CN113069595A - Plastic patch and preparation method thereof - Google Patents

Plastic patch and preparation method thereof Download PDF

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Publication number
CN113069595A
CN113069595A CN202110398118.4A CN202110398118A CN113069595A CN 113069595 A CN113069595 A CN 113069595A CN 202110398118 A CN202110398118 A CN 202110398118A CN 113069595 A CN113069595 A CN 113069595A
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plastic patch
layer
prothrombin
dyeing
plastic
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Inventor
吴俊�
耿如霞
颜光前
徐丹
张榆锋
孙亮
李海燕
余韩梅
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Yunnan University YNU
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Yunnan University YNU
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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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/227—Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
    • 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
    • A61L27/14—Macromolecular materials
    • A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/225—Fibrin; Fibrinogen
    • 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
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/252—Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
    • A61L2300/254—Enzymes, proenzymes
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/418—Agents promoting blood coagulation, blood-clotting agents, embolising agents
    • 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/34—Materials or treatment for tissue regeneration for soft tissue reconstruction

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  • Health & Medical Sciences (AREA)
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Abstract

The invention belongs to the technical field of medical materials, and provides a plastic patch and a preparation method thereof. The plastic patch provided by the invention comprises a plastic patch substrate which is woven with an alignment mark, and an instant adhesive layer coated on the plastic patch substrate; the adhesive layer comprises a prothrombin layer and a fibrinogen compound layer; the prothrombin layer is in contact with the plastic patch substrate. The plastic patch provided by the invention solves the problems of alignment between the plastic patch and a tissue part in the process of being implanted into a human body and adaptability to internal tissues of the human body in the implantation process, and the plastic patch can be quickly attached to the tissues without sutures or drawing pins during implantation, so that nerve damage caused by fixation can be avoided, the operation time is greatly saved, and the effects of quick hemostasis and wound healing are realized.

Description

Plastic patch and preparation method thereof
Technical Field
The invention relates to the technical field of medical materials, in particular to a plastic patch and a preparation method thereof.
Background
The abdominal hernia is a common and frequently-occurring disease in general surgery, and the hernia repair is the only cure means. At present, the main treatment of abdominal hernia is tension-free hernia repair using a hernia patch, but complications such as infection, foreign body rejection, chronic pain, intestinal adhesion, intestinal obstruction, intestinal fistula and recurrence occurring after operation are more and more emphasized, and the selection of a proper hernia patch becomes the key point of hernia and abdominal wall surgery. However, no repair material can meet the requirement of an ideal patch at present. The implantation of the synthetic material greatly improves the clinical curative effect of hernia, but the permanent defect of foreign matters also brings the possibility of long-term complications to patients. While a series of absorbable materials, represented by "tissue-inducing biomaterials", are closer to human tissue and may represent a direction of hernia surgical materials development, long-term follow-up results are still needed to demonstrate their clinical utility.
The improvement of the biosynthesis material and the laparoscope technology and the continuous and deep research on the hernia repair, the inguinal hernia operation gradually develops towards the minimal invasion, and the early abdominal cavity patch repair operation has more complications and higher recurrence rate and has little application. The first laparoscopic membrane anterior repair and the complete extraperitoneal repair reported by McKernan have been previously performed by Ger et al and have become the gold standard and mainstream surgical procedure for treating adult inguinal hernias, whichever is the laparoscopic surgical procedure for repairing the weakened musculo-pubic opening through the preperitoneal space. Through research and analysis on the membrane dissection plane of the pubic pore area of the muscle in the preperitoneal space of the inguinal region, the area is found to have a spatial structure which is easily ignored by people. The current 3D shaping patch is transformed according to the space structures, so that the adverse effect of the preperitoneal space patch in the process of being placed in the laparoscopic inguinal hernia repair operation can be effectively eliminated, and the postoperative complications and recurrence rate of the laparoscopic inguinal hernia repair operation are reduced.
In the prior art, the hernia repair patch commonly used in clinic is usually made of polypropylene material, which has the advantages of low density, corrosion resistance, moderate inflammatory stimulation, and the like. To accurately locate the patch position, researchers developed three-dimensional plastic patches with alignment marks, but did not teach how to make alignment marks on plastic patches. Furthermore, the three-dimensional plastic patch with alignment marks is secured by surgical sutures or "tacks" that may or may not be absorbable, but either may cause chronic pain in the patient after surgery due to tissue or nerve damage during the suture securement process. In addition, the literature reports that the mesh patch is folded and displaced due to infirm fixation after implantation, thereby generating hard and sharp edges to cause strong foreign body sensation and discomfort after the operation of a patient, and even serious complications such as intestinal fistula, bladder fistula and the like are generated seriously.
