阅读说明：本技术 用于制造伤口敷料的方法和伤口敷料 (For manufacturing the method and wound dressing of wound dressing ) 是由 乌尔夫·约翰尼森 斯蒂恩·约根森 马格努斯·帕莱兹基 于 2018-03-21 设计创作，主要内容包括：披露了一种用于制造具有基底的伤口敷料的方法以及通过这种方法制造的伤口敷料。该方法包括提供材料牺牲层,该材料牺牲层将要通过热钉穿孔器来打孔,以便在使用热钉穿孔器的加热钉在基底中制孔之前去除这些钉上的任何熔融残留物。所提出的方法是成本有效的、稳健的,并且降低了在制孔过程中污染物质嵌入基底中的风险。(Disclose a kind of method for manufacturing the wound dressing with substrate and the by this method wound dressing that manufactures.This method includes providing materials sacrifice layer, which will be punched by thermal spike perforator, to remove these any melting residue objects nailed on before using the heating of thermal spike perforator nail in the substrate drilling.The method proposed is cost-effective, steady, and reduces risk during drilling in polluter insertion substrate.)

1. a kind of method for manufacturing the wound dressing with substrate, which comprises

The thermal spike perforator for having heating nail array is provided；

The materials sacrifice layer for being suitable for punching by these heating nails is provided；

It is punched on the sacrificial layer with heating nail；

The drilling in the substrate is followed closely with the heating of the thermal spike perforator.

2. according to the method described in claim 1, wherein, the thermal spike perforator is arranged such that these heating nails reach It is punched on the sacrificial layer before the proximal face of the substrate, to remove these before these heating nails are contacted with the substrate Heat the residue nailed on.

3. method according to claim 1 or 2, wherein include that the material is sacrificial the step of the offer materials sacrifice layer Domestic animal layer is located between the thermal spike perforator and the substrate.

4. method according to any of the preceding claims further comprises:

Adhesive phase is administered on the perforated surface of the substrate.

5. method according to any of the preceding claims further comprises: back sheet is administered to the remote of the substrate On side surface, wherein the back sheet includes liquid-tight material.

6. method according to any of the preceding claims, wherein the sacrificial layer includes from including plastic foil, thin paper material The material selected in the group of material and non-woven material.

7. method according to any of the preceding claims, wherein the temperature of these heating nails is at or greater than the base The fusing point at bottom.

8. method according to any of the preceding claims, wherein described to be included in the step of drilling in the substrate Through-hole is made in the substrate.

9. method according to any one of claim 1 to 7, wherein described to be included in the step of drilling in the substrate Blind hole is made in the substrate.

10. according to the method described in claim 9, wherein, described the step of making blind hole in the substrate includes production depth Blind hole within the scope of 0.2mm to 6.0mm.

11. method according to any of the preceding claims, wherein the heating follows closely the nail density of array at every square li In the range of rice 3-10 root nail.

12. method according to any of the preceding claims, wherein the substrate includes absorbent foam.

13. method according to any one of claim 1 to 11, wherein the substrate includes absorbent nonwoven materials.

14. method according to any of the preceding claims, wherein the thermal spike perforator includes roller, the roller More heating nails are installed on outer surface.

15. method according to any of the preceding claims further comprises:

Support surface is provided for the substrate in the side opposite with the hot needle perforator of the sacrificial layer and the substrate, so that the thermal spike Perforator and the support surface form the substrate and the gap of the sacrificial layer therethrough.

16. according to the method for claim 15, wherein the support surface is the outer surface of reversed roller.

17. a kind of wound dressing with substrate, wherein the wound dressing is by according to claim 1 to any in 16 What the method described in manufactured.

18. wound dressing according to claim 17, wherein range of the open surface region of the substrate in 0.1-20% It is interior.

19. wound dressing described in 7 or 18 according to claim 1, wherein the substrate includes absorbent material.

20. wound dressing according to claim 19, wherein the absorbent material is selected from the group including the following terms: poly- Close object foam, non-woven material, fibrous material, gel-forming fiber, hydrogel, the matrix comprising hydrocolloid, weaving fiber with And knitted fibers.

Technical field

The present invention relates to art of wound dressings, more particularly to a kind of method for manufacturing wound dressing.The present invention is also It is related to a kind of wound dressing manufactured according to the method.

Background technique

In the medical field, it is known that wound location is covered, to protect wound location to invade (i.e. from foreign matter Keep wound site clean), and collect or absorb the exudate of wound location.Therefore, it is arranged to absorb the letter of exudate Single flock is generally viewed as traditional wound dressing.

However, wound healing process is more complicated, and there are many progress to improve and accelerate in technical field This agglutination.In general, wound healing process is divided into three phases in principle.Firstly, cleaning a wound, so It is to form new tissue afterwards, the group restored after this is woven in the final stage of ripeness and settles out while growing up to less fragile And more flexible structure.Regeneration stage be related to capillary, fibroblast and epithelial cell growth into wound location with For constructing new tissue.The tissue newly formed is extremely fragile, and influences tetchiness to the external world.It is known, however, that in order to The optimum conditions for obtaining wound healing, in this stage of wound reparation, it should keep wound moist, but without excessive wound Mouth exudate.

The example for being intended to improve this wound dressing of agglutination can be by the applicant, i.e. Gothenburg, Sweden'sHealth Care AB is commercially available, and for example in european patent number 0 855 921 It is described in B1, the patent is incorporated herein by reference.

