Dispenser Components And Methods For Patient Infusion Device

Abstract

A device for delivering fluid to a patient including an exit port assembly, a reservoir including a side wall extending towards an outlet connected to the exit port assembly, a threaded lead screw received at least partly in the reservoir and longitudinally extending towards the outlet, and a plunger secured to the lead screw and having an outer periphery linearly slideable along the side wall of the reservoir. A tube is coaxially received on the lead screw and includes a longitudinal slot, a pin extending through the lead screw and the slot of the tube, and a gear is secured to the tube for rotation therewith.

1 - 70 . (canceled)  
     
     
         71 . A device for delivering fluid to a patient, comprising: 
 an exit port assembly;    a reservoir including a side wall extending towards an outlet connected to the exit port assembly;    a threaded lead screw received at least partly in the reservoir and longitudinally extending towards the outlet, the lead screw including one of a longitudinal extending groove and a laterally extending pin;    a plunger secured to the lead screw and having an outer periphery linearly slideable along the side wall of the reservoir; and    a housing containing the reservoir, the lead screw and the plunger and including the other of the longitudinal extending groove and the laterally extending pin, wherein the laterally extending pin is slidingly received within the longitudinally extending groove to allow longitudinal advancement of the lead screw and prevent rotation of the lead screw.    
     
     
         72 . A device according to  claim 71 , wherein the lead screw includes the longitudinally extending groove and the housing includes the laterally extending pin.  
     
     
         73 . A device according to  claim 72 , wherein the lead screw includes two of the longitudinally extending grooves and the housing includes two of the laterally extending pins, with one pin received in each groove.  
     
     
         74 . A device according to  claim 71 , wherein the lead screw includes the laterally extending pin and the housing includes the longitudinally extending groove.  
     
     
         75 . A device according to  claim 74 , wherein the longitudinally extending groove is unitarily formed as part of a portion of the housing.  
     
     
         76 . A device according to  claim 74 , wherein the lead screw includes two of the laterally extending pins and the housing includes two of the longitudinally extending grooves, with one pin received in each groove.  
     
     
         77 . A device according to  claim 76 , wherein the longitudinally extending grooves are unitarily formed as part of portions of the housing.  
     
     
         78 . A device according to  claim 71 , wherein the reservoir contains a therapeutic fluid.  
     
     
         79 . A device according to  claim 78 , wherein the therapeutic fluid is insulin.  
     
     
         80 . A device according to  claim 71 , wherein the exit port assembly includes a transcutaneous patient access tool.  
     
     
         81 . A device according to  claim 80 , wherein the transcutaneous patient access tool comprises a needle.  
     
     
         82 - 111 . (canceled)  
     
     
         112 . A device for delivering fluid to a patient, comprising: 
 an exit port assembly;    a reservoir including a side wall extending towards an outlet connected to the exit port assembly;    a threaded lead screw received at least partly in the reservoir and longitudinally extending towards the outlet;    a plunger secured to the lead screw and having an outer periphery linearly slideable along the side wall of the reservoir; and    a non-rotating nut assembly receiving the lead screw and including,    at least two laterally movable threaded inserts having threaded surfaces for threadedly receiving the lead screw upon being biased laterally inwardly against the lead screw,    a spring biasing the threaded inserts laterally inwardly against the lead screw; and    at least one spacer cam movable between a first position preventing the threaded inserts from being biased laterally inwardly against the lead screw and a second position allowing the threaded inserts to be biased laterally inwardly against the lead screw.    
     
     
         113 . A device according to  claim 112 , wherein, in the first position, the spacer cam is positioned between the threaded inserts.  
     
     
         114 . A device according to  claim 113 , wherein the spacer cam is laterally movable with respect to the lead screw.  
     
     
         115 . A device according to  claim 113 , wherein the spacer cam is longitudinally movable with respect to the lead screw.  
     
     
         116 . A device according to  claim 112 , further comprising a gear operatively secured to the lead screw such that rotation of the gear causes rotation of the lead screw, and wherein the spacer cam is operatively connected to the gear such that rotation of the gear causes movement of the spacer cam to the second position.  
     
     
         117 . A device according to  claim 116 , further comprising: 
 a gear cam connected to the gear; and    a spacer follower connected to the spacer cam and received against the gear cam, wherein the gear cam and the spacer follower are shaped such that rotation of the gear cam with the gear causes movement of the spacer follower and movement of the spacer cam to the second position.    
     
