CN106420109A - Composite porous cross-linked breast patch and preparation method - Google Patents
Composite porous cross-linked breast patch and preparation method Download PDFInfo
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- CN106420109A CN106420109A CN201611000802.8A CN201611000802A CN106420109A CN 106420109 A CN106420109 A CN 106420109A CN 201611000802 A CN201611000802 A CN 201611000802A CN 106420109 A CN106420109 A CN 106420109A
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- cross
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- linked layer
- sticking patch
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/12—Mammary prostheses and implants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3683—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/58—Materials at least partially resorbable by the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
Abstract
The invention belongs to the technical field of tissue engineering and particularly relates to a composite porous cross-linked breast patch and preparation method, wherein the composite porous cross-linked breast patch adopts double layer structure. For one thing, the combination of the double layer structure ensures that the material has good histocompatibility and degradation performance. Furthermore, the occurrence of the prosthesis displacement caused by the high degradation velocity of materials and other complications can also be avoided. The preparation method of the composite porous cross-linked breast patch is executed by special bonding and freeze-drying on the cross-linked layers and the non-cross-linked layers. And the composite porous cross-linked breast patch is made by perforation. The preparation method has the advantages of easy industrialization and good market application value.
Description
Technical field
The invention belongs to tissue engineering technique field, and in particular to a kind of compound cross linked porous breast sticking patch and its preparation
Method.
Background technology
In recent years, as the development of shaping technique and women are to beautiful pursuit, Mammaplasty operation has become increasingly popular
One of plastic operation.Mammaplasty operation mainly includes breast congenital malformation, the breast enlargement of suckling atrophy, mastoptosiss
Suspension, Jushi Garden art, Elipten AG note take rear udder attachment prothesiss and the breast reconstruction after mammary gland carcinectomy etc..?
When carrying out breast finishing or breasst reconstruction using prosthese, usually as short and small weak, the implantation post gap of pectoralis major is less, it is difficult to cover
Lid prosthetic surface, causes postoperative udder shape unsightly, and breast is harder, easily touches prosthese profile, in addition cause capsule contracture,
The generation of the complication such as prostheses migration, even causes infection when serious, needs operation to take out prosthese, has had a strong impact on and asked beautiful person's
Physically and mentally healthy and orthobiosiss.
Clinically need in such breast enlargement the breast soft tissue of defect or deficiency is repaired, have prosthetic surface
Sufficient soft tissue is covered, while play support and fixation to prosthese, so that Using prosthesis lacuna is sufficient, natural, no
Easily shift, the breast shape that is repaired is attractive in appearance, feel is true, be difficult prosthese is touched, reduce the generation of postoperative related complication.
In order to solve the above problems, the invention provides a kind of compound cross linked porous breast sticking patch and preparation method thereof,
The compound cross linked porous breast sticking patch, repairs to defect breast tissue in Mammaplasty operation, while can be to planting
The breast prosthesises for entering are drawn and are fixed, and make the breast after trimming more natural, attractive in appearance.
Content of the invention
It is an advantage of the invention to provide a kind of compound cross linked porous breast sticking patch, which adopts double-decker
Biomembrane material, so as to constitute existing cross-linked layer, have the compound breast sticking patch of non-cross-linked layer again；
It is still another object of the present invention to provide a kind of compound cross linked porous breast sticking patch, which is in the table of sticking patch
Face is punched, prosthetic augmentation mammoplasty operation in, on the premise of mechanical property is not changed, can discharge beneficial to hydrops, minimizing by
The generation of the complication such as the seroma for causing in hydrops；
It is still another object of the present invention to provide a kind of preparation method of compound cross linked porous breast sticking patch, its
Above-mentioned compound cross linked porous breast sticking patch of good performance can be prepared.
In order to solve the above problems, the invention provides a kind of compound cross linked porous breast sticking patch, including：
Non-cross-linked layer, which is membrane tissue；
Cross-linked layer, which is the membrane tissue for processing through cross-linking agent；
Wherein, the cross-linked layer and non-cross-linked layer are respectively provided with matsurface and shiny surface, by complex method, by the crosslinking
The shiny surface of the matsurface of layer and the non-cross-linked layer is combined into double-decker, forms breast sticking patch.
Preferably, the non-cross-linked layer is animal derived accellular pericardial film, peritoneum, pleura or goldbeater's skin, the friendship
Connection layer is animal derived accellular pericardial film, peritoneum, pleura or the goldbeater's skin for processing through cross-linking agent.
Preferably, the thickness of the non-cross-linked layer is 0.1～0.8mm, and the thickness of the cross-linked layer is 0.1～1.2mm.
Preferably, the thickness of the breast sticking patch is 0.2～2.0mm.
