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 delivering a substance through at least one layer of the skin of a subject, the device comprising:
 a body having a top face, a bottom face spaced from the top face, and a side edge, and a channel formed within the body,   wherein the bottom face includes a first surface area and a second surface area adjacent to and recessed from the first surface area, the bottom face further including at least one raised protrusion disposed on the second surface area; and   a dermal-access means being provided in each of the at least one raised protrusion and being in fluid communication with the channel to deliver the substance, wherein only the dermal access means penetrates the skin of the subject.   
     
     
         2 . The device of  claim 1 , wherein the channel extends longitudinally from the side edge to the at least one dermal-access means. 
     
     
         3 . The device of  claim 1 , wherein each at least one raised protrusion is a raised conical protrusion. 
     
     
         4 . The device of  claim 1 , wherein the raised protrusion is one of
 a) recessed relative to the first surface area,   b) flush with the first surface area, and   c) projects beyond the first surface area.   
     
     
         5 . The device of  claim 1 , wherein the at least one raised protrusion includes an odd number of raised protrusions. 
     
     
         6 . The device of  claim 1 , wherein the at least one raised protrusion includes an even number of raised protrusions. 
     
     
         7 . The device of  claim 1 , wherein the at least one raised protrusion includes three raised protrusions spaced at 120° angles from one another, radially equidistant from the center of the bottom face. 
     
     
         8 . The device of  claim 1 , wherein the second surface area includes a recessed area surrounding each of the at least one raised protrusion. 
     
     
         9 . The device of  claim 8 , wherein the recessed area is substantially circular. 
     
     
         10 . The device of  claim 1 , wherein the dermal-access means is a needle. 
     
     
         11 . The device of  claim 1 , wherein the dermal-access means is a microneedle. 
     
     
         12 . The device of  claim 11 , wherein the microneedle is a 34, 35, or 36 gauge needle. 
     
     
         13 . The device of  claim 11 , wherein the microneedle is smaller than 34 gauge. 
     
     
         14 . The device of  claim 11 , wherein the tip of the microneedle has approximately a 28° bevel. 
     
     
         15 . The device of  claim 1 , wherein the body is substantially circular shaped. 
     
     
         16 . The device of  claim 1 , further comprising means for securing the device to the skin. 
     
     
         17 . A device for delivering a substance through at least one layer of the skin of a subject, the device comprising:
 a body having a top face, a bottom face spaced from the top face, and a side edge, and a channel formed within the body,   wherein the bottom face includes a first surface area and a second surface area adjacent to and recessed from the first surface area; and   a dermal-access means being provided on the second surface area and being in fluid communication with the channel to deliver the substance, wherein only the dermal access means penetrates the skin of the subject.   
     
     
         18 . The device of  claim 17 , further comprising means for supporting the dermal-access means on the second surface area. 
     
     
         19 . A device for delivering a substance through at least one layer of the skin of a subject, the device comprising:
 a body having a top face, a bottom face spaced from the top face, and a side edge comprising a interior channel;   wherein the bottom face includes a first surface area and a second surface area adjacent to and recessed from the first surface area, the bottom face further including at least one raised protrusion disposed on the second surface area; and   a dermal-access means being provided in each of the at least one raised protrusion and being in fluid communication with the channel which is in fluid communication with means for delivering the substance, wherein only the dermal access means penetrates the skin of the subject.   
     
     
         20 . The device of  claim 19 , wherein the side edge is substantially non-perpendicular to said bottom face. 
     
     
         21 . The device of  claim 19 , further comprising means for supporting the dermal-access means on the raised protrusion.