CN103691010B - Multi-layered foamed dressing for negative-pressure sealed drainage and preparation method thereof - Google Patents

Multi-layered foamed dressing for negative-pressure sealed drainage and preparation method thereof Download PDF

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Publication number
CN103691010B
CN103691010B CN201310393784.4A CN201310393784A CN103691010B CN 103691010 B CN103691010 B CN 103691010B CN 201310393784 A CN201310393784 A CN 201310393784A CN 103691010 B CN103691010 B CN 103691010B
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negative
dressing
pressure
foam
conducting shell
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CN103691010A (en
Inventor
刘昕婷
裴国献
康皓
喻爱喜
肖宝钧
宋九宏
官红霞
万颖婕
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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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Priority to CN201310393784.4A priority Critical patent/CN103691010B/en
Publication of CN103691010A publication Critical patent/CN103691010A/en
Priority to PCT/CN2014/078650 priority patent/WO2014194786A1/en
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    • A61F13/05
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/91Suction aspects of the dressing
    • A61M1/915Constructional details of the pressure distribution manifold
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/91Suction aspects of the dressing
    • A61M1/918Suction aspects of the dressing for multiple suction locations

Abstract

The present invention provides a kind of multi-layered foamed dressing for negative-pressure sealed drainage and its manufacture method; multi-layered foamed dressing for negative-pressure sealed drainage includes negative pressure conducting shell; set the drain protective layer for contacting with wound surface or wound chamber in negative pressure conducting shell bottom, 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, and between materials at two layers, fixing connection and hole interpenetrate UNICOM.Have two longitudinal breaking joints, longitudinal breaking joint to be positioned at the position that negative-pressure drainage tube is installed in described multi-layered foamed dressing, negative-pressure drainage tube the position that the one end installed is installed through negative-pressure drainage tube pore extends in the middle part of multi-layered foamed dressing.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.Present invention also offers bonding and compound two kinds of methods making above-mentioned foam dressing simultaneously.The present invention uses multiple structure, and while ensureing material safety, it is possible to being effectively improved its negative pressure conductive performance, and be in use not easily blocked, permeability is stable, therapeutic effect is excellent.

Description

Multi-layered foamed dressing for negative-pressure sealed drainage and preparation method thereof
Technical field
The present invention relates to medical trauma therapeutic device field, specifically, refer to a kind of many for negative-pressure sealed drainage Layer foam dressing and preparation method thereof.
Background technology
Negative-pressure sealed drainage technology (vacuum sealing drainage is called for short VSD) is Germany ULM university Wim Doctor Fleischman initiated in 1992, and formed theoretical blank, for the drain of limb wounds;Chinese Qiu Huade in 1994 Negative-pressure sealed drainage technology is applied to department of general surgery by professor first, has started the elder generation that negative-pressure sealed drainage technology is applied in department of general surgery River, Wang Yanfeng, Qiu Huade professor in China in authorized patent CN 2236350 on March 17th, 1997, for negative-pressure sealed First patent of drainage technology.
Existing VSD technology basic configuration includes that negative pressure source (includes the 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 or sponge kind dressing or yarn Dry goods dressing (below above-mentioned medical material being referred to as perforated foams), Pasting sealing film, drainage container composition.Connect Negative pressure source drain, can draw liquefied materials such as the oozing of blood in tissue, sepage, the fragment of tissue of liquefaction and necrosis and puss It flow in drainage container.Slough and toxin, pus etc. can be expelled directly out external by above-mentioned technology, it is to avoid toxin is heavily inhaled Receive, rapid cleaning wound surface;Meanwhile, high negative pressure attracts to effectively facilitate granulation and mushrooms out, and shortens wound healing time.Use This technology, patient can be not required to change dressings in 3-7 days, it is to avoid cross infection, reduces medical personnel's workload, decreases patient Misery, reduces the fatality rate of wound, disability rate.
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 that slough, pus, sepage, other material such as toxic product and toxin are introduced drainage tube simultaneously Drainage medium.It is broadly divided into two kinds in the market: hydrophobicity dressing and hydrophilic for the foam dressing of negative-pressure sealed drainage Property dressing.Hydrophobicity dressing mostly is PU foaming materials and forms, and foam pores is relatively big, and Penetration ration is higher;Due to the characteristic that it is hydrophobic, Typically will not be aqueous in foam, therefore negative pressure conductive performance is splendid.Hydrophilic dressing mostly is PVA foaming materials and forms, foam hole Gap is less than hydrophobicity dressing, and material Penetration ration is relatively low, but also can meet the needs of negative pressure drainage treatment;Due to the spy that it is hydrophilic Property, dressing surface can form one layer of water molecule film, has separated dressing and has directly contacted with the endotheliocyte with granulation tissue, it is possible to Granulation tissue is stoped to grow in dressing, it is to avoid tractive is hemorrhage, and material safety is high.