Preferably, by the composite square of silk sutures, medical adhesive bonding, mechanical press or reagent bonding
Formula, the shiny surface of the matsurface of the cross-linked layer and the non-cross-linked layer is combined into double-decker, forms breast sticking patch.
Preferably, described cross-linking agent is 1- (3- dimethylamino-propyl) -3- ethyl carbodiimide, genipin, glutaraldehyde
Or one kind of epoxides, the concentration of the cross-linking agent is 0.01～0.5M.
Preferably, the cross-linking agent is the dense of 1- (3- dimethylamino-propyl) -3- ethyl carbodiimide, the cross-linking agent
Spend for 0.05～0.2M.
Preferably, multiple apertures are also included, which is opened on the double-decker, the aperture of the plurality of aperture is
0.5～2.5mm, the hole density of the plurality of aperture is 0.5～2.0/cm2.
A kind of preparation method of compound cross linked porous breast sticking patch, comprises the following steps：
The preparation of non-cross-linked layer：From fresh animal source property pericardium, peritoneum, pleura or this goldbeater's skin, through pre-treatment, take off
Prepared by fat, sterilization and de- cell, obtain non-cross-linked layer, and the non-cross-linked layer has shiny surface and matsurface, the non-cross-linked layer
Thickness be 0.1～0.8mm；
The preparation of cross-linked layer：The non-cross-linked layer is processed in cross-linking agent, is crosslinked 2～5 times repeatedly, cross-linked layer is obtained,
The cross-linked layer has shiny surface and matsurface, and the thickness of the cross-linked layer is 0.1～1.2mm；
Double-decker is combined：The non-cross-linked layer and the cross-linked layer are tiled, the smooth of the cross-linked layer faces down, non-
The coarse of cross-linked layer faces up, and after being suppressed using mould, is dried, and carries out after drying cutting into variously-shaped, formation bilayer
Structural material；
Fixing：Using absorbable medical suture, from the 0.5～1cm of edge of the double-decker material by double-deck knot
The suture of structure material is fixed, and needle gage is 0.5～1cm, or uses degradable medical glue such as cyanoacrylate, polyurethane or machinery
Double-decker material is fixed by pressing or reagent bonding, and the thickness of the double-decker material for fixing is 0.2～2.0mm；
Packaging, sterilizing：The double-decker material for fixing is packed, and ethane via epoxyethane or 60Coradiation sterilizing,
Obtain breast sticking patch.
Preferably, also include punch out step before packaging, sterilizing, specific as follows：
Using puncher, the double-decker material for fixing is punched, multiple apertures are formed, the plurality of aperture
Aperture is 0.5～2.5mm, and the hole density of the plurality of aperture is 0.5～2.0/cm2.
Beneficial effects of the present invention：
1st, the compound cross linked porous breast sticking patch that the present invention is provided, the breast tissue in its Mammaplasty operation to defect
Repaired, while can be drawn to the breast prosthesises of implantation and be fixed, make the breast after finishing more natural, attractive in appearance.
2nd, the compound cross linked porous breast sticking patch that the present invention is provided, which is organized as raw material using animal membrane, fully profit
With the advantage of biomembrane material itself, reduce the postoperative related complication for being caused by prosthese.
3rd, the compound cross linked porous breast sticking patch that the present invention is provided, cross-linked layer and non-cross-linked layer are used in combination by which,
When carrying out breast finishing operation using prosthese, the dense face of its cross-linked layer is fitted towards prosthese with prosthesis, as structure is caused
Close, cell can be intercepted and grown into, reduce the related complication for being caused by prosthese；Its non-cross-linked layer for using loose facing to group
Knit, can rapid induction peripheral cell grow into and revascularization, promote material and tissue ready integration in a short time.
4th, the compound cross linked porous breast sticking patch that the present invention is provided, the cross-linked layer explanation which adopts is relatively slow, can maintain whole
Individual material mechanical support effect long-term in vivo, it is to avoid as material is explained too fast caused prostheses migration, comes off etc. now
The generation of elephant.
5th, the compound cross linked porous breast sticking patch that the present invention is provided, which is designed punching to double layer material so as to should
For when in breast augmentation, beneficial to postoperative hydrops seepage, it is to avoid caused the generation of the phenomenons such as seroma by hydrops, make operation more
Safely, effectively.
6th, the manufacture method that the present invention provides compound cross linked porous breast sticking patch, which passes through to be organized as original using animal membrane
Material, prepares the compound cross linked porous breast sticking patch that safely and effectively can use.
