CN201888954U - Non-adhesion film - Google Patents

Non-adhesion film Download PDF

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CN201888954U
CN201888954U CN2010202625936U CN201020262593U CN201888954U CN 201888954 U CN201888954 U CN 201888954U CN 2010202625936 U CN2010202625936 U CN 2010202625936U CN 201020262593 U CN201020262593 U CN 201020262593U CN 201888954 U CN201888954 U CN 201888954U
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antiadhesive film
roughness
matsurface
lactide
antiadhesive
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周晓军
可大年
孟坚
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BEIJING MAIDI DINGFENG MEDICAL TECHNOLOGY Co Ltd
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BEIJING MAIDI DINGFENG MEDICAL TECHNOLOGY Co Ltd
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Abstract

The utility model provides an elastic non-adhesion film made from copolymer of carbonic ester and lactide, the elastic non-adhesion film is provided with a smooth surface and a coarse surface relative to the smooth surface; the coarse surface roughness is 0.32 Mum-10 Mum, the non-adhesion thickness is 20 Mum-500 Mum, the lactide is dl-lactide and/ or glycolide. The coarse surface of the non-adhesion film provided in the utility model obstructs the light-admitting quality of the non-adhesion film leaving the non-adhesion film semitransparent; therefore the film can be easily distinguished out when covered on the wound, and the after-operation nursing is greatly improved; and due to the roughness, the friction between the non-adhesion film and the tissue is strengthened to the benefit of preventing the non-adhesion film displacement in the body.

Description

A kind of Antiadhesive film
Technical field
This utility model belongs to field of medical materials, is specifically related to a kind of Antiadhesive film.
Background technology
In clinical field, biological tissue can occur after operation and the irrelevant bad adhesion of tissue repair, and bad adhesion meeting causes metaplasia, obstruction, distortion, causes serious consequence.For example, the bad adhesion meeting of postoperative causes the dysfunction of pain or biological tissue, also needs to carry out other operation and be used to peel off bad adhesion under serious situation.And postoperative produces once more perform the operation also can become very the difficulty of bad adhesion to original disease.In order to prevent to produce the bad adhesion phenomenon of postoperative, the general Antiadhesive film with good biocompatibility and bioresorbable that uses covers and protects the tissue that may stick together.
In the prior art, disclose the Antiadhesive film of various material, wherein Chang Yong Antiadhesive film has two kinds, and a kind of is polylactic acid (PLA) class Antiadhesive film, and another kind is a chitosan class Antiadhesive film.Polylactic acid-based Antiadhesive film has advantages such as good mechanical property, biodegradable and good biocompatibility, but also there is inevitable shortcoming, wherein topmost problem is the hardening that becomes fragile easily after implanting, and influences preventing adhesiving effect, therefore uses to be very restricted.Compare with polylactic acid-based Antiadhesive film, the advantage of chitosan class adhesion membrane is a good springiness, but that its shortcoming is a mechanical strength is low, and meets the problem that is easy to generate aquation behind the water, therefore uses and also has been subjected to very big restriction.
The general slick water white Antiadhesive film in two sides that uses in the prior art, though transparent Antiadhesive film provides the open visual field for operation, but owing to be melted into of the same colourly, be difficult to distinguish, therefore make troubles for operation stitching with itself and the tissue site of fitting; And the slick Antiadhesive film in two sides is in when wriggling tissue, the problem that is subjected to displacement easily.In order to solve the displacement problem of the slick Antiadhesive film in two sides, someone uses the method for stitching that Antiadhesive film is fixed in the biological tissue, but the process of sewing up Antiadhesive film has increased extra surgical work, so the use of this method also has been subjected to certain restriction.
The utility model content
Problem to be solved in the utility model is to provide a kind of Antiadhesive film, and compared with prior art, the Antiadhesive film that this utility model provides has good elasticity, can prevent to slide in vivo, helps playing better anti effect.
