The present application is a divisional application of the chinese patent application with the patent office of china, application number CN201610743422.7, entitled "a multifunctional negative pressure drainage device of silicone gel and method for making the same" filed on 29/08/2016, the entire contents of which are incorporated by reference in the present application.
Disclosure of Invention
In order to solve the defects of the prior art, the invention provides a multifunctional silica gel negative pressure drainage device and a preparation method thereof.
The technical scheme of the invention is realized as follows:
a multifunctional silicone gel negative pressure drainage device comprises: the dressing body, the drainage mechanism connected with the dressing body and the negative pressure source;
the dressing body comprises a polyurethane film, an absorption layer, a filter layer and a glue layer which are sequentially arranged from top to bottom, the glue layer is a double-sided glue layer with vent holes, one side of the double-sided glue layer, which is connected with the filter layer, is a medical pressure-sensitive adhesive, and the other side is silica gel which can be connected with a human body; the lower surface of the polyurethane film is also provided with medical pressure-sensitive adhesive, the outer edge of the polyurethane film is adhered to the outer edge of the adhesive layer, so that the absorption layer and the filter layer are coated between the polyurethane film and the adhesive layer (in order to improve the filtering effect and prevent small-volume necrotic tissues from entering theabsorption layer 2, a biological filter membrane is also arranged between theabsorption layer 2 and the filter layer 3);
the two sides of the adhesive layer are respectively provided with a first handheld side and a second handheld side, the adhesive layer is provided with a plurality of knife edges, the knife edges are staggered and evenly distributed, and when the first handheld side and the second handheld side are pulled open to the two sides, the knife edges form a penetration area with a rhombic gap.
Preferably, the silicone gel of 100 parts by weight further comprises the following components in parts by weight: 0.01-0.05 parts of nano silver, 0.2-0.4 parts of plant extract, 0.5-4 parts of growth factor and 0.3-0.5 parts of antipruritic.
According to the invention, the double-sided adhesive layer with good adhesion and good skin-friendly performance is adopted, the firsthandheld edge 42 and the secondhandheld edge 43 are respectively arranged on the two sides of theadhesive layer 4, and under the action of external force, the knife edge on theadhesive layer 4 automatically cracks to form thepenetrating area 44 with the diamond-shaped gap, so that the adaptability of theadhesive layer 4 and a human body is improved, the tight feeling is not generated, the drawing-out and the leading-out of seepage are facilitated, and the use is convenient. The side of theadhesive layer 4 provided with the silica gel is bonded with the human body, and the side provided with the medical pressure-sensitive adhesive is bonded with thefilter layer 3, so that the tightness and the drainage efficiency of the silica gel negative pressure drainage device are improved, and the faster healing of the wound is facilitated. In addition, growth factors capable of promoting skin growth, plant extracts with the functions of sterilization, inflammation diminishing and itching relieving and special antipruritic are added, discomfort caused by wound healing is effectively relieved, and wound healing is remarkably accelerated.
Preferably, the nano silver has a particle size range of 25-50nm, and the plant extract is prepared from the following raw materials in a weight ratio of 1: 2: 3, the mixture extract of the lightyellow sophora root, the mint, the camphor tree trunk or the camphor tree root, the camphor tree is the camphor tree with the age of more than 50 years, and the antipruritic agent is methylnaltrexone.
Epidermal Growth Factor (EGF) is the earliest growth factor found and plays an important role in regulating cell growth, proliferation and differentiation. Epidermal growth factor is a small peptide consisting of 53 amino acid residues, a member of the EGF-like large family.
The nano silver has super-strong permeability and bactericidal property, and can promote wound healing, promote the repair and regeneration of damaged cells, remove the necrotic tissue and promote granulation, resist bacteria and diminish inflammation, improve the microcirculation of tissues around the wound, effectively activate and promote the growth of the tissue cells, accelerate the healing of the wound and reduce the generation of scars.
