Drug Delivery Systems and Methods for Modulating the Fetal Environment and Pregnancy Process

Abstract

Systems and Methods are described for treatment of fetal disorders, promotion of fetal health, and extension of the pregnancy period. A drug delivery system (DDS) can perform both bolus and continuous delivery of substances in accordance with sensed data reflecting the current state of a fetus. The methods and systems for promotion of healthy pregnancy and treatment of a developing fetus can alter the drug delivery, by evaluating the sensed data with respect to the age or physical characteristics of the fetus and/or mother.

1 . A method using a drug delivery system for modulating the fetal environment, said method comprising: 
 a. sensing data from at least one sensor configured to provide sensed data from at least one of the following: a pregnant female and a fetus,    b. evaluating said sensed data to obtain a positive or negative result, and    c. in the case of a positive result operating a drug delivery system according to a drug delivery protocol to cause drug delivery.    
     
     
         2 . The method of  claim 1  wherein said positive result determines which of at least two drug delivery protocols is used to accomplish drug delivery.  
     
     
         3 . The method of  claim 1  wherein said positive result serves as a control signal which controls drug delivery.  
     
     
         4 . The method of  claim 1  wherein said positive result occurs when a medical event is detected.  
     
     
         5 . The method of  claim 1  wherein evaluating said data to obtain a positive or negative result comprises comparing sensed data to at least one of the following comparison measures: a self norm, population norm, an absolute value, percentage value, a value calculated from a ratio, multivariate equation, and a model.  
     
     
         6 . The comparison measures of  claim 1  wherein any of the comparison measures are derived in relation to at least one of the following: age, gestational age, physical characteristics including fetal head or abdominal circumference, or body volume, maternal or fetal weight, and predicted age.  
     
     
         7 . The method of  claim 1  wherein said at least one sensor includes at least one of: a biosensor, a chemical sensor, an optical sensor, an electrode for sensing ECG and EEG signals, a PH sensor, a gas sensor, a flow sensor, and a pressure sensor.  
     
     
         8 . The method of  claim 1  wherein said drug delivery consists of delivering at least one of the following: blood thinning agents, anticoagulants.  
     
     
         9 . The method of  claim 1  wherein said drug delivery consists of delivering drugs to at least one of the following: a vessel in the umbilical cord, an umbilical vein, the placenta, the womb, the amniotic fluid, the maternal side of the placenta, the fetal side of the placenta, the arterial passageways of the umbilical cord, the chorion plate, the placenta, and the uterus.  
     
     
         10 . The method of  claim 1  wherein said sensors sense data from at least one of the following: a vessel in the umbilical cord, an umbilical vein, the placenta, the womb, the amniotic fluid, the maternal side of the placenta, the fetal side of the placenta, the arterial passageways of the umbilical cord, the chorion plate, the placenta, and the uterus.  
     
     
         11 . The method of  claim 1  wherein said drug delivery system periodically operates in a sample-push mode in order to provide samples to medical personal.  
     
     
         12 . A method of using the drug delivery system of  claim 1  wherein modulating the fetal environment decreases the risk of pre-term labor and drug delivery delivers at least on of the following: tocolytics, oxytocin antagonists, cyclo-oxygenase inhibitors, calcium channel blockers, and beta2 agonists.  
     
     
         13 . A method of  claim 1  wherein modulating the fetal environment decreases the incidence of intrauterine infection and abnormal bacterial levels.  
     
     
         14 . The method of  claim 1  in which the at least one sensor is configured to sense at least one of the following: interleukin-6 or fibronectin in cervical secretions and in amniotic fluid, C-reactive protein level of the maternal venous blood, and the said drug delivery is an antibiotic.  
     
     
         15 . The method of  claim 1  wherein modulating the fetal environment augments the immune system of the fetus, and wherein drug delivery comprises delivering selenium.  
     
     
         16 . A method for modulating the fetal environment using a drug delivery system, said method comprising implanting a drug delivery system to provide drug delivery directly to at least one of the following: the umbilical cord, the placenta, the amniotic fluid.  
     
     
         17 . The method of  claim 16 , wherein the drug delivery system is at least one of the following: at coated stent, a constant flow implantable drug pump.  
     
     
         18 . The method for treating a fetal disorder of  claim 1 , wherein the step of delivering drug therapy comprises the steps of: 
 scheduling a drug delivery event;    awaiting the drug delivery event; and    delivering drug delivery even representative of the treatment protocol.    
     