Disclosure of Invention
In view of the above, the present invention aims to provide a plastic patch and a preparation method thereof. The plastic patch of the invention has both the alignment mark and the adhesive layer, and the presence of the alignment mark enables the plastic patch to be easily aligned when in use, i.e. the presence of the adhesive layer avoids the use of surgical sutures or "tacks", reducing postoperative chronic pain and complications.
In order to achieve the above object, the present invention provides the following technical solutions:
the invention provides a plastic patch, which comprises a plastic patch substrate, an instant adhesive layer and a plastic patch, wherein the plastic patch substrate is woven with an alignment mark;
the adhesive layer comprises a prothrombin layer and a fibrinogen compound layer;
the prothrombin layer is in contact with the plastic patch substrate;
the fibrinThe loading amount of fibrinogen in the original composite layer is 0.5-7 mg/cm2The load capacity of prothrombin of the prothrombin layer is 60-800 IU/cm2。
Preferably, the alignment marks are dyed polypropylene strips.
The invention also provides a preparation method of the plastic patch in the technical scheme, which comprises the following steps:
manufacturing a plastic patch substrate;
making dyed polypropylene strips;
weaving the dyed polypropylene strip into a plastic patch matrix, and carrying out heat setting to obtain a precursor;
and sequentially coating a prothrombin layer and a fibrinogen composite layer on the precursor to obtain the plastic patch.
Preferably, the making of the dyed polypropylene strip comprises the steps of:
washing the polypropylene strip to obtain a washed polypropylene strip;
carrying out priming treatment on the washed polypropylene strip to obtain a primed polypropylene strip;
and sequentially dyeing, leaching, fixing color and soaping the primed polypropylene strip to obtain the dyed polypropylene strip.
Preferably, the reagent for the priming treatment is a naphthol solution, and each liter of the naphthol solution contains: 13g of naphthol, 10mL of Turkey red oil, 13mL of caustic soda and the balance of water.
Preferably, the dye bath for dyeing is an aqueous solution comprising the following substances in mass concentration: 1% of blue base BB, 0.8-1.2% of pancreatic bleaching T, 4% of chlorobenzene and 1.5% of ethylene diamine tetraacetic acid trisodium salt.
Preferably, the dyeing comprises the steps of: placing the primed polypropylene strip in a dyeing bath for dyeing at 100 ℃ for 30 min; and then adjusting the pH value of the dyeing bath for dyeing to 6-7, and continuously dyeing for 30min at 100 ℃.
Preferably, the fixing reagent is an aqueous solution comprising the following substances in mass concentration: 6-9% of formic acid, 6-9% of sodium nitrite and 0.8-1.2% of pancreas bleaching T; the color fixing mode is impregnation, the color fixing temperature is room temperature, and the color fixing time is 20 min.
Preferably, the soaping agent is a soaping agent aqueous solution with the concentration of 2 g/L.
Preferably, the heat setting temperature is 108-112 ℃ and the time is 25-35 min.
The invention provides a plastic patch, which comprises a plastic patch substrate, an instant adhesive layer and a plastic patch, wherein the plastic patch substrate is woven with an alignment mark; the adhesive layer comprises a prothrombin layer and a fibrinogen compound layer; the prothrombin layer is in contact with the plastic patch substrate; the loading amount of the fibrinogen composite layer is 0.5-7 mg/cm2The load capacity of prothrombin of the prothrombin layer is 60-800 IU/cm2。
Has the advantages that:
the plastic patch provided by the invention solves the problems of alignment between the plastic patch and a tissue part in the process of being implanted into a human body and adaptability to internal tissues of the human body in the implantation process, and the plastic patch can be quickly attached to the tissues without sutures or drawing pins during implantation, so that nerve damage caused by fixation can be avoided, the operation time is greatly saved, and the effects of quick hemostasis and wound healing are realized.
The invention also provides a preparation method of the plastic patch in the technical scheme. The preparation method successfully programs the alignment mark on the plastic patch substrate, and the alignment mark can solve the problem of inaccurate positioning of the plastic patch. Meanwhile, by optimizing the preparation raw materials and the process of the alignment mark, no new postoperative adverse reaction is brought to the use of the plastic patch.
