CN1212613A

CN1212613A - Wound dressing

Info

Publication number: CN1212613A
Application number: CN 97192746
Authority: CN
Inventors: W·J·瓦尔德
Original assignee: Smith and Nephew PLC
Current assignee: Smith and Nephew PLC
Priority date: 1996-01-12
Filing date: 1997-01-13
Publication date: 1999-03-31
Also published as: AU1391197A; EP0873098A1; JP2000517202A; MX9805633A; AU716270B2; WO1997025012A1; CA2241791A1

Abstract

A wound dressing has a film dressing layer (10) which is coated with adhesive on one side. The dressing is supported in a flat, wrinkle-free condition by two edge portions of the adhesive protector layer and a support layer (13a, 13b) on the non-adhesive surface of the dressing layer.

Description

Wound dressing

The present invention relates to wound dressing, especially but not only relate to film dressing.

Film dressing is a kind of dressing of popular form of extensive employing, is used to comprise the wrapping of the various wound symptoms of serious wound, conduit insert division, epidermic grafting, and is used to prevent the maintenance of decubital ulcer and other type dressing.The film adhesive wound dressing has many useful characteristics, and it has the adaptability of height usually, so its comfortable and mouldable body contour, transparent and moisture vapor permeable-steam.Yet, when handling and using them, be difficult to make them not crease or crumple, this is because the adhesive surface of dressing makes easily self to stick together, unless keep dressing smooth on one's body the time dressing being used patient.

The profile of multiple multi-form film dressing has been proposed for many years.The described a kind of such dressing of European patent EP-A-051935 has disposed a framework for the non-binder side in this dressing, so as before to adhere to thin film on the skin support film always, make it to be in flat, non-wrinkled state.Seen in the dressing of the OPSITE by name (trade mark) that is sold by Smith and Nephew health care limited company (Smithand Nephew Healthcare Ltd) to a different way of head it off be that the non-binder side of film dressing releasably is connected on the supporting layer, this supporting layer comprises a thin film harder than this film dressing.Usually after having used dressing, just remove supporting layer.

The purpose of this invention is to provide a kind of improved wound dressing.

According to the present invention; wound dressing comprises that dressing layer, the one deck with first surface and second surface adheres to contact adhesive and the protective layer that gets loose that covers described binding agent on the described first surface of described dressing layer; it is characterized in that described protective layer comprises two marginal portions and a middle body; described marginal portion is along two opposite edges settings of dressing; also comprise a supporting layer, this supporting layer covers the part of the second surface of above-mentioned dressing layer at least.

Dressing can be any rule or irregular shape easily, but preferably polygon, circle or oval.When dressing was polygon, wedge angle can be rounded.

Thin polymer film is very preferred dressing layer, and it is breathable that this thin polymer film is preferably, and that is to say, it preferably has at least every square metre 200 moisture vapor transmission rate that restrains every day under 37 ℃ and 10% relative humidity.Suitable thin film comprises such as being used to make the such polyurethane film of known dressing, for example those thin film described in British patent GB1280631, European patent EP 51935, EP91800 and the EP178740.Specially suitable material is a polyurethane, for example, and polyester or the polyether-polyurethane sold with the ESTANE trade mark by B.F.Goodrich.Other suitable material is flexible polyether polyester, for example those flexible polyether polyester of commercially available HYTREL by name (trade mark of DuPont), and polyethers polyamide, those polyethers polyamide of commercially available PEBAX by name (trade mark) for example.Other preferable material comprises hydrophilic polymers, for example, comprises some hydrophilic polyurethane, the particularly polyurethane described in the example 1 of those the hydrophilic polyurethane described in the British patent GB2093190B.Thin film can have high moisture vapor transmission rate, for example, greater than every square metre 1000 gram every day, perhaps, has bigger moisture vapor transmission rate when ratio does not contact water during thin film contact water.Thin film is preferably transparent, but also preferably elastic, so that meet body contours.Thin film is thinner, that is to say, the thickness of thin film is preferably less than 200 microns, more preferably less than 100 microns.

The dampness transfer rate of the material that is adopted among the present invention can be measured with well-known " Payne agar diffusion method ".This method has been used 1.5 centimetres of dark, that the top has flange cups.The internal diameter of described flange provides one 10 square centimeters the zone that is used to transmit dampness.In this method, give the distilled water that adds 10 milliliters in the cup, and even as big as the specimen holder of being tested that covers flange fully on cup.The whole device of weighing then, and whole device is placed on temperature and relative humidity remains on respectively in 37 ℃ and 10% the cabinet.After 17 hours, from cabinet, take out cup and this cup is at room temperature cooled off.Again after weighing, calculate, and be that 37 ℃, relative humidity difference are the g/m of unit under 100% to 10% with temperature owing to the quality that transmits the water that dampness loses ²/ 24hrs represents result of the test.

