System for cardiac procedures

• US 5,868,702 A
• Filed: 03/17/1997
• Issued: 02/09/1999
• Est. Priority Date: 07/16/1991
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Machold, Timothy R., Gifford, Hanson S. III, Stevens, John H., Sterman, Wesley D.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): AT, Hguyen
• Application Number:
  US08/819,455
• Time in Patent Office: 694 Days
• Field of Search: 604/4, 604/49, 604/53, 604/28, 604/30, 604/96, 606/192, 606/194
• US Class Current: 604/96.01
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/22097 Valve removal in veins
• 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: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2025/0078 for fluid inflow from the body into the catheter lumen
• CPC Class Codes: A61M 2025/015 Details of the distal fixation of the movable mechanical means
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• 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 2025/1052 for temporarily occluding a vessel for isolating a sector
• 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 2025/1095 : with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• 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 2210/127 : Aorta
• CPC Class Codes: A61M 25/0032 : characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• 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 25/0125 : Catheters carried by the bloodstream, e.g. with parachutes; Balloon catheters specially designed for this purpose
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0152 : with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• 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 system for accessing a patient'"'"'s cardiac anatomy which includes an endovascular aortic partitioning device that separates the coronary arteries and the heart from the rest of the patient'"'"'s arterial system. The endovascular device for partitioning a patient'"'"'s ascending aorta comprises a flexible shaft having a distal end, a proximal end, and a first inner lumen therebetween with an opening at the distal end. The shaft may have a preshaped distal portion with a curvature generally corresponding to the curvature of the patient'"'"'s aortic arch. An expandable means, e.g., a balloon, is disposed near the distal end of the shaft proximal to the opening in the first inner lumen for occluding the ascending aorta so as to block substantially all blood flow therethrough for a plurality of cardiac cycles, while the patient is supported by cardiopulmonary bypass. The endovascular aortic partitioning device may be coupled to an arterial bypass cannula for delivering oxygenated blood to the patient'"'"'s arterial system. The heart muscle or myocardium is paralyzed by the retrograde delivery of a cardioplegic fluid to the myocardium through patient'"'"'s coronary sinus and coronary veins, or by antegrade delivery of cardioplegic fluid through a lumen in the endovascular aortic partitioning device to infuse cardioplegic fluid into the coronary arteries. The pulmonary trunk may be vented by withdrawing liquid from the trunk through an inner lumen of an elongated catheter. The cardiac accessing system is particularly suitable for removing the aortic valve and replacing the removed valve with a prosthetic valve.

Claims

1. A method of arresting a patient'"'"'s heart and establishing cardiopulmonary bypass, the method comprising the steps of:

positioning a bypass cannula in a patient'"'"'s artery through an arterial penetration, the bypass cannula having a lumen;

introducing a distal end of a catheter shaft through the lumen of the bypass cannula so that a portion of the catheter shaft is coextensive with a portion of the bypass cannula;

transluminally positioning the catheter shaft so that an expandable occluding member attached to the catheter shaft is disposed in the gatient'"'"'s ascending aorta between the coronary ostia and the brachiocephalic artery, the catheter including a lumen having an outlet in fluid communication with the patient'"'"'s aortic root;

infusing oxygenated blood into the patient through the lumen of the bypass cannula in a space between the bypass cannula and catheter shaft, the lumen being sufficiently sized to provide full bypass with the catheter shaft positioned therein;

expanding the occluding member within the ascending aorta to completely block blood flow therethrough; and

paralyzing the patient'"'"'s myocardium.

2. The method of claim 1 wherein the step of paralyzing comprises delivering cardioplegic fluid through the lumen in the catheter shaft into the ascending aorta.

3. The method of claim 1 wherein the bypass cannula is first positioned in the patient'"'"'s artery and the catheter shaft is slidably inserted through the lumen of the bypass cannula and into the patient'"'"'s artery.

4. The method of claim 2 further comprising the steps of:

withdrawing blood from a venous location in the patient, oxygenating the blood, and delivering the oxygenated blood to the lumen in the bypass cannula.

5. The method of claim 4 wherein the step of withdrawing blood comprises receiving blood from a lumen in a venous cannula positioned in a vein of the patient.

6. The method of claim 5 further comprising the steps of:

positioning a vent catheter in a vein so that the vent catheter extends through the patient'"'"'s tricuspid and pulmonary valves; and

withdrawing blood through a lumen in the vent catheter.

7. The method of claim 6 wherein the vent catheter is slidably inserted through a lumen in the venous cannula.

8. The method of claim 5 wherein the vein comprises a femoral vein on a first side of the patient.

9. The method of claim 8 wherein the artery comprises a femoral artery on the first side of the patient.

10. The method of claim 1 wherein the artery comprises a femoral artery.

11. The method of claim 1 wherein the occluding member comprises an inflatable balloon having an interior for receiving an inflation fluid, the step of expanding comprising delivering an inflation fluid to the interior of the balloon through an inflation lumen in the catheter shaft.

12. The method of claim 1 wherein oxygenated blood is infused into the artery at a rate of at least about 4 liters/minute at a pressure of less than about 250 mmHg.

13. A method of occluding a patient'"'"'s ascending aorta and delivering a fluid to the patient'"'"'s ascending aorta, comprising the steps of providing an arterial return member having a lumen and an opening fluidly coupled to the lumen;

inserting the arterial return member into a patient'"'"'s artery;

passing a catheter through the lumen of the arterial return member, the catheter having an occluding member and a lumen, the occluding member having a collapsed shape and an expanded shape, the lumen having an outlet;

coupling the lumen of the arterial return member to a bypass system which provides oxygenated blood;

delivering the oxygenated blood to the patient through the lumen of the arterial return member with the catheter extending through the lumen, the oxygenated blood passing through a space between the arterial return member and the catheter, the lumen of the arterial return member being sufficiently sized to provide full cardiopulmonary bypass with the catheter positioned therein;

positioning the occluding member in the patient'"'"'s ascending aorta;

expanding the occluding member after the positioning step so that the patient'"'"'s ascending aorta is occluded by the occluding member; and

arresting the patient'"'"'s heart by introducing a cardioplegic fluid into the patient'"'"'s ascending aorta through the catheter lumen and the outlet.

14. The method of claim 13, wherein:

the providing step is carried out with the arterial return member including a plurality of openings in fluid communication with the lumen.

15. The method of claim 13, wherein:

the providing step is carried out with the catheter having a circular, external cross-sectional shape and the lumen of the arterial return member having a cylindrical portion.

16. The method of claim 13, wherein:

the passing step is carried out with the arterial return member at least partially surrounding the catheter, a blood flow path being at least partially defined by a space between the catheter and the arterial return member.

17. The method of claim 13, wherein:

the providing step is carried out with the arterial return member having a substantially circular cross-sectional shape and a diameter in a range of about 6 mm to about 10 mm.

18. The method of claim 13, wherein:

the providing step is carried out with the catheter having a substantially circular cross-sectional shape and a diameter in a range of about 2 mm to about 5 mm.