WO2003061720A1 - Adhesive system and method for activating or deactivating said adhesive - Google Patents

Abstract

The invention relates to an adhesive system in which adhesiveness can be activated or deactivated, comprising an adhesive composition which is based on hydrocolloids and is applied on a base such as the skin, and at least one agent that is able to act on the hydrocolloids in such a way that the physico-chemical state thereof is modified and adhesiveness is activated or deactivated. The invention also relates to a device for carrying out the inventive system and a method for activating or deactivating the adhesiveness of an adhesive composition.

Description

^S YTEM ^E ADHESIVE AND P ^RO ASSIGNED TO AC Ivation or Off _T IVATI _O N OF _THE ADHE _S IVE

The invention relates to the field of adhesives bonded to a support such as the skin, in particular in the medical field, and more particularly adhesives whose adhesion properties are triggerable, that is to say activatable and / or deactivable.

In the medical field in particular, it is frequent that it is necessary to fix a device or product (hereinafter designated by the single term "product") directly on the human body. It can be a bandage, a band, a colostomy bag, or any other product. The fixing is done by means of an adhesive present on a surface of the product to be fixed, which is brought into contact with the skin of an individual.

Adhesives which can be bonded to the skin are known to those skilled in the art, and various adhesive compositions have been developed for a very long time. Some of these adhesive compositions contain hydrocolloids. Mention will in particular be made of the documents FR 2 393 838 and US 4,253,460 from E.R. Squib & Sons, Inc., the document WO 00/54820 from COLOPLAST A / S, the document FR 2 733 508 from B BRAUN BIOTROL.

Given their use, these adhesive compositions must have several sometimes contradictory characteristics. First of all, they should preferably not contain components which are irritating to the skin, since they are in direct contact with the latter, sometimes for prolonged periods of time (several hours, several days, or even more).

The adhesion must be strong enough to keep the product in place for sometimes long periods of time, despite normal activity of the individual wearing the product. It must occur easily and quickly when the product is put in place.

However, it is also necessary that the product can be removed, that is to say unglued, either immediately after installation to allow repositioning of the product, or at the end of the normal period of use of the product, without this step is painful for the individual carrier and without leaving residue on the skin.

This problem has been studied, and several solutions have been considered to date, based on the use of a deactivable adhesive.

A particular adhesive composition is known which sticks under pressure and which is deactivated when it is brought into contact with an excess of water (US 5,032,637 and US 5,352,516 from Adhesives Research, Inc.). Also known is a particular adhesive composition which can be deactivated by UV irradiation (US 4,286,047 from Minnesota Mining and Manufacturing Company). Particular adhesive compositions are also known which can be deactivated by irradiation. with visible light or a low dose of UV (US 6,184,264 and WO 00/61692 of Smith & Nephe pic). Finally, there are known adhesive compositions which can be activated or deactivated by a change in temperature (WO 90/13420, US 6,210,724, and 5,387,450 from Landec Labs, Inc., and WO 01/60302 from Procter & Gamble Company).

Disadvantages remain, however. Deactivation in the presence of water is not recommended at all in certain applications, especially in the case of a colostomy bag intended to contain a liquid medium and for which, on the contrary, it is sought to avoid any leakage and to maintain a maximum adhesion in the presence of moisture. Furthermore, it is not always easy or recommended to irradiate an individual with UV, or to subject him to a rise in temperature.

The inventors have therefore sought to overcome the known drawbacks, and to develop a new adhesive composition, the adhesiveness of which can be easily activated and / or deactivated.

After extensive research, the inventors have shown that, quite surprisingly, it was not necessary to develop a new composition, but that, contrary to the teaching of the prior art, it was possible to activate and / or deactivate the adhesiveness of a known adhesive composition by simple modification of its environment.

More specifically, the adhesive compositions whose adhesiveness can be activated or deactivated according to the invention are based on hydrocolloids. The advantage of the invention is particularly evident in the medical field for any application on the human body, but it is also evident for any non-medical application on the human body, as well as for any use of an adhesive for which one wishes to control the moment of adhesion or detachment of said adhesive.

