Micro-needles and methods of manufacture and use thereof
First Claim
13. The micro-needle of claiml2 wherein said distal tip is beveled.
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Accused Products
Abstract
A micro-needle is provided which is particularly useful for the minimally invasive sampling of a biological fluid and/or the minimally invasive delivery of a drug or other formulation across the skin. The micro-needle has a structure having a base at a proximal end and a vertex at a distal end, and an open lumen extending there through and through which fluid may be transferred. The structure defines a structural axis that intersects the lumenal axis defined by the open lumen. The point of intersection between these axes is at a point below the vertex of the micro-needle to provide a sharp apex at the distal end of the micro-needle and defines the general configuration of the distal end of the micro-needle, which may be selected or customized depending on the intended use of the microneedle. The micro-needle may be integral with a measurement device for measuring the concentration of a constituent within sampled biological fluid and/or with a fluid reservoir for containing a fluid to be delivered, and may also be used in conjunction with a remote control means. Methods of making and using the micro-needle of the present invention as well as kits comprising one or more of the micro-needles are also provided.
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Citations
44 Claims
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13. The micro-needle of claiml2 wherein said distal tip is beveled.
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32. A method of manufacturing a structure comprising the steps of:
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providing a suitable material from which said structure can be fabricated by means of one or more micro-replication techniques;
fabricating said structure from said suitable material by means of one or more micro-replication techniques, wherein said structure has a proximal end defining a base and a distal end having a vertex wherein said base has a diameter in the range from about 100 to 2,000 μ
m and the line extending from the center of the base to the vertex defines a structural axis having a length in the range from about 100 to 10,000 μ
m;
forming an open lumen within said structure, said open lumen extending from said base to said distal end, wherein the distal end of said open lumen intersects said vertex; and
customizing a tip at said vertex end, said customized tip being selectively angled for a particular application. - View Dependent Claims (34, 35)
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33-1. A kit for sampling a biological fluid from the skin of a patient and for measuring the concentration of an analyte within the sampled biological fluid, the kit comprising at least one micro-needle according to claim 1.
Specification