CN109077767A

CN109077767A - Surgical incision and closure equipment

Info

Publication number: CN109077767A
Application number: CN201811248784.4A
Authority: CN
Inventors: 埃米尔·贝尔森; 埃里克·斯托内; 艾伦·斯切尔; 潘卡杰·瑞斯; 柳庆郎; 一柳庆一郎; 彼得·达瓜尼; 卢克·克劳森
Original assignee: Qi Pulin Pharmaceuticals
Current assignee: Qi Pulin Pharmaceuticals; Zipline Medical Inc
Priority date: 2013-07-24
Filing date: 2014-02-14
Publication date: 2018-12-25
Also published as: KR102223703B1; KR101826450B1; KR20180091968A; EP3024401A1; EP3024401A4; KR20210010950A; JP2018114382A; JP6924809B2; KR20170104670A; AU2019204693A1; KR102354693B1; KR102008155B1; AU2014293653B2; AU2014293653A1; CN105578972B; JP2020036973A; WO2015012887A1; JP7216160B2; KR20160037186A; JP2021184806A

Abstract

The present invention discloses a kind of cut closure instrument, including first substrate, and for being adhered to the first side of notch or wound, first substrate includes a upper surface and a tissue adhension lower surface；The second substrate, for being adhered to second side opposite with the first side of notch or wound, the second substrate includes a upper surface and a tissue adhension lower surface；The supporting element that a longitudinal gap is opened more than first is coupled to the upper surface of first substrate；The supporting element that a longitudinal gap is opened more than second is coupled to the upper surface of the second substrate；And multiple sway braces, first substrate and the second substrate is coupled to each other.Each sway brace has a first end and a second end, first end is permanently fixed relative to the supporting element of first substrate, second end reversibly and is adjustably connected to the laterally opposed supporting element of the second substrate, to allow sway brace to be laterally pulled together first substrate and the second substrate, to compress the notch or wound that are covered by cut closure instrument.

Description

Surgical incision and closure equipment

The application be the applying date be on 2 14th, 2014, application No. is 201480050158.8, entitled " surgeries The divisional application of the Chinese invention patent application of notch and closure equipment ".The Chinese invention patent application is that application No. is PCT/ The National Phase in China application of the PCT application of US2014/016587.

Cross reference to related applications

This PCT application requires the 61/889,569 (attorney of U.S. Provisional Application No. for being filed on October 11st, 2013 Reel number 35383-712.101), be filed in the 61/958,259 (attorney docket of U.S. Provisional Application No. on July 24th, 2013 Number 35383-710.101) and it is filed in the 61/958,254 (attorney docket of U.S. Provisional Application No. on July 24th, 2013 Number 35383-711.101) equity, the complete disclosure of above-mentioned provisional application is incorporated by reference into this.

Present context is related to being filed in (the agency of U.S. Patent Application No. 13/665,160 on October 31st, 2012 People file number 35383-709.501), it is 13/286, the 757 (generation of U.S. Patent Application No. for being filed on November 1st, 2011 Manage people file number 35383-709.201) continuation-in-part application, the complete disclosure of above-mentioned application is incorporated by reference into In this.

Present context is related to being filed on 2 14th, 2014 Co-pending U.S. Patent Applications number 14/180, 524 (attorney number 35383-712.201) and it is filed on 2 14th, 2014 Co-pending U.S. Patent Applications Numbers 14/180,564 (attorney number 35383-709.502), the complete disclosure of the application of above-mentioned co-pending passes through It is incorporated by this.

Background of invention

1. invention field.Present invention relates in general to Medical Devices and method.More particularly the invention relate to Form and be closed the device and method of surgical incision.

It is known including the surgical closure device with right panel and the binding agent based patch of left plate.Institute of the present invention Such device of special interest is described in co-pending, jointly owned PCT application US 2010/000430, this application Complete disclosure be incorporated by reference into this.As described in the PCT application, surgery is desirably formed on patient skin Bioadhesive patch is placed at the position of notch.After placing patch, notch is formed along the axis extended through in the middle part of patch. After forming the notch, notch can be opened to carry out desired surgical procedure, and after surgical procedure completion, Ke Yitong It crosses and is pulled together the inward flange of the plate and close incisions with clip, zipper or other enclosed members.

The main target of such surgical closure device is cicatrization caused by improving healing and reducing because of notch.However, This target but obstruction by certain characteristics of currently available device.For example, organization edge is not always equal along a line It gathers together evenly, this can increase final cicatrization.Many such closing devices, which do not have, to be adjusted in organization edge Closing force or closing distance ability, thus limit have been found to reduce cicatrization so that tissue slightly " is wrinkled " Ability.It can include being difficult with the other shortcomings of notch and Wound closure devices, and during subsequent operation plan It can not be adapted to tissue manipulation, that is, sufficiently rigid device often can not be in surgery hand for securely closing tissue for those It is mobile that tissue is adapted in art operating process.

Self-adhering type wound closure patch will appear particular problem when it be used to adhere to below surgical incision drop cloth.This Class drop cloth is used to assist in keeping the aseptic of tissue surface in surgical procedure, and drop cloth can be placed on On the tissue closure patch of first prelocalization.Since surgical incision drop cloth has the adherency lower surface for being adhered to tissue, drop cloth The upper surface of following tissue closure patch will be adhered to.The removal of surgical incision drop cloth is thus often removed and is previously put The tissue closure patch set at least makes its displacement.If any pith of tissue closure patch is removed or displacement, patch Piece is just no longer useful for closure surgical wound.

For these reasons, improved surgical incision closing device and its application method are intended to provide.Offer is provided Such Tncision closing device: it can be adhered to tissue, notch is allowed to be formed, fitted in subsequent surgical operation operating process Should be in the deformation of tissue, and the controlled closure at adjacent tissue edge is provided after surgical procedure.Specifically, expectation is cut While mouth closing device causes the least commitment or stretching of tissue in surgical procedure, it is capable of providing to tissue It the control of closing force on edge and is uniformly distributed.It is also expected to providing such improved surgical incision closing device and its making With method: wherein will resist removal and dislocation when lower section use when the device in surgical incision drop cloth.Hair described below It is bright to realize at least some of these targets target.

2. background technique describes.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.? 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 Publication WO 2011/139912, WO 2011/159623, WO 2011/043786 and WO 2013/ Further surgical closure device is described in 067024, the full content of above-mentioned document is incorporated by reference into this.Commercialization is cut Mouth closing device can be bought from the Ethicon department of Johnson&Johnson, trade name Ethizip^TMInterim abdomen wound Mouth closing device.

Summary of the invention

The present invention provides improved device and method for being closed wound, especially by surgical procedure Wound caused by the incision of progress.Notch will usually be formed on the skin of the patient, such as across abdomen, but one In a little situations, it is also possible on internal organs, in oral cavity, in body cavity etc..

Apparatus and method of the present invention will have the minimum upset to the surgical procedures carried out after notch are made Or interference.In particular, described device and method will allow to cut with the least commitment as caused by the presence of closing device Tissue opposite edges open, stretch and Free Transform.Once however, surgical procedure completion, apparatus and method of the present invention It will provide for being uniformly distributed closing force, so that so that organization edge is pulled in one by the mode that cicatrization minimizes It rises.In particular, the spacing that is slightly moved closer to of the spacing that the closing device initially there are when can be to be formed than notch is by tissue Edge is pulled together, to make organization edge turn up upwards and to lead to " corrugation " that can reduce cicatrization.

Apparatus and method of the present invention will also be able to avoid or reduce when cut closure instrument is used for surgical incision drop cloth Upset when lower section, the surgical incision drop cloth must be moved up from closure instrument and be removed.At at least one of the upper surface of closure instrument Divide upper offer sacrificial layer, wherein sacrificing covering when surgical incision drop cloth to be placed on cut closure instrument and being kept just Position.After notch and surgical procedures are completed, it will pull down surgical incision drop cloth from the skin of patient.Surgical drape is viscous Be attached to sacrifice covering, rather than be adhered to tissue closure instrument and make its dislocation, and only sacrifice covering with drop cloth from Patient pulls down with it, and the rest part for leaving cut closure instrument keeps in situ.

In the first aspect of the present invention, cut closure instrument includes base portion, which includes left plate and right panel.Each plate With tissue adhension lower surface, upper surface, inward flange and outer edge.The tissue adhension lower surface usually will be at least partly Ground is coated with common tissue adhension adhesive, such as those adhesives used in surgical bandage and patch.

Cut closure instrument further include be coupled to each plate power distributed architecture (that is, each plate will have it is coupled thereto At least one power distributed architecture), wherein each power distributed architecture is adapted to allow for the plate axially expanding along inward flange, Lateral magnification over the entire length is limited simultaneously and is axially expanded along outer peripheral.By allowing the plate along inner edge Edge axially expands, and organization edge is by the smallest constraint to allow tissue to be stretched in surgical procedure time-varying Shape.On the contrary, both axially expand by limitation lateral magnification and along outer peripheral, the plate will can be in surgery hand Apply controlled and distribution closing force when the plate is pulled together after art operation is completed, as described in more detail below.

Cut closure instrument further includes closing assembly or assembly, and the closing assembly or assembly are attached to power distribution knot Structure be adhered in the plate opposite sides of cutting part tissue and surgical procedures be completed after will be described The inward flange of plate is pulled together.Each plate of base portion will usually will include at least partly flexible matrix, usually have each It is elastic (that is, plate is evenly stretched in all directions) to the same sex, but optionally have anisotropic elasticity (wherein described Matrix preferentially stretches in one direction or on part of it).The elastic matrix includes elastomer film or piece (for example, poly- Urethane piece or thermoplastic elastomer (TPE) (TPE)), Woven fabric (typically at least in part by elastomer filament, elastomer silk thread or Elastomeric fibre is weaved), short fibre fabric etc..In some embodiments, elastic matrix (elastic matrix) can Including woven by elastic element (usually silk thread, filament, fiber etc.), and have along outer edge dispose and across its Between the fabric of inelastic component that is laterally extended, to provide expansion feature described above relative to power distributed architecture.Also That is, in some cases, power distributed architecture may include being woven in or being otherwise incorporated to nonelastic member in fabric membrane Part is made of such inelastic component.

In general, power distributed architecture will will include the individual component of cut closure instrument, for example including the outer edge with plate The spine of axially adjacent placement and multiple axially spaced-aparts that are laterally positioned and extending from the spine towards the inward flange of plate The horizontal support piece opened.Such " pectination " structure will usually be formed by flexible but nondistensible material, so as to member Part can with the deformation of tissue and together buckling, but will not be stretched along its length, allow them in transverse direction Upper and outer edge along plate provides dimensional stability.The example of such material includes nylon, polypropylene, polyethylene and gathers Carbonic ester or other thermoplastic polymers.It should be noted that power distributed architecture will not restriction plate inward flange axial tension, To provide desired expansivity and adaptability to tissue in surgical procedure.Such individual power distribution Structure is attached to the upper surface of plate, or alternatively embeddable or be stacked in plate.In general, power distributed architecture will not prolong The lower surface of plate is extended into or crosses, so that it will not intervene the adherency of plate to skin or its hetero-organization.

The assembly of substrate and power distributed architecture will be usually carried on removable backing, which is using The adhesive surface of plate is covered and protected before.Backing can be removed so that base portion to be applied to the skin at surgical intervention position Or its hetero-organization.In addition, right panel and left plate will usually be covered by removable auricle, axial bars band or other removables Cover material or structure keep together, so as to when plate is adhered to tissue by the inner surface of plate be maintained at preset distance or Away from.For example, removable auricle can be placed at each axial end of base portion, to be temporarily fastened on two substrates Together.Alternatively, removable band or adhesive tape can be placed in the axial gap between left plate and right panel, in base portion Plate is held in place relative to each other when being adhered to tissue surface.Such auricle or band usually will be self-adhering type, Them are allowed to be fastened to plate, and then correct placement is moved and simply shutting down after tissue in plate It removes.Then covering, auricle or band can be removed, so that plate is formed before surgical incision therebetween and is left in place but not phase Even.

First representative configuration of closing assembly or assembly includes right engagement member, left combination member and multiple transverse directions Pillar, the multiple lateral struts keep the spaced preset distance of engagement member.Right engagement member is suitable for releasable Ground engages its supporting element along the inward flange of right panel, and left engagement member is suitable for releasedly engaging along the inward flange of left plate Its supporting element.In a specific embodiment, at least some of supporting element of power distribution component supporting element, which will have, is located at Chock near inner edges, and engagement member will have the slot for receiving the chock.After surgical intervention completion, Then closing assembly can be placed on power distributed architecture, wherein being located at the chock of side first by an engagement member institute Engagement, and opposite engagement member is then pulled on the chock of opposite side.

Alternatively, closing assembly or assembly may include multiple independent sway braces, the tie-rod is attached at least one A little horizontal support pieces.Such sway brace is configured for being fastened between horizontal support piece, is normally fixed to one On plate and another plate can be adjustably attached to.For illustrative embodiments, can adjustably it be attached End may include ratch tensioning mechanism or similar structure, the ratch tensioning mechanism or similar structure allow right panel with Each sway brace is independently adjusted between left plate with different spacing.In this way it is possible to along the inner edge of right panel and left plate Edge differentially tensioning right panel and left plate, to control and optimize the power applied to the adjacent tissue edge being pulled together.