Drawings
FIG. 1 is a close-up appearance topography of an instant adhesive layer of a plastic patch provided by the present invention;
FIG. 2 is a schematic structural diagram of a plastic patch provided by the present invention, wherein A is an alignment mark;
fig. 3 is an overall schematic view of a hot press mold, wherein 1 is an upper plate of the hot press mold, 2 is a raw material of a plastic patch substrate, and 3 is a lower plate of the hot press mold;
fig. 4 is a graph showing the effect of the plastic patch provided by the present invention placed on an abdominal cut of a pig.
Detailed Description
The invention provides a plastic patch, which comprises a plastic patch substrate, an instant adhesive layer and a plastic patch, wherein the plastic patch substrate is woven with an alignment mark;
the adhesive layer comprises a prothrombin layer and a fibrinogen compound layer;
the prothrombin layer is in contact with the plastic patch substrate;
the loading amount of the fibrinogen composite layer is 0.5-7 mg/cm2The load capacity of prothrombin of the prothrombin layer is 60-800 IU/cm2。
The plastic patch provided by the invention comprises a plastic patch substrate which is woven with an alignment mark, wherein the material of the plastic patch substrate preferably comprises one or more of polypropylene, polytetrafluoroethylene, polyvinylidene fluoride, polyester and expanded polytetrafluoroethylene, and further preferably polypropylene. In the present invention, the shape of the plastic patch matrix is preferably matched to the characteristics of the pubic region of the human preperitoneal interstice muscle.
In the present invention, the alignment mark is preferably a dyed polypropylene strip.
The plastic patch provided by the invention comprises an adhesive layer coated on a plastic patch substrate; the adhesive layer comprises a prothrombin layer and a fibrinogen compound layer; the prothrombin layer is in contact with the plastic patch substrate. In the invention, the loading amount of fibrinogen in the fibrinogen composite layer is 0.5-7 mg/cm2Preferably 1.0 to 5.0mg/cm2More preferably 3.0 to 4.0mg/cm2(ii) a The supporting amount of prothrombin of the prothrombin layer is 60-800 IU/cm2Preferably 100 to 700IU/cm2More preferably 300 to 500IU/cm2More specifically, it is preferably 500IU/cm2。
Fig. 1 is a close-up appearance topography of the plastic patch, i.e. the adhesive layer, provided by the invention, and can be seen from fig. 1: namely, the adhesive layer is firmly attached to the plastic patch substrate and can increase the flexibility of the plastic patch.
Fig. 2 is an external view of the plastic patch provided by the present invention, wherein a is an alignment mark.
The invention also provides a preparation method of the plastic patch in the technical scheme, which comprises the following steps:
manufacturing a plastic patch substrate;
making dyed polypropylene strips;
weaving the dyed polypropylene strip into a plastic patch matrix, and carrying out heat setting to obtain a precursor;
and sequentially coating a prothrombin layer and a fibrinogen composite layer on the precursor to obtain the plastic patch.
The invention manufactures a plastic patch matrix.
In the present invention, the making of the plastic patch substrate preferably comprises the steps of:
designing and manufacturing a hot-pressing die of the plastic patch matrix by using a metal material according to clinical experimental data;
and placing the raw material of the plastic patch matrix into the hot-pressing mold, then placing the hot-pressing mold on a vulcanizing press for curing, and removing the hot-pressing template after curing to obtain the plastic patch matrix.
In the invention, the metal material is preferably 5Cr4W5Mo2V steel, called RM-2 steel for short; or 5Cr4Mo3SiMnVAl, abbreviated as O12 Al.
In the present invention, the overall schematic diagram of the hot pressing mold is shown in fig. 3, where 1 is an upper plate of the hot pressing mold, 2 is a raw material of the plastic patch substrate, and 3 is a lower plate of the hot pressing mold.
In the present invention, the raw material of the plastic patch matrix is preferably a large-aperture lightweight patch material; the large pore size lightweight patch material is preferably a large pore size lightweight patch material available from bard.
In the invention, the curing temperature is preferably 110-150 ℃, the pressure is preferably 0.101-0.1013 MPa, and the time is preferably 20-25 min.
The invention produces dyed polypropylene strips.
