Device for extracorporeal photo-isomerization for hyperbilirubinemia, and method thereof

Abstract

The invention provides a device for extracorporeal photo-isomerization of bodily fluid containing bilirubin. The bodily fluid derives from a patient suffering from an elevation of unconjugated bilirubin. The device includes a sterile tubing which accesses the patient's bodily fluids (especially blood), routes the fluid into an extracorporeal chamber within which irradiation of bodily fluids takes place, and returns bodily fluids to the patient. Bodily fluids are continuously circulated through a single length of sterile tubing using an adjustable pump to regulate the flow, and as the fluid passes into the extracorporeal chamber it is irradiated by blue light within the chamber with an emission wavelength range of approximately 450 to 530 nm. This irradiation induces a photochemical reaction in bilirubin that changes its structure and facilitates improved excretion of bilirubin once it is returned to the patient. The extracorporeal photo-isomerization turns the bilirubin into a more readily excreted form.

What is claimed is: 
     
         1 . A closed-loop extracorporeal photo-isomerization apparatus for treating mammalian fluids having abnormal levels of bilirubin, said apparatus comprising:
 (a) an extracorporeal irradiation chamber for exposing said fluids to blue light;   (b) means for receiving from a mammal said fluid and pumping it through flexible and clear sterile tubing housed in said irradiation chamber and returning to the mammal said fluid after passage through the irradiation chamber;   (c) optional means for oxygenating said body fluids.   
     
     
         2 . A closed loop method for reducing harmful high levels of bilirubin in the blood supply of a mammal afflicted with a disorder causing said high levels of bilirubin, comprising the steps of:
 (a) withdrawing whole blood from said mammal;   (b) forming said whole blood into an extracorporeal stream;   (c) flowing said stream through flexible and clear sterile tubing housed in an irradiation chamber;   (d) irradiating said withdrawn whole blood while flowing in said irradiation chamber with blue light radiation to effect photoisomerization of bilirubin, thereby reducing the harmful levels of bilirubin; and   (e) returning the irradiated whole blood to said mammal.   
     
     
         3 . The method according to  claim 2 , whereby irradiation with electromagnetic radiation with wavelengths of at least 430 nm is conducted. 
     
     
         4 . The method of  claim 3 , wherein said electromagnetic radiation has a wavelength in the spectrum from 450 to 530 nm. 
     
     
         5 . The method of  claim 2 , wherein said mammal is a human patient. 
     
     
         6 . The method of  claim 5 , wherein said patient has liver failure. 
     
     
         7 . The method of  claim 5 , wherein the patient is past the onset of puberty. 
     
     
         8 . The method of  claim 5 , wherein the patient is an adult. 
     
     
         9 . The method of  claim 5 , wherein the patient has Crigler-Najjar Syndrome. 
     
     
         10 . The method of  claim 5 , wherein the patient has Sickle cell anemia. 
     
     
         11 . The method of  claim 5 , wherein the patient has Hereditary spherocytosis. 
     
     
         12 . The method of  claim 5 , wherein the patient has α- and β-Thalassemia. 
     
     
         13 . The method of  claim 2  further including the step of oxygenating the blood. 
     
     
         14 . The method of  claim 13 , wherein said oxygenation is done in conjunction with an oxygen mask fitted to the patient. 
     
     
         15 . The method of  claim 2 , wherein said withdrawing and returning of the blood to the patient is done via an arteriovenous fistula. 
     
     
         16 . The method of  claim 2 , wherein said withdrawing and returning of the blood to the patient is done via venous catheter or arteriovenous graft. 
     
     
         17 . The apparatus of  claim 1 , wherein the tubing passes across the irradiation chamber's clear horizontal surface. 
     
     
         18 . The apparatus of  claim 1 , wherein said optional means for oxygenating the blood is an oxygen-filled antechamber surrounding oxygen-permeable tubing. 
     
     
         19 . The apparatus of  claim 1 , used in conjuction with a hemodialysis or dialysis apparatus. 
     
     
         20 . The apparatus of  claim 1 , used in conjuction with a transfusion apparatus.