CN107185053A - Controllable stomach anastomosis bracket of a kind of degradation rate and preparation method thereof - Google Patents
Controllable stomach anastomosis bracket of a kind of degradation rate and preparation method thereof Download PDFInfo
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- CN107185053A CN107185053A CN201710364588.2A CN201710364588A CN107185053A CN 107185053 A CN107185053 A CN 107185053A CN 201710364588 A CN201710364588 A CN 201710364588A CN 107185053 A CN107185053 A CN 107185053A
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- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
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- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
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- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/18—Materials at least partially X-ray or laser opaque
-
- 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
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/12—Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
Abstract
The invention discloses controllable stomach anastomosis bracket of a kind of degradation rate and preparation method thereof, the support is mainly mixed by degradable high polymer material and developer, wherein, the degradable high polymer material is the blend using HMW PGA as base material, and the developer is selected from nanoscale medical material.Anastomosis bracket of the present invention is made up to HMW PGA of the degradable high polymer material of base material with nanoscale medical material blending and modifying, with preferably physicochemical property and processing characteristics, complication and potential safety hazard that residue is brought can be prevented effectively from, and its preparation technology is simple, low production cost, it is easy to control operation, degradation rate can be changed by adjusting each raw material different ratio, improve the strength of materials and processing characteristics, be adapted to industrialized production, have a good application prospect.
Description
Technical field
The present invention relates to medical degradable high polymer material and its preparation field, and in particular to a kind of degradation rate is controllable
Stomach anastomosis bracket and preparation method thereof.
Background technology
Stomach anastomosis operation is relatively conventional operation, and such as small intestine anastomosis, stomach-intestinal coincide, low level colorectal anastomosis.
Main at present to be coincide and Anastomat hemorrhoidal circumcision using manual silk thread, the identical shortcoming of manual silk thread is a lot, complex operation, bothersome,
Therefore the Probability of the complication such as anastomotic leakage, bleeding, narrow, previous anastomotic inflammation is high；Though stapler is simple to operate, can
Shorten the time of coincideing, but we are when doing two sections of end Surgical healings, if, it is necessary to separately be done below previous anastomotic during selection end to end anastomosis
A kerf can be coincide, and this otch adds wound and the time of operation, while the probability of infection is added, if selection
End-to-side anastomosis, in addition it is also necessary to change nail bin to close its section of end and anastomosis staple is always remained in vivo, has and causes various related concurrent
The possibility of disease.
Application number CN201320155587.4 discloses a kind of absorbable operation suture thread, and the patent is only to suture
Structure is described, and the material of suture is not described in detail.It is well known that human body different tissues are for suture
The influence of line degradation cycle is different, and healing cycle is also differed, therefore the research for suture material in itself is essential.
Patent of invention CN201310059342.6 discloses a kind of Pancreiatic duct jejunum anastomat, though the stapler is to a certain degree
On overcome the problem of manual Pancreiatic duct jejunum anastomat operation technique fine degree requires high and big operating difficulty, it is but this
The metal anastomotic device later stage also needs to close by changing anastomosis staple, and anastomosis staple belongs to non-degradable material, will always remain in
In vivo, it is most likely that cause various related complications.
Biodegradable material has preferable biocompatibility, implantation human body for a period of time after can it is biodegradable and
It is excreted or internal eubolism can be participated in and disappeared, is filled therefore, Biodegradable material is used for into stomach and coincide
The complication hidden danger that non-degradable stapling apparatus is brought can be prevented effectively from by putting.Current degradable stomach stapling apparatus is main by poly- second
Lactide, poly (glycolide-lactide) or PGA and other materials (PLA, poly- ε~caprolactone, PTMC, poly- hydroxyl
Base fatty acid ester, PPDO, poly butylene succinate etc.) copolymerization is mixed.But PGA in itself into
This costliness, its harsher cost of copolymer synthetic technological condition costly, serious financial burden is caused to patient, no
Beneficial to widely using for degradable stapling apparatus.As patent of invention 200710071563.X disclose a kind of stomach and intestine anastomosis bracket and
Its preparation method, the anastomosis bracket is made of the method for copolymerization, so not only causes the production technology of product relative complex, raw
Produce cost high, and also introduce other harmful substances matter, be highly detrimental to the rehabilitation of stomach.
