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 adds
Gu sub-assembly can not only provide enough intensity for pending tissue, prevent suture mouth from tearing, but also can be with kiss/closure
The nail bin face of device, nail anvil face complete anastomosis procedure, are 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-assembly
Including previous anastomotic reinforcing member, support member and fixture, the previous anastomotic reinforcing member is arranged at the support member to bend mode
On at least part of outer surface, be fixed on previous anastomotic reinforcing member 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, described the
The two ends of three reinforcing portions one end respectively with the first reinforcing portion, one end of the second reinforcing portion are connected, the previous anastomotic reinforcing member bag
Include 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 most
Small width.Preferably, the 3rd reinforcing portion (23) is internal and/or side is provided with one or more otch.Back-up coat is installed
During any trickle mismatch be likely to produce stress between the first reinforcing portion and the second reinforcing portion, when the 3rd reinforcing portion
When not having otch, these stress may in this place produce distortion or fold, so as to influence the bonding of back-up coat, the present invention is by subtracting
The width of small 3rd reinforcing portion, or can be used for discharging and eliminating these stress in the otch that the 3rd reinforcing portion is set, so as to protect
Demonstrate,proving whole first reinforcing portion, the second reinforcing portion can be effectively bond in target face.
Preferably, being shaped as the otch be linear, rectangle, triangle, arc, it is trapezoidal in one or more shape
Combination.One or more otch can be set inside the 3rd reinforcing portion, and otch can be opening or joint-cutting.Alternatively, it is interior
The otch in portion and the otch of avris can be applied in combination.
Preferably, the wherein one side of the support member is pasted with the opposite in face where strippable coating in first reinforcing portion
Close, the back side of the support member is fitted with the opposite in face where strippable coating in second reinforcing portion, the one of the support member
Hold and fitted with the opposite in face where strippable coating in the 3rd reinforcing portion, 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 coating
Total length, the total length of the total length of more preferably described strippable coating more than tack coat;The fixture is at least in part
On back-up coat, the previous anastomotic reinforcing member is fixed on support member.The fixture is located at the length sides of back-up coat
Along and strippable coating length sides between so that fixture can be fixing reinforcing by way of clamping back-up coat end
Part, to be conducive to removing 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, it is ensured that tack coat
Unsuitable position is bonded to before will not reusing.
The effect of back-up coat is the suture reinforced for destination organization, auxiliary stapler, 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 factor
Sheet with glycoprotein removes antigen animal sources cell epimatrix material;The material non-immunogenicity of the back-up coat, can drop in vivo
Solution, with three-dimensional netted loose structure, can reinforce previous anastomotic.
The material of back-up coat, can be any suitable biocompatible materials, reconstruct or the collagen support of natural origin
Material etc..Collagen backing material, spy is cell epimatrix material, is me because of its advantage in hemostasis and promotion wound healing
It is of interest.Cell epimatrix material, may come from submucosa, cyst membrane, dura mater, pericardium, peritonaeum, dermal collagen, flesh
Counterdie etc..In the present invention, it is preferred to submucosa, submucosa particularly homoiothermous, as the material of back-up coat.It is optional
Additional crosslink agent and the type for being not added with crosslinking agent, preferably maintain the extracellular base of mammalian submucosa of native three dimensional structure
Material.Consider the abundant and easy availability of material source, as meat or other rules of origin letting animals feed for example pig, ox,
The cell epimatrix material of sheep is more particularly suitable.Trees-Osima jacoti, Osima excavata is preferred material of the invention, and source and processing method can
With reference to Chinese patent ZL201310203603.7.
Cell epimatrix material optionally retains the growth factor or other bioactive ingredients of basic stitch.Example
Such as, cell epimatrix material can include one or more growth factors, such as basic fibroblast growth factor (FGF-2), turn
Change growth factor-beta (TGF-β), EGF (EGF), and/or platelet derived growth factor (PDGF).Meanwhile, mucous membrane
Lower floor or other may also include heparin, heparin sulfate, hyaluronic acid, fibronectin for cell epimatrix material of the invention
Etc. biomass.Therefore, as a rule, cell epimatrix material may include a bioactive ingredients, can be direct or indirect
Inducing cell reaction, such as change in cellular morphology, division, growth, protein or gene expression.Additionally, as to this
The supplement or replacement of source bioactive ingredients, the non-indigenous organisms active material obtained by recombinant technique or other method also may be used
To be added to cell epimatrix material.