     
         118 . A device according to  claim 117 , wherein the spacer follower and the spacer cam are connected through a spacer ring coaxially positioned about the lead screw.  
     
     
         119 . A device according to  claim 118 , wherein the gear cam is provided as part of a gear ring coaxially positioned about the lead screw and including at least one spline extending into a keyway of the gear.  
     
     
         120 . A device according to  claim 119 , wherein the gear cam is formed in a radially outwardly facing surface of the spline.  
     
     
         121 . A device according to  claim 120 , wherein the gear ring includes a latch allowing the spacer follower to exit the gear cam and preventing the spacer follower from re-entering the gear cam.  
     
     
         122 . A device according to  claim 112 , wherein the reservoir contains a therapeutic fluid.  
     
     
         123 . A device according to  claim 122 , wherein the therapeutic fluid is insulin.  
     
     
         124 . A device according to  claim 112 , wherein the exit port assembly includes a transcutaneous patient access tool.  
     
     
         125 . A device according to  claim 124 , wherein the transcutaneous patient access tool comprises a needle.  
     
     
         126 . A device for delivering fluid to a patient, comprising: 
 an exit port assembly;    a reservoir including a side wall extending towards an outlet connected to the exit port assembly;    a threaded lead screw received at least partly in the reservoir and longitudinally extending towards the outlet, the lead screw comprised of electrically resistive material;    a plunger secured to the lead screw and having an outer periphery linearly slideable along the side wall of the reservoir;    a non-rotating longitudinally fixed nut made from electrically conductive material, the nut threadedly receiving the lead screw such that rotation of the lead screw causes linear movement of the lead screw with respect to the nut; and    a processor connected to the nut and the lead screw and programmed to detect an electrical signal between the nut and the lead screw.    
     
     
         127 . A device according to  claim 126 , wherein the processor is further programmed to determine a relative position between the nut and the lead screw based on one of the electrical signal and changes to the electrical signal.  
     
     
         128 . A device according to  claim 126 , wherein the reservoir contains a therapeutic fluid.  
     
     
         129 . A device according to  claim 128 , wherein the therapeutic fluid is insulin.  
     
     
         130 . A device according to  claim 126 , wherein the exit port assembly includes a transcutaneous patient access tool.  
     
     
         131 . A device according to  claim 130 , wherein the transcutaneous patient access tool comprises a needle.  
     
     
         132 . A device for delivering fluid to a patient, comprising: 
 an exit port assembly;    a reservoir including a side wall extending towards an outlet connected to the exit port assembly;    a threaded lead screw received at least partly in the reservoir and longitudinally extending towards the outlet;    a plunger secured to the lead screw and having an outer periphery linearly slideable along the side wall of the reservoir;    a non-rotating longitudinally fixed nut threadedly receiving the lead screw such that rotation of the lead screw causes linear movement of the lead screw with respect to the nut; and    a rotary motor mated to a proximal end of the lead screw for causing rotation of the lead screw relative to the motor; and    a longitudinal guide extending parallel with the lead screw and receiving the motor, wherein the guide allows longitudinal movement of the motor and prevents rotation of the motor.    
     
     
         133 . A device according to  claim 132 , wherein the rotary motor and the longitudinal guide have non-circular cross-sections preventing rotation of the motor with respect to the guide.  
     
     
         134 . A device according to  claim 132 , further comprising: 
 a reflector secured to the motor;    at least one light emitter fixed with respect to the motor and directed longitudinally at the reflector; and    at least one light detector fixed with respect to the motor and directed longitudinally at the reflector.    
     
     
         135 . A device according to  claim 134 , wherein the reflector is oriented at an angle with respect to the guide of the motor.  
     
     
         136 . A device according to  claim 134 , further comprising a processor connected to the light emitter and the light detector and programmed to determine a longitudinal distance of the reflector from the light emitter based upon a lateral distance between a beam of light directed from the light emitter to the reflector and the beam of light as received by the light detector from the reflector.  
     
     
         137 . A device according to  claim 132 , further comprising: 
 at least one light emitter directed laterally within the longitudinal guide; and    at least one light detector directed laterally within the longitudinal guide;    wherein one of the guide and the motor is relatively light reflective.    
     
     
         138 . A device according to  claim 137 , wherein the motor is relatively reflective.  
     
     
         139 . A device according to  claim 137 , comprising a plurality of the light emitters and light detectors spaced longitudinally within the guide.  
     
     
         140 . A device according to  claim 132 , wherein the reservoir contains a therapeutic fluid.  
     