Therefore, Development and Production technique is simple, low production cost, nontoxic degradable stomach stapling apparatus seem outstanding
To be important.
The content of the invention
In view of the above-mentioned problems existing in the prior art, it is an object of the invention to provide a kind of controllable stomach of degradation rate
Anastomosis bracket and preparation method thereof, anastomosis bracket preparation technology is simple, and low production cost is with HMW PGA
It is made up, with preferably physicochemical property and processing characteristics, can effectively keeps away of the degradable high polymer material blending and modifying of base material
Exempt from complication and potential safety hazard that residue is brought.
To reach above-mentioned purpose, the technical scheme that the present invention takes is：
A kind of preparation method of the controllable stomach anastomosis bracket of degradation rate, the support is main by degradable macromolecule material
Material and developer are using mass ratio as 60：40~90：10 ratio is mixed, wherein, the degradable high polymer material be with
HMW PGA is the blend of base material and modified feedstock, and HMW PGA inherent viscosity [η] value exists
1.7 more than；The developer be selected from nanoscale medical material, the developer be sodium iodide, hydroxyapatite, cardiografin,
One or more in Iohexol or barium sulfate；The preparation method of the support comprises the following steps：1) by degradable macromolecule
Each raw material blending of material, obtained blend dries 2~5h under 60~105 DEG C of vacuum environments, until water content is less than
10ppm；2) to step 1) developer is proportionally added into blend, and uniformly mixed using high-speed mixer；3) by step 2)
The mixture of middle gained is by miniature extruder melting extrusion, pelletizing, and the blended particles of gained are under 60~105 DEG C of vacuum environments
2~5h is dried, until water content is less than 10ppm；4) by step 3) obtained by material pass through melt injection, melting molding or melt
Pressure injection obtains being molded anastomosis bracket, annealing into the mould cavity of given shape；5) by step 4) in shaping anastomosis bracket enter
Vacuum sealed package after the processing of row radiation sterilization.The structure of gained intermingling material of the invention：The less material of content is by shape
Into a kind of tridimensional network, HMW PGA is filled wherein as continuous phase, and such a structure is conducive to the strength of materials
Raising and the extension of degradation cycle.
It is preferred that, the modified feedstock is low molecule amount PGA, PLA, poly- ε~caprolactone, polytrimethylene carbon
One or more in acid esters, polyhydroxyalkanoate, polyvinyl alcohol, low molecule amount PGA inherent viscosity [η] value
Below 1.2.
It is preferred that, the quality proportioning of the HMW PGA and modified feedstock is 30：70~90：10.
It is preferred that, the HMW PGA is the blending of the HMW PGA of a variety of different molecular weights
Thing, inherent viscosity [η] value of this blend is more than 1.7.
Existing degradable stomach stapling apparatus product main composition is PGA or poly (glycolide-lactide) or PGA
With other materials (PLA, poly- ε~caprolactone, PTMC, polyhydroxyalkanoate, PPDO,
Poly butylene succinate etc.) copolymer, but PGA is costly in itself, and its copolymer synthetic technological condition is more
Harsh cost is costly.Anastomosis bracket of the present invention is made by the way of blending and modifying, i.e., by base material of PGA with can
Green wood is made in degradable material blending and modifying, also or the blending and modifying between PGA different molecular weight, processing technology is simple, into
This reduction, it can extend that degradation cycle and product quality are stable, in addition, can also be degradable with different degradation rates by selecting
High polymer material, the different developer of addition and change its addition to control the degradation rate of product, improve the strong of product
Degree and processing characteristics.
The developer micron order material of current degradable product is more, and nanometer materials are using less, nano material tool
There is following advantage：Skin effect, small-size effect are that nano-particles size is small, specific surface area big, active good, good dispersion, can
With and polymeric substrate closely combine, can effectively improve compatibility between the physicochemical property of polymer and each component.The present invention
Added using the blending method of mechanical mixture in degradable high polymer material nano material cardiografin, Iohexol, sodium iodide,
Hydroxyapatite or barium sulfate etc. so that nano-particle can be uniformly dispersed in degradable high polymer material, compared to single
Radiography function, nano material can realize contrasting effects, while can also improve compatible between intermingling material crystal property, each component
The physicochemical property and processing characteristics of property and product.
