Patent Publication Number: US-2009234331-A1

Title: Electronically controlled pill and system having at least one sensor for delivering at least one medicament

Description:
The present disclosure relates generally to medication delivery systems. More particularly, the present disclosure it relates to an electronically controlled pill and system having at least one sensor for delivering at least one medicament. 
     A medicament, such as aspirin, taken by the person generally traverses the gastrointestinal (GI) tract where it is absorbed for treating an ailment or condition. Objects typically pass through the GI tract in 20-40 hours. Several medicaments are available as time-release capsules for releasing portions of the medicament into the body at different times. Time-release capsules utilize chemical reactions between chemical substances in the gastrointestinal tract and the coating of the capsules for dissolving and releasing the medicament. Food, particularly proteins and fats, and the GI chemistry affect the speed of the journey of medicaments through the stomach. As such, medicaments, including medicaments available as time-release capsules, do not follow an exact dispensing or dissolving pattern while traveling through the GI tract. 
     For example, one person may have more than a “normal” amount of chemical substances in the gastrointestinal tract due to a condition, an earlier-administered medicament, etc. and therefore, cause the coating of the time-release capsule to react quicker than normal. Accordingly, the medicament is released by the time-release capsule at a faster rate than an intended rate. However, another person may have less than the “normal” amount of chemical substance in the gastrointestinal tract and cause the coating of the time-release capsule to react slower than normal, thereby releasing the medicament at a slower rate than the intended rate. 
     The present disclosure provides an electronically controlled pill or medicament delivery system having at least one sensor for delivering or dispensing a medicament. The dispensing of the medicament is based on location detection using at least one sensor reading, i.e., at least one sensed condition or parameter, such as pH, level of conductivity (water content), etc., taken by the at least one sensor along the gastrointestinal tract. For example, for a normal patient, if the at least one sensor senses a low pH level, the electronically controlled pill can determine that it is located within the stomach. If the pH level begins to rise, the electronically controlled pill can determine that it is exiting the stomach and entering the small intestine. 
     The electronically controlled pill includes decision and control logic circuitry for controlling the opening and closing of a valve, pump or hatch according to the sensed conditions for dispensing a medicament stored within a medicament reservoir of the pill. Preferably, after the electronically controlled pill is swallowed the one or more sensors are read out continuously and the data is provided to the decision and control logic circuitry. At least one processor of the logic circuitry analyzes the data and determines the relative position of the pill along the gastrointestinal tract. The position of the pill can be determined by accessing one or more look-up tables stored within the processor. The look-up tables preferably correlate the one or more sensed conditions with relative positions along the gastrointestinal tract. 
     Once the relative position is determined, the decision and control logic circuitry determines whether to control the opening and closing of the valve to dispense the medicament stored within the medicament reservoir. The pill is programmed with the locations or positions it is to dispense the medicament. Therefore, if the determined relative position substantially corresponds with at least one preprogrammed position, the logic circuitry transmits a signal to the valve for opening the valve. The voltage level of the signal determines the amount of opening of the valve. 
     It is envisioned that the pill is custom programmed or designed according to a patient&#39;s medical profile or preexisting ailments which can alter the sensed conditions, such as pH, level of conductivity (water content), etc., along the gastrointestinal tract. 
    
    
     
       Various embodiments of the present disclosure will be described herein below with reference to the figures wherein: 
         FIG. 1  is a schematic diagram of an electronically controlled pill having at least one sensor in accordance with the present invention; and 
         FIG. 2  is a block diagram of the electronically controlled pill having the at least one sensor in accordance with the present invention. 
     
    
    