Radix Sophorae Flavescentis has antibacterial and anti-inflammatory effects; the mint extract contains menthol which can induce the cool feeling same as low temperature, cool the skin and relieve the induced skin itch; the camphor tree leaf extract contains camphor, the camphor has the functions of killing insects, relieving itching, reducing swelling, relieving pain and mild anesthesia, and can be used for treating skin itch, the camphor tree leaf extract mainly contains pure dextro camphor, and the trunks or roots of camphor trees with the age of more than 50 years contain more dextro camphor; the methylnaltrexone has the function of treating skin itch. The common action of the radix sophorae flavescentis, the menthol, the camphor and the methylnaltrexone can treat both symptoms and root causes of skin itch generated in wound healing, and the addition proportion has a very good treatment effect and does not damage wounds.
Preferably, the upper surface of the polyurethane film is provided with a PE protective film; the lower surface of the adhesive layer is provided with a PE or PET fluoroplastic release film, the PE or PET fluoroplastic release film comprises two PE or PET fluoroplastic release films covering the lower surface of the adhesive layer, and adjacent sides of the two PE or PET fluoroplastic release films are mutually overlapped; the adhesive layer also comprises a PU film for loading medical pressure-sensitive adhesive and silica gel; the area of the absorption layer is not less than that of the filter layer, and the absorption layer completely covers the filter layer.
The invention also provides a preparation method of the multifunctional silica gel negative pressure drainage device, and the production process of the dressing body comprises the following steps:
step one, preparing an adhesive layer:
arranging the medical pressure-sensitive adhesive on the PU film carrier in a screen printing or scraper coating mode, and covering a protective layer on the medical pressure-sensitive adhesive;
coating the mixed silica gel on the other side of the PU film carrier, curing to obtain a silica gel layer, and then covering the PE or PET fluoroplastic release film subjected to disinfection and sterilization on the silica gel layer;
performing transparent cutting on the product obtained in the last step in a staggered mode to form a plurality of rows and a plurality of columns of knife edges, wherein only part of the positions of the knife edges in the front column and the positions of the knife edges in the back column are positioned on the same level in the two adjacent columns;
secondly, preparing a polyurethane film provided with the medical pressure-sensitive adhesive:
arranging the medical pressure-sensitive adhesive on the polyurethane film in a screen printing or scraper coating mode;
thirdly, compounding:
tearing off the protective layer, and sequentially compounding the filter layer and the absorption layer between the side of the adhesive layer provided with the medical pressure-sensitive adhesive and the side of the polyurethane film provided with the medical pressure-sensitive adhesive;
step four, subsequent processing: comprises sterilizing, blanking, screening, quality testing, and packaging.
The production needs to be carried out in a clean environment of more than 10 ten thousand grades, and the PU film carrier, the protective layer and the PE or PET fluoroplastic release film can be used after being subjected to aseptic processing.
Preferably, a 100-150 mesh/inch stainless steel screen or a PET screen is used in the screen printing.
Preferably, the thickness of the layer of silicone gel is 0.08-0.25 mm.
More preferably, the thickness of the silicone gel layer is 0.15 to 0.2 mm.
Compared with the prior art, the double-sided adhesive layer with good adhesion and skin-friendly performance is adopted, and the appropriate amount of nano silver, plant extract, growth factor and antipruritic agent are added into the silica gel, so that the healing of the wound is accelerated under the combined action of the nano silver, the plant extract, the growth factor and the antipruritic agent.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to 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.