In order to solve above technical problem, this utility model provides a kind of elasticity Antiadhesive film of being made by the copolymer of carbonic ester and lactide, it is characterized in that, described elasticity Antiadhesive film have shiny surface and with the corresponding matsurface of described shiny surface, the roughness of described matsurface is 0.32 μ m~10 μ m, the thickness of described Antiadhesive film is 20 μ m~500 μ m, and described lactide is lactide and/or Acetic acid, hydroxy-, bimol. cyclic ester.
Preferably, the roughness of described matsurface is 1 μ m~5 μ m.
Preferably, described roughness 1.5 μ m~4 μ m.
Preferably, described roughness 2 μ m~3 μ m.
This utility model also provides a kind of elasticity Antiadhesive film of being made by the mixture of Biodegradable polyester and Merlon, it is characterized in that, described elasticity Antiadhesive film have shiny surface and with the corresponding matsurface of described shiny surface, the roughness of described matsurface is 0.32 μ m~10 μ m, the thickness of described Antiadhesive film is 20 μ m~500 μ m, and described Biodegradable polyester is one or more in PHA, poly-anhydride, polycaprolactone, polylactic acid, polyglycolic acid, polyimides, polylysine, poe, the poly phosphazene.
Preferably, the roughness of described matsurface is 1 μ m~5 μ m.
Preferably, described roughness 1.5 μ m~4 μ m.
Preferably, described roughness 2 μ m~3 μ m
The matsurface of the Antiadhesive film that this utility model provides has hindered the light transmission of Antiadhesive film, can make Antiadhesive film become translucent, covers like this to be easy on the wound distinguish, and greatly facilitates the postoperative operation.And, owing to have certain roughness, therefore increased the frictional force of Antiadhesive film and tissue, help stoping Antiadhesive film displacement in vivo.
Description of drawings
The sketch map of the Antiadhesive film that this utility model provides.
The specific embodiment
In order further to understand this utility model, below in conjunction with the specific embodiment this utility model is described, but should be appreciated that these describe just to further specifying feature and advantage of the present utility model, rather than to the restriction of this utility model claim.
See also Fig. 1, the sketch map of the Antiadhesive film that provides for this utility model, described Antiadhesive film 11 comprises shiny surface 11b and matsurface 11a, and the thickness of described Antiadhesive film is 20 μ m~500 μ m, and the roughness of described matsurface is 0.32 μ m~10 μ m
According to this utility model, the copolymer of described Antiadhesive film carbonic ester and lactide, described lactide are lactide and/or lactide.Described lactide is preferably lactide, and described lactide can be in levorotatory lactide, dextrorotation lactide, Study of Meso-Lactide, the rac-lactide one or more.Described Merlon can be in mesomethylene carbon acid esters, ethylidene carbonic ester, the inferior carboxylic acid carbonic ester one or more.
Merlon is the material of the human implantable of U.S. food Drug Administration (FDA) approval, under the temperature of human body, has certain elasticity.After using carbonic ester and lactide as polymerizable raw material, this utility model obtains the copolymer of carbonic ester and lactide, test result shows, this polymer has excellent mechanical intensity and elasticity, has the better fit effect with the tissue of biology, therefore plays better anti effect.
According to this utility model, when using lactide and carbonic ester to carry out copolymerization, the weight ratio of described lactide and carbonic ester is preferably 20~80: 80~20, more preferably 30~70: 70~30.According to this utility model, when preparing the copolymer of described lactide and carbonic ester, the catalyst that preferably uses is metal chloride, carboxylate, oxide, and metal chloride can be the chloride of Sn, Mn, Fe or the Mg of bivalence.The copolymer of described lactide and carbonic ester is preferably the ring opening copolymer thing of lactide and carbonic ester.
According to this utility model, when described lactide and carbonic ester were carried out ring opening copolymer, the ring opening copolymer temperature was preferably 120 ℃~180 ℃, and more preferably 130 ℃~160 ℃, more preferably 140 ℃~150 ℃.According to this utility model, the viscosity-average molecular weight of the ring opening copolymer thing that obtains is preferably 10,000~300,000, and more preferably 20,000~200,000, more preferably 50,000~150,000.