It is preferred that, step 1) in, the mode of blending is mill, banburying or extrusion.
It is preferred that, the particle diameter of the developer is 10-100nm.The developer nano-particle of appropriate particle diameter can be uniform
It is dispersed in degradable high polymer material.With the less fragment that is degraded into of timbering material, most developer will be with
Fragment to exclude in vitro, so as to avoid the risk residued in tissue in developing material.
It is preferred that, step 2) in, the temperature of extrusion is 220~260 DEG C.
It is preferred that, step 1) in, each raw material of degradable high polymer material is dried under 60~105 DEG C of vacuum environments respectively
2~5h is less than after 10ppm to water content to be blended.
It is preferred that, step 4) in, 55~180 DEG C of annealing temperature, 1~3h of annealing time.
The invention also discloses the degradable anastomosis bracket being made of the above method.
Compared with prior art, the beneficial effects of the invention are as follows：(1) present invention using be blended processing technology and by adjust
The component and proportioning of degradable high polymer material and developer is saved to control the degradation rate and mechanical property of material so that
Anastomosis bracket has the degradation cycle corresponding with wound healing time, has in degradation process and treatment or regeneration work(
The corresponding mechanical property of energy；(2) blending material can also be improved while the addition of nanoscale developer can reach contrasting effects
Expect the compatibility between crystal property, each component and the physicochemical property and processing characteristics of product；(3) by improving anastomosis bracket
Preparation technology, largely reduces production cost；(4) product is made in the present invention by way of blending, it is easy to control behaviour
Make, compared to the product of copolymer systems, technique is simple, yield is higher, quality is more stable, is adapted to industrialized production；(5) it is of the invention
Raw material do not cause lasting inflammation or toxic reaction after using medical degradable material, implantation organism, and degrade most
End-product is exactly carbon dioxide and water, can be excreted by metabolism or infiltration, and effectively prevent that residue brings is concurrent
Disease and potential safety hazard, have a good application prospect.
Accompanying drawing
Fig. 1 is embodiment 1 and the support stability tendency chart of comparative example 4；
Fig. 2 is embodiment 1 and the support external degradation tendency chart of comparative example 4.
Embodiment
Below in conjunction with the embodiment of the present invention, technical scheme is clearly and completely described, it is clear that institute
The embodiment of description is only a part of embodiment of the invention, rather than whole embodiments.Based on the embodiment in the present invention,
The every other embodiment that those of ordinary skill in the art are obtained under the premise of creative work is not made, belongs to this hair
The scope of bright protection.
Embodiment 1
A kind of controllable stomach anastomosis bracket of degradation rate：The degradable high polymer material is handed over for high-molecular-weight poly second
Ester/polylactic acid blend；Developer is nanoscale barium sulfate
The preparation method of the present embodiment：
1) preparation of HMW PGA/polylactic acid blend
Vacuum drying treatment 4h will be carried out after HMW PGA and polylactic acid blend at 80 DEG C, in mixed at high speed
By HMW PGA, PLA, barium sulfate with mass ratio 72 in machine：8：20 ratio is well mixed, then in melting
Extrusion (extrusion temperature is 260 DEG C), granulation, in carrying out vacuum drying treatment 4h at 80 DEG C, are less than its water content in extruder
5ppm, is placed in drier, standby.
2) injection molding
1) material in is molded by extruding, is molded into particular mold, obtains being molded anastomosis bracket.
3) anastomosis bracket is made annealing treatment
By the anastomosis bracket obtained in 2 under the conditions of 140 DEG C, 1h is made annealing treatment.
4) 3) anastomosis bracket is subjected to irradiation sterilization processing and vacuum sealed package.
Embodiment 2
A kind of controllable stomach anastomosis bracket of degradation rate：The degradable high polymer material is HMW PGA
(height molecular weight) blend；Developer is nanoscale cardiografin.
