CN113621247A - Polymerization mesh-shaped composite patch - Google Patents

Polymerization mesh-shaped composite patch Download PDF

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Publication number
CN113621247A
CN113621247A CN202110945673.4A CN202110945673A CN113621247A CN 113621247 A CN113621247 A CN 113621247A CN 202110945673 A CN202110945673 A CN 202110945673A CN 113621247 A CN113621247 A CN 113621247A
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China
Prior art keywords
acellular matrix
mesh
composite patch
polypropylene
polyester
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Pending
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CN202110945673.4A
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Chinese (zh)
Inventor
潘华倩
潘银根
吴锋
陈件忠
陆界瑾
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Jiangsu Utrust Biomedical Technology Co ltd
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Jiangsu Utrust Biomedical Technology Co ltd
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Priority to CN202110945673.4A priority Critical patent/CN113621247A/en
Publication of CN113621247A publication Critical patent/CN113621247A/en
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    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08JWORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J5/00Manufacture of articles or shaped materials containing macromolecular substances
    • C08J5/18Manufacture of films or sheets
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29DPRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
    • B29D7/00Producing flat articles, e.g. films or sheets
    • B29D7/01Films or sheets
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08JWORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J2399/00Characterised by the use of natural macromolecular compounds or of derivatives thereof not provided for in groups C08J2301/00 - C08J2307/00 or C08J2389/00 - C08J2397/00
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08JWORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J2423/00Characterised by the use of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Derivatives of such polymers
    • C08J2423/02Characterised by the use of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Derivatives of such polymers not modified by chemical after treatment
    • C08J2423/10Homopolymers or copolymers of propene
    • C08J2423/12Polypropene
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08JWORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J2467/00Characterised by the use of polyesters obtained by reactions forming a carboxylic ester link in the main chain; Derivatives of such polymers
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08JWORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J2489/00Characterised by the use of proteins; Derivatives thereof

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  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Manufacturing & Machinery (AREA)
  • Materials Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Chemistry (AREA)
  • Polymers & Plastics (AREA)
  • Organic Chemistry (AREA)
  • Mechanical Engineering (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The invention relates to a polymerization mesh-shaped composite patch, which comprises the following components in parts by weight: 60-80 parts of acellular matrix fiber; 10-30 parts of reticular polyester or reticular polypropylene; 1-10 parts of gelatin; wherein the acellular matrix fiber is prepared by mashing wet acellular matrix and mixing the mashed acellular matrix with glacial acetic acid and purified water for homogenate. The invention adopts acellular matrix fiber and polymer (such as polyester or polypropylene) patch to compound, and the acellular matrix fiber is an absorbable isolation layer and can form an effective barrier; the acellular matrix fiber adopts physical or chemical crosslinking, can control the in vivo degradation time, and is favorable for better in vivo healing and tissue regeneration.