Other not-bio-absorbables or biodegradable synthesis macromolecular material such as polytetrafluoroethylmaterial material (PTFE,
Such as GORE-TEX materials), nylon, PP, polyurethane, organosilicon, PGA, PLA or polycaprolactone, it is also possible to for making in the present invention
It is 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 difficulty
To realize effectively reinforcing, limited is increased to tissue intensity, can not effectively seal hemostasis to nail mouth.If it is necessary, can make
With the back-up coat of sandwich construction.Such as, a collagen-based materials for multilayer (i.e. more than two-layer or two-layer), such as submucosa or its
His cell epimatrix material, can be grouped together into an identical reinforcing material for sandwich construction.Specifically, two,
3rd, four, five, six, seven, eight or more submucosa or other cell epimatrix materials can be combined together to form one
The back-up coat of multilayer.
Tack coat can be used for for forming connection between the working face and back-up coat of kiss/closer so that back-up coat can
To transport to destination organization, and between the working face and destination organization of kiss/closer, the reinforcing to staple line of coincideing is realized, made
For 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 that
The material of the support member is ceramics, metal, rubber or plastics.Under normal circumstances, when support member is the harder or rigid of plane
Material, for on-plane surface nail anvil face of the prior art and nail bin face, it is impossible to ensure the firm installation of back-up coat, especially for
For curved, bending side shape working face and stepped working face, the tack coat on back-up coat cannot be fully contacted with working face,
Effectively bonding cannot thus be realized, it is possible to cause coming off for back-up coat.Can be using the support matched with on-plane surface working face
Part 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 face
Tread.Additionally, it is also possible to use flexible or elastomeric material provides transformable supporting surface.These materials are planes when being acted on without external force
Structure;When install reinforcing member when, these materials are deformed upon because being squeezed, thus can also provide curved surface, bending side or
Cascaded surface.Because fixture is usually flexibility, therefore back-up coat can be still fixed on support member using fixture,
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 flexibility
To deform, so in the case where nail anvil and nail bin are clamped, the tack coat on support member will be tight with nail anvil and nail bin
It is closely connected to merge well-bonded, hereby it is ensured that adhesion strength.
When reinforcing sub-assembly of the invention is made, first tack coat can be coated on strippable coating, will be coincide after drying
Mouth reinforcing member is fitted 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, it is also possible to be discontinuously arranged at the surface of back-up coat.
After using above structure, a kind of previous anastomotic of the invention reinforces sub-assembly compared with prior art with following excellent
Point:The previous anastomotic reinforcing member is secured precisely on the nail bin of stapler and/or anvil block by way of pasting, and companion
Kiss/closer front end is in body surface or enters in vivo to complete anastomosis procedure.Fixation between previous anastomotic reinforcing member and kiss/closer
It is to be completed under free space, is not limited by operating space.And the previous anastomotic reinforcing member for assembling is with kiss/closer together
No longer there is relative displacement in motion.
It is a further object of the present invention to provide the application method that a kind of previous anastomotic reinforces sub-assembly, the method will can be reinforced
Layer is disposably adhered on the working face of kiss/closure, simplifies surgical procedure, is 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 provided
Be bonded in back-up coat on kiss/closer by method:The nail anvil and nail bin on kiss/closer are opened, is removed and is followed closely with the kiss/closer
The 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 nail
The working face alignment of anvil, nail bin, after alignment, closure nail anvil, nail bin are clamped, and tack coat is bonded on nail anvil, nail bin, are removed
Fixture, opens nail anvil and nail bin again, removes support member.
Preferably, bonding of the tack coat on kiss/closer nail anvil and nail bin is connected for removable, the branch
The thickness of support member can 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, can control its viscosity by controlling coating thickness in use, make bonding of the tack coat on kiss/closer be removable
Formula is connected, 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 in nail bin the back-up coat of global design by tack coat
On the working face of nail anvil, fragile tissue is strengthened with surgical procedure, it is to avoid produce undesirable damaged and ooze
Leakage.And further, by the setting of structure and supporting piece structure to back-up coat, it is ensured that back-up coat and nail bin and nail anvil
Working face is combined closely.
Specific 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, branch
Support 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 4
On, previous anastomotic reinforcing member 2 includes the first reinforcing portion 21, the second reinforcing portion 22 and the 3rd reinforcing portion 23, the two of the 3rd reinforcing portion 23
End one end respectively with the first reinforcing portion 21, one end of the second reinforcing portion 22 be connecteds, and previous anastomotic reinforcing member 1 includes strippable coating
2c, tack coat 2b and back-up coat 2a.
