Arterial perfusion cannula and method for providing cardiopulmonary bypass

A process of preparing a multichannel catheter that is of a size suitable for insertion into a blood vessel of a mammal, which process comprises:

• extrusion molding a catheter having distal and proximal ends wherein the catheter comprises:
• a first channel extending substantially the length of the catheter, the first channel comprising a major portion of the available channel volume of the catheter and being defined by the wall of the catheter;
• a second channel extending substantially the length of the catheter parallel to said first channel but independent thereof, the second channel being integrated into the wall of the first channel;
• a third channel extending substantially the length of said catheter parallel to said first and second channels but independent thereof, the third channel comprising, in combination with the second channel, not more than a minor portion of the available channel volume of the catheter, the third channel being integrated into the wall of the first channel and being spaced from said second channel.

A process for providing oxygen-rich blood to a patient's arterial circulation while providing a biologically active fluid to the heart of the subject, which process comprises:

• positioning a multichannel catheter having a proximal end and a distal end in the patient's aorta, wherein said multichannel catheter comprises:
• a first channel extending substantially the length of the catheter, the first channel comprising a major portion of the available channel volume of the catheter and being closed at the distal end of said catheter, the first channel being defined by the wall of the catheter;
• a second channel extending substantially the length of the catheter parallel to said first channel but independent thereof and being integrated into the wall of the first channel;
• a third channel extending substantially the length of said catheter parallel to said first and second channels but independent thereof, the third channel comprising, in combination with the second channel, a minor portion of the available channel volume of the catheter and being integrated into the wall of the first channel and spaced from said second channel;
• a plurality of openings near the distal end of said catheter communication only with said first channel;
• at least one opening at the distal end of the catheter communicating with said second channel;
• an inflatable means integrated into the distal end of the catheter between said first channel openings and said second channel opening and communicating with said third channel through an opening in the wall of the catheter;
• providing a source of oxygen-rich blood to the proximal end of said first channel;
• providing a source of biologically active fluid to the proximal end of said second channel;
• providing a source of fluid for inflating said inflatable means at the proximal end of said third channel;
• positioning said multichannel catheter within the subject's blood circulatory system such that the distal end of said catheter is positioned in the ascending aorta so that the first channel openings are located upstream of the inflatable means, the inflatable means being located on the cephalid side of the aortic valve and the distal end of the second channel being located downstream of the inflatable means and proximate the aortic valve;
• optionally inflating said inflatable means to block the flow of blood to the heart;
• pumping biologically active fluid into the heart;
• pumping oxygen-rich blood through said first channel out the first channel openings at a rate sufficient to maintain the subject's metabolism and perfusion;
• optionally performing cardiovascular surgery on the heart as needed;
• and
• maintaining the circulatory support for said subject as needed.

A process for performing cardiovascular surgery, which process comprises:

• inserting at least one cannula into the mammal's peripheral veins so that the distal open end of the cannula is adjacent the vena cava regions of the mammal's heart and the proximal end of the cannula is attached to a cardiopulmonary machine through a pump, said cardiopulmonary machine having a blood oxygenation means fluidly connected to said pump;
• inserting a multichannel catheter having a proximal end and a distal end into a femoral artery, wherein said multichannel catheter comprises:
• a first channel extending substantially the length of the catheter, the first channel comprising a major portion of the available channel volume of the catheter, the first channel being closed at the distal end of said catheter and being defined by the wall of the catheter;
• a second channel extending substantially the length of the catheter parallel to said first channel but independent thereof and being integrated into the wall of the first channel;
• a third channel extending substantially the length of said catheter parallel to said first and second channels but independent thereof, the third channel comprising, in combination with the second channel, a minor portion of the available channel volume of the catheter, the third channel being integrated into the wall of the first channel and spaced from said second channel;
• a plurality of openings near the distal end of said catheter in communication only with said first channel;
• at least one opening at the distal end of the catheter communicating with said second channel;
• an inflatable means integrated into the distal end of the catheter between said first channel openings and said second channel opening and communicating with said third channel through an opening in the wall of the catheter;
• positioning said multichannel catheter within the subject's blood circulatory system such that the distal end of said catheter is positioned in the ascending aorta such that the first channel openings are located upstream of the inflatable means and proximate the great arteries, the inflatable means being located on the cephalid side of the aortic valve and the distal end of the second channel is located downstream of the inflatable means and proximate the aortic valve;
• providing a source of oxygenated blood from the cardiopulmonary machine to the proximal end of said first channel;
• providing a source of biologically active fluid to the proximal end of said second channel;
• providing a source of fluid for inflating said inflatable means to the proximal end of said third channel;
• inflating said inflatable means to block the flow of blood to the heart;
• optionally pumping cardioplegia solution into the heart to arrest the mammal's heart;
• pumping oxygen-rich blood through the first channel out the first channel openings at rate sufficient to maintain the subject's metabolism and perfusion;
• removing oxygen depleted blood from the mammal's vena cavae regions through the femoral vein cannula by applying a negative pressure using the centrifugal pump;
• performing cardiovascular surgery as needed;
• and
• maintaining the circulatory support for said subject as needed.

In a method for performing cardiovascular surgery on a patient using a cardiopulmonary machine for extracorporeal circulation of blood, the improvement that comprises using a single, multichannel catheter for the extracorporeal circulation wherein the multichannel catheter comprises:

• at least three independent channels and an expandable balloon at the distal end of the catheter;
• a first, largest channel of a size to allow delivery of an amount of blood to the patient that is sufficient to support the patient metabolism and perfusion throughout the surgery;
• a second channel, smaller than the first channel and integrated into the wall of the fist channel, said second channel suitable for delivering cardioplegia solution to the heart and venting the left heart;
• and
• a third channel also smaller than the first channel and integrated into the wall of the first channel, said third channel being suitable for delivery of a fluid to the balloon for its expansion when positioned in the ascending aorta to occlude the flow of blood.

A method of delivering a biologically active agent to a subject in need thereof, which method comprises administering the agent using a single, multichannel catheter for the extracorporeal circulation wherein the multichannel catheter comprises:

• at least three independent channels and an expandable balloon at the distal end of the catheter,
• a first, largest channel of a size to allow delivery of an amount of blood to the patient that is sufficient to support the patient metabolism and perfusion throughout the surgery;
• a second channel, smaller than the first channel and integrated into the wall of the first channel, said second channel being suitable for delivering cardioplegia solution to the heart and venting the left heart;
• and
• a third channel also smaller than the first channel and integrated into the all of the first channels, said third channel being suitable for delivery of a fluid to the balloon for its expansion when positioned in the ascending aorta to occlude the flow of blood.