Non-Invasive Agent Applicator

Abstract

There is disclosed systems and methods for non-invasive delivery of an agent to biological tissues. Delivery of the agent to the tissues can be by one or more modalities. In some embodiments the systems and methods use agent carrier body including a tissue contacting surface for non-invasively engaging tissues under treatment. The tissue contacting surface can be at least partly defined by a plurality of protrusions that are in fluid communication with one or more reservoirs forming part of the agent carrier body. The protrusions may extend outward from an inside of a void and terminate at said tissue contacting surface.

1 . A method of inducing an immune response in a subject, including the steps of:
 applying ultrasound to an agent, wherein the agent is provided within an agent carrier body, an agent carrier, or an agent applicator, wherein ultrasound is a transportation stimulus for the agent; the agent carrier body comprising a tissue contacting surface for engaging the tissue; and   configuring the operational parameters of the agent applicator to enhance or enable delivery of said agent to one or more selected layers of a tissue,   wherein delivery of the agent induces an immune response in the subject, and   the immune response comprises a mucosal immune response.   
     
     
         2 . The method of  claim 1 , wherein delivery of the agent to induce a mucosal immune response comprises controlling the amount of the agent delivered into the epithelial layer, or into the epithelial and sub-epithelial layers, of a mucous membrane. 
     
     
         3 . The method of  claim 1 , further comprising one or more steps selected from the group consisting of:
 loading the agent carrier body and/or agent carrier with agent;   providing the agent carrier body or agent carrier holding the agent;   bringing the tissue contacting surface of the agent carrier body or agent carrier into direct or indirect contact with said tissue; and   dispensing the agent from the agent carrier body or agent carrier to the tissue surface, wherein the step of dispensing the agent includes generating an ultrasonic signal to enable or enhance transportation of the agent to the tissue contacting surface.   
     
     
         4 . The method of  claim 1 , wherein the operational parameters include one or more of the group consisting of application pressure, ultrasonic frequency, ultrasonic power level, ultrasonic waveform, ultrasonic application duration, ultrasonic application duty cycle; and ultrasound direction. 
     
     
         5 . The method of  claim 1 , the method further comprising delivering the agent to or beyond any one or more tissues or tissue layers selected from the group consisting of mucous membrane, mucosa, sub-mucosa, and mucous membrane vasculature. 
     
     
         6 . The method of  claim 1 , wherein the agent carrier or agent carrier body comprises a tissue contacting surface for engaging tissues under treatment, the tissue contacting surface being at least partly defined by a plurality of protrusions. 
     
     
         7 . The method of  claim 6 , wherein the agent carrier includes one or more agent reservoirs for carrying said agent, and
 wherein said protrusions are in fluid communication with the one or more reservoirs forming part of the agent carrier.   
     
     
         8 . The method of  claim 7 , wherein each agent reservoir comprises a void formed within the agent carrier body. 
     
     
         9 . The method of  claim 6 , wherein the protrusions extend outward from the inside of a void and terminate at said tissue contacting surface. 
     
     
         10 . The method of  claim 8 , wherein the void is formed by a peripheral structure, wherein at least part of said peripheral structure terminates at the tissue contacting surface. 
     
     
         11 . The method of  claim 10 , wherein the peripheral structure terminates in a common plane with the protrusions. 
     
     
         12 . The method of  claim 10 , wherein at least some of said protrusions defining the tissue contacting surface extend outward from the void beyond the peripheral structure. 
     
     
         13 . The method of  claim 12 , wherein the protrusions terminate in a plane and the peripheral structure terminates short of the plane such that the protrusions extend beyond the peripheral structure. 
     
     
         14 . The method of  claim 1 , wherein the agent carrier body includes a stack of layers comprising a tissue-contacting layer, wherein the tissue contacting layer includes the tissue contacting surface and at least one other layer. 
     
     
         15 . The method of  claim 14 , wherein at least the tissue contacting layer has at least one hole extending through it to define at least a portion of a respective micro channel in the agent carrier body. 
     
     
         16 . The method of  claim 15 , wherein a micro channel enables the agent to be transported from one layer to the next. 
     
     
         17 . The method of  claim 1 , wherein the agent carrier conducts the transportation stimulus. 
     
     
         18 . The method of  claim 1 , wherein the agent carrier body conducts the transportation stimulus. 
     
     
         19 . The method of  claim 1 , wherein the agent carrier body includes one or a multiplicity of micro channels extending at least partially through the agent carrier body to the tissue contacting surface enabling transportation of the agent to a tissue surface. 
     
     
         20 . The method of  claim 19 , wherein the micro channels extend through the agent carrier body to fluidly connect to an agent reservoir.