 201b under tension.Across the covering of otch I Binding agent on 220 part can also be directly attached to skin S at notching edge, so as to further shorten the otch for being bonded The distance between edge simultaneously further enhances vertical skin alignment.As shown in figure 23 c, in a preferred embodiment, across cutting The part of the covering 220 of mouth I is rectangle article tape 225 '.Between the axial direction between the width and band 225 ' of each band 225 ' Gap can be directed to the effusion of notching edge control, otch visibility and wound fluid and be optimized.Preferred implementation can It is located between each band with the band including 12mm width and interval 6mm, and band.It is contemplated that to other width and Away from.By not bridge joint/covering on each band 130, band 225 can more flat against skin S, preferably viscous to obtain Echo Edge position control.

In some embodiments, reinforce feature 225,225 ' to be constructed to be limited in the bending at cutting part Amount.In these embodiments, reinforcing feature 225,225 ' can be harder than skin S, and preferably than substrate 104,106 Surrounding component is harder.In this way it is possible to isolate caused by normal patient moving to the skin S around cutting part Bending or compression, or limit its propagation.The motion isolation of even now or restriction will may consequently contribute to strengthen cutting under tension force Oral area position, but bigger benefit can be prevent notching edge significantly or unevenly varus, turn up or perpendicular to skin The square upward displacement on skin surface.Using reinforcement material as discussed above, and thickness can be adjusted, it is desired firm to create Degree.Preferably, the complex of base portion assembly 102 and covering 220 can be built, so as to create rigidity seamlessly transit and From surrounding skin to the compliance of segregate cutting part.

In specific using method, in the first closure that otch is realized using base portion assembly 102 so that skin edge connects After near, further substrate 104,106 can be pushed together, " to push " the otch I for closing upwards, so that edge is somewhat The skin S around notching edge is turned up and/or compresses to discharge tension force.Figure 25 A- Figure 25 C illustrate this method group in vivo Embodiment in organization model.Figure 25 A show step 250A, adhere to substrate 104,106 wherein adjacent with otch I Skin S, and they are pushed together " to push " the otch I for closing upwards.Then further substrate 104,106 can be drawn Together, tissue is maintained in this orientation.By substrate 104,106 is remotely located from notching edge 5-10mm, These methods can be strengthened.In step 250B shown in Figure 25 B, with band 130 and 132 can be locked by substrate 104,106 phases It is in place for being locked to each other.In step 250C shown in Figure 25 C, then can using covering 220 come lock substrate 104, 106 and " pushing " otch I relative position.Can be cut further to reinforce with fastening element 225,225 ' as discussed above Mouth I.

In many embodiments, given covering 220 can be equipped with release liner to help user cover Covering 220 is processed before thing 220 is applied to patient and during application.As shown in Figure 22 A and Figure 22 B, covering 220 can be with With release liner 223a, 223b that application is configured with three parts.User can remove longitudinal center liner 223b first, with By center exposed binding agent application to base portion assembly 102 and skin incision region.Liner 223b's removes first, with reference to By the visualization of transparent plastic or opening intracardiac in base portion 220, user can be allowed to see the base portion assembling of lower section Part 102, so that can be appropriately aligned covering 220 with base portion assembly 102 when using covering 220.This is also Can help provide the region for not adhering to the covering 220 with user, until covering 220 is initially fastened to base portion assembling Part 102 and/or skin S.Next, side release liner 223a can removed on the direction of otch I.Liner 223a Keep and the very thin urethane of tensioning, to keep which substantially wrinkle resistant when skin S is applied to.Additionally, by covering first The center of cover material 220 is pasted on base portion assembly 102 and/or skin S, can be held in place covering 220, so as to Apply enough tension force and control to side release liner 223a, for scribbling the remainder of the covering 220 of thin binding agent To the smooth application of patient.Alternatively or in combination, can be by pad structure into so that the first liner is removed to expose covering Narrow strips (perpendicular to otch I) on the whole width of thing 220, to allow on base portion assembly 102 and/or skin S Initial placement, subsequently removes one or two additional liner on the direction parallel to otch I.First liner can be located at length Centre, either end, or fall between.If not being located at end, two added with padding may be needed, each lining Pad is removed in the length outwardly direction from the position of the first liner along device.If the first liner is last positioned at one End, then the end that can be outwardly directed to device from the position of the first liner removes the second single liner.