Contact adhesive is preferably to the skin binding agent of sticking wound well and not.Suitable bonding comprises some compositions, and these compositionss comprise the acrylic acid salt and based on the binding agent of polyethylene alkyl ether, but also can adopt other any known binding agent that is applicable to medical dressing.Some suitable bonding have been described among British patent GB-A-1280631, European patent EP-A-35399 and the EP-A-51935.Preferred adhesive comprises the polyvinylether binding agent or by the copolymer adhesive of 2-ethylhexyl acrylates, butylacrylate and the formed acrylate of acrylic acid co-polymerization.Adhesive phase can be successive or discontinuous, for example, has the pattern of distribution.

The protective layer that can get loose comprises layer of material, and this layer material is easy to remove from the adhesive surface of dressing when needing.Suitable material comprises having can make paper and the thin-film material of this material from the surface that binding agent strips down.Can give described surface-coated a kind of such as containing for example such adhesive of silicon of chemical compound, so that make this surface have good antiseized character.Should to protect laminating described adhesive on the contact adhesive in place by protective layer is adhered to.Like this, protective layer should adhere on the employed binding agent at least weakly.Protective layer can comprise a fold back portion, helps to remove this protective layer so that form a handle.Protective layer can comprise some reference markers, product information/illustrate or other mark.

Protective layer comprises two or more marginal portions of arranging along at least two opposite edges of dressing.Protective layer preferably has only two marginal portions when dressing is rectangle.Each marginal portion of protective layer is preferably narrow than middle body.Therefore in a preferred embodiment, protective layer is divided into the part of three adjacency, the middle body that one of them is is both sides with two marginal portions.Described middle body can comprise the protective layer material of a monolithic, and perhaps, it can be divided into more than a slice, and these sheets form the middle body that covers the adhesive area central part together.

Can on-the-spot die-cut protective layer, so that form three parts.Each marginal portion can be rectangle basically, and perhaps they can be other shapes.For example, the inward flange of each marginal portion (promptly with those edges of the central protective layer part adjacency) can be straight or curved, so that for example determine convex or erose middle body.If each marginal portion is along two or more joining edge location, then they can be whole.When dressing is circle or oval; so-called " marginal portion " is meant such some parts of protective layer; that is: these parts are arranged on each arch section of the adhesive phase of each marginal portion, preferably are arranged at the relative basically each several part place at the edge of dressing.

The marginal portion of protective layer can comprise a part that extends beyond the dressing edge, so that as little protuberance or the handle of being convenient to remove protective layer.Perhaps, thus the part of each marginal portion can extend through the remainder of binding agent-protective layer to make and can hold it.Similarly, the part of the middle body of binding agent-protective layer can extend through described each marginal portion, so that remove this protective layer.Can turn back in any such extension, so that extend along the direction of leaving binding agent, for example form the V-arrangement handle, thereby further be easy to control or remove binding agent-protective layer and/or support bar.

Come to remove each marginal portion in the mode of peeling off from the binding agent of dressing from this dressing.Yet, for example also can make binding agent and dressing layer be suitable for tearing off the remainder of dressing by perforation along the line that separates protective layer marginal portion and middle body.

Supporting layer is by making with the hard material of the material compared of dressing layer, thereby it can the support dressing layer and can prevent dressing crumple and bending.The material that is fit to comprises being polyethylene or polyacrylic polyalkylene thin film for example, perhaps for example is the polyester of polyethylene terephthalate.The material of paper substrate also is suitable for.Supporting layer can be transparent, translucent or opaque, and can select to be printed on reference marker or the information relevant with the use of dressing.

Supporting layer is positioned at second side of the non-binding agent of dressing layer.Supporting layer can only cover a part of dressing layer, and this dressing layer part is an edge of adjacency or a plurality of edge preferably.In a preferred embodiment, supporting layer comprises a backing material of placing along at least one edge of dressing at least.Two support bars preferably are provided, and these two support bars are preferably placed along each opposite edges of dressing.So-called opposed edges, we are meant that when dressing is rectangle or Else Rule polygon each support bar is along each opposed edges location of dressing.When dressing was circular, oval or other shape, " each opposed edges " do not exist usually, and we are meant that each support bar all is positioned on the arch section of dressing, and each arch section is radially relative basically.Each can be rectangle or other shape, for example can make their shape meet the shape of dressing, particularly meets the peripheral shape of dressing.For this structure, the zone that supporting layer covered is usually less than 50% of the dressing gross area.Support bar preferably is provided with transverse to each marginal portion of protective layer.

