Injection Methods Using A Servo-Controlled Needle-Free Injector

Abstract

A method for injecting a substance through a biological body surface includes providing a needle-free transdermal transport device configured to inject the substance through the surface. The substance is injected into the biological body with the transport device while a parameter of the injection is sensed and a servo-controller is used to dynamically adjust at least one injection characteristic based on the sensed parameter. The substance is injected for (i) a first time period during which a first portion of a volume of the substance is injected at a first injection pressure, and (ii) a second time period during which a remainder of the volume of the substance is injected at a second injection pressure. A viscosity of the substance may be determined, and a pressure calculated for injecting the substance based on the viscosity. The substance may be injected with the transport device by using the calculated pressure.

1 . A method for injecting a substance through a surface of a biological body, the method comprising the steps of:
 providing a needle-free transdermal transport device configured to inject the substance through the surface of the biological body; and   injecting the substance into the biological body with the transport device while
 (i) sensing at least one parameter associated with the injection, the at least one parameter comprising temperature of the injected substance; and 
 (ii) using a servo-controller to dynamically adjust at least one injection characteristic based on the at least one parameter, the servo-controller adjusting an injection profile during the injection in response to the at least one Parameter, 
   wherein the substance is injected according to the injection profile for (i) a first time period during which a first portion of a volume of the substance is injected at the first injection pressure, and (ii) a second time period during which a remainder of the volume of the substance is injected at a second injection pressure.   
     
     
         2 . The method of  claim 1 , wherein sensing the at least one parameter further comprises sensing at least one of injection pressure, sensed pressure within the transport device, position, volume, mechanical impedance, force, current, and voltage. 
     
     
         3 . The method of  claim 1 , wherein the at least one injection characteristic is selected from the group consisting of depth of injection and volume of injected substance. 
     
     
         4 . The method of  claim 1 , further comprising, prior to injecting the substance, pre-programming the transport device with a jet velocity waveform. 
     
     
         5 . The method of  claim 4 , wherein the jet velocity waveform comprises a first jet velocity, the first time period, a second follow-through velocity, and the volume. 
     
     
         6 . The method of  claim 5 , wherein the second time period is determined by the needle-free transdermal transport device. (Original) The method of  claim 1 , wherein the needle-free transdermal transport device comprises a coil, and the injection characteristic is dynamically controlled on the basis of measured coil displacement. 
     
     
         8 . The method of claim  7 , wherein the needle-free transdermal transport device comprises a position sensor, and coil displacement is measured by sensing the coil displacement with the position sensor. 
     
     
         9 . (canceled) 
     
     
         10 . The method of  claim 1 , wherein the substance comprises a viscous solution. 
     
     
         11 . The method of  claim 1 , wherein the substance comprises a polymeric material having at least one property that is temperature-dependent. 
     
     
         12 . The method of  claim 11 , wherein the substance comprises a biodegradable polymer allowing controlled release of a drug contained therein. 
     
     
         13 . (canceled) 
     
     
         14 . (canceled) 
     
     
         15 . (canceled) 
     
     
         16 . (canceled) 
     
     
         17 . A control system for a needle-free transdermal transport device configured to inject a substance through a surface of a biological body, the control system comprising:
 a sensor for sensing a parameter of the injection, the parameter comprising temperature of the injected substance; and   a servo-controller to dynamically adjust at least one injection characteristic based on the parameter, the servo-controller adjusting an injection profile during the injection in response to the parameter,   wherein the sensor and the servo-controller control the injection of the substance such that the substance is injected according to the injection profile for (i) a first time period during which a first portion of a volume of the substance is injected at a first injection pressure, and (ii) a second time period during which a remainder of the volume of the substance is injected at a second injection pressure.   
     
     
         18 . (canceled) 
     
     
         19 . The control system of  claim 17 , wherein the needle-free transdermal transport device comprises a jet injector including an electromagnetic actuator having a moving element, and wherein the injection characteristic is dynamically controlled on the basis of measured displacement of the moving element. 
     
     
         20 . The control system of  claim 19 , wherein the servo-controller comprises a velocity-driven feed-forward (FF) model that predicts an electrical input required to drive the electromagnetic actuator to achieve a given jet-speed, and a proportional-integral (PI) displacement feed-back controller to counteract noise and disturbances to the jet injector. 
     
     
         21 . A needle-free transdermal transport device comprising:
 a needle-free injector configured to inject a substance through a surface of biological body;   a sensor for sensing a parameter of the injection, the parameter comprising temperature of the injected substance;   a servo-controller to dynamically adjust at least one injection characteristic based on the parameter, the servo-controller adjusting an injection profile during the injection in response to the parameter,   wherein the sensor and the servo-controller control the injection of the substance such that the substance is injected according to the injection profile for (i) a first time period during which a first portion of a volume of the substance is injected at a first injection pressure, and (ii) a second time period during which a remainder of the volume of the substance is injected at a second injection pressure.   
     
     
         22 . The device of  claim 21 , wherein the needle-free injector comprises a jet injector including an electromagnetic actuator having a moving element, and wherein the injection characteristic is dynamically controlled on the basis of measured displacement of the moving element. 
     
     
         23 . The device of  claim 22 , wherein the servo-controller comprises a velocity-driven feed-forward (FF) model that predicts an electrical input required to drive the electromagnetic actuator to achieve a given jet-speed, and a proportional-integral (PI) displacement feed-back controller to counteract noise and disturbances to the jet injector.