CN103691010A - Multi-layer foam dressing for negative pressure closed drainage and preparation method thereof - Google Patents
Multi-layer foam dressing for negative pressure closed drainage and preparation method thereof Download PDFInfo
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- CN103691010A CN103691010A CN201310393784.4A CN201310393784A CN103691010A CN 103691010 A CN103691010 A CN 103691010A CN 201310393784 A CN201310393784 A CN 201310393784A CN 103691010 A CN103691010 A CN 103691010A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/05—Bandages or dressings; Absorbent pads specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
- A61M1/91—Suction aspects of the dressing
- A61M1/915—Constructional details of the pressure distribution manifold
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
- A61M1/91—Suction aspects of the dressing
- A61M1/918—Suction aspects of the dressing for multiple suction locations
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- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Vascular Medicine (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Materials For Medical Uses (AREA)
Abstract
The invention provides a multi-layer foam dressing for negative pressure closed drainage and a preparation method thereof. The multi-layer foam dressing for negative pressure closed drainage comprises a negative pressure conduction layer; the lower part of the negative pressure conduction layer is provided with a drainage protection layer which is contacted with a wound surface or a wound cavity; the negative pressure conduction layer and the drainage protection layer are porous foam material layers; the negative pressure conduction layer is a hydrophobic porous foam material layer; the drainage protection layer is a hydrophilic porous foam material layer; the two layers of materials are fixedly connected and pores mutually penetrate and are communicated. Two longitudinal broken joints are formed on the multi-layer porous foam dressing; the longitudinal broken joints are formed at the installation positions of negative pressure drainage tubes, and extend to the middle part of the multi-layer porous foam dressing from the installation ends of the negative pressure drainage tubes by passing through the installation positions of negative pressure drainage tube holes. The thickness a of the negative pressure conduction layer is 0.5cm to 10cm, the pore diameter is 1mm to 2.5mm, the thickness b of the drainage protection layer is 0.1cm to 3.5cm, and the pore diameter is 0.2mm to 1mm. Meanwhile, the invention also provides a splicing method and a compound method for preparing the foam dressing. According to the dressing and the method, a multi-layer structure is adopted, so that the negative pressure conduction performance can be effectively improved while the material safety is ensured; in addition, blockage does not easily occur during a use process, the permeability is stable, and the treatment effect is excellent.
Description
Technical field
The present invention relates to medical trauma therapeutic device field, specifically, refer to a kind of multi-layered foamed dressing for negative-pressure sealed drainage and preparation method thereof.
Background technology
Negative-pressure sealed drainage technology (vacuum sealing drainage is called for short VSD) is that German ULM Wim doctor Fleischman of university is pioneering in 1992, and forms theoretical blank, for the drain of limb wounds; Within 1994, Chinese professor Qiu Huade is applied to department of general surgery by negative-pressure sealed drainage technology first, started the beginning of negative-pressure sealed drainage technology in department of general surgery's application, Wang Yanfeng, Qiu Huade professor in authorized patent CN 2236350 on March 17th, 1997, is first patent of negative-pressure sealed drainage technology in China.
Existing VSD technology basic configuration comprises negative pressure source (comprising central negative pressure device that medical suction machine, hospital use or negative pressure drainage vessel etc.), drainage tube, hydrophilic foam or other medical hydrophobic foam material or sponge kind dressing or the dressing of gauze class (below to above-mentioned medical material general designation perforated foams), Pasting sealing film, drainage container form.Connect negative pressure source drain, the liquefied materials such as the fragment of tissue of the oozing of blood in tissue, sepage, liquefaction and necrosis and pus can be drained in drainage container.Above-mentioned technology can directly excrete slough and toxin, pus etc., avoids toxin heavily to absorb, rapid cleaning wound surface; Meanwhile, high negative pressure attracts effectively to promote granulation ramp, shortens wound healing time.Use this technology, patient can not need to change dressings in 3-7 days, avoids cross infection, has reduced medical personnel's workload, has reduced patient suffering, has reduced fatality rate, the disability rate of wound.
VSD technology mainly relies on this medical high polymer dressing of porous foam cushion to realize.This dressing is negative pressure transmitting medium, is also the materials such as slough, pus, sepage, other toxic product and toxin to be introduced to the drain medium of drainage tube simultaneously.Foam dressing for negative-pressure sealed drainage is mainly divided into two kinds in the market: hydrophobicity dressing and hydrophilic dressing.Hydrophobicity dressing mostly is the foaming of PU material and forms, and foam hole is larger, and penetrating rate is higher; Due to its hydrophobic characteristic, generally can be not moisture in foam, so negative pressure conductive performance is splendid.Hydrophilic dressing mostly is the foaming of PVA material and forms, and the dressing of foam void ratio hydrophobicity is little, and the penetrating rate of material is lower, but also can meet the needs of negative pressure drainage treatment; Due to its hydrophilic characteristic, dressing surface can form one deck water molecule film, has separated dressing and has directly contacted with the endotheliocyte of granulation tissue, can stop granulation tissue to be grown in dressing, avoids tractive hemorrhage, and material safety is high.
Yet all there is defect in above-mentioned two kinds of dressing in clinical practice.Hydrophobicity dressing (PU) is due to its hydrophobic characteristic, and material surface does not have protective layer, and granulation tissue can be grown in foam hole, tractive very easily occurs hemorrhage; Also because hydrophobicity dressing (PU) stretching resistance is poor, easily produce chip and come off, then cause foreign body inflammatory reaction (rejection) and the secondary infection in wound surface wound chamber, so material safety exists larger problem.U.S. FDA report shows, uses PU dressing, and patient exists the dead situation with increasing the weight of wound.Use PU dressing to change dressings the cycle short (U.S. FDA report and pertinent literature show can not over three days), cost is high, and medical personnel's labor intensity is large, and patient is also more painful.Hydrophilic dressing (PVA) is due to its water-wet behavior, material itself is moistening, although its penetrating rate is also lower, also can meet the treatment requirement of negative pressure drainage, but because material is moisture, so its negative pressure conductive performance is poor, when large area wound surface is used, easily produce negative pressure and conduct weak district, secondly after the dehydration of PVA material, easily slowly become dry gradually, cause penetrating rate further to decline, weaken therapeutic effect.