Perhaps, supporting layer can cover the surface of the whole of dressing layer or whole basically non-binding agent.For this structure, supporting layer can comprise one or more parts.For example, it can comprise one deck of the whole non-adhesive surface that covers dressing layer basically, and this supporting layer preferably is cut into two or more parts, to help the stickiness of removing and improve dressing.In a kind of like this structure, cut supporting layer along straight line, this straight line can be substantially parallel or perpendicular to the orientation of each marginal portion of protective layer.In a kind of improved structure, supporting layer can comprise plural part.It is straight that the edge of the each several part of supporting layer need not, and for example, supporting layer can be divided into for example two parts by a wave or curve.

Can supporting layer be adhered in the dressing by means of binding agent, but preferably by intrinsic captivation, for example electrostatic force or the basic mechanical force that is present between two kinds of materials supporting layer is adhered in the dressing, this point is known in the field of the supporting layer that is provided for film dressing.It is most preferred that, when needs, for example by peeling off or secondly preferably making supporting layer be easy to remove from dressing by tearing that part of dressing thereon of this supporting layer position.Supporting layer can comprise a part that extends beyond dressing layer, so that as the little protuberance that supplies to pull usefulness, thereby helps to remove support bar.Perhaps, supporting layer can comprise the part that direction that dressing layer is left on an edge is turned back, thereby removes supporting layer so that make to be easy to hold.

A kind of preferred construction of dressing is orthogonal and has two marginal portions of two support bars and protective layer; two the opposite edges settings of described two support bars on the non-adhesive surface of dressing layer, and all the other two the opposed edges settings on the adhesive surface of dressing layer of two marginal portions of described protective layer.

In a kind of structure, dressing has a hole that extends through dressing layer and can also optionally pass a part of protective layer at least.Described Kongzui preferably extends from an edge of dressing, and this edge can be or can not be that edge along its setting, the marginal portion of binding agent-protective layer.Supporting layer can be passed in described hole, and this supporting layer is arranged in the zone in this hole on the non-adhesive surface of dressing, and described hole can be extended or do not extended beyond such supporting layer.Described hole preferably elongated shape, extend towards the middle body of dressing.The form of a seam is adopted in this hole, but in a kind of preferred construction, it is a key shaped.A hole is set makes dressing be particularly suitable for being applied to one such as on the such device of venous duct or intubate and around this device.

The dressing of this structure also can comprise a reinforce in the zone in above-mentioned hole, this reinforce is used for tearing when dressing prevents this dressing during around intubate or similar device molding.Reinforce can comprise a glued or laminated skim or the woven or non-woven fabric of one deck on the non-binder side of dressing.Therefore, a kind of suitable reinforce material can be included in second the enhanced thin film adhesive tape of lip-deep thin film adhesive tape, fabric adhesive tape or fabric that places dressing in the zone in above-mentioned hole.Described hole extends through such enhancement layer (if any).Reinforce can provide additional support to dressing layer in the zone in above-mentioned hole.

In an embodiment with foraminous dressing, available second kind of harder material replaces dressing layer in dressing layer includes the zone in this hole.Described harder material preferably conforms to body contours, simultaneously should be enough hard, so that prevent in the zone in described hole the dressing crumple and crease, thereby make it possible to the dressing of holding.Second kind of harder material can comprise a kind of fabric (woven or non-woven) or a kind of thin film, and this thin film optionally contains the reinforce such as fiber.

In addition, dressing can comprise an absorption region, and this absorption region for example is the form of an absorbing material pad on the adhesive phase that medially is arranged on dressing.

Dressing is disinfectant preferably, and is that form with moistureproof and bacteriological protection bag provides.Protective layer or its some part can be whole ingredients of this bag.

According to the present invention, a kind of method that forms wound dressing comprises following these steps:

A) form one first lamination, this first lamination comprises a dressing layer and a supporting layer;

B) form one second lamination, this second lamination comprises one deck pressure-sensitive adhesion immunomodulator compounds and the binding agent protective layer that can get loose;

C) described first and second laminations are grouped together, thereby described contact adhesive is adhered on the described dressing layer; And

D) the described binding agent protective layer of cutting is so that form a middle body and two marginal portions.

Preferably, on described supporting layer, form described dressing layer by " on the spot " and form described first lamination with coating, cast or squeezing and pressing method.