Description of the drawings
Fig. 1 is the side schematic view of the compound cross linked porous breast sticking patch；
Fig. 2 is the front schematic view of the compound cross linked porous breast sticking patch；
Fig. 3 is the front pictorial diagram of the compound cross linked porous breast sticking patch；
Fig. 4 is the reverse side pictorial diagram of the compound cross linked porous breast sticking patch；
Fig. 5 is the scanning electron microscope (SEM) photograph on the dense face surface of the cross-linked layer；
Fig. 6 is the scanning electron microscope (SEM) photograph on the loose face surface of the non-cross-linked layer；
Fig. 7 is the scanning electron microscope (SEM) photograph in the section of the compound cross linked porous breast sticking patch；
Fig. 8 is the detection data figure of the tensile break strength of the compound cross linked porous breast sticking patch；
Fig. 9 is the detection data figure of the bursting power of the compound cross linked porous breast sticking patch；
Figure 10 is that the compound cross linked porous breast sticking patch subcutaneous rat is implanted into 8W and draws materials HE coloration result figure；
In Fig. 1,1 is cross-linked layer；2 is non-cross-linked layer.
Specific embodiment
With reference to specific embodiment and accompanying drawing, the present invention is described in further detail, to make people in the art
Member can implement according to this with reference to specification word.
It should be appreciated that such as " with ", "comprising" and " including " term used herein are not precluded from one or many
The presence of other combinations individual or interpolation.
Following examples in the present invention are raw material, to prepare non-cross-linked layer and cross-linked layer all using bovine pericardium, certainly also
Can select other animal derived accellular pericardial films, peritoneum, pleura or goldbeater's skin, cross-linked layer and non-cross-linked layer be respectively provided with light
Sliding surface and matsurface, wherein, shiny surface compact structure is compacted zone, and matsurface short texture is weaker zone.
Embodiment 1
A kind of compound cross linked porous breast sticking patch, including：
Thickness is the non-cross-linked layer 2 of 0.1mm,；
The obtained friendship of non-cross-linked layer 2 is processed through cross-linking agent 1- (3- dimethylamino-propyl) -3- ethyl carbodiimide (EDC)
Connection layer 1, the thickness of the cross-linked layer is 0.1mm；
Wherein, the cross-linked layer 1 and non-cross-linked layer 2 are respectively provided with matsurface and shiny surface, by complex method, by the friendship
The shiny surface of the matsurface of connection layer 1 and the non-cross-linked layer 2 is combined into double-decker, forms breast sticking patch of the thickness for 0.2mm,
Opening up multiple apertures 3 on breast sticking patch, the aperture of the aperture 3 is 0.5mm, the hole density of the aperture 3 is 0.5/
cm2.
Wherein, the concentration of cross-linking agent is 0.01M.
Embodiment 2
A kind of compound cross linked porous breast sticking patch, including：
Thickness is the non-cross-linked layer 2 of 0.4mm；
Cross-linked layer 1 obtained in non-cross-linked layer 2 is processed through cross-linking agent genipin, the thickness of the cross-linked layer 1 is 0.5mm；
Wherein, the cross-linked layer 1 and non-cross-linked layer 2 are respectively provided with matsurface and shiny surface, by complex method, by the friendship
The shiny surface of the matsurface of connection layer 1 and the non-cross-linked layer 2 is combined into double-decker, forms breast sticking patch of the thickness for 0.9mm,
Opening up multiple apertures 3 on breast sticking patch, the aperture of the aperture 3 is 1.0mm, the hole density of the aperture 3 is 1.0/
cm2.
Wherein, the concentration of cross-linking agent is 0.05M.
Embodiment 3
A kind of compound cross linked porous breast sticking patch, including：
Thickness is the non-cross-linked layer 2 of 0.6mm；
The obtained friendship of non-cross-linked layer 2 is processed through cross-linking agent 1- (3- dimethylamino-propyl) -3- ethyl carbodiimide (EDC)
Connection layer 1, the thickness of the cross-linked layer 1 is 0.9mm；
Wherein, the cross-linked layer 1 and non-cross-linked layer 2 are respectively provided with matsurface and shiny surface, by complex method, by the friendship
The shiny surface of the matsurface of connection layer 1 and the non-cross-linked layer 2 is combined into double-decker, forms breast sticking patch of the thickness for 1.5mm,
Opening up multiple apertures 3 on breast sticking patch, the aperture of the aperture 3 is 1.5mm, the hole density of the aperture 3 is 1.5/
cm2.
Wherein, the concentration of cross-linking agent is 0.2M.
