CN109350363B - Manufacturing process of sealed negative-pressure drainage wet sponge - Google Patents

Manufacturing process of sealed negative-pressure drainage wet sponge Download PDF

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Publication number
CN109350363B
CN109350363B CN201811405263.5A CN201811405263A CN109350363B CN 109350363 B CN109350363 B CN 109350363B CN 201811405263 A CN201811405263 A CN 201811405263A CN 109350363 B CN109350363 B CN 109350363B
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sponge
top bag
bag
polyvinyl alcohol
storage bin
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CN201811405263.5A
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CN109350363A (en
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朱玉明
肖进
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Wuhan VSD Medical Science and Technology Co Ltd
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Wuhan VSD Medical Science and Technology Co Ltd
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    • A61F13/05
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/00051Accessories for dressings
    • A61F13/00072Packaging of dressings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/00987Apparatus or processes for manufacturing non-adhesive dressings or bandages
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20Gaseous substances, e.g. vapours
    • A61L2/206Ethylene oxide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/21Pharmaceuticals, e.g. medicaments, artificial body parts

Abstract

The invention relates to a manufacturing process of a sealed negative pressure drainage wet sponge, which is characterized in that dry polyvinyl alcohol sponge is filled into a top bag, and the top bag is connected with a liquid storage bin through a connecting pipe and sealed; fumigating and sterilizing in an environment containing ethylene oxide gas, sealing and packaging the sterilized belt, unscrewing a one-way valve in a top bag outside the top bag through the top bag to inject liquid in a liquid storage bin into the surface of the sponge, pulling out a connecting pipe and the liquid storage bin after the liquid injection is finished, sealing the top bag part containing polyvinyl alcohol sponge, and cutting off the top bag part containing a Tyvek paper surface and the liquid storage bin to obtain the negative pressure drainage wet-state sponge. The process of the invention packs the polyvinyl alcohol sponge for rehydration to obtain the negative pressure drainage wet sponge which has excellent cytotoxicity close to neutral pH value and provides a good growth environment for granulation tissues required by wound healing, thereby keeping the comfort of patients and being used for body surface and body cavity wound repair.

