Endovascular system for arresting the heart

• US 6,913,600 B2
• Filed: 09/25/1998
• Issued: 07/05/2005
• Est. Priority Date: 07/16/1991
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Snow, David W., Valley, Kirsten L., Fan, Sylvia W., Mueller, Richard J. Jr., Corvi, Timothy C., Gifford, Hanson S. III, Roth, Alex T., Peters, William S., Boyd, Stephen W., Donlon, Brian S.
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US09/161,109
• Publication Number:
  US 20010016725A1
• Time in Patent Office: 2,475 Days
• Field of Search: 604/101, 604/915, 604/916, 604507-509, 604/96.01, 606/192, 606/194
• US Class Current: 604/96.01
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/06061 Holders for needles or sutures, e.g. racks, stands hand-held holding instruments A61B17/0483; holders for articles A61B50/20; racks for syringes or for hypodermic or infusion needles A61M5/008
• CPC Class Codes: A61B 17/2909 Handles
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/0243 for immobilizing local areas of the heart, e.g. while it beats
• CPC Class Codes: A61B 2017/047 having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0474 Knot pushers
• CPC Class Codes: A61B 2017/0475 using sutures having a slip knot
• CPC Class Codes: A61B 2017/2943 Toothed members, e.g. rack and pinion
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/3405 using mechanical guide means
• CPC Class Codes: A61B 2017/3492 against the outside of the body
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00232 having an irregular shape
• CPC Class Codes: A61B 2018/00261 : arranged in a line
• CPC Class Codes: A61B 2018/00291 : using suction
• CPC Class Codes: A61B 2018/00363 : Epicardium
• CPC Class Codes: A61B 2018/00392 : Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00577 : Ablation
• CPC Class Codes: A61B 2090/064 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/306 : using optical fibres
• CPC Class Codes: A61B 90/50 : Supports for surgical instruments, e.g. articulated arms
• 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 1/3621 : Extra-corporeal blood circuits single-needle circuits A61M1/30
• 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 2025/0002 : with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0004 : having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0031 : characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0046 : Coatings for improving slidability
• 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 2025/105 : having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1059 : having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties
• 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 2205/3344 : Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3355 : Controlling downstream pump pressure
• 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 25/0023 : by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0028 : characterized by features relating to at least one lumen located at the proximal part of the catheter, e.g. alterations in lumen shape or valves catheter hubs A61M25/0097
• 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 25/0054 : with regions for increasing flexibility
• 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 25/0155 : with hydraulic or pneumatic means, e.g. balloons or inflatable compartments
• 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
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 25/1029 : Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/1034 : Joining of shaft and balloon
• CPC Class Codes: A61M 25/1038 : Wrapping or folding devices for use with balloon catheters
• CPC Class Codes: A61M 39/0247 : Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053

Abstract

Devices and methods are provided for temporarily inducing cardioplegic arrest in the heart of a patient and for establishing cardiopulmonary bypass in order to facilitate surgical procedures on the heart and its related blood vessels. Specifically, a catheter based system is provided for isolating the heart and coronary blood vessels of a patient from the remainder of the arterial system and for infusing a cardioplegic agent into the patient'"'"'s coronary arteries to induce cardioplegic arrest in the heart. The system includes an endoaortic partitioning catheter having an expandable balloon at its distal end which is expanded within the ascending aorta to occlude the aortic lumen between the coronary ostia and the brachiocephalic artery. Means for centering the catheter tip within the ascending aorta include specially curved shaft configurations, eccentric or shaped occlusion balloons and a steerable catheter tip, which may be used separately or in combination. The shaft of the catheter may have a coaxial or multilumen construction. The catheter may further include piezoelectric pressure transducers at the distal tip of the catheter and within the occlusion balloon. Means to facilitate nonfluoroscopic placement of the catheter include fiberoptic transillumination of the aorta and a secondary balloon at the distal tip of the catheter for atraumatically contacting the aortic valve. The system further includes a dual purpose arterial bypass cannula and introducer sheath for introducing the catheter into a peripheral artery of the patient.

Claims

1. A method of positioning a catheter in a patient'"'"'s ascending aorta between the palent'"'"'s coronary ostia and the patient'"'"'s brachiocephalic artery, comprising:

introducing a distal end of a shaft of an aortic catheter into a blood vessel downstream of the patient'"'"'s ascending aorta, the shaft comprising an inner tubular member within an outer tubular member, the inner tubular member extending at least to the distal end of the outer tubular member;

transluminally positioning the shaft so that the distal end of the shaft is in the ascending aorta and an expandable occluding member attached to the shaft near the distal end is disposed between the coronary ostia and the brachiocephalic artery;

expanding the occluding member within the ascending aorta to prevent migration of the occluding member into the aortic root by passing an inflation fluid through a flow passage formed by the inner tubular member and the outer tubular member; and

measuring pressure within the expandable occluding member with a pressure transducer within the expandable occluding member.