Optionally, closure instrument of the invention may also include fastened layer, which is suitable in base portion and closing assembly Assembly has been fastened on the notch on patient skin and surgical procedures have been completed to be placed on the assembling later On part.Fastened layer will usually have self-adhering type lower surface, which can be placed on base portion and closing assembly To help to be fastened in place and keep cleaning on assembly.Fastened layer optionally has opening, to allow for observing And close to wound, delivering disinfectant etc..

In still another aspect of the invention, the method for forming notch in the tissue includes providing as described above cut Mouth closure instrument.The right panel and left plate of the instrument are adhered to the skin of patient, and wherein the inward flange of plate is between the distance that preselects It separates, the distance is usually from 0.5mm to 15mm.It is (logical that notch is formed on tissue or skin surface between the inward flange of plate Often be straight line), and then separate incision tissue edge to carry out desired surgical procedures.The inward flange of plate can It stretches and complies with movement and deformation with organization edge, and the outer edge of each plate and lateral extent are dimensionally protected It is fixed to keep steady.After completing surgical procedure, closing assembly is fastened to power distributed architecture retracting the inward flange of plate one It rises.Optionally, closing assembly has organization edge than size that it is more closely pulled together after just forming notch (or adjustable spacing between plates).Tissue, which is pulled together, in this way causes edge to turn up and makes tissue " corrugation ", can subtract in this way Few cicatrization.

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

In order to form snakelike arrangement, left axial support by every a pair of axially adjacent left closing assembly end on a left side Be coupled on plate and/or right axial support by every a pair of axially adjacent right closing assembly end in right panel On be coupled.The left plate and/or right panel can have one or more perforation, and one or more of perforation are placed in Therebetween between the axially adjacent corresponding left and/or right closing assembly end without axial support.It is one or Multiple perforation may include multiple such perforation: it facilitates the substrate in the axial tension of substrate and is separated into substrate segment.

One or more of left substrate or right substrate may include multiple individual substrate segments.At least two left sides are closed Seaming element end or at least two right closing assembly ends can be coupled to each substrate segment.Left substrate may include a multiple left sides Substrate segment, and right substrate may include multiple right substrate segments.The left substrate segment and the right substrate segment can be It is axially offset to one another when applied to notch and surrounding tissue.The multiple closing assembly can be by left substrate segment and right substrate Segment is laterally coupled together to form snakelike arrangement.

One or more of left substrate or right substrate may include tissue adhension lower surface, for be adhered to adjacent to The tissue of notch.One or more of left substrate or right substrate may include lower adhesion layer and upper layer, the lower adhesion layer packet The tissue adhension lower surface is included, and the upper layer includes upper surface.It upper layer can be harder than lower adhesion layer.Lower adhesion layer can With with enough elasticity, so that when covering notch and surrounding tissue due to being laterally adjacent to the Tncision closing device Tissue movement and caused by blistering and adhesion loss minimize.The adherency lower layer may include hydrophily adhesion material. The hydrophily adhesion material may include one of hydrocolloid, hydrogel, acrylate copolymer or poly(ethylene glycol) or more Kind.The upper layer may include rubber, latex, urethane, polyurethane, silicone, thermoplastic elastomer (TPE) (TPE), Woven fabric or One of short fibre fabric is a variety of.Left closing assembly end, right closing assembly end, left axial support or right axle are to branch One or more of support member can be embedded in the upper surface of left substrate and right substrate or be laminated to left substrate and right substrate Upper surface.

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

The multiple 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 notch and surrounding tissue does not make capped notch substantially It is expanded with surrounding tissue.It therefore, can be with the movement in the laterally adjacent the first tissue region in periphery of the Tncision closing device It is essentially converted to and the periphery is laterally adjacent and identical with the opposite minor microstructure region in the first tissue region Movement.

One or more closing assemblies in the multiple closing assembly may include tie-rod, which couples securely Extremely left closing assembly end or right closing assembly end, and it is adjustably attached to opposite closing assembly end.The phase Pair closing assembly end may include ratch tensioning mechanism.

The multiple closing assembly can be configured for for the inward flange of left substrate and right substrate being pulled together, with compression The notch covered by the cut closure instrument.

One or more of the multiple left axial support or the multiple right axial support can be C-shaped.Institute Stating C-shaped left and/or right axial support can respectively include axial component and lateral part, and the axial component is for limiting Corresponding substrate axially expands, and the lateral part is used to limit the lateral magnification of corresponding substrate.

The system that the notch for being closed in tissue can also be provided in this aspect of the invention.The system may include institute Tncision closing device and flexible covers are stated, the flexible covers are for covering the Tncision closing device and capped Notch 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 Covering can have one or more perforation, to allow the covering in response to being covered by the Tncision closing device Notch and surrounding tissue axial tension and be at least partly axially stretched.One or more of perforation can be along covering The central axis of cover material disposes.Covering may include one or more strenthening members, one or more of strenthening members It is coupled at least part of the adhesion layer of the covering.Strenthening member may include rubber, latex, urethane, polyurethane, One of silicone, thermoplastic elastomer (TPE) (TPE), Woven fabric or short fibre fabric are a variety of.Covering may include hydrophily Adhesion layer, the hydrophily adhesion layer may include one of hydrocolloid, hydrogel, acrylate copolymer or poly(ethylene glycol) Or it is a variety of.

In still another aspect of the invention, a kind of cut closure instrument is provided.The cut closure instrument includes flexible adhesive Bottom, middle layer and top layer.The flexible adhesive bottom can have the first elasticity.The middle layer can be coupled to and cover institute At least part of flexible adhesive layer is stated, and there is the second elasticity for being less than first elasticity.The top layer can be coupled to And at least part of the middle layer is covered, and there is the third elasticity for being less than second elasticity.It is described flexible viscous Tension gradient between attached bottom and the top layer can provide enough rigidity for the cut closure instrument, so that working as The movement for the tissue for being laterally adjacent to the instrument when covering notch and surrounding tissue does not make capped notch and week substantially Enclose tissue bulking.

The tension gradient can provide enough elasticity for cut closure instrument, so that when covering notch and surrounding Blistering and adhesion loss as caused by the movement of the tissue adjacent to the instrument minimize when tissue.

Cut closure instrument can be in response to the axial direction by cut closure the instrument notch covered and surrounding tissue It stretches and is flexible in the axial direction.The movement in adjacent the first tissue region can be basic with the periphery of flexible adhesive bottom On be converted into and flexible adhesive bottom periphery it is adjacent and identical with the opposite minor microstructure region in the first tissue region Movement.

Flexible adhesive bottom may include hydrophily adhesion material.The hydrophily adhesion material may include hydrocolloid, One of hydrogel, acrylate copolymer or poly(ethylene glycol) are a variety of.

The upper layer may include rubber, latex, urethane, polyurethane, silicone, thermoplastic elastomer (TPE) (TPE), knit One of object or short fibre fabric are a variety of.

Flexible adhesive bottom may include the first adhesion sublayer and the second adhesion sublayer.Middle layer may include being coupled to First upper layer of first adhesion sublayer and the second upper layer for being coupled to second adhesion sublayer.Top layer may include more A axial support structure and be coupled to the axial support structure multiple lateral closing assemblies arrangement, for by described the One adhesion sublayer and first upper layer are fastened to second adhesion sublayer and second upper layer.The multiple axial branch Support structure and the multiple closing assembly can be coupled to each other to form serpentine pattern, for allowing the lower adhesion layer or institute One or more of middle layer is stated to draw in response to the notch and the axial of surrounding tissue covered by the Tncision closing device It stretches and is at least partly stretched on the axial direction of the closing device.The multiple axial support structure and the multiple Lateral closing assembly can be coupled to each other to form scalariform pattern.The multiple axial support structure or the multiple transverse direction are closed One or more of seaming element can be formed by flexible not expandable material.The multiple transverse direction closing assembly can be configured to use After being adhered to the tissue of opposite sides of notch in flexible adhesive bottom, first adhesion sublayer or second are adhered to The inward flange on one or more of bottom and first upper layer or the second upper layer is pulled together.The transverse direction closed group One or more of part may include left-end point, right end and tie-rod, and the tie-rod is coupled to the left-end point securely Or right end and it is adjustably attached to opposite end.The multiple axial support structure or the multiple laterally closure One or more of component can be embedded in first upper layer and the second upper layer or be laminated to first upper layer and Two upper layers.

The system that the notch for being closed in tissue can also be provided in this aspect of the invention.The system comprises described Cut closure instrument and flexible covers, the flexible covers are for covering the cut closure instrument and capped cutting Mouth and surrounding tissue.

Flexible covers can be configured to extend on the transverse edge of the flexible adhesive bottom and axial edge.Institute Stating covering can have one or more perforation, to allow the covering in response to being covered by the cut closure instrument The notch of lid and the axial tension of surrounding tissue and at least partly stretched on the axial direction of the covering.Described one A or multiple perforation can be disposed along the central axis of covering.Covering may include one or more strenthening members, One or more of strenthening members are coupled at least part of the adhesion layer of the covering.The strenthening member can be with Include one of rubber, latex, urethane, polyurethane, silicone, thermoplastic elastomer (TPE) (TPE), Woven fabric or short fibre fabric Or it is a variety of.Covering may include hydrophily adhesion layer.The hydrophily adhesion layer may include hydrocolloid, hydrogel, third One of olefin(e) acid polymer or poly(ethylene glycol) are a variety of.

In still another aspect of the invention, a kind of cut closure instrument is provided.The cut closure instrument may include having the One elasticity lower part, be less than it is described first elasticity 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 instrument, so that working as The movement for the tissue that covering notch and when surrounding tissue are laterally adjacent to the instrument do not make substantially capped notch and Surrounding tissue expansion.The tension gradient can provide enough elasticity for the cut closure instrument, so that when covering is cut Blistering and adhesion loss as caused by the movement for the tissue for being laterally adjacent to the instrument minimize when mouth and surrounding tissue.

In still another aspect of the invention, a kind of cut closure instrument is provided.The cut closure instrument 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 group Knit adherency lower surface, upper surface, the first transverse edge, the second transverse edge.The left power distributed architecture and right power distributed architecture The left plate and right panel can be correspondingly coupled to.Each power distributed architecture may be adapted to allow the plate along described first One of transverse edge or the second transverse edge axially expand, and be suitable for limiting lateral magnification across the plate and along Opposite transverse edge axially expands.The multiple closing assembly can be fastened to the left plate and right panel, in the plate The plate is pulled together by the notch for being adhered to tissue and being formed therebetween later.

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

Second transverse edge of each plate may include the outer edge of each plate.The outer edge of each plate can be backwards to that This.

One or more of the left plate of base portion and right panel may include elastic matrix.The elastic matrix may include Elastomer film, Woven fabric or short fibre fabric.The elastic matrix may include woven by elastic element, and have edge First transverse edge or the second transverse edge and across the fabric for the inelastic component being laterally extended therebetween.

Each power distributed architecture may include the spine for being located axially adjacent to first transverse edge placement of the plate, And multiple axially-spaced transverse directions that are laterally positioned and extending from the spine towards first transverse edge of the plate Supporting element.The spine and horizontal support piece can be formed by flexible not expandable material.The power distributed architecture can be embedded in In the upper surface of each plate or it is laminated to the upper surface of each plate.

Closing assembly may include right engagement member, left engagement member and multiple lateral struts, the multiple laterally branch Column keeps the spaced preset distance of engagement member.The right engagement member may be adapted to be releasably engaged right panel Supporting element, and the left engagement member may be adapted to the supporting element for being releasably engaged left plate.In the supporting element at least Some supporting elements can have the chock close to one or more of first transverse edge or the second transverse edge, and And the engagement member can have the slot for receiving the chock.The lateral struts can be adjustably coupled to described connect At least one of component is closed, to allow the adjusting of the preset distance.The closing assembly may include multiple independent cross To tie-rod, the multiple independent sway brace is attached at least some of horizontal support piece horizontal support piece.It is described Sway brace can be configured for being fastened between horizontal support piece.The independent sway brace, which can respectively have, to be fixed To an end of plate, and it is adjustably attached to the second end of another plate.The second end may include that ratch is drawn Tight mechanism.

The cut closure instrument can also include fastened layer, which is suitable in the base portion and the closed group After the assembly of part has been anchored on the notch on patient skin, it is placed on the assembly.The fastened layer can be with With self-adhering type inner surface.

Detailed description of the invention

Fig. 1 is the exploded view of the cut closure instrument of principle building according to the present invention.

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

Fig. 3 is the sectional view intercepted along the line 3-3 of Fig. 2.

Fig. 4-Fig. 7 is illustrated using cut closure instrument of the invention and is formed and be closed the notch in patient skin.

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

Fig. 9 is the exploded view of the further embodiment of the cut closure instrument of principle building according to the present invention.

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

Figure 11 A and Figure 11 B illustrate the alternative sway brace construction used in the instrument of Fig. 1 or Fig. 9.

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

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

Figure 14 A1- Figure 14 A3 is the saturating of the further embodiment of the cut closure instrument of principle building according to the present invention View.

Figure 14 B is according to the present invention similar to the cut closure instrument of Figure 14 A1- Figure 14 A3 and is placed in subject's knee The top view of the cut closure instrument covered.

Figure 15 A shows principle, cutting with the pulley system to two adjacent substrates of transverse coupling according to the present invention The schematic diagram of mouth closure instrument.

Figure 15 B shows the sectional view of the cut closure instrument of Figure 15 A.

Figure 15 C show according to the present invention, the cut closure instrument of Figure 15 A that is placed on model knee.

Figure 15 D shows the schematic diagram of cut closure instrument similar with the cut closure instrument of Figure 15 A.

