Extracorporeal blood oxygenation system and method for providing hemoperfusion during transluminal balloon angioplasty procedures

Claim 1

A method of providing a flow of extracorporeally oxygenated perfusion fluid through a balloon angioplasty catheter inserted into an artery of a patient whose heart and lungs are functioning absent extracorporeal cardiopulmonary support, said method comprising the steps of: a) passing a perfusion fluid through an extracorporeal membrane oxygenation device such that the perfusion fluid will become oxygenated thereby; and, subsequently, b) passing the oxygenated perfusion fluid through the catheter lumen and causing the oxygenated perfusion fluid to exit the catheter distal to the angioplasty balloon.

Claim 2

A method of providing a flow of extracorporeally oxygenated perfusion fluid through a balloon angioplasty catheter inserted into an artery of a patient whose heart and lungs are functioning absent extracorporeal cardiopulmonary support, said method comprising the steps of: a) passing a perfusion fluid through an extracorporeal membrane oxygenation device such that the perfusion fluid will become oxygenated thereby; and, subsequently, b) passing the oxygenated perfusion fluid through the catheter lumen and causing the oxygenated perfusion fluid to exit the catheter distal to the angioplasty balloon.

Claim 6

A method of providing a flow of extracorporeally oxygenated blood through a balloon angioplasty catheter, said method comprising the steps of: inserting a dual lumen introducer sheath into a blood vessel, said dual lumen introducer sheath having a first catheter introducer lumen for insertion of the angioplasty catheter therethrough and a second blood withdrawal lumen for withdrawal of blood therethrough; inserting an angioplasty catheter into the vasculature of the patient through the catheter introducer lumen of the dual lumen introducer sheath; fluidly connecting the blood withdrawal lumen of the dual lumen introducer sheath to an extracorporeal membrane oxygenation device; withdrawing blood from the blood vessel through the blood withdrawal lumen and passing the withdrawn blood through the extracorporeal oxygenation device for oxygenation therein; and passing the oxygenated blood through a lumen of the catheter and causing the oxygenated blood to exit the catheter distal to the angioplasty balloon.

Claim 7

A method of providing a flow of extracorporeally oxygenated blood through a balloon angioplasty catheter, said method comprising the steps of: inserting a dual lumen introducer sheath into a blood vessel, said dual lumen introducer sheath having a first catheter introducer lumen for insertion of the angioplasty catheter therethrough and a second blood withdrawal lumen for withdrawal of blood therethrough; inserting an angioplasty catheter into the vasculature of the patient through the catheter introducer lumen of the dual lumen introducer sheath; fluidly connecting the blood withdrawal lumen of the dual lumen introducer sheath to an extracorporeal membrane oxygenation device; withdrawing blood from the blood vessel through the blood withdrawal lumen and passing the withdrawn blood through the extracorporeal oxygenation device for oxygenation therein; and passing the oxygenated blood through a lumen of the catheter and causing the oxygenated blood to exit the catheter distal to the angioplasty balloon.

Claim 20

A method of performing transluminal balloon angioplasty in an artery of a patient whose heart and lungs are functioning absent extracorporeal cardiopulmonary support, using a balloon angioplasty catheter which has a proximal end, a distal end, at least one lumen extending therethrough and an opening distal to the balloon to permit fluid passing through the lumen to exit the catheter distal to the balloon, said method comprising: a) inserting the distal end of said angioplasty catheter into a blood vessel and advancing said angioplasty catheter such that the balloon is positioned in its desired operative position; b) inserting an intravascular cannula into a blood vessel of the patient to withdraw blood therefrom; c) providing an extracorporeal blood oxygenation device having a blood inlet and a blood outlet; d) fluidly connecting the intravascular cannula to the blood inlet of the extracorporeal blood oxygenation device; e) fluidly connecting the blood outlet of the extracorporeal blood oxygenation device to the lumen of the angioplasty catheter; and f) withdrawing blood through the intravascular cannula and pumping the withdrawn blood through the extracorporeal oxygenation device such that the blood will become oxygenated by the oxygenation device and will subsequently flow through the lumen of the catheter and out of the distal opening thereof.

