Methods of agent delivery using ingestible probe

Abstract

Methods of use of an electronic probe which is introduced into the intestinal tract of a living organism and which operates autonomously therein, adapted to deliver one or more therapy agents. In one embodiment, the method includes loading the probe with one or more therapy agents, and selectively releasing the agents from the probe at a desired location of the intestinal tract in order to provide increased efficacy over traditional oral ingestion or intravenous introduction of the agent(s). In one variant, the one or more agents comprise low-specificity agents, and the method is used to significantly reduce side effects which might otherwise occur without direct delivery.

What is claimed is: 
     
         1 - 14 . (canceled) 
     
     
         15 . A method of delivery at least one therapy agent to a human being, comprising:
 causing oral ingestion of an electronic probe comprising the at least one therapy agent;   allowing the probe to move to a location within an intestinal tract of the human being that is past a stomach of the human being; and   selectively releasing the at least one therapy agent from the probe at the location, the releasing causing exposure of at least a portion of the intestinal tract at the location to the at least one therapy agent.   
     
     
         16 . The method of  claim 15 , wherein the at least one therapy agent comprises an agent which can bind to a plurality of different types of molecules, at least a portion of the types of molecules comprising at least one of: (i) a protein or (ii) an enzyme. 
     
     
         17 . The method of  claim 16 , wherein the at least one of: (i) a protein or (ii) an enzyme comprises a receptor on targeted tumor tissue. 
     
     
         18 . The method of  claim 16 , wherein the at least one of: (i) a protein or (ii) an enzyme comprises a receptor on a tumor associated with a predetermined cancer type. 
     
     
         19 . The method of  claim 15 , wherein the movement comprises movement due to digestive function of the human being. 
     
     
         20 . The method of  claim 15 , wherein the selectively releasing comprises:
 receiving at a wireless receiver of the probe a command signal; and   using at least the command signal and a digital processing apparatus of the probe in data communication with the wireless receiver, causing expulsion of the at least one therapy agent from a reservoir disposed within an external housing of the probe.   
     
     
         21 . The method of  claim 20 , wherein the causing expulsion comprises causing pressurization of at least a portion of the at least one therapy agent to a pressure greater than atmospheric pressure which is sufficient to cause said expulsion. 
     
     
         22 . The method of  claim 15 , wherein the at least one therapy agent comprises a radioisotope, and wherein the agent can bind to at least one predetermined type of site on a cancerous tumor within the tract. 
     
     
         23 . The method of  claim 22 , wherein the at least one predetermined type of site on a cancerous tumor within the tract comprises a membrane-expressed protein unique to the cancerous tumor. 
     
     
         24 . The method of  claim 15 , wherein the at least one therapy agent comprises a monoclonal antibody directed to at least one tumor-associated antigen or molecule of a cancer cell. 
     
     
         25 . The method of  claim 15 , wherein the at least one therapy agent comprises a radioactively tagged peptide or ligand able to bind to a receptor associated with a particular type of cancer cell. 
     
     
         26 . The method of  claim 15 , wherein the electronic probe comprises:
 a housing;   digital processor apparatus disposed within the housing;   a first wireless interface disposed at least partly within the housing and in data communication with the digital processor apparatus;   a reservoir at least partly disposed within the housing and capable of storage of the at least one therapy agent; and   release apparatus in data communication with the digital apparatus and configured to selectively release at least a portion of the at least one agent to a region exterior to the housing; and   wherein the selectively releasing comprises:   receiving at the first wireless receiver of the probe a signal; and   using at least the signal and the digital processor apparatus, causing release of the at least one therapy agent from the reservoir.   
     
     
         27 . The method of  claim 26 , wherein the method further comprises determining that the probe has reached the location prior to said selectively releasing. 
     
     
         28 . The method of  claim 27 , wherein:
 the probe further comprises image gathering apparatus in data communication with the digital processing apparatus and the first wireless interface, and configured to obtain image data from an interior portion of the tract and transmit at least a portion of the obtained data to an external receiver via the first wireless interface; and   the determining that the probe has reached the location comprises evaluating at least a portion of the transmitted obtained data.   
     
     
         29 . The method of  claim 27 , wherein the determining that the probe has reached the location comprises determining that the probe has reached a location proximate a previously determined location of a tumor or other cancerous formation within the tract, the location proximate comprising a location where the at least one therapy agent will contact the tumor or other cancerous formation when the at least one agent is released from the reservoir. 
     
     
         30 . A method of delivery of at least one therapy agent directly to a targeted location of an intestinal tract of a human being, comprising:
 causing oral ingestion of an electronic probe comprising the at least one therapy agent stored therein, the probe comprising a non-dissolvable housing such that none of the at least one therapy agent can be released without affirmative action to cause such release;   allowing the probe to move to a target location within the intestinal tract that is past a stomach of the human being, at least part of the movement comprising movement due to peristaltic action of the intestinal tract; and   selectively releasing the at least one therapy agent from the probe at the target location, the releasing causing direct exposure of at least epithelial tissue at the target location to the at least one therapy agent;   wherein an efficacy of the at least therapy agent when released from the probe at the target location is used is greater than as compared to one or more of: (i) oral ingestion of the at least one agent in dissolvable pill or other medicant form; and/or (ii) intravenous delivery of the at least one agent.   
     
     
         31 . The method of  claim 30 , wherein the at least one therapy agent comprises a radionuclide, the radionuclide bound to a substance which is configured to selectively mate to a receptor of tumerous or cancerous tissue. 
     
     
         32 . The method of  claim 30 , wherein the at least one therapy agent comprises a low-selectivity therapy agent, and the greater efficacy is provided at least in part by the selective delivery of the at least one therapy agent only in regions of the intestinal tract not populated by two or more substances able to interact with the low-selectivity therapy agent. 
     
     
         33 . A method of delivery a radionuclide therapy agent to the intestinal tract of a human being, comprising:
 causing oral ingestion of an electronic probe comprising the radionuclide therapy agent stored therein;   allowing the probe to move to a target location within an intestinal tract of the human being that is past a stomach of the human being and which comprises at least one tumor; and   selectively releasing at least a portion of the therapy agent from the probe only at the target location, the releasing causing exposure of at least a portion of the at least one tumor to the at least one therapy agent;   wherein the radionuclide therapy agent further comprises a bonding agent which enables the radionuclide therapy agent to bond to one or more receptor sites of the at least one tumor, thereby delivering an ionizing radiation dose to the at least one tumor in situ.   
     
     
         34 . The method of  claim 33 , wherein the electronic probe comprises:
 a housing;   digital processor apparatus disposed within the housing;   a first wireless interface disposed at least partly within the housing and in data communication with the digital processor apparatus;   a reservoir at least partly disposed within the housing and capable of storage of the radionuclide therapy agent; and   release apparatus in data communication with the digital apparatus and configured to selectively release at least a portion of the radionuclide therapy agent to a region exterior to the housing; and   wherein the selectively releasing comprises:   receiving at the first wireless receiver of the probe a signal; and   using at least the signal and the digital processor apparatus, causing release of the radionuclide therapy agent from the reservoir.   
     
     
         35 . A method of extended delivery a therapy agent to the intestinal tract of a human being, the method comprising:
 causing oral ingestion of an electronic probe comprising the therapy agent stored therein;   allowing the probe to move to a target location within an intestinal tract of the human being that is past a stomach of the human being;   causing the electronic probe to cease further movement down the intestinal tract for at least a period of time; and
 selectively releasing at least a portion of the therapy agent from the probe at the target location, the releasing causing exposure of at least a portion of an epithelium of the intestinal tract to the at least one therapy agent for at least the period of time.