Embodiment 4
A kind of compound cross linked porous breast sticking patch, including：
Thickness is the non-cross-linked layer 2 of 0.8mm；
Cross-linked layer 1 obtained in non-cross-linked layer 2 is processed through cross-linking agent glutaraldehyde, the thickness of the cross-linked layer 1 is 1.2mm；
Wherein, the cross-linked layer 1 and non-cross-linked layer 2 are respectively provided with matsurface and shiny surface, by complex method, by the friendship
The shiny surface of the matsurface of connection layer 1 and the non-cross-linked layer 2 is combined into double-decker, forms breast sticking patch of the thickness for 2.0mm,
Opening up multiple apertures 3 on breast sticking patch, the aperture of the aperture 3 is 2.5mm, the hole density of the aperture 3 is 2.0/
cm2.
Wherein, the concentration of cross-linking agent is 0.5M.
Embodiment 1 can see tool by accompanying drawing 1 to accompanying drawing 4 to the compound cross linked porous breast sticking patch in embodiment 4
The structure of body, wherein Fig. 1 are the side schematic views of the compound cross linked porous breast sticking patch, it can be seen that cross-linked layer and Fei Jiao
The double-decker of connection layer, it is non-cross-linked layer that upper strata is cross-linked layer, lower floor；Fig. 2 is the compound cross linked porous breast sticking patch
Front schematic view.
Embodiment 1 to the compound cross linked porous breast sticking patch in embodiment 4, be all by silk sutures, doctor
With gluing and, the complex method of mechanical press or reagent bonding, by the matsurface of the cross-linked layer and the non-cross-linked layer
Shiny surface is combined into double-decker, forms breast sticking patch, and generally circular in shape, oval, the square, triangle of aperture or its
He is irregularly shaped.
The front pictorial diagram of the described compound cross linked porous breast sticking patch in embodiment 1 is shown in accompanying drawing 3, it can be seen that front
Pictorial diagram is the dense face of cross-linked layer；The reverse side pictorial diagram of the described compound cross linked porous breast sticking patch in embodiment 3 is shown in attached
Fig. 4, it can be seen that reverse side pictorial diagram is the loose face of non-cross-linked layer.
Compound cross linked porous breast sticking patch to embodiment 2, carries out the detection of tensile break strength：Repeated detection is implemented
The tensile break strength of the compound cross linked porous breast sticking patch in example 2, averages, the crosslinking in repeated detection embodiment 2
The tensile break strength of layer, averages, and the tensile break strength of the non-cross-linked layer in repeated detection embodiment 2 is averaged,
Then, the meansigma methodss of the tensile break strength of three are contrasted, data are shown in Table 1, and the result of meansigma methodss contrast is shown in accompanying drawing 8,
As a result show, the tensile strength of non-cross-linked layer is less than the tensile strength of cross-linked layer, the stretching of breast sticking patch prepared by the present invention is strong
Degree is all higher than the tensile strength of single non-cross-linked layer and the tensile strength of cross-linked layer.
Table 1
To the compound cross linked porous breast sticking patch in embodiment 4, bursting power detection is carried out, such as tensile break strength
Detection, repeated detection breast sticking patch, the bursting power of cross-linked layer and non-cross-linked layer, are averaged, respectively then, by three's respectively
The meansigma methodss of tensile break strength are contrasted, and data are shown in Table 2, and the Data Comparison of meansigma methodss contrast is shown in accompanying drawing 9, as a result shows,
The bursting power of the breast sticking patch that the bursting power of non-cross-linked layer is prepared less than the bursting power of cross-linked layer, the present invention is all higher than individually non-
The bursting power of cross-linked layer and the bursting power of cross-linked layer.
Table 2
The breast sticking patch of embodiment 4 is carried out electron-microscope scanning, as shown in accompanying drawing 5 to accompanying drawing 7, Fig. 5 is the cross-linked layer
The scanning electron microscope (SEM) photograph on dense face surface, it is seen that the structure of breast sticking patch is very fine and close；Fig. 6 is the loose face table of the non-cross-linked layer
The scanning electron microscope (SEM) photograph in face, it is seen that the loose arrangement of fiber, hole is larger；Fig. 7 is cutting for the compound cross linked porous breast sticking patch
The scanning electron microscope (SEM) photograph in face, the visible clearly double-decker of in figure, more loose layer is that non-cross-linked layer, it is seen that fiber is relatively thin, arranges relatively
Loose, hole is larger, grows into beneficial to tissue；It is that cross-linked layer, it is seen that fiber is arranged in tufted compared with compacted zone, structure is very fine and close,
Hole is less.
