Safe device for iontophoretic delivery of drugs

Abstract

Provided is a device for iontophoretic delivery of a drug to or into a tissue, including an arrangement that prevents operation of the device at a current density that is higher than a predetermined value, the arrangement including first means responsive to a first data item, indicative of the surface area through which the current is to pass, as to set the maximal current allowed at the surface area indicated by the data item. Also provided is a method for iontophorectivally administering drug to or into a tissue, including determining a maximal allowed level of current density and preventing application of current density above the maximal allowed level.

1 .- 24 . (canceled) 
     
     
         25 . A device for iontophoretic delivery of a drug to or into a tissue, comprising: an arrangement that prevents operation of the device at a current density that is higher than a predetermined value, said arrangement including first means responsive to a first data item, indicative of the surface area through which the current is to pass, as to set the maximal current allowed at the surface area indicated by said data item. 
     
     
         26 . The device according to  claim 25 , further comprising second means, being responsive to a second data item, indicative of the tissue to be treated, said first and second means being responsive to said first and second data items as to set the maximal current allowed at the surface area indicated by said first data item for treating the tissue indicated by said second data item. 
     
     
         27 . The device according to  claim 25 , further comprising an arrangement that prevents the continuous operation of the device for a time duration longer than a predetermined time value, said arrangement including means responsive to said first and/or second data item as to set the maximal duration of continuous operation in accordance with the surface area indicated by said first data item and optionally also in accordance with the tissue indicated by said second data item. 
     
     
         28 . The device according to  claim 25 , further comprising input means for manually inputting data that is indicative to the surface area. 
     
     
         29 . The device according to  claim 25 , comprising:
 a contacting member capable of contacting with the tissue a drug-containing sponge, said contacting member being capable of transmitting a signal indicative of the surface area of said sponge; and   a receiving element, capable of receiving said signal and being in communication with said first means.   
     
     
         30 . The device according to  claim 29 , wherein said contacting member comprises a transducer and said receiving element is a microprocessor in communication with said transducer. 
     
     
         31 . The device according to  claim 25 , further comprising a microprocessor programmed with a table comprising predetermined values of maximal current as function of the surface area or as function of the data indicative thereof. 
     
     
         32 . The device according to  claim 31 , wherein said microprocessor is also programmed with a table comprising predetermined values of maximal current as function of the surface area and the tissue, or as function of the data indicative thereof. 
     
     
         33 . The device according to  claim 31 , wherein said microprocessor is also programmed with a table comprising predetermined values of maximal operation durations as function of operation current and the tissue, or as function of data indicative thereof. 
     
     
         34 . The device according to  claim 33 , designed specifically for iontophoretic administration of charged drugs to eye tissue, mucosal tissue, or internal tissue. 
     
     
         35 . The device according to  claim 34 , comprising:
 an applicator formed with a receiving portion adapted for holding a replaceable sponge loaded with said charged drug and allowing contact of at least a portion of the sponge with a surface of the tissue;   a first data input element, allowing to input thereby data indicative of the area of said receiving portion;   an electric current generating element, for generating currents not higher than a predetermined value, being electrically coupled to said receiving portion such that the current once generated passes through the sponge in a direction essentially normal to said surface; and   a processor capable of determining said predetermined value in accordance with the data inputted by said first data input element.   
     
     
         36 . The device according to  claim 35 , further comprising a second data input element allowing to input thereby the specific tissue to be treated and said processor is being capable of determining said predetermined value in accordance with this data and in accordance with the data indicative of the sponge's area. 
     
     
         37 . The device according to  claim 25 , wherein said first means comprises a processor. 
     
     
         38 . A method for iontophoretically administering drug to or into a tissue, comprising determining a maximal allowed level of current density and preventing application of current density above said maximal allowed level. 
     
     
         39 . The method according to  claim 38 , wherein said determining is done in consideration of the tissue's sensitivity to electric current. 
     
     
         40 . The method according to  claim 38 , further comprising determining a maximal allowed duration of continuous current application to the tissue and preventing the continuous application of current for time durations longer than said maximal allowed duration. 
     
     
         41 . A sponge having a porous structure, wherein said porous structure allows the sponge to absorb and hold at least 30% w/w aqueous solutions without dissolving or disintegrating, said sponge carries a data transmitting module capable of transmission of a data indicative of the sponge's size and/or surface area of contact of the sponge with the tissue. 
     
     
         42 . The sponge according to  claim 41 , wherein said transmitting module is a chip. 
     
     
         43 . The sponge according to  claim 42  made of hydrophilic substances with functional groups that associate well with water molecules, such as hydroxy, ether, amide, thiol, carboxylic acid, and amine groups.