When described ring opening copolymer thing is made Antiadhesive film, can use method well known to those skilled in the art, object lesson can be in the methods such as curtain coating, calendering or blowing one or more.According to this utility model, during the preparation Antiadhesive film, the thickness of adhesion membrane is preferably 20 μ m~500 μ m, more preferably 50 μ m~400 μ m, more preferably 100 μ m~300 μ m.
The matsurface roughness of the anti of this utility model preparation is preferably 1 μ m~5 μ m, more preferably 1.5 μ m~4 μ m, more preferably 2 μ m~3 μ m.The roughness of described shiny surface is less than 0.2 μ m.In order to obtain having the Antiadhesive film of shiny surface and matsurface, can use the mould of a work surface as matsurface, the roughness of described matsurface is preferably 0.32 μ m~10 μ m, 1 μ m~5 μ m more preferably, 1.5 μ m~4 μ m more preferably, another work surface of mould is the shiny surface of roughness less than 0.2 μ m, can prepare one side like this and be the shiny surface of matsurface.Because matsurface has hindered the light transmission of Antiadhesive film, can make Antiadhesive film become translucent, cover like this and be easy on the wound distinguish, greatly facilitate the postoperative operation.And, owing to have certain roughness, therefore increased the frictional force of Antiadhesive film and tissue, help stoping Antiadhesive film displacement in vivo.
According to this utility model, the material of described Antiadhesive film can be the mixture of Biodegradable polyester and Merlon, and described Biodegradable polyester can be in PHA, poly-anhydride, polycaprolactone, polylactic acid, polyglycolic acid, polyimides, polylysine, poe, the polyphosphazene one or more; Described Merlon can be in polymethylene carbonic ester, poly-ethylidene carbonic ester, the poly-inferior carboxyl carbon acid esters one or more.The weight ratio of described Merlon and described Biodegradable polyester is preferably 20~80: 80~20, more preferably 30~70: 70~30, more preferably 40~60: 60~40.The weight average molecular weight of described Merlon is preferably 30,000~100,000, and more preferably 4.5 ten thousand~7.8 ten thousand.The weight average molecular weight of described Biodegradable polyester is preferably 5000-30000, and more preferably 7000~15000.
According to this utility model, preferably blend in organic solvent with described Biodegradable polyester and Merlon, described organic solvent can be in toluene, dimethylbenzene, chloroform, the dichloromethane one or more, is preferably chloroform and/or dichloromethane.
According to this utility model, when using the mixture of described Biodegradable polyester and Merlon to prepare Antiadhesive film, can use method well known to those skilled in the art, object lesson can be in the methods such as curtain coating, calendering or blowing one or more.According to this utility model, during the preparation Antiadhesive film, the thickness of adhesion membrane is preferably 20 μ m~500 μ m, more preferably 50 μ m~400 μ m, more preferably 100 μ m~300 μ m.
The roughness of the matsurface of the Antiadhesive film of this utility model preparation is preferably 1 μ m~5 μ m, more preferably 1.5 μ m~4 μ m.For the roughness of described shiny surface less than 0.2 μ m.In order to obtain having the Antiadhesive film of shiny surface and matsurface, can use the mould of a work surface as matsurface, the roughness of described matsurface is preferably 0.32 μ m~10 μ m, more preferably 1 μ m~5 μ m, more preferably 1.5 μ m~4 μ m, more preferably 2 μ m~3 μ m.Another work surface of mould is the shiny surface of roughness less than 0.2 μ m, can prepare one side like this and be the shiny surface of matsurface.Because matsurface has hindered the light transmission of Antiadhesive film, can make Antiadhesive film become translucent, cover like this and be easy on the wound distinguish, greatly facilitate the postoperative operation.And, owing to have certain roughness, therefore increased the frictional force of Antiadhesive film and tissue, help stoping Antiadhesive film displacement in vivo.
Below in conjunction with embodiment the technical solution of the utility model is described, just to the illustrating of this utility model preferred embodiment, protection domain of the present utility model also is not limited by the following examples following examples.
