CN101573091B - The film dressing - Google Patents

Abstract

The invention relates to a thin film dressing having a release liner which is able to support the dressing during application. The resilience or stiffness of the release liner is higher ' than the resilience or stiffness of the dressing so as to enable the control of the dressing during application. The invention further relates to a method of application of the thin film dressing where a minor part of the dressing initially is applied to the skin afterwards the dressing is folded backwards so the release liner faces upwards. Finally, the remaining part of the dressing is applied by pushing the release liner forwards in a rolling motion thereby rolling the dressing onto the skin. This dressing assembly allows the dressing to be applied by using only one hand.

Description

Film dressing

Technical field

The present invention relates to film dressing and more specifically relate to a kind of film dressing that has during applying release liner that can support dressing.

Background technology

For example owing to being subject to psoriasis, burning or the need protection additional skin of short or long time of the impact of other wound, film dressing is particularly advantageous for normal skin.Usually, when around skin extending or when folding, the skin around film dressing can conform to and therefore not feeling well wearing Shi Buhui.Yet, when dressing is that useful this effect is so that be difficult to apply dressing during suitable position on skin.This be because, during applying, the vulnerability of dressing causes that dressing trends towards rolling and is wrinkling or may even adhere to himself.

EP0434258 provides a kind of film dressing assembly with release liner of two comparable size.Each release liner is all longer than dressing and be folded in half, and Lower Half is bonded to dressing and the outstanding distance that surpasses the one section weak point in dressing edge of the first half, keeps simultaneously the free end of release liner in edge.Release liner is lower than dressing flexibility, thereby keeps dressing to be in flat condition and wrinkle resistant during applying.By dressing component is remained on the skin, and the expose portion of release liner contact skin, and then outwards and be parallel to dressing and skin in the pulling of the free end place of release liner, finished the coating of dressing.

Yet, still need a kind of film dressing controlled during applying.

Summary of the invention

The present invention relates to a kind of dressing component, this dressing component comprises film dressing, and this film dressing has the binding agent that is arranged on the backing layer, and wherein this assembly further is included in the sclerosis release liner that supports this thin film when applying dressing.The backing of this film dressing has the thickness less than 300 μ m.Rigidity or the rigidity of whole dressing component (comprising release liner) mainly come from release liner, and this is because dressing self is very little for the contribution of rigidity.

Have the release liner of the rigidity higher than dressing can be during applying support dressing and therefore prevent that dressing is wrinkling or be bonded to himself.Because supportive release liner covers the major part of dressing, so can only use a hands to apply dressing.This is the most fact that will always cover the dressing that not yet is applied on the skin owing to supportive release liner during applying.

The invention still further relates to a kind of method of coated film dressing, wherein the less part of initial dressing is bonded to skin, and the major part of release liner still is present in the dressing.After the less part of initial attachment dressing, dressing component is folded back and release liner is pushed away along applying direction, simultaneously dressing is rolled on the skin.

Peel value between release liner and film dressing has certain value, thereby can relatively easily release liner be pushed away from dressing.

Concrete summary of the invention

One aspect of the present invention relates to a kind of viscosity dressing component, this viscosity dressing component comprises dressing, described dressing comprises the binding agent that is arranged on the backing layer, and this dressing component further comprises most at least one supportive release liner of the adhesive surface that covers this dressing, wherein

-this dressing has the thickness less than 300 μ m,

The rigidity of-this supportive release liner is higher than the rigidity of this dressing, and

-peel value is arranged so that this release liner can easily be pushed away from binding agent.

Supportive release liner refer to have can be during applying the rigidity of support dressing or the release liner of rigidity.That is to say that the rigidity of supportive release liner or rigidity are higher than the analog value of dressing.