Example 1
A multifunctional silicone gel negative pressure drainage device comprises: the dressing body, a drainage mechanism connected with the dressing body and a negative pressure source 9;
the dressing body comprises apolyurethane film 1, anabsorption layer 2, afilter layer 3 and aglue layer 4 which are sequentially arranged from top to bottom, wherein theglue layer 4 is a double-sided glue layer with a vent hole, one side of the double-sided glue layer, which is connected with thefilter layer 3, is medical pressure-sensitive glue, and the other side is silica gel which can be connected with a human body; the lower surface of thepolyurethane film 1 is also provided with medical pressure-sensitive adhesive, and the outer edge of thepolyurethane film 1 is adhered to the outer edge of theadhesive layer 4, so that theabsorption layer 2 and thefilter layer 3 are coated between thepolyurethane film 1 and theadhesive layer 4;
a firsthandheld edge 42 and a secondhandheld edge 43 are respectively arranged on two sides of theadhesive layer 4, a plurality of knife edges are arranged on theadhesive layer 4 and are uniformly distributed in a staggered manner, and when the firsthandheld edge 42 and the secondhandheld edge 43 are pulled open towards the two sides, the knife edges form apenetration area 44 with a diamond-shaped gap;
the silicone gel of 100 weight portions also comprises the following components of: 0.05 part of nano silver, 0.3 part of plant extract, 0.5 part of growth factor and 0.5 part of antipruritic.
The particle size range of the nano silver is 30nm, and the weight ratio of the plant extracts is 1: 2: 3, the mixed extract of the lightyellow sophora root, the mint, the camphor tree trunk or the camphor tree root with the age of more than 50 years, and the antipruritic agent is methylnaltrexone.
The production process of the dressing body comprises the following steps:
step one, preparing a glue layer 4:
arranging a medical pressure-sensitive adhesive on the PU film carrier in a screen printing mode, and covering a protective layer on the medical pressure-sensitive adhesive;
coating the mixed silica gel on the other surface of the PU film carrier, curing to obtain a silica gel layer with the thickness of 0.08mm, and then covering the PETfluoroplastic release film 41 subjected to disinfection and sterilization on the silica gel layer;
performing transparent cutting on the product obtained in the last step in a staggered mode to form a plurality of rows and a plurality of columns of knife edges, wherein only part of the positions of the knife edges in the front column and the positions of the knife edges in the back column are positioned on the same level in the two adjacent columns;
step two, preparing apolyurethane film 1 provided with a medical pressure-sensitive adhesive:
arranging the medical pressure-sensitive adhesive on thepolyurethane film 1 in a screen printing mode, wherein a 120-mesh/inch stainless steel screen plate or a PET screen plate is adopted in the screen printing in the first step and the second step;
thirdly, compounding:
tearing off the protective layer, and sequentially compounding thefilter layer 3 and theabsorption layer 2 between the surface provided with the medical pressure-sensitive adhesive in theadhesive layer 4 and the surface provided with the medical pressure-sensitive adhesive in thepolyurethane film 1;
step four, subsequent processing: comprises sterilizing, blanking, screening, quality testing, and packaging.
Example 2
A multifunctional silicone gel negative pressure drainage device comprises: the dressing body, a drainage mechanism connected with the dressing body and a negative pressure source 9;
the dressing body comprises apolyurethane film 1, anabsorption layer 2, afilter layer 3 and aglue layer 4 which are sequentially arranged from top to bottom, wherein theglue layer 4 is a double-sided glue layer with a vent hole, one side of the double-sided glue layer, which is connected with thefilter layer 3, is medical pressure-sensitive glue, and the other side is silica gel which can be connected with a human body; the lower surface of thepolyurethane film 1 is also provided with medical pressure-sensitive adhesive, and the outer edge of thepolyurethane film 1 is adhered to the outer edge of theadhesive layer 4, so that theabsorption layer 2 and thefilter layer 3 are coated between thepolyurethane film 1 and theadhesive layer 4;
a firsthandheld edge 42 and a secondhandheld edge 43 are respectively arranged on two sides of theadhesive layer 4, a plurality of knife edges are arranged on theadhesive layer 4 and are uniformly distributed in a staggered manner, and when the firsthandheld edge 42 and the secondhandheld edge 43 are pulled open towards the two sides, the knife edges form apenetration area 44 with a diamond-shaped gap;
the silicone gel of 100 weight portions also comprises the following components of: 0.03 part of nano-silver, 0.2 part of plant extract, 4 parts of growth factor and 0.4 part of antipruritic agent.
