Low profile actuator and improved method of caregiver controlled administration of therapeutics

Abstract

A polymer actuator, power supply and method of using the activation are described.

1 - 102 . (canceled) 
     
     
         103 : A polymeric actuator assembly comprising:
 a housing;   a carrier having an upper surface within the housing;   a plurality of discrete polymeric actuators disposed across the upper surface;   an electrolyte contained in the housing and in contact with the plurality of discrete polymeric actuators; and   an apparatus for changing the pH in the electrolyte;   wherein, each discrete polymeric actuator has a volume that expands in response to the change in pH, and each discrete polymeric actuator is physically constrained to cause the expansion to be predominantly in a direction that is directed away from the upper surface.   
     
     
         104 : The polymeric actuator assembly of  claim 103 , characterized by one or more of the following features:
 (a) wherein the carrier has a plurality of wells with openings across the upper surface, and each discrete polymer actuator is disposed within one of the wells that provides physical constraint, and wherein each well preferably has a volume defined by the upper surface and a surface of the well below the carrier surface, and wherein most of the volume of each discrete polymeric actuator is contained within the volume to provide said physical constraint;   (b) wherein the carrier is formed from a porous polymer that facilitates contact between the electrolyte and each discrete polymeric actuator;   (c) wherein the carrier has a lower surface opposing the upper surface, and further comprising a second plurality of discrete polymeric actuators defining a second area arrangement across the lower surface;   (d) wherein the upper surface is substantially planar, and each polymeric actuator is constrained to exert a force that is normal to the upper surface;   (e) wherein each polymeric actuator has a long axis that is substantially normal to the upper surface;   (f) wherein the apparatus is an electrode set;   (g) wherein the electrode set includes an individual electrode that passes into each of the discrete polymeric actuators; and, optionally, wherein
 (i) each of the individual electrodes are individually addressable; 
 (ii) wherein the electrode set includes an electrode that is commonly coupled to multiple individual electrodes; 
 (iii) wherein the electrode set includes a rigid electrode that functions as a platen for exerting a force, and wherein the rigid electrode receives a normal force from the plurality of discrete polymers in response to the change in pH; and 
 (iv) wherein the electrode set includes an electrode that is formed upon one of a housing surface, a polymeric actuator surface, the carrier surface; and 
   (h) wherein the apparatus is a container within the housing containing a solution configured to modify the pH of the electrolyte when the solution is released from the container.   
     
     
         105 : A polymeric actuator assembly of  claim 103 ,
 wherein the carrier has an upper surface and a plurality of wells formed in the carrier, each well opening onto the surface; and   wherein said plurality of polymeric actuators each has a volume that is partially contained in a corresponding one of the wells.   
     
     
         106 : The polymeric actuator assembly of  claim 105 , characterized by one or more of the following features:
 (a) wherein the polymeric actuator is configured to expand in response to modifying the pH, and each well corresponding to a polymeric actuator constrains the polymeric actuator to predominantly expand in a direction that is normal to the upper surface;   (b) wherein the means for changing the pH includes an electrode set; and, optionally,   wherein
 (i) the electrode set includes: 
   an upper electrode in contact with an upper portion of the electrolyte solution;   a lower electrode in contact with a lower portion of the electrolyte solution; and   a porous separator that separates the lower portion from the upper portion;
 (ii) wherein the carrier is the porous separator; and/or 
 (iii) wherein one or more of the upper and lower electrodes is in direct contact with one or more of the polymeric actuators; and 
   (c) wherein the means for changing the pH within the electrolyte solution includes a container with pH modifying solution within the housing.   
     
     
         107 : A polymeric actuator system comprising:
 a housing;   a polymeric actuator within the housing;   a first electrode in contact with the electrolyte;   a first electrolyte in contact with the polymeric actuator and the first electrode;   a second electrode;   a second electrolyte in contact with the second electrode; and   a porous separator configured to separate the first electrolyte from the second electrolyte;   wherein the first electrolyte is configured to change in pH in response to current passing between the first electrode to the second electrode and, the polymeric actuator is configured to change volume in response to the change in pH.   
     