The subject of the invention is therefore an adhesive system with activatable or deactivatable adhesiveness, comprising an adhesive composition based on hydrocolloids intended to be applied to a support, and at least one chemical agent capable of acting on said hydrocolloids of said adhesive composition. to modify their physico-chemical state so as to activate or deactivate the adhesiveness of the system. The term “act on” means both acting on and reacting with.

The support will preferably be the skin of an individual.

The term "activate" means to make the composition adhesive or substantially more adhesive. The term "deactivate" means to make the composition non-adhesive or substantially less adhesive.

Without wishing to be bound by any theory, it is assumed that the activation or deactivation of the adhesiveness is linked to a modification of the interactions between the polymer chains existing within the adhesive composition in the presence of the agent, which has for consequence of modifying the visco-elastic state of the adhesive composition, and in particular of modifying its capacity for dissipating energy at the time of separation, this change being linked to the agent's modification of the physico-chemical state of the polymers, in particular plasticization, swelling, dissolution, formation of complexes, bridges or interactions. The chemical agent capable of acting on the hydrocolloids by modifying their physicochemical state so as to deactivate the adhesiveness can be any agent capable of forming a complex or bridges or interactions with the hydrocolloids or between the hydrocolloids, which l 'we will qualify by the general term "deactivation". This is known as a release agent.

The chemical agent capable of acting on hydrocolloids by modifying their physicochemical state so as to activate the adhesiveness can be any agent capable of improving the affinity of the polymeric system with water, which can be translate in particular by plasticization, swelling or even dissolution in water of a hydrocolloid or a complex based on hydrocolloids, and what will be qualified by the general term "activation". This is called an adhesive agent.

A non-stick agent according to the invention can be chosen from, in particular, divalent ions, trivalent ions, tetravalent ions, such as Ba ²⁺ , Ca ²⁺ , Mg ²⁺ , Al ³⁺ , Zn ⁺ , Fe ²⁺ , Fe ³⁺ , Cu ²⁺ , Ce ³⁺ , Cr ³⁺ , Zr ⁴⁺ , said ions possibly being hydroxylated or not, or other complexing species such as borates, carbonates, Congo Red, phosphates and polyphosphates, nonionic surfactants, cationic or anionic surfactants, cationic polyelectrolytes, anionic polyelectrolytes or zwitterionics, vegetable tannins, synthetic polyphenols or any other organic molecule capable of exercising an astringent function.

An adhesive agent according to the invention can be water or an aqueous solution of ions or molecules facilitating the plasticization or swelling of the hydrocolloid and in particular of monovalent ions such as H ⁺ , Li ⁺ , Na ⁺ , K ⁺ , Cs ⁺ , Ag ⁺ , Hg ⁺ , NH ₄ ⁺ , OH ^" , Cl ^" , Br ^" , N0 ₃ ^" or non-complexing ionic species such as sulfate, perchlorate or tetrafluoroborate.

The chemical agent acting on the hydrocolloids can be provided in particular in the form of a liquid, for example an aqueous solution. Those skilled in the art will know how to choose the most suitable form, just as they will know how to choose the appropriate amount of chemical agent. As an indication, the chemical agent will be used at a mass concentration of 0.5 to 10%, preferably 0.5 to 5%.

The invention also relates to a device for implementing the adhesive system with activatable or deactivatable adhesiveness according to the invention, comprising a product intended to be bonded to a support comprising on a surface an adhesive composition based on hydrocolloids, and comprising means for bringing a release agent or adhesive into contact with the adhesive composition so as to activate or deactivate the adhesiveness.

The product can be an ostomy bag

(urostomy, ileostomy, or colostomy), a bandage, a band, in particular post-operative protective band, a patch, in particular a nicotine patch, a diaper, an article for adult incontinence, a cosmetic or medical facial mask, etc., and in general any medical or non-medical product which must be bonded to a support, for example the skin of an individual. In one embodiment, the means for bringing an anti-adhesive or adhesive agent into contact with the adhesive composition may be a channel or a pocket disposed in close proximity to the surface comprising the adhesive composition and the material separating it from the composition adhesive is permeable to the adhesive or anti-adhesive agent (for example non-woven fabric). The user can introduce the anti-adhesive or adhesive agent, for example in the form of a solution, into the channel or pocket to trigger the activation or deactivation of the adhesiveness. The introduction can be done by injection of an external solution, or by opening a reservoir present in the device and containing the non-stick or adhesive agent.

