The content of the invention
The technical problems to be solved by the invention are：A kind of previous anastomotic is provided and reinforces sub-assembly, previous anastomotic of the invention addsGu sub-assembly can not only provide enough intensity for pending tissue, prevent from suturing mouth tear, but also can be with kiss/closureAnastomosis procedure is completed in nail bin face, the nail anvil face of device, is not limited by operating space.
The technical solution used in the present invention is：A kind of previous anastomotic is provided and reinforces sub-assembly, the previous anastomotic reinforces sub-assemblyIncluding previous anastomotic reinforcing member, support member and fixture, the previous anastomotic reinforcing member is arranged at the support member in a manner of bendingOn at least part outer surface, previous anastomotic reinforcing member is fixed on the support member by the fixture.
Preferably, the previous anastomotic reinforcing member includes the first reinforcing portion, the second reinforcing portion and the 3rd reinforcing portion, describedOne end with the first reinforcing portion, one end of the second reinforcing portion are connected respectively at the both ends of three reinforcing portions, the previous anastomotic reinforcing member bagInclude strippable coating, tack coat and one or more layers back-up coat.
Preferably, the minimum widith of first reinforcing portion and the second reinforcing portion is all higher than the 3rd reinforcing portion mostSmall width.Preferably, the 3rd reinforcing portion (23) is internal and/or side is provided with one or more otch.Back-up coat is installedDuring any trickle mismatch be likely to produce stress between the first reinforcing portion and the second reinforcing portion, when the 3rd reinforcing portionWhen not having otch, these stress may produce distortion or fold in this place, and so as to influence the bonding of back-up coat, the present invention is by subtractingThe width of small 3rd reinforcing portion, or can be used for discharging in the otch that the 3rd reinforcing portion is set and eliminate these stress, so as to protectDemonstrate,prove whole first reinforcing portion, the second reinforcing portion can be effectively bond in target face.
Preferably, being shaped as the otch is linear, rectangle, triangle, arc, trapezoidal middle one or more shapesCombination.One or more otch can be set inside the 3rd reinforcing portion, and otch can be opening or joint-cutting.Alternatively, it is interiorThe otch in portion and the otch of avris can be applied in combination.
Preferably, the wherein one side of the support member and the opposite in face where strippable coating in first reinforcing portion are pastedTo close, the back side of the support member is bonded with the opposite in face where strippable coating in second reinforcing portion, and the one of the support memberThe opposite with face where strippable coating in the 3rd reinforcing portion is held to be bonded, the other end of the support member is connected with fixture.
Preferably, the total length of the back-up coat of the previous anastomotic reinforcing member is respectively greater than the tack coat, strippable coatingTotal length, the total length of more preferably described strippable coating is more than the total length of tack coat；The fixture is at least in partOn back-up coat, the previous anastomotic reinforcing member is fixed on support member.The fixture is located at the length sides of back-up coatAlong the length sides with strippable coating between so that fixture can be fixing reinforcing in a manner of clamping back-up coat endPart, to be advantageous to remove strippable coating from reinforcing member.
Preferably, the strippable coating includes silicon layer and basalis, the material of basalis is paper or PET film,The effect of strippable coating is to maintain the stickiness of tack coat, and isolation is formed between tack coat and external environment, ensures tack coatUnsuitable position is bonded to before will not reusing.
The effect of back-up coat is to be used for destination organization, the suture that auxiliary stapler is reinforced, plays support humidification,Injury of the anastomosis staple to destination organization is alleviated or avoided.
Preferably, the material of the back-up coat is further selected from comprising non-crosslinked type collagen fiber, mucopolysaccharide, growth factorAntigen animal sources cell epimatrix material is removed with the sheet of glycoprotein；The material non-immunogenicity of the back-up coat, can drop in vivoSolution, has three-dimensional netted loose structure, can reinforce previous anastomotic.
The material of back-up coat, can be any suitable biocompatible materials, the collagen support of reconstruct or natural originMaterial etc..Collagen backing material, spy are cell epimatrix materials, are me because it stop blooding and is promoting the advantage in wound healingIt is of interest.Cell epimatrix material, it may come from submucosa, cyst membrane, dura mater, pericardium, peritonaeum, dermal collagen, fleshCounterdie etc..In the present invention, it is preferred to submucosa, submucosa particularly homoiothermous, the material as back-up coat.It is optionalAdditional crosslink agent and the type for being not added with crosslinking agent, preferably maintain the extracellular base of mammalian submucosa of native three dimensional structureMaterial.Consider the abundant and easy availability of material source, as the letting animals feed of meat or other rules of origin for example pig, ox,The cell epimatrix material of sheep is more particularly suitable.Trees-Osima jacoti, Osima excavata is the preferred material of the present invention, and source and processing method canWith reference to Chinese patent ZL201310203603.7.