Providing a kind of dressing that will be easy to control during applying so that relatively be easy to push away balance between the rigidity of the peel value of supportive release liner and release liner, this be because, dressing paste is being attached between skin stage, and supportive release liner will provide necessary support and hardness for thin film.Then, during applying, dressing trend wrinkling or encirclement bubble between dressing and skin will be lowered.Because the peel value of dressing component is lower, this will prevent that dressing stretches during applying, so further reduced gauffer or besieged bubble.Gauffer or besieged bubble are undesirable, and this is the wrinkle that cause because dressing will have bubble or gauffer.If dressing is touched or for example stands from one of the wrinkle in the clothes light pressure, then therefore the folding pressure that can strengthen on damaged skin of dressing cause further damage to skin.

Binding agent can be the binding agent of any suitable skin known per se, for example comprises hydrocolloid or the binding agent of other moisture absorption composition of being used for extending working time.Binding agent suitably can be in GB patent specification No.1280631, at DK patent specification No.127,578, No.148,408, No.154,806, No.147 is in 226 and No.154,747, openly apply among No.0097846 and the No.0415183, openly apply for No.365 at SE at EP, in 410, in the open No.88/06894 of WO, at US patent specification No.4, openly apply for No.157 in 867,748 and at NO, the type that discloses in 686.Particularly preferably be at US patent No.4 the binding agent that discloses in 367,732 and 5,051,259 and DK patent specification No.169,711.

In a preferred embodiment of the invention, binding agent comprises hydrocolloid adhesive.By introducing moist wound healing environment but avoid maceration, use hydrocolloid adhesive that good protection can be provided as the skin of wound circumference.The thickness of binding agent is preferably between 60 μ m and 300 μ m, more preferably between 60 μ m and 200 μ m.Adhesive layer is between 60 μ m and 70 μ m in one embodiment, and in another embodiment adhesive layer between 110 μ m and 130 μ m.

Also can comprise from large-scale dissimilar binding agent acrylic-type and the type selecting of deriving from PIB (polyisobutylene), polyurethane, EVA chemical compound (ethylene vinyl acetate chemical compound), APAO (amorphous polyalpha olefin), silicones, polyvinylether any other binding agent out for example towards the layer of skin, be preferably pressure sensitive adhesives and/or hot melt agent.

Release liner is used to protect the binding agent of dressing and gives the supporting role that dressing needs owing to the weak characteristic of dressing.It also should easily be peeled off from binding agent.This value should be arranged so that can easily from binding agent release liner be pushed away during applying.On the other hand, release liner should automatically break away from binding agent.

Peel value determines to roll out from diaphragm dressing the easy degree of release liner.What require is that peel value between the binding agent of the first supportive release liner and dressing is lower, thereby so that dressing can easily be applied.

In one embodiment, when dressing can and be out of shape by high elongation, for example when backing layer is formed by the polyurethane film that binding agent is set in the above, the peel value between release liner and dressing is provided so that dressing can be released and is not stretched or otherwise distortion.

As measuring explaining in the example that relates to the peel value test, peel value is preferably lower than 3N/mm.This value should be higher than 0.02N/mm, thereby prevents that release liner automatically breaks away from.The value that is more preferably is lower than 1.6N/mm and the most preferred 0.1N/mm of being roughly.

In one embodiment, the first supportive release liner covers the whole adhesive surface of dressing, namely has 100% coverage rate.

In other embodiments, can be preferably, when dressing will be glued to skin, before removing the first supportive release liner, bonding be the part of dressing, thereby initial adhesion is provided.In these embodiments, should be appreciated that the first supportive release liner covers the major part of the binding agent of dressing, for example between 60% and 100%.According to the flexibility of binding agent and the dressing of dressing, described major part can at random cover the binding agent of the dressing between 60%, 65%, 70%, 75%, 80%, 85%, 90% or 95% and 100%.

In one embodiment of the invention, the hardness, rigidity or the stretch-proof that have of the first supportive release liner and bending resistance curvature are respectively greater than hardness, rigidity or stretch-proof and the bending resistance curvature of dressing.Can for example utilize the elastic modelling quantity (MOE) of release liner and dressing to determine this value.

