Method and Apparatus for the Transdermal Administration of a Substance

Abstract

A transdermal delivery device includes a plurality of microneedles for injecting a substance such as a pharmaceutical agent into or below the stratum corneum of the skin. The device has housing formed from a top and bottom wall to define a chamber for containing a pharmaceutical agent. An inlet port is provided in the top wall of the housing for supplying the pharmaceutical agent to the chamber and directing the agent to the microneedles. The housing can have a Luer lock type fitting for coupling with a syringe having a Luer lock collar to inject the pharmaceutical agent into the housing. The housing can be divided into a plurality of chambers by an internal wall for supplying different agents simultaneously or sequentially to a patient. The microneedles have a length of about 5-250 microns and generally about 50-100 microns.

1 . A delivery device for delivering a substance into a patient comprising:
 a syringe having a syringe barrel with an outlet tip and a plunger operable by manual pressure for dispensing said substance contained in said syringe;   said device includes a housing defining a fixed volume reservoir having at least a top and bottom wall;   a check valve disposed at between said syringe and said reservoir to prevent flow from said reservoir to said syringe, wherein said check valve is the only entry point for said substance into said reservoir; and   a plurality of 15-40 gauge microneedles coupled to said outlet tip and having a channel extending through the microneedles in continuous fluid communication with said reservoir for delivering the substance to a patient.   
   
   
       2 . The device of  claim 1 , wherein said syringe includes a Luer lock collar and said housing having a Luer for coupling with said syringe, said microneedles being in communication with said reservoir for delivering said substance to said skin. 
   
   
       3 . The device of  claim 2 , further comprising a Luer lock collar for supplying a fluid to said reservoir and expelling the fluid through said opening in said bottom wall. 
   
   
       4 . The device of  claim 1 , further comprising at least one internal wall to divide said reservoir into at least two chambers, each of said chambers communicating with at least one opening in said top wall and with at least one opening in said bottom wall. 
   
   
       5 . The device of  claim 4 , wherein each of said chambers includes a dry pharmaceutical agent. 
   
   
       6 . The device of  claim 5 , wherein said top wall includes a coupling member attached to said top wall and surrounding said openings in said top wall. 
   
   
       7 . The device of  claim 1 , further comprising a flexible film having a dimension greater than a dimension of said top wall, said film including an adhesive layer on a bottom side thereof, and being attached to said top wall by said adhesive layer and overlying said top wall and extending beyond said top wall a distance whereby said film is able to attach said device to the skin of a patient. 
   
   
       8 . The device of  claim 1 , further comprising a cover removably coupled to said bottom wall and enclosing said microneedles. 
   
   
       9 . The device of  claim 8 , wherein said cover includes an outer wall and at least one side wall, said side wall being frictionally attached to said delivery device. 
   
   
       10 . The device of  claim 1 , wherein said reservoir contains a substantially dry pharmaceutical compound, which can be reconstituted by introducing a solvent into said reservoir. 
   
   
       11 . The device of  claim 1 , wherein said microneedles are of different lengths. 
   
   
       12 . The device of  claim 1 , wherein said microneedles include a tip for penetrating the stratum corneum of the skin and a fluid passage for directing a fluid from said reservoir to said tip. 
   
   
       13 . A device for administering a substance to the skin of a patient comprising:
 a substantially planar base having a top surface, a bottom surface and an opening extending between said top and bottom surfaces which comprises a fixed volume reservoir;   a coupling member attached to said top surface of said base for directing said substance through said openings in said base and for coupling to a fluid source, wherein said coupling member is the only entry point for said substance into said reservoir;   a check valve disposed at said coupling member to prevent flow from said reservoir through said coupling member   a plurality of 15-40 gauge microneedles attached to and extending from said bottom surface of said base in continuous fluid communication with said reservoir; and   a plurality of channels formed in said bottom surface of said base and extending outwardly from said opening and being positioned between said microneedles.   
   
   
       14 . The device of  claim 13 , wherein said coupling member is a Luer lock collar. 
   
   
       15 . The device of  claim 14 , further comprising a syringe removably coupled to said Luer lock collar for directing said substance through said opening in said base. 
   
   
       16 . The device of  claim 13 , further comprising a flexible film having a dimension greater than a dimension of said top surfaces, said film including an adhesive layer on a bottom side thereof, and being attached to said base by said adhesive layer and overlying said base and extending beyond said base a distance whereby said film is able to attach said device to the skin of a patient. 
   
   
       17 . The device of  claim 13 , further comprising a cover removably coupled to said base and enclosing said microneedles. 
   
   
       18 . The device of  claim 17 , wherein said cover includes an outer wall and at least one side wall, said side wall being frictionally attached to said base. 
   
   
       19 . The device of  claim 13 , wherein said channels contain a substantially dry pharmaceutical compound, which can be reconstituted by introducing a solvent or carrier through said opening in said base. 
   
   
       20 . The device of  claim 13 , wherein said microneedles are of different lengths.