Intradermal delivery device

#This application includes subject matter related to that of U.S. Pat. No. 6,537,242, to Phyllis Palmer, entitled “Method And Apparatus For Enhancing Penetration Of A Member For The Intradermal Sampling Or Administration Of A Substance”, issued Mar. 25, 2003, and in U.S. patent application Ser. No. 10/238,958, filed on Sep. 11, 2002 by Ronald Pettis et al., entitled “Microneedle-Based Pen Device For Drug Delivery And Method For Using Same”, the entire contents of each being incorporated herein by reference.

#1. Field of the Invention

#The present invention relates generally to substance delivery devices. Specifically, the invention relates to an injection device and method that incorporates microneedles and skin tensioning systems for providing an optimal interface for an injection.

#These and other objects, advantages and novel features of the present invention will be more readily appreciated from the following detailed description when read in conjunction with the accompanying drawings, in which:

#FIG. 1 is a perspective view of a drug outlet and biological interface for use with a microneedle system in accordance with an embodiment of the present invention;

#FIG. 2 is an enlarged cross sectional view of a skin tensioning system having a limiter and stabilizer ring in accordance with an embodiment of the present invention;

#In the drawing figures, it will be understood that like numerals refer to like elements, features and structures.

#For delivery devices, various microneedle systems can be incorporated to function both as the drug outlet and the biological interface with the patient or end-user. In the exemplary embodiments of the present invention described below, the microneedle device includes a single or multineedle-array needle head or hub assembly that can be integral with an injection device or used as a simple attachment, and is adaptable to a variety of currently manufactured devices.

#Exemplary embodiments of the present invention incorporate a limiter and ring configuration in which each needle of the assembly protrudes from a limiting member, such as a post, surrounded by a valley or gap, and is then circumscribed by an additional skin tensioning member, such as a ring of a height and diameter relative to the limiter. This arrangement assists in skin tensioning, limits needle penetration, and allows an area for formation of the intradermal bleb or wheal during injection such that injection leakage is minimized.