Summary of the invention
Technical problem to be solved by this invention is just to provide a kind of multi-layered foamed dressing for negative-pressure sealed drainage and its manufacture method, can overcome the defect of existing negative-pressure sealed drainage dressing, when guaranteeing material safety, can effectively improve its negative pressure conductive performance, and be in use difficult for stopping up, permeability is stable, and therapeutic effect is excellent.
Technical scheme of the present invention: a kind of multi-layered foamed dressing for negative-pressure sealed drainage provided by the invention comprises negative pressure conducting shell, in negative pressure conducting shell bottom, establish the drain protective layer for contacting with wound surface or wound chamber, described negative pressure conducting shell and drain protective layer are perforated foams layer; Described negative pressure conducting shell is hydrophobic porous sponge layer, and described drain protective layer is hydrophilic porous sponge layer, is fixedly connected with and hole interpenetrates UNICOM between two layers of material.
Described negative pressure conductive layer thickness a is 0.5～10cm, and pore diameter is 1～2.5mm, and described drain protective layer thickness b is 0.1～3.5cm, and pore diameter is 0.2～1mm.
Preferably, described negative pressure conductive layer thickness a is 1～3cm, and pore diameter is 1～1.5mm.
Preferably, described negative pressure conductive layer thickness a is 3～6cm, and pore diameter is 1～2.0mm.
Preferably, described negative pressure conductive layer thickness a is 6～9cm, and pore diameter is 1～2.5mm.
Preferably, described drain protective layer thickness b is 0.3～0.5cm, and pore diameter is 0.2～0.5mm.
Preferably, described drain protective layer thickness b is 0.5～1.5cm, and pore diameter is 0.5～1.0mm.
Preferably, described drain protective layer thickness b is 1.5～3.5cm, and pore diameter is 0.8～1.0mm.
Preferably, described negative pressure conducting shell adopts the PU foam of hydrophobic PU foam, eva foam or recombination chitosan to make.
Preferably, the PVA foam of the PVA foam of described drain protective layer employing PVA foam, recombination chitosan or composite antibacterial, antibacterial medicament is made.
In the time of on the product that described multi-layered foamed dressing is installed for negative-pressure drainage tube, there are two longitudinal breaking joints, article two, longitudinal breaking joint is positioned at and will the position of negative-pressure drainage tube be installed, an end opening of being installed by negative-pressure drainage tube, longitudinally as long as the length of breaking joint is the position of installing through negative-pressure drainage tube pore.
On negative pressure conducting shell top, away from a side of wound surface, establish outer surface layer, outer surface layer is fixedly connected with on negative pressure conducting shell top.
Described outer surface layer is porous foam outer surface layer, and porous foam outer surface layer is hydrophilic porous sponge layer.
Described porous foam outer surface layer thickness c is 0.1～0.5cm.
Described outer surface layer is one deck sealed Cellophane outer surface layer.
Described sealed Cellophane outer surface layer thickness is 0.1～0..5mm.
One of a kind of manufacture method of making the described multi-layered foamed dressing for negative-pressure sealed drainage of the present invention, comprises the following steps:
The first step, cutting cutting makes negative pressure conducting shell and drain protective layer;
Second step, between the negative pressure conducting shell foamed materials that the described first step is made and drain protective layer foamed materials, adopt the gluing mode connecing of point to be fixedly connected with, two-layer perforated foams layer contact surface is provided with a glue point, point glue point place by doing, hydrophilic compound adhesive puts bondingly by adjacent two layers perforated foams is stacked, forms straticulate structure;
Two of a kind of manufacture method of making the described multi-layered foamed dressing for negative-pressure sealed drainage of the present invention, comprises the following steps:
The first step, cutting cutting makes negative pressure conducting shell and drain protective layer;
Second step, stacks, produces multilayer foams adopting the bonding mode of contact surface brush coating to be fixedly connected with between negative pressure conducting shell and drain protective layer;
The 3rd step, the multilayer foams that second step is made is bored a hole on pin type perforating apparatus, and aperture is at 1～4mm, and guarantees that its needle body penetrates adhesive-layer, makes to be communicated with between two layers of foam material, makes multi-layered foamed dressing.
In described the 3rd step, the aperture of perforation is 2～3mm.
Three of a kind of manufacture method of making the described multi-layered foamed dressing for negative-pressure sealed drainage of the present invention, comprises the following steps:
The first step, makes negative pressure conducting shell and drain protective layer according to design size cutting cutting;
Second step, the drain protective layer that cutting in the first step is completed is placed in mold box, appropriate hydrophilic foam foaming raw material liquid is injected to its surface, standing 10-30 second, the negative pressure conducting shell after surfacing, cutting in the first step being completed is covered in material liquid surface, use instrument, to evenly smooth the exerting pressure of negative pressure conducting shell, makes negative pressure conducting shell evenly fully contact with former liquid level;
The 3rd step; the mold box that injects material liquid in second step is heated, make foaming raw material liquid reaction curing molding, now negative pressure conducting shell is together with drain protective layer meeting composite joint; then the foamed materials adhesive linkage of the new bubble in centre is cut to cutting, make two-ply foam dressing.
In three, the three steps of the manufacture method manufacture method of the described multi-layered foamed dressing for negative-pressure sealed drainage, foamable reaction process, for being first heated to 30～50 ℃, continues 0.5～1 hour, makes it to close in advance; Then be warming up to 50～90 ℃, heat 2～8 hours.
Preferably, closing in advance temperature is 35～45 ℃, and be 0.5 hour heat time heating time.
Preferably, intensification temperature is 55～75 ℃, and be 4～8 hours heat time heating time.
