Micro-needles and methods of manufacture and use thereof

• US 20030208138A1
• Filed: 04/16/2003
• Published: 11/06/2003
• Est. Priority Date: 07/09/2001
• Status: Abandoned Application

• Current Assignee: Lorin Olson
• Original Assignee: Lorin Olson
• Inventors: Olson, Lorin
• Application Number:
  US10/417,541
• Publication Number:
  US 20030208138A1
• Time in Patent Office: Days
• US Class Current: 600/573
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles

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.

Claims

13. The micro-needle of claiml2 wherein said distal tip is beveled.

32. A method of manufacturing a structure comprising the steps of:

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.

34. The method according to claim 32, wherein said step of customizing comprises the use of an electrical discharge machining device.

35. The method according to claim 32 wherein said selectively angled tip comprises a beveled edge.

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.