But above two dressing equal existing defects in clinical practice.Hydrophobicity dressing (PU) is due to its hydrophobic spy Property, the unprotected layer of material surface, granulation tissue can be grown in foam pores, easily occurs tractive hemorrhage;Also due to it is hydrophobic Property dressing (PU) stretching resistance poor, easily producing chip comes off, and then causes the foreign body inflammatory reaction in wound surface wound chamber (to repel anti- Should) and secondary infection, therefore there is bigger problem in material safety.U.S. FDA report display, uses PU dressing, Bing Rencun In situation that is dead and that increase the weight of wound.Short (U.S. FDA report and pertinent literature showed and not can exceed that the cycle to use PU dressing to change dressings Three days), cost is high, and the labor intensity of medical personnel is big, and patient is the most painful.Hydrophilic dressing (PVA) due to its water-wet behavior, Material itself is moistening, although its Penetration ration is relatively low, also can meet the treatment requirement of negative pressure drainage, but owing to material contains Water, therefore its negative pressure conductive performance is poor, easily produces negative pressure when large area wound surface uses and conducts weak district, secondly PVA material Easily the most slowly become dry after material dehydration, cause Penetration ration to decline further, weaken therapeutic effect.
Summary of the invention
The technical problem to be solved be just to provide a kind of multi-layered foamed dressing for negative-pressure sealed drainage and Its manufacture method, it is possible to overcome the defect of existing negative-pressure sealed drainage dressing, while ensureing material safety, it is possible to effectively Improving its negative pressure conductive performance, and be in use not easily blocked, permeability is stable, and therapeutic effect is excellent.
Technical scheme: a kind of multi-layered foamed dressing for negative-pressure sealed drainage that the present invention provides includes bearing Pressure conducting shell, set in negative pressure conducting shell bottom for wound surface or the drain protective layer that contact of wound chamber, described negative pressure conducting shell with Drain protective layer is perforated foams layer;Described negative pressure conducting shell is hydrophobic porous sponge layer, and described drain is protected Sheath is hydrophilic porous sponge layer, and between materials at two layers, fixing connection and hole interpenetrate UNICOM.
Described negative pressure conductive layer thickness a is 0.5~10cm, and pore diameter is 1~2.5mm, described drain protective layer thickness b Being 0.1~3.5cm, 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 uses hydrophobic PU foam, eva foam or the PU foam of recombination chitosan Make.
Preferably, described drain protective layer uses PVA foam, the PVA foam of recombination chitosan or composite antibacterial, antibacterial The PVA foam of medicament is made.
When described multi-layered foamed dressing is on the product that negative-pressure drainage tube is installed, there is two longitudinal breaking joints, indulges for two Being positioned at the position by installing negative-pressure drainage tube, the negative-pressure drainage tube one end open installed to breaking joint, the length of longitudinal breaking joint is only The position that negative-pressure drainage tube pore to be passed is installed.
Setting outer surface layer on negative pressure conducting shell top, the i.e. side away from wound surface, outer surface layer is fixedly connected with in negative pressure Conducting shell top.
Described outer surface layer is porous foam outer surface layer, and porous foam outer surface layer is hydrophilic porous foamed materials Layer.
Described porous foam outer surface layer thickness c is 0.1~0.5cm.
Described outer surface layer is one layer of sealed Cellophane outer surface layer.
Described sealed Cellophane outer surface layer thickness is 0.1~0..5mm.
The a kind of of the present invention makes one of described manufacture method of multi-layered foamed dressing for negative-pressure sealed drainage, including Following steps:
The first step, cutting cutting prepares negative pressure conducting shell and drain protective layer;
Second step, adopts between the negative pressure conducting shell foamed materials described first step made and drain protective layer foamed materials With putting, the gluing mode connect is fixing to be connected, and two-layer perforated foams layer contact surface is provided with a glue point, at some glue point by doing, parent Adjacent two layers perforated foams stacking is put bonding by aqueous compound adhesive, forms straticulate structure;
The two of a kind of manufacture method making the described multi-layered foamed dressing for negative-pressure sealed drainage of the present invention, including Following steps:
The first step, cutting cutting prepares negative pressure conducting shell and drain protective layer;
Second step, folded fixing for the mode using contact surface brush coating bonding between negative pressure conducting shell with drain protective layer connection Put, produce multilayer foams;
3rd step, by second step make multilayer foams bore a hole on pin type perforating apparatus, aperture 1~4mm, and Ensure that its needle body penetrates adhesive-layer, make to connect between two layers of foam material, prepare multi-layered foamed dressing.
In described 3rd step, the aperture of perforation is 2~3mm.
The three of a kind of manufacture method making the described multi-layered foamed dressing for negative-pressure sealed drainage of the present invention, including Following steps:
The first step, prepares negative pressure conducting shell and drain protective layer according to design size cutting cutting;
Second step, drain protective layer cutting in the first step completed is placed in mold box, by appropriate hydrophilic foam material Material foaming raw material liquid injects its surface, stands the 10-30 second, negative pressure conducting shell cutting in the first step completed after surfacing It is covered in material liquid surface, uses the instrument applying pressure to negative pressure conducting shell uniform ground, make negative pressure conducting shell and stock solution face Uniformly it is fully contacted;
3rd step, heats the mold box injecting material liquid in second step, makes foaming raw material liquid react curing molding, now The foamed materials adhesive linkage of middle new foaming, together with drain protective layer meeting composite joint, is then cut by negative pressure conducting shell Cut cutting, prepare two-ply foam dressing.