     
         108 : The polymeric actuator system of  claim 107 , characterized by one or more of the following features:
 (a) wherein at least one of the electrodes is in direct contact with the polymeric actuator;   (b) further comprising an electrode coupled to the first electrode that passes into the polymeric actuator;   (c) wherein the polymeric actuator comprises a plurality of discrete polymeric actuators; and, optionally, wherein the separator isolates a polymeric actuator and a corresponding electrode from another polymeric actuator and corresponding electrode;   (d) further comprising a porous carrier and wherein the polymeric actuator comprises a plurality of discrete polymeric actuators supported on the carrier in an area arrangement;   (e) wherein each carrier is the porous separator; and, optionally, wherein the porous carrier includes a surface with a plurality of wells formed therein, and each of the discrete polymeric actuators is at least partially contained by one of the wells; and wherein the surface preferably includes an upper surface, and each discrete polymeric actuator is a polymeric pillar having a long axis that is normal to the upper surface.   
     
     
         109 : An actuator system comprising:
 a housing;   a polymeric actuator having a volume disposed within the housing;   an electrolyte within the housing and in contact with the polymeric actuator;   an electrode set within the housing and configured to modulate an ion concentration or pH of the electrolyte in response to charge being passed through the electrode set; and   a power supply configured to:   (A) deliver a first positive bias charge through the electrode set during a first time period, the volume being configured to change from a first volume to a second volume in response to the delivery of the first positive bias charge; and   deliver a negative bias charge through the electrode set having a magnitude that is less than the first positive bias charge, a rate of change of the volume is configured to be reduced in response to the delivery of the negative bias charge;   (B) deliver a first positive bias charge through the electrode set during a first time period, the volume being configured to change from a first volume to a second volume in response to the delivery of the first positive bias charge;   pause for a second time period that is longer than the first time period; and   deliver a second positive bias charge during a third time period, the second positive bias charge having a greater magnitude than the first positive bias charge; or   (C) a power supply configured to programmably pass charge through the electrode such that the polymeric actuator alternates between relatively short periods of rapid expansion each followed by a relatively longer period with reduced expansion.   
     
     
         110 : The actuator system of  claim 109 , characterized by one or more of the following features:
 (A)(1) wherein the power supply is further configured to deliver a second positive bias charge through the electrode set after having delivered the first negative bias charge; and wherein the second positive bias charge preferably has a greater magnitude than the first positive bias charge;   (A)(2) wherein the polymeric actuator is configured to expand in response to the delivery of the first bias charge, and, optionally wherein
 (i) the polymeric actuator expansion substantially ceases in response to the delivery of the negative bias charge; or 
 (ii) wherein the rate of change of the volume is reduced in magnitude by at least 70% in response to the delivery of the negative bias charge; 
 (A)(3) wherein the polymeric actuator includes a plurality of discrete polymeric actuators; and, optionally, further comprising a carrier having a plurality of wells formed therein, each of the plurality of discrete polymeric actuators being partially contained within one of the wells; 
   (A)(4) further comprising:   a controller for controlling the power supply; and   a sensor configured to provide information to the controller based upon a sensed characteristic of the actuator system, the controller being configured to modify operation of the power supply in response to the provided information, and, optionally, wherein
 (i) the controller is configured to modify the magnitude of the first positive bias charge in response to the provided information so as to more accurately control the change in volume; or 
 (ii) wherein the controller is configured to modify the magnitude of the negative bias charge in response to the provided information in order to minimize the rate of change in volume, and 
   (A)(5) wherein the power supply is configured to repeatedly deliver a positive bias charge followed by a negative bias charge, the negative bias charge having a magnitude that is less than the positive bias charge; or   (B)(1) the housing is configured to expand along a single axis in response to the change in volume of the actuator, and/or   (B)(2) wherein the power supply is configured to repeatedly execute a cycle of delivering a positive bias charge during relatively short periods of more rapid expansion that are each followed by relatively long periods of reduced or no expansion.   a polymeric actuator having a volume;   an electrolyte in contact with the polymeric actuator;   an electrode set configured to modulate an ion concentration or pH of the electrolyte in response to charge being passed through the electrode set; and   (B)(3) the power supply is configured
 (i) to pass a positive bias charge through the electrode set to cause each relatively short period of rapid expansion; or 
 (ii) to pass a negative bias charge having a smaller magnitude than the positive bias charge through the electrode set to initiate each relatively longer period with reduced expansion; and, optionally, 
   (B)(4) further comprising a housing containing the polymeric actuator, the electrolyte, and the electrode set, the housing having a linear dimension configured to increase in response to the expansion.   
     
