“Micro-patch” for assessment of the local microvasculature and microcirculatory vasoreactivity

申请公布号：: US8961932(B2)
申请号：: US200812059383
申请日期：: 2008.03.31
申请公布日期：: 2015.02.24
发明人：: Silverman David G.
分类号：: A61K51/00;A61K31/04;A61B5/026;A61K31/221;A61B5/00
主分类号：: A61K51/00
代理机构：: Welsh Flaxman & Gitler LLC
代理人：: Welsh Flaxman & Gitler LLC
摘要：: A method for interrogating the microcirculation of a subject for use in characterizing function in health and disease, monitor changes in microcirculation over time, and identify responses in microcirculation to potentially harmful or beneficial interventions. The method includes delivering a study agent to a study surface for trans-surface delivery to the microvasculature of the subject and monitoring the microvasculature of the subject in the area of the study surface. A system is also provided which includes a micro-patch for delivery of study agent to a study surface for trans-surface delivery to the microvasculature of the subject and a monitoring probe for monitoring the microvasculature of the subject in the area of the study surface.
主权项：: 1. A method for assessing local microvasculature and local microcirculatory vasoreactivity of a patient or research subject by selective noninvasive and nondisturbing monitoring of local microvasculature and local microcirculatory vasoreactivity at an accessible site to noninvasive and nondisturbing trans-surface delivery of a study agent with a known microvascular effect in normal subjects, comprising: noninvasively delivering a vasoactive study agent to skin of the subject for trans-surface delivery to the microvasculature of the subject, including arterioles, capillaries, venules or to neural structures which selectively innervate microvascular components, in a non-iontophoretic manner to exclusively affect local microvascular vasoreactivity without systemic effects or changes, wherein the step of delivering includes application of a micro-patch containing the study agent to the skin of the subject, the micro-patch containing the study agent selectively affecting the microvasculature at the skin of the subject without potential for confounding influence as a consequence of impact of the study agent on remote sites or on systemic cardiovascular indices, wherein the vasoactive study agent is acetylcholine delivered in an amount equivalent to <0.25 ml of 1% or nitroglycerin delivered at a rate of 0.008 mg/hr; determining the subject's microvascular responsiveness by measuring changes in microvascular perfusion that are limited to the microvasculature in the area of the skin of the subject beneath the micro-patch; ensuring that drug delivery does not induce alterations in measurements by delivery to remote sites or by systemic effects wherein this is accomplished by real-time monitoring of heart rate, blood pressure, or flow at other sites or such monitoring has been used to establish parameters for delivery of said agent below those which might induce said confounding changes; and assessing local microvasculature and local microcirculatory vasoreactivity based upon the steps of delivering, determining, and ensuring.