Method for delivering a fluid to the coronary ostia

• US 6,913,601 B2
• Filed: 05/22/2001
• Issued: 07/05/2005
• Est. Priority Date: 12/07/1994
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Boyd, Stephen W., Adams, Craig L., Mueller, Richard L. Jr., Stevens, John H., Peters, William S., Evard, Philip C., St. Goar, Frederick G.
• Primary Examiner(s): Hayes, Michael J.
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US09/863,135
• Publication Number:
  US 20010023334A1
• Time in Patent Office: 1,505 Days
• Field of Search: 604/96.01, 604/264, 604/523, 604/113, 604/4.01, 604/6.14, 604/101.01, 604/101.02, 604/101.04, 604/101.05, 604/102.03, 604/500, 604506-510, 604/6.13, 606/194, 606/192, 128/772, 128/898, 600/18
• US Class Current: 604/509
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2018/00232 having an irregular shape
• CPC Class Codes: A61B 2018/00261 arranged in a line
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/0078 for fluid inflow from the body into the catheter lumen
• CPC Class Codes: A61M 2025/0087 Multiple injection needles protruding laterally from the distal tip
• CPC Class Codes: A61M 2025/028 having a mainly rigid support structure
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2025/1077 having a system for expelling the air out of the balloon before inflation and use
• CPC Class Codes: A61M 2202/047 cardioplegic
• CPC Class Codes: A61M 2205/11 with means for preventing cross-contamination when used for multiple patients
• CPC Class Codes: A61M 2205/366 by liquid heat exchangers
• CPC Class Codes: A61M 2210/125 : Heart
• CPC Class Codes: A61M 25/0041 : pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/005 : with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0068 : Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/008 : Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/01 : Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0125 : Catheters carried by the bloodstream, e.g. with parachutes; Balloon catheters specially designed for this purpose
• CPC Class Codes: A61M 25/0662 : Guide tubes
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

A catheter system is provided for accessing the coronary ostia transluminally from a peripheral arterial access site, such as the femoral artery, and for inducing cardioplegic arrest by direct infusion of cardioplegic solution into the coronary arteries. In a first embodiment, the catheter system is in the form of a single perfusion catheter with multiple distal branches for engaging the coronary ostia. In a second embodiment, multiple perfusion catheters are delivered to the coronary ostia through a single arterial cannula. In a third embodiment, multiple perfusion catheters are delivered to the coronary ostia through a single guiding catheter. In a fourth embodiment, multiple catheters are delivered to the coronary ostia through a single guiding catheter which has distal exit ports that are arranged to direct the perfusion catheters into the coronary ostia. In each embodiment, the catheters are equipped with an occlusion means at the distal end of the catheter for closing the coronary ostia and isolating the coronary arteries from the systemic blood flow. The occlusion means can take the form of an inflatable occlusion balloon cuff, a tapered occlusion device or an O-ring encircling the distal end of the catheter. An optional ventricular venting catheter can be included in the system for venting blood and fluids from the left ventricle of the heart. The catheter system is combined with a femoral-to-femoral cardiopulmonary bypass system to provide a system for cardioplegic arrest and total cardiopulmonary support during minimally invasive cardiac surgical procedures.

Claims

1. A method of delivering a fluid to the heart of a patient, the heart having a coronary vasculature, comprising the steps of:

introducing at least one distal end of at least one perfusion catheter into a peripheral artery of the patient;

advancing the distal end of the perfusion catheter from the peripheral artery into at least one coronary ostium communicating with the coronary vasculature of the patient;

occluding the coronary ostium with an occlusion device;

delivering a fluid to the heart through a lumen of the perfusion catheter; and

maintaining systemic circulation of the patient with peripheral cardiopulmonary bypass.

2. The method of claim 1, wherein the maintaining step comprises:

positioning an arterial cannula in a peripheral artery of the patient;

positioning a venous cannula in a peripheral vein of the patient;

withdrawing venous blood from the patient through a blood flow lumen in the venous cannula; and

infusing oxygenated blood into the patient through an infusion lumen in the arterial cannula.