In the present invention, the making of the dyed polypropylene strip preferably comprises the steps of:
washing the polypropylene strip to obtain a washed polypropylene strip;
carrying out priming treatment on the washed polypropylene strip to obtain a primed polypropylene strip;
and sequentially dyeing, leaching, fixing color and soaping the primed polypropylene strip to obtain the dyed polypropylene strip.
The polypropylene strip is washed by the method, so that the washed polypropylene strip is obtained.
In the present invention, the washing agent is preferably an aqueous solution of a nonionic surfactant; the mass concentration of the nonionic surfactant aqueous solution is preferably 0.1-0.3%, and more preferably 0.3%; the pH of the aqueous solution of the nonionic surfactant is preferably 9. In the invention, the nonionic surfactant in the nonionic surfactant aqueous solution is preferably a polyethanol type nonionic surfactant with fatty acid polyoxyethylene ester hydrophobic groups; the type of the fatty acid polyoxyethylene ester hydrophobic group polyethanol type nonionic surfactant is particularly preferably Dow polyethylene glycol PEG 400.
In the invention, the washing mode is preferably dipping, and the dipping temperature is preferably 65-75 ℃, and more preferably 70 ℃; the time for the immersion is preferably 30 to 35min, and more preferably 30 min.
After the washed polypropylene strip is obtained, the washed polypropylene strip is subjected to priming treatment to obtain the primed polypropylene strip.
In the present invention, the reagent for the priming treatment is preferably a naphthol solution, and each liter of the naphthol solution contains: 13g of naphthol, 10mL of Turkey red oil, 13mL of caustic soda and the balance of water. In the present invention, the naphthol is preferably naphthol AS-ITR. In the present invention, the baume degree of the caustic soda is preferably 360 Be.
In the present invention, the priming method is preferably rinsing, that is, rinsing the washed polypropylene strip with the priming reagent.
After obtaining the primed polypropylene strip, the invention sequentially dyes, leaches, fixes color and soaps the primed polypropylene strip to obtain the dyed polypropylene strip.
In the present invention, the dye bath for dyeing is preferably an aqueous solution comprising the following substances in concentration by mass: 1% of blue base BB, 0.8-1.2% of pancreatic bleaching T, 4% of chlorobenzene and 1.5% of ethylene diamine tetraacetic acid trisodium salt. In the present invention, the mass concentration of the pancreatic bleaching T in the dyeing bath of the dyeing is preferably 1.0%; the model of the pancreas bleaching T is preferably CO-630.
In the present invention, the dyeing preferably comprises the steps of: placing the primed polypropylene strip in a dyeing bath for dyeing at 100 ℃ for 30 min; and then adjusting the pH value of the dyeing bath for dyeing to 6-7, and continuously dyeing for 30min at 100 ℃. In the invention, the reagent for adjusting the pH value of the dyeing bath for dyeing to be 6-7 is preferably acetic acid.
In the present invention, the rinsing agent is preferably an aqueous solution of pancreatic bleaching T; the mass concentration of the pancreas bleaching T water solution is preferably 0.3-0.6%, and more preferably 0.5%; the type of the pancreas buoyance T in the pancreas buoyance T aqueous solution is preferably pancreas buoyance T CO-630.
In the present invention, the fixing agent is preferably an aqueous solution comprising the following substances in mass concentration: 6-9% of formic acid, 6-9% of sodium nitrite and 0.8-1.2% of pancreas bleaching T. In the invention, the mass concentration of formic acid in the color fixing reagent is preferably 7-8%. In the invention, the mass concentration of sodium nitrite in the color fixing reagent is preferably 7-8%. In the invention, the mass concentration of the pancreas bleaching T in the color fixing reagent is preferably 1.0%; the model of the pancreas float T is preferably pancreas float T CO-630.
In the present invention, the fixing means is preferably impregnation. In the present invention, the temperature of fixation is preferably room temperature, and the time is preferably 20 min.
In the invention, the soaping agent is preferably a soaping agent aqueous solution with the concentration of 2 g/L; the soaping agent of the soaping agent aqueous solution is preferably a printed white stain-resistant soaping agent Goon 501. In the present invention, the soaping mode is preferably impregnation. In the present invention, the temperature of the soaping is preferably 20 ℃ and the time is preferably 30 min.
After said soaping, the present invention preferably further comprises drying the resulting soaped polypropylene strands. In the invention, the drying temperature is preferably 60-80 ℃, and the drying time is preferably 60 min. In the present invention, the drying method is preferably air drying.