Another release liner configuration can be that, with single liner, the single liner can before application from covering 220 Bottom remove completely.Such liner may need adventitia or casting piece, the adventitia or casting piece lightly to adhere to Outer surface to covering 220 is to help thin urethane to keep its shape, and provides in side and/or end not to user User position on hand is not sticked in application process with binding agent and therefore.Adventitia can be in whole outer surface On, or be only in the specific width around the circumference of covering 220.The film and/or release liner can also have prolong Stretch the region of the thin urethane in covering 220.Once covering binding agent is attached to base portion assembly 102 or skin S, just Casting piece can be removed from the outside of covering 220 easily.

As described herein, flexible wound dressing and wound or Tncision closing device or apparatus are typically flexible and can draw Stretch, to follow the sweep (for example, arm, curved longer otch etc.) of body or undergo the region for stretching (for example, Knee) profile.In order to aid in the drape of such device, it is possible to use help the back of the body of dressing shape is kept in application process Lining material.Such interim back lining materials as herein described can have multiple advantages.Back lining materials can be transparent right to support Wound is checked.The material can be non-stretchable, to prevent dressing or closing device or apparatus in application process Elongation.Backing can be easily removed afterwards in the application of wound dressing or closing device or apparatus, so as not to affect reality Adhesion of the dressing in wound location.Back lining materials may also help in process in the fabrication process to dressing.In many enforcements In mode, back lining materials can use the ripping type release liner of the adhesion side of dressing to be coupled to dressing or closing device, to support Back lining materials simple and reliably remove.

With reference to Figure 26 A, wound dressing covering 2600 may include to be made up of flexible materials such as rubber, urethane, silicone Flexible sheets 2610.Flexible material 2610 can be layered in form for casting piece or the relatively harder material of carrier layer 2620 On.Casting piece 2620 prevents flexible material volume 2610 to itself and becomes to use.Flexible sheets 2610 can be in side (for example, Bottom side) there is relatively hard (hard) carrier layer or casting piece 2620 with binding agent and in opposite side.Binding agent side Protected by two liners 2630,2640, described two liners 2630,2640 can be removed successively, so as in a controlled manner Expose binding agent.In order to dressing 2600 is applied on wound or otch, by removing one of described release liner, generally Less release liner 2630 is removed, a little bar binding agent is exposed.The release liner 2630 can be attached using adhesive tape 2650 It is connected to casting piece 2620.The expose portion of flexible sheets 2610 can be adhered to one end of wound or otch then.With second Release liner 2640 is slowly removed continuously to expose binding agent, flexible covers 2600 follow then wound or otch with And the profile of the bending on body.

Then can be using the first release liner 2630 of casting piece 2620 be generally still attached to adhesive tape 2650 come from soft Property dressing 2610 lifts casting piece 2620.

The manufacture process of wound dressing covering 2600 and associated cushion 2630,2640 can be cutting using single module Cut out the duplexer of release liner 2630, release liner 2640, flexible dressing 2610 (with binding agent) and casting piece 2620 Common profile (circumference).Removing liner 2630,2640 and by the application of dressing sheet 2610 to skin, casting piece 2620 can be protected Stay in dressing sheet 2610.The removing of casting piece 2620 may be needed by making the edge of casting piece 2620 from 2610 points of dressing sheet Layer and by its strip off causing.Once having caused, then it can be simple direct that the continuation of casting piece 2620 is peeled off and removed. The initiation at the edge of casting piece 2620 and lift and not always intuitively, and may may need to be connected to casting piece 2620 Free edge lifts a little to help recognize and starts to peel off.Adhesive tape 2650 can be used for for casting piece 2620 bridging to release liner 2630, and readily identified auricle can be provided, the auricle can be used for causing to be peeled off.

As shown in Figure 26 B- Figure 26 E, it is possible to use the alternative configurations of casting piece 2620 are causing the stripping of casting piece 2620 From.

As shown in Figure 26 B, casting piece module can be cut, so that casting piece 2620a is axially extending applying beyond flexible Tablet 2610 (for example, can be by the liner 2630,2640 of flexible dressing sheet 2610 and urethane material " osculating " to casting piece The surface of 2620a).

