Claims for Patent: 10,569,004

Summary for Patent: 10,569,004

Title:	Apparatus for removing chemotherapy compounds from blood
Abstract:	A filter apparatus for removing small molecule chemotherapy agents from blood is provided. The filter apparatus comprises a housing with an extraction media comprised of polymer coated carbon cores. Also provided are methods of treating a subject with cancer of an organ or region comprising administering a chemotherapeutic agent to the organ or region, collecting blood laded with chemotherapeutic agent from the isolated organ, filtering the blood laden with chemotherapeutic agent to reduce the chemotherapeutic agent in the blood and returning the blood to the subject.
Inventor(s):	Daniel S. Johnston, Jacques Chammas, William M. Appling, Samantha J. Barton
Assignee:	Delcath Systems Inc
Application Number:	US16/439,620
Patent Claims:	1. A method of treating a subject with cancer of the liver, comprising: isolating blood flow out of the liver; administering a chemotherapeutic agent arterially to the isolated liver; collecting blood laden with the chemotherapeutic agent from the isolated liver; filtering the blood laden with the chemotherapeutic agent with a filter apparatus comprising a housing having an inlet and an outlet, an extraction media comprising hemocompatible polymer coated carbon cores contained within the housing, wherein the carbon cores have a pore volume of about 1.68 cc/g to about 2.17 cc/g, to provide filtered blood, and returning the filtered blood to the subject. 2. A method according to claim 1, wherein the carbon cores have a particle diameter of about 0.45 mm to about 1.15 mm. 3. A method according to claim 1, wherein the apparent density of the carbon cores is about 0.19 g/cc to about 0.2 g/cc. 4. A method according to claim 1, wherein the apparent density of the carbon cores is less than 0.2 g/cc. 5. A method according to claim 1, wherein the carbon cores have a median microporous diameter (D50, micro) of between about 9.3 Å to about 10.5 Å. 6. A method according to claim 1, wherein the carbon cores have a median mesoporous diameter (D50,meso) of between about 30 Å to about 156 Å. 7. A method according to claim 1, wherein the chemotherapeutic agent is melphalan hydrochloride. 8. A method according to claim 1, wherein the housing is a filter cartridge and the filter apparatus achieves an extraction efficiency of greater than 98% for removing melphalan hydrochloride from blood in an in vitro system where blood flow through the filter cartridge is at a rate of about 250 ml/min. 9. A method according to claim 8, wherein the extraction efficiency of greater than 98% for removing melphalan hydrochloride from blood is achieved where blood flow rate through the filter cartridge is at a rate of about 500 ml/min or less. 10. A method according to claim 1, wherein the chemotherapeutic agent is doxorubicin. 11. A method according to claim 1, wherein the filter apparatus comprises one or more filter cartridges. 12. A method of treating a cancer in a liver of a patient in need of treatment, comprising: introducing a first catheter into a femoral artery to provide access to a region of proper hepatic artery; guiding the first catheter to within the region of the proper hepatic artery for delivering melphalan hydrochloride; inserting an isolation-aspiration catheter having two balloons fixedly spaced apart into the femoral vein and guiding the isolation-aspiration catheter into the inferior vena cava; inflating the two balloons to block normal venous outflow of blood from the liver to isolate the liver; delivering a dose of melphalan hydrochloride to the liver via the first catheter within the region of the proper hepatic artery over a period of from about 15 minutes to about 45 minutes; collecting melphalan-laden blood as it exits the liver between the two inflated balloons, fixedly spaced apart, of the isolation-aspiration catheter; passing the melphalan-laden blood through a filter apparatus at a rate of between about 250 ml/min and about 1000 ml/min, wherein the filter apparatus comprises a housing having an inlet and an outlet, an extraction media comprising hemocompatible polymer coated carbon cores contained within the housing, and wherein the carbon cores have a pore volume of about 1.68 cc/g to about 2.17 cc/g, and returning blood that has passed through the filter apparatus and has been filtered to the patient. 13. A method according to claim 12, wherein returning blood that has passed through the filter apparatus and has been filtered to the patient comprises passing the blood through a third catheter that is placed in the patient's internal jugular vein. 14. A method according to claim 12, wherein the carbon cores have a particle diameter of about 0.45 mm to about 1.15 mm. 15. A method according to claim 12, wherein the apparent density of the carbon cores is about 0.19 g/cc to about 0.2 g/cc. 16. A method according to claim 12, wherein the apparent density of the carbon cores is less than 0.2 g/cc. 17. A method for delivering a small molecule chemotherapeutic agent to a selected organ, or section of an organ, of a mammalian subject while restricting systemic exposure of the mammalian subject to the small molecule chemotherapeutic agent, comprising: placing one or more catheters within venous vasculature which drains the organ, or section of an organ, at least one of the catheters having two or more expandable members; isolating the organ, or section of the organ, by occluding flow of blood within the venous vasculature which drains the organ, or section of the organ, by inflating the expandable members; delivering the small molecule chemotherapeutic agent to the isolated organ or isolated section of the organ; perfusing the small molecule chemotherapeutic agent to perfuse within the isolated organ, or section of an organ, for a period of time sufficient to provide a therapeutic effect; removing blood from the isolated organ, or section of the organ, the blood comprising the small molecule chemotherapeutic agent, and filtering the blood to remove the small molecule chemotherapeutic agent by passing the blood through a filter apparatus comprising a housing having an inlet and an outlet, an extraction media comprising hemocompatible polymer coated carbon cores contained within the housing, wherein the carbon cores have a pore volume of about 1.68 cc/g to about 2.17 cc/g. 18. A method according to claim 17, wherein the carbon cores have a particle diameter of about 0.45 mm to about 1.15 mm. 19. A method according to claim 17, wherein the apparent density of the carbon cores is about 0.19 g/cc to about 0.2 g/cc.