Figure 15 E and Figure 15 F respectively illustrate various for being used together with Figure 15 A with the cut closure instrument of Figure 15 D Sway brace assembly structure.

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

Figure 17 shows principle according to the present invention, for the linkwork of cut closure instrument.

Figure 18 is principle, similar to the cut closure instrument of Figure 14 A and be placed on subject's knee according to the present invention The top view of cut closure instrument.

Figure 19 shows cut closure instrument according to the present invention, including single substrate segment pair.

Figure 20 A shows principle, cut closure device similar with the cut closure instrument of Fig. 9 and Figure 10 according to the present invention The perspective view of tool.

Figure 20 B shows the enlarged view of the sway brace assembly of the cut closure instrument of Figure 20 A.

Figure 21 shows the exploded view of a part of the cut closure instrument of Figure 20.

Figure 22 A shows the perspective of covering in accordance with the principles of the present invention, for cut closure instrument disclosed herein Figure.

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

Figure 23 A shows the covering of cut closure instrument and Figure 22 A in accordance with the principles of the present invention, including Figure 21 The exploded view of cut closure instrument assembly.

Figure 23 B shows the perspective view of the cut closure instrument assembly for Figure 23 A being adhered on patient skin.

Figure 23 C shows the top view of the elastomer reinforcing layer of the covering of Figure 22 A.

Figure 24 A shows the cut closure instrument group of Figure 23 A that is in accordance with the principles of the present invention, being adhered on patient skin The perspective view of piece installing.

Figure 24 B shows the cut closure instrument of Figure 23 A that is in accordance with the principles of the present invention, being adhered on patient skin Diagrammatic cross-section.

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

Figure 26 A- Figure 26 E illustrates covering in accordance with the principles of the present invention, for wound dressing and cut closure instrument Embodiment.

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

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

Figure 29 illustrates principle, another sacrifice covering being positioned on cut closure instrument according to the present invention.

Specific embodiment

Device and method of the invention, which will be used in, makes patient skin or its hetero-organization during outer section's surgical procedure Surgical incision formation and closing course in.As described below, the direction of notch will limit " axial direction " used herein (axial) and the direction " transverse direction " (lateral).Most of notch will be made along substantially straight line, which will limit Axial direction.Transverse direction will be substantially across axial direction, usually but not necessarily perpendicular or normal to axial direction.Greatly Most notch will be generally linear, but notch may be curved or with other geometries in some cases. Term " axial direction " then would be appropriate for use in the direction for being in the notch of any specific location, to generate also transformable cross To direction.

With reference to Fig. 1-Fig. 3, cut closure instrument 10 includes base portion assembly 12, which includes right panel 14 With left plate 16.Right power distributed architecture 18 is fastened to right panel 14, usually and power distributed architecture to be laminated to the upper surface of plate Fastening；And left power distributed architecture 20 is similarly attached to the upper surface of left plate 16.Cut closure instrument further includes closing assembly 22, which can be removably attachable to right power distributed architecture 18 and left power point as described in more detail below Cloth structure 20 is so as to close incisions, and the instrument further includes optional fastened layer 24, which can be in combination Base portion assembly 12 and closing assembly 22 have been secured to patient and have been pulled together the plate by using closing assembly And make to be placed on the base portion assembly 12 and closing assembly 22 of combination after cut closure.

Closing assembly 22 be intended to and be suitable for by the interior section of power distributed architecture 18 and power distributed architecture 20 inwardly that This drawing, to be closed the surgical incision formed therebetween.In the embodiment shown, by power distributed architecture 18 and power point Multiple chocks 26 are formed on the horizontal support piece 36 that the spine 37 of cloth structure 20 axially retains.Chock 26 is accepted in slot 38, The slot 38 is formed along the inward flange of the opposite engagement member 40 of closing assembly 22.The opposite engagement member 40 by Lateral struts 42 keep together, to make distance that engagement member is kept fixed, spaced (in other embodiment party In formula, spacing distance can be adjustable).Slot 38 can be preferably formed in flexible ear laminated structure 44, this permission The slot is pulled up, on corresponding chock so that closing assembly 22 is anchored on power distributed architecture 18 and power distributed architecture On 20.

The lower surface 32 of each plate 18 and 20 will usually be covered with pressure response adhesive, wherein described adhesive Initially covering matcoveredn 48, the protective layer 48 can be removed just before the use.It is furthermore possible to also provide be pulled away from auricle 50 or Other similar structure, so as to after removed layer 48 and by plate be adhered to patient skin or other tissue surfaces it Preceding distance at a predetermined interval keeps together right panel 14 and left plate 16.Importantly, being connect as far as possible with original object spacing Near-earth keeps the distance between the inward flange 28 of each plate 14 and 16, so that organization edge will when being closed by closing assembly 22 It can accurately be gathered together, usually slightly be turned up.

Referring now to Fig. 4 to Fig. 7, it will description is in accordance with the principles of the present invention, is used to form notch and cuts in subsequent closure The scheme of mouth.Firstly, as shown in Figure 4, right panel 14 and left plate 16 are placed on the patient skin marked by reference letter S. Plate 14 and plate 16 are applied and being pulled away from protective layer 18 first and plate is placed into tissue, auricle can be removed after this 50, to leave the kerf path 52 being defined between inward flange 28.The spacing of inward flange 28 will be selected in order to provide solid Fixed predetermined distance d₁。

Right panel 14 and left plate 16 in place after, as shown in Figure 5, can be used scalpel or other surgery cuts dress Set formation notch I in the space of CD between the plates.

After making notch I, as shown in Figure 6, surgical operation behaviour can be carried out by beating scalloping inward flange Make, this transfers to deform right panel 14 and the inward flange of left plate 16 28.Since the most inner side end of supporting element 36 is not connected, because This they can be freely separating and allow right panel 14 and the elastic matrix of left plate 16 to expand, as being clearly shown in Fig. 6.However, The dimensional stability of the rest part of plate will be kept by horizontal support piece 36 and axial ridges 37, the horizontal support piece 36 and axial ridges 37 will not be extended under the influence of by stretching open power that notch applied.

As shown in Figure 7, after surgical procedures completion, closing assembly 22 will be fastened onto power distributed architecture 18 and power distributed architecture 20 on.Specifically, the slot 38 in ear laminated structure 44 is engaged on opposite chock 26, so as to The opposite edges of the opposite edges of plate and tissue cut are pulled together.It, can be with by the depth for the fluting 38 that is properly spaced Adjust closing assembly 22, so as to by plate 14 and plate 16 with preselected distance d₂It gathers together.In general, distance d₂It will be less than just Begin interval d₁, the inward flange of tissue to be gathered together to cause organization edge slightly to be turned up along notch and (rise upwards Wrinkle), healing can be improved in this way and reduce cicatrization.

Optionally, as shown in Figure 8, closing assembly 22' may include engagement member 40', wherein passing through adjustable buckle Hook or other mechanisms 54 link an end of each lateral struts 42', so as to adjust opposite engagement member 40''s The distance between inward flange, to increase or reduce distance d therebetween₂。

The alternate embodiment 100 of cut closure instrument of the invention is illustrated in figure 9 and in figure 10.Instrument 100 includes Base portion assembly 102, the base portion assembly 102 have right panel 104 and left plate 106.If being best shown in Figure 10, positioning or Aligned stripes 108 are provided for tightening together the inward flange of each plate, and positioning or aligned stripes 108 include end Hold auricle 109, the end auricle 109 allows user in plate 104 and plate 106 after being in place on tissue surface The band is pulled out from the plate.

Cut closure instrument 100 further includes backing 110, which has the end that can partly turn back, will under The adherency backing in face is exposed on the plate, and allows the end of base portion assembly 102 being adhered to tissue, while making base The rest part of portion's assembly is still covered by the backing.The fastened layer 112 including reinforcing frame 113 is provided, in base Portion's assembly 102 is placed on right panel 104 and left plate 106 after closure on notch, this generally contacts previously implementation Mode describes.In general, will provide for keeping pallet 114, for aseptically the component of instrument to be kept together, Middle pallet 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, which is embedded in or is laminated to base portion band 121.Snakelike axial ridges 120 will usually be formed by elastoplastic flexible (usually duroplasts), and base portion band 121 will include polyurethane or similar plastic layer.The lower surface of layer of polyurethane will be covered with hydrocolloid layer, for tissue Adherency.The structure of left power distributed architecture 118 will be identical, including left axial ridges 124, left horizontal support piece 126 and a left side Base portion band 127.

As shown in Figure 9, cut closure instrument 100 will will include close mechanism, which includes multiple transverse ties Bar assembly 128.As in Figure 10 best seen from each sway brace assembly 128 will will include bar and ratch mechanism 132, institute It states bar and is anchored on left horizontal support piece 126 an end, and the ratch mechanism 132 is fastened to right horizontal support piece 122. Each bar 130 will be usually aligned with the axis of 106 part of left plate, so that the gap 129 between right panel 104 and left plate 106 will It can keep unlimited, so as to make notch therebetween.After making notch, it will each bar 130 is drawn and arrives right panel 104 Upper associated ratch 132.A series of ratch rings on each bar will be pulled in associated ratch mechanism 132, and after And the bar laterally is pulled, until being applied with desired closure tension along the point of base portion assembly 102.It is particularly advantageous Place is, can individually adjust each sway brace assembly 128, so as to along the length for the notch being closed across group Knit the desired closure tension of supply.Once desired closure tension is provided along entire notch, it can be by fastened layer 112 are placed on base portion assembly 102, and the instrument and tissue are kept in place.

Referring now to Figure 11 A and Figure 11 B, the alternative design of sway brace assembly 140 of the invention is shown in figure. These sway brace assemblies 140 can be used together with previously described any of cut closure instrument 10 or 100.Often A sway brace assembly 140 includes right power distributed architecture 142 and left power distributed architecture 144.Right power distributed architecture includes right ridge Portion 146 and multiple horizontal support pieces 148.Though it is shown that three horizontal support pieces, it is to be understood that, can also include 4, 5,6 or more horizontal support pieces.Left spine 150 and multiple left cross-braces is similarly included in left power distributed architecture 144 Part 152.In order to provide closure, right power distributed architecture 142 includes the bar 154 extended from center horizontal support piece 148.In general, Bar 154 is linked to the supporting element by actively or passively connecting piece 158.Pull ring 156 is provided in the free terminal of bar 154, and Multiple ratchets 162 are provided along the middle section part of bar 154.

Left power distributed architecture 144 includes ratch mechanism 160, which is suitable for receiving the bar of right power distributed architecture Tooth 162 on 154.In this way, bar 154 can be made to fall into soldered tooth 162 in ratch 160, to allow to push institute forward Bar is stated, so that right power distributed architecture 142 and left power distributed architecture 144 to be pulled together, to apply tension 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 instrument 100, wherein illustrating only right panel 104 and left plate 106 and right power distributed architecture 116 and left power distributed architecture 118.Remaining System component is not shown for the ease of illustration.

Right panel 104 is covered by right sacrifice covering 170, and left plate 106 is covered by left sacrifice covering 172.It is right Plate 104 and left plate 106 can be with limited areas 175, and right sacrifice covering 170 and left sacrifice covering 172 are by right panel wherein 104 and left plate 106 separate.Covering 170 and 172 is respectively removably fastened along each edge of associated substrate, is made It is former in normal processing of the cut closure instrument 100 on the tissue surface to be cut and holding in placement process to obtain covering Position.These uses and purposes for sacrificing covering 170 and 172 are described with reference to Figure 13 A and Figure 13 E.

Figure 13 A illustrates right panel 104 and left plate 106 in place on tissue surface T before making notch.Right panel 104 It is covered by right sacrifice covering 170, and left plate 106 is covered by left sacrifice covering 172.Such as it is common in many surgeries In operation like that, adherency surgical incision drop cloth 180 is placed on tissue surface T.Any conventional drop cloth can be used, such as may be used The Ioban bought from the 3M of Minnesota State St.Paul^TMAntimicrobial notch drop cloth.

After notch drop cloth 180 is in place on cut closure instrument, surgical incision I can be made for it is expected Surgical intervention.As seen in the figure, it can be correspondingly cut into right panel 104 and left plate 106 across surgical drape 180 Notch I.After completing surgical procedures, it will remove surgical drape 180 from tissue surface T.Since surgical drape has Lower adhesive surface, therefore before making the present invention, the removal of drop cloth may make any of right panel 104 and left plate 106 or whole The two displacement.However, the presence of sacrificial layer 170 and sacrificial layer 172 prevents such displacement.The removal of surgical drape 180 will Sacrificial layer 170 and sacrificial layer 172 can be removed, but since each layer in these layers is configured for relatively low point Removal from power dialysis, therefore sacrificial layer will not result in following plate 104 or plate 106 and be shifted.Therefore, plate 104 and plate 106 will stay put as shown in Figure 13 D, and as shown in Figure 13 E, can be distributed as previously described using power Structure 116 is together with power distributed architecture 118 is by plate closing so as to close incisions.