2. The method of claim 1 wherein the step of introducing the distal end of the shaft into a blood vessel is preceded by the step of withdrawing the outer tubular member proximally with respect to the inner tubular member to reduce the profile of the occluding member on the shaft of the aortic partitioning device.

3. The method of claim 1 wherein the step of introducing the distal end of the shaft into a blood vessel is preceded by the step of rotating the outer tubular member with respect to the inner tubular member to reduce the profile of the occluding member on the shaft of the aortic partitioning device.

4. The method of claim 1, wherein the expanding step comprises expanding the occluding member such that the passage of debris generated during a cardiovascular procedure is precluded by the occluding member.

5. The method of claim 1, wherein the expanding step comprises expanding the occluding member to a pressure sufficient to substantially prevent blood from passing by the occluding member and into the aortic root.

6. The method of claim 1, wherein the expanding step comprises expanding the occluding member to a pressure sufficient to block blood flow between the coronary ostia and the brachiocephalic artery.

7. A method of positioning a catheter in a patient'"'"'s ascending aorta between the patient'"'"'s coronary ostia and the patient'"'"'s brachiocephalic artery,

introducing a distal end of a shaft of an aortic catheter into a blood vessel downstream of the patient'"'"'s ascending aorta, the shaft comprising an inner tubular member within an outer tubular member;

transluminally positioning the shaft so that the distal end of the shaft is in the ascending aorta and an expandable occluding member, having a distal end attached to the inner tubular member and a proximal end attached to the outer tubular member, is disposed between the coronary ostia and the brachiocephalic artery;

expanding the occluding member within the ascending aorta to block blood flow therethrough by passing an inflation fluid through a flow passage between the inner tubular member and the outer tubular member; and

measuring pressure within the expandable occluding member with a pressure transducer within the expandable occluding member.

8. A method of positioning a catheter in a patient'"'"'s ascending aorta between the patient'"'"'s coronary ostia and the patient'"'"'s brachiocephalic artery:

providing an aortic catheter having a shaft comprising an inner tubular member within an outer tubular member and an expandable occluding member attached to the shaft near the distal end thereof;

withdrawing the outer tubular member proximally with respect to the inner tubular member to reduce the profile of the occluding member on the shaft of the aortic catheter;

introducing the distal end of the shaft into a blood vessel downstream of the patient'"'"'s ascending aorta;

transluminally positioning the shaft so that the distal end of the shaft is in the ascending aorta and the expandable occluding member is disposed between the coronary ostia and the brachiocephalic artery; and

expanding the occluding member within the ascending aorta to block blood flow therethrough.

9. A method of positioning a catheter in a patient'"'"'s ascending aorta between the patient'"'"'s coronary ostia and the patient'"'"'s brachiocephalic artery, comprising:

introducing a distal end of a shaft of an aortic catheter into a blood vessel downstream of the patient'"'"'s ascending aorta, the shaft comprising an inner tubular member within an outer tubular member, the inner tubular member extending at least to the distal end of the outer tubular member;

transluminally positioning the shaft so that the distal end of the shaft is in the ascending aorta and an expandable occluding member attached to the shaft near the distal end is disposed between the coronary ostia and the brachiocephalic artery;

expanding the occluding member within the ascending aorta to prevent migration of the occluding member into the aortic root; and

measuring pressure within the occluding member with a pressure transducer positioned within the occluding member.

10. A method of positioning a catheter in a patient'"'"'s ascending aorta between the patient'"'"'s coronary ostia and the patient'"'"'s coronary ostia and the patient'"'"'s brachiocephalic artery, comprising:

introducing a distal end of a shaft of an aortic catheter into a blood vessel downstream of the patient'"'"'s ascending aorta, the shaft comprising an inner tubular member within an outer tubular member, the inner tubular member extending at least to the distal end of the outer tubular member;

rotating the outer tubular member with respect to the inner tubular member to reduce the profile of an expandable occluding member on the shaft of the aortic partitioning device;

transluminally positioning the shaft so that the distal end of the shaft is in the ascending aorta and the expandable occluding member attached to the shaft near the distal end is disposed between the coronary ostia and the brachiocephalic artery; and

expanding the occluding member within the ascending aorta to prevent migration of the occluding member into the aortic root.