To only also further specify the present invention with reference to the accompanying drawings now by embodiment, wherein:

Fig. 1 is a kind of plane graph of dressing of structure,

Fig. 2 is the profile of dressing among the Fig. 1 that cuts open along Fig. 1 center line " 2 ",

Fig. 3 is the profile of dressing among the Fig. 1 that cuts open along Fig. 1 center line " 3 ",

Fig. 4 is a kind of plane graph of binding agent protective layer of dressing of structure,

Fig. 5 is the plane graph of second kind of structure of binding agent protective layer,

Fig. 6 is the plane graph of the third structure of binding agent protective layer,

Fig. 7 is a kind of plane graph of non-binder side of dressing with holes,

Fig. 8 is the plane graph of second kind of dressing with holes seeing from non-binder side.

Dressing comprises thin (40 a microns) polyurethane transparent film, and this film has one deck contact adhesive 11 on a surface.Cover binding agent with a paper that has applied silicone 12 as protective layer.This protective layer is divided into three the part 12a that do not wait, 12b, 12c along line 14, and these three parts that do not wait have been determined a middle body 12b and two opposed edges part 12a, 12c.

Form support bar

13a, 13b with the transparent polypropylene thin film that scribbles coating, described cated transparent polypropylene thin film is compared firmly with film 10, and is attached on the non-adhesive surface of film 10.

When using dressing, remove the middle body 12b of binding agent protective layer, and dressing can be kept by its edge,

bar

12a, 12c are used for preventing that binding agent from adhering to user on hand, and along their each edge strengthening

dressing.Support bar

13a, 13b prevent that film 10 from laterally creasing, and so just the reinforcement effect with

ceiling

12a, 12c helps to keep when being applied to dressing on the wound dressing flat and non-wrinkled.The middle body of dressing does not have reinforcement material, and therefore it keeps the comfortableness of height during use, thereby can be around for example irregular wound or conduit molding.When the middle body of dressing adheres to when in place, can remove

ceiling

12a, 12c, thereby make each edge to adhere on one's body the patient.Can remove

support bar

13a, 13b at last.

As Fig. 4 to shown in Figure 6, the desirable various forms of binding agent protective layer.In Fig. 4 and Fig. 5,

marginal portion

12a, 12c divide and to open and along two opposed edges settings of a rectangle dressing.In Fig. 6, marginal portion 12a extends along three continuous edge of dressing, and middle body 12b is irregularly shaped.

Fig. 7 and Fig. 8 show the dressing of form with holes.Be configured on the non-adhesive surface of dressing with regard to this point with regard to backing material bar 13, the dressing among Fig. 7 has identical structure basically with the dressing shown in Fig. 1.The edge of elongated hole 15 along the direction that approximately is parallel to binding agent protective layer

marginal portion

12a, 12c from dressing that passes supporting layer 13b, film 10 and binding agent 11 extends towards the center of this dressing.The dressing of Fig. 8 also comprises a hole 15, but in this embodiment, the reinforcing material 16 that a kind of material than supporting layer 13 has more comfortableness is laminated on the film 10 in the zone in described hole.Described hole is included in fully and strengthens in the zone 16, and this has just reduced the danger that film is torn when dressing centers on conduit or intubate molding.Reinforce 16 is adhesive tapes of non-woven spunbond polyester material.Film 10 can extend jointly with reinforcing material 16, and perhaps it can be only covers this reinforcing material at one among a small circle, and it is connected with this reinforcing material along an edge.

Make the example of dressing

A kind of four-layer structure that comprises supporting layer, dressing layer, pressure sensitive adhesive layer and binding agent protective layer of following formation.A kind of polyether-polyurethane solution (by " ESTANE " that B.F.Goodrich provided) is cast in a segment length the polypropylene film supporting layer on the surface that silicidation is crossed, and make it the dry polyether-polyurethane thin film that forms as dressing layer, thereby form dressing layer-supporting layer structure.Form the medically acceptable polyacrylate pressure sensitive adhesive of one deck separately by applying on the protective layer of a segment length, the protective layer of described that segment length is included in and well-knownly in this purposes the sort ofly scribbles poly paper through what silicone-treated was crossed.Then, two double-layer structures are grouped together, so that binding agent is adhered on the dressing layer thin film.Therefore, the interlayer of resulting material is supporting layer-dressing layer-adhesive phase-protective layer.