Embodiment 1
Getting 30g mesomethylene carbon acid esters and 70g levorotatory lactide mixes, add 0.1% (percentage by weight) stannous chloride as catalyst, polymerization temperature is 160 ℃, and the 70Pa response time is 10 hours, obtain the polymer of carbonic ester lactide, the viscosity-average molecular weight of measuring this polymer is 12.3 ten thousand.
Polymer is carried out physical property test, and the result is as follows: solvent residual amount<0.06%, moisture entrapment amount are 0.45%, the stannum residual quantity is that 190 μ g/g, lead content are that 280 μ g/g, sulfate ash content are 0.3%, level of residual monomers is 1.7%.
Get the polymer that makes and make Antiadhesive film with casting method, radiation sterilization.The work surface of curtain coating mould is that roughness is the matsurface of 5 μ m; Obtaining thickness after the curtain coating is the translucent Antiadhesive film of 50 μ m, and this Antiadhesive film is corresponding with mould, have a shiny surface and with the corresponding matsurface of described shiny surface, the roughness of matsurface is 5 μ m.
The physical property result of test Antiadhesive film is as follows:
25 ℃ of density of testing Antiadhesive film down are 1.28g/cm 2, hot strength is that 10.5Mpa, extension at break are 158.9%, above-mentioned measurement result shows that this Antiadhesive film has better elastic.The medical performance test result of Antiadhesive film is as shown in table 1
Table 1 Antiadhesive film medical performance test result
Figure BSA00000196465800051
Figure BSA00000196465800061
Embodiment 2
Getting 200g ethenylidene carbonic ester and 800g rac-lactide mixes, add 0.5% (percentage by weight) stannous octoate as catalyst, polymerization temperature is 140 ℃, and the 80Pa response time is 6 hours, obtain the carbonic ester lactide polymer, the viscosity-average molecular weight of measuring this polymer is 80,000;
Polymer is tested, and the result is as follows: solvent residual amount<0.055%, moisture entrapment amount are 0.043%, the stannum residual quantity is that 105 μ g/g, lead content are that 202 μ g/g, sulfate ash content are 0.081%, level of residual monomers is 1.3%.
Get the polymer blowing that makes and make Antiadhesive film, radiation sterilization.A work surface of blow mold is a shiny surface, and another work surface is that roughness is the matsurface of 5 μ m; Obtaining thickness after the blowing is the translucent Antiadhesive film of 50 μ m, and this Antiadhesive film is corresponding with mould, have a shiny surface and with the corresponding matsurface of described shiny surface, the roughness of matsurface is 5 μ m.
The physical property result of test Antiadhesive film is as follows:
25 ℃ of density of testing Antiadhesive film down are 1.26g/cm 2, hot strength is that 12.35Mpa, extension at break are 236.27%, above-mentioned measurement result shows that this Antiadhesive film has better elastic.
The medical performance test result of Antiadhesive film is as shown in table 2
Table 2 Antiadhesive film medical performance test result
Figure BSA00000196465800062
Embodiment 3
Get 25g mesomethylene carbon acid esters and 50g rac-lactide lactide, the mixing of 50g Acetic acid, hydroxy-, bimol. cyclic ester, add the stannous chloride of 0.8% (percentage by weight), polymerization temperature is 130 ℃, response time is to obtain the copolymer of lactide-Acetic acid, hydroxy-, bimol. cyclic ester-carbonic ester in 9 hours, and the viscosity-average molecular weight of measuring this polymer is 110,000;
Polymer is tested, and the result is as follows: solvent residual amount<0.03%, moisture entrapment amount are 0.043%, the stannum residual quantity is that 132 μ g/g, lead content are that 137 μ g/g, sulfate ash content are 0.081%, level of residual monomers is 1.3%.
Get the polymer that makes and make Antiadhesive film with casting method, radiation sterilization.The work surface of curtain coating mould is that roughness is the matsurface of 5 μ m; Obtaining thickness after the curtain coating is the translucent Antiadhesive film of 50 μ m, and this Antiadhesive film is corresponding with mould, have a shiny surface and with the corresponding matsurface of described shiny surface, the roughness of matsurface is 5 μ m.