With reference to Figure 29, right sacrifice blanket layer 170 and left sacrifice blanket layer 172 can each free urethane film (for example, 0.001 " is thick) it is built-up.The middle part of urethane piece can be adhered to the top of right panel 104 and left plate 106, and power is distributed and is tied Structure 116, power distributed architecture 118 and any band 130 and lock 132 are assembled on urethane piece.Then urethane piece can be twined It is wound on power distributed architecture 116, (and band 130 can curve inwardly as shown in Figure 29, make around power distributed architecture 118 Them are obtained to be comprised on plate 106), wherein the free terminal of urethane piece is stacked on one another along its length.Therefore, it can will urinate Alkane piece is wrapped in power distributed architecture 116, power distributed architecture 118 and closure member 130, on closure member 132, to protect it From surgical drape 180 influence.Urethane piece preferably includes multiple perforation, and the multiple perforation is disposed along its length, And it is aligned with each plate 104, the inward flange 104e of plate 106 and outer edge 106e.The perforation, which can permit, is removing surgery When drop cloth (for example, surgical drape 180 as described herein), urethane piece is torn with surgical drape 180 in a controlled manner.Perforation can It is preferably built-up by the notch of 3mm and 1mm tie-rod, but definite size can be changed also to control desired tear edge.It wears Hole can be formed along single ordinate or multiple lines.Multiple longitudinal direction perforation lines can permit reliable separation, regardless of in surgery Drop cloth and sacrificial layer 170, sacrificial layer 172 adherency in variation.Perforation can be made for more easily close to plate 104, A possibility that being unclamped in place of 106 edge, the separation at edge 104e, 106e of close plate 104, plate 106 improved with help, And it minimize the extra urethane left.It, can by auricle in order to help sacrificial layer 170, sacrificial layer 172 to lift 170t, auricle 172t are adhered to each end of the urethane packet comprising sacrificial layer 170, sacrificial layer 172.Auricle 170t, auricle 172t can be preferably glued to the inside of the upper surface of urethane packet.Auricle 170t, auricle 172t can be shaped to prevent urethane To its own adherency or adherency from the adhesive to any ends exposed from each plate 104, plate 106.Each plate 104, The pre- fracture of the perforation of the end of plate 106 can help to auricle 170t, auricle 172t initially lifts and user couple The initiation of tearing.

Referring now to Figure 14 A1- Figure 14 A3, the further embodiment of cut closure instrument is shown in figure.Base portion group Piece installing 1400a (Figure 14 A1), base portion assembly 1400b (Figure 14 A2) and base portion assembly 1400c (Figure 14 A3) can respectively include Right substrate 1402 and left substrate 1404.Right substrate 1402 may include upper layer 1406 and lower layer 1408.Similarly, left substrate 1404 It may include upper layer 1410 and lower layer 1412.Upper layer 1406,1410 will be usually flexible, but hard enough, with securely Closure tissue simultaneously minimizes the upset to notch and surrounding tissue.Upper layer 1406,1410 may include plastic layer, the plastic layer It is made of rubber, latex, polyurethane, silicone, thermoplastic elastomer (TPE), Woven fabric, short fibre fabric or similar material.Adherency Bottom 1408,1412 will be usually flexible, and more flexible than upper layer 1406,1410, with follow following skin and Any movement of tissue, to keep adhering to, blistering is made to minimize and in addition to this reduce stimulation.Adhesion sublayer 1408, 1412 may include hydrophily adhesion material, hydrocolloid, hydrogel, acrylate copolymer, poly(ethylene glycol) 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 being applied on notch, and can assemble along base portion The axial length of part 1400a, base portion assembly 1400b and base portion assembly 1400c are placed on them.Right substrate 1402 It may include one or more right power distributed architectures or axial support 1414.Each right axial support 1414 may include axial direction Support section or spine 1414a and two cross-brace part 1414b, the cross-brace part 1414b are coupled to spine The axial end of 1414a.Spine 1414a and described two cross-brace part 1414b are formed together C-shaped, and the C-shaped is some It can be axially opened in embodiment to a certain degree, to promote right substrate 1402 in two transverse directions of adjacent supporting piece 1414 Axial tension between adjacent cross-brace part 1414b, while being limited in two cross-braces of single supporting element 1414 Axial tension between the 1414b of part.In many embodiments, C-shaped axial support 1414 only has and is enough to allow vertically The flexibility of flexure, but be it is hard so as to make axial tension and cross directional stretch minimize.As shown in Figure 14 A1, right axle to Supporting element 1414 can be inward-facing.As shown in Figure 14 A2 and Figure 14 A3, right axial support 1414, which can be, to be faced out , this can help to be distributed between right substrate 1402 and left substrate 1404 for any mechanical load of tissue closure Notch I.Similar, left substrate 1404 may include one or more left power distributed architectures or axial support 1416.Each left side Axial support 1416 may include axial support portion or spine 1416a and two cross-brace part 1416b, the cross The axial end of spine 1416a is coupled to support section 1416b.Spine 1416a and described two cross-brace parts 1416b is formed together C-shaped, which can axially open in some embodiments to a certain degree, to promote left substrate 1402 axial tension between two laterally adjacent cross-brace part 1416b of adjacent supporting piece 1416 limits simultaneously Axial tension between two cross-brace part 1416b of single supporting element 1416.In many embodiments, C-shaped axis Only there is the flexibility for being enough to allow vertical deflection to supporting element 1416, but be hard to make axial tension and laterally to draw Stretch minimum.As shown in Figure 14 A1, left axial support 1416 can be inward-facing.Such as institute in Figure 14 A2 and Figure 14 A3 Show, left axial support 1416, which can be, to be faced out, this can help be distributed for any mechanical load of tissue closure Notch I between right substrate 1402 and left substrate 1404.

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 described below.For example, each skirt section 1424,1426 may include 0.001 English The urethane film of very little thickness, the urethane film are coupled to the acryloid cement of 0.002 inch.Adhesive can be applied to skirt section 1424,1426 entire lower surface, or the skirt section 1424,1426 beyond substrate 1402 or substrate 1404 can be applied only to Region.In the building process of substrate in batch piece installing 1400c, skirt section 1424,1426 can correspondingly directly apply to all viscous On attached layer 1408,1412 or part of it.Can correspondingly it come alternately or additionally using skirt section 1424,1426 in film upper layer 1406,1410.Cable release as described herein can be further provided for cross the adherency lower surface in skirt section 1424,1426. Skirt section 1424,1426 can each extend over the outer 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 carries out visualization and/or clean energy to cutting part to improve Power.Therefore, skirt section 1424,1426 can help to provide additional adherency to the adhesion layer 1408,1412 of substrate 1402,1404 Support and/or creep reduce, without being directed at and placing individual covering or covering piece in substrate in batch piece installing 1400. After the fabrication, skirt section 1424,1426 has usually been accurately aligned with relative to substrate 1402,1404.Still this can be used Individual covering or covering piece described in text prevent the play of the component of cutting part and substrate in batch piece installing 1400c. Since skirt section 1424,1426 is laterally extended on substrate 1402,1404 respectively, such individual covering or Covering piece can not need the accurate placement relative to substrate in batch piece installing 1400c, and with other coverings as described herein Or covering piece is compared to can be narrower.

One or more perforation can be provided between the axially adjacent right axial support 1414 on right panel 1402 1418, to promote the axially and/or laterally stretching of right substrate 1402.Perforation 1418 can run through upper layer 1406 and lower layer 1408 To provide ventilation to following tissue, or can be only present on upper layer 1406.It similarly, can be in left plate 1404 One or more perforation 1420 are provided between axially adjacent left axial support 1416, to promote the axial direction of substrate 1402 And/or cross directional stretch.Perforation 1420 can be through upper layer 1410 and lower layer 1412 to provide ventilation, Huo Zheke to following tissue To exist only on upper layer 1410.As shown in Figure 14 A1, can only have between axial support 1414 or 1418 single Perforation 1418 or 1420.As shown in Figure 14 A2 and 14A3, cross can be lined up between axial support 1414 or 1418 Multiple perforation 1418 or 1420 to line.Perforation 1418,1420, which can also reduce, radially outward to be stretched due to skin from notch I Stress caused by (such as, during joint motions or swelling).

For example, can be along right line 1424 shown in Figure 14 B and left line 1426 on right axial support 1414 and/or a left side Multiple perforation 1418,1420 are provided between the axial end of axial support 1416.It can be on each line segment 1424 or 1426 Multiple axially aligned perforation are provided, so that at least the upper layer 1410 of substrate 1402,1404 and lower layer 1412 can be as follows It further describes and is broken into individual segment respectively when being axially stretched like that.In some cases, in the pendant of device 1400 During wearing, perforation 1418,1420 can permit the layer 1406 and 1408 of right panel 1402 and the layer 1410 and 1412 of left plate 1404 It fully separates and separates at perforation line, this shows in Figure 14 A2 and Figure 14 A3.Completely separable and isolated ability into One step allows that skin is axially stretched as needed, wherein by axial support 1414 and 1416 discussed below and closing The connection of seaming element 1422 allows (and limitation) elongation.It as described herein, can be in substrate after notch I closure 1402, application flexibility, compliance covering on 1404.The covering can be further used for providing (and limitation) base portion knot The axial movement of structure 1400b and transverse shifting.Alternatively or in combination, can power distributed architecture or axial support 1414, Transverse cuts and one or more of the right substrate 1402 of separation or left substrate 1404 between 1416, to promote right substrate 1402 And/or the axially and/or laterally stretching of left substrate 1404.

In order to by right substrate 1402 together with left 1404 transverse coupling of substrate and optionally in order to by right substrate 1402 It is tensed against each other with left substrate 1404, base portion assembly 1400 may also include multiple lateral closing assemblies or tie-rod assembling Part 1422.Lateral closing assembly or tie-rod assembly 1422 may include and sway brace assembly 128 and 140 described above Similar ratch mechanism of ratch mechanism.Sway brace assembly 1422 can be by laterally adjacent right axial support 1414 It is coupled with left axial support 1416, usually axially end couples.It is right as shown in Figure 14 A1- Figure 14 A3 The corresponding placement of axial support 1414 and left axial support 1416 on right panel 1402 and left plate 1404 can be staggered Or axial dipole field, and right axial support 1414 and left axial support 1416 can be C-shaped configuration, the C-shaped configuration With the lateral end portions for laterally facing and being aligned (and being connected with each other by sway brace assembly 1422) 1414b,1416b.For example, the remote end lateral part 1414b of the first right axial support 1414 can be with the first left axle to support The proximal end lateral part 1416b of part 1416 is laterally aligned to, the remote end lateral part of the first left axial support 1416 1416b can be laterally aligned to the proximal end lateral part 1414b of the second right axial support 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, with The line of continuous sway brace assembly 1422 and right axial support 1414 and left axial support 1416 is formed, and The line can have snakelike arrangement, and the snakelike arrangement is as shown in Figure 14 A1- Figure 14 A3 laterally across right substrate 1402 and left substrate 1404 (that is, passing through the distance between right substrate 1402 and left substrate 1404).Sway brace assembly 1422 and right axle are to branch The snakelike arrangement of support member 1414 and left axial support 1416 may be implemented following one or more: by base portion assembly 1400 Provided closing force is uniformly distributed on notch；The axial elasticity of (and limitation) base portion assembly 1400 is provided；It and is base Portion assembly 1400a, 1400b and 1400c provide hardness or rigidity with fully close incisions and allow it with minimum It upsets and expands and heal (that is, lateral stability and axial stability are provided).In many embodiments, horizontal support piece 1414,1416 be hard, so that the region of the substrate 1402,1404 not covered with horizontal support piece 1414,1416 stretches. Since these uncovered regions are offset from one another from right substrate 1402 to left substrate 1404, tie-rod assembly 1422 can With with notch I it is axially pivoting from its anchor point by axial tension.Tie-rod assembly 1422 it is such it is axially pivoting can Right substrate 1402 and left substrate 1404 are gathered together closer to ground, to keep the closure of notch I.

Sway brace assembly 1422 and the material of right axial support 1414 and left axial support 1416 can examples It such as include elastoplastic flexible, usually duroplasts, such as nylon, polypropylene, polyethylene, polycarbonate or other thermoplastics Property polymer.In general, sway brace assembly 1422 and right axial support 1414 and left axial support 1416 may include Elasticity is less than the material of right substrate 1402 and left substrate 1404.Therefore, with many of cut closure instrument disclosed herein Other base portion assemblies are the same, and bigger rigidity can be provided towards the top of base portion assembly 1400a, 1400b and 1400c (and smaller elasticity).That is, can be deposited between the top and bottom of base portion assembly 1400a, 1400b and 1400c In tension gradient.The top of base portion assembly 1400a, 1400b and 1400c can be hard enough or firm, so that notch closes Clutch tool prevents the movement for the tissue for being laterally adjacent to the instrument when being applied to notch and surrounding tissue, so as to substantially not Make capped notch and surrounding tissue expansion.Also that is, at least part of the cut closure instrument of application is (for example, harder Part under hard layer) movement be collective, and do not upset following notch.Also, base portion assembly 1400a, The bottom of 1400b and 1400c can be flexible enough, so that because of the tissue of cut closure instrument adjacent to applied by Blistering and adhesion loss caused by movement minimize.Although the major function of sway brace assembly 1422 can be to each Substrate 1402,1404 applies tension to keep notch I to be closed, but in many embodiments, sway brace assembly 1422 It can be also used for providing column intensity, be made with will pass through from the distraction force that may upset notching edge alignment and pairing The compression (or bending or fold along notch I) of notch I is minimized and notch I is isolated.Enough axial directions can be directed to Bending is flexible and transverse compression and bent support and optimizes the axial spacing, material properties and size of sway brace 1422.? In preferred embodiment, the spacing between tie-rod 1422 is 10mm, and the material of tie-rod 1422 is nylon, and having a size of 0.030 The circular section of inch.