After the plastic patch matrix and the dyed polypropylene strip are obtained, the dyed polypropylene strip is woven into the plastic patch matrix and subjected to heat setting to obtain a precursor.
The invention is not particularly limited to the manner in which the dyed polypropylene strip is woven into the plastic patch matrix, and weaving means well known to those skilled in the art may be employed.
In the present invention, the position of the dyed polypropylene strip knitted into the plastic patch base is preferably located at the convex portion of the plastic patch base, and in the specific embodiment of the present invention, the position of the dyed polypropylene strip knitted into the plastic patch base is preferably the position a shown in fig. 2.
In the invention, the heat setting temperature is preferably 108-112 ℃, and more preferably 110 ℃; the time is preferably 25 to 35min, and more preferably 35 min.
After the precursor is obtained, the prothrombin layer and the fibrinogen composite layer are sequentially coated on the precursor to obtain the plastic patch.
In the present invention, the coating of the prothrombin layer preferably comprises the steps of:
the prothrombin layer solution is coated onto the precursor and then subjected to a first freeze-drying.
In the present invention, the prothrombin layer solution is preferably prepared by a method comprising the steps of: dissolving prothrombin in phosphate buffer solution with pH value of 7 to prepare solution with concentration of 50U/mL; and adding calcium chloride into the solution for activation to obtain the prothrombin layer solution.
In the present invention, the mass ratio of calcium chloride to prothrombin is preferably 3: 1. in the present invention, the calcium chloride is preferably used in the form of an aqueous calcium chloride solution, and the mass concentration of the aqueous calcium chloride solution is preferably 1%; the amount of the calcium chloride aqueous solution used is not particularly limited, and may be such that the mass ratio of calcium chloride to prothrombin is satisfied.
In the present invention, the temperature of the activation is preferably 37 ℃ and the time is preferably 10 min.
The amount of the prothrombin solution to be coated is not particularly limited in the present invention, as long as the amount of prothrombin loaded on the final plastic patch meets the above requirements.
In the present invention, the temperature of the first freeze-drying is preferably-85 ℃ to-70 ℃.
In the present invention, the coating of the fibrinogen composite layer preferably includes the steps of:
and coating the fibrinogen compound layer solution on the precursor, and performing second freeze drying.
In the present invention, the fibrinogen composite layer solution is preferably prepared by a method comprising the steps of:
dissolving fibrinogen in phosphate buffer solution with the pH value of 7, and adding blood coagulation factor XIII, fibronectin, polyethylene glycol and aprotinin glycerol solution to obtain the fibrinogen composite layer solution. In the present invention, the fibrinogen complex layer solution preferably has a fibrinogen concentration of 200mg/mL, a factor XIII concentration of 80U/mL, a fibronectin concentration of 10mg/mL, a polyethylene glycol concentration of 100mg/mL, a glycerol concentration of 100mg/mL, and an aprotinin concentration of 200 KU/mL. In the present invention, the pH of the fibrinogen composite layer solution is 6.5.
The amount of coating of the fibrinogen composite layer solution is not particularly limited in the present invention, as long as the amount of fibrinogen loaded on the final plastic patch meets the above requirements.
In the present invention, the temperature of the second freeze-drying is preferably-85 ℃ to-70 ℃.
After coating the fibrinogen composite layer, the present invention preferably further comprises drying, ethylene oxide sterilizing and vacuum packaging the resulting coated precursor to obtain the plastic patch.
In the present invention, the temperature of the drying is preferably-60 to-40 ℃; the drying mode is preferably vacuum drying.
The operation and parameters of ethylene oxide sterilization are not particularly limited in the present invention, and ethylene oxide sterilization methods well known to those skilled in the art may be used.
The plastic patch and the method for producing the same according to the present invention will be described in detail with reference to the following examples, which should not be construed as limiting the scope of the present invention.