Its preparation method of the present embodiment：
1) preparation of HMW PGA (height molecular weight) blend
HMW PGA ([η]=2.6) and low molecule amount PGA ([η]=1.0) are carried out at 90 DEG C
Vacuum drying treatment 3h, by HMW PGA, low molecule amount PGA, cardiografin with matter in high-speed mixer
Amount compares 75：10：15 ratio is well mixed, then extruding pelletization (extrusion temperature is 220 DEG C) in melt extruder, in 100
Vacuum drying treatment 2h is carried out at DEG C, its water content is less than 5ppm, is placed in drier, it is standby.
2) injection molding
1) material in is molded by extruding, is molded into particular mold, obtains being molded anastomosis bracket.
3) anastomosis bracket is made annealing treatment
By the anastomosis bracket obtained in 2) under the conditions of 160 DEG C, 2h is made annealing treatment.
4) timbering material sterilization treatment and vacuum packaging.
Embodiment 3
A kind of controllable stomach anastomosis bracket of degradation rate：The degradable high polymer material is handed over for high-molecular-weight poly second
Ester/polyhydroxyalkanoate blend；Developer is nanoscale Iohexol.
The preparation method of the present embodiment：
1) preparation of HMW PGA/polyhydroxyalkanoate blend
HMW PGA and polyhydroxyalkanoate particle are subjected to vacuum drying treatment 4h at 100 DEG C,
By HMW PGA, polyhydroxyalkanoate, Iohexol with mass ratio 30 in high-speed mixer：70：15 ratio is mixed
Close uniform, pelletizing (extrusion temperature is 240 DEG C) is then extruded in plastic mixer, in carrying out vacuum drying treatment at 105 DEG C
2h, makes its water content be less than 5ppm, is placed in drier, standby.
2) injection molding
1) material in is molded by extruding, is molded into particular mold, obtains being molded anastomosis bracket.
3) anastomosis bracket is made annealing treatment
By the anastomosis bracket obtained in 2) under the conditions of 120 DEG C, 3h is made annealing treatment.
4) 3) anastomosis bracket is subjected to irradiation sterilization processing and vacuum sealed package.
Embodiment 4
A kind of controllable stomach anastomosis bracket of degradation rate：The degradable high polymer material is handed over for high-molecular-weight poly second
Ester/poly- ε~caprolactone blend；Developer is nano-grade hydroxy apatite.
The preparation method of the present embodiment：
1) preparation of HMW PGA/poly- ε~caprolactone blend
HMW PGA, poly- ε~caprolactone are subjected to vacuum drying treatment 5h at 60 DEG C, in high-speed mixer
It is middle by HMW PGA, PTMC, poly- ε~caprolactone, hydroxyapatite with mass ratio 70：70：40
Ratio be well mixed, then the extruding pelletization (extrusion temperature be 220 DEG C) in melt extruder, does in carrying out vacuum at 60 DEG C
Dry processing 5h, makes its water content be less than 5ppm, is placed in drier, standby.
2) injection molding
1) material in is molded by extruding, is molded into particular mold, obtains being molded anastomosis bracket.
3) anastomosis bracket is made annealing treatment
By the anastomosis bracket obtained in 2) under the conditions of 160 DEG C, 2h is made annealing treatment.
4) timbering material sterilization treatment and vacuum packaging.
Embodiment 5
A kind of controllable stomach anastomosis bracket of degradation rate：The degradable high polymer material is handed over for high-molecular-weight poly second
Ester/PTMC/poly- ε~caprolactone blend；Developer is nanoscale sodium iodide.
The preparation method of the present embodiment：
1) preparation of HMW PGA/PTMC/poly- ε~caprolactone blend
HMW PGA, PTMC and poly- ε~caprolactone are dried in vacuo at 90 DEG C
Handle 3h, in high-speed mixer by HMW PGA, PTMC, poly- ε~caprolactone, sodium iodide with
Mass ratio 70：20：10：20 ratio is well mixed, then extruding pelletization (extrusion temperature is 220 DEG C) in melt extruder,
In carrying out vacuum drying treatment 2h at 100 DEG C, its water content is less than 5ppm, be placed in drier, it is standby.