Referring now to Figure 14 B, base portion assembly 1400b can be placed on the joint (such as knee) of patient or subject Skin in notch on.Close to movement joint in place of, especially proximate to knee place notch in, closing device or Closure instrument integrality suffers from the challenge of many factors.These factors include: the longitudinal direction of the wound when joint motions occur Elongation, is opened at circumferential swelling；The skin injuries such as blistering；Adhesion loss；And the discharge of wound fluid.Such as knee The joints such as lid, ancon, ankle and shoulder may undergo movement, this there may come a time when to cause to cover the joint fortune mobile more than 135 ° It is dynamic, so as to cause above-mentioned challenge.

Skin around bending position, knee may axial (that is, being parallel to notch) and laterally (that is, transverse to or it is vertical Directly in notch) stretch up to 50%.The cut closure instrument for the skin being adhered in the region can be preferably able to provide foot Enough tension carrys out close incisions, but adapts to stretch with the smallest local stress.Minimize local stress is set to prevent office Portion's skin adherence is lost or in the case where adhesion loss does not occur to the damage of skin.Many notch disclosed herein close It is bigger than tension element attachment point itself that the critical nature of clutch tool is that the tension load by the closure member of instrument is distributed in Area on ability.In addition, the structure including adhesive attached by tensioning element can have in skin in many cases The ability of the compliance of the structure is distributed on the region that skin stretches, so that instrument protects notch when skin moves around it Hold original position.Embodiments described herein may include the composite design of non-stretching tension element (commonly referred to as " band "), The non-stretching tension element links to " lock " for being held in place band.For example, this class component may include described 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 helps to be distributed tension load.In many cases, such elastomeric polymer can bent There is high elongation rate before clothes or permanent deformation, and may include the thermoplastic elastomer (TPE)s such as polyurethane and various etc. The silicone of grade.Such material can also be easily formed film necessary to keeping slim and enough compliance.

The surgical appliance adhesive used in instrument may also need to bear the elongation of skin, and can restore in skin It retracts/rebounds when to unstretched state (for example, in knee position of full extension).Hydrocolloid adhesives can provide in this way Property, and be preferably suitable for such application.This can also be provided using other adhesives such as acrylic acid Kind property.In general, such adhesive may need to be attached to all elastic films as above, so as to Its structure is kept in expansion and rebound process.If without such support, adhesive may be torn with cyclic extension and Separation.

A series of cut closure instrument for being built as short segments can be in the case where no adhesion loss or skin injury Adapt to higher percentage of total elongation.Each individually segment can suffer from the local elongation of skin under it.Two adjacent Space between segment can serve as stress elimination space, so that skin be allowed to stretch within this space.Segmentation can be with a variety of Mode is realized: (1) by being laid with individual segment along cut line, or (2) allow device when it is applied to skin Or it is divided into short segment later applied to skin.

The preferred embodiment that segmentation is realized after being applied to skin includes as described above in layer of polyurethane (that is, substrate 1402,1404 upper layer 1406,1410) middle creation perforation (for example, horizontal line of perforation, to promote to tear), and keep following Adhesive is perfect, as shown in Figure 14 B.Perforation can be at it with knee flexion (that is, carrying out joint motions) and through tension Lead at least upper layer (for example, upper layer 1406,1410) tearing along perforation line (for example, line 1424,1426) of substrate when stretching It splits.In the preferred embodiment, the adhesion sheet of the every side of notch can be 12mm wide, and the perforation being located in given plate It is spaced apart about 12-20mm.Test and prove, the perforation of the notch and 1mm tie-rod of 3mm is in knee flexion Realize that the segmentation in the urethane substrate of 0.001 inch is effective.With knee flexion, skin may be on some position edges Axial (along notch) and transverse direction extend up to 50%.Therefore, the separation of polyurethane can be when device be through Tensile Stress in alleviator.

As an example, the knee through surgical repair may the inflammation within a couple of days, it is big after closure that this may cause joint About 30% radial swelling.As polyurethane etc elastic material allow cut closure instrument (e.g., including be adhered to figure The base portion assembly 1400b of the notch I formed in 14B) it is expanded with such circumferential swelling.Minimize the width of instrument (for example, each substrate segment 1402,1404 be 12mm or less) can make instrument on the direction perpendicular to notch I by Amount of expansion minimize, and adherency is kept while therefore can minimize a possibility that making skin injury.Figure 14 B shows The perforation in adherency segment is gone out, the perforation extends to notch along line 1424,1426 in a lateral direction, to allow more Readily axial tension.Notch can also be parallel in the outer edge close to adherency segment make perforation or other windowings, So as to reduce with skin radially outward stretched (such as during joint motions and swelling) from notch caused by stress.

Referring now to Figure 15 A- Figure 15 D, notch may be often subject to the buckling as knee or other joints and caused by Tend to beat scalloping power.In many embodiments, cut closure instrument has retaining mechanism, which passes through It is closed during buckling to fight opening force, to assist in keeping cut closure.Figure 15 A and Figure 15 B show cut closure The base portion assembly 1500 of instrument comprising utilize the mechanism of pulley effect, that is, when skin is along lancing-drawing, notch The distance between locking point of either side shortens.In the preferred embodiment, substrate is to the notch between 1510a, 1510b Adhesion sheet 1510a, 1510b of every side are 12mm wide, and are located at the perforation 1530 at line in given plate 1510 and are spaced Open about 18 mm.In general, all components of retaining mechanism are non-stretching formula.As shown in Figure 15 C, by anchoring piece 1540, cunning The triangle that wheel 1520, lock 1550 and flexible locking element 1580 (for example, tethers or band) are formed has axially along cutting Mouthful bottom edge B and height H laterally across notch.With knee flexion, triangle base length increases.In general, triangle All components be non-stretching formula, this require height must reduce to remain attached to the single member between any two points The length of part, to generate the additional closing force across notch.Figure 15 A and Figure 15 B are also shown under substrate 1510a, 1510b Surface may include hydrocolloid adhesives 1560, and one of plate 1510a or 1510b may include locking arm 1570, be used for By 1580 lock into place of band.Although the bottom edge for showing triangle in Figure 15 A is located on left substrate 1510b, it is contemplated that It arrives, the bottom edge of triangle can be alternatively positioned on right substrate 1510a.

Although foring triangle by anchoring piece 1540, pulley 1520, lock 1550 and flexible locking element 1580, also It is contemplated that other shapes.For example, pulley 1520 can wind around two anchoring pieces 1540 to form square or square Shape shape or pulley 1520 can wind around three or more anchoring pieces 1540 to form trapezoidal shape.With reference to figure 15D shows the base portion assembly 1500a of cut closure instrument in figure, is similar to base portion assembly 1500.In substrate In 1500a, 1540, two pulleys 1520 of anchoring piece, lock 1550 and flexible locking element 1580 form rectangle following Additional closure is provided at notch I when skin stretch.In the rectangular arrangement shown in Figure 15 D, the two of notch I either side Spacing between a fixed point usually will be identical.And in the triangular arrangement shown in Figure 15 A and Figure 15 C, pulley The fixed point of 1520 sides can be spaced apart farther than the other side notch I.Although rectangle is shown as " opening wide " in left substrate On 1510b, but it is contemplated that the rectangle can alternatively " unlimited " on right substrate 1510a.

Cut closure instrument base portion assembly 1400a, 1400b and 1400c shown in Figure 14 A1- Figure 14 A3 and In other cut closure instrument base portion assemblies described herein, single band 1422 can be used to engage positioned at notch I Opposite side single lock.In Figure 15 A- Figure 15 D, each flexible locking element or band 1580 are usually anchored in notch I's Side is wrapped in around the other side, and then engagement is located at the lock of the side notch I identical with the position of anchoring piece 1540 1550.In the embodiment shown in Figure 15 D, flexible locking element or band 1580 are engaging the lock 1550 for being located at the same side It is wrapped in around two fixing spools (spool/pulley 1520) of the other side of notch I before.Flexible band 1580 is wound In spool 1520 can preferably be coupled with rigid member so that the distance between they are in closing device substrate in batch piece installing 1500 do not increase when extending in the axial direction.In the alternative, it may be desirable to allow pulley or spool 1520 it Between expansion.It should be noted that flexible locking element 1580 can be anchored in a substrate segment, while being locked in by substrate In the adjacent segment that perforation 1530 in 1510a or 1510b is separated.Such anchoring and locking can be in base portion bands Connection is created between three segments (two segments are located at the same side, and a segment is located at the other side).It is filled when across cut closure It sets or when the length of base portion assembly 1500 or 1500a consider together, across the notch I of attachment mechanism forms continuous serpentine (that is, snakelike) connection.

The flexible connector 1580 for being wrapped in the tensioning around mandrel, spool or pulley 1520 can be configured for leading Tension attempts to open notch and following skin is through providing the additional compression to notch I when Tensile.In some cases, If the external force that two substrate 1510a are got together further is compressed, flexible band 1580 may be potentially from mandrel 1520 slip and fluff, any stretching without causing following skin.Such slippage, flexibility winding occur in order to prevent Component 1580, which can be slidably received in or be anchored in, to be anchored in the element 1590 on base portion band 1510a.Figure 15 E and Figure 15 F shows the flexible member 1580 across pipe 1590, which transfers to be attached to or be anchored to substrate 1510a.Work as base When plate 1510a, 1510b are gathered together closer to ground, flexible taped components 1580 will still be captured, and will Continue to provide necessary closure function.In other embodiments, spool feature 1590 shown in Figure 15 E and Figure 15 F can have Have across the hole at center, which is slid through by band 1590.Flexible band 1580 and its element 1590 slid through can It is preferably designed to make the minimum friction forces between element 1580 and element 1590.

Carried out test and prove, on bottom edge B be 12mm, and after cut closure by two substrate 1510a, The distance between band tie point on 1510b determines in the case where height H (normally about 16mm), on human knee The buckling of instrument 1500 causes height H to reduce 5% in the maximum region of elongation of wherein skin S.It should be noted that height Reduction is likely to be dependent on Multiple factors, the bottom edge of such as triangle, the elongation degree of lower surface skin and notch either side two The distance between a base portion.Connection " band " between anchoring piece 1540 and lock 1550 may need at least partly flexible , to allow to recycle around pulley.In the preferred embodiment, by monofilament plastics silk thread and the spy that engages in retaining mechanism Sign is integrated.Such feature can be the circle " tooth " in the ratch shape mechanism being engaged in lock.Such plastics can be with For obtaining desired flexible, longitudinal hardness, low Carried bacteria is inclined to, and allows extrusion and/or injection molding technique.Also Braided suture (preferably having coating to carry with restricting bacterial) can be used to create flexible and non-stretchable connector. Circle silk or round tube made of the flexible materials such as silicone can also be used to obtain flexibility.The band of pulley can be all Such as compound of moulded plastic and braided suture material.In other embodiments, the band of pulley can be by making to mold Band constriction and formed.Molding band, which is drawn to, can for good and all reduce the cross section of band beyond its yield point, and make It is more flexible in elongation.Heat can be used in necking process to promote the reduction of elongation and cross-sectional area.It can make The alternate mechanism shown in Figure 16 A- Figure 16 B, to lock band material once realizing desired closure, Such as suture and softer plastics.Figure 16 A shows retaining mechanism comprising slot 1610 and anchoring frame 1620 for sliding. Figure 16 B shows retaining mechanism comprising locking teeth 1630.Figure 16 C shows retaining mechanism comprising the slot for sliding 1640 and anchoring frame 1650.Figure 16 D shows retaining mechanism comprising cylindrical tube 1660 and locking teeth 1670.

It additional is closed by using what linkwork 1700 as shown in Figure 17 can obtain in knee flexion across notch With joint efforts.As shown in Figure 17, can with the non-stretching arm 1730 of X-shaped by four points of notch either side (cut closure instrument Two anchor points 1720 on every side or substrate 1710) it connects, and provided hingedly at crosspoint 1740.With knee The distance between two points of the same side of lid buckling and notch increase, and the distance between segment of either side of notch can be with Reduce, to generate additional closing force.As shown in Figure 17, substrate 1710 can also have multiple perforation 1750 with promotion pair The axial tension of substrate 1710, or promote its vertical segment of separated component in axial tension.

As shown in Figure 18, according to many embodiments, the band and lock of cut closure instrument 1800 be can be configured for It is formed across the S-shaped or snakelike connection or arrangement of the whole length of the notch I on the skin S of knee.Cut closure instrument 1800 It can cut closure instrument 1400 similarly as described above in many aspects.By by each segment of the side of notch I Two adjacent segment 1810b of the opposite side of 1810a and notch connect and make segment 1810a, 1810b of device 1800 It is connected with each other.This can be by installing a pair of of band 1820 and in the correspondence segment of the other side in each segment 1810a A pair of of lock 1830 is installed to realize on 1810b.Each pair of lock 1830 and band 1820 can be connected with each other.In closing for wound or notch I During conjunction, one of band 1820 of substrate segment 1810a (for example, 1810a1) (for example, band 1820a) can be with notch Lock 1830 (for example, 1830a) on the segment 1810b (for example, 1810b1) of the other side of I is connected, and the second band 1820 (for example, band 1820b) can with adjacent in the section for wherein connecting the band 1820 (for example, band 1820a) being previously paired 1830 (example of lock in the segment 1810 (for example, segment 1810b2) of section 1810b (for example, 1810b1), notch I opposite side Such as, 1830b) it is connected.The above-mentioned list for constituting substrate segment 1810, the S-shaped of band 1820 and lock 1830 or snakelike arrangement Ring.Perforation line 1850 can separate axially adjacent substrate segment 1810a and 1810b.Side perforation line 1850 (for example, It can interlock with the perforation line 1850 (for example, adjoint substrate segment 1810b) of the other side with substrate segment 1810a).It is similar to Figure 15 A, in the preferred embodiment, the adhesion sheet positioned at every side of notch can be 12mm wide, and in given plate Perforation can be spaced apart about 18mm.