Preferably, in the 3rd step, component and the ratio of hydrophilic foam foaming raw material liquid is: the polyvinyl alcohol of different polymerization degree and alcoholysis degree: strong acid: polyaldehyde: alcohol=1:0.5～2:0.5～3:0.5～1.
Preferably, in the 3rd step, hydrophilic foam foaming raw material liquid also comprises antibacterial, antibacterial, the reinforcing agent of described material liquid gross mass 0.5%～5%.
A described manufacture method that adds porous foam outer surface layer for the multi-layered foamed dressing of negative-pressure sealed drainage, comprises the following steps:
Making the method that multi-layered foamed dressing top adds porous foam outer surface layer is: the negative pressure conducting shell of two-ply foam dressing is positioned in square dies box down, and repetition methods three makes three layers of foam dressing.
Described in the second, for the multi-layered foamed dressing of negative-pressure sealed drainage, add the manufacture method of porous foam outer surface layer, comprise the following steps:
Multi-layered foamed dressing top brush coating by making, is bonded in upper surface by sealed Cellophane outer surface layer, makes three layers of foam dressing.
In multi-layered foamed dressing, cut two longitudinal breaking joints, longitudinally breaking joint is positioned at the position that negative-pressure drainage tube is installed, and the position that install through negative-pressure drainage tube pore the one end of being installed by negative-pressure drainage tube in multi-layered foamed dressing extends multi-layered foamed dressing middle part.
Compared with prior art, beneficial effect of the present invention is:
1) in foam dressing lower floor, be provided with drain protective layer, this layer of foamed materials is hydrophilic foam, can effectively intercept granulation tissue, avoids being adhered between granulation tissue and dressing, causes tractive hemorrhage, effectively guaranteed the safety for the treatment of;
2) adopt multiple structure, centre arranges negative pressure conducting shell, is exclusively used in conduction negative pressure, effectively improve negative pressure conduction efficiency, when guaranteeing safety, can effectively improve the negative pressure conductive performance of dressing, avoid producing negative pressure conduction dead angle, guaranteed therapeutic effect;
3) adopt hydrophilic foam as drain protective layer, can form moist environment at wound surface surf zone, be conducive to promote the growth of wound surface granulation tissue, wound healing, and hydrophilic environments can effectively reduce patient's misery;
4) the present invention has taken the lead in proposing the imagination of multi-layered foamed dressing, medical circle puzzlement and the worries to the clinical treatment that the superiority-inferiority separately of simple, single use hydrophilic negative pressure material or hydrophobicity negative pressure material causes have clinically for many years been overcome, utilize simple structural design and manufacture method, adopt multiple structure, combine the advantage of above-mentioned material, overcome its deficiency;
5) adopt multi-layered foamed dressing structure, bottom drain protective layer is due to its hydrophilic characteristic, consistency and elasticity is all higher, and negative pressure conducting shell can guarantee that high negative pressure can not lose in conductive process, under high negative pressure effect, bottom drain protective layer can be effectively fritter by massive necrosis tissue segmentation, negative pressure conducting shell can effectively be drawn the slough that is divided into fritter, effectively avoided negative pressure conducting shell clogged with material, can more effectively clean wound surface simultaneously, avoid toxin to produce, also avoid the absorption of toxin, reduce infection rate;
6) adopt after multi-layered foamed dressing structure, because drain is unobstructed, and material safety is high, negative pressure conduction efficiency is high, dressing can effectively extend service time, said structure can effectively extend the cycle of changing dressings, and further slows down patient's misery, reduces Comprehensive Treatment expense;
7) adopt hydrophilic foam as drain protective layer, because hydrophilic foam tensile strength is high, can not produce chip, can effectively avoid chip to enter wound surface, cause wound healing difficulty, the treatment safety that has further improved foam dressing.
Accompanying drawing explanation
Fig. 1 is basic structure-embodiment 1 schematic diagram of the present invention;
Fig. 2 is that embodiment of the present invention 2-is with the structural representation of porous foam outer surface layer;
Fig. 3 is that embodiment of the present invention 3-is with the structural representation of sealed Cellophane outer surface layer;
Fig. 4 is the perspective view of Fig. 1;
Fig. 5 is Fig. 1,2,3 and add the plan structure schematic diagram of drainage tube;
Fig. 6 is the structural representation of processing product of the present invention pin type perforating apparatus used;
Fig. 7 is the top view of Fig. 6;
In figure, 1-negative pressure conducting shell, 2-drain protective layer, 3a-porous foam outer surface layer, 3b-sealed Cellophane outer surface layer, 4-pin type perforating apparatus, 5-needle body, two longitudinal breaking joints that 6-cuts in multi-layered foamed dressing.
The specific embodiment
Below in conjunction with accompanying drawing, specific embodiments of the invention are described in further detail:
As Fig. 1, Fig. 4, Fig. 5: a kind of multi-layered foamed dressing for negative-pressure sealed drainage of the present invention comprises negative pressure conducting shell 1, in negative pressure conducting shell 1 bottom, establish the drain protective layer 2 for contacting with wound surface or wound chamber, described negative pressure conducting shell 1 and drain protective layer 2 are perforated foams layer; Described negative pressure conducting shell 1 is hydrophobic porous sponge layer, and described drain protective layer 2 is hydrophilic porous sponge layer, is fixedly connected with and hole interpenetrates UNICOM between two layers of material.
In the time of on the product that described multi-layered foamed dressing is installed for negative-pressure drainage tube, there are two longitudinal breaking joints 6, article two, longitudinal breaking joint 6 is positioned at and will the position of negative-pressure drainage tube be installed, an end opening of being installed by negative-pressure drainage tube, longitudinally as long as the length of breaking joint 6 is the position of installing through negative-pressure drainage tube pore.The length of general longitudinal breaking joint 6 is 1/10～1/2 of multi-layered foamed dressing length.