It is improved however, industrially still needing, and the improvement of the manufacture more particularly to this wound dressing.More in detail It carefully says, wound dressing generally includes certain class absorbed layer, such absorbed layer can be by certain porous material such as such as polyurethane foam Material is made, to absorb the exudate for being originated from wound.Moreover, with a large amount of Wound exudates or high viscosity Wound exudate In the case of, naturally occurring hole may be insufficient for appropriate absorb.On the contrary, people must be by foamed material The mode in the hole significantly bigger than the hole of foamed material or unit is formed to increase open surface region (open surface Area) (it is properly termed as open area (open area)).

This some holes can be made by using a kind of heating nail technology (being referred to as hot needle technology).Typically, add The roller of thermal spike rolls on absorbent foam layer, so that heating nail is guided in material, to form hole in fusion process.

Common disadvantage relevant to heating nail technology is, since nail forms hole in absorbent foam, to heat Nail is by the pollution for being sticked to retained material thereon.Accordingly, there exist residues, and absorption sex vesicle is introduced in subsequent punch operation The risk of absorbent foam layer is polluted in foam material.

As the remedial measure of the problem related to contaminated nail, GB 1 552 491 proposes a kind of in foam The manufacturing method of synthetic thermoplastic plastic's on piece punching, wherein passing through gas burner after each punch operation for residue Burn-up is nailed on from heating.At the position opposite with the perforation of foamed sheet (i.e. heating nail roller opposite side on) into The cleaning of row nail.However, the setting of these types with auxiliary heating element would generally reduce overall craft speed, and same The complexity and cost of the entire technique of Shi Zengjia.

However, industrially there is still a need for the manufacturing process for being modified to wound dressing.More specifically, it needs for making The method for making wound dressing, this method is less complicated, and at the same time having cost-effectiveness and Saving in time costs.

Summary of the invention

Therefore, the purpose of the present invention is to provide a kind of method for manufacturing wound dressing, this method is alleviated at present All or at least some disadvantages in the disadvantages discussed above for the system known.

This purpose is realized by being used to manufacture the method for wound dressing as defined in the appended claims.

The present invention is based on the insight that the material layer of a part that not will form final products can be used for " cleaning " heat Thus the heating nail for following closely perforator at least partly alleviates many relevant to the pollutant in insertion gained wound dressing and asks Topic.

According to the first aspect of the invention, a kind of method for manufacturing the wound dressing with substrate, the party are provided Method includes:

The thermal spike perforator for having heating nail array is provided；

The materials sacrifice layer for being suitable for punching by these heating nails is provided；

Hole on the sacrificial layer is followed closely with these heating；

The drilling in the substrate is followed closely with the heating of the thermal spike perforator.

The method of the present invention is more cost effective not only for each manufacturing cell, and it keeps productivity higher, same with this When products obtained therefrom (wound dressing) still meet the regulatory requirements of medical equipment in terms of the polluter level in insertion substrate. Wound dressing produced has substrate (alternatively referred to as basal layer), which has when using dressing to the close of the substrate The hole that the side of the skin of wearer is opened.It will be readily appreciated by those skilled in the art that wound dressing is in addition to being only used for absorbing Other purposes are applied also for except Wound exudate.Therefore, which should be read to include interface dressing and wound prevention Dressing, for example, it can also be administered on healthy skin to absorb sweat or provide pressure releases.In other words, wound dressing It may be used as interface dressing or wound prevention dressing, such as Bedsore prevention.

Substrate may include absorbent material, and the absorbent material may, for example, be such as hydrophilic polyurethane foam Equal foam of polymers, non-woven material, such as the fibrous materials such as fibroid hydrophilic polymer material, gel-forming fiber, water Gel, the matrix comprising hydrocolloid, weaving fiber and knitted fibers, or combinations thereof.

In more detail, the feature of absorbent material can be the free wxpansion measured by EN 13726-1:2002 Absorbability (corresponding to maximum absorbance capacity) is at least 3 times of its own weight.According to the present invention, term " hydrophilic " Ying Li Solution are as follows: such as IUPAC: technical terms of chemistry compilation, second edition (" golden skin book "), A.D.McNaught and A.Wilkinson establishment, Bu Lai Ke Weier scientific publications department (Blackwell Scientific Publications), Oxford (Oxford) (1997), ISBN Defined in 0-9678550-9-8, generally refer to molecular entity or substituent group and polar solvent (especially and water) or and its The ability of his Electronic interactions.

Preferably, term " hydrophilic " refers to the characteristic of the infiltration characteristic of material or the attraction water of molecule.With hole Material (such as open celled foam) or material with through-hole in the case where, if this material absorbs water, which is " hydrophilic ".In the case where the material of no hole or any through-hole, if this material non resistance water flows into or through the material, Then think that the material is " hydrophilic ".It is, for example, possible to use the water columns of a up to inch height to apply pressure up at least to material 60 minutes, at least 90 minutes or at least carry out within 24 hours the hydrophily of test material." resistance " refer to enter in this test or Any water flow across foam is below the detectable limit tested.

According to an embodiment of the invention, substrate is one layer or is included in one layer that is, substrate can be basal layer.Then substrate Layer with a thickness of at least 250 μm, it is therefore preferable at least 1 μm, more preferably at least 3 μm." layer " used according to the invention is answered This is interpreted as having being extended continuously on a plane (direction x and y) and the thickness perpendicular to the plane (direction z).