As shown in Figure 26 C, casting piece 2620 can have adhesive tape 2650, the adhesive tape 2650 be applied to either axial side side or Whole two axial sides, to extend beyond casting piece.Adhesive tape 2650 may not necessarily be attached to release liner 2630.

As shown in Figure 26 D, casting piece adhesive tape 2650 is attached at one or more axial edges of casting piece 2620 Or near which, and also extend in the profile of casting piece 2620, with the non-stick attachment edge 2652 unclamped so that user is grabbed Hold.

As shown in Figure 26 E, can be from casting piece 2620 axial edge to the part of another axial edge or complete Cutting casting piece module (for example, carrying out osculating so that casting piece 2620 is not cut in flexible dressing sheet 2610) over long distances. The casting piece 2620 for cutting out can be separated by using " nip " of person, to create the edge for grasping.As in Figure 26 E Shown, internal module cut edge can also have the adhesive tape or similar auricle for being applied to one or both internal edge 2654 for grasping and peel off.

In many embodiments, casting piece 2620,2620a and/or adhesive tape 2650,2652,2654 can be different face Color, or there is labelling, to be different from flexible dressing sheet 2610 and release liner 2630,2640.

The one or more assemblies of cut closure apparatus disclosed herein or cut closure apparatus assembly, including it is various Base portion assembly, substrate, power distributed architecture, axial support, horizontal support piece, closing assembly, tie-rod assembly, band, lock, Including one or more among adhesion layer, adhesion layer, covering, blanket structure, drop cloth etc., can include, scribble or with Other modes are incorporated to one or more in the following：Anti-mycotic material, anti microbial materials, antimicrobial material, preserving timber Material or medicinal materials.For example, such material can be incorporated in hydrocolloid adhesion layer, used as another between skin and adhesion layer Layer or the coating at least a portion of adhesion layer (cover), are incorporated into base portion assembly covering or at least in its adhesion layer, etc.. It is such to promote that one or more holes, groove, opening, hole or similar structure can be provided on device or apparatus assembly It is incorporated to.In many embodiments, such material can include the natural materials such as silver, iodide, zinc, chlorine, copper or tea tree oil One or more in material is used as activating agent.Such anti-mycotic material, anti microbial materials, antimicrobial material, anti-corrosion material or The Acticoat that the example of medicinal materials including but not limited to can be buied from the Smith＆Nephew plc of Britain^TMSeries material, Can buy from the Smith＆Nephew plc of BritainHumid control series material, can be from Denmark Coloplast A/S are buiedFoam series material, can from the Urgo Limited of Britain (France The subsidiary of Laboratoires URGO) buySilver-colored series material, can be from the Smith＆Nephew of Britain What plc was buiedHydrocolloid series material, can buy from the ConvaTec Inc. of New Jersey SkillmanSeries material, can buy from the Kinetic Concepts of Texas San Antonio, Inc. 'sSeries material, can from the Kinetic Concepts of Texas San Antonio, what Inc. was buiedSilver 220, can (son of the Laboratoires URGO of France be public from the Urgo Limited of Britain Department) buySeries material, can be from the Kinetic of Texas San Antonio What Concepts, Inc. were buiedSeries material, can buy from the Smith＆Nephew plc of BritainSeries material, the Sorbsan that can be buied from the Aspen Medical Europe Ltd. of Britain Silver^TMSeries material, can buy from the Ferris Mfg.Corp. of Illinois Burr RidgeSeries material, can be from the Kinetic Concepts of Texas San Antonio, Inc. The Promogram for buying^TMSeries material, can buy from the Kinetic Concepts of Texas San Antonio, Inc. Promogram Prisma^TMSeries material and can purchase from the Medline Industries of Illinois Mundelein Series material.In jointly owned U.S. Patent number 8,313,508,8,323,313 and 8,439,945； U.S. Patent Publication No. 2013/0066365；And PCT Application No. US 2010/000430, US 2011/139912, US 2011/40213rd, the component of the closing device described in US 2011/34649 and US 2013/067024 can also include, scribble or One kind for being otherwise incorporated in anti-mycotic material, anti microbial materials, antimicrobial material, anti-corrosion material or medicinal materials or Various, in material including but not limited to listed above one or more.