2) injection molding
1) material in is molded by extruding, is molded into particular mold, the anastomosis bracket being molded.
3) anastomosis bracket is made annealing treatment
By the anastomosis bracket obtained in 2) under the conditions of 180 DEG C, 2h is made annealing treatment.
4) timbering material sterilization treatment and vacuum packaging.
Embodiment 6
Controllable stomach anastomosis bracket of a kind of degradation rate and preparation method thereof, with differing only in for embodiment 1：High score
Son amount PGA, PLA, the mass ratio of barium sulfate are 60：15：50.
Embodiment 7
Controllable stomach anastomosis bracket of a kind of degradation rate and preparation method thereof, with differing only in for embodiment 1：High score
Vacuum drying treatment 3h is carried out at 105 DEG C after son amount PGA and polylactic acid blend, by macromolecule in high-speed mixer
Measure PGA, PLA, barium sulfate to be well mixed, (extrusion temperature is 220 DEG C) is then extruded in melt extruder, is made
Grain, in carrying out vacuum drying treatment 5h at 60 DEG C, makes its water content be less than 5ppm, is placed in drier, standby.
Embodiment 8
Controllable stomach anastomosis bracket of a kind of degradation rate and preparation method thereof, with differing only in for embodiment 1：It coincide
Support annealing temperature is 55 DEG C, annealing time 3h.
Comparative example 1
A kind of anastomosis bracket and preparation method thereof, the difference with embodiment 1 is：Degradable high polymer material and developer
Ratio not within the scope of the present invention, specific HMW PGA, PLA, the mass ratio of barium sulfate are 72：8：8, sulphur
Sour barium is micron order developer, and preparation method is identical.
Comparative example 2
A kind of anastomosis bracket and preparation method thereof, the difference with embodiment 1 is：HMW PGA and modified material
Not within the scope of the present invention, specific HMW PGA, PLA, the mass ratio of barium sulfate are 70 to the ratio of material：72：
20, preparation method is identical.
Comparative example 3
A kind of anastomosis bracket and preparation method thereof, the difference with embodiment 1 is：Degradable high polymer material is macromolecule
Measure PGA-copolymer of poly lactic acid.
Comparative example 4
A kind of anastomosis bracket and preparation method thereof, the difference with embodiment 1 is：Degradable high polymer material is embodiment
The single composition of HMW PGA described in 1.
First, material properties test：The mechanical property carried out to timbering material prepared by embodiment 1-8 and comparative example 1-4
Index is tested, and test result is shown in Table 1.In order to investigate the degraded situation of degradable anastomosis bracket, to embodiment 1-8 and right
Anastomosis bracket prepared by ratio 1-4 has carried out external degradation experiment, and anastomosis bracket is immersed in 37 DEG C of simulation simulated intestinal fluid
In (SIF is replaced once a week), Mechanics Performance Testing is carried out in the test point pre-set.
The testing performance index result of the anastomosis bracket material of table 1
Comparative example, table are superior to by the performance indications of above-mentioned results showed that embodiment of the present invention anastomosis bracket material
Bright reasonable raw material proportioning of the present invention, preparation method is preferable.The combination property of wherein embodiment 1 is optimal, and its weight-loss ratio, which is presented, to be risen
Trend (see Fig. 1), at the 3rd week, its weight-loss ratio only reached 11.52%, reached 18.41% in the 5th week weight-loss ratio, its weight-loss ratio energy
Enough meet requirement of the previous anastomotic to anastomosis bracket product quality stability；Downward trend (see Fig. 2) is presented in its pulling force retention rate,
Pulling force retention rate can just reach less than 56.9% within 3rd week, and less than 48.2% can be reached in the 5th week pulling force retention rate, and it is protected
Rate is stayed to realize stapler with autologous tissue's collective effect to the effectively identical of previous anastomotic.The combination property of the embodiment of the present invention
The need for stomach wound can be met completely to stapler, meet the requirement of medical material.The test of embodiment 1 and comparative example 1
As shown by data, nanoscale developer can improve the compatibility between intermingling material and the physicochemical property and processing characteristics of product.