Description

Manufacturing process of sealed negative-pressure drainage wet sponge
Technical Field
The invention relates to the field of medical sponges, in particular to a manufacturing process of a sealed negative-pressure drainage wet sponge.
Background
Along with the popularization of the negative pressure drainage technology, the application of the negative pressure drainage sponge is gradually wide: the application of the deep cavity wound surface is changed from body surface application to deep cavity wound surface application, and the deep cavity wound surface application has higher requirement on the biological safety of the negative pressure drainage sponge. Therefore, the manufacture of the high-performance negative pressure drainage sponge is very important.
Currently, most of commercially available negative pressure drainage sponges adopt an irradiation sterilization process, and the irradiation sterilization achieves the effect of killing bacteria by providing electron beams and energy. However, in the sterilization process, due to the introduction of high-energy electron beams, the aging of the sponge product can be accelerated, the molecular cross-linking points are damaged, and a part of small molecular substances are decomposed to cause the pH value of the product to be reduced and become acidic, and the reducing substances in the product are increased.
Since the radiation sterilization presents the above problems, the biosafety requirements for deep cavity wound use cannot be met.
Disclosure of Invention
The invention aims to solve the technical problem of providing a manufacturing process of a sealed negative-pressure drainage wet sponge, the process is to package and rehydrate polyvinyl alcohol sponge to obtain the negative-pressure drainage wet sponge which has excellent cytotoxicity and is close to neutral pH value and provides a good growing environment for granulation tissues required by wound healing so as to keep the comfort of a patient and be used for repairing wounds on the body surface and body cavities.
In order to achieve the purpose, the invention provides a manufacturing process of a sealed negative-pressure drainage wet sponge, which comprises the following steps:
1) and (3) sterilization: putting the dried polyvinyl alcohol sponge into a top bag, connecting the top bag with a liquid storage bin through a connecting pipe, and sealing; then filling the polyvinyl alcohol sponge into a top bag, sending the top bag into an environment containing ethylene oxide gas, allowing the ethylene oxide gas to enter the top bag through holes in a Tyvek paper surface on the top bag to fumigate and sterilize the polyvinyl alcohol sponge, and standing the polyvinyl alcohol sponge in a wind environment;
2) rehydration: and (3) packaging the product in a sealed manner after sterilization, screwing off a one-way valve in the top bag outside the top bag through the top bag to inject liquid in the liquid storage bin into the surface of the sponge, pulling out the connecting pipe and the liquid storage bin after the liquid is injected, sealing the top bag part containing the polyvinyl alcohol sponge, cutting off the top bag part containing the Tyvek paper surface and the liquid storage bin to obtain a packaged and sealed wet sponge product, namely the negative pressure drainage wet sponge.
The polyvinyl alcohol sponge is prepared according to actual conditions, and the preparation method of the polyvinyl alcohol sponge comprises the following steps:
stirring 1kg of 10 wt% polyvinyl alcohol aqueous solution and 10ml of formaldehyde in a reaction kettle at 15-25 ℃ and 200-300 RPM for 6-30 min under an acidic condition, then stirring for 2-10 min under a 100-200 RPM condition, adding a cross-linking agent, and curing for 12-48 h at 50-85 ℃; the prepared sponge is cut, washed finely, and dried by a microwave drying process at a vacuum degree of-0.5-1 MPa and a temperature of 30-50 ℃ for 1-3 h.
Further, in the step 1), the tip bag is made of two materials, namely transparent plastic and tyvek paper, and the two sides of the tip bag are respectively as follows:
one surface is made of transparent plastic, the other surface is made of transparent plastic and Tyvek paper, and the Tyvek paper is the upper part or the middle part of one surface of the ejector bag;
or both sides are made of transparent plastic and Tyvek paper, and the Tyvek paper is the upper part or the middle part of one side of the top bag;
the Tyvek paper is medical sterilizing paper and is woven by fibers, and under the condition of magnification, holes which are formed by weaving the fibers in a staggered mode can be observed, and the holes can not only allow ethylene oxide gas to pass through, but also can prevent bacteria from passing through. The design purpose of the top bag is that for the convenience of the product in the ethylene oxide gas sterilization process, gas can enter into the sponge the inside, reaches the purpose of sterilization, treats the successful back of sterilization, fully squeezes into the sponge the inside with the moisture in stock solution storehouse, makes the sponge moist, at this moment, pulls out stock solution storehouse to top bag paper face one end, seals a mouth again on top bag packing, cuts unnecessary strong paper of tyvek and stock solution storehouse, convenient transportation.
Further, in the step 1), the temperature for sterilizing the ethylene oxide is 45-55 ℃, and the fumigating time is 3-4 h.
Still further, in the step 2), the liquid is water or normal saline, and when the liquid is injected, the injection is carried out every 1cm3The sponge contains 0.3-1 ml of liquid
The principle of the invention is as follows:
the negative pressure drainage sponge is manufactured in an ethylene oxide gas (EO) sterilization mode to meet the high performance requirement, but the EO sterilization has the following requirements:
1) ethylene oxide gas (EO) sterilization requires that the sterilized product be a dry product because the moisture in the wet product reacts with the ethylene oxide gas to form ethylene glycol, which can cause the sterilization process to fail.
2) The negative pressure drainage technology requires the sponge to be wet sponge in the use process of the wound surface, and the edges and corners of the dry sponge have hard hand feeling, so that the patient can be stabbed, and the sponge cannot be pasted with a film for sealing to form a closed environment;
aiming at the problems, the liquid storage bin is placed in advance in the final sterilization package, then the operation is carried out outside the sterilization package bag, the water in the liquid storage bin is injected into the sponge, the sponge is soaked, the secondary sealing is carried out, and the liquid storage bin is removed.
The invention has the beneficial effects that:
the pH value of the sponge product is between 6 and 7 and is close to neutral;
② the biological safety of the sponge is high, the cell toxicity test is first grade,
the above two points. The final appearance is as follows: provides good environment for the growth of granulation tissue of the wound surface and accelerates the healing time of the wound surface.