Cell epimatrix material optionally retains the growth factor of basic stitch or other bioactive ingredients.ExampleSuch as, cell epimatrix material can include one or more growth factors, such as basic fibroblast growth factor (FGF-2), turnChange growth factor-beta (TGF-β), EGF (EGF), and/or platelet derived growth factor (PDGF).Meanwhile mucous membraneLower floor or other cell epimatrix materials for being used for the present invention may also include heparin, heparin sulfate, hyaluronic acid, fibronectinEtc. biomass.Therefore, as a rule, cell epimatrix material may include a bioactive ingredients, can be direct or indirectInducing cell reaction, such as change in cellular morphology, division, growth, protein or gene expression.In addition, as to thisThe supplement or replacement of source bioactive ingredients, the non-indigenous organisms active material obtained by recombinant technique or other method also may be usedTo be added to cell epimatrix material.
Other not-bio-absorbables or biodegradable synthesis high polymer material such as polytetrafluoroethylmaterial material (PTFE,Such as GORE-TEX materials), nylon, PP, polyurethane, organosilicon, PGA, PLA or polycaprolactone can be used for making in the present inventionFor the material of back-up coat.
Back-up coat in the present invention should not be too thick, because too thick can influence penetrating for anastomosis staple；Also should not be too thin, too thin difficultyEffectively reinforced with realizing, it is limited to tissue intensity increase, hemostasis can not be effectively sealed to nail mouth.If it is necessary, it can makeWith the back-up coat of sandwich construction.Such as the collagen-based materials of a multilayer (i.e. two layers or more than two layers), such as submucosa or itsHis cell epimatrix material, the identical reinforcing material of a sandwich construction can be grouped together into.Specifically, two,3rd, four, five, six, seven, eight or more submucosa or other cell epimatrix materials can be combined together to form oneThe back-up coat of multilayer.
Tack coat can be used for being used to form connection between the working face and back-up coat of kiss/closer so that back-up coat canTo transport destination organization, and between the working face and destination organization of kiss/closer, the reinforcing to staple line of coincideing is realized, is madeTo be preferred, the material of the tack coat includes protein adhesive.
Preferably, the support member can provide the supporting surface of plane, curved surface, bending side or cascaded surface.It is highly preferred thatThe material of the support member is ceramics, metal, rubber or plastics.Under normal circumstances, when support member is the harder or rigid of planeMaterial, for on-plane surface nail anvil face of the prior art and nail bin face, the firm installation of back-up coat can not be ensured, especially forFor curved, bending side shape working face and stepped working face, the tack coat on back-up coat can not fully contact with working face,Effective bonding thus can not be realized, it is possible to cause coming off for back-up coat.The support matched with on-plane surface working face can be usedPart provides support to back-up coat.The seating surface of support member can be curved surface, bending side or the rank matched with kiss/closer working faceTread.In addition, also flexible or elastomeric material can be used to provide transformable supporting surface.These materials are planes when being acted on without external forceStructure；When installing reinforcing member, these materials deform upon because being squeezed, thus can also provide curved surface, bending side orCascaded surface.Because fixture is usually flexible, therefore back-up coat can be still fixed on using fixture on support member,During bonding, because the surface of support member and the shape of working face are identical, and back-up coat and tack coat sheet can as flexibilityTo deform, so in the case where nail anvil and nail bin clamp, the tack coat on support member will be tight with nail anvil and nail binIt is closely connected merge it is well-bonded, hereby it is ensured that adhesion strength.
When making the reinforcing sub-assembly of the present invention, first tack coat can be coated on strippable coating, will be coincide after dryingMouth reinforcing member is bonded with support member, tack coat is transferred on back-up coat；Directly tack coat can also be produced on fixed bed；Tack coat can be continuously provided in reinforcing layer surface, can also discontinuously be arranged at the surface of back-up coat.