The three of the manufacture method manufacture method of the described multi-layered foamed dressing for negative-pressure sealed drainage, foam in the 3rd step Course of reaction, for be first heated to 30~50 DEG C, continues 0.5~1 hour, is allowed to pre-conjunction;Then be warming up to 50~90 DEG C, heating 2~ 8 hours.
Preferably, pre-temperature of closing is 35~45 DEG C, and heat time heating time is 0.5 hour.
Preferably, warming temperature is 55~75 DEG C, and heat time heating time is 4~8 hours.
Preferably, in the 3rd step, component and the ratio of hydrophilic foam foaming raw material liquid are: different polymerization degree and alcohol The polyvinyl alcohol of Xie Du: 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 includes described material liquid gross mass 0.5%~5% Antibacterial, antibacterial, reinforcing agent.
A kind of described multi-layered foamed dressing for negative-pressure sealed drainage adds the manufacture method of porous foam outer surface layer, Comprise the following steps:
The method that prepared multi-layered foamed dressing top adds porous foam outer surface layer is: by the negative pressure of two-ply foam dressing Conducting shell is positioned in square dies box down, and repetition methods three prepares three layers of foam dressing.
The multi-layered foamed dressing being used for negative-pressure sealed drainage described in the second adds the making side of porous foam outer surface layer Method, comprises the following steps:
The multi-layered foamed dressing top brush coating that will make, is bonded in upper surface by sealed Cellophane outer surface layer, prepares three layers Foam dressing.
Cutting two longitudinal breaking joints in multi-layered foamed dressing, longitudinal breaking joint is positioned at the position that negative-pressure drainage tube is installed, by One end that in multi-layered foamed dressing, negative-pressure drainage tube is installed extends multi-layered foamed applying through the position that negative-pressure drainage tube pore is installed In the middle part of material.
Compared with prior art, the beneficial effects of the present invention is:
1) being provided with drain protective layer in foam dressing lower floor, this layer of foamed materials is hydrophilic foam, it is possible to have Effect intercepts granulation tissue, it is to avoid is adhered between granulation tissue and dressing, causes tractive hemorrhage, and the peace for the treatment of has been effectively ensured Quan Xing;
2) using multiple structure, centre arranges negative pressure conducting shell, is exclusively used in conduction negative pressure, is effectively increased negative pressure conduction effect Rate, while ensureing safety, it is possible to be effectively improved the negative pressure conductive performance of dressing, it is to avoid produces negative pressure conduction dead angle, protects Demonstrate,prove therapeutic effect;
3) use hydrophilic foam as drain protective layer, it is possible to form moist environment in region, wound surface surface, have It is beneficial to promote that the growth of wound granulation tissue, wound healing, and hydrophilic environments can effectively reduce patient painful;
4) present invention takes the lead in proposing the imagination of multi-layered foamed dressing, overcome medical circle for many years to clinically simple, The puzzlement of the clinical treatment that the respective superiority-inferiority of single use hydrophilic negative pressure material or hydrophobicity negative pressure material is caused and hardship Angry, utilize the design of simple structure and manufacture method, use multiple structure, the advantage combining above-mentioned material, overcome it not Foot;
5) using multi-layered foamed dressing structure, bottom drain protective layer is due to its hydrophilic characteristic, and consistency and elasticity is all Higher, and negative pressure conducting shell ensure that high negative pressure will not lose in conductive process, under high negative pressure effect, bottom drain is protected Massive necrosis tissue segmentation can be effectively fritter by sheath, and negative pressure conducting shell effectively can will be divided into the slough of fritter Draw, effectively prevent the blocking of negative pressure conducting shell material, can more effectively clean wound surface simultaneously, it is to avoid toxin produces, also Avoid the absorption of toxin, reduce infection rate;
6) after using multi-layered foamed dressing structure, owing to drain is unobstructed, and material safety is high, negative pressure conduction efficiency Height, dressing uses the time effectively to extend, and said structure can effectively extend the cycle of changing dressings, and slows down patient's misery further, Reduce Comprehensive Treatment expense;
7) use hydrophilic foam as drain protective layer, owing to hydrophilic foam tensile strength is high, will not produce Chip, it is possible to be prevented effectively from chip and enter wound surface, causes wound healing difficulty, further increases the treatment safety of foam dressing Property.
Accompanying drawing explanation
Fig. 1 is basic structure-embodiment 1 schematic diagram of the present invention;
Fig. 2 is the structural representation of embodiment of the present invention 2-band porous foam outer surface layer;
Fig. 3 is the embodiment of the present invention 3-structural representation with sealed Cellophane outer surface layer;
Fig. 4 is the perspective view of Fig. 1;
Fig. 5 is Fig. 1,2,3 and the plan structure schematic diagram adding drainage tube;
Fig. 6 is to process the structural representation of pin type perforating apparatus used by product of the present invention;
Fig. 7 is the top view of Fig. 6;
In figure, 1 negative pressure conducting shell, 2 drain protective layers, 3a-porous foam outer surface layer, outside 3b sealed Cellophane Surface layer, 4 pin type perforating apparatus, 5 needle bodies, two longitudinal breaking joints that 6-cuts in multi-layered foamed dressing.