The rigidity of release liner should have so that it will have this value of the lower crooked or trend that stretches during applying dressing especially.Thus, it will guarantee the support effect of release liner.

Can measure MOE by different modes.A kind of mode of measuring it is that sample to be tested is applied tension force and the relation of measurement between load applying and sample rate elongation.According to these data, can calculate MOE.When measuring modulus relating to as shown in the example of modulus test, the MOE of release liner is preferably between 200N/mm and 600N/mm.Most preferred value is between 350N/mm and 450N/mm and most preferably be roughly 400N/mm.

Dressing component can be provided with the release liner more than, preferably two release liners.In such an embodiment, supportive release liner still covers the most of and less less part of release liner covering of binding agent.In related embodiment, two or more branched support release liner can be arranged, and between them, limit fold line.

Release liner can be provided with one or more pulling-on piece, because their purpose is and can removes release liner with the risk of the binding agent of the touch dressing of minimum that it is non-touch that described pulling-on piece is known as.This simplifies grasping release liner when preparing to remove release liner.

The thickness of release liner is preferably at least 40 μ m, at least 60 μ m more preferably, perhaps at least 80 μ m, even at least 100 μ m or may reach 150 μ m.Preferred value between 45-95 μ m, more preferably between 70 μ m and 80 μ m and most preferred value be 75 μ m roughly.This will provide necessary support effect for release liner.Release liner can be by PE or is alternately made by PET.

Backing layer is such part of dressing, and this part as the supporting layer of binding agent, and provides protection for skin according to its purpose and in use the time when dressing at production period.Preferably, backing layer has 5-50 μ m at least, the thickness of at least 10 μ m or at least 20 μ m or general 50 μ m preferably.Most preferred value is between 10 μ m and the 20 μ m or between 25 μ m and 35 μ m.This provides necessary flexibility for dressing, thereby when skin extending with when folding, it follows skin.The preferred material of backing layer is PU, PE or PET.

Have with for example roughly roughly dressing of the adhesive layer of 65 μ m that combines of the backing layer as thin as a wafer of 15 μ m (with the backing layer of the binding agent that arranges) in the above, to be that dressing that thickness is roughly 80 μ m (for example between 75 μ m and 85 μ m) will provide a kind of for for example useful especially dressing for the open sore part such as the cold sore of some purposes.Have the adhesive layer of 120 μ m roughly and the roughly dressing of the backing of 30 μ m (thickness is roughly 150 μ m for example in the dressing between 140 μ m and the 160 μ m) and will provide a kind of when the flexible very useful dressing that requires when of crucial importance, is used for covering large zone.

In use that side in the face of the backing layer of skin is a side that is coated with binding agent, and this side is defined as nearside or towards skin side.That side that in use deviates from skin is defined as the distally.

The MVTR value is at 0-250mg/cm²Between/day, preferably at 15mg/cm²/ day and 100mg/cm²/ day between and most preferably be 60mg/cm²/ day.MVTR is moist steam air penetrability, and by having 60mg/cm²The value of/day, dressing can be carried by dressing the dampness of skin blemishes or wound.

In a further embodiment, dressing component comprises the top-film that covers the backing layer distally.The purpose of top-film is to control during manufacture this backing layer, namely control backing layer when binding agent is applied to backing layer.Yet at memory period, this top-film is also as protective layer.Preferably before applying dressing, remove top-film from backing layer.Top-film preferably is made of paper, and is only temporarily used at memory period because of it, thereby the thickness of top-film is not too important.

Another aspect of the present invention relates to a kind of method for dressing being coated to skin surface, and wherein this dressing comprises the binding agent on the nearside that is arranged at backing layer and covers the release liner of at least a portion of dressing binding agent.The method comprises following step:

-first of dressing is bonded to skin surface,

-around the fold line second portion of dressing that folds back, thereby the distal face that makes backing layer to skin surface and make release liner deviate from skin surface, and

-transversely in the direction displacement release liner of fold line, thus the second portion of dressing is discharged from release liner.