The physical property result of test Antiadhesive film is as follows:
25 ℃ of density of testing Antiadhesive film down are 1.26g/cm 2, hot strength is that 8.65Mpa, extension at break are 279.65%, above-mentioned measurement result shows that this Antiadhesive film has better elastic.
The medical performance test result of Antiadhesive film is as shown in table 2
Table 2 Antiadhesive film medical performance test result
Embodiment 4
Get 3g weight average molecular weight 50,000 the polymethylene carbonic ester and and the 7g weight average molecular weight be that polylactic acid blend in the 600mL dichloromethane of 80,000 obtains blend;
Get the polymer that makes and make Antiadhesive film with casting method, radiation sterilization.The work surface of curtain coating mould is that roughness is the matsurface of 5 μ m; Obtaining thickness after the curtain coating is the translucent Antiadhesive film of 50 μ m, and this Antiadhesive film is corresponding with mould, have a shiny surface and with the corresponding matsurface of described shiny surface, the roughness of matsurface is 5 μ m.
The physical property result of test Antiadhesive film is as follows:
25 ℃ of density of testing Antiadhesive film down are 1.36g/cm 2, hot strength is that 13.27Mpa, extension at break are 235.35%, above-mentioned measurement result shows that this Antiadhesive film has better elastic.
The medical performance test result of Antiadhesive film is as shown in table 4
Table 4 Antiadhesive film medical performance test result
Figure BSA00000196465800081
Embodiment 5
Get the poly-ethylidene carbonic ester of 2g weight average molecular weight 40,000 and 8g weight average molecular weight and be polycaprolactone blend in the chloroform of 300mL of 60,000 and obtain blend;
Get the polymer that makes and make Antiadhesive film with casting method, radiation sterilization.The work surface of curtain coating mould is that roughness is the matsurface of 5 μ m; Obtaining thickness after the curtain coating is the translucent Antiadhesive film of 50 μ m, and this Antiadhesive film is corresponding with mould, have a shiny surface and with the corresponding matsurface of described shiny surface, the roughness of matsurface is 5 μ m.
The physical property result of test Antiadhesive film is as follows:
25 ℃ of density of testing Antiadhesive film down are 1.18g/cm 2, hot strength is that 12.13Mpa, extension at break are 218.46%, above-mentioned measurement result shows that this Antiadhesive film has better elastic.
The medical performance test result of Antiadhesive film is as shown in table 5
Table 5 Antiadhesive film medical performance test result
Figure BSA00000196465800082
Figure BSA00000196465800091
Embodiment 6
Get 5g weight average molecular weight 40,000 poly-inferior carboxylic acid carbonic ester and and polyglycolic acid blend in the dichloromethane of 500mL of 5g molecular weight 80,000 obtain blend;
Get the polymer that makes and make Antiadhesive film with casting method, radiation sterilization.The work surface of curtain coating mould is that roughness is the matsurface of 5 μ m; Obtaining thickness after the curtain coating is the translucent Antiadhesive film of 50 μ m, and this Antiadhesive film is corresponding with mould, have a shiny surface and with the corresponding matsurface of described shiny surface, the roughness of matsurface is 5 μ m.
The physical property result of test Antiadhesive film is as follows:
25 ℃ of density of testing Antiadhesive film down are 1.38g/cm 2, hot strength is that 12.46Mpa, extension at break are 221.46%, above-mentioned measurement result shows that this Antiadhesive film has better elastic.
The medical performance test result of Antiadhesive film is as shown in table 6
Table 6 Antiadhesive film medical performance test result
Figure BSA00000196465800092
Comparative example 1
Get the 5g molecular weight and be 6.5 ten thousand poly-D, the L lactic acid dissolution obtains mixture in the dichloromethane of 200mL;
Get the polymer that makes and make Antiadhesive film with casting method, radiation sterilization.The work surface of curtain coating mould is that roughness is the matsurface of 5 μ m; Obtaining thickness after the curtain coating is the translucent Antiadhesive film of 50 μ m, and this Antiadhesive film is corresponding with mould, have a shiny surface and with the corresponding matsurface of described shiny surface, the roughness of matsurface is 5 μ m.