Using the made compound cross linked porous breast sticking patch in the embodiment of the present invention 1 to 4, aseptic 1cm × 1cm is cut to
Size, SD rat back carry out aseptic be subcutaneously implanted, draw materials respectively at postoperative 1W, 4W, 8W, 12W and 26W.As a result show,
Draw materials in the cycle, material is all visible, and no substantially inflammatory reaction, wherein, when 8W draws materials, material is through hematoxylin-eosin staining (HE
Dyeing) result is as shown in Figure 10, it is seen that and obvious cross-linked layer and non-cross-linked layer structure, wherein non-cross-linked layer fiber are relatively thin, arrangement
Rule, therebetween visible fibroblast grow into；And cross-linked layer fiber is thicker, and acellular grow into.
Cross-linked layer and non-cross-linked layer are used in combination by the present invention, when breast finishing operation is carried out using prosthese, its crosslinking
Layer dense face is fitted with prosthesis, due to compact structure, can intercept cell and grow into towards prosthese, and minimizing is caused by prosthese
Related complication, simultaneously because cross-linked layer degraded is relatively slow, the mechanical support effect that whole material can be maintained at a specified future date in vivo, it is to avoid
Due to the too fast caused prostheses migration of material degradation, the generation of the phenomenon such as come off；Non-cross-linked layer is loose facing to tissue, can be fast
Fast inducing peripheral fibrocyte grows into and revascularization, promotes material and organizes ready integration in a short time.
In addition, be designed punching to double layer material so as to when being applied in breast augmentation, beneficial to postoperative hydrops seepage,
Avoid being caused the generation of the phenomenons such as seroma by hydrops, make operation more safely, effectively.
Double-decker is used in combination, and designs punching, on the one hand ensure that histocompatibility and the degradability of material high
Can, while the generation of the complication such as the prostheses migration that causes because material degradation is too fast will not be caused again, furthermore it is also possible to avoid because
The generation of seroma that hydrops is caused and infection etc..
Embodiment 5
A kind of preparation method of the compound cross linked porous breast sticking patch of any one to embodiment 4 of embodiment 1, its bag
Include following steps：
1st, the preparation of non-cross-linked layer
Method for removing cells in referenced patent CN201410780482.7, (1) pre-treatment：Take butcher fresh in 6 hours
Bovine pericardium, is laid on flat board, removes fat lump and the connective tissue of surface attachment, is cleaned to no color with purified water, obtain
Bovine pericardium material；
(2) defat：By gained bovine pericardium material, as methanol, isopropanol mixed liquor, (volume ratio is 1:2), in, concussion is de-
Liquid is changed after fat 6h, is repeated defat 3 times, is cleaned to odorlessness with purified water；
(3) sterilize：Bovine pericardium material after defat is placed in immersion 1h in the ethanol solution that volumetric concentration is 75%, with
Purified water is cleaned to odorlessness；
(4) inactivation of virus：Bovine pericardium material after sterilization is placed in KOH solution containing 0.5M, room temperature stands 1h, with
Purified water is cleaned to solution non-foam；
(5) cell is taken off：Bovine pericardium material after inactivation is placed in the hyperosmotic solution of NaCl containing 5M and 1M NaOH, shake
Swing 1h, after proceed in purified water concussion 20min, complete for 2 times repeatedly to take off cell, finally cleaned with purified water left to pH value of solution 7.0
The right side, obtains non-cross-linked layer material；
The non-cross-linked layer has shiny surface and matsurface, and the thickness of the non-cross-linked layer is 0.1～0.8mm；
2nd, the preparation of cross-linked layer
By part non-cross-linked layer material as in the solution containing cross-linking agent, concussion is crosslinked 6h, is cleaned 3～5 times with purified water,
So it is crosslinked 3 times repeatedly, obtains crosslinking layer material；
The cross-linked layer has shiny surface and matsurface, and the thickness of the cross-linked layer is 0.1～1.2mm；
3rd, double-decker is combined
Obtained crosslinking layer material is laid on polytetrafluoroethylene, wherein densification faces down, by obtained non-friendship
Connection layer material be laid in crosslinking layer material on, wherein coarse face up, fit tightly double layer material, bubble-free, place pressure
Molding jig, which is put in freezer dryer in the lump, is cooled to -80 DEG C with the speed of 12 DEG C/min, and at -10 DEG C, holding 10 is little
When complete lyophilizing, then material cut take various shapes, it can be rectangle, ellipse, circle, square, triangle to cut shape
Or other are irregularly shaped, double-decker material is formed；
4th, fixing
Using sub-thread absorbable medical suture, from the edge 0.5cm of the double-decker material by double-decker material
Material suture is fixed, needle gage be 0.5cm, or using degradable medical glue such as cyanoacrylate, polyurethane or mechanical press or
Double-decker material is fixed by the bonding of person's reagent, and the thickness of the double-decker material for fixing is 0.2～2.0mm；
5th, punch
Using puncher, the double-decker material for fixing is punched, multiple apertures are formed, but hole shape is not limited
In circle, can be oval, square, triangle or other are irregularly shaped, the aperture of the plurality of aperture is 0.5～2.5mm,
The hole density of the plurality of aperture is 0.5～2.0/cm2.