Example 1
A method of making a plastic patch comprising the steps of:
(1) firstly, according to clinical experimental data, a hot-pressing die shown in figure 3 is designed and manufactured by adopting a metal material (5Cr4W5Mo2V, RM-2 steel for short), and the preparation process of the hot-pressing die is to construct a main body hot-pressing die with a specific radian and three-dimensional size according to a clinical anatomical picture;
(2) cutting a raw material (a large-aperture light patch material purchased from Bade company) of a plastic patch matrix with a certain size, placing the raw material between an upper plate and a lower plate of a hot pressing die, tightly pressing the upper plate and the lower plate, placing the hot pressing die on a flat vulcanizing machine, setting the temperature to be 110 ℃ and the pressure to be 0.101MPa, conducting temperature and pressure so as to perform a hot pressing experiment on a planar mesh, taking out the hot pressing die after a certain time, and rapidly cooling to obtain the plastic patch matrix;
(3) weaving a polypropylene strip, soaking the polypropylene strip in a non-ionic surfactant (the non-ionic surfactant is Dow polyethylene glycol PEG400) water solution with the mass concentration of 0.3% and the pH value of 9, and keeping the temperature at 70 ℃ for 30min to obtain the washed polypropylene strip. Then, carrying out priming treatment on the washed polypropylene strip to obtain a primed polypropylene strip; the reagent for the priming treatment is a naphthol solution, and each liter of the naphthol solution contains: 13g of naphthol, 10mL of Turkey red oil, 13mL of caustic soda (Baume degree of 360Be), and the balance of water. The dyeing bath for dyeing is an aqueous solution comprising the following components in percentage by mass: 1% of blue base BB, 1% of pancreatic bleaching T CO-6300.8%, 4% of chlorobenzene, 1.5% of ethylene diamine tetraacetic acid trisodium salt; dipping the primed polypropylene strip in the dyeing bath for dyeing at 100 ℃ for 30 min; and then adjusting the pH value of the dyed dye bath to 6-7 by using acetic acid, and continuously dyeing for 30min at 100 ℃. Taking out the dyed polypropylene strips, and leaching by using a pancreas bleaching T CO-630 aqueous solution with the mass concentration of 0.5%; soaking the washed polypropylene strip in a color fixing reagent for 20min, wherein the color fixing reagent is an aqueous solution containing the following substances in percentage by mass: formic acid 8%, sodium nitrite 8%, pancreas bleaching T CO-6301%; taking out the fixed polypropylene strips, and soaping the fixed polypropylene strips for 30min at 20 ℃ by using a soaping agent aqueous solution with the concentration of 2g/L (soaping agent is a white-printed stain-proof soaping agent Goon 501); and taking out the polypropylene strips washed by the soap, and drying at 70 ℃ for 60min to obtain dyed polypropylene strips.
(4) And (3) crosswise weaving the dyed polypropylene strips into the plastic patch matrix according to the shape and the track shown in figure 2, and carrying out heat setting on the combined plastic patch matrix at the temperature of 108 ℃ for 30min to obtain a precursor.
(5) Preparation of fibrinogen layer composite layer solution: dissolving fibrinogen in phosphate buffer solution with pH value of 7, and adding blood coagulation factor XIII, fibronectin, polyethylene glycol and aprotinin glycerol solution to obtain fibrinogen composite layer solution; in the fibrinogen composite layer solution, the concentration of fibrinogen is 200mg/mL, the concentration of coagulation factor XIII is 80U/mL, the concentration of fibronectin is 10mg/mL, the concentration of polyethylene glycol is 100mg/mL, the concentration of glycerol is 100mg/mL, the concentration of aprotinin is 200KU/mL, and the pH of the obtained fibrinogen is 6.5.
Preparation of prothrombin layer solution: dissolving prothrombin in phosphate buffer solution with pH value of 7 to prepare solution with concentration of 50U/mL; adding 1% of CaCl by mass concentration into the solution2The solution (wherein the mass ratio of the added amount of the calcium chloride to the prothrombin is 3: 1) is subjected to heat preservation for 10min under the condition of 37 ℃ water bath to activate the prothrombin, so as to obtain a prothrombin layer solution.
(6) Coating the prothrombin layer solution on the precursor in the step (4), cooling at room temperature, transferring the prothrombin layer solution to an ultralow temperature of-85 to-70 ℃ after cooling to the room temperature for freezing treatment, then coating the fibrinogen compound layer solution on the prothrombin layer, and freezing at the ultralow temperature of-80 to-75 ℃; wherein the loading amount of fibrinogen is 4mg/cm2The loading amount of the prothrombin is 500IU/cm2。
(7) And (3) placing the coated precursor prepared by the steps at the temperature of-60 to-40 ℃ for vacuum drying, and finally sterilizing by using ethylene oxide, vacuumizing and packaging to obtain the plastic patch.