The step of drilling includes making through-hole and/or production blind hole in the substrate in the substrate.Under current background, blind hole It is understood to the hole for the other side for having certain depth without wearing out material, rather than runs through the through-hole of material always.Under The step of Wen Zhong, drilling, can be referred to as puncture or drilling operation.

Further, present inventors have recognized that the conventional production process for manufacturing wound dressing be easy to occur it is some universal The shortcomings that.For example, the laser technology of usually used puncture substrate surface (i.e. drilling in the substrate) inherently slowly and Expensive process.On the other hand, even if heating nail technology has advantage under its most basic form in terms of speed and cost, But prove that its problem is to avoid the puncture operation by absorbent material caused in residue shape in operation in subsequent pierce through The pollution of formula is guided in substrate.Therefore, the medical equipments such as manufacture such as wound dressing are made it unsuitable for.Even if piercing through every time Duration long enough between operation and be possible to burn-up residue in the case where evaporating residue, but this is unfavorable for giving birth to Produce speed.Moreover, increased operating temperatures or using auxiliary equipment " burn up " at faster speed residue increase production at Sheet and complexity, or be practically impossible due to the material property of heating nail perforator and substrate.More specifically, The operating temperature that cannot make thermal spike perforator is more than some threshold value.Therefore, by will follow closely guide in substrate before it is suitably fixed The materials sacrifice layer to be heated for following closely and perforating/penetrating is significantly reduced the problem related to pollution residue by position.

In more detail, the perforation of sacrificial layer is construed as " cleaning " operation, wherein heating nail wears it when pushing and It is out-of-date, any melting residue object for being sticked to heating as caused by perforation procedure and nailing on is removed or wiped off by sacrificial layer.Sacrificial layer Perforation can be used as the processing step that mutually separates with drilling in the substrate to execute, or alternatively, the perforation of sacrificial layer It can be completed in the same step with drilling in the substrate.However, will be furtherd elucidate in detailed description with reference to attached drawing Both alternative solutions.Sacrificial layer can be discarded in subsequent process steps.

In some embodiments of the invention, sacrificial layer can be made of aluminium (such as thin aluminium foil) or tissue materials.However, Sacrificial layer can also alternatively be made of non-woven material or plastic foil (such as polyester or polypropylene).Preferably, sacrificial layer Melting temperature at or below thermal spike perforator operating temperature.By having in sacrificial layer, fusible/meltable (i.e. fusing point is low In the operating temperature of thermal spike perforator) material, when by heating nail punching when, heating nail made of perforate and will be different And boundary clear, the risk ruptured in layer is reduced, increases the amount of the residue of sacrificial layer capture in this way, and is thus increased The efficiency of the setting (setup) is added.

Further, according to an embodiment of the invention, thermal spike perforator is arranged such that heating nail reaches substrate It is punched on sacrificial layer before proximal face, so as to the residual that removal heating nails on before these heating nails are contacted with substrate Object.

It should be understood that even if expression is that heating nail punches on sacrificial layer in being introduced to substrate " before ", it should Term also should be read to include heating nail, and progress punch operation " later " is punched on sacrificial layer in the substrate.This depends on a The viewpoint of people, and later case is construed as heating nail and carries out subsequent drilling operation " before " in the substrate in sacrificial layer Upper punching.Term " before " selects with being without prejudice, as it is assumed that it becomes apparent from terms of effect, i.e., in each subsequent system " cleaning " is carried out to nail before the process of hole, but as set forth above, it is possible to is equally understood as after drilling process to nail It carries out " cleaning ".

For example, if spike roller is used as thermal spike perforator and substrate relative to roller is positioned in 6 o'clock position Place, then sacrificial layer can be arranged in relative to 3 o'clock of roller position, 12 o'clock position, 9 o'clock position or even 6 points Zhong Weizhichu is punched by heating nail, however, in 6 o'clock position, sacrificial layer will be disposed between substrate and roller.

Further, according to an embodiment of the invention, heating nail array includes the range in 3-10 root every square centimeter nail It is interior, preferably 4-8 root every square centimeter follow closely in the range of and more preferably 4-7 root every square centimeter follow closely in the range of Nail density.Naturally, nail density is converted into the hole density in obtained substrate, that is, is converted into the proximal face of substrate On hole count every square centimeter.Follow closely diameter can for example in the range of 1-5mm, preferably in the range of 1.5-4mm, and And more preferably in the range of 2-3.5mm.Obtained bore dia depends on a variety of different factors, for example, the shape followed closely and (i.e. nail connects with substrate for penetration depth, nail diameter, the operating temperature (heating the temperature of nail) of thermal spike perforator and process speed How long is touching).Even so, according to an embodiment of the invention, thermal spike perforator be arranged such that it is obtained in substrate The diameter in hole is in the range of 0.2-4mm or makes the open surface region of substrate in the range of 0.1-20%, depends on The intended application of final products.As previously mentioned, naturally occurring hole can in the case where wound has a large amount of sticky exudates It can be insufficient for appropriate absorb.On the contrary, people must be bigger than the hole of substrate or unit by being formed in the substrate The mode in hole increase open area.