Detailed description of the invention
Below in conjunction with accompanying drawing, the specific embodiment of the present invention is described in further detail:
Such as Fig. 1, Fig. 4, Fig. 5: a kind of multi-layered foamed dressing for negative-pressure sealed drainage of the present invention includes that negative pressure is conducted Layer 1, set in negative pressure conducting shell 1 bottom for wound surface or the drain protective layer 2 that contact of wound chamber, described negative pressure conducting shell 1 with draw Stream protective layer 2 is perforated foams layer;Described negative pressure conducting shell 1 is hydrophobic porous sponge layer, and described drain is protected Sheath 2 is hydrophilic porous sponge layer, and between materials at two layers, fixing connection and hole interpenetrate UNICOM.
When described multi-layered foamed dressing is on the product that negative-pressure drainage tube is installed, there is two longitudinal breaking joints 6, indulges for two It is positioned at the position by installing negative-pressure drainage tube, the negative-pressure drainage tube one end open installed, the length of longitudinal breaking joint 6 to breaking joint 6 If the position installed through negative-pressure drainage tube pore.The generally longitudinally a length of multi-layered foamed dressing length of breaking joint 6 1/10~1/2.
Article two, the effect of longitudinal breaking joint 6 is, for there is the wound surface of severe infections, and can be by glued membrane, drawing of exposing Flow tube and flush pipe are turned to drain protective layer 2 by the gap of cutting, directly negative pressure conducting shell 1 are contacted with wound surface and control Treat.
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 is thick Degree b is 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 is 0.5 ~1.5cm, when pore diameter is 0.5~1.0mm, it is adaptable to various formation fistulas, the abundant drain of disease of sinus tract and negative pressure Conduction.
Described negative pressure conducting shell 1 thickness a is 3~6cm, and pore diameter is 1~2.0mm;Drain protective layer 2 thickness b is 0.3 ~0.5cm, when pore diameter is 0.2~0.5mm, it is adaptable to various chronic, acute, traumatic, subacute and open wound, burn Wound, ulcer (such as diabetic ulcer and pressure ulcer), flap and skin-grafting before and after etc. type wound etc. abundant drain and Negative pressure is conducted).
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 Being 1.5~3.5cm, pore diameter is abundant drain and the negative pressure biography being applicable to the damage of various open abdominal when 0.8~1.0mm Lead.
Researching and analysing through inventor's Long-term clinical, under high negative pressure effect, the diameter of wound granulation is typically at below 1mm. Drain protective layer 2 uses this hole to configure, and on the one hand can be conducive to the conduction of negative pressure, on the other hand can be prevented effectively from meat Bud tissue growth enters in foam pores, improves overall security and the therapeutic effect of foam dressing.
Use relatively thin drain protective layer 2, it is possible to effectively reduce the negative shadow that negative pressure conduction is produced by hydrophilic foam layer Ring, and certain thickness effectively can produce iris action to wound granulation tissue.Use thicker negative pressure conducting shell 1, it is possible to It is effectively improved the overall negative pressure conductive performance of foam dressing.Above-mentioned data are that inventor is drawn through a large amount of clinical and experimental studies 's.
Drain protective layer 2 is preferably hydrophilic porous sponge layer.Described drain protective layer 2 can use PVA foam, The PVA foam of the PVA foam of recombination chitosan or composite antibacterial, antibacterial medicament is made.
The preferred hydrophobic porous sponge layer of described negative pressure conducting shell 1.Hydrophobic PU foam, EVA can be used to steep The PU foam of foam or recombination chitosan is made.The PU foam using recombination chitosan is more suitable for the needs used in turn.
The most hydrophobic porous foam material foam hole is relatively big, and Penetration ration is higher, due to the characteristic that it is hydrophobic, in foam Typically will not be aqueous, therefore negative pressure conductive performance is splendid, it is possible to be effectively improved the overall negative pressure conductive performance of foam dressing.
Medical circle respective to use hydrophilic negative pressure material the most simple, single or hydrophobicity negative pressure material for many years Superiority-inferiority causes a lot of puzzlements and the worries of clinical treatment.
Setting outer surface layer 3 on negative pressure conducting shell 1 top, the i.e. side away from wound surface, outer surface layer 3 is fixedly connected with negative Pressure conducting shell 1 top, is used for stoping material dehydration;Meanwhile, when for intracavitary therapy, outer surface layer 3 can effectively prevent from bearing Pressure conducting shell 1 directly contacts with wound cavity tissue.
Fig. 2 is the structural representation of embodiment of the present invention 2-band 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 foamed materials Layer.
Described porous foam outer surface layer 3a thickness c is 0.1~0.5cm.
Fig. 3 is the embodiment of the present invention 3-structural representation with sealed Cellophane outer surface layer:
Outer surface layer 3 is one layer of sealed Cellophane outer surface layer 3b.Described sealed Cellophane outer surface layer 3b thickness be 0.1~ 0.5mm。
The a kind of of the present invention makes one of described manufacture method of multi-layered foamed dressing for negative-pressure sealed drainage, including Following steps:
The first step, cutting cutting prepares negative pressure conducting shell 1 and drain protective layer 2;
Second step, between the negative pressure conducting shell 1 foamed materials described first step made and drain protective layer 2 foamed materials Using that the gluing mode connect of point is fixing to be connected, two-layer perforated foams layer contact surface is provided with a glue point, at some glue point by doing, Adjacent two layers perforated foams stacking is put bonding by hydrophilic compound adhesive, forms straticulate structure.