6th, packaging, sterilizing
Double-decker material that is having openning hole and fixing is packed, and ethane via epoxyethane sterilizing, obtain compound
Cross linked porous breast sticking patch.
As long as the suture in step 4 will be fixing for double-decker suture from 0.5～1cm of double layer material edge, such as
0.6cm, 0.7cm, 0.8cm, 0.9cm etc., needle gage is advisable in 0.5～1.0cm, such as 0.6cm, 0.7cm, 0.8cm, 0.9cm
Etc..
Embodiment 6
A kind of preparation method of the compound cross linked porous breast sticking patch of any one to embodiment 4 of embodiment 1, its bag
Include following steps：
1st, the preparation of non-cross-linked layer
(1) pre-treatment：The fresh bovine pericardium that butchers in 6 hours is taken, is laid on flat board, remove the fat of surface attachment
Block and connective tissue, are cleaned to no color with purified water, obtain bovine pericardium material；
(2) defat：By gained bovine pericardium material, as methanol, isopropanol mixed liquor, (volume ratio is 1:2), in, concussion is de-
Liquid is changed after fat 6h, is repeated defat 3 times, is cleaned to odorlessness with purified water；
(3) sterilize：Bovine pericardium material after defat is placed in immersion 1h in the ethanol solution that volumetric concentration is 75%, with
Purified water is cleaned to odorlessness；
(4) inactivation of virus：Bovine pericardium material after sterilization is placed in KOH solution containing 0.5M, room temperature stands 1h, with
Purified water is cleaned to solution non-foam；
(5) cell is taken off：Bovine pericardium material after inactivation is placed in the hyperosmotic solution of NaCl containing 5M and 1M NaOH, shake
Swing 1h, after proceed in purified water concussion 20min, complete for 2 times repeatedly to take off cell, finally cleaned with purified water left to pH value of solution 7.0
The right side, obtains non-cross-linked layer material；
The non-cross-linked layer has shiny surface and matsurface, and the thickness of the non-cross-linked layer is 0.1～0.8mm；
2nd, the preparation of cross-linked layer
By part non-cross-linked layer material as in the solution containing cross-linking agent, concussion is crosslinked 6h, is cleaned 3～5 times with purified water,
So it is crosslinked 5 times repeatedly, obtains crosslinking layer material；
The cross-linked layer has shiny surface and matsurface, and the thickness of the cross-linked layer is 0.1～1.2mm；
3rd, double-decker is combined
Obtained crosslinking layer material is laid on polytetrafluoroethylene, wherein densification faces down, by obtained non-friendship
Connection layer material be laid in crosslinking layer material on, wherein coarse face up, fit tightly double layer material, bubble-free, place pressure
Molding jig, which is put in freezer dryer in the lump, is cooled to -80 DEG C with the speed of 12 DEG C/min, and at -10 DEG C, holding 10 is little
When complete lyophilizing, then material cut take various shapes, it can be rectangle, ellipse, circle, square, triangle to cut shape
Or other are irregularly shaped, double-decker material is formed；
4th, fixing
Using degradable medical glue such as cyanoacrylate, polyurethane, double-decker material is fixed, the bilayer for fixing
The thickness of structural material is 0.2～2.0mm；
5th, punch
Using puncher, the double-decker material for fixing is punched, multiple apertures are formed, but its hole shape is not
It is limited to circle, can is oval, square, triangle or other are irregularly shaped, the aperture of the plurality of aperture is 0.5～
2.5mm, the hole density of the plurality of aperture is 0.5～2.0/cm2.
6th, packaging, sterilizing
Double-decker material that is having openning hole and fixing is packed, and is sterilized through 60Coradiation, obtained compound
Cross linked porous breast sticking patch.