When the user wishes to take off the device, he injects a non-stick agent or opens the reservoir containing a non-stick agent, which spreads in the channel or the pocket and which, thanks to the permeability of the material, will enter into contact with the adhesive composition, act on the hydrocolloids of the adhesive composition and modify their physicochemical state. This results in deactivating the adhesiveness, and facilitating the detachment of the device. The detachment can take place either to allow a repositioning of the product, or at the end of the normal duration of use of the product. Conversely, when it is desired to activate an adhesive composition, either at the time of laying or after repositioning, it is advisable to bring into contact at the appropriate time an adhesive composition based on hydrocolloids (by hypothesis in the non-adhesive state or little adhesive) with an adhesive agent which changes the physico-chemical state of the hydrocolloids and activates the adhesiveness. The contacting can be done either through the channel or the pocket, as previously, or by simple application of an adhesive agent on the surface of the device comprising the adhesive composition or on the surface of the support on which the adhesive composition must be applied.

The invention therefore also relates to a method for activating or deactivating the adhesiveness of an adhesive composition based on hydrocolloids.

More specifically, the subject of the invention is a process for deactivating the adhesiveness of an adhesive composition based on hydrocolloids, in which: a product comprising on a surface an adhesive composition based on hydrocolloids, and comprising a means of bringing a non-stick agent into contact with the adhesive composition, - a non-stick agent is brought into contact with the hydrocolloid-based adhesive composition so as to deactivate the tack, leave to act, we take off the product from the support. Those skilled in the art or the user can easily determine the contact time, that is to say the time necessary for the release agent to deactivate the adhesiveness. The invention also relates to a method for activating the adhesiveness of an adhesive composition based on hydrocolloids, in which: an adhesive composition based on hydrocolloids present on a surface is brought into contact with an adhesive agent of a product intended to be bonded to a support, and comprising a means of bringing the adhesive agent into contact with the adhesive composition, so as to activate the adhesiveness, - it is left to act, the product is bonded to a support . Those skilled in the art or the user can easily determine the contact time, that is to say the time necessary for the adhesive agent to activate the adhesiveness. The hydrocolloids which can be used in the adhesive compositions of the adhesive system according to the invention can be any hydrocolloid, in particular polysaccharides such as guar gum, locust bean gum, carrageenans, amylose, amylopectin, pectic substances, gum arabic, xanthan gum, cellulose derivatives and in particular cellulose ethers and esters, protein substances of animal or vegetable origin such as casein, lecithin, albumin, gelatin, bone glue, fish glue as well as synthetic polypeptides such as polyaspartic acid, polyglutamic acid. The hydrocolloids which can be used can also be based on synthetic hydroxylated or carboxylated polymers such as polyacrylic or polymethacrylic acid, polyvinyl alcohol, as well as any synthetic polymer or copolymer containing units capable of complexing ions in aqueous solution.

In addition to the hydrocolloids, the adhesive composition can comprise any component conventionally used in such compositions. The following components may for example be present: elastomers and thermoplastic elastomers such as natural rubber, polyisoprene, polybutadiene, polyisobutylene, polyacrylonitrile, poly-2, 3-dimethylbutadiene, polychloroprene (neoprene), poly-dimethylsiloxane, polyacrylates, polymethacrylates as well as any copolymer random or block and in particular the copolymers containing at least two of the following monomers: styrene, butadiene, isoprene, acrylonitrile, butyl acrylate or other acrylates and methacrylates.

Most generally, the adhesive composition of the adhesive system according to the invention contains by weight on dry matter at least 5% of hydrocolloids, preferably from 7.5 to 70%, more preferably from 10 to 65%. The remainder of the adhesive composition consists essentially of elastomers and thermoplastic elastomers mentioned above. Most generally, their percentage by weight on dry matter is from 30 to 95%, preferably from 35 to 90%, more preferably from 50 to 90%. The composition may also contain one or more additives such as inert fibrous materials (natural or synthetic), celluloses, hemi-celluloses, lignins, tannins, protopectin, as well as plasticizers, tackifying resins, antioxidants, dyes, etc.