In many embodiments, topical pharmaceutical formulation is directly incorporated into in wound closure apparatus as herein described.Due to Wound closure devices are often applied to close in place of needing the wound or otch of medicament protection, thus such medicine is to closure dress Being directly incorporated in putting is possibly beneficial.For example, in having the wound of infection risk, Antimicrobial agent is incorporated to possibly Beneficial.Antimicrobial agent may include antimicrobial agents and non-corrosive metal (NCM) ion and the compound for associating, and this can wrap Include the natural materials such as silver, iodine, copper and chlorine or tea tree oil.For example, in the wound of easy fungal infection, can be approved to make With pharmaceutical preparatioies such as zinc.The combination of any medicament in these medicaments is also likely to be beneficial, and therefore can be incorporated to To in wound closure apparatus.

Topical pharmaceutical formulation can be incorporated in closing device by this way：Giving closing device is keeping wound to fill Transudate is wicked out wound while aqueous enough, and (for example, the undesirable organism of guiding leaves wound and/or prevents skin Impregnate) to improve the ability of healing.

With reference to Figure 27 A, wound or cut closure apparatus 2700 include base portion, the base portion include two substrate 2710R, 2710L, described two substrate 2710R, 2710L include polymeric layer 2720R, 2720L and are applied to close to surgical incision I's Lower adhesion layer 2730R, 2730L in place of per side.The features such as the band 2740 of plate 2710R, 2710L can be allowed in healing The skin of the either side of otch I is pulled together and keeps in situ by period.Binding agent preferably includes glue body preparation, but also May include acrylic acid or other binding agents as known in the art.Upper polymeric layer 2710R, 2710L (for example, 1 Mill (mil) Polyurethane) be preferably applied to the top of adhesion layer 2720R, 2720L, to isolate adhesion layer 2720R, 2720L.Can be by Pharmaceutical preparation is incorporated in the structure of substrate 2710R, 2710L.For bottom line, medicament can its from substrate 2710R, Suppress the growth of undesirable organism in place of 2710L contact tissues.Medicament can discharge from substrate 2710R, 2710L and migrate to In wound or close to the region of wound.Medicament can be accommodated by carrier structures such as adhesion layer 2730R, 2730L, the carrier Structure can absorb fluid and help the release of medicament.This class formation may include that (such as those contain for hydrocolloid, hydrophilic fibre The hydrophilic fibre of sodium carboxymethyl cellulose), hydrogel, collagen protein, alginate, polyurethane foam or silicone foam or Other associated materials as known in the art.Carrier can be ointment, emulsifiable paste, gel or powder alternatively or in combination.Medicine system Agent (such as silver ion) can put on alternatively or in combination via solvent coating process or gas deposition metal or polymer (for example, the metal or polymer of web form).Such netted product can with reference to or the structure of embedded closing device in.

In the exemplary embodiment, the pharmaceutical preparation comprising silver compounds such as silver sulfates can be incorporated into substrate In 2710R, 2710L.As substrate 2710R, 2710L are contacted with wound fluid and/or perspiration or external fluid, Ke Yichao Medicament is transported to wound.As fluid is absorbed in substrate 2710R, 2710L, substrate 2710R, 2710L can be can discharge The silver ion of interference bacterial growth.In Figure 28 A- Figure 28 B illustrate how the medicaments such as silver can be incorporated in substrate Example, each embodiment of the sample sections 2750 of right substrate 2710R in Figure 27 is shown in figure.These examples are also applicable to In left substrate 2710L.

Figure 27 B show pharmaceutical preparation 2760R, and which is mixed directly in the adhesion layer 2730R in sample sections 2750.It is viscous Mixture is usually hydrocolloid, and which may can absorb the fluid of the notable percentage ratio for accounting for its weight, so as to help the release of medicament.

Figure 27 C show another embodiment of the sample sections 2750 of right substrate 2710R, and pharmaceutical preparation wherein is incorporated to To in the carrier structure 2770R being incorporated on substrate 2710R, the part of the substrate 2710R near otch I is preferably collected in On.Further feature can be incorporated to, so as to carrier structure 2770R by transudate or other fluid institute's saturations and/or The concentration of pharmaceutical preparation peels (and replacing as needed) carrier structure 2770R off in the case of being brought down below effect level.