Article two, the effect of longitudinal breaking joint 6 is, for the wound surface that severe infections occurs, glued membrane, the drainage tube exposing and syringe pipe can be turned to drain protective layer 2 by the gap of cutting, and directly negative pressure conducting shell 1 is contacted and is treated with wound surface.
Described negative pressure conducting shell 1 thickness a is 0.5～10cm, and pore diameter is 1～2.5mm, and described drain protective layer 2 thickness b are 0.1～3.5cm, and pore diameter is 0.2～1mm.
Described negative pressure conducting shell 1 thickness a is 1～3cm, and pore diameter is 1～1.5mm; Drain protective layer 2 thickness b are 0.5～1.5cm, when pore diameter is 0.5～1.0mm, are applicable to abundant drain and the negative pressure conduction of the disease of various formation fistulas, sinus tract.
Described negative pressure conducting shell 1 thickness a is 3～6cm, and pore diameter is 1～2.0mm; Drain protective layer 2 thickness b are 0.3～0.5cm; when pore diameter is 0.2～0.5mm; be applicable to various chronic, acute, traumatic, the subacute and wounds that split; burn; ulcer (for example diabetic ulcer and pressure ulcer), abundant drain and the negative pressure conduction of the wound of the types such as flap and skin-grafting front and back etc.).
Described negative pressure conducting shell 1 thickness a is 6～9cm, and pore diameter is 1～2.5mm; Described drain protective layer 2 thickness b are 1.5～3.5cm, and pore diameter is applicable to abundant drain and the negative pressure conduction of various open abdominal damages while being 0.8～1.0mm.
Through inventor's Long-term clinical, research and analyse, under high negative pressure effect, the diameter of wound surface granulation is generally below 1mm.Drain protective layer 2 adopts this hole configuration, can be conducive on the one hand the conduction of negative pressure, can effectively avoid on the other hand granulation tissue to grow in foam hole, improves overall security and the therapeutic effect of foam dressing.
Adopt thinner drain protective layer 2, can effectively reduce the negative effect that conduction produces to negative pressure of hydrophilic foam layer, and certain thickness can effectively produce iris action to wound surface granulation tissue.Adopt thicker negative pressure conducting shell 1, can effectively improve the whole negative pressure conductive performance of foam dressing.Above-mentioned data are that inventor is drawn through a large amount of clinical and experimental studies.
Drain protective layer 2 is preferably hydrophilic porous sponge layer.Described drain protective layer 2 can adopt the PVA foam of the PVA foam of PVA foam, recombination chitosan or composite antibacterial, antibacterial medicament to make.
The preferred hydrophobic porous sponge layer of described negative pressure conducting shell 1.Can adopt the PU foam of hydrophobic PU foam, eva foam or recombination chitosan to make.The needs that the PU foam of employing recombination chitosan is more suitable for using conversely.
Preferred hydrophobic porous foamed materials foam hole is larger, and penetrating rate is higher, due to its hydrophobic characteristic, generally can be not moisture in foam, so negative pressure conductive performance is splendid, can effectively improve the whole negative pressure conductive performance of foam dressing.
Medical circle has caused a lot of puzzlements and the worries of clinical treatment for many years to the superiority-inferiority separately of simple, single use hydrophilic negative pressure material or hydrophobicity negative pressure material clinically.
On negative pressure conducting shell 1 top, away from a side of wound surface, establish outer surface layer 3, outer surface layer 3 is fixedly connected with on negative pressure conducting shell 1 top, for stoping material dehydration; Meanwhile, when for intracavitary therapy, outer surface layer 3 can effectively prevent that negative pressure conducting shell 1 from directly contacting with wound cavity tissue.
Fig. 2 is that embodiment of the present invention 2-is with the structural representation of porous foam outer surface layer;
Outer surface layer 3 is porous foam outer surface layer 3a, and porous foam outer surface layer 3a is hydrophilic porous sponge layer.
Described porous foam outer surface layer 3a thickness c is 0.1～0.5cm.
Fig. 3 is embodiment of the present invention 3-with the structural representation of sealed Cellophane outer surface layer:
Outer surface layer 3 is one deck sealed Cellophane outer surface layer 3b.Described sealed Cellophane outer surface layer 3b thickness is 0.1～0.5mm.
One of a kind of manufacture method of making the described multi-layered foamed dressing for negative-pressure sealed drainage of the present invention, comprises the following steps:
The first step, cutting cutting makes negative pressure conducting shell 1 and drain protective layer 2;
Second step; between negative pressure conducting shell 1 foamed materials that the described first step is made and drain protective layer 2 foamed materialss, adopt the gluing mode connecing of point to be fixedly connected with; two-layer perforated foams layer contact surface is provided with a glue point; point glue point place by doing, hydrophilic compound adhesive puts bondingly by adjacent two layers perforated foams is stacked, forms straticulate structure.
Described in the second, for the multi-layered foamed dressing of negative-pressure sealed drainage, add the manufacture method of porous foam outer surface layer, comprise the following steps:
The first step, cutting cutting makes negative pressure conducting shell 1 and drain protective layer 2;
Second step, stacks, produces multilayer foams adopting the bonding mode of contact surface brush coating to be fixedly connected with between negative pressure conducting shell 1 and drain protective layer 2;
The 3rd step, the multilayer foams that second step is made is bored a hole on pin type perforating apparatus, and aperture is at 1～4mm, and guarantees that its needle body penetrates adhesive-layer, makes to be communicated with between two layers of foam material, makes multi-layered foamed dressing.
Fig. 6, Fig. 7 are the structural representation of processing product of the present invention pin type perforating apparatus used:
In described the 3rd step, the aperture of perforation is 2～3mm.