The method of this coating dressing makes it possible to apply dressing when only utilizing a hands.This is so that the arm that the patient can oneself apply dressing and especially dressing is coated to him.

Below, should be appreciated that, for quoting of the nearside of dressing component, dressing or its any member all be to when dressing is just coated in the face of or will quoting in the face of that side of user skin.Like this, the distally of identity element will be that side that deviates from skin when dressing is just coated.

If dressing comprises more than a release liner, then can be that the less part of non-support is removed fully.Otherwise, thereby the part of supportive release liner is removed the fraction that exposes binding agent, and then the fraction of this binding agent is attached to skin.When release liner had pulling-on piece, this pulling-on piece can be used to easily cause that release liner peels off.Alternately, can peel off by using fingernail to cause.

---corresponding to the first of dressing---when being coated to skin, major part (perhaps second portion) is folded back when the smaller portions with dressing, thereby the distal face that makes dressing is to skin.Defiber between binding agent and release liner then will be towards skin.Then can by only use a hands towards skin dressing apply a light pressure and with slide, rolling movement pushes away release liner and is parallel to simultaneously skin ground promotion release liner and applies dressing from binding agent.This also can be regarded as impacting (stroking) motion.In this way, during applying dressing, eliminate and prevent any gauffer or besieged bubble from the hand applied pressure.

This in addition so that the bad user of motility can easily apply dressing when only using a hands.

If dressing component is provided with two or more branched support release liner, then fold back dressing again at the defiber place between supportive release liner.Then, the identical step according to as using during removing the first supportive release liner removes the second supportive release liner.Then follow this process, until dressing fully is bonded to skin.

Description of drawings

Below, utilize with reference to the accompanying drawings more detailed example that the present invention is disclosed, wherein:

Fig. 1 illustrates according to dressing of the present invention with the cross section;

Fig. 2 is by schematically illustrating the method according to the dressing for applying Fig. 1 of the present invention;

And

Fig. 3 and Fig. 2 illustrate described method with the cross section in the same manner.

The specific embodiment

Explain in further detail below with reference to the accompanying drawings the present invention, accompanying drawing illustrates the preferred embodiments of the present invention.

In Fig. 1, dressing component 1 is shown.This dressing component comprisesdressing 2, the first release liner 7 and thesecond release liner 8 and top-film 11.Dressing 2 comprises the backing layer 3 with nearside 4 and distally 5.At nearside 4 adhesive layer 6 is set, and 5 arranges top-film 11 in the distally.

Support the first release liner 7 and cover the most of at least of adhesive layer 6, and thesecond release liner 8 covers adhesive layer 6 remaining smaller portions.

In alternate embodiments, this supportive release liner covers all surfaces of adhesive layer.

Pulling-on piece 9,10 is arranged on the release liner 7,8.Pulling-on piece 9,10 allows easily to handlerelease liner 7,8, so that the least risk of finger touch adhesive layer 6.

Fig. 2 a-2g and Fig. 3 a-3g illustrate an embodiment who applies the method for dressing 2 to user skin.Fig. 2 a-2g illustrates this coating of using a hands with perspective view.Fig. 3 a-3g is illustrated in this same painting method of seeing in the dressing cross section.

Fig. 2 a and 3a illustrate dressing component as shown in FIG. 1, and wherein top-film 11 has been removed.And in order to simplify drawing, backing layer and binding agent are illustrated as a dressing unit 2.On the nearside of dressing, arrange and support the first release liner 7 and the second release liner 8.The first release liner 7 covers the major part of the proximal face 4 of dressing.

In Fig. 2 b and 3b, thesecond release liner 8 is removed, and exposes the littleadhesive area 15 ofdressing 2.

As shown in Fig. 2 c and the 3c, the littleadhesive area 15 of dressing is applied to theskin 16 of user.