Figure 27 D show the embodiment similar with the embodiment of Figure 27 C, wherein the carrier comprising pharmaceutical preparation is tied Structure 2770R is incorporated on the inward flange of substrate 2710R.

Figure 27 E illustrate how carrier 2770R can be incorporated on the top and inward flange of substrate 2710R.At these In example, arbitrary inward flange of substrate 2710R or the carrier structure 2770R on each inward flange can be pressed on wound or be cut On mouth I, to help its stability on wound or otch I.

Pharmaceutical preparation and its carrier structure can be incorporated into alternatively or in combination in the covering of cut closure apparatus.As above Literary described, covering is commonly used on the substrate of cut closure apparatus, to help apparatus is fastened to skin and skin is protected. As depicted in fig. 28 a, covering 2800 can have to be incorporated into and possess or do not possess carrier structure and (such as mix with pharmaceutical preparation Adhesion layer covering 2,800 2810) whole surface in pharmaceutical preparation 2810.Alternatively or in combination, medicament can be simultaneously Enter in the discrete parts of covering 2800, preferably in the carrier knot in wound location as shown in FIG. 28 B In structure 2820.

In at least some cases, carrier structure 2820 may become saturation and/or lose its medicine over time Intensity, and replace medicines structure 2820 would is that it is beneficial.As shown in Figure 28 C, medicines structure 2820 can be removable (for example, by tearing the perforation in covering 2,800 2830), and alternatively by coupled to the narrow covering shown in Figure 28 D Another medicines structure 2821 of band 2801 is replaced.In narrow covering tape 2801, the adhesive portion of covering 2801 can Medicines structure 2821 is extended beyond, with holding structure 2821 against skin.Narrow strips 2801 alternatively can apply covering Wound location was applied to before 2800.Covering 2800 can be designed to cover narrow strips 2801, or can have perforation 2830 allowing removing for following band.

For arbitrary or whole two substrates 2710R, 2710L and covering 2800, carrier structure 2770R or 2820 (with or without pharmaceutical preparation) or individually pharmaceutical preparation can carry the pattern of the adhesion layer of respective structure.Band pattern Construction can include the repetition shape (for example, circle, ellipse, polygon, groove etc.) of adhesive material, the repetition shape and carrier The similar repetition shape (or remainder of its matrix) of structure is adjacent.This will may consequently contribute to guarantee substrate 2710R, 2710L Or the adhesion of covering 2800, and while pharmaceutical preparation is integrated in carrier structure 2770R or 2820.Show in Figure 29 E One simple examples, wherein carrier structure 2820 include repetition shape 2850.Pharmaceutical preparation and carrier structure 2820 can also be answered For the base portion band 2740 across otch I.

Although the preferred embodiment of the present invention has been illustrated and described herein, it is aobvious for those skilled in the art and It is clear to, such embodiment is only through way of example offer.Those skilled in the art can be without departing from the present invention's In the case of many changes may be made, change and replace.It should be appreciated that in the practice of the invention can be using for as herein described The various replacements of embodiment of the present invention.Claims are intended to limit the scope of the present invention, and therefore cover these rights Method and structure and its equivalent in claimed range.

Claims

1. a kind of cut closure apparatus, which includes：

Base portion, which includes left plate and right panel, and each plate has tissue adhension lower surface, upper surface, the first transverse edge and Two transverse edges；

Left power distributed architecture and right power distributed architecture, which is correspondingly coupled to the left plate and right panel, wherein each power distribution knot Structure is adapted to allow for the plate axially expanding along one of first transverse edge or the second transverse edge, and is suitable to limit Make across the lateral magnification of the plate or along one or more in the axially expanding of relative transverse edge；And

Multiple closing assemblies, which can be fastened to the left plate and right panel, to adhere to tissue and cutting of being formed therebetween in the plate The plate is pulled together after mouthful；

Wherein the plurality of closing assembly includes being fastened to the left closing assembly end of the left plate and is fastened to the right panel Right closing assembly end, and

Wherein the plurality of closing assembly is laterally positioned across the left plate and right panel, also, one or more described left power point Cloth structural arrangement is between at least some axially adjacent left closing assembly end, and one or more described right power distributed architectures It is placed between at least some axially adjacent right closing assembly end, to form the snakelike cloth of power distributed architecture and closing assembly Put.