The invention will be described in more detail by means of the figures below in which: FIG. 1 shows diagrammatically in cross section a device for implementing the adhesive system according to the invention, FIG. 2 represents a device for implementing of the system according to the invention, FIG. 3 (3a and 3b) shows in section a means of bringing an anti-adhesive or adhesive agent into contact with the adhesive composition based on hydrocolloids. Figure 4 (4a and 4b) shows in section another means of contacting.

Figure 1 shows schematically in cross section a device for implementing the adhesive system according to the invention. The device is intended to be glued to a support (2). It comprises on a surface an adhesive composition based on hydrocolloids (1) and is provided with means for bringing an adhesive or anti-adhesive agent into contact with the adhesive composition so as to activate or deactivate the adhesiveness. In this embodiment, said means is a channel (3) formed by the assembly of two heat-sealed membranes (4) on either side of the channel, the membrane located between the channel and the adhesive composition being permeable to the non-stick or adhesive agent (for example non-woven fabric).

FIG. 2 very schematically represents a colostomy bag (5) comprising an adhesive circular element at the level of the flow zone (6). The circular adhesive element (1) is heat sealed (4) on the pocket so as to form a circular channel (3) into which the adhesive or anti-adhesive agent can be introduced.

FIG. 3 (FIGS. 3a and 3b) represents another means of bringing the adhesive / anti-adhesive agent into contact with the hydrocolloid-based adhesive composition fixed to a surface of a product, for example a pouch colostomy (5). In this embodiment, the channel (3) is connected to a small reservoir (7) which is opened by removal of a clip or similar means (8). Once this clip has been removed, the adhesive or anti-adhesive agent in the form of a liquid can spread in the channel (3), come into contact with the adhesive composition (1) and activate or deactivate the adhesiveness. FIG. 4 (FIGS. 4a and 4b) represents yet another means of bringing the adhesive / non-stick agent into contact with the adhesive composition based on hydrocolloids. In this embodiment, the adhesive / non-stick agent in the form of a liquid is stored before use in a fold (10) of a double-membrane of the product to be glued / peeled off on a support. This double membrane is adjacent to the surface (12) comprising the adhesive composition (1), said surface being made of a material permeable to the adhesive / anti-adhesive agent (example: non-woven fabric). A traction exerted on a bead (9) placed on the double-membrane makes it possible to tear the internal membrane (11) and therefore to release the adhesive / non-stick agent in the form of a liquid which comes into contact with the adhesive composition based on hydrocolloids and activate or disable stickiness.

EXAMPLE 1

A hydrocolloid dressing (sold under the brand

URGO bulbs) is glued to a rigid flat surface (formica). A solution of sodium tetraborate (0.95g Borax + 1mL HCl (0.1N) + 99mL H ₂ 0, pH = 8.6) is injected into the thickness of the hydrocolloid layer. After ten minutes of contact between the solution and the hydrocolloid layer, it is found that the separation of the dressing is facilitated compared to an identical reference dressing bonded to the same surface but not brought into contact with the solution.

EXAMPLE 2 A retention pocket for ostomy patients or colostomy pocket (sold under the brand Almarys Optima of BBraun) is provided with a disc provided on its external face with an adhesive composition, the disc being heat-sealed on the retention pocket. The adhesive disc is modified to create a channel near the flow area of the colostomy bag.

Tests are carried out by sticking the colostomy bag via the adhesive disc on a glass wall. The central hole is filled with an aqueous 0.9% NaCl solution (simulation of a fixation on a human body) and is kept immersed in this solution for the entire duration of use set here at 24 hours.

At the end of this period, a non-stick solution is injected into the canal using a syringe.

After two hours of contact with different non-stick solutions, the disc is manually peeled off. A video sample makes it possible to assess the difficulty of detachment compared to a control (no non-stick solution).

The results are given in the following table.

There is a noticeable improvement, and in particular a considerably reduced detachment time, with all the solutions tested, by comparison with the control.