After littleadhesive area 15 is coated to skin, dressing is turned over, be about to dressing around folding such as the fold line a-a that in Fig. 2 d and 3d, sees, thereby make the distally that is not glued to skin 5 of dressing towards the skin of user.

As shown in Fig. 2 e, 2f, 3e and the 3f, the first supportive release liner 7 is separated release liner 7 subsequently by transverse to fold line a-a displacement with binding agent 6.Although along the direction displacement that mainly is parallel to skin, this step will expose the binding agent that is glued to subsequently skin simultaneously continuously, apply dressing thus in continuous motion.

Therefore, as shown in Fig. 2 g and the 3g, when supporting the first release liner 7 by fully displacement (namely being removed from dressing), dressing 2 has been coated to the skin of user equably and easily.

Should be appreciated that more than explanation is exemplary embodiment and can provides a lot of modifications and alternate embodiments within the scope of the invention.

Therefore, this dressing component can for example be provided with only release liner, and the fraction of this release liner then is removed at first.

Yet alternately, this dressing component is placed on the skin, release liner contact skin.Then the second less release liner is removed fully.Subsequently, the expose portion of binding agent is applied to skin; Afterwards, dressing is folded back so that the distal face of backing layer to skin.Now, when as described above supportive release liner being pushed away from dressing, in transverse to the slip of fold line, rolling movement, applied the major part of dressing.

Example-elastic modelling quantity test

Test MOE at two samples.Sample 1 is by the release liner with silicone coatings, consists of with the PETP (polyethylene terephthalate) of 75 μ m of 1720silicones.Sample 2 consists of by dressing (backing and binding agent) with the release liner of silicone coatings: backing PU-film 30 μ m, rec.96 (a kind of binding agent) 120 μ m, with the PETP of 75 μ m of 1720 silicones.According to ISO527-3 (1995): " plastic nature determining section 3: the test condition that is used for thin film and thin slice " carries out test.

In the 1nstron stretching machine of model 5569, load 5 and use 0.1kN load cell test sample book.Test speed is made as 1mm/ minute.In order to measure stretching MOE (stretch modulus), use the external video extensometer of the gauge length (gauge length) of grip distance (grip distance) with 100mm and 50mm.

Sample 1 tested 6 times andsample 2 tested 4 times.Shown in result's table 1 below.

Table 1. stretch modulus test result.

When calculating MOE take Mpa as unit, the area of section of sample (width and thickness) has effect of altitude for result (modulus equals active force divided by area of section).Value take N/mm as unit is (modulus equals active force divided by width) who only uses width gauge to calculate.Value take N/mm as unit is be used to the most correct numerical value that compares, and but this is to make contributions do not have contributive adhesive layer for intensity becausesample 2 also comprises for thickness.According to this table, and to compare about the value of the roughly 400N/mm of release liner only, the backing roughly value of 45N/mm seems insignificant for the contribution of modulus.This means, compare with backing that release liner is difficult to stretch with 10 times degree roughly more, and therefore release liner can be during applying support dressing.

The test of example-peel strength

Also test peel strength at two samples.Sample 1 consists of by dressing (backing and binding agent) with the release liner of silicone coatings: backing PU-thin film 30 μ m, rec.96 (a kind of binding agent) 120 μ m, with the PETP of 75 μ m of 1720silicones.Sample 2 is made of similar elements but this sample is exposed under the radiation of 2x50kGy.Radiation has the effect of the bonding that strengthens dressing and release liner, and this is corresponding to strengthening peel strength.Separate 180 ° angle of two layers tests along the direction that is parallel to the sample length direction.Test speed is made as 400mm/ minute and calculates peel strength between 100-250mm peels off.The result provides as the active force of unit width; See following table 2.

Table 2. peel strength test result.

