Materials and methods for delivering compositions to selected tissues

Abstract

This invention relates to devices, systems and methods for delivering preprogrammed quantities of an active ingredient to a biological system over time without the need for external power or electronics.

1 . A composition comprising:
 a silicon-containing material comprising a plurality of pores selectively dimensioned to obtain a desired reflective wavelength; and   a drug or biologically active material within the pores.   
   
   
       2 . The composition of  claim 1 , wherein the silicon material comprises a silicon dioxide material. 
   
   
       3 . The composition of  claim 1 , comprising a particulate size of between about 0.1 μm and 100 μm. 
   
   
       4 . The composition of  claim 1 , further comprising a polymeric material capping the pores. 
   
   
       5 . A multilayer silicon composition comprising:
 a silicon material;   a first surface and a second surface on the silicon material;   a plurality of pores of a first tunable size on the first surface;   a plurality of pores of a second tunable size on the second surface; and   a drug or biological agent disposed within the pores on the first and/or second surface;   wherein the silicon composition comprises a particle size between 0.1 μm and 100 μm.   
   
   
       6 . The multilayer silicon composition of  claim 5 , wherein the silicon material is a silicon dioxide. 
   
   
       7 . The multilayer silicon composition of  claim 5 , further comprising a polymer capping the pores on the first side, second side, or surrounding the material. 
   
   
       8 . A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a composition of  claim 1  or  5 . 
   
   
       9 . A method for treating a disease or disorder of the eye comprising injecting a composition of  claim 1  or  5  into the eye. 
   
   
       10 . The method of  claim 8 , wherein the release of a drug from the composition is monitored by a change in reflective wavelength. 
   
   
       11 . A method of preparing a device for controlled drug delivery to a location of the eye comprising: providing a porous nanostructured silicon-containing template having pores configured to receive a particular drug, said template being sized and configured to be delivered into or upon a surface of the eye; and loading the template with the drug. 
   
   
       12 . The method of  claim 11  further comprising providing one of a silicon template, a SiO 2  template, and a SiO 2 /polymer composite template. 
   
   
       13 . The method of  claim 11  further comprising disposing one of an organic polymer, an inorganic polymer, and a bio polymer in the template. 
   
   
       14 . The method of  claim 13  further comprising removing the silicon-containing template from the polymer by one of chemical corrosion and dissolution. 
   
   
       15 . The method of  claim 11  further comprising sizing and configuring the template to be a carrier configured to be included in a contact lens. 
   
   
       16 . The method of  claim 15  further comprising placing the contact lens in abutment with a front extraocular surface. 
   
   
       17 . The method of  claim 11  further comprising sizing and configuring the template to be a scleral plaque for the retrobulbar surface of the eye. 
   
   
       18 . The method of  17  further comprising suturing the scleral plaque to the retrobulbar surface. 
   
   
       19 . The method of  claim 11  further comprising fracturing the template into particles of size less than or equal to 100 micrometers in any dimension. 
   
   
       20 . The method of  claim 19  further comprising injecting the particles intraocularly. 
   
   
       21 . The method of  claim 10  further comprising configuring the particles to have a monitorable optical response depending on a quantity of drug disposed in the pores. 
   
   
       22 . The method of  claim 10  further comprising configuring the particles to have a monitorable optical response depending on the amount of porous material present. 
   
   
       23 . The method of  claim 11  further comprising trapping the drug or drugs in the pores by oxidizing the porous template around the drug or drugs. 
   
   
       24 . The method of  claim 11  further comprising configuring inner walls of the pores to enhance binding efficacy of the at least one drug and to tune release profiles of said pores. 
   
   
       25 - 36 . (canceled) 
   
   
       37 . The composition of  claim 1  wherein said drug or drugs comprises one of the group consisting of angiostatic steroids, metalloproteinase inhibitors, VEGF, pigment epithelium derived factor, an 8-mer peptide fragment of urokinase, modified RNA, modified DNA, fragments derived from immunoglobulins, and dexamethasone. 
   
   
       38 - 41 . (canceled) 
   
   
       42 . A device for the controlled release of an active ingredient comprising:
 a) a polymer layer comprising a plurality of nano-apertures;   b) a base comprising a non-porous substrate layer; and   c) at least one reservoir juxtaposed between the polymer layer and the base, wherein the reservoir is in fluid communication with the nano-apertures of the polymer layer and is configured to contain an active ingredient.   
   
   
       43 . The device of  claim 42 , wherein the polymer layer is produced by:
 a) applying a biocompatible polymer to a porous silicon template thereby forming a polymer-silicon composite;   b) removing the porous silicon template; and   c) obtaining the polymer layer comprising a plurality of nano-apertures.   
   
   
       44 . The device of  claim 42 , wherein the device is suitable for implantation or explantation in a biological system. 
   
   
       45 . The device of  claim 44 , wherein the biocompatible polymer comprises poly(lactide), chitosan, silicone, or poly(norborene), or any combination thereof. 
   
   
       46 . The device of  claim 43 , wherein the porous silicon template is a thermally oxidized porous silicon template. 
   
   
       47 . The device of  claim 42 , wherein the active ingredient is suitable for inhibiting neovascularization. 
   
   
       48 . The device of  claim 42 , wherein the active ingredient comprises one of the group consisting of angiostatic steroids, metalloproteinase inhibitors, VEGF, pigment epithelium derived factor, an 8-mer peptide fragment of urokinase, modified RNA, modified DNA, fragments derived from immunoglobulins, and dexamethasone 
   
   
       49 . The device of  claim 47 , wherein the active ingredient is avastin. 
   
   
       50 . A method of producing a hydrophilic, porous silicon substrate comprising heating a porous silicon substrate to a temperature above 80° C. in the presence of an agent suitable for oxidizing or hydrosilylating the silicon substrate thereby producing a hydrophilic, porous silicon oxide substrate. 
   
   
       51 . The method of  claim 50 , further comprising contacting the hydrophilic, porous silicon substrate with a hydrophilic active ingredient under conditions suitable for associating the substrate with the active ingredient. 
   
   
       52 . The method of  claim 50 , further comprising treating the substrate in a manner that produces biocompatible particles for the controlled delivery of the active ingredient to a biological system. 
   
   
       53 . The method of  claim 50 , wherein the porous silicon substrate is heated to a temperature above 400° C. to 800° C. in an oxidizing environment. 
   
   
       54 - 55 . (canceled) 
   
   
       56 . A hydrophilic, porous silicon substrate produced by the method of  claim 50 . 
   
   
       57 - 58 . (canceled) 
   
   
       59 . A pulse therapy method for treating a subject, the method comprising:
 a) identifying a subject having a condition and selecting one or more active ingredients suitable for treating the condition;   b) correlating the quantity and type of active ingredients with a pulse therapy dosing profile suitable for treating the condition;   c) configuring a device of  claim 42  to obtain a device suitable for delivering the dosing profile of b) to the subject; and   e) implanting or explanting the device in or on a target tissue associated with the subject.   
   
   
       60 . The method of  claim 59 , wherein the target tissue is ocular tissue. 
   
   
       61 . The method of  claim 59 , wherein the target tissue is associated with joint tissue.