Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Conjugate or complex
Reexamination Certificate
1999-01-11
2001-01-09
Tate, Christopher (Department: 1651)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Conjugate or complex
C424S443000, C424S445000, C424S447000, C424S448000, C604S304000, C604S307000, C602S042000, C602S043000, C602S048000, C602S049000
Reexamination Certificate
active
06171594
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to an adhesive agent for application to human or animal skin, a method of producing such adhesive agent and an adhesive paste for application to human or animal skin. Furthermore, the invention relates to the use of the adhesive agent for securing of ostomy appliances and sealing around an ostomy, for wound dressings, for securing of devices for collecting urine, wound drainage bandages, orthoses and prostheses and for protection of skin areas and parts of the body against pressure, impacts, friction and/or exudates from the body, and the use of the adhesive agent as an ostomy paste.
2. Description of the Related Art
Skin adhesive agents are today among other things, used for the above-mentioned purposes.
A widely used embodiment of skin adhesive agents comprises a pressure sensitive adhesive elastomeric matrix in which water absorbing and water-swellable particles of hydrocolloids are dispersed. The pressure sensitive adhesive matrix will adhere to skin and contribute to the cohesion of the adhesive. The water absorbing properties of the hydrocolloids enable adhesion to moist skin by removing moisture from the surface. As the hydrocolloids constantly absorb moisture emanating from the skin or originating from exuding wounds or from, e.g., a stoma, the hydrocolloids also contribute to securing a good adherence over extended periods of time and also prevent maceration of the skin.
In the fields of use mentioned above, the adhesive agents will come into contact with body fluids of different kinds: faces, urine, wound exudates, sweat et cetera. Existing skin adhesives often suffer from the drawback that the adhesiveness are destroyed by contact with body fluids. The parts of the adhesive being in direct contact with the skin or which is exposed to the body fluids will gradually swell due to the water absorbing and water-swelling properties of the hydrocolloids which will eventually cause a disintegration of the adhesive matrix.
Skin problems are common for persons having a stoma. Generally, about 40% have skin problems (Pearl et al. 1985 “Early local complications from intestinal stomas”, Arch. Surg. 120; 1145-1147.) and the frequency is especially high for persons having an urostomy or ileostomy. About 80% of the persons having an ileostomy have skin problems (Hellman, J. D., Lago, C. P. 1990 “Dermatologic complications in colostomy and ileostomy patients”, International Journal of Dermatology, 29 (2); 129-133.). The skin problems are mostly pronounced in a circular area around the stoma (½ inch from the stoma) (Hellman and Lago 1990).
Two common causes for skin problems are:
Inflammatory changes caused by cronical irritation and
Infection by bacteria and/or fungi.
Skin problems associated with an ostomy are different from skin problems generally associated with adhesives for skin (dressings or plasters) as the adhesives of ostomy appliances are placed permanently at the same site during long periods of time (cronical irritation) whereas other adhesives for skin are normally only placed at the same site for a short period of time.
It is desirable that the adhesives for use in connection with ostomy appliances are formulated so as to minimise the risk of skin problems and even more desirable if the adhesive might directly alleviate skin problems which have occurred.
During use in ostomy appliances it is observed that the adhesive agent around the stoma is often gradually eroded due to the disintegration of the adhesive giving access to the skin for the exudates. This is particularly a problem for ostomy patients having a urostomy or an ileostomy from which the exudates are fluid and aggressive. The result is that the risk of leakage increases as will the risk of direct contact between exudate and skin which may lead to severe skin problems and the ostomy appliance and with this, the adhesive will have to be changed more frequently than desired which again will stress the skin and cause higher expenses.
If the adhesive has been extensively eroded by aggressive exudates, the changing of the adhesive appliance may be rendered more inconvenient and laborious as left eroded adhesive will have to be removed mechanically which may cause further stress and strain to the skin. If optional remnants of adhesive are not removed entirely, they may hamper the adhering of the substitute appliance.
Similar problems may be encountered when using adhesive agents for wound drainage bandages or for bandages for use with cronical wounds or especially exuding wounds.
When bandaging wounds, contact between the adhesive and wound exudate will have a similar disintegrating effect on the adhesive leading to problems of the same kind as discussed above when changing the bandage, and furthermore, left parts of adhesive in the wound may affect the wound-healing process. In case of leakage, a further risk of contamination ana microbial infection of the wound exists.
Adhesive agents are also used for securing devices such as uridomas for collecting urine from incontinent males. In such an application, a similar risk of disintegration of the adhesive due to direct contact with urine exists and the direct contact between urine and skin may lead to similar problems as discussed above.
Adhesive agents are also used for securing orthoses and prostheses, e.g., breast prostheses, and for protection of skin areas or Darts of the body against pressure, impacts and/or friction. In these applications secretion of sweat will be the primary cause for swelling and disintegration of the adhesive agent and irritation of the skin leading to the inconveniences and problems mentioned above in connection with exchange of the appliance.
Typical examples of adhesives used as skin adhesives are the hydrocolloid adhesives disclosed in DK patent specifications Nos. 147,034 and 147,035 and in U.S. Pat. No. 4,551,490.
Adhesive pastes are especially used for filling cavities or irregularities in the skin around e.g., an ostomy in order to obtain a plane surface for adhesion of the adhesive for securing an ostomy appliance and for sealing between the adhesive agent and an ostomy. A paste is normally of a semi-liquid, more plastic consistency and may e.g., be based on a solution of a film forming polymer in which hydrocolloid particles are dispersed in an alcohol such as ethanol. Agents conventionally used for enhancing the adhesiveness may also be added. Such an adhesive agent may further comprise agents for regulating the viscosity and/or stabilisers and/or preservatives and such adhesives suffer from the same drawbacks as mentioned above.
Typical examples of the composition of adhesive agents are disclosed in DK patent specification No. 155.571 and EP patent specification No. 48.556.
Thus, there is still a need for an adhesive agent or paste having improved performance with respect to alleviating the skin problems caused by the action of aggressive exudates or excretions from a body.
BRIEF SUMMARY OF THE INVENTION
It has surprisingly been found that when adding Aloe vera to an adhesive agent for use in appliances to be used in connection with collection of exudates or excretions from a body, a better protection of the skin against the aggressive action of excretions from the body is achieved.
Thus, the invention relates, in its broadest aspect to an adhesive agent for application to human or animal skin comprising a pressure sensitive adhesive and optionally additives conventionally used in adhesives of this kind which adhesive agent comprises Aloe vera.
Furthermore, the invention relates to a method of producing such adhesive agent, and an adhesive paste for application to human or animal skin, to the use of such adhesive agent for securing of ostomy appliances and sealing around an ostomy, for wound dressings, for securing of devices for collecting urine, wound drainage bandages, orthoses and prostheses and for protection of skin areas and parts of the body against pressure, impacts, and friction, and/or exudates from the body and the use of th
Colorplast A//S
Jacobson Price Holman & Stern PLLC
Tate Christopher
LandOfFree
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