The multi-layered foamed dressing being used for negative-pressure sealed drainage described in the second adds the making side of porous foam outer surface layer Method, comprises the following steps:
The first step, cutting cutting prepares negative pressure conducting shell 1 and drain protective layer 2;
Second step, connects fixing for the mode using contact surface brush coating bonding between negative pressure conducting shell 1 with drain protective layer 2 Stack, produce multilayer foams;
3rd step, by second step make multilayer foams bore a hole on pin type perforating apparatus, aperture 1~4mm, and Ensure that its needle body penetrates adhesive-layer, make to connect between two layers of foam material, prepare multi-layered foamed dressing.
Fig. 6, Fig. 7 are to process the structural representation of pin type perforating apparatus used by product of the present invention:
In described 3rd step, the aperture of perforation is 2~3mm.
The three of a kind of manufacture method making the described multi-layered foamed dressing for negative-pressure sealed drainage of the present invention, including Following steps:
The first step, prepares negative pressure conducting shell 1 and drain protective layer 2 according to design size cutting cutting;
Second step, the drain protective layer 2 cutting in the first step completed is placed in mold box, by appropriate hydrophilic foam material Material foaming raw material liquid injects its surface, stands 10~30 seconds, and negative pressure cutting in the first step completed after surfacing is conducted Layer 1 is covered in material liquid surface, uses the instrument applying pressure to negative pressure conducting shell 1 uniform ground, makes negative pressure conducting shell 1 with former Liquid level is uniformly fully contacted;
3rd step, heats the mold box injecting material liquid in second step, makes foaming raw material liquid react curing molding, now The foamed materials adhesive linkage of middle new foaming, together with drain protective layer 2 meeting composite joint, is then carried out by negative pressure conducting shell 1 Cutting cutting, prepares two-ply foam dressing.
In described 3rd step, foamable reaction process is for be first heated to 30~50 DEG C, continues 0.5~1 hour, is allowed to pre-conjunction;And After be warming up to 50~90 DEG C, heat 2~8 hours.Be heated to 30~50 DEG C be in order to preferably merge, prefoam, be warming up to 50 ~90 DEG C of heating 2~8 are to preferably solidify.
Described pre-conjunction temperature is 35~45 DEG C, and heat time heating time is 0.5 hour.
Described warming temperature is 55~75 DEG C, and heat time heating time is 4~8 hours.
In described 3rd step, component and the ratio of hydrophilic foam foaming raw material liquid are: different polymerization degree and alcoholysis degree Polyvinyl alcohol: strong acid: polyaldehyde: alcohol=1:0.5~2:0.5~3:0.5~1.
The concentration of strong acid and polyaldehyde is the biggest, and hole is the least, and the hardness of product is the biggest, otherwise then strong acid and polyaldehyde is dense Spending the least, hole is the biggest, and the hardness of product is the least;The hydrophilic of alcohol content more high product is the strongest, otherwise alcohol content is the lowest, product Hydrophilic the most weak.At this, hydrophilic foam foaming raw material liquid is mainly used in bonding, typically its composition and ratio and product The drain protective layer 2 that product are used is consistent.
In described 3rd step, hydrophilic foam foaming raw material liquid also includes described material liquid gross mass 0.5%~5% Additive, includes but not limited to antibacterial, antibacterial, reinforcing agent etc..
Use hydrophilic foam foaming raw material liquid by fixing side compound between described each layer perforated foams layer Formula connects, and adjacent two layers foamed materials interpenetrates and is adhered, and permeability is more preferable.
By the method that prepared multi-layered foamed dressing top adds porous foam outer surface layer 3a it is: by two-ply foam dressing Negative pressure conducting shell 1 is positioned in square dies box down, repeats three second, third steps of manufacture method, prepares three layers of foam and apply Material.
Make multi-layered foamed dressing top add porous foam outer surface layer 3a method two be: by multi-layered foamed dressing Top brush coating, is bonded in upper surface by sealed Cellophane outer surface layer 3b, prepares three layers of foam dressing.
Cutting two longitudinal breaking joints in multi-layered foamed dressing, longitudinal breaking joint is positioned at the position that negative-pressure drainage tube is installed, by One end that in multi-layered foamed dressing, negative-pressure drainage tube is installed extends multi-layered foamed applying through the position that negative-pressure drainage tube pore is installed In the middle part of material.
Embodiment 1:
Composite foam dressing
This dressing is double-decker, one layer of negative pressure conducting shell 1 and one layer of drain protective layer 2 are composited.Negative pressure is conducted Layer 1 uses hydrophobic foam, and drain protective layer 2 uses hydrophilic foam.
Negative pressure conducting shell 1 thickness is 1cm, and drain protective layer 2 thickness is 0.5cm.Negative pressure conducting shell 1 pore diameter is 2.5mm, drain protective layer 2 pore diameter is 0.5mm.
The perforated foams layer outer surface of the described side outer layer away from wound surface is fixedly connected with outside one layer of sealed Cellophane 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 uses hydrophobic foam, and drain is protected Sheath 2 uses hydrophilic foam.
Negative pressure conducting shell 1 thickness is 1cm, and drain protective layer 2 thickness is 0.5cm.Negative pressure conducting shell 1 pore diameter is 2.5mm, drain protective layer 2 pore diameter is 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, is formed by one layer of negative pressure conducting shell 1 and one layer of drain protective layer 2 are bonding.Negative pressure is conducted Layer 1 uses hydrophobic foam, and drain protective layer 2 uses hydrophilic foam.
