Device and method for administering an anti-cancer substance

Abstract

An anti-cancer substance is administered via the patient's blood ex vivo and in line by establishing a connection between the patient and a device having a chamber containing the anti-cancer substance. The patient's blood in the chamber and the anti-cancer substance interact so that immune cells in the blood (1) are activated to produce an immune response in the patient, or (2) are pre-armed by attaching to the cells antibodies, or (3) both. After activating or pre-arming the cells, the patient's treated blood is returned to the patient. The anti-cancer substance may be within the chamber prior to drawing the patient's blood into the chamber, may be introduced into the chamber after drawing the patient's blood into the chamber, or may be introduced into the chamber concurrent with the introduction of the patient's blood into the chamber. The connection is terminated after returning to the patient's blood including the activated or pre-armed cells.

1 . A method of administering an anti-cancer substance via the patient's blood ex vivo and in line, said method comprising the steps of
 establishing an intravenous connection between the patient and a chamber containing antibodies,   drawing the patient's blood into the chamber to treat the effector cells in the blood by attaching the antibodies to said effector cells via Fc receptors on said effector cells,   without terminating the intravenous connection and after treating the effector cells, returning the patient's blood including the treated effector cells to the patient, and   terminating the intravenous connection.   
     
     
         2 . A medical device for introducing into the blood of a patient an anti-cancer substance, said device comprising
 a chamber containing the anti-cancer substance,   a first mechanism for establishing a connection between the patient and the chamber to enable blood to be withdrawn from the patient and treated by mixing with the anti-cancer substance, and   a second mechanism for returning to the patient the patient's blood including the treated cells and then for terminating the connection.   
     
     
         3 . The device of  claim 2  where the first mechanism establishes an intravenous connection. 
     
     
         4 . The device of  claim 2  where the second mechanism establishes an intravenous connection. 
     
     
         5 . The device of  claim 2  where the second mechanism establishes a subcutaneous connection. 
     
     
         6 . The device of  claim 2  where the chamber has an internal surface comprising a polymeric material that interacts with immune cells to stimulate effector cell functions. 
     
     
         7 . The device of  claim 2  where the chamber has an internal structure that provides multiple surfaces to which antibodies can attach themselves and to which immune cells can contact. 
     
     
         8 . The device of  claim 7  where interiors of a plurality of microtubules provide said multiple surfaces. 
     
     
         9 . The device of  claim 2  where the internal structure is a polymeric material. 
     
     
         10 . The device of  claim 2  where said chamber comprises a plurality of microtubules bundled into an array having a opposed open ends and an anti-cancer substance attached internal surfaces of the microtubules to contact with blood flowing through the microtubules between the open ends. 
     
     
         11 . A medical device for introducing into the blood of a patient an anti-cancer substance, said device comprising
 a chamber having a port,   a first mechanism for establishing an intravenous connection between the patient and the chamber to draw blood from the patient and mix the patient's blood with an anti-cancer substance introduced into the chamber, and   a second mechanism operably connected to the port while the intravenous connection is established for drawing the patient's blood into the chamber and for expelling treated blood from the chamber to return to the patient said mix of the patient's blood and anti-cancer substance.   
     
     
         12 . The device of  claim 11  where said chamber includes a plurality of microtubules. 
     
     
         13 . A medical device for introducing into the blood of a patient an anti-cancer substance, said device comprising
 a chamber having a first port into which blood from the patient is introduced and a second port adapted to be connected to a syringe to enable blood from the patient to be drawn into or expelled from the chamber through the first port upon operation of the syringe,   said chamber comprising a plurality of parallel microtubules, said microtubules being in communication via opposed open ends of the microtubules with the first and second ports so that the patient's blood flows into or from the chamber through the open ends of the microtubules in response to the operation of the syringe,   said microtubules having interior wall surfaces to which at numerous points thereof are attached individual molecules of the anti-cancer substance, said interior wall surface comprising a material that electrostatically attracts and holds individual molecules, said attached individual molecules oriented in a predetermined manner to assist in binding to effector cells in the patient's blood upon said blood being drawn into the chamber and flowing into the microtubules.   
     
     
         14 . A medical device for introducing into the blood of a patient an anti-cancer substance, said device comprising
 a chamber having a sidewall and opposed end walls enclosing an open space,   first and second spaced apart ports in the sidewall, a third port in one end wall and a forth port in the other end wall, and   an array of microtubules within an open space within the chamber in fluid communication with the first and second ports so that when the ports in the sidewall are connected to the patient blood from the patient flows through the chamber,   said second and third ports being adapted to be placed in communication with a source of fluid in a manner enabling the fluid to flow through the open space concurrent with blood from the patient flowing through the chamber.   
     
     
         15 . A method of activating immune cells in a patient's blood comprising the steps of
 treating the patient's blood in line by establishing a connection between the patient and a chamber comprising a plurality of microtubules bundled into an array having opposed open ends, said microtubules providing an internal surface structure to which antibodies are attached,   drawing the patient's blood into the chamber so that the blood flows through the microtubules between the open ends and is retained in the chamber for a predetermined dwell time that is on average a minimum of 15 seconds so that immune cells in the blood contact and interact with the antibodies to produce a beneficial response in the patient,   returning the treated patient's blood to the patient, and   terminating the connection.   
     
     
         16 . The method of claim  35  where the internal surface comprises a polymeric material that interacts with immune cells to stimulate effector cell functions. 
     
     
         17 . The method of claim  36  where said individual antibodies are oriented so Fc receptors on individual antibodies are remote from the points of attachment to enable the receptors to bind to the immune cells in the patient's blood.