Three of a kind of manufacture method of making the described multi-layered foamed dressing for negative-pressure sealed drainage of the present invention, comprises the following steps:
The first step, makes negative pressure conducting shell 1 and drain protective layer 2 according to design size cutting cutting;
Second step, the drain protective layer 2 that cutting in the first step is completed is placed in mold box, appropriate hydrophilic foam foaming raw material liquid is injected to its surface, standing 10～30 seconds, the negative pressure conducting shell 1 after surfacing, cutting in the first step being completed is covered in material liquid surface, use instrument, to even smooth the exerting pressure of negative pressure conducting shell 1, makes negative pressure conducting shell 1 evenly fully contact with former liquid level;
The 3rd step; the mold box that injects material liquid in second step is heated, make foaming raw material liquid reaction curing molding, now negative pressure conducting shell 1 is together with drain protective layer 2 meeting composite joints; then the foamed materials adhesive linkage of the new bubble in centre is cut to cutting, make two-ply foam dressing.
In described the 3rd step, foamable reaction process, for being first heated to 30～50 ℃, continues 0.5～1 hour, makes it to close in advance; Then be warming up to 50～90 ℃, heat 2～8 hours.Being heated to 30～50 ℃ is for fusion, prefoam better, is warming up to 50～90 ℃ of heating 2～8th, in order to solidify better.
The described temperature of closing is in advance 35～45 ℃, and be 0.5 hour heat time heating time.
Described intensification temperature is 55～75 ℃, and be 4～8 hours heat time heating time.
In described the 3rd step, component and the ratio of hydrophilic foam foaming raw material liquid are: the polyvinyl alcohol of different polymerization degree and alcoholysis degree: strong acid: polyaldehyde: alcohol=1:0.5～2:0.5～3:0.5～1.
The concentration of strong acid and polyaldehyde is larger, and hole is less, and the hardness of product is larger, otherwise the concentration of strong acid and polyaldehyde is less, and hole is larger, and the hardness of product is less; The alcohol content more hydrophilic of high product is stronger, otherwise alcohol content is lower, and the hydrophilic of product is more weak.This place's hydrophilic foam foaming raw material liquid is mainly used in bonding, and the drain protective layer 2 that generally its composition adopts with product with ratio is consistent.
In described the 3rd step, hydrophilic foam foaming raw material liquid also comprises the additive of described material liquid gross mass 0.5%～5%, includes but not limited to antibacterial, antibacterial, reinforcing agent etc.
Adopt hydrophilic foam foaming raw material liquid that compound fixing mode between described each layer of perforated foams layer is connected, adjacent two layers foamed materials interpenetrates and is adhered, and permeability is better.
By the method that makes multi-layered foamed dressing top and add porous foam outer surface layer 3a, be: the negative pressure conducting shell 1 of two-ply foam dressing is positioned in square dies box down, repeats three second, third steps of manufacture method, make three layers of foam dressing.
Make multi-layered foamed dressing top add porous foam outer surface layer 3a method two be: by multi-layered foamed dressing top brush coating, sealed Cellophane outer surface layer 3b is bonded in to upper surface, makes three layers of foam dressing.
In multi-layered foamed dressing, cut two longitudinal breaking joints, longitudinally breaking joint is positioned at the position that negative-pressure drainage tube is installed, and the position that install through negative-pressure drainage tube pore the one end of being installed by negative-pressure drainage tube in multi-layered foamed dressing extends multi-layered foamed dressing middle part.
Embodiment 1:
Composite foam dressing
This dressing is double-decker, by one deck negative pressure conducting shell 1 and one deck drain protective layer 2, is composited.Negative pressure conducting shell 1 adopts hydrophobic foam material, and drain protective layer 2 adopts hydrophilic foam.
Negative pressure conducting shell 1 thickness is 1cm, and drain protective layer 2 thickness are 0.5cm.Negative pressure conducting shell 1 pore diameter is 2.5mm, and drain protective layer 2 pore diameters are 0.5mm.
The described outer field perforated foams layer of the side outer surface away from wound surface is fixedly connected with one deck sealed Cellophane outer surface layer 3b.
Embodiment 2:
Composite foam dressing
This dressing is three-decker, and negative pressure conducting shell 1 is placed in the middle.Negative pressure conducting shell 1 adopts hydrophobic foam material, and drain protective layer 2 adopts hydrophilic foam.
Negative pressure conducting shell 1 thickness is 1cm, and drain protective layer 2 thickness are 0.5cm.Negative pressure conducting shell 1 pore diameter is 2.5mm, and drain protective layer 2 pore diameters are 0.5mm.Adding porous foam outer surface layer 3a is 0.5cm, and pore diameter is 0.5mm.
Embodiment 3:
Adhesion type foam dressing
This dressing is double-decker, by one deck negative pressure conducting shell 1 and one deck drain protective layer 2 bonding forming.Negative pressure conducting shell 1 adopts hydrophobic foam material, and drain protective layer 2 adopts hydrophilic foam.
Negative pressure conducting shell 1 thickness is 1cm, and drain protective layer 2 thickness are 0.5cm.Negative pressure conducting shell 1 pore diameter is 2.5mm, and drain protective layer 2 pore diameters are 0.5mm.
Described bonding way is that multi-point adhesive is bonding.The described outer field perforated foams layer of the side outer surface away from wound surface is fixedly connected with one deck sealed Cellophane outer surface layer 3b.
Embodiment 4:
Adhesion type foam dressing
This dressing is double-decker, by one deck negative pressure conducting shell 1 and one deck drain protective layer 2 bonding forming.Negative pressure conducting shell 1 adopts hydrophobic foam material, and drain protective layer 2 adopts hydrophilic foam.
Negative pressure conducting shell 1 thickness is 1cm, and drain protective layer 2 thickness are 0.5cm.Negative pressure conducting shell 1 pore diameter is 2.5mm, and drain protective layer 2 pore diameters are 0.5mm.
Described bonding way is that face is bonding, is equipped with through hole on glue-line, and aperture is 2mm.
Embodiment 5:
Composite foam dressing
This dressing is double-decker, by one deck negative pressure conducting shell 1 and one deck drain protective layer 2, is composited.Negative pressure conducting shell 1 adopts hydrophobic foam material, and drain protective layer 2 adopts hydrophilic foam.