Claim 21

A method of performing transluminal balloon angioplasty in an artery of a patient whose heart and lungs are functioning absent extracorporeal cardiopulmonary support, using a balloon angioplasty catheter which has a proximal end, a distal end, at least one lumen extending therethrough and an opening distal to the balloon to permit fluid passing through the lumen to exit the catheter distal to the balloon, said method comprising: a) inserting the distal end of said angioplasty catheter into a blood vessel and advancing said angioplasty catheter such that the balloon is positioned in its desired operative position; b) inserting an intravascular cannula into a blood vessel of the patient to withdraw blood therefrom; c) providing an extracorporeal blood oxygenation device having a blood inlet and a blood outlet; d) fluidly connecting the intravascular cannula to the blood inlet of the extracorporeal blood oxygenation device; e) fluidly connecting the blood outlet of the extracorporeal blood oxygenation device to the lumen of the angioplasty catheter; and f) withdrawing blood through the intravascular cannula and pumping the withdrawn blood through the extracorporeal oxygenation device such that the blood will become oxygenated by the oxygenation device and will subsequently flow through the lumen of the catheter and out of the distal opening thereof.

Claim 29

A method of performing transluminal balloon angioplasty using a balloon angioplasty catheter having a proximal end, a distal end and at least one lumen extending through the catheter and opening distal to the balloon to permit fluid passing through the lumen to exit the catheter distal to the balloon, said method comprising: a) inserting a dual lumen introducer sheath into a blood vessel, said dual lumen introducer sheath having a first lumen for insertion of the angioplasty catheter therethrough into the blood vessel and a second lumen for withdrawal of blood from the blood vessel; b) inserting the distal end of the angioplasty catheter into the blood vessel through the catheter introduction lumen of the dual lumen introducer sheath and advancing said angioplasty catheter to a desired operative location; c) providing an extracorporeal blood oxygenation device having a blood inlet and blood outlet; d) fluidly connecting the blood withdrawal lumen of the dual lumen introducer sheath to the blood inlet of the extracorporeal oxygenation device; e) fluidly connecting the blood outlet of the extracorporeal oxygenation device to the perfusion lumen fluid of the angioplasty catheter; and f) withdrawing blood through the blood withdrawal lumen of the dual lumen introducer sheath and pumping the withdrawn blood through the extracorporeal oxygenation device and subsequently through the lumen of the catheter and out of the distal opening thereof.

Claim 30

A method of performing transluminal balloon angioplasty using a balloon angioplasty catheter having a proximal end, a distal end and at least one lumen extending through the catheter and opening distal to the balloon to permit fluid passing through the lumen to exit the catheter distal to the balloon, said method comprising: a) inserting a dual lumen introducer sheath into a blood vessel, said dual lumen introducer sheath having a first lumen for insertion of the angioplasty catheter therethrough into the blood vessel and a second lumen for withdrawal of blood from the blood vessel; b) inserting the distal end of the angioplasty catheter into the blood vessel through the catheter introduction lumen of the dual lumen introducer sheath and advancing said angioplasty catheter to a desired operative location; c) providing an extracorporeal blood oxygenation device having a blood inlet and blood outlet; d) fluidly connecting the blood withdrawal lumen of the dual lumen introducer sheath to the blood inlet of the extracorporeal oxygenation device; e) fluidly connecting the blood outlet of the extracorporeal oxygenation device to the perfusion lumen fluid of the angioplasty catheter; and f) withdrawing blood through the blood withdrawal lumen of the dual lumen introducer sheath and pumping the withdrawn blood through the extracorporeal oxygenation device and subsequently through the lumen of the catheter and out of the distal opening thereof.

