Micro-needles and methods of manufacture and use thereof
First Claim
1. A method of manufacturing a micro-needle structure for penetrating the skin and other tissue barriers, said method comprising:
- providing a suitable material from which said micro-needle structure can be fabricated by at least one micro-replication technique;
fabricating said micro-needle structure from said suitable material by said at least one micro-replication technique, wherein said micro-needle structure comprises a conical configuration comprising a proximal end defining a base having a center and a distal end having a vertex comprising a sharp tip, wherein said base has a diameter in the range from about 100 to 2,000 μ
m and wherein a line extending from said center of the base to said vertex defines a structural axis having a length in the range from about 100 to 10,000 μ
m and forming open lumen within said micro-needle structure, said open lumen defining a lumenal axis and extending from said base to said vertex, wherein a distal end of said open lumen intersects said vertex and wherein said lumenal axis and said structural axis intersect at an intersection angle.
1 Assignment
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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
18 Claims
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1. A method of manufacturing a micro-needle structure for penetrating the skin and other tissue barriers, said method comprising:
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providing a suitable material from which said micro-needle structure can be fabricated by at least one micro-replication technique;
fabricating said micro-needle structure from said suitable material by said at least one micro-replication technique, wherein said micro-needle structure comprises a conical configuration comprising a proximal end defining a base having a center and a distal end having a vertex comprising a sharp tip, wherein said base has a diameter in the range from about 100 to 2,000 μ
m and wherein a line extending from said center of the base to said vertex defines a structural axis having a length in the range from about 100 to 10,000 μ
m andforming open lumen within said micro-needle structure, said open lumen defining a lumenal axis and extending from said base to said vertex, wherein a distal end of said open lumen intersects said vertex and wherein said lumenal axis and said structural axis intersect at an intersection angle. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A method of manufacturing a micro-needle structure, said method comprising:
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providing a plastic material;
fabricating said micro-needle structure by injection molding said plastic material, wherein said micro-needle structure comprises an oblique cone configuration having a base and a vertex comprising a sharp tip;
forming an open lumen within said micro-needle structure, said open lumen extending from said base to said vertex wherein a distal end of said open lumen intersects said vertex; and
wherein said vertex defines a vertex angle, a line extending from a center of said base to said vertex defines a structural axis, and said open lumen defines a lumenal axis, wherein said lumenal axis and said structural axis intersect at an intersection angle. - View Dependent Claims (12)
said vertex angle is greater than twice the intersection angle.
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13. A method of manufacturing a device comprising a micro-needle structure, said method comprising:
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providing a suitable material from which said micro-needle structure can be fabricated by at least one micro-replication technique;
fabricating said micro-needle structure from said suitable material by said at least one micro-replication technique, wherein said micro-needle structure comprises an oblique cone configuration having a base and a vertex configured for penetrating the skin and other tissue barriers;
forming an open lumen within said micro-needle structure, said open lumen extending from said base to said vertex wherein a distal end of said open lumen intersects said vertex;
wherein said vertex defines a vertex angle, a line extending from a center of said base to said vertex defines a structural axis, and said open lumen defines a lumenal axis, wherein said lumenal axis and said structural axis intersect at an intersection angle, and integrating said micro-needle structure with another structure wherein said open lumen is in fluid communication with said other structure. - View Dependent Claims (14, 15, 16, 17, 18)
said vertex angle is greater than twice the intersection angle.
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Specification