2. cut closure apparatus according to claim 1, the first transverse edge of wherein each plate include the interior of each plate The inward flange face each other at edge, wherein each plate.

3. cut closure apparatus according to claim 2, wherein the plurality of closing assembly is arranged to the left side The inward flange of plate and right panel is pulled together, to compress the otch covered by the cut closure apparatus.

4. cut closure apparatus according to claim 1, the second transverse edge of wherein each plate include the outer of each plate The outward flange at edge, wherein each plate is dorsad each other.

5. cut closure apparatus according to claim 1, wherein one or more in the left plate and right panel of the base portion Including elastic matrix.

6. cut closure apparatus according to claim 5, wherein the elastic matrix include elastomer film, Woven fabric, Short fibre fabric, rubber, latex, urethane, polyurethane, silicone or thermoplastic elastomer (TPE) (TPE).

7. cut closure apparatus according to claim 5, wherein the elastic matrix includes fabric, the fabric is by elastic unit Part is weaved and with along first transverse edge or the second transverse edge and across the nonelastic unit for extending laterally therebetween Part.

8. cut closure apparatus according to claim 5, wherein each power distributed architecture include spine and multiple axial directions every The horizontal support piece opened, the spine are located axially adjacent to the first transverse edge placement of the plate, and the plurality of axially-spaced Horizontal support piece it is laterally positioned and extend from the spine towards first transverse edge of the plate.

9. cut closure apparatus according to claim 8, wherein the spine and horizontal support piece be not inflatable by flexibility Material is formed.

10. cut closure apparatus according to claim 8, wherein the power distributed architecture is embedded in the upper surface of each plate Or it is laminated to the upper surface of each plate.

11. cut closure apparatuses according to claim 8, wherein the plurality of closing assembly includes multiple right engagement structures Part, multiple left engagement members and multiple lateral struts, the plurality of lateral struts are by the right engagement member and left combination structure Part remains spaced preset distance, wherein the right engagement member is suitable to the support for being releasably engaged the right panel Part, and the left engagement member is suitable to be releasably engaged the support member of the left plate.

12. cut closure apparatuses according to claim 11, wherein at least some support member in the support member has The chock of one or more in first transverse edge and the second transverse edge, and the engagement member has and connects Receive the groove of the chock.

13. cut closure apparatuses according to claim 11, wherein the lateral struts are adjustably coupled to described connecing At least one of component is closed, to allow the regulation of the preset distance.

14. cut closure apparatuses according to claim 8, wherein the closing assembly includes multiple independent transverse ties Bar, the plurality of independent sway brace are attached at least some horizontal support piece in the horizontal support piece, wherein described Sway brace is arranged to be fastened between horizontal support piece.

15. cut closure apparatuses according to claim 14, wherein the independent sway brace each has being fixed to One end of plate, and the second end for being adjustably attached to another plate.

16. cut closure apparatuses according to claim 15, wherein the second end includes ratch tensioning mechanism.

17. cut closure apparatuses according to claim 1, also including fastened layer, the fastened layer be suitable in the base portion and After the assembly of the closing assembly has been anchored on the otch in patient skin, it is placed on the assembly.

18. cut closure apparatuses according to claim 17, wherein the fastened layer has self-adhering type inner surface.

19. cut closure apparatuses according to claim 17, wherein the fastened layer is configured on the left plate and the right side Extend in one or more in first transverse edge or the second transverse edge of plate.

20. cut closure apparatuses according to claim 17, wherein the fastened layer is bored a hole with one or more, to permit Perhaps otch and the axial tension of surrounding tissue that described fastened layer is positioned in response to the cut closure apparatus and at least portion Divide ground axial tension.

21. cut closure apparatuses according to claim 1, wherein left power distributed architecture is by every a pair axially adjacent left sides Closing assembly end is coupled in the left plate.

22. cut closure apparatuses according to claim 1, wherein right power distributed architecture is by every a pair axially adjacent right sides Closing assembly end is coupled on the right panel.

23. cut closure apparatuses according to claim 1, wherein the tissue adhension lower surface adheres to material comprising hydrophilic Material.

24. cut closure apparatuses according to claim 23, wherein the hydrophilic adhesion material includes hydrocolloid, water-setting One or more in glue, acrylate copolymer or Polyethylene Glycol.