The peel value that obtains at sample 1 is corresponding to most preferred dressing performance.Dressing with peel value of 0.1N/mm will be easy to apply and can not cause gauffer, and will be easy to roll extrusion on skin.To so that dressing is difficult to apply more in the peel value thatsample 2 obtains, but whether can not apply.Yet, may produce little gauffer and besieged bubble.Approximately the peel value of 3N/mm will be so that such dressing that applies that can not be as described.

Claims (19)

1. viscosity dressing component (1), described viscosity dressing component (1) comprises dressing (2), described dressing (2) comprises the binding agent (6) that is arranged on the backing layer (3), and described dressing component (1) further comprises most at least one supportive release liner (7) of the adhesive surface that covers described dressing, wherein

-described backing layer (3) has the thickness less than 300 μ m,

The rigidity of-described release liner (7) is higher than the rigidity of described dressing, thereby provides support to described dressing (2) during applying,

It is characterized in that,

The elastic modelling quantity of-described release liner (7) is 10 times high according to the elastic modelling quantity of the described dressing (2) of ISO 527-3 test, and

-peel value is arranged so that described release liner (7) can easily be left from binding agent (6),

-described dressing can be by high elongation and distortion, and

-wherein, when testing under 180 ° angle and under 400mm/ minute the test speed, the described peel value between the binding agent (6) of described release liner (7) and described dressing is between 0.02N/mm and 3.0N/mm.

2. according to claim 1 viscosity dressing component (1), the described peel value between the binding agent (6) of wherein said release liner (7) and described dressing is 0.1N/mm.

3. according to claim 1 viscosity dressing component, the elastic modelling quantity of wherein said release liner (7) is between 200N/mm and 600N/mm.

4. according to claim 3 viscosity dressing component, the elastic modelling quantity of wherein said release liner (7) is between 350N/mm and 450N/mm.

5. the viscosity dressing component (1) of any one according to claim 1-4, wherein said dressing component (1) comprises two release liners (7,8).

6. the viscosity dressing component (1) of any one according to claim 1-4, wherein said release liner (7,8) has one or more pulling-on piece (9,10).

7. the viscosity dressing component (1) of any one according to claim 1-4, wherein said release liner (7) has the thickness of 40-150 μ m.

8. the viscosity dressing component (1) of any one according to claim 1-4, wherein said release liner (7) has the thickness between 70 μ m and 80 μ m.

9. the viscosity dressing component (1) of any one according to claim 1-4, wherein said backing layer (3) has the thickness of 5-50 μ m.

10. the viscosity dressing component (1) of any one according to claim 1-4, wherein said backing layer (3) has the thickness between 10 μ m and 20 μ m.

11. the viscosity dressing component (1) of any one according to claim 1-4, wherein said backing layer (3) has the thickness between 25 μ m and 35 μ m.

12. the viscosity dressing component (1) of any one according to claim 1-4, wherein said adhesive layer (6) has the thickness of 60-300 μ m.

13. the viscosity dressing component (1) of any one according to claim 1-4, wherein said adhesive layer (6) has the thickness between 60 μ m and 70 μ m.

14. the viscosity dressing component (1) of any one according to claim 1-4, wherein said adhesive layer (6) has the thickness between 110 μ m and 130 μ m.

15. the viscosity dressing component (1) of any one according to claim 1-4, wherein said dressing (2) has the thickness between 75 μ m and 85 μ m.

16. the viscosity dressing component (1) of any one according to claim 1-4, wherein said dressing (2) has the thickness of 140 μ m and 160 μ m.

17. the viscosity dressing component (1) of any one according to claim 1-4, wherein said dressing (2) has 0-250mg/cm²The MVTR value of/day.

18. the viscosity dressing component (1) of any one according to claim 1-4, wherein said dressing component (1) comprise the top-film (11) in the distally (5) that covers described backing layer (3).

19. the viscosity dressing component (1) of any one according to claim 1-4, wherein said dressing (2) has 15-100mg/cm²The MVTR value of/day.

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