Drawings
FIG. 1 is a schematic diagram of a package of a polyvinyl alcohol sponge EO after sterilization
FIG. 2 is a schematic view of a polyvinyl alcohol sponge being rehydrated within a header bag;
FIG. 3 is a schematic view of the separation of the PVA sponge and the reservoir in the header bag;
FIG. 4 is a schematic diagram of the header bag cutting;
FIG. 5 is a schematic view of a sealed negative pressure drainage wet sponge;
in the figure, a top bag 1, transparent plastic 1.1, tyvek paper 1.2, a liquid storage bin 2, polyvinyl alcohol sponge 3, a connecting pipe 4 and a one-way valve 5.
Detailed Description
In order to better explain the invention, the following further illustrate the main content of the invention in connection with specific examples, but the content of the invention is not limited to the following examples.
Example 1 a polyvinyl alcohol sponge 3 was prepared as follows:
stirring 1kg of 10 wt% polyvinyl alcohol aqueous solution and 10ml of formaldehyde in a reaction kettle at 15-25 ℃ and 200-300 RPM for 6-30 min under an acidic condition, then stirring for 2-10 min under a 100-200 RPM condition, adding a cross-linking agent, and curing for 12-48 h at 50-85 ℃; the prepared sponge is cut, washed finely, and dried by a microwave drying process at a vacuum degree of-0.5-1 MPa and a temperature of-30-50 ℃ for 1-3 h.
Example 2
The manufacturing process of the sealed negative pressure drainage wet sponge comprises the following steps:
1) and (3) sterilization: the method comprises the following steps of (1) filling dried polyvinyl alcohol sponge 3 into a header bag 1, connecting the header bag 1 with a liquid storage bin 2 through a connecting pipe 4, and sealing; then filling the polyvinyl alcohol sponge 3 into the top bag 1, sending the top bag 1 into an environment containing ethylene oxide gas, allowing the ethylene oxide gas to enter the top bag 1 through holes on the surface 1.2 of the Tyvek paper on the top bag 1, carrying out fumigation sterilization on the polyvinyl alcohol sponge 3 at the temperature of 50 ℃ for 4 hours, and standing the polyvinyl alcohol sponge in a ventilation environment; wherein one surface of the header bag 1 is made of transparent plastic 1.1, the other surface of the header bag is made of transparent plastic 1.1 and Tyvek paper 1.2, and the Tyvek paper 1.2 is the upper part of one surface of the header bag 1;
2) rehydration: sealing the packaged product after sterilization, screwing off a one-way valve 5 in the top bag 1 outside the top bag 1 through the top bag 1 to inject the normal saline in the liquid storage bin 2 into the surface of the sponge, pulling out the connecting pipe 4 and the liquid storage bin 2 after the injection of the normal saline is finished, sealing the part of the top bag 1 containing the polyvinyl alcohol sponge 3, cutting off the part of the top bag 1 containing the 1.2 surfaces of the Tyvek paper and the liquid storage bin 2 to obtain the packaged and sealed wet sponge product, namely the negative pressure drainage wet sponge, wherein every 1cm of the wet sponge is sealed3The sponge has a normal saline content of 0.3ml
Example 3
The manufacturing process of the sealed negative pressure drainage wet sponge comprises the following steps:
1) and (3) sterilization: the method comprises the following steps of (1) filling dried polyvinyl alcohol sponge 3 into a header bag 1, connecting the header bag 1 with a liquid storage bin 2 through a connecting pipe 4, and sealing; then filling the polyvinyl alcohol sponge 3 into the top bag 1, sending the top bag 1 into an environment containing ethylene oxide gas, allowing the ethylene oxide gas to enter the top bag 1 through holes on the surface 1.2 of the Tyvek paper on the top bag 1, carrying out fumigation sterilization on the polyvinyl alcohol sponge 3 at the temperature of 45 ℃ for 4 hours, and standing the polyvinyl alcohol sponge in a ventilation environment; wherein one surface of the header bag 1 is made of transparent plastic 1.1, the other surface of the header bag is made of transparent plastic 1.1 and Tyvek paper 1.2, and the Tyvek paper 1.2 is the middle part of one surface of the header bag 1;
2) rehydration: sealing the packaged product after sterilization, screwing off a one-way valve 5 in the top bag 1 outside the top bag 1 through the top bag 1, injecting normal saline in the liquid storage bin 2 into the surface of the sponge, pulling out the connecting pipe 4 and the liquid storage bin 2 after the injection of the normal saline is finished, sealing the part of the top bag 1 containing the polyvinyl alcohol sponge 3, and cutting off the part of the top bag 1 containing the surface 1.2 of the Tyvek paper and the liquid storage bin 2 to obtain a packaged and sealed wet sponge product, namely the negative pressure drainage wet sponge; wherein each 1cm3The sponge of (2) had a physiological saline content of 0.6 ml.
Example 4
The manufacturing process of the sealed negative pressure drainage wet sponge comprises the following steps:
1) and (3) sterilization: the method comprises the following steps of (1) filling dried polyvinyl alcohol sponge 3 into a header bag 1, connecting the header bag 1 with a liquid storage bin 2 through a connecting pipe 4, and sealing; then filling the polyvinyl alcohol sponge 3 into the top bag 1, sending the top bag 1 into an environment containing ethylene oxide gas, allowing the ethylene oxide gas to enter the top bag 1 through holes on the surface 1.2 of the Tyvek paper on the top bag 1, carrying out fumigation sterilization on the polyvinyl alcohol sponge 3 at the temperature of 55 ℃ for 3 hours, and standing the polyvinyl alcohol sponge in a ventilation environment; wherein, both sides of the header bag 1 are made of transparent plastic 1.1 and Tyvek paper 1.2, and the Tyvek paper 1.2 is the upper part or the middle part of one side of the header bag 1;
2) rehydration: sealing the sterilized packaged product, unscrewing a one-way valve 5 in the top bag 1 outside the top bag 1 through the top bag 1 to inject water in the liquid storage bin 2 into the surface of the sponge, pulling out the connecting pipe 4 and the liquid storage bin 2 after the water injection is finished, and packaging the packaged productSealing the part of the top bag 1 with the polyvinyl alcohol sponge 3, cutting off the part of the top bag 1 containing the 1.2 surfaces of the Tyvek paper and the liquid storage bin 2 to obtain a packaged and sealed wet sponge product, namely negative pressure drainage wet sponge, wherein each 1cm of the wet sponge product is3The sponge of (2) had a water content of 1 ml.
Other parts not described in detail are prior art. Although the present invention has been described in detail with reference to the above embodiments, it is only a part of the embodiments of the present invention, not all of the embodiments, and other embodiments can be obtained without inventive step according to the embodiments, and the embodiments are within the scope of the present invention.

