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 substance through at least one layer of the skin of a subject, the device comprising: 
 a substantially circular shaped body having a top face, a bottom face spaced from the top face, and a side edge, the body having a channel, wherein the bottom face includes at least one raised conical frustum shaped protrusion disposed on the bottom face having a skin abutment surface;    at least one dermal-access member being provided in each of the at least one raised conical frustum shaped protrusion and in fluid communication with the channel, wherein the at least one dermal-access member extends from about 0.3 mm to about 3 mm from the skin abutment surface;    a fitting wherein the fitting is operatively and fluidically coupled to a fluid delivery system selected from the group consisting of syringe, pump, and medication delivery pen; and    a tubing having a lumen and a first end and second end, wherein the first end is attached to the top face of the body, wherein the lumen of the tubing in fluid communication with the channel, and the second end of the tubing is connected to the fitting, and the lumen of the tubing is in fluid communication with the fitting.    
     
     
         2 . The device of  claim 1 , wherein the at least one raised protrusion conical frustum shaped includes an odd number of raised conical frustum shaped protrusions.  
     
     
         3 . The device of  claim 1 , wherein the at least one raised conical frustum shaped protrusion includes an even number of raised conical frustum shaped protrusions.  
     
     
         4 . The device of  claim 1 , wherein the dermal-access member is a needle.  
     
     
         5 . The device of  claim 4 , wherein the dermal-access member is a microneedle.  
     
     
         6 . The device of  claim 5 , wherein the microneedle is a 34, 35, or 36 gauge needle.  
     
     
         7 . The device of  claim 5 , wherein the microneedle is smaller than 34 gauge.  
     
     
         8 . The device of  claim 5 , wherein the tip of the microneedle has approximately a 28° bevel.  
     
     
         9 . The device of  claim 5 , wherein the channel, the lumen, and the fitting are adapted to withstand fluid pressures of up to about 200 psi.  
     
     
         10 . The device of  claim 1 , further comprising a flange surrounding at least a portion of the body and extending outwardly from the side edge of the body.  
     
     
         11 . The device of  claim 1 , further comprising a needle shield constructed and arranged to protect the at least one dermal-access member.  
     
     
         12 . The device of  claim 1 , wherein the fitting further comprises a luer fitting.  
     
     
         13 . The device of  claim 1 , wherein the skin abutment surface of the at least one raised conical frustum shaped protrusion is a generally flat surface having a diameter of less than 2 mm.  
     
     
         14 . The device of  claim 1 , wherein the skin abutment surface of the at least one raised conical frustum shaped protrusion is a generally flat surface having a diameter of about 1 mm.  
     
     
         15 . The device of  claim 4 , wherein the needle extends about 1 mm from the skin abutment surface.  
     
     
         16 . The device of  claim 1 , wherein the body is constructed a substantially clear material.  
     
     
         17 . A method of delivering a substance through at least one layer of the skin of a subject, the method comprising the steps of: 
 providing a device having a substantially circular shaped body having a top face, a bottom face spaced from the top face, and a side edge having a flange, the body having a channel, wherein the bottom face includes at least one raised conical frustum shaped protrusion disposed on the bottom face having a skin abutment surface; 
 at least one dermal-access member being provided in each of the at least one raised conical frustum shaped protrusion and in fluid communication with the channel, wherein the at least one dermal-access member extends from about 0.3 mm to about 3 mm from the skin abutment surface wherein the channel is fluidically coupled to a fluid delivery system selected from the group consisting of syringe, pump, and medication delivery pen;  
   positioning the at least one dermal-access member on a target site of the skin of the subject;    applying a pressure against the device sufficient for the at least one dermal-access member to penetrate the skin and for the skin abutment surface to contact the skin; and    delivering a substance to the target site of the subject.    
     
     
         18 . The method of  claim 17 , further comprising adhesively attaching the device to the skin of the subject.  
     
     
         19 . The method of  claim 17 , wherein the dermal-access member penetrates the skin at a targeted depth.  
     
     
         20 . The method of  claim 17 , wherein the substance is delivered to an intradermal layer of the skin.  
     
     
         21 . A device for intradermally delivering a substance from a fluid delivery system 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, the body defining a channel and the body being adapted to be disposed proximate to the subject's skin;    a flange extending outwardly from the side edge of the body and adapted to be grasped by a caregiver;    a raised protrusion disposed on the bottom face, wherein the raised protrusion has a conical frustum shape that defines a skin abutment surface;    a needle extending from the body a fixed distance, wherein the needle is disposed proximate to but at a selected distance from the skin abutment surface of the raised protrusion, wherein the needle has an inner diameter that is in fluid communication with the channel and wherein the needle extends between about 1.0 mm to about 1.7 mm beyond the skin abutment surface;    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 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.    
     
     
         22 . The device of  claim 21  wherein the raised protrusion comprises three protrusions, each having conical frustum shapes and being disposed at 120° with respect to each other.  
     
     
         23 . The device of  claim 21  wherein the raised protrusion comprises three protrusions, each having conical frustum shapes and being disposed in a linear array.  
     
     
         24 . The device of  claim 21 , wherein the needle is a 34, 35, or 36 gauge needle.  
     
     
         25 . The device of  claim 21 , wherein the needle is smaller than 34 gauge.  
     
     
         26 . The device of  claim 21 , wherein the tip of the needle has approximately a 28° bevel.  
     
     
         27 . The device of  claim 21 , wherein the channel, the lumen, and the fitting are adapted to withstand fluid pressures of up to about 200 psi.  
     
     
         28 . The device of  claim 21 , further comprising a needle shield constructed and arranged to protect the needle.  
     
     
         29 . The device of  claim 21 , wherein the fitting further comprises a luer fitting.  
     
     
         30 . The device of  claim 21 , wherein the skin abutment surface of the at least one raised conical frustum shaped protrusion is a generally flat surface having a diameter of less than 2 mm.  
     
     
         31 . The device of  claim 21 , wherein the skin abutment surface of the at least one raised conical frustum shaped protrusion is a generally flat surface having a diameter of about 1 mm.