Cut closure instrument or device as described herein can be applied in many ways.Figure 19 is shown according to some The exemplary cut of embodiment is closed instrument 190.Here it is possible to which single base portion arranged in pairs is provided in segment 1910 On single carrier/release liner.Each pair of substrate segment 1910 includes band 1920 and lock 1930, the band 1920 and lock 1930 can independently be adhered to skin with cut alignment and adjacent to each other.Release liner and outer carrier band 1950 can be used Single segment 1910 is kept together relative to each other.Release liner 1950 can be removed to expose adhesive, but entire dress Set 1900 or the packet partial of device 1900 can be coupled with outer carrier band.When being applied to skin, carrier band can be removed 1950, to leave adherency segment 1910, the adherency segment 1910 is aligned with each other but can independently move.

The perforation segment (generally comprising polyurethane) on substrate upper layer (can be generally comprised by one layer of continuous adhesion sublayer Hydrocolloid adhesives) it keeps together, to allow to be laid on skin in a continuous movement.Figure 14 A- Figure 14 B, figure The cut closure instrument 1400,1500 and 1800 of 15A- Figure 15 C and Figure 18 can have such continuous adhesion sublayer respectively.

The base portion assembly or substrate of cut closure instrument as described herein can be in the ends of wound or cut closure by soft Property adherency membrane material covered.The diaphragm area preferably may be larger than base portion cut closure panel element, so that it makes the element It is overlapped on skin.The film can help to prevent the migration of base portion, and can prevent any of anchoring piece and retaining mechanism Accidental movement.The cover film can be by Stretch materials systems such as rubber, latex, polyurethane, silicone or thermoplastic elastomer (TPE)s At.In the preferred embodiment, thin covering is (for example, the stacking of 0.001 " urethane and 0.002 " thick acryloid cement Body) there will be the compliance bigger than the composite construction of base component.Therefore, covering can be in exposed skin and base Some strain reliefs are provided between portion segment.Covering can also be transparent, to allow the visual inspection to notch.Covering (for example, as barrier to infection) can be fully sealed in object across notch, or can have on covering and cut-out Quasi- opening, to allow the discharge of any diffusate from wound.Covering can also be used in through bridge joint substrate and be adhered to Skin edge between base portion band improves the pairing of notching edge.Covering can be also built into additional reinforcing Element, the additional fastening element improves the tensile strength between base component, but allows complying with along incision length Property.Preferred embodiment may include a series of polyethylene glue tapes applied to covering.

Although user can be after base portion assembly and plate be placed on the skin using covering, it is contemplated that arriving Covering material can be supplied as " skirt section " extended around the outer perimeter of base segment.Therefore, covering material is relative to base The alignment in portion can be independent of the placement of user.These identical covering materials can provide following effect: anti-water-stop glue Body adhesive is exposed to patient garments, the migration of limitation hydrocolloid or other adherency lower layers, offer on base segment The strain relief etc. of power.

In many embodiments, hydrocolloid adhesives are used for for cut closure tensioning skin.It can be by following In one or more modes prevent the creep of hydrocolloid: (1) creep, or (2) are limited using laminated body on the surface Across skin and hydrocolloid adhesives application adherency covering to prevent creep and provide strain relief to skin to prevent skin from damaging Wound.

In many embodiments, the covering being used together with base portion assembly may include one in perforating or being open It is a or multiple, to allow to remove wound fluid (and any application in the case where the base portion assembly without removing adherency Bandage/absorbing material).

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

In many embodiments, the covering combined with base portion assembly in the axial direction with transverse direction this two It is aligned skin incision edge on person, or significantly prevents subsequent skin edge from misplacing.

In many embodiments, cover gasket configuration is provided, so as to first to the one of dermal application covering Part, this removal for then helping other to pad, and therefore can help to control thin material, so that it is with the smallest fold Equably it is laid with.

In many embodiments, the removal of the first liner can permit the visualization in placement process, and can be with The rest part of anti-locking apparatus clings user.

Referring again to Fig. 9 and Figure 10, in many preferred embodiments, two adhesion sheets 104,106 are applied to surgery The either side of notch (before or after making notch).Close mechanism may be mounted on adhesion sheet 104,106, and It is preferably attached to component 120, which helps to be distributed closing force between the attachment point of close mechanism.Such as Fig. 9 With shown in Figure 10 and Figure 20 A and Figure 20 B, which may include band 130 and lock 132.Band 130 may include tool There is the elongated member of soldered tooth.Lock 132 may include the feature for capturing the soldered tooth of band 130.Band 130 can tense In lock 132, so that adhesion sheet 104,106 (and thus by notching edge) is pulled together.If necessary, user can To disengage and be re-engaged the band 130 in lock 132, suitably to adjust the amount of skin closure.Meanwhile it being illustrated in Figure 20 A Cut closure instrument 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 combine Ground, surgical appliance adhesive may include one of many propylene acid supplements known in the art.Hydrocolloid adhesives can have very viscous And moisture can be absorbed and make the benefit of skin cell exfoliation.Therefore, hydrocolloid adhesives can be particularly suitable for long periods of wear Instrument (for example, being up to 14 days).However, at least some cases, hydrocolloid structure may be soft, and be easy Creep occurs under tension, unless reinforce in some manner, such as by with harder substrate 120,104 or disclosed herein Other overlay structures are reinforced to cover hydrocolloid adhesion layer.

Correspondingly, another aspect of the present invention additionally provides the base of reinforcing and protection cut closure instrument as described herein The various means of adhesion layer in portion's assembly, and skin edge is kept together (especially in the axial direction) Additional means.In at least some cases, individual hydrocolloid adhesives have low-down tensile strength, and may need Means are reinforced to prevent it from tearing in use or creep.As shown in Figure 21, used in the substrate 104,106 Adhesion layer 211 can mutually be laminated with compliance plastics or polymer 212 (such as urethane) thin layer, the compliance plastics or polymerization 212 thin layer of object is preferably 0.001 inch, and potential range is up to 0.010 " thickness, may assist in guarantor during clinical use Hold its structure.Adhesion layer itself can be nominally 0.010 inch, but can be in 0.005 inch and the range of 0.020 inch Between.Since the tensioning element for including the band 130 or lock 132 that are attached to power load distributing component 118 may will be installed to adherency The top of structure 211, thus there are materials can be over time and a possibility that creep.Laminated body 212 and be located at adhesion layer Any other adherency laminated body 215a, 215b between 211 and power load distributing component 118 can help to provide to prevent from gluing The structure of attached layer creep.

As shown in FIG. 22 A, it in order to further prevent the migration of adhesion sheet 211, can also be applied on plate 104,106 Covering 220.As shown in Figure 22 B, covering 220 may include compliance elastomer 221 that is thin, being coated with adhesive.? In many embodiments, covering 220 further includes being coated with the surgical appliance adhesives such as acryloid cement (preferably 0.002 inch) thin urethane layer (preferably 0.001 inch), may be provided in one or more release liners On 223a, 223b.Covering, which may also include, reinforces feature 225.

As shown in Figure 23 A and Figure 23 B, covering 220 can be constructed so that its it is extensible beyond substrate 104, 106, to bridge the distance between skin S and plate 104,106 d3.Typical minimum must distance d3 can be 8mm, but can In the range of 2-15mm.Other than helping prevent the adhesion layer creep of substrate 104,106, the urethane of covering 220 Surgical appliance adhesive can also help the tension for being applied to substrate 104,106 to the movement by surrounding skin S to carry out strain relief.This It can be used for preventing the skin injury (for example, rotten to the corn or blistering) of substrate 104,106 edges.It should be noted, however, that glue The compliance property of body mobile and thereby resistance can provide for blistering the damage of skin S by itself with skin S Localised protection.In many embodiments, even if having the harder structure of installation to the outer surface of adhesion layer, down toward skin Compliance in 0.010 " nominal thickness of the adhesion layer on skin surface stills provide the resistance to skin injury.

In addition to board structure is stabilized and strain relief other than, covering 220 can be used for other purposes.By covering Lid band 130 will engage the position of lock 132, and covering 220 can prevent patient from will lock 132 plays may take off to band 130 The degree opened.As shown in Figure 23 A- Figure 23 C, covering 220 can be along the length in the region be overlapped with notch equipped with opening 224,224 ', so that wound fluid can be absorbed in the external gauze applied.In other embodiments, covering 220 can be with Without opening, to protect the wound from the evil of the source of infection.Covering 220 itself can have reinforce feature 225,225 ' with The additional resistance power opened for notch is provided to base portion 102, especially in the region between band 130.Figure 23 C is shown Particular implementation, wherein reinforcing feature 225 ' can be rectangle article tape.Preferably, adhesive tape 225 ' can be than surrounding 221 more hard place of compliance urethane layer is perpendicular to skin incision.Adhesive tape 225 ' can be built-up by any combination of the following terms: It is coated with Woven fabric, polymer fiber, polyethylene, polypropylene, nylon, PET, the hydrocolloid or known in the art of adhesive Other materials.Reinforcing feature 225 ' can also increase " body " or rigidity to covering 220, to help its placement.Urethane layer 210 Can be built-up by this class material, to give its biaxial tension.

The spacing of feature 225,225 ' is reinforced for ensuring longitudinal direction (being parallel to cut line) compliance (example of covering 200 Such as, due to the thin urethane of compliance) it may be important.This can be used for by allowing covering 220 and following base portion group Piece installing 102 is moved with the movement of body, to improve the comfort level of patient and for the resistance of skin injury.The effect Covering 220 may individually be come from, or feature as permissible longitudinal compliance with base portion assembly 102 is answered Close effect.Reinforcing member 225,225 ' can also be uniform construction, but otherwise interrupt by perforation, fluting or mechanically, To allow stretching and/or controlled tearing with body kinematics.(one or more of covering 220 can also mechanically be interrupted It is a) thin urethane layer to be to realize identical effect.In at least some cases, the reinforcing feature 225,225 ' of covering 220 can Not extend over the entire width of object 220 (perpendicular to notch).This limited cover width can help to ensure that for hanging down Directly in the strain relief of the body kinematics of the separate base portion assembly 102 of notch I.In the preferred embodiment, by strenthening member 225, the region of the 225 ' coverings 220 reinforced upwardly extends 10 mm in the side of each separate notching edge, but this can be In the range of 2-50mm.

Another feature of covering 220 can be the control that can increase for notching edge, especially assemble in base portion Between the tensioning element 130,132 of part.As shown in fig. 24 a, the tensioning element 130,132 combined with substrate 104,106 can For making notching edge 205 close to together.Once skin S is approached, and skin edge is vertical (perpendicular to skin surface) Alignment may be important.Vertical dislocation may cause visible " sublevel " or rib ridge in the slower and notch that heals, this can It can lead to undesirable scar aesthetics.By the way that some parts of covering 220 are attached to substrate 104,106 along notch Each edge can make each edge keep perpendicular alignmnet under tension as shown in arrow 201a, 201b.Across covering for notch I Adhesive on the part of cover material 220 can also be directly attached to skin S at notching edge, be bonded to further shorten The distance between notching edge and further enhance vertical skin alignment.As shown in figure 23 c, in the preferred embodiment, Part across the covering 220 of notch I is rectangle article tape 225 '.Between the width and band 225 ' of each band 225 ' Axial gap can for notching edge control, the evolution of notch visibility and wound fluid and optimized.It is preferred that Embodiment may include the band of 12mm wide and interval 6mm, and band is between each band.It is contemplated that arriving other Width and spacing.By not bridge joint/covering on each band 130, band 225 can more flat against skin S, with Obtain preferably adherency and Edge position control.

In some embodiments, reinforcing feature 225,225 ' can 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 it is harder.In this way it is possible to be isolated through normal patient motion to the skin S's around cutting part Bending or compression, or limit its propagation.The motion isolation of even now or limitation will may consequently contribute to cutting under enhancing tension Oral area position, but bigger benefit can be to prevent the significant ground of notching edge or unevenly varus, turn up or perpendicular to skin The square upward displacement on skin surface.Reinforcement material as discussed above can be used, and adjust thickness, it is desired rigid to create Degree.Preferably, the compound of base portion assembly 102 and covering 220 can be constructed, so as to create the smooth transition of rigidity with And from surrounding skin to the compliance of segregate cutting part.

In specific application method, the notch first closure for making skin edge close using base portion assembly 102 it Afterwards, further substrate 104,106 can be pushed together, so as to the notch I of upward " pushing " closure, so that edge is slightly outer It turns over and/or compresses the skin S around notching edge to discharge tension.Figure 25 A- Figure 25 C illustrates this method and organizes in vivo Embodiment in model.Figure 25 A shows step 250A, adjacent with notch I being wherein adhered to substrate 104,106 Skin S, and they are pushed together with the notch I of upward " pushing " closure.It then can be further by substrate 104,106 It is pulled together, will organize to be maintained in this orientation.By the way that substrate 104,106 is remotely located from notching edge 5-10mm Place, can be enhanced these methods.In the step 250B shown in Figure 25 B, can with band 130 and lock 132 by substrate 104, 106 lock in place relative to each other.In the step 250C shown in Figure 25 C, then base can be locked using covering 220 The relative position of plate 104,106 and " pushing " notch I.It can be with fastening element 225,225 ' as discussed above come into one Step reinforces notch I.