Description

Polymerization mesh-shaped composite patch
Technical Field
The invention relates to the technical field of biological materials, in particular to a polymerization mesh-shaped composite patch.
Background
The tensionless hernia repair uses artificial biological material as a patch to strengthen the back wall of the inguinal canal, the method overcomes the interference of the traditional operation on the normal tissue anatomical structure, the level is clear, and the repaired surrounding tissues have no tension. The hernia repair material is classified into non-absorbable materials, composite repair materials and biological materials according to chemical components and biological characteristics of the hernia repair material. The common polymer (such as polyester or polypropylene) patch is a non-absorbable material, and organ adhesion and various secondary complications exist after the abdominal cavity implantation. Michael et al continuously observed abdominal wall defects repaired with polypropylene mesh using laparoscope, optical microscope and electron microscope. He found that adhesions had already formed on day 1 of placement of the prosthetic mesh, and that adhesions had formed on 91% of the surface covered by the implant 7d after surgery. After 7d, the adhesion formation did not progress any further, and on day 7, no adhesion continued to form on the part of the prosthesis where no adhesion was present. The surfaces of the parts without adhesion are covered with a layer of mesothelial cells, which are formed in 3-5 days and completely cover the mesh on 7 days. Therefore, it is considered that if no adhesion occurs within 7d after the implantation of the patch mesh, no adhesion occurs at the site thereafter. If a temporary barrier mechanism is available to resist the occurrence of adhesion during this period of time, the occurrence of adhesion can be prevented.
The composite patch is the most ideal design applied to the current abdominal cavity hernia repair, and can improve the complications of organ adhesion, tissue rejection, slow healing, pain and the like caused by the implantation of the traditional polyester or polypropylene mesh; the added acellular matrix fibers can be effectively isolated from the viscera; the polymer mesh is coated by the acellular matrix fibers, so that vascularization is fast, and tissue growth is facilitated; meanwhile, compared with the common biological patch, the biological patch has higher strength and more price advantage.
Thus, there is a need for a polymeric mesh composite patch.
Disclosure of Invention
The invention aims to overcome the defects in the prior art and provide a polymerization mesh-shaped composite patch.
In order to achieve the purpose, the invention adopts the technical scheme that:
the invention provides a polymerization reticular composite patch, which comprises the following components in parts by weight:
60-80 parts of acellular matrix fiber
10-30 parts of reticular polyester or reticular polypropylene
1-10 parts of gelatin
Wherein the acellular matrix fiber is prepared by mashing wet acellular matrix and mixing the mashed acellular matrix with glacial acetic acid and purified water for homogenate.
Preferably, said trituration comprises: taking wet acellular matrix, and shearing into pieces smaller than 1cm2After the breaking of the pieces, high-speed mashing is carried out within 1 min.
Preferably, the mixing comprises: according to the weight percentage, 0.5 to 3.0 percent of the acellular matrix, 0.01 to 0.1 percent of the glacial acetic acid and the balance of the purified water are mixed and cooled to 2 to 8 ℃.
Preferably, the homogenate comprises: homogenizing at 30Hz-35Hz frequency, homogenizing the collected feed liquid for 5 times, filtering out coarse particles, adjusting pH of the filtered slurry to 7.5-8.0 by using 8-10% NaOH solution, and centrifuging.
Preferably, the reticular polyester or reticular polypropylene is formed by weaving medical polyester or polypropylene wires.
Preferably, the mesh-shaped polyester or mesh-shaped polypropylene has a pore size of 1 to 3 mm.
A second aspect of the present invention provides a method for preparing the polymeric mesh composite patch as described above, comprising the steps of:
mixing the acellular matrix fiber, the gelatin and water to prepare the acellular matrix fiber with the mass concentration of 0.5-1.5% and the mass concentration of the gelatin of 0.05-0.1%Suspending, adding glacial acetic acid to adjust pH to 4.0-6.5 at a ratio of 20-60g/100cm2Is injected into a mold, covered with the reticulated polyester or reticulated polypropylene, and then at a rate of 20-60g/100cm2Pouring the suspension, after vacuum freeze drying, balancing for 0.5-5 hours under the environment humidity with the RH of 60% -99%, flattening, freeze drying again, vacuum dehydrating for 12-36 hours at the temperature of 110-150 ℃, and crosslinking, cleaning, freeze drying, cutting, packaging and sterilizing to obtain the polymerization reticular composite patch.
Preferably, the crosslinking comprises: one or more of chemical crosslinking agent crosslinking, vacuum thermal crosslinking, or ultraviolet crosslinking.
Preferably, the chemical crosslinking agent comprises: one or more of formaldehyde, acetaldehyde, cyanamide, glutaraldehyde, genipin, N-hydroxysuccinimide, hexamethylene diisocyanate, diphenylphosphoryl azide, 1, 4-butane diglycidyl ether, 1-ethyl-3- (3-dimethylaminopropyl) -carbodiimide, or N-sulfosuccinimidyl-6- (4 '-azido-2' -nitrophenylamino) hexanoate.
By adopting the technical scheme, compared with the prior art, the invention has the following technical effects:
the invention adopts acellular matrix fiber and polymer (such as polyester or polypropylene) patch to compound, and the acellular matrix fiber is an absorbable isolation layer and can form an effective barrier; the acellular matrix fiber adopts physical or chemical crosslinking, can control the in vivo degradation time, and is favorable for better in vivo healing and tissue regeneration.