25. cut closure apparatuses according to claim 1, wherein the plurality of left power distributed architecture and right power distributed architecture At least one of power distributed architecture be C-shaped.

26. cut closure apparatuses according to claim 25, wherein the C-shaped power distributed architecture includes axial component and horizontal stroke To part, the axial component is used to limiting axially expanding for the left plate or right panel, and the lateral part is used to limit institute State the lateral magnification of left plate or right panel.

A kind of 27. cut closure apparatuses, which includes：

Base portion, which includes left plate and right panel, and each plate has tissue adhension lower surface, upper surface, interior transverse edge and outer horizontal stroke To edge；

Left power distributed architecture and right power distributed architecture, which is correspondingly coupled to the left plate and right panel, wherein each power distribution knot Structure includes multiple axially spaced axial supports, and each support member has distal attachment point and proximal attachment point；And

Distal attachment point on multiple sway braces, wherein axial support of each sway brace in the left plate with it is described Extend between axially aligned proximal attachment point on right panel, to form the snakelike arrangement of axial support and sway brace, its Described in sway brace each have and be fixed to an end of an attachment point, and be adjustably attached to another institute The second end of attachment point is stated, so as to allow the sway brace after the plate adheres to tissue by the left plate and right panel It is pulled together.

28. cut closure apparatuses according to claim 27, wherein the plurality of sway brace be arranged to will be described The inward flange of left plate and right panel is pulled together, to compress the otch covered by the cut closure apparatus.

29. cut closure apparatuses according to claim 27, wherein each in the left plate and right panel of the base portion It is individual including elastic matrix.

30. cut closure apparatuses according to claim 29, wherein the elastic matrix includes elastomer film, knits Thing, short fibre fabric, rubber, latex, urethane, polyurethane, silicone or thermoplastic elastomer (TPE) (TPE).

31. cut closure apparatuses according to claim 30, wherein the elastic matrix includes fabric, the fabric is by elasticity Element is weaved and with along the interior transverse edge or outer transverse edge and across the inelastic component for extending laterally therebetween.

32. cut closure apparatuses according to claim 27, wherein each power distributed architecture are located axially adjacent to the plate Inward flange is disposed.

33. cut closure apparatuses according to claim 27, wherein each power distributed architecture are located axially adjacent to the plate Outward flange is disposed.

34. cut closure apparatuses according to claim 27, wherein each power distributed architecture are axially disposed in the plate Between inward flange and outward flange.

35. cut closure apparatuses according to claim 27, wherein the power distributed architecture and sway brace are comprising flexibility Not expandable material.

36. cut closure apparatuses according to claim 35, wherein the power distributed architecture is embedded in the upper surface of each plate In or be laminated to the upper surface of each plate.

37. cut closure apparatuses according to claim 27, wherein each sway brace are regularly attached an end To an attachment point, and the lock being releasably attached at another attachment point, wherein the sway brace and lock are together Form ratch tensioning mechanism.

38. cut closure apparatuses according to claim 27, also including fastened layer, the fastened layer be suitable in the base portion and After the assembly of the closing assembly has been anchored on the otch in patient skin, it is placed on the assembly.

The 39. cut closure apparatuses according to claim 38, wherein the fastened layer has self-adhering type inner surface.

The 40. cut closure apparatuses according to claim 38, wherein the fastened layer is configured on the left plate and the right side Extend in one or more in the described interior transverse edge or outer transverse edge of plate.

The 41. cut closure apparatuses according to claim 38, wherein the fastened layer is bored a hole with one or more, to permit Perhaps otch and the axial tension of surrounding tissue that described fastened layer is positioned in response to the cut closure apparatus and at least portion Divide ground axial tension.

42. cut closure apparatuses according to claim 27, wherein the tissue adhension lower surface is adhered to comprising hydrophilic Material.

43. cut closure apparatuses according to claim 42, wherein the hydrophilic adhesion material includes hydrocolloid, water-setting One or more in glue, acrylate copolymer or Polyethylene Glycol.

44. cut closure apparatuses according to claim 27, wherein the axial support is C-shaped.

45. cut closure apparatuses according to claim 44, wherein the C-shaped axial support includes axial component and horizontal stroke To part, the axial component is used to limiting axially expanding for the left plate or right panel, and the lateral part is used to limit institute State the lateral magnification of left plate or right panel.