Claims

1. Adhesive system with activatable or deactivatable adhesiveness, comprising an adhesive composition (1) based on hydrocolloids intended to be applied on a support (2), and at least one chemical agent capable of acting on said hydrocolloids of the composition for modify their physico-chemical state so as to activate or deactivate the adhesiveness. 2. Adhesive system according to claim 1, characterized in that the support (2) is the skin. 3. Adhesive system according to either of Claims 1 and 2, characterized in that the chemical agent capable of acting on the hydrocolloids by modifying their physicochemical state so as to deactivate the adhesiveness is all agent capable of forming a complex or bridges or interactions with or between hydrocolloids. 4. Adhesive system according to claim 3, characterized in that the chemical agent is chosen from divalent ions, trivalent ions, tetravalent ions, such as Ba ²⁺ , Ca ²⁺ , Mg ²⁺ , Al ³⁺ , Zn ⁺ , Fe ²⁺ , Fe ³⁺ , Cu ⁺ , Ce ³⁺ , Cr ³⁺ , Zr ⁴⁺ , said ions may or may not be hydroxylated, or other complexing species such as borates, Congo Red, phosphates and polyphosphates, surfactants nonionic, cationic or anionic surfactants, cationic polyelectrolytes, anionic or zwitterionic polyelectrolytes, vegetable tannins, polyphenols synthesis or any other organic molecule capable of exercising an astringent function. 5. Adhesive system according to either of Claims 1 and 2, characterized in that the chemical agent capable of acting on the hydrocolloids by modifying their physico-chemical state so as to activate the adhesiveness is all agent capable of improving the affinity of the polymer system with water, which can result in particular by plasticization, swelling or even dissolution in water of a hydrocolloid or of a complex based on hydrocolloids. 6. Adhesive system according to claim 5, characterized in that the chemical agent is chosen from water, or monovalent ions such as H ⁺ , Li ⁺ , Na ⁺ , K ⁺ , Cs ⁺ , Ag ⁺ , Hg ⁺ , NH ₄ ⁺ , OH ^" , Cl ^" , Br ^" , N0 ₃ ^" or from non-complexing ionic species such as sulfate, perchlorate or tetrafluoroborate. 7. Adhesive system according to any one of claims 1 to 6, characterized in that the agent capable of acting on the hydrocolloids is in the form of a liquid, in particular an aqueous solution. 8. Adhesive system according to any one of claims 1 to 7, characterized in that the adhesive composition contains by weight on dry matter at least 5% of hydrocolloids, preferably from 7.5 to 70%, more preferably from 10 to 65%. 9. Device for implementing the adhesive system with activatable or deactivatable adhesion according to any one of claims l to 8, characterized in that it comprises a product intended to be bonded to a support (2), comprising on a surface an adhesive composition (1) based on hydrocolloids, and also comprising means for bringing an adhesive or anti-adhesive agent into contact with the hydrocolloids of the adhesive composition, so as to activate or deactivate the adhesiveness. 10. Device according to claim 9, characterized in that the means for bringing the adhesive or anti-adhesive agent into contact with the adhesive composition is a channel (3) or a pocket disposed in close proximity to the surface comprising the composition adhesive and the material separating it from the adhesive composition is permeable to the adhesive or anti-adhesive agent. 11. Device according to either of Claims 9 and 10, characterized in that the product is chosen from ostomy bags, dressings, strips, patches, and the products to be bonded to a support, especially the skin of an individual. 12. Method for deactivating the adhesiveness of an adhesive composition based on hydrocolloids, in which: a product comprising on an surface an adhesive composition (1) based on hydrocolloids is bonded to a support (2), and comprising a means of bringing an anti-adhesive agent into contact with the adhesive composition, an anti-adhesive agent is brought into contact with the adhesive composition based on hydrocolloids so as to deactivate the adhesiveness, it is left to act, takes off the product from the support. 13. A method of activating the adhesiveness of an adhesive composition based on hydrocolloids, in which: an adhesive composition (1) based on ydrocolloids present on a surface of an adhesive is brought into contact with an adhesive agent product intended to be stuck on a support (2), and comprising a means of bringing the adhesive agent into contact with the adhesive composition, so as to activate the adhesiveness, it is left to act, - the product is bonded to a support (2). 14. Method according to either of claims 12 and 13, characterized in that the support (2) is the skin.