Negative pressure conducting shell 1 thickness is 1cm, and drain protective layer 2 thickness is 0.5cm.Negative pressure conducting shell 1 pore diameter is 2.5mm, drain protective layer 2 pore diameter is 0.5mm.
Described bonding way is that multi-point adhesive is bonding.The perforated foams layer appearance of the described side outer layer away from wound surface Face is fixedly connected with one layer of sealed Cellophane outer surface layer 3b.
Embodiment 4:
Adhesion type foam dressing
This dressing is double-decker, is formed by one layer of negative pressure conducting shell 1 and one layer of drain protective layer 2 are bonding.Negative pressure is conducted Layer 1 uses hydrophobic foam, and drain protective layer 2 uses hydrophilic foam.
Negative pressure conducting shell 1 thickness is 1cm, and drain protective layer 2 thickness is 0.5cm.Negative pressure conducting shell 1 pore diameter is 2.5mm, drain protective layer 2 pore diameter is 0.5mm.
Described bonding way is that face is bonding, and glue-line is equipped with through hole, and aperture is 2mm.
Embodiment 5:
Composite foam dressing
This dressing is double-decker, one layer of negative pressure conducting shell 1 and one layer of drain protective layer 2 are composited.Negative pressure is conducted Layer 1 uses hydrophobic foam, and drain protective layer 2 uses hydrophilic foam.
Negative pressure conducting shell 1 thickness is 3cm, and drain protective layer 2 thickness is 1cm.Negative pressure conducting shell 1 pore diameter is 1.5mm, Drain protective layer 2 pore diameter is 1mm.
The perforated foams layer outer surface of the described side outer layer away from wound surface is fixedly connected with outside one layer of sealed Cellophane Surface layer 3b.
Embodiment 6:
Composite foam dressing
This dressing is double-decker, one layer of negative pressure conducting shell 1 and one layer of drain protective layer 2 are composited.Negative pressure is conducted Layer 1 uses hydrophobic foam, and drain protective layer 2 uses hydrophilic foam.
Negative pressure conducting shell 1 thickness is 6cm, and drain protective layer 2 thickness is 0.75cm.Negative pressure conducting shell 1 pore diameter is 1mm, drain protective layer 2 pore diameter is 1mm.
The perforated foams layer outer surface of the described side outer layer away from wound surface is fixedly connected with outside one layer of sealed Cellophane Surface layer 3b.
Embodiment 7:
Composite foam dressing
This dressing is double-decker, one layer of negative pressure conducting shell 1 and one layer of drain protective layer 2 are composited.Negative pressure is conducted Layer 1 uses hydrophobic foam, and drain protective layer 2 uses hydrophilic foam.
Negative pressure conducting shell 1 thickness is 8cm, and drain protective layer 2 thickness is 1cm.Negative pressure conducting shell 1 pore diameter is 2.5mm, Drain protective layer 2 pore diameter is 0.5mm.
The perforated foams layer outer surface of the described side outer layer away from wound surface is fixedly connected with outside one layer of sealed Cellophane Surface layer 3b.
Embodiment 8:
Composite foam dressing
This dressing is double-decker, one layer of negative pressure conducting shell 1 and one layer of drain protective layer 2 are composited.Negative pressure is conducted Layer 1 uses hydrophobic foam, and drain protective layer 2 uses hydrophilic foam.
Negative pressure conducting shell 1 thickness is 10cm, and drain protective layer 2 thickness is 3.5cm.Negative pressure conducting shell 1 pore diameter is 2.5mm, drain protective layer 2 pore diameter is 0.5mm.
The perforated foams layer outer surface of the described side outer layer away from wound surface is fixedly connected with outside one layer of sealed Cellophane Surface layer 3b.
Embodiment 9:
Composite foam dressing
This dressing is double-decker, one layer of negative pressure conducting shell 1 and one layer of drain protective layer 2 are composited.Negative pressure is conducted Layer 1 uses hydrophobic foam, and drain protective layer 2 uses hydrophilic foam.
Negative pressure conducting shell 1 thickness is 6cm, and drain protective layer 2 thickness is 2.5cm.Negative pressure conducting shell 1 pore diameter is 2.5mm, drain protective layer 2 pore diameter is 0.5mm.
The perforated foams layer outer surface of the described side outer layer away from wound surface is fixedly connected with outside one layer of sealed Cellophane Surface layer 3b.
Embodiment 10:
Composite foam dressing
This dressing is double-decker, one layer of negative pressure conducting shell 1 and one layer of drain protective layer 2 are composited.Negative pressure is conducted Layer 1 uses hydrophobic foam, and drain protective layer 2 uses hydrophilic foam.
Negative pressure conducting shell 1 thickness is 6cm, and drain protective layer 2 thickness is 2cm.Negative pressure conducting shell 1 pore diameter is 2.5mm, Drain protective layer 2 pore diameter is 0.5mm.
The perforated foams layer outer surface of the described side outer layer away from wound surface is fixedly connected with outside one layer of sealed Cellophane Surface layer 3b.