Embodiment 7
A kind of preparation method of the compound cross linked porous breast sticking patch of any one to embodiment 4 of embodiment 1, its bag
Include following steps：
1st, the preparation of non-cross-linked layer
(1) pre-treatment：The fresh bovine pericardium that butchers in 6 hours is taken, is laid on flat board, remove the fat of surface attachment
Block and connective tissue, are cleaned to no color with purified water, obtain bovine pericardium material；
(2) defat：By gained bovine pericardium material, as methanol, isopropanol mixed liquor, (volume ratio is 1:2), in, concussion is de-
Liquid is changed after fat 6h, is repeated defat 3 times, is cleaned to odorlessness with purified water；
(3) sterilize：Bovine pericardium material after defat is placed in immersion 1h in the ethanol solution that volumetric concentration is 75%, with
Purified water is cleaned to odorlessness；
(4) inactivation of virus：Bovine pericardium material after sterilization is placed in KOH solution containing 0.5M, room temperature stands 1h, with
Purified water is cleaned to solution non-foam；
(5) cell is taken off：Bovine pericardium material after inactivation is placed in the hyperosmotic solution of NaCl containing 5M and 1M NaOH, shake
Swing 1h, after proceed in purified water concussion 20min, complete for 2 times repeatedly to take off cell, finally cleaned with purified water left to pH value of solution 7.0
The right side, obtains non-cross-linked layer material；
The non-cross-linked layer has shiny surface and matsurface, and the thickness of the non-cross-linked layer is 0.1～0.8mm；
2nd, the preparation of cross-linked layer
By part non-cross-linked layer material as in the solution containing cross-linking agent, concussion is crosslinked 6h, is cleaned 3～5 times with purified water,
So it is crosslinked 2 times repeatedly, obtains crosslinking layer material；
The cross-linked layer has shiny surface and matsurface, and the thickness of the cross-linked layer is 0.1～1.2mm；
3rd, double-decker is combined
Obtained crosslinking layer material is laid on rustless steel steel disk, wherein densification faces down, by obtained non-cross-linked layer
Material be laid in crosslinking layer material on, wherein coarse face up, fit tightly double layer material, bubble-free, place pressing die
Tool, which is put in freezer dryer in the lump, is cooled to -80 DEG C with the speed of 12 DEG C/min, at -10 DEG C keep 10 hours complete
Become lyophilizing, then material is cut take various shapes, cut shape can be rectangle, ellipse, circle, square, triangle or its
It is irregularly shaped, forms double-decker material；
4th, fixing
Using mechanical press, double-decker material to be fixed, the thickness of the double-decker material for fixing is 0.2～
2.0mm；
5th, punch
Using puncher, the double-decker material for fixing is punched, multiple apertures are formed, but its hole shape is not
It is limited to circle, can is oval, square, triangle or other are irregularly shaped, the aperture of the plurality of aperture is 0.5～
2.5mm, the hole density of the plurality of aperture is 0.5～2.0/cm2Between any density.
6th, packaging, sterilizing
Double-decker material that is having openning hole and fixing is packed, and is sterilized through 60Coradiation, obtained compound
Cross linked porous breast sticking patch.
The non-cross-linked layer material for obtaining has the natural loose face of biomembrane tissue and dense face bilateral structure, by non-friendship
The cross-linked layer that connection layer is obtained, the crosslinking layer material of gained equally has the natural loose face of biomembrane tissue and the two-sided knot of dense face
Structure, but gained crosslinking layer material is finer and close than step 1 gained non-cross-linked layer material structure, with more excellent mechanical strength and
Anti- degradation property.
It is an object of the invention to provide a kind of compound cross linked porous breast sticking patch, to defect in Mammaplasty operation
Breast tissue is repaired, while can be drawn to the breast prosthesises of implantation and be fixed, makes the breast after finishing more natural, beautiful
See.
Compound cross linked porous breast sticking patch of the present invention, is to be organized as raw material using animal membrane, makes full use of life
The thing membrane material advantage of itself, that is, have and be easy to surrounding tissue and grow into and new vascular generation, degradable, good mechanics compliance
And the features such as tolerance infection ability, part biological membrane material is crosslinked, while by the natural loose face of biomembrane material
With the bilateral structure of dense face, suture through absorbable suture after the loose face of cross-linked layer is fitted with non-cross-linked layer dense face or cure
It is glued, while being punched in patch faces, so as to constitute existing cross-linked layer, the compound porous for having non-cross-linked layer again is handed over
Connection breast sticking patch.
In prosthetic augmentation mammoplasty and breasst reconstruction operation, the dense face of cross-linked layer is fitted towards prosthese with prosthesis, due to
Compact structure, can play a part of to intercept cell, reduce the postoperative related complication for being caused by prosthese, simultaneously because degraded is relatively
Slowly, can play long term mechanical support effect, non-cross-linked layer loose facing to tissue, grown into using its rapid induction cell
Advantage, after the implantation can rapid induction peripheral cell grow into and revascularization, enable new life tissue quickly carry out with sticking patch
Fusion.While punching is designed, in prosthetic augmentation mammoplasty operation, under the premise of mechanical property is not changed, can discharge beneficial to hydrops, subtract
The generation of the complication such as the seroma for being caused due to hydrops less.