Negative pressure conducting shell 1 thickness is 3cm, and drain protective layer 2 thickness are 1cm.Negative pressure conducting shell 1 pore diameter is 1.5mm, and drain protective layer 2 pore diameters are 1mm.
The described outer field perforated foams layer of the side outer surface away from wound surface is fixedly connected with one deck sealed Cellophane outer surface layer 3b.
Embodiment 6:
Composite foam dressing
This dressing is double-decker, by one deck negative pressure conducting shell 1 and one deck drain protective layer 2, is composited.Negative pressure conducting shell 1 adopts hydrophobic foam material, and drain protective layer 2 adopts hydrophilic foam.
Negative pressure conducting shell 1 thickness is 6cm, and drain protective layer 2 thickness are 0.75cm.Negative pressure conducting shell 1 pore diameter is 1mm, and drain protective layer 2 pore diameters are 1mm.
The described outer field perforated foams layer of the side outer surface away from wound surface is fixedly connected with one deck sealed Cellophane outer surface layer 3b.
Embodiment 7:
Composite foam dressing
This dressing is double-decker, by one deck negative pressure conducting shell 1 and one deck drain protective layer 2, is composited.Negative pressure conducting shell 1 adopts hydrophobic foam material, and drain protective layer 2 adopts hydrophilic foam.
Negative pressure conducting shell 1 thickness is 8cm, and drain protective layer 2 thickness are 1cm.Negative pressure conducting shell 1 pore diameter is 2.5mm, and drain protective layer 2 pore diameters are 0.5mm.
The described outer field perforated foams layer of the side outer surface away from wound surface is fixedly connected with one deck sealed Cellophane outer surface layer 3b.
Embodiment 8:
Composite foam dressing
This dressing is double-decker, by one deck negative pressure conducting shell 1 and one deck drain protective layer 2, is composited.Negative pressure conducting shell 1 adopts hydrophobic foam material, and drain protective layer 2 adopts hydrophilic foam.
Negative pressure conducting shell 1 thickness is 10cm, and drain protective layer 2 thickness are 3.5cm.Negative pressure conducting shell 1 pore diameter is 2.5mm, and drain protective layer 2 pore diameters are 0.5mm.
The described outer field perforated foams layer of the side outer surface away from wound surface is fixedly connected with one deck sealed Cellophane outer surface layer 3b.
Embodiment 9:
Composite foam dressing
This dressing is double-decker, by one deck negative pressure conducting shell 1 and one deck drain protective layer 2, is composited.Negative pressure conducting shell 1 adopts hydrophobic foam material, and drain protective layer 2 adopts hydrophilic foam.
Negative pressure conducting shell 1 thickness is 6cm, and drain protective layer 2 thickness are 2.5cm.Negative pressure conducting shell 1 pore diameter is 2.5mm, and drain protective layer 2 pore diameters are 0.5mm.
The described outer field perforated foams layer of the side outer surface away from wound surface is fixedly connected with one deck sealed Cellophane outer surface layer 3b.
Embodiment 10:
Composite foam dressing
This dressing is double-decker, by one deck negative pressure conducting shell 1 and one deck drain protective layer 2, is composited.Negative pressure conducting shell 1 adopts hydrophobic foam material, and drain protective layer 2 adopts hydrophilic foam.
Negative pressure conducting shell 1 thickness is 6cm, and drain protective layer 2 thickness are 2cm.Negative pressure conducting shell 1 pore diameter is 2.5mm, and drain protective layer 2 pore diameters are 0.5mm.
The described outer field perforated foams layer of the side outer surface away from wound surface is fixedly connected with one deck sealed Cellophane outer surface layer 3b.
Heating-up temperature is directly related with mechanical strength and the hardness of product with the time.Temperature is higher, and heat time heating time is longer, and mechanical strength and hardness are larger; Temperature is lower, and heat time heating time is shorter, and the mechanical strength of product and hardness are less.
Contrast is tested in two-layer compound PVA and existing PVA dressing and PU dressing, and concrete outcome is as following table:
* A: first stage for the treatment of lapses to the time and refers to that wound surface, wound chamber form the wound bed repair time that can do the second phase directly stitching or skin-grafting or tissue flap shift after the treatment of negative-pressure sealed drainage technology.
* C: epithelium rate.Epithelization process comprises migration, propagation and the differentiation three phases of keratinocyte, is the important symbol of process of tissue reparation; Epithelium rate is the remarkable index of epithelization repair process.
* D: wound surface, wound chamber blood perfusion amount, refer to that every 100g blood is per minute interiorly can flow into the wound surface of every square centimeter or the blood flow volume (ml) of wound chamber, chamber wall; Wound surface, wound chamber blood perfusion amount are larger, in unit are the generation of blood capillary more active, the growth rate of granulation tissue is faster.PU=ml·100g-1·min-1
* F: granulation tissue filling rate, refers to the ratio that in wound surface, wound chamber, granulation tissue is filled; Granulation tissue filling rate is larger, represents that wound surface, wound chamber are newly granulated and fill more, wound healing situation
* G: count of bacteria, refers to the viable bacteria number in unit volume; Count of bacteria is larger, represents that infection potential is larger.
* K: comprehensive cost, comprises the drug expenditures such as while in hospital Master Cost, antibiotic, Operation Fee, treatment cost, berth expense, nutrition cost etc.
Known according to above-mentioned contrast experiment, product of the present invention is at therapeutic effect, and the many-sides such as Comprehensive Treatment expense are all better than existing product.
In sum, core of the present invention is to utilize the foam dressing of the MULTILAYER COMPOSITE that outside is drain protective layer, has solved dexterously existing negative-pressure sealed drainage foam dressing hydrophobicity dressing materials poor safety performance, the problem that hydrophilic dressing negative pressure conductive performance is poor.In single foam dressing, can use as required bilayer or multiple structure, extremely flexible.Therefore, do not changing under the prerequisite of the principle of the invention, any change or the distortion done, all belong to protection scope of the present invention.