The stability of the embodiment of the present invention is good compared with the stability of comparative example 3, shows the mode compared to copolymerization, the system by the way of blending
Standby identical material, is conducive to improving the stability of product quality.The weight-loss ratio and pulling force retention rate of embodiment 1 and embodiment 4
Comparison diagram (such as Fig. 1-2) shows, can extend the degradation cycle of product by the way of modified blending, improve the stabilization of product quality
Property.
2nd, zoopery
Material and method：60 small-sized bar horse pigs, stochastic averagina is divided into 12 groups, under all animal general anesthesias, will implement
The anastomosis bracket that example 1-8 and comparative example 1-4 method prepares identical appearance corresponds to the small-sized bar horse pig progress of this 12 groups respectively
Small intestine anastomosis are performed the operation.Observe postoperative complications and animal dead situation.
Phenomenon：All animals are not dead, HE dyeing carried out to previous anastomotic histotomy within postoperative 10th day, by micro-
Whether sem observation intestinal wall has infection and morbid state to occur.There are a large amount of fibres between the corresponding bar horse chitling wall of embodiment 1-8 anastomosis brackets
Dimensional tissue hyperplasia, and there is a small amount of inflammatory cell infiltration and more capillary to be formed, show that previous anastomotic recovers preferable, capillary
Normal blood circulation can be carried out by forming explanation bar horse pig, and turnaround time is fast, and no infection and morbid state are found.Comparative example 1-4 kisses
There are a large amount of inflammatory cell infiltrations between the corresponding bar horse chitling wall of conjunction support, previous anastomotic recovery effects are compared with the embodiment of the present invention
Difference, turnaround time is relatively slow.
3rd, clinical test is simulated
Preparing anastomosis bracket using 1-4 of embodiment of the present invention method is used to simulate in human body stomach anastomosis operation, performs the operation
Operation：Surgical healing two ends varus is fixed on duct jejunum anastomotic scaffold with purse string suture, closure anastomosis bracket formation mechanicalness lock,
Intestines is filled Mo Yu pairing between Installed films, reaches identical purpose, play support effect.
Result of the test：Gradually degraded after the anastomosis bracket two weeks of embodiment 1, but still keep global shape, after 3 week
Broken exclusion of gradually degrading is external；2 anastomosis bracket of embodiment is gradually degraded after 13 days, but still keeps global shape, after 23 days
Broken exclusion of gradually degrading is external；3 anastomosis bracket of embodiment is gradually degraded after 13 days, but still keeps global shape, after 23 days
Broken exclusion of gradually degrading is external.Gradually degraded after the anastomosis bracket two weeks of embodiment 4, but still keep global shape, one
Broken exclusion of gradually being degraded after month is external.
Above-mentioned all result of the tests, which are integrated, to be shown：The anastomosis bracket prepared using present invention method is implanted into organism
Do not cause lasting inflammation or toxic reaction afterwards, can effectively prevent the illnesss such as human body anastomotic stenosis after surgery, mouth fistula, promote
Wound healing, it is degradable and catabolite is nontoxic, it can be excreted by metabolism or infiltration, it is to avoid it is concurrent that residue is brought
Disease and potential safety hazard, have a good application prospect.
Although an embodiment of the present invention has been shown and described, for the ordinary skill in the art, can be with
A variety of changes, modification can be carried out to these embodiments, replace without departing from the principles and spirit of the present invention by understanding
And modification, the scope of the present invention is defined by the appended.
Claims (10)
1. the preparation method of the controllable stomach anastomosis bracket of a kind of degradation rate, it is characterised in that the support is main by that can drop
Solution high polymer material and developer be mixed, wherein, the degradable high polymer material be using HMW PGA as
The blend of base material and modified feedstock, the developer is selected from nanoscale medical material；The preparation method of the support is included such as
Lower step：1) each raw material of degradable high polymer material is blended in the way of mill, banburying or extrusion, obtained blend exists
2~5h is dried under 60~105 DEG C of vacuum environments, until water content is less than 10ppm；2) to step 1) it is proportionally added into blend
Developer, and uniformly mixed using high-speed mixer；3) by step 2) in gained mixture by miniature extruder melt squeeze
Go out, pelletizing, the blended particles of gained dry 2~5h under 60~105 DEG C of vacuum environments, until water content is less than 10ppm；4) will
Step 3) obtained by material by melt injection, melting be molded or melting pressure injection into the mould cavity of given shape, obtain into
Type anastomosis bracket, annealing；5) by step 4) in shaping anastomosis bracket carry out radiation sterilization processing after vacuum sealed package.