     
         141 . A device according to  claim 140 , wherein the therapeutic fluid is insulin.  
     
     
         142 . A device according to  claim 132 , wherein the exit port assembly includes a transcutaneous patient access tool.  
     
     
         143 . A device according to  claim 142 , wherein the transcutaneous patient access tool comprises a needle.  
     
     
         144 . A device for delivering fluid to a patient, comprising: 
 an exit port assembly;    a reservoir including a side wall extending towards an outlet connected to the exit port assembly;    a threaded lead screw received at least partly in the reservoir and longitudinally extending towards the outlet;    a plunger secured to the lead screw and having an outer periphery linearly slideable along the side wall of the reservoir;    a non-rotating longitudinally fixed nut threadedly receiving the lead screw such that rotation of the lead screw causes linear movement of the lead screw with respect to the nut;    an encoder disk coaxially secured to the lead screw for rotation therewith and including radially spaced light reflective indicia thereon;    a light emitter directed at the encoder disk; and    a light detector directed at the encoder disk.    
     
     
         145 . A device according to  claim 144 , wherein the radially spaced light reflective indicia are located on an outer circumferential surface of the encoder disk.  
     
     
         146 . A device according to  claim 144 , further comprising: 
 a relatively light reflective reference element secured to the lead screw for longitudinal movement therewith;    at least one light emitter directed laterally at the lead screw; and    at least one light detector directed laterally at the lead screw.    
     
     
         147 . A device according to  claim 146 ,wherein the encoder disk includes a recess on a face thereof to receive the reference element.  
     
     
         148 . A device according to  claim 144 , wherein the reservoir contains a therapeutic fluid.  
     
     
         149 . A device according to  claim 148 , wherein the therapeutic fluid is insulin.  
     
     
         150 . A device according to  claim 144 , wherein the exit port assembly includes a transcutaneous patient access tool.  
     
     
         151 . A device according to  claim 150 , wherein the transcutaneous patient access tool comprises a needle.  
     
     
         152 - 158 . (canceled)  
     
     
         159 . A device for delivering fluid to a patient, comprising: 
 an exit port assembly;    a reservoir including a side wall extending towards an outlet connected to the exit port assembly;    a threaded lead screw received at least partly in the reservoir and longitudinally extending towards the outlet;    a plunger secured to the lead screw and having an outer periphery linearly slideable along the side wall of the reservoir;    a gear radially extending from the lead screw and made from electrically conductive material, wherein the gear and the lead screw are operatively connected such that rotation of the gear causes longitudinally movement of the lead screw towards the outlet of the reservoir;    a ratchet engaging teeth of the gear such that movement of the ratchet in a first direction causes rotation of the gear while movement of the ratchet in a second direction causes no rotation of the gear, wherein the ratchet is made from electrically conductive material;    a first electrical lead connected to the gear; and    a second electrical lead connected to the ratchet.    
     
     
         160 . A device according to  claim 159 , further comprising a processor connected to the first and second electrical leads and programmed to determine whether the gear has rotated based at least in part on electrical discontinuities between the ratchet and the gear.  
     
     
         161 . A device according to  claim 159 , further comprising at least one pawl allowing rotation of the gear in a single direction and a third electrical lead connected to the pawl, and wherein the pawl is made from electrically conductive material.  
     
     
         162 . A device according to  claim 161 , further comprising a processor connected to the first, the second and the third electrical leads and programmed to determine whether the gear has rotated based at least in part on electrical discontinuities between the ratchet, the pawl and the gear.  
     
     
         163 . A device according to  claim 159 , further comprising: 
 an elongated shape memory element having a changeable length decreasing from an uncharged length to a charged length when at least one charge is applied to the shape memory element, wherein the shape memory element is secured to the ratchet such that the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes movement of the ratchet in one of the first and the second directions; and    a processor connected to the shape memory element and the first and second electrical leads, and programmed to, 
 apply a charge to the shape memory element in order to cause rotation of the gear,  
 determine whether the gear has been rotated based at least in part on electrical discontinuities between the ratchet and the gear, and  
 remove the charge from the shape memory element upon determining that the gear has been rotated.  
   
     
     
         164 . A device according to  claim 159 , wherein the reservoir contains a therapeutic fluid.  
     
     
         165 . A device according to  claim 164 , wherein the therapeutic fluid is insulin.  
     
     
         166 . A device according to  claim 159 , wherein the exit port assembly includes a transcutaneous patient access tool.  
     