     An electronically controlled pill or medicament delivery system according to the present invention is shown by  FIGS. 1 and 2 , and further described with specificity hereinafter. The electronically controlled pill  100  is a self-contained, electronically controlled medicine delivery system. As described in detail below, the electronically controlled pill  100  includes programmed electronics that control a release mechanism in accordance with at least one sensed condition or parameter, such as pH, level of conductivity (water content), etc., along the gastrointestinal tract for dispensing a medicament. The pill  100  is made from bio-compatibles materials such that the pill  100  is bio-compatible for at least the amount of time it requires to traverse the gastrointestinal tract. The bio-compatible materials are preferably stable in room temperature, such that the pill has a long shelf life. 
     As used herein and in the claims the word “medicament” refers to medicines, non-medicinal substances, contrast agents, gases, fluids, liquids, chemicals, radiological agents, imaging markers, sensors for monitoring the person&#39;s vitals, and other substances capable of being dispensed by the pill  100 . 
     The electronically controlled pill  100  includes an outer shell or housing  102  defining an opening  103 ; a medicament reservoir  104  for storing a medicament; an electronically controlled release valve, pump or hatch  106  for dispensing the medicaments stored in the medicament reservoir  104  via the opening  103 ; decision and control logic circuitry  108  for opening and closing the valve  106 ; and at least one sensor  110  (sensors  110 A and  110 B are shown in  FIGS. 1 and 2 ). The pill  100  further includes a battery  112  for powering the various components of the pill  100 . The decision and control logic circuitry  108  opens and closes the valve  106  in accordance with conditions sensed by the at least one sensor  110  as further described below. 
     Preferably, the shell  102  is resistant to body fluids such as gastric acid and gall from the bile. The shell  102  is preferably manufactured from materials used to fabricate implantable devices, including pacemaker leads and cardiac prosthesis devices, such as artificial hearts, heart valves, intraaortic balloons, and ventricular assist devices. These materials include titanium, Pellethane® 2363 polyetherurethane series of materials available from Dow Chemical Company and Elasthane polyetherurethane available from the Polymer Technology Group, Inc. Other materials include PurSil® and CarboSil® also available from the Polymer Technology Group, Inc. 
     At least a portion of the shell  102  preferably includes a metallic liner  111  as shown by  FIG. 1  for use in detecting the location of the pill  100  along the gastrointestinal tract by placing a magnetic detector on the patient. When the magnetic detector senses the metallic liner  111 , one can easily verify the location of the pill  100  along the gastrointestinal tract. The shell  102  can include one or more other devices or substances, other than the metallic liner  111 , such as RF devices, antennas, radioluscent substances, imaging markers, infrared detectors, etc., for enabling detection of the pill ( 100 ) from outside the patient. 
     Preferably, after the electronically controlled pill  100  is swallowed the one or more sensor readings from one or both of the sensors  110 A,  110 B are read out continuously and the data is provided to the decision and control logic circuitry  108  which includes at least one processor  200 . The at least one processor  200  analyzes the data and determines the relative position of the pill  100  along the gastrointestinal tract. The position of the pill  100  can be determined by accessing one or more look-up tables or other data structures stored within the processor  200 . The look-up tables correlate the one or more sensor readings or sensed conditions with relative positions along the gastrointestinal tract. An exemplary look-up table correlating sensed pH levels with a respective relative position along the gastrointestinal tract is shown by the following Table. 
     
       
         
           
               
               
               
             
               
                   
                   
               
               
                   
                 pH Level 
                 Position-Gastrointestinal Tract 
               
               
                   
                   
               
             
            
               
                   
                 7.4-7.7 
                 Mouth 
               
               
                   
                 6.3-6.9 
                 Esophagus 
               
               
                   
                 4.0-4.8 
                 Stomach 
               
               
                   
                 7.0-9.0 
                 Small Intestine 
               
               
                   
                 4.0-6.5 
                 Colon 
               
               
                   
                   
               
            
           
         
       