Further, according to another embodiment of the present invention, fusing point of the temperature at or greater than substrate of nail is heated.Example Such as, the temperature for heating nail can be in the range of the 100% to 200% of the melting temperature of substrate.Therefore, the work of thermal spike perforator The material selection of substrate is based preferably on as temperature to choose, but can be for example in the range of 200 DEG C to 600 DEG C, preferably Ground is in the range of 250 DEG C to 500 DEG C, such as 300 DEG C, 350 DEG C, 400 DEG C or 450 DEG C.Advantageously heating nail is arranged as Temperature is in the upper limit of aforementioned range so as to improve technique (i.e. in the range of the 150% to 200% of the fusing point of substrate) Speed.Nail temperature with higher leads to the hole that is more quickly formed in the substrate, and therefore improves handling capacity and yield.

Further, according to another embodiment of the present invention, which includes roller, on the outer surface of the roller More heating nails are installed.In other words, roller is understood to be the cylinder-shaped body with more heating nails, these add Thermal spike extends in radial directions from the enveloping surface of cylindrical body.In roller form thermal spike perforator the advantages of be have be easy to tie up The simple and firm construction of shield.

However, in an alternative embodiment, thermal spike perforator can also be in the form of formed punch, which can be hydraulic cause It is dynamic, pneumatically actuated or electric actuation.Therefore, formed punch can wrap rubbing board, which, which has from its more heating outstanding, follows closely, this A little heating nails then activate towards sacrificial layer and pass through sacrificial layer, so as in substrate with press type configuration drilling.

In addition, according to still another embodiment of the invention, this method further comprise the sacrificial layer and the substrate with The opposite side of the hot needle perforator provides support surface for the substrate, so that the thermal spike perforator and the support surface form this Substrate and the gap of the sacrificial layer therethrough.Support surface may, for example, be the outer surface of reversed roller.In fact, manufacture system The general layout of system can be in the form of rolling conveyor system.Further, by being provided during puncture or drilling operate Support surface can use the depth of accurate mode control hole using the base portion or supporting element as substrate.In other words, pass through control The size (i.e. between the two at a distance from) in the gap that is formed between support surface of heating nail perforator, can control obtained Hole depth.

Moreover, support surface may include flexible/soft or elastic material, such as silica gel, rubber etc..By with flexible Support surface, reduce pierce through operation during damage thermal spike tip risk, to extend the service life of thermal spike perforator. For example, the outer surface of reversed roller may include the silicon of application on it in the case where support surface is in reversed roller form Film or sheet rubber.

Further, according to still another embodiment of the invention, the step of providing materials sacrifice layer includes that material is sacrificial Domestic animal layer is located between thermal spike perforator and substrate.By the way that sacrificial layer to be located between thermal spike perforator and substrate, reduce Complexity is manufactured, this is because " cleaning " and drilling operation of heating nail can be carried out in same step.Therefore, in substrate and Sacrificial layer is in that the sheet-form rolled is arranged on conveyer roller, then can roll this two layers in a parallel manner, so that They pass through thermal spike perforator with the setting for rolling conveyor-type, to improve speed of production.Then, it can continuously pass It send substrate to be used for any possible post-processing operation, while sacrificial layer can be transferred separately in order to discard.

Mentioned post-processing may, for example, be applied adhesives layer or adhesive coating.Therefore, according to the present invention another One embodiment, this method further comprise that adhesive phase/coating is administered in the proximal face of substrate.The proximal face of substrate Should be understood substrate when drilling in face of the side or surface of thermal spike perforator.When dressing dressing, this is proximate to dress The same surface of the skin of person, in the present embodiment, the surface is by gel coating.Adhesive phase may include viscous based on silica gel Mixture, acryloid cement or contact adhesive (PSA) hot melt adhesive.Adhesive phase preferably has hydrophobic property, to prevent The fluid absorbed when dressing wound dressing is spontaneous to flow back into skin or wound.Patient comfort is improved in this way, and is reduced The risk for deteriorating agglutination since wound tissue is impaired during removing or replacing wound dressing.

Wound tissue also can be with removal and more change dressings are relatively mechanically damaged.In order to avoid such case, favorably Be that the dressing being applied on wound is not bound in dry Wound exudate or any coagulation being likely to form.This is corresponding Ground is realized by adhesive phase, which will serve as the spacer between the skin of wearer and substrate, bonding Agent extends slightly into the circumferential edge edge in hole and covering hole, without plugging hole (or any naturally occurring hole of blocking).From And it prevents from contacting between substrate and skin, while but also Wound exudate being drawn into substrate.Naturally, a some holes or hole Gap may be blocked due to manufacturing tolerance, however, the hole at least some made holes and naturally occurring is towards substrate Nearside keep open.

Further, according to still another embodiment of the invention, adhesive phase is administered on the perforated surface of substrate Step includes: that the transfer scraps of paper including binder combination are administered in the proximal face of substrate, consolidates binder combination Change, and remove transfer paper, to leave adhesive phase in the proximal face of substrate.It thus provides a kind of for that will bond Oxidant layer is administered to the simple and efficient way in the proximal face (i.e. perforated surface) of substrate.The thickness of obtained adhesive phase Degree is preferably in the range of 0.1mm to 2.0mm.

Further, according to still another embodiment of the invention, this method further comprises that back sheet is administered to the base In the distal surface at bottom, wherein the back sheet includes liquid-tight material.Distal surface correspondingly should be understood base The side of the skin for being located remotely from wearer in use at bottom.In other words, distal surface is in puncture or drilling operation phase Between deviate from thermal spike perforator surface.By coating distal surface with back sheet, reduce by the fluid leakage of absorbed by the substrate Risk.Back sheet can be for example including thermoplastic polymer, and in the form of film, such as polyurethane film.