Heating-up temperature is directly related with the mechanical strength of product and hardness with the time.Temperature is the highest, and heat time heating time is the longest, machine Tool intensity and hardness are the biggest;Temperature is the lowest, and heat time heating time is the shortest, then mechanical strength and the hardness of product are the least.
Two-layer compound PVA carries out Experimental comparison with existing PVA dressing and PU dressing, concrete outcome such as following table:
* A: first stage for the treatment of lapse to the time refer to wound surface, wound chamber through negative-pressure sealed drainage technology treat after formed can do two Phase is directly sewed up or makes skin graft or the wound bed repair time of tissue flap transfer.
* C: epithelium rate.Epithelization process includes the migration of keratinocyte, breeds and break up three phases, is group Knit the important symbol of repair process;Epithelium rate is the notable index of epithelization repair process.
* D: wound surface, wound chamber blood perfusion amount, refer to every 100g blood interior wound surface that can flow into every square centimeter per minute or Person creates the blood flow volume (ml) of chamber cavity wall;Wound surface, wound chamber blood perfusion amount are the biggest, and in unit are, the generation of blood capillary is the most alive Jumping, the growth rate of granulation tissue is the fastest.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 more Greatly, represent that wound surface, wound chamber are filled by newly granulating the most, wound healing situation
* G: count of bacteria, refers to the viable bacteria number in unit volume;Count of bacteria is the biggest, represents that infection potential is the biggest.
* K: comprehensive cost, drug expenditure, Operation Fee, treatment cost, the berth such as including while in hospital Master Cost, antibiotic Take, nutrition cost etc..
According to above-mentioned contrast experiment, product of the present invention is superior in therapeutic effect, the many-side such as Comprehensive Treatment expense Existing product.
In sum, the core of the present invention is the foam dressing of the MULTILAYER COMPOSITE outside utilizing for drain protective layer, ingenious Solve existing negative-pressure sealed drainage foam dressing hydrophobicity dressing materials poor safety performance, hydrophilic dressing negative pressure conductivity The problem of energy difference.In single foam dressing, bilayer or multiple structure can be used as required, the most flexibly.Therefore, not On the premise of changing the principle of the invention, done any change or deformation, belong to protection scope of the present invention.

Claims (24)

1. for a multi-layered foamed dressing for negative-pressure sealed drainage, including negative pressure conducting shell (1), it is characterised in that: in negative pressure Conducting shell (1) bottom sets the drain protective layer (2) for contacting with wound surface or wound chamber, and described negative pressure conducting shell (1) and drain are protected Sheath (2) is perforated foams layer;Described negative pressure conducting shell (1) is hydrophobic porous sponge layer, and described drain is protected Sheath (2) is hydrophilic porous sponge layer, is connected by hydrophilic foam foaming raw material liquid-solidization between materials at two layers, Between materials at two layers, hole interpenetrates UNICOM.
Multi-layered foamed dressing for negative-pressure sealed drainage the most according to claim 1, it is characterised in that: described negative pressure passes Conducting shell (1) thickness a is 0.5~10cm, and pore diameter is 1~2.5mm, described drain protective layer (2) thickness b be 0.1~ 3.5cm, pore diameter is 0.2~1mm.
Multi-layered foamed dressing for negative-pressure sealed drainage the most according to claim 1 and 2, it is characterised in that: described negative Pressure conducting shell (1) thickness a is 1~3cm, and pore diameter is 1~1.5mm.
Multi-layered foamed dressing for negative-pressure sealed drainage the most according to claim 1 and 2, it is characterised in that: described negative Pressure conducting shell (1) thickness a is 3~6cm, and pore diameter is 1~2.0mm.
Multi-layered foamed dressing for negative-pressure sealed drainage the most according to claim 1 and 2, it is characterised in that: described negative Pressure conducting shell (1) thickness a is 6~9cm, and pore diameter is 1~2.5mm.
Multi-layered foamed dressing for negative-pressure sealed drainage the most according to claim 1 and 2, it is characterised in that draw described in: Stream protective layer (2) thickness b is 0.3~0.5cm, and pore diameter is 0.2~0.5mm.
Multi-layered foamed dressing for negative-pressure sealed drainage the most according to claim 1 and 2, it is characterised in that draw described in: Stream protective layer (2) thickness b is 0.5~1.5cm, and pore diameter is 0.5~1.0mm.
Multi-layered foamed dressing for negative-pressure sealed drainage the most according to claim 1 and 2, it is characterised in that draw described in: Stream protective layer (2) thickness b is 1.5~3.5cm, and pore diameter is 0.8~1.0mm.
Multi-layered foamed dressing for negative-pressure sealed drainage the most according to claim 1 and 2, it is characterised in that: described negative Pressure conducting shell (1) uses hydrophobic PU foam, eva foam to make.
Multi-layered foamed dressing for negative-pressure sealed drainage the most according to claim 1 and 2, it is characterised in that draw described in: Stream protective layer (2) uses the PVA foam of PVA foam or composite antibacterial, antibacterial medicament to make.
The 11. multi-layered foamed dressing for negative-pressure sealed drainage according to claim 1 and 2, it is characterised in that: described When multi-layered foamed dressing is on the product that negative-pressure drainage tube is installed, there are two longitudinal breaking joints (6), two longitudinal breaking joint (6) positions In the position by installing negative-pressure drainage tube, negative-pressure drainage tube the one end open installed, longitudinal breaking joint (6) as long as length pass The position that negative-pressure drainage tube pore is installed.