After above structure, a kind of previous anastomotic of the invention reinforces sub-assembly compared with prior art with following excellentPoint：The previous anastomotic reinforcing member is secured precisely on the nail bin and/or anvil block of stapler by way of stickup, and companionKiss/closer front end is in body surface or enters in vivo to complete anastomosis procedure.Fixation between previous anastomotic reinforcing member and kiss/closerIt is to be completed under free space, is not limited by operating space.And the previous anastomotic reinforcing member assembled and kiss/closer are togetherRelative displacement no longer occurs for motion.
It is a further object of the present invention to provide the application method that a kind of previous anastomotic reinforces sub-assembly, this method will can reinforceLayer is disposably adhered on the working face of kiss/closure, simplifies surgical procedure, easy to operation.
The technical solution used in the present invention is：The application method that a kind of previous anastomotic reinforces sub-assembly, the user are providedBack-up coat is bonded on kiss/closer by method：The nail anvil and nail bin on kiss/closer are opened, removes and is followed closely with the kiss/closerThe corresponding previous anastomotic of storehouse, anvil shape reinforces the strippable coating of sub-assembly, be put between the opening of nail anvil, nail bin and with nailThe working face alignment of anvil, nail bin, after alignment, closure nail anvil, nail bin, clamp, tack coat is bonded in nail anvil, on nail bin, removeFixture, nail anvil and nail bin are opened again, removes support member.
Preferably, the tack coat is that removable connects with the bonding on nail bin in kiss/closer nail anvil, the branchThe thickness of support member can be set according to the permission thickness between nail bin and nail anvil, and preferably the thickness of support member is that 50-1000 is micro-Rice, in use can be by controlling coating thickness to control its viscosity, and it is removable to make bonding of the tack coat on kiss/closerFormula connects, and the suture confining force of the back-up coat is in more than 5N.
The present invention provides a kind of reinforcing sub-assembly, is one-time fixed the back-up coat of global design in nail bin by tack coatOn the working face of nail anvil, to strengthen in surgical procedure the tissue of fragility, avoid producing undesirable damaged and oozeLeakage.And further, by the structure to back-up coat and the setting of supporting piece structure, ensure back-up coat and nail bin and nail anvilWorking face is combined closely.
Embodiment
The invention will be further described with reference to the accompanying drawings and detailed description.
As shown in Figure 1 and Figure 2, the present invention provides a kind of previous anastomotic and reinforces sub-assembly 1, and it includes previous anastomotic reinforcing member 2, branchSupport member 3 and fixture 4, previous anastomotic reinforcing member 2 are coincide with support member 3, and previous anastomotic reinforcing member 2 is fixed on support member 3 by fixture 4On, previous anastomotic reinforcing member 2 includes the first reinforcing portion 21, the second reinforcing portion 22 and the 3rd reinforcing portion 23, and the two of the 3rd reinforcing portion 23One end with the first reinforcing portion 21, one end of the second reinforcing portion 22 are connected respectively at end, and previous anastomotic reinforcing member 1 includes strippable coating2c, tack coat 2b and back-up coat 2a.
The one side of support member 3 is bonded with the opposite in face where strippable coating 2c in the first reinforcing portion 21, the support member 3Another side is bonded with the opposite in face where strippable coating 2c in the second reinforcing portion 22, one end of support member 3 and the 3rd reinforcing portion 23The opposite fitting in face where middle strippable coating 2c, fixture 4 are enclosed on the other end of support member 3, that is to say, that support member 3 is with coincideingThe back-up coat 2a fittings of mouth reinforcing member 2.
The back-up coat 2a of previous anastomotic reinforcing member 2 total length is respectively greater than tack coat 2b, strippable coating 2c total length, canPeel ply 2c total length is more than tack coat 2b total length, and fixture 4 is located at back-up coat 2a length sides edge and strippable coating2c length sides are between, that is to say, that fixture 4 entangles tack coat 2b and is secured on support member 3.Preferably, it is peelableLayer 2c total length is more than tack coat 2b total length, is more beneficial for removing strippable coating 2c.
When previous anastomotic reinforcing sub-assembly 1 is installed on support member 3, back-up coat 2a the first reinforcing portion 21 and second addsGu portion 22 deforms upon, when the 3rd reinforcing portion 23 is identical with the width of the first reinforcing portion 21 and the second reinforcing portion 22, the 3rd addsGu will occur distorting because of the bending again after doubling at portion 23 and fold, this distortion and fold cause the first reinforcing portion 21And/or second the working face of reinforcing portion 22 (especially at the 3rd reinforcing portion 23) between nail anvil 51 and nail bin 52 combined not enoughClosely.