The one side of support member 3 is fitted with the opposite in face where strippable coating 2c in the first reinforcing portion 21, the support member 3
Another side fit 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 23
The opposite laminating in face where middle strippable coating 2c, fixture 4 is enclosed within the other end of support member 3, that is to say, that support member 3 with coincide
The back-up coat 2a laminatings of mouth reinforcing member 2.
The total length of the back-up coat 2a of previous anastomotic reinforcing member 2 is respectively greater than tack coat 2b, the total length of strippable coating 2c, can
Total length of the total length of peel ply 2c more than tack coat 2b, fixture 4 is located at length sides edge and the strippable coating of back-up coat 2a
The length sides of 2c are between, that is to say, that fixture 4 entangles tack coat 2b and is secured on support member 3.Preferably, it is peelable
The total length of the total length more than tack coat 2b of layer 2c, is more beneficial for removal strippable coating 2c.
When previous anastomotic reinforcing sub-assembly 1 is installed on support member 3, first reinforcing portion 21 and second of back-up coat 2a adds
Gu 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 adds
Gu will occur distortion and fold because of the bending again after doubling at portion 23, this distortion and fold cause the first reinforcing portion 21
And/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 enough
Closely.
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 reinforced
The 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 23
Minimum widith is less than the first reinforcing portion 21 and the minimum widith of the second reinforcing portion 22, it becomes possible to discharges stress, reduces or eliminates torsion
Bent and fold.One or more otch, for example, rectangle, triangle, arc can be provided with the inside of the 3rd reinforcing portion 23 or side
Shape, trapezoidal middle a kind of, or various shapes combinations, or even otch can be only one or two gaps.The otch can
To be arranged on two side edges of the 3rd reinforcing portion 23, it is also possible to be provided only on a side edge, it is also possible to using internal otch with
The notch combinations of avris are used.
The surface of support member 3 can be it is flat, also dependent on nail anvil 51 and nail bin 52 shape be processed into curved surface, bending side or
Cascaded 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 conditions
Selection, support member 3 can also be any one of Fig. 4 examples.The selection of support member 3 can be macromolecular material, plastics, pottery
Porcelain, metal or its composition.The thickness of support member 3 can set according to the permission thickness between nail anvil 51 and nail bin 52, this
The thickness of the support member 3 used in invention is preferred 50-1000 microns, 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 force
Structure;Support member 3 is deformed upon when previous anastomotic reinforcing member 2 is bonded due to the extruding of nail anvil 51 and nail bin 52, thus provides bent
Face, bending side or cascaded surface.Support member 3 including elastomeric material is combined with the previous anastomotic reinforcing member 2 with otch, Neng Gouyou
The 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 schematic diagram when using the previous anastomotic reinforcing installation back-up coat 2a of sub-assembly 1.From fig. 5, it is seen that kiss/
Kiss/the 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 1
When, open the nail anvil 51 of kiss/closer 5 and nail bin 52;Reinforced on sub-assembly 1 from previous anastomotic and remove strippable coating 2c, and put
Enter between the working face of nail anvil 51 and nail bin 52.Tack coat 2b is aligned with the working face of nail anvil 51 and nail bin 52, to ensure to glue
Knot 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 sides
Tightly, tack coat 2b is contacted the working face of nail anvil 51 and nail bin 52, and bond each other, remove for fixing back-up coat 2a
Fixture 4, nail anvil 51 and nail bin 52 are opened again, remove support member 3.Now, back-up coat 2a has been bonded in kiss/closer
On 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/close
Closing operation.
Medical device provided by the present invention can be used for easy various surgical operation, and these operations include but do not limit
In various pneumonectomies operation, the treatment of soft tissue injury and defect, and other various surgical operations.Doctor provided by the present invention
Treat apparatus and can be used for people, it is also possible to for animal.Medical device provided by the present invention can be used for various
Surgery bracing means, it is also possible to be adjusted to size, size, the shape of various suitable feature surgery bracing means.
The present invention is introduced with the application on kiss/closer, but purposes of the invention is not limited to surgery kiss/closer
Field, it is also possible to for other reparation fields, can be also sized according to purposes, size, adhesive consumption etc..
Medicine equipment of the invention can be provided with being suitable for the aseptic packaging form of medical device product, and sterilizing can lead to
Cross irradiation, ethylene oxide gas or other sterilization technologies 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 hair
Bright 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 invention
The various change of work is within the scope of the present invention.