2. a kind of preparation method of the controllable stomach anastomosis bracket of degradation rate according to claim 1, it is characterised in that
The modified feedstock is low molecule amount PGA, PLA, poly- ε~caprolactone, PTMC, poly- hydroxy aliphatic
One or more in acid esters, polyvinyl alcohol.
3. a kind of preparation method of the controllable stomach anastomosis bracket of degradation rate according to claim 1 or 2, its feature exists
In the quality proportioning of the HMW PGA and modified feedstock is 30：70~90：10.
4. a kind of preparation method of the controllable stomach anastomosis bracket of degradation rate according to claim 1, it is characterised in that
The HMW PGA is the blend of the HMW PGA of a variety of different molecular weights.
5. a kind of preparation method of the controllable stomach anastomosis bracket of degradation rate according to claim 1 or 2, its feature exists
In the quality proportioning of the degradable high polymer material and developer is 60：40~90：10.
6. a kind of preparation method of the controllable stomach anastomosis bracket of degradation rate according to claim 1 or 2, its feature exists
In the developer is sodium iodide, hydroxyapatite, cardiografin, Iohexol or barium sulfate.
7. a kind of preparation method of the controllable stomach anastomosis bracket of degradation rate according to claim 1, it is characterised in that
Step 2) in, the temperature of extrusion is 220~260 DEG C.
8. a kind of preparation method of the controllable stomach anastomosis bracket of degradation rate according to claim 1, it is characterised in that
Step 1) in, dry 2~5h is small to water content under 60~105 DEG C of vacuum environments respectively for each raw material of degradable high polymer material
In blending after 10ppm.
9. a kind of preparation method of the controllable stomach anastomosis bracket of degradation rate according to claim 1, it is characterised in that
Step 4) in, 55~180 DEG C of annealing temperature, 1~3h of annealing time.
10. the degradable anastomosis bracket being made using claim 1 methods described.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108577916A (en) * | 2018-03-08 | 2018-09-28 | 戴庆涛 | A kind of preparation method of the operative anastomat of gastrointestinal surgery |
| CN109880329A (en) * | 2019-03-20 | 2019-06-14 | 亳州科蔚科技服务有限公司 | A kind of preparation method of developability Biomedical Polymer-based Composite Materials |
| CN109893683A (en) * | 2019-03-14 | 2019-06-18 | 杭州越阡生物科技有限公司 | A kind of application and products thereof of biodegradation material in preparation children's alimentary tract anastomosis ring |
| CN110327141A (en) * | 2019-07-22 | 2019-10-15 | 上海交通大学医学院附属仁济医院 | Degradable Colon and rectum internal bypass device and preparation method thereof |
| CN110548176A (en) * | 2019-08-27 | 2019-12-10 | 杭州圣石科技有限公司 | preparation process of degradable intestinal anastomosis stent |
Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4674506A (en) * | 1984-11-29 | 1987-06-23 | Kirk Alcond | Surgical anastomosis stent |
| WO1994013356A1 (en) * | 1992-12-17 | 1994-06-23 | Avatar Design And Development, Inc. | Anastomosis stent and stent selection system |
| CN101133973A (en) * | 2007-10-09 | 2008-03-05 | 浙江铭众科技有限公司 | Stomach and intestine inosculated bracket and method for preparing the same |
| CN102247623A (en) * | 2011-08-17 | 2011-11-23 | 微创医疗器械(上海)有限公司 | Multilayer degradable stent having shape memory and preparation method thereof |