Claims (28)
1. the multi-layered foamed dressing for negative-pressure sealed drainage, comprise negative pressure conducting shell (1), it is characterized in that: in negative pressure conducting shell (1) bottom, establish the drain protective layer (2) for contacting with wound surface or wound chamber, described negative pressure conducting shell (1) and drain protective layer (2) are perforated foams layer; Described negative pressure conducting shell (1) is hydrophobic porous sponge layer, and described drain protective layer (2) is hydrophilic porous sponge layer, is fixedly connected with and hole interpenetrates UNICOM between two layers of material.
2. the multi-layered foamed dressing for negative-pressure sealed drainage according to claim 1; it is characterized in that: described negative pressure conducting shell (1) thickness a is 0.5～10cm; pore diameter is 1～2.5mm, and described drain protective layer (2) thickness b is 0.1～3.5cm, and pore diameter is 0.2～1mm.
3. the multi-layered foamed dressing for negative-pressure sealed drainage according to claim 1 and 2, is characterized in that: described negative pressure conducting shell (1) thickness a is 1～3cm, and pore diameter is 1～1.5mm.
4. the multi-layered foamed dressing for negative-pressure sealed drainage according to claim 1 and 2, is characterized in that: described negative pressure conducting shell (1) thickness a is 3～6cm, and pore diameter is 1～2.0mm.
5. the multi-layered foamed dressing for negative-pressure sealed drainage according to claim 1 and 2, is characterized in that: described negative pressure conducting shell (1) thickness a is 6～9cm, and pore diameter is 1～2.5mm.
6. the multi-layered foamed dressing for negative-pressure sealed drainage according to claim 1 and 2, is characterized in that: described drain protective layer (2) thickness b is 0.3～0.5cm, and pore diameter is 0.2～0.5mm.
7. the multi-layered foamed dressing for negative-pressure sealed drainage according to claim 1 and 2, is characterized in that: described drain protective layer (2) thickness b is 0.5～1.5cm, and pore diameter is 0.5～1.0mm.
8. the multi-layered foamed dressing for negative-pressure sealed drainage according to claim 1 and 2, is characterized in that: described drain protective layer (2) thickness b is 1.5～3.5cm, and pore diameter is 0.8～1.0mm.
9. the multi-layered foamed dressing for negative-pressure sealed drainage according to claim 1 and 2, is characterized in that: described negative pressure conducting shell (1) adopts the PU foam of hydrophobic PU foam, eva foam or recombination chitosan to make.
10. the multi-layered foamed dressing for negative-pressure sealed drainage according to claim 1 and 2, is characterized in that:
The PVA foam of the PVA foam of described drain protective layer (2) employing PVA foam, recombination chitosan or composite antibacterial, antibacterial medicament is made.
The 11. multi-layered foamed dressing for negative-pressure sealed drainage according to claim 1 and 2, it is characterized in that: in the time of on the product that described multi-layered foamed dressing is installed for negative-pressure drainage tube, there are two longitudinal breaking joints (6), article two, longitudinal breaking joint (6) is positioned at and will the position of negative-pressure drainage tube be installed, an end opening of being installed by negative-pressure drainage tube, longitudinally the length of breaking joint (6) is as long as the position of installing through negative-pressure drainage tube pore.
The 12. multi-layered foamed dressing for negative-pressure sealed drainage according to claim 1 and 2, it is characterized in that: on negative pressure conducting shell (1) top, away from a side of wound surface, establish outer surface layer (3), outer surface layer (3) is fixedly connected with on negative pressure conducting shell (1) top.
The 13. multi-layered foamed dressing for negative-pressure sealed drainage according to claim 12, is characterized in that: outer surface layer (3) is porous foam outer surface layer (3a), and porous foam outer surface layer (3a) is hydrophilic porous sponge layer.
The 14. multi-layered foamed dressing for negative-pressure sealed drainage according to claim 13, is characterized in that: described porous foam outer surface layer (3a) thickness c is 0.1～0.5cm.
The 15. multi-layered foamed dressing for negative-pressure sealed drainage according to claim 12, is characterized in that: outer surface layer (3) is one deck sealed Cellophane outer surface layer (3b).
The 16. multi-layered foamed dressing for negative-pressure sealed drainage according to claim 15, is characterized in that: described sealed Cellophane outer surface layer (3b) thickness is 0.1～0.5mm.
17. 1 kinds of making for the manufacture method of the multi-layered foamed dressing of negative-pressure sealed drainage, comprise the following steps as described in claim 1～11:
The first step, cutting cutting makes negative pressure conducting shell (1) and drain protective layer (2);
Second step; between negative pressure conducting shell (1) foamed materials that the described first step is made and drain protective layer (2) foamed materials, adopt the gluing mode connecing of point to be fixedly connected with; two-layer perforated foams layer contact surface is provided with a glue point; point glue point place by doing, hydrophilic compound adhesive puts bondingly by adjacent two layers perforated foams is stacked, forms straticulate structure.
18. 1 kinds of making for the manufacture method of the multi-layered foamed dressing of negative-pressure sealed drainage, comprise the following steps as described in claim 1～11:
The first step, cutting cutting makes negative pressure conducting shell (1) and drain protective layer (2);
Second step, stacks, produces multilayer foams adopting the bonding mode of contact surface brush coating to be fixedly connected with between negative pressure conducting shell (1) and drain protective layer (2);
The 3rd step, the multilayer foams that second step is made is bored a hole on pin type perforating apparatus, and aperture is at 1～4mm, and guarantees that its needle body penetrates adhesive-layer, makes to be communicated with between two layers of foam material, makes the multi-layered foamed dressing of hole intercommunication.
The manufacture method of the 19. multi-layered foamed dressing for negative-pressure sealed drainage according to claim 18, is characterized in that: in described the 3rd step, the aperture of perforation is 2～3mm.