Claims (1)

1. A manufacturing process of sealed negative pressure drainage wet sponge is characterized in that: the method comprises the following steps:
1) and (3) sterilization: putting the dried polyvinyl alcohol sponge into a top bag, connecting the top bag with a liquid storage bin through a connecting pipe, and sealing; then filling the sponge filled with the polyvinyl alcohol into a top bag, sending the top bag into an environment containing ethylene oxide gas, allowing the ethylene oxide gas to enter the top bag through holes in a Tyvek paper surface on the top bag, fumigating and sterilizing the polyvinyl alcohol sponge at the temperature of 45-55 ℃ for 3-4 h, and standing in a ventilation environment; the top bag is made of two materials, namely transparent plastic and tyvek paper, and the two sides of the top bag are respectively as follows:
one surface is made of transparent plastic, the other surface is made of transparent plastic and Tyvek paper, and the Tyvek paper is the upper part or the middle part of one surface of the ejector bag;
or both sides are made of transparent plastic and Tyvek paper, and the Tyvek paper is the upper part or the middle part of one side of the top bag;
the preparation method of the polyvinyl alcohol sponge comprises the following steps: stirring 1kg of 10 wt% polyvinyl alcohol aqueous solution and 10ml of formaldehyde in a reaction kettle at 15-25 ℃ and 200-300 RPM for 6-30 min under an acidic condition, then stirring for 2-10 min under a 100-200 RPM condition, adding a cross-linking agent, and curing for 12-48 h at 50-85 ℃; cutting the prepared sponge, finely washing, and drying by a microwave drying process at a vacuum degree of-0.5-1 MPa and a temperature of 30-50 ℃ for 1-3 h;
2) rehydration: sealing the sterilized product, and screwing off a one-way valve in the bag outside the bag via the bag to inject the liquid in the storage tank into the surface of the sponge, wherein the injection time is 1cm3The content of the liquid in the sponge is 0.3-1 ml, the connecting pipe and the liquid storage bin are pulled out, the head bag part containing the polyvinyl alcohol sponge is sealed, then the head bag part containing the Tyvek paper surface and the liquid storage bin is cut off, and a packaged and sealed wet sponge product, namely the negative pressure drainage wet sponge, is obtained, wherein the liquid is water or normal saline.
CN201811405263.5A 2018-11-23 2018-11-23 Manufacturing process of sealed negative-pressure drainage wet sponge Active CN109350363B (en)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1534377A2 (en) * 2002-08-20 2005-06-01 General Wound Kare, Inc. (A Corporation of Deleware) Medical pad, and method for making and using
CN102078639A (en) * 2009-11-26 2011-06-01 许高琴 Medicine carrying method of medical sponge
CN102218875A (en) * 2011-03-31 2011-10-19 常州市嘉鹏塑料制品有限公司 Anti-adhesion medical composite film
CN103536954A (en) * 2013-10-22 2014-01-29 山东颐诺生物科技有限公司 Crosslinked alginate-bacterial cellulose sponge and preparation method thereof
CN106916399A (en) * 2017-03-17 2017-07-04 广州润虹医药科技有限公司 A kind of environmental friend type multifunction composite negative pressure drainage shield wound sponge and preparation method thereof

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080114096A1 (en) * 2006-11-09 2008-05-15 Hydromer, Inc. Lubricious biopolymeric network compositions and methods of making same

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1534377A2 (en) * 2002-08-20 2005-06-01 General Wound Kare, Inc. (A Corporation of Deleware) Medical pad, and method for making and using
CN102078639A (en) * 2009-11-26 2011-06-01 许高琴 Medicine carrying method of medical sponge
CN102218875A (en) * 2011-03-31 2011-10-19 常州市嘉鹏塑料制品有限公司 Anti-adhesion medical composite film
CN103536954A (en) * 2013-10-22 2014-01-29 山东颐诺生物科技有限公司 Crosslinked alginate-bacterial cellulose sponge and preparation method thereof
CN106916399A (en) * 2017-03-17 2017-07-04 广州润虹医药科技有限公司 A kind of environmental friend type multifunction composite negative pressure drainage shield wound sponge and preparation method thereof

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