Method of drug delivery for ovarian cancer

Abstract

A drug delivery device has been designed to directly deliver an agent to the ovaries through direct contact with the fallopian tubes. The device consists of three main components: a tubular inserter, a cylindrical chamber and a plunger. The device is a single-use applicator designed in a shape similar to a tampon to facilitate its insertion through the vagina and into the uterus. Positioning of the device centrally in the uterus is accomplished through the use of ultrasound. The chamber is inserted into the tubular inserter. Adjusting the length of the chamber inserted into the tubular inserter controls the amount of tubing released from the apertures in the tubular inserter. Ultrasound is used to ensure the proper placement of each tube at the entrance of each fallopian tube. The plunger is inserted into the chamber and adjustment of the plunger controls the amount of the agent released into the tubes.

What is claimed is: 
     
         1 . A method of treating a disease of a female reproductive system in a patient in need thereof comprising:
 providing a drug delivery device comprising:
 a tubular inserter having a first insertion end and a first opposing end wherein a distalmost portion of the first insertion end is rounded and the first opposing end has a first flange disposed thereon; 
 a pair of apertures disposed in the first insertion end of the tubular inserter; 
 at least one tubing channel disposed within the first insertion end of the tubular inserter wherein the at least one tubing channel terminates at the pair of apertures; 
 a pair of tubes disposed in the at least one tubing channel; 
 a cylindrical chamber having a second insertion end and a second opposing end having a second flange disposed thereon wherein the cylindrical chamber is slidably received and retained within the first opposing end of the tubular inserter; and 
 a plunger having a third insertion end and a third opposing end wherein the plunger is slidably received and retained within the second opposing end of the cylindrical chamber; 
   inserting the first insertion end of the tubular inserter through vagina of the patient and into uterus so that the tubular inserter is positioned within the uterus;   inserting the cylindrical chamber into the tubular inserter;   advancing the cylindrical chamber into the tubular inserter wherein depth of advancement of the cylindrical chamber into the tubular inserter controls an amount of the pair of tubes protruding from the pair of apertures;   inserting the plunger containing a therapeutic agent for treating a disease of the female reproductive system into the cylindrical chamber;   advancing the plunger into the cylindrical chamber wherein depth of advancement controls an amount of the therapeutic agent administered to the patient; and   removing the drug delivery device from the vagina of the patient once the therapeutic agent is administered;   wherein administration of the therapeutic agent treats the disease of the female reproductive system in the patient.   
     
     
         2 . The method of  claim 1 , further comprising imaging the uterus of the patient using an ultrasound device to ensure the tubular inserter is positioned centrally in the uterus. 
     
     
         3 . The method of  claim 1 , further comprising imaging the uterus and fallopian tubes of the patient using the ultrasound device after advancement of the cylindrical chamber into the tubular inserter to a determined depth to ensure placement of the pair of tubes at entrance to the fallopian tubes. 
     
     
         4 . The method of  claim 1 , wherein the drug delivery device is further comprised of a tube extension system selected from the group consisting of:
 (a) a full chamber tubing system wherein the pair of tubes is disposed on the second flange of the cylindrical chamber and extend through the chamber and into the at least one tubing channels;   (b) a reinforced tubing extension system, further comprising
 a section of the pair of tubes extending from the at least one tubing channel wherein the section of the pair of tubes is substantially rigid and can contact the second insertion end of the chamber; 
   (c) a disc extension system, further comprising
 a disc having a first side and a second side; 
 a pair of apertures extending from the first side of the disc to the second side of the disc; 
 a pair of tubes extending from the apertures on the second side of the disc into the at least one tubing channel; 
 wherein the second side of the disc is in contact with the second insertion end of the chamber; and 
   (d) a cylindrical chamber tube extension system, wherein the pair of tubes is disposed on the second insertion end of the cylindrical chamber.   
     
     
         5 . The method of  claim 1 , wherein the drug delivery device is further comprised of a first opening in the first flange to receive the second insertion end of the chamber. 
     
     
         6 . The method of  claim 1 , wherein the drug delivery device is further comprised of a second opening in the second flange to receive the third insertion end of the plunger. 
     
     
         7 . The method of  claim 1 , wherein the drug delivery device is further comprised of a dispensing compartment disposed at the third insertion end of the plunger wherein the dispensing compartment contains the therapeutic agent. 
     
     
         8 . The method of  claim 7 , wherein advancement of the plunger positions the dispensing compartment in contact with the second insertion end of the cylindrical chamber thus dispensing the therapeutic agent. 
     
     
         9 . The method of  claim 1 , wherein the pair of tubes is substantially longer in length than the at least one tubing channel. 
     
     
         10 . The method of  claim 1 , wherein the tubular inserter is cylindrical. 
     
     
         11 . The method of  claim 1 , wherein the apertures are positioned on opposing sides of the first insertion end of the tubular inserter. 
     
     
         12 . The method of  claim 1 , wherein the disease is ovarian cancer. 
     
     
         13 . A method of delivering a therapeutic agent to a female reproductive system of a patient in need thereof comprising:
 providing a drug delivery device comprising:
 a tubular inserter having a first insertion end and a first opposing end wherein a distalmost portion of the first insertion end is rounded; 
 at least one aperture disposed in the first insertion end; 
 at least one channel disposed within the first insertion end of the tubular inserter wherein the at least one channel terminates at the at least one aperture; and 
 a plunger slidably received within the first opposing end of the tubular inserter; 
   inserting the first insertion end of the tubular inserter through vagina and into uterus of the patient;   inserting the plunger containing a therapeutic agent for treating a disease of the female reproductive system into the tubular inserter;   advancing the plunger into the tubular inserter wherein depth of advancement controls an amount of the therapeutic agent administered to the patient; and   removing the drug delivery device from the vagina of the patient once the therapeutic agent is administered;   wherein administration of the agent treats the disease of the female reproductive system in the patient.   
     
     
         14 . The method of  claim 14 , further comprising imaging the uterus of the patient using an ultrasound device to ensure the tubular inserter is positioned centrally in the uterus. 
     
     
         15 . The method of  claim 14 , wherein the drug delivery device is further comprised of at least one tube disposed within the at least one channel. 
     
     
         16 . The method of  claim 16 , wherein the at least one tube is substantially longer than the at least one channel. 
     
     
         17 . The method of  claim 16 , further comprising imaging the uterus and fallopian tubes of the patient using an ultrasound device prior to advancement of the plunger into the tubular inserter to ensure placement of the at least one tube. 
     
     
         18 . The method of  claim 14 , wherein the disease of the female reproductive system is ovarian cancer.