Surgery – Diagnostic testing – Measurement of skin parameters
Reexamination Certificate
2001-08-01
2004-09-14
Hindenburg, Max F. (Department: 3736)
Surgery
Diagnostic testing
Measurement of skin parameters
C600S365000
Reexamination Certificate
active
06790179
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a method of examining and diagnosing skin health in a subject.
BACKGROUND OF THE INVENTION
Dermal interstitial fluid is a clear, water-like fluid present between the cells in the living skin tissues (i.e., epidermis and dermis) under the stratum corneum. The composition of the interstitial fluid is substantially free of blood cells, but does contain small molecules and proteins. Interstitial fluid both transports nutrients (e.g., glucose) from the blood to the skin cells and removes cellular metabolic wastes (e.g., urea) from the skin cells to the blood. Various components of the interstitial fluid are in equilibrium with living cells in both the epidermis and dermis as well as macromolecular structures located in the subcutaneous tissue.
The correlation of certain endogenous chemicals between the blood and interstitial fluid has been well established. For example, Service et al. used a novel minimally invasive technique to sample minuscule amounts (0.5 microliter) of the interstitial fluid from both healthy volunteers and diabetic patients. See Service et al., Diabetes Care, 20: 9, 1426-9 (1997). Service et al. assessed the accuracy of the glucose concentrations in the interstitial fluid in predicting concurrently measured venous plasma and capillary plasma glucose concentrations. Service et al. concluded that interstitial fluid sampling was a bloodless, minimally invasive technique that provided a medium for glucose measurement, the concentrations of which closely reflected ambient glycemia to a degree comparable with that of capillary glucose measurements. A similar conclusion was also drawn by Krogstad et al., British Journal of Dermatology, 134:6, 1005-12 (1996).
Others have also studied the concentration changes of certain drugs in the interstitial fluid following oral administration. See, e.g., Zimmerli et al., Antimicrobia. Agents. Chemother., 40:1, 102-4 (1996) and Vaillant et al., Eur. J. Clin. Pharmcol. 33:5, 529-30, (1987).
Although sampling interstitial fluid by minimally invasive techniques for diagnostic applications to monitor diseases such as diabetes is known, Applicant has found that certain endogenous substances present in the skin tissues (such as vitamin C) are at a different concentration in the interstitial fluid than in serum. Thus, analysis of substances in the serum is not indicative of the corresponding concentration levels of such substances in the skin. Also, Applicant has also found that the concentration of certain endogenous substance in the interstitial fluid varies as a result of diet, aging, or the effect of external aggressions. Applicant has discovered that the determination of the concentration of certain endogenous substances present in the interstitial fluid, thus, can be used to assess the health of a subjects skin, permitting the administration of cosmetic or pharmaceutical agents to specifically treat the needs of the subject's skin.
SUMMARY OF THE INVENTION
In one aspect, the invention features a method of examining skin health in a subject, the method including the steps of: accessing a sample of interstitial fluid from the skin of the subject; and measuring the amount of a skin analyte in the sample.
In one aspect, the invention features a method of diagnosing the skin health in a subject, the method including the steps of: (a) accessing a sample of interstitial fluid from the skin of the subject; (b) measuring the amount of a skin analyte in the sample; and (c) comparing the amount of the skin analyte to a reference standard.
In one aspect, the invention features a method of treating the skin of a subject, the method including the steps of: (a) accessing a sample of interstitial fluid from the skin of the subject; (b) measuring the amount of a skin analyte in the sample; and (c) applying a skin care product to the subject to alter the amount of the skin analyte in the skin of the subject.
In one aspect, the invention features a method of distributing a skin care product to a subject, the method including the steps of: (a) obtaining a sample of interstitial fluid from the skin of the subject; (b) measuring the amount of a skin analyte in the sample; and (c) distributing a skin care product to the subject to alter the amount of the skin analyte in the skin of the subject.
Other features and advantages of the present invention will be apparent from the detailed description of the invention and from the claims.
DETAILED DESCRIPTION OF THE INVENTION
It is believed that one skilled in the art can, based upon the description herein, utilize the present invention to its fullest extent. The following specific embodiments are to be construed as merely illustrative, and not limitative of the remainder of the disclosure in any way whatsoever.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs. Also, all publications, patent applications, patents, and other references mentioned herein are incorporated by reference.
Definitions
What is meant by “examining skin health” is a obtaining information regarding the current biological condition of the skin. Such information, for example, may provide insight into the current health of the skin (e.g., to determine whether certain cosmetic or pharmaceutical skin treatments are necessary) as well as provide insight regarding the response of the skin to external trauma or treatment. In one embodiment, the information is obtained on a periodic basis, e.g., once a year, once a month, once a week, or once a day, to continually monitor skin health.
What is meant by “skin analyte” is a chemical entity present in the interstitial fluid of the skin that either participates in the biological processes of the skin or is a product of such processes. In one embodiment, the skin analyte is an endogenous substance. In one embodiment, the skin analyte is an exogenous substance that entered the skin intentionally or unintentionally, which may exert desirable or undesirable biological effects on the skin.
Interstitial Fluid
The present invention relates to a method of examining skin health in a subject by obtaining a sample of interstitial fluid from the skin of said subject (e.g., a mammalian subject such as a human). What is meant by “interstitial fluid” is the clear fluid present between the cells in the living epidermis and dermis, which is substantially free of blood cells.
Creation of Openings in the Skin
The epidermis and dermis are protected by the stratum corneum, which is a barrier layer of keratinized skin cells and lipids. Thus, in order to gain access to interstital fluid, one must permeabilize the stratum corneum to access the interstitial fluid from the skin. In one embodiment, the method of obtaining such sample of interstitial fluid comprises creating a opening in the stratum corneum of the skin of said subject and obtaining said sample through the opening. In one embodiment, the opening is also within the epidermis of the subject. Although not preferred, in one embodiment the opening is also within the dermis of said subject. Preferably, the opening results in minimal residual tissue damage in order not to alter the composition of the interstitial fluid. For example, creating a blister on the skin and then sampling the resulting interstitial fluid in the blister is not preferred.
In one embodiment, about 1 to about 1000 openings are created in the skin of the subject, such as about 2 to about 50 openings. In one embodiment, the width of the opening is about 1 to about 500 microns, such as about 50 to about 250 microns. In one embodiment, the depth of the opening is about 50 to about 500 microns, such as about 75 to about 200 microns. The number and size of openings will depend on the subject being treated and the area of skin being analyzed.
In one embodiment, the opening is created by a mechanical device. Examples of such mechanical devices include, but are not limited to, hollow and solid needles, micro stylus
Hindenburg Max F.
Johnson & Johnson Consumer Companies Inc.
Woodcock & Washburn LLP
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