In many embodiments, given covering 220 can be equipped with release liner to help user that will cover Object 220 is applied to handle covering 220 before patient and during application.As shown in Figure 22 A and Figure 22 B, covering 220 can To have with release liner 223a, 223b of three parts configuration application.User can remove longitudinal center's liner first The adhesive of center exposure is applied to base portion assembly 102 and skin incision region by 223b.Liner 223b is first It removes, in conjunction with the visualization by transparent plastic or opening in the center of base portion 220, can permit user and see lower section Base portion assembly 102 so that can be appropriate by covering 220 and base portion assembly 102 in application covering 220 Ground alignment.This may also help in the region for providing and not adhering to the covering 220 with user, until covering 220 is initial It is fastened to base portion assembly 102 and/or skin S.Next, release lining in side can be removed on the direction perpendicular to notch I Pad 223a.Pad 223a keep and the very thin urethane of tensioning, with keep its be applied to skin S when it is substantially wrinkle resistant.This It outside, can be by covering 220 by first pasting at the center of covering 220 on base portion assembly 102 and/or skin S It is held in place, so as to apply enough tension and control to side release liner 223a, for being coated with covering for thin adhesive Smooth application of the rest part of cover material 220 to patient.Alternatively or in combination, liner can be constructed so as to the first lining Pad is removed the narrow strips (perpendicular to notch I) on the entire width to expose covering 220, to allow to assemble in base portion Initial placement on part 102 and/or skin S, then removes one or two additional lining on the direction for being parallel to notch I Pad.First liner can be located at centre, the either end of length, or fall between.It, may if not being located at end Two added with padding are needed, are moved in each length outwardly direction padded in the position from the first liner along device It removes.If the first liner is located at an end, second can be removed from the end that the position of the first liner is outwardly directed to device Single liner.

Another release liner configuration can be with single liner, which can be before application from covering 220 Bottom remove completely.Such liner may need outer membrane or casting piece, and the outer membrane or casting piece lightly adhere to To the outer surface of covering 220 to help thin urethane to keep its shape, and provide to user in side and/or end Therefore the position of user on hand is not sticked to without adhesive and in application process.Outer membrane can be in entire appearance It on face, or is only in the specific width around the circumference of covering 220.The film and/or release liner can also have Extend beyond the region of the thin urethane in covering 220.Once covering adhesive is attached to base portion assembly 102 or skin S, so that it may easily remove casting piece from the external of covering 220.

As described herein, flexible wound dressing and wound or Tncision closing device or instrument are usually flexible and can It stretches, to follow the bending part (for example, arm, curved longer notch etc.) of body or the region (example through Tensile Such as, knee) profile.In order to aid in the drape of such device, help can be used and keep dressing shape in application process Back lining materials.Such interim back lining materials as described herein can have the advantages that multiple.Back lining materials can be it is transparent with Wound is checked in support.The material can be it is non-stretchable, to prevent dressing or closing device or instrument from applying Elongation in journey.Backing can easily remove after the application of wound dressing or closing device or instrument, so as not to shadow Ring adherency of the practical dressing in wound location.Back lining materials may also help in the processing to dressing in the fabrication process.? In many embodiments, back lining materials can be coupled to dressing or closure dress with the ripping type release liner of the adherency side of dressing It sets, is reliably removed with supporting the simple of back lining materials.

Referring now to Figure 26 A, wound dressing covering 2600 may include by flexible materials such as rubber, urethane, silicone Manufactured flexible sheets 2610.It is the relatively harder of casting piece or carrier layer 2620 that flexible material 2610, which can be layered in form, On material.Casting piece 2620 prevents flexible material volume 2610 to itself and becomes not being available.Flexible sheets 2610 can be in side (for example, bottom side) has relatively hard (hard) carrier layer or casting piece 2620 with adhesive and in the other side.It is viscous Mixture side is protected by two liners 2630,2640, and described two liners 2630,2640 can successively remove, thus with by The mode of control exposes adhesive.In order to which dressing 2600 to be applied on wound or notch, by removing in the release liner One of, lesser release liner 2630 is removed, usually to expose one small adhesive.The release liner 2630 can be used Adhesive tape 2650 is attached to casting piece 2620.Then the expose portion of flexible sheets 2610 can be adhered to the one of wound or notch End.As the second release liner 2640 is slowly removed continuously to expose adhesive, flexible covers 2600 are then followed Curved profile on wound or notch and body.

Then it can be used and be usually still attached to the first release liner 2630 of casting piece 2620 with adhesive tape 2650 come from soft Property dressing 2610 lifts casting piece 2620.

The manufacturing process of wound dressing covering 2600 and associated cushion 2630,2640 can be to be come using single matrix It is cut into release liner 2630, release liner 2640, flexible dressing 2610 (with adhesive) and the stacking of casting piece 2620 The common profile (circumference) of body.After removing liner 2630,2640 and dressing sheet 2610 be applied to skin, casting piece 2620 It can be retained in dressing sheet 2610.The removal of casting piece 2620 may be needed by making the edge of casting piece 2620 from dressing sheet 2610 are layered and are peeled off to cause.Once having caused, then the continue removing and removal of casting piece 2620 can be simply Directly.The initiation at the edge of casting piece 2620 and to lift may be not always intuitive, and may need to be connected to casting The free edge of piece 2620 lifts a little to help to identify and starts to remove.Adhesive tape 2650 can be used for bridging casting piece 2620 To release liner 2630, and readily identified auricle can be provided, which can be used for causing removing.

As shown in Figure 26 B- Figure 26 E, the alternative configurations of casting piece 2620 can be used to cause the stripping of casting piece 2620 From.

As shown in Figure 26 B, casting piece matrix can be cut, is applied so that casting piece 2620a is axially extending beyond flexible Tablet 2610 is (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, which is 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 attaches (one or more) axial edge in casting piece 2620 Place or its near, and also extend in the profile of casting piece 2620, the non-stick attachment edge 2652 with release is for user It grasps.

It, can be from an axial edge of casting piece 2620 to the part of another axial edge or complete as shown in Figure 26 E Cutting casting piece matrix is (for example, carry out osculating, so that casting piece 2620 is not cut flexible dressing sheet 2610 over long distances In).The casting piece 2620 being cut into can be separated by " nip " of user, to create the edge for grasping.Such as figure Shown in 26E, internal matrix cut edge can also have the adhesive tape or class applied to one or both internal edge As auricle 2654 for grasping and remove.

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

The one or more components of cut closure instrument disclosed herein or cut closure instrument assembly, including it is each Kind of base portion assembly, substrate, power distributed architecture, axial support, horizontal support piece, closing assembly, tie-rod assembly, band, Lock, adhesion layer, adhesion layer, covering, blanket structure, drop cloth etc. one or more of including, may include, be coated with Or be otherwise incorporated to one of the following terms or a variety of: anti-mycotic material, antimicrobial material, is prevented anti microbial materials Rotten material or medicinal materials.For example, such material can be incorporated into hydrocolloid adhesion layer, as between skin and adhesion layer Another layer or the coating at least part of adhesion layer (covering), be incorporated into base portion assembly covering or at least its adhesion layer In, etc..Can be provided on device or apparatus assembly one or more holes, groove, opening, hole or similar structure with It is incorporated to as promotion.In many embodiments, such material may include silver, iodide, zinc, chlorine, copper or such as tea tree One of natural materials such as oil are a variety of as activating agent.Such anti-mycotic material, anti microbial materials, antimicrobial material, The example of anti-corrosion material or medicinal materials includes but is not limited to that can buy from the Smith&Nephew plc of Britain Acticoat^TMSeries material can be bought from the Smith&Nephew plc of BritainHumid control series material Material can be bought from the Coloplast A/S of DenmarkFoam series material, can be from the Urgo of Britain Limited (subsidiary of French Laboratoires URGO) is boughtSilver-colored series material, can be from English What the Smith&Nephew plc of state was boughtHydrocolloid series material, can be from New Jersey Skillman's ConvaTec Inc. is boughtAg series material, can be from the Kinetic of Texas San Antonio What Concepts, Inc. were boughtSeries material, can be from the Kinetic of Texas San Antonio What Concepts, Inc. were boughtSilver 220, can be (French from the Urgo Limited of Britain The subsidiary of Laboratoires URGO) buySSD series material, can be from Texas San The Kinetic Concepts of Antonio, what Inc. was boughtSeries material, can be from the Smith& of Britain Nephew plc is boughtSeries material can be bought from the Aspen Medical Europe Ltd. of Britain Sorbsan Silver^TMSeries material can be bought from the Ferris Mfg.Corp. of Illinois Burr Ridge PolymemSeries material, can be from the Kinetic Concepts of Texas San Antonio, Inc. purchase The Promogram obtained^TMSeries material can be bought from the Kinetic Concepts of Texas San Antonio, Inc. Promogram Prisma^TMSeries material and can be from the Medline Industries of Illinois Mundelein It buysSeries 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, The component of closing device described in US 2011/40213, US 2011/34649 and US 2013/067024 also may include, apply Have or is otherwise incorporated in anti-mycotic material, anti microbial materials, antimicrobial material, anti-corrosion material or medicinal materials It is one or more, one of material including but not limited to listed above or a variety of.

In many embodiments, topical pharmaceutical formulation is directly incorporated into wound closure instrument as described herein.Due to Wound closure devices are often applied to close in place of the wound or notch for needing medicament protection, thus such drug is to closure Being directly incorporated into device may be beneficial.For example, being incorporated to for Antimicrobial agent can in the wound for having infection risk It can be beneficial.Antimicrobial agent may include antimicrobial agents and non-corrosive metal (NCM) ion and associated compound, this It may include the natural materials such as silver, iodine, copper and chlorine or tea oil.For example, in easily fungi-infected wound, it can To be approved using pharmaceutical preparations such as zinc.The combination of any medicament in these medicaments is also likely to be beneficial, and therefore It can be incorporated into wound closure instrument.

Topical pharmaceutical formulation can be incorporated into closing device in this way: being given closing device and kept wound Diffusate wound is wicked out while sufficiently aqueous (to leave wound for example, guiding undesirable organism and/or prevent Skin maceration) to improve the ability to heal.

With reference to Figure 27 A, wound or cut closure instrument 2700 include base portion, the base portion include two substrate 2710R, 2710L, described two substrate 2710R, 2710L include upper polymeric layer 2720R, 2720L and are applied to close to surgical incision I Every side in place of lower adhesion layer 2730R, 2730L.The features such as the band 2740 of plate 2710R, 2710L allow The skin of the either side of notch I is pulled together during healing and keeps in situ.Adhesive preferably includes glue system Agent, but also may include acrylic acid or other adhesives as known in the art.Upper polymeric layer 2710R, 2710L are (for example, 1 is close You (mil) polyurethane) preferably be applied to adhesion layer 2720R, 2720L top, be isolated adhesion layer 2720R, 2720L.Pharmaceutical preparation can be incorporated into the structure of substrate 2710R, 2710L.For bottom line, medicament can be at it Inhibit the growth of undesirable organism in place of substrate 2710R, 2710L contact tissue.Medicament can from substrate 2710R, 2710L is discharged and is migrated in wound or close to the region of wound.Medicament can be carried by adhesion layer 2730R, 2730L etc. Body structure is accommodated, which can absorb fluid and help the release of medicament.This class formation may include hydrocolloid, parent Aqueous fiber (such as those hydrophilic fibres for containing sodium carboxymethylcellulose), collagen, alginate, gathers hydrogel Urethane foam or silicone foam or other associated materials as known in the art.Carrier can be alternatively or in combination ointment, Emulsifiable paste, gel or powder.Pharmaceutical preparation (such as silver ion) can be alternatively or in combination via solvent coating process or vapour phase It deposits and is applied to metal or polymer (for example, metal or polymer of web form).Such netted product it is combinable or It is embedded in the structure of closing device.

In the exemplary embodiment, the pharmaceutical preparation comprising silver compounds such as silver sulfates can be incorporated into base In plate 2710R, 2710L.It, can as substrate 2710R, 2710L are in contact with wound fluid and/or sweat or external fluid To transport medicament towards wound.As fluid is absorbed into substrate 2710R, 2710L, substrate 2710R, 2710L can The silver ion of release interference bacterial growth.It illustrates how that the medicaments such as silver base can be incorporated into Figure 28 A- Figure 28 B Example in plate shows each embodiment of the sample segment 2750 of right substrate 2710R in Figure 27 in figure.These examples are also It is applicable to left substrate 2710L.

Figure 27 B shows pharmaceutical preparation 2760R, is mixed directly into the adhesion layer 2730R in sample segment 2750. Adhesive is usually hydrocolloid, can absorb the fluid for accounting for the significant percentage of its weight, to help releasing for medicament It puts.

Figure 27 C shows another embodiment of the sample segment 2750 of right substrate 2710R, and pharmaceutical preparation is simultaneously wherein Enter into the carrier structure 2770R being incorporated on substrate 2710R, is preferably collected in the portion of the substrate 2710R close to notch I On point.Further feature can be incorporated to, to be saturated in carrier structure 2770R by diffusate or other fluids and/or The concentration of person's pharmaceutical preparation peels (and replacement as needed) carrier structure off in the case where being brought down below effective level 2770R。

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

Figure 27 E illustrates how to be incorporated into carrier 2770R on the top and inward flange the two of substrate 2710R. In these examples, the carrier structure 2770R on any inward flange or each inward flange of substrate 2710R can be pressed on On wound or notch I, to help its stability on wound or notch I.