20. 1 kinds of making for the manufacture method of the multi-layered foamed dressing of negative-pressure sealed drainage, comprise the following steps as described in claim 1～11:
The first step, makes negative pressure conducting shell (1) and drain protective layer (2) according to design size cutting cutting;
Second step, the drain protective layer (2) that cutting in the first step is completed is placed in mold box, appropriate hydrophilic foam foaming raw material liquid is injected to its surface, standing 10～30 seconds, the negative pressure conducting shell (1) after surfacing, cutting in the first step being completed is covered in material liquid surface, use instrument, to evenly smooth exerting pressure of negative pressure conducting shell (1), makes negative pressure conducting shell (1) evenly fully contact with former liquid level;
The 3rd step; the mold box that injects material liquid in second step is heated; make foaming raw material liquid reaction curing molding; now negative pressure conducting shell (1) is together with drain protective layer (2) meeting composite joint; then the foamed materials adhesive linkage of the new bubble in centre is carried out to burr cutting cutting, make two-ply foam dressing.
21. according to described in claim 20 for the manufacture method of the multi-layered foamed dressing of negative-pressure sealed drainage, it is characterized in that: in the 3rd step, foamable reaction process, for being first heated to 30～50 ℃, continues 0.5～1 hour, makes it to close in advance; Then be warming up to 50～90 ℃, heat 2～8 hours.
22. according to described in claim 21 for the manufacture method of the multi-layered foamed dressing of negative-pressure sealed drainage, it is characterized in that: closing in advance temperature is 35～45 ℃, and be 0.5 hour heat time heating time.
23. according to described in claim 21 for the manufacture method of the multi-layered foamed dressing of negative-pressure sealed drainage, it is characterized in that: intensification temperature is 55～75 ℃, be 4～8 hours heat time heating time.
24. according to described in claim 20 or 21 for the manufacture method of the multi-layered foamed dressing of negative-pressure sealed drainage, it is characterized in that: in the 3rd step, the component of hydrophilic foam foaming raw material liquid and ratio are: the polyvinyl alcohol of different polymerization degree and alcoholysis degree: strong acid: polyaldehyde: alcohol=1:0.5～2:0.5～3:0.5～1.
25. according to described in claim 24 for the manufacture method of the multi-layered foamed dressing of negative-pressure sealed drainage, its feature
Be: in the 3rd step, hydrophilic foam foaming raw material liquid also comprises antibacterial, antibacterial, the reinforcing agent of described material liquid gross mass 0.5%～5%.
26. 1 kinds of making for the manufacture method of the multi-layered foamed dressing of negative-pressure sealed drainage, comprise the following steps as described in claim 12～14:
One of claim 17～25 is made to the method that multi-layered foamed dressing top adds porous foam outer surface layer (3a) is: the negative pressure conducting shell (1) of two-ply foam dressing is positioned in square dies box down, repeat second, third step of claim 20, make three layers of foam dressing.
27. 1 kinds of making as described in claim 15～16 for the manufacture method of the multi-layered foamed dressing of negative-pressure sealed drainage, comprise the following steps: the multi-layered foamed dressing top brush coating that one of claim 17～25 is made, sealed Cellophane outer surface layer (3b) is bonded in to upper surface, makes three layers of foam dressing.
28. according to the manufacture method of the multi-layered foamed dressing for negative-pressure sealed drainage described in claim 17 or 18 or 20, it is characterized in that: in multi-layered foamed dressing, cut two longitudinal breaking joints (6), longitudinally breaking joint (6) is positioned at the position that negative-pressure drainage tube is installed, and the position that install through negative-pressure drainage tube pore the one end of being installed by negative-pressure drainage tube in multi-layered foamed dressing extends multi-layered foamed dressing middle part.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201310393784.4A CN103691010B (en) | 2013-06-04 | 2013-09-02 | Multi-layered foamed dressing for negative-pressure sealed drainage and preparation method thereof |
| PCT/CN2014/078650 WO2014194786A1 (en) | 2013-06-04 | 2014-05-28 | Multi-layer foam dressing for negative pressure sealing drainage and manufacturing method therefor |
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| CN201310393784.4A CN103691010B (en) | 2013-06-04 | 2013-09-02 | Multi-layered foamed dressing for negative-pressure sealed drainage and preparation method thereof |
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2014194786A1 (en) * | 2013-06-04 | 2014-12-11 | 武汉维斯第医用科技股份有限公司 | Multi-layer foam dressing for negative pressure sealing drainage and manufacturing method therefor |
| CN104225768A (en) * | 2014-06-16 | 2014-12-24 | 武汉维斯第医用科技股份有限公司 | Multilayer negative-pressure closed drainage wound protecting device |
| CN105944220A (en) * | 2016-05-18 | 2016-09-21 | 浙江保尔曼生物科技有限公司 | Negative-pressure drainage device capable of flushing |
| CN109640903A (en) * | 2016-08-30 | 2019-04-16 | 史密夫及内修公开有限公司 | For applying the system of reduced pressure therapy |
| 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 |
| CN106916399B (en) * | 2017-03-17 | 2018-05-15 | 广州润虹医药科技股份有限公司 | A kind of environmental friend type multifunction composite negative pressure drainage shield wound sponge and preparation method thereof |
| CN110996867A (en) * | 2017-06-12 | 2020-04-10 | 凯希特许有限公司 | Foamed and textured sintered polymeric wound fillers |
| CN110025430A (en) * | 2019-04-04 | 2019-07-19 | 江门泓一生物医疗科技有限公司 | A kind of anti-clogging negative pressure drainage device |
| CN110152052A (en) * | 2019-05-17 | 2019-08-23 | 武汉大学 | A kind of multifunctional medical material and preparation method thereof |
| CN112773927A (en) * | 2020-12-24 | 2021-05-11 | 江苏申思生物科技有限公司 | Efficient and environment-friendly PVA/PU multilayer foam dressing manufacturing method |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2014194786A1 (en) | 2014-12-11 |
| CN103691010B (en) | 2016-09-14 |
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