The 12. multi-layered foamed dressing for negative-pressure sealed drainage according to claim 1 and 2, it is characterised in that: in negative pressure Conducting shell (1) top, the i.e. side away from wound surface set outer surface layer (3), and outer surface layer (3) is fixedly connected on negative pressure conducting shell (1) top.
The 13. multi-layered foamed dressing for negative-pressure sealed drainage according to claim 12, it is characterised in that: outer surface layer (3) being porous foam outer surface layer (3a), 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, it is characterised in that: described many Hole foam layer (3a) thickness c is 0.1~0.5cm.
The 15. multi-layered foamed dressing for negative-pressure sealed drainage according to claim 12, it is characterised in that: outer surface layer (3) it is one layer of sealed Cellophane outer surface layer (3b).
The 16. multi-layered foamed dressing for negative-pressure sealed drainage according to claim 15, it is characterised in that: described is close Sealing film outer surface layer (3b) thickness is 0.1~0.5mm.
The making of 17. 1 kinds of multi-layered foamed dressing for negative-pressure sealed drainage made as described in one of claim 1~11 Method, comprises the following steps:
The first step, prepares negative pressure conducting shell (1) and drain protective layer (2) according to design size cutting cutting;
Second step, the drain protective layer (2) cutting in the first step completed is placed in mold box, by appropriate hydrophilic foam Foaming raw material liquid injects its surface, stands 10~30 seconds, negative pressure conducting shell cutting in the first step completed after surfacing (1) it is covered in material liquid surface, uses the instrument applying pressure to negative pressure conducting shell (1) uniform ground, make negative pressure conducting shell (1) Uniformly it is fully contacted with stock solution face;
3rd step, heats the mold box injecting material liquid in second step, makes foaming raw material liquid react curing molding, now negative pressure The foamed materials adhesive linkage of middle new foaming, together with drain protective layer (2) meeting composite joint, is then carried out by conducting shell (1) Burr cutting cutting, prepares two-ply foam dressing.
The method of the 18. multi-layered foamed dressing for negative-pressure sealed drainage according to claim 17, it is characterised in that: the In three steps, foamable reaction process is for be first heated to 30~50 DEG C, continues 0.5~1 hour, is allowed to pre-conjunction;Then it is warming up to 50~90 DEG C, heat 2~8 hours.
19. according to the manufacture method of multi-layered foamed dressing for negative-pressure sealed drainage described in claim 18, it is characterised in that: Pre-temperature of closing is 35~45 DEG C, and heat time heating time is 0.5 hour.
20. according to the manufacture method of multi-layered foamed dressing for negative-pressure sealed drainage described in claim 18, it is characterised in that: After pre-conjunction, warming temperature is 55~75 DEG C, and heat time heating time is 4~8 hours.
21. according to the manufacture method of multi-layered foamed dressing for negative-pressure sealed drainage described in claim 17 or 18, its feature It is: in the 3rd step, component and the ratio of hydrophilic foam foaming raw material liquid are: different polymerization degree and the poly-second of alcoholysis degree Enol: strong acid: polyaldehyde: alcohol=1:0.5~2:0.5~3:0.5~1.
22. according to the manufacture method of multi-layered foamed dressing for negative-pressure sealed drainage described in claim 21, it is characterised in that: In 3rd step, hydrophilic foam foaming raw material liquid also includes the antibacterial of described material liquid gross mass 0.5%~5%, antibacterial Agent, reinforcing agent.
23. 1 kinds of making sides making the multi-layered foamed dressing being used for negative-pressure sealed drainage as described in one of claim 12~14 Method, its multi-layered foamed dressing top prepared in one of claim 17-22 adds porous foam extexine (3a), specifically includes Following steps:
The first step, prepares porous foam extexine (3a) according to design size cutting cutting;
Second step, the porous foam extexine (3a) cutting in the first step completed is placed in mold box, by appropriate hydrophilic sex vesicle Foam foaming materials material liquid injects its surface, stands 10~30 seconds, takes one of claim 17~22 and prepare after surfacing Two-ply foam dressing, the negative pressure conducting shell (1) of described two-ply foam dressing is covered in down material liquid surface, uses instrument Applying pressure to two-ply foam dressing uniform ground, makes the negative pressure conducting shell (1) of two-ply foam dressing uniformly fill with stock solution face Tap is touched;
3rd step, heats the mold box injecting material liquid in second step, makes foaming raw material liquid react curing molding, now negative pressure Conducting shell (1) is together with porous foam extexine (3a) meeting composite joint, then bonding to the foamed materials of middle new foaming Layer carries out burr cutting cutting, prepares three layers of foam dressing.
The manufacture method of the 24. multi-layered foamed dressing for negative-pressure sealed drainage according to claim 17, its feature exists In: cutting two longitudinal breaking joints (6) in multi-layered foamed dressing, longitudinal breaking joint (6) is positioned at the position that negative-pressure drainage tube is installed, by One end that in multi-layered foamed dressing, negative-pressure drainage tube is installed extends multi-layered foamed applying through the position that negative-pressure drainage tube pore is installed In the middle part of material.
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