     
         111 : A method of controlling an expansion of a polymeric actuator comprising:
 providing a housing containing a polymeric actuator, an electrolyte in contact with the polymeric actuator, and an electrode set configured to modulate ion concentration or pH within the electrolyte in response to current being passed through the electrode set, the polymeric actuator having a volume that is responsive to the change in ion concentration or pH;   passing a first forward bias charge through the electrode set that is sufficient to change the volume from a first volume to a second volume; and   passing a reverse bias charge through the electrode set that is of smaller magnitude than the forward bias charge and that is sufficient to reduce a rate of change of the volume.   
     
     
         112 : The method of  claim 111 , characterized by comprising one or more of the following features:
 (a) wherein the second volume is larger than the first volume, and, optionally, further comprising passing a second forward bias charge through the electrode set that is sufficient to change the volume to a third volume that is larger than the second volume;   (b) further comprising repeatedly repeating the steps of (1) passing a forward bias charge through the electrode set sufficient to increase the volume of the polymeric actuator and (2) passing a negative bias charge through the electrode set that is sufficient to reduce a rate of change of the volume; and   (c) further comprising sensing an impedance between two electrodes of the electrode set, and optionally, wherein
 (i) the magnitude of the first forward bias charge is modified based upon the sensed impedance in order to more accurately control the change in volume, and/or 
 (ii) wherein the reverse bias charge is modified based upon the sensed impedance in order to minimize the rate of change of the volume. 
   
     
     
         113 : A method of providing a therapeutic liquid comprising:
 providing a liquid delivery device comprising:
 a housing configured to be mounted to a patient body; 
 a reservoir within the housing; 
 a fluid delivery device coupled to the reservoir and configured to deliver fluid to the patient; and 
 a controller having a memory device; 
   selecting a medication type and concentration based upon a particular class of patient conditions;   filling the reservoir with the type and concentration of the medication; and   storing information on the memory device that defines parameters that govern operation of the fluid delivery device pursuant to safety and efficacy of administration specific to the medication type and concentration.   
     
     
         114 : The method of  claim 113 , characterized by one or more of the following features:
 (a) further comprising placing the liquid delivery device into a health care facility inventory after filling the reservoir and storing the information, and, optionally, further comprising:   retrieving the liquid delivery device from inventory;   placing the liquid delivery device upon the patient's body; and   coupling the liquid delivery device to the patient's body;   (b) wherein filling the reservoir occurs prior to storing information on the memory device that defines the parameters;   (c) wherein storing information on the memory device that defines the parameters occurs before filling the reservoir; and   (d) including the step of loading an operating system on the controller;   (e) including the step of providing the liquid delivery device to a health care facility inventory, wherein the liquid delivery device includes:   the reservoir within the housing containing a medication having a type and concentration;   the controller having a memory device storing information defining parameters that govern operation of the fluid delivery device according to safety and efficacy of administration of the medication type and concentration;   a user interface; and   the controller configured to:   read the information defining the parameters;   receive inputs from the user interface; and   operate the fluid delivery device to administer the medication to the patient pursuant to the parameters;   based on a physician order, a caregiver retrieving the liquid delivery device from inventory;   the caregiver placing the housing onto the patient body;   the caregiver coupling the fluid delivery device to the patient body; and   the caregiver activating the liquid delivery device to deliver the medication to the patient;   and optionally further characterized by one or more of the following features:   (i) further comprising activating the liquid delivery device while in a pharmacy prior to retrieval by the caregiver;   (ii) wherein the fluid delivery device is in locked state when the fluid delivery device is in inventory and further comprising receiving a security input from the caregiver to unlock the device in order to enable the activation; and wherein the security input optionally is one of (1) a wireless input, (2) an input from a keypad, and (3) an input from a touch screen; and   (iii) further comprising the device issuing a warning to the caregiver if the caregiver operates the device outside of guidelines for the medication type and concentration.   
     