Although embodiment of the present invention is disclosed as above, but its be not restricted in description and embodiment listed
With various suitable the field of the invention can be applied to entirely, for those skilled in the art, be easily achieved
Other modification, therefore under the general concept for being limited without departing substantially from claim and equivalency range, the present invention is not limited to spy
Fixed details and shown here as with description legend.
Claims (10)
1. a kind of compound cross linked porous breast sticking patch, it is characterised in that include：
Non-cross-linked layer, which is membrane tissue；
Cross-linked layer, which is the membrane tissue for processing through cross-linking agent；
Wherein, the cross-linked layer and non-cross-linked layer are respectively provided with matsurface and shiny surface, by complex method, by the cross-linked layer
The shiny surface of matsurface and the non-cross-linked layer is combined into double-decker, forms breast sticking patch.
2. compound cross linked porous breast sticking patch as claimed in claim 1, it is characterised in that the non-cross-linked layer be
Property accellular pericardial film, peritoneum, pleura or goldbeater's skin, the cross-linked layer is the animal derived de- cell heart for processing through cross-linking agent
Peplos, peritoneum, pleura or goldbeater's skin.
3. compound cross linked porous breast sticking patch as claimed in claim 1, it is characterised in that the thickness of the non-cross-linked layer is
0.1～0.8mm, the thickness of the cross-linked layer is 0.1～1.2mm.
4. compound cross linked porous breast sticking patch as claimed in claim 1, it is characterised in that the thickness of the breast sticking patch is
0.2～2.0mm.
5. compound cross linked porous breast sticking patch as claimed in claim 1, it is characterised in that by silk sutures,
The complex method of medical adhesive bonding, mechanical press or reagent bonding, by the matsurface of the cross-linked layer and the non-cross-linked layer
Shiny surface be combined into double-decker, form breast sticking patch.
6. compound cross linked porous breast sticking patch as claimed in claim 1, it is characterised in that the cross-linking agent be
Methylaminopropyl) -3- ethyl carbodiimide, genipin, one kind of glutaraldehyde or epoxides, the concentration of the cross-linking agent is
0.01～0.5M.
7. compound cross linked porous breast sticking patch as claimed in claim 6, it is characterised in that the cross-linking agent be
Methylaminopropyl) -3- ethyl carbodiimide, the concentration of the cross-linking agent is 0.05～0.2M.
8. compound cross linked porous breast sticking patch as claimed in any of claims 1 to 7 in one of claims, it is characterised in that also include
Multiple apertures, which is opened on the double-decker, and the aperture of the plurality of aperture is 0.5～2.5mm, the plurality of aperture
Hole density is 0.5～2.0/cm2.
9. a kind of preparation method of compound cross linked porous breast sticking patch, it is characterised in that comprise the following steps：
The preparation of non-cross-linked layer：From fresh animal source property pericardium, peritoneum, pleura or this goldbeater's skin, through pre-treatment, defat,
Prepared by sterilization and de- cell, obtain non-cross-linked layer, and the non-cross-linked layer has shiny surface and matsurface, the thickness of the non-cross-linked layer
Spend for 0.1～0.8mm；
The preparation of cross-linked layer：The non-cross-linked layer is processed in cross-linking agent, is crosslinked 2～5 times repeatedly, cross-linked layer is obtained, described
Cross-linked layer has shiny surface and matsurface, and the thickness of the cross-linked layer is 0.1～1.2mm；
Double-decker is combined：The non-cross-linked layer and the cross-linked layer are tiled, the smooth of the cross-linked layer faces down, non-crosslinked
The coarse of layer faces up, and after being suppressed using mould, is dried, and carries out after drying cutting into variously-shaped, formation double-decker
Material；
Fixing：Using absorbable medical suture, from the 0.5～1cm of edge of the double-decker material by double-decker material
Material suture is fixed, and needle gage is 0.5～1cm, or uses degradable medical glue such as cyanoacrylate, polyurethane or mechanical press
Or double-decker material is fixed by reagent bonding, the thickness of the double-decker material for fixing is 0.2～2.0mm；
Packaging, sterilizing：The double-decker material for fixing is packed, and ethane via epoxyethane or 60Coradiation sterilizing, obtain
Breast sticking patch.
10. the preparation method of compound cross linked porous breast sticking patch as claimed in claim 9, it is characterised in that packing, going out
Also include punch out step before bacterium, specific as follows：
Using puncher, the double-decker material for fixing is punched, form multiple apertures, the aperture of the plurality of aperture
For 0.5～2.5mm, the hole density of the plurality of aperture is 0.5～2.0/cm2.
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| CN114306755A (en) * | 2022-02-11 | 2022-04-12 | 诺一迈尔（苏州）医学科技有限公司 | Biological patch for posterior scleral reinforcement and preparation method thereof |
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