Claim 37

A system for maintaining hemoperfusion during transluminal angioplasty procedures, said system comprising: a balloon angioplasty catheter having a distal end, a proximal end and a perfusion lumen extending longitudinally therethrough an opening distal to the balloon such that perfusion fluid flowing through the perfusion fluid lumen may exit the catheter distal to the balloon; an extracorporeal blood oxygenation device fluidly connected to the perfusion fluid lumen of the angioplasty catheter such that oxygenated blood exiting the blood oxygenation device will pass through the perfusion fluid lumen and will exit the catheter distal to the balloon; and a pump for pumping blood through the extracorporeal blood oxygenation device and subsequently through the perfusion fluid lumen of the catheter.

Claim 38

A system for maintaining hemoperfusion during transluminal angioplasty procedures, said system comprising: a balloon angioplasty catheter having a distal end, a proximal end and a perfusion lumen extending longitudinally therethrough an opening distal to the balloon such that perfusion fluid flowing through the perfusion fluid lumen may exit the catheter distal to the balloon; an extracorporeal blood oxygenation device fluidly connected to the perfusion fluid lumen of the angioplasty catheter such that oxygenated blood exiting the blood oxygenation device will pass through the perfusion fluid lumen and will exit the catheter distal to the balloon; and a pump for pumping blood through the extracorporeal blood oxygenation device and subsequently through the perfusion fluid lumen of the catheter.

Claim 40

A system for maintaining hemoperfusion during transluminal angioplasty procedures, said system comprising: a balloon angioplasty catheter having a distal end, a proximal end and a perfusion lumen extending longitudinally therethrough an opening distal to the balloon such that perfusion fluid flowing through the perfusion fluid lumen may exit the catheter distal to the balloon; an extracorporeal blood oxygenation device fluidly connected to the perfusion fluid lumen of the angioplasty catheter such that oxygenated blood exiting the blood oxygenation device will pass through the perfusion fluid lumen and will exit the catheter distal to the balloon; a pump for pumping blood through the extracorporeal blood oxygenation device and subsequently through the perfusion fluid lumen of the catheter; and a dual lumen introducer sheath having a first lumen through which the angioplasty catheter is insertable and a second lumen through which blood may be withdrawn, said second lumen being connectable to the pump such that blood may be withdrawn from the patient through the second lumen, passed through the extracorporeal blood oxygenation device and subsequently reinfused into the patient through the perfusion lumen of the angioplasty catheter.

Claim 41

A system for maintaining hemoperfusion during transluminal angioplasty procedures, said system comprising: a balloon angioplasty catheter having a distal end, a proximal end and a perfusion lumen extending longitudinally therethrough an opening distal to the balloon such that perfusion fluid flowing through the perfusion fluid lumen may exit the catheter distal to the balloon; an extracorporeal blood oxygenation device fluidly connected to the perfusion fluid lumen of the angioplasty catheter such that oxygenated blood exiting the blood oxygenation device will pass through the perfusion fluid lumen and will exit the catheter distal to the balloon; a pump for pumping blood through the extracorporeal blood oxygenation device and subsequently through the perfusion fluid lumen of the catheter; and a dual lumen introducer sheath having a first lumen through which the angioplasty catheter is insertable and a second lumen through which blood may be withdrawn, said second lumen being connectable to the pump such that blood may be withdrawn from the patient through the second lumen, passed through the extracorporeal blood oxygenation device and subsequently reinfused into the patient through the perfusion lumen of the angioplasty catheter.

Claim 43

A method of maintaining myocardial perfusion during coronary balloon angioplasty procedures wherein an angioplasty balloon causes substantial occlusion of a coronary artery, said method comprising: a) withdrawing blood from the patient at a rate of 30-60 ml/min.; b) providing an extracorporeal membrane oxygenator which is sized and configured to operate with a bloodflow rate of 30-60 ml/min. and to substantially raise the Po 2 of blood flowing therethrough at such flow rate to a Po 2 which is above normal arterial blood Po 2 ; c) passing the withdrawn blood through the extracorporeal membrane oxygenator at 30-60 ml/min. and causing said blood to be oxygenated to a Po 2 above normal arterial Po 2 ; and d) reinfusing the oxygenated blood through the angioplasty catheter and causing the oxygenated blood to exit the angioplasty catheter distal to the occlusive balloon.