The particle size range of the nano silver is 25nm, and the weight ratio of the plant extracts is 1: 2: 3, the mixed extract of the lightyellow sophora root, the mint, the camphor tree trunk or the camphor tree root with the age of more than 50 years, and the antipruritic agent is methylnaltrexone.
The production process of the dressing body comprises the following steps:
step one, preparing a glue layer 4:
coating the medical pressure-sensitive adhesive on the PU film carrier in a manner of coating by a scraper, and covering a protective layer on the medical pressure-sensitive adhesive;
coating the mixed silica gel on the other side of the PU film carrier, curing to obtain a silica gel layer with the thickness of 0.15mm, and then covering the PE subjected to disinfection and sterilization on the silica gel layer;
performing transparent cutting on the product obtained in the last step in a staggered mode to form a plurality of rows and a plurality of columns of knife edges, wherein only part of the positions of the knife edges in the front column and the positions of the knife edges in the back column are positioned on the same level in the two adjacent columns;
step two, preparing apolyurethane film 1 provided with a medical pressure-sensitive adhesive:
coating the medical pressure-sensitive adhesive on thepolyurethane film 1 in a manner of blade coating;
thirdly, compounding:
tearing off the protective layer, and sequentially compounding thefilter layer 3 and theabsorption layer 2 between the surface provided with the medical pressure-sensitive adhesive in theadhesive layer 4 and the surface provided with the medical pressure-sensitive adhesive in thepolyurethane film 1;
step four, subsequent processing: comprises sterilizing, blanking, screening, quality testing, and packaging.
Example 3
A multifunctional silicone gel negative pressure drainage device comprises: the dressing body, a drainage mechanism connected with the dressing body and a negative pressure source 9;
the dressing body comprises apolyurethane film 1, anabsorption layer 2, afilter layer 3 and aglue layer 4 which are sequentially arranged from top to bottom, wherein theglue layer 4 is a double-sided glue layer with a vent hole, one side of the double-sided glue layer, which is connected with thefilter layer 3, is medical pressure-sensitive glue, and the other side is silica gel which can be connected with a human body; the lower surface of thepolyurethane film 1 is also provided with medical pressure-sensitive adhesive, and the outer edge of thepolyurethane film 1 is adhered to the outer edge of theadhesive layer 4, so that theabsorption layer 2 and thefilter layer 3 are coated between thepolyurethane film 1 and theadhesive layer 4;
a firsthandheld edge 42 and a secondhandheld edge 43 are respectively arranged on two sides of theadhesive layer 4, a plurality of knife edges are arranged on theadhesive layer 4 and are uniformly distributed in a staggered manner, and when the firsthandheld edge 42 and the secondhandheld edge 43 are pulled open towards the two sides, the knife edges form apenetration area 44 with a diamond-shaped gap;
the silicone gel of 100 weight portions also comprises the following components of: 0.01 weight part of nano silver, 0.4 weight part of plant extract, 2 weight parts of growth factor and 0.3 weight part of antipruritic.
The particle size range of the nano silver is 50nm, and the weight ratio of the plant extracts is 1: 2: 3, the mixed extract of the lightyellow sophora root, the mint, the camphor tree trunk or the camphor tree root with the age of more than 50 years, and the antipruritic agent is methylnaltrexone.