Suitable back sheet is, for example, film, foil, foam or diaphragm.In addition, back sheet can have from >=5 μm up to≤ In the range of 80 μm, particularly preferably at >=5 μm until in the range of≤60 μm and particularly preferably at >=10 μm until≤ Thickness and/or back sheet in the range of 30 μm have the elongation at break greater than 450%.Back sheet is preferably steam can It penetrates.

According to another aspect of the present invention, it provides a kind of by being appointed according to what is discussed about aforementioned aspects of the invention The wound dressing of the method manufacture of one embodiment.

According to an embodiment of the invention, the substrate of wound dressing includes hole, the model of the diameter in obtained hole in 0.2-4mm In the enclosing or open surface region of substrate is in the range of 0.1-20%.

Below with reference to embodiment as described below these and other feature and advantage that the present invention is furture elucidated.

Detailed description of the invention

For illustrative purposes, below with reference to the accompanying drawings shown in embodiment the present invention will be described in more detail, in attached drawing In:

The schematic flow chart diagram that Fig. 1 illustrates the manufacturing method of embodiment according to the present invention shows；

Fig. 2A illustrates schematically cutting for the system or equipment for manufacturing wound dressing of embodiment according to the present invention Face view；

Fig. 2 B illustrates the signal of the system or equipment for manufacturing wound dressing according to another embodiment of the present invention Property section view；

Fig. 2 C illustrates showing for the system or equipment for manufacturing wound dressing according to still another embodiment of the invention Meaning property section view；

Fig. 2 D illustrates showing for the system or equipment for manufacturing wound dressing according to still another embodiment of the invention Meaning property section view；

Fig. 3 illustrates the nearside for being used to for surgical appliance adhesive gel layer being administered to basal layer of embodiment according to the present invention The perspective schematic view of method and step on surface；

Fig. 4 illustrate embodiment according to the present invention for liquid-tight material layer to be administered to basal layer The perspective schematic view of method and step in distal surface.

Specific embodiment

In the following detailed description, some embodiments of the present invention will be described.It should be appreciated, however, that unless otherwise indicated Any other content, otherwise the feature of different embodiments be between the embodiments it is interchangeable and can differently into Row combination.Although in the following description, numerous specific details are set forth to provide to more thorough explanation of the invention, right It is clear that the present invention can be practiced without these specific details for those skilled in the art.At other In the case of, it is not described in well known structure or function, in order to avoid the fuzzy present invention.

Fig. 1 shows showing for the method 10 for manufacturing the wound dressing with substrate 4 of embodiment according to the present invention Meaning property flow chart indicates.The method of the present invention is particularly suitable for the drilling in aperture absorbent foam, and therefore, substrate 4 can To be, for example, the absorbent foam with open space or unit, such as by including the prepolymer based on the following terms The polyurethane foam of composition production: hexamethylene diisocyanate (HDI), toluene di-isocyanate(TDI) (TDI) or methylene two Phenyl diisocyanate (MDI).Substrate is preferably selected to aperture in the range of 30 μm to 1000 μm.However, As previously mentioned, absorbent material is also possible to absorbent nonwoven materials, such as vinal, carboxymethyl cellulose (CMC) fiber or any other equivalent and suitable material.

Here, substrate 4, in the form of basal layer 4, which preferably has in the range of 0.25-10mm, such as Thickness in the range of 2-8mm, this depends on the requirement of absorbability and flexible aspect.However, in other realities of the invention It applies in a (not shown), substrate 4 includes the first sublayer and the second sublayer.In other words, substrate 4 may include the son of multiple superpositions Layer.

Firstly, 11 provide thermal spike perforator 2,2 '.Thermal spike perforator for example can be roller 2, on the outer surface of the roller More heating nails (being referred to as spike roller 2) are disposed with, as shown in the Far Left diagram on 11 the right of frame.However, thermal spike Perforator can also be in the form of compacting arrangement 2 ', as shown in the adjacent rightmost diagram of frame 11.Further, it 12 provides Suitable for the materials sacrifice layer 3 punched by heating nail.Sacrificial layer 3 is preferably by melting temperature lower than thermal spike perforator 2,2 ' The material of operating temperature (i.e. lower than the temperature of heating nail) is made.Sacrificial layer 3 can for example by nowoven membrane or plastic foil (such as Polyester or polypropylene) it is made, alternatively sacrificial layer can be made of tissue materials.Sacrificial layer 3 can have at 50 μm to 200 Thickness in the range of μm, or thickness can be in the case where sacrificial layer 3 is in the form of non-woven material or tissue materials 50g/m²To 200g/m²In the range of.