| CN102284087A (en) * | 2011-06-16 | 2011-12-21 | 微创医疗器械(上海)有限公司 | Novel degradable support and preparation method thereof |
| CN103239265A (en) * | 2013-05-10 | 2013-08-14 | 杭州铭众生物科技有限公司 | Anastomat for gastrointestinal tract anastomosis surgery and production method thereof |
| CN103342882A (en) * | 2013-06-28 | 2013-10-09 | 厦门大学 | Gastroenterostomy holder composite and processing and forming method thereof |
| CN104001221A (en) * | 2014-06-10 | 2014-08-27 | 上海锦葵医疗器械有限公司 | Developing biological heart occluder with controllable degradation rate |
| CN105999425A (en) * | 2016-05-24 | 2016-10-12 | 德州海利安生物科技股份有限公司 | Developing type degradable repairing stent |
-
2017
- 2017-05-22 CN CN201710364588.2A patent/CN107185053A/en active Pending
Patent Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4674506A (en) * | 1984-11-29 | 1987-06-23 | Kirk Alcond | Surgical anastomosis stent |
| WO1994013356A1 (en) * | 1992-12-17 | 1994-06-23 | Avatar Design And Development, Inc. | Anastomosis stent and stent selection system |
| CN101133973A (en) * | 2007-10-09 | 2008-03-05 | 浙江铭众科技有限公司 | Stomach and intestine inosculated bracket and method for preparing the same |
| CN102284087A (en) * | 2011-06-16 | 2011-12-21 | 微创医疗器械(上海)有限公司 | Novel degradable support and preparation method thereof |
| CN102247623A (en) * | 2011-08-17 | 2011-11-23 | 微创医疗器械(上海)有限公司 | Multilayer degradable stent having shape memory and preparation method thereof |
| CN103239265A (en) * | 2013-05-10 | 2013-08-14 | 杭州铭众生物科技有限公司 | Anastomat for gastrointestinal tract anastomosis surgery and production method thereof |
| CN103342882A (en) * | 2013-06-28 | 2013-10-09 | 厦门大学 | Gastroenterostomy holder composite and processing and forming method thereof |
| CN104001221A (en) * | 2014-06-10 | 2014-08-27 | 上海锦葵医疗器械有限公司 | Developing biological heart occluder with controllable degradation rate |
| CN105999425A (en) * | 2016-05-24 | 2016-10-12 | 德州海利安生物科技股份有限公司 | Developing type degradable repairing stent |
Non-Patent Citations (5)
| Title |
|---|
| 俞耀庭: "《生物医用材料》", 31 December 2000, 天津：天津大学出版社 * |
| 孙红岭: "《商品与商品养护》", 30 April 2016, 中国财富出版社 * |
| 张书华: "《高性能电缆材料及其应用技术》", 31 December 2015, 上海：上海交通大学出版社 * |
| 张春红，徐晓东，刘丽佳: "《高分子材料》", 27 February 2016, 北京：北京航空航天大学出版社 * |
| 王璐: "《生物医用纺织品》", 30 November 2011, 中国纺织出版社 * |
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108577916A (en) * | 2018-03-08 | 2018-09-28 | 戴庆涛 | A kind of preparation method of the operative anastomat of gastrointestinal surgery |
| CN108577916B (en) * | 2018-03-08 | 2020-10-23 | 戴庆涛 | Preparation method of anastomat for gastrointestinal surgery |
| CN109893683A (en) * | 2019-03-14 | 2019-06-18 | 杭州越阡生物科技有限公司 | A kind of application and products thereof of biodegradation material in preparation children's alimentary tract anastomosis ring |
| CN109880329A (en) * | 2019-03-20 | 2019-06-14 | 亳州科蔚科技服务有限公司 | A kind of preparation method of developability Biomedical Polymer-based Composite Materials |
| CN109880329B (en) * | 2019-03-20 | 2021-09-17 | 阜阳佳派生产力促进中心有限公司 | Preparation method of developing medical polymer composite material |
| CN110327141A (en) * | 2019-07-22 | 2019-10-15 | 上海交通大学医学院附属仁济医院 | Degradable Colon and rectum internal bypass device and preparation method thereof |
| CN110548176A (en) * | 2019-08-27 | 2019-12-10 | 杭州圣石科技有限公司 | preparation process of degradable intestinal anastomosis stent |
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Application publication date: 20170922 |