The physical property result of test Antiadhesive film is as follows:
25 ℃ of density of testing Antiadhesive film down are 1.2g/cm 2, hot strength is that 12.27Mpa, extension at break are 120.12%, above-mentioned measurement result shows that this Antiadhesive film has better elastic.
The medical performance test result such as the table 7 of Antiadhesive film:
Table 7 Antiadhesive film medical performance test result
Figure BSA00000196465800101
The Antiadhesive film of this utility model embodiment 1 to 5 preparation is compared as can be known with the Antiadhesive film in the comparative example 1, and the Antiadhesive film of this utility model preparation has better elastic, therefore is suitable for implant into body and uses.In addition, because that the Antiadhesive film of this utility model preparation because one side is a matsurface, therefore presents is translucent, the characteristics of translucent Antiadhesive film are to cover to be easy in the wound tissue distinguish, and greatly facilitate the postoperative operation.And, when matsurface contacts with tissue, can avoid Antiadhesive film displacement in vivo, help its better effect of performance anti.
More than Antiadhesive film provided by the utility model is described in detail.Used specific case herein principle of the present utility model and embodiment are set forth, the explanation of above embodiment just is used for helping to understand method of the present utility model and core concept thereof.Should be understood that; for those skilled in the art; under the prerequisite that does not break away from this utility model principle, can also carry out some improvement and modification to this utility model, these improvement and modification also fall in the protection domain of this utility model claim.

Claims (8)

1. elasticity Antiadhesive film of making by the copolymer of carbonic ester and lactide, it is characterized in that, described elasticity Antiadhesive film have shiny surface and with the corresponding matsurface of described shiny surface, the roughness of described matsurface is 0.32 μ m~10 μ m, the thickness of described Antiadhesive film is 20 μ m~500 μ m, and described lactide is lactide or Acetic acid, hydroxy-, bimol. cyclic ester.
2. elasticity Antiadhesive film according to claim 1 is characterized in that, the roughness of described matsurface is 1 μ m~5 μ m.
3. elasticity Antiadhesive film according to claim 2 is characterized in that, described roughness 1.5 μ m~4 μ m.
4. elasticity Antiadhesive film according to claim 3 is characterized in that, described roughness 2 μ m~3 μ m.
5. elasticity Antiadhesive film of making by the mixture of Biodegradable polyester and Merlon, it is characterized in that, described elasticity Antiadhesive film have shiny surface and with the corresponding matsurface of described shiny surface, the roughness of described matsurface is 0.32 μ m~10 μ m, the thickness of described Antiadhesive film is 20 μ m~500 μ m, and described Biodegradable polyester is a kind of in PHA, poly-anhydride, polycaprolactone, polylactic acid, polyglycolic acid, polyimides, polylysine, poe, the poly phosphazene.
6. elasticity Antiadhesive film according to claim 5 is characterized in that, the roughness of described matsurface is 1 μ m~5 μ m.
7. elasticity Antiadhesive film according to claim 6 is characterized in that, described roughness 1.5 μ m~4 μ m.
8. elasticity Antiadhesive film according to claim 7 is characterized in that, described roughness 2 μ m~3 μ m.
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105999428A (en) * 2016-06-15 2016-10-12 湖州科达化工燃料有限公司 Anti-adhesion membrane with effects of resisting bacteria and stopping bleeding
CN114224609A (en) * 2021-12-14 2022-03-25 曹佩培 Middle ear/eustachian tube anti-adhesion membrane and preparation method thereof

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105999428A (en) * 2016-06-15 2016-10-12 湖州科达化工燃料有限公司 Anti-adhesion membrane with effects of resisting bacteria and stopping bleeding
CN114224609A (en) * 2021-12-14 2022-03-25 曹佩培 Middle ear/eustachian tube anti-adhesion membrane and preparation method thereof
CN114224609B (en) * 2021-12-14 2024-01-30 曹佩培 Middle ear/eustachian tube anti-adhesion film and preparation method thereof

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