Continue, 13 drillings in substrate 4.In more detail, this some holes is manufactured in piercing through operation, is grasped in the puncture In work, the heating nail 21 of thermal spike perforator 2,2 ' contacts with the proximal face 61 of substrate 4 and allows to penetrate in material, to have Pore-forming is melted in the material in effect ground.However, thermal spike perforator 2,2 ' is arranged such that heating nail 21 in the nearside for reaching substrate 4 It is punched on sacrificial layer 3 before surface 61 (as shown in the diagram on 13 the right of frame).Although the diagram in Fig. 1 shows sacrificial layer Example of 3 settings between heating 21 (i.e. thermal spike perforators) of nail and substrate 4, but other arrangements are also feasible, and will Other arrangements are further discussed see, for example Fig. 2 B.In addition, by having in sacrificial layer 3 when being contacted with heating nail 21 slightly (i.e. fusing point is lower than the operating temperature of thermal spike perforator 2,2 ') material of fusing, will be different by the perforation that heating nail 21 is formed And boundary clear, while reducing the risk of the rupture of sacrificial layer 3 or tearing.Therefore, it increases and is sacrificed the residual of the capture of layer 3 The amount of object 101 is stayed, and improves the efficiency of manufacturing process, carry out clean efficiency especially by 3 pairs of sacrificial layer nails 21.It is sacrificial Domestic animal layer 3 preferably has 30% to 100% (i.e. the 30% of the operating temperature of thermal spike perforator 2,2 ' in the temperature of heating nail 21 To the fusing point in the range of 100%).For example, sacrificial layer 3 is preferably disposed in if heating nail has 400 DEG C of temperature With fusing point in the range of 120 DEG C to 400 DEG C.

Moreover, the graphic sequence on 13 the right of frame illustrates the example of " the cleaning process " of heating nail 21.Firstly, to pollution The heating nail 21 of retained material 101 (residue caused by being operated by previous drilling) is positioned to drilling in the substrate. Then, nail 21 is moved through into sacrificial layer 3 towards substrate 4, so as to the drilling in substrate 4.Finally, withdrawing heating nail 21, thus Obtained hole is formed in substrate 4.As shown in rightmost diagram, especially in enlarged view 100, sacrificial layer 3 is being heated Nail 21 nails on collection or " scraping off " pollution retained material 101 from heating during passing through sacrificial layer 3.As can also be seen that, The melting residue object pollution (middle illustration) caused by being operated by drilling from substrate again of heating nail 21.Therefore, in substrate It is middle progress separately produce once hole when, when heating nail 3 perforation sacrificial layers 3 in unperforated annular region when, these residues will again by Sacrificial layer 3 captures.

Obtained hole is preferably blind hole in substrate 4, but can be through-hole in some applications, in latter situation Under, heating nail 21 is all the way through absorbent foam layer 4.The combination of blind hole and through-hole is also to be contemplated that, for example, thermal spike The heating nail 21 of perforator 2 can have different length.

Further, adhesive phase 32 is administered in the proximal face 61 of substrate 4 by method 10 including 14 and 15 will back Lining 33 is administered to the optional step in the distal surface 62 of substrate 4.However, these steps will further be begged for referring to Fig. 3 and Fig. 4 By.

Fig. 2A is the manufacturing equipment for being used to manufacture wound dressing 50 of embodiment according to the present invention or showing for manufacture arrangement 1 Meaning property section view.Manufacture arrangement 1 includes thermal spike perforator 2 (herein in the form of spike roller), is arranged on its outer surface There are heating 21 arrays of nail.Arrangement 1 further has one group of rolling conveyer element 22a, 22b, 24, to make substrate 4 and to sacrifice Layer 3 is contacted with the heating of thermal spike perforator 2 nail 21.These nail can for example be arranged by infra-red radiation, suitably heating element, Gas burner etc. heats.In other words, thermal spike perforator may include any suitable dress for being heated to nail It sets.The temperature (i.e. the operating temperature of thermal spike perforator 2) of nail can be for example in the range of 200 DEG C to 600 DEG C, but the temperature It is configured preferably relative to the melting temperature of substrate.For example, the temperature of heating nail 21 can be in the melting temperature of substrate 4 In the range of 100% to 200%.

Further, every heating in heating nail 21, which is followed closely, can have in the range of 1mm to 15mm, preferably exists Length in the range of 5mm to 10mm and diameter in the range of 1mm to 5mm.Heating nail 21 can have with circular cone The substantially cylindrical shape of shape or taper tip.Moreover, the nail density of thermal spike perforator 2 is followed closely in 3-10 root every square centimeter In the range of, preferably in the range of 4-8 root every square centimeter is followed closely, and more preferably in 4-7 root every square centimeter nail In range.The nail density of thermal spike perforator 2,2 ' is properly selected, and therefore properly selects obtained hole density and base The open surface region at bottom, to control the flexibility of obtained dressing, i.e., higher hole density or biggish open surface area Domain will obtain wound dressing more flexible.

In fig. 2, deliver substrate 4 from left to right and very close to thermal spike perforator 2, as a result, since thermal spike is perforated Device 2 rotates, and heating nail 21 penetrates in substrate 4, as indicated by diagram.Manufacture arrangement 2 also has support surface 23, herein the branch Support surface in include in the outer surface of the reversed roller in conveyer element 22a, 22b, 24 in the form of.Reversed roller 24 and thermal spike Perforator 2 together forms the gap of substrate 4 therethrough.Sacrificial layer 3 is parallel to the traveling of substrate 4, and also defeated by rolling Device element 22a, 22b is sent to be passed through the gap formed by hot piercing device 2 and reversed roller 24.Correspondingly, heating nail 21 exists Sacrificial layer 3 is penetrated before reaching the proximal face 61 of substrate 4 first.Therefore, when heating nail is across sacrificial layer 3, it is sticked to heating Residue " being wiped off " on nail 21.Sacrificial layer 3 can discard after it is perforated.Preferably, sacrificial layer is by being suitable for back The material of receipts is made, and makes it possible to and is melted and is configured to again thin sheet or layer, to be re-used for manufacturing method of the present invention.