The production process of the dressing body comprises the following steps:
step one, preparing a glue layer 4:
arranging a medical pressure-sensitive adhesive on the PU film carrier in a screen printing mode, and covering a protective layer on the medical pressure-sensitive adhesive;
coating the mixed silica gel on the other side of the PU film carrier, curing to obtain a silica gel layer with the thickness of 0.2mm, and then covering the PETfluoroplastic release film 41 subjected to disinfection and sterilization on the silica gel layer;
performing transparent cutting on the product obtained in the last step in a staggered mode to form a plurality of rows and a plurality of columns of knife edges, wherein only part of the positions of the knife edges in the front column and the positions of the knife edges in the back column are positioned on the same level in the two adjacent columns;
step two, preparing apolyurethane film 1 provided with a medical pressure-sensitive adhesive:
arranging the medical pressure-sensitive adhesive on thepolyurethane film 1 in a screen printing mode, wherein a 150-mesh/inch stainless steel screen plate or a PET screen plate is adopted in the screen printing in the first step and the second step;
thirdly, compounding:
tearing off the protective layer, and sequentially compounding thefilter layer 3 and theabsorption layer 2 between the surface provided with the medical pressure-sensitive adhesive in theadhesive layer 4 and the surface provided with the medical pressure-sensitive adhesive in thepolyurethane film 1;
step four, subsequent processing: comprises sterilizing, blanking, screening, quality testing, and packaging.
Example 4
A multifunctional silicone gel negative pressure drainage device comprises: the dressing body, a drainage mechanism connected with the dressing body and a negative pressure source 9;
the dressing body comprises apolyurethane film 1, anabsorption layer 2, afilter layer 3 and aglue layer 4 which are sequentially arranged from top to bottom, wherein theglue layer 4 is a double-sided glue layer with a vent hole, one side of the double-sided glue layer, which is connected with thefilter layer 3, is medical pressure-sensitive glue, and the other side is silica gel which can be connected with a human body; the lower surface of thepolyurethane film 1 is also provided with medical pressure-sensitive adhesive, and the outer edge of thepolyurethane film 1 is adhered to the outer edge of theadhesive layer 4, so that theabsorption layer 2 and thefilter layer 3 are coated between thepolyurethane film 1 and theadhesive layer 4;
a firsthandheld edge 42 and a secondhandheld edge 43 are respectively arranged on two sides of theadhesive layer 4, a plurality of knife edges are arranged on theadhesive layer 4 and are uniformly distributed in a staggered manner, and when the firsthandheld edge 42 and the secondhandheld edge 43 are pulled open towards the two sides, the knife edges form apenetration area 44 with a diamond-shaped gap;
the silicone gel of 100 weight portions also comprises the following components of: 0.01 weight part of nano silver, 0.4 weight part of plant extract, 2 weight parts of growth factor and 0.3 weight part of antipruritic.
The particle size range of the nano silver is 50nm, and the weight ratio of the plant extracts is 1: 2: 3, the mixed extract of the lightyellow sophora root, the mint, the camphor tree trunk or the camphor tree root with the age of more than 50 years, and the antipruritic agent is methylnaltrexone.
The production process of the dressing body comprises the following steps:
step one, preparing a glue layer 4:
arranging a medical pressure-sensitive adhesive on the PU film carrier in a screen printing mode, and covering a protective layer on the medical pressure-sensitive adhesive;
coating the mixed silica gel on the other side of the PU film carrier, curing to obtain a silica gel layer with the thickness of 0.25mm, and then covering the PE subjected to disinfection and sterilization on the silica gel layer;
performing transparent cutting on the product obtained in the last step in a staggered mode to form a plurality of rows and a plurality of columns of knife edges, wherein only part of the positions of the knife edges in the front column and the positions of the knife edges in the back column are positioned on the same level in the two adjacent columns;
step two, preparing apolyurethane film 1 provided with a medical pressure-sensitive adhesive:
arranging the medical pressure-sensitive adhesive on thepolyurethane film 1 in a screen printing mode, wherein 130-mesh/inch stainless steel screen plates or PET screen plates are adopted in the screen printing in the first step and the second step;
thirdly, compounding:
tearing off the protective layer, and sequentially compounding thefilter layer 3 and theabsorption layer 2 between the surface provided with the medical pressure-sensitive adhesive in theadhesive layer 4 and the surface provided with the medical pressure-sensitive adhesive in thepolyurethane film 1;
step four, subsequent processing: comprises sterilizing, blanking, screening, quality testing, and packaging.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.