3. A method of delivering a fluid to the heart of a patient, the heart having a coronary vasculature, comprising the steps of:

introducing at least one distal end of at least one perfusion catheter into a peripheral artery of the patient;

advancing the distal end of the perfusion catheter from the peripheral artery into at least one coronary ostium communicating with the coronary vasculature of the patient;

occluding the coronary ostium with an occlusion device;

delivering a fluid to the heart through a lumen of the perfusion catheter;

introducing a second distal end of the perfusion catheter through an aortic valve of the heart of the patient; and

venting a left ventricle of the heart by withdrawing fluid through a venting lumen communicating with the second distal end of the perfusion catheter.

4. A method of delivering a fluid to the heart of a patient, the heart having a coronary vasculature, comprising the steps of:

introducing a single perfusion catheter having at least two distal ends into the peripheral artery of the patient;

advancing the at least two distal ends into at least two coronary ostia;

occluding each of the at least two coronary ostia with an occlusion device proximate each of the at least two distal ends, respectively; and

delivering a fluid through at least one lumen communicating with the at least two distal ends of the perfusion catheter into the coronary vasculature downstream of the occlusion devices.

5. The method of claim 4, further comprising the steps of:

introducing a third distal end of the perfusion catheter through an aortic valve of the heart of the patient;

venting a left ventricle of the heart by withdrawing fluid through a venting lumen communicating with the third distal end of the catheter.

6. The method of claim 4, wherein the delivering step comprises delivering the fluid through at least two lumina communicating with the distal ends of the at least two perfusion catheters, respectively, into the coronary vasculature downstream of the at least two occlusion devices.

7. The method of claim 6, further comprising the steps of:

introducing a distal end of a venting catheter through an aortic valve of the heart of the patient; and

venting a left ventricle of the heart by withdrawing fluid through a venting lumen communicating with the distal end of the venting catheter.

8. The method of claim 6, wherein the introducing step comprises the steps of:

introducing a guide catheter having at least one internal lumen into the peripheral artery of the patient; and

introducing the distal ends of the at least two perfusion catheters through the at least one internal lumen of the guide catheter.

9. The method of claim 6, wherein the introducing step comprises the steps of:

introducing a guide catheter having at least two internal lumina into the peripheral artery of the patient; and

introducing the distal end of a first perfusion catheter through a first internal lumen in the guide catheter, and introducing the distal end of a second perfusion catheter through a second internal lumen in the guide catheter.

10. A method of delivering a fluid to the heart of a patient, the heart having a coronary vasculature, comprising the steps of:

a) introducing at least one distal end of at least one perfusion catheter into a peripheral artery of said the patient;

b) advancing the said distal end of the said perfusion catheter from the said peripheral artery into at least one coronary ostium communicating with the said coronary vasculature of the said patient;

c) occluding the said coronary ostium with an occlusion device;

d) infusing a cardioplegic agent through a lumen of the perfusion catheter into the coronary vasculature downstream of the occlusion device; and

e) performing coronary artery bypass graft surgery on the heart of the patient.

11. A method of delivering a fluid to the heart of a patient, the heart having a coronary vasculature, comprising the steps of:

a) introducing at least one distal end of at least one perfusion catheter into a peripheral artery of said the patient;

b) advancing the said distal end of the said perfusion catheter from the said peripheral artery into at least one coronary ostium communicating with the said coronary vasculature of the said patient;

c) occluding the said coronary ostium with an occlusion device;

d) infusing a cardioplegic agent through a lumen of the perfusion catheter into the coronary vasculature downstream of the occlusion device; and

e) introducing a distal end of a venting catheter through an aortic valve of the heart of the patient and venting a left ventricle of the heart by withdrawing fluid through a venting lumen communicating with the distal end of the venting catheter.