Drawings
FIG. 1 is a schematic representation of the structure of a polymeric mesh composite patch prepared in example 1 of the present invention;
FIG. 2 is a schematic microstructure of a polymeric mesh composite patch made in example 2 of the present invention.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
It should be noted that the embodiments and features of the embodiments may be combined with each other without conflict.
The invention is further described with reference to the following drawings and specific examples, which are not intended to be limiting.
Example 1
As shown in fig. 1, the present embodiment provides a polymeric mesh composite patch, which is prepared by the steps of:
s0, taking an animal tissue biomembrane, and preparing an acellular matrix (including but not limited to an acellular dermal matrix, an acellular peritoneal matrix, an acellular pericardial matrix and an acellular vesicular membrane matrix, wherein the preparation method is not repeated herein, and the preparation can be carried out according to Chinese patent CN103191466B or other similar methods by ordinary technicians in the field);
s1, taking the wet acellular matrix, and shearing the matrix into pieces smaller than 1cm2Crushing at high speed within 1 min; according to the weight percentage, 0.5 percent of wet weight of the acellular matrix, 0.01 percent of glacial acetic acid and the balance of purified water are mixed and cooled to 2 ℃; homogenizing at 30Hz, homogenizing the collected feed liquid for 5 times, filtering out coarse particles, adjusting the pH value of the filtered slurry to 7.5 by adopting a NaOH solution with the concentration of 8%, and centrifuging;
s2, weaving commercially available medical polyester or polypropylene wires into reticular polyester or reticular polypropylene with the aperture of 1mm by a weaving process;
s3, mixing the acellular matrix fiber, the gelatin and water to prepare a suspension with the mass concentration of 0.5% of the acellular matrix fiber and the mass concentration of 0.05% of the gelatin, adding glacial acetic acid to adjust the pH to 4.0, and controlling the pH to be 20g/100cm2Is injected into a mold, covered with the reticulated polyester or reticulated polypropylene and then at a rate of 20g/100cm2Pouring the suspension, carrying out vacuum freeze drying, balancing for 0.5 hour under the environment humidity with the RH of 60%, flattening, carrying out freeze drying again, carrying out vacuum dehydration for 12 hours at the temperature of 110 ℃, carrying out crosslinking for 6 hours by adopting 0.01% hexamethylene diisocyanate, cleaning, freeze drying, cutting, packaging, and carrying out ethylene oxide sterilization to obtain the polymerization reticular composite patch.
Example 2
As shown in fig. 2, this embodiment provides a polymeric mesh composite patch, which is prepared by the steps of:
s0, taking an animal tissue biomembrane, and preparing an acellular matrix (including but not limited to an acellular dermal matrix, an acellular peritoneal matrix, an acellular pericardial matrix and an acellular vesicular membrane matrix, wherein the preparation method is not repeated herein, and the preparation can be carried out according to Chinese patent CN103191466B or other similar methods by ordinary technicians in the field);
s1, taking the wet acellular matrix, and shearing the matrix into pieces smaller than 1cm2Crushing at high speed within 1 min; according to the weight percentage, 3.0 percent of the acellular matrix by wet weight, 0.1 percent of the glacial acetic acid and the balance of the purified water are mixed and cooled to 8 ℃; homogenizing at 35Hz, homogenizing the collected feed liquid for 5 times, filtering out coarse particles, adjusting the pH value of the filtered slurry to 8.0 by adopting a NaOH solution with the concentration of 10%, and centrifuging;
s2, weaving commercially available medical polyester or polypropylene wires into mesh polyester or mesh polypropylene with a pore diameter of 3mm by a weaving process;
s3, mixing the acellular matrix fiber, the gelatin and water to prepare a suspension with the mass concentration of the acellular matrix fiber being 1.5% and the mass concentration of the gelatin being 0.1%, adding glacial acetic acid to adjust the pH to 6.5, and adjusting the pH to 60g/100cm2Is injected into a mold, covered with the reticulated polyester or reticulated polypropylene and then at a rate of 60g/100cm2Pouring the suspension, vacuum freeze-drying, balancing for 5 hours at an ambient humidity with 99% RH, flattening, freeze-drying again, and vacuum dehydrating at 150 deg.C for 36 hoursAnd crosslinking for 24 hours by adopting ultraviolet rays, cleaning, freeze-drying, cutting, packaging and sterilizing by using ethylene oxide to obtain the polymerized reticular composite patch.
Example 3
Example 2 Polyester patch Biological patch
Chemical crosslinking Is free of Is free of Is provided with
Tensile strength High strength High strength Is weaker
Hydrophilic property Hydrophilic Hydrophobic Hydrophilic
Liquid absorbing capacity About 15 to 20 times Hardly absorbs and has a surface adhered with a part of liquid About 15 to 20 times
Wherein, the liquid absorption capacity refers to the increased weight after absorbing liquid compared with the weight in the original dry state; the biological patch is a inguinal hernia biological patch prepared from a decellularized pig small intestine submucosa material by Beijing Bopfurri Biotech Co.
In conclusion, the invention adopts the acellular matrix fiber and the polymer (such as polyester or polypropylene) patch to be compounded, and the acellular matrix fiber is an absorbable isolation layer and can form an effective barrier; the acellular matrix fiber adopts physical or chemical crosslinking, can control the in vivo degradation time, and is favorable for better in vivo healing and tissue regeneration.
While the invention has been described with reference to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention.