Claim 44

A method of maintaining myocardial perfusion during coronary balloon angioplasty procedures wherein an angioplasty balloon causes substantial occlusion of a coronary artery, said method comprising: a) withdrawing blood from the patient at a rate of 30-60 ml/min.; b) providing an extracorporeal membrane oxygenator which is sized and configured to operate with a bloodflow rate of 30-60 ml/min. and to substantially raise the Po 2 of blood flowing therethrough at such flow rate to a Po 2 which is above normal arterial blood Po 2 ; c) passing the withdrawn blood through the extracorporeal membrane oxygenator at 30-60 ml/min. and causing said blood to be oxygenated to a Po 2 above normal arterial Po 2 ; and d) reinfusing the oxygenated blood through the angioplasty catheter and causing the oxygenated blood to exit the angioplasty catheter distal to the occlusive balloon.

Claim 45

A method of decreasing the volume of perfusion blood necessary to maintain adequate myocardial perfusion during a coronary balloon angioplasty procedure wherein the angioplasty balloon causes substantial occlusion of a coronary artery, said method comprising: passing a quantity of perfusion blood through an extracorporeal blood oxygenation device to raise to Po 2 of said perfusion blood above normal arterial blood Po 2 ; and passing the oxygenated perfusion blood through the angioplasty catheter and causing the oxygenated perfusion blood to exit the angioplasty catheter distal to the occlusive balloon.

Claim 46

A method of decreasing the volume of perfusion blood necessary to maintain adequate myocardial perfusion during a coronary balloon angioplasty procedure wherein the angioplasty balloon causes substantial occlusion of a coronary artery, said method comprising: passing a quantity of perfusion blood through an extracorporeal blood oxygenation device to raise to Po 2 of said perfusion blood above normal arterial blood Po 2 ; and passing the oxygenated perfusion blood through the angioplasty catheter and causing the oxygenated perfusion blood to exit the angioplasty catheter distal to the occlusive balloon.

Claim 47

A method of providing a flow of extracorporeally oxygenated blood through a balloon angioplasty catheter, said method comprising the steps of: inserting a dual lumen cannula into a blood vessel; said dual lumen cannula having a first catheter introducer passageway for insertion of the angioplasty catheter therethrough and a second blood withdrawal passageway for withdrawal of blood therethrough; inserting an angioplasty catheter into the vasculature of the patient through the catheter introducer passageway of the dual lumen introducer cannula; fluidly connecting the blood withdrawal passageway of the dual lumen introducer cannula to an extracorporeal membrane oxygenation device; withdrawing blood from the blood vessel through the blood withdrawal passageway and passing the withdrawn blood through the extracorporeal oxygenation device for oxygenation therein; and passing the oxygenated blood through a lumen of the catheter and causing the oxygenated blood to exit the catheter distal to the angioplasty balloon.

Claim 48

A method of providing a flow of extracorporeally oxygenated blood through a balloon angioplasty catheter, said method comprising the steps of: inserting a dual lumen cannula into a blood vessel; said dual lumen cannula having a first catheter introducer passageway for insertion of the angioplasty catheter therethrough and a second blood withdrawal passageway for withdrawal of blood therethrough; inserting an angioplasty catheter into the vasculature of the patient through the catheter introducer passageway of the dual lumen introducer cannula; fluidly connecting the blood withdrawal passageway of the dual lumen introducer cannula to an extracorporeal membrane oxygenation device; withdrawing blood from the blood vessel through the blood withdrawal passageway and passing the withdrawn blood through the extracorporeal oxygenation device for oxygenation therein; and passing the oxygenated blood through a lumen of the catheter and causing the oxygenated blood to exit the catheter distal to the angioplasty balloon.