And (3) testing the bonding strength: the plastic patch obtained in example 1 was cut into small pieces of 5cm × 6cm, soaked in physiological saline for 5 seconds and then placed on a preselected abdominal cut of a pig as a test material, as shown in fig. 4, and was press-balanced for 2min, and then the bonded position was repeatedly washed with water, and as a result, it was found that the plastic patch was still firmly attached to the abdominal wall of the pig when the washing was continued for 60 min. The amount of force required to separate the plastic patch from the porcine abdominal wall was measured. As a result, it was found that: an average force of 6.8N to 8.2N is required to separate the plastic patch from the abdominal wall.
The plastic patch provided by the invention can simplify the operation process of the operation, all factors are directly and completely preloaded on the plastic patch substrate, and the plastic patch is crosslinked into a protein clot to be quickly adhered to the operation position under the in vivo environment without using an additional hemostatic agent. When the plastic patch is used, the plastic patch is directly placed at the operation defect part, the alignment problem of the three-dimensional patch with a tissue part in the process of being implanted into a human body and the adaptability problem of the three-dimensional patch to the internal tissue of the human body in the body can be effectively improved, the three-dimensional patch can be quickly attached to the tissue without sewing threads or drawing pins during implantation, thrombin and fibrinogen are crosslinked under the body fluid humid environment to quickly form fibrin glue, and the plastic patch is fixed on the tissue, so that nerve injury caused by fixation can be avoided, the operation time is greatly saved, and the effects of quick hemostasis and wound healing are realized.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.

Claims (10)

1. A plastic patch comprising a plastic patch substrate incorporating an alignment mark, a tie-coat applied to said plastic patch substrate;
the adhesive layer comprises a prothrombin layer and a fibrinogen compound layer;
the prothrombin layer is in contact with the plastic patch substrate;
the loading amount of the fibrinogen composite layer is 0.5-7 mg/cm2The load capacity of prothrombin of the prothrombin layer is 60-800 IU/cm2。
2. The plastic patch as claimed in claim 1, wherein the registration mark is a dyed polypropylene strip.
3. A method of manufacturing a plastic patch according to any one of claims 1 to 2, characterized in that it comprises the following steps:
manufacturing a plastic patch substrate;
making dyed polypropylene strips;
weaving the dyed polypropylene strip into a plastic patch matrix, and carrying out heat setting to obtain a precursor;
and sequentially coating a prothrombin layer and a fibrinogen composite layer on the precursor to obtain the plastic patch.
4. The method of claim 3, wherein the step of making a dyed polypropylene strip comprises the steps of:
washing the polypropylene strip to obtain a washed polypropylene strip;
carrying out priming treatment on the washed polypropylene strip to obtain a primed polypropylene strip;
and sequentially dyeing, leaching, fixing color and soaping the primed polypropylene strip to obtain the dyed polypropylene strip.
5. The method according to claim 4, wherein the reagent for the priming treatment is a naphthol solution containing, per liter of the naphthol solution: 13g of naphthol, 10mL of Turkey red oil, 13mL of caustic soda and the balance of water.
6. The method according to claim 4, characterized in that the dye bath for dyeing is an aqueous solution comprising the following substances in mass concentration: 1% of blue base BB, 0.8-1.2% of pancreatic bleaching T, 4% of chlorobenzene and 1.5% of ethylene diamine tetraacetic acid trisodium salt.
7. The method for preparing according to claim 4 or 6, characterized in that said dyeing comprises the following steps: placing the primed polypropylene strip in a dyeing bath for dyeing at 100 ℃ for 30 min; and then adjusting the pH value of the dyeing bath for dyeing to 6-7, and continuously dyeing for 30min at 100 ℃.
8. The preparation method according to claim 4, characterized in that the fixing reagent is an aqueous solution comprising the following substances in mass concentration: 6-9% of formic acid, 6-9% of sodium nitrite and 0.8-1.2% of pancreas bleaching T; the color fixing mode is impregnation, the color fixing temperature is room temperature, and the color fixing time is 20 min.
9. The method according to claim 4, wherein the soaping agent is an aqueous soaping agent solution having a concentration of 2 g/L.
10. The method according to claim 3, wherein the heat setting temperature is 108 to 112 ℃ and the time is 25 to 35 min.
CN202110398118.4A 2021-04-14 2021-04-14 Plastic patch and preparation method thereof Pending CN113069595A (en)

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Application publication date: 20210706