Cancer treatment and catheter for use in treatment

• US 5,411,479 A
• Filed: 04/30/1993
• Issued: 05/02/1995
• Est. Priority Date: 10/21/1988
• Status: Expired due to Term

• Current Assignee: Delcath Systems, Inc.
• Original Assignee: Delcath Systems, Inc.
• Inventors: Bodden, William L.
• Primary Examiner(s): RIMELL, SAMUEL G
• Application Number:
  US08/056,583
• Time in Patent Office: 732 Days
• Field of Search: 604/4, 604/5, 604/6, 604/8, 604/9, 604/10, 604/96, 604/98, 604/101, 604/102, 604/264, 604/280, 604/191, 604/192, 604/194
• US Class Current: 604/101.03
• CPC Class Codes: A61M 1/3615 Cleaning blood contaminated by local chemotherapy of a body part temporarily isolated from the blood circuit
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 2025/0003 having an additional lumen transmitting fluid pressure to the outside for measurement
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/232 Centrifugal pumps
• CPC Class Codes: A61M 60/31 for enhancement of in vivo organ perfusion, e.g. retroperfusion
• CPC Class Codes: A61M 60/36 for specific blood treatment; for specific therapy
• CPC Class Codes: A61M 60/37 Haemodialysis, haemofiltration or diafiltration
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61M 60/554 of blood pressure
• CPC Class Codes: A61M 60/818 Bearings
• CPC Class Codes: A61M 60/833 Occluders for preventing backflow
• CPC Class Codes: A61M 60/849 Disposable parts

Abstract

Perfusing a high concentration of an agent to treat an organ, such as anti-cancer agents through a body organ containing a tumor, without their entering the body'"'"'s general circulation, removing them from the organ with effluent blood and transporting the contaminated blood to an extracorporeal circuit where the blood is treated to remove the contamination, and returning the treated blood to the body. The process prevents toxic levels of the agents from entering the body'"'"'s general circulation while delivering lethal doses of the agents to the tumor. There are described various apparatus for effecting the intra- and extracorporeal treatment of such contaminated blood.

Claims

1. Apparatus for isolation and treatment of a portion of the body comprising a first catheter adapted for percutaneous insertion into a vein or artery, comprising (a) a plastic tube having a cranial end and a caudal end, said plastic tube defining a main lumen for outflowing blood, two balloons, fixedly spaced apart about said plastic tube and bonded thereto for inflation thereabout, one being contiguous to said cranial end, and said balloons, when inflated, having a size sufficient to block the flow of blood in a vein or artery into which said catheter is designed to be inserted;

fenestrations in said plastic tube between said balloons to said main lumen;

second and third lumina within said plastic tube, said second lumen connecting to one of said balloons and said third lumen connecting to the other of said balloons for effecting inflation or deflation of said balloons, said cranial end of said plastic tube being closed to any appreciable inflow of blood and (2) a second catheter for returning blood removed through said main lumen to the patient.

2. The apparatus of claim 1 wherein said cranial end is tapered to a diameter of an angiographic guide wire.

3. The apparatus of claim 2 wherein said plastic tube has a fourth lumen adapted to accommodate an angiographic guide wire.

4. The apparatus of claim 1 wherein said second and third lumina connect and are common to the interiors of said balloons.

5. The apparatus of claim 1 wherein said second and third lumina lie within the wall of said plastic tube.

7. The apparatus of claim 1 wherein said plastic tube contains an additional lumen adapted to monitor blood pressure.

8. The apparatus of claim 1 wherein the length of said plastic tube obtaining said fenestrations is in the range of nine to ten centimeters and said plastic tube has a maximum outside diameter of 24 French.

9. An apparatus of claim 1 wherein said caudal end extends through the skin of the patient to the outside of the body and terminates in a Luer fitting and a shut-off valve.

10. The apparatus of claim 1 wherein said balloons are spaced apart to isolate effluent blood from the hepatic veins when said catheter is inserted in the inferior vena cava and said fenestrations are sufficient to remove blood issuing from said hepatic veins without elevating blood pressure.

