Surgery: splint – brace – or bandage – Bandage structure – Skin laceration or wound cover
Patent
1998-06-23
2000-09-19
Weiss, John G.
Surgery: splint, brace, or bandage
Bandage structure
Skin laceration or wound cover
602 51, 602 56, 602 58, 428355R, 428355AC, A61F 1300
Patent
active
061215082
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
This invention relates to polar, lipophilic pressure-sensitive adhesive compositions for contacting a variety of types of mammalian skin. In another aspect, the invention relates to a biomedical electrode having a pressure-sensitive adhesive as the ionically-conductive, skin interfacing material. In another aspect, the invention relates to skin-contacting medical articles that include either a drug in the adhesive composition to form a transdermal delivery device or an anti-microbial agent as a wound dressing.
BACKGROUND OF THE INVENTION
Pressure-sensitive adhesives find broad utility in skin-contacting medical applications providing the means for reversibly securing tapes, dressings, and devices to the patient as detailed in "Porous and Other Medical Pressure Sensitive Adhesives", K. Krug and N. M. Marecki, Adhesives Age, p. 19, November 1983 and "Hospital and First Aid Products", D. Satas and A. M. Satas, Chapter 25 in Handbook of Pressure Sensitive Adhesive Technology, Second Edition, D. Satas, Editor, Van Nostrand, Rheinhold, 1989.
An adhesive composition can also serve to adhere a biomedical electrode to skin and to establish an electrical connection between skin and an electrical medical apparatus desirably has multiple characteristics that are difficult to achieve in one composition. The composition should have the characteristics of a good medical adhesive and those of a good electrical conductor. Electrical conductivity is imparted by ionic species in polar adhesive compositions.
Ionically-conductive, pressure-sensitive adhesives suitable for use in many biomedical electrodes are shown in many patents. U.S. Pat. No. 4,524,087; U.S. Pat. No. 4,539,996; U.S. Pat. No. 4,554,924; U.S. Pat. No. 4,581,821; U.S. Pat. No. 4,674,512; U.S. Pat. No. 4,777,954; U.S. Pat. No. 4,684,558, and U.S. Pat. No. 4,848,353 are exemplary.
Ionically-conductive adhesives made according to the above listed patents are used in patient grounding plates, transcutaneous electrical nerve stimulation (TENS) electrodes, and diagnostic electrocardiogram (EKG/ECG) electrodes. While these adhesives provide adequate adhesive and electrical properties for some applications, optimizing the electrical properties without adversely affecting adhesion properties has been difficult. It is known that increasing the water content of the adhesive compositions described in the above mentioned U.S. patents to about 25% improves the electrical performance of electrodes coated with the adhesives. The reason for this empirical observation is not known. One possible explanation is that the increased water facilitates hydration of skin, thereby reducing skin impedance. Unfortunately, increasing water content to optimum levels for electrical performance is found to decrease the tack of the adhesive, resulting in lower skin adhesion.
Another ionically-conductive adhesive is disclosed in GB-A-2,115,431 and U.S. Pat. Nos. 4,699,146 and 4,750,482. The adhesives described therein are formed by dissolving or dispersing polymers in a plasticizing liquid and subjecting the mixture to radiation energies at least equivalent to 100,000 electron volt (X-ray, gamma and beta ray, and electron beam irradiation). Present with the polymers are irradiation-compatible, nonvolatile elasticizers that among others include mono- or diethers of a polyalkylene glycol, mono- or diesters of a polyalkylene glycol, and an imidazoline derivative amphoteric surfactant. But cautions are also provided not to permit plasticizers containing surfactants or detergents from contacting skin, in order to assure that the adhesive is hypoallergenic and not skin irritating. These patents also fail to recognize the beneficial effect of having such surfactants or detergents present in a polar adhesive to allow for absorption of skin oil away from the adhesive/skin interface providing better bond formation. Indeed these patents caution that such materials are better employed so as not to be in contact with skin, in order to assure that skin irritation is not caused.
Mam
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Bischof Katharina J.
Kantner Steven S.
Kuester Wilhelm
3M Innovative Properties Company
Hart Kelmar
Maki Eloise J.
Weiss John G.
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