     
         19 . The method of claims  1  and  16  wherein the modulating of the fetal environment comprises using a drug treatment protocol designed to achieve at least one of the following 
 a. improve the nutritional content of fluids flowing to the fetus    b. treat a disorder of the placenta    c. treat at least one of: a hypoxic disorder, a metabolic disorder, a genetic disorder, physiological disorder, hormonal disorder, and an anatomic disorder of the fetus    d. treat at least one of: a metabolic disorder, genetic disorder, nutritional disorder, physiological disorder, hormonal disorder, and anatomic disorder, of the mother    e. compensate for substances to which the fetus is exposed due to a drug to which the mother is exposed    f. reduce the risk of preterm labor    g. treat fetal insufficiency    h. reduce the likelihood of, or in the treatment of infections and bacterial growth.    i. reduce the effects of toxins, and other harmful substances    j. reduce the effects of at least one substance that has at least one harmful effect on the fetus when said substance is present above a specific level    k. reduce the effects of at least one substance that has at least one harmful effect on the fetus when said substance fluctuates over a specified amount of time beyond a specified level.    
     
     
         20 . The methods of  claim 1  and  16  wherein drug delivery constitutes delivering a drug which causes a chemical or molecular transformation in at least one substance that produces a harmful effect on the fetus so that the harmful effect of this substance is decreased.  
     
     
         21 . The method of  claim 20 , where the substance is carbon dioxide, bicarbonate, lactic acid, and hydrogen ions and the harmful effect is acidosis.  
     
     
         22 . The disorders of the placenta of  claim 19 , wherein the disorder is chosen from at least one of the following: an anatomical, a biochemical, metabolic, or a transport disorder.  
     
     
         23 . The method of  claim 19  wherein the drug delivery protocol is based upon at least one characteristic of the fetus, said characteristic chosen from the following: gestational age, fetal metabolic level, metabolites produced by the fetus, fetal weight, fetal head circumference, and the volume of an anatomic structure of the fetus.  
     
     
         24 . A method of using an implantable drug delivery system to deliver one or more drugs to provide medical treatment to a patient#1 which comprises a modification of the drug delivery regimen based upon data relating to at least one of the following: data relating to prior drug delivery, data relating to the patient #1, data relating to the patient #2, and data relating to both patient #1 and patient #2.  
     
     
         25 . A method of using the implantable DDS for delivering one or more drugs to provide medical treatment to patient #1  claim 24 , wherein said patient #1 is a mother and patient #2 is a fetus and modification comprises limiting the total amount of drug delivered with respect to a specified amount of time.  
     
     
         26 . A method of using the implantable DDS for delivering one or more drugs to provide medical treatment to patient #1  claim 24 , wherein said patient #1 is the mother and patient #2 is a fetus and said modification comprises delivering a second drug.  
     
     
         27 . A method of using the implantable DDS for delivering one or more drugs to provide medical treatment to patient #1  claim 24 , wherein said patient #1 is a fetus and patient #2 is a mother and modification comprises limiting the total amount of drug delivered with respect to a specified amount of time.  
     
     
         28 . A method of using an implantable drug pump to provide medical treatment to a fetus which includes removing a substance which is harmful to a fetus by at least one of the following: controlled shunting of said substance to a distal location, filtration, dispensing a drug which will chemically affect said harmful substance to provide therapeutic relief.  
     
     
         29 . The method of  claim 28  wherein the substance which is harmful is a heavy metal and the disorder is autism.  
     
     
         30 . A drug delivery system, for modulating the fetal environment comprising an implantable drug delivery system containing a drug selected to treat a specific medical condition in a pregnant female.  
     
     
         31 . The drug delivery system of  claim 30 , wherein said drug is selected to be at least one of the following: tocolytics, oxytocin antagonists, cyclo-oxygenase inhibitors, calcium channel blockers, selenium, and beta2 agonists.  
     
     
         32 . The drug delivery system of  claim 30 , wherein, said implantable drug delivery system provides a rate of drug delivery which is approximately 5-50% that provided by drug delivery systems configured for adults.  
     
     
         33 . The drug delivery system of  claim 30 , which also includes a database of at least one drug delivery protocol configured to treat or deter the harmful affects of a fetal disorder.