Surgery – Means for introducing or removing material from body for... – Treating material applied to or removed from external...
Patent
1993-11-23
1995-08-15
Kruter, Jerome L.
Surgery
Means for introducing or removing material from body for...
Treating material applied to or removed from external...
604290, 604200, 128743, A61M 3500
Patent
active
054414903
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
This invention relates to transdermal perfusion of fluids through the skin of the human or animal body and in particular but not exclusively to apparatus for de-epithelialising the skin by the suction blister method to enable perfusion to take place directly via the dermis layer.
BACKGROUND OF THE INVENTION
The transdermal perfusion of fluids for drug delivery has in recent years become an increasingly favoured alternative to intravenous or oral drug delivery. The technique has however found limited application because the epidermis (outer skin layer) forms an effective barrier to the perfusion of substances and in particular drugs having a large molecular size.
Various techniques have been proposed to enhance transdermal delivery including iontophoresis and the use as chemical enhancers. (Chemical enhancement is for example described in Int. J. Pharm. 1989, 49, 199-201 and Iontophoresis in J. Pharm. Sci. 1990, 79, 490-93). Mechanical stimulation for instance by ultrasound has also been used to enhance transdermal delivery. (Use of ultrasound is for example described in Pharm. Res. 1992, 9, 559-564). There remains a need however to provide a more effective transdermal technique particularly for peptides and hormones which hitherto have not been capable of being transdermally administered.
SUMMARY OF THE INVENTION
It is also known from US-A-3486504 to provide a resilient housing with an air release valve which can be held against an infected skin area by suction. A medicated and absorbent dressing within the housing is thereby held in contact with the skin.
It is also known in the field of skin grafting to remove portions of the epidermis to expose the dermis layer of skin by the application of suction in which a partial vacuum of about 200 mm of mercury applied for a period of two or three hours has the effect of delaminating the epidermis from the dermis to form a blister containing a clear blister fluid. (A suction blister method is for example described by Kiistala U, "The suction blister method for the in vivo separation of epidermis from dermis in human skin", Thesis, Univ of Helsinki, 1976). Such blisters have a roof which comprises the epidermis and can easily be removed for skin grafting.
According to the present invention there is disclosed apparatus for use in transdermal perfusion of fluids through the skin of the human or animal body, the apparatus comprising a housing attachable to the body and having a contact surface which in use is held in contact with a portion of skin, the housing defining a chamber and the contact surface defining an aperture communicating with the chamber, and fluid supply means operable during a perfusion phase of operation of the apparatus to supply fluid to the chamber characterised in that the apparatus further comprises de-epithelialising means operable during a preparatory phase of operation of the apparatus to expose an area of dermis of the skin at a treatment site which is accessible via the aperture such that subsequently during the perfusion phase direct contact is made between fluid in the chamber and the dermis.
An advantage of such apparatus is that it allows a drug to be administered directly to an exposed dermis layer of the skin so that perfusion then proceeds in a manner which is not dependent upon any property of the epidermis. In particular the apparatus can be used on different parts of the body without needing to take account of the variation in thickness of the epithelium. A further advantage is that the micro circulation in the exposed dermis is found to be enhanced by the blister forming procedure and this hyperaemia is found to persist for some days after de-epithelialisation of the dermis and this effect is believed to assist the perfusion process.
The fluid may be a liquid, gel or cream.
The de-epithelialising means may comprise suction means operable to form a partial vacuum in the chamber during a blister forming period in which an area of epithelium of the skin at the treatment site is separated from the dermi
REFERENCES:
patent: 1348504 (1969-12-01), Austin
patent: 2743723 (1956-05-01), Hein
patent: 3486504 (1969-12-01), Austin, Jr.
English-language translation of column 1, line 43 to column 2, line 39 of German Patent No. 1 238 616 (1 page), Apr. 13, 1967.
English-language translation of p. 1, lien 39 to p. 2 line 34 of French patent No. 75 07924 (2 pages), Oct. 18, 1976.
English-language translation of column 2, lines 3 to 38 of French patent No. 983 602 (1 page), Jun. 26, 1951.
"Suction Blister Device for Separation of Viable Epidermis from Dermis", by Urpo Kiistala, Journal of Investigative Dermatology, vol. 50, No. 2, pp. 129-137.
"The Suction Blister Method", by Urpo Kiistala, University of Helsinki Hospital, May 21, 1976, pp. 3-37.
"Biochemical Composition of Suction Blister Fluid Determined by High Resolution Multicomponent Analysis (Capillary Gas Chromatography-Mass Spectrometry and Two-Dimensional Electrophoresis)" by Gunnar Volden, et al., Journal of Investigative Dermatology, vol. 75, No. 5, 1980, pp. 421-424.
"Pharmacokinetic Studies of Antibacterial Aents Using the Suction Blister Method", by Johan N. Brunn, et al., Scandinavian Journal of Infectious Diseases Supplement, 74, 1991, pp. 49-53.
"Suction Blister Device with Regulation of Temperature: Demonstration of Histamine Release and Temperature Change in Cold Urticaria", by H. Neittaanmaki, et al., Archives of Dermatological Research, 276, 1984, pp. 317-321
"Some Factors Affecting the Speed of Suction Blister Formation in Normal Subjects", by R. D. G. Peachey, British Journal of Dermatology, 84, 1971, pp. 435-446.
Dreger Walter H.
Kaufman Michael A.
Kruter Jerome L.
Principal AB
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