Pharmaceutical preparation and its carrier structure can be incorporated into alternatively or in combination in the covering of cut closure instrument.Such as Described above, covering is usually applied on the substrate of cut closure instrument, to help instrument being fastened to skin and protect skin Skin.As depicted in fig. 28 a, covering 2800 can have be incorporated into possess or do not possess carrier structure (such as with pharmaceutical preparation phase Mixed adhesion layer 2810) covering 2800 whole surface in pharmaceutical preparation 2810.Alternatively or in combination, medicament Can be incorporated into the discrete parts of covering 2800, preferably as shown in Figure 28 B in wound location In carrier structure 2820.

In at least some cases, carrier structure 2820 may become to be saturated and/or lose its drug over time Intensity, and replace medicines structure 2820 and will be beneficial.As shown in Figure 28 C, medicines structure 2820 can be removable (for example, by tearing the perforation 2830 in covering 2800), and optionally as being coupled to narrow shown in Figure 28 D cover Another medicines structure 2821 of cover fillet band 2801 is replaced.In narrow covering tape 2801, the adhesive portion of covering 2801 It is extensible to exceed medicines structure 2821, to keep structure 2821 against skin.Narrow strips 2801 can be covered alternatively in application It is applied to wound location before object 2800.Covering 2800 can be designed to covering narrow strips 2801, or can have Perforation 2830 is to allow the removal of following band.

For any or whole two substrates 2710R, 2710L and covering 2800, carrier structure 2770R or 2820 (with or without pharmaceutical preparation) or individually pharmaceutical preparation can be with the patterns of the adhesion layer of respective structure.Band figure The construction of case may include the repetition shape (for example, circle, ellipse, polygon, slot etc.) of adhesive material, the repetition shape with The similar repetition shape (or rest part of its matrix) of carrier structure is adjacent.This will may consequently contribute to ensure substrate 2710R, The adherency of 2710L or covering 2800, and pharmaceutical preparation is integrated in carrier structure 2770R or 2820 simultaneously.In Figure 28 E A simple examples are shown, carrier structure 2820 includes repetition shape 2850 wherein.Pharmaceutical preparation and carrier structure 2820 apply also for the base portion band 2740 across notch I.

It is aobvious for those skilled in the art although the preferred embodiment of the present invention has been illustrated and described herein And be clear to, such embodiment is only through way of example offer.Those skilled in the art can be without departing from the present invention In the case where many changes may be made, change and replacement.It should be appreciated that in the practice of the invention can be using for this paper institute The various substitutions for the embodiment of the present invention stated.Appended claims are intended to limit the scope of the invention, and therefore cover this Method and structure and its equivalent in a little scopes of the claims.

Claims

1. a kind of cut closure instrument comprising:

First substrate, is used to be adhered to the first side of notch or wound, and the first substrate includes a upper surface and a tissue Adhere to lower surface；

The second substrate is used to be adhered to second side opposite with first side of the notch or wound, second base Plate includes a upper surface and a tissue adhension lower surface；

The supporting element that a longitudinal gap is opened more than first is coupled to the upper surface of the first substrate；

The supporting element that a longitudinal gap is opened more than second is coupled to the upper surface of the second substrate；And

Multiple sway braces, the first substrate and the second substrate is coupled to each other,

Wherein each sway brace has a first end and a second end, support of the first end relative to the first substrate Part is permanently fixed, and the second end reversibly and is adjustably connected to the laterally opposed supporting element of the second substrate, thus Allow the sway brace to be laterally pulled together the first substrate and the second substrate, is closed with compression by the notch The notch or wound that clutch tool is covered,

Wherein the first end of each sway brace is integrated with the corresponding supporting element on the first substrate, and

Wherein each sway brace reversibly and is adjustably connected to the second substrate, so that the first substrate Horizontal spacing between the second substrate is adjustable.

2. cut closure instrument according to claim 1, wherein the second end of each sway brace is from described Correspondence supporting element in the second substrate can be detached from and can be re-engaged.

3. cut closure instrument according to claim 1, wherein the sway brace be it is individually adjustable so that described The horizontal spacing between first substrate and the second substrate along the first substrate and the second substrate length It is transformable.

4. cut closure instrument according to claim 1, wherein the second end of each sway brace is releasable Ground is connected to a locking piece, and wherein a ratch tensioning mechanism is collectively formed in the sway brace and the locking piece.

5. cut closure instrument according to claim 1, wherein a longitudinal gap is opened more than described first supporting element and institute Stating one or more of supporting element that a longitudinal gap is opened more than second includes power distributed architecture.

6. cut closure instrument according to claim 1, wherein a longitudinal gap is opened more than described first supporting element and institute The one or more stated in the supporting element that a longitudinal gap is opened more than second is transversely arranged on the first substrate or the second base respectively Between the inward flange and outer edge of plate.

7. cut closure instrument according to claim 1, wherein a longitudinal gap is opened more than described first supporting element and institute Stating one or more of supporting element that a longitudinal gap is opened more than second includes flexible not expandable material.

8. cut closure instrument according to claim 1, wherein a longitudinal gap is opened more than described first supporting element and institute The one or more in the supporting element that a longitudinal gap is opened more than second is stated to be embedded in the upper surface of each substrate or be laminated To the upper surface of each substrate.

9. cut closure instrument according to claim 1, wherein a longitudinal gap is opened more than described first supporting element and institute Stating one or more of the supporting element that a longitudinal gap more than second is opened is C-shaped.

10. cut closure instrument according to claim 1, wherein one in the first substrate or the second substrate Or multiple includes elastic matrix.

11. cut closure instrument according to claim 10, wherein the elastic matrix includes elastomer film, knits Object, short fibre fabric, rubber, latex, urethane, polyurethane, silicone or thermoplastic elastomer (TPE).

12. cut closure instrument according to claim 11, wherein the elastic matrix includes fabric, the fabric is by elasticity Element weave and have along one or more of the first substrate or the second substrate transverse edge and across The inelastic component being laterally extended therebetween.

13. cut closure instrument according to claim 1, wherein one in the first substrate or the second substrate Or multiple includes one or more preferential separated regions, with facilitate in the first substrate or the second substrate described one It is a or multiple to be longitudinally separated or one or more of cross directional stretch.

14. cut closure instrument according to claim 13, wherein one or more of preferential separated regions include one A or multiple perforation.

15. cut closure instrument according to claim 14, wherein one or more of perforation are in the first substrate Or it is longitudinally arranged between the axially adjacent supporting element in one or more of described the second substrate.

16. cut closure instrument according to claim 14, wherein one or more of perforation include along described the Multiple perforation of the x wire arrangement of one or more of one substrate or the second substrate.

17. cut closure instrument according to claim 14, wherein one or more of perforation are along first base The transverse edge arrangement of one or more of plate or the second substrate.

18. cut closure instrument according to claim 1, wherein one in the first substrate or the second substrate Or multiple tissue adhension lower surfaces includes hydrophily adhesion material.

19. cut closure instrument according to claim 18, wherein the hydrophily adhesion material includes hydrocolloid, water-setting One of glue, acrylate copolymer or polyethylene glycol are a variety of.

20. cut closure instrument according to claim 1, further includes fastened layer, the fastened layer is suitable for described first After the assembly of substrate, the second substrate and the sway brace has been anchored on the notch or wound, it is placed on institute It states on assembly.

21. cut closure instrument according to claim 20, wherein the fastened layer has self-adhering type inner surface.

22. cut closure instrument according to claim 20, wherein the fastened layer is configured to be laterally extended beyond described The outer transverse edge of first substrate or the second substrate.

23. cut closure instrument according to claim 20, wherein the fastened layer has one or more preferential separation Region, to allow the fastened layer in response to the cut closure instrument notch placed thereon or wound and surrounding group The cross directional stretch knitted and at least partly longitudinal stretching.

24. cut closure instrument according to claim 23, wherein one or more of preferential separated regions include one A or multiple perforation.

25. cut closure instrument according to claim 1, wherein each sway brace is relative to its first end or Two ends can longitudinally pivot.

26. cut closure instrument according to claim 25, wherein each sway brace is configured that when described first When one or more of substrate or the second substrate are longitudinally stretched, each sway brace relative to its first end or Second end can be pivoted longitudinally.

27. cut closure instrument according to claim 25, wherein when the sway brace longitudinally pivots, the cross The first substrate and the second substrate are horizontally more closely pulled together to tie-rod.

28. a kind of cut closure instrument comprising:

Base portion comprising left plate and right panel, each plate have tissue adhension lower surface, upper surface, the first transverse edge and second Transverse edge；

Left power distributed architecture and right power distributed architecture, are 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 for limit Make one or more of lateral magnification across the plate or axially expanding along opposite transverse edge；And

Multiple closing assemblies can be fastened to the left plate and the right panel, to be adhered to tissue in the plate and do therebetween The plate is pulled together after notch out,

Wherein the tissue adhension lower surface includes hydrophily adhesion material, and the hydrophily adhesion material includes glue One of body, hydrogel, acrylate copolymer or polyethylene glycol are a variety of.

29. cut closure instrument according to claim 28, wherein first transverse edge of each plate includes each The inward flange of plate, wherein the inward flange facing each other of each plate.

30. cut closure instrument according to claim 29, wherein be configured for will be described for the multiple closing assembly The inward flange of left plate and right panel is pulled together to compress the notch covered by the cut closure instrument.

31. cut closure instrument according to claim 28, wherein second transverse edge of each plate includes each The outer edge of plate, wherein the outer edge of each plate is backwards to each other.

32. cut closure instrument according to claim 28, wherein one or more in the left plate and right panel of the base portion A includes elastic matrix.

33. cut closure instrument according to claim 32, wherein the elastic matrix includes elastomer film, knits Object, short fibre fabric, rubber, latex, urethane, polyurethane, silicone or thermoplastic elastomer (TPE).

34. cut closure instrument according to claim 32, wherein the elastic matrix includes fabric, the fabric is by elasticity Element is weaved and is had along first transverse edge or the second transverse edge and nonelastic across what is be laterally extended therebetween Element.

35. cut closure instrument according to claim 32, wherein each power distributed architecture includes spine and multiple axis To the horizontal support piece separated, the spine is located axially adjacent to first transverse edge placement of the plate, the multiple axis It is laterally positioned to the horizontal support piece that separates and extend from the spine towards first transverse edge of the plate.

36. cut closure instrument according to claim 35, wherein the spine and horizontal support piece can not be swollen by flexibility Swollen material is formed.

37. cut closure instrument 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.

38. cut closure instrument according to claim 35, wherein the multiple closing assembly includes multiple right engagement structures Part, multiple left engagement members and multiple lateral struts, the multiple lateral struts keep the right engagement member and left engagement The spaced preset distance of component, wherein the right engagement member is suitable for being releasably engaged the supporting element of the right panel, and The left engagement member is suitable for being releasably engaged the supporting element of the left plate.

39. the cut closure instrument according to claim 38, wherein at least some of described supporting element supporting element has Close to the chock of one or more of first transverse edge and the second transverse edge, and the engagement member has and connects Receive the slot of the chock.

40. the cut closure instrument according to claim 38, wherein the lateral struts are adjustably coupled to described connect At least one of component is closed, to allow the adjusting to the preset distance.

41. cut closure instrument according to claim 35, wherein the closing assembly includes multiple independent transverse ties Bar, the multiple independent sway brace are attached at least some of horizontal support piece horizontal support piece, wherein described Sway brace is configured for being fastened between horizontal support piece.

42. cut closure instrument according to claim 41 is fixed to wherein the independent sway brace respectively has One end of plate, and it is adjustably attached to the second end of another plate.

43. cut closure instrument according to claim 42, wherein the second end includes ratch tensioning mechanism.

44. cut closure instrument according to claim 28, further includes fastened layer, the fastened layer is suitable in the base portion After being anchored on the notch in patient skin with the assembly of the closing assembly, it is placed on the assembly.

45. cut closure instrument according to claim 44, wherein the fastened layer has self-adhering type inner surface.

46. cut closure instrument according to claim 44, wherein the fastened layer is configured as in the left plate and institute State the upper extension of one or more of first transverse edge or second transverse edge of right panel.

47. cut closure instrument according to claim 44, wherein the fastened layer has one or more perforation, to permit Perhaps the described fastened layer in response to the cut closure instrument notch and surrounding tissue placed thereon axial tension and at least Partly it is axially stretched.

48. cut closure instrument according to claim 28, wherein the multiple closing assembly includes being fastened to the left side The left closing assembly end of plate and the right closing assembly end for being fastened to the right panel, and

Wherein across the left plate and the right panel by the multiple closing assembly located lateral, wherein by the left power distributed architecture One or more of be placed between at least some axially adjacent left closing assembly ends, and by the right power distribution knot One or more of structure is placed between at least some axially adjacent right closing assembly ends, with formed power distributed architecture and The snakelike arrangement of closing assembly.

49. cut closure instrument according to claim 48, wherein left power distributed architecture will be every a pair of axially adjacent Left closing assembly end is coupled in the left plate.

50. cut closure instrument according to claim 48, wherein right power distributed architecture will be every a pair of axially adjacent Right closing assembly end is coupled on the right panel.

51. cut closure instrument according to claim 28, wherein the multiple left power distributed architecture and right power distribution knot At least one power distributed architecture in structure is C-shaped.

52. cut closure instrument according to claim 28, wherein the power distributed architecture of C-shaped includes axial component and transverse direction Part, the axial component are used to limit axially expanding for the left plate or the right panel, and the lateral part is for limiting institute State the lateral magnification of left plate or the right panel.