In next step of described technical process, the width that laterally strides across dressing layer in place with a punch die is cut and is worn protective layer, so that demarcate for each marginal portion of protective layer and middle body.For 10 square centimeters dressing layer, described each die-cut limit can suitably separate 6 centimetres to 8 centimetres, so that the formation width is each marginal portion of 1 centimetre to 2 centimetres.In the supporting layer side of four-layer structure, punch die or blade are cut edge only to cut perpendicular to initial those and are worn supporting layer and cut a pair of successive side cut.For 10 centimetres wide finished product dressing layer, each side cut also is to separate 6 centimetres to 8 centimetres.These cut edge to form along 1 centimetre to 2 centimetres of each edge of dressing layer wide supporting layer bar, and described these edges are parallel to each edge on the length direction of four layers of dressing structure.If necessary, can remove the middle body of the supporting layer between two side cuts.At last, pass all four layers, each angle cam trimming cutting material that aligns, so that form some independent dressing.Subsequently, give these dressing packing and sterilizations.

Claims

1, a kind of wound dressing; comprise that dressing layer, the one deck with first surface and second surface adheres to contact adhesive and the protective layer that gets loose that covers described binding agent on the described first surface of described dressing layer; it is characterized in that described protective layer comprises at least two marginal portions and a middle body; described each marginal portion is along two opposite edges settings of described dressing layer; also comprise a supporting layer, described supporting layer covers the part of the second surface of described dressing layer at least.

2, a kind of wound dressing as claimed in claim 1 is characterized in that described dressing layer comprises thin film.

3, a kind of as claim 1 or the described wound dressing of claim 2, comprise two marginal portions.

4, the described wound dressing of a kind of any one claim as described above is characterized in that described each marginal portion of described protective layer is narrower than described middle body.

5, the described wound dressing of a kind of any one claim as described above, each all comprises independent a slice protective layer material to it is characterized in that described each marginal portion and described middle body.

6, a kind of as any one the described wound dressing in the claim 1 to 4, it is characterized in that any one and/or the middle body in described each marginal portion all comprises the protective layer material that a slice is above.

7, the described wound dressing of a kind of any one claim as described above is characterized in that each protective layer marginal portion comprises a part that extends beyond the dressing edge, and this part is as the little protuberance or the handle that supply to pull usefulness, so that with its removal.

8, the described wound dressing of a kind of any one claim as described above is characterized in that each protective layer marginal portion is included in the part of the middle body top extension of binding agent protective layer.

9, the described wound dressing of a kind of any one claim as described above is characterized in that described middle body comprises the part that extends beyond an edge of dressing layer.

10, the described wound dressing of a kind of any one claim as described above is characterized in that described middle body is included in the part that extend at least one top, described marginal portion.

11, a kind of as any one the described wound dressing in the claim 7 to 10, it is characterized in that turn back in described extension so that extend along the direction of leaving adhesive phase.

12, the described wound dressing of a kind of any one claim as described above is characterized in that described supporting layer compares harder with described dressing layer.

13, the described wound dressing of a kind of any one claim as described above is characterized in that described supporting layer only is arranged on that part of top that is adjacent to an edge or a plurality of edges of dressing layer.

14, the described wound dressing of a kind of any one claim as described above is characterized in that described supporting layer comprises a backing material that is provided with along at least one edge of dressing layer at least.

15, a kind of wound dressing as claimed in claim 14 is characterized in that two the opposite edges settings of two support bars along dressing layer.

16, a kind of as claim 14 or the described wound dressing of claim 15, it is characterized in that making the shape of described support bar to meet the shape of dressing basically.

17, a kind of as any one the described wound dressing in the claim 14 to 16, it is characterized in that described basically with respect to each protective layer marginal portion horizontally set.

18, the described wound dressing of a kind of any one claim as described above is characterized in that on the surface of described supporting layer by means of the uncoated binding agent that adheres to described dressing layer in the electrostatic force between described supporting layer and the described dressing layer or inherent mechanical captivation.

19, the described wound dressing of a kind of any one claim as described above is characterized in that described supporting layer comprises that an edge leaves that the direction of described dressing layer is extended so that as the part of grasps handle.

20, the described wound dressing of a kind of any one claim as described above also comprises a hole passing described dressing layer and described adhesive phase.

21, a kind of wound dressing as claimed in claim 20 also comprises the intensifier in the zone that is arranged in described hole.

22, a kind of method of making wound dressing, this method comprises following these steps:

C) described first and second laminations are grouped together, thereby make described contact adhesive adhere on the described dressing layer; And

23, a kind of method as claimed in claim 22 also comprises the described supporting layer of cutting so that form the step of a bar at least, and described this at least one edge along dressing layer is provided with.

24, a kind of as claim 22 or the described method of claim 23, it is characterized in that forming described first lamination by on described supporting layer, forming described dressing layer with the method " on the spot " that applies, pours into a mould or push.

25, a kind of as any one the described method in the claim 22 to 24, it is characterized in that carrying out described cutting by die-cut described layer to be cut.