     
     Preferably, the at least one processor  200  includes timing circuitry for timing the time the pill  100  is traversing the gastrointestinal tract. Based on a specific time at any given moment, the at least one processor  200  is programmed to determine which data to analyze, i.e., data provided by sensor  110 A or data provided by sensor  110 B, or both. For example, from two minutes to three minutes after the pill  100  is administered, the at least one processor  200  is programmed to analyze data from sensor  110 A. From three minutes to five minutes after the pill  100  is administered, the at least one processor  200  is programmed to analyze data from sensor  110 B. From five minutes to ten minutes after the pill  100  is administered, the at least one processor  200  is programmed to analyze data from both sensors  110 A,  110 B. The time provided by the timing circuitry can also be correlated with a look-up table stored within the at least one processor  200  to determine where along the gastrointestinal tract the pill  100  is at any given time after being administered. 
     Once the relative position is determined, the decision and control logic circuitry  108  determines whether to control the opening and closing of the valve  106  to dispense the medicament stored within the medicament reservoir  104 . The pill  100  is programmed with the locations or positions it is to dispense the medicament. Therefore, if the determined relative position substantially corresponds with at least one preprogrammed position as determined by the logic circuitry  108  using, for example, a comparator, the logic circuitry  108  transmits a signal to a release controller  120  for controlling the valve  106 . The release controller  120  is operatively associated or in operative communication with the valve  106  for opening the valve  106 . The release controller  120  includes circuitry for interpreting the signal transmitted by the logic circuitry  108  and controlling the amount of the valve opening. 
     Accordingly, when the pill  100  reaches the target location, the valve  106  opens under the control of the logic circuitry  108  and the release controller  120  and the drug dispenses from the medicament reservoir  104 . By opening the valve  106  partially, or by pumping slowly using a pump valve, the medicament dispenses in a controlled manner. Since the logic circuitry  108  controls the dispensing of the medicament, the medicament, in essence, dispenses in accordance with a release profile. An exemplary release profile entails the dispensing of the medicament when the pill  100  is traversing the small intestine. 
     In accordance with the present invention, a preferred release profile is adhered to during the pill&#39;s travel through the gastrointestinal tract, since the decision and control logic circuitry  108  is programmed for closing the valve  106  and controlling the amount the valve  106  is opened for controlling the size of the valve opening. By controlling the size of the valve opening or frequency of valve opening, such as is enabled by microfluidic systems of inkjet printers and the like, the electronically controlled pill  100  can precisely control the quantity of medicament released following one or more sensed conditions by the sensors  110 A,  110 B. 
     The voltage level of a signal relayed to the release controller  120  of the valve  106  by the at least one processor  200  determines the size of the valve opening for controlling the quantity of the medicament dispensed at a particular locale along the gastrointestinal tract. When dispensing of the medicament is to be terminated, another signal is transmitted to the release controller  120  of the valve  106  by the at least one processor  200  for closing the valve  106 . 
     The logic circuitry  108  determines to terminate dispensing of the medicament by continuously correlating at least one sensed condition with the relative position of the pill  100  along the gastrointestinal tract using a look-up table. As stated above, the pill  100  is programmed with the locations or positions it is to dispense the medicament. Therefore, if the determined relative position does not substantially correspond with at least one preprogrammed position as determined by the logic circuitry  108  using, for example, the comparator, the logic circuitry  108  transmits a signal to the release controller  120  for closing the valve  106 . 
     The release controller  120  is preferably a micro-electromechanical mechanism capable of receiving the signal from the at least one processor  200  and generating a signal having a variable voltage level to the electronically controlled valve  106  for closing the valve  106  and controlling the size of the valve opening or degree of opening of the valve  106  (in accordance with the voltage level of the received signal). In the simplest case, the release controller  120  is a transistor or D/A circuit that provides voltages to the valve  106  causing it to open or close. 
     The electronically controlled valve  106  is preferably a micro-electromechanical mechanism, such as a MEMS-valve, capable of being electrically controlled by a signal capable of having a variable voltage levels. Each voltage level corresponds to a different size opening for the valve opening and one voltage level (or no voltage at all, i.e., no signal) corresponds to the valve  106  being closed. The valve  106  is similar in operation to valves used in ink-jet printers for dispensing ink in accordance with the amount that the valve is opened. The valve  106  is characterized as a microfluidic valve for controlling the movement of minute amount of liquids or gases in a miniaturized system. 
     It is envisioned that the pill  100  is custom programmed or designed according to a patient&#39;s medical profile or preexisting ailments which can alter the sensed conditions, such as pH, level of conductivity (water content), etc., along the gastrointestinal tract. With reference to  FIG. 2 , the decision and control logic circuitry  108  includes a start timer mechanism  114  for causing the activation of the logic circuitry  108  and the sensors  110 A,  110 B for continuously reading out data. In a preferred embodiment, the start timer mechanism  114  is a micro-electromechanical (MEM) mechanism having a sensor  116  for sensing the presence of a liquid, such as water, saliva, etc. When the pill  100  is taken or administered, the sensor  116  senses the presence of a liquid, and transmits an electrical signal to the logic circuitry  108  for activation thereof. In turn, the logic circuitry  108  transmits a signal to the sensors  110 A,  110 B for activation thereof and the continuous read out of data. 
     In an alternate embodiment, the start timer mechanism  114  is a button which is pushed to transmit the electrical signal to the logic circuitry  108 . The button is pushed just before the pill  100  is administered to a person or animal. 
     In another embodiment, activation of the logic circuitry  108  and the sensors  110 A,  110 B is achieved by dissolving a thin, water soluble coating that separates two electrical contacts of a switch, thereby enabling the switch to close the circuit. In still another embodiment, the switch is manually triggered by the patient or caregiver. 
     One skilled in the art can appreciate that the electronically controlled pill  100  in accordance with the present disclosure is suitable for dosing pharmaceutical components which are hard to dose using soluble capsules or pressed pills that might harm the mouth or stomach, or that might be damaged themselves in the mouth or stomach. Fluid phase drugs are also easier to dose using the pill  100  of the present disclosure than using conventional pills. 
     Preferably, the at least one processor  200  stores the data received from the sensors  110 A,  110 B, such that the data can be retrieved once the pill  100  passes through the gastrointestinal tract. The data can also be transmitted from within the patient to a data recorder situated outside the patient by fitting the pill  100  with communications circuitry having at least one antenna. The data can be used to determine whether the sensed conditions or parameters are normal. For example, one can determine if the pH levels at various parts of the gastrointestinal tract are within a range considered to be normal. If not, treatment can be administered for correcting the pH levels at one or more parts of the gastrointestinal tract as known in the art, or by administering one or more pills  100  for dispensing at least one medicament for increasing or decreasing the pH level at one or more parts of the gastrointestinal tract. 
     The described embodiments of the present disclosure are intended to be illustrative rather than restrictive, and are not intended to represent every embodiment of the present disclosure. Various modifications and variations can be made without departing from the spirit or scope of the disclosure as set forth in the following claims both literally and in equivalents recognized in law.