It can be solved the above problems in the otch of the 3rd reinforcing portion 23.As shown in figure 3, the first reinforcing portion 21 and second is reinforcedThe minimum widith in portion 22 is all higher than the minimum widith of the 3rd reinforcing portion 23, otch is set, as long as making the 3rd reinforcing portion 23Minimum widith is less than the minimum widith of the first reinforcing portion 21 and the second reinforcing portion 22, it becomes possible to discharges stress, reduces or eliminates torsionBent and fold.One or more otch, for example, rectangle, triangle, arc can be provided with the inside of the 3rd reinforcing portion 23 or sideShape, trapezoidal middle a kind of or various shapes combinations, or even otch can be only one or two gaps.The otch canTo be arranged on two side edges of the 3rd reinforcing portion 23, a side edge can also be provided only on, can also use internal otch andThe notch combinations of avris use.
The surface of support member 3 can be flat, can be also processed into according to the shape of nail anvil 51 and nail bin 52 curved surface, bending side orCascaded surface, as shown in figure 4, rib can be the rib of chamfering wherein in cascaded surface；And the quantity of ladder can be according to actual conditionsSelection, support member 3 can also be any one of Fig. 4 examples.The selection of support member 3 can be high polymer material, plastics, potteryPorcelain, metal or its composition.The thickness of support member 3 can be set according to the permission thickness between nail anvil 51 and nail bin 52, thisThe preferred 50-1000 microns of thickness for the support member 3 used in invention, more preferably 100-600 microns, most preferably 100-350 microns,Support member 3 can also include flexible or elastomeric material, such as rubber or plastics.Elastomeric material is planar junction when being acted on without external forceStructure；Support member 3 is deformed upon when bonding previous anastomotic reinforcing member 2 due to the extruding of nail anvil 51 and nail bin 52, thus is provided bentFace, bending side or cascaded surface.Support member 3 including elastomeric material is combined with the previous anastomotic reinforcing member 2 with otch, Neng GouyouThe tack coat 2b for helping previous anastomotic reinforcing member 2 is fully be bonded with the working face of nail anvil 51 and nail bin 52.
Fig. 5 is that schematic diagram when sub-assembly 1 installs back-up coat 2a is reinforced using previous anastomotic.From fig. 5, it is seen that kiss/Kiss/closing structure of closer 5 is jaw formula structure, including with nail anvil 51 and nail bin 52.Previous anastomotic is installed and reinforces sub-assembly 1When, the nail anvil 51 and nail bin 52 that make kiss/closer 5 open；Reinforced from previous anastomotic on sub-assembly 1 and remove strippable coating 2c, and putBetween the working face for entering nail anvil 51 and nail bin 52.Tack coat 2b is aligned with the working face of nail anvil 51 and nail bin 52, it is viscous to ensureKnot layer 2b can be glued on the working face of nail anvil 51 and nail bin 52 exactly.After alignment, close nail anvil 51 and nail bin 52 and press from both sidesTightly, make the working face of tack coat 2b contact nail anvils 51 and nail bin 52, and bond between each other, remove for fixing back-up coat 2aFixture 4, open nail anvil 51 and nail bin 52 again, remove support member 3.Now, back-up coat 2a has been bonded in kiss/closerOn 5 nail anvil 51 and the working face of nail bin 52, and depart from support member 3, afterwards, kiss/closer 5 can further be implemented to kiss/closesClosing operation.
Medical device provided by the present invention can be used for easy various surgical operation, and these operations include but unlimitedPerformed the operation in various pneumonectomies, the treatment of soft tissue injury and defect, and other various surgical operations.Doctor provided by the present inventionTreat apparatus and can be used for people, can be used for animal.Medical device provided by the present invention can be used for variousSurgery bracing means, size, size, the shape of various suitable feature surgery bracing means can also be adjusted to.
The present invention is introduced with the application on kiss/closer, but the purposes of the present invention is not limited to surgery kiss/closerField, other reparation fields are can be used for, can be also sized according to purposes, size, adhesive dosage etc..
The medicine equipment of the present invention can be provided in the form of the aseptic packaging for being suitable for medical device product, and sterilizing can lead toIrradiation, ethylene oxide gas or other sterilization technologies is crossed to realize, while the material and performance of corresponding selection packaging.
Preferred embodiments of the present invention are described above, but are not to be construed as limiting the scope of the invention.This hairBright to be not only limited to above example, its concrete structure allows to change, all institutes in the protection domain of demand for independence of the present inventionThe various change of work is within the scope of the present invention.