     
         115 : A therapeutic liquid delivery device comprising:
 a housing configured to be mounted to a patient body;   a reservoir within the housing containing a medication;   a fluid delivery device coupled to the reservoir and configured to deliver fluid to the patient;   a controller having a memory device storing information including:   (1) an operating system that is factory loaded that enables operation of the device; and   (2) parameters received from a filling and programming facility that are specific to the medication type and concentration;   a user interface;   the controller configured to:
 Read information defining the parameters; 
 Receive inputs from the user interface; and 
 Operate the fluid delivery device to administer the medication to the patient pursuant to the parameters. 
   
     
     
         116 : The device of  claim 115 , characterized by one or more of the following features:
 (a) wherein the memory device includes write once memory storing the information to prevent modification of the parameters;   (b) Wherein the parameters define selectable bolus dosages wherein a caregiver can select a bolus dosage by utilizing the user interface; and   (c) Wherein the parameters define a range of bolus dosages.   
     
     
         117 : An article of manufacture for providing a therapeutic liquid comprising:
 a liquid delivery device comprising:
 a housing configured to be mounted to a patient body; 
 a reservoir within the housing, and optionally containing a medication; 
 a fluid delivery device coupled to the reservoir and configured to deliver fluid to the patient; 
 a user interface; and 
 a controller having a computer readable storage medium having computer readable code disposed thereon for: 
   (a) storing information on the memory device that defines parameters that govern operation of the fluid delivery device pursuant to safety and efficacy of administration specific to the medication type and concentration;   (b) reading information defining parameters received from a filling and programming facility that are specific to the medication type and concentration;   receive inputs from the user interface; and   operate the fluid delivery device to administer the medication to the patient pursuant to the parameters; or   (c) storing information defining parameters that govern operation of the fluid delivery device according to safety and efficacy of administration of the medication type and concentration;   the controller configured to:   read the information defining the parameters;   receive inputs from the user interface; and   operate the fluid delivery device to administer the medication to the patient pursuant to the parameters;   based on a physician order, a caregiver retrieving the liquid delivery device from inventory.   
     
     
         118 : The article of manufacture of  claim 117 , characterized by one or more of the following features:
 (a) wherein the memory device includes write once memory storing the information to prevent modification of the parameters;   (b) wherein the parameters define selectable bolus dosages wherein a caregiver can select a bolus dosage by utilizing the user interface;   (c) wherein the parameters define a range of bolus dosages.   (d) wherein the computer readable program code further includes a computer readable program step of activating the liquid delivery device while in a pharmacy prior to retrieval by the caregiver;   (e) wherein the fluid delivery device is in locked state when the fluid delivery device is in inventory, and the computer readable program code further includes a computer program step, upon receiving a security input from the caregiver, to unlock the device in order to enable the activation; and   (f) wherein the computer readable program code further includes a computer readable program step of causing the device to issue a warning to the caregiver if the caregiver operates the device outside of guidelines for the medication type and concentration.   
     
     
         119 : A medication delivery system comprising a computer controlled liquid delivery device, including a pump, and a patient monitoring device, wherein the patient monitoring device provides feedback to the computer controlled liquid delivery device for adjusting or stopping the pump, or for signaling an alarm, if the patient monitoring device detects signs of over-or-under-medication of the patient, wherein the patient monitoring device preferably is selected from the group consisting of a pulse oximeter, a blood CO 2  sensor, a respiration rate monitor, a blood pressure monitor, and a glucose monitor.