Device and method for delivering or withdrawing a substance through the skin

Abstract

An apparatus for delivering or withdrawing a fluid through at least one layer of the skin is provided. A device includes a body having a top face, a bottom face, a side edge and at least one channel. The bottom face includes a first surface area and a second surface area adjacent to and recessed at a first distance from the first surface area. The bottom face further includes at least one raised protrusion disposed on the second surface area. The protrusion has a height from the first surface greater than the first distance. At least one dermal-access member is provided in the protrusion and is in fluid communication with the channel to deliver or withdraw the fluid.

1 . A device for intradermally delivering a fluid substance dose from a fluid delivery system through at least one layer of skin of a subject, the device comprising:
 a substantially clear body having a top face, a bottom face spaced from the top face, and a side edge, the body defining at least one channel wherein the bottom face is adapted to be disposed onto to the subject's skin;   a raised protrusion disposed on the bottom face, wherein the raised protrusion has a conical frustum shape having a top surface with a diameter from 0.5 mm to 10 mm and said raised protrusion having a draft from said top surface to said bottom face from approximately 10° to 60°;   a needle extending from the raised protrusion a skin penetration distance, wherein the skin penetration distance is a pre selected distance from the top surface of the raised protrusion from between 0.3 mm to 2 mm, wherein the needle has an inner diameter that is in fluid communication with the at least one channel;   a recess on said bottom face having a diameter surrounding each raised protrusion which provides a gap from the subjects skin from about 0.1 mm to about 10 mm, wherein the recess diameter is pre selected from 5 mm to 50 mm and is correlated to the fluid substance dose thereby providing space for a bleb to form in the subjects skin;   a fitting is adapted to be operatively and fluidically coupled to the fluid delivery system; and   a flexible tubing defining a lumen and having a first end and second end, wherein the first end is engaged to the body such that the lumen of the tubing is in fluid communication with the at least one channel, and the second end of the tubing is connected to the fitting such that the lumen is in fluid communication with the fitting, wherein the tubing has a larger internal diameter than the needles.   
     
     
         2 . The device of  claim 1  wherein the raised protrusion comprises three protrusions, each having conical frustum shapes and being disposed at 120° with respect to each other. 
     
     
         3 . The device of  claim 1  wherein the raised protrusion comprises three protrusions, each having conical frustum shapes and being disposed in a linear array. 
     
     
         4 . The device of  claim 1 , wherein the needle is a 34, 35, or 36 gauge needle. 
     
     
         5 . The device of  claim 1 , wherein the needle is smaller than 34 gauge. 
     
     
         6 . The device of  claim 1 , wherein the channel, the lumen, and the fitting are adapted to withstand fluid pressures of up to 200 psi. 
     
     
         7 . The device of  claim 1 , further comprising a needle shield constructed and arranged to protect the needle. 
     
     
         8 . The device of  claim 1 , wherein the fitting further comprises a luer fitting. 
     
     
         9 . The device of  claim 1 , wherein the top surface of the at least one raised conical frustum shaped protrusion is a generally flat surface having a diameter of less than 2 mm. 
     
     
         10 . The device of  claim 1 , wherein the top surface of the raised conical frustum shaped protrusion is a generally flat surface having a diameter of 1 mm. 
     
     
         11 . The device of  claim 1 , wherein the recess diameter is about 5 mm. 
     
     
         12 . The device of  claim 1 , wherein the recess gap is from about 0.1 mm to 5 mm. 
     
     
         13 . The device of  claim 1 , wherein the bottom face comprises a plurality of raised conical frustum shaped protrusions spaced on a protrusion radius wherein said protrusion radius is measured from a center of the bottom face. 
     
     
         14 . The device of  claim 13 , wherein the protrusion radius is about 7.5 mm.