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 introducing a substance into the skin of a patient for delivering the substance to the patient, said device comprising: 
 a top wall having at least one opening;    a bottom wall coupled to said top wall and spaced from said top wall to define a reservoir therebetween for containing said substance, said bottom wall having a plurality of openings;    a coupling member attached to said top wall for supplying said substance through said openings in said top wall and into said reservoir;    a check valve disposed at said coupling member to prevent flow from said reservoir through said coupling member    a plurality of microneedles coupled to said outer surface of said bottom wall and being in fluid communication with said openings in said bottom wall for directing said substance from said reservoir into the skin of a patient.    
   
   
       2 . The device of  claim 1 , wherein said coupling member is a Luer lock collar.  
   
   
       3 . The device of  claim 2 , further comprising a syringe removably coupled to said 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 extending between said top and bottom walls 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;    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;    a check valve disposed at said coupling member to prevent flow from said reservoir through said coupling member    a plurality of microneedles attached to and extending from said bottom surface of said base; 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.  
   
   
       21 . A delivery device for delivering a substance into a patient comprising: 
 a syringe having a syringe barrel with an outlet tip and a plunger for dispensing said substance contained in said syringe;    said device includes a housing defining a reservoir;    a check valve disposed at between said syringe and said reservoir to prevent flow from said reservoir to said syringe; and    a plurality of microneedles coupled to said outlet tip and having a channel extending through the microneedles for delivering the substance to a patient.    
   
   
       22 . The device of  claim 21 , wherein said syringe includes a Luer lock collar and said housing having a Luer lock collar for coupling with said syringe, said microneedles being in communication with said reservoir for delivering said substance to said skin.  
   
   
       23 . A method of administering a substance through the skin of a patient comprising: 
 providing a device having 
 a body with a top surface, a bottom surface and at least one opening extending between said top and bottom surfaces,  
 a coupling member attached to said top surface for supplying said substance in a forward flow through said coupling member and into said opening;  
 a check valve disposed at said coupling member to prevent reverse flow from said opening back through said coupling member  
 a plurality of microneedles attached to and extending from said bottom surface of said body;  
   contacting said device with the skin of a patient and applying sufficient pressure for said microneedles to pierce the stratum corneum of said patient; and    delivering a substance to said microneedles for delivery through the skin.    
   
   
       24 . The method of  claim 23 , wherein said method further comprises coupling a container containing a substance to said coupling member for supplying said substance to said microneedles.  
   
   
       25 . The method of  claim 24 , wherein said coupling member is a Luer lock collar and said container is a syringe.  
   
   
       26 . The method of  claim 23 , wherein said device further includes a plurality of channels formed in said bottom surface of said body and extending outwardly from said at least one opening, and being positioned between said microneedles for directing said substance from said opening to said microneedles.  
   
   
       27 . The method of  claim 23 , wherein said body includes a spaced apart top wall and bottom wall to define a chamber, and a plurality of openings in said bottom wall for directing said substance to said microneedles.  
   
   
       28 . The method of  claim 27 , wherein said microneedles include passages in communication with said openings in said bottom wall.  
   
   
       29 . The method of  claim 26 , wherein said channels include a dry pharmaceutical agent contained therein and said method comprises directing a solvent or diluent through said at least one opening and along said channels to dissolve or suspend said pharmaceutical agent.  
   
   
       30 . The method of  claim 27 , wherein said chamber contains a dry pharmaceutical agent and said method comprises feeding a solvent or diluent to said chamber to dissolve or suspend said pharmaceutical agent.