6. A catheter adapted for percutaneous insertion into a vein or artery, comprising:

a plastic tube having a cranial end and a caudal end and defining a main lumen for outflowing blood, caudal and cranial balloons, fixedly spaced apart about said plastic tube and bonded thereto for inflation thereabout, one being contiguous to the cranial end of said plastic tube, and said balloons, when inflated, having a size sufficient to block the flow of blood in a vein or artery into which said catheter is designed to be inserted;

fenestrations in said plastic tube between said balloons to said main lumen, a second and third lumina within said plastic tube, said second lumina connecting to the balloon at said caudal end and said third lumina connecting to the cranial of balloon at the cranial end for effecting inflation or deflation of said balloons, the cranial end of said plastic tube is adapted to carry a smaller return catheter and said cranial end tapers to fit about said return catheter.

11. A kit for removing a treating agent from blood perfused through a body organ of a patient, comprising:

a first catheter for isolating and removing the blood issuing from said body organ and containing said treating agent;

a detoxification means for treating said blood so removed to remove said treating agent; and

a second catheter for returning the blood so treated to said patient;

said first catheter comprising;

a plastic tube having a cranial end and a caudal end, said plastic tube defining a main lumen for outflowing blood, two balloons, fixedly spaced apart about said plastic tube and bonded thereto for inflation thereabout, one being contiguous to said cranial end of said plastic tube and said balloons, when inflated, having a size sufficient to block the flow of blood in a vein into which said catheter is designed to be inserted;

fenestrations in said plastic tube between said balloons to said main lumen and second and third lumina within said plastic tube, said second lumen connecting to one of said balloons and said third lumen connecting to the other of said balloons for effecting inflation or deflation of said balloons, said cranial end of said plastic tube being closed to any appreciable inflow of blood.

12. The kit of claim 11 wherein the detoxification means includes a treatment selected from the group consisting of hemoperfusion, hemodialysis, hemofiltration and hemoabsorption.

13. The kit of claim 11 wherein said second catheter fits within said plastic tube and said cranial end tapers to fit thereabout such that the treated blood is returned past the cranial balloon and said kit includes arterial injection means for introducing said treating agent into an artery leading to said body organ.

14. The kit of claim 11 wherein said body organ is the liver and said treating agent is an anti-cancer agent.

15. The kit of claim 11 including, in addition, an angiographic guide wire and said cranial end is tapered to a diameter of an angiographic guide wire.

16. A process for removing a treating agent from blood perfused through a body organ of a patient comprising:

isolating blood issuing from said body organ with a catheter;

removing said blood containing said treating agent from said patient through said catheter;

detoxifying the blood so removed to remove said treating agent; and

returning the blood so detoxified to the patient;

said catheter comprising;

a plastic tube having a cranial end and a caudal end, said plastic tube defining a main lumen for outflowing blood, two balloons, fixedly spaced apart about said plastic tube and bonded thereto for inflation thereabout, one being contiguous to said cranial end of said plastic tube and said balloons, when inflated, having a size sufficient to block the flow of blood in a vein into which said catheter is designed to be inserted;

fenestrations in said plastic tube between said balloons to said main lumen and second and third lumina within said plastic tube, said second lumen connecting to the one of said balloons and said third lumen connecting to the other of said balloons for effecting inflation or deflation of said balloons, said cranial end of said plastic tube being closed to any appreciable inflow of blood.

17. The process of claim 16 wherein said treating agent is an anti-cancer agent and said blood is returned to the superior vena cava, subclavian or jugular vein or to the right atrium.

18. A catheter adapted for percutaneous insertion into a vein or artery, comprising:

a plastic tube having a cranial end and defining a main lumen for outflowing blood;

two balloons fixedly spaced apart about said plastic tube and bonded thereto for inflation thereabout, one being contiguous to said cranial end, said balloons when inflated, having a size sufficient to block the flow of blood in a vein or artery into which said catheter is designed to be inserted;

fenestrations in said plastic tube between said balloons to said main lumen;

second and third lumina within said plastic tube, said second lumen connecting to one of said balloons and said third lumen connecting to the other of said balloons for effecting inflation or deflation of said balloons and a return lumen within said main lumen and extending to said cranial end, said cranial end sealing thereabout to prevent blood inflow from said cranial end into said main lumen, said return lumen discharging into the vein or artery beyond said cranial end.