Further, by providing support surface 23 (substrate 4 is positioned on the support surface during drilling operation), It can be by control the distance between hot piercing device 2 and support surface 3 come the depth of control hole.However, in alternate embodiment In, then substrate 4 can carry out in free space drilling operation, and do not need to make under tension by transmission (not shown) Substrate 4 is pressed into heating nail 21 with support surface 23, to reduce the demand to support surface 23.

Further, thermal spike perforator is preferably disposed in the drilling in substrate with the speed of 1-20m per minute.Base It is selected in the material of substrate, manufacturing speed is biased to the lower limit or the upper limit of above range.Because hole is formed in fusion process, So having the material compared with low melting point that can quickly be processed, and similarly, have for the formation in hole appropriate Higher melting-point material needs more times.

Fig. 2 B-2D shows the manufacture arrangement 1 for manufacturing wound dressing 50 of different embodiment according to the subject invention Diagrammatic cross-sectional view.Operating principle is closely similar referring to the principle of Fig. 2A description with front, and for simplicity will not It repeats.

However, sacrificial layer 3 is positioned in spike perforation relative to substrate 4 in the alternate embodiment shown in fig. 2b The opposite side of device 2.In other words, in the embodiment shown in Fig. 2 B, substrate is arranged in relative to thermal spike perforator 2 6 o-clock positions are pierced, and sacrificial layer is arranged in and is perforated relative to 12 o-clock positions of thermal spike perforator 2.Cause This, after the heating nail 21 of thermal spike perforator 2 has pierced through a part of substrate 4, it will have the residual of some melted materials Object is sticked on the outer surface of heating nail 21.Then, in subsequent puncture operation, before the proximal face 61 for reaching substrate 4, with Heating nail 21 is cleaned by perforation sacrificial layer 3 afterwards.

Fig. 2 C shows the arrangement of the manufacture for manufacturing wound dressing 50 1, and wherein support surface includes elastic material, such as Layer of silica gel or rubber layer.In more detail, elastic piece is disposed with around the outer surface of reversed roller 24.It thereby reduces and is piercing through behaviour The risk of the tip of damage heating nail 21, especially is configured to be made the feelings of through-hole in substrate 4 in manufacture arrangement 1 during work Under shape.In alternate embodiment (not shown), support surface 23 can be arranged to operate with recess or recess in drilling Period, heating nail 21 can protrude through in recess or recess.

In figure 2d, manufacturing device 1 includes the conveyer belt as support surface 23.Preferably, conveyer belt includes elastic material The bed of material.Elastic material may, for example, be the foamed material with naturally occurring hole.Similar to the arrangement in Fig. 2 C, work as heating When nail 21 applies pressing force to the first substrate 4 during piercing through operation, conveyer belt bending.

Fig. 3 shows the perspective schematic view of two step sequences, illustrates the proximal face with 32 coated substrate 4 of adhesive phase 61 method and step.After substrate 4 has been provided with 40 array of hole in drilling operation, substrate is provided preferably with adhesive phase 32. Hole 40 is preferably blind hole, has opening in the proximal face 61 of substrate 4.

In an embodiment of the present invention, adhesive phase 32 may include adhesive based on silica gel, acryloid cement or Contact adhesive (PSA) hot melt adhesive.For example, the adhesive based on silica gel can be soft Silica hydrogel adhesive, the adhesive is because of it Advantageous skin-friendly characteristic and it is well-known, especially will not when removing the adhesive phase of soft Silica hydrogel adhesive from skin surface Or hardly make skin peeling.Term " Silica hydrogel " refers to the Silica hydrogel comprising cross-linked network, which includes lower The silica gel of molecular weight.For example, suitable soft Silica hydrogel adhesive can be by RTV (room temperature vulcanization) silica gel system group of addition curing At the system is crosslinked upon mixing and forms self-adhering, elastomeric body.One of commercially available RTV addition curing silica gel system Example is Wacker SilGel 612, is bicomponent system, wherein being formed by the pliability of elastomer and viscosity can lead to It crosses from 1.0:0.7 to change the ratio A:B of two kinds of components to 1.0:1.3 and change.Other examples of adhesive based on silica gel The especially NuSil of the NuSiI Technology company including State of Georgia, US (GA) Ka Piluoniya (Carpinteria) The DOW CORNING of MED-6340, NuSil MED3-6300 and NuSiI MED 12-6300 and U.S.'s Midland (Midland) is public Take charge of the Dow Corning 7-9800 of (Dow Corning Corporation).In addition, adhesive phase can have from 20g/m² To 300g/m²Coating weight, such as from 50g/m²To 200g/m², such as from 80g/m²To 150g/m²。

Coating operation is shown in Figure 3 for using transfer paper 31, which has the proximal face for being applied to substrate 4 Incured adhesives mixture layer 34 on 61.After the curing process, transfer paper 31 is shelled from the proximal face 61 of substrate 4 From to leave (cured) adhesive phase 32 on it.

Since adhesive will be inhaled into hole 40 and the part on the inner surface in each hole 40 by capillarity Thin adhesive coating is arranged in ground, therefore obtained adhesive phase 32 will have in position corresponding with following substrate 4 Through-hole 41.In other words, adhesive phase 32 will extend slightly into hole 40 and cover the circumferential edge edge in hole 40, without completely stifled Consent.It is carried out in the baking oven for having air of binder combination 34 solidified preferably in the range of 50 DEG C to 200 DEG C.It is inciting somebody to action Transfer paper 31 remove when, a small amount of binder substance can be retained on transfer paper 31 with following hole 40,41 corresponding positions It sets.