     
         167 . A device according to  claim 166 , wherein the transcutaneous patient access tool comprises a needle.  
     
     
         168 . A device for delivering fluid to a patient, comprising: 
 an exit port assembly;    a reservoir including a side wall extending towards an outlet connected to the exit port assembly;    a lead screw received at least partly in the reservoir and longitudinally extending towards the outlet;    a plunger secured to the lead screw and having an outer periphery linearly slideable along the side wall of the reservoir, such that linear movement of the lead screw towards the outlet of the reservoir forces fluid within the reservoir through the outlet to the exit port assembly;    a sensor detecting linear movement of the lead screw;    an elongated shape memory element having a changeable length decreasing from an uncharged length to a charged length when at least one charge is applied to the shape memory element, wherein the shape memory element is operatively connected to the lead screw such that the changeable length of the shape memory element decreasing from an uncharged length to a charged length causes linear movement of the lead screw towards the outlet of the reservoir; and    a processor connected to the shape memory element and the sensor detecting linear movement of the lead screw, and programmed to apply a charge to the shape memory element and remove the charge upon receiving a signal from the sensor indicative of linear movement of the lead screw.    
     
     
         169 . A device according to  claim 168 , wherein the reservoir contains a therapeutic fluid.  
     
     
         170 . A device according to  claim 169 , wherein the therapeutic fluid is insulin.  
     
     
         171 . A device according to  claim 168 , wherein the exit port assembly includes a transcutaneous patient access tool.  
     
     
         172 . A device according to  claim 171 , wherein the transcutaneous patient access tool comprises a needle.  
     
     
         173 . A device according to  claim 168 , wherein the sensor comprises: 
 a reflector secured to the lead screw;    at least one light emitter fixed with respect to the lead screw and directed longitudinally at the reflector; and    at least one light detector fixed with respect to the lead screw and directed longitudinally at the reflector.    
     
     
         174 . A device for delivering fluid to a patient, comprising: 
 an exit port assembly;    a reservoir including a side wall extending towards an outlet connected to the exit port assembly;    a threaded lead screw received at least partly in the reservoir and longitudinally extending towards the outlet;    a plunger secured to the lead screw and having an outer periphery linearly slideable along the side wall of the reservoir, such that linear movement of the lead screw towards the outlet of the reservoir forces fluid within the reservoir through the outlet to the exit port assembly;    a reflector secured to the lead screw;    at least one light emitter fixed with respect to the lead screw and directed longitudinally at the reflector; and    at least one light detector fixed with respect to the lead screw and directed longitudinally at the reflector.    
     
     
         175 . A device according to  claim 174 , wherein the reflector is oriented at an angle with respect to the lead screw.  
     
     
         176 . A device according to  claim 174 , further comprising a processor connected to the light emitter and the light detector and programmed to determine a longitudinal distance of the reflector from the light emitter based upon a lateral distance between a beam of light directed from the light emitter to the reflector and the beam of light as received by the light detector from the reflector.  
     
     
         177 . A device according to  claim 174 , wherein the reservoir contains a therapeutic fluid.  
     
     
         178 . A device according to  claim 177 , wherein the therapeutic fluid is insulin.  
     
     
         179 . A device according to  claim 174 , wherein the exit port assembly includes a transcutaneous patient access tool.  
     
     
         180 . A device according to  claim 179 , wherein the transcutaneous patient access tool comprises a needle.  
     
     
         181 . A device for delivering fluid to a patient, comprising: 
 a housing;    a reservoir contained within the housing and including a side wall extending towards an outlet;    a threaded lead screw received at least partly in the reservoir and longitudinally extending towards the outlet;    a plunger secured to the lead screw and having an outer periphery linearly slideable along the side wall of the reservoir;    means for rotating the lead screw;    means for engaging the lead screw such that rotation of the lead screw in a first direction causes the lead screw to advance longitudinally towards the outlet; and    means for sensing rotation of the lead screw.    
     
     
         182 . The device of  claim 181 , wherein the means for engaging the lead screw comprises means for moving from a disengaged state to an engaged state.  
     
     
         183 . The device of  claim 181 , further comprising a fluid path coupled to the outlet, said fluid path comprising a transcutaneous patient access tool, wherein said fluid path and transcutaneous access tool are contained within the housing when the transcutaneous access tool is in a first position.  
     
     
         184 . The device of  claim 181  further comprising means for sensing longitudinal displacement of the lead screw.