Claims (9)

1. A polymerization mesh-shaped composite patch is characterized by comprising the following components in parts by weight:
60-80 parts of acellular matrix fiber
10-30 parts of reticular polyester or reticular polypropylene
1-10 parts of gelatin
Wherein the acellular matrix fiber is prepared by mashing wet acellular matrix and mixing the mashed acellular matrix with glacial acetic acid and purified water for homogenate.
2. The polymeric mesh composite patch as claimed in claim 1, wherein the pounding comprises: taking wet acellular matrix, and shearing into pieces smaller than 1cm2After the breaking of the pieces, high-speed mashing is carried out within 1 min.
3. The polymeric mesh composite patch as claimed in claim 1, wherein the mixing comprises: according to the weight percentage, 0.5 to 3.0 percent of the acellular matrix, 0.01 to 0.1 percent of the glacial acetic acid and the balance of the purified water are mixed and cooled to 2 to 8 ℃.
4. The polymeric mesh composite patch according to claim 1, wherein the homogenate comprises: homogenizing at 30Hz-35Hz frequency, homogenizing the collected feed liquid for 5 times, filtering out coarse particles, adjusting pH of the filtered slurry to 7.5-8.0 by using 8-10% NaOH solution, and centrifuging.
5. The polymeric mesh composite patch as claimed in claim 1, wherein the mesh polyester or mesh polypropylene is woven from medical polyester or polypropylene wires.
6. The polymeric mesh composite patch as claimed in claim 1, wherein the mesh polyester or mesh polypropylene has a pore size of 1-3 mm.
7. A method of making a polymeric mesh composite patch according to any one of claims 1-6, comprising the steps of:
mixing the acellular matrix fiber, the gelatin and water to prepare a suspension with the mass concentration of 0.5-1.5% of the acellular matrix fiber and the mass concentration of 0.05-0.1% of the gelatin, adding glacial acetic acid to adjust the pH to 4.0-6.5, and adding glacial acetic acid at a ratio of 20-60g/100cm2Is injected into a mold, covered with the reticulated polyester or reticulated polypropylene, and then at a rate of 20-60g/100cm2Pouring the suspension, after vacuum freeze drying, balancing for 0.5-5 hours under the environment humidity with the RH of 60% -99%, flattening, freeze drying again, vacuum dehydrating for 12-36 hours at the temperature of 110-150 ℃, and crosslinking, cleaning, freeze drying, cutting, packaging and sterilizing to obtain the polymerization reticular composite patch.
8. The method of claim 7, wherein the cross-linking comprises: one or more of chemical crosslinking agent crosslinking, vacuum thermal crosslinking, or ultraviolet crosslinking.
9. The method of claim 8, wherein the chemical cross-linking agent comprises: one or more of formaldehyde, acetaldehyde, cyanamide, glutaraldehyde, genipin, N-hydroxysuccinimide, hexamethylene diisocyanate, diphenylphosphoryl azide, 1, 4-butane diglycidyl ether, 1-ethyl-3- (3-dimethylaminopropyl) -carbodiimide, or N-sulfosuccinimidyl-6- (4 '-azido-2' -nitrophenylamino) hexanoate.
CN202110945673.4A 2021-08-16 2021-08-16 Polymerization mesh-shaped composite patch Pending CN113621247A (en)

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Application Number Priority Date Filing Date Title
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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102266585A (en) * 2011-07-20 2011-12-07 中国人民解放军第三军医大学第一附属医院 Biological composite patch for female pelvic floor and manufacturing method thereof
CN102631708A (en) * 2012-05-17 2012-08-15 重庆市畜牧科学院 Preparation method of pelvic floor patch composite biological material and product of preparation method
EP3181152A1 (en) * 2015-12-18 2017-06-21 BSN medical GmbH Multi-layered wound care product

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102266585A (en) * 2011-07-20 2011-12-07 中国人民解放军第三军医大学第一附属医院 Biological composite patch for female pelvic floor and manufacturing method thereof
CN102631708A (en) * 2012-05-17 2012-08-15 重庆市畜牧科学院 Preparation method of pelvic floor patch composite biological material and product of preparation method
EP3181152A1 (en) * 2015-12-18 2017-06-21 BSN medical GmbH Multi-layered wound care product

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
沈光裕等: "猪脱细胞真皮基质在人皮肤创伤修复中的临床应用", 《华南国防医学杂志》 *

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Application publication date: 20211109

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