Method And Device For Drug Delivery

Abstract

Systems, devices and methods for delivery of a chemical substance to the body of the patient are provided. Such embodiments may include an infusion catheter configured to be inserted into tissue, a catheter securing element configured to be adhered to the skin of the patient and further configured to secure the infusion catheter to the skin, a drug delivery pump configured to infuse a drug into the infusion catheter for delivery to a drug infused region on the body of the patient, and a treatment element configured to apply a treatment to the drug infused region to improve pharmacodynamics of the drug during a period of delivery of the drug to the patient.

1 - 346 . (canceled) 
     
     
         347 . A system for delivering a therapeutic substance into the body of a patient, comprising:
 a drug delivery device including
 a drug delivery pump coupled to a drug reservoir containing the therapeutic substance; and 
 a detection unit coupled to the drug delivery pump, the detection unit including a sensor for detecting delivery of the therapeutic substance; 
   an infusion set including
 an infusion catheter for insertion into the body of the patient; 
 a tube connecting the infusion catheter with the drug delivery device and configured to allow delivery of the therapeutic substance from the drug delivery device to the infusion catheter; 
 a treatment element for applying treatment to a region on the body of the patient in which the therapeutic substance is infused; and 
 a control unit for initiating a predetermined treatment profile using the treatment element when the drug delivery device starts drug infusion; 
   at least one power source for powering at least one of the drug delivery device and the infusion set;   wherein the detection unit is configured to transmit a wireless communication signal to the control unit upon detection of the delivery of the therapeutic substance, the wireless communication signal is indicative of at least a rate at which the therapeutic substance is being delivered to the body of the patient;   wherein the control unit is configured to initiate the predetermined treatment profile based on at least the rate at which the therapeutic substance is being delivered to the body of the patient.   
     
     
         348 . The system according to  claim 347 , wherein the therapeutic substance is selected from a group consisting of: insulin, insulin analogues and insulin mimetics. 
     
     
         349 . The system according to  claim 347 , wherein the treatment is applied short time before, during and/or after an infusion of the therapeutic substance. 
     
     
         350 . The system according to  claim 347 , wherein the treatment is configured to modify pharmacokinetic and/or pharmacodynamic profile of the therapeutic substance;
 wherein the pharmacokinetic and/or pharmacodynamic profile of the therapeutic substance is modified to perform at least one of the following actions: enable a faster onset of action of the substance infused into the infused region; enable a faster peak of action of the substance infused into the infused region; enable a faster clearance of the therapeutic substance from the infused region to the circulatory system of the patient; improve the repeatability of the pharmacokinetic and/or pharmacodynamics profile in response to the infusion of the therapeutic substance; to reduce a variability of absorption of the therapeutic substance into the blood system and/or lymphatic system of the patient; to reduce a variability of onset of action of the therapeutic substance; to reduce a variability of time to peak of action of the therapeutic substance; and to reduce a variability of the clearance of the therapeutic substance from the infused region to the circulatory system of the patient.   
     
     
         351 . The system according to  claim 347 , wherein the rate at which the therapeutic substance is being delivered is selected from a group consisting of: a bolus rate and a basal rate. 
     
     
         352 . The system according to  claim 347 , wherein the treatment is selected from a group consisting of: a heating device configured to heat the infused region; an optical radiation device configured to irradiate the infused region with optical radiation; a microwave generator or emitter configured to irradiate the infused region with microwave radiation; a radio frequency electromagnetic radiation generator or emitter configured to irradiate the infused region with radio frequency electromagnetic radiation; a vibration device configured to vibrate and/or massage the infused region; a vacuum device configured to apply suction to the infused region; an electric field generator and/or emitter configured to apply an electric field to the infused region; a magnetic field generator or emitter configured to apply magnetic field to the infused region; and an acoustic signal generator and/or emitter configured to apply acoustic stimulation to the infused region. 
     
     
         353 . The system according to  claim 347 , wherein the treatment device is configured to apply one or more additional substances to the infused region wherein the one or more additional substances is configured to perform at least one of the following actions: modify the pharmacokinetic and/or pharmacodynamic profile of the therapeutic substance; modify absorption of the therapeutic substance into the blood system and/or lymphatic system of the patient; and promote clearance of the therapeutic substance from the infusion region. 
     
     
         354 . The system according to  claim 347 , wherein the treatment element is a heater element configured to apply heat to the infused region. 
     
     
         355 . The system according to  claim 354 , further comprising a thermostat for automatically regulating a heating temperature at which heat is applied by the heater element to the infused region, the heating temperature is being detected by a temperature sensor disposed in the thermostat;
 wherein the thermostat is configured to increase and/or decrease power supplied to the heater element based on the temperature detected by the temperature sensor.   
     
     
         356 . The system according to  claim 354 , wherein the infused region is heated to a temperature that does not damage the therapeutic substance. 
     
     
         357 . The system according to  claim 354 , wherein the heater does not heat the drug reservoir. 
     
     
         358 . The system according to  claim 354 , wherein the heater element is configured to heat the infused region without heating the therapeutic substance above a limiting temperature prior to infusion of the therapeutic substance into the infused region, or prior to the therapeutic substance being infused into an end of the infusion catheter. 
     
     
         359 . The system according to  claim 358 , wherein the limiting temperature is about 37 degrees C. 
     
     
         360 . The system according to  claim 354 , where the control unit is configured to regulate heating of the infused region to stabilize a temperature of the infused region at a predetermined temperature. 
     
     
         361 . The system according to  claim 360 , wherein the predetermined temperature is between about 37 degrees C. and about 42 degrees C. 
     
     
         362 . The system according to  claim 360 , wherein, wherein the predetermined temperature is between about 37 degrees C. and about 39 degrees C. 
     
     
         363 . The system according to  claim 360 , wherein, wherein the predetermined temperature is between about 32 degrees C. and about 37 degrees C. 
     
     
         364 . The system according to  claim 354 , wherein the heater element is configured to apply heat subsequent to an infusion of a bolus dose of the therapeutic substance for a period of between about 10 minutes and about 30 minutes. 
     
     
         365 . The system according to  claim 354 , wherein the heater element is configured to apply heat subsequent to an infusion of a bolus dose of the therapeutic substance for a period of between about 1 minutes and about 10 minutes. 
     
     
         366 . The system according to  claim 347 , further comprising a glucose level sensor for detecting glucose level in the body of the patient;
 wherein the control unit is configured to receive the detected glucose level reading from the glucose level sensor and further configured to control by way of an algorithm an infusion rate of the therapeutic substance into the infused region and the treatment element to regulate the glucose level in the body of the patient.