Skilled addressee readily understands that further details of coating procedure and for adhesive phase to be administered to wound Alternative method in the substrate of mouth dressing, and these details and method for example disclose in the EP0855921 of the applicant, The patent is incorporated herein by reference.

Because hole 40 will not be sealed or closed in adhesive layer 32, but covers a part of the inner wall in each hole 40, more It says to body, covers the inner wall towards wound when dressing dressing of the end sections in hole.Excessive Wound exudate still can be with It is inhaled into substrate 4 and is retained in wherein.Similar effect will occur in one through to substrate 4 proximal face 61 appoint In the hole of what naturally occurring and its surrounding (not shown).

In the case where not including any penetrate in substrate 4, the thickness of adhesive phase 32 is preferably in 0.1mm to 1.0mm In the range of.

In addition, substrate 4 is not only used as absorbent but also is used as the carrier of adhesive phase 32, therefore dressing 50 as a whole will very It is soft and flexible.Because adhesive layer 32 will adhere on the skin of wound circumference, dressing 50 will be retained on position appropriate securely It sets, while adhesive layer 32 provides sealing function and prevents from impregnating, that is, prevents Wound exudate from reaching the surrounding skin of health.Bonding Layer 32 and the open architecture of substrate 4 are but also skin is breathable.

Fig. 4 shows the perspective view of two step sequences, illustrates the method for the distal surface 62 with 33 coated substrate 4 of back sheet Step.In this specific diagram, back sheet 33 is shown for illustrative purpose and is sprayed onto the distal surface 62 of substrate 4, However, back sheet 33 can be applied in distal surface 62 for example, by printing, rolling or similar fashion.More specifically, applying It may include the distal surface for using (acrylic acid) adhesive coated substrate with the step of back sheet, then to glue back sheet 33 It is attached in substrate 4.

Back sheet 33 preferably in thin liquid cannot penetrate but the film or diaphragm of vapor-permeable in the form of.This is advantageous , in order to provide the wound dressing 50 with dry outer surface and prevent any wound fluid from leaking out dressing during use 50。

Back sheet 33 can be in the form of film, foil, foam or diaphragm.According to DIN 53333 or DIN 54101, back sheet It may be implemented as being that vapor can pass through.

Preferably, back sheet 33 may include thermoplastic polymer (such as coating), or can be by thermoplastic poly Close object composition.Firstly, thermoplastic polymer should be understood to be typical temperature for each processing or application conditions It is interior that polymer is repeatedly heated and keeps thermoplastic polymer in the case where cooling.Thermoplasticity is understood to polymer material It is being softening and the while cooling property of cyclic hardening repeatedly when heated in typical temperature range for respective material Matter, wherein material is remained able in softening stress-displacement stage repeatedly by flowing for example formed as moulded products, can be extruded Deng.

Preferred thermoplastic polymer be polyurethane, polyethylene, polypropylene, polyvinyl chloride, polystyrene, polyethers, polyester, Polyamide, polycarbonate, polyether-polyamide copolymer, polyacrylate, polymethacrylates and/or poly ester.It is excellent Selection of land, thermoplastic polymer are elastic.Particularly preferably carrier foils include thermoplastic polyurethane (TPU) or are made from it. Be particularly suitable to the thermoplastic polyurethane of the group selected from the following terms composition: aliphatic polyester polyurethane, aromatic polyester are poly- Urethane, aliphatic polyether polyurethane and/or aromatic polyether polyurethane.By using these polymer, back sheet can be obtained 33 are used as breathable elastic film.They are characterized in that the higher flexible and elasticity in wide temperature range, also have for (liquid Body) water advantageous sealing characteristics, while water vapour permeability with higher.These materials are further characterized by low noise Sound, advantageous fabric feeling, wash resistant and cleaning, extraordinary chemical resistance and mechanical resistant and their not plasticizer-containings It is true.

It is particularly preferred to serve as the barrier for germ there are also back sheet 33, and have to the exudate flowed out from wound It is permeable compared with high sealing ability, while to vapor.In order to realize same purpose, back sheet 33 can for example be embodied as Semi-permeable membrane.Back sheet can be plastic foil, it may for example comprise polyurethane, polyethylene or polypropylene are made from it.Of the invention In embodiment, back sheet be thickness in the range of 5 μm to 100 μm, such as 10 μm to 80 μm (such as 10 μm to 50 μm), preferably Polyurethane film of the ground from 10 μm to 30 μm.

Describe the present invention referring especially to specific exemplary embodiment above, many different changes, modifications etc. for It will become obvious for those skilled in the art.For example, dressing further can for example pass through ethylene oxide sterilizing or steaming Vapour sterilizes, and is intended to different shape and size to be suitble to different types of wound to realize.In addition, for side Just for the sake of, the hole shown has been circular, however, other suitable cross sectional shapes are also feasible, such as ellipse, just Rectangular, rectangle etc..In addition, different substances (such as active carbon, silver, different salt, fungicide etc.) can be mixed to substrate In, to obtain desired pharmacological effect.Word " including (comprising) " is not excluded the presence of except arranging in claim The other elements or step except element or step out.Word " one (a) " or " one (an) " before the component is not arranged Except there are this multiple class components.