Method of perfusing the coronary vasculature

• US 5,807,318 A
• Filed: 03/12/1996
• Issued: 09/15/1998
• Est. Priority Date: 07/28/1994
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Peters, William S., Boyd, Stephen W., Stevens, John H., Evard, Philip C., St. Goar, Frederick G., Adams, Craig L., Mueller, Richard L. Jr.
• Primary Examiner(s): Mendez, Manuel
• Application Number:
  US08/615,152
• Time in Patent Office: 917 Days
• Field of Search: 604/96, 604/101, 604/4, 604/52, 604/53, 604/264, 604/280, 604/113, 604/51, 606/194, 606/192, 128/772, 600/18
• US Class Current: 604/508
• 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 inducing cardioplegic arrest in a 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 patient;

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

c) occluding said coronary ostium of the coronary artery with an occlusion device mounted to said perfusion catheter;

d) arresting the heart.

2. The method of claim 1, wherein step d) comprises the substep of infusing a cardioplegic agent through a lumen of said perfusion catheter into said coronary vasculature downstream of said occlusion device.

3. The method of claim 2 wherein said cardioplegic agent is infused through said lumen of said perfusion catheter at a rate of at least approximately 100 ml/min at a pump pressure not exceeding 350 mmHg.

4. The method of claim 1, wherein step d) comprises the substep of infusing a mixture of oxygenated blood and a cardioplegic agent through a lumen of said perfusion catheter into said coronary vasculature downstream of said occlusion device at a rate of at least approximately 100 ml/min at a pump pressure not exceeding 350 mmHg.

5. The method of claim 1, further comprising the step of:

e) isolating said coronary vasculature from systemic circulation of said patient by continuing to occlude said coronary ostium with said occlusion device while the heart is arrested.

6. The method of claim 5, further comprising the step of:

f) maintaining systemic circulation of said patient with peripheral cardiopulmonary bypass.

7. The method of claim 6, wherein step f) comprises:

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

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

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

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

8. The method of claim 1, further comprising the steps of:

g) introducing a venting lumen through an aortic valve of said heart of said patient;

h) venting a left ventricle of said heart by withdrawing fluid through the venting lumen.

9. The method of claim 1, wherein step a) comprises introducing a single perfusion catheter having at least two distal ends into said peripheral artery of said patient;

step b) comprises advancing said at least two distal ends into at least two coronary ostia;

step c) comprises occluding each of said at least two coronary ostia with an occlusion device proximate each of said at least two distal ends, respectively; and

step d) comprises infusing a cardioplegic agent through at least one lumen communicating with said at least two distal ends of said perfusion catheter into said coronary vasculature downstream of said occlusion devices.

10. The method of claim 9, further comprising the steps of:

g) introducing a third distal end of said perfusion catheter through an aortic valve of said heart of said patient;

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

11. The method of claim 1, wherein step a) comprises introducing the distal ends of at least two perfusion catheters into said peripheral artery of said patient;

step b) comprises advancing said distal ends of said at least two perfusion catheters into at least two coronary ostia;

step c) comprises occluding each of said at least two coronary ostia with an occlusion device proximate each of said distal ends of said at least two perfusion catheters, respectively; and

step d) comprises infusing a cardioplegic agent through at least two lumina communicating with said distal ends of said at least two perfusion catheters, respectively, into said coronary vasculature downstream of said at least two occlusion devices.

12. The method of claim 11, further comprising the steps of:

g) introducing a distal end of a venting catheter through an aortic valve of said heart of said patient;

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

13. The method of claim 1, wherein step c) comprises inflating an inflatable occlusion device to occlude said coronary ostium.

14. The method of claim 1, wherein step a) comprises the substeps of:

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

introducing said at least one distal end of said at least one perfusion catheter through said at least one internal lumen of said guide catheter.

15. The method of claim 11, wherein step a) comprises the substeps of:

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

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

16. The method of claim 11, wherein step a) comprises the substeps of:

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

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

18. The method of claim 1, further comprising the step of:

infusing oxygenated blood into the patient through an arterial cannula; and

the inserting step is carried out by passing the at least one perfusion catheter through the arterial cannula;

the advancing step being carried out with the at least one perfusion catheter being slidably moved relative to the arterial cannula.

20. The method of claim 1, wherein step d) comprises infusing a cold fluid containing a cardioplegic agent into said coronary vasculature through said first lumen in a greater quantity than the quantity of fluid withdrawn from said coronary vasculature through said second lumen in step e), whereby at least some of said cold fluid containing a cardioplegic agent is forced to flow through said coronary vasculature.

17. The method of claim l further comprising the step of:

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

19. A method of cooling myocardial tissue in a heart of a patient, the heart having a coronary vasculature, comprising the steps of:

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

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

c) occluding said coronary ostium of the coronary artery with an occlusion device mounted to the at least one catheter;

d) infusing a cold fluid into said coronary vasculature through